EPIDEMIOLOGY

A MANUAL FOR SOUTH AFRICA

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G Joubert
SS Abdool Karim
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OREGON HEALTH SCIENCES UNIVERSITY
LIBRARY
SEP 24 1999
PORTLAND, OREGON
 ) Epidemiology :
A manual for South Africa

Editedby JM Katzenellenbogen
G Joubert
SS Abdool Karim

Cape Town
OXFORD UNIVERSITY PRESS
SOUTHERN AFRICA
Ugo
Oxford University Press Walton Street, Oxford ox2 6 pp, United Kingdom

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Epidemiology: A Manual for South Africa

ISBN 0 19 571308 7
First published 1991 by the Medical Research Council as
Introductory Manual for Epidemiology edited by J M
Katzenellenbogen, G Joubert, and D Yach. This expanded edition
first published 1997
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 contents

List of contributors
Acknowledgements
How to use this book
Foreword
Preface

Section A Contextualizing epidemiology

Introduction
N Key concepts in epidemiology 10
General philosophical issues in epidemiology 25

Section B Epidemiological research methods and

protocol development
Planning a research project 49
Literature review 94
Setting objectives for research 56
Study design 64
Sampling 74
Data collection and measurement 82
Other issues
Seaman
oua to consider in the protocol 95

Section C Data presentation, analysis, and interpretation

11 An introduction to data presentation, analysis,
and interpretation 101
12 Integrating epidemiological concepts 124
Section D Common approaches in epidemiology
13 The use of routinely available data in
epidemiological studies 133
14 Disease surveillance 140
15 Health systems research (HSR) 147
16 Rapid epidemiological assessment 158
17 Community studies 164
18 Knowledge, attitude, belief, and practice
(KABP) surveys 169
19 Qualitative methodology: an introduction 176

Section E Epidemiology applied to content areas

20 Mortality studies 187
21 Outbreak investigations 196
22 Estimating immunization coverage 205
23 Environmental epidemiology 211
24 Occupational epidemiology 218
25 Disability studies 224
26 Psychiatric epidemiology 230
27 Anthropometric studies 243
28 Assessment of dietary intake 248
29 Measurements in dental epidemiology 254
30 Health economics 261

APPENDIX 1: Standardization (adjustment) of rates 213

APPENDIX 2: Standardization of observers and
instruments Zee
APPENDIX 3: Derivation of the 30 x 7 EPI sample 243
APPENDIX 4: Random number table 276
Bibliography Zot
Index 289
 list of contributors
Max Bachmann, MB BCh, DOH, MSc, FFCH,
Department of Community Health, University of
Cape Town
Donald Berry, ms Bch, University of the
Witwatersrand
David Bourne, Bsc, B Phil, Department of
Community Health, University of Cape Town
Debbie Bradshaw, Bsc (Hons), MSc, D Phil,
CERSA, Medical Research Council
David Coetzee, BA, MB BCh, DTM&H, DPH, FFCH,
Department of Community Health, University of
the Witwatersrand
Nicol Coetzee, MB BCh, FFCH (SA), DIM&H, DA,
Department of Community Health, University of
Cape Town
Judy M Dick, Ba, B Soc Sc, MSc Med, PhD, National
Programme for TB Research, Medical Research
Council
Athmanundh Dilraj, Bsc, BSc (Hons), M Med Sc,
CERSA, Medical Research Council
John S S Gear, BSc, MB BCh, DTM&H, DPH, D Phil, FCP,
Wits Rural Faculty, University of the
- Witwatersrand
Margaret N Hoffman, MB BCh, BSc (Hons),
Department of Community Health, University of
Cape Town
CarelB IJsselmuiden, MD, FFCH, MPH, DPH, DTM&H,
Department of Community Health, University of
Pretoria, CERSA, Medical Research Council
Georgina Joubert, Ba, MSc, Department of
Biostatistics, University of the Orange Free State
Salim S Abdool Karim, MB BCh, MSc, Dip Data, FFCH,
M Med, CERSA, Medical Research Council
Judith M Katzenellenbogen, Bsc, BSc (Hons), MSc,
CERSA, Medical Research Council
Louise Kuhn, MA, MPH, PhD, Gertrude H Sergievsky
Center, Columbia University, New York
Marietjie L Langenhoven, Msc, National Research
Programme for Nutritional Intervention, Medical
Research Council
Catherine Mathews, msc, CERSA, Medical
Research Council, Department of Community
Health, University of Cape Town
Dale McMurchy, ma, Health Economics Unit,
Department of Community Health, University of
Cape Town
Carol A Metcalf, mB BCh, BSc (Hons), MPH, Department
of Epidemiology and Human Papillomavirus
Research Group, University of Washington, Seattle
Mohamed H Moola, BDs, LDSRCS, DDPH, MSc,
Faculty of Dentistry, University of the Western
Cape
Jonathan E Myers, Bsc, MB BCh, DIM&H, MD,
Department of Community Health, University of
Cape Town
Charles D H Parry, B Soc Sci, BSc Hons, MSc, MA, PhD,
National Urbanisation & Health Research
Programme, Medical Research Council
Linda M Richter, php, CERSA, Medical Research
Council
Leslie Swartz, MSc, PhD, Child Guidance Clinic,
Cape Town
Donald H Skinner, B Bus Sc, B Soc Sc (Hons), MA,
Trauma Centre for Victims of Violence & Torture
’ Elmar Thomas, MB BCh, B Soc Sc (Hons), MA,
Department of Medical Anthropology, University
of California, Berkeley
Stephen M Tollman, Bsc, MB BCh, MA, MPH, Health
Systems Development Unit, Department of
Community Health, University of the
Witwatersrand
Yasmin E R von Schirnding, BSc, BSc (Hons), MSc,
PhD, Greater Johannesburg Transitional
Metropolitan Council, Department of
Environmental Health, Johannesburg
Hester van der Walt, Dip Nursing, Midwifery,
Paediatric Nursing, Community Health, mea,
CERSA, Medical Research Council
Petro Wolmarans, Msc, National Research
Programme for Nutritional Intervention, Medical
Research Council
Derek Yach, MBBCh, BSc (Hons), MPH, Policy Advisory
Coordinating Team, World Health Organization
Merrick Zwarenstein, MB BCh, MSc(Med), MSc,
Health Systems Division, CERSA, Medical
Research Council
acknowledgements
We acknowledge the substantial contribution of
Derek Yach both as co-editor of the 1991 edition
of the Introductory Manual for Epidemiology in
Southern Africa, as well as for conceptualizing the
idea of producing such a manual.
We thank Neil Cameron, Margaret Hoffman, and
Marian Jacobs for contributing to the epidemiologi-
cal manual used in the 1987 workshop at the annual
Epidemiological Society of Southern Africa con-
ference; Debbie Bradshaw, Yusuf Chikte, Nicol
Coetzee, Di Cooper, Rudi Eggers, Margaret Hoffman,
Sarie Human, Rod Jackson, Marian Jacobs, Trefor
Jenkins, Neil Myburgh, Sue Naidoo, David Rees,
Robert Schall, Donald Skinner, Malcolm Steinberg,
Krisela Steyn, Mary Lou Thompson, and Ruth
Watson for reviewing parts of the manual, Tryphina
Masuku, Amelia Mulder, Wynda van Eyssen, and
Nazneen Ally for typing, administration, and co-
ordination, Jenny Altschuler and Sharoni Cohen for
selected graphics, Helen Moffett for her valuable
editorial contribution and guidance, and finally the
many students who attended our various basic
epidemiology courses and urged us to produce this
book.
Copyright acknowledgements can be found on
p. 288.
This book was made possible by the financial
support of the Medical Research Council.
MEDICAL RESEARCH COUNCIL
CERSA
how to use this book
This book is divided into sections, each of which
addresses a particular aspect of epidemiology.
Sections A, B, and C explain the theory and
principles of epidemiology. Here the basic
abstract ideas and skills of epidemiology are
described in a way that is designed to be clear and
accessible not only to medical students and
professionals, but also to others who are interest-
ed in epidemiology. You will need to read all three
of these sections, preferably in order, to under-
stand how epidemiology works, and before you
can go on to make full use of Sections D and E.
Sections D and E constitute the ‘applied’ part of
this manual; they show how the theory and prin-
ciples explained in the first three sections can be
applied in different subject areas of health. So
these last two sections demonstrate what
happens when epidemiology is used in specific
disciplines and ‘in the field’. Here you can
browse, choosing to focus on whatever particu-
larly interests you. Or you can look up various
subject areas to get an idea of how epidemiology
can be used in the various disciplines that you
study or practice.
This manual also introduces and explains the
technical terms used in epidemiological study
and practice. The first time that a term appears in
the text, it is defined. If you are browsing and
would like to check the definition of a term, or if
you need to look up a term, turn to the index. The
first page number that is listed for a term will have
the definition of the term (which will be marked
in bold for easy identification) on that page.
The bibliography contains both references and
further reading for those who wish to explore
topics in more detail.
 foreword
‘Catch-up growth’ describes the accelerated
response of a stunted child once the adverse
circumstances that caused the stunting are
removed. This phenomenon serves as a metaphor
for what must happen in the new South Africa ifa
new public health is to break out of the caked and
soiled shell that encased the country in the
apartheid era. While the effects on the population
will be felt for generations to come, much that is
new will have to be done to ensure long-term
good health for all South Africans.
Public health and its basic sciences were among
the fields most starved during the apartheid era.
This impoverishment of South African epidemiol-
ogy and public health must be dealt with in this
new and hopeful era. More than that, it must be
quickly remedied. Public health is a key element if
the historical impoverishment of the whole
society is to be undone. Public health in South
Africa therefore has a mission, which can not be
effectively pursued without rebuilding and
_ deploying the academic disciplines on which the
field must rely.
Epidemiology, according to a recognised defin-
ition, is the study of the distribution and the
determinants of states of health in populations,
with the object of preventing and controlling ill
health. There can be no rational and effective
public health without a foundation of epidemio-
logicai understanding. It is therefore important to
grasp the scope of epidemiological knowledge:
how it is acquired and evaluated, what uncertain-
ties and likelihoods attend it, and how it is tested
and advanced.
A first need is thus to build a new cadre of
epidemiologists. South Africa is fortunate that in
the years since the mid-1980s, as the isolation of
* ** *
the apartheid state began to break down, a
number of gifted young epidemiologists sought
training both within the country and abroad. A
second and simultaneous need is to transmit to
all public health workers the basic elements of the
discipline needed to work in the field. To meet
this need, the new generation of epidemiologists
must spread the knowledge they have acquired
beyond the narrow bounds of those with whom
they can make personal contact. With this book,
they can begin the process.
This book takes an essentially practical
approach that should make it accessible to
professional health workers. It incorporates
substantial applications of epidemiology in the
primary health care arena, reinforcing the fact
that the discipline must make a significant contri-
bution to the planning and evaluation of public
health care programmes. Furthermore, it takes a
step towards raising the level of understanding of
the results of epidemiological studies so central to
policy analysis.
Not only does South Africa need a new cadre of
epidemiologists, but the incorporation of epide-
miology training for every kind of health worker.
This book represents an important beginning in
the education that is essential to create a healthier
South African future.
Mervyn Susser
Editor: American Journal of Public Health
New York
Rachel Gumbi
Chief Director: Human Resources Directorate
Department of Health
Pretoria
preface
Over the last decade and a half, epidemiology has
undergone a sustained resurgence in South Africa.
Increasingly, there has been a recognition of the
need for epidemiology to provide a research base
that can inform policies to transform health in the
country.
Epidemiological skills in South Africa, however,
were few and the Epidemiological Society of
Southern Africa, recognising the broad education-
al needs for the discipline, organised training
workshops both regionally and nationally to
address this need. Workshops, organised in
tandem with annual Epidemiological Conferences,
have been particularly successful and have
reached a wide range of health professionals inter-
ested in epidemiology. The demand for copies and
reprints of the manuals and booklets produced for
participants of these workshops prompted us to
produce a more comprehensive manual which
incorporated aspects of earlier material, but with a
broader epidemiological scope, to coincide with
the 10th Annual Epidemiological Conference held
in Cape Town in July 1991.
A wide range of contributors ably provided the
material for publication and the technical produc-
tion was done by staff of the Medical Research
Council. The manual was launched at the confer-
ence, and complimentary copies were sent to
institutions where epidemiology was being
taught. Lecturers and other users of the manual
were asked to evaluate it.
Increasingly, the manual was being prescribed
for epidemiology courses at universities, nursing
colleges, technikons, and since 1992 at the newly
developing Schools of Public Health. By mid-
1994, the 1 000 copies had run out and the editors
had dispersed geographically. The future of the
manual was uncertain, in spite of an obvious
need for a basic local epidemiological text and the
very positive response by users of the manual.
* K
A chance meeting in August 1994 with a repre-
sentative from Oxford University Press resulted in
the production of a fresh version of the manual.
The new editorial team took note of the criticisms
and comments received from users of the manual.
With the co-operation of the contributors, the text
was revised and extended, and the examples and
information updated to produce a new book. We
are grateful to all the contributors who, despite
their busy schedules, made the effort to improve
their sections or write new sections.
In this book, as with the first manual, we have
aimed to give a comprehensive introduction to
epidemiology, with a specific South African
flavour, using local examples and highlighting
local issues. An effort has been made to further
simplify the language to make the text accessible
to those whose first language is not English. We
have avoided complex formulae as much as
possible, noting that the manual does not replace
a good introductory statistical text. We have dedi-
cated a chapter to qualitative research as well as
citing uses of such research throughout the book
to highlight how both qualitative and quantitative
research are useful and often complementary
tools to investigate public health issues.
This manual targets the community of health
workers — and interested members of the public
— who have little or no experience of epide-
miology. We felt that it was important that this
book meet the needs of all health workers (such as
doctors, nurses, and physiotherapists) who are
starting their first research projects. In order to
meet this need, this book stands as a comprehen-
sive text on epidemiology while retaining a pract-
ical, down-to-earth approach.
Judy Katzenellenbogen
Gina Joubert
Salim Abdool Karim
K *
SECTION A

Contextualizing epidemiology

Introduction
J pay eter negen, JGear, STollman

Key concepts in epidemiology

Causation of disease
J Katzenellenbogen, M Hoffman
Levels of prevention
J Katzenellenbogen, M Hoffman
Measures of the frequency ofhealth evenis _
G Joubert |
Demography
D Bourne, G Joubert
Health indicators
J Katzenellenbogen

General philosophical iissues in

epidemiology
Ethical aspects of epidemiolagical research —
C IJsselmuiden
Community participation
J Katzenellenbogen, C Mathews, H van derWalt
Planning for the implementation of research —
J Dick

When you study epidemiology you will find the
textbooks are full of surprising facts. Do you know
who described the benefits of fresh fruit in the
prevention of scurvy? It was Andrew Lind, an
officer in the British Royal Navy. What has the
Broad Street pump got to do with cholera? It was
the source of contaminated water during
London’s cholera epidemic of the mid-19th
century. John Snow was the man who recognized
the hazard and took the handle off the pump.
Birth and death statistics have been collected for
centuries and recorded in church records. It was
Florence Nightingale in Britain who promoted
their use as a planning tool. Today, birth and mor-
tality data are indicators of changing circum-
stances in countriés and communities, and are
important weapons in the epidemiologist’s fight
against disease.
South Africa too, had its early pioneers who
contributed significantly to the control of disease
through critical observation and analysis. It is
essential to develop these characteristics if you
want to become an epidemiologist. It is like being
a detective; the clues are always there. Your chal-
lenge is first to find them and then to interpret
what they mean.
So what is the essence of epidemiology and
how can it make a difference to people’s health?
To answer these questions we need to start by
considering what research is and why it is done.
Research
Research is the systematic search or inquiry (‘re-
search’) for knowledge. Scientifically acceptable
methods are used to investigate issues in order to
arrive at valid conclusions. Every discipline has its
Introduction
own ‘bag of research tools’ which can be used to
further knowledge in the field.
The research methods and findings have to be
open to scrutiny by others and peer review of
research is an essential aspect of the research
process.
Broadly speaking, there are two types of
research: basic (fundamental) and applied
research. While both types of research lead to the
creation of new knowledge, basic research gener-
ates fundamentally new knowledge and tech-
nologies requiring the involvement of highly spe-
cialized academics from the basic sciences. Basic
scientists are less interested in what can be done
with the new knowledge: they really pursue the
knowledge for its own sake and may spend years
working before their research efforts bear fruit.
Applied research, on the other hand, investigates
current problems, and uses existing knowledge
and technology to address the problems.
In general, knowledge and understanding are
advanced by attempts to formally test a proposed
theory. The way theories/hypotheses have been
tested has changed over time. Ways of establish-
ing causal relationships have been debated
throughout the history of scientific philosophy.
Currently, there are two main schools of thought
on the growth of knowledge. Verificationists
support the concept of new research findings
being confirmed through repeated studies, that
is, new information is accepted when new
research findings are ‘sufficiently’ verified. Falsifi-
cationists, on the other hand, support the con-
cept that all knowledge is provisional until
refuted through research. This means that infor-
mation, like existing knowledge, cannot be
proven conclusively but can become provisional
3
a contextualizing epidemiology
knowledge if repeated attempts to refute it fail.
Knowledge, in this instance, is regarded as provi-
sional until a better explanation replaces current
explanations.
These philosophical differences have implica-
tions when it comes to conducting a study. Is your
study trying to refute a hypothesis or confirm new
information? Falsificationists (also referred to as
refutationists) have drawn from the philosophies
propounded by Popper, while verificationists
have drawn from the philosophical approach
promoted by Bradford Hill and Susser (see
Chapter 2: Causation of disease).
Generally, the public health ethic has de-
manded action to prevent and control disease
even if information is incomplete. Whether new
information is derived through the approach of
verificationists or falsificationists, public health
practitioners will view the finding no differently.
This highlights the need for public health practi-
tioners to implement control programmes versus
the need of scientists to ensure that a new finding
is valid.
The combination of theory and observation
is still challenged because it is impossible to
prove absolutely that the conclusions reached
reflect ‘the truth’. Thus, philosophically, a funda-
mental connection between cause and effect can
never be proved, and the search for ‘the truth’
continues.
Why is research done?
People have many reasons for conducting
research. For some individuals research is merely
a means to an end, such as the attainment of
further qualifications or public recognition. Some
have entered the ‘paper chase’ rat race and focus
solely on publications which emerge from the
study. Sometimes the survival of the institute or
department even relies on the income generated
by publications.
However, most people pursue an investigation
out of an interest in the topic or a perceived need
for information in their work situation. They use
the results of the research to further scientific
knowledge and/or as a rational basis for their
work. This may mean that the results can assist
when making decisions, motivating for resources
from funders and/or government agencies, or
monitoring progress and evaluating programmes.
Research can also be used to empower the sub-
jects of the research or to gather information
which can be used to advocate changes in policy
and resource allocation.
4
Public health (community health)
Public health is defined in Last’s Dictionary of
Epidemiology as ‘one of the efforts organised by
society to protect, promote and restore the health
of the population. It is a combination of sciences,
skills and beliefs that are directed to the mainte-
nance and improvement of the health of the
people through collective and social action. The
programmes, services and institutions involved
emphasise the prevention of disease and the
health needs of the population as a whole. Public
health activities change with changing tech-
nology and social values but the goals remain the
same: to reduce the amount of disease, pre-
mature death, discomfort and disability in the
population. Public health is thus a social institu-
tion, a discipline and a practice’ (Last 1988).
Thus in contrast to clinical medicine, which
focuses largely on medical care of ill individuals
who present themselves for examination, diagno-
sis and treatment, public health focuses on the
group or the community at large.
Public health has its origins in attempts to
control epidemics through the segregation and
quarantine of affected individuals. During the
industrial revolution, methods of environmental
control, including occupational health, were
developed, and sanitary reform promoted.
Further impetus was provided by the discovery
of vaccinations, of which smallpox was the first.
At the turn of the century, high-risk groups (for
example, children) were targeted for health
promotion activities — introducing an aspect of
personal health to public health practice.
In Britain, public health practice was modelled
around the concept of the Medical Officer of
Health (MOH), who co-ordinated and directed
health activities at district level, carving a domi-
nant role for medically trained people in this field.
In the United States, students and practitioners
were from the outset drawn from a wide variety of
disciplines, and the field developed a strong
multi-disciplinary tradition.
Worldwide, the public health movement has
been marginalized since the 1940s by the increas-
ing curative focus in health. The saying ‘Preven-
tion is better than cure’ has not won political
dominance, and public health programmes —
which have the potential to improve the health of
large groups — have had relatively low priorities
on national health budgets.
The terminology used to describe the public
health field has changed over time. In recent

times, the field has been referred to as ‘commu-
nity medicine’ or ‘community health’ in some
countries. In South Africa the term ‘community
health’ is generally used and the field is still
largely under the control of the medical profés-
sion. However, people involved in a wide variety
of disciplines are centrally involved in the field,
including nurses, health inspectors, sociologists,
psychologists, biostatisticians and epidemiolo-
gists.
Public health programmes require a variety of
skills to ensure adequate planning, implementa-
tion and evaluation of the effort. Core disciplines
are epidemiology and _ biostatistics; health
services evaluation and administration; beha-
vioural and biological sciences; occupational and
environmental health; health education and
health economics.
Public health research
The findings of the Commission on Health
Research for Development (1990) indicate the key
role of research in improving health, especially
the health of disadvantaged groups. The commis-
sion concluded that health research is a vital
investment in the future and that the seeds of
research can yield a wealth of effective action.
The commission sees health research as serving
two main purposes. Firstly, country-specific
research is essential to determine health prob-
lems, analyse measures for dealing with them and
help decide on actions to achieve health improve-
ments with limited resources. The second area,
global health research, relates to the development
of new knowledge and technology to cope with
the major unsolved problems worldwide. This
category of research requires global co-operation.
The commission called these two purposes —
country-specific and global health research —
‘essential national health research’ (ENHR):
‘essential’ because they address a country’s prio-
rity health problems, and ‘national’ referring to
the importance of research that is directly tar-
geted at local or national level problems. While
every country should develop a strong capacity to
undertake country-specific research, each coun-
try needs to consciously decide for itself the
resources it can contribute to the global health
agenda.
ENHR is, in effect, a strategy for setting prior-
ities, and managing and developing a country’s
resources for health research. It depends crucially
on working partnerships between researchers;
health service policy-makers, managers and
1_sintroduction
providers; and communities. The idea is not that
priorities will be set purely at national level, but
rather that national priorities will be forrned from
an ‘upward synthesis’ of local, district and provin-
cial concerns.
In South Africa, the ENHR framework has been
endorsed by a wide range of organizations and
institutions as an organizing framework well
suited to local needs. An ENHR strategy can be
expected to strengthen the capacity of the provin-
cial and national departments of health to
address important yet previously neglected prob-
lenis.
Epidemiology
Epidemiology is ‘the study of the distribution and
determinants of health-related conditions and
events in populations, and the application of this
study to the control of health problems’ (Last
1988).
Descriptive epidemiology describes the occur-
rence of disease and other health-related charac-
teristics in human populations in terms of person
(the who: age, sex, social class), place (the where:
geographic location) and time (the when: season,
time of day/week).
Analytic epidemiologic studies investigate the
association between a given disease or health
status and possible causative or protective fac-
tors. An attempt is made to explain why health-
related outcomes occur ‘and whether interven-
tions work.
Epidemiology forms the research arm of public
health, providing the scientific basis upon which
public health policy decisions are made. It pro-
vides methodological research skills in order to
manage public health problems in a more effec-
tive way.
An important distinction to make is the differ-
ence between the terms ‘the epidemiology of a
particular disease’ and ‘epidemiology the disci-
pline’. The epidemiology of a particular disease
describes the distribution and determinants of
that disease. So for example, the epidemiology of
HIV infection demonstrates that young adults
aged 16-30 years have the highest incidence rate
of HIV infection, women have a threefold higher
risk of HIV infection and that approximately 25%
of children born to HIV positive women are
infected with HIV.
Epidemiology the discipline describes particu-
lar methodological tools/approaches used to
gather information about the prevalence, distri-
5
a contextualizing epidemiology
bution, determinants and course of any condi-
tion. It is epidemiology the discipline that forms
the content of this book.
The role of epidemiologists
Epidemiologists function at two levels, often
simultaneously. On the first level, as ‘pure’ scien-
tists, they try to find ‘truth’ or the real cause(s) of
disease, encouraging sceptical debate about
causal inference. At a second level they function
as public health officials, where they advise others
involved in making public health decisions. In
these public health roles, they and the public they
serve must recognize the crucial need to act in
such a way as to err on the side of public health.
This often means taking action in the presence of
scientific uncertainty and it also means that in-
correct decisions may be made. Epidemiologists
have a key role in ensuring that decisions
involving policies and practices are continuously
evaluated and redefined in the light of new
evidence.
Epidemiology in South Africa
For centuries South Africans have been cared for
by herbalists. These skilled practitioners had, by
observation and analysis, identified plants with
therapeutic properties. If we were to learn more
of their ways and techniques, there can be no
doubt that we would describe some of them as the
ancestors of modern epidemiology.
In modernizing, South Africa became exposed
to diseases of overcrowding and urbanization.
The mining industry heralded an explosion in
respiratory disease. Pneumonia was a huge
problem; Sir Spencer Lister, one of the early direc-
tors of the South African Institute for Medical Re-
search, was a pioneer in pneumococcal vaccine
development. The 1918 flu epidemic led the
health planners of the day to lay down strict na-
tional health measures to control and monitor the
spread of infectious disease. Their rules were
guided by epidemiological principles. Siegfried
Annecke helped to dramatically reduce malaria in
South Africa through his observation of the effi-
cacy of DDT in mosquito control.
In the realm of primary health care epidemio-
logy, South Africa was a world leader by the mid-
1940s.
Pholela and the roots of primary health care
(PHC)
Given South Africa’s painful history, many people
6
are surprised to learn that 50 years ago the
country embarked on a series of PHC experi-
ments which gained the attention of practitioners
and researchers worldwide.
This started in 1938 with a nutrition survey
which documented, for the first time, the health
status of South Africa’s African majority. The
study, initiated by Harry Gear (then Deputy Chief
Medical Officer of the Union), Sidney Kark and
Harding Le Riche, concluded that: ‘Diet defi-
ciency diseases, syphilis, malaria, bilharzia,
tuberculosis, scabies and impetigo, and prevent-
able crippling ... form no small array of factors
contrary to the maintenance of good health ... No
amount of juggling can succeed in separating the
influence of one as opposed to the others ... The
outstanding fact is that they are all preventable
...’ (Kark 1994).
Faced with this reality, and without a ready-
made solution, in 1940 the government initiated a
rural health unit staffed by Kark, his colleague and
wife Emily, and Edward and Amelia Jali. Within
five years, work at Pholela provided evidence for a
revolutionary model of health care provision
(Slome 1962; Tollman 1994).
What, then, was so extraordinary about
Pholela? The work is impressively documented
and well worth reading (Kark 1962), but we single
out three innovations:
analysis of the health and health-related issues
of groups or communities (community diagno-
sis) parallel with individual patient assessment;
use of epidemiology as a tool for daily use, to
monitor, evaluate and inform health actions;
recognition that social, cultural and environ-
mental factors are crucial determinants of
community health status.
We take the last point for granted, but have yet to
fully incorporate our understanding of these
determinants to strengthen our health promotion
efforts, whether the problem is diarrhoea and the
use of oral rehydration therapy (ORT) or ischae-
mic heart disease and exercise programmes.
Using tuberculosis as an example, the near-
legendary John Cassel gives insight to the under-
standing of local customs and values needed if
new ideas are to fit with existing cultural frame-
works (Cassel 1955).
From model to movement: Gluckman, the
IFCH, and COPC
Henry Gluckman, later Minister of Health,
chaired the National Health Service Commission.

In 1944, this commission recommended a coun-
trywide network of health centres as the basis for
fundamental health reform in South Africa
(Gluckman 1945). Their recommendation was
based on the Pholela experience, the pilot study.
Forty health centres were established. Eight in
and around Durban formed practice-research
sites for an Institute of Family and Community
Health (IFCH). Linked to Natal University, the
Institute trained staff for health centre teams,
including a new category — ‘health recorders’ —
to maintain community, household and family
records.
Although abruptly and prematurely curtailed
by the political events following the change of
government in 1948, such efforts caught the inter-
national imagination. They showed the link
between community epidemiology, primary care
and community health. Based on adaptations
from many countries — the USA, Israel, Spain,
Nicaragua, Britain — this approach became
known as ‘community oriented primary care’ or
COPC. As an important research base for the
World Health Organization and Unicef’s ‘Health
for All’ strategies, COPC continues as one of
several broad strands making up the fabric of
contemporary primary health care (Tollman
1991). l two, epidemiologists were doing work which
‘Failure to build upon [such] early models cost
the country dear, not only in financial terms but
also,'and more importantly, in terms of prevent-
able death, disease and disability’ (Yach, Tollman
1993). After all this time, the work done in places
such as Alexandra (Alexandra Health Centre
1991), Mamre (Mamre Community Health
Project 1988), Gelukspan (Bac 1990) and else-
where is once again inspiring South African
efforts in district health development.
South African epidemiology in the 50s, 60s
and 70s
From the 1950s to the mid-1970s, the science of
epidemiology was developed as acritical tool
both in the description of disease and in monitor-
ing the control of disease. Many diseases were
notifiable and research scientists used this
routinely collected data to develop hypotheses
about causation and distribution of disease. A few
examples from Gauteng illustrate the kind of
epidemiological research done during this
period.
Gear’s work on the Coxsackie virus, poliomye-
litis and rickettsial diseases such as tickbite fever,
had a strong epidemiological foundation. Work
1 _sintroduction
on the epidemiology of rheumatic heart disease, a
major cause of morbidity and mortality in urban
blacks, was limited. However, the definitive study
was conducted by Margie McLaren, who per-
suaded the clinical cardiologists of Johannesburg
to join her in a massive survey of Soweto school-
children. This survey revealed many cases of
advanced and previously undetected rheumatic
heart disease. Her work stimulated a number of
major attempts at rheumatic heart disease
control.
What about South Africa’s major killers; gastro-
enteritis, pneumonia, malnutrition, violence,
tuberculosis, cervical cancer, cardiovascular
disease? Did epidemiologists pay enough atten-
tion to these priorities? Turning the pages of the
South African Medical Journal during this period
tells us that they did not; information about the
distribution, causation and control of many of
these disorders remained inadequate. We have
virtually no useful baseline information about
how effective our interventions have been.
Epidemiology and epidemiologists have let us
down — certainly in the mid-70s, priorities were
still with the exotic and the intellectually novel.
There are a few notable exceptions: in the areas of
nutrition and iron metabolism, to mention just
would make an impact on South Africa’s health
problems.
Epidemiology in the 1980s
Until the 1980s, much of South African epidemio-
logy had been targeted at disease description, had
been conventional in its adherence to a biomed-
ical paradigm, and had steered away from
confronting South Africa’s greatest disease, apart-
heid.
All of this changed in the 1980s. A ‘new’ genera-
tion of epidemiologists emerged. The thrust of
this new wave of epidemiology spread across the
country. It was essentially a multi-disciplinary
movement, but was somewhat under-repre-
sented by nurses and environmental health offi-
cers. Centres of endeavour were found at univer-
sities, research organizations and rural hospitals.
Notable activity in the training of nurses in field
epidemiology took place in the small epidemio-
logy unit in the Department of Health. This unit,
with limited resources, also conscientiously
analysed the routinely collected national data,
reporting findings monthly in the publication
Epidemiological Comments.
The notable thing about the ‘new’ epidemio-
7
a contextualizing epidemiology
logy was its content. It began to address quality
and provision of care. It confronted unequivocally
the horrendous inequalities in mortality amongst
South Africa’s population groups. It revealed in-
equalities in per capita expenditure on health
between the ‘homelands’ and white South Africa.
It pointed to the horrific working conditions
experienced by much of South Africa’s labour
force. Cholera epidemics were revealed to be
almost exclusively epidemics within ‘homelands’.
Immunization rates in white cities were high; in
black townships, they were abysmally low.
Epidemiology’s torch shone into the dark,
excluded and forgotten corners of South Africa’s
disease cave and what was hidden in these
corners was disgraceful. Epidemiology brought
legitimacy and factual support to the rhetoric of
the politically oppressed. The struggles for health
and political rights had been irresistibly joined.
The evidence would not go away, although many
tried to suppress the emerging information.
Coming of age
It is clear that much of the basis for a vibrant
culture of epidemiology now exists in South
Africa.
The Epidemiology Society of Southern Africa
(ESSA), founded in 1982, has become a meeting
place for the learned, the learning and anyone
else remotely interested in public health research
and the measurement sciences.
Epidemiology is now being taught in courses
dedicated to the subject. These courses, first
developed in the Cape, are forming the founda-
tion upon which epidemiology is being taught in
the schools of public health which emerged in the
mid-1990s. There is a commitment to strengthen-
ing epidemiological training and practice among
nurses. Occupational health epidemiology flour-
ishes in Cape Town, Johannesburg and Durban.
The Centre for Epidemiological Research in
Southern Africa (CERSA) has played a unique
role, providing first a training ground, and then
ample opportunity for methodological and
thematic applications: from urbanization to in-
fectious diseases to chronic diseases of lifestyle.
And health policy and health systems research
and development have been identified as critical
to the thrust of health reform. Epidemiological
skills are being drawn upon extensively in the
development of health policy on the national and
regional levels.
International contact and recognition, minimal
in the pre-democracy years, are now abundant
8
and epidemiology in South Africa is being
strengthened by this. Indeed, international orga-
nizations such as the World Health Organization
are increasingly utilizing the epidemiological
expertise in South Africa to strengthen their pro-
grammes and efforts.
The practice of epidemiology in the
rest of Africa
The practice of epidemiology in Africa is, on the
whole, weak. A large proportion of epidemio-
logical research in Africa is done by organizations
based in Europe and the United States, without
always involving indigenous Africans. There is
concern about foreign agencies ‘using’ Africa as a
laboratory for research. This can result in the
development of undue dependency and failure to
increase epidemiological expertise on the conti-
nent.
However, some organizations, such as the
Ulma group in Sweden (which has been active in
Tanzania, Ethiopia and Somalia in particular)
have a long-term commitment to their projects.
In these cases, development of local expertise is
already evident. The French INSERM group,
London School of Hygiene and Tropical Medi-
cine, and the Tropical Disease Research Pro-
gramme of the WHO have been focusing strongly
on developing epidemiological expertise in parts
of Africa. The Centers for Disease Control (CDC)
have initiated the global Field Epidemiology
Training Programme on the African continent
and have shown substantial involvement in 11
countries through the Combating Childhood
Communicable Diseases programme.
There is also a great need for further formal
training courses in epidemiology. The WHO has
been instrumental in instituting two Master of
Public Health (MPH) programmes in Nairobi and
Dar-es-Salaam that have a strong epidemio-
logical bias. In Southern Africa, the Blair Research
Laboratory focuses on tropical disease research in
Zimbabwe, and the WHO Ndola group fulfils a
similar role in Zambia. Most countries, however,
still lack a core group inside the country to
develop epidemiological expertise.
The 1990s and beyond
This overview presents a chequered history: origi-
nal contributions in the 1940s and 50s; consider-
able achievement accompanied by a turning
away from harsh reality in the 60s and 70s; and

highly motivated re-engagement during the 80s
and 90s, accompanied by the laying of a strong —
though still incomplete — foundation.
A host of challenges lie ahead. Some of those
that stand out are the following.
For departments of community health, nursing
colleges and the new schools of public health,
to strengthen their expertise and ensure that
essential epidemiological skills are soundly
acquired by the new generation of public
health practitioners and researchers.
¢ For clinical departments and medical faculties,
through the tools of clinical epidemiology, to
improve clinical judgement, understand costs
and consequences, and appreciate that quality
of care is both science and art, technique and
judgement.
@ For policy-makers, managers and providers, to
cultivate the critical outlook and open-minded-
ness that recognizes policy analysis and pro-
gramme evaluation as integral to sound health
practice.
For the epidemiological method, to embrace
more analysis and less description. We know
much about the problems; we still have to get to
grips with what works, what does not and why.
1_sintroduction
For epidemiologists, to nationalize their exper-
tise. There are structures helping to achieve
closer collaboration. The emerging Essential
National Health Research framework, the pro-
gressive Primary Health Care Network and the
Community Health Association of Southern
Africa are suitable structures.
@ For CERSA, to become a truly national resource,
better able to respond to geographically
peripheral needs, and with its expertise more
accessible to universities.
@ For us all, to extend our working relationships
with our neighbours in Southern Africa, as well
as colleagues in the rest of Africa.
Epidemiologists have risen above the polarizing
differences of the past. Today we look forward to
building on the expertise and the capacity for crit-
ical analysis we already have, and on a new gene-
ration of energetic people, whose commitment to
justice and equity will ensure they pursue the
truth as best they can in the interests of a healthy
new South Africa.

Causation of disease
The definition of epidemiology reflects the cen-
tral role that the identification of factors involved
in the causation of disease has in the discipline.
For example, epidemiological (and other) re-
search has given us insight into factors causing
tuberculosis. This enables us to say that tuber-
culosis is an infectious disease caused by the my-
cobacterium Tuberculosis found especially in
malnourished or immuno-compromised individ-
uals, often from socio-economically deprived
environments. Clearly, this description is an over-
simplification, but it does highlight the nature of
disease causation where multiple factors are
involved.
Necessary and sufficient causes of disease
Causes of disease are rarely a single entity. Several
factors often need to be present before the
disease process occurs and becomes clinically
evident. These factors are referred to as ‘risk
factors’, ‘agents’, ‘causes’, ‘causative factors’, and
a variety of other terms. For the purpose of this
section, the term risk factors will be used.
There are two central concepts in the causation
of disease. The first comprises the risk factor or
group of risk factors that is essential before a
disease occurs. For example, malaria cannot
occur unless the malaria parasite, plasmodium
species, is present. A risk factor that must be
present before a disease occurs is called a neces-
sary cause. A necessary cause need not be a single
risk factor.
The following combination of three risk factors,
namely:
¢ hepatitis B virus carrier state;
10
Key concepts in
epidemiology
¢ age of onset of hepatitis B virus infection below
the age of one year;
current age over 30 years
can constitute a necessary cause of hepatocellular
cancer.
A necessary cause can thus be a combination of
risk factors that must be present in order for the
disease to occur.
A sufficient cause, on the other hand, will in-
variably lead to disease if it is present. A sufficient
cause is distinct from a necessary cause: for
example, the poliovirus is a necessary cause for
paralytic polio, but it is not a sufficient cause
because only about one out of 50-100 people who
become infected with poliovirus will develop
paralytic polio. The rabies virus is one of the very
few risk factors which is both a necessary and a
sufficient cause. Clinical rabies can only occur if
infection with the rabies virus occurs (necessary
cause) and clinical rabies will always occur if in-
fection with rabies virus occurs (sufficient cause).
Most single risk factors are neither necessary
nor sufficient causes. For example, lung cancer
occurs among non-smokers (smoking is not a
necessary cause) and many smokers do not get
lung cancer (smoking is not a sufficient cause).
Smoking, however, is an important risk factor for
lung cancer (as well as many other diseases) and
is widely accepted as a cause of lung cancer. The
concept of cause is not synonymous with a neces-
sary or a sufficient cause, since many causes of
disease are neither necessary nor sufficient.
The organisms which cause infectious diseases
are necessary causes and are sometimes referred
to as ‘agents’. This concept of ‘agent’ is useful to
distinguish the role of the organism from that of
the environment and the host (human beings).

Other factors related to the host and the environ-
ment may need to be present for the disease to
occur. For example, infection with the TB bacillus
is a necessary but not sufficient cause of tuber-
culosis disease, that is, even if the agent is
present, the disease will not definitely occur.
Other factors must be present as well.
Factors related to the host which commonly
influence occurrence of disease include age, sex,
social class, status, lifestyle, and psychological
character.
Environmental (extrinsic) factors include, for
example, the presence of disease-transmitting
vectors and the availability of food (biological
environment); social customs related to living
habits, interpersonal behaviour and attitudes
(social environment); the economic organization
of the society and the level and distribution of
wealth (economic environment); and climatic
conditions and the presence of industrial waste
products (physical environment).
In non-communicable diseases, there is no
‘agent’ and various concepts have been devised to
understand the interplay of a multitude of risk
factors which eventually lead to disease.
Models depicting multiple causation
An understanding of the disease and its causation
are wee Mee acm
Agent(s)
(biological, nutrient, chemical,
physical, mechanical)
At equilibrium
Balance upset by
change in fulcrum po-
sition
(physical, social, eco-
nomic, biologic)
Adapted from: Leavell H R, Clark E G, 1965.
2 = keyconcepts in epidemiology
does not hinge on the agent alone. Tuberculosis
specifically, and disease in general, cannot be
attributed to one factor only — hence the accep-
tance of the concept of multiple causation. This
multi-factorial nature of disease can be under-
stood in terms of the interaction, often complex,
between three groups of factors: those related to
the agent, the host and the environment. The
concept applies as much to infectious diseases as
it does to non-infectious ones, although, as men-
tioned above, in non-infectious diseases there
may be no single agent.
The interaction of these three groups of factors
largely determines an individual’s state of health
at a given point. The health status of a person may
be seen as an equilibrium between the agent-
host-environment with the host and the agent
balancing on a fulcrum of the environment — the
epidemiological triangle (Figure 2.1). Harmful
change in any of the factors could lead to a
change in equilibrium, causing disease. Small
negative changes can, at times, be compensated
for, if the existing balance is not too precarious.
The epidemiological triangle is particularly
useful for understanding the causation of infec-
tious diseases. Since the application of epidemi-
ology to chronic and non-infectious diseases,
new models have developed which de-emphasize
Human host
(age, Sex, race, genetic
factors, personality)
Balance upset by
changes in host and/or
Environment environment
FULCRUM
11
a contextualizing epidemiology
the agent or organism (for example, there is no
known ‘organism’ for heart disease) by regarding
it as one component of the environment. The idea
of a ‘web of causation’ was developed to depict
the extremely complex chain of events/factors
that contribute to the occurrence of disease
(MacMahon, Pugh 1970). Another model which
puts less emphasis on the agent is that of the
‘wheel’, where the biological, social and physical
environment impinge on the hub or, core of the
wheel corresponding to the individual’s genetic
constitution. For different diseases, the different
components may play a more or less prominent
role in the causation of the disease (Mausner,
Kramer 1985).
Evaluating research evidence to establish
causation
While the above description of the factors associ-
ated with tuberculosis sounds straightforward,
many laboratory, epidemiological, and clinical
investigations had to be undertaken in order to
arrive at this understanding. In general, an under-
standing of what causes a particular disease
depends on an accumulated body of knowledge
based on sound research.
In the case of a living organism being an agent
or necessary cause of a disease, the following
criteria were postulated by Koch:
the organism must be present in every case of
the disease
the organism must be isolated and grown in
pure culture
the organism must, when inoculated into a
susceptible animal, cause the specific disease
the organism must then be recovered from the
animal and identified.
Koch’s postulates are of limited use because
several diseases do not have animal models, and
behavioural and environmental causes of disease
cannot fulfil his criteria.
More recently, guidelines have been developed
for deciding whether a factor causes a disease or
not. The emphasis is on strong research design
with evidence from experimental designs having
the most influence (see Chapter 7: Study design).
However, because such trials are rarely used to
establish causes of disease in humans, strict crite-
ria are used to evaluate non-experimental (obser-
vational) studies investigating causation.
Sackett, Bradford Hill (Bradford Hill 1965; Sack-
ett, Haynes, Tugwell 1985) and others published
guidelines which can be summarized as follows.
12
Establish whether the risk factor or exposure
occurred before the disease/outcome. That
is, the temporal sequence of the exposure
and disease must be compatible with causa-
tion.
@ The stronger the association between the expo-
sure and the disease, the more likely the expo-
sure is to be a cause of the disease.
¢ Ifastudy shows that an increased exposure
results in an increased occurrence of the
disease (for example, if the lung cancer rate
among heavy smokers is higher than among
light smokers), it meets the dose-response cri-
terion.
Results from different studies using different
approaches in different settings should give
similar results (consistency). The reason for in-
consistent results should be explained.
A plausible explanation of the mechanism by
which the causative agent causes the disease
should be put forward to fulfill the criterion of
biological plausibility.
More recently, Susser has suggested a hierarchical
approach to applying the causal criteria. Rather
than a mechanical application of the use of causal
criteria, the hierarchical approach proposes a
rational approach which begins with the strength
of association. If an association does indeed exist,
the next step is to determine the temporal relation-
ship between cause and outcome. Only if the cause
occurs conclusively before the outcome are the
other criteria applied (Susser 1991).
Conclusion
It is essential to know about the different causes
of diseases and their interaction in order to
develop appropriate intervention programmes to
prevent or control disease. Health programmes
can have a major impact on disease directly at the
level of the agent (for example, improved water
supplies decrease agents for diarrhoea), the host
(for example, immunization against measles pre-
vents disease even when overcrowding occurs),
and/or the environment (for example, improved
road design decreases traffic accidents). Health
policy and services (curative and preventive) thus
play an important role in determining the final
health status of the population.
Levels of prevention
The following anonymous poem, while by no
means a major literary work, contains an import-
 2 keyconcepts in epidemiology

rs Cer eRe lem ll oeg

TELA 7J

SZ
LWW
y
SS

sy
PSssSe
YSSS
j
SOSsS
RSS
Seawe:
So

a) No prevention b) Secondary and c) Primary prevention

tertiary prevention

ant message for those interested in public health.
It was a dangerous cliff as they freely confessed,
Though the walk near its crest was so pleasant;
But over its terrible edge there had slipped
A duke and full many a peasant.
So people said something would have to be
done,
But their projects did not tally;
Some said ‘Put a fence around the edge of the
cliff,
Some ‘An ambulance in the valley’.
This poem describes one of the major dilemmas
found in modern health care. Much time and
money is spent providing ambulance and emer-
gency services at the bottom of the proverbial cliff
(Figure 2.2). Thought is seldom given to whether
it might be better to go to the top of the cliff, build
a fence and put up notices warning people of the
dangers of going near the edge — thus identifying
the primary preventive needs of the community.
While there seems to be agreement that pre-
vention is better than cure, traditionally very little
is done to actively promote prevention. This can
be understood when examining the historical
development of medicine, where orientation
toward treatment has dominated. Over the years,
activities have been restricted to treating the
injured and the sick who present themselves to
health services. Only more recently has there
been an appreciation that health responsibilities
need to be more extensive.
Before being able to take fuller responsibility in
the control and management of a disease, it is
important to understand both the multiple
causes of the disease and the natural history of
the disease.
Natural history of disease
The natural history of disease refers to the sys-
tematic description of the course of disease over
time, unaffected by treatment. Several stages
form part of the natural history.
HS
a contextualizing epidemiology
During the susceptibility phase, risk factors
only are present.
During the preclinical phase, the biological
process of the disease has started. There are
some physical manifestations, but no disease is
present.
¢ In the’clinical disease phase, signs and symp-
toms of disease are present.
Recovery, the presence of chronic disease, dis-
ablement, and death are all possible outcomes
of the disease process.
Once these stages have been documented, a com-
prehensive approach can be planned for the
management and control ofa disease.
Epidemiology, through the use of its different
study designs, contributes substantially to the
generation of knowledge concerning the natural
history of diseases. This is done by identifying risk
factors (stage of susceptibility), evaluating screen-
ing programmes (presymptomatic stage) and
describing consequences of disease and treat-
ment (stage of clinical disease and disability). On
the basis of this information, interventions can be
planned and promoted.
Intervention at different stages of disease
Interventions must be on as many levels as pos-
sible. Each level of action is seen as a level of
prevention. Thus there should be an attempt to
prevent the disease from occurring at all. Once
the disease has occurred, it should be identified
as early as possible and prevented from getting
worse. If residual effects of the disease remain,
these should be minimized, and _ disability
prevented wherever possible. The effectiveness of
interventions differs according to the level tar-
geted.
Essentially, a framework is needed for prevent-
ative endeavours. A common approach to pre-
vention divides the process into four parts repre-
senting all potential levels of intervention, as
applicable.
Primordial prevention: This level aims to curb
the development of unhealthy lifestyle patterns
among groups/populations which have not yet
developed these unhealthy patterns. Health
promotion is thus aimed at populations and
groups, and attempts to deal with anticipated
health risks which are not yet present. The classi-
cal example of the need for primordial prevention
is in the cardiovascular disease area, where com-
munities which have low levels of cardiovascular
14
disease and the lifestyle associated with this
should be targeted for prevention. In South
Africa, there are communities who are currently
undergoing urbanization and cultural transition,
which should be targeted for primordial preven-
tion programmes. Government and legislative
support should protect the population from the
promotion and sale of unhealthy products, while
encouraging activities in all sectors of the
community to promote health (Steyn, Buch
1992).
Primary prevention: At this level, interventions
are aimed at healthy people — individuals or
groups. Measures are taken to promote optimum
health or provide specific protection of target
groups against disease and injury. This can be
done on a non-personal level, where the risk of
the condition is reduced by engineering out the
risk (for example, banning asbestos products),
or on the personal level by prevention (for
example, providing of measles vaccination and
promotion.
Secondary prevention: At this level, measures are
aimed at people who have a disease which has not
yet produced symptoms. Thus secondary preven-
tion measures include early diagnosis and
prompt treatment to prevent the development of
clinical disease and complications from the
disease. For example, secondary prevention of
tuberculosis can take place through screening in
the workplace (for early diagnosis) and prompt
treatment by means of medication.
Tertiary prevention: At this level, measures
involve the treatment of the disease/condition in
its later stages and rehabilitation to optimize
function, thus preventing/minimizing impair-
ment and disability. For example, a tuberculosis
patient may be treated after going to a doctor with
clinical symptoms. In most cases, the patient can
be treated with medication and return to normal
function. In some cases, there may be residual
respiratory problems and rehabilitation may be
needed, including occupational training in a new
type of job.
Figure 2.3 provides the outline of the frame-
work for levels of prevention and gives examples
of each type of activity.
Conclusion
Epidemiology provides the findings which are’
used to plan interventions on all levels of preven-
 2 = keyconcepts in epidemiology

Figure 2.3 Framework for levels of prevention

ONSET OF DISEASE DISEASE OUTCOME

Recovery
Healthy state py Preclinical > Clinical Chronic disease
: ae
(pre-disease) disease disease Disablement
Death

PRIMORDIAL PRIMARY PREVENTION SECONDARY PREVENTION TERTIARY PREVENTION

PREVENTION
Health Health Specific Early Prompt Treatment Rehabilitation
promotion promotion protection diagnosis treatment

target lifestyle @ health @ immunization @ screening @ arrest of prevention ¢@ retrain

factors with education @ personal @ case-finding disease orlimitation remaining
highdisease | nutrition hygiene process of disability capacities
risk personal @ environmental maximally
@ target groups development controls @ retrain
where risks education @ protection from maximal
are not yet @ housing occupational independence,
high @ recreation hazards and including
accidents employment

tion of a disease. In doing so it forms one of the
pillars of public health, which aims to improve
the health of the population as a whole.
Measures of the frequency of health
events
Most epidemiological studies focus on the occur-
rence or frequency of disease or risk factors. It is
useful to know the numbers of people with
certain conditions to determine the case load on
the health services. However, to be able to
compare the frequency of disease in different
groups or in a group over time, one has to calcu-
late rates, since they relate the number of cases to
the size of the population at risk in the specified
group in the specified period. If one determines
that in AreaA there are 50 cases of a disease and in
Area B 500, one cannot conclude that the disease
is a bigger problem in Area B. What if there are
only 100 people in Area A compared to 10 000 in
Area B? For comparison, one has to take into
account the size of the populations (and popula-
tion structure with respect to age, for example) in
the two areas.
Rates
A rate is calculated by dividing the numerator
(number of cases) by the denominator (the popu-
lation at risk and the period of observation) (Table
2.1). Rates express the frequency of some charac-
teristic per 1 000 (or 10 000 or 100 000) persons in
the population per unit of time. Some key rates
are listed in Table 2.2. For some rates the numera-
tor is not actually part of the denominator, for
example, in the case of the infant mortality rate,
where the numerator is the number of deaths of
children under the age of one ina given year, and
the denominator is the number of live births in
the same year. (A child of three months who dies
in January will contribute to the numerator of that
year’s IMR despite having been born in the
previous year and thus not contributing to the
denominator.) Strictly speaking such quanti-
ties are ratios, but the terminology ‘rate’ is
firmly entrenched (see Table 2.1). A critical part
of a rate is the period of observation/study
expressed, for example, as ‘per year’ or ‘per
month’.
Incidence and prevalence
Disease frequency can be measured by incidence
or prevalence.
Incident cases are the number of new cases
reported during a specified period in a defined
population (Figure 2.4). The epidemiologist can
determine the number of new cases by making
use of routine surveillance systems (such as noti-
15
a contextualizing epidemiology

Table 2.1 Components of a rate: numerator and denominator

If there are two sick people in one year in a population of size 100,

the disease rate = 2 i ———— numerator

100 x 1 year —<_——____——_ denommator

= 20 per 1000 per year

(or 200 per 10 O00 or 2 000 per 100 OOO per year)

The numerator is a sub-part of the denominator. In the case of a ratio, however, the numerator is not
necessarily part of the denominator. For example, if 20 boys and 25 girls are born, the ratio of boys to
girls is 20:25 or 0,80.

Table 2.2 Key Ce

Birth rate
Number of live births during the year x 1.000
Total population

Fertility rate
Number of live births to women 15-49 years of age during the year x 1000
Number of women 15-49 years of age in the population

Death rates
Crude death rate
Total number of deaths during the year
x 1 000
Total population
Cause-specific death rate
Number of deaths due to a specific cause during the year
x 100 000
Total population
Maternal mortality rate
Number of deaths of women due to pregnancy or childbirth during year
x 10 000
Number of births (live and stillbirths) during the year
Infant mortality rate (IMR)
Number of deaths of children under 1 year of age during the year
x 1000
Number of live births during the year
Neonatal death rate
Number of deaths of children under 28 days of age during the year
x 1 000
Number of live births during the year
Perinatal mortality rate
Number of fetal deaths (28+ weeks) and deaths of children under 7 days
x 1 000
Number of fetal deaths (28+ weeks) and live births during the year

fications) but has to take into account the quality
of the surveillance system, for example, in terms
of completeness. Studies which follow individuals
up for a specified time can also be conducted to
determine the number of incident cases.
To calculatea rate for incidence, one can calcu-
late the cumulative incidence or the incidence
rate. The cumulative incidence is the proportion
of the at-risk population who become diseased in
a specified period. The at-risk population im this
case only consists of individuals who are at risk of
becoming new cases, that is, it excludes those

16

Table 2.3 Difference pee rates of incidence and prevalence
Incidence
Numerator = new cases
Denominator = healthy population at risk
at start of time period (cumulative incidence)
OR
Sum of person-time of ppeeneian
(incidence rate)
Measured over a specified time period
who have the disease at the start of the time
period. For example, to calculate the cumulative
incidence of measles in the unvaccinated, the de-
nominator excludes all old cases and those who
have been vaccinated.
Cumulative incidence is:
Number of new cases in a specified time period
The number in the at-risk population at the start
of the time period
However, when cumulative incidences are calcu-
lated‘ for large populations, for example, for a
country as a whole, the denominator consists of
the total population, since excluding those who
are already diseased will change the resulting cu-
mulative incidence very little.
The cumulative incidence assumes that the
entire population at risk at the beginning of the
time period is followed up for the specified period
(for example, one year). However, some individ-
uals may be lost to follow-up and thus different
members of the at-risk population may have dif-
fering lengths of follow-up.
The incidence rate (sometimes referred to as
incidence density) takes into account the length
of time each individual in the at-risk population
remained under observation. The numerator is
the number of new cases and the denominator is
the sum of the individual time periods of observa-
tion till disease onset or loss to follow-up, in terms
of person-time (person-days, person-months or
person-years). For example, if person 1 is follow-
ed for the whole period of one year, without
developing disease, this person contributes one
year to the denominator, and nothing to the
2 keyconcepts in epidemiology
Prevalence
Numerator = all cases
Denominator = total population at risk to be a case
Measured at a point in time
numerator. If person 2, on the other hand, is fol-
lowed for 3 months, and then develops disease,
this person contributes 0,25.years to the denomi-
nator and one disease case to the numerator.
Person 3, who is followed for 6 months before
being lost to follow-up, being healthy at that time,
contributes 0,5 years to the denominator and
nothing to the numerator.
The incidence rate is:
Number of new cases of a disease during a speci-
fied time period
Total person-time of observation
The incidence rate is thus expressed as the
number of cases per person-time.
Prevalent cases, in contrast with incident
cases, are the number of people who have a
particular disease at a specific time (Figure 2.4).
Prevalence thus focuses on whether a disease is
present at a specific time and not on when it
occurred. It is also known as point prevalence,
since it refers to the number of cases at a point
in time. Prevalent cases include cases which
developed some time ago and new cases (inci-
dent cases), but excludes the cases which have
died or recovered (Figure 2.5).
To calculate the prevalence, the numerator is
the number of prevalent cases (that is, all cases at
a given time) and the denominator all at-risk
people in the group investigated (that is, all indi-
viduals at risk of being a case, thus also including
old cases) (Table 2.3). For example, to calculate
uterine cancer prevalence, the denominator
would be all women, excluding those who have
had hysterectomies.
ia
a contextualizing epidemiology
Figure 2.4 Counting incident and
prevalent cases
DAY 1 DAY 30 DAY 60
The day on which healthy individuals develop a disease
is indicated by the point where the line under the case
number starts. The duration of the disease is indicated
by the length of the line. The number of incident cases in
the period Day 1 to Day 30 is 9 cases (cases 1 to 9) and
in the period Day 30 to Day 60 4 cases (cases 10 to 13).
If a cross-sectional study is done on Day 30 to
determine prevalence, prevalence will be 2 (cases 8 and 9).
Featc= We BE) =e)
Pete eee ieemait
and prevalence
Prevalence:
existing cases
Source: Kibel M A, Wagstaff LA, 1995.
18
Prevalence is:
Number of existing cases
The number in the at-risk population (at a spec-
ific point in time)
Prevalence is commonly referred to as prevalence
rate; this is incorrect, because it is not expressed
per unit of time.
The longer the duration of a disease, the higher
its prevalence. Thus, if a disease is rapidly fatal, it
may have a low prevalence in spite of a high inci-
dence. On the other hand, if treatment success
improves so that more cases survive, but with
some residual disease, prevalence would increase
even if incidence remains unchanged.
Primary prevention strategies aim to reduce
new cases of disease, that is, incidence. Secondary
prevention strategies aim to decrease prevalence
by decreasing the severity and the duration of
disease (thus increasing the number of cases who
become cured).
Table 2.3 summarizes the differences between
prevalence and incidence.
Crude and specific rates
If the total number of cases in a population is
divided by the size of the population at risk, a
crude (overall) rate is calculated. So, for example,
one can determine the crude death rate in a
population. However, the epidemiologist is more
interested in what the rates are for subgroups, for
example, for the sexes or for different age groups.
These are called specific rates and they enable the
researcher to study the variation of the condition
of interest between subgroups of a population.
Thus one could have disease rates which are sex-,
age-, and cause-specific, for example, heart
disease death rates for men aged 55-64 years.
Comparison of rates
Epidemiologists often wish to compare disease or
death rates between groups, for example, be-
tween countries, sexes or age groups, or in the
same group over time. To be able to meaningfully
compare such rates, one needs to be sure that any
observed differences in rates are real and not due
to differences between the groups in the distribu-
tion of other factors. For example, what conclu-
sions can one reach if the overall mortality rate in
Group A is higher than that in Group B, but it is
known that Group A has a larger proportion of
elderly people than Group B? Because death rates
increase rapidly with age, older populations have

higher crude mortality rates. If the mortality rate
of a population has increased over the last
century, is it due to a real change in mortality
experience, or to changes in the age structure of
the population? If two populations are similar
with respect to factors related to the disease, one
could feel confident about comparing crude
rates. If they differ, however, a comparison of
crude rates may give misleading results.
Standardization (also called adjustment) is a
way of removing the effect of differences in the
composition of various populations and so over-
coming the problem of making erroneous com-
parisons based on crude rates. If, for example, age
is related to the outcome of interest (for example,
heart disease), and the two populations differ
with respect to age distribution, one needs to
adjust the rates. The standardized rates provide a
new summary rate which takes into account the
differences between the groups. (Details are given
in Appendix 1.) It is, however, important to always
examine the subgroup-specific rates (for exam-
ple, age-specific rates) prior to standardization. If
the rates differ markedly between subgroups,
standardization will obscure these differences.
Comparing the rates of two groups in a study
requires a different approach to the one discussed
here and is dealt with in Chapter 11: An introduc-
tion to data presentation, analysis, and interpreta-
tion.
Demography
From the previous section on measuring health
events, it is clear that knowledge of the size and
characteristics of a population or community is
necessary to be able to interpret health informa-
tion meaningfully. The composition of the popu-
lation also has implications for its pattern of
health. To plan and deliver health services effect-
ively it is necessary to know what the community
looks like. For these reasons, there is a close rela-
tionship between public health, epidemiology
and demography.
Demography is the scientific description of the
characteristics of populations, and embraces all
aspects of population structure and changes
which can be measured numerically. This
involves primarily the measurement of the size of
a population (how many people there are), com-
position (what the characteristics, such as sex and
age, of the people are), distribution (where the
people in the region are), and changes in num-
bers of people. The main demographic processes
2 = keyconcepts in epidemiology
which lead to changes in the number of people
and composition of a population are fertility,
mortality and migration.
Population-based rates are essential in epi-
demiology. While great care is often taken in
establishing the numerator, too often in the South
African context, less attention is given to obtain-
ing an accurate estimate of the denominator —
the population size. The primary source of demo-
graphic data is the census, which endeavours to
obtain basic data for the whole population. Cen-
suses are usually conducted once every ten years,
but since 1980 there has been a South African
census approximately once every five years,
because of large-scale migratory population
movements. In using census data, it is important
to realize that there is often an undercount, and it
must be established whether the published
census figures have been adjusted or not. Census
data is often supplemented by routine surveys.
Population composition
The composition of a population can be
described in terms of factors such as age, sex,
race/ethnicity, occupation, income, education
and literacy. The population composition deter-
mines to a large extent the types of health prob-
lems experienced, and which health services have
to be delivered. An important measure of popula-
tion composition is the dependency ratio, which
describes the relationship of the dependent part
of the population to the potentially productive
part of the population. In Table 2.4, the depen-
dency ratios for South Africa as a whole, as well as
for specified subgroups, are given. These figures
were calculated by Mazur (1995) from the house-
hold survey conducted during the second half of
1994 by the University of Cape Town’s Southern
African Labour and Development Research Unit,
for the Project for Statistics on Living Standards
and Development.
A population pyramid is a useful summary
representation of certain aspects of population
composition. It is a graphical display of the per-
centage composition of a population in terms of
age and sex. Age is usually grouped in five-year
intervals. The percentages are represented by
proportionately drawn horizontal bars. By con-
vention, the percentages relating to the males are
drawn on the left of the pyramid and the females
on the right. The age groups are drawn from the
youngest at the bottom of the pyramid to the
oldest at the top.
The influence of births, deaths and migration
19
a contextualizing epidemiology
on the population composition can be seen from
the shape of the pyramid. A developing country
with high birth rates and low life expectancy will
have a high proportion of young people and thus
a population pyramid with a triangular shape and
a broad base. On the other hand, a developed
country with higher life expectancy will have a
higher percentage of people in the older age
groups and thus a population pyramid with a
narrower base and steeper sides. Events such as
famines, wars, or mass migration in the recent
past will be reflected by irregularities in the shape
of the pyramid. Population pyramids of the rural
and urban populations of South Africa are shown
in Figure 2.6 (Mazur 1995). The rural population
clearly has a broader base than the urban popula-
tion.
Demographic processes
Three processes determine the changing size of a
population: fertility (births), mortality (deaths)
and migration. The balance between these three
determines whether a population increases, de-
creases or remains stable in size.
The growth rate of a population is given by the
following equation:
(births-deaths) + (immigration-emigration)
total population
Fertility
The determinants of fertility are complex. We will
restrict ourselves to some basic measures of fertil-
ity.
Crude birth rate:
The number of births per 1 000 persons in the
population. This measure requires only total
births and total population. It is a crude measure,
since it does not take into account the age or sex
structure of the population.
General fertility rate:
The number of births per 1 000 women aged 15-
44 years. In this case, the denominator consists
only of the females of child-bearing age in the
population. Sometimes the age group used is
15-49 years.
Age-specific fertility rate:
If the numbers of the female population and
births are known by age of the mother, an age-
specific fertility rate can be calculated. It is
obtained by dividing the total number of births to
20
mothers in each age group (for example, 15-19)
by the number of women in that age group. In
Table 2.4, the percentage of teenagers (15-19)
ever pregnant is given for South Africa as a whole,
as well as for various subgroups (Mazur 1995).
This figure is an approximation of the 15-19 year
age-specific fertility rate.
Total fertility rate:
The best single summary index of fertility (if the
age-specific data are available) is the total fertility
rate. It is calculated by adding the age-specific
fertility rates together over the reproductive ages.
If five-year age intervals are used, each rate is first
multiplied by 5. This represents the number of
children (disregarding mortality) who would be
born to a group of women over the reproductive
period, as they experience current age-specific
fertility rates. It incorporates the age structure of
the reproductive female population, which the
general fertility rate does not. In Table 2.4, the
number of children ever born alive to women
aged 45-49 is given (Mazur 1995). This is an
approximation of the total fertility rate.
Mortality
Mortality is of great importance in demography
as well as epidemiology. In epidemiology, it is
often used as a substitute (although a biased one)
for morbidity (disease), since mortality informa-
tion is collected routinely and is more easily
obtainable than morbidity information.
The crude death rate expresses the number of
deaths per 1000 population. As pointed out
earlier, other more specific death rates, for
example, by cause or age, may be more useful.
Important death rates are listed in Table 2.2. The
infant mortality rate (IMR) is considered to be of
great importance for public health. It is not only
an indicator of health among the young, but the
WHO has used the IMR as an indicator of the
quality of the social, economic and physical
environment of the whole community, as well as
the effectiveness of health services. In South
Africa, the IMR varies widely between population
groups, but decreases in the IMR have occurred
because of improvements in socio-economic
conditions, nutrition and access to health care.
In recent years, the under-5 year mortality rates
have received increasing attention. These values
for South Africa are indicated in Table 2.4 (Mazur
1995). These values were obtained using indirect
methods (see Chapter 20: Mortality studies).
A useful index of overall longevity is life
 2 keyconcepts in epidemiology

Sr re CCR Rec mc Cea

Tw Vine ye
Rural population

e
&}/o}+
Male Do
oO}
Female
oa ao oO

a woa4
wo

kf
Nm
| nm|<
a)o
ASI o|s/o|s
|wola|ala

oO

Percent

Urban population

Male

-8 a, -4 -2
Percent

Source: Mazur RE, 1995

expectancy. It is easily understood, as it is
expressed in years. Life expectancy at birth is, on
average, how many years a person just born can
be expected to live for. It is a theoretical concept
which imagines a cohort of people just born expe-
riencing the current age-specific mortality rates
throughout their lives. Because of the differences
in mortality rates of males and females, women
have a longer expectation of life than men. This
index is often represented separately for males
and females.
An increase in life expectancy can be due to
people living longer, or less people dying in the
young age groups. In most countries, increases in
expectation of life has been brought about mainly
by the reduction of infant mortality.
21
a contextualizing epidemiology

Table 2.4 Selected demographic indicators for South Africa

Depend- % Female Children Mortality rates life

ency ratio teenagers ever born per 1000 expectancy
pregnant* alive to at birth
mothers IMR Child Under 5
45-49
years**

SA Total 66,7 22 4,30 81 38 116 57,8

Race
African 71,8 25 5,01 86 43 125 56.5
Coloured 62,6 17 4A7
Indian 48,8 2 3,37
White 44,7 1 2,56

Residence
Rural 25 5.37 94 50 139 54,5
Urban 20 3,80 69 30 96 60,9
Metro 49,5 15 3,37 57 22 78 64,2

Education
0-6 24 4,95 95 51 140 54.2
7s 22 3,51 62 25 85 62,9
9+ 15 2,62 58 23 79 64,0

Expenditure
(monthly, per person)-
<R150 O27 27 5,91 — 89 45 130 55,7
R150-R499 63,1 © 22 4,36 79 Ee 113 58,3
R450+ 3/,9° 4 2,94 63 26 87 62,6

*15-19 year old age specific fertility rate

** an approximation of the total fertilityrate
Source: Mazur R E, 1995.

Life expectancies are usually calculated during tion for which services need to be provided is a
census years, when reliable information on popu- major public health priority. Urbanization is also
lation size is available, and reliable mortality rates important to health in that it is often associated
can be calculated. with lifestyle or environmental changes which
impact on health (Yach, Mathews, Buch 1990).
Migration and urbanization Defining a migrant is difficult, as many people do
Migration refers to human movement in a geo- not necessarily remain in the urban area they
graphical sense. Socio-economic and political move to, but shift back and forth between rural
factors lead to the migration of people. Migration and urban regions cyclically.
consists of immigration (people moving into a
specific region) and emigration (people moving Demographic transition
out ofa specific region). Populations are not static. Over time, societies
In recent years, there has been rapid urbaniza- tend to experience decreases in the birth and
tion in South Africa caused by migration to cities. mortality rates. The drop in mortality tends to
The counting of the ever-changing urban popula- occur first, followed by a drop in fertility some

ae

time later. There is thus a rise in the population in
the intermediate period. At the beginning of such
a period of change, the majority of deaths are due
to infectious diseases, whereas at the end, the
majority are due to the chronic diseases of later
life. This change in disease pattern is sometimes
called the ‘epidemiological transition’ (Omran
1971). Chronic diseases, often referred to as ‘con-
ditions of affluence’, now contribute substantially
to the burden of disease in developing countries,
especially among the poor. South Africa and other
developing countries may well experience a ‘pro-
tracted transition’ where the mixture of chronic
disease and infection could co-exist for some
time, as happened in Mexico (Soberon, Frenk,
Sepulveda 1986).
Conclusion
Without accurate demographic information and
a knowledge of how to interpret demographic
data, an epidemiologist will not be able to evalu-
ate the extent or patterns of health problems, or
foresee any changes which are likely to take place
in these.
Health indicators
Measuring the health of populations
Health is a difficult concept to define because of
its complex and multifaceted nature. For the pur-
poses of determining the health of populations,
an important aspect of any definition is its
measurability. Given the holistic nature of health,
no single measure would do justice to the con-
cept, although measurement of single com-
ponents can provide useful information. The
researcher interested in single or multiple com-
ponents of health can choose from a variety of
health statistics.
There are health measurements selected from a
larger pool of health statistics which summarize
or represent several statistics, or serve as useful
proxy (substitute) measures for the relevant in-
formation. These measurements, called health
indicators, reflect health situations, and are vari-
ables which ‘help to measure changes’, especially
when these changes cannot be measured directly.
They usually reflect only partial components of
health, for example, the infant mortality rate
focuses only on the health of children under the
age of one year. However, the WHO does view this
indicator as also being an indicator of the health
status of the community as a whole, as well as of
2 = keyconcepts in epidemiology
the accessibility of health services.
Although the value of a single indicator is lim-
ited, the use of a standard set of indicators
enables public health professionals to compare
key health outcomes between areas and over
time. Such routine monitoring of the population’s
health status requires standard, easily collectable
and interpretable measures.
Health indicators are different from health
indices, which are composite measures combin-
ing several individual indicators. An example of a
newly developed health index to determine the
national burden of disease is the Disability
Adjusted Life Years (DALY). Demographic data is
used in conjunction with information collected
from community studies of disablement to deter-
mine this index. It is calculated by adding the
years lived with a disability (weighted according
to severity of the disability) to the years lost due to
premature mortality. The DALY is thus a compre-
hensive measure of ill health, reflecting both non-
fatal outcomes and mortality, that can be used to
quantify the extent of disease.
Health indices may initially appear to provide a
more adequate assessment of the health of popu-
lations. However, not all indices are particularly
valuable. They can never truly summarize health
in its totality, and can at best address some of its
components. If a single composite measure is
used, the specific influence of the contributory
measures is often lost, and composite measures
may be more open to abuse than simple
measures.
Uses of health indicators
Health indicators have several uses. They help to
identify and quantify health problems. Since
health status depends on economic factors,
health indicators may provide insight beyond the
health status of the populations. For example,
Table 2.5 Common sources of
data for health indicators
@ Vital events registers, e.g. death tapes
@ Census
@ Routine health services records
@ Epidemiological surveillance
@ Sample surveys
Disease registers
¢ Alternative sources of data, e.g. church
records
23
a_contextualizing epidemiology
Table 2.6 Health indicators
sheetbe A ae)
1Healthpoiley Indicators
— ee commitment to health for all
24
they often reflect socio-economic development,
exposures to specific risks, health services access
and utilization, and other factors related to health
in the population. By identifying the magnitude
of health problems, such indicators help in
setting priorities and allocating resources. This
often provides the necessary stimulus for new,
improved strategies. Indicators may also help to
evaluate national and local health activities by
being used as markers of progress (or failure).
_The usefulness of an indicator is judged by its
validity, reliability, and ability to provide
adequate information relative to the cost of
collecting information. Indicators should also be
well understood and accepted by the providers of
the services and the users of the information.
Selection of health indicators for monitoring
population health
Indicators rarely comply with all the above crite-
ria. The decision to use a health indicator
depends to a large extent on the organization or
technical and financial feasibility of data collect-
ing and analysis. Common sources of data for
health indicators are included in Table 2.5.
The WHO compiled a list which — while by no
means complete — provides an outline of the
basic types of indicators that can be used to
monitor health in the context of the ‘Health for all
by the year 2000’ programme. The different types
of health indicators include health policy indica-
tors, social and economic indicators related to
health, indicators of the provision of health care,
and health status indicators (Table 2.6). Most
health indicators in categories 3 and 4 in Table 2.6
are covered in detail in sections D and E.
The particular indicators recommended by the
WHO are the simpler and cheaper ones that
would be accessible to health departments in
developing countries. It is recommended that
each country compile its own list of indicators to
monitor the health ofits population.

Ethical aspects of epidemiological
research
Introduction
The purpose of this section of the chapter is to
make ethical reasoning and its application to re-
search more accessible to the readers of this book.
This is not a comprehensive treatise on research
ethics, but rather an introduction to the nature
and processes of ethical reasoning in research.
Specifically, the aims are: : that no experimentation could be done on a
- @ to make ethical considerations accessible to all
who conduct, read, or commission research,
specifically epidemiological research
@ to highlight the major ethical issues surround-
ing the proper conduct of research
to indicate some common controversies in
research ethics, and to suggest ways of dealing
with them.
Ethics is the branch of philosophy dealing with
morality. That is, ethics attempts to distinguish
between what is right and what is wrong in order
to give people guidance on how to behave. Over
time, most of the the ethical aspects of our beha-
viour have been clarified, and most of us know
what is good and what is bad. However, if a new
situation arises, it is not always clear what action
is ethically good and what is not. In research,
because we almost always deal with new situa-
tions, ethical reasoning is prominent. The appli-
cation of ethics to medical and health practice
and research is called bio-ethics. This chapter is
about bio-ethics, but for the sake of simplicity,
the words ‘ethics’ and ‘ethical reasoning’ rather
than ‘bio-ethics’ and ‘bio-ethical reasoning’ are
used throughout.
General —
philosophical
issues in
epidemiology
The increased awareness of the importance of
ethical considerations in research followed the
experimentation on prisoners by Nazi doctors
during the Second World War. In this case help-
less people were forcibly exposed to medical
experiments of dubious scientific value, the
results of which would not have been made avail-
able to them in any case. The post-war Nurem-
berg trials (in which Nazi war criminals were
tried) highlighted these abuses and pronounced
person without their specific permission. The
Nuremberg Code of 1947, and subsequently the
Declaration of Helsinki adopted by the World
Medical Association in 1964, made voluntary
informed consent a central requirement of ethic-
ally conducted research. In spite of this, the prac-
tice of obtaining informed consent or refusal from
research subjects/participants did not become
routine until well into the 1970s in most Western
countries.
Since then, the ethics of medical and health
research have been the subject of intense debate
and scrutiny by governmental agencies, research
institutions, the public at large, and — especially
in the United States — the courts. Because of this,
there is now a much deeper understanding of
ethical and moral values related to research, and a
far greater awareness of these issues among the
general public (the potential research subjects/
participants). A series of general and institution-
specific reports have been drawn up to outline to
prospective researchers what requirements need
to be met for their research to be considered
ethical, and what procedures research proposals
must undergo to ensure that future research is
ethically sound. One of the most important of
25
a contextualizing epidemiology
these is an independent ethical review.
To understand the need for an independent
ethical review related to research, it is important
to understand some of the major motives behind
research. To illustrate how these motives may
operate in preparing or conducting research,
three examples are given of cases where well-
intentioned research was done in an ethically un-
acceptable way.
EXAMPLE A:
In a now classic article on bio-medical ethics,
Beecher reviewed 22 studies in the New England
Journal of Medicine in 1966 which in his view en-
dangered the health or the life of the study sub-
jects without informing them of the risks or
obtaining their permission. He concluded that
‘unethical or questionably ethical procedures’
were not uncommon among researchers. He
further concluded that the motivations for such
procedures could be found in pressures on young
researchers for personal advancement (Beecher
1966). His article stimulated increased regulation
of research, including the establishment of com-
pulsory review procedures by institutional ethics
committees.
EXAMPLE B:
In a similarly classic case, researchers from the
United States Public Health Service conducted an
experiment involving over 400 black male resi-
dents of Tuskegee County in the southern state of
Alabama. Between 1932 and 1972, when the study
was terminated, these men were observed for the
effects of untreated syphilis. This study was ini-
tiated at a time when syphilis treatment was rela-
tively ineffective. Nevertheless, while the men
were told that they were being ‘tested’, many
thought this was for ‘rheumatism’ or ‘bad
stomach’. They were not told that syphilis treat-
ment was being withheld. Even after penicillin
became available during the 1940s, and was
found to be effective against syphilis, the men
were not given this information. They remained
under observation without receiving penicillin ‘to
allow the important scientific process to conti-
nue’ (Jones 1993).
EXAMPLE C:
AIDS activists in the United States are demanding
that the normal route of Phase I, II and III clinical
trials — which involve animal experimentation
followed by testing of drugs on small groups of
healthy human volunteers to test for toxicity and
26
positive responses before the drugs are tested on
large groups of patients — be short-circuited so
that AIDS sufferers do not have to wait for poten-
tially beneficial drugs until the lengthy clinical
trial process has been completed.
These three examples provide a good insight into
the context of research ethics. In the first two
examples, the main function of ethical review
would have been to protect research subjects
from being exposed to risks related to research. In
example A, risky procedures were being used
without subjects’ permission. In example B,
denial of existing treatment in the first instance,
and denial of more effective treatment when it
became available during the course of the study,
posed risks to the study subjects. In example C,
the usual ethical requirements that are put in
place to protect people from research risks have
come under pressure because of perceived bene-
fits of this research. Demands for the reform of
the ethical review process during the 1980s
included the suggestion that not only should
research subjects be protected from research
risks, but the potential benefits of research should
also be considered in deciding on the ethics of a
proposal. Several trials were halted midway
because the benefits of a new treatment had been
shown beyond doubt. This was done so that the
benefit could be applied widely. Protection from
research risks is therefore only one reason for
ethical review. The second major reason is to
ensure the fair distribution of potential benefits.
Although we focus below on more detailed
issues in ethical aspects of research, it is these two
facets that are the real focus of ethical review: the
protection from risks related to research and the
equitable distribution of potential benefits of
research.
Ethics and ethical reasoning
Acomprehensive description of ethics and ethical
reasoning is given by Beauchamp in his book
Principles of Biomedical Ethics (1989). Here,
we will provide only a brief insight into the area
of ethical reasoning to enable prospective
researchers to understand the processes that
should be followed by review committees to
which research protocols are submitted.
Most people have a good grasp of the moral
values in society. There is no difficulty, for exam-
ple, in making judgements about corruption,
deception, killing, telling the truth, and ensuring
that research results are made available to the

public. But there are two instances when the use
of ‘common sense morality’ is not sufficient.
Firstly, new challenges are being provided by
each new research protocol, by new therapies, by
new interventions, or by the use of new techno-
logies. Although existing morality can help guide
us towards appropriate action in known situa-
tions, the new situation may not fit existing moral
rules or behaviour. In the recent context, for
example, there has been an intense debate in
South Africa on whether or not abortion should
be legalized. We have the technology and medical
skills to ensure that abortion can be done in a way
that guarantees the health of the pregnant
woman. Given this background, there is a moral
dilemma. The dilemma is that there are solid
moral reasons why abortion should be legalized
(such as a doctor’s duty to optimize the health of
the pregnant woman, or society’s duty to uphold
the right of a pregnant women to self-determina-
tion) while, at the same time, there are equally
solid reasons why abortion should be prohibited
(such as society’s duty to uphold the right to life of
unborn babies, or society’s duty to protect those
who cannot protect themselves). We have to go
beyond ‘common sense’ moral reasoning, and
to develop a comprehensive understanding of
morality, ethics and ethical reasoning, in order to
solve these difficult moral problems.
A second series of challenges to ethical reason-
ing is‘ provided by the differences in morality
between cultures, religions, and ideologies. These
challenges are compounded by the absence of a
common basis for making moral judgements.
Instead, we are slowly developing our own set of
moral values and virtues in a process that is slow
and painful. For example, the decision by the
Constitutional Court to abolish capital punish-
ment is a first attempt to emphasize one particu-
lar moral value, namely the right of persons to life.
Yet this decision has elicited extremely emotional
reactions, especially from those who feel that
another moral value, namely the right to a safe
and crime-free environment, should have a
higher priority than the right to life. The role of
the Constitutional Court in this case is similar to
that of an ethical review committee in the context
of research: to attempt to develop a shared basis
of ethical arguments that can be applied to the
individual research proposal and to similar pro-
posals in the future. Given the multi-cultural
heritage of our country, it is likely that there will
often be disagreement between reviewers. How-
ever, if these differences are discussed publicly
3 general philosophical issues in epidemiology
and constructively, they can contribute towards
the development of more stable moral values that
are accepted by large sections of society.
Ethical reasoning takes place whenever there
is a need to provide a moral justification for
a particular action, for example a particular
research project or procedure. Such actions may
be justified on the basis of ethical rules, which, in
turn, are based on ethical principles derived from
an ethical theory. Telling the truth is a generally
accepted moral value, and lying, therefore, is
morally wrong. A researcher who decides to
deceive research subjects must therefore justify
his or her decision to engage in an immoral
action. The researcher may argue that obtaining
the truth is an accepted moral rule, and that
deception must take place, otherwise he or she
cannot obtain the truth. (For example, if we want
to research the quality of care given by practition-
ers to patients or clients, telling the practitioners
what is being studied may change the way they
deliver care. We will therefore not be able to find
out the truth.) This rule of obtaining the truth can
be based on one or more ethical principles such
as the principle of beneficence (interventions or
actions, including research, must, on balance, do
more good than harm). This principle, in turn, is
derived from a more complex body of principles
and rules that make up ethical theory (Figure 3.1).
The two most prominent types of ethical theory
are the utilitarian and the deontological theories.
In utilitarian theory, the most important under-
lying value for judging whether an action is ethic-
ally right or wrong is the amount of ‘good’ it
produces. Thus this approach prioritizes the
‘greatest benefit to the greatest number of people’
as the main criterion for judging an action.
Deontological theories hold that actions are to be
judged on the basis of certain values, irrespective
of the consequences for the ‘general good’ they
produce. All religious moral reasoning falls in this
group, as it generally holds that certain actions
are right (or wrong), not because of the results
they produce, but because the religion’s manifest
(such as the Bible, Torah, or Koran) states that
such actions are required and, therefore, good.
Ethical principles in medical and health-
related research
In spite of these differences, there is often agree-
ment between different theories on the moral
value of particular actions. These agreements
have been reached through ethical review, court
judgements, popular debates, and in many other
27
a contextualizing epidemiology

ways. As a consequence, ethical review of medical
and health-related research has distilled three
main ethical principles against which almost any
proposal can be assessed from an ethical perspec-
tive. These principles have provided a very valu-
able tool to assist in the ethical review of medical
practice and research. Theyare outlined in Figure
3.2 and discussed below.
The principle of respect for persons
Respect for persons has two major components.
The first one, often called the principle of
autonomy, relates to the notion that a competent
individual has the right to self-determination.
Other people, including health and medical prac-
titioners and researchers, must respect this right
to self-determination and have an obligation to
enable the autonomy of persons by, for example,
providing information that allows individuals to
make autonomous decisions.
Secondly, the.principle of respect for persons
calls for special measures to be taken to maximize
the autonomy of and protection for incompetent
persons. These include people with an intellec-
tual disability (permanent incompetency) or
persons under the influence of alcohol or pre-
medication for surgery, or in a state of emotional
shock (temporal incompetency), and persons
with reduced autonomy (such as children, pris-
oners or refugees).
The principle of autonomy is the main principle
underlying the process of obtaining informed
consent for medical procedures or for research. To
allow an autonomous person to make an auton-
omous choice about whether or not to participate
in research, five conditions have to be met.

Figure 3.1 Process ofethical reer y4

General approach Example: Practical use of approach

Ethical theory Utilitarian approach

it
Ethical principles Principle of beneficence

Ethical rules Obtain ietruth

fed fson how to act with moral justification Refrain sa disclosing to health workers why the
research is being done

Figure 3.2 Application of ethical principles to health research

Ethical principles

Respect for persons Beneficence Justice

Autonomy Maximization of Non-malevolence Beneficence Right of person Duty of other

autonomy and to demand certain person to provide
protection of things these
incompetent persons

@ assessment of competence minimize negative effects on @ benefits of the research must

to make decisions
disclosure of information
@ understanding of information
@ voluntary decision-making
specific authorization when
participating
individuals/groups being
studied
@ research subjects should benefit
¢ consultation if conflict concerning
‘benefit’
be made available to persons/
populations being studied
@ all who stand to benefit from
research should contribute to
risks or discomfort endured
make benefits of research
widely available

28

1 The person must be competent to make deci-
sions
As outlined above, the competence to make deci-
sion may be impaired both permanently or tem-
porarily. In general, any adult is regarded as com-
petent unless there is evidence to the contrary. In
addition, although children are often declared
‘legally competent’ at a certain age (18 in South
Africa), it is obvious that between childhood and
adulthood, the child becomes progressively more
competent. This means that there are certain
decisions about research participation or medical
interventions that a child can make before being
legally competent. Researchers are therefore
encouraged to elicit consent (or refusal) from
children who are old enough to be able to make
decisions about participation, in addition to
obtaining consent from their parents.
2 There has to be disclosure of information
An autonomous person can only make an auton-
omous decision if all the relevant facts needed to
make a decision are provided. The researcher is,
therefore, under an obligation to inform prospec-
tive study participants about: . taken.
what the study is for
@ what will be done to or with the participant
¢ what potential risks or discomforts the partici-
pant faces.
The disclosure requirement also explicitly places
researchers under the obligation to inform all
study participants of innovations in medicine
that could make participants change their mind
about participation. This requirement was
ignored in the Tuskegee study.
3 There has to be understanding of the
information
If the information being provided in the process
of full disclosure is phrased in a language or in a
manner that does not allow the person to under-
stand the information, then there can be no in-
formed consent. This is especially important for
researchers in a cross-cultural situation, as is
often the case in South Africa. Researchers often
come from a different social class and cultural
background to study participants. They also come
from a specific discipline with its own profes-
sional jargon. Special care needs to be taken to
3 general philosophical issues in epidemiology
ensure not only disclosure, but also understand-
ing of what is being disclosed.
4 Any decision, whether consent or refusal, needs
to be voluntary
In other words, there should be no undue influ- -
ence on the prospective participant to consent (or
refuse) to participate. This includes the duty of
researchers not to coerce or manipulate subjects.
For example, prospective study subjects taken
from a health care setting must be told specific-
ally that refusal to participate in research will not
lead to a reduction in the health care they will
receive. If incentives to participate are being con-
templated, it would constitute an ‘undue incen-
tive’ to offer an unemployed or poor person a
significant cash benefit for participation. Simi-
larly, research on persons with restricted auton-
omy, for example, prisoners or students (if the
researcher is also their professor), needs to make
special provisions to ensure that their decisions
are not influenced by coercion. Lastly, manipu-
lating people to participate by over-emphasizing
the potential social benefits of the research would
also infringe on the voluntariness of any decision
5 Aspecific authorization needs to be given by
the participant
After disclosure has taken place, the researcher
has an obligation to ask for explicit consent or
refusal to participate, whether written or oral.
The principle of beneficence
In general, this principle requires that the actions
of health and medical practitioners or researchers
be directed at improving the well-being of
patients or study participants, and they should
not cause harm to the patient or participant.
While this may sound obvious, there are several
important issues in research that violate or may
potentially violate this principle.
This principle is often divided into two com-
ponents: firstly, a principle of non-malevolence
_ (the obligation not to do harm), and secondly, a
principle of beneficence (the obligation to pre-
vent harm, to remove harm, and to do good). For
purposes of this text, both are considered under
one ethical principle of beneficence.
Firstly, even a non-invasive questionnaire or
interview may have detrimental consequences
29
a contextualizing epidemiology
for study subjects. Participants offer time which
may result in other priorities not being met (for
example, interviewing rural women may reduce
the time they have for water or wood collection or
child care). Confidentiality of answers may be
broken, and the participant may suffer as a conse-
quence (for example, an opinion about legaliz-
ation of prostitution may be counted against a
church member). Results of a study may detri-
mentally affect the group to which the particip-
ants belong (for example, the initial findings that
HIV was predominantly transmitted through
homosexual contact reinforced public stigmati-
zation of homosexual behaviour. Later recogni-
tion of heterosexual transmission has to some
extent countered this).
Secondly, research may be done for the benefit
of the researcher, not for the benefit of the partici-
pants or for society in general. Typically, many
students are required to conduct a research
project for degree purposes, while in other set-
tings, research is required for promotion. In such
cases, it is not always clear how the study partici-
pants will benefit.
Thirdly, there is often a tension between the
researcher’s opinion of what is good for partici-
pants, and the participants’ opinion of what is
good for themselves. This is typically the case in
situations where foreign researchers come to
Africa to conduct studies, on HIV/AIDS for exam-
ple. Whereas African priorities, at least in the short
term, are usually to develop appropriate preven-
tive education programmes or to investigate
optimal home-care mechanisms, foreign research
often focuses on the biological properties of HIV
infection. In such a case, extensive consultation
with the participants or their representatives is
essential to develop a study that will satisfy the
needs of both participants and researchers.
Research always demands some inputs, costs,
or discomfort from study participants. For
example, in the case of more invasive research,
such as taking blood specimens, discomfort and
possibly more serious side effects are expected.
The ‘do no harm’ interpretation of the benefi-
cence principle must therefore be restated as the
notion that, on balance, the research must do
more good than harm. This leads to another
important notion, namely that the research risks
must be commensurate with the expected bene-
fits. In other words, in the case of research into a
life-threatening condition (for example, cancer
treatment) the research risks may be more severe
than in case of research that pursues knowledge
30
in less dramatic areas (for example, effectiveness
of a breast-feeding education campaign).
Lastly, research risks in case of research on
minors (‘legally incompetent persons’) should
always be minimal. This is based on the principle
that only competent adults can make an in-
formed decision to subject themselves to severe
risk, and that no one has the right to make such a
decision on behalf of others.
The principle of justice
The notion of justice means that people receive
what is due to them. It includes, therefore, both
the right of the person to demand certain goods,
and the duty of others, such as researchers, to
provide these. This principle is extremely com-
plex in that it has an application in almost every
field of life. In the context of research ethics, this
principle is probably the least well developed of
the three principles discussed.
In research, the concept of justice is usually
interpreted to mean afair distribution of benefits
of the research (‘distributive justice’). For exam-
ple, although most AIDS/HIV vaccine research
being prepared will be conducted in the develop-
ing world, developing countries (and the popula-
tions originally researched) may not be able to
afford these very vaccines and will thus not get
the benefit of the research.
The principle of justice also leads to the inter-
pretation that all who stand to benefit from the
research should contribute to its risks and dis-
comforts. In other words, research that may
benefit both the rich and the poor should be con-
ducted among both groups, not only the poor.
Similarly, although medical students are an easy
target group for medical researchers, they should
not always be the study subjects for research that
may have applications for a wider audience. The
same applies to communities that tend to be-
come ‘over-surveyed’ because they happen to be
co-operative, or because they have a well-orga-
nized clinic.
There are now demands that research be dis-
tributed more fairly to make the potential benefits
more widely available. For example, in the pro-
cess of setting up research, both facilities and
human resource development need to be pro-
vided. This provides a direct benefit to the group
being researched. Similarly, in many areas of the
world, the only opportunity poor people may
have to obtain good quality medical care is if they
participate in a research project. In South Africa,
for example, anti-retro-viral medication against

HIV infection is not provided through the public
health services because of its costs. Conse-
quently, only the rich and those in clinical trials
testing these drugs will have access to them.
Some specific ethical issues and controversies
in epidemiological research
The substance and components of ‘informed
consent’ have been discussed under the principle
of respect for persons. There are, however, some
areas that need to be dealt with in more detail.
Communal versus individual consent
Informed consent requirements usually refer to
obtaining consent from the individuals who are
prospective research participants. However, in
South Africa and elsewhere, when conducting epi-
demiological research, researchers often ask for
consent from traditional or other local leaders to
research ‘their’ communities. This is a difficult
issue. Insofar as some cultures are more commu-
nally than individually oriented, it seems appro-
priate. Yet it clearly reduces the principle of auto-
nomy. If a communal leader gives permission, the
researcher continues and obtains consent from
individuals. However, if the leader refuses for
whatever positive or negative reasons, the indi-
viduals concerned can no longer be asked whether
or not they wish to participate. In this case, poten-
tial benefits of research may not accrue to them
because of someone else’s decision.
This presents a dilemma, as obtaining consent
from leaders appears to violate the right to self-
determination of individuals in the community.
On the other hand, studying a community or
group without the consent of those in authority
may either put participants at risk, or make it im-
possible to undertake the research. The imple-
mentation of later health interventions may also
be compromised.
Where research or interventions deal with
communities rather than with individuals, it is
advisable to seek consent from the ‘community’
rather than the individual. In such cases, it makes
sense to ask for consent from legitimate commu-
nity leaders. (Examples of such situations could
include studies on the fluoridation of drinking
water, mass education campaigns on HIV/
AIDS prevention, or on the influence of infra-
structural projects.)
Proxy consent as opposed to ‘first person’
informed consent
In general, informed consent refers to consent
3 general philosophical issues in epidemiology
obtained from the prospective study participant.
In the case of minors, the legal parents or carers
are allowed to consent on their behalf. For
research that carries no risk or only minimal risk,
this is usually adequate. Where research is con-
templated in which a minor may be exposed to
more than minimal risk, a debate arises as to
whether or not proxy consent is acceptable.
Those who find it unacceptable believe that
research with more than minimal risks on child-
ren can never be ethical. Because of this extreme
conclusion, many believe that the appropriate
way to approach this dilemma is to ask whether
the child would consent if he or she were a
‘reasonable adult’.
Similar issues arise in the case of research to be
conducted on temporarily or permanently in-
competent persons, such as people with an intel-
lectual disability, aged people with neuro-cere-
bral diseases, or unconscious persons.
A special situation arises when an otherwise
competent adult refers the researcher to a third
person. This may happen, for example, in the
case of a married woman who states that ‘her
husband or her children must decide’.
Typically, the ‘Western’ approach to this situation
is to demand first-person informed consent in
spite of the expressed wish. A more culturally
sensitive way might be to consider that the
prospective study participant has exercised the
right to self-determination by making the
decision that a ‘significant other person’ should
decide.
Partial disclosure
The requirement for full disclosure as part of the
informed consent process argues against delib-
erate omission of relevant information and de-
ception. Yet there are situations in which full dis-
closure will influence the subject of study. For
example, in a study of the attitudes of health
workers towards HIV-positive patients, the
results of a questionnaire survey would probably
differ widely according to how the aim of the
study was explained. Rather than fully explaining
the aim of the study before asking the questions,
the participants could be asked to take part in a
general questionnaire on hospital or health
matters, and subsequently be asked attitude
questions interspersed with questions on
different matters. In such a case, omission or
apparent deception may be the only way of
obtaining a true insight, and may therefore be
considered ethical.
3
a contextualizing epidemiology
Written versus oral consent
The emphasis on written consent, sometimes wit-
nessed written consent, stems from the need of
health workers to protect themselves from the
possibility of future court proceedings instituted
by participants who may claim not to have been
adequately informed. A second motivation is that
a clearly presented consent form will assist the
researcher in ensuring that all relevant topics
have been covered. A third reason for emphasiz-
ing written consent is that the process of signing
the consent form will help the participant to
realize that he or she is now aresearch partici-
pant. In other words, placing their signature on
the form brings home the reality of the decision
made by the participants.
The first reason, protection of health workers, is
only a relative one, in that no court will accept a
consent form as proof of adequate disclosure. The
second motivation to use written consent is not a
real motivation, in that one can have a clearly pre-
pared guideline on what to say to participants
without the need for a signature. The third moti-
vation may be the most important reason for
obtaining written informed consent. Yet it is this
very motivation which often causes people such
as illegal immigrants, refugees, sex workers and
those with any fear of authority to refuse to
participate. This is not because they do not wish
to participate in the research project, but because
they fear they will be harmed by unintended con-
sequences of having their names listed. These
fears may be justified, if research records should
be made public by negligence, break of confiden-
tiality, or court orders. In cultures where signing
is considered superfluous once someone has
given his or her word, insisting on a signature
could offend participants.
In general, ethics review committees in South
Africa demand written informed consent even in
the above cases, and even if the population
studied is illiterate. This seems irrational, and
may be based on a routine application of North
American procedures rather than on well-consid-
ered ethical reasoning. Should a researcher there-
fore not wish to obtain written consent, it is wise
to provide a full motivation, including ethical
arguments where possible, to the reviewers.
Informed consent: an occasion versus a process
The procedure of ‘getting informed consent’ is
often seen as a one-off action. This may be appro-
priate if the research is of a one-off nature, such as
a cross-sectional survey. However, when the
32
research requires a long relationship between the
participants and the researchers, it is more
appropriate to consider informed consent as an
ongoing process. In longitudinal studies and
long-term trials, for example, it would be wise to
continue the process of information provision
and obtaining consent. The case of Tuskegee is a
clear example of the need to consider informed
consent as a process rather than as an occasion.
Confidentiality and the use of databases or
medical records
Study participants can usually expect the results
obtained from their participation to remain
confidential. Efforts to ensure this are essential,
such as not obtaining personal information
unless it is absolutely necessary, and deleting per-
sonal information as soon as there is no longer a
need for it. However, in studies where large
numbers of participant characteristics are
collected, it may be possible to identify persons
even after removal of personal information. For
example, in a study of a village in a rural area,
there will be very few male teachers of 35 years old
who are member of the church choir. In such
cases, additional measures must be taken to
ensure that individuals cannot be identified.
Patients entering hospitals or clinics may rea-
sonably expect their records to remain confiden-
tial. Medical researchers should ensure this. Simi-
larly, use of other databases must guarantee con-
fidentiality of data. In South Africa, the study of
medical records and other databases is allowed,
provided adequate steps are taken to keep data
confidential. In some European countries,
however, use of records and databases is only
allowed after obtaining written informed consent
from the persons involved.
Use of specimens for other purposes
There are many laboratories that store speci-
mens, especially blood specimens, that have
served their purpose. Originally, consent would
have been obtained from the research partici-
pants to take the specimen for a specific purpose.
Once that has been done, can other research be
undertaken on these specimens without obtain-
ing further consent? It appears that current think-
ing considers this practice to be acceptable, pro-
vided the additional research has been submitted
once more to an ethical review committee, and
provided that the results remain unlinked to the
individuals concerned. Nevertheless, this is not
an easy issue. Even if precautions are taken

regarding confidentiality, the research may have
negative results for groups of people.
Quality of research
Low quality research is unethical in that it
exposes participants to the risks or costs of
research without the chance of future benefit.
Similarly, simple duplication of research done
elsewhere (for example, to obtain a degree) may
be unethical because it will not lead to any new
knowledge or action, even if the research was
conducted perfectly. However, conducting a
research project that was done elsewhere because
there may be sincere doubt as to whether or not it
would work in the local situation can be defended
on the basis that it might lead to new knowledge
or action, and therefore costs or risks on the part
of the participants can be justified. It is good to
distinguish between these two types of repeating
research by naming the first ‘duplication’ and the
second ‘replication’. Duplication of research is
not justifiable, and therefore not ethical, whereas
replication is justifiable, and therefore ethically
acceptable.
Conflicts of interest
As elsewhere in life, conflicts of interest may
occur in research. Often this takes the form of
sponsorship of research by a company that has an
interest in a particular outcome of the study, such
as in ‘drug trials. It is important to ensure absolute
independence between researcher and sponsor-
ship for the study to be considered ethically
acceptable. A not-so-obvious conflict of interest
occurs when research is done for degree and pro-
motional purposes. The double motives in such
research may at times be at odds with each other.
Whereas the research should, for example, be of
benefit to those participating, pressures from
promoters or deadlines may force the research
process to be modified to serve the student’s aims
first and those of the participants second or not at
all.
Obligation to feedback and publish
A last point, often forgotten in the rush to produce
research reports towards a degree, is that degree
manuscripts tend to gather dust in libraries with-
out their contents becoming known. Most ethics
review committees will nowadays insist on an
acceptable plan for the dissemination of informa-
tion gained from research before approving
research proposals. Publication in relevant peer-
reviewed journals is an obvious way of doing this,
3 general philosophical issues in epidemiology
but direct feedback to individuals and communi-
ties, or publication through the media, or to rele-
vant government departments, is an essential
part of an ethical study proposal.
Ethical review of research
In the United States, all academic and research
institutions are required by law to have ethical
review committees. These are called Institutional
Review Boards, or IRBs, whose members include
health professionals, ethicists, and ‘lay’ commu-
nity members. No such legislation exists in South
Aftica, but probably all academic and research
institutions, and even some of the large service-
rendering health institutions, do have a commit-
tee charged with the ethical review of research
proposals. Most committees do not, however,
include ethicists or community members.
Researchers working in institutions without a
specifically appointed ethics review committee,
or practitioners working on their own who want
to carry out research, can send their proposals to
the review committees of nearby institutions. In
addition, the Medical Research Council and the
Medical Association of South Africa provide
ethical review services in such cases.
From the previous sections of this chapter, it is
immediately apparent that there are many vague
areas in the field of bio-ethics. For example, how
can we balance research risks and benefits? Who
balances them? What is ‘minimal risk’? When is a
person temporarily or permanently incompetent?
At what age can children be expected to make
decisions concerning non-invasive research?
What constitutes full disclosure? When is decep-
tion appropriate?
The purpose of ethics review committees is to
apply ethical theory and ethical principles to
particular (research) situations and proposals,
and to assist in the development of ethical
research. It should be clear that many situations
preclude easy answers, and that deliberations
should often be extensive. For purposes of trans-
parency and of empowering the researchers (and
communities), it would be beneficial if ethics
review committees would open their delibera-
tions to at least the researchers, yet this is often
not done. As a researcher, however, one should
insist on a full report of the ethical reasoning that
was applied if the research proposal was rejected,
or substantial modifications were suggested. For-
tunately, most ethics review committees will
enter into debate with prospective researchers in
such instances.
33
a contextualizing epidemiology
Conclusion
It should be clear from-this section that it is not
always easy to come up with the ‘correct answers’
to ethical dilemmas. The ethical dilemmas out-
lined here attest to this fact. To ensure ethical
conduct of research, it is essential to use ethical
guidelines (Medical Research Council 1993;
CIOMS 1991) and to speak to colleagues, mem-
bers of groups among whom the research will be
conducted, and ethical review committees. Even
then, the research proposal may still be rejected.
The only way open is to then either accept this
judgement, or to elicit the opinion of another,
credible, ethics review committee.
Note that there is no accreditation mechanism
for ethics review committees in South Africa.
Although most research organizations and aca-
demic institutions, and even some health service
departments, have committees that deal with the
ethical review of research proposals, the compo-
sition, expertise, continuous education, and
reporting requirements of such committees has
not been regulated by law or otherwise. This is
unlike the situation in the United States, where
Institutional Review Boards are established in
terms of legislation and must comply with regula-
tions concerning important characteristics such
as membership, including non-professionals and
community members, composition in terms of
disciplines (such as ethicists, philosophers, law-
yers), and reports to be produced. It is hoped that
such regulations will be forthcoming in South
Africa in the near future. Until then, it is not wise
to ‘shop around’ until you find an ethics commit-
tee that will approve your proposal. Rather stick
with a review committee from one of the larger
research or academic institutions.
Whatever the choice, it is not ethical to go
ahead with the research without credible ethical
approval. The system may be slow and sometimes
incorrect, but it is the best system available to
protect society against researchers with divine
aspirations!
Community participation
Introduction
During the last three decades there has been
increasing emphasis on the concept and practice
of ‘participation by the people’ in a wide variety of
activities related to health, education, socio-
economic development and research. This
change in emphasis was a result of the poor
success of projects, mainly in developing coun-
34
tries, where communities were simply passive
recipients of assistance. More importantly, it re-
flected a commitment to involve previously mar-
ginalized communities in the social, political and
economic processes that affected them.
Community participation plays an important
role in epidemiology, since many epidemiological
studies take place in the community or involve
the evaluation of community health projects. It is
hoped that by involving non-researchers in the
research process, they will learn skills and gain
confidence. The community will be more likely to
accept the project and it will be easier to imple-
ment the results of the study.
The community
The ‘community’ is usually referred to in geo-
graphic terms as a group of people living in the
same defined area, sharing the same basic organi-
zation. A community can also be thought of as a
group of people sharing the same basic interests,
with membership changing as interests change.
Target populations or risk groups may also be
considered as communities, for example the
community of people with disabilities ina village.
Community participation
Community participation is a social process
whereby specific groups are actively involved in
decision-making and the implementation of
development, health or research projects, as well as
sharing in the benefits of the project/ programme.
The concept of ‘empowerment’ has become
central to the practice of community participa-
tion in projects. The term refers to a liberating
grassroots process of the acquisition of power by
oppressed or marginalized people. Participants
are favourably influenced by their involvement in
the programme/activity. They increasingly take
responsibility, initiative and decisions, thereby
increasing self-reliance and self-determination
on an individual, project and community level.
Application of community participation
It is useful to differentiate between community
participation in projects or programmes (which
focus on an ongoing community activity or
service), and community participation in re-
search, also referred to as participatory research
(which involves an investigation or evaluation).
Community participation in programmes
There is no single view on the role of the commu-
nity in educational, social service and health pro-
 3 general philosophical issues in epidemiology

Table 3.1 Common approaches to community participation in health

projects

Approach Initiation Role of Role of Strategies to Orientation

professional lay-people achieve goals to power
structures

Public Existing Full responsib- None, passive Environmental Completely

Health services ility for design recipients infrastructural part of
and execution and mass
of programme programmes to
promote health

Health Professionals, Initiate and Used as addi- Projects which Work closely
planning academics control tional manpower include members with power
and to gain of the community structures
public support in order to be
for projects successful

Community Community- Limited role: Dominant, self- Process goals Question the
development elected worker part of group help, voluntary very important commitment of
facilitates co-operation involvement in power struc-
initiation by and develop- economic, health tures to real
community ment of indi- and social issues progress
genous leader-
ship

Activists and Dominant and Mobilization of Demand redis-

disadvantaged serving the disadvantaged tribution
groups interests of the sectors. Demands of power,
disadvantaged for redistribution resources and
of power decision-
making

grammes. Approaches to participation differ Participatory research

regarding the process of initiating the activities,
the role of professionals and lay people in such
activities, the strategies used to achieve project *
goals and the orientation towards the established
power structures.
Four common approaches to community
involvement in community programmes are
contrasted in Table 3.1 (see also Rothman 1987;
Rifkin 1981). It is important to choose the appro-
priate approach for a particular community and
project. A flexible approach should be used. Com-
munity participation is not an all-or-nothing ap-
proach, so failure to achieve complete participa-
tion in all aspects of the project does not mean
that meaningful participation did not occur at
some levels, involving some people.
Participatory research is a co-operative enquiry
between researchers and the community being
researched, aimed at the identification and crit-
ical analysis of the community’s problems and
needs, and the search for solutions to these prob-
lems (Le Boterf 1994). Participatory research
essentially consists of three interrelated and
traditionally distinct activities: research, educa-
tion and collective action (usually for develop-
ment or social transformation). The combination
of the creation of knowledge about a commu-
nity’s problems and needs with collective, con-
crete action to change and improve that commu-
nity’s situation is perhaps the most unique aspect
of participatory research (De Koning 1994).
In participatory research ‘the community’

35
a contextualizing epidemiology
a
refers in general to potential users, beneficiaries
or subjects of research. The varying motivations
for participatory research will determine whether
‘the community’ refers to the most oppressed and
disadvantaged in society, the clients of a health
service, or the health workers in a health project
or service.
The concept of participatory research evolved
in the early 1970s as an alternative social science
research method which began to challenge the
notions of neutrality and objectivity on which
social science research methodology was based.
Various important historical trends contributed
to the development of participatory research
(Tandon 1994). One of these trends came from
the practice of adult educators in Third World
countries, who developed an approach to educa-
tion in which the learner began to control his or
her own learning process. These adult educators
then began to develop a similar approach to
research, in which the researched individuals or
community participate in the research process
and have some control over it. Another influence
was the work of Paulo Freire and Ivan Illich, who
placed participatory research as an educational
process within the framework of an ‘alternative
pedagogy’ or popular education. During the mid-
1970s, with the failures of top-down, expert-
designed development projects and programmes,
the debate on development began to view the
question of participation as a critical variable in
human development (Tandon 1994). This further
influenced the evolution of participatory re-
search.
The main aim of participatory research is to
provide a forum for the voiceless and powerless to
be creative actors and subjects, not merely
‘objects’ in the process of research and know-
ledge creation. The intention is to provide ways
for ordinary and oppressed people to produce the
information they require to understand and to
deal with problems in their lives and larger insti-
tutional structures.
However, motivations for participatory re-
search will vary, in ways similar to those
described for community participation in pro-
grammes in Table 3.1. Where community partici-
pation is seen as a process in which disadvan-
taged people work together to overcome prob-
lems, challenge the distribution of power and
resources in society, and gain more control over
their lives, participatory research is used to
enhance their awareness and confidence, and to
empower their actions (Lammerink 1994). Other
36
motivations for participatory research could vary
from obtaining more reliable data, to encourag-
ing people to cooperate in a programme, to giving
people more control over facilities (Lammerink
1994).
The action component of participatory re-
search could, for example, have as its goal the em-
powerment of the community concerned (a
process), or the more efficient service delivery for
that community (a product).
The extent of community participation in
research can vary from involvement in every step
through to the other extreme, where researchers
use community participation to facilitate data
collection and the implementation of their own
results. In any one research project there are a
range of activities in which a variety of partici-
pants can be involved. This has been termed the
participatory continuum (Maquire 1994).
Many epidemiological studies are carried out
with very little involvement from the commu-
nities or health workers that are the subjects of
research. Their involvement seldom extends
beyond being interviewed, answering question-
naires, occasionally being recruited as field-
workers, or utilizing some of the results. In con-
trast, a participatory research approach could
mean that:
the research question and the research priori-
ties are based on the needs of the community as
seen and formulated by the community itself;
the methods of data collection are designed
with community members and are under-
standable and acceptable to the community;
@ the data collection is undertaken by commu-
nity members;
@ there is community participation in the ana-
lysis;
@ the results are distributed in a way that makes it
possible for people from outside the scientific
profession to participate in the discussion.
Full participation of all the people in the com-
munity, or health workers in a project, in all
aspects of the research may be clumsy, cumber-
some and not always appropriate. The extent of
participation can be decided on by the commu-
nity and may depend on the project’s aims and
resources, and whether there is time for all parti-
cipants to take part in each stage of the research
process. The level of motivation of the group is an
important consideration.
Full participation may slow down the research
process to such an extent that all impetus and

enthusiasm is lost. Progress must be evident to
maintain the interest and commitment of the
group, while not compromising the process. The
balance is a delicate one. For specialized tasks,
the group may need to consider delegating
responsibility. Each participant remains account-
able to the group, and the value of the participa-
tory approach need not be lost.
Participatory methodology and participatory
research can be qualitative or quantitative. There
are no typical participatory research methods.
Conventional research methods such as struc-
tured questionnaires can be used in a participa-
tory way. Other unconventional, accessible
methods of data collection, analysis and report-
ing results may need to be created in response to
the problem, the context, and in response to
‘where the participants are at’ (Meulenberg-
Buskens 1994).
Examples of these are mapping exercises in
which community members create diagrams and
pictures (maps) visually illustrating information
about their community, group discussions, a ‘pic-
tionnaire’ (see Figure 3.6), group tallying exer-
cises to collate results, the use of visual images,
radio, photographs, exhibitions and popular
theatre to report results. The participatory
researcher needs flexibility and creativity -to
design innovative, appropriate methods.
A participatory approach to research does not
mean that the scientific merit of the methods or
the validity of the results needs to be compro-
mised. The researchers need to facilitate an
educational process in which the community
participants are introduced to previously un-
familiar research methods, technologies and
processes in accessible language, free of scientific
jargon. Thus the researcher needs to take on the
role of educator or trainer. Time must be set aside
for the learning and the participation processes.
In the research process, the researcher too
becomes a learner and may find him- or herself
changed and challenged in sometimes profound
and unsettling ways through the process of
engaging in collective investigation, education
and perhaps action (Maquire 1994).
Respect and clear communication are crucial
qualities in the relationship between the re-
searchers and the community in the research
process. The resources and experience brought
by each party into the research partnership are
different. This should be acknowledged, and each
group should appreciate and respect what they
can learn from and share with the other. The allo-
3 general philosophical issues in epidemiology
cation of tasks and the process of accountability
need to be clearly and openly communicated
during the research.
The participatory research process has advan-
tages which go beyond the research itself. It can
strengthen the democratic processes in a health
project or community; it can lead to greater self-
reliance in the participating group and greater
involvement in decision-making; it can encour-
age trust, responsibility and equality among all
concerned; and it can equip project and com-
munity members with the knowledge, skill and
attitudes needed for working together to tackle
their problems and meet their needs. While the
research process can be empowering, the re-
search product itself may also benefit from
community involvement, although this is not a
primary motivation for participatory research. It
may be a more accurate reflection of local real-
ities, problems and needs, thus providing a better
grounding for more culturally relevant and thus
more effective and meaningful local action
(Maquire 1994). Thus any action, policy or social
programme emerging from such research is less
likely to marginalize these communities, and
more likely to truly serve them (Khanna 1994).
One of the requirements for engaging in partici-
patory research is time. One of its major dis-
advantages is that it is often a long, very time-
consuming process. In participatory research, the
researchers may relinquish control over the identi-
fication of the research question, as well as over re-
search funds, and they may experience this as a dis-
advantage. A further difficulty researchers may ex-
perience relates to the process of establishing the
involvement of a community, or accountability to a
community. In deciding which individuals or orga-
nizations represent the community’s interests, re-
searchers may become embroiled in that commu-
nity’s political conflicts and power struggles.
Evaluation of community participation in
projects
Many health projects explicitly state community
participation as a goal of the project. Indeed,
community participation is seen as an important
component of the primary health care approach
which has been adopted by many countries,
including South Africa. However, it is usually
difficult to evaluate how well this aspect of a
service or project is being implemented.
A variety of criteria for judging the quality of
participation in projects have been put forward
by different authors. Cohen and Uphoff (1977)
37
a contextualizing epidemiology

suggest three main criteria for evaluation. The

first considers the kind of participation which Pet ge ee Ce framework to
takes place in the project/service, and suggests assess participation in projects
that evaluators reflect on participation in deci-
sion-making, implementation, benefits and eval-
uation. The second criterion considers the kind of
people participating (who?) — local residents, Z

&o
local leaders, government personnel or foreign %,oD
personnel. The last criterion considers how patti- f
.
cipation takes place. A suggested adaptation to %2
this framework is to include an autonomy/ ’ Management
a

dependency scale with each item to incorporate

the issue of empowerment.
A framework proposed by Rifkin, Muller and
Bichmann (1988) assesses how wide participation
in projects is on a continuum developed for each
of five important aspects of project development:
needs assessment, management, resource mobil-
ization, organization, and leadership.
Values are plotted along the five axes to give a
visual presentation of the width of participation Source: Rifkin S B, Muller F, Bichmann W, 1988.
(see Figure 3.3). These values are not ‘absolute’ or
‘correct’, but provide a value against which re-
peated assessments can be compared. Results of munity participation is something that develops
repeated assessments can be superimposed on gradually, and programmes need a tool which can
the baseline to see if participation in the project provide an assessment of current situations while
has broadened. This is important because com- also allowing for comparisons over time.

Sree CCRC Ce Rm Ce |
community participation
Needs and skills assessment Organization of health committee

Initial needs assessment Formation of committee

Skills identification Decision making of committee
Ongoing research and evaluation Accountability of committee

Management

Management by committee
Management by staff
Skills development

Leadership of health committee Resource mobilization

How leader was chosen Raising resources

Role of leader in allowing participation Resources from the community
Role of other committee members Control over allocation

Source: Chetty K, Owen P, 1994.

38
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a contextualizing epidemiology
Chetty and Owen (1994) adapted and expanded
Rifkin’s criteria to allow assessment of participa-
tion using a more detailed method of scoring.
Rifkin’s five axes were each divided into three
components, assessed, and ranked from 1 to 5
according to predetermined guidelines. This was
developed in the South African setting, recogniz-
ing the diverse contexts in which community
participation takes place.
Figure 3.4 gives the components into which
each of Rifkin’s axes were divided and provides a
useful guideline for projects in the initial plan-
ning stage, as well as later in the project when
participation needs to be improved. Table 3.2
describes criteria for ranking each of the three
components along the ‘management’ axis, show-
ing some of the qualities that allow a project to be
ranked high on community participation.
When evaluating community participation it is
important to identify exactly what aspects and
degree of community participation the specific
project or service aims at. Once these have been
identified, qualitative and quantitative methods
can be used to see if the goals have been reached.
Chetty and Owen propose the use of semi-struc-
tured interviews with as many different role
players as possible in a given project. Qualitative
methods in the form of focus groups and in-depth
interviews can also be extremely useful.
Conclusion
An approach embodying community participa-
tion can be applied to many public health
endeavours, including epidemiological studies.
Such an approach demands that researchers
acknowledge, respect, understand and involve
the ‘populations’ they study. A participatory
approach, while not appropriate in all epidemio-
logical studies, can enhance both the research
results and the implementation of its findings and
recommendations. Public health has been
defined as efforts ‘directed to the maintenance
and improvement of the health of the people
through collective or social action’ (Last 1988).
Community participation provides a way of
ensuring that epidemiological findings can facil-
itate such action.
Planning for the implementation of
research
Introduction
‘Much of the material remains unprocessed, or
if processed, unanalysed, or -if analysed, not
40
written-up, or if written-up, not read, or if read,
not used or acted upon. Only a minuscule propor-
tion, if any, of the findings affect policy and they
are usually a few simple totals’ (Chambers 1989).
As the costs of research escalate, there is grow-
ing concern about the value society receives in
return for the investment it makes in research.
The traditional view that the pursuit of knowledge
for its own sake is the mark of a civilized society,
and should be supported as an act of faith, is no
longer unquestioningly accepted. A limited
research budget demands that choices have to be
made. The current trend in research funding
focuses positively on areas that are most likely to
yield a return to society (Twiss 1988).
The purpose of epidemiological research is to
improve public health by identifying and redefin-
ing solutions to problems through the generation
of new knowledge. The generation of new know-
ledge or technologies alone is not an adequate
goal in such an applied discipline.
Most researchers hope their results will be read
and acted upon by policy-makers, and assume
that the utilization of research information
depends primarily on the intrinsic worth of that
information. This assumption has been proved
empirically to be false (Weiss, Bucuvalas 1977).
For a research project to make a contribution to
health problems, the researcher needs to be inno-
vative not only in generating new knowledge, but
also in disseminating it to potential users (stake-
holders). Training in epidemiological research
skills rarely emphasizes any aspects of the imple-
mentation of research recommendations, result-
ing in limited practical application of research
findings in the public health field.
The ‘implementation of research’
To ‘implement’ means to ‘bring into effect’. The
definition must be interpreted in a flexible way if
it is to be a useful concept in research. It may be
used in a situation when the extension of know-
ledge leads to changes in policy, behaviour, deci-
sion-making rules or the allocation of resources.
Research may yield a wide range of changes. At
the simplest level, the change may be in the level
of knowledge or understanding of a problem. This
knowledge may precipitate the development of
new skills or lead to a change in the behaviour of
individuals or groups. The new information may
lead to changes in organizational policy or, at the
most complex level, a change in individual
assumptions, values and beliefs. These changes
may infiltrate from the individual to the social

group. The research objective of changing the
level of knowledge of individuals is simple to
achieve. Developing new skills, attitudes and
values is increasingly difficult to achieve.
The researcher has a role to play in all four steps
of the policy development cycle (see Figure 3.5).
Researchers can help health providers clarify
loosely identified problems and develop an
appropriate research approach. The major input
of research tends to consist of describing the
nature, extent and determinants of the problem.
This information is useful to health providers who
are planning an intervention designed to remedy
the problem. The researcher may have a limited
role to play in the actual implementation of the
intervention strategy. During the evaluation of
the strategy, the researcher makes a major contri-
bution by assessing outcomes related to interven-
tions introduced. Frequently, the outcome eval-
uation will proceed to an economic evaluation to
determine the cost-effectiveness of health care
interventions.
Obstacles to the utilization of research
information
Effective communication between the researcher
and the research user facilitates the fuller use of
research results. Effective communication is nota
one-way process, but a dialogue that takes place
over. time. Good communication allows both
sides to share their concerns, and enables the
message to be reshaped to suit the needs, con-
cerns and circumstances of the receiver. The fact
that the researcher and the decision-maker
seldom form part of the same health team
hampers communication. Researchers may lack
understanding of the decision-making process
and may frame the research question in a way
that has little relevance to decision-makers. The
research process takes time to execute, and this
may result in a delay in providing the research
user with essential information for decision-
making. Policy-makers may want information in
days while researchers may need months to
provide research results.
Decision-making in health care services is a
complex process which may be affected by vari-
ables other than research-based information,
such as economic, political or cultural agendas.
Researchers tend to communicate their results
in highly specialized terminology which may not
be easily interpreted by policy-makers who are
not trained in biostatistics and research method-
ology. The tendency for researchers to make
3 general philosophical issues in epidemiology
Figure 3.5 Policy development
cycle
Identify problem
tie eggs
Evaluate strategy Plan strategy
Implement strategy
global rather than specific recommendations
may confuse the policy-makers. Policy-makers
complain that research recommendations are
frequently too impractical to implement.
The information generated from research is
often published in scientific journals. These jour-
nals may not be easily accessible or of interest to
potential research users. If research information
were published in more appropriate ways, then
decision-makers might be more likely to use it
(Gouws 1988). This would require a careful ana-
lysis of the target population and the optimal way
in which the information could affect their deci-
sion-making.
While there is a gap between policy-makers/
providers and researchers, there is an even
greater gap between the public and researchers. It
is thus important to consider not only the imple-
menters of change but also the would-be reci-
pients of that change.
Facilitating the implementation of research
Closing the communication gap between the
world of research and routine organizational
practice helps to ensure better use of research
results. Participation in the knowledge-building
process has proved to be a successful way of
ensuring that research-based information is
appropriately implemented.
Researchers need to:
co-operate with decision-makers in establish-
ing their information needs. Decision-makers
should be involved in the development of
research objectives. Consultation with people
in the field of application — clinicians and
managers alike — will ensure that the research
will be relevant outside the strictly research/
academic environment.
@ identify all potential users and benefactors
(stakeholders) of the research information at
the inception of the project. These may include
governmental and non-governmental service
providers, and community-based organiza-
4l
a contextualizing epidemiology
tions. It is very important that the stakeholders
closest to the unit of study be involved; for
example, village structures and not regional
structures, if the focus is on village level.
¢ define the implementation objectives at the
protocol development stage. These differ from
general scientific objectives in that they state
the purpose of the study and what is to be done
with the results. For example, a study of the
prevalence of malnutrition (scientific objec-
tive) is only one step towards the true imple-
mentation objective — reduction of malnutri-
tion in the community.
@ involve the stakeholders in the research
process and keep their interest in the methods
and analysis of results.
@ give feedback regarding the results directly,
accessibly and promptly to the stakeholders.
Conclusion
The issue of how intimately the researcher should
be involved in facilitating the implementation of
research recommendations is a controversial
one. In the past, there has been a tendency for
epidemiological research to be practised inde-
pendent of any health practice application. There
is a need to link research to policy and many re-
search organizations and funders are now insist-
ing that implementation objectives are stated
explicitly in epidemiological protocols and fund-
ing proposals. Many of the issues involved in
implementing research recommendations are
difficult to negotiate. In attempting to define the
issues, researchers may take the first step in
developing a strategy to improve the utilization of
research-based information.
EXAMPLE 3.1
Some ethical dilemmas to stimulate
ethical reasoning
1. The development of an effective preventive HIV
vaccine would constitute one of the great medical
miracles of this or the next century. HIV vaccine
trials are in the process of beginning, and many
have proposed developing countries as trial sites.
In any HIV trial, researchers will have to compare
a vaccinated group with an unvaccinated (or
placebo-vaccinated) group for incidence of infec-
tion with HIV. To become infected with HIV,
however, one needs to engage in ‘unsafe sexual
practices’. One of the great moral dilemmas pre-
42
sented by HIV vaccine trials is the extent to which
researchers must educate the study subjects
about ‘safer sex’ practices. The research needs
‘unsafe sex’ to prove the value of the vaccine, yet
the principle of beneficence demands that we go
out of our way to encourage ‘safer sex’ practices.
If you were asked to take part in this trial as a re-
searcher, how would you solve this dilemma?
2. A research project involving prostitutes in
inner-cities needs their co-operation over a
period of time. The researcher has to obtain their
personal details to ensure follow-up, and devel-
ops an intricate system of recording information
so that only she knows the identity of the persons.
The moral dilemma in this case centres around
the researcher. The only way to help improve the
health of the prostitutes is through the research,
for which personal details are needed. Yet, prosti-
tution is illegal, and if a court of law were to order
the researcher to hand over all records, she would
then be required to do so, thus breaking her pro-
mise of confidentiality.
What would you do in this case?
3. A researcher wishes to investigate the quality of
care given by pharmacists to children with infan-
tile gastro-enteritis. The questions relate both to
the diagnosis reached and to the therapy pro-
vided. Ideally, the researcher would like to com-
pare the quality of care given by pharmacists to
the care given by general practitioners. However,
this will not be possible for methodological
reasons, as the two professions will require en-
tirely different assessment procedures. On asking
the opinion of a pharmacist about the study, she
suggests that the study not be conducted at this
time, as it could prejudice the tense debate
between medical practitioners and pharmacists
about providing, and charging, for primary care.
In other words, any negative results of the study
could be used by medical practitioners to argue
their case for not allowing pharmacists to engage
in primary care activities.
Clearly, the information on the quality of care
delivered by any health worker is pertinent to a
good health service, and is therefore morally jus-
tified on the basis of beneficence. On the other
hand, the results may lead to an unfair advantage
(at least perceived as such by pharmacists) in the
dispute between the two groups, and may there-
fore not be justifiable on the basis of the principle
of justice.
How would you deal with this?

EXAMPLE 3.2
Community participation: Mamre
Community Health Project
The Mamre Community Health Project was
launched by the Medical Research Council and
the Community Health Department of the
University of Cape Town (UCT) primarily as a
public health research initiative in 1986.
Community participation was a working princi-
ple of the project from its inception. Access to the
community was first negotiated by members of the
research team together with the major groupings
in Mamre: the church, the Village Management
Board, and the school. A public meeting attempted
to get broader support for the project from Mamre
residents. A steering committee, comprising
mainly professional Mamre residents, volunteered
to assist the project in its research, thus function-
ing as a reference group for research efforts. By the
time the baseline research was undertaken, con-
sent had been obtained and limited participation
of the community had been achieved through its
representation on the steering committee, and
involvement of local women as interviewers.
Efforts by the research team to popularize the
research findings included posters at community
events, slide-tape shows facilitated by the inter-
viewers in the homes of Mamre residents, and the
delivery of a simple, illustrated booklet of results
to each household in Mamre.
The completion of the baseline study describ-
ing the community and its health stimulated inte-
rest in the project from different quarters. More
clinically orientated departments at UCT became
involved in the project, and the community itself
expressed the need to see something ‘done’ about
the problems identified. Thus the project focus
broadened to include substantial service and
training components.
The introduction of new types of activities in
the project provided the opportunity to increase
community participation and control. The aim
was to involve the community as much as pos-
sible in deciding on the policy and activities of the
project. Academics, clinicians, and researchers
from UCT and the Medical Research Council
remained involved as technical advisors or con-
sultants on the project, and staff employed by the
project (who were members of the community)
ran the day-to-day activities of the project.
A quarterly meeting of representatives from all
organizations and clubs in Mamre provides an
opportunity for consultation with and feedback to
3 general philosophical issues in epidemiology
the ‘organized’ sector of the community. Addition-
ally, a community-elected committee works
closely with the academic arm of the project in
planning and running activities. Initially, the com-
mittee’s absence in the day-to-day management
of the project and its lack of access to the funds
which were administered by the university threat-
ened to undermine its full participation in the
project. Restructuring of the project and redefini-
tion of the role of the committee has addressed
these problems. Currently, the committee has the
power to veto research, teaching, and services, and
cettain of the funds have been placed under their
direct control. The most recent development, in
keeping with the ultimate goal of integrating the
project into the district health plan, is that certain
services have been incorporated into the local
health services and funded by the local authority.
The Mamre Community Health Project has had
an influence on the broader development of the
community. The politically non-aligned position
of the project and the fact that health is an issue
around which people of differing political persu-
asions are prepared to cooperate, created the
space for members of this politically divided com-
munity to co-operate in a project for the common
good. The policy of broad consultation and
accountability was in itself an important process
for the (then) disenfranchised and marginalized
community, and contributed in a substantial way
to the community’s increasing sense of determin-
ing its own development. The community is able
to participate in research, understand the results,
and use them for advocating changes to improve
the quality of life for the community at large.
On a less visible level, the project has been
responsible for human resource development
through the training of project staff, as well as
through its specific activities. These include life-
skills training and career guidance among the
youth, involvement of members of the commun-
ity as facilitators for the lifestyle modification pro-
grammes, and the training of families to cope with
the disabled or chronically ill in the community.
In terms of the evaluation of community parti-
cipation using the Chetty and Owen adaptation of
Rifkin’s participation criteria of the management
component, the project ranks 3 on management
by committee, 5 on management by project staff,
and 5 on skills development.
The exposure and access to health, welfare
and community development agencies outside
Mamre have increased substantially as a result of
the policy of promoting the development of net-
43
a contextualizing epidemiology
works to support and inform activities in Mamre.
Close working relationships have been developed
with people in the community, and communal
efforts, now largely independent of the Mamre
Community Health Project, continue to flourish.
References:
Katzenellenbogen J, Pick W, Hoffman M, Weir G. ‘Commun-
ity participation in the Mamre Community Health Project.’
South African Medical Journal 1988; 74:335-8.
Katzenellenbogen J, Swartz L, Hoffman M. ‘From research to
service provision: the Mamre Community Health Project —
seven years later’ (editorial). South African Medical Journal
1995; 85(9): 843-4.
Louw], Katzenellenbogen J, Carolissen R. ‘Community
health needs, community participation and evaluation.’
Evaluation and Programme Planning 1995; 18(14): 365-9.
EXAMPLE 3.3
Community participation: Ithusheng
VHW evaluation
During 1990, the Ithusheng Health Project in the
Northern Transvaal did a community survey to
evaluate the work of their Village Health Workers
(VHWs). The external researchers first involved the
VHWs in determining which aspects of their work
they saw as most important and how they would
evaluate those aspects of their work. The VHWs
then drew up aset of evaluation questions to use in
a community survey. In order to accommodate
VHWs with relatively low literacy, the questions
were put into a pictionnaire (see Figure 3.6). This
made it possible for less literate VHWs to use in
their own villages. After collecting the data, the
VHWSs analysed the data by means of the hand-
tally method. The responses on each completed
pictionnaire were called out by the VHWs and
recorded on a big sheet (see Figure 3.7). After
adding up the totals, VHWs got immediate feed-
back of the results. They then participated in the
analysis of the results and in discussing the impli-
cations of the results on their work. In this case, the
health workers participated in the design as well as
the implementation and analysis of the evaluation.
The main objective of the researchers was to teach
the VHWs how to evaluate their own work and how
to build evaluation into their project planning.
Reference:
Van der Walt H, Hoogendoorn L. ‘Training for self-evalu-
ation. Experiences at Ithusheng Health Centre, South
Africa.’ Learning for Health 1995; 7:8-12.
44
EXAMPLE 3.4
Community participation: Respira-
tory health survey
A union identified a particular health problem
facing its workers and asked the Health Inform-
ation Centre (HIC) in Johannesburg to help inves-
tigate the problem. A respiratory health survey was
undertaken to determine whether a certain dust in
the workplace could cause respiratory disease,
and a participatory approach was adopted.
The request came from a democratic trade
union representing the interests of the people
who were to be researched. Information about
the study was given to the entire workforce, and
the go-ahead was confirmed at the hostels and at
the start of the early morning shift.
The protocol, designed by the HIC according to
the union’s requirements, was discussed with
management, and shift changes were allowed to
accommodate the study. The study consisted of a
respiratory questionnaire and lung function tests
at the beginning and end of the working week.
Bronchodilator and skin-prick testing was done
to determine the atopic status of the working
population.
The data analysis was done by HIC staff and the
results presented to the union and management
in writing. In addition, a workers’ report-back was
organized. The entire workforce came to a 6 am
meeting, where, through translation, the results
of the study were explained.
Together with the union, the researchers
produced education booklets on the hazards of
the industry. Workers used the results of this
study to put forward demands for safer methods
of handling the raw material, with less dust. After
two years, better working conditions were intro-
duced in every factory organized by this union.
Action was thus taken as a result of the research.
In this example, research was conducted
through the initiative of the workers. Limited par-
ticipation was achieved in the research process it-
self in that few, if any, research skills were learned
by the workers. However, the researchers re-
mained accountable to the workforce throughout
and did involve the union in the production of the
booklet, one component of the implementation
of the results. The target population also received
benefit from the study.
Reference:
‘Health Information Centre. Worker participation in a
respiratory health survey.’ Critical Health 1989; 20:30-34.
 3 general philosophical issues in epidemiology

SP eM MCC MUR UCm hmeCLeCd)

Husheng VHW survey October 1990

eme kae?
1. Ngawana wa gogo wa mafelelo ona le mengwago
(How old is your child ?)

fi. Pale rsEa Ee

2. Ofepile ngwana wogogo wa matelelo bjang®
€ Did you L hioe your child?)

%,O mamisite ngwana wa gago mako e kae ?

CIF yes, for how long!P)

Sone TB eee tO Fil le

4.© ubora!
naa: >
eb lela lagago le hlwekile pit ?)
a 's es Pues ey yard? |s there melee

[= ®|2 “ef p1__—

5. eae int ees rte
eb dir etse a Motswako:
ge Fos opt ei ane make thesu dai
ee Taet¥o Cif yes,tell me how) [Eee]
6. LO
meetse a motswako neng ?
O mota
CHew much and when do you give it )

8, Le nyaka gore ba tsa Maphelo bale direle eng©

(What would you like your health worker tp do°

45
a contextualizing epidemiology

ar ee eM Na ORCC hme LE

s 135 (897%)

46
 Literature review _
_ G Joubert,J Katzenellenbc

Sampling oe
G Joubert, J Katzenellenbogen

Datacollection and measurement

. oe
iv

Introduction
The research process includes planning, execu-
tion, analytic and reporting phases (Figure 4.1).
This section covers the planning phase, which
involves systematic preparation for a research
study.
Figure 4.1 The research process
Planning phase
Execution phase
Analytic phase
Reporting phase
Assembling the research team
Community health research is often done by
research teams rather than by individuals. The
research team should not have too many mem-
bers, as this may hinder effective communication
and make meetings cumbersome. However, it is
good to have people who contribute different
skills and input into the design and implementa-
tion of the study. Co-workers should preferably
be people with whom you know you will work
well, are reliable, facilitate action and have good
Planning a
research project
track records. It is also good to have one or two
people with research experience on your research
team.
The roles of the different team members must
be spelt out to avoid duplication or omission of
tasks. Researchers should be given clear areas of
responsibility, for example data manager, field
co-ordinator, questionnaire designer-in-chief
and sampling, so that continuity is provided for
each task.
Regular meetings should be held to keep every-
body in touch with the study, to make joint deci-
sions and to provide a forum for discussing
concepts and understandings that are different
among the different members.
At the protocol development stage it should be
discussed which team members will take
responsibility for the writing up of publications
resulting from the study. In this way, ambiguities
and conflict about authorship can be avoided at a
later stage.
The following three common mistakes should
be avoided when assembling the research team:
¢ giving over-committed and high-profile people
token co-investigator status on the project.
Before any individual researcher can be recog-
nized as a co-investigator, that person’s role
and responsibilities must be made clear;
including incompetent people who fail to do
their tasks well and in time. It can be very frus-
trating for a group when one member’s incom-
petence has to be continually considered and
compensated for;
@ creating the impression that everyone men-
tioned on the protocol will be a co-author of
every publication resulting from the study. It
should be made clear that there is no ‘right’ to
49
b epidemiological research methods and protocol development
authorship — it must be earned through intel-
lectual contribution and work.
The study protocol
The study protocol, sometimes called a research
proposal, is a formal written document which is
prepared prior to the study. It documents the
reasons for the study and the details of the
methodology and, in doing so, gives a clear plan
of exactly what needs to be done.
The study protocol has many purposes. It helps
the researcher focus on critical issues, clarify
ideas and keep on track. It also enables outsiders
to understand what is intended so they can
comment critically either on the written docu-
ment itself, or at peer group protocol meetings
where protocols are reviewed. A clearly written
protocol also enables other researchers to repeat
the same design in another setting and allows for
Table 4.1 Major headings ina
chteateted
Tite,piraeet investigator, co-investi
institutional affiliations, and qualifications
Summary/Abstract
1 Introduction
1.1 Literature revi W
1.2 Motivation for the study (problem)
1.3 Purpose
1.4 Specific objectives
41.5 Implementation ee
Methods o A protocol should start with a title and authors
2.1 Definition of terms
2.2 Study design
2.3 Study population and sampling
3.1 Responsibilities of investigators
3.2 Responsibilities of staff
3.3 Time schedule : do not accept more than one principal invest-
Data management and ae
_ Resources _ list of co-investigators (either in order of import-
5.1 Available resources
5.2 Budget and budget motivation.
Ethical and legal considerations —
Reporting of results _
References _
Appendices
50
comparability of results. Protocols are also
submitted to funding agencies (for example the
Medical Research Council) when funds are
sought, and to ethical committees for approval.
Universities require protocols before confirming
the registration of a student for postgraduate
study. The protocol eventually helps in the
writing up of the study.
The protocol is a dynamic document which
keeps changing as the planning of the project
progresses. A very crude protocol might be pre-
sented in a pre-protocol session where colleagues
review the initial ideas and brainstorm their feas-
ibility with the researcher. Based on input at these
sessions, a more thorough and systematic proto-
col can be drawn up and critiqued at a later proto-
col meeting. Changes and adaptations based on
recommendations made by peers and consult-
ants should be made so that the benefit of the
peer review process is not lost. Key stakeholders
in the research should be invoived in the protocol
development to ensure that there is agreement on
the importance of the issues being studied, that
there is acommitment to act on the results, and to
enhance participation. Once the protocol has
been accepted by an ethics committee it should,
however, not be changed further. If more changes
are required, these changes have to be approved
by the ethics committee.
The process of protocol development can be
slow if the researcher is inexperienced, if there are
few resources and consultants available, and if
the area of research is a new one.
Contents of the protocol
page. An informative (but not cumbersome) title
which clearly describes the purpose of the study is
important. This information is placed on many
databases. Cryptic titles are not desirable. The
principal investigator’s name, qualifications and
institutional affiliation should then be stated.
Some funding or reviewing institutions (for exam-
ple, the National Institutes for Health in the USA)
igator, while other institutions are more lenient. A
ance to the study or in alphabetical order) with
qualifications and institutional affiliations must
also be included.
The title page is followed by a brief summary or
abstract which gives the reader a general over-
view of the proposed study. A short statement of
the purpose of the study, the major research

questions to be asked and the methods to be
used, should be included.
The major headings to be used in a protocol are
included in Table 4.1. A brief indication of what
each heading covers is given below. The main
points are discussed in detail in the other chap-
ters of this section.
1 The introduction describes the problem to be
studied and reviews relevant available informa-
tion. It provides the motivation for the re-
search, and the specific research questions that
are being asked. The overall purpose or aim,
and specific objectives of the study should be
clearly stated.
2 The methods section gives a comprehensive
description of the methodology to be used. For
the sake of exactness and clarity, definition of
terms must be included. All key terms referred
to in the aim or topic of the study, and the
specific objectives, must be defined. This
ensures that all people reading the protocol
have the same understanding. Definitions also
help the researcher clarify concepts for him- or
herself.
The investigator must state which type of
epidemiological study (study design) will be
used to best meet the objectives. ; 9 Appendices should include a copy of the ques-
The study population must be identified
precisely in terms of sex, age, place, condition,
and any other relevant factor. If sampling is to
be used, the sampling strategy must be
described in detail. The source of the sampling
frame, and the intended sample size (and
reasons for this) should be stated.
The method of data collection (measurement)
should be specified, as well as the variables or
characteristics to be measured. Measuring
instruments should be described, and an indi-
cation of their validity and reliability provided.
The protocol should report on or state the
intention to conduct any pilot studies. These
are mini-studies which test part(s) of the study
before the main study. Pilot studies usually
check the methods (for example, instruments
or logistics), obtain data to assist in sample size
estimation and/or test the adequacy of field
training.
3 The practical logistics of the study must be
carefully planned. These include clear task allo-
cation, organization of venues, shifts or duties,
and transport. A realistic approximate time
schedule for carrying out various aspects of the
study should be attached.
4 planning a research project
4 Data management and.analysis: Details
should be given of the means of data manage-
ment and analysis (computer or not), the
methods of analysis, and any statistical support
or advice received to date, or planned for the
future. Useful additions to a protocol are
‘dummy’ or mock tables which indicate how
the final tables of results will look.
5 Resources: Detailed estimates of personnel,
equipment and financial resources (for salaries,
travel costs, equipment, computing, telephone
calls, stationery) need to be recorded. An esti-
mated budget is useful and often essential.
6 Ethical and legal considerations: In the proto-
col, plans for safeguarding the rights and wel-
fare of participants should be explained. Steps
to ensure ethical and legal access to commu-
nities, groups or records should be specified.
\] Reporting of the results: The protocol should
state the specific format and manner in which
results will be reported to both the public in
general and particular individuals and groups.
Target groups which can facilitate the imple-
mentation of recommendations based on the
research findings should be identified.
8 References should be included, using an
accepted format.
tionnaire/data capture sheet and any other
items of importance.
A detailed checklist of points which should be
covered in a protocol is given in Table 4.2. This
checklist was drawn up to ensure that all impor-
tant scientific issues would be covered in the
protocol and considered by the protocol reviewer.
If a protocol is submitted to a funding agency, a
detailed budget would also have to be provided.
Bias in research
Bias can enter the research process at any stage,
and special attention should be given in the pro-
tocol to outlining how bias will be avoided at the
various stages.
The Chambers Dictionary defines bias as a
‘one-sided inclination of the mind’. In research,
bias takes on a more technical meaning, but
_remains true to the above definition in some
ways. It is any process which produces results or
conclusions that differ from the truth in a sys-
tematic (one-sided) way.
Bias can enter the research process at any stage:
in the stage of reviewing the literature (for
example, the researcher restricts articles to
ol
b epidemiological research methods and protocol development

Table 4.2 Protocol checklist

Protocol title
i LARA

Date received Date to be presented

Components to be considered when reviewing the protocol — please attach detailed comments, if any

Acceptable Minor Major Should N/A

changes changes be
required required included

Literature review
Definition of the problem/
hypothesis/research question
Aims and objectives
Implementation objective
Method: Study design
Study population
Sample size
Variables
Measurement
Validity
Reliability
Questionnaire
Coding
Data management
Analysis
Write-up
Pilot study
Project management
Timetabie
Ethics
Additional aspects (specify)

10 Do you recommend that this protocol be

¢@ Accepted (i.e. the suggested changes are minor)
Revised and resubmitted for acceptance
@ Rejected (i.e. the hypothesis has a major flaw)

Comments:

(Source: Centre for Epidemiological Research, Medical Research Council)

52
 4 planning aresearch project

those that support a certain view or finding)
insample selection (for example, selection of
non-comparable groups as cases and controls
may give spurious results)
in executing an intervention (for example,
patients from a control group may unintention-
ally receive or be influenced by intervention,
thus ‘contaminating’ the results)
in measuring exposures and outcomes (for
example, instruments can over- or under-score
" measurements taken, hiding real differences or
showing differences where there are none)
@ in data analysis (for example deciding on the
significance level after rather than before the
analysis can lead to biased results)
in interpreting the data (for example, there may
be over-interpretation of statistically but not
clinically significant results)
@ in publication of results (for example, publica-
tion of positive results only may give a false
impression of the findings).
Sackett (1979) published a catalogue of some
50 biases which can occur in epidemiological
studies. It is less important to know all the differ-
ent ‘jokers’ which can invalidate research find-
ings than to know the principal situations in
which they can arise in the design of the research.
In this manual, attention is given to bias which
can occur in the selection process, data collection
process, and due to confounding.
Once present, bias is difficult to deal with and it
is well worth the effort to be cautious in the proto-
col design phase, so as to avoid bias wherever
possible.
Conclusion
However well a study is planned, difficulties will
arise. Public health research does not take place
in ‘an isolated, structured environment like a
laboratory, and thus the chances are quite high
that something unforeseen can happen.
The development and completion of the proto-
col is merely the beginning of an often rather
difficult emotional experience for the researcher.
Figure 4.2 describes some of the ups and downs
that researchers can anticipate during the differ-
ent phases of research.
The other chapters in this section will describe
selected elements of the research process in
detail. These include literature review, setting
objectives for a study, study design, study popula-
tion and sampling, measurement, data manage-
ment and analysis, resources, ethical and legal
considerations, and reporting of data.

TSPattes CM sel meet itm

©) Submit for ©
Q publication In print
Ecstatic Completion of fieldwork
CS Ready to andparty)
Y collect data
Click The idea Try to implement
“ results/ ,
Rejections recommendations
Initial protocol
development Corrections
Delays
Emotional ©

reaction Adjustments
Implement
Practical action at last
difficulties Peer review
feedback
Critique
cS

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Coding a What now? Start writing up
catastrophe 6 @&) mental block

Miserable Planning Data collection Analytic Reporting Publication Implementation

phase phase phase phase phase phase

Experience has shown that researchers undergo similar patterns of emotions while involved with any research project.
Each stage of the research process tends to start on a positive note, but inevitably obstacles arise, with each stage having
its own set of difficulties. Problem-solving abilities and persistence are tested to the utmost. Beginner researchers should
note that once the fieldwork is completed, there is still a lot of work to be done. :
The above graphic describes emotional reactions (Y axis) to typical events during the different phases of a study (X
axis). It aims to help the researcher anticipate some of the emotional swings so that when (not if!) they occur, difficulties
can be seen to fit into a common pattern.

58

Introduction
Before starting a research project, the researcher
should review the relevant literature to find out
what work has been done in that field (content
area) and what methods have been used. At
times, methods used in other content areas are
reviewed in order to adapt them to the research
question. Such a review will enable the researcher
to clearly define what contribution the planned
study will make: how it would contribute to exist-
ing knowledge or how it differs from what has
already been done. The researcher will become
aware of the problems that other researchers
have had to face. The literature review can be
used as motivation for the study or for the specific
way in which the study will be carried out.
Finding the literature
Doing a thorough review of the relevant literature
may seem a daunting task to the researcher. One
way to start is to obtain one relevant article and
follow up the articles referenced within that
article, carrying on in this way. A review article of
the area or methodology (that is, an article which
gives a broad overview) will provide excellent
references to follow up. Researchers attached to
universities can request such articles at the
university library or obtain them from other
libraries through the interlibrary loan system.
Relevant articles can be identified using the Index
Medicus at medical school libraries. Other
researchers, such as health personnel working at
rural clinics, may have problems gaining access to
the literature. The ideal would be to have a con-
tact at a university through whom requests could
be channelled, but some time should be allocated
54
Literature review
for the researcher to spend at a university library.
Rural researchers can form their own support
system by organizing a journal club which meets
regularly to discuss recent publications.
The MRC and several universities provide a
computer literature search service. This facility
enables researchers to gain access to abstracts of
all articles published in indexed journals (that is,
reputable journals that have been accepted onto
a computer database) all over the world. By speci-
fying keywords (words that describe the main
topics of the article), users can extract a listing of
all articles on a specified topic published over a
certain period. This listing usually consists of
authors’ names, journal name, article title and the
abstract. By specifying the years of interest, the
researcher can decide whether to look only at
recent publications or at what has been published
in the last 20 years. There are various journal
databases, for example, those dealing with
medical journals and those dealing with psycho-
logical journals. Most of the medical literature
can be found on the Medline data base. De-
pending on one’s area of interest, various data-
bases may be useful. But the aim is to obtain rele-
vant articles and therefore keywords should be
clearly specified. Unfortunately, not all local jour-
nals are indexed, for example, the Southern
African Journal of Epidemiology and Infection.
One may thus have to look through these journals
individually to trace relevant articles. In addition,
theses available at university libraries may
provide valuable information.
Such a literature review covers published
results only. If you know of other researchers
working on the same topic, you should contact
them for copies of draft articles or internal

reports. There may, in addition, be many reports
which are unpublished because they show incon-
clusive or negative results. They may be very diffi-
cult to track down, but their absence may bias the
review. Relevant official reports, such as reports
by the Medical Officer of Health, or reports pub-
lished by the Medical Research Council, Human
Sciences Research Council, or other bodies
should also be reviewed.
Reading the literature
While going through the literature, whether
through a computer-based search or a reading of
various journals, the researcher will of course
come across articles which are not directly related
to the topic of interest. These should not be
discussed in the literature review, since the litera-
ture review should show one’s knowledge and
summarize relevant literature, not provide an
exhaustive (and boring!) list of everything that has
ever been written on the subject. The aim is to
synthesize relevant literature in a critical way.
From the title of an article, you should be able
to determine whether the article is at all relevant
to the research topic. If it does seem relevant, you
should carefully read the summary. If it indicates
that the paper is relevant, read the entire article
carefully, paying special attention to the Methods
section, to be sure that the Results and Conclu-
sion have a sound basis. Attention should be
given to measurement, sampling and issues con-
cerning study design, and articles should be
classified according to the quality of methods
used. (Details given in the rest of Section B will
enable you to judge the quality of the methods
used.) Ideally, articles should not be included in
the write-up of the literature review if you did not
read more than just the abstract or summary.
5 literature review
Systematizing and summarizing the
literature
A large number of articles can be identified as
relevant to a specific topic, and one should there-
fore devise a system of organizing and summariz-
ing them before they start piling up. Various ap-
proaches can be used. For example, the research
topic can be divided into various themes, and ar-
ticles can be grouped into these themes. One
article may, however, fit into more than one
theme, and you could make copies of the article,
or use a system of cross-referencing. Whichever
system you use, it is useful to have a card index
system as well. Each article should be numbered
and the details of authors and publication noted
on the card, as well as keywords and quality of the
article. The cards should be ordered alphabetic-
ally so that you can quickly check whether you
have an article by a certain author.
Conclusion
When writing up the literature review for a proto-
col or paper, you should draw together your
reading, critically summarizing only the really key
issues. In a thesis, the write-up would however be
more detailed in order to show afull understand-
ing of the issues. In both instances, the literature
review should describe scientific discoveries
which build on past knowledge, thus drawing a
picture of the current state of knowledge and
highlighting gaps in the current state of know-
ledge. This will ensure that the contribution your
study might make is clearly contextualized.
55

Introduction
Every research protocol must state what the
intended study wants to achieve. The process of
deciding on the research question might be
lengthy, but is an extremely important one as it
lays the foundation of the protocol. This chapter
deals with the process of formulating the research
question(s) for a particular study and describes
steps taken before deciding on the methodolo-
gical detail of the study.
Each step will be described. It is useful to note
that while most researchers use a similar step-
wise approach, they do not always call the steps
by the same name. So for example, Step 2 might
be called setting up the purpose or aim or topic or
general objective of the study. These are words
that all mean more or less the same thing. It is
thus useful to remember the content of the steps
rather than the words used to decribe them.
Step 1: Identification and analysis of
the research problem
Just as necessity leads to invention, so a public
health problem leads to public health research.
However, prospective researchers often decide
on a topic without thoroughly considering the
original problem motivating the investigation
and thus skip an essential step in the process of
identifying objectives.
Since a public health problem can be broad and
complex, it is important for the researcher to
come to grips with all aspects of the problem
56
Setting
objectives
for research
before deciding on the focus and scope of a spec-
ific project motivated by the problem. Exploring
the problem thoroughly can help you to identify a
suitable topic or research question.
Any problem, whether it is a health system
problem (for example, the clinic is crowded; why?
What can be done about it?) or a problem relating
to the relationship between exposure and out-
come (for example, does smoking cause lung
cancer?), should be broken down systematically
into its major components by the prospective
researcher so that the problem may be viewed
critically.
It is thus important to develop skills in critical
thinking. Such skills enable one to look at prob-
lems in such a way that preconceptions are put
aside, and issues are not considered at face value,
but from all angles, acknowledging complexities.
This should lead the researcher to a better under-
standing and a clearer idea of which aspects of the
problem would be most appropriate to tackle
initially. (Note that critical thinking is not a skill
needed for research only — it is essential for any
task requiring a good grasp of problems and plan-
ning for effective action.)
David Werner, community development theo-
rist and health activist, emphasizes the need to
develop a critical understanding of health issues.
A much-used tool to facilitate critical thinking is
the ‘why game’ (Werner and Bower 1991). We use
a South African example to illustrate the game
and how it can help develop a critical under-
standing of health problems.
 6 setting objectives for research

Consider the following scenario in an urban with arrows pointing to the circles they ‘caused’.
squatter setting: Repeat asking ‘why?’ to each response (brain-
Raa storm) until you run out ofideas.
/ 3-year old This process is repeated for each of the events.
Sipho plays You may return a few times to earlier ‘whys’ as
in stagnant you gain momentum and get new ideas. Some of
water / the events have similar causes, so these common
causes should be linked with arrows.
a " Sipho / mother tries It would be useful for the reader to do this exer-
/ dies on to care for him cise before going on to the next paragraph.
thewayto | ; athome giving | Once the ‘why?’ process has been exhausted, it
hospital _/ anenema _/ is useful to present the analysis in a clear, more
systematic way. This can be done by organizing
Starting with the first event circled (that is, Sipho factors and causes into larger categories such as
playing in stagnant water) ask the question ‘why?’ political factors, socio-economic factors, health
and put your response in a circle with an arrow service factors, disease-related factors and so on.
pointing towards the event. There may be a The choice of categories is up to you, but they
number of reasons why Sipho is playing in stag- should flow from the ‘reasons’ generated in the
nant water, so add these to the diagram. It is problem analysis. You should now be able to give
useful to generate as many reasons as possible. a critical analysis of why Sipho died. Table 6.1
Now for each reason generated, ask ‘why?’ and shows the factors which possibly contributed to
put your second-generation reasons in circles his death.

Preis)
( Rome Mle eile mie mM Met LC tee)
ROR yee ey 141]

Environmental factors Socio-economic factors

@ poor housing
¢ poor (or absent) sewage system
poor drainage
poor roads and layout of township
@ inadequate water supply
no recreational facilities (safe and hygienic
play areas)
Service-related factors
@ no 24-hour health service in the community
¢@ hospital inaccessible
poor transport system
¢ poor health education of mothers concerning
causes and treatment of diarrhoea
¢ poor planning, budgeting, and thus imple-
mentation of primary health care policy
Disease-related factors
water-borne disease
virulent virus
virus /bacteria induce diarrhoea and vomiting,
resulting in dehydration of the child
if child malnourished, the illness is more
severe and compromising to the child
if untreated, child can die from dehydration
@ high cost of living coupled with low salary or
unemployment
extreme poverty impacting on Sipho' s life
through malnutrition
¢ low maternal education
Cultural factors
« high fertility considered desirable, thus ee
family size
some traditional practices harmful when ne
has diarrhoea (enema)
Political factors
@ maldistriobution of land and wealth created and
reinforced by past political regimes
despite the political will to improve the quality
of life for all South Africans, change on the
ground is slow
@ economic restraints exist which disallow the
government to rectify all social and economic
imbalances in the short term

Sf
b epidemiological research methods and protocol development
a eee I ee
In the early planning stage of a research project,
we often do not have aseries of events to analyse,
but a central issue or problem. The same process
of asking ‘why’ can be undertaken in exploring
the central problem, for example, the high inci-
dence of unplanned teenage pregnancy.
It is useful to do part of the problem exploration
with colleagues and to consult the literature —
outside input always helps you to find further
factors and question your own preconceived ideas.
Illustrated are diagrams of analyses of two
health problems which are commonly of concern
in South Africa (Figures 6.1 and 6.2). Note that the
same process was undertaken, but that the
diagrams represent the end-product after all the
messy and challenging work of asking ‘why?’ has
been completed.
The problem-exploration process does not
automatically suggest a research topic or ques-
tion. Instead, it improves understanding of the
problem and the multiple issues which impact on
it. Ithelps to isolate the component of the problem
that the researcher wants to study. The exact re-
search question depends on existing knowledge
(including descriptive information about the size
of the problem, who it affects, where and when it
occurs), what other studies have been done, what
is feasible to do in terms of logistics, money and
resources, and the possible usefulness of results
yielded by the proposed study.
Step 2: Explicit statement of the
purpose or aim of the study
Once the central problem has been fully explored,
the focus or topic of study needs to be decided
upon and explicitly stated. Step 2 thus involves
detailing the purpose, aim or intent of the study.
This states in general terms what information the
study hopes to obtain.
The statement of purpose of the study should
preferably be no longer than one sentence, but
this sentence must state clearly and precisely
what the most important contribution of this
study will be. The purpose serves as a reference
point by which the relevance of each specific
objective (see Step 3) will be measured.
The purpose is the part of the protocol that
many people will read before deciding whether to
read the whole protocol. The purpose is not a
general statement of the problem; rather it is a
specific (not woolly or vague) statement which
articulates the main issue being described or the
central hypothesis being tested.
58
aaa
Vague statements of purpose lead to vague
studies. The purpose is a statement of the exact
‘destination’ that you want to reach with the
study: the methods are the ‘road’ you will take to
get there. Exactness in the purpose requires deep
consideration of the problem which motivated
the study and a purposeful decision to restrict the
study to one key aspect of the problem or its solu-
tion.
The purpose may be expressed in the form of a
statement that is as specific as possible, using
action verbs (for example, ‘To determine the inci-
dence of diarrhoea among children under five in
the summer months in Mamelodi’) or in the form
of a question (for example, ‘What proportion of
Mamelodi children get diarrhoea during the
summer months?’).
Here are some examples of vague versus expli-
cit purpose statements.
Vague purpose statements:
1 to study the problem of measles in South Africa.
dS to investigate alcohol consumption as a con-
tributor to adult mortality.
oo to determine the health profile of the Mamelodi
community.
Carefully considered purpose statements:
ltto study trends in measles notifications in
South Africa from 1985 to 1994.
2 to determine the proportion of adult deaths
that are due to alcohol-related conditions.
3 to determine the nutritional status of children
under tive years in Mamelodi.
In practice, the process of narrowing the focus of
study from all the components and aspects of the
problem to a clear, definable and achievable pur-
pose is not easy. It is at this stage of the research
process that initial contact can be made with
experienced researchers, supervisors or tutors
who could assist in this process.
Usually, the general problem as defined and
explored can give rise to many possible research
questions which each need study in themselves.
Thus, in order to do full justice to researching the
problem, a number of studies may need to be
done over a period of time, each contributing to
the overall understanding of the problem and
thus to the solution (see Figure 6.3).
Generally, in a single study one should only
attempt to answer one or at the most two general
research questions. It is more useful to be able to
answer one or two questions well than to provide
setting objectives for research

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b epidemiological research methods and protocol development

St ee CELE eC re Ce aMTE
CYT Eertom rtm cL
Class factors Socio-political factors Service factors

pueeeal=7
Unemployment Apartheid in No sexuality education

Emphasis on unacceptable
Poor schooling methods: limited choice

Poor economic op-

| Distrust of services
Limited options portunity
No recreational Poor No contracep- Teenagers poorly
Delayed marriage facilities compliance tive use catered for

Psyche: Sexual abuse, Judgemental attitude

logical incest, rape of health workers

Ee HIGH RATE OF No abortion Abortion

[Boredom
TEENAGE PREGNANCY services illegal

Peer pressure Early sexual

activity

Adolescent rebellion

Limited planning to
Poor locus of control avoid pregnancy

Defeatism/fatalism

Limited conscious
future planning

Limited Limited decision-making Set hehavigural Gender

super- power
as : re customs for teenage relations
vision Denial of vulnerability g
pregnancy
A to pregnancy
Gender ster: :
Poor teenage/parent No sex pplicetaaidat
communication education Emphasis on prove fertility
Pace fertility and men to prove virility
model Breakdown of
cultural norms \dealized expectation
Pressure not to cohesion of women
fall pregnant
Teenage pregnancy in community
increasingly acceptable

Familial factors Cultural factors Gender-related factors

60

rst Mee MFCM] cere researching a problem
specific problem
ed
specific problem Se sseiahie
General smn A Cr ag Ce
ae
problem >[speaiteproblem| 5 study|
specific problem ERTS | een
inconclusive information on a broad range of
questions. The researcher needs to be patient and
systematic, and humble in recognizing that the
project will not solve the entire health problem.
We will use the Sipho scenario described earlier
to illustrate how aparticular public health prob-
lem can give rise to a number of separate studies,
each with their own purpose, aim or topic, but
still relating to the overall problem described.
Studies arising from the Sipho scenario:
1 Aprofile of environmental conditions in the
squatter camp.
2 Asituational analysis of health facilities in the
area, including access to primary, secondary
and tertiary care.
3 Aprofile of childhood mortality in the area,
including cause-specific mortality rates.
4 The prevalence of malnutrition among child-
ren under five in the community.
a A study describing knowledge, attitudes and
practices of caregivers concerning diarrhoea
and its treatment.
6 Acomparison of the childhood mortality in
communities with and without piped water.
Socio-economic risk factors for diarrhoea.
onMaternal education as arisk factor for death
among children who get diarrhoea.
9 Acomparison of the diarrhoea mortality in a
community before and after the introduction
of piped water into that community.
10 An evaluation of the effect of acommunity
health worker programme focusing on appro-
priate treatment by mothers of children with
diarrhoea.
11 An evaluation of different methods of rehydra-
tion to determine which is most effective in a
hospital setting.
The above represent some of the studies emerg-
ing from the problem exploration done in this
case. The exact choice of study depends on the
kind of information already available, the interest
and skills of the researcher, the money and
6 setting objectives for research
General
result or
rest solution
resources available and the usefulness of the
results. If no descriptive information is available,
that is, if there is a need for numbers and frequen-
cies of characteristics related to the problem, one
of the first five studies should be undertaken. If
there is enough basic information, but a need to
understand more about what may be contribut-
ing to the problem, studies asking similar ques-
tions to numbers 6, 7 or 8 should be undertaken.
If there is good understanding of the causes of the
illness, then studies should be done to evaluate
interventions designed to reduce the problem
(numbers 9 to 11).
Step 3: Setting specific objectives
The purpose or aim of a study should be broken
down into clear, mutually exclusive objectives
which are logically connected. To a large extent,
these determine the subsequent planning of the
study. Specific objectives indicate the specific in-
formation the study must yield and the detailed
research questions that must be answered. Spec-
ific objectives are often stated in operational
terms, which are easy to apply in practice. They
are also commonly phrased in measurable terms
(in such a way that the answer is a number or rate)
and need to be clear, specific and unambiguous.
Specific objectives indicate the individual com-
ponents of what will be achieved (but not how it is
to be done: that is left for the methods section of
the protocol).
Descriptive studies usually set out to describe
characteristics of the group being investigated,
and the statistical goal is usually simple data
description or estimation of a characteristic in the
study population (see Chapter 7: Study design).
In analytic studies, the objectives are to
examine associations between characteristics
and possibly to seek new knowledge on the
cause(s) and the natural history of diseases or
conditions. Intervention studies attempt to deter-
mine if an intervention is associated with an
improvement (or deterioration) in health status.
61
b epidemiological research methods and protocol development
a
a a a
Thus analytic and intervention studies always
involve hypotheses or predictions of a relation-
ship between a factor (or factors) and the
outcome under study. The hypothesis or predic-
tion is statistically tested after relevant informa-
tion has been collected and analysed, and the
hypothesis is either rejected or not rejected.
The research hypothesis or question is the pre-
diction or supposition which motivates the study.
Once the question or hypothesis statement has
been framed carefully, the hypothesis has to be
stated in such a way that the prediction may be
evaluated by appropriate statistics. This new
statement of the hypothesis is called the statis-
tical hypothesis. Thus the research hypothesis or
question leads to the statistical hypothesis, a
statement made in mathematical terms. For
example, the research question ‘Is there an asso-
ciation between education level and food hygiene
practice?’ needs to be framed in the appropriate
statistical terminology to enable the use of the
t-test or the calculation of confidence intervals for
mean differences. Thus the statistical hypothesis
will state that there is no difference in the mean
education level of people who practice ‘good’
versus ‘bad’ hygiene.
The intention to test a hypothesis is stated as a
specific objective, along with other specific objec-
tives where appropriate.
Step 4: Implementation objectives
It is important to state what will be done with the
research results and what will be done before and
during the study to ensure that the results are
used. This links into ‘why’ the study is being done.
There should be clarity about the implementa-
tion objectives of the study so that decision-
makers, service providers, and possible benefac-
tors can join the research team early and ensure
that results are useful and used.
Conclusion
Exploration of the problem motivating the
research helps the researcher to get a broad, crit-
ical view of the issues related to the central
problem identified.
Setting objectives for the study is another
important (and often difficult) part of the re-
search process, as it helps to focus the study by
describing exactly what it hopes to achieve. It
helps the researcher break the study into different
parts, and acts as a guide during the design of the
methods, as well as during later parts of the
62
project. It helps to keep the researcher on the
path originally set out, and enables outsiders to
evaluate the protocol and/or study.
EXAMPLE 6.1
Setting research objectives: Sipho’s
death
Step 1: The problem (what is motivating the
study?)
Sipho’s death, which was explored at the begin-
ning of Chapter 6 (see Table 6.1).
Step 2: The purpose or aim of the study (overall
topic of a particular study, chosen from a number
of possible topics)
To identify risk factors for diarrhoea among pre-
school (under the age of six) children in Khaye-
litsha, Cape Town.
Step 3: Specific objectives (specific information
the study will yield, linked to the purpose or aim)
To ascertain which of the following factors are
associated with diarrhoea.
¢ Factors related to water: distance to nearest
tap, quality of water used
Personal factors: mother’s hygiene practices,
mother’s level of education, mother’s knowl-
edge of causes and prevention of diarrhoea and
dehydration
@ Environmental factors: method of water
storage, location of toilet, site of refuse disposal
Socio-economic factors: availability of sugar
and salt for oral rehydration solution, ability to
afford transport to health services
@ Health service factors: distance from home,
opening times, cost of services, consultation of
traditional healer
Step 4: Implementation objectives
To make recommendations for interventions tar-
geted at reducing the incidence and prevalence of
diarrhoea based on the results of the study.
Reference:
Adapted from Vundule C. ‘A study on the risk factors for
diarrhoea in Khayelitsha, a peri-urban settlement area in the
Western Cape.’ Epidemiology research report, Community
Health Department, UCT, 1994.

EXAMPLE 6.2
Setting research objectives: the case
of AIDS research
Step 1: The problem. (what is motivating the
study?)
There is an AIDS epidemic worldwide and in
Africa. Currently no cure or vaccine for AIDS
exists. Behaviour change remains the only imple-
mentable intervention area.
Step 2: The purpose or aim (overall topic of a par-
ticular study, chosen from a number of possible
topics)
Given the above problem, one of the following
purposes/aims could be appropriate for the
study.
To determine the practice of behaviours related
to AIDS (in different target groups)
To investigate psychological factors associated
with behaviour change (in different target
groups)
To determine access to condoms (in different
target groups)
To evaluate AIDS education techniques
To determine difficulties in implementing new
AIDS education programmes
@ To determine factors related to the receptive-
ness (of different groups) to AIDS health educa-
tion programmes
6 setting objectives for research
Step 3: Specific objectives (specific information
the study will yield, linked to the aim)
Assume that the aim chosen to be most appro-
priate at this stage is:
to investigate psychological factors associated
with behaviour change among high school
students in Soweto.
The following objectives may be stated.
¢ To determine knowledge of HIV transmission
and prevention among individuals in the group
targeted for research
To determine attitudes towards people infected
with HIV among individuals in the group tar-
geted for research
¢ To investigate the extent to which individuals
in the group targeted for research believe them-
selves to be at risk
To determine attitudes towards particular pre-
ventive behaviours (for example, condom use)
@ To determine self-confidence in asserting pre-
ventive behaviours
Step 4: Implementation objectives
To make recommendations to education author-
ities concerning health education in schools
regarding sexuality and AIDS.
63

Introduction
Study design or study type refers to the overall
research approach or strategy taken. Studies
which share the same approach are said to have
the same study design despite having different
subject matter (content).
Studies can be categorized according to various
criteria.
Study design and the research question
The most fundamental categorization is accord-
ing to the nature of the research question. When
you have clearly formulated the objectives of your
study, you decide which study design is most
appropriate to reach these objectives. In practice,
you also have to consider time, money and per-
sonnel resources.
Here are three typical research questions:
A Whatis the prevalence of HIV infection in the
Free State?
B Does passive smoking cause lung cancer?
C Is drug A or B the most effective treatment
against typhoid?
How would you decide to approach these three
studies?
If the study aims to determine the size (how
much?) of a problem, or the demographic (who?),
seasonal (when?) or geographical (where?) distri-
bution of a problem, then the study aims to
describe the problem. Such a study is called a
descriptive study. StudyA would thus be descrip-
tive.
If the study aims to investigate whether there is
a relationship or a causal link between a factor
64
Study design
and a health outcome, the study aims to explain
or analyse the problem. This is called an analytic
study, and study B would be an analytic study.
If the study aims to see if an intervention has an
effect, it aims to evaluate the intervention. This is
an intervention study, also called an experi-
mental study. Study C would be an intervention
study.
Study design and researcher control
In studies investigating whether an exposure is
associated with a particular outcome, study
design is also determined by the amount of con-
trol the researcher has over who is exposed.
Broadly speaking, studies can be classified as
experimental or observational (Figure 7.1). In
experimental studies, the researcher conducts an
experiment, allocating participants to different
exposures to determine the influence these expo-
sures have on characteristics of the participants.
The researcher determines which participants
will be in which group (exposed or unexposed).
Since humans are the research participants,
ethical considerations mean that the exposures
can only take the form of interventions aimed at
decreasing disease or improving health. Epide-
miological studies to analyse the effect of a risk
factor cannot be done through an experiment (for
example to investigate smoking as a risk factor for
disease, the researcher cannot order certain
participants to smoke and others not to smoke).
Most risk factor studies are thus observational;
this means that the researcher observes charac-
teristics of respondents who have selected to be
in exposure or non-exposure categories (for
example, people who decide to be smokers) or are
exposed or not exposed due to circumstances (for

example, people who live in highly polluted
areas). Of the three studies described above, A
and B are observational, compared to C, which is
experimental. Observational studies can be either
descriptive or analytic.
Study design and the presence ofa
comparison group
Analytic studies can explain or analyse a situation
by virtue of the formal (statistical) comparison of
groups of subjects. On the other hand, descriptive
studies primarily describe a group as a whole.
Often subgroups are examined and compared in
a descriptive study, but not to investigate a causal
relationship. Informal or exploratory compar-
isons in descriptive studies are useful for generat-
ing ideas for future analytic studies.
Study design and the temporal sequence of
exposure and outcome
When we try to determine if an exposure is caus-
ing an illness, we need to determine when the
outcome (illness) and exposure (factor) occur
relative to each other.
Consider the following chain of events:
exposure to cause
beginning state___....__-_—-—_—i: end state
An individual starts off in the beginning state.
@ She is then exposed to some factor, possibly a
causal factor.
@ The end state occurs after the exposure.
In health, this chain of events may occur as fol-
lows:
exposure to cause
healthy state____-_______»_—_—___ ill state
For example,
maternal smoking
¢ healthy foetus ______ low birth weight
hepatitis B
¢ healthy person ____ liver cancer
high fat diet
@ healthy person _____ high cholesterol
The starting point need not always be a healthy
state. The effect of an exposure (the treatment) on
illness can also be studied:
7 ~~ study design
exposure to treatment
Sick aee Ee eahy state
For example:
appendectomy
appendicitis _____.o.o4.4§ , healthy state
TB medication
@ tuberculosis ____________» healthy state
As can be seen, the beginning state comes first,
then the exposure, and then the outcome. This
may seem like common sense. However, these
three elements are not always studied in the
temporal sequence in which they occur.
Ideally, a study to determine a causal relation-
ship should follow the ‘natural’ temporal se-
quence. Such a study would thus collect informa-
tion as events occur, that is, forward in time.
Information on the exposure is collected before
the outcome is known. Studies which collect
exposure data after the outcome is known, go
‘backwards in time’ to collect exposure data.
Some studies collect exposure and outcome data
at the same time from a group whose outcome
status is unknown before the study.
Subjects can be selected for a study:
when they are all well (or all sick) prior to expo-
sure
according to outcome, that is, by virtue of being
ill (cases) or not ill (controls)
@ by virtue of membership of a large group where
neither exposure or outcome is known before
selection.
Study design and study base
While the criteria above are used to differentiate
between study designs, we need to recognize that
different designs are merely different approaches
to representing what happens in a given popula-
tion in a given time period.
The study population (that is, those at risk of
the outcome) is also referred to as the source
population from which cases and controls or
exposed and unexposed subjects are selected.
The term ‘study base’ describes the population
being studied and the time period over which
outcomes are measured in the study population.
All outcomes measured in a study come from the
study base: this means that they occur in the
defined source population during the time period
stipulated in the study base. The study base can
thus be seen as the denominator measured in a
65
b epidemiological research methods and protocol development

Figure 7.1 Study types

Descriptive
(describes)

Observational studies

Cross- sectional
Analytical ————————————__>
(explains) > Case-control
se,dana diigisoetigmenies si Cohort

> Community trial

Experimental studies ——_—_—___————-© Field trial
(evaluates intervention) —_———+—8 Randomized controlled clinical trial

longitudinal study. The study base constitutes the
number of people at risk and the time they are at
risk. The study base is typically measured in units
of ‘person-time’ (for example, person-years
exposed to a risk factor or treated with a drug.
Also see Chapter 2: Measures of the frequency of
health events).
In a cohort or case-control study, the study
base is all individuals who could potentially have
had the study outcome over the time period of the
study. In a cross-sectional study, the measure-
ments are all taken at the same time, so time does
not have to be measured.
The concept of a study base is particularly
useful when designing an analytic or intervention
study, or when critically evaluating the methods
of a study. If the researcher does not ensure that
all outcomes (cases) from the study base are
accounted for, or if controls are not a represent-
ative sample of the study base producing the
cases, the results of the study may be biased.
(We suggest that the above section be reread
after analytic studies have been covered later in
this chapter.)
Figure 7.1 summarizes the classification of
study types according to the criterion of the
research question. The rest of the chapter will
give more details on the most common study de-
signs used in epidemiology. The broad categories
of study design have already been mentioned
above.
Descriptive studies
A descriptive study, also referred to as a survey,
sets out to quantify the extent of a problem (for
example, the prevalence of hypertension in Free
State residents over 25 years of age). As discussed
earlier, the situation regarding a single group is
described in terms of the size of the problem, who
is affected, where it is found, or when it occurs.
Why do we do such studies? The main use of
descriptive studies is to give service providers and
planners information that will help them design
services and allocate resources efficiently. Often
such studies generate questions for further
studies. So, for example, a case series which
describes the socio-demographic and medical
characteristics of a few patients with a similar
disease may provide the impetus for a more rigor-
ous investigation of risk factors in an analytic
study.
A descriptive study which sets out to compre-
hensively describe the current state of affairs of a
certain aspect of health is also known as a situa-
tional analysis. A community diagnosis which
consists of detailed information about health
problems and perceptions in a community is a
descriptive study. If the community diagnosis
also includes information on the associations
between exposures and disease, it is analytic.
Analytic studies
Analytic studies attempt to explain or analyse the
situation by comparing groups, in this way identi-
fying risk factors for disease. For example, the
question ‘Is hypertension in Free State residents
related to obesity/smoking/alcohol use?’ is a
research question which requires an analytic
study. A number of different analytic study de-
signs are available to answer this type of question.
Analytic studies can be done in the form of
cross-sectional, case-control or cohort studies.

66

Table 7.1 Contrasting eT eae
Exposed
Not exposed
Cross-sectional A+B+C+D individuals
Case-control (A + C) cases and
(B + D) controls
Follow-up (A + B) exposed and
(C + D) unexposed
These three designs differ with respect to how in-
dividuals are sampled and the sequence in which
exposure and outcome information is collected
(see Table 7.1).
Cross-sectional analytic studies
In across-sectional analytic study, a sample of the
study population is investigated and information
is collected on risk factors (exposures) and
disease (outcome) at a point in time. The
information sought can be current (how many
cigarettes do you smoke a day at present?) or past
(how many cigarettes did you smoke on average
each day during the past year?).
The study has a descriptive component which
enables researchers to calculate the prevalence
of risk factors as well as prevalence of disease.
The analytic part of the study consists of com-
paring exposure groups with respect to disease
presence. The total sample is thus divided into
four subgroups (shown in Table 7.1), namely: (A)
those who are exposed and diseased; (B) those
who are exposed and not diseased; (C) those
who are unexposed and diseased; and (D) those
who are unexposed and not diseased. Examples
of such cross-classifications are given in Sec-
tion C.
Such cross-classification allows statistical
comparisons between subgroups, and may
show arelationship between exposure and out-
7 study design
EE ater
Cross-classified for
exposure/disease status
Determine exposure status
Follow-up to determine
disease outcome
come. But be careful of the joker in the pack! For
example, a superficial look at the results may
show that people who have hypertension (expo-
sure) are more likely to have heart disease (dis-
ease) than normotensives and one may deduce
that this is because of hypertension. But this
finding may be explained by the fact that hyper-
tensives tend to be older than normotensives,
and older people are more likely to have heart
disease. This example illustrates how age can
confound the relationship between blood pres-
sure and heart disease.
In this case, age has distorted the relationship
between exposure and disease and is therefore
called a confounder. Thus when comparing the
exposed and unexposed, it is important to con-
sider, on the basis of knowledge of the subject
area, whether there are factors which are or could
be related to exposure as well as disease. Such
confounders can distort the relationship between
exposure and disease, masking a real association
or showing an apparent, but spurious associa-
tion. Confounding occurs in all types of studies,
not just cross-sectional studies. (See Chapter 11
for further discussion on confounding.)
Because cross-sectional studies take a ‘slice’ in
time, current behaviour (for example, current
smoking habits) is usually obtained. But diseased
people may have stopped smoking because of ill-
ness and so current smoking information will not
67
b epidemiological research methods and protocol development
a
help the researcher to illuminate smoking as a
risk factor. It may be more useful to take a
smoking history, rather than asking only about
current smoking habits. In general, when decid-
ing which questions to ask about risk factors, one
has to consider whether past exposure may be
more relevant than recent exposure. Neverthe-
less, it is usually difficult to assess the temporal
relationship between exposure and disease in a
cross-sectional study. The researcher can seldom
be sure which occurred first — the disease or the
exposure. However, the temporal sequence of
exposure and outcome can occasionally be estab-
lished (for example, exposure during pregnancy,
followed by outcome in the child).
If the disease of interest is rare, a very large
sample has to be studied to be sure of selecting
enough diseased people to allow for adequate
analysis. The cross-sectional analytic study may
turn out to be too costly, due to the large sample
size required. In such circumstances, one would
rather consider doing a case-control study.
Case-control studies
Essentially in a case-control or case-referent
study, cases (those with disease) are compared to
appropriately selected controls (without disease)
to determine whether they differ with respect to
exposures. So, for example, the proportion of pas-
sive smokers among cases of lung cancer is com-
pared to the proportion of passive smokers
among controls (without lung cancer). In tradi-
tional case-control studies, after cases and con-
trols have been selected, exposure information is
gathered.
The case-control design can be considered an
efficient sampling technique to measure expo-
sure-disease associations in a study base (the set
of persons or person-time from which diseased
subjects become cases). Exposure is only mea-
sured in a sample of all subjects in the study base
(those who were selected as cases and controls
from the source population). Typically, all the
outcomes from the study base (that is, cases) are
included in a case-control study. The controls are
used to represent the probability of exposure in
the population at risk of becoming cases.
A disadvantage of such case-control studies is
that the retrospectively gathered exposure in-
formation may be inaccurate or biased (measure-
ment bias). People with disease (cases) may
remember past events more clearly, or, on the
other hand, may deny certain past behaviours
which their doctor had warned against. If pos-
68
sible, exposure information should thus be valid-
ated by objective sources.
Case-control studies are increasingly done as
part of larger cohort studies. Such case-control
studies are termed nested case-control studies.
Exposure information on all participants is
collected at the start of the study period. During
follow-up, cases are identified and a sample of the
remainder of the group is selected as controls.
Exposure status is thus measured before disease
status is determined, and recall bias is avoided.
Case-control studies are very vulnerable to
selection bias. The essential requirement is that
the control group accurately represents the
source population, that is, those contributing to
the study base. The cases (selected according to a
clear case definition) need not be representative
of all cases in the population, but could be cases
at one clinic, or cases among factory workers.
Similarly, the controls need not represent the
entire non-diseased population but should come
from the same source population as the cases (for
example from the referral area of the clinic, or
from the same factory).
In a case-control study, careful definition of the
study base is important to ensure that the cases
and controls selected are from the same study
base. When the study base (or source population)
is defined at the outset, the challenge is to find all
the cases that arise from this (primary) study
base. If the study base comprises all individuals
living in a particular area over a set period of time,
it may be difficult to track down all the cases. On
the other hand, if cases are defined at the outset,
the challenge is to find a suitable control group
which represents the source population that gave
rise to the cases. A tertiary hospital-based case-
control study is an example of a study base being
defined on the basis of the cases recruited into the
study.
If hospital or clinic cases are selected, one or
two control groups may be used: one hospital-
based group and one community group. Hos-
pital-based controls should not have a condition
related to the disease or exposure being invest-
igated. Neighbourhood controls are examples of
community controls where there is an attempt to
control for socio-economic factors. When two
separate control groups are used (this rarely hap-
pens), the cases and each control group are com-
pared separately and results are checked for con-
sistency.
Matching is often used in case-control studies.
This means that for each case, one (or more)

control with similar characteristics is selected. If
cases and controls are matched individually, a
matched analysis has to be done, otherwise asso-
ciations will be underestimated. An alternative to
individual matching is group matching, where
controls are chosen to ensure that the control
group as a whole is similar to the group of cases
with respect to the matching variables. Thus the
proportion of males amongst the controls will, for
example, be the same as among the cases. The
variables that need to be matched are the ones
that are possible confounders. Matching does not
remove confounding, but it does ensure that
numbers are equal in stratified analyses (see
Chapter 11).
A case-control study can only investigate one
disease, but many exposures can be considered. If
the exposures of interest are rare in the popula-
tion, however, a case-control study is inefficient.
As stated before, it is an excellent approach if the
disease is rare. In recent years, however, the use
of case-control studies has been extended to the
study of common diseases. New case-control de-
signs (new in the way in which the controls are
sampled) have also been described. The selection
of cases for a case-control study can be made
from prevalent or incident cases. If incident cases
are being recruited, then the controls can be se-
lected either after all cases have been recruited, or
as each case is recruited. In the latter situation, a
person originally selected as a control can there-
fore become a case at a later stage. Further discus-
sion of these designs, as well as the appropriate
methods of analysis, are given by Rodrigues and
Kirkwood (1990). A synthesis of issues involved in
the selection of controls in case-control studies is
given by Wacholder, McLaughlin, Silverman,
Mandel (1992).
Cohort studies
These studies are also called follow-up studies
since healthy individuals with known exposure
are followed up for a period of time during which
disease status is determined. These studies can
investigate the cause of disease as well as the
natural history of disease.
A cohort is a group which shares a certain char-
acteristic. For example, a birth cohort is a group
born during a certain period. Some of these will
have had a low birthweight (exposed) and others
a normal birthweight (unexposed). In a cohort
study, a group of disease-free individuals who are
exposed to a certain risk factor (for example, low
birthweight) and a group which is not exposed
7 study design
(normal birthweight) are followed up. The disease
or outcome rates (for example, failure at school)
within these two groups are then compared at the
end of a predetermined follow-up period. The
cohort’s time spent under observation is the
study base out of which cases arise.
The major disadvantages of cohort studies are
time and cost considerations. If the disease(s) of
interest take a long time to manifest, individuals
have to be followed up for a long period. The
longer the follow-up needed, the more likely you
are to lose touch with participants, thus produc-
ing bias in the study. At the start of the study,
steps should be taken to minimize this loss to
follow-up. One approach is to ask participants to
provide the names and addresses of some close
friends and relatives through whom they could be
traced. Health personnel can also be co-opted to
do frequent home visits. It is important to trace a
sample of drop-outs to establish whether they
represent a subgroup which differs from those
who do not drop out. Statistical methods, namely
survival techniques, exist which enable one to use
incomplete follow-up information in the calcula-
tion of risk of disease.
If adequate historical records (for example,
hospital, medical or university alumni databases)
exist, one can assemble exposed and non-
exposed groups from such records and follow
them up to the present to determine disease
status. Historical records can also be used to
determine disease outcome. These are examples
of historical cohort studies, in which data collec-
tion is non-concurrent.
Experimental studies
As outlined before, a study is experimental if the
researcher assigns the exposure to the subjects.
Such studies are also called intervention studies
since they evaluate some intervention aimed at
decreasing or preventing disease.
Different intervention studies have different
levels of scientific rigour. The main criteria by
which experimental studies are judged are: 1)
whether the intervention is compared to some
other group (another intervention or a control
group); and 2) the way in which people are alloc-
ated to experimental and control groups. Valid
evaluation of an intervention is generally only
possible if the intervention is compared to some
other group. In addition, the researcher should
follow very strict rules in allocating participants,
to ensure that all individuals have the same
69
b epidemiological research methods and protocol development
a ee
chance of being allocated to a given group.
Randomized controlled clinical trials (RCTs),
in which patients are assigned to different treat-
ments, are regarded as the gold standard for
intervention studies. In a randomized controlled
clinical trial, a group of patients is selected and
patients are then randomly allocated (random-
ized) to different treatments, or treatment and
placebo groups. (Please refer to Chapter 8 for fur-
ther discussion of the random _ principle.)
Random allocation in two groups of 15 each is, for
example, done by drawing 15 random numbers
between 1 and 30. These 15 patients are allocated
to one group and the remainder to the other
group. Special rules can be followed (for example,
block randomization) to ensure that after a given
number of patients have been enrolled in the
study, there will be equal numbers in each treat-
ment group.
Randomization aims to ensure that patients on
different treatments are comparable with respect
to baseline characteristics, as well as known and
unknown risk factors. The possibility of con-
founding, which can occur in analytical studies, is
thus reduced. For example, the most severely
affected patients should not get one treatment
and the milder cases another. To ensure that the
groups are similar with respect to disease severity,
prognostic stratification can be used: randomiza-
tion is done in strata (subgroups) of disease sever-
ity. It may be expected that people with differing
characteristics (for example, males and females)
will differ in their response to treatment. In such
cases, it is important that patients should be
stratified by sex at the start of the study, and ran-
domization then done within each sex. Stratifica-
tion can range from stratification in two large
strata to randomization of matched pairs. The
main purpose of stratification is to ensure that
important confounders are distributed similarly
in the treatment and control groups. It is particu-
larly important in trials with small samples where
randomization alone may not ensure this.
If the condition being studied is such that after
treatment has been withdrawn, the patient re-
verts to the disease status he or she had before the
study, as in chronic conditions such as asthma, a
cross-over design can be used. Each participant
receives all treatments, in a randomly chosen se-
quence, with wash-out periods in between, to
remove the effect of the previous treatment.
Fewer patients are needed, but since all parti-
cipants undergo all treatments, the study takes
longer to complete than in the design where
70
patients are randomized to different treatment
(parallel design).
In RCTs, patients are followed for a specified
period to determine outcome (for example, alive/
dead, recover/do not recover). The person obser-
ving the outcome after the intervention should be
unaware which treatment a patient received (so
that the observer is ‘blind’ to the exposure). The
patient should be similarly unaware, so that nei-
ther the patient nor the observer can be biased by
knowledge of the treatment received (double
blind), especially if the outcome is subjective,
such as the extent of pain experienced on a scale
from 0 to 10.
The different treatments should be equally
acceptable according to present knowledge, that
is, patients should not be subjected to an inter-
vention that is known to be inferior or unsafe.
This is why it is important for an ethics committee
to scrutinize the study protocol. Other ethical
considerations are that patients should give in-
formed consent, all adverse events (for example,
headaches or nausea) should be noted, and it
should be clearly specified when patients will be
withdrawn from the study in the event of harmful
effects being found, or a clear indication of the
superiority (or inferiority) of one of the inter-
ventions.
Randomized controlled trials are trials of effi-
cacy (see Chapter 15: Health systems research). In
cases where randomized controlled trials are not
possible because of ethical or logistic reasons,
case-control and follow-up studies can be used
to assess interventions. So, for example, case-
control studies have been used to assess the effi-
cacy of aspirin in reducing the risk of myocardial
infarction.
Besides RCTs, experimental epidemiological
studies include field trials, in which healthy indi-
viduals are assigned to different interventions
aimed at prevention (for example, a new typhoid
vaccine), and community intervention trials, in
which groups from the general population are
assigned to interventions. Since the risk of devel-
oping disease may be very low amongst healthy
individuals, more subjects may be needed for a
field trial than for a clinical trial. Furthermore,
individuals have to be visited in the community.
Intervention studies on people in the community
are therefore more generally performed through
community trials. So, for example, in the Coro-
nary Risk Factor Study (CORIS) conducted by the
MRC, HSRC and Department of Health, three
southwestern Cape towns each received a differ-

ent level of intervention aimed at reducing heart
disease (Rossouw, Jooste, Charlton, Jordaan,
Langenhoven, Jordaan, Steyn, Swanepoel, Ros-
souw 1993). Some interventions (for example,
water fluoridation), cannot be randomized by
individual, only by group, and are thus ecologic
studies. The randomization of groups rather than
individuals leads to fewer administrative prob-
lems and decreases the chances of contamination
(where a person randomized to one intervention
actually receives the other interventicn). How-
ever, the analysis has to take into account that
groups and not individuals have been random-
ized. Standard statistical procedures thus cannot
be used. An approach which can be used if the
number of groups per intervention is large (say 15
or more) is to calculate a summary outcome for
each group. Standard methods can then be used
to analyse these group summaries. If only one
group is randomized for each intervention, it is
impossible to disentangle the effect of the inter-
vention from the natural variation between
groups.
In a before-after study, measurements are
made before and after some intervention on a
group of individuals. Such studies are quasi-
experimental, since there is no random alloca-
tion of intervention: all participants receive the
intervention. For example, the AIDS knowledge
of school children may be measured before and
after an AIDS education programme. The before
and after results are compared to determine
whether the intervention has improved the
children’s knowledge. This type of study is the
weakest form of intervention study. If the educa-
tion programme is conducted over, say, a period
of six weeks, there might have been an AIDS
poster campaign in the community which in-
creased the children’s knowledge, rather than
the education programme. Only if there is some
comparable control group who did not receive
the intervention and in whom the researcher can
determine whether any changes in knowledge
occurred, can the effect of the intervention be
evaluated.
In some before/after studies, the before
measurement is made in a community and the
after measurement some time later in the same
community. Clearly, some members of the initial
group might have left and newcomers arrived.
Thus, before and after measurements are made
on groups including different individuals. If the
before/after groups are not comparable, evalua-
tion is very difficult.
7 ~~ study design
Ecologic studies
Let us consider the following example of an
ecologic study: From published data, it is clear
that in South Africa the infant mortality rate (IMR)
among coloured babies is much lower than that
among African babies. It is also known that
maternal smoking rates are high among pregnant
coloured women and low among pregnant
African women. From this information, it seems
as if there is a relationship between maternal
smoking (exposure) and IMR (outcome), namely
that maternal smoking protects against infant
deaths. This does not make much sense since we
know that IMR is linked to low birthweight, and
low birthweight is linked to maternal smoking.
What aspect of this study design is different from
the other designs we have mentioned, and has led
us to this fallacy?
In all study types described above (apart from
the community trial), observations are made on
individuals. In an ecologic study, such as the one
described above, however, the unit of observation
is a group of individuals, for example, in acity,
region or country. Such a study requires informa-
tion on exposure and disease for each of the
groups being investigated. Such information can
usually be obtained from routinely available data
sources. So, for example, one could examine the
relationship between the Gross National Product
per capita of selected countries (exposure) and
the IMR of the countries (disease).
Often proxy (substitute) measures for exposure
and disease have to be used, for example, mortal-
ity as a proxy for disease. The degree of associa-
tion between exposure and disease is made
tenuous by the use of such proxies and by the fact
that measurements are averages over groups.
Furthermore, there may be other factors
(confounders) which are related to both exposure
and disease and which may distort the associa-
tion between exposure and disease. Information
on such factors may not be available and appro-
priate analysis cannot be done. In the example
above, level of urbanization could be a possible
confounder: coloured women are more urban-
ized than African women, therefore coloured
women tend to smoke more but also tend to have
’ better access to health care, which leads to a
lower IMR. Smoking does not prevent infant
deaths!
Despite their limitations, ecologic studies are
useful for describing differences between groups,
and pointing out possible avenues for further
ral
b epidemiological research methods and protocol development
a
investigation. The value of ecologic studies is
often underrated because of the possibility of
ecologic fallacy. Within ecologic study designs, it
is possible to assess the extent of the fallacy and to
some extent adjust for this. Furthermore, certain
studies can only be conducted as ecologic studies
because the exposure and/or outcome can only
be assessed ecologically, for example, the rela-
tionship between fluoride levels in water and
dental caries. In other instances, ecologic level
variables are more appropriate and accurate
measures than individual level variables. For
example, the variable ‘poverty’ is an ecologic vari-
able demarcating a depressed socio-economic
neighbourhood, whereas ‘individual income’
provides no information on the general socio-
economic conditions of the environment that the
subject is exposed to. Studies of community-
based health promotion activities using mass
media often require ecologic studies.
Conclusion
The research topics given below represent some
of the studies emerging from the problem explo-
ration done in the previous chapter. Having read
the chapter on study design, you can now decide
which design would best suit a given research
topic or question.
We suggest that you go through the list on page
61 and try to allocate a suitable design before
reading our comments below. Please note that for
some topics, there may be more than one ‘cor-
rect’ option and some alternative approaches are
not described.
Studies arising from the Sipho scenario
1 Asituational analysis of environmental condi-
tions in the squatter camp (situational analyses
often require multiple approaches)
Descriptive study:
@ A full assessment of environmental infrastruc-
ture done by environmental officers
@ Adescriptive sample survey of houses to
determine the environmental profile at house-
hold level
2 Asituational analysis of health facilities in the
area
Descriptive study:
@ Areview of services offered, staff employed
and expenditure
¢ Acollection of descriptive information on
clinic attendance, illness profile, medicines
72
prescribed, health promotion activities, and
referral to secondary and tertiary centres
@ Areview of non-clinical activities that impact
on care
@ Adescriptive survey of staff and patient atti-
tudes towards the service and perceived needs
3 Aprofile of childhood mortality in the area,
including cause-specific mortality rates
Descriptive study:
a) Where mortality statistics are well kept:
Use of routinely collected mortality and
demographic data to determine mortality
rates
b) Where no coherent system of mortality data
collection exists:
@ Ahousehold survey where caregivers report
on children in their care and any childhood
deaths over the previous year
4 The prevalence of malnutrition among child-
ren under five in the community
Descriptive study:
@ Ahousehold survey in which every child under
the age of five has a nutritional assessment
5 Astudy describing knowledge, attitudes and
practices of caregivers concerning diarrhoea
and its treatment
Descriptive study:
@ Asample of caregivers is interviewed using a
questionnaire which determines their know-
ledge of diarrhoea and its treatment, their atti-
tudes, and also the treatments they administer
6 Acomparison of the childhood mortality in
communities with and without piped water
Ecologic study:
@ This can be done by comparing mortality
statistics from communities with and without
piped water
7 Socio-economic risk factors for diarrhoea
Cohort study:
@ Agroup of children are followed up fora
period of time to see if they get diarrhoea. At
the end of the study, a comparison is made of
diarrhoea rates among children from homes
with ‘low’ and ‘high’ socio-economic status
Case-control study:
@ Socio-economic variables are compared be-
tween cases of diarrhoea attending a PHC
clinic and a group of neighbourhood controls
who do not have diarrhoea

8 Maternal education as a risk factor for death
among children who get diarrhoea
Case-control study (hospital or clinic-based):
@ The education level of mothers of children
who die from diarrhoea is compared to the
education level of mothers of children who get
diarrhoea but do not die
9 Acomparison of the diarrhoea mortality ina
community before and after the introduction of
piped water into that community
Before-after study (evaluating an intervention)
10 An evaluation of the effect ofa community
health worker (CHW) programme focusing on
appropriate treatment by mothers of children
with diarrhoea
Community trial:
@ Villages are randomly selected to be recipients
of a CHW programme focusing on appropriate
7 ~~ study design
treatment by mothers of children with diar-
rhoea. The CHW programme is introduced
and after a set period of time, various outcome
measures (for example, maternal knowledge
of ORS, under-five mortality rate, incidence of
severe dehydration following diarrhoea) are
compared between the experimental and con-
trol villages
11 To evaluate which method of rehydration is
most effective in a hospital setting
Randomized controlled clinical trial:
¢@ ‘Children with severe dehydration admitted to
the hospital are randomly allocated to two
treatment groups (there is no group that does
not receive treatment). They are followed up
and various outcome measures are taken
73

Introduction
While the study design chosen determines the
general approach of the study, it does not de-
scribe who the study will investigate or who it will
involve. This chapter looks at the concepts of
study population and sampling and gives details
of sampling techniques used mainly in descrip-
tive studies.
Study (target) population
When doing a study, it is important to clearly
define the group you want to gather information
and make conclusions about. This group, called
the study (target) population, should be clearly
defined in terms of place and time, as well as
other factors relevant to the study. For example, if
one wants to study the use of maternal health ser-
vices in Kimberley, the study population is
defined as ‘all women of child-bearing age (15—49
years)’ (who), ‘resident in Kimberley’ (place), ‘at
the time of the study’ (time).
It is essential to be sure who is included in your
study population and who is not. For example,
researchers who want to determine some charac-
teristic of members of a community often decide
to conduct the study on clinic attenders (for
example, HIV status of antenatal clinic attenders),
since they are community members who can
be reached with little effort. Clinic attenders are,
however, not representative of the general
population, since those who attend the clinic
usually differ from community members who do
not.
74
Sampling
The sample
If we want to investigate the use of maternal ser-
vices in Kimberley, for example, do we need to
interview everyone in the study population? It
would be a very cumbersome, expensive, and
almost impossible task.
It is neither practical nor necessary to study all
individuals in the study population. Rather, a
sample (subset or subgroup) of individuals can be
studied closely, ensuring that good quality in-
formation is obtained. By summarizing the find-
ings of the sample, the researcher intends to
make deductions about the study population.
Therefore, the sample should closely reflect or
represent the study population. If the sample is
representative, one can generalize sample results
to the population.
Scientific sampling methods have been devel-
oped to ensure that samples are representative.
The way in which a sample will be selected must
be described clearly in the protocol so that-
readers can judge how representative the sample
will be.
As outlined in Chapter 7: Study design, in case-
control, follow-up, and experimental studies, it is
important that the groups being compared are
comparable: it is no use comparing apples and
pears. In descriptive and cross-sectional studies,
where the aim of the study is to decribe some
characteristic(s) of a population, the samples
should be representative and thus reflect what
exists in the study population as a whole. This
chapter is thus of specific relevance for the latter
two study designs.

Random sampling
Random sampling (not to be confused with hap-
hazard or arbitrary sampling!) is a selection tool
which can ensure that one’s sample is representa-
tive of the population. This is also known as prob-
ability sampling, since each individual in the
study population has a known chance (probabil-
ity) of being included in the sample. While the
researcher controls the sampling process, she or
he has no control over exactly which individuals
are selected. In the end, whether an individual is
selected or not is determined by chance.
In the discussion that follows, it will be
assumed that information is required on indi-
viduals. If, however, information on households
(water, sanitation, income, density) is needed,
random samples are similarly drawn from all
households.
To be able to do random sampling, one needs a
sampling frame. This is a list or some representa-
tion (for example, a map) of the study population,
either in terms of individuals or in terms of groups
of individuals (for example, households or
villages), depending on the specific type of
random sampling used. The items on the sam-
pling frame are called sampling units. It is import-
ant that the sampling frame contains all the indi-
viduals in the study population: a sample can only
be representative if the original frame is com-
plete. Table 8.1 is an example of a section of a
sampling frame consisting of medical doctors
listed in the Cape Peninsula telephone directory.
It is often fairly difficult to get a good sampling
frame from which to sample: where would one get
a sampling frame for selecting households in a
large squatter camp? In townships or peri-urban
areas, there are often no reliable maps to use as
sampling frames. It is then necessary to explore
other possibilities, such as aerial photographs or
hand-drawn maps to use as a sampling frame.
Figure 8.1 shows a hand-drawn map of part of
Khayelitsha (Pick, Cooper, Klopper, Myers, Hoff-
man, Kuhn 1990).
Simple random sampling
In simple random sampling of individuals, the
sampling unit refers to an individual and each
individual in the population has an equal chance
of being selected for the sample. The researcher
has to draw up a complete list of all individuals in
the population and each individual has to be
given a number. So, in order to choose a simple
random sample of medical doctors in Cape Town
8 sampling
Table 8.1 Medical doctors listed
in the Cape Peninsula telephone
‘ directory
Abbas MR
Abdurahman N
Abdurahman Z
Abel S,‘Opthalmic -—
Abels CS
Abrahams A
Abrahams L
Abrahamse C GA, Ophthalmologist
Ackovic K L, Gynaecologist
Adam A
AdamOFAS, ree
Adam SA
Adam U
Adams AA
Adams G, Gastro-enterologist
Adams MC -
Adams S
Adendorff T W J
etc.
in order to investigate their knowledge of emer-
gency services, you would make a list of all
doctors and give each doctor on the list a number
(Dr Abbas is number 1, Dr N Abdurahman
number 2, and so on). In the case of a simple
random sample of households having to be se-
lected in the mapped area, each house is alloc-
ated a number, as shown in Figure 8.1.
To select those who are to be included in the
sample, one has to draw random numbers. This
can be done by drawing numbers from a hat,
using a table of random numbers (see Appendix
4), or by generating random numbers on the
computer. If one wishes to select a sample of 20
from a population of 80, the individuals whose
numbers correspond to the first 20 random num-
bers drawn (between 1 and 80) will be included in
the sample (see Table 8.2).
Stratified random sampling
If you have some knowledge that strata (sub-
groups) of the population differ with regard to the
measurements being made, you would want
these strata to be represented adequately in the
sample. For example, new peri-urban squatters
may be at highest risk for disease. Although they
form only a small proportion of the study popula-
75
b epidemiological research methods and protocol development
Figure 8.1 Hand-drawn map of houses in Khayelitsha
SITE B
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tion, they can be chosen as a distinct stratum. In
the case of the medical doctors, some are general
practitioners and some are specialists, and they
may have different levels of knowledge about
emergency services. The population should
therefore be divided into these mutually exclusive
(that is, no individual should fit into more than
one stratum) and exhaustive (that is, each indi-
vidual should be able to find a stratum to fit into)
strata. A simple random sample of individuals is
then selected from each stratum. This is called
stratified random sampling.
It is thus necessary to have a full list of the indi-
viduals in each stratum. Typical strata are age
groups, sexes, geographical areas or social class
categories. Strata should be selected so that the
variation of the characteristic of interest between
strata is maximized and variation within strata
minimized. Thus there should be little difference
with respect to the characteristic of interest
within a subgroup, and large differences between
subgroups.
Often the number of individuals selected from
each stratum is proportional to the size of the
stratum in the study population. This is called
76
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proportional stratified sampling. So, in the exam-
ple of the medical practitioners in Cape Town, if
20% of the doctors are specialists, then 20% of the
sample must be drawn from the list of specialists.
The results of the specialists and the general prac-
titioners are then combined to get the result of the
group overall.
However, equal numbers can be chosen from
each stratum to facilitate comparisons between
strata. This is often needed when there are very
small strata, which, if chosen proportionately, will
not have enough sampled individuals to allow
statistical comparison. If strata are not chosen
proportionately to their size in the study popula-
tion, the analysis involved in obtaining overall
results is more complex. The researcher has to
weigh stratum-specific results proportionately to
obtain overall results (see Appendix 1: Standard-
ization).
Simple random sampling and stratified ran-
dom sampling are easy to apply in, for example, a
school where full class lists can be obtained and
grouped in strata according to sex, age or stand-
ard. If, however, one wishes to study households
in a metropolitan area, it may be cumbersome to

Table 8.2 How to draw a simple random sample
The following example describes the drawing of
a sample of 20individuals from a population of
80 using random number tables.
Give every individual a number (80 individuals).
Select a table of two-digit random numbers
(these may be found in most
statistics textbooks).
Close your eyes and put your pen on one of the
numbers in the random number table, for exam-
ple 45. This will be your starting point.
Start with the selected number and choose a di-
rection (up, down, left or right).
We have chosen downwards. Record the num-
bers that appear in the table, moving in the
chosen direction until you have selected 20 num-
bers which lie between 1 and 80.
Any number above 80, and numbers which
have already been selected, are ignored.
give each household a unique number to enable
simple random sampling, and then to travel
through the area visiting the selected households
which are dispersed all over the area. In such
situations, cluster sampling may be considered.
Cluster sampling
In cluster sampling, the study population is first
divided into groups or bunches (clusters) of a
certain size. So, for example, the map could be
divided into city blocks and the doctors could be
divided into clusters according to columns on a
page in the telephone directory. Clusters and not
individual units are then selected at random. Typ-
ical clusters are schools, city blocks or villages.
After a random sample of the clusters has been
selected, all individuals, or a random sample of
the individuals in the selected clusters, are
included in the sample.
This method is convenient in studies involving
large geographical areas. In rural research,
villages are often treated as clusters. A full list of
villages is drawn up, a sample of villages is drawn
at random and individuals within these villages
included in the sample. Considerable savings are
8 sampling
RANDOM NUMBER TABLE
Os
@@OG+
roe)BB
@)
thus made in terms of time, personnel, and trans-
port.
This method is especially convenient if there is
a list of clusters, but not of individuals in each
cluster. Many community-based studies are done
using cluster sampling. On a map, households in
a metropolitan area can easily be grouped into
clusters of, say, five households each, and clusters
selected randomly. In Chapter 22: Immunization
coverage, examples of specific types of cluster
samples are given.
One of the most often-used forms of sampling
is stratified cluster sampling. In a study (Yach,
Katzenellenbogen, Conradie 1987) which aimed
to estimate the infant mortality rate in a rural area
of Ciskei, strata were defined in terms of village
type: urban, traditional, resettled and re-reset-
tled. All villages were classified into one of the
strata and villages (the clusters) were then chosen
randomly from each stratum. In small villages, all
households were included in the sample. Large
villages were divided into clusters, some of which
were then randomly selected. Within a house-
hold, all women of the specified age group were
studied. This is an example of multistage sam-
Hig
b epidemiological research methods and protocol development
pling: sampling takes place at various stages or
levels, for example, villages are first selected
according to type of village, and thereafter clus-
ters of households within a selected village are
chosen.
Cluster sampling does have disadvantages. If
the characteristics being measured are random
(heterogeneous) within each cluster (for example,
some children are immunized, some not) then
the clusters are representative of the population.
The results obtained from the cluster sample
would be similar (precise and unbiased) to that
from a simple random sample, and the cluster
sample would have been easier to study than a
random sample. But if people in the same cluster
tend to be alike (for example, all are immunized)
and different from those in other clusters, then
the cluster sample is much less efficient than a
simple random sample, and results could be
biased. It is therefore suggested that the sample
size of a cluster sample should be at least double
that of the corresponding sample size in a study
using a simple random sample. Additionally,
many clusters with few individuals per cluster
should be chosen, rather than few clusters con-
taining many individuals. In general, no fewer
than 30 clusters should be selected. Furthermore,
it is very important that the analysis takes the
cluster design into account. (See Chapter 22:
Immunization coverage.) Statistical techniques
for doing this adequately are still being devel-
oped.
Systematic sampling
Systematic sampling is often done intuitively. A
teacher may choose the child in every third desk
to go to see the school nurse, or a nursing man-
ager may go through every fifth patient’s file to
see what kind of patients come toa clinic.
Thus in systematic sampling, individuals are
selected systematically from some list or order-
ing, for example, a queue. In the example of the
medical practitioners, every tenth doctor may be
selected from the list. Similarly, every third house
may be selected from the map.
The complete population need not be known
before one starts to select the sample. So, for
example, you could select a random sample from
the admissions to a hospital, as people are admit-
ted. The procedure is random, since the starting
point is selected at random. Each nth individual
after the starting point is then selected systemat-
ically.
If the population size is known, the strategy
78
depends on the number in the population and the
size of the sample. If one wishes to draw a system-
atic sample of 20 individuals from a population of
80, the sampling interval is 80/20 = 4, that is every
fourth person will be selected. To determine the
random starting point one has to select a random
number within the first sampling interval, in this
case between 1 and 4.
It is important that the list or queue is not
ordered according to some system or cyclical pat-
tern. If street blocks consist of five houses each, of
which the two corner houses are bigger than the
others, a systematic sample of every fifth house
would not give a representative sample.
Systematic sampling is particularly practical ifa
sample of patient records has to be selected.
Non-random sampling
Various types of non-random (haphazard) sam-
pling exist, for example, judgement or quota sam-
pling. In judgement sampling, the researcher se-
lects individuals based on his or her own judge-
ment. Clearly, no matter how objective one tries
to be in choosing a balanced sample, it is impos-
sible to say how representative such a sample is.
In quota sampling, the interviewer is given a
description of the types of people who should be
interviewed and the number needed of each type.
The selection of individuals is left to the inter-
viewer and there is no attempt at randomness.
Often consecutive persons are included in a
sample until a certain number has been studied,
or patients seen over a certain period constitute
the sample. For example, to study the prevalence
of major depression in a rural community, all
patients attending the clinic in the community
during one calendar month could be included in
the sample. Clearly those visiting the clinic may
differ from those who do not visit the clinic. In
addition, the prevalence of the disease during
December may differ from that during July. If, to
address the problems of seasonal variation, it is
decided therefore to rather study a sample of
patients attending the clinic throughout the year,
including the first ten patients each morning, one
has to consider whether the patients arriving first
in the morning may differ from those who come
later (for example, those who are employed prob-
ably visit the clinic before work, and may be less
inclined to have depression than the unemployed
who come later in the day). These are examples of
bias (see below) to which non-random samples
are particularly prone.

Non-random sampling is generally not recom-
mended in quantitative studies, since the level of
representativeness is questionable and _ infer-
ences (generalizations) can thus not be made
about the study population. Most statistical pro-
cedures also assume that samples have been ran-
domly drawn.
There are, however, situations where non-
random sampling is useful and the only way open
to the researcher. In studying rare diseases, it is
often very difficult to locate sufficient cases in a
community-based random sample. Thousands of
people may have to be screened at great cost
before a handful of cases are found who can be
interviewed. Snowballing (or networking) is a
sampling technique whereby each case is asked
to name all other people he or she knows with the
disease. By following these people up and obtain-
ing further names from them, a sample is col-
lected. Similarly, members of a community could
be asked to name all the people they know with
the disease. Clearly, this sample could be biased,
since the most isolated cases may not be men-
tioned by anyone and thus not included. The
cases could also form separate non-overlapping
networks which would mean that networking
would lead only to cases belonging to one net-
work, which may be very different from the
others.
A similar approach has also been used to reach
so-called ‘hidden’ populations: hidden because
their activities are clandestine, for example, intra-
venous drug users. Many studies on drug usage
have been done by studying random samples of
drug users who present at some institution (drug
treatment programmes, criminal courts), but
those not presenting could be vastly different
from those who do. A sampling technique called
targeted sampling has been developed to reach
members of ‘hidden’ populations in the commu-
nity through a combination of techniques such as
networking and key informants (Watters and
Biernacki 1989). A study of sexual behaviour and
condom use among prostitutes serving the mine
hostels used snowball sampling to identify the
subjects. Since prostitution is illegal and a hidden
activity, this was the only feasible sampling
method (Jochelson, Mothibeli, Leger 1991).
If the researcher wishes to form a focus group
for discussion or do in-depth interviews on a
topic (see Chapter 19: Qualitative methodology), it
may be perfectly acceptable (and indeed desir-
able) not to select a random sample. Purposive
sampling allows for selection of individuals from
8 sampling
the spectrum one is interested in. Issues which
emerge in the interviews or discussion could be
quantified or explored further in (quantitative)
studies using representative samples.
Sampling bias
Bias occurs if the sample is not representative of
the study population, that is, if the individuals in
the sample’ differ systematically from the study
population. For example, if you use volunteers as
respondents, you must realize that those who
choose to volunteer may be people who are par-
ticularly interested in the research topic, perhaps
more so than the study population from which
they come. Similarly, hospital cases may be more
severely ill than cases in the community. Sackett
(1979) has outlined a number of biases which may
occur and it is useful for researchers to familiarize
themselves with these.
Bias can occur even if random sampling is
used. If the sampling frame used is not a full list of
the study population, one may obtain biased
results. For example, using telephone directory
entries as the sampling frame for a city’s inhabit-
ants would lead to a biased sample consisting
only of those people who have telephones and
listed numbers. They would probably differ
demographically from those who do not have
telephones or prefer to have unlisted telephone
numbers.
Even if the researcher has a complete list of the
study population, it may be difficult to locate cer-
tain people for interviewing. If you conduct a
community survey by visiting homes during the
day, you are likely to find children, the elderly,
and unemployed people at home. Special
attempts have to be made to reach the employed
people who were selected to be in the sample, by
going back in the evening or over a weekend. An
individual cannot be excluded from the sample
just because he or she is not at home at the time of
the interviewer’s visit. Furthermore, such an indi-
vidual should not be replaced by a ‘similar’
person who happens to be available. The person
who is at home in the afternoon may be very dif-
ferent from the one who is not.
People do refuse to participate, however. Espe-
cially in postal surveys where respondents have to
return completed questionnaires by mail, the
initial response rate can be very low. In postal sur-
veys attempts (second and third mailings, incen-
tives for participation) should be made to
increase the response rate. In any study where the
79
b epidemiological research methods and protocol development
response is less than 100% (the ideal, but a
response rate of above 80% would also be accept-
able) you should try to obtain demographic in-
formation on the non-respondents or a random
sample of the non-respondents. In this way, you
could investigate whether the respondents and
non-respondents differ in any substantial way,
thus introducing bias in the results.
Sample size
When the researcher has decided to select a
sample from the study population, the question is
how big a sample should be selected. An unneces-
sarily large sample entails wastage. On the other
hand, if a study is done on a sample which is too
small, the results produced will be neither useful
or conclusive, and a lot of time and money will
have been wasted. For example, if a study is done
to determine the prevalence of asthma in a
community, a sample size of 10 might yield two
asthmatics, giving a result of 2/10 = 20%. Had one
additional asthmatic been identified, the percent-
age would have been 30%. Likewise, if one less
had been identified, the percentage would have
been 10%. We can see that these results are very
unstable — one extra case swings the percentage
tremendously. If we had a sample of size 200, 40
cases would have yielded the 20% prevalence, but
one or two extra cases (41/200 or 42/200) would
hardly have affected the percentage. Thus the
larger sample size has yielded a result that is
much more stable and reliable.
Formulae exist for calculating the ‘correct’
sample size needed, but the researcher has to be
able to provide some information before these
formulae can be applied. If the study sets out to
estimate the prevalence of a certain characteris-
tic, the researcher has to have an idea of what the
prevalence is likely to be (2%, 20% or 50%). If the
aim is to estimate the level of a certain variable,
for example, blood pressure, you have to consider
the expected level and variability of the charac-
teristic. Similarly, if the difference in risk in two
groups is to be estimated, some idea of the ex-
pected difference is needed. Such information
can be obtained from a pilot study or from the
published results of previous studies. In addition,
you have to consider how precise or stable you
want the sample estimates to be. The more stable
the estimates must be, the larger the sample size
needed. For example, if you expect the prevalence
to be 30%, and would like to be 95% sure that the
sample estimate is within 5% of the population
80
value, a sample of 323 is needed. To be within
10%, one would only need 81 subjects.
If the study sets out to determine the signi-
ficance of a difference between groups or the
association between factors, the researcher has to
specify how large a clinical difference or associa-
tion needs to be detected as statistically signi-
ficant. For example, if a difference in blood pres-
sure of 10 mm Hg (clinical difference) has to be
detected as statistically significant, a smaller
sample will be required than if a difference of 5
mm Hg has to be detected as statistically signi-
ficant. On the basis of knowledge of the subject
matter, the size of a clinically important differ-
ence has to be decided on. Ina large sample, a dif-
ference of 2 mm Hg may be detected as statis-
tically significant, but this may not be a clinically
significant difference. For further discussion on
clinical significance, statistical significance and
sample size, refer to Chapter 11.
Often time, staff and cost constraints are the
most important factors influencing the sample
size chosen. The researcher can only complete a
sample if the size is practically feasible. The size of
the study population and the duration of each
interview or examination must be taken into
account to determine what is practically feasible.
It is usually necessary to get the help ofa statis-
tician or epidemiologist in order to calculate
the formula-based sample size, and to discuss
whether the study is worth doing if the practically
feasible size differs from the theoretically calcu-
lated one. Most formulae for calculating sample
size assume that simple random sampling will be
used. You should therefore discuss with the statis-
tician or epidemiologist which sampling strategy
will be used (for example, cluster sampling), so
that the sample size can be adjusted.
Many studies set out to calculate the preva-
lence or level not of one variable but of many. For
example, in a community survey to investigate
various possible risk factors for heart disease
(smoking, alcohol usage, obesity, cholesterol
levels) none of the risk factors can be said to be
the one of prime interest. So in this case, the for-
mulae based on the level and variability ofa single
variable are not useful. A statistician or epidemio-
logist should be consulted to help decide on a
sample size which would give some meaningful
results.
To obtain good estimates for prevalences in
subgroups (for example, of obesity in the age
categories 15-24 and 25-34 years), adequate sam-
ple sizes are needed in each subgroup. A sample

whose size was calculated to give an overall crude
estimate will not yield precise subgroup-specific
estimates.
Conclusion
Sampling is done in order to study a subgroup ofa
population, while still being able to make general-
izations that apply to the population from which
the group was drawn. To minimize the chances of
unrepresentativeness, probability sampling is
used. This requires a sampling frame and a proce-
dure which provides randomness in the selection.
Often a simple procedure will suffice, but in other
cases, more complex sampling strategies are
required, and a statistician should be consulted.
EXAMPLE 8.1
Sampling strategy to eliminate bias
Each year, approximately 35 000 patients attend
the Paediatric Outpatient Department at King
Edward VIII Hospital in Durban for the first time.
8 sampling
To determine which percentage of patients were
referred from other levels of the health service
and which percentage could have been treated at
a primary care facility, patients’ records had to be
studied. Since the study population is so large, a
sample of records had to be drawn.
The sampling strategy used was as follows. The
period from March 1988 to February 1989 was
divided into quarters. One month was randomly
selected from each quarter. From each selected
month, a random sample of days was selected.
Thereafter, a 20% systematic sample of records
(every fifth record) of patients attending for the
first time were chosen. In this way, bias due to
seasonal, day of the week, or time of the day vari-
ation was minimized, using a multistaged sam-
pling strategy with stratification, simple random
and systematic sampling.
Reference:
Rutkove S B, Abdool Karim S S, Loening WE. ‘Patterns of
care in an overburdened tertiary hospital outpatients
department.’ South African Medical Journal 1990; 77:476-8.
81

Introduction
The collection of information for a study is called
measurement. It is the process by which values
are obtained for the characteristics (variables) of
individuals being studied. This is obviously a
central aspect of research. Whether you want to
measure children’s weights, compliance with a
treatment, illness rates in a community, or
women’s attitudes towards contraception, you
need to measure some characteristics.
Measurement can be done bya variety of means:
@ by measurement with instruments (baumano-
meter, scale, thermometer, histological
measurement);
by questioning (by interviewer or self-adminis-
tered questionnaire);
@ by the use of documentary sources (such as
hospital folders, clinic reports);
@ by direct observation.
There is usually more than one method of collect-
ing the desired data. For example, information
about the prevalence of hypertension may be
obtained by measuring blood pressure with a
sphygmomanometer (instrument measurement),
by asking subjects whether a doctor has ever told
them that they have high blood pressure (ques-
tioning in an interview), or by referring to medical
records (documents). In practice, information
gathered often consists of replies to questions
asked of respondents as well as measures made
by the interviewer, for example, heights and
weights.
82
Data collection
and measure-
ment
Measurement instruments
The type of measurement instrument used de-
pends on:
the population under investigation
@ the type of information needed
@ the environment of data collection
@ the type of observer/interviewer
time/money/human resources available.
Questionnaires are commonly used in epidemio-
logical surveys and will receive closer attention in
this manual than other methods of measurement.
Even when questionnaires are not used in a study,
the information gathered has to be recorded ona
data capture sheet. Many of the issues in ques-
tionnaire design also apply to the data capture
sheet. On some occasions, data can be entered
directly onto computers in the field.
Questionnaires
Loosely defined, a questionnaire is a list of ques-
tions which are answered by the respondent, and
which give indirect measures of the variables
under investigation.
Questions can be asked in different ways — by
self-administration or by interview. A self-admin-
istered questionnaire requires the respondents
to fill in the questionnaire by themselves. In most
instances, the respondent reads the questionnaire
independently, but at times the questions may be
read out one at a time and answers filled in in a
structured manner. An interviewer may stand by
to assist with any problems that may arise. Self-
administered questionnaires are commonly com-
pleted in groups (for example, in a class) or posted
to respondents. The latter is called a postal ques-

tionnaire. In all these circumstances, the ques-
tionnaires have to be extremely clear and well laid
out, since untrained people will be completing
them.
In structured interviews, the interviewers
follow a well-defined structure to prevent them
from placing their own interpretation on the
question. Questions are asked in the same way,
with the same probes and clarifications, while
recording is also uniform.
The reliability of the information obtained
(stability on repeated measurement) increases
with objectivity and standardization.
In an unstructured interview, an interviewer
has a set of guide questions or themes that must
be covered during the interview. The sequence,
wording and approach used depends on the
interview situation. The respondent is thus given
much more freedom to express thoughts and
opinions. The interviewer tries to achieve the
study aims without imposing a structure on the
respondent. Reliability decreases with the sub-
jectivity of the unstructured interview, and thus
interviewers need to be more skilled and expe-
rienced for these types of interviews. (See Chapter
19: Qualitative methodology.)
Each method of questioning has advantages
and disadvantages, and the choice of the method
for the project must be practical and appropriate
for that project. Table 9.1 outlines some advan-
tages ‘and disadvantages of some of the methods
discussed above.
Steps in questionnaire development
It is necessary to allow adequate time to develop a
questionnaire methodically and thoroughly. The
following steps provide a guide for questionnaire
development.
Step 1: List the variables to be measured
One should aim for a well-conceived, concise
questionnaire. Variables to be collected should be
within the scope of the study. Make a short list of
variables based on the study objectives stated in
the protocol. Many researchers do not analyse all
their information. Ensure that only essential
issues are covered. Unnecessary or unrelated
questions which create the impression ofa ‘fish-
ing trip’ should be avoided.
Step 2: Formulate the questions
(a) Decide on the questions.
Questions can be open-ended where the
respondent replies in whatever way she or he
9 datacollection and measurement
chooses, for example, ‘What is your opinion on
the use of oral contraception?’ The alternative is
to have closed questions where the answer is
either ‘yes’ or ‘no’, anumber, or a choice of one of
a group of predetermined answer categories.
Closed questions encourage quicker, more
standardized data collection, but may limit
responses or inhibit the respondent. At times, a
question may be asked in an open-ended way,
but the answer may be placed into a predeter-
mined category when recording the response to
the question.
For example:
Question: ‘What is your opinion about the use of
oral contraceptives?’
Actual response: ‘They disturb the hormones in
one’s body and don’t work.’
Recorded response:
(i) approved (ii) disapproved; (iii) indifferent.
Questionnaires often have a mixture of open- and
closed-ended questions. Respondents often have
to indicate on a scale of 3, 4, 5 or 6 (called a Likert
Scale) what their attitudes towards some issues
are.
For example:
Please indicate your opinion on the following
statement by circling the appropriate number
along the line.
A cure will be found for AIDS within the next five
years.
Strongly Strongly
Agree Disagree
1 2 3 4 5 6
In general, it is advisable to have an even-
numbered scale to avoid excessive selection of
the middle value. The greater the number of
values provided, the greater the tendency among
respondents to avoid extreme values. Thus it is
not advisable to offer too wide a scale.
(b) Develop questions which will best elicit the
variables to be measured.
At times, one variable may need a series of two
or three questions to capture the true characteris-
tic. This is often true of a variable that has. a
number of components or facets (for example,
socio-economic status) or of a complex variable
comprising a few variables (for example, house-
hold density is the number of individuals in a
83
b epidemiological research methods and protocol development

Table 9.1 Main advantages and disadvantages of different methods of

data collection

Advantages Disadvantages

Survey of records:

@ little expense collecting the data format cumbersome as data cellected for
non-research reasons

allows historical comparison e data incomplete

can be quick (although time often ¢ variables inconsistently defined and recorded
underestimated) by different people at different times

set variables collected, so limits scope of study

Individual interviews

personal contact can facilitate response time-consuming and expensive

and quality information

can be done when respondents have low ¢ interpersonal dynamics may interfere with
literacy and cannot fill in self-administered data collection (e.g. suspicion)
forms

can collect data from people who are interviewer variation affects reliability
otherwise not reachable (e.g. people
from rural or informal areas)

Telephone surveys
@ relatively cheap (no transport and travel @ sampling bias: excludes people with unlisted
time costs) numbers or no phone at all

@ can cover wide area: no need to move @ nonverbal cues absent: affects
between locations communication

@ suspicions aroused when call received

at home

¢ questionnaire usually needs to be short, thus

limiting information

Mailed questionnaires

relatively cheap and can cover wide @ generally response rates very low (<30%)
geographical area

no interviewer variation @ people may have problems filling in the form,

leading to poor quality data

@ can be anonymous @ difficult to assess who filled in the form

84

household divided by the number of rooms in the
house).
For example:
Variable = number of live births
Questions:
How many of your liveborn children are living
with you?
How many of your liveborn children are living
away from you?
How many of your liveborn children have died?
(c) Phrase the questions.
@ Questions should be simple, concise, and very
specific. Make sure that there are no ambigui-
ties. The respondent should know exactly what
is being asked.
@ Decide where open- or closed-ended questions
are most appropriate.
Ask one question at a time. At times, questions
can be broken up into component parts to pro-
vide a fuller, more meaningful answer.
Avoid questions which suggest to the respon-
dent the answer that is expected or wanted
(leading question). For example,
‘Do you think smoking is bad for your health?’
versus ‘What is your attitude towards smoking:
do you think it is good for one’s health, bad for
one’s health or that it has no effect on one’s
health?’
@ Avoid loaded questions, that is, questions that
lead to specific associations or emotional reac-
tions (sensitive or personal information).
People differ as to the types of questions that
they perceive as sensitive or threatening, and
no assumptions should be made about this.
Examples of sensitive characteristics may
include: income, age, race, educational level,
alcohol use, sexual practice, and psychological
stress.
Closed question categories should be mutually
exclusive (that is, no overlap of categories) and
exhaustive (that is, they cover all possibilities).
Thus, always allow for an ‘other’ category
where the interviewer specifies the answer
when recording.
For example:
What language do you speak at home?
1 Zulu
2 Xhosa
3 Sotho
4 Tswana
5 English
9 datacollection and measurement
6 Afrikaans
7 Other {specify..:..d.5.4.0: )
@ Find out from potential respondents what
questions are meaningful to them and how to
phrase the questions to ensure that they are
understandable and acceptable. Local slang
may enhance the suitability of the question-
naire. Avoid technical language wherever
possible.
Step 3: Decide on the detailed practical logistics
of each question
¢ Does this question or section need introduc-
tion or explanation?
¢ Certain questions may only apply to some of
the respondents, and thus should be
‘funnelled’. This means that the questions for
the ‘select’ group should be put into a block
labelled clearly so that these questions are only
asked to suitable respondents, or are only
answered by suitable respondents. The follow-
ing example funnels the questions twice, once
selecting only females, and then selecting only
those who are not menstruating.
Females only:
Do youstill get your periods?
ayes
2 No
If no:
Did your periods stop:
1 Naturally
2 Due to surgery
3 Due to radiation/chemotherapy
4 Due to injectable contraception
5' Other (specify) 1G22.08
KOM R ens
6 Unknown
Design the recording procedure keeping in
mind who the interviewers or recorders of in-
formation are.
@ Should prompts (a question or statement
which triggers a response, usually without
actually suggesting what the answer should be)
be used at all? If yes, how and when?
For example, if the question ‘Have you ever
used contraception?’ is asked but not under-
stood by the respondent, rather than use exam-
ples like pills and injections (which gives them
clues as to what they think you want to hear),
interviewers are trained to paraphrase the
question, saying ‘Have you ever done anything
to prevent yourself from getting pregnant?’
85
b epidemiological research methods and protocol development
sry it gene Al ine 9 me A aa A EA AS AO AI A Re

There is still the danger that someone will
give a negative answer when they should not
have. In that case, the interviewer can ask from
alist prompting the respondent. The answers
are divided into categories which make it clear
which responses were prompted and which
were not. So, using our example of contra-
ceptive use:
Have you ever used any type of birth control or
family planning?
Have you ever used any of the following:
unprompted |prompted
_ Birth control pills yes/no yes/no
(oral contraceptives/
‘the pill’)
Injections
Intra-uterine device
won
(IUD, loop, coil)
Diaphragm
Foam/jelly/cream
Condom
NOSterilization
(tubes tied)
o Partner’s vasectomy
9 Other (for example,
withdrawal)
Specify.
It is important to train interviewers to use
prompts in a uniform way. Record on the ques-
tionnaire whether responses were prompted or
not.
@ At times, a question may require that the inter-
viewee be shown an example or picture to
choose from. Decide when this is necessary and
howit will be done.
Step 4: Determine the sequence of the questions
The sequence of the questions must be carefully
planned to ensure logical flow. Basic demo-
graphic information is usually unthreatening and
is often asked first. Sensitive questions are usually
put later in the questionnaire, so that some trust
has been built up by the time they are asked. In
addition, if subjects refuse to answer these sensi-
tive questions, the interviewer has at least col-
lected some information.
Step 5: Plan the layout and design of the ques-
tionnaire
The visual presentation of the questionnaire is an
important aspect which can influence the whole
data collection process. Whether the question-
naire is done by interview or by self-administra-
tion, try to make it as clear as possible so that
errors can be minimized. Here are some guide-
lines:
type the questionnaire whenever possible
@ ensure good visual spacing (double spacing
may make the questionnaire too cumbersome,
but may be possible if the print is reduced)
@ use highlights if needed
@ indent intelligently
@ print without smudges
@ make neat blocks (on computer or using a sten-
cil) for ticking answers or filling in numbers
@ different colour paper may be used for the dif-
ferent sections of the interview, for example,
household information on white, demographic
information on green, and environmental in-
formation on blue paper
@ visual markers such as arrows and blocks can
make administering the questionnaire easier.
Step 6: Consider the scale of measurement of the
variables
In considering the process and means of
measurement, an awareness of the scale of
measurement of the variables (see Chapter 11)
helps the researcher to plan adequately for the
analysis stage. For example, when collecting in-
formation on heights, measures are done and
recorded. Here the observations have numeric
meaning, and an average can be calculated. How-
ever, when collecting information on blood type,
each observation is categorized as O, A, B, or AB,
and the number of observations in each category
is counted. Here we cannot find an ‘average’
blood type: we have to calculate the percentage of
observations in each category. An understanding
of the scales of measurement is very important, as
different analyses are suitable for different types
of variables.
Step 7: Consider what coding needs to be done
once the data has been collected
Before the raw information can be analysed
quantitatively it must be prepared for analysis.
The process by which the information is con-
verted into numbers or categories is called
coding. So, for example, if male = 1 and female = 2,
all the respondents who are male are given a
number 1 next to the variable ‘gender’. Note that
for the variable ‘gender’ the code ‘1’ is merely a
category, but for the variable ‘age’ the code ‘1’
would have numeric meaning.

86

Every variable that is being collected must have
set codes with which to code responses. This is
easy for variables which measure characteristics,
such as weight and height, but gets more cumber-
some when open-ended questions have to be
given codes. These open-ended questions should,
where possible, be given codes before the study
so that responses can be coded rapidly. In prac-
tice, many researchers only allocate codes to
these more qualitative questions once they see
the types of responses that have emerged. They
then allocate codes to the broad themes that
come up in the data.
Coding is an important task during the data col-
lection phase. It can be time-consuming, espe-
cially when large surveys are done and the ques-
tionnaire is long. Adequate time should be alloc-
ated to this process, and money budgeted to pay
coders. The task can also serve as a form of super-
vision and checking to assess the quality of the
data. If mistakes are found while still in the field,
errors can be checked and corrected. Sometimes
coding can be done directly by the interviewer,
but in this case the recording skills of the inter-
viewer must be of a high standard, and some
checking procedures should be built into the
process.
Step 8: Consider the means of data analysis
Information collected on the questionnaire or
data capture sheet needs to be summarized and
analysed. If a quantitative analysis is planned, the
design must be discussed with the person(s) who
will do the analysis, since the design must take
into account how the data will be analysed. There
are several possibilities.
(a) Analysis by hand
A data capture sheet (Figure 9.1) can be made,
with each variable going vertically and each
observation running horizontally. Information is
filled into each space.
From suchalisting, the researcher can easily do
counts of certain variables, for example, the
number of males in the group. Cross-classifica-
tion (for example, how many of the males com-
pared to the females have high blood pressure?)
may be rather cumbersome.
Alternatively, a special data card can be de-
signed to capture data for each individual. The
card can be used for the research only, or can
form part of clinical records. Variables are spaced
along the edge of the card with punch holes corre-
sponding to each possible option on all variables
9 datacollection and measurement
Figure 9.1 Data capture sheet
Observa- | Age | Sex | BP | Height |Weight| Rx | Hos-
tion pital
1 ELSE
oe © wl eS
2 Ae bi 5Vesbashes ds ea
3 3) 4 a
4 Mecobb) SE BR sil:eg ll
5 AES ll,tlh edeSe
B fedJ Necline
8
a on
nh oO
25 a!
ee lo
(Figure 9.2). The hole corresponding to the
appropriate category for each variable for that
individual is torn or punched out. Analysis is done
by threading a knitting needle through the hole
corresponding to the variable option that is being
analysed. After giving the pack of cards a
thorough shake, all those cards conforming to a
certain option on the variable will fall to the
ground. Simply counting the fallen cards will give
the frequency of that option.
(b) Analysis by computer
Computer analysis of data is by far the quickest
and most accurate way of obtaining results. How-
ever, many people do not have access to com-
puters or do not know how to use them.
Researchers can choose between personal
computers or mainframe computers. Mainframe
computers are extremely big computers which
analyse large data sets. They are used by big insti-
tutions such as universities, businesses, and
government departments. As computer technol-
87
 epidemiological research methods and protocol development
Oa

Figure 9.2 Tuberculosis clinic card designed for hand analysis

SAISOd QAIISOd
e
aAleHaN e 9AINSOd
OAeBoN e QAIISOd
e
aaneban ¢ BAIISOd
¢
aaneban
ISSLNINS
©
JILSONSVIC ADOIOLSIH
«
AWY-X
LSSHO
¢
|EINI|d
UOISNJ9
© JeIIH
Auyyedoupe
SNOILVDILSSANI ynpy
ad aAlssalHOld
Wid
e
aseasip LOAYIG
WALAdS
AYNLINIWNALAdS
e

DIAGNOSTIC CRITERIA

PLACE OF SUPERVISION AT
END OF TREATMENT MOVEMENT OF PATIENT THROUGH TREATMENT SERVICES
Referred by to date
SPUTUM CULTURE
AT 60 DOSE
School
Positive
Domiciliary (sisters) Ne
ia
itce Negative
So
cc
e
cr
rts COMPLIANCE
REASON FOR EXIT cst
oOWw
ec ON EXIT
Cured TB ke
a LNIWLVIYL
STIWLIG
Less than 75%
i =
2
oF 75% or more

Absconded, etc
Transferred out of health region END COMPLIANCE (except fortransfer within health region)

OUTCOME
transferred
stopped
Rx
Date
or health
region
of
out
no. of doses 100
possible no. of Rx days

Source: Dick J, Youngleson S M, 1994.

ogy develops, mainframe computers are being re-
placed by more efficient, smaller machines.
Personal computers (PCs) are (generally) small
computers which are suitable for personal use or
departmental use. While very large data sets
cannot be accommodated by PCs, many software
programmes are now available which enable
researchers to do sophisticated analyses on these
machines. A suitable data capture system (for
example, Lotus, dBASE, Epi Info) needs to be
decided upon. The questionnaire must be de-
signed to ensure easy transfer of information by
the researcher from the questionnaire onto the
PC.
If the data analysis of a project is being done
within a big institution, special computer
punchers will punch the information onto the
mainframe. Preparation of the data for computer-
ization is important and specific procedures have
to be adhered to. The variables for each individual
need to be coded in such a way that the computer
can receive the information. Usually the answers
are given numeric codes (for example, male = 1
and female = 2). There must be blocks for coding
along the right-hand margin of the questionnaire.
Only coded information may be placed in this
space (usually marked ‘For official use only’) and
this information is then typed into the computer

88

by the punchers. Each coding block has a unique
number. The coding blocks start from 1 and are
numbered consecutively. The coding block num-
bers allow the punchers to find their way around
the questionnaire and allow the computer to read
in specific blocks as specific variables. For exam-
ple, the data in block 1 might be allocated for area
of residence, blocks 2 and 3 for the age of the
respondent, and so on.
Micro hand-held computers are compact port-
able computers which allow for entry cf data at
the point of data collection. Values are punched
in by the interviewer, circumventing the need for
filling in questionnaires and coding. This method
also allows for the rapid analysis of data so that
interim results are available immediately, and the
monitoring of fieldwork is possible. Possible tech-
nical problems such as power or battery failure
must be kept in mind and planned for, otherwise
the data collection can become a nightmare.
Step 9: Pilot (‘pretest’) the questionnaire
A pilot study is a test run of aspects of the main
study. In developing a questionnaire, a series of
small pilot studies are needed to refine the instru-
ment.
Pilot studies require an in-depth look at the
questionnaire with the aim of improving its qua!-
ity. Usually only a few subjects are chosen per
pilot study, for example, 5 to 20 individuals.
In the early stages of developing the question-
naire, rudimentary questions can be asked of col-
leagues and friends in order to investigate the
wording and the clarity of the questionnaire.
Glaring problems will be picked up at this stage.
Later pilot studies should be addressed to
groups which are increasingly similar to the target
population. For example, if the study hopes to
determine the immunization coverage of chil-
dren under five years in a particular community,
the pilot studies could take place at the paediatric
outpatient department of a teaching hospital,
then at a day hospital covering a similar popula-
tion, and lastly using a small community sample.
At first the researcher must be active in the pilot,
but later the questionnaire should be adminis-
tered by interviewers similar to those to be used
in the main study.
During the pilot study, the interviewer should
record words and sentences that are not under-
stood and questions that require prompting or
explanation. There should be space on the ques-
tionnaire to write down the respondents’ reac-
tions to certain questions, especially sensitive
9 datacollection and measurement
ones. Open-ended questions will generate a
variety of responses, which can be used to deter-
mine the options for the main study or the codes
to be used. Common responses will be chosen as
the categories that will appear on the final ques-
tionnaire or coding sheet. Logistical issues, such
as the time taken and the suitability of categories
should also be recorded.
At the end of the pilot interview, the responder
might be asked how he or she felt about being
asked questions in this way. Comments on the
timing and the situation should be welcomed.
Suth feedback could be crucial for the main
study.
Step 10: Make necessary changes
After the pilot study, the interviewers should be
fully debriefed and comments noted. As many of
the criticisms as possible should be addressed, so
that the final questionnaire benefits fully from the
feedback.
The training of the interviewers for the main
study should also help as a final pilot. Inter-
viewers often pick up problems and should feel
part of the questionnaire design. In order to bene-
fit from their input, make sure that there is
enough time between the interviewer training
and the start of the study to make the final neces-
sary changes.
Remember to check and recheck coding block
numbers. A miscount can cause havoc when the
data is being punched into the computer.
Quality of the data collected
If the results of an epidemiological study are to be
sound, the quality of the information collected
needs to be good. How cana researcher evaluate
the quality of the information?
The first, rather intuitive, way of checking data
quality is to look at indicators of the context in
which the measurement process took place. The
second is a more formal evaluation of measure-
ment error.
Indicators of the context in which measure-
ment takes place
Before full analysis of the data, it is useful to ex-
tract information which can give a sense of how
and from whom data were obtained. Three types
of data are useful for this purpose.
1 Data indicating how much data is missing
Data may be missing because of failure to locate
89
b epidemiological research methods and protocol development
ee
he 8 Eee
an individual, non-co-operation of an individual
(either by refusal to be included in the survey or
refusal to answer specific questions), illegible
entries,or lost records. The extent to which data is
missing should be investigated and reported in
writing up the results of the study.
2 Data on the characteristics of respondents
Different types of respondents may give different
information concerning the same issues. The
respondents’ age and sex, status in the home,
occupational status, and other relevant variables
should be recorded. These may give an indication
of the reliability of response.
When information on a particular person is
being collected, that person is called the index
person. Self-reporting by the index person is desir-
able in most cases, although in unusual situations,
for example, in the case of trauma victims or
peopie with intellectual disability, proxy responses
may be preferred. A proxy response means that
someone else responds on behalf of the index
person. In such cases, it is important to record the
relationship of the proxy to the index person.
3 Data on the setting in which the information
was collected
The environment in which data collection takes
place can influence the data. It may be important
to note the time, place, and even the temperature,
as such details may influence the quality of the
data. It may also be possible for the interviewer to
record a subjective assessment of the interview
and the quality of the information provided.
Formal evaluation of measurement error:
reliability and validity
Data is only as good as the measurement instru-
ments used to measure the characteristics.
Ideally, we would like to measure ‘the truth’ every
time we measure the characteristics. Any devia-
tion from this constitutes measurement error.
Measures are usually considered in terms of
their reliability and validity.
Reliability refers to the degree of similarity of
the information obtained when the measurement
is repeated on the same subject or the same
group. Is the same value arrived at every time the
measurement is taken, or do the values vary a lot
on repeated administration?
Validity refers to the extent to which a measure
actually measures what it is meant to measure.
The measure lacks validity if an observer or
instrument measures the characteristic in the
90
same individual (or group) repeatedly higher or
repeatedly lower than the real value. This
systematic error is called bias. See Chapter 12 for
more information on precision and bias.
These two concepts are illustrated in the bull’s-
eye diagrams in Figures 9.3 to 9.6. The centre of the
bull’s-eye represents the ‘truth’ which we would
like our data to reflect (thus, deviation from the
centre will represent poor validity). We would also
like our data to reflect this ‘truth’ when the mea-
sures are repeated. So, repeated studies should give
similar results represented by the close proximity of
the ‘shots’ to each other (repeatability).
(Please note: the concepts of reliability and valid-
ity extend to other research processes as well. So
we can refer to bias in sampling analysis, and so
on. Please refer to Chapter 4 and Chapter 12.)
The possible sources of error in measurement are:
1 the instrument
2 the observer
3 the subject
4 the environment.
Improving and evaluating reliability
Variation between measures (that is, poor reli-
ability) can be decreased by addressing the
source of the variation.
(i) The instrument variation (giving different
results for the same individuals) can be
reduced by standardization and calibration of
the instrument. The quality of the instrument
or questionnaire must be improved. (See
Appendix 2: Standardization of observers and
instruments.)
(ii) Observer variation can stem from differences
among observers or interviewers (inter-
observer variation), as well as differences in
the same observer or interviewer on separate
occasions (intra-observer variation).
These variations between measures can be
reduced by:
@ setting exact ways of measuring (standardiza-
tion of measurement or interview)
@ intensive training periods for all observers and
interviewers
supervision and periodic checks on their work
selection of observers and interviewers along
similar criteria with reference to age, sex,
educational level, and other relevant character-
istics.
(iii) Subject variations may be due to biological
inconsistencies (for example, blood pressure
 9 datacollection and measurement

FT ge eeMy Yi i TELT nor Figure 9.4 Reliable but not ae

outs bites itis -@ measurement

Sr aM NAT Figure es ELIC RTM lire

lel(=)
CMe ire Cemiiterei cites measurement

Source: Botha JL, Yach D, 1986.

does not stay the same all day) or inconsisten-
cies of memory. Repeated measures make it
possible to assess and adjust for biological
variation.
Instrument, observer, and subject variations
can be evaluated by repeating measures of a sub-
sample of the study sample, or (in the case of ques-
tionnaires) by asking related questions which, if in
disagreement, will show inconsistencies.
Statistics used to assess the agreement on
91
b epidemiological research methods and protocol development
i a
E I e

repeated application of questions depend on the class.

type of variable, and a biostatistician should be
consulted about how to evaluate repeat measures
meaningfully.
Improving and evaluating validity
Different levels of validity exist:
Face validity refers to the validity ‘on the face of
it’ and refers to the extent to which the measure or
question makes sense.
Content validity requires that the measure in-
cludes or accounts for all the elements of a vari-
able or issue being investigated. For example,
educational level and occupational class do not
account for all the elements of the variable social
Criterion-related validity involves evaluating the
results of the index study against the most valid
measure available (the gold standard). The gold
standard is used as a criterion to see how many
values were correctly identified. The sensitivity
and specificity of a measurement instrument are
statistics which assess the criterion-related valid-
ity of variables (see Figure 9.7).
Predicted validity requires that the measure, if
used, confirms a known or theoretically hypo-
thesized association. For example, social class is
known to be associated with school performance.
If the validity of using ‘family ownership of a
motor car’ as a measure of social class is being

Figure 9.7 Evaluation of CCRC Rm

ECLA e
sensitivity and specificity

The true situation as yielded by criterion measure

Positive Negative

Positive

Results
yielded by
instrument
being assessed
Negative

A
Sensitivity: (true positive rate)= (A+C)
Percentage of positive test results out of all true positives

BBP
one
Specificity: (true negative rate) = (B+D)
Percentage of negative test results out of all true negatives

A
Positive predictive value = (A+B)
The percentage of positive test results that are truly positive

eet
Negative predictive value = (C+D)
The percentage of negative test results which are truly negative

92

assessed, the investigator will determine to what
extent ‘family ownership of a motor car’ is associ-
ated with school performance.
Inconsistent validity may refer to a measure
which is valid for one population or group, but
might be different in different groups, popula-
tions, and environments. Thus questionnaires or
tests designed for a particular population in the
northern hemisphere might be unsuitable and in-
valid for populations in developing communities.
Questionnaires are particularly vulnerable to
measurement bias, and numerous types have
been described in the literature (Sackett 1979).
Please refer to Chapter 18: Knowledge, attitude,
beliefand practice studies.
Other issues related to data
collection
Ethics
It is important to get permission from partici-
pants to be interviewed, after you have explained
the study and method of interview to them. This is
called informed consent.
Ethically, researchers are required to protect
the identity of study participants. Ideally inform-
ation should remain anonymous, that is, names
should not be recorded at all, not even on the
questionnaire. However, often some record of the
respondents’ names needs to be kept so that
follow-up or even referral is possible. If it is
planned that all participants will be informed of
their personal results (for example, blood results)
or the overall study results, names and addresses
are clearly needed. In such cases, it is ethically
acceptable that information remains confiden-
tial, which means that information that can be
traced to a particular individual is available only
to the researchers.
Translation
Clearly, the best way to interview people is to ad-
dress them in their own language. If the question-
naire is to be used on people who speak a lang-
uage other than that of the researcher, translation
will be an issue.
Interviewers should be fluent in the language of
interview. One option is for the questionnaire
itself to be in a language that the researcher
understands (for example, English), but for the
interview to be conducted in another language. In
such a case, the interviewer translates the ques-
tionnaire, and thus has to be fluent in the lang-
uage of the questionnaire. The advantage of this
9 datacollection and measurement
approach is that the researcher understands what
is on the questionnaire and can monitor the
answers. However, it is very important that the
translation is standardized between interviewers
during the training sessions. This method is not
suitable for in-depth and semi-structured inter-
views, where exact replies must be recorded and
interpreted by the researcher.
The second option is for fully translated ques-
tionnaires to be used in the interviews. The initial
translation should be done by someone fluent in
the language, who can judge whether certain
plirases are understandable and acceptable. This
translation should be proofread by a second
person. The next step is for someone else to re-
translate the questionnaire back into the original
language. If the re-translation corresponds well to
the original questionnaire, the translation is
accepted as adequate. Please note that linguists
are not necessarily the best people to translate
questionnaires. Often health workers who work
with people similar to the respondents will have a
better feel for what can be understood by the
person on the street.
Interviewers
Interviewers should be carefully selected (on the
basis of, for example, educational level, sex, expe-
rience), well trained, well supervised, and ade-
quately paid. It is important that similar types of
people collect similar information, so that inter-
views are as similar as possible. This improves the
reliability of information.
One study might employ different types of
people to do different tasks in the data collection
process. A registered nurse might measure
heights, weights, and blood pressures while a
middle-aged woman with high school education
might do the interviews. Yet another person, well
known in the community and with good interper-
sonal skills, might inform people ahead of time of
the study and motivate them to participate. (See
Chapter 17: Example 17.2.)
Training
Training of staff involved in the data collection is
fundamental to good quality information. It is
well worth spending a few days training inter-
viewers, observers, and motivators so that every-
one knows exactly what is expected of them.
During the training period, the nature of the
research, the reason why the research is being
done, and the objectives of the study should be
carefully explained before the tasks are discussed
93
b epidemiological research methods and protocol development
in detail. Cohesion among the team should be
facilitated and rules, conditions of employment,
and other specific instructions explicitly dis-
cussed.
There should be clear lines of accountability
and the nature of the supervision should be ex-
plained. For example, the interviewers should
know that they will receive instructions from the
field co-ordinator or supervisor, who will also
check their work for errors.
Field supervision
There should be a clear plan of how supervision
will be done in the field. Site visits, checking of
94
forms, and checking that the data was not fudged
all have to be considered. From time to time, the
fieldworkers may have to meet with the super-
visor or co-ordinator to discuss important issues.
Conclusion
Whether data is collected in the community (see
Chapter 17), the workplace (see Chapter 24), the
health care setting (see Chapter 15), or by post or
telephone, the measurement tools need to be
carefully considered to ensure good quality data.
The validity and reliability of the data should be
evaluated when describing the results.
10
Data management and analysis
The proposed analysis of the data should form an
integral part of the planning stage of the research
project. On a practical and technical level, the
researcher has to decide beforehand who will be
analysing the data, and this person should be
involved from the start. Where and how will the
data will be analysed? Will it be necessary to buy a
PC or a special analysis programme (and learn
how to use these)? Will you have to approach pro-
fessional biostatisticians, for example, at a uni-
versity or research institution? Funds may be
needed for the analysis (for buying special equip-
ment or paying for the services of a biostatisti-
cian), and these have to be budgeted for. In set-
ting up a time schedule for the project, you
should include a reasonable period for analysis,
and not think that the time-consuming part of the
project is completed once the data has been
collected.
More fundamentally, however, the analysis
forms part of each step of the study. It is not just
the final step before write-up. When defining the
study objectives, you have to decide how to
analyse the data in order to reach the objectives.
Is such an analysis at all possible, or would you
have to reformulate your objectives? It is thus
necessary to express objectives in measurable
terms.
When doing the literature review, you should
note the methods of analysis used by other
researchers. When deciding on study type and
sampling scheme, you have to consider whether
methods are available for the analysis needed. For
example, if a complex sampling scheme is used,
you must be sure that the appropriate means of
Other issues to
consider in the
protocol
analysis is planned and available (see Chapter 22:
Immunization coverage).
The decisions what to measure and how to
measure it are closely linked to the analysis. In
drawing up a questionnaire, you have to consider:
how will I analyse this question? At this stage, you
should draw up dummy tables (or table shells).
These are tables which indicate how you intend
to represent your data. There should be tables
describing sample characteristics (for example,
age/sex), as well as associations between vari-
ables. These tables should clarify whether you
have included questions on all the factors needed
for the proposed analysis, or whether many
redundant questions are asked.
Once the data has been collected, you can start
by completing these dummy tables; this gives a
good starting point for analysis. Researchers who
have not thought about their analysis throughout
their project planning often find that once the
data has been collected, they do not know what to
do with it. A project which proceeded well
through its field-work stage can grind to a halt at
the analysis stage if limited thought has been
given to the analysis. Dumping the collected data
on a Statistician who has not been involved in the
rest of the project does not solve this problem,
since the researcher is the one who has to tell the
statistician what questions he or she would like to
have answered.
Sometimes during the analysis phase, the
_researcher discovers that some of the intended
analyses cannot be performed (for example,
because there is too much missing data or too few
people with a certain characteristic). This can be
minimized by carefully considering the analysis
beforehand. Similarly, you may find new associa-
95
b epidemiological research methods and protocol development

‘Table 10.1 Budget for AIDS study — 1 March 1994 to 28 February 1995

A Recurrent expenses

Personnel 270 000

Current employees
Dr A (10% effort) 20 000
Ms G (25% effort) 35 000
Ms K (10% effort) 15 000
To be employed
Research officer 110 000
Fieldworker (x 2) 80 000
Consultants
Dr Y (R 100 per hour) 10 000

Supplies 15 500
Questionnaires (x 1 000)
Blood collection kits (x 1 000)
Stationery and photocopying
Emergency first aid kit

Travel 37 800
Lease of vehicle (x 12 months)
Vehicle maintenance (40c per km x 18 000 kms)
Use of private vehicle (R1,10 per km x 6 000 kms)

Patient care costs 7 500

Hospital visits and in-patient stays
Laboratory tests
Drug treatments

General 3 000
Cost of reprints 1000
Attending local conference 2 000

B Capital expenses

Purchase of vehicle (4x4 van) 120 000

Equipment for laboratory tests 8 000

Total capital expenses

Total direct costs R461 800

Cc Administrative overhead (20%) R92 560

TOTAL BUDGET R554 360

96
 10 other issues to consider in the protocol

tions to investigate in the analysis, but you should

concentrate on the intended analysis and not Table 10.2 Actions to facilitate an
spend too much time ‘fishing’ for findings. ethical approach

Resources Obtain permission from a recognized ethics

committee
The execution of a research study depends on the
availability of funds and resources needed for the Obtain permission for access to information/
investigation. Some studies can be completed on groups from:
a shoestring budget, but research planners @ Authorities (for example, local government,
should be cautious of under-budgeting, as this institution
can compromise the validity of the study. Organizations
The additional resources needed for the study *e Community
(overt costs) and those that are available (hidden
costs) need to be considered. Personnel needs Regarding people:
may include technical staff (for example, field- @ Informed consent
workers, coders, field co-ordinators), and acade- @ Confidentiality/Anonymity
mics such as statisticians and other consultants. @ Protection from risk
Other costs include equipment, printing, station- — physical
ery, transport, venues, and special tests or invest- — emotional
igations. — social
You should use whatever resources are avail- — other
able in the setting in which the research will take
place. Service providers may second some health Act on findings
personnel to do the field work, and may provide @ Keep in mind implementation goals when
some of the equipment needed. planning
You can apply for research funds from the Med- @ Write up
ical Research Council, the universities, private ¢@ Publish
corporations (for example, Anglo American), and @ Motivate for action
non-governmental organizations (for example,
the Health Systems Trust and the Heart Founda- Publish
tion). Acknowledge the work of others
A formal budget should be prepared, whether Obtain permission to publish or use
applying for funds or not. Table 10.1 illustrates a material
budget. Depending on the type of project, differ- Report negative and positive findings
ent items may be listed, and some of those
mentioned here eliminated.

Ethical and legal considerations

All researchers have a responsibility to provide
benefits to people in general and to stay within
the law. To ensure that methods and approaches
used in a study are legally and ethically accept-
able, it is essential that protocols be submitted to
an ethics committee well before the start of the
study. All universities, as well as some other insti-
tutions, have such committees.
Benefits must outweigh the personal risk —
physical, psychological or social — of participa-
tion in the study. Study techniques should thus
not be harmful, and participants should be
informed of the nature of the study, its proce-
dures, and their right to refuse or withdraw at any
time. Confidentiality or anonymity should be
ensured.
In a protocol, plans for safeguarding the rights
and welfare of the participating subjects and the
method of obtaining informed consent should be
explained.
Other issues to be considered include permis-
sion for access, the need for action on findings,
and procedures to adhere to when publishing re-
sults. Table 10.2 provides brief guidelines to facili-
tate an ethical approach.
A full discussion of the ethical aspects of
epidemiological research can be found in Chapter
3: General philosophical issues in epidemiology.
97
b epidemiological research methods and protocol development
Report writing
Many research projects are never written up as
reports or journal articles. The knowledge gained
from both the results and the methods is thus not
passed on to others. This is obviously a waste of
resources. All researchers should be encouraged
to make their project available for others (other
researchers, service providers, and decision-
makers) to read. This should be done even if the
project was a ‘failure’, for example, if sampling
biases were encountered or a poor response was
achieved. A description of problems encountered
will help other researchers to avoid such prob-
lems.
No project can be considered finished before it
has been written up. The write-up could be in the
form of a scientific article, a comprehensive
working paper containing all details, or a special
report to decision-makers/service providers.
Results should also be reported back to inter-
viewers and research participants in an accessible
form.
The qualities of a good report
@ The title should clearly explain what the report
is about. It should attract potential readers.
The summary or abstract should inform the
potential reader in brief what the aims,
methods, population, and results were.
@ The style of the report should be easily under-
standable. Language should be clear and
simple, while the structure should have a
logical flow (outlined below). Graphics and
tables should be clear and informative.
@ The report should be concise with no unneces-
sary information. Digression and waffling have
no place in a good report.
The logical structure of areport
1 The Abstract is asummary written after the rest
of the report has been written.
2 The Introduction puts the reader in the picture.
The motivation for the study and the objectives
98
and scope of the study are stated. The study is
located in terms of reviewed literature.
3 The Study population and Methods section
gives details of the study methods and should
include:
study design
study population
how the sample was selected
response rate
@ characteristics measured
@ methods of data collection
@ quality of the data
@ how the data was analysed.
4 The Results section includes written descrip-
tions of the findings, as well as tables and charts
to clarify the text. The results of statistical tests
should be given.
All tables and graphs should be clearly titled,
and totals and figures should make sense.
Everything in the tables and figures should be
relevant to the topic.
ao The Discussion provides the chance for the
writer to interpret the findings, air opinions,
compare the results with other findings, and
point out the shortcomings of the study.
6 The Conclusion rounds off the report and gives
some indication of the scientific and practical
implications of the study.
7 References should always be included.
The report has a similar structure to the protocol.
If the protocol has been prepared carefully, the
writing up flows easily. The results and the dis-
cussion are the sections which need new effort.
Conclusion
From the above, it is clear that many administra-
tive issues need to be considered in the protocol,
in addition to the methodological issues. These
administrative issues should receive close atten-
tion, since they could sabotage an otherwise well
planned project.
 Data presentation, analysis,
and interpretation

11 An introduction to data presentation,

analysis, and interpretation
G Joubert

12 Integrating epidemiological concepts |

S S Abdool Karim .
11
Introduction
This chapter aims to provide an (almost) formula-
free introduction to the presentation, analysis
and interpretation of epidemiological data.
Statistics have a contribution to make in all
phases of a research project from the planning,
through the data analysis, the interpretation and
discussion of the results, to their publication. In
this section, we focus on the processing and ana-
lysis of data, as well as the presentation and inter-
pretation of results, with the aim of familiarizing
researchers with important statistical concepts. A
researcher should consult a statistician to discuss
the statistical aspects of the research project in
the planning phase, as well as the analysis and
write-up phase. A basic understanding of statis-
tical concepts will ensure that the researcher gets
the most benefit from interaction with a statis-
tician. Such an understanding will also enable him
or her to evaluate published research findings.
Statistical concepts play a dominant role in
epidemiology, as you can see when reading any
epidemiological journal article. However, the
statistical techniques used are not always appro-
priate. This might be because many statistical
textbooks place the emphasis on ‘how’ a statis-
tical method is applied (the cookbook approach),
rather than ‘when’ and ‘why’. In addition, the
widespread availability of personal computers
(PCs) and statistical software enables a researcher
to do complex analyses without having to under-
stand the techniques used, or even looking at the
data closely. The PC will provide an answer,
whether the question asked is appropriate or not.
Data analysis cannot be done adequately by
simply following a few ‘how to’ rules.
An introduction
to data
presentation,
analysis, and
interpretation
Many researchers may feel at a disadvantage
since they do not have a good mathematical back-
ground, and may even fear formulae. Such a
background is not necessary to enable you to
master the basic statistical concepts. However,
researchers should consider upgrading their
mathematical skills (by attending courses or
working through textbooks) to fully come to grips
with the statistical methodology. We hope that
this section will instil an interest even in those
readers who have a fear of numbers, and encour-
age them to develop the necessary skills.
Variables
The characteristics which one measures, and
about which data are collected, are referred to as
variables (Figure 11.1).
Categorical variables specify which category an
observation falls into. Such variables are called
nominal if categories are in no order, but are only
identified by name, for example, the categories
male or female for the variable sex. If there is
some order amongst the categories, the variable
is called ordinal, for example, the variable social
class which may be recorded in categories 1
Figure 11.1 Types of variables
Categorical
ae te
Nominal Ordinal
Numerical
eyeaten
Discrete
iach a
Continuous
101
c datapresentation, analysis, and interpretation
(professional) to 5 (manual), or the severity of a
disease (mild, moderate, severe). A categorical
variable which has only two categories is called a
dichotomous or binary variable. Categorical vari-
ables are also often referred to as qualitative vari-
ables. .
Quantitative variables are called numerical
since the allocated numbers have intrinsic quan-
titative meaning. Numerical variables are dis-
crete if the variable can only take on certain
values (for example, the number of children in a
family can be 2 but not 2,75 or 2,751). Discrete
variables are often counts of events, for example
the number of patients seen at a clinic per day. A
numerical variable is continuous if the variable
can assume any numerical value (for example,
height can be measured very precisely on a conti-
nuous scale).
The choice of appropriate methods of analysis
depends on the types of variables under invest-
igation.
Data checking before analysis
Before any analysis is done, the data set must be
carefully checked to identify strange values (out-
liers) and errors. Such errors can strongly influ-
ence and bias the results, and should therefore be
detected and corrected before the data is ana-
lysed (as the saying goes, garbage in, garbage out).
Errors could occur when data is coded on ques-
tionnaires or transcribed from patient files. It is
Table 11.1 Suggested data checking procedures
One variable at a time
Categorical variables
@ Check that all the categories on the computer
listing are plausible codes e.g. for the variable
sex M = Male, F = Female, X= ?Z=?
¢ Check missing values
Numerical variables
@ Check that the values fall in plausible range.
Are the extremes possible? e.g. height = 250
height = 5 - @ Do related questions give plausible results? _
@ Are values of 0 really zero or do they indicate
missing values? (if the latter, then O must be
made missing).
¢ Are missing values really missing or do they in-
dicate 0, e.g. a missing value for the number
of cigarettes smoked per day may indicate a
102
therefore important to check questionnaires or
data recording sheets regularly during the data
collection phase so that any queries can be
followed up, ideally while-still in the field. Errors
can also occur when the data is entered onto the
computer. Double entry of data (which means
that the data is typed independently by two data
typists and the two sets compared for discrepan-
cies) should be done to minimize typing errors.
There may also have been errors in the original
data source, such as a hospital file. The data
checking outlined below is done after computer-
ization, but before analysis.
Table 11.1 lists suggested data checking pro-
cedures. For these procedures, you need a com-
puter listing of the values of all variables, as well
as the interrelationship of variables. If any strange
values are found, you should make alist of the
subject observation numbers or questionnaire
numbers of those cases. Any queries resulting
from the data checking procedure should be
investigated by going back to the raw data (for
example, questionnaires), not by guessing. It is
therefore important that questionnaires are kept
and ordered so that it is easy to pull out the forms
with queries. Some queries will be easy to solve,
for example, a 1 might be punched as a 7. Others
may be difficult to solve, and if the value in the
raw data is completely impossible (for example,
sex = Z instead of M or F and the sex cannot be
deduced from the name), the value should be
non-smoker and the missing value should be
made 0.
@ Check missing values
Cross-checking of variables _
¢ If demographic information
is asked in more
than one question, do the answers agree:
sexi = M and sex2 = F?
@ Ina longitudinal study, are the changes in
values between assessments plausible? age
at week 1 = 25 years, age at week 52 = 35?
1. Sex = M and oral contraceptive usage = Yes
2. Age = 27 and age at which started smoking
= 33.
_ 3. Do you smoke? = No
How many cigarettes do you smoke? = 10
 11 anintroduction to data presentation, analysis, and interpretation
Table 11.2 Listing of 10 observations
| Subject Age Sex
ae
2
3
4
5
6
4 %
8
9 TS
eee
StS
10
classified as missing. The aim is to eliminate
errors, not fudge the data. Respondents may give
conflicting responses when asked their opinions
or attitudes. These are not data errors and cannot
be ‘cleaned’. (If extreme values which are not im-
plausible occur and cannot be checked for some
reason, statistical techniques which are robust
against extreme values can be used in the ana-
lysis. See Summarizing the sample data, below.)
Graphical display of the data is described below
and is also useful in the data checking phase.
If data is entered directly onto a PC in the field,
the ‘data entering programme (for example, Epi
Info) should be set up in such a way that implaus-
ible values can be discovered immediately. So, for
example, one should specify a plausible range for
a continuous variable such as height. If a value
which falls outside this range is typed in, the pro-
gramme alerts the data typist that a strange value
has been entered, and must be corrected.
Table 11.2 gives a listing of the information
regarding age, sex and certain aspects of smoking
history of 10 subjects included in a study of
community members aged 20 years and older.
How many problems can you identify?
Exploratory data analysis
Before any formal statistical analysis is done, the
data (especially numerical variables) should be
explored through graphical display (also known
as exploratory data analysis). Such an exploration
helps the researcher get to know the data. Errors
or strange values, and patterns and relationships
in the data can be detected. Furthermore, many
statistical procedures make assumptions about
Current smoker Ever smoked Age
started
smoking
415
ss
22
4
<2
2k <
x2
ZeaxxZ2eix
the data (for example, about the distribution of
the data). Through graphical display you can
determine whether your data satisfies these
assumptions and thus whether the intended
statistical analyses are appropriate. Graphical
display makes the data accessible to the re-
searcher, as well as to the readers when results are
published. Patterns or relationships detected
through, or questions raised by, exploratory data
analysis can be evaluated by formal statistical
methods (also called confirmatory data analysis).
Graphical display of numerical variables
The aim of displaying a numerical variable is to
investigate certain characteristics of the data,
namely where the central value lies, and what the
spread and shape (distribution) of the data are.
The distribution shows how many observations
have a given value or lie within a certain range of
values out of all the possible values. As will be dis-
cussed later, the shape of the distribution is
important in deciding on appropriate summary
statistics and statistical analyses. A distribution
has a symmetric shape if approximately the same
number of observations lie above and below the
centre value of the distribution. This will be illus-
trated later, using various types of graphical dis-
plays (Figure 11.2).
The following small data sets will be used to
illustrate basic concepts.
i) Inahypertension study, diastolic blood pres-
sure was measured on a sample of 16 respond-
ents. Their values were:
75, 84, 80, 97, 105, 188, 64, 78, 68, 86, 79, 105, 89,
88, 93, and 92.
103
ce data presentation, analysis, and interpretation

Figure 11.2 Types of data distribution

Shape of stem and Shape of

leaf plot box plot

Skewed to high
values

low

Skewed to low
values

Symmetric =

; could be difficult to
Bimodal C detect in box plot

ii) Two groups of children were scored on apsy- From: Joubert G, Schall R. ‘Some statistical con-
chological test. The scores were (in order): cepts.’ In Kibel M A and Wagstaff L A (eds). Child
Group 1 Group 2 health for all: A manual for Southern Africa, Cape
(n= 24) (n=25) Town: Oxford University Press, 1995.
38 46 46 50 52 41 41 414146
52 55 57 59 62 46 46 48 52 52 Stem and leaf plot
63 63 64 65 69 54 54 58 60 60 In a stem and leaf plot, each observation of a
6971717475 6171747680 numerical variable is plotted. All possible leading
79 81 87 94 84 85 93 104 148 values form the stem, and each data value is

104
 11 = anintroduction to data presentation, analysis, and interpretation

represented by writing its trailing digit in the
appropriate row next to the stem, in this way
forming the leaves. Before the plot can be drawn,
the data are ordered from small to large.
In the blood pressure example, the ordered
data set is:
64, 68, 75, 78, 79, 80, 84, 86, 88, 89, 92, 93, 97, 105,
105, 188
Since the values range from 64 to 188, the leading
digits which are to form the stem are 6, 7, 8, 9, 10,
11, 12, 13, 14, 15, 16, 17, 18. The stem andleaf plot
is then as follows:
18 8 plotted in a box plot, only selected summary
Lt
16
15
14
13
12
1l
10 55
9 237
8 04689
é 589
6 48
Any value which lies far away from the other
values (an outlier) can be detected easily. The
valué 188 is suspect and should be checked. It
may be a typing error: 88 typed as 188. Apart from
the extreme value, the values seem to follow a
symmetric distribution. Figure 11.2 depicts what
different data distributions would look like when
illustrated by a stem and leaf plot.
If groups are to be compared, stem and leaf
plots drawn next to one another are useful for
detecting distributional differences between
groups. The back-to-back stem and leaf plot of
the psychological data is depicted in Figure 11.3.
The value 148 in Group 2 seems to be an outlier
and should be checked. From the stem and leaf
plot, it is clear that the values in Group 1 followa
symmetric distribution, but the values in Group 2
are not symmetric (also called skew), as most of
the values are low.
Box plot
Asecond graphical display appropriate for nume-
ri¢al variables is the box plot. A box plot displays
the date in summarized form. Not all points are
values — namely the median, 25th and 75th
percentiles, and the maximum and minimum
values.
The median (or 50th percentile) is that value
which divides the sample values, ordered from
small to large, in half, that is, half the values lie
above the median, the other half below. If the
sample size is odd, the middle value in the
ordered series is the median. If the sample size is
even, the median is the average of the two middle
values. Therefore the median of the 16 blood
pressure values is the average of the 8th and 9th
values, namely the average of 86 and 88, thus 87.
Quartiles divide the sample values in quarters.
The lower quartile is also called the 25th percen-
tile, and the upper quartile the 75th percentile.
The distance between the lower and upper quar-
tile is called the interquartile range. For the 16
blood pressure values, the lower quartile must lie
between the 4th and 5th values in the ordered
series (values 78 and 79). The 25th percentile is
defined as being a quarter of the way between
these two values, namely at 78,25. The upper

Figure 11.3 Stem and leaf plot of children’s psychological test scores

GROUP1 GROUP2
(n= 24) (n= 25)

105
c data presentation, analysis, and interpretation
a a
quartile lies between the 12th and 13th values
(values 93 and 97). The-75th percentile is defined
as being three-quarters of the way between the
two values, namely at 96.
In the box plot, the upper and lower quartiles
are displayed by the top and bottom of the rect-
angle which contains the central 50% of the data.
The median is indicated by a horizontal line
within the rectangle. The quartiles are connected
by lines to the largest and smallest value in the
sample. (Some computer packages also indicate
extreme values other than the maximum and
minimum in the box plot.) If the distance from
the lower quartile to the median is approximately
equal to the distance from the upper quartile to
the median, the distribution is symmetric. Box
plots can thus be used to detect outlying values,
as well as to determine the shape of the distribu-
tion of the values. The box plot of the 16 blood
pressure values is as follows:
¥
180
160
140
120
100
80
60 x
The box plots of the psychological test data are
shown in Figure 11.4. The symmetry of Group 1is
clear, since the median lies approximately half-
way between the two quartiles. Group 2 is asym-
metric, as can be seen from the fact that the
median is much closer to the lower quartile than
to the upper quartile. Figure 11.2 depicts how dif-
ferent data distributions look when illustrated by
a box plot.
Histogram
This graphical display is generally used not to
evaluate the distribution of a numerical variable
at the start of the analysis, but rather to summa-
rize a number of observations in compact form. A
histogram is drawn for a numerical variable
which has been grouped into categories. For
example, blood pressure can be grouped into 10
mm Hg groups. Each rectangle in the histogram
can represent either the number of observations
or the percentage of observations that fall in that
interval. The population pyramid described in
the section on demography in Chapter 2 is a spe-
cial type of histogram used to depict the age and
sex composition of a population.
106
a eR
are weee eee mee
psychological test scores
100
90
80
70
60
50
40
30
GROUP 1 GROUP2
n=24 n=25
Source: Kibel M A, Wagstaff L A, 1995
Bivariate plot
Bivariate or scatter plots are used to plot two
numerical variables against one another, one
variable on the X axis (horizontal), the other on
the Y axis (vertical).
These plots are especially helpful when one
wishes to investigate relationships between vari-
ables, and should be drawn before astatistical
evaluation of a relationship is done by means of,
for example, correlation or regression. They can
help to identify errors (Figure 11.5) and clarify
relationships between variables (Figure 11.6).
Graphical display of categorical variables
Whereas the graphical display of numerical vari-
ables described above is essential before formal
statistical analysis can be done, the methods
described here for categorical variables are pri-
marily used to present the results. The choice of
method is a matter of personal preference. Bar
graphs and pie charts can be used to represent
categorical variables. The height of the bar in a
bar graph (or the size of the slice in a pie chart)
can represent either the number of observations
in a given category of the variable, or the percent-
 11. = anintroduction to data presentation, analysis, and interpretation

ori wwMeN CMe mre rs

44 54 64 74 84 94 104 Weight

in the bivariate plot of height and weight, the case with height = 189 cm and weight = 44 kg stands out as being question-
able. In an investigation of only height or weight, the values for this case would not have seemed strange.

Figure 11.6 Bivariate plot of the relationship between TT Femited)

and age

AGE
Year
20 40 60

The relationship between lung function and age is depicted in the following plot. The plot clearly indicates that lung
function values only start to decrease with increasing age after the age of 40 years.

107
c data presentation, analysis, and interpretation

Advanced graphical techniques can be used in

Figure 11.7 Bar graph showing
MCR My My qrlescmt Cyto
bution of a sample of factory
workers (n = 100)
exploratory data analysis to look at complex rela-
a tionships between variables.
Graphical display of data is done to let the data
reveal the truth about itself. The way the
researcher chooses to depict the data graphically
should reflect this truth. Figure 11.9 discusses
honesty in graphical display.

Summarizing the sample data

low medium high extremely
high
Dust exposure category
age of all observations that fall in a given category.
So, for example, the dust exposure category distri-
bution of factory workers can be represented by a
bar graph, as shown in Figure 11.7. It is important
that the graph is clearly labelled, indicating the
categories depicted, whether percentages or fre-
quencies are indicated, and the sample size. A bar
graph is similar to a histogram, but the bars are
drawn with spaces in between.
Figure 11.8 is an example of a so-called block
chart or three-dimensional bar graph. For four
different age/sex groups, the percentages of
respondents who mentioned different categories
of AIDS prevention strategies are displayed (a
respondent could choose more than one option).
So, for example, 18,2% of males under the age of
18 mentioned condoms, whereas 8,1% of females
under 18 years mentioned condoms. From the
bar graph it is clear that males tended to mention
condoms more often than females did, whereas
females mentioned one partner more often than
males did.
Conclusion
Exploratory data analysis has been presented
here as a tool for getting to know the data. How-
ever, it is an approach to data analysis which goes
much further than what has been outlined above.
By examining the graphical display of the data,
the researcher can decide which measures should
be used to summarize the data.
Summary statistics, also known as descriptive
statistics, are used to summarize and describe the
data in a concise form. The basic summary of the
data is the first step of the statistical analysis,
whether you have conducted a descriptive study
where the aim is to estimate the level or distribution
of a characteristic, or an analytic study where the
aim is to investigate associations between charac-
teristics. By summarizing the information asafirst
step, you can immediately see whether all intended
analyses will be meaningful. If, for example, only
two individuals out of asample of 100 have a certain
characteristic, there is little point in exploring the
association of that characteristic with other factors,
due to the problem of small sample size.
Categorical variables
Categorical variables can be summarized by the
number and percentage of study subjects which
are classified into a given category. For example, a
sample of 95 contains 16 males (17%) and 79 fe-
males (83%). It is important to state the sample
size. The percentage can be rounded to the near-
est whole number (especially in small samples),
or can be given to one decimal place.
Numerical variables
For numerical variables, on the other hand, one
needs to indicate where the central location of the
data lies, as well as what the variability of the data
is (that is, what the spread of the data is).
Measures of central location
The most commonly used measure of the central
location is the arithmetic mean or average
(denoted by xX). This is the sum of all individual
values (xj) divided by the number of individuals
in the group (n):x; (where > is the sum of all the
n
observations from 1 to n).

108
 11 = anintroduction to data presentation, analysis, and interpretation

So, for the 16 blood pressure values the mean is
(64+ 68+ 75+ 78+ 79 +80 + 84+ 86+ 88+89+92+
93 + 97+ 105+ 105+ 188) /16=91,9
(The mean has at most one decimal place more
than the original values. The above mean should
not be given as 91,9375 since it implies spurious ac-
curacy in the original measurements, namely that
the original measurements were taken to the fourth
decimal place.)
The mean is sensitive to extreme values, espe-
cially in small samples. For example, if the sample
consists of five values, namely 1, 2, 3, 4 and 5, the
mean is 15/5 = 3. However, if the values are 1, 2, 3,
4 and 50, the mean is 60/5 = 12 . The high value 50
has a large influence on the mean, pulling it away
from the other four values. If the distribution is
asymmetric or if there are outliers, you should
rather use the median as measure of central loca-
tion. The median is called a robust alternative to
the mean, since it is not sensitive to outliers or
asymmetry in the distribution of the data. For the
values 1, 2, 3, 4, 5, the median is 3. For the values
1, 2, 3, 4, 50, the median is also 3, indicating that
the median is not influenced by the extreme value
of 50. If the distribution of the data is symmetric,
the median and mean will be close together.
‘For some variables (especially laboratory deter-
minations), you may encounter censored obser-
vations. These are observations for which the

Figure 11.8 Block chart of the percentage of respondents (in four age/
ese RRR Cue roe me it
strategies (a respondent could mention more than one option)

‘| FEMALE > 18
=53
11,3 % als £A18,9%

FEMALE
< 18
n=/74

foal|8,1 % 18,9 % 149%

MALE
= 18
nase
34,4 % 5,7 % 11,4%

MALE < 18
4
31,8 %

Condoms One Careful Visit Other

partner about Clinic
partner
choice

Mathews C, Kuhn L, Metcalf C A, Joubert G. Cameron N A. ‘Knowledge, attitudes and beliefs about
AIDS in township school students in Cape Town.’ South African Medical Journal 1990; 78:511-16.

109
c data presentation, analysis, and interpretation
i LCE CL A AAA AA ICC EAT EA A A
ee cat csc ate

Figure 11.9 Honesty in graphical display

To ensure that the graphical display reveals the truth about the data, one should keep the following in mind.

Categorical variables
If bar graphs or pie charts are drawn to reflect percentages in different categories, one should state (in the caption or title
of the graphic) the number out of which percentages were calculated. To represent 1 out of 3 as 33,3%, without stating
that the sample only consisted of 3 individuals, is misleading.

Numerical variables
When drawing scatter plots of two variables, it is important that reasonable scales are used. Reasonable scales are scales
which do not put too much ortoo little emphasis on the actual results. Scales should also start at the nought value if
possible. The following plot seems to indicate that there was abig increase in the percentage of mortality due to cause X
between 1985 and 1986. However, close inspection of the scales reveals that the percentage increased from 10,5% in
1985 to 11,0% in 1986, hardly as dramatic an increase as the plot suggests. It may therefore be a good idea to include the
0 value on the scales.

Percentage
11,0

10,9

10,8

10,7

10,6

10,5

10,4

10,3

10,2

10,1

10,0
1981 1982 1983 1984 1985 1986 1987
Year

actual value is not known, but it is known that the
value is greater than a certain maximum (for
example, age greater than 65 years) or smaller
than a certain minimum (for example, a labora-
tory instrument can detect very low levels of
cholesterol, lower than a certain minimum, but it
cannot determine the exact values). In these cases,
since the exact extreme values are not known, the
median is the appropriate summary measure.
The mode is the value which occurs most often.
This may be useful in determining whether a
measuring instrument has a preference for a cer-
tain value (for example, a scale which weighs
most respondents as 60 kg), but is of little use as a
measure of central location.
In the case of a skew distribution, a mathe-
matical transformation of each value (for exam-
ple, the log transformation where the log of each
value is calculated) can be used to make the dis-
tribution more symmetric. The mean of the trans-
formed values is calculated and then transformed
back. In the case of the log transformation, the
antilog of the mean of the transformed values is
taken. This is known as the geometric mean.

110
 11 = anintroduction to data presentation, analysis, and interpretation
For the psychological test scores in Group 1, the
mean (64,3) is the appropriate measure of central lo-
cation. For the other group, however, the median has
to be used. If you want to compare the two groups,
you must, of course, use the same summary statistics
for both groups. If the values of one group are asym-
metric or if there is an extreme value, the locations of
both groups should be summarized by medians.
Measures of variability (spread)
The variability of a data set is the degree to which
observations in the data set vary from each other
with respect to a particular characteristic. For
example, consider two samples of 10 children
each with ages as follows:
Group 1: 2, 4, 6, 7, 8, 10, 11, 12, 14, 16
Group 2:6, 6, 8, 8, 8, 10, 10, 10, 12, 14
The mean and median ages in both groups are 9
years, but the observations in Group 1 vary much
more than those in Group 2. The variability of
Group1is thus greater than that of Group 2.
The range (the largest value minus the smallest
value, or denoted by indicating the largest and
smallest values separately) is a measure of vari-
ability which we might consider using intuitively:
in Group 1, the range is 2 to 16, in Group 2, it is 6
to 14. However, the range is not very useful as a
measure of variability, since it is greatly influ-
enced by one extremely large or small value.
A commonly used measure of variation is the
standard deviation. The standard deviation is
defined as:
¥ (x;-X)?
n-1
and thus gives an indication of the average dis-
tance from the mean. The variance is the square
of the standard deviation.
A robust alternative to the standard deviation is
the interquartile range (75th percentile minus 25th
percentile). The standard deviation is used with the
mean, the interquartile range with the median.
Thus, if the data is asymmetric or if there are out-
liers, the median and interquartile range (or 25th
and 75th percentiles) should be used as summary
measures.
Conclusion
Summary statistics should give a true representa-
tion of the data. The distribution of the data
should therefore be considered (through some
graphical display) in order to decide on appro-
priate summary statistics. The following type of
data is often encountered: grams of alcohol con-
sumed weekly were noted in a heart disease risk
factor survey. 76% of respondents did not drink
(so grams of alcohol consumed equal zero) and
the remainder drank between 20 and 1 000 grams.
Is it sensible to summarize the group’s alcohol
consumption with the overall mean of 78,2 g? Per-
centiles would be more appropriate (median = 0
and 75th % = 0), or alternatively the researcher
could state that 76% did not drink, and then state
the mean or the median consumption of the
drinkers.
For a given numerical variable, the central
value (summarized by the mean or median) may
be of little interest. For example, it may be more
relevant to the researcher to know what percent-
age of the sample has high blood pressure than
what the mean blood pressure is. A numerical
variable can be categorized and then summarized
as a categorical variable. The choice of categories
for a numerical variable should make sense clini-
cally (for example, hypertension is defined as sys-
tolic blood pressure of 160 and above or diastolic
blood pressure of 95 and above). The choice can
depend on the distribution of the data (for exam-
ple, grouping individuals over 65 all together in
one age group if there are only a few who are be-
tween 65 and 74, 75 and 84, and so on), but should
not be made in such a way as to influence the
results in a given direction.
Estimating the population
parameters
A researcher studies a sample in order to make
statements (inference) about the population from
which the sample was selected. The summary
statistics outlined above describe the sample
data, but what can be said about the population?
A parameter is a characteristic (for example, the
mean) of a population. A statistic is a character-
istic of a sample of the population, and is an es-
timate of the corresponding parameter in the
population (for example, the sample mean es-
timates the population mean). However, as the
simple example in Table 11.3 indicates, different
samples of the same size randomly selected from
a given population will not necessarily provide
the same estimates, nor will they provide es-
timates which are identical to the population
parameters. This is due to random variation in
any sample and is known as sampling error. If the
111
ce data presentation, analysis, and interpretation

eee RRC Tela Cer from

the same population

The population consists of 50 individuals. Two characteristics are of interest: age and sex

Individual Age Sex Individual Age Sex

q 55 EF 26 81 M
2 38 M 2/1 63 F
3 63 M 28 87 M
4 1s F . 29 94 M
5 62 M 30 68 M
6 46 F BL #1 F
i 59 F 32 69 M
8 a2 r 33 46 M
9 65 M 34 tt F
10 64 M 20 87 M
a1 50 F 36 62 Fr
42 | 55 M 37 94 M
13 67 M 38 52 M
14 69 M 39 81 M
15 38 F 40 19 F
16 59 M 41 74 M-
17 69 F 42 fae M
18 52 _M 43 63 F
19 46 F 44 19 M
20 64 M 45 £21 F
21 74 M 46 63 F
22 50 e 47 57 M
23 | 67 M 48 65 M
24 15 F 49 69 M
25 46 E 50 62 M

Two simple random samples of size 10 are selected

Sample 1: individuals 17,14,46,11,39,30,02,08,15,22

Sample 2: individuals 32,08,16,13,24,48,23,42,14,21

Sample 1 estimates : 4 males out of 10 subjects (40%); mean age 57,8 years

Sample 2 estimates : 8 males out of 10 subjects (80%); mean age 66,2 years

Population parameters:
30 males out of 50 subjects (60%); mean age 64,6 years

entire population were studied, the population on imprecise estimates.

parameters (for example, population mean)
could be calculated exactly. By studying only a
sample, the researcher obtains imprecise esti-
mates. It is important, therefore, to calculate the
precision of a sample estimate (for example, the
precision of a mean, mean difference, proportion,
or odds ratio). Statistical techniques are needed
to enable researchers to make statements based
The precision of an estimate depends on.both
the variability of the data (if all the data values are
within a small range, there is small underlying
variability in the measurement, and the estimate
will consequently be more precise) and the
sample size (the smaller the sample, the less
precise the estimate). The standard error is a
measure of the (im)precision of a sample statistic

112
 11 = anintroduction to data presentation, analysis, and interpretation
as an estimate of the population parameter. The
standard error is calculated using the sample size
and the variability of the data. For example, the
standard error of the sample mean is ja The
sample estimate, however, remains the best
single estimate of the population parameter.
Before we discuss how the standard error can
be used to make a statement about the popula-
tion parameter, we need to know something
about probability distributions.
Probability distributions
A probability distribution is a theoretical distribu-
tion which provides information on the probabil-
ity of observing different ranges of values for a
given variable. A probability distribution can be
thought of as a data distribution based on an in-
finitely large sample. Such probability distribu-
tions exist for categorical as well as numerical
variables. Probability distributions are commonly
characterized by their mean and variance.
One of the probability distributions used most
often is the Normal (Gaussian) distribution. Most
of the commonly used methods of statistical
analysis (for example t-tests, correlation, and
regression) are based on the assumption that the
continuous variables which are analysed follow a
Normal distribution. The Normal distribution. is
bell-shaped and is symmetric around its mean
(Figure 11.10). Furthermore, the area within one
standard deviation on either side of the mean
Figure 11.10 ur Normal distribution
68% of area
<< 95% of area
includes 68% of the observations, and the area
within 1,96 standard deviations on either side of
the mean includes 95% of the observations.
Many biological variables, for example, birth-
weight, are in fact approximately normally distri-
buted. In small data sets, it may be difficult to
validate the assumption of normality adequately,
and in small samples with skew distributions,
normality cannot be assumed. In such cases,
nonparametric methods of analysis need to be
considered (see Parametric versus nonparametric
methods below).
Other important probability distributions are
the Binomial distribution for binary variables, the
Poisson distribution for count data, and the expo-
nential distribution for continuous variables.
Confidence intervals
As discussed before, if various samples of the
same size are drawn from a given target popula-
tion, a range of different estimates will be ob-
tained. These estimates will follow some theo-
retical distribution. We use this information to
calculate a confidence interval for the population
parameter, based on our sample estimate.
A confidence interval gives a range of para-
meter values considered plausible for the popula-
tion, based on the sample data, and is a useful
way of describing the (im)precision of the es-
timate. A confidence interval is calculated by
using the sample estimate, its standard error, the
—_—_—__—_—__>
sd = standard deviattion
113
ce data presentation, analysis, and interpretation
ei
a a
degree of certainty (confidence) we want to asso-
ciate with the confidence interval (say 95% or
99%), and the cutoff value of the appropriate
probability distribution (for example 1,96 in the
case of 4 95% confidence interval based on the
Normal distribution). If we calculate a 95% confi-
dence interval, we can say that, in a series of iden-
tical studies based on different samples from the
same population, 95% of the 95% confidence
intervals calculated from these studies will
include the true population parameter. An impre-
cise estimate (with large standard error due to
small sample size and/or large variability in the
sample data) will lead to a wide confidence inter-
val (that is, a wide range of values which are
considered plausible for the population para-
meter). For example, if in a sample of 10 clinic
attenders, four are found to be HIV positive, the
percentage positive is 40% with a 95% confidence
interval ranging from 12% to 74% (indicated as
[12% ; 74%] or [12%-74%]). The confidence inter-
val is wide since the sample is small. We are thus
uncertain what the HIV prevalence is. If, however,
the sample consists of 100 and 40 are HIV posi-
tive, the percentage positive is 40% with a 95%
confidence interval ranging from 30% to 50%, a
narrower confidence interval than in the case of
the smaller sample. (See Table 11.4 for a further
example.)
Methods for calculating confidence intervals
for most epidemiological applications (for exam-
ple, means, differences between means, medians,
proportions, odds ratios, correlation coefficients,
and survival time) are described, with examples,
in Statistics with Confidence by Gardner and
Altman (1989).
Hypothesis (significance) testing
If the researcher is interested in determining the
level of a characteristic (for example, the preva-
lence of HIV infection in the Free State), the size
of any difference between groups (for example,
the mean age difference of mothers with low
birthweight babies and mothers with normal
birthweight babies), or the strength of an associa-
tion (for example, the risk of heart disease in
hypertensive patients compared to normotensive
patients), confidence intervals should be calcu-
lated as outlined above. On the other hand, the
researcher may wish to test some hypothesis: are
two factors significantly associated or are two
groups significantly different? In this case, the re-
searcher is interested in hypothesis testing.
A statistical hypothesis is an assumption made
114
a a
about a parameter of one or more populations
(see Chapter 6: Setting objectives for research). To
determine whether, for example, two factors are
associated, we need to formulate a null hypo-
thesis (Hg) which can then be tested. The null
hypothesis is the hypothesis of no association or
no difference.
A test statistic is then calculated byastatistical
formula, using the sample data. When the null hy-
pothesis is true (that is, there is no difference or
association), this test statistic follows a certain
distribution (for example t, x7). By comparing the
test statistic with this distribution, we can deter-
mine how likely it is to obtain the observed
sample data if the null hypothesis were true (that
is, if there were no association or no difference).
This probability is known as the p-value associ-
ated with the test statistic. The p-value is the
probability of observing the test statistic or a
more extreme result if the null hypothesis is true.
The p-value is thus the probability of finding an
association or a difference, if there is in reality no
association or no difference.
If the p-value is large (for example, p = 0,80), the
data is consistent with the null hypothesis. This
implies that the null hypothesis cannot be re-
jected, using the observed data. However, a large
p-value does not imply that the null hypothesis
can be accepted. For example, the sample may be
too small to detect the difference that really exists.
This is known as the Type II error.
If the p-value is small (for example p = 0,01) the
data is unlikely to have been as observed if the
null hypothesis is true. In other words, there is
evidence that there is indeed a significant asso-
ciation or difference, and the null hypothesis is
rejected.
An arbitrary cut-off point of the p-value,
namely 0,05, is often chosen. This cut-off value is
called the significance level of the test, and refers
to the probability of rejecting the null hypothesis
ifit is in fact true (the Type I error). Ifwe are trying
to prove that an association or difference exists,
we would like the probability of finding a relation-
ship or difference when there is in fact none, to be
small. P-values are often classified as ‘significant’
if p<0,05 and ‘non-significant’ (often written in
the literature as NS) if p>0,05. This over-simplistic
use of p-values is now strongly discouraged in the
medical literature. If the reader of an article sees
that a difference between two groups was found
to be ‘non-significant’, there is no information
whether the p-value might have been 0,06 or 0,60.
Clearly p-values of 0,06 and 0,60 should be inter-
 11 an introduction to data presentation, analysis, and interpretation
preted differently and both should not be simply
classified ‘non-significant’. Exact p-values should
be given in papers so that readers can decide for
themselves whether they agree with the re-
searcher on the ‘significance’ of the results.
Significance testing can indicate whether there
is a statistically significant difference between
two groups, ora Statistically significant associa-
tion between two variables. As pointed out above,
a significance test cannot indicate that there is no
difference.
Statistical versus clinical/public health
significance
Hypothesis testing determines the statistical
significance of an observed effect. If two large
samples are compared, small differences between
groups may be found to be statistically signific-
ant, although such small differences may not be
of clinical or public health importance, or prac-
tical value. Similarly, in small samples, large dif-
ferences may fail to reach statistical significance,
although they seem clinically important. (See
Table 11.4 for an example of sample size and
statistical significance.) A researcher thus cannot
base decision-making purely on statistical signi-
ficance, but must consider the clinical or public
health significance of the results. This can be
done by calculating confidence intervals and
interpreting them clinically, that is, interpreting
the size of the difference or association in terms of
its meaning for the patient, disease, or health ser-
vice.
In a follow-up study to determine associations
between high density lipoprotein (HDL) choles-
terol and women’s employment (Haertel, Heiss,
Filipiak, Doering 1992), it was found that the 761
women who had been homemakers during the
first survey and had remained homemakers
during the second survey had a mean decrease in
HDL cholesterol of 0,99 mg/dl. The standard error
was 0,41 andastatistical test to assess whether
this decrease was greater than zero revealed that
the decrease was statistically significant (p =
0,015). The 95% confidence interval for the mean
decrease was 0,19 to 1,79. There is clearly a de-
crease, but on the basis of clinical knowledge, it
has to be decided whether a decrease of at most
two units over a period of more than two years is
clinically meaningful on a variable which had a
mean value of 65 at the first visit. The fact that
such a small difference is statistically significant is
due to the large sample size. A significance test
thus indicates whether there is a difference, but
the confidence interval is interpreted to decide
whether the differenceis clinically important.
Whereas a significance test cannot indicate that
there is no difference, a confidence interval can. If
in the above example, a change of three units or
more is taken to be clinically meaningful, the con-
fidence interval indicates that there was no clin-
ically meaningful change. If the confidence inter-
val had ranged from 2 to 4, we would not be able
to draw a conclusion, since the interval includes
values which indicate a clinically meaningful
change, as well as values which indicate that there
was no clinically meaningful change.
The decision on how large a difference or
change is required for it to be clinically meaning-
ful, is based on knowledge of the subject matter.
In the case of measurements such as blood pres-
sure, it may be clear what is clinically meaningful,
but in other circumstances it may be less clear-
cut. For example, if the prevalence of HIV in one
group is 3%, but 5% in the other, is that a meaning-
ful difference?
Confidence intervals and p-values are closely
related: if the difference between the means of
two groups is significant at the 5% level (that is,
p<0,05), then the 95% confidence interval for the
difference will exclude the value zero (that is, the
confidence interval will also indicate that there is
a difference). Confidence intervals are thus some-
times also used for purposes of statistical signific-
ance (the result is significant, since the null value
is not inside the confidence interval). This is not
the purpose of a confidence interval. If the focus
is on estimation (which is most often the case),
confidence intervals should be calculated and the
range of values interpreted clinically to determine
whether the findings are clinically important.
Parametric versus non-parametric methods
If we can assume that our data comes from an
underlying distribution such as the Normal distri-
bution, statistical methods (hypothesis testing or
confidence intervals) based on the assumptions
of the underlying distribution can be used. These
methods are called parametric, since the underly-
ing distribution is assumed to come from a para-
metric family of distributions. Nonparametric
methods are used if such assumptions cannot be
made. For example, the Mann-Whitney U test is
the nonparametric equivalent of the two-sample
t-test. These distribution-free methods which
make no assumptions about the data distribution
are often ranking techniques, which focus on the
order or ranking of observations, and not on their
115
ce data presentation, analysis, and interpretation
numerical values.
What to consider when choosing an
appropriate analysis
There will be no attempt to provide a detailed
outline of which statistical technique to use under
which conditions; we rather give some idea of the
factors which need to be considered when choos-
ing a statistical analysis.
The type of variable being analysed
Categorical and numeric variables require differ-
ent statistical techniques. Clearly we would not
summarize a categorical variable by a mean (what
is the meaning of a mean sex of 1,2?) Similarly, if
we wish to compare two groups on a categorical
variable, we would not use at-test or a confidence
interval for mean differences, but a x? test, or
Fisher’s exact test, or a confidence interval for the
differences in percentages.
Assumptions necessary for the procedures
As mentioned before, there are many proce-
dures which should only be used if the variables
are normally distributed. All distributional as-
sumptions of the intended analysis should be
investigated to determine whether they are sat-
isfied by your data. A further assumption which
has to be considered is whether groups are inde-
pendent. If controls were matched to cases, or
repeat measurements were made on the same
individuals, the groups (controls and cases,
before and after measurements) are not inde-
pendent.
The characteristic being tested
Different techniques are appropriate for differ-
ent characteristics. For example, if normality
and independence can be assumed, a two-
sample t-test would be appropriate to compare
the means of two groups, while an F-test would
be appropriate to compare the variability in the
two groups.
Analyses commonly used in
epidemiology
Measures of strength of association
ina2x2 table
Definitions and interpretation
Many epidemiological studies set out to invest-
igate the association between an exposure (for
example, smoking) and a disease (for example,
116
lung cancer). Often the information gathered in
such studies can be summarized in a 2 x 2 table as
follows:
Diseased Not diseased
Exposed A B A+B
Notexposed __C D C+D
A+C B+D A+B+C+D=N
Out of a total of N respondents, there are A who
are exposed and diseased, B exposed and not
diseased, C not exposed but diseased, and D not
exposed and not diseased.
To investigate the association, we could per-
form a statistical test, namely a chi-square or
Fisher’s exact test. Such a test would determine
whether there is a statistically significant differ-
ence between the proportion of exposed who are
diseased, and the proportion of unexposed who
are diseased. The test result will depend on the
sample size. For example, it may be significant in
a large sample, but in not a small sample (see
Table 11.4). The test result will merely say
whether there is a statistically significant differ-
ence, and will tell us nothing about how strong
the relationship between the exposure and out-
come is. Researchers often want to have an estim-
ate of the degree or strength of the association (for
example, the exposed are twice as likely to devel-
op disease as the unexposed). Such measures of
the strength of association, which have the added
advantage of not being dependent on sample
size, are described below.
Let us first assume that the data has been col-
lected by means of a cross-sectional study, and
that N individuals have been sampled and cross-
classified as to exposure and disease status. Con-
sidering the hypothetical example with real num-
bers below may make the concepts clearer.
Diseased Not diseased
Exposed 20 80 100
Notexposed 30 270 300
50 350 400
Clearly, among the exposed (A + B) we can say
that the risk of disease is A/(A + B) (in the example
20/100 = 0,2 or 20%). Similarly, among the non-
exposed (C + D) the risk of disease is C/(C + D) (in
the example 30/300 = 0,1 or 10%). One measure of
the strength of association between exposure and
disease is the ratio of the risk among the exposed
to the risk among the non-exposed. This is called
the relative risk (or risk ratio) and is given by
 11 = anintroduction to data presentation, analysis, and interpretation
A/(A+B) = A(C+D)
C/(C+D) C(A+B).
In this example, it is thus 0,2/0,1 = 2.
Since risks are probabilities or proportions which
lie between 0 and 1 (or percentages which lie be-
tween 0% and 100%), the relative risk is always a
positive number. A relative risk of 1 indicates that
the risk of disease in the exposed group is the
same as in the unexposed group. The exposure
and disease are thus not associated. A relative risk
larger than 1 (as in our example) indicates that the
exposure is a risk factor, whereas a relative risk
less than 1 indicates that the exposure is protec-
tive.
A risk difference, that is, the difference be-
tween the risk among exposed and non-exposed
can also be calculated: A/(A + B) — C/(C + D). In
our example, the risk difference is 10% or 0,10.
The risk difference lies between -1 and 1 (or
-100% and 100% if the risks are expressed as per-
centages) with a difference of 0 indicating no
association.
A third measure of the strength of the associa-
tion is the odds ratio. The chance of disease can
be measured by the odds, where the odds of
disease among the exposed is A/B (20/80 = 0,25.in
our example) and among the non-exposed C/D
(30/270 = 0,11 in our example). The odds ratio is
then’
(A/B) = AD
(C/D) BC.
In our example the odds ratio is thus 0,25/0,11 =
Zeek
The interpretation of the odds ratio is similar to
that of the relative risk. If the disease is rare (that
is, if A is very small relative to A + B, and C is very
small relative to C + D), the odds ratio approx-
imates the relative risk.
If we are analysing data from a follow-up (pro-
spective) study (in which groups of exposed and
non-exposed are sampled and followed up), the
chances of disease and therefore the relative risk,
risk difference, and odds ratio can be calculated
as for the cross-sectional study. In a case-control
study, however, a predetermined number of cases
(diseased) and controls (not diseased) are
selected and their numbers may not reflect the
proportions of diseased and non-diseased in the
population. It is therefore not possible to estimate
the risk of disease among the exposed and unex-
posed, and thus the relative risk and risk differ-
ence cannot be calculated. It is also not possible
to calculate the odds of disease among the
exposed and unexposed. A case-control study
does however provide information on the odds of
exposure among the cases (A/C) and controls
(B/D) which can be used to calculate the odds
ratio:
A/G cy VAD
B/D BC.
From the above, it is clear that it is very important
to identify the type of study in which the exposure
and disease information was gathered in order to
know which measure of strength of association
can be estimated. In cross-sectional and follow-
up studies, the relative risk or risk difference
should be the measure of preference.
The odds ratio and relative risk are dimension-
less and have been criticized because of this fea-
ture. Say, for example, the rate among the ex-
posed is 5 per million and 1 per million among the
unexposed, then the relative risk is 5 and the risk
difference 4 per million. If the rate among the ex-
posed is 5 per thousand and among the unex-
posed 1 per thousand, the relative risk is also 5 but
the risk difference 4 per thousand, indicating a
more serious increase than in the first case, al-
though the relative risks are the same. It has
therefore been said that the risk difference is the
appropriate measure of the practical magnitude,
in terms of public health importance, of an asso-
ciation. However, if one risk factor has a higher
relative risk than another, the first risk factor is
thought to play a more important role in the
causation of the disease.
The attributable risk indicates the proportion
by which the rate of disease will be reduced if the
exposure were eliminated. It takes into account
the relative risk, as well as how common the risk
factor is in the population being studied. So,
factor A may have a lower relative risk than risk
factor B, but because more people are exposed to
risk factor A, the attributable risk will indicate that
factor A is more important to the health of the
community. The proportion by which the rate of
disease will be reduced if the exposure were
‘ eliminated is higher for factor A. The attributable
risk is therefore of great importance in health
services planning, namely in deciding which
risk factors to target for prevention and inter-
vention. The attributable risk is calculated as
follows:
Ve
c data presentation, analysis, and interpretation

P(RR-1)
1+P(RR-1)
where Pis the proportion of the population who
are affected by the factor.
The risk ratio, risk difference, odds ratio, and
attributable risk are estimates and should there-
fore be reported with standard errors or 95% con-
fidence intervals to indicate the precision of the
estimates.
Paired observations
The 2 x 2 tables outlined above cannot be used if
observations are paired, for example, in a
matched case-control study where a control was
selected for a specific case. The 2 x 2 table is then
set up as follows, consisting not of the number of
individuals included in the study but the number
of pairs.
Controls
Exposed Not exposed
C
a Exposed A B A+B
s Not exposed _C D C+D
e A+C B+D A+B+C+D
s pairs
The odds ratio is then estimated by B/C.
More than two levels of exposure
If an exposure has more than two levels, an r x 2
table can be set up (where r is the number of
levels of exposure). For example, daily cigarette
smoking can be classified as 0, 1-2, 3-4, 5-9, 10
and more. If the association between the level of
smoking and the presence of lung disease is to be
studied, a 5 x 2 table can be formed. To calculate
relative risks or odds ratios, one level of exposure is
chosen as the reference level (generally the level

Table 11.4 Statistical significance, strength of association .

FLOMre Lil (oe Phe

A study is done on 50 subjects to investigate the association between exposure A and disease B.
The following results are obtained:

present absent
A: present 15 (75%) 5 (25%) 20 (100%)
absent 20 (66%) 10 (33%) 30 (100%)
35 50
Null hypothesis : the two factors are not associated.

Atest statistic which follows the X? distribution is calculated to evaluate the association between the
two categorical variables A and B, and the p-value equals 0,53. One would thus conclude that the two
factors are not associated. If, however, the study was done on 500 subjects and exactly the same con-
figuration of results obtained, namely:

B
present absent
A: present 150 (75%) 50 (25%) 200 (100%)
absent 200 (66%) 100 (33%) 300 (100%)
350 150 500

the test statistic results in a p-value of 0,05, thus there seems to be evidence of an association.
The statistical test measures the significance of the association (which depends on the sample size),
but not the degree of association. The odds ratio, on the other hand, measures the degree or strength
of the association, independent of sample size.
The odds ratio in the 50 subject case is 1,50 with a 95% confidence interval of 0,36 to 6,42. For the
500 subjects, the odds ratio is also 1,50, but the narrower confidence interval of O, “ to 2,28 reflects
the better precision of the odds ratio estimate from the bigger sample.

118
 11 = anintroduction to data presentation, analysis, and interpretation

with the least risk of disease is taken as the refer- Males Females
ence, thus in this case, the level of 0 cigarettes) Diseased Not Diseased Not
and each of the other levels is compared to the diseased diseased
reference level in turn (thus forming four 2 x 2 Exposed 20 (45%) 24} 44 | 131 (61%) 84) 215
tables). Not
exposed 36 (33%) 73|109} 48 (45%)
Stratification 56 971153 | 179 143 |322
Extraneous factors, such as sex or age, may compli- RR=1,38 RR=1,36
cate the estimation of the measure of association
between exposure and disease (see Chapter 7: Omitting the confounder sex thus introduced a
Study design). By using a stratified analysis, the re- slightly stronger relationship than actually exists.
searcher attempts to adjust for, or remove the effect Confounders can also mask a real association. For
of, an extraneous factor (confounder) which is re- example, sex can be a confounder in the association
lated to both the exposure and the disease. Rather between smoking and hypertension. In this case,
than one (crude) measure of association, one women have a low prevalence of smoking but a high
would calculate measures of association for each of risk of disease, whereas men have a lower risk of dis-
the strata of the extraneous factor and possibly ease, but a higher prevalence of smoking. It may
compute an adjusted (common) measure. therefore seem as if smokers (because they are pre-
Age is often an extraneous factor which has to be dominantly males) have a lower risk of hypertension
accommodated in the analysis. For example, in a than non-smokers (because they are predominantly
cross-sectional study investigating the association females). S
between hypertension and heart disease, it might After stratification, an adjusted (common) rel-
be found that the hypertensives are significantly ative risk using the Mantel-Haenszel method can
older than the non-hypertensives, and those with be calculated. This technique calculates a com-
heart disease older than those without heart dis- mon relative risk by using the stratum-specific
ease. Is the significant association between hyper- relative risks and the stratum size.
tension and heart disease perhaps only due to the The extraneous factor can also act as an effect
fact that the hypertensives are older people and modifier, in which case the relative risks or odds
therefore more likely to have heart disease? We thus ratios in the different strata are markedly differ-
want to remove the effect of age to get a clear pic- ent. This is also often called interaction, as the
ture of the hypertension and heart disease associa- exposure and disease association interacts with
tion. In this case, we would calculate relative risks the extraneous variable, and depends on which
or odds ratios for separate age strata, for example, stratum of the extraneous variable we are invest-
20-29, 30-39, 40-49, 50-59, 60-69, 70+. igating. In the following example, sex is an effect
Confounders can have various effects on the as- modifier for the relationship between insulin and
sociation between exposure and disease. The triglycerides:
confounder can lead to over- or under-estimation
of the association between exposure and disease. Males Females
In the following example, the association be-
high normal high _ normal
tween obesity (exposure) and hypertension (out-
insulinhigh 16(12%) 113
come) is investigated in a sample of QwaQwa resi-
insulinnormal 14(8%) 160 {174 | 5(5%) 96
dents 45 years and older (Mollentze, Joubert 30 273 303 | 14 129 | 143
1994). The crude relative risk is 1,50. RR= 1,54 RR=4,33

Diseased Not diseased

Exposed 151 (58,3%) 108 259 In such a case, you should report the stratum-
Notexposed 84 (38,9%) 132 216 specific relative risks and not attempt to calculate
235 240 475 acommon relative risk.
Having decided to stratify, you might find that
However, sex is a possible confounder, since the stratum-specific relative risks and the crude
relative risk are very similar. In this case, the vari-
women are more likely to be obese, and women
able used to stratify cannot be considered to be a
are more likely to be hypertensive. Sex is thus
confounder, and the stratification can be ignored
associated with the exposure and the disease.
Stratifying by sex, the results are as follows: and the crude relative risk reported.

119
ce data presentation, analysis, and interpretation
a ec
Correlation
Measures of the strength of association between
two dichotomous variables have been outlined
above. If, however, the researcher wants to
describe the relationship between two numerical
variables, she or he can calculate a correlation co-
efficient. (The term correlation is often used in-
correctly, when association between categorical
variables is in fact what is meant.)
Two variables are positively correlated if an
increase in one variable is associated with an
increase in the other (for example, an increase in
height is usually associated with an increase in
weight). If a decrease in one variable is associated
with an increase in the other, the two variables are
negatively correlated (for example, lung function
decreases as age increases). If a decrease or
increase in one variable is not associated with any
change in the other variable, the variables are not
correlated (for example, birthweight and hour of
birth). The correlation coefficient provides a
quantitative measure of the relationship between
two numerical variables. The correlation coeffi-
cient can range from —1 (perfect negative correla-
tion) to 1 (perfect positive agreement), with 0
indicating no correlation.
The Pearson correlation coefficient (r) is given
by
(2 @&j-X) Yj-Y) / WL@ji-H? Xj-N)
where X is the mean of one variable, y the mean of
the other. The individual values of the two vari-
ables are indicated by x; and yj.
If either or both of the variables have outlying
values, a nonparametric correlation coefficient
based on the ranks of the observations can be cal-
culated. This is called the Spearman rank correla-
tion coefficient (r,).
A high correlation does not imply cause and
effect. Furthermore, the correlation between two
variables may be spurious due to the influence of
a third variable. The effect of a third variable can
be removed by calculating a partial correlation
coefficient.
Correlation measures the linear (straight line)
relationship between two variables. Thus a strong
correlation coefficient implies a strong linear
relationship. It is therefore important to draw a
scatter plot (see Exploratory data analysis earlier
in this chapter) to see whether the relationship is
indeed linear, before calculating a correlation co-
efficient. Figure 11.11 shows the relationship be-
tween two variables. The correlation between the
two equals zero, but from the scatter plot it is
120
clear that there is in fact a very distinct relation-
ship between the two variables. This relationship
is not linear, however: where x is less than 100, the
two variables are negatively correlated, whereas
for x above 100, the correlation is positive.
Correlation does not measure agreement. If, for
example, two examiners have to do blood pres-
sure readings, and they both evaluate the same 20
patients to determine how well their measure-
ments agree, it is not appropriate to calculate the
correlation coefficient. As Figure 11.12 indicates,
there can be a strong linear relationship (that is, a
strong correlation) even if one examiner consis-
tently notes a higher reading than the other.
Correlation measures whether the readings ‘go in
the same direction’ (that is, whether if one exam-
iner notes a high reading, the other does as well),
not whether they actually get exactly the same
readings. Bland and Altman (1986) describe the
appropriate methods of analysis to measure
agreement between numerical variables.
Correlation is closely related to simple linear
regression. In simple linear regression, the values
of one numerical variable (the dependent vari-
able) are predicted by the values of the other vari-
able (the independent variable), for example,
lung function can be predicted using age. If you
specifically want to predict one variable from
another, regression should be done. However, if
you do not want to make predictions, but rather
wish to describe the relationship between two
variables, the correlation coefficient should be
calculated.
Multivariate analysis
Multivariate analysis encompasses a range of
statistical techniques which, on the basis of math-
ematical models, can evaluate the inter-relation-
ship of more than two variables. A mathematical
model is one which describes the relationship be-
tween variables in mathematical form. For exam-
ple, whereas simple linear regression is used to
predict a dependent (y variable or outcome vari-
able) from one independent variable (x variable),
multiple linear regression is a multivariate tech-
nique which predicts a dependent variable from
two or more independent variables, assuming a
linear relationship. So, for example, a person’s
lung function can be predicted from their age,
height and weight.
Multiple linear regression can only be used if
the dependent variable is numerical, for example,
a person’s lung function. However, often the
dependent variable is dichotomous, for example,
 11 an introduction to data presentation, analysis, and interpretation

arte wemeOe Teramr acct ee als tig

display before calculating a correlation coefficient

pas
x
2
>
—
o
a
2
oO

7 21 Se OR BT at ae 4G
Observer 2
Two observers were asked to score 16 individuals. A strong positive correlation was found when calculating a correlation
coefficient. The graphical display is more informative, however, indicating that observer 2 consistently gave higher scores
than observer 1.

121
c datapresentation, analysis, and interpretation
died/survived or recovered/not recovered. In
such cases, multiple logistic regression is the
appropriate method of analysis. The proportional
hazards model, which is used to investigate the
role of independent variables on survival time, is a
further example of a multivariate technique.
Multivariate techniques can use data very effi-
ciently and enable the researcher to identify
which variables from a large set of independent
variables are related to the dependent variable,
after adjusting for other important independent
variables (confounders). However, these tech-
niques are complicated and should not be per-
formed without a thorough understanding of the
mathematical models and assumptions under-
lying them. This understanding is also required
for an accurate interpretation of the computer
output of such analyses. A statistician should be
consulted for such analyses.
As Rothman (1989) points out, these tech-
niques can place a barrier between the researcher
and the data. Other methods of analysis (for
example, stratification) can bring about a closer
understanding of the data. It is therefore import-
ant to do the simpler analyses first, in order to get
to know the data and its irregularities, before an
appropriate multivariate analysis is considered.
Conclusion
This chapter has provided an introduction to
statistical concepts, and we encourage readers to
refer to the recommended reading for further
details. Not every researcher needs to become a
statistician to be a good epidemiologist. Rather,
researchers should make a point of working
closely with statisticians on research projects.
However, an understanding of the terminology
and principles used by statisticians will make the
collaboration with statisticians more fruitful and
enjoyable, and will enable researchers to handle
122
Table 11.5 Guidelines on the
presentation of results
@ In asurvey, the response rate should be cal-
culated and responders compared to non-re-
sponders on key characteristics.
¢ If reliability or validity st
have been included in theda
phase, the quality of the information
- gathered should be described by outlining
the validity and reliability.
Adequate description ofthe basicdata
should precede and complement the stat
istical analysis. There is no point in stating
‘the difference was significant’ without sum-
marizing what the difference was.
The basic description will also indicate
how representative the sample |is of the
population. /
¢ Distributional sccuripuene a statistical
methods used must be justified.
¢ Confidence intervals should be presented if
the aim of the investigation is estimation.
many analyses themselves.
Table 11.5 gives some guidelines on the presen-
tation of results, emphasizing that the basic data
should be displayed and described clearly, and
that the data should be explored. Table 11.6 is a
copy of the checklist for statistical review of
general papers submitted to the British Medical
Journal (a more detailed checklist is used for
papers dealing with clinical trials). This checklist
outlines the major statistical questions re-
searchers should consider. Clearly, a statistical
analysis can only be considered good if the study
design and sampling of the project were appro-
priate.
 11. = anintroduction to data presentation, analysis, and interpretation

pel Ce er amie UC merece): we

British Medical Journal

EVE CT INO ee a Ge ee Hate GT EVICW! ace

ee es

Design features .
1 Was the objective of the study sufficiently described? Yes Unclear No

2 Was an appropriate study design used to achieve Yes Unclear No

the objective?

3 Was there a satisfactory statement given of source Yes Unclear No

of subjects?

4 Was apre-study calculation of required sample size reported? Yes No

Conduct of study
5 Was a Satisfactory response rate achieved? Yes No Unclear

Analysis and presentation :

6 Was there a statement adequately describing or referencing Yes No
all statistical procedures used?

7 Were the statistical analyses used appropriate? Yes Unclear No

8 Was the presentation of statistical material satisfactory? Yes No

9 Was the conclusion drawn from the statistical Yes Unclear No

analysis justified?

Recommendation on paper
10 _ Is the paper of acceptable statistical standard for publication? Yes No

11. If ‘No’ te question 10, could it become acceptable with Yes No

suitable revision?

FREVIC WER eo irer ies seacatecs ee ere eee eile tas

(Taken from Statistics with Confidence, Gardner and Altman 1989)

123
12
The relationship between sample
size, study design and precision of
estimates
Introduction
Epidemiological studies are fundamentally about
measurement. Variability is intrinsic to biological
systems and the process of sampling from a
population also introduces variability. In this sec-
tion of the chapter, we deal with the issue of pre-
cision, sometimes referred to as ‘random error’ or
‘reliability’.
Precision and validity are two separate con-
cepts, since it is possible to be precise yet not
valid. If, for instance, a scale for measuring weight
in an anthropometric study was not calibrated,
and all measurements started from 1 kg instead of
0 kg, the mean weight would not be valid since it
would be 1 kg more than the true mean weight.
However, when the same child is weighed repeat-
edly on the same scale, the scale produces iden-
tical weights, demonstrating that the scale is pre-
cise even though the weights are not valid. Preci-
sion refers to the degree of variability around an
estimate of a parameter, and is reflected by the
width of the confidence interval.
The precision of an estimate is affected by sam-
ple size. The more subjects studied, the greater the
degree of precision of the estimate. This is reflected
in narrower confidence intervals as sample size in-
creases. Precision is also influenced by study
design. The degree of precision of an estimate can
be increased if the study is designed efficiently.
Sample size
In Table 11.3 in Chapter 11, an example was pro-
vided which showed how the estimates from dif-
124
Integrating
epidemiological
concepts
ferent samples from the same population differed
from the population parameters. Using the same
population data, Table 12.1 shows how the confi-
dence intervals become narrower as the sample
size increases.
However, the magnitude of the benefit in terms
of greater precision diminishes as the sample size
increases. A critical sample size is reached when
the standard error does not decrease substan-
tially, even though the sample size increases. This
situation, which exemplifies the ‘law of diminish-
ing returns’, highlights the importance of select-
ing the most appropriate sample size. If the
sample is too small, precision is compromised,
while if the sample is too big, resources are being
wasted.
At one extreme, when the entire population is
sampled (that is, a census is taken), the sample
mean is the population mean. Generally, increas-
ing the sample size also has the effect of moving
the sample mean closer to the population mean
(Table 12.1).
More importantly, sample size plays a substan-
tial role in determining the standard error, since
the formula to calculate the standard error is the
standard deviation divided by the square root of
the sample size. For example, in the case of the
mean, the standard error is given by:
ze & (xj-X)?
\a n=1
The large influence of the sample size in the
denominator of the formula above, makes sample
size an important determinant of the width of the
confidence interval, and therefore of the level of
precision. When preparing a study protocol,
 12 integrating epidemiological concepts

Table 12.1 Estimates yielded by increasing eT Cy TP het)

The population of 50 individuals is provided in Table 11.3 in Chapter 11.

Sample 1: Individuals: 17, 14, 46, 11, 39, 30, 02, 08, 15, 22
Sample 2: Individuals: (Sample 1) and 37, 10, 45, 33, 36, 07, 26, 09, 42, 25
Sample 3: Individuals: (Sample 2) and 24, 44, 23, 21, 12, 16, 01, 03, 34, 13

Sample 1 Sample 2 Sample 3

Sample size
Mean age 57,8 62,1 63,2
Standard deviation 14,4 14,9 13,1
Standard error 4,5 3.3 2,4
95% confidence interval (47,5;68,1) (55,1;69,0) (58,3;68,1)
% Males 40% 50% 56,/%
95% confidence interval (9,6%; 70%) (28,1%;71,9%) (39%; 74,4%)

There are 60% males in the population and the mean age is 64,6 years.

careful consideration should be given to the
calculation of the sample size (see Chapter 8:
Sampling).
Design considerations
For a given sample size, it is possible to improve
the tevel of precision in the study by designing the
study differently, namely more efficiently. This
section will present some ways in which precision
may be improved without increasing the sample
size. Many of the issues raised in this section are
to be considered as trade-offs between the need
for precision and the cost or feasibility of con-
ducting the study. This approach of trying to con-
sider the costs of the study on the one hand, and
the level of precision on the other, is sometimes
referred to as the ‘efficiency’ of the study design.
Greater efficiency is achieved if more precision is
obtained with the same number of (or fewer)
subjects.
The sampling strategy selected when designing
a study influences the degree of precision. Cluster
samples are prone to distortions due to the simil-
arity between subjects in a cluster (intra-cluster
homogeneity). Therefore, in order to obtain the
same degree of precision as a simple random
sample, larger samples are required. For example,
a community-based study to assess vaccination
coverage, which is expected to be about 50% with
a 10% margin of error, requires a sample size of 97
if simple random sampling is used, but a sample
size of 210 if cluster sampling of 7 per cluster is
used (assumed design effect of 2). However, in
certain instances, such as rural areas where the
total number of potential subjects is not known,
the larger sample size for a cluster survey may be
cheaper and logistically simpler than a simple
random sample survey with a smaller sample
size.
Increasing the proportion of subjects with the
exposure being studied can improve precision. In
a cross-sectional survey to assess the association
between having pierced ears (for earrings) and
hepatitis B virus infection, the following was
found:
Hepatitis B virus infection
Yes No
Pierced ears Yes 6 14 20
No 38 342 380
44 356 400
Prevalence of pierced ears = 5%
Relative Risk (RR) = 3 (95% confidence interval:
1,44; 6,25)
The same study, conducted in a community
where ear piercing was encouraged, produced the
following results:
c¢ data presentation, analysis, and interpretation
ng ng ee
Hepatitis B virus infection
Yes No
Pierced ears Yes 30 70 100
No 30 270 300
60 340 400
Prevalence of pierced ears = 25%
RR=3 (95% confidence interval: 1,91; 4,72)
Both studies had a sample size of 400, an RR of 3
and a 10% prevalence of hepatitis B virus infec-
tion among subjects without pierced ears. How-
ever, the latter community has a higher preva-
lence of pierced ears, thereby leading to a higher
precision in the estimate of the RR as reflected by
the narrower confidence intervals. However, it is
not simply increasing the prevalence of the expo-
sure (in this example, pierced ears) that improves
precision; rather, it is the effect that increasing
the prevalence of the exposure has on increasing
the value of the smallest cell in the table. In the
first table, the smallest cell is 6, while in the
second table, the smallest cell is 30. To demon-
strate this point further, if the prevalence of
pierced ears was 50%, the following results would
have been obtained:
Hepatitis B virus infection
Yes No
Pierced ears Yes 60 140 200
No 20 180 200
80 320 400
Prevalence of pierced ears = 50%
RR=3 (95% confidence interval :1,88; 4,78)
In this table, the prevalence of pierced ears
increases to 50% from 25% in the previous table.
Yet the precision is lower, demonstrating that in-
creasing the level of exposure does not uniformly
lead to improved precision. An increase in pre-
valence has led to a decrease in the size of the
smallest cell.
A study in which a higher proportion of sub-
jects has the exposure leads to a higher level of
precision, as long as the smallest value in the cells
of the 2 x 2 table increases as well. On the other
hand, the disadvantage of purposefully selecting
a community with a higher prevalence of expo-
sure in order to improve the precision of the esti-
mates is that the findings may no longer be
generalizable, since the study subjects may no
longer represent the wider population.
A similar benefit is achieved by altering the
ratio of cases to controls in order to improve pre-
cision in a case-control study. Where the cost of
126
a
recruiting a case and a control subject is the same,
altering the ratio of cases to controls is efficient
and improves precision, as long as the smallest
cell in the 2 x 2 table increases. In most instances,
however, recruiting a control is cheaper and
quicker, particularly where the disease is rare. In
this instance, increasing the number of controls
for a given number of cases leads to higher preci-
sion. However, the law of diminishing returns
applies and there is a critical point beyond which
a substantial increase in the number of controls
has little benefit in terms of improved precision.
Conclusion
Precision should not simply be equated with
sample size. The precision of the estimates ob-
tained from a sample depends on sample size and
the way the study was designed. For a fixed sam-
ple size, improved efficiency is possible with care-
ful design of the study. While sample size plays an
important part in determining the level of preci-
sion, study design becomes particularly import-
ant when resources preclude an increase in the
sample size.
Validity and bias: in search of truth
Introduction
Bias was described in Chapter 4. This section aims
to synthesize information and provide some
additional insights. Bias is a deviation from that
which is correct and true. Bias is distinct from
precision; precision refers to repeatability, while
bias refers to systematic deviation from the truth.
Bias is also referred to as ‘systematic error’ as
opposed to ‘random error’, which is another term
for precision. Validity is the absence of significant
bias.
A small degree of bias may be inevitable in re-
search, for example, in almost all studies some of
the selected subjects may choose not to partici-
pate (participation bias), with the result that the
sample does not fully represent the study popula-
tion. While the presence or absence of bias should
be evaluated in a study, it is more important to
assess the magnitude of the bias and the direction
in which it is likely to alter the study findings.
The first step in assessing the validity of a study
estimate is to identify potential biases. The next
step is to assess whether each bias is large or
small. Then each bias needs to be assessed in
terms of whether the bias could reduce the esti-
mate, exaggerate the estimate, or do either. The
final step is to identify methods by which each

bias could have been reduced (for example, cali-
brating the scale after every 20 subjects have been
weighed) and determine if adequate steps were
taken in the study to reduce bias.
The presence of a large bias in a study (for
example, the bias introduced by a low response
rate of only 30%) seriously undermines the valid-
ity and value of the findings. Every effort should
be made to reduce and avoid bias in a study, for
example, by conducting repeat follow-ups with
incentives to increase the response rate.
Types of bias
In a case-control study to assess whether passive
smoking during the antenatal period was asso-
ciated with stillbirth, mothers who had had still-
births were interviewed soon after the birth. A
control group of mothers who had had normal
births were also interviewed soon after birth to
get a history of passive smoking during the ante-
natal period. The verbal histories of exposure
were compared to urinary cotinine levels (a bio-
logical measure of cigarette smoke exposure used
here as a ‘gold standard’). It was found that many
of the women with normal births underestimated
their exposure to passive smoke, while the
women with stillbirths overestimated their expo-
sure to passive smoke. This is an example of recall
bias. The women who had just been through the
traumatic experience of having astillbirth were
searching for antenatal factors to blame for their
loss, with the result that they overestimated
smoke exposure. On the other hand, the women
with normal healthy babies were too busy enjoy-
ing their newborns to think back and consider
whether they were exposed to smoke during the
antenatal period.
In a cohort study to assess whether obesity is
associated with hypertension, the blood pressure
of obese and non-obese subjects was measured
using the same sphygmomanometer and cuff.
Since this cuff was not big enough for obese arms,
there was a systematic exaggeration of the blood
pressure levels among those obese subjects with
large arms. This bias led to an artificially raised
relative risk of the association between obesity
and hypertension. This is an example of measure-
ment bias.
In a cross-sectional study of coffee consump-
tion and history of emergency medical care for
myocardial infarction, it was found that subjects
who drank more than four cups of coffee a day
had twice as many myocardial infarction emer-
gencies as subjects who drank less than one cup
12 = integrating epidemiological concepts
of coffee a day. It also transpired that those who
drank more than four cups of coffee per day also
smoked more cigarettes. Since it is known that
smoking is associated with ischaemic heart
disease, it is possible that heavy coffee drinkers
had more myocardial infarction emergencies be-
cause of their smoking, and not because of their
coffee consumption. This is an example of bias
due to confounding.
There are many kinds of bias, but all biases can
be classified into one of three categories: selec-
tion bias, information bias, and confounding.
This section deals with the first two types.
Selection bias
Representative samples are drawn from a popula-
tion in order to make the findings of the study
applicable to the population. In some instances,
the subjects being studied do not represent the
population from which they were selected. The
two main ways in which selection bias occurs is
through a flaw in the sampling procedure or
through non-participation of certain subjects,
either at the start of the study (non-responders), or
during the course of the study (loss to follow-up).
Sampling bias, which is one form of selection
bias, is covered in Chapter 8. In summary, incom-
pleteness of the sampling frame and the use of
non-random sampling procedures are the main
sources of sampling bias. In an opinion poll for
the 1994 South African elections, interviews were
conducted at shopping malls and showed similar
levels of support for the two major political
parties. The sample was however biased, since
shopping mall samples under-represent the poor
sections of the community, as well as rural popu-
lations, while urban, middle-class people are
overrepresented. This sample did not represent
the voters of South Africa, since the sampling
frame did not include all voters.
In a descriptive survey to assess vaccination
coverage in Durban, the register of electricity
consumers was used as the sampling frame and a
random sample of houses from the register were
visited to obtain information on vaccination
coverage of children in the household. This study
found a vaccination coverage level which was
higher than all previous estimates. This was
ascribed to selection bias as a result of the exclu-
sion of houses without electricity (for example,
shacks in squatter settlements), where vaccina-
tion coverage is known to be low.
In studies which include a representative
sample of homes, non-participation becomes an
127
c data presentation, analysis, and interpretation
ee

issue when several homes are too difficult to antibodies. The test is 99% sensitive and 98% spe-
reach, or no one is found at home, even with cific. This means that for every 100 HIV infected
repeat visits. The exclusion or replacement of individuals who are tested, one will be misclassi-
these homes can lead to a biased sample, since fied as HIV negative. Similarly, for every 100 truly
these very hard-to-reach homes often occur HIV negative subjects, two will be misclassified as
where health status is poor and access to health HIV positive (see below).
services is difficult. From a practical point of view,
the study protocol should include a procedure for True status
dealing with hard-to-reach and locked homes. HIV+ HIV-
For example, after two visits, a non-responding ELISA result HIV+ 99 2 101
home may be replaced with the next closest HIvV- 1 98 99
house. The extent of replacement must be docu- 100 100 200
mented and included in the discussion of the
main study findings. Sensitivity = 99%
In a community-based cohort study, 1 000 Specificity = 98%
adults were followed up annually to assess the False positive rate = 2%
incidence rate of ischaemic heart disease. It was False negative rate = 1%
found that over 10 years, 30% of the subjects
moved out of the study area — many moving to In an analytic study, the exposure variable, the
wealthier suburbs. This 30% of subjects who were outcome variable, and/or the related variables
lost to follow-up left behind a sample which was could be misclassified. (Misclassification of
biased. The bias ocurred due to the selection related variables such as confounders is beyond
process of who left; in this case, most of the the scope of this book; more information on this
upwardly mobile business-orientated people, can be obtained from Ahlbom and Norell (1990):
mostly smokers with type A personalities, left the Introduction to Modern Epidemiology.) When the
area. Ischaemic heart disease is more common in degree of misclassification of the exposure vari-
this group, with the result that the cohort study able is influenced by the outcome variable, differ-
would underestimate the incidence rate for ential misclassification of exposure is said to
ischaemic heart disease if only the remaining 70% have occurred. When the degree of misclassifica-
of subjects were studied. tion of the outcome variable is influenced by the
Selection biases are often subtle and it is exposure variable, differential misclassification
important to pay particular attention to the sam- of outcome has occurred. Non-differential mis-
pling design in order to reduce selection bias to a classification occurs when the degree of mis-
minimum. classification of either the exposure or outcome
variable is not dependent on the other.
Information bias
Information bias refers to systematic inaccuracies Non-differential misclassification
in measurement, recording, management, and Differential and non-differential misclassification
analysis of data. Such inaccuracies lead to mis- can have markedly different effects on the esti-
classification, for example, subjects who have mates obtained in a study. Non-differential mis-
been exposed to the risk factor being studied may classification of either exposure or outcome
be misclassified as unexposed. Misclassification usually biases the study estimate towards the
occurs when the measurement ascribed to a sub- null, that is no effect or RR=1.
ject is incorrect and the margin of error is suffi- Extending the previous example to condoms
ciently large to lead to the subject being placed in and HIV infection, in a study of 10 000 subjects
a different category during the data analysis. the following results were obtained:
Misclassification is most simply understood in
terms of the sensitivity and specificity of the ELISA
measurement method used. (See Figure 9.7 in HIV+ HIV-—
Chapter 9 for more details on sensitivity and Condom use Yes 100 1900 2 000
specificity.) For example, in a study to assess No 800 7200 8000
whether condoms protect against HIV infection, 900 9100 10000
the presence or absence of HIV infection is deter-
mined by an immunological test (ELISA) for HIV RR=0,50 (95% confidence interval: 0,41; 0,61)

128

Based on the HIV ELISA results, there appears
to bea substantial protective effect of condoms in
this study, since 5% of condom users and 10% of
non-users were HIV positive.
Since the level of inaccuracy of the ELISA result
is not dependent upon whether condoms were
used, the HIV status has been non-differentially
misclassified. The misclassification of HIV status
can be crudely taken into account by adjusting for
99% sensitivity and 98% specificity of the ELISA
test.
ELISA
HIV+~ HIV-—
Condom use Yes 63 1937 2000
No 664 7336 8000
727 9273 10000
RR =0,38 (95% confidence interval: 0,29; 0,49)
The value of 63 for the first cell in the above
table is derived by adjusting as follows:
@ the sensitivity of 99% means that 1 of every 100
truly HIV infected has been incorrectly labelled
HIV negative; adjusting for this among condom
users results in 101 HIV positive and 1 899 HIV
negative.
@ the specificity of 98% means that 38 (2% of
1 899) HIV negative condom users have been
incorrectly classified as HIV positive; adjusting
for this results in 63 (101 minus 38) HIV positive
and 1 937 HIV negative condom users.
repeat the above steps for condom non-users.
The above adjustment to remove the non-differ-
ential misclassification emanating from the inac-
curacy of the Elisa test, results in an even larger
protective effect. That is, the non-differential mis-
classification of HIV status biased the RR towards
the null. Even though the HIV Elisa test has a high
degree of accuracy, namely 99% sensitive and
98% specific, the effect on the RR is substantial,
moving it from 0,38 to 0,5.
Most measurements undertaken in a study are
not 100% accurate, so there is some degree of in-
accuracy. As long as this measurement inac-
curacy leads to non-differential misclassification,
any non-null finding in a study could not have
been the result of this measurement bias, since
non-differential misclassification usually biases
towards the null. In statistical terms, non-differ-
ential misclassification generally leads to a Type
I] error and not a Type |error. In order to increase
the probability of finding an association where
one truly exists, the amount of non-differential
12 integrating epidemiological concepts
misclassification should be minimized by using
the most accurate measurement methods.
Differential misclassification
Differential misclassification of exposure occurs
when the degree of misclassification of the expo-
sure variable varies across strata of the outcome
variable. Similarly, differential misclassification
of outcome occurs when the degree of misclassi-
fication of the outcome variable varies across
strata of the exposure variable. Differential mis-
classification can bias the study estimate towards
or away from the null, unlike non-differential
misclassification, which usually biases the study
estimate towards the null.
Earlier in this chapter, an example of a case-
control study to investigate the association be-
tween stillbirths and passive smoking was used to
demonstrate information bias. This investigation
included 100 women who had experienced still-
births and 200 women with healthy newborns.
The results, based on a verbal history to assess
passive smoking, were as follows:
Stillbirth
Yes ___No
Verbalhistoryof Yes 30 40 70
passive smoking No (0. et60230
100 200 #300
OR = 1,71 (95% confidence interval: 0,95; 3,08)
An association was found, although not statist-
ically significant, between passive smoking and
stillbirths when verbal history was used to
measure passive smoking. In addition, urinary
cotinine was measured to corroborate the history;
and produced the following results:
Stillbirth
Yes _No
Urinarycotinine Yes 25 50 75
No Co 150 225
100 200 #300
OR = 1 (95% confidence interval: 0,55; 1,8)
The biological measurement of passive smok-
ing revealed that five women with stillbirths had
overestimated their exposure to passive smoke,
while 10 women with healthy newborns had
underestimated their exposure. This is an exam-
ple of differential misclassification; the misclassi-
fication of exposure differs across the outcome
categories. It is noteworthy that only 5% of the
subjects had been misclassified, yet the effect on
29
ce data presentation, analysis, and interpretation
a

the odds ratio is substantial — the odds ratio of 1 ence of asthma among both those who had been
is biased to 1,71. exposed and those who had not been exposed to
In a cross-sectional study investigating the rela- passive smoke. However, the overestimation was
tionship between passive smoking and asthma substantially higher among subjects who had
(measured by peak expiratory flow rate), 1 000 been exposed to passive smoke, resulting in dif-
children were investigated and the following ferential misclassification. The effect of the bias in
results were found: this study was to exaggerate the association be-
tween passive smoking and-asthma.
Asthma Misclassification is often difficult to avoid be-
Yes No cause of inherent inaccuracies in many measure-
Passivesmoking Yes 160 240 400 ment tools. When misclassification cannot be
No 60 540 600 avoided, the design of the study should ensure
220 780 #1000 that the misclassification arising from measure-
ment inaccuracy is non-differential.
RR =4 (95% confidence interval: 3,06; 5,23)
It was later learned that the fieldworker who Conclusion
performed the peak expiratory flow rate measure- Selection bias produces results that may not
ment knew the passive smoking history of the be generalizable to the study population. In
subjects. There was concern that he may have analytic studies, a bias in the selection of one
biased the peak flow measurement by making group, for example, the control group in a case-
more effort when performing the peak flow control study, can produce results which are not
measurement on subjects who had a history of valid.
passive smoking. To assess this potential bias, the Information bias manifests in misclassification,
measurements were performed again by another which can be interpreted by the sensitivity and
fieldworker, who was blinded to the subject’s specificity of the measurement. When the mis-
smoking history status. The repeat study pro- classification is non-differential, the study esti-
duced the following results: mate is usually biased towards the null. Should a
study demonstrate an association in the presence
Asthma of non-differential misclassification, then the
Yes- No association is probably much stronger. Differen-
Passivesmoking Yes 100 300 400 tial misclassification can bias the study estimate
No 50 550 600 either towards or away from the null.
150 850 1000 Selection and information bias call into ques-
tion the validity of the study findings. Every
RR=3 (95% confidence interval: 2,19; 4,11) attempt should be made to reduce both these
The first fieldworker overestimated the preval- biasés to a minimum.

130
1 418 Knowledge, attitude, belief, and
practice poe er

4 19 Quaativemethodology a"
introduction - /
_ D Skinner, H van der Walt
ey
og
a
RES
13
Introduction
Routinely available data is data collected on an
ongoing basis or at regular intervals through sur-
veillance systems or registration procedures. This
information is used by health professionals and
policy-makers at various levels to monitor ser-
vices and formulate policy.
Routinely available data is collated regularly
and can provide a rich source of health-related
information. In this chapter, we will focus on
information which has already been collated.
Generally, large numbers are collected, with wide
coverage (for example, nationally registered
deaths). Since the researcher using such data
often spends little or no time on data collection,
most effort can be channelled into a thorough
analysis. It is, however, a disadvantage that the re-
searcher plays no part in the data collection, since
one normally gets a feel for the quality of one’s
data during the collection phase. Researchers
who make use of routinely available data should
ensure that (in addition to acknowledging the
source), they know exactly how the data was col-
lected and what they represent: all small print in
the published reports should be scrutinized! The
researcher should also, as part of the analysis,
carry out quality checks if possible (see Example
14.1).
Routinely available data can be of poor quality
because of incompleteness; for example, not all
notifiable cases are in fact notified, and censuses
of populations can be undercounts. Routinely
available data can also be out of date. To be able
to calculate disease rates in an area, an estimate
of the population size is needed. Official censuses
are generally only conducted at certain time
intervals (usually every five or 10 years). Due to
The use of
routinely
available data in
epidemiological
studies
migration, population sizes can change dramat-
ically over relatively short periods (particularly in
informal settlements), rendering census figures
out of date in such areas. Data can be inaccurate,
as in the case of cause of registered deaths, where
high percentages of deaths are classified as ‘signs,
symptoms, and ill-defined conditions’ (see Chap-
ter 20). When using published data, one must be
aware of the possibility of changes in definitions
or coding practices over time (see Example 20.3).
Keeping these problems in mind, the researcher
can however gain important insights by using
routinely available data sensibly. Table 13.1 lists
routinely available South African data, their
sources, and asummary of their limitations.
Various types of epidemiological studies can be
performed using routinely available data.
Descriptive studies of the prevalence or incidence
of diseases and health resources availability are
most commonly conducted. However, analytical
studies can be conducted; for example, to deter-
mine factors related to TB treatment defaulting at
a clinic (see Example 13.1). The impact of inter-
vention programmes can also be evaluated using
routinely available data.
Because of legislation, routinely available data
was often collected according to population
group (race), but not according to other import-
ant socio-economic indicators. Researchers who
analysed data on the basis of population group
were often criticized for promoting a racial cate-
- gorization of the population. Careful attention
needs to be paid to the appropriate use of race as
a variable for analysis. Without being racist, race
can be used when genetic factors play a role, or
where issues of racial or ethnic equity are being
analysed. As the government strives to undo the
133
d common approaches in epidemiology
ey eee MM eM CMCC
ATT WNa(er:|
TYPE SOURCE
MORTALITY
— national Death reports by Central Statistical
Services (yearly)
Historical death tapes MRC, UCT
(1968 onwards)
— local Annual reports by Medical Officers of
Health (yearly)
MORBIDITY
— national Notifiable (mainly infectious) conditions
reported in Epidemiological Comments
of Dept of Health (monthly)
Cancer register kept by SAIMR
(yearly report)
Virology surveillance from all RSA
laboratories reported by the National
Institute for Virology (monthly)
SASPREN: surveillance conducted
by volunteer primary care practitioners
— local Notifiable conditions reported by local
authorities (Annual reports)
Hospital discharge records
POPULATION
— national Census reports and data by Central
Statistical Services (5—10 yearly)
Intercensual estimates by Central
Statistical Services (periodically)
HSRC estimates and projections
(irregularly)
Population register (ongoing)
Development Bank reports on
‘homeland’ areas (irregularly)
134
ACC cL
LIMITATION
Summary data
Excluding TBVC* until 1994
Under-registration and misclassification
of cause for Africans in particular
Excluding TBVC until 1994
Under-registration and misclassification
of cause for Africans in particular
Summary data
Selected urban areas only
Misclassification of cause of death
Summary data
Under-reporting
Regional variation in diagnosis
reporting practices
Histology based, i.e. only cases
confirmed by histology
Under-reported
Only public laboratories
Not a random sample of practitioners
Summary data
Selected urban areas only
Under-reporting
No knowledge of the exact population data
Diagnoses not standardized
Excluding TBVC until 1994
Under-enumeration
Excluding TBVC until 1994
Under-enumeration
Untested
Summary data
Under-enumeration
 13 = the use of routinely available data in epidemiological studies
Table 13. 7 (continued) Type, sources, and limitations of chet
available data in South Africa
TYPE SOURCE
BIRTHS
— national Central Statistical Service reports
(yearly)
Population register (ongoing)
— local Annual reports by Medical Officers
of Health (yearly)
HEALTH CARE
South African Medical and Dental
Council's register of doctors and
dentists (ongoing) (1975, 1983, 1986,
1989 at MRC)
Census of doctors by Central Statistical
Services (1979, 1983)
South African Nursing Council’s
register of enrolled and registered
nurses (angoing) (1983,
1986, 1988, 1989 at MRC)
South African Hospital and Nursing
Yearbook including hospital and
clinical resources (yearly)
RAMS — register of medical aid
doctors (ongoing)
RAMS — medical aid claims report
and data on tape (ongoing)
ReHMIS — survey of resources in
the public sector
* TBVC = Transkei, Bophuthatswana, Venda, Ciskei
damage of previous apartheid policies, it will be
important to monitor progress towards equity in
health services and health status. It will therefore
be necessary to continue to record population
group for certain data. However, at the same time,
it is important that ethnicity, education, occupa-
tion, and income variables are used to reflect the
cultural and socio-economic stratification of
South African society. These variables need to be
included in the routine information systems.
Researchers who do not wish to promote a
racial categorization often express their views
LIMITATION
Excluding TBVC until 1994
Under-registration
Out of date
Untested
Selected urban areas only
Under-reporting
Postal address and not address of
practice
Inconsistent inclusion of practitioners
outside RSA
Inconsistent inclusion of
non-practising nurses
Postal address and not address of
practice
Summary data
Limited information
Untested
through a disclaimer justifying the inclusion of
population group in their analysis. Debates have
arisen over the naming of certain categories. In
the past, the use of ‘coloured’ rather than colour-
ed, and African rather than black usually reflected
dissent from official apartheid terminology.
Mortality data
In the past, all registered deaths in the RSA ex-
cluding Transkei, Bophuthatswana, Venda, and
Ciskei were collected by the Central Statistical
135
d= common approaches in epidemiology
a a
Services and published annually by age, sex,
population group, and cause of death, as well as
by magisterial district and occupational group.
Since the- repeal of the Population Registration
Act during 1991, this data has not been collected
according to population group. During 1994, the
independent homelands were re-incorporated
into South Africa and their data is now being
processed by the Central Statistical Services. The
data available before and after 1994 is thus not
strictly comparable.
The underlying cause of death is coded accord-
ing to the International Classification of Diseases
(ICD) into one of 999 causes. These causes are
grouped into 17 main chapters (for example, neo-
plasms, circulatory). The ICD is revised and
expanded occasionally. During the 1980s and the
first half of the 1990s, the ninth revision of the ICD
was the standard one. It has subsequently been
replaced by the 10th revision. The ICD is used
internationally and provides a basis for inter-
national comparison. The quality of the classifi-
cation and of the reporting are crucial in deter-
mining the quality of the data.
Although death registration is compulsory and
permission for burial can only be obtained if the
death is registered, it has been estimated that as
many as 50% of African deaths are not registered
(Botha and Bradshaw 1985), and thus not re-
flected in the national mortality figures. Since we
cannot assume that underregistration is uniform
with regard to cause, age, sex, or area, this data
must be used cautiously. In addition, it has been
found that up to 20% of registered African deaths
are coded as being due to ‘symptoms, signs, and
ill-defined conditions’. The majority of such
death certificates are completed by police officers
(Van der Merwe, Yach, Metcalf 1991) and head-
men in the rural areas. This hampers the inter-
pretation that can be made regarding the other
causes of death in this group.
The Births and Deaths Act was revised in 1992
and the medical certificate changed so that
details of the cause of a non-natural (external
cause) death need not be submitted. This has
been disastrous for surveillance of injury-related
deaths. Authorities such as the Western Cape
Regional Services Council have therefore set up
their own surveillance system by collecting this
data at the mortuaries.
To gain insight from the published mortality
data, we can calculate proportional mortality or
mortality rates. In the case of proportional
mortality, one calculates what proportion of all
136
a re
deaths in a specific age/sex group are due to the
cause of death of interest. So, for example, it was
found that 7,8% of all deaths in children under 15
years during 1981-5 were due to injuries (non-
natural causes) (Kibel, Bradshaw, Joubert 1990).
When calculating mortality rates, in addition to
the mortality information, we need information
on the size and composition of the population.
Using such information, it was determined that
annually 55,3 per 100 000 coloured children aged
five to nine died due to injuries during 1981-5
(Kibel et al 1990). Mortality obviously looks at the
most extreme outcome on the health/disease
spectrum, but in the absence of national morbid-
ity data, it provides useful information. (Also see
Cha 20:pte r
Mortality studies.)
Population data (denominator)
National censuses are usually conducted every
five years. Any census has the problem of possible
under-enumeration. It has been estimated that
the 1991 census under-enumerated the African
population by as much as 17% (Central Statistical
Services 1992). In the other population groups,
these figures are somewhat lower. Of course, the
extent of under-enumeration differs geographic-
ally, but this has not been estimated. It is thus
problematic to calculate rates for Africans, espe-
cially in the case of mortality where the numer-
ator data (mortality figures) are also inaccurate.
For the African population, it is best to use locally
available metropolitan or regionally collected
data (such as the African population estimates
which the HSRC provided for the greater Cape
Town area in 1988).
As health services move to district manage-
ment, there is an increasing need for an author-
itative source of district level population projec-
tions for the years after a census.
Births
This information is crucial for determining the
infant mortality rate. National data are only avail-
able some years after collection, and in the case of
Africans, are particularly incomplete. Most large
cities include the number of births, based on noti-
fications, in their annual reports.
Morbidity data
Certain diseases, mostly of an infectious nature,
are notifiable to the Department of Health. The
 13 = the use of routinely available data in epidemiological studies
major diseases include tuberculosis, hepatitis B,
measles, malaria and typhoid. Unfortunately,
health professionals do not always notify the
authorities of these conditions, and deaths are
particularly poorly reported. When considering
deaths due to notifiable conditions, it is advisable
to use the registered mortality data.
A national cancer registry based on histological
diagnoses has been created by the South African
Institute for Medical Research. Annual reports are
published giving incidence rates by age, sex,
population group and site of the cancer. Disease-
specific registers are very important for the sur-
veillance of the disease, as they can provide more
accurate measures of incidence than mortality
data.
Many records are kept by hospital administra-
tions. Not much epidemiological use has been
made of South African hospital records. Analyses
of records from Groote Schuur and Red Cross
Children’s hospitals have shown the potential
value of such sources, as long as the quality of dis-
charge diagnoses can be standardized (Henley,
Smit, Roux, Zwarenstein 1991).
Clinic records also provide a rich source of
information. Much of this information is not
generally collated, and anyone who wishes to
analyse such data may have to spend a lot of time
extracting the needed information from patient
records. Example 13.1 describes how clinic
records were used to investigate methodological
issues regarding the measurement of treatment
compliance.
The South African Sentinel Practitioner Re-
search Network (SASPREN) is a network of pri-
mary care practitioners who have developed a
surveillance system (Volmink, Furman 1991). A
pilot project has demonstrated the feasibility and
value of the routine collection and processing of
selected data, such as trends in hypertension and
depression.
Health services data
Information about the available human health
resources can be obtained from registers of the
South African Medical and Dental Council, the
South African Nursing Council, and the register of
medical aid doctors. Information regarding other
resources can be obtained from the South African
Hospital and Nursing Yearbook, which publishes
statistics on the number of beds available in each
hospital or clinic. Such information is often
expressed in terms of resources per population
(for example, doctors to population ratio). This
can be used to describe the distribution of avail-
able resources (see Example 13.2).
Various budgets can be used to gather inform-
ation about health care expenditures in the public
sector, and data from RAMS medical aid claims
can be used for information about expenditure on
services. It is, however, extremely difficult to
obtain information regarding private consump-
tion of pharmaceuticals. Health care expenditure
can be expressed either as a total amount, or per
capita.
* ReHMIS (Regional Health Management In-
formation System) is a national survey of the
resources in the public health service (REHMIS
System Documentation 1994). This was initiated
to help in the restructuring of the health service,
and is expected to be repeated on a regular basis.
Conclusion
The epidemiologist has an important role to play
at all levels of the health service by assessing the
quality of routinely available data and meaning-
fully interpreting such data. By letting the data
providers know how the data is used and what its
limitations are, it is possible to change the data
collection procedure so that it yields better qual-
ity data. The data providers are generally willing
to discuss ways of improving the routinely col-
lected data once they realize that someone is
making use of it. Feedback should also be given to
the staff who collect routine data, particularly at
local level. These staff are often unaware of what
happens to the information, and they may feel
they are wasting their time filling in endless forms
that no one ever looks at. Feedback may motivate
them and thus result in better quality inform-
ation. In addition, they can describe the practical
problems they experience in collecting the in-
formation, and solutions can be found jointly.
EXAMPLE 13.1
Measuring patient compliance with
tuberculosis treatment
At a community-based TB clinic in Cape Town, a
cohort of all new patients entered on the official
notification list for the two major suburbs served
by the clinic during a period of 120 treatment days
was studied. Demographic information about
these patients was collected from clinic or noti-
fication records. Treatment, outcome, and com-
137
d= common approaches in epidemiology
i ee EE EE
pliance information was collected from the pa-
tients’ treatment cards.
On the last day of acceptance into the group (30
June 1987), a cross-sectional survey was con-
ducted identifying those patients in the group
who were still on the clinic treatment list. Compli-
ance and associations between demographic
variables and compliance were measured at this
point (cross-sectional study, compliance to date),
as well as at the end of treatment (longitudinal
study, end compliance). A patient was defined as
compliant if he or she had attended on 75% or
more of possible treatment days. In the longitudi-
nal survey, a time lag of some months was anti-
cipated until all patients had completed their
treatment. To contain the study, a cut-off point
was defined after which compliance was impos-
sible (160 days after entry into the cohort, since
treatment consists of 120 treatment days).
The cross-sectional study underestimated non-
compliance: 19,5% compared to 40,3% obtained
in the longitudinal study. The cross-sectional
result was biased, as this study only included
treatment survivors, and measured compliance
of all patients on a particular day, irrespective of
the time since notification.
In both analyses it was found that children were
less compliant than adults.
Reference:
Youngleson S M, Joubert G. ‘A comparison of cross-sectional
and longitudinal survey methods in measuring patient com-
pliance with tuberculosis treatment.’ South African Medical
Journal 1991; 80(7):331-5.
EXAMPLE 13.2
Health facilities in the nine provinces
of South Africa
Since the provision and distribution of health ser-
vices is an important aspect of the development
of a national health plan, this study was done to
collate, verify, and analyse data on the number
and types of hospital beds (Table 13.2) and the
number of fixed clinics (Table 13.3), and relate
these to the population sizes in each of the nine
provinces of South Africa. A comprehensive data-
base of this information was compiled for the
period 1988-1993.
138
The Hospital and Nursing Yearbook, statistical
reports from the provinces and the Central Stat-
istical Services, as well as reports from the Na-
tional Association of Private Hospitals were used
as sources of hospital data. For the clinic data, the
Yearbook, reports from the regional directors of
the then Department of National Health and
Population Development, timetables from clinics
under various local authorities, and the statistical
abstracts from the Development Bank of South-
ern Africa were used.
To verify hospital information, the 1988 Hos-
pital and Nursing Yearbook was regarded as the
most comprehensive source. All other sources, as
well as other editions of the Yearbook, were com-
pared to it. For a random sample of hospitals, in-
formation was confirmed telephonically with
hospital administrators. The hospital data of the
Yearbook was found to be comprehensive, but
errors were found in totals of figures. Hospital bed
data of the various sources did not differ mark-
edly. The hospital data was updated using the
1994 Yearbook.
No data source was found to have a compre-
hensive list of clinics within the provinces. There-
fore, exhaustive telephone contact with local
authorities was made to improve the information.
The provincial distribution of hospital beds per
1000 population is shown in Table 13.2. The
report points out that the total number of private
and public sector beds does not accurately reflect
the number of beds accessible to the general
population. Therefore, the number of public
sector beds (referral, general, and special) as well
as acute public beds (only referral and general)
per 1 000 population was also calculated by pro-
vince. The provinces were fairly comparable with
respect to acute public beds, apart from Mpuma-
langa which had 1,5 acute beds per 1 000 popula-
tion (compared to the other provinces, which
ranged from 2,0 to 2,5 per 1 000 population).
The distribution of clinics is shown in Table
13.3. Some provinces do worse than the WHO’s
recommended 10000 people per clinic. This
information has not been routinely analysed
before, and the quality is thus not known.
The report recommends that comprehensive
analyses should be carried out at regional and
subregional level, taking into account, for exam-
ple, population density and growth, location and
accessibility of services (Chetty 1995).
 13 the use of routinely available data in epidemiological studies

Table 13.2 Distribution of total public and private hospital beds per 1 itil)
population, South Africa 1993

Province Number of hospital beds Beds per 1 000 population

Eastern Cape 23 207 3,5

Mpumalanga 6 058 2,1
Free State 11 493 4,1
Gauteng 41 297 6,0
KwaZulu-Natal 32 826 3,8
Northern Cape 3 090 4,0
Northern Province 12846 -* 2,5
North-West 14518 3,3
Western Cape 19 664 5,4

Total 161 949 4,0

Table 13.3 Total number of clinics and population per clinic,

South Africa 1993

Province Number of clinics Population per clinic

Eastern Cape 530 12576

Mpumalanga 162 Tf 522
Free State ' 168 16 694
Gauteng 213 25 080
KwaZulu-Natal ais 22919
Northern Cape 422 6 261
Northern Province 287 17 842
North-West 268 13 085
Western Cape 365 9918

Total 2 548 15979

Reference:
Medical Journal 1995;
Chetty K S. ‘An integrated analysis of health facilities in the nine provinces of South Africa.’ South African
85:245-50.

139
14
Introduction
Disease surveillance in public health is the
systematic collection, collation and analysis of
outcome-specific data, and timely dissemination
to those who need to know, especially those who
can use this information to improve public
health. Hence, surveillance has also been referred
to as the collection of data for action. It is a type of
ongoing observational study that involves con-
tinuous monitoring of disease occurrence within
a population.
The dictionary defines surveillance in terms of
police surveillance, as meaning to ‘watch or guard
over a person, especially a suspected person, a
prisoner, or the like’. In terms of public health
surveillance, the suspect is the disease in a popu-
lation.
Since the surveillance of infectious diseases
constitutes the bulk of public health surveillance
in South Africa, infectious diseases examples will
mainly be used to illustrate the general principles
of surveillance in public health.
Historical background
The history of public health surveillance can be
traced back to efforts to control bubonic plague in
Europe in the 14th century. The principles of sur-
veillance were first exemplified by William Farr,
Superintendent of the Statistical Department of
the General Registry in London, in a series of
letters on the causes of death in England appear-
ing from 1839 to 1870, and a collection of papers
on ‘Vital Statistics’ published in 1885. The
modern era of disease surveillance was initiated
in the 1950s by Langmuir and his colleagues, who
focused on the collection, analysis, and dissemi-
140
Disease
surveillance
nation of data on specific diseases to those who
needed to know.
The 1918 influenza epidemic in South Africa,
which caused 150000 deaths, occurred largely
because there was no surveillance system in place
to recognize it at an early stage, or to target effect-
ive interventions. Thus, when the Department of
Health was constituted in 1919, certain diseases
were made notifiable.
Uses of surveillance
The primary use of surveillance systems is to
establish the long-term trends and patterns in
disease occurrence at local, regional, and national
levels. This serves as a background which allows
for the detection of unusual disease patterns. For
example, long-term trends in tuberculosis (TB)
show that since 1987, the overall incidence of TB
has been rising, after remaining fairly constant for
about 10 years (Figure 14.1). A breakdown of the
data into racial groups shows that this increase is
largely attributable to an increase in the rate in
the coloured population. This example shows
how surveillance enables high-risk groups to be
identified.
The immediate use of surveillance data is to
trigger disease control efforts. In the latter part of
1988, paediatricians and general practitioners in
Cape Town reported an increase in the occur-
rence of pertussis (whooping cough) (Strebel,
Metcalf, Hussey, Smith, Hanslo, Cameron 1989).
Once it became clear that an epidemic of Borde-
tella pertussis was being experienced, the follow-
ing control measures were recommended: clin-
ical guidelines to consider a case as pertussis,
antimicrobial (erythromycin) therapy, affected
 14 disease surveillance
Se Se
a a

Sram meMC em Re mE tl

Incidence rate

4 Overall x Black -A- Coloured -~- White —< Asian

Source: ‘The trend of tuberculosis through the eyes of cohorts.’ Epidemiological Comments Nov 1992.

schoolchildren to remain at home for seven days
after treatment or three weeks if appropriate
treatment was not given, treatment for contacts
(erythromycin for upper respiratory tract infec-
tion) and strict adherence to immunization
schédules regarding diphtheria, pertussis, and
tetanus (DPT). Whooping cough had been made
notifiable in the city of Cape Town in 1974, unlike
the rest of the country, where it was not notifiable.
In 1994, pertussis was made notifiable nationally.
Surveillance data is useful in evaluating inter-
vention measures. A mass measles immunization
campaign in 1990 was evaluated using surveil-
lance data on measles admissions to a tertiary
hospital. An initial short-term evaluation (six
months post-campaign) found the campaign to
be effective in reducing measles incidence (Figure
14.2) (Abdool Karim S$ S, Abdool Karim Q, Cha-
mane 1991).
However, when a second evaluation was done
using the same surveillance data over a longer
period (21 months post-campaign), it was found
that the effect of the campaign had been lost
(Abdool Karim S S, Abdool Karim Q, Dilraj, Cha-
mane 1993). The prime reason for this was that
the high level of vaccination coverage achieved
during the campaign had not been sustained.
The main purposes of surveillance are sum-
marized below. Unusual events detected by sur-
veillance often stimulate health-related research.
Main purposes of surveillance:
@ Morbidity and mortality reporting
¢@ Documenting distribution and spread of
diseases
@ Establishing long-term trends in disease occur-
rence
Detection of epidemics
@ Identifying high-risk groups or areas
@ Estimation of magnitude of the health problem
Facilitating planning of control and prevention
measures
Evaluation of intervention measures
@ Resource allocation in public health planning
@ Setting research priorities
@ Archival information for describing the natural
history of diseases.
Surveillance data can also be used to direct
resources for swift and effective control, as well as
to estimate the magnitude of the health problem
(in the long term).
Methods of surveillance
Surveillance data is typically obtained through
health provider-initiated reports, such as noti-
fication forms filled in by nurses (passive surveil-
141
d common approaches in epidemiology
Figure 14.2 Monthly measles admissions to a KwaZulu-Natal tertiary
hospital
Measles admissions
200
Pre-campaign
N J
1989 1990
Source: Abdool Karim S S, Abdool Karim Q, Dilraj R, Chamane M, 1993.
lance) or health department-solicited reports,
such as the recruitment of throat swab specimens
from health centres by the National Institute for
Virology for the isolation and monitoring of
influenza viruses (McAnerney, Johnson, Schoub
1994) (active surveillance). Passive surveillance is
good for conditions that have clear symptomato-
logy (and few asymptomatic infections), such as
measles. Active surveillance is useful for diseases
which can be easily missed — it reminds health
care providers to be on the lookout for these con-
ditions. A good example of a disease that needs
active surveillance is malaria, where it is import-
ant in controlling malaria to detect asymptomatic
malaria carriers, in order to reduce the prevalence
of parasite carriers.
Passive surveillance is much less costly than
active surveillance and is therefore used most
often.
Methods of disease surveillance include rou-
tine reporting, sentinel reporting, special surveys
or programmes, and outbreak investigations.
These are discussed in turn below. Several sur-
142
Post-campaign
M M J $ M M
Month 1991
veillance systems may be used to support or com-
plement each other.
Routine surveillance
Routine surveillance means that every case of a
particular condition seen must be reported and
counted. Routinely reported data is typically
obtained via passive surveillance. A typical exam-
ple of routine surveillance is notifiable disease
reporting. The main reason for making diseases
notifiable is to control those diseases which con-
stitute a danger to public health. Thirty-six condi-
tions are notifiable in South Africa, and these are
mainly infectious diseases. A current list of notifi-
able conditions is readily available in Epidemio-
logical Comments, a publication of the Depart-
ment of Health. The 1994/95 list of notifiable con-
ditions is shown in Table 14.1. Notifiable disease
reporting is the main routine system for morbid-
ity data collection in South Africa.
If a condition is notifiable, the notification to
health authorities is a statutory obligation, the
regulations of which are contained in the Health
 14 = disease surveillance

Act (63 of 1977). A notification may be submitted

Table 14.1 Notifiable diseases in
by any person who is legally competent to diag-
nose the condition, not necessarily a medical South Africa, 1994/5
practitioner. The Act stipulates that if the condi-
tion is a communicable disease, it must be re- Acute flaccid paralysis*
ported without delay orally and confirmed in Acute rheumatic fever
writing within 24 hours. The notification is made Anthrax
to the health section of the local authority, or to Brucellosis
the provincial department of health, in areas Cholera
where no local authority exists. If a death occurs, Congenital syphilis |
the authorities must be notified separately to Diphtheria
allow estimation of case fatality rates. Food poisoning —
Each local authority is required to submit, on a «Haemorrhagic fevers of Africa (Congo fever,
weekly basis, a summary of all notifications Dengue fever, Ebola fever, Lassa fever,
(including nil returns, which are blank forms indi- Marburg fever, Rift Valley fever) _
cating that no cases were seen) and deaths to the Haemophilus influenza type b*
provincial department of health for processing Lead poisoning
and analysis. Regular feedback is done via Legionellosis
Epidemiological Comments. Responsibility for Leprosy
control rests, in the first instance, with the local Malaria
authority, while resource provision, surveillance, Measles
and record-keeping are functions provided by the Meningococcal infection
provincial and national departments of health. Paratyphoid fever
Laboratory-based surveillance is another Plague
method of routine surveillance. This system uses Poisoning from agricultural or stock remedy
biological specimens sent to state laboratories by Poliomyelitis
health providers. Laboratory-based surveillance Rabies
is particularly important in infectious disease sur- Smallpox
veillance and data from this system is often tied Tetanus
into the notifiable disease reporting system. Its Tetanus neonatorum
potential in this country has been largely unex- Trachoma
plored and its role therefore needs to be ex- Tuberculosis: Pulmonary and other forms.
panded. The laboratory is useful in finding the Typhoid fever
etiological agent. Some diseases, such as typhoid, Typhus fever (louse and rat flea borne)
salmonellosis, and shigellosis can only be notified Viral hepatitis A & B, non-A non-B, unspecified
after laboratory confirmation, because of the Yellow fever
non-specificity of the clinical syndrome. In South Whooping cough (Bordetella pertussis)
Africa, laboratory data on viruses are compiled by
the National Institute for Virology (NIV) from re- *Notifiable as from 1994
ports submitted by the seven diagnostic labor-
atories in the country, and published monthly in
the South African Virus Laboratories: Surveillance free of polio until most cases of acute flaccid
Bulletin. Special clinics, such as those for ante- paralysis are fully evaluated in terms of stool cul-
natal care, sexually transmitted diseases, and tures and/or 60-day follow-up to confirm that
tuberculosis, are important ongoing sources of suspected or possible cases are not polio.
biological specimens for specific disease occur-
rence. Sentinel surveillance
Laboratory-based surveillance becomes essen- Sentinel surveillance uses data from a few se-
tial when it comes to the eradication of diseases lected sites rather than data from all sites. Most
that can be clinically confused with others. For sentinel surveillance systems are passive surveil-
example, polio can be confused clinically with lance systems. Since it is much easier to monitor
other causes of acute flaccid paralysis (such as and improve information collection at a few sites,
Guillain-Barre syndrome or transverse myelitis). it is possible to get accurate and more complete
Thus, it will not be possible to certify countries data on the sentinel population using sentinel
143
d= common approaches in epidemiology
surveillance rather than with total population
passive surveillance. Data from well-selected sites
such as specific hospitals or health centres is
available more quickly, is more reliable, and costs
much less than data for a whole region. This in-
formation can act as an early warning system. For
diseases with a relatively high incidence, such as
tuberculosis, health centres (TB clinics) could be
selected as sentinel reporting sites. For less fre-
quently occurring diseases requiring special care,
for example, neonatal tetanus, tertiary hospitals
could be used. An example of a sentinel hospital is
Clairwood Hospital in Durban, as it is a referral
hospital for several infectious diseases, in particu-
lar measles. Admission data from this hospital has
been used with reasonable accuracy to depict the
trend in measles incidence that occurs in the
whole province of KwaZulu-Natal.
Other sentinel surveillance systems include the
influenza surveillance system run by the National
Institute of Virology, the Medical Research Coun-
cil’s trauma surveillance system in the Cape and
KwaZulu-Natal, the South African General Practi-
tioner Network, and the National Cancer Registry.
Special surveys/special surveillance
programmes
Periodically, new or unusual disease problems
require special surveillance programmes to be set
up. With the emergence of multi-drug resistance
and the greater risk of tuberculosis among those
with HIV/AIDS, a national tuberculosis pro-
gramme was initiated to document cases and
treat tuberculosis more accurately. A National TB
Register was initiated in 1994 to document in-
formation on every case of TB in South Africa.
Since malaria is endemic to northern KwaZulu-
Natal and sections of Mpumalanga, a special pro-
gramme, the Malaria Control Programme, was
developed to address this problem in this region.
Surveillance agents of this programme visit
almost all houses approximately once every six
weeks and collect clinical data as well as blood for
parasite microscopy. In this way, effective surveil-
lance of malaria in this region is maintained. The
malaria programme is one of the few examples of
active surveillance undertaken by the Depart-
ment of Health in South Africa.
Another example is sewer pads for active sur-
veillance for cholera in water sources. To find out
whether cholera is present in the community, it is
more cost-effective to place a pad which retains
microorganisms from sewage than it is to screen
members of the community.
144
While data from sentinel sites, such as ante-
natal and sexually transmitted diseases clinics,
have traditionally been used to estimate the pre-
valence of HIV, special population-based HIV
sero-surveys conducted on several occasions in
conjunction with the malaria programme have
also been useful in estimating the HIV prevalence
in rural KwaZulu-Natal (see Kustner, Swane-
velder, Van Middelkoop 1994, and Abdool Karim
Q, Abdool KarimSS, Singh, Short, Ngxongo 1992).
Outbreak surveillance
Without surveillance it would be difficult to
detect outbreaks of disease — if the baseline pre-
valence of disease is not known, then epidemics
cannot be recognized. Many epidemics can go
undetected if no surveillance is in place. When a
disease outbreak occurs, investigation becomes a
high priority. Outbreak investigations are under-
taken to establish the source and/or cause of the
outbreak. The main aim of an outbreak investig-
ation is to quickly control the outbreak with tar-
geted interventions. It also provides important in-
formation on vaccine efficacy, age-specific attack
rates and age-specific case fatality rates. The
increase in measles incidence in South Africa in
the 1992-4 period has been largely due to out-
breaks in older children (over five years) who had
been previously vaccinated. An investigation of a
measles outbreak in a Cape Town school revealed
an attack rate of 7,6% (25/329 children), immuni-
zation coverage (at least 1 dose) of 91% and vac-
cine efficacy of 79% (Coetzee, Hussey, Visser,
Barron, Keen 1994). Outbreak investigations can
also identify certain social, ethnic, or religious
clusters of susceptible individuals.
The steps in conducting outbreak investiga-
tions are covered in Chapter 21 of this book. The
importance of surveillance in the post-outbreak
phase, as a tool for evaluating preventive inter-
vention during the outbreak, should not be over-
looked.
Problems in surveillance
Health care providers, health officials and policy-
makers need rapid access to accurate, timely data
in a useful form. Lack of such data results in poor
planning, unnecessary illness, mortality, and
economic costs.
There have been many criticisms of passive
surveillance. Under-reporting has often been
cited as the major problem with passive surveil-
lance. Consequently, a study to determine the

tte cn pee sen sc
ei
reasons for under-reporting of notifiable condi-
tions was conducted amongst doctors at King
Edward VIII Hospital in Durban (Abdool Karim,
Dilraj 1996). Some of the reasons for under-
reporting highlighted in that study are discussed
here.
@ There is poor knowledge of conditions that are
notifiable. Although 35 conditions were report-
able in the year of the study, doctors correctly
mentioned an average of only six of them.
@ Health workers are not aware that any person
who is legally competent to diagnose the condi-
tion is required by law to report it.
@ The notification form is too complicated, as too
many details are requested. This discourages
reporting, or results in poor-quality data being
sent in from service level. This in turn compli-
cates analysis of data at higher levels of the
health services.
@ There is lack of feedback on reported cases. The
analysis of data received at every level of report-
ing is not fed back timeously to those who do
the reporting. If and when feedback occurs, it is
often not done ina useful and accessible form.
Without feedback, health workers adopt the
attitude that it makes no difference whether or
not they report or what they report. National
publications of the Department of Health such
as Epidemiological Comments, and provincial
newsletters such as Epidemiology Focus in
KwaZulu-Natal, address this problem to some
extent. Data on isolations and antibiotic resist-
ance of several bacterial organisms are pub-
lished in the South African Medical Journal.
This feedback is provided by the Antibiotic
Study Group of South Africa, which collates the
data from seven academic hospitals through-
out the country.
@ There is lack of training in surveillance at
undergraduate level and continuing medical
education. The medical schools and nursing
colleges need to include the notification
process and the importance of notification for
disease control and health planning in their
undergraduate training.
@ At understaffed institutions, the doctors are too
busy to spendalot of time filling in the notifica-
tion form. In such instances, other hospital per-
sonnel should be used to support the doctors in
their reporting function.
Completeness of reporting is another problem
with routine surveillance, in that returns are sent
incomplete to the regional offices. This is prob-
14 = disease surveillance
A
ably because unqualified staff fill in the forms
without adequate supervision.
Since one of the main uses of surveillance data
is to institute swift disease control efforts, time-
liness of reporting is important. However, admin-
istrative delays often hamper timely and effective
disease control efforts.
Surveillance programmes are very seldom sub-
ject to regular evaluation or validation. Despite
the problem of under-reporting in passive sur-
veillance, it is still possible to obtain meaningful
incidence rates and trends from notification data,
provided that both the level of under-reporting
and the consistency of these levels are estimated.
Such an approach was used to validate hepatitis B
reporting (Abdool Karim SS, Abdool Karim Q
1991; see Example 14.1).
Active surveillance is an effective form of data
collection because completeness and timeliness
can be ensured, but it is not implemented widely
because of the high cost involved. Where speci-
mens are essential for diagnosis in asymptomatic
cases, laboratory cost is an added expense.
Depending on the disease condition under active
surveillance, telephone and transport expenses
could add to the cost. A further limitation of active
surveillance is that the size of the area may be too
small for proper estimation of incidence rates.
For example, for cancer, which has an incidence
of 150/100 000, a large area is needed to get stable
rates.
In sentinel surveillance, the selection of sites is
crucial. If sites are not well chosen, the introduc-
tion of bias will make the results unrepresentative
of the total population. People who choose to
make use of these services and who are included
in the surveillance may be different from those
who use other services. Sentinel surveillance is
also inappropriate for monitoring rare diseases,
such as polio. Since a single case of polio is re-
garded as an epidemic, the consequence of miss-
ing one case is enormous. Thus every health ser-
vice has to be involved in the monitoring in order
to detect every single case of suspected polio.
Conclusion
While the major criticism of passive surveillance
is under-reporting, it is not always critical to
obtain complete counts of most diseases in order
to plan and undertake disease control interven-
tions. When the incidence of a disease is high, the
trends instead of the complete counts of the cases
are adequate to plan and institute disease control
145
d= common approaches in epidemiology
efforts. This is provided that the under-reporting
rates are reasonably consistent and the under-
lying reporting mechanism does not vary unpre-
dictably.
On the other end of the spectrum, diseases tar-
geted for eradication, such as polio, demand sur-
veillance systems that are sensitive enough to
rapidly detect every case of the target disease. For
polio eradication, use of the case definition based
on acute flaccid paralysis (AFP) enables the sur-
veillance system to detect virtually all cases of
paralytic polio. The choice of a case definition can
thus determine the sensitivity of the surveillance
system for the disease in question. Effective
surveillance systems have detected AFP rates of
1/100 000 and 0,45/100 000 children aged under
five years in the Americas and Tunisia respect-
ively. In such instances, zero reporting is very
important when there are no cases.
It should be borne in mind that for vaccine
preventable diseases, surveillance should include
not only disease data, but also vaccination cover-
age and vaccine efficacy. In vector-borne diseases
such as malaria, surveillance of the vector popu-
lations (distribution and species) is also part of
the surveillance system.
While the technology for good surveillance sys-
tems is available, the necessary commitment to
apply these for the benefit of public health is not
always present. Surveillance systems should be
evaluated to assess the accuracy and complete-
ness of reporting, as well as the timeliness of
results and the usefulness of the results to policy-
makers.
EXAMPLE 14.1
Validation of the hepatitis B report-
ing system in South Africa
Since the different types of viral hepatitis infec-
tions are clinically indistinguishable, serology is
essential for diagnostic purposes. Consequently,
clinicians with access to laboratory facilities tend
to use them, and the laboratory data includes a
large proportion of the clinical cases of hepatitis B
being seen in the health care service. The high
146
utilization of the virology laboratory service was
used as a basis of comparison to validate the
hepatitis B notification data.
The level of under-notification was estimated
by comparing the number of notifications for
hepatitis B received by the Department of Health
with the number of positive hepatitis B laboratory
results submitted to the NIV for the period
1985-8. Virologists estimated that approximately
10% of positive laboratory results were repeat
tests, and the number of positive results was
therefore adjusted by this figure. It was found that
hepatitis B was grossly under-reported. Nation-
ally, on average only one case of hepatitis B was
notified for every seven positive hepatitis B labor-
atory results. There was a marked difference in
the regional notification : laboratory result ratios,
ranging from 1:3 in the Cape to 1:17 in the Trans-
vaal.
The consistency of under-notification over
time was fairly good nationally, ranging from 1:7
to 1:9 over the four-year study period. The con-
sistency of under-notification varied greatly
according to region, however. The Cape region
had the highest and most constant level (1:3) in
each year of the study, while the former Transvaal
at the other extreme had very low and erratic
levels ranging between 1:14 and 1:25 over this
period.
The marked differences in the level of notifica-
tion between regions may spuriously create
considerable inter-region differences in incid-
ence rates. It is essential therefore that differences
in the reporting level be taken into consideration
when making regional comparisons of hepatitis B
incidence rates calculated from notification data.
On the other hand, the small differences between
the national reporting ratios for each of the study
years indicate that the analysis of hepatitis B noti-
fications could provide useful information on
trends in the incidence of this disease at a na-
tional level.
Reference:
Abdool Karim, S S, Abdool Karim, Q. ‘Under-reporting in
hepatitis B notifications.’ South African Medical Journal
1991; 79:242-4.
15
Introduction
Health Systems Research (HSR) is research done
on the health system and all its component parts
and activities.
HSR is applied research, which aims to support
the decision-making process at all levels of the
health system by providing relevant information.
The purpose of this research is to improve the
operation of the health system, leading to an
improvement in the impact of health care, which
in turn leads to an improvement in thehealth of
the population.
HSR encourages collaboration between re-
searchers, health care users, communities, health
care providers, managers, and politicians in the
design and conduct of research. Collaborative
research can help different stakeholders to reach
a common understanding of problems, their
causes, and solutions.
Health system goals, evaluation
research, and quality improvement
Until recently, we (the public, politicians, health
care managers, and professionals delivering care)
have simply assumed that the care we provide or
receive is of high quality. This assumes that we
know what is meant by quality, we know how to
assess whether it is present, and we have com-
pleted such assessments. These assumptions are
seldom true. HSR can help us replace assump-
tions with evaluation.
Evaluation means looking back at our work to
see if we have reached our planned goals, and, if
not, examining where the problems lie (Mathews,
Yach, Buch 1989). Evaluation is a systematic way
Health systems
research (HSR)
of learning from experience. We should use the
lessons learned to improve existing activities and
those we are planning. Evaluation should not
stop at a list of problems and their possible
causes, but should include recommendations to
increase, decrease, or change activities.
Evaluation requires a standard for comparison.
This would usually be drawn from the stated goals
of the service under evaluation. But the health
system has grown and developed its traditions over
time, and so explicit goals are seldom stated or writ-
ten down. This is a weakness, because if we do not
specify where we are trying to get to (in other words,
if we do not have an explicit goal), we may never get
there. It is often required of HSR that it starts by
clarifying and stating the goals of the health system
or health care under evaluation.
These goals can be drawn from an understand-
ing of the concept of quality. What is quality in
health care? Quality health care is safe, contri-
butes to good health, meets user expectations,
and is the best use of finite health care resources.
Thus we see that HSR is often evaluation re-
search, aimed at measuring, and helping to im-
prove, the elements which together make up
‘quality health care’. Figure 15.1 outlines the
components of health care that can be evaluated.
Understanding health care and the
health system
The health system is a set of components that
function together to support and improve the
health of the population. The health system con-
sists of a set of cultural beliefs about health, ill-
ness, and health care, as well as the societal and
institutional framework in which these beliefs
147
d= common approaches in epidemiology
Figure 15.1 Tc of health care irate
Inputs ————————_———————_»> Processes
Staff Affordability
Equipment Accessibility
Money Acceptability
Availability
Utilization
Coverage
Equity
Efficiency
and values are turned into health and health care
behaviours. The cultural beliefs about health and
health care form the basis for health seeking and
health care delivery behaviour. The societal
framework includes the family and the commu-
nity, while the institutional framework includes
other sectors, such as the education system,
which impact on health and the health care
system.
The health care system is the collection of
people (clinical and support staff, communities,
families, and patients), things (buildings and
vehicles, drugs and money, timetables, rules and
plans) and events (consultations, procedures,
meetings, and evaluations) that come together (as
health care) to provide assistance for illness, ill-
ness prevention, and health promotion. Although
HSR offers useful insights for research on the
entire health system, in this chapter we empha-
size research on the health care system.
The stages of health care delivery
Health care can be thought of as if it were an
industrial process, which starts with production
plans (policy), builds a factory and develops rules
and procedures for running it, adds raw materials
(inputs), combines them in processes to produce
health care of different kinds (outputs), which
may lead to improved health (outcome).
This production line is permanent, but not un-
changing. A well-managed health care system is
repeatedly re-examined and improved. HSR can
contribute to this repeated cycle of planning, pro-
duction, and evaluation, followed by improved
planning and production.
Policy development is the first stage of health
care delivery. Policy is the vision of a government
or organization, stated as goals and plans of
148
LCs
————_—__————————_> Outcomes
User satisfaction
Complete health
Residual disease
Residual disability
Death
Efficacy
Effectiveness
Cost effectiveness
action to achieve these goals. Once the goals of
the entire health system or a part of it are defined,
policies for achieving these goals must be se-
lected. Policy evaluations assess whether the poli-
cies of stakeholders are consistent with each
other and with health goals, and whether or not
they are being implemented.
A large NGO is funding a national project which
aims to improve the partnership between organi-
zations training health professionals, the com-
munities to be served, and the health services
authorities, by providing support to conduct
more student training in clinics within the com-
munities concerned (Zwarenstein, Lewin 1995).
An evaluation is planned which will assess the
perceptions of the project aim held by each of
these partners. Descriptions of the number of stu-
dents spending time in community clinics will
help to showif the policy is being implemented.
The infrastructure of the health service consists
of the physical and human inputs, and the proc-
edural framework which forms the underlying
foundation of the service. Evaluations of inputs
may assess the distribution and amount of long-
lasting inputs, such as buildings. Another type of
structural evaluation may assess the procedural
framework — such as the quality of the training,
facilities, administrative and technical proce-
dures needed to provide care — against existing
norms, previous measurements, or other com-
parable areas, services, or facilities.
A study was done to evaluate the quality of
health care provision in a sample of public and
private sector primary care sites (Beattie, Rispel,
Broomberg, Price, Cabral 1995). Several indica-
tors of quality of care were measured. These were
assessed using indicators for the condition of the
buildings and grounds, privacy for examination

and changing, adequacy of space, and presence
of patient toilets. These assessments were con-
ducted by an external team of evaluators.
Inputs are the people, material goods, and
financial resources which go into making up the
health care system. They include both the long-
lasting capital inputs (fixed facilities such as clinic
or hospital buildings, durable capital equipment
such as ambulances and X-ray machines) and the
shorter duration inputs paid for with running
costs (including equipment and consumables,
such as scalpels, intravenous catheters, ban-
dages, drugs, and stationery, and personnel, such
as nurses, doctors, administrators, and cleaners).
Input evaluations compare the inputs provided
against existing norms or standards, previous
measurements, or comparable areas and ser-
vices. They may also be analysed to see whether
resources are being distributed fairly (equity).
Where comparison between areas or over time is
the main purpose, an indicator might be selected
from among all the inputs to illustrate the com-
parison. One example of such an indicator is ‘hos-
pital beds’. Inputs are measured to get an idea of
the cost of an element of health care. The various
inputs are often summarized by their total money
value.
A major problem in national health planning in
South Africa is the absence of expenditure data.
The National Health Expenditure review (Health
Systems Trust 1995) has added up how much
money is being spent on what kinds of health
care. This understanding of total financial input
into the health sector is a great help in national
planning. Data on physical resources, such as
staff and beds, is also described by province and
by magisterial district. Thus, for the first time,
resources can be allocated fairly according to geo-
graphical area. This helps in planning the redistri-
bution of resources to ensure increasing equity.
Processes are the complex interactions which
occur in the delivery of health care, and which
take place when infrastructure and other inputs
are applied to communities or individual patients
with health problems. Process evaluations assess
the way in which care is provided, and whether it
meets any institutional guidelines which may
exist.
A study of the quality of diabetes care in public
sector primary care clinics was done in the
Western Cape (Levitt, Bradshaw, Zwarenstein,
Bawa, Katzenellenbogen, Dopfmer [1996]). This
study assessed a representative sample of patient
records to see what proportion of patients at-
15 health systems research
tended regularly, and whether the care that they
received (for example, regular eye testing to look
for early, treatable complications of the disease)
met internationally accepted guidelines.
Outputs are the items or units of care which are
produced in the interaction between health care
processes and inputs. Output evaluations fre-
quently tell us how much care is being produced.
We may want to know if these outputs are being
produced with a minimum of waste, which
requires a comparison of inputs and outputs.
Routine output evaluation of immunization
programmes can be based on the number of
immunizations conducted ata site by bringing in
a denominator, the number of children of immu-
nizable age. This will measure coverage as a pro-
portion of eligible children, and is reported
annually in most cities’ Medical Officer of Health
reports.
Outcomes are health states of people, groups,
or communities that result from interaction with
the health system. Outcome evaluations check
that the intervention was effective, that the
desired health goal was achieved, and that the
patient, client, or community obtained preven-
tion, amelioration, cure, or rehabilitation of a
particular problem.
Continuing the immunization example above,
the outcome of improved immunization coverage
is decreased incidence of the diseases against
which immunization was conducted. A study was
done of the trends in admissions to a major infec-
tious diseases hospital, to assess the impact of a
measles immunization programme on the
disease (Abdool Karim S S, Abdool Karim Q,
Chamane 1991). It showed an initial fall in admis-
sions, followed by a gradual rise to previous levels
(see Chapter 14: Disease surveillance).
Health care goals: the elements of quality
The idea of quality is more complicated in health
care than in most industries, because so many
elements are included in the notion of quality
(Table 15.1). Each element of quality can offer a
starting point from which to develop a standard
against which a health care activity can be evalu-
ated.
Although quality is sometimes used as a
- synonym
ynonym for single
g elements, it is also an overall
term for all of these elements. Quality care offers
all of the elements described.
The table excludes a number of elements, such
as cost. Cost, the amount of resources used to
offer a service measured in money terms, is dealt
149
d= common approaches in epidemiology

gee) (eweRoe Rem Um CU ears

ELEMENT DESCRIPTION

Accessibility Geographical, financial, social, physical access to health care services

Effectiveness How well does a process or intervention work?

Comprehensiveness The ability of the service to meet the wide range of needs of individuals and
communities

Appropriateness The level and range of care given the needs of the patient and community and
the resources available

Acceptability The match between patient and community expectations and the care provided

Coverage The proportion of the target population successfully in contact with the health
service

Adherence How well treatment regimens are followed — determined by clinical, patient,
and community factors

Continuity The potential for continued interaction between the health service and pa-
tients or communities, such as through defaulter tracing programmes, out-
reach, and a coherent record-keeping system

Relations The quality of the social interaction between health workers and patients

Efficiency _ The relationship between input and output: maximizing the outputs for a given
Input

Equity The availability of equal care for people with equal needs

with in Chapter 30: Health economics.
Availability, affordability, accessibility, and
acceptability are terms for different aspects of the
‘fit’ between the health care supplied and the
potential users’ needs and wants. Availability
describes the degree to which supply of services
and resources meets the theoretical need.
Affordability is an economic concept: to what
extent do the prices of services match the clients’
income and willingness to pay? Accessibility
takes into account transport, travel time, and
distance. Acceptability describes users’ percep-
tions of the appropriateness of services, and
emphasizes communication and mutual respect
between staff and patients, continuity of care,
and convenience.
Equity studies try to find out if a health service
is fairly shared out in proportion to need. These
studies are usually based on routine information
150
about the distribution of input, process, or output
per capita, in different areas, or by different social
groups. We may compare demand with need, or
utilization with need as a way to identify commu-
nities with excess or under-utilization. Commu-
nities should have equal use for equal need. See
Chapter 30 for further discussion of equity.
Efficacy, effectiveness, and efficiency refer to
different aspects of the concept ‘how well does
this care work?’
Efficacy studies ask the question: Does the
health care intervention (usually a drug) work
when given under ideal circumstances (a care-
fully carried out randomized double blind con-
trolled trial with complying patients)?
Effectiveness describes the ability of the inter-
vention to work in the messy real world, with
ordinary patients under normal health service
conditions.

Efficiency is an economic term with two broad
meanings.
Technical efficiency involves minimization of
resources (such as staff and time) used in under-
taking a particular task. This is often evaluated
using operations research methods. Allocative
efficiency asks whether a particular health service
approach is the best way to use resources to max-
imum effect. Here the term is used for studies
which ask either ‘Is this the cheapest way to
achieve these results?’ or, ‘Is this health pro-
gramme worth implementing in comparison with
other uses of these resources?’ These studies
usually require help from an economist (see
Chapter 30: Health economics).
An integrated view of HSR: linking
research design with sectors, levels,
units, stages and elements of care
HSR can address many different questions. In
order to understand the possibilities, it may be
useful to see health care as a complicated system
in which different sectors operate (public and pri-
vate), each with several levels (first contact, refer-
ral). Health care delivery consists of several stages
(policy, process, outcome), is organized into dif-
ferent units (clinic, carer, consultation, client)
and can be evaluated according to performance
in any of several elements (equity, effectiveness,
accessibility).
Any HSR study can be categorized and placed
by selecting one description from each column in
Table 15.2. It shows some examples of descrip-
tions, but others might be added. Any study can
be fully described by stating the sector and level
of the health system to which it refers, the unit,
stage and particular element of health care deliv-
ery to be studied, and the study design (how the
Table 15.2 Ways i looking at a
Public Ward Carer
Private (for profit) District Clinic
Private (not for profit) Region Hospital
Province Contact
National Script
International Patient
Individual
Community
15 health systems research
study is to be done). This will be illustrated with
an example of a health care activity, and the HSR
which could be carried out to evaluate and plan
improvements to it.
One of the most cost effective interventions in
all of health care is immunization against child-
hood illnesses, especially in impoverished com-
munities, where immunity is poor and severe
complications of otherwise mild diseases are
common. Several different HSR studies could be
useful in improving immunization programmes.
We will illustrate a few of the most important
questions that managers may wish to answer
about immunization, categorizing them accord-
ing to the structure outlined in Table 15.2.
Often, immunization programmes have been
operating for some time, but their success is un-
known. A study looking at the output (stage) of
the immunization programme would be useful.
In this study, coverage (element) would be appro-
priate to assess success. One approach would be
to do a descriptive, random community sample
survey (study design) in one district (level) of chil-
dren (unit) to see if they were immunized appro-
priately for age. This study thus determines out-
put per population.
We immunize children because we want to
protect them against a particular disease, say
measles. The desired outcome (stage), then, is a
fall in incidence of the disease, measles, and a
reduction in deaths caused by it. Another
approach would be to look at time trends (study
design similar to a before and after study, but over
a longer period) in reported measles cases, with
the assumption that a fall is due to the immuniza-
tion programme. This is a study of effectiveness
(element); the unit of study (children) remains
the same, while the level (district) could stay the
same or change. If the level was raised (provincial
care systems
eae
Input Effectiveness
study deste
Rapid appraisal
Process Equity Descriptive
Output Cost Analytic
| Outcome Efficiency Before-after
Coverage Cross-sectional
Satisfaction Case-control
Need Cohort
Trial
151
d= common approaches in epidemiology
or national), the main purpose of the study might
be to assess equity (element) between areas.
What would a manager do if coverage was
found to be good (the output stage of the pro-
gramme is successful) but measles cases or
deaths were still being recorded (the programme
is failing to achieve the desired outcome)? This
implies that either the inputs or the processes of
immunization (stages) are deficient in some way,
and studies of these should be done urgently.
Since protection may fail if the vaccine is not kept
cold (a subsidiary goal of the measles immuniza-
tion programme), evaluation of the process of
vaccine storage needs to be conducted.
Other studies could also be useful: immuniza-
tion has to be given in certain ways, which could
be evaluated, as could the success of the training
received by nurses in administering the immu-
nization. (Both of these are process evaluations of
quality, the first of the unit contact, the second of
the carer.) Do patients believe in and want
measles immunization (the element of accept-
ability)?
While the child is being immunized against
measles, are its other health problems attended to
(the element of comprehensiveness)? Do staff
relate well to patients (the element of relations)?
Characteristics of HSR
HSR is different from most epidemiological re-
search in its approach and the way it uses differ-
ent methods. The characteristics of HSR are listed
below:
¢@ HSR focuses on finding implementable solu-
tions to priority problems.
@ HSR findings help to improve services which
lead to better health.
HSR provides usable timely information to
decision-makers at all levels.
HSR is participatory, involving concerned
parties in all stages of research.
@ HSR demystifies research and decentralizes it
from high-level institutions.
@ HSR can be done by people in services as part of
their daily activities.
¢@ HSR emphasizes simple, fast, low-cost study
designs.
@ HSR is multi-disciplinary, and uses multiple
methods.
@ HSR is iterative: it follows the chain of action/
evaluate/plan/new action/ re-evaluate/re-plan.
Approach
HSR is problem-based, usually responding to a
Wa2
problem identified by a health service purchaser
(in some countries, health ministries have
created authorities which ‘buy’ health services
from providers on behalf of the government),
provider, or user. The problem is often tackled
in such a way that more issues are taken into
account than appeared in the original problem
statement. In other words, a comprehensive
understanding of health and health care in a
social, political, and economic context is applied
to research.
Because it is problem-based, it is also problem-
solving — often providing cure, but sometimes
prevention. If patients are dissatisfied with care,
service providers need to know quickly what the
main problems are, and how these can be rem-
edied. If the research is only made ayailable in
two or three years time (the usual gap between
beginning and publishing research), patients will
have moved on or died. Often such studies must
be quick and their questions must be very
focused. Much of the skill in HSR lies in making
trade-offs between speed of answer on the one
hand, and depth of information on the other.
Solutions also have to be relevant to local needs
and circumstances. This requires more local
knowledge than any outsider can have, and so,
given that HSR skills are scarce, projects are often
conducted as collaborative research, where a
skilled consultant collaborates with an insider
who needs the results of the research to improve
his or her health care provision. The research
users may then conduct the study with help from
a consultant. The ability to share research skills is
an absolute requirement, and itself an important
goal of HSR.
Methodology
HSR problems are usually complex, and may
need a combination of several methods from
multiple disciplines. An HSR project will often
begin with a situation analysis. This may help to
formulate the problem to be solved. From this, a
number of questions might be generated. These
questions could be addressed by qualitative or
quantitative methods.
Qualitative approaches drawn from the social
sciences include depth and focus group inter-
views and text analysis. Thus an HSR study might
include depth interviews to understand patient or
staff perceptions of a service or a care problem, or
focus group interviews to allow different percep-
tions of a problem to be discussed.
HSR studies create a number of specific diffi-

culties when using qualitative methods. HSR is
oriented towards problem definition and solu-
tion, and towards participatory research
approaches. All options and viewpoints should
be heard. Sometimes vested interests may bias
the inquiry, especially where one collaborating
partner attempts to drive the study according to
those vested interests. This is less difficult if the
problem is being handled in a non-adversarial
way, in other words, if all parties have the same
interest in solving the problem. This is rarely the
case, and HSR researchers need to be aware of
potential conflicts and the ethical implications
of conducting research whose recommenda-
tions may favour one or another party in a
conflict.
Another issue to take into account is the lack of
trust that staff and patients might feel towards
each other and management. If a study is per-
ceived to be launched by management, without
participation from staff, some informants might
not be open.
In both of these situations, an external consult-
ant with health systems experience can play a
valuable role in resolving conflict and bridging
barriers.
Quantitative approaches derived from epide-
miology and biostatistics might include descrip-
tive, analytic, and intervention studies, as well as
analyses of routinely collected data from health or
management information systems. The methods
used are dictated by the problem and the context.
HSR raises specific difficulties here too. The
main difficulty derives from the complex nature
of the data collected in some HSR studies. While
an immunization prevalence survey produces a
simple data set, a study whose goal is to improve
the quality of care in an ambulatory clinic may
consist of many more variables, each of which is
itself complex to collect and analyse.
The underlying phenomena which we are
trying to measure (such as equity, access, and the
other elements in Table 15.1) are complex, and af-
fected by many factors. These phenomena are not
the same everywhere, and so data collection tools
and indicators are not standardized, and may
need to be designed according to the local need
for, and availability of, information.
These difficulties can be alleviated by keeping
the main problem in mind, generating clear
hypotheses before designing the data collection
methods, and collecting only data whose use in
analysis is clear from the start. Good pilot studies
help.
15 health systems research
Table 15.3 Examples of an
aaa
~ @ What proportion of the population X has con- —
dition Y?
¢ Given condition Y, what proportion of a
group seeks care? _
¢ What type of care is sought? :
@ What proportion of those who seek care re- .
ceive it?
,@ At what cost to Hoceler, the health care
system, and the society?
¢ Is the proportion ofpeople who obtain are :
for this condition the same in all areas
¢ What proportion of those who obtain careis
satisfied with the care obtained?
@ is treatment or care of type A better|
(more effective) than that of type B?
Is treatment of type A cheaper than.
given similar effectivenéss? =
-@ What proportion of those with condition | i
correctly identified using test Z?
¢ How well do staff and patients -
communicate? _ es
¢ Why is staff morale low?
Tips for conducting health systems
research
Carl Taylor, an experienced health care evaluator,
has said that the most important single issue in
HSR is to learn to ask the right research question
(Taylor 1984). Some examples of typical HSR
questions are shown in Table 15.3.
The following section might help to guide you
in developing a successful HSR project.
The aim of HSR is to understand and help solve
particular priority problems in specific situations,
and so these questions should be applied in rela-
tion to areal problem in a specific situation.
1 Are you patient enough to start an HSR
process?
Promoting improvements in the health system is
seldom a single one-off event — it is an ongoing,
long-term process which should be flexible
enough to respond to changing needs in the
population. HSR is like music: timing is import-
ant.
Sometimes we may raise questions before
others are ready for them; if no response is ob-
153
d= = common approaches in epidemiology
ee a a i ST
tained, that issue may need to be put on hold for
some time, until it rises higher on the agenda. The
exact evaluation question might also change over
time, to match the changing needs for inform-
ation. Health care programmes may also change,
both in personnel and methods of operation.
Evaluations should thus also be repeated and
ideally integrated into the process of health care
delivery, to be conducted regularly by those who
deliver care.
2 Do you understand the context?
Before an evaluation is possible, the environment
should also be understood: the background, the
surroundings, or the context in which the prob-
lem is defined. The objective and subjective
health needs of the community served by the
health system are an important part of this con-
text. The community and the society, its politics,
its culture, its economy, the available resources,
its social development, and the degree of partici-
pation in decisions are all important aspects of
the environment which should be understood
before embarking on an HSR study. The health
system itself is part of this environment. The
researcher needs to understand where the prob-
lem and service under study fits into the picture
of the structure and functioning of the whole
health system: its size, its place in the organiza-
tion, the organizational culture, the cost of care,
the skill and experience of staff, their relations
with each other, with managers, politicians,
users, the community, and other services. The
‘target’ population and the planned activities and
expected benefits of the health care programme
under study should be clear. These details are
usually found by studying the goals and object-
ives of the programme closely. If these are not
understood, you should probably undertake a
situation analysis before starting a specific HSR
study.
3 Is your research question specific?
Evaluation questions need to be specific. Is your
question understood by all participants in the
same way?
Does the question specify a sector, level, stage
of care, unit of study, and issue which are to be
investigated? Vague questions result in vague
projects which may never finish. Even if the pro-
ject does reach an end point, the answers may be
vague, open to re-interpretation, not phrased so
154
as to influence decisions, or not implementable.
4 Is your chosen research problem important?
Research skills and resources are scarce, and
should be focused on important problems. A
problem is important if many people are affected,
if the diseases involved are serious, with major
health consequences, or if many people use the
health care services that are identified for evalu-
ation. If the costs of care, or lack of it, are high and
if policies are about to change, the issue becomes
more important. Sometimes a question is of aca-
demic interest only. If, for example, no alternative
policy option exists, there is little point evaluating
policy options. Also, are you sure that research is
necessary? Are you sure that adequate answers
are not already available?
5 Is your research politically feasible?
The questions for an HSR study should be
discussed with and reflect the priorities of man-
agers and providers of care, as well as the con-
cerns of the community in which the service
exists. If any stakeholder groups are hostile to the
research, or feel it is irrelevant, success is unlikely.
Either the research itself will fail or the recom-
mendations will be out of touch with key stake-
holders’ needs, and therefore not implemented.
But, on the other hand, there must be enough un-
certainty among all stakeholders to allow space
for research to influence policy. If minds are
made up already, this may not happen.
6 Can your research be done in the available
time?
Policy-makers have shorter deadlines than
researchers; often a decision has to be taken fast
for budgetary or public pressure reasons. In this
situation, an HSR researcher needs to assess if the
research can be completed in time to influence
the decision. If not, a simpler, quicker, less
acceptable research design may be needed, or a
longer-term question needs to be formulated.
7 Will your answer be heard?
Sometimes the perceived quality of an answer is
affected by whose answer it is. Will the research
team have the credibility to produce an accept-
able answer? If not, you should consider collab-
orating with people whose credibility is greater.

Conclusion
HSR is an important development in the history
of research. It offers an approach to applied re-
search in health care which is more engaged with
and linked to health service needs. It offers a help-
ing hand to decision-makers in the health system,
caught between rising costs and higher expecta-
tions, between community wants and health ser-
vice plans, between increasing health needs, and
shortages of personnel and resources.
To those who do HSR and those who use it (in-
creasingly the same people, as skills spread more
widely), HSR offers tools to make better use of
resources to achieve better health (Zwarenstein
1990).
EXAMPLE 15.1
Rural child survival programme
evaluations: Hewu, Eastern Cape
A series of studies formed part of a four-year-long
collaborative research project between Medical
Research Council researchers and the staff of the
community-based health service in the Hewu dis-
trict of the Eastern Cape. Hewu is a poor rural
area, with substantial resettlement. Its health
problems are mostly childhood disease and
mortality. The health services focus on these,
relying mainly on rural clinics staffed by nurses,
with a village health worker scheme to improve
outreach to communities.
The first collaboration evaluated was a pro-
posed new education programme for village
health workers (VHWs). The research question
was: does a training programme for VHWs in oral
rehydration methods result in an improved oral
rehydration solution (ORS) programme in the
community served by the VHWs in comparison to
the community whose VHWs did not receive the
programme? This study was a community trial of
the effectiveness of a training programme in a real
community setting. The evaluation looked at pro-
cess measures (mothers’ knowledge) rather than
output (successfully treated diarrhoea cases) or
outcome (reduced diarrhoeal complications and
death).
A survey of ‘experimental’ villages (where
VHWs received the training) and control villages
(no training) was conducted six weeks after the
training programme. Results showed that more
mothers in the experimental villages had been
visited, suggesting that the training programme
15 health systems research
increased VHW activity in comparison with that
in the control villages, and that more mothers in
‘experimental’ villages had appropriate ORS and
diarrhoea knowledge and practices. This com-
munity trial gave firm evidence of benefit
assessed by process measures, suggesting that
dehydration from diarrhoea would be reduced if
the programme was implemented widely. The
ORS training programme was subsequently
widely introduced and was extended to deal with
other interventions for childhood diseases.
A further aspect of the programme was the sys-
tématic training of VHWs in using a new record
card, with monthly follow-up visits and recording
of information for the whole group of interven-
tions, rather than the irregular visits that had
occurred previously without documentation. A
second survey undertook to evaluate this
strengthened programme. One particular village,
Thornhill, was selected as the site for the imple-
mentation of the VHW cards and follow-up sys-
tem. The researchers selected an indicator by
which each of the interventions would be meas-
ured. Some of these indicators measured afinal
health outcome (for example, weight for age),
while some measured intermediary outputs such
as coverage of children in the community by the
VHWs (what proportion of households had been
visited within the last month) and ORS knowledge
of mothers, and others measured.
A survey of the village children was done to es-
timate the coverage and effectiveness of the long-
standing approach on each of the indicators. The
new approach began immediately after the
survey, and was evaluated by two follow-up sur-
veys, a year and two years later. In other words, it
was a before/after design. The new programme,
in comparison with the previous one, resulted in
better immunization rates, longer duration of
breast-feeding, better coverage with village
health workers visiting more regularly, but basic-
ally the same poor nutritional status (outcome
measure). This shows that health care has com-
plex relationships to health, especially in the
presence of poverty. Even though many elements
of the programme were working well, the pro-
gramme did not make a major impact on one of
the key indicators of child health, namely growth.
References:
Kuhn L, Zwarenstein M, Thomas GC, Yach D, Conradie H H,
Hoogendoorn L, Katzenellenbogen J. ‘Village health-
workers and GOBI-FFF: An evaluation ofa rural pro-
gramme.’ South African Medical Journal 1990; 77:471-5.
155
d common approaches in epidemiology
ee
ee
Kuhn L, Zwarenstein M. ‘Evaluation ofa Village Health
Worker Programme: The Use of Village Health Worker
Retained records.’ International Journal of Epidemiology
1990; 19(3):11-18.
Yach D, Hoogendoorn L, Von Schirnding YE R. ‘Village
health workers are able to teach mothers how to safely pre-
pare sugar/salt solutions.’ Paediatric and Perinatal Epidemi-
ology 1987; 1:153-61.
Yach D, Katzenellenbogen J, Conradie H. ‘Infant Mortality
Rate Study: Hewu District.’ South African Journal of Science
1987; 83:417-21.
EXAMPLE 15.2
Evaluating health care to help imple-
ment change: the Khayelitsha studies
Sometimes an HSR collaboration must first find
the questions that need to be answered through
an overview or situation analysis, and then look
for appropriate methods of answering them. This
example describes how research contributed to
the process of trying to improve the quality of care
in a community health centre (CHC) in a large
peri-urban settlement in Cape Town.
The CHC treated about 1 000 patients oe day,
and had more than 150 staff, employed by three
different health authorities. The local authority
was responsible for running specialized clinics for
sexually transmitted diseases (STDs), family plan-
ning (FP), tuberculosis, and preventive and pro-
motive care for well children under six. They felt
that fragmentation of health authorities had
caused gaps and overlaps in services provided
within one CHC, and wanted to co-ordinate their
services with those provided by the other author-
ities, especially the provision of curative care for
ill children. Community organizations had also
criticized the quality of care and demanded im-
provements.
However, nobody had studied what the various
problems were, how severe they were, what was
causing them, or how they could be solved. The
local authority thus asked a researcher to conduct
a situation analysis, or rapid appraisal of the CHC,
working part-time over two months. The situ-
ation analysis tried to identify overlaps and gaps
in the services provided by different authorities,
and to collect problems, their main causes and
solutions as perceived by staff, management,
patients, and local organizations. Qualitative and
quantitative methods were used.
This study was a multi-method overview of a
given health setting, to identify priority problems,
156
and establish broad priorities for improvements.
It relied heavily on qualitative methodology to
understand service providers’ perceptions, and
simple routine data sources to estimate the load
and available capacity of the staff to take on more
work.
The researcher interviewed experienced staff,
held group discussions with patients, staff, NGO
staff, and representatives of political organiza-
tions to gain insights into the running of the CHC.
He examined and re-analysed some routine data,
reviewed previous research on similar health ser-
vices in Khayelitsha and elsewhere, and observed
the functioning of CHC services by walking
around at different times of the day and week.
The CHC was clearly busy, but it had under-
utilized resources available, especially as staff
members were not always busy during after-
noons. There were gaps in services; for example,
sick children were not always treated if they
arrived for immunization, and children who
arrived ill and also needed immunization often
received care, but not immunization. There were
also overlaps; for example, patients with STDs
were being treated by all three authorities, in
three different places, at different times, by differ-
ent staff, using different methods. The study also
collected many ideas for improving the services
using existing resources.
The situation analysis was presented, circu-
lated, and widely discussed. It recommended that
the managers of separate authorities working in
the CHC should initially focus on combining cur-
ative and preventive services for children under
six years old, to eliminate overlaps and gaps.
While the integration of preventive and
curative services was being planned, managers
focused on the problem of long periods of waiting
for care, which had been identified in the situa-
tion analysis, having attracted frequent patient
complaints.
Waiting times
The researcher designed a study in collaboration
with management to measure how long patients
spent at the CHC curative and preventive clinics.
The study also aimed to find out when (times of
the day, and days of the week) waiting times were
longest, and whether the flow of patients and
work processes could be improved. One specific
suggestion had been that patients receive their
drugs during the consultation, without having to
wait at the pharmacy. The study needed to assess
whether this would save time. The idea was that

after a first study, improvements would be made
to reduce waiting times, and then the study could
be repeated.
The study hired a fieldworker who stood at the
only gate to the CHC for a week, noting patients’
entry and exit times. Each patient was given a slip
of paper with the time of entry, which was taken
back at time of exit. Information on which cur-
ative or preventive clinics were visited were also
entered by staff. Also, on three days, at different
times each day, a fieldworker recorded the times
at which patients arrived at the pharmacy, and
the times at which they left with their drugs. The
researcher developed a flow diagram of how
patients moved though the clinic, noting every
point at which patients were served, or waited to
be served. This survey was repeated in exactly the
same way (excluding the pharmacy study) a year
later.
The study showed that waiting times were very
long (an average of 4,1 hours in the curative clinic
and 2,6 hours in the preventive clinic). Waiting
times varied a lot in the preventive clinic because
immunization was only provided during a few
15 health systems research
hours of the week. Most patients arrived early,
causing crowding in the mornings, and an empty
CHC in the afternoons. Patients waited only 15
minutes at the pharmacy, which did not justify
changing the way drugs were issued. The patient-
flow mapping showed a number of stops where
patients were waiting unnecessarily (for example,
they could be weighed while waiting for a health
education session) or that could be cut out. The
follow-up survey, after the preventive clinic had
been streamlined, but the curative clinic had not
changed, showed that average waiting times in
the curative clinic increased to 5,1 hours, but
dropped to 1,5 hours in the preventive clinic.
The study thus confirmed that waiting times
were a problem, and that reorganizing the pre-
ventive clinic reduced the problem, but that
changing the way of issuing drugs would not solve
the problem.
References: _
Bachmann M. Site B Health Centre Khayelitsha: Situation
Analysis and Recommendations. Community Health
Department, UCT, February 1993.
157
16
Introduction
In 1981, the term ‘rapid epidemiological assess-
ment’ was coined by the United States National
Academy of Science’s Advisory Committee on
Health for Medical Research and Development.
Rapid epidemiological assessment (REA) was
described as a collection of methods which pro-
vide health information more rapidly and simply
and at a lower cost than standard methods of data
collection, yet also yield reliable results for use
primarily at the local level (that is, quick but not
dirty!) For example, in many developing coun-
tries, the use of methodology such as random
sample surveys is not feasible and too costly, and
other innovative REA methods have thus been
developed.
The uses of REA
REA methods are strongly goal-orientated to
health service and community needs, as opposed
to the use of more complex methods that aim to
answer more theoretical questions. The users of
REA usually have in mind the implementation of
their findings.
REA can be used under routine conditions to
evaluate health service functioning where time
constraints on staff and financial constraints on
resources are a Critical factor. For example, the
evaluation of vaccination coverage in the com-
munity by means of the EPI methodology or lot
quality assurance sampling (see Chapter 22:
Immunization coverage), and the evaluation of
missed opportunity for vaccination in the clinical
setting, provide rapid and reliable results and
require minimal technology and resources.
REA can also be effectively and efficiently used
158
Rapid
epidemiological
assessment
during emergencies or in times of crisis. After
natural disasters such as droughts, earthquakes,
or floods, REA can be used to find the highest risk
populations to which food supplementation pro-
grammes will be targeted.
At present, REA largely focuses on two aspects
of epidemiology. The first is sampling methods
which reduce the time and resources required to
collect and analyse data from individuals. The
second aspect includes methods for the collec-
tion, organization, analysis, and presentation of
data at the community level.
Broad types of REA
Table 16.1 outlines the broad types of REA
methods used. These are discussed in more detail
below.
Small area surveys and sampling methods
Epidemiological sampling techniques generally
aim to obtain representative samples of fairly
large areas. This usually involves many resources,
and results are often not fed back to the local level
in time to influence the actions or decisions taken.
REA samples should be relevant to a particular
service. This could be the area served by an indi-
vidual community health worker, the area for
which a clinic is responsible, or an entire local
authority. Information is required at the local
level to evaluate whether the services are meeting
preset targets.
Expanded Programme on Immunization (EPI)
The WHO Expanded Programme on Immuniza-
tion (EPI) developed a rapid method for assessing
vaccination coverage using cluster sampling that
 159
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d common approaches in epidemiology
is well suited to settings in which a sampling
frame is not readily available (Henderson, Sunda-
resan 1982). In the 30 x 7 cluster sampling tech-
nique, 30 clusters and a starting point in each
cluster are chosen randomly, while subsequent
houses are chosen according to fixed easy-to-
follow rules until seven children of the appro-
priate age are found.
The use of this simple approach can be general-
ized to many other health service-related prob-
lems. However the effects of clustering (and the
associated standard error) must be taken into
account during the analysis (Bennett, Woods,
Liyanage, Smith 1991; Coetzee, Ferrinho, Reinach
1993).
Lot Quality Assurance Sampling (LQAS)
Lot Quality Assurance Sampling (LQAS) has its
origin in industrial quality control where a certain
number of items (for example, tins) in a batch or
lot is tested. On the basis of the number of defect-
ive items, the whole batch is judged as being
defective or acceptable. Since testing is costly,
one would like to test as few items as possible.
The researcher has to take into account two pos-
sible risks: the risk of classifying a lot with less
than a specified threshold of defective items as
being defective (‘provider risk’); and the risk of
classifying a lot with more defective items than a
certain threshold as acceptable (‘consumer risk’).
The technique is increasingly being used in the
health care setting for health programme evalu-
ation and continual monitoring (Lemeshow,
Taber 1991). When applied to health services
management, an area under a particular manager
could be divided into subunits which are called
lots. An ideal lot is the smallest unit that could
provide meaningful information when evaluating
a programme. Each ‘lot’ (which could be the geo-
graphical terrain of a community health nurse) is
sampled and some characteristic of interest is
measured, for example, the use of contraception
by women 12 to 49 years of age. If the lot is
rejected, some management initiative is insti-
tuted in that sub-area. This means that resources
do not have to be expended in sub-areas that are
actually doing well and: can rather be applied
where most needed.
Recently the technique has been adapted to
assess immunization coverage, and the quality of
care and adequacy of health services provided by
local primary health care units (Lanata, Black
1991). Coverage is judged adequate or inadequate
by comparing it with a series of predetermined
160
criteria. Both adaptations required very small
sample sizes and have been useful in identifying
areas urgently needing attention.
Although LQAS requires relatively small sample
sizes, the sampling technique is more compli-
cated than the EPI method. A shortcoming of the
method compared to the EPI approach is that it
requires a sampling frame from which lots are
randomly chosen. In addition, the method does
not provide an estimate of the variable of interest
for the lot sampled. For example, it will not pro-
vide an immunization rate or contraceptive utili-
zation rate. This is because the samples are too
small to provide acceptable confidence limits,
and can only classify a lot as acceptable or not
acceptable.
Thus LQAS has limited use in estimating overall
coverage rates. EPI methods are preferable if the
major interest is a community-wide coverage
figure.
Rapid ethnographic assessment
Rapid ethnographic assessment can be used to
obtain important in-depth anthropological data
about cultural and other factors that influence
health-seeking behaviour, without requiring ex-
pensive large-scale studies.
By the use of focus groups, health care provider
interviews and natural group interviews (groups
assembled not for the purpose of the study but
who are formed ‘naturally’, such as roadside food
sellers, mothers waiting at a clinic), important
information is obtained. They can provide in-
sights into motivation, attitudes, feelings, and
behaviour related to the use of health facilities.
Simple self-administered questionnaires can also
be distributed through an existing administrative
system. Rapid ethnographic assessment has been
used in this way to identify maternal factors that
influence the use of preventive health services
and treatment compliance.
Often such qualitative assessments are the best
way of forming the basis for more substantial
quantitative studies. Such assessments are crit-
ical prior to designing interventions.
Rapid environmental health assessment
Small area surveys are also useful in rapid en-
vironmental health assessment. They were ori-
ginally developed for assessing environmental
health factor needs, for example, in the peri-
urban areas of Zaire (Bertrand, Mock, Franklin
1988). The aim was to determine environmental
indicators which could be simply, cheaply, and

quickly monitored as measures of community
health. Three classes of indicators were consid-
ered:
@ those associated with the individual
@ those associated with the dwelling
@ those related to the broader social and physical
environment.
Socio-economic status is defined according to
local circumstances. For example, in Zaire, a
quality of life scale was developed using items in-
cluding the presence of electricity, type of water
supply, and type of food preparation. The assess-
ments are useful for defining the relationship
between child health status and physical/social
environmental factors, and have their main use in
peri-urban areas where there are informal settle-
ments.
Surveillance methods
Surveillance refers to the need for ‘continual
watchfulness’ of the distribution and trends of
selected health outcomes with a view to acting
when certain boundaries are passed. Surveillance
methods are needed to continually monitor
change. This is particularly important during a
period of rapid socio-economic growth, urban-
ization, and political change, when the impact.of
several variables, from a change in the bread price
to an increase in the level of political violence,
could have major impacts on health. Most sys-
tems collect too much data, however, (often with
loss of quality and accuracy) and analysis or
action is not timely, or is based on too small a pro-
portion of data collected. In addition, the best
surveillance is usually found where the risk is
least! (See also Chapter 14.)
Sentinel surveillance
Because of the lack of resources and the burden of
routine surveillance at all health facilities, a sam-
ple of facilities or sentinel surveillance sites can
be identified in order to measure the health status
of the population without studying the entire
population.
An example of this is the influenza early warn-
ing system used by the National Institute of Virel-
ogy in South Africa. Absenteeism surveillance is
carried out in a number of schools prior to deter-
mining the activity of the influenza virus on an
annual basis. This surveillance system enables
the authorities to determine the current virus
type so that an appropriate vaccine can be devel-
oped and deployed.
16 rapid epidemiological assessment
The use of sentinel surveillance could be ex-
panded to include a list of tracer conditions (that
is, selected diseases of importance) reflecting a
range of changes that need to be monitored and
demand an immediate public health response.
Sentinel health event surveillance has been used
for infectious diseases (for example, poliomyelitis
and acute flaccid paralysis) as well as in occupa-
tional health (for example, a report of malignancy
of the lung in a chemical worker should trigger an
evaluation for possible work site carcinogens).
Preceding birth technique
Mortality data are not strictly classified as surveil-
lance, but do provide important information for
health surveillance. Although infant and child-
hood mortality are sensitive indicators of social
welfare and the relative health of a population,
mortality surveillance is a problem in most devel-
oping countries. This is because neither the
numerators (the deaths by-age) nor the denom-
inator (the population at risk) for conventional
death rates are accurate or even available.
Besides the use of sentinel surveillance to
decrease the problem of inaccurate reporting, an
alternative method of assessing childhood mor-
tality rates has been developed by the demo-
graphers Brass and McCrae. It is called the ‘pre-
ceding birth technique’ and has been tried in
many developing countries (Hill, David 1988). All
it requires is a question to mothers at delivery
about whether or not the child preceding the cur-
rent delivery is still alive.
This provides a useful simple method, requir-
ing limited resources, of monitoring the child-
hood mortality of an area at delivery facilities in
that area. If the delivery rate at health facilities is
above 70%, the method has been shown to accu-
rately reflect the true childhood mortality rate of
the community.
Verbal autopsies
To overcome the problem of the high proportion
of ill-defined deaths in developing countries,
retrospective maternal interviews (verbal autop-
sies) have been developed in a standardized way
to assist in determining cause of death. Algo-
rithms (a’series of questions which allow a dia-
- gnosis to be made easily) for commonly occurring
childhood conditions have been tested in a
number of settings (Kalter 1990). In general,
verbal autopsies were shown to be able to diag-
nose major illnesses contributing to death in chil-
dren with acceptable sensitivity and specificity.
161
d common approaches in epidemiology
eee
This approach is particularly important in reduc-
ing uncertainty about the causes of death that are
lurking inside the ‘ill-defined’ categories, as well
as validating the diagnoses given by police offi-
Cers.
Community indicators of risk or health status
Several approaches are used to identify ‘at risk’
populations towards which public health efforts
or health services need to be directed. Groups as
opposed to individuals are the target of the study.
One approach is to use proxy measures of health
status to determine which communities are at
risk.
For example, the nutritional status of primary
schoolchildren is a useful indicator of community
malnutrition (if school attendance is high). Sim-
ilarly, night blindness is a useful proxy for vitamin
A deficiency. Tracer conditions, for example diar-
rhoea, can be used to evaluate the quality of pri-
mary health care in a community. Other indic-
ators of health service functioning have been
developed. For example, in missed opportunity
studies, each contact a client makes with the
health service is seen as an opportunity for health
workers to intervene more comprehensively on
issues other than the original reason for the visit.
Missed opportunity studies are thus able to
rapidly assess the extent to which, for example,
curative services perform preventive functions
(see Example 16.2).
Case-control methods for evaluation of
health services
Traditionally, the case-control design has been
restricted to risk-factor studies of chronic
diseases. Most health service utilization studies
have been based on large population-based stud-
ies which are expensive and may take a long time
to complete. Case-control studies are more rapid
and efficient. They can provide reliable results
and are an effective means of evaluating health
programmes, products, and procedures, pro-
vided attention is paid to confounding.
In a study in Columbia, users were compared to
non-users (as outcomes) in a child health service
study (Selwyn 1978). The non-user group is
usually not included in studies of health services.
It is, however, important to study the character-
istics of non-users.
In a Cebu study, children who were brought to
the clinic with diarrhoea (cases) were compared
to children who were brought in with respiratory
complaints (controls) in order to assess the effect
162
ee ——————E———— ee
of exposure to improved water supply and sanita-
tion on diarrhoeal disease (De Zoysa, Feachem
1991).
Similar methods can be used to assess the
effectiveness (rather than efficacy) of vaccination.
Cases (with disease) are compared to controls
with respect to their vaccination status. However,
one shortcoming of such a study can be that the
vaccinated group may differ from the non-vac-
cinated group in ways which are related both to
the risk of disease and vaccine status. For exam-
ple, poorer people are more likely to get tuber-
culosis and also not to be vaccinated (Comstock
1990). The impact of this bias can be assessed and
can be minimized by selecting appropriate con-
trols (for example, by using household controls to
limit socio-economic bias).
The case-control design can also be used in the
evaluation of the Pap test in preventing cervical
cancer through early case detection (cases are
those who have cervical cancer) and the health
impact of family planning practice (cases are
those classified by some standard means as
having ‘poor health’).
Case-control studies nested inside large popu-
lation-based surveys can also be very effective.
Conclusion
REA is not a new discipline, but it represents a
new approach to epidemiological research. It
draws on many well-known methods and also
stresses speed and simplicity, adaptation to local
conditions, and the need to obtain information
timeously at a level of precision demanded by ser-
vice providers. The strengths and weaknesses of
each method need to be identified so that it is
always used appropriately. As with any epidemio-
logical study, rapid assessments should be con-
ducted according to high standards.
EXAMPLE 16.1
Accessibility of condoms to teenagers
visiting family planning services
By distributing condoms and promoting their
use, Clinics that provide family planning services
can play an important role in preventing the
spread of AIDS. To assess the accessibility of con-
doms to teenagers at family planning services in
Durban, a simple random sample of 12 clinics run
by the Natal Provincial Administration and the
Durban City Health Department was selected.

The fieldwork was conducted during April and
May 1991 by four trained and supervised teenage
fieldworkers, who visited clinics on different days
and at different times. They kept detailed notes of
their experiences, and these notes were subse-
quently analysed for content.
Clinics were found to be accessible to people
using public transport, but some were difficult to
locate due to lack of signposts. Fieldworkers (par-
ticularly the two female fieldworkers) were em-
barrassed and intimidated by security guards at
the clinics. Clinic staff were generally efficient
and welcoming, but did not give a high priority to
condom distribution, and gave them ina setting
which lacked privacy. Information on how to use
condoms, if given at all, was supplied by means of
pamphlets. Information on AIDS was rarely
offered.
The recommendations of the study include the
following:
@ signs providing directions to clinics should be
put up;
adequate stocks of condoms should be kept;
@ privacy should be ensured;
@ clinic staff should use the opportunity to dis-
cuss AIDS prevention with teenagers attending
the clinic.
Reference:
Abdool Karim Q, Preston-Whyte E, Abdool Karim SS.
‘Teenagers seeking condoms at family planning services.
Part I. Auser’s perspective.’ South African Medical Journal
1992 82;356-9.
EXAMPLE 16.2
Missed opportunities for measles
immunization
Measles is still a major cause of childhood mortal-
ity and morbidity in South Africa. The WHO
recommends that all contacts with health ser-
vices, for curative as well as preventive health
care, should be used to immunize children who
do not have proof of immunization. To determine
16 rapid epidemiological assessment
the percentage of children leaving curative health
facilities in the Western Cape who do not have
evidence of measles immunization, a study was
carried out over a two-week period from the end
of January 1990, immediately before the start of
the national measles immunization campaign.
The sample consisted of two major teaching hos-
pitals in the greater Cape Town area, two second-
ary referral hospitals (one in central Cape Town,
the other in a small country town), and four day-
hospitals (the latter serving communities of low
socio-economic status).
All parents or carers leaving the hospitals with
child patients aged 6 to 59 months were inter-
viewed at the exit from the hospital. Approx-
imately 1000 such exit interviews were con-
ducted. Interviews were conducted by trained
fieldworkers who were not health service em-
ployees. Only a few senior staff members at the
selected hospitals were informed of the purpose
of the study. ,
In 47% of cases, the health personnel at the
hospital had not asked to see the child’s health
card. If the fact that the carer could provide no
documentation of measles immunization is taken
as indicating that the child had not been immun-
ized, more than 60% of children were missed
opportunities (that is, they were in a setting in
which they could have been vaccinated but were
not). If no documentation was available and no
history of measles immunization could be pro-
vided by the carer, between 2% and 39% of chil-
dren (depending on the type of hospital and its
location) were missed opportunities.
Similar studies could be applied to many other
aspects of prevention that could be practised
cheaply and easily in the curative sector. These
studies can be carried out over a 24- to 48-hour
period and have a large implementation
potential.
Reference:
Yach D, Metcalf C, Lachman P, Hussey G, Subotsky E, Blig-
naut R, Flisher AJ, Schaaf H S, Cameron N. ‘Missed oppor-
tunities for measles immunization in selected Western Cape
hospitals.’ South African Medical Journal 1991: 79;437-9.
163
17
Introduction
In the absence of adequate routinely available
health data, sample surveys may be the only way
to investigate health issues in specific commu-
nities or the population at large. To investigate a
community, it may be logistically easier to con-
duct surveys at certain institutions in the commu-
nity, for example, health centres, the workplace or
school, rather than in the general population.
However, if the sample is not drawn from the
general population, sections of the population
may not be represented, and results will not be
generalizable to the population. For example,
clinic attenders are not necessarily representative
of the community in which the clinic is found:
they may be poorer, sicker, or older than the
community. In work-based studies research is
done on workers, who by virtue of being in the
workforce are healthier than the general popula-
tion (‘healthy worker effect’). For these reasons, a
large proportion of epidemiological studies have
to be conducted in the community.
Community surveys are often descriptive stud-
ies which try to estimate health-related events in
the community. However, other study designs
(for example, case-control and intervention stud-
ies) can also be community-based.
Sampling
The researcher must decide whether the sam-
pling unit will be the plot, the household, the indi-
vidual, the street, or some other unit. The house-
hold is a useful and commonly used unit of sam-
pling, but it is not a simple concept. Careful
consideration needs to be given to how to define
‘the household’. For example, a study of women’s
164
Community
studies
health in the Khayelitsha township of Cape Town.
defined the household as ‘anyone who shared the
same pot or who had economic links with the
household’ (Cooper, Pick, Myers, Hoffman,
Sayed, Klopper 1991). This definition was prob-
lematic, as absentee members (for example, chil-
dren living away from home and elderly parents
living in the homelands but dependent on the
income generated by household members) also
had to be included. Ina study of diabetes in a sim-
ilar population, the household was defined as
those who lived together (for at least four nights a
week) and shared the same pot (Levitt, Katzenel-
lenbogen, Bradshaw, Hoffman, Bonnici 1993). So
boarders who rented space in a house but did not
share food with the rest of the household formed
a separate household, but someone who lived in a
shack alongside the main house and shared food
with the main household formed part of that
household.
The sampling frame (that is, some listing of the
community from which sampling units are
chosen) should be as complete as possible. The
sampling frame and the way it is compiled
depend on which unit is taken as the sampling
unit. If the sampling unit is a household or plot,
street maps and aerial photographs often provide
the most complete sampling frame possible.
Scouting or drawing up one’s own maps (for
_example, in new peri-urban communities) may
be necessary in certain communities. In addition,
estimates of the population size are sometimes
needed for stratification. For example, a propor-
tional stratified sample of a city, with stratifica-
tion by suburb, requires population estimates of
the different suburbs or the relative proportions
of the different suburbs’ population sizes. Even

when the number of households selected per sub-
urb reflects the correct proportions per suburb,
differential household sizes between suburbs
may produce disproportional sampling at the
level of the individual. That is, if one suburb has
larger household sizes on average than another,
these suburbs may be over- or under-represented
in the sample.
In general, sampling in a community setting is
often complex and difficult, and may involve
many stages (see Examples 17.1 and 17.2).
Selection plans need to be predetermined so
that no selection bias occurs in the field. For
example, if on a selected plot only one household
(out of, say, four) must be studied, the convention
may be to spin a bottle from the middle of the plot
and choose the house to which the spun bottle
points. Likewise, if sampling is done in stages, the
household might be selected first and then one
individual within that household may be ran-
domly selected for interviewing or measurement
by drawing numbers out of a bag. The researcher
must ensure that sampling methods are not cul-
turally offensive. Some community members
may become suspicious that ‘witchcraft’ is being
performed if the research involves throwing dice,
spinning a bottle, or picking names from a bag.
In some situations, a survey may include all the
people in an area, with no sampling taking place.
This occurs when the community is relatively
smal or when one of the purposes of the study is
to provide a full census of the population.
Data collection
Data collection may occur in people’s homes, at a
central venue in the community, or even outside
the community. Participants often have to be
motivated and encouraged to participate in the
study. Many individuals may refuse to parti-
cipate, and this must be taken into account
during the planning stage of the study. This does
not mean increasing the sample size, but implies
planning strategies to increase the willingness of
individuals to participate. In the community,
people are not a captive audience and therefore
need to be met on their own ground and on their
own terms. After-hour visits, repeat visits, and
appointments with absent household members
can help improve the response rate.
The location where data is collected also deter-
mines exactly what information can be collected.
Some types of surveys require that the parti-
cipants have privacy when they answer ques-
17 community studies
tions. Others might require a physical examina-
tion. All this needs to be taken into account before
the exact location is determined. Equipment
must be light and convenient to transport. If data
is to be collected at central venues, these must be
acceptable to community members. If for any
reason there is a stigma attached to a particular
venue, the response rate will drop and the validity
of the study will be compromised.
Fieldworkers
Fieldworkers are the key to the success of a
community study. They may be interviewers or
recruiters, that is, individuals who motivate
people to come to the central venue where others
do the interviewing. Yet another group may do
physical measurements or observe features in the
participants. Most commonly, fieldworkers in a
community study enter people’s homes and
interview them there. s
It is often helpful to have recruiters and/or
interviewers from the community itself. Such
fieldworkers understand the community, speak
the same language, understand what is con-
sidered a stigma by the community, and could be
useful in motivating people to participate. The
use of local interviewers, however, may put
people off. If the data being collected is sensitive
in nature, community members might not feel
comfortable giving this information to people
they would occasionally meet in the street. There
might be competition for jobs and other
resources in that particular community, causing
resentment towards an interviewer who has
gained employment from the study.
Researchers should ensure that the study is not
manipulated to benefit an individual or a particu-
lar group. In a community where there are reli-
gious, political, or other divisions, it is not advis-
able to choose people from only one camp as
interviewers. Data collection is a neutral process
and should not alienate any potential particip-
ants. Interviewers need to be extremely sensitive
to avoid further polarization of divided commu-
nities.
Careful attention needs to be given to issues
such as how the interviewers introduce them-
selves, how they dress (for example, do nurses
wear uniforms or not?), and what security precau-
tions they take.
Another fieldwork issue is that data collection
in the community is often extremely hard work. If
people are not at home, repeat visits (often after
165
d= common approaches in epidemiology
hours and on weekends) need to be made, and in
the end the selected person might still refuse to
participate. Often researchers do not acknow-
ledge the work of interviewers, who may have
spent three days getting only a few interviews,
despite working very hard. The issue of produc-
tivity of interviewers can be very sensitive and at
times interviewers may try to fudge the data so as
to appear hard-working. After all, this is their job,
and they wish to produce what is expected!
Fieldwork co-ordinators need to ensure that
the quality of the data remains good by closely
supervising workers and checking forms regu-
larly. The co-ordinator(s) must also provide sup-
port to fieldworkers, who are faced with an ex-
tremely difficult task.
Dealing with the community
Permission to enter and work in the community
may need to be requested from any formal civic
body that exists in the area, as well as any other
social, political, or religious grouping that repre-
sents significant sections of the community. In a
rural area, this might mean getting permission
from the headman and in an urban area, from the
local authority, civic association, and/or local
community organization. Different authorities
may have to be approached for permission for
different areas and different groupings.
The process of consulting with community
representatives in this way is often cumbersome,
requiring many meetings, many appointments,
and many explanations. Inevitably, researchers
with the best intentions are likely to leave out
some groupings or leaders, especially where
groupings are very mobile and informal. How-
ever, it can be very important to go through these
steps, especially in areas where there is suspicion
and instability.
In a sense, organizing access to a community is
also the first step towards providing feedback of
your results to the target population, in that
permission is often given on condition that the
results are fed back after the study.
This enables the community to understand
what the problems are and to work from a more
informed position. This is especially important
from an implementation point of view, if any fur-
ther interventions are planned for the future.
In many community studies, community
participation is a stated goal of the project. How-
ever, the ‘community’ cannot be considered as a
homogeneous group: different people in the
166
Table 17.1 Possible stakeholders
in a research project
the community at large
¢ local leaders
@ project health workers
_ @ outside professionals
- @ local authorities
@ government bodies (e.g. to
‘@ commercial companies —
¢ universities and research councils
the ‘researched’ — the subjects of study
target groups
@ churches ©
funders
@ welfare agencies
researchers
| project staff
community often have different interests, and
there are often different power blocks. The con-
cept of stakeholders is a useful one for under-
standing the nature and extent of participation.
Stakeholders are individuals or groups who have
particular interests in the project in that they are
affected by it or stand to gain from it in different
ways (see Table 17.1).
Many people may be affected by the project,
but may not have power over it. A participatory
approach may aim to include all or only some of
the stakeholders. Certain stakeholders can be
prioritized from the outset; this is a value choice
of the researcher. The involvement of targeted
people should be stated explicitly as a goal from
the beginning. Stakeholders may have a conflict
of interests over time and resolution of the con-
flict will be important for the future of the project.
Barriers to community participation do exist.
Professional health workers and researchers are
usually distinguished from most community
members by their class position and their access
to resources. They have often been trained in spe-
cialized urban-based institutions, and may be
regarded by community members as outsiders.
They often lack the necessary skills or insight
needed to cope with community dynamics and
problems. The legacy of oppression in South
Africa can exacerbate the miscommunication and
suspicion.
Facilitators for communication are listed in
Table 17.2.

Table 17.2 Facilitators for
Creel
@ Active listening rather than top-down com-
munication and giving of advice.
@ Consultation should not be limited to
individual leaders: broad consultation
should be encouraged. An activity initiated
by a well organized group or structure
(preferably with a grassroots base) has the
best chance of survival.
A framework for dialogue needs to be set
up, uSually in the form of a contract in which
mutual responsibilities and conditions for
compensation and benefit are ciearly set
out. This facilitates a sense of ownership
and accountability.
Respect the means (process), not only the
end (outcome) of the project. This means
that participation takes time and cannot be
rushed.
@ Non-directive approach.
The researcher(s) may also set unrealistic goals
for community participation and empowerment,
which may create unnecessary tension and stress.
An understanding of the structure and composi-
tion of the community will assist in setting realis-
tic goals. The level of internal organization of the
target group and the material conditions of their
lives will determine to a large extent the level of
participation possible. Professional workers and
community members often have different ex-
pectations of the project, creating conflicting
agendas. Material benefits may be a priority for
some groups, and some may doubt their own
capacity for participation and underestimate
their potential contribution. Often there may be
no representative or credible bodies to work
through, and true consultation may be difficult.
Conclusion
Studies conducted in the community are very dif-
ferent from those based in a clinic, hospital,
institution, or centralized location. In the com-
munity, many factors impinge on the study. Com-
munity, political, social, and economic events
may interfere or facilitate the success of a study.
The time of sunset and climatic conditions are
also factors to be considered when planning a
community study. Day-to-day management
17 community studies
needs constant problem solving and adaptation
to cope with community dynamics and pressures.
Details of the study must be well-planned and
organized, but also flexible.
EXAMPLE 17.1
The prevalence of late-onset diabetes
in the Cape Town African townships
The prevalence of late-onset diabetes in the
urban African community in Cape Town was the
focus of a study done in 1990. A multi-staged pro-
portional cluster sample (1 000 in all) of the com-
munity in the townships was drawn from an array
of official maps, scouted maps, and aerial photo-
graphs. Fieldworkers who acted as motivators
had to visit clusters of homes, hostels, shacks and
tents, take a census of everybody in the house-
hold, and randomly (by means of picking a num-
ber out of a bag) choose a person over the age of
30 as the candidate for the study. The selected
individual then had to be motivated to attend a
clinic where a blood test would be performed, a
questionnaire administered, and anthropometric
measurements taken. An additional requirement
was that participants had to fast from 10 pm on
the night preceding the clinic visit.
Transport was provided to and from their
homes. Participants were provided with a meal
and a food parcel on completion of their inter-
view and measurements. If a selected person
refused to participate, he or she was not replaced
by another person.
Permission to conduct the study was negoti-
ated with a variety of governmental and non-
governmental groups — health authorities, town
councils, community and civic organizations, and
non-governmental health organizations. The
same interviewers were used throughout the
study, but motivators covered only the area in
which they themselves lived, because much of
the work required after-hours (early morning and
evening) involvement.
The logistics of the study caused it to run into
many practical, financial, unrest, labour-related,
and respondent-related problems. After six
months, the final response rate of 76% was
beyond expectation and was a result of an ex-
treme effort by all involved.
Newly diagnosed diabetics and hypertensives
were traced personally and referred for treat-
ment. Non-diabetics were informed of their
results by post. Unfortunately, a number of
167
d= common approaches in epidemiology
i =
notices were not delivered due to problems with
postal services in squatter areas.
This example is one of a typical complex urban-
based community study. The logistical problems
of covering multiple areas, bringing people to a
central venue, using relatively invasive tech-
niques (taking blood), and following up people
identified as positive are exemplified in this
study. The fact that the study was conducted in a
politically turbulent period exacerbated many
problems. The researchers identified a need for
extra training of researchers in the future in pro-
ject management, including conflict resolution
and financial management.
Reference:
Levitt N S, Katzenellenbogen J M, Bradshaw D, Hoffman M
N, Bonnici B. ‘The prevalence and identification of risk
factors for NIDDM in urban Africans in Cape Town, South
Africa.’ Diabetes Care 1993;16(4):601-7.
EXAMPLE 17.2
The profile of infant mortality in
Hewu, Ciskei (1986)
In 1986, a community survey was conducted by
researchers of the MRC in the Hewu district of the
Ciskei to determine the infant mortality rate in
the region and to look at risk factors for infant
deaths.
168
EE
The study was initiated by the District Medical
Officer of Health, who approached headmen in
the area for permission. Villages, stratified by
village type (traditional, resettlement, and urban),
were randomly chosen, with all households in
selected villages being included in the sample.
Village health workers (VHWs) who were part of
the district health service were trained to admin-
ister questionnaires to all women of childbearing
age in their villages. Focusing on children born in
the previous five years, the infant mortality rate
was found to be 42 per 1 000; infants who were at
greatest risk were those who were one of a twin,
born at home, or living in a resettlement village.
Gastroenteritis was the most common cause of
death.
Feedback in the form of pie charts, histograms,
and other illustrative material was given to the
VHWs at a meeting. Discussion of the results led
to improved VHW understanding of the issues
and enabled VHWSs to integrate their new know-
ledge and experience into their work.
This study illustrates a typical rural commu-
nity-based epidemiological study where existing
infrastructure was used to the maximum, and ser-
vices strengthened by the long-term involvement
of outside researchers.
Reference:
Yach D, Katzenellenbogen J, Conradie H. ‘Infant mortality
rate study: Hewu District.’ South African Journal of Science
1987; 83:417-21.
18
Introduction
Many of the major health problems facing society
today, including the HIV/AIDS pandemic, heart
disease, cancer, and injury, amongst others,
require public health interventions to change
personal behaviour. Personal health-related
behaviour may be influenced by many factors.
Knowledge, Attitude, Belief and Practice (KABP)
surveys are based on the theory that individuals’
knowledge (facts), combined with their attitudes
and beliefs (positive or negative feelings and
opinions), may predict their health-related beha-
viour. KABP surveys aim to measure these psy-
chological and personal variables in order to
better understand why people act the way they do
(often in ways which are detrimental to their own
health), so that more effective programmes may
be developed to reduce the toll of these diseases.
Social psychological theories as
applied to health-related behaviour
Several social psychological theories address the
question of how behaviour is determined by atti-
tudes and beliefs. The most prominent of these is
the Health Belief Model (Janz, Becker 1984),
which attempts to identify beliefs and the way
they may interact to influence individuals’ con-
scious decisions to undertake certain health-
related actions.
The most important health beliefs that influence
actions are thought to be:
¢ the person’s perceived vulnerability to a par-
ticular condition or illness
the person’s perceptions of the severity or
Knowledge,
attitude, belief,
and practice
(KABP) surveys
effects of the condition or illness
¢ their perception of the efficacy, costs, and bene-
fits of any proposed actions
In addition, it is suggested that events or situ-
ations may trigger the necessity, or urgency of
health-related decisions or actions.
Several other theories have been combined
with the Health Belief Model in an effort to under-
stand the role of psychological factors in health-
related behaviour. Attribution theory, as applied
to the health field (for example, Hewstone 1983)
emphasizes two key concepts — locus of control
and locus of causality — both of which concern
the individual’s perception of events as being
under personal control in contrast to being deter-
mined by external influences. So, for example,
people with limited locus of control may feel
powerless to change their lifestyle or behaviour
because they feel influences outside themselves
control their lives.
Bandura’s Social Learning Theory (Bandura
1992) stresses the need for personal, social, and
behavioural skill development to enable indi-
viduals to put into practice their convictions re-
garding health-maintaining or health-promoting
behaviour. So, those who want to change their
behaviour may need ‘training’ (for example, time
management skills or assertiveness training) to en-
able them to behave in a health-promoting manner.
Ashort history of KABP surveys
KABP surveys were originally developed as KAP
surveys to assist the development and imple-
mentation of family planning programmes
(Bulmer, Warwick 1983). The first surveys were
169
d common approaches in epidemiology
concerned with knowledge of contraceptive
methods and reproductive functioning, attitudes
towards family size, child spacing, contraception,
sterilization, and abortion, and practice or use of
birth control methods (Population Council 1972).
The extensive application of KAP surveys in the
field of population research led to the concept of
the KAP gap (Bongaarts 1991; Westoff 1988). This
concept referred to the common finding of a gap
or discrepancy between women’s expressed
desire to limit or space their children (usually
high), and their reported use of contraceptive
methods (usually low). Within this context, the
KAP gap was believed to be a measure of the un-
met need for contraception, particularly among
women in developing countries and in countries
with strong religious or ideological opposition to
family planning.
Subsequently, KABP surveys have been applied
to a wide range of problems, including tobacco
and alcohol consumption, adherence to medica-
tion schedules, use of preventive health services,
traffic safety, and many others. KABP surveys re-
emerged strongly in the 1980s in response to the
need to curb and prevent the spread of HIV infec-
tion. In 1987, the Global Programme on AIDS of
the WHO produced a KABP survey instrument
which has subsequently been applied extensively.
What are KABP surveys?
KABP surveys are based on the theory that an
individual’s health-related behaviour is influ-
enced by their knowledge of the disease and
necessary health-promoting actions to prevent or
ameliorate the condition, as well as their attitudes
and beliefs (positive or negative feelings and
opinions) towards the disease or health-promot-
ing actions. KABP questionnaires aim to measure
these psychological variables of knowledge, atti-
tudes, and beliefs, and to measure the health-
related behaviour these variables are believed to
predict. KABP surveys usually take the form of
interviewer-administered or self-administered
standardized questionnaires. The information is
collected to assist with the design, implementa-
tion and evaluation of health programmes.
The uses of KABP surveys may be categorized
as follows.
¢ Description: to describe personal health beha-
viour and the demographic and psychological
characteristics associated with this behaviour
among aspecified population at a particular
point in time.
170
Table 18.1 Important steps in
rite Cad ire Bele
41 Consult educationalists, programme man-
agers, programme participants, social sci-
entists, and health workers who will use the
information or who will develop the health
promotion programme.
2 Review literature to identify which variables
- may be associated with the behaviour of in-
terest. 2
3 Explore, using qualitative, open-ended or in-
formal methods, the characteristics of the
target audience, and identify what issues
are important to their understanding of the
topic, and how they express their concerns
in their own language.
4 Design the questionnaire, making sure that
terms are unambiguous and non-leading,
and attempt to build in ways of evaluating
reliability and validity.
5 Administer the questionnaire after identify-
ing the sample. Ensure a high response
rate, and maintain confidentiality.
6 Analyse the data. Interpret the results crit-
ically and consider what effect each aspect
of the methods may have had on the re-
sults.
7 Report back to all involved in the research
and synthesize into pilot programme recom-
mendations.
@ Programme design: to guide programme devel-
opment and implementation by identifying
psychological, social, and behavioural factors
associated with health problems.
Evaluation: to evaluate the success and cover-
age of programmes by measuring changes in
KABP factors. Repeated KABP surveys may
identify the shortcomings or strengths of an
existing programme. This knowledge may help
in the modification of a programme to make it
more effective.
@ Advocacy: to generate support for health pro-
grammes by demonstrating existing attitudes
and needs.
@ Advancement of social and health sciences: to
increase understanding of associations be-
tween social or psychological factors, and
health problems.
See Table 18.1 for important steps in conducting a
KABP survey.
 18
Measurement of knowledge, atti-
tudes, beliefs, and behaviour
The characteristics measured by KABP surveys
are difficult to define and quantify. For a long
time, people have been trying to define these con-
cepts, debating whether or not they are the most
important variables to predict behaviour, and
developing appropriate psychometric instru-
ments to measure these variables. Unfortunately,
some KABP surveys may treat the measurement
of the psychological variables too simplistically.
Knowledge
Knowledge poses the fewest problems of mea-
surement. The most important items of know-
ledge need to be defined. These may be based on
the content of health education programmes, or
on common misconceptions. Questions need to
be devised which are unambiguous and which do
not pre-empt, lead, or steer the respondent into
certain answers. Kelsey, Thompson, and Evans
(1986) provide helpful guidelines on how to
develop questions for surveys in general.
A typical question dealing with knowledge is
taken here from the WHO Global Programme on
AIDS Research Package (1990):
‘Do you think that a person can be infected and
have the virus that causes AIDS but not have
any symptoms?’
The response possibilities are:
YES, NO, DO NOT KNOW, NOT SURE.
KABP surveys may also raise novel questions
about the health topic in respondents’ minds and
some feedback or information (debriefing) may
be helpful after the survey interview.
Attitudes and beliefs
The most common approach to measuring atti-
tudes and beliefs is to ask respondents to indicate
how far they agree with selected statements. The
intensity of the attitude is quantified using
measurement scales such as Likert scales, forced-
choice descriptions or Semantic Differentials. For
more detailed information on how to develop
measurement scales and items, see DeVellis
(1991) and Maloney and Ward (1976).
For example, a question from the WHO AIDS
questionnaire in the section dealing with atti-
tudes towards condoms is phrased as follows:
knowledge, attitude, belief, and practice (kabp) surveys
‘Condoms are good at preventing pregnancy if
used properly.’
STRONGLY AGREE, MILDLY AGREE, MILDLY
DISAGREE, STRONGLY DISAGREE, DO NOT
KNOW. :
And from the section dealing with beliefs:
‘What are the chances that you yourself might
catch AIDS? Would you say that it is ...?”
NOT LIKELY AT ALL, VERY SMALL CHANCE,
MODERATE CHANCE, GOOD CHANCE, DO NOT
KNOW, NOT SURE.
The response possibilities in these questions are
in the form of Likert scales.
Behaviours/practice
In terms of the measurement of behaviours or
practice, it has to be kept in mind that survey
questionnaires assess reports of behaviour and
not behaviour itself. Reports of behaviour are
subject to a number of influences which can
potentially distort them.
@ Social desirability: People may be reluctant to
divulge information about themselves which
portrays them in a bad light, and may say that
they engage in behaviours which are socially
desirable even when this is not the case. This
tendency is likely to be most pronounced with
behaviours which carry severe social sanction,
such as illegal activities, but may extend to
many health-related behaviours, especially in-
timate, sexual, and associated social beha-
viours. This tendency may also be observed in
the reporting of attitudes and beliefs. It may be
stronger if the interviewer fails to convince the
respondent that strict confidentiality will be
maintained, or if there are hints that the inter-
viewer judges certain attitudes or behaviours in
a negative way.
Recall: People may forget details of their beha-
viours, particularly those of minimal psycholo-
gical significance to them. Some questions may
require attention to detail which respondents
have neither the ability nor the motivation to
recall. A different phenomenon (known as tele-
scoping) occurs when certain events are so
significant that they are compressed in
memory into the reference time period. In
other words, if you ask someone whether an
event which may have been particularly
important to them (for example, whether they
have been hospitalized, lost a child, been
Pal
d common approaches in epidemiology
arrested, or had an unplanned pregnancy)
occurred within a specified time frame, say,
within the last two years, they may report its
occurrence even if it happened earlier than two
years ago.
In general, questions which are simple and which
refer to recent and short time periods are likely to
obtain the most reliable information in response.
KABP surveys as one type of survey
procedure
KABP surveys form part of a wider class of sur-
veys. Therefore, issues of sampling, questionnaire
design, interviewing and data analysis, which
apply to surveys in general, apply also to KABP
surveys. Issues specific to KABP studies will be
outlined here.
Sampling
KABP surveys rely on probability sampling to
ensure that the results are representative of the
population of interest in the study. Bias (system-
atic or non-random error) may be introduced if a
large percentage of people who should have been
interviewed are not, either because they refused,
or because they could not be located by the inter-
viewers. For example, if those who are strongly
opposed to family planning refuse to be inter-
viewed, the results of a survey will portray more
favourable attitudes towards family planning
than truly exist among the population being
studied.
Questionnaire design
KABP surveys employ standard questionnaires,
usually with fixed or closed-form response altern-
atives. To maximize reliability and standard-
ization, these questionnaires are administered
according to a fixed question order. Interviewers
are not encouraged to allow the respondent to
expand on certain points, because the same ques-
tions must be asked in the same way.
Questionnaires should be designed to have a
high reliability and validity. Most of the time, reli-
ability refers to the degree of consistency found
when the same questionnaire is administered to
the same respondent at a later stage (test-retest
reliability), or the same questionnaire is adminis-
tered by a different interviewer (inter-rater reli-
ability). In addition, different questions asking
about the same topic should elicit consistent
replies. On the other hand, determining the valid-
172
ity of a questionnaire usually depends on com-
paring the answers on the questionnaire to an
external criterion. However, KABP surveys mea-
sure hypothetical variables which are not directly
observable. Validity therefore has to be inferred
from the extent to which different methods of
measuring the same variables or constructs agree
with each other, and the extent to which expected
relationships among variables, and in predicting
behaviour, are observed. For more discussion of
how to investigate reliability and validity, see De-
Vellis (1991). (See also Chapter 9.)
Data analysis
KABP survey data are normally analysed descript-
ively, with response preferences being associated
with demographic and sociological character-
istics.
Specific criticisms of KABP studies
KABP studies have come under considerable crit-
icism. Some critics have argued that the meth-
odology is so seriously flawed that KABP surveys
may lead to a systematically distorted under-
standing of health phenomena, particularly in
cross-cultural settings. Some specific criticisms of
KABP studies include the common finding that
knowledge, attitudes and beliefs are poor predic-
tors of behaviour, that KABP surveys are too rigid,
that they lack reliability and validity, and that they
provide simplistic answers to complex questions
about the determinants of behaviour.
KAB do not predict P (practice)
In general, research indicates at best a weak con-
nection between knowledge, attitudes, beliefs,
and behaviour (Tanur 1992). It is important to
realize that not all attitudes and beliefs are alike;
some are strong in the sense that they have pro-
found effects on individuals’ thinking and beha-
viours, and may resist very strong pressures
toward change. Other attitudes and beliefs are
weak, vulnerable to situational pressures, and
have little, if any, impact on an individual’s think-
ing or action. Attitudes which are very strongly
held may be better predictors of behaviours than
weaker ones. Attitudes and beliefs which are
closely linked and specific to the behaviour of
interest may be more important than more
general attitudes and beliefs.
An important criticism of KABP surveys is that
they may ignore the social and material context in
which behaviour or practice occurs. For example,
 18
the competing influence of the opinion of a
woman’s male partner may override the woman’s
own opinions about unprotected sexual inter-
course. Under certain circumstances, situational
factors, such as drug or alcohol use, economic
imperatives, environmental factors, peer pres-
sure, and social norms may play a greater role in
predicting behaviour than the individual psycho-
logical variables usually included in a KABP
survey.
The rigidity of KABP questionnaires
KABP surveys rely on pre-coded questions. They
may, therefore, provide answers many respond-
ents might not otherwise be capable of formulat-
ing for themselves or find suitable for themselves.
It has been pointed out that KABP surveys assume
the respondent already has a well-formed evalu-
ative opinion on the subject in mind (that is, they
have thought about the subject and have views
about it) and merely needs to access this response
and report it to the interviewer. From this point of
view, the attitude is assumed to be accessible and
spontaneous (Tanur 1992). However, when the
respondent has no prior attitude (when they have
not thought about the topic or their relation to it),
they may have to construct a response on the
spot. In this case, the attitude may be transient,
unstable, and somewhat meaningless for predict-
ing behaviour assumed to be related to the atti-
tude or belief. Attitude and belief questions in
KABP studies are seldom preceded by enquiries
about how much respondents have thought
about the matter beforehand, if at all. Some
responses to KABP questionnaires may be efforts
at politeness to apparently irrelevant queries,
especially in developing countries where subjects
are unaccustomed to being interviewed, and may
be overwhelmed by the presence of a stranger in
their home and the pressure to be hospitable.
KABP surveys may neglect to collect inform-
ation on attitudes and beliefs which are most
important to the respondents, if not originally
conceived as important in the survey. As the con-
tent of KABP surveys is defined by researchers,
they may overlook issues important to the
respondents. This is most likely to occur when the
researchers are unfamiliar with the social and cul-
tural conditions of the communities being stud-
ied (Ratcliffe 1976; Stone and Campbell 1984),
and particularly when the cultural and social gap
between the researcher and the researched com-
munity is wide.
knowledge, attitude, belief, and practice (kabp) surveys
The reliability and validity of KABP surveys
Where they have been specifically examined, the
reliability and validity of some existing KABP sur-
veys have not been as good as frequently assumed
(Okediji 1973; Stone, Campbell 1984). For exam-
ple, a study from Bangladesh showed that one-
fifth of men and one-third of women who used
contraceptives in a sample denied this in a subse-
quent KAP survey (Bulmer, Warwick 1983).
The availability of existing KABP survey ques-
tionnaires may encourage their uncritical use in
new settings. The re-use of questionnaires used in
other studies in new settings is useful to facilitate
comparisons across studies, but should not stop
extensive piloting to iron out the problems of
using the questionnaire in the novel setting.
Furthermore, the reliability and validity of the
questionnaires used should be tested through
methods such as repeat questions within the
questionnaire, intensive probing, combining
open and closed questions, repeat interviews
with single respondents, interviews with altern-
ative sources (for example, husbands, if wives
were the initial primary target), and so on.
Simplistic approaches to KABP surveys
No one would deny that the relationships be-
tween health-related behaviour and the charac-
teristics measured by KABP surveys are complex
and difficult to quantify. However, KABP surveys
are sometimes substantially over-interpreted. For
example, many KABP studies of family planning
and HIV prevention are based on interviews with
individual women of reproductive age. This im-
plies that sexual and reproductive decisions are
an individual matter, which is largely controlled
by women. Simply interpreting responses indi-
cating a willingness to prevent HIV transmission
or prevent pregnancy to mean that condoms or
birth control methods will be used by these
women, and that they are probably the best
method for dealing with the problem, may over-
look the many social and other impediments that
bar these women from actually carrying out their
stated intent. Further interviews with women’s
partners may also be informative.
Another example which shows that the know-
ledge, attitudes, beliefs, and practices of others
may be more important than that of the people
whose health is directly affected, comes from a
South African study. In this study, knowledge,
attitudes, and practices with regard to hyperten-
sion and its management were investigated
among family practitioners (Pick, Steyn 1992).
173
d= common approaches in epidemiology
Family practitioners are likely to be primarily
responsible for ensuring appropriate detection
and management of hypertension among their
patients. Therefore, hypertension management
aids to assist family practitioners may be more
effective in controlling high blood pressure in the
community than simply directing education at
the community itself.
Problems of applying KABP surveys
in developing countries and cross-
cultural settings
Many problems of surveys become exaggerated
when surveys are applied in developing coun-
tries, and especially among largely poor and une-
ducated populations. It is not so much that there
are problems which are unique to these circum-
stances, but that they are more frequent and
severe (Bulmer, Warwick 1983).
Translation
It is difficult to ensure that translated question-
naires truly represent the original. This is espe-
cially important if a study uses questionnaires in
more than one language. Translation poses fur-
ther problems when the target language(s) lacks
the vocabulary suited to the goals of the ques-
tionnaire. In many instances, these complex lin-
guistic issues are left to interviewers to navigate
on the spot. This may place unrealistic demands
on interviewers. To evaluate comparability, it
may be necessary to translate the original into the
target language, and then to get someone else to
back-translate the new questionnaire into the
original language. Discussion of the translated
and the original version of the questionnaire by
bilingual people may be of further benefit.
Socio-cultural context
A proper understanding of the socio-cultural con-
text is essential to being able to conduct research
(see also Chapter 26: Psychiatric epidemiology).
Pilot and pre-testing of basic ideas, question-
naires, and field strategy is essential for achieving
accessibility to the population and discovering
relevant cultural practice and expression. It is
essential to involve individuals from local com-
munities in all stages of the research.
Qualitative research procedures, such as
anthropological methods, in-depth or unstruc-
tured interviewing, participant observation, and
focus groups, may be a useful starting point in
formulating the questions asked in a KABP
174
survey. Extensive exploratory research and pre-
testing, some of which needs to make use of
qualitative methods, is essential for the com-
petent design, execution, and interpretation of
KABP surveys.
Conclusion
KABP surveys may provide useful baseline in-
formation when designing health programmes
that aim to influence personal behaviour, and re-
peated KABP surveys may provide useful inform-
ation about the effectiveness of programmes.
How the information from a KABP survey can be
used in the design, implementation, or modifica-
tion of health programmes needs to be planned
from the outset. Too often KABP studies are done
without bridging the gap to implementation and
building this information into intervention. It is
essential that educationalists, programme man-
agers, programme participants, social scientists
and health workers are involved in the research
process.
Several possible problems in the design and
execution of these surveys may threaten the
validity of the research findings. It is important to
bear this in mind, and to interpret data critically
and cautiously. To clarify the role of the many
social and psychological factors in public health,
and to better assist the development of health
promoting programmes, data from KABP surveys
may need to be combined with further inform-
ation, including that arising from in-depth and
qualitative research.
EXAMPLE 18.1
The use of KABP surveys in a school
setting
A KABP survey of 377 high school students in
Cape Town found that students had a poor and
superficial knowledge of how HIV was trans-
mitted, and had fragmentary and inaccurate in-
formation about how to protect themselves. Few
recognized AIDS as a threat to themselves or their
community, and people with AIDS were viewed
with hostility. Three-quarters of the students
were sexually active, and almost all expressed a
strong desire to learn more about the disease
(Mathews, Kuhn, Metcalf, Joubert, Cameron
1990). This descriptive information was used to
lobby support for school-based AIDS education
programmes, which at that time had received
 18 _ knowledge, attitude, belief, and practice (kabp) surveys

little attention.
The information also formed the basis of the
development of a pilot education programme.
KABP surveys were undertaken before and after
this pilot programme was implemented, and at
similar intervals at a comparison school. These
surveys showed that there were significant
increases in students’ knowledge of HIV transmis-
sion and prevention, and significant increases in
students’ reported acceptance of people with
AIDS following the programme. However, there
were no significant changes in behavioural inten-
tions. Again, this information was used to garner
support for further school-based AIDS education
programmes, and to modify and improve the pro-
gramme.

Reference:
Kuhn L, Steinberg M, Mathews C. ‘Participation of the
school community in AIDS education: An evaluation ofa
high school programme in South Africa.’ Aids Care 1994;
6:161-71.

EXAMPLE 18.2 Knowledge and education about dangerous health

Survey into attitudes, beliefs and practices don’t necessarily change behaviour
practices regarding smoking
Using a population-based sampling frame, a
representative sample of adult South Africans
weré selected and interviewed by professional
survey workers. The subjects were interviewed
about their knowledge of the harmful effects of
smoking, their attitudes and beliefs towards to-
bacco control measures, and their own smoking
practices.
The study found that the majority of smokers
(68,5%) knew that smoking was harmful to health,
but that a larger proportion of non-smokers
(79,7%) knew this to be the case. Most people
interviewed supported public policies to control
tobacco consumption, such as stopping the sale
of cigarettes to children, increasing taxes on ciga-
rettes, and preventing advertisement of tobacco
products in the media. The study suggests that
there is widespread support among the public for
legislative measures to create a social environ-
ment which is conducive to reduce smoking.

Reference:
Martin G, Steyn K, Yach D. ‘Beliefs about smoking and
health and attitudes towards tobacco control measures.’
South African Medical Journal 1992; 82:241-5.

175
19
Introduction
Many of the most pressing questions about
human health care are linked to the attitudes and
perceptions of both caregivers and users of health
services. Sometimes people behave in ways or
hold views which are difficult to understand. For
instance, some people stubbornly refuse to take
their medication, no matter what. If you try to
understand their motivation, they may tell you a
number of things that you did not think were
important, but are important to them.
Qualitative methods allow researchers to
understand how the subjects of research perceive
their situation and their role within this context. It
is out of these perceptions that behaviour, includ-
ing health-related behaviour, is born. Qualitative
research can help us find out why these beha-
viours occur or why people hold these views.
Qualitative methods are a collection of formal
research methodologies that allow researchers
to get in-depth information on their subjects,
generally by talking to them or observing them.
Qualitative data consists mainly of descriptions of
people or places, or of conversations. Such infor-
mation cannot easily be handled by statistical
procedures, and these procedures are generally
inappropriate.
Philosophical approach
Underlying the qualitative approach is a philo-
sophy concerning how behaviours and social pro-
cesses are determined. This philosophy argues
that attempts to explain the social world in terms
of overt behaviour miss the most vital part of it,
namely that each behaviour or action carries
meaning which needs to be explored. People and
176
Qualitative
methodology:
an introduction
contexts are seen as being shaped by the norms
and conventions of the society in which they are
found. All these norms, conventions, and social
institutions find their final form in cultural and
belief systems. The personal and social meaning
that people use to structure their lives cannot just
be treated asa statistical variable, but needs to be
explored if the researcher hopes to answer many
basic research questions.
The qualitative approach is subjective in that
the focus is on how the respondents experience
and understand the particular situation.
Uses of qualitative research
Four instances in which qualitative research can
be used are outlined below.
1 Qualitative research may be used in the early
phase ofa study when the researcher wants to
get the feel of an area before starting with a
survey, or to clarify the basic conditions that are
present there. Qualitative research can be used
onan exploratory basis to establish hypotheses
for future research.
bh Qualitative research can be used along with
other types of research in order to get an addi-
tional perspective on the problem. It can also
provide the meaning behind a superficial
connection made bya statistical survey.
wo It is often the only method used when the aim is
to get an in-depth sense of what people think of
a particular object or event.
4 The in-depth interaction makes this approach
particularly appropriate when used as part ofa
process to establish some form of action or
campaign in a community.

Methods of data collection
Research objectives are formulated broadly and
not framed around variables which are defined in
rigorous measurable dimensions, or in terms of
specific hypotheses. The emphasis is on invest-
igating the variables in their complexity and in
context. Overviews of the three most commonly
used methods of data collection will be provided
here to give a flavour of the research style. It is
important to note that the style of the research
method used has to be adapted to the situation,
and the demands of the research question.
Depth interviews
This is probably the most common form of qualit-
ative data collection. It generally takes the form of
a discussion between the interviewer and inter-
viewee about the area of research. The interview
is commonly recorded on a tape recorder (with
permission from the interviewee). The inter-
viewer has to direct the discussion to some extent
so that the required information can be obtained,
but respondents are allowed to talk and cover the
area in their own terms and from their own
perspective. This method is generally used when
detailed information is needed from individuals.
Examples of its use would be to determine how
TB patients feel about a new treatment plan, to
assess the illness experience of a person with
cancer, or to find out how STD patients feel about
the idea of using condoms.
The major advantage is that it gives the re-
spondent the opportunity for personal explana-
tion and detailed responses. In addition, the indi-
vidual focus allows the interviewer to draw out
more detail while the respondent is talking and
thinking about the subject. The major disadvan-
tage is that, compared to the other qualitative
methods, the respondent is more removed from
his or her own context and may feel threatened.
This could result in bias.
Considerable preparation must take place
before going into the field. The researcher needs
to be clear about the purpose of the research,
have a good knowledge of the setting in which the
research takes place, and have read widely in the
area to be researched. Interviewers may also have
to prepare themselves emotionally, as they often
have to deal with difficult and emotive issues.
Most commonly, the interviewer will enter the
field with alist of points to be covered in the inter-
view. These points give direction, but ideally
should not inhibit the interviewer from discuss-
19 qualitative methodology: an introduction
ing other points if they seem important during the
course of the interview. No sequence is imposed,
and each point can be the beginning of a series of
probing questions. The greater the level of struc-
ture provided, the less spontaneity the inter-
viewee is allowed.
An appointment should be organized well in
advance at a mutually acceptable place, so that
time is allocated and the respondent can prepare.
When organizing the meeting, the nature of the
research should be explained. A person’s unwill-
ingness to be interviewed must be respected, but
reservations should be discussed if possible.
The initial phase of the interview is very impor-
tant, as this is when trust is established or lost.
Openness and frankness about the nature of the
research will help to gain trust at this point. Con-
firm that the person is agreeable to having the
interview taped, reaffirm the nature of the re-
search, and re-establish consent. Privacy and
quiet should be ensured where possible.
The interviewer asks an open question, and
then by the use of summarizing techniques and
questions of clarification, draws out the meaning
and sense of reality that the interviewee places on
the issues under question. Summarizing involves
reflecting back to the interviewee what was said in
such a way as to provide an immediate check on
the interviewer’s understanding, and to allow the
interviewee to further develop his or her thoughts
on the question. Clarification questions serve to
get explanations on issues raised by the inter-
viewee about which the researcher is unclear.
The atmosphere should be kept cordial and
open. An interview should preferably not last
more than an hour in most cases. It can be carried
on later if more time is required.
The interview needs to be concluded with great
discretion and care. Any emotions and hopes that
the interview raises should be respected and
talked through, as appropriate. At the end of the
interview, the respondent must be told where the
research will be going from this point, should be
reassured about confidentiality, and, where pos-
sible, the offer of later feedback should be made.
Focus group interviews
The focus group method involves a number of
people meeting in a group in which the parti-
cipants talk to one another under the guidance of
a facilitator. The purpose is to generate relevant
ideas and information around a pre-arranged
topic. The aim of focus groups is to provide
insights into the attitudes, perceptions, and
177
d= = common approaches in epidemiology
ee
opinions of participants.
Focus groups can be set up ina relatively short
time. They can produce results that may directly
represent how people are feeling as they attempt
to re-create the social situation. People are often
stimulated by the discussion, and reveal facts and
opinions that they might not otherwise have
chosen to reveal. It may also give group members
the chance to clarify their attitudes and beliefs.
Focus groups can be used flexibly, for example,
to evaluate health projects and educational at-
tempts, and to obtain perceptions of what the
major needs in a community are. Focus groups
can help to build community involvement in the
research or the intervention being evaluated or
planned. The major disadvantage of this method
is possible peer pressure within the group, which
may prevent the members from saying what they
believe.
Ideally, a group should number between six
and ten members, plus a facilitator and observer
or recorder. Membership of the group should be
fairly homogeneous. If the subject is sensitive,
care needs to be taken in mixing groups. For
example, if the subject is sexuality, one should
consider interviewing men and women separ-
ately.
The selection of group members should aim to
represent all relevant subgroups. On the other
hand, natural groupings, such as women who
meet every day around a central water tap, may
also be used, as they represent a specific target
group.
The site selected for the discussion should be
private and comfortable, free from disturbance,
and at a convenient spot for the members of the
group. The optimal time span for a group discus-
sion is between 60 and 90 minutes, but the
demands of the study need to be taken into
account. It may also be possible to organize more
than one meeting of the group.
As with the depth interviews, the facilitator
should work from a pre-established list of points
or schedule, which can be used to ensure that all
important points are covered. As with the depth
interviews, the schedule should not be allowed to
limit discussion.
Prior to starting the group interview, it is im-
portant for the facilitator to open the discussion
by welcoming the group and getting everybody
introduced, providing an overview of the topic,
outlining the ground rules of the discussion, get-
ting permission for the use of the tape recorder,
and explaining the role of the observer or re-
178
— ee
corder. There are a number of special issues that
the facilitator should be aware of while running
the group. These include the following.
¢ The group must remain focused and discus-
sions on Side issues should be limited.
@ Difficult personalities such as dominant
people, excessively shy people, those who
ramble, and argumentative members need to
be monitored and controlled so that they do
not disrupt the group. It is important to geta
balance of participation between the different
members.
¢ Potential group members need to be reminded
of the meeting by the facilitator (or some other
intermediary person) in advance, to minimize
the problem of cancellations and no-shows.
@ The facilitator needs to guard against his or her
powerful role biasing the group.
@ The facilitator will at times have to use probes,
such as direct questions, to elicit additional
information of interest. Probes should not be
overused, as this will inhibit discussion.
At the end of the discussion, group members
should be thanked for their participation and told
what will happen to the information that was
gathered in the group. For every group discus-
sion, there should be an audio tape record. In
addition, the recorder should keep detailed notes
on the body language and social processes in the
group, as well as brief notes on what was said.
Participant observation
This particular style of data collection requires re-
searchers to involve themselves directly in the
lives and worlds of those being studied and expe-
rience their reality. In this process, the researcher
gains a greater understanding of the context. The
method is based on the assumption that under-
standing of the inner perspectives of subjects can
only be achieved by actively participating in the
subjects’ world and gaining insight by means of
observation. This makes it potentially the most
powerful tool for developing an understanding of
the experience and meanings attached to certain
behaviours and phenomena. Its major disadvan-
tage is its time-consuming nature.
The method is not commonly used in health
research, but it does have potentially important
applications. Some such applications include
observations of how the flow of patients through a
clinic is working (health services setting), an
assessment of how well safety regulations are
adhered to, and how the workers feel about these

(occupational health setting), and in investig-
ations of infectious diseases (such as AIDS), it
may determine indicators of risky patterns of
sexual behaviour. The data collection covers a
range of activities, including observing, listening,
asking questions, and recording, which can be
done either covertly or overtly.
The first stage in a participant observation is to
select and get access to the site of the research.
The researcher needs to be free to move around
easily and participate in the activities of the
community or group, while preferably remaining
relatively inconspicuous. The process of gaining
access is vitally important, as it determines in
many ways how responsive the community or
group is likely to be to the researcher. The nature
of the research should be explained to the re-
search subjects as far as possible, especially how
the information will be used. Where possible,
access should not only be negotiated with those
in authority, but also with individuals at different
levels, so that a broader understanding can be
achieved. A number of techniques to facilitate the
process of gaining access are covered in the refer-
enced texts.
Once in the field, the researcher has to decide
to what extent to participate in the activities of the
community. Some researchers merely act as
observers and try to maintain a distance from the
activities of the community, while others seek to
get involved as much as possible. This is both a
practical and an ethical decision.
Collecting field notes can be difficult. While
it will be impossible to record everything that
happens, it is vital that very detailed data record-
ing takes place. This can be done in a range of
ways, most commonly field notes, audio taping,
and video taping. Field notes should consist of
relatively concrete, complete, accurate, and
detailed descriptions of social processes and their
contexts.
One particular issue concerning field notes is
that the subjects being observed may be threat-
ened by the note-taking, and this could in turn
compromise the research. In such instances, only
brief notes should be made as unobtrusively as
possible and the fuller version should be done ata
later stage from memory, when the researcher is
alone.
Finally, when leaving the field, the researcher
must be aware of the powerful social connections
made in this type of research, and the effect that
the research process has had on the community.
Full and proper goodbyes need to be said and
19 = qualitative methodology: an introduction
details of the future research plans given. The
researcher needs to be clear about when to leave
the field by either setting a date or a point in terms
of the quantity of data obtained, as it is tempting
to stay in the field indefinitely.
Other methods
There are a number of other qualitative methods
which are available to the researcher, but are less
commonly used.
Researchers often keep research diaries to
supplement the data collected. Research diaries
utifize valuable information picked up while the
researcher is interacting in the research setting.
The use of documentary evidence includes the
analysis of photographs, tapes, life histories, and
old documents. Other more experiential methods
would include activities such as role play, project-
ive techniques and visualization exercises. While
all the methods of data collection discussed in
this chapter are often used individually, they may
also be used in combination. The different meth-
ods are used to assess different types of inform-
ation and to back up findings found in one of the
other research methods.
Other methodological issues
Sampling
The usual epidemiological practice of formal
random sampling with ‘concern for adequate
sample size is inappropriate in qualitative stud-
ies. The depth of the data gathered is the primary
goal, rather than statistical inference. Within
qualitative methods, greater emphasis is placed
on purposive sampling. This is a sampling
method in which the researcher deliberately
chooses respondents or settings in order to en-
sure that the sample covers the full range of pos-
sible characteristics. In this approach to sam-
pling, the researcher purposively tries to obtain a
sample that represents all important subgroups
of the population, by targeting specific sectors.
This includes sampling deviant or extreme cases,
typical cases, critical cases, politically important
or sensitive cases, and sampling to maximize the
variation. It is hoped that the diversity of the
target group, as well as what is typical can be
covered in this way. Haphazardly selecting
people for convenience is discouraged, as the
results can be heavily biased (Patton 1980).
Sample size is often determined by logistical
issues of available time and funding. Two poten-
179
d= common approaches in epidemiology
Date pile, Te IEE A SR Re re
tial ways of defining sample size in the field are
firstly to continue in the field until the researcher
has enough information to answer the initial re-
search questions, or until no more or very little
new information is being gained from successive
interviews. The second method is to use the initial
interviews to establish hypotheses and use suc-
cessive interviews to validate or adjust these
hypotheses. Interviews will continue until the
hypotheses require no further adaptations in
terms of the new information being gathered, and
the researcher feels that they adequately explain
what is being researched.
Analysis of qualitative data
The development of methods for analysis has
lagged behind the development of data collec-
tion, but some important texts have appeared
(Miles and Huberman 1984; Strauss 1987). It is
important, however, that the researcher does not
blindly follow others’ practices, but adapts the
analytic procedures to the demands of the situ-
ation and the data. While there are no fixed rules
for the analysis of qualitative data, there are some
key aspects that need to be noted.
The general term often used for the process is
content analysis, which basically means that the
data is explored in detail for common themes and
these are then established into units of meaning
or codes. At a later stage, these codes become the
basis of further analysis in terms of their content
and meaning. Although this is costly and time-
consuming, taped material should be typed or
written out (transcribed), as the written word is
the basic medium for analysis. The task of tran-
scribing should not be underestimated. Depend-
ing on the quality of the tape recording, it can take
four to eight hours to transcribe a one-hour tape.
Every single word that is said by both the inter-
viewer and the interviewee has to be written
down. From early on in the data collection pro-
cess, coding should begin so that the key areas
can be drawn out to re-inform the data collection
process.
Coding consists of searching the data for
common themes which can be established
categories into which later information can be
inserted. Over time, this coding should move
from the original crude codes to becoming more
complex. At this point, codes should start to over-
lap, so more complex codes may need to be devel-
oped and subdimensions of these codes created.
For example, if the general code concerns atti-
tudes towards the use of condoms, the subdimen-
180
eS
sions could be that they are unerotic, that they are
embarrassing to use, or that they are difficult to
obtain. :
As the data collection continues and the codes
become more complex, there is a need to start
summarizing and to begin making some sense of
the data. The use of theoretical memos is import-
ant and should begin early on. These are brief
notes of potential hypotheses or observations
that can be made while coding and examining the
data. All notes should be filed away to be used as
a resource later on when doing the final inter-
pretation of the data. During the project, the
notes will become more complex and closer to
the final interpretations that will need to be
made. From all of the above, the key issues and
important factors need to be drawn out and the
final interpretations stated. It is important to
relate the final interpretations to existing theories
about the subject to obtain greater depth and
understanding.
A number of techniques may be used to verify
and interpret results. These include the triangu-
lation method, in which the results using differ-
ent methods are compared to see if they comple-
ment each other. Another method is to set up ini-
tial hypotheses and then to search the data for
disconfirmatory results. If any such results are |
found, then the hypotheses may need .to be
adapted to take them into account. These help to
make qualitative results generalizable. Validity
and reliability can be further enhanced by com-
paring results between interviewers, by getting a
number of people to analyse the same sections of
the same material, or by relating the results to the
theory on which the research was based.
Training
This chapter is a brief overview of qualitative
methods and cannot be considered a training
guide. The references for this chapter will give
some additional guidelines on theory and tech-
niques, but do need to be backed up with experi-
ential learning and support. Initial training can
often be passed on via a short set of workshops by
as . someone who is skilled in this area. It is only in
the process of working with others that the tech-
niques can really be known and mastered. Key to
this is the fact that the researcher as a person is
the research instrument for qualitative methods.
Just as the questionnaire is the instrument in a
survey, the researcher is the means by which in-
formation is collected in qualitative techniques.
For this reason, a lot of hard work needs to go into

getting yourself ready for the task, even though
many skills are simply extensions of existing
social skills. Short courses on qualitative methods
are offered by most research training institutions.
Additional suggestions. for training include the
establishment of study groups within institutions
to learn about the methods. Another would be to
work alongside more senior and experienced
researchers.
Advantages and disadvantages of
qualitative methods
Advantages of qualitative methods
@ Since qualitative research is done within
people’s contexts, it can produce results that
directly represent how people feel. During this
process, the researcher will also get a closer
feeling of the general social functioning of the
person or the community.
@ The results obtained are often more accessible,
as they are descriptions of real situations rather
than statistical measures or diagrams, which
are often beyond people’s experience.
@ Innewareas of research, qualitative methods
can be useful for the production of new ideas.
They can also provide information for other
studies.
@ Ifnew information appears during the research
precess, there is space within the research
structure to explore it.
The ‘Hawthorn effect’ is used to describe the
effect of being watched or observed: people
often change their behaviour when they think
they are being observed. In qualitative re-
search, a skilled researcher will be able to use
the greater flexibility of the qualitative method
to get around this problem by using probes and
picking up on non-verbal cues.
Disadvantages of qualitative methods
@ There are often problems with the analysis of
the information, particularly due to researcher
subjectivity and bias.
@ The process of transcribing and analysing data
can be time-consuming and costly.
@ The material acquired may also not be easily gen-
eralizable, due to the small sample size, and the
non-random sampling technique often used.
Conclusion
Qualitative research methods are a useful and
valuable addition to an epidemiologist’s collect-
19 qualitative methodology: an introduction
ion of skills. Epidemiology has traditionally
focused on the use of quantitative data, which
allows for focused projects and the testing of pre-
set hypotheses. The qualitative method provides
research opportunities which extend the amount
of information that may be gathered, particularly
as it provides a greater level of understanding of
the processes that affect the results we seek in the
health field. Interest in the area is increasing, but
it remains an undeveloped field in epidemiology.
EXAMPLE 19.1
Depth interviews to evaluate a
community health worker project
Depth interviews were used as one of the research
methods for evaluating a community health
worker (CHW) project in Khayelitsha near Cape
Town. A sample of 10 community members who
had been visited by a CHW during the previous two
weeks were interviewed in their own homes. Inter-
viewing techniques such as clarifications and
reflective summaries were used to allow respond-
ents to explore how they felt about the visit by the
CHW. The interview schedule was built around a
single main question: ‘Please tell me about the last
visit of the CHW.’ Prompts were prepared to elicit
information that was not volunteered, for instance,
the purpose of the CHW visit, how the respondent
felt about the visit, the health problems experi-
enced by the respondent, whether the CHW asked
about these problems, and the information or ser-
vice rendered by the CHW. With the permission of
the respondents, the interviews were tape-
recorded.
On analysis it was found that community mem-
bers had volunteered examples of social and per-
sonal issues that they had discussed with CHWs.
Comments like ‘I feel very happy to talk to Nom-
philo about my problems and my secrets that are
worrying me. To talk to her gives me great relief’
and ‘Nomphilo is like a sister to me’ enabled re-
searchers to understand the texture of the rela-
tionship between the community members and
the CHWs.
Reference: :
Matthews C, Van der Walt H, Barron P. ‘A shotgun marriage:
Qualitative evaluation of a community health worker project
in Khayelitsha.’ South African Medical Journal 1994;
84(10):659-63.
181
d= common approaches in epidemiology

EXAMPLE 19.2 eight patients with tuberculosis were asked what

TB photonovel
There is a rising incidence of tuberculosis in the
Western Cape and one of the most serious prob-
lems is that only about 60% of patients complete
their treatment. During 1991, a project was started
with the aim of developing effective materials for
patient education (see Table 19.1). During the
first stage of the project, nurses who work in the
TB service used focus groups to discover how pa-
tients experience their illness. Groups of six to
it was like for them to live with the disease.
The results showed that patients felt stigmat-
ized and they were concerned about infecting
their relatives and friends. They also spoke about
the difficulty of continuing with directly observed
therapy once their symptoms disappeared. This
information was used as the basis for a photo
novel targeted at TB patients and their relatives
(Figure 19.1). The photo novel was pre-tested in
focus groups with TB patients. They were asked to

Table 19.1 TB case holding qualitative research process

PHASE WHO ACTIVITIES LEARNING

PARTICIPATED OPPORTUNITIES

1 Problem Committee of health Discuss problem and

Identification of service managers and __ possible strategies
high incidence of TB researchers

2 Problem exploration Core team (4) — Literature survey

Non-adherence to TB — Analyse patient
treatment : education

3. Data gathering Clinic nurses (7) Focus group discussion Skills in focus group |
‘How do patients Data analysis discussions. Listening
experience TB?’ gives new insight

Groups of patients Tell nurse about Affirmative of own

experience experience

4 Data gathering Coreteam(1) . Depth interview Deeper understanding

Life story of TB
patient TB patient (1) Tells life story Her story can help others

5 Useofdata Core team Script writing Media skills

Development of
photo novel Clinic nurses and Advice on script More insight into life of
domestic workers - Act as models TB patients

Neighbours at ‘shoot’ Contribute ‘props’ Awareness of TB

6 Pre-testing Core team Focus group Confirmation.

‘What do you think : discussion It works well
of the photo novel?’
TB patients Feedback on photo Others share similar
novel experiences. Their
experiences count.
Were recorded for
others to see

182
 19 qualitative methodology: an introduction

re wR Ut mC it oD
COUGH A LOT ? YOU SWEs

Suster, ek is altyd so moeg )

en ek skel heeldag my 4& pan
J

man en kinders. :
bYOU] MAYEHAVEST. Bo) TU GLY Cia wae
VT YOUR CLINE G8 DOCTOR aut youd CL 08 DOCTOR
AS SOON AS POSE ad SOOM AS MORALE
.

Jy is verniet bang vir aansteek, as

Sarah! Ek is op volle TB behandeling
en nou kan ek geen kieme versprei

HII

ALIVITINILIILIIN
a F
 d= common approaches in epidemiology
es a a eS
ve oe ot
first read the booklet and then say what they
thought and felt about the booklet.
Their response was enthusiastic and they
strongly identified with the booklet. Some of the
patients said ‘This could have been my life’. This
feedback convinced the management of the TB
Control Programme that the booklet fulfilled a
patient need and they decided to use it as one of
the means to support and encourage patients to
adhere to their treatment.
Reference:
Van der Walt H. ‘The role of participatory research to
enhance patient adherence to tuberculosis treatment’ in
Proceedings of the International Symposium on Participatory
Research in Health Promotion. Compiled by Korrie de
Koning, Liverpool School of Tropical Medicine, August 1994.
EXAMPLE 19.3
An intervention study to determine
levels of care in a hospital
During an intervention study which focused on
the levels of care in a large tertiary urban hospital,
a medical anthropologist used participatory
observation to examine the communication be-
tween nurses and doctors, and between health
care workers and patients. The researcher and her
research assistant alternated on the daily 07:00 to
16:00 shifts between the intervention and control
wards. Their observations included routine activ-
ities of nursing and medical staff, ward rounds,
and meetings related to the intervention. In addi-
tion, the researchers used individual and group
interviews. The data gave a description of the
organizational culture on the wards; for instance,
the differences in autonomy and authority be-
tween nurses and doctors, gender and class dif-
ferences between doctors and nurses, verbal and
nonverbal communication between health care
workers, and between health care workers and
patients.
The following example is a description of an
observation which illustrates a typical interaction
between nurse and patient.
One patient was observed for about two con-
secutive hours from 07:15 when the patient was
lying in bed, groaning from time to time. Nurses
184
SS Se SSS eel
walked past him all the time, and a student nurse
came to his bed, read his bed letter, paged
through his file, and apparently checked the in-
formation against the computer printout in her
hand.
08:42 Two student nurses were standing next to
the patient’s bed, talking to each other. A staff
nurse and student nurse came to tidy up the
patient’s bed. As they moved him around, he
groaned at times. Although they spoke to each
other, they never addressed him.
09:11 A student nurse came to take the patient’s
blood pressure. The patient was lying down with
his blankets pulled over his head. The student
nurse pulled the blankets away, took his arm and
started to take his blood pressure. She was speak-
ing in Xhosa to the staff nurse who was at the
opposite bed, taking patients’ temperatures.
When she had finished, she made a note of the
blood pressure in the patient’s file, washed her
hands, and walked on.
09:15 The staff nurse reached the patient’s bed-
side and said: ‘I must take your temperature.’ She
shook the thermometer and put it in the patient’s
mouth, saying ‘Okay, close your mouth.’ She
stood staring out of the window as she stood
holding his wrist but said nothing further. She
took the thermometer out and the patient asked
‘How much is it?’ ‘Thirty seven,’ she answered.
‘Thirty seven?’ the patient repeated. The staff
nurse smiled, wrote the temperature down on the
chart and walked away.
09:20 A second student nurse came to the
patient, apparently wanting to take his blood
pressure. ‘Hulle het dit al gevat’ (‘They have taken
it already’) he said. The nurse ignored him, took
his arm, and took his blood pressure again. After-
wards she stood staring at his file for a long time,
and then wrote something in it and walked away.
During those two hours the patient received
two orders, asked one question, and gave a nurse
information that an observation had already been
done. She chose to ignore him.
Reference:
Gibson, D. ‘Communication between health care workers
per se and between health care workers and patients: Level
of Care Intervention Study, Qualitative findings.’ Unpub-
lished report, MRC, 1994.
 SECTION

Epidemiology applied tto

content areas

Mortality Studies:
_ D Bradshaw
Outbreak investigations
SMetcalf, N Coetzee —
2 Estimating amunieation esverage
N Coetzee, D Berry, D Yach
Environmenta epidemiology:
Y von Schirnding .
Occupational epidemiology
JMyers .
Disability studies
J Katzenellenbogen
Psychiatric epidemiology
C Parry, L Swartz
Anthropometric studies
G Joubert
Assessment of dietary intake
M Langenhoven, P Wolmarans
Measurements in dental epidemiology
M Moola
Health economics
D McMurchy, E Thomas
20
Introduction
When placed in the context of public health, in-
formation about the number of deaths and their
underlying causes can be used to develop strat-
egies for improving lifespan and quality of life. Al-
though death provides a negative image of health,
the difficulties of actually measuring health or
even disease make mortality rates very useful
indicators. Routinely collected death information
or data collected from surveys and follow-up
studies can be used for both descriptive and ana-
lytic purposes. In the most basic type of study, the
level. of mortality is assessed for a particular
population or study group. In more sophisticated
analyses, geographic variations, trends over time,
seasonal or occupational variations, or other fac-
tors related to mortality are investigated to gain
an understanding of the risk factors associated
with mortality. The terms death rates and mortal-
ity rates are used interchangeably in this text.
It is strongly recommended that readers study
Chapter 2: Key concepts in epidemiology before
reading this chapter.
Issues in mortality studies
Determining the level of mortality
Summary rates
In order to measure the level of mortality, one
needs to calculate a rate by taking the number of
deaths relative to the population over a defined
period of time. Mortality rates can only be calcu-
lated if the death data as well as the population
figures are reliable.
In general, mortality levels vary with age, and
the rates typically follow a ‘bath-tub’ shape, with
Mortality studies
high infant and child mortality, low adolescent
and young adult mortality, and increasing rates
with increasing age. This pattern can be seen in
Figure 20.1 which shows, as.an example, the male
mortality rates due to the ill-defined causes for
each race group. Male rates tend to be higher than
female rates.
When comparing the mortality rates experienced
by different populations, it is therefore essential
to take account of any differences in the age and
sex structure of the populations. A comparison of
the crude mortality rates might reflect differences
in the age and sex distribution of the populations,
rather than differences in the actual levels of
mortality. The hypothetical example in Appendix
1 (see p. 273) is an illustration of how the older
group has a higher crude mortality rate, despite
having consistently lower mortality rates for each
age group. The crude death rate in Group B is 180
per 100 000 compared to the death rate of 155 per
100 000 in Group A. However, when the death
rates for each age group are compared, it is
noticed that the rates in Group B are actually
lower than those in Group A. The age distribu-
tions of the two populations differ, with popula-
tion B having a higher proportion in the older age
categories. The crude rates consequently reflect
the difference in the age structures. When com-
paring mortality in two populations, mortality
rates for each of the different age and sex groups
of the populations should be compared whenever
possible. These are known as age- and sex-
specific rates.
When there are many age and sex categories,
the comparison will become very complex and
difficult to assimilate. In this case, it will be neces-
sary to use a summary index which removes the
187
e epidemiology applied to content areas
rte we Meester CR
African males for the period 1984-86
- - White
— Coloured
-- Asian
— Urban Black
Oo
Oo
Oo
w
~
@
—
SO
fee
effect of the age and sex differences. The results
are known as standardized rates. A ‘directly’ stan-
dardized rate is the average rate of the study
population that would occur if the study popula-
tion were to have the age and sex distribution of
the selected standard population. In the hypothet-
ical example in Appendix 1, the age-standardized
rate for Group B is 150 per 100 000, compared to
190 per 100 000 in Group A. Calculating the age-
standardized rates allows one to compare the two
summaty rates after having removed the effect of
the age differences in the two populations.
Relative rates
A relative index that compares the mortality in two
populations can be calculated. The comparative
mortality factor (CMF) is the ratio of the ‘directly’
standardized rate of the one population divided by
that of the other population. In Appendix 1, the
CMF when comparing group A to Group B is 127%.
The age-adjusted mortality in GroupAis 1,27 times
higher than the age-adjusted mortality in Group B.
On the other hand, the standardized mortality
ratio (SMR) is based on ‘indirect’ standardization
and is used when the category-specific rates (for
example, age- and sex-specific rates) cannot be
calculated. In Appendix 1, the SMR is the number
of observed deaths divided by the number that
would be expected if the category-specific rates of
the standard population occurred in the study
188
me Cm Ce eT dy)
35 - 44 45 - 54 55 - 64 65 + Age
population. The SMR for Group A compared to
Group B as a standard would be 1,35. The
observed number of deaths was 620, and we would
expect 458 deaths if the age-specific rates from
Group B occurred in the population of Group A.
It can be seen from Appendix 1 that the value of
a relative index depends on the method used to
calculate it. While the nature of the relationship
will remain the same, the magnitude also de-
pends on what population was selected as the
standard. It is crucial to report details of the stan-
dard population and the method of standardiza-
tion when reporting standardized rates.
Directly standardized rates have the advantage
that when the same standard population has
been used for the standardization, the rates may
be compared to one another. This is because the
age and sex distribution for each CMF has been
adjusted in the identical way. Unfortunately,
when the same standard population is used for
indirect standardization, the SMRs are not com-
parable to one another, as the age and sex distri-
butions have been adjusted differently for each
SMR. However, the sampling error for the SMR is
generally smaller than the sampling error in the
case of the CMF, because only the total number of
deaths need to be estimated, compared to all the
specific rates in the case of the CMF. The variabil-
ity of an SMR will therefore be smaller than that of
a CMF, which makes it a useful index when the

numbers of deaths in categories are relatively
small. Since accurate data on the age distribution
of the population is often not available in South
Africa, the SMR is generally used to analyse data.
Key mortality rates used as indicators of health
The infant mortality rate (IMR) is a particularly
valuable age-specific mortality indicator. It is de-
fined as the number of deaths of children under
the age of one year divided by the number of
births in that year. It is used not only as an indic-
ator of the health status of children under one
year, but is also used to reflect the health status of
the whole population. Clearly, it is easier to moni-
tor this rate than the mortality rates over all ages.
However, in South Africa there is insufficient in-
formation to calculate the IMR for all groups.
Many births and deaths are not registered. Rou-
tinely available data can thus not be used to cal-
culate nationwide IMRs.
For this reason, surveys are conducted to col-
lect this information. Information is collected
from women included in the survey on the
number of children they have had in the past five
(or two or 10) years, and of those, how many have
died. This data is grouped into a cohort of births
and the probability of dying in each time-period is
calculated. This is known asalife table analysis,
and is used to estimate the IMR or the childhood
mortality rate (the probability of a child dying
before the age of five). Surveys can also be done to
collect information which can be used to estimate
the IMR through indirect demographic tech-
niques. These do not collect the number of births
and infant deaths that occur during the study
period, as these are subject to various biases when
collected directly, and require very large samples.
Instead, these surveys depend on the relationship
between some more easily obtained data and the
desired mortality indicator. Indirect methods
provide estimates of IMR which relate to a prior
period. The most commonly used example of an
indirect method, the Brass method, is to survey a
sample of women and ask them how many chil-
dren they have ever had, and how many of those
children have died. The proportion of those dead,
according to the age of mother, can be converted
into an infant mortality rate on the basis of model
life tables. The advantage of the Brass method is
that it does not require the dates of birth or death
of the children, but relies rather on the mother’s
age. Both these survey methods have problems
with recall bias and proxy reporting (some house-
hold members may not be aware of infant deaths
20 = mortality studies
which occurred a long time ago). Since popula-
tions are often very mobile, it is also unclear what
groups the respondents in a survey represent.
In another indirect method, the McCrae and
Brass method, women are asked at the time of
delivery about the outcome of their previous
delivery. This clinic-based approach is much
more practicable than a field survey. However,
the potential biases in this method are unknown
in South Africa.
Although the infant mortality rate is widely
used, many demographers are now proposing
that a childhood mortality rate, which reflects the
chance of dying over a few years, would be a better
index to estimate, as it is less subject to error than
the infant mortality rate. The childhood mortality
rate usually considers children up to the age of
five years and is known as the Under 5 Mortality
Rate (U5MR). It is also important to focus on the
U5MR rather than the IMR as the burden of high
risk of death shifts from infants to toddlers.
In South Africa, the importance of adult mortal-
ity is increasingly becoming apparent. The 45Q15
is a very useful summary index of adult mortality.
Based on a life table calculation, it is the probabil-
ity of a 15-year-old individual dying before reach-
ing the age of 60. In 1985, it was estimated that
40% of 15-year-old South African males and 23%
of 15-year-old South African females would die
before the age of 60. These rates of adult mortality
are extremely high, and are comparable with
those in the rest of sub-Saharan Africa.
Determining cause of death
In the health context, it is important to investigate
the causes of death. Unfortunately, the death
certificate used in South Africa in the 1980s and
1990s does not facilitate the systematic collection
of information needed to determine the under-
lying cause of death. No distinction is made on
the certificate between the direct cause of death
and the underlying cause, which means that the
certifiers have to use their discretion as to which
cause they report. Causes are coded according to
the International Classification of Diseases. The
underlying cause of death is of public health im-
portance, since it is the cause at which prevention
should be aimed.
If the size and age distribution of the popula-
tion is known, an analysis of the cause of death
can be based on age- and cause-specific rates, or
age-adjusted rates by cause. In the case of the
denominator (that is, population figures) not
being known or being unreliable, it is possible to
189
e epidemiology applied to content areas
assess the relative importance of different causes
of death by considering the proportional mortal-
ity.
As in the case of mortality rates, the cause of
death pattern is influenced by age and sex. For
comparative purposes, it might be necessary to
calculate the proportion of deaths due to a part-
icular cause within each age and sex group. When
there are numerous age/sex categories, a method
of summarizing the information is necessary. One
index is the Proportional Mortality Ratio (PMR).
This is calculated by taking the total number of
observed deaths due to a particular cause, and
dividing it by the total number of deaths expected
due to that cause if the proportion for each
age/sex group is that of the standard population.
Sometimes it is difficult to interpret the PMR. For
example, if the PMR is high for a particular cause
of death, it is not possible to distinguish whether
the death rate due to this cause of death is high or
the rates for the other causes are low, making the
proportion appear high.
The potential years of life lost (PYLL) is also a
summary index. This index does not attempt to
standardize for age, but actually utilizes the differ-
ences in the age structure of the deaths. The total
number of years of life lost by a population can be
calculated by totalling the years that each death is
‘premature’ (for example, the number of years
that each death occurs before the age of 65, or any
other selected age cut-off point). In order to calcu-
late the total PYLL, the number of deaths at a par-
ticular age is multiplied by the difference between
that age and the selected age cut-off. In South
Africa, it is reasonable to consider 65 as a suitable
cut-off age, as this is close to the life expectancy at
birth. Mathematically, the PYLL is expressed as
64
PYLL => d,(65-x), where d, is the number of
deaths occurring at age x.
The total potential years of life lost can be divided
according to the underlying cause of death, and
the relative importance of different causes of
death can be measured by taking the potential
years of life lost for a particular cause relative to
the total potential years of life lost. In this index, it
is clear that the deaths that occur in younger age
groups are given greater weighting than the
deaths that occur in older age groups. This gives
the PYLL particular importance in public health,
where there might be more incentive to reduce
premature mortality.
190
The disability adjusted life year (DALY) is a
newly developed index that combines the years
lived with a disability (weighted according to the
severity) with the years of life lost due to premature
death. This index uses data from morbidity and dis-
ability surveys in conjunction with mortality data.
Determining geographic variations
The geographic variation in mortality is often
investigated to identify factors related to the
disease. The magisterial district of residence of
each person who dies is available from routinely
collected mortality data. This allows rates over the
whole country to be calculated at the level of
magisterial district. An example of such a study
indicated that the rates of certain cancers were
unusually high in the areas around Prieska in the
Northern Cape, where asbestos is found, thus
implicating asbestos as a cause of the cancer
(Botha, Irwig, Strebel 1986).
Indirect standardization is often incorrectly
applied in such analyses. If the population data is
available, it would be better to use direct standard-
ization, as the SMR for one magisterial district is
not comparable to the SMR for another. Further-
more, it must be borne in mind that the coding of
magisterial district information might not be con-
sistent; for example, some deaths of Wynberg resi-
dents have been coded as occurring in Cape Town.
Determining trends over time
It is important to assess whether mortality levels
change over time. The first step in such an ana-
lysis is to examine graphs showing the mortality
rates over time. If possible, age-specific rates or
standardized rates should be investigated to
check that apparent changes in mortality rates are
not due to changes in the age structure over time.
Cervical cancer mortality trends in South Africa
from 1949 to 1990 are shown in Figure 20.2 (Bailie,
Selvey, Bourne, Bradshaw 1996). The world age
standard was used as standard population. It can
be seen that the age-standardized rate for white
women declined after the mid-1960s, while that
of coloured women rose. The rate for Asian
women fluctuated from year to year because of
the relatively small number of deaths each year.
However, it also shows a downward trend from
1970. The data for African women was not avail-
able for this period.
Many factors are related to changes in cervical
cancer mortality, but the introduction of cytolo-
gical screening (PAP smears) during the 1960s
and 1970s has had an impact in many developing
 20 = mortality studies

srw erm A eee er mac Lae Cr

000
/1Mortality
rate

1949 1954 1959 1964 1969 1974 1979 1984

—+ Coloured —A— Asian

Sra we me LB birth cohorts — whites

Birth cohorts

-¥— 1951= 1960

1941 - 1950

1931 - 1940

1921 - 1930

1911 - 1920

000
/1Mortality
rate 1901 - 1910

1891 - 1900

1881 - 1890

F
OF
koe
+ 1871 - 1880
Age of death

191
e epidemiology applied to content areas
Figure 20.4 Cancer of the cervix: mortality rates for birth cohorts — coloureds
°So
S
a
2
wo
= O 1921 - 1930
os
4c
oO
=|
KZ
ee: a if | I L 1
20 25 30 35 49 45 50
Age of death
countries. A cohort analysis of the South African
data is shown in Figures 20.3 and 20.4. These
show that the pattern of mortality in successive
birth cohorts for white women has dropped and is
consistent with a reduction in mortality following
the advent of cytological screening in the 1960s.
The same trend is not evident in the birth cohort
analysis of the mortality for coloured women,
where there is no evidence ofa drop.
When analysing the trends in mortality rates, it is
important to distinguish between a cohort effect
— the effect of mortality on an entire population
born at the same time — andaperiod effect,
which is a change in mortality patterns over time.
Statistical models can be used to extract the three
components from trend data: age, period, and
cohort effects.
Another way of analysing mortality data is to
select a cohort at birth and follow their mortality
pattern through life. This is often used in the form
of a historical cohort analysis, where historical
records are investigated to retrieve mortality
information. Records might be those routinely
available through the registration system, or might
be obtained from less conventional sources such
as church records, immigration records, or special
interest collections. Data collected in this way
needs to be assessed carefully for completeness.
192
Birth cohorts
“7 1951
-1960
“?~ 1941 - 1950
~ 4931
-1940
AX 1911 - 1920
-@ 1901
-1910
1891 - 1900
L
59 60 65 70
One method of summarizing cohort mortality
information is to use the life table technique. For
each age, the probability of dying is calculated by
taking the number of deaths in that age group
relative to the average number of individuals in
that age group. From this cohort life table, the
expectation of life at any age can easily be calcu-
lated. The expectation of life at birth is commonly
used as a summary index to describe the overall
mortality pattern.
It is important to be aware of possible changes
in coding practices which might account for
changes in the mortality level (Example 20.3). The
type of analysis will depend on the variability in
the data and the patterns seen. For example, the
analysis of the trend in diarrhoea will require the
seasonal variation (high summer rates, low winter
rates) to be taken into account through a special
statistical procedure called time series analysis.
Comparisons in proportions over time are very
difficult to interpret, as apparent changes in one
cause might be due to changes in a different
cause. For example, the proportion of deaths due
to circulatory diseases in white males dropped
between 1970 and 1984, but this could be due to
the increase in injury-related deaths rather than
to a decrease in circulatory diseases.

Ecologic studies
Mortality statistics from different areas are often
combined in an effort to understand the relation-
ship between a particular factor and the mortality
levels in these areas. These are known as ecologic
studies. A scattergram or bivariate plot, compar-
ing the mortality rates against some other factor,
usually indicates whether there is an underlying
relationship or not. It is unlikely that a relation-
ship will be demonstrated unless the mortality
rates as well as the factor being investigated dis-
play a wide variation. Genuine relationships do,
however, tend to be masked by various biases in
the data. For example, the quality of mortality in-
formation varies from region to region. Similarly,
the ability to measure the exposure of interest
may vary. Ecological studies are becoming in-
creasingly important with the growing awareness
of the effects of environmental agents on health.
Although they can contribute towards an under-
standing of the etiology of a disease, it is import-
ant to realise the limitations of these studies.
There is an ‘ecological fallacy’ in assuming that a
population relationship between a certain expo-
sure and some mortality implies that individuals
who are exposed to the factor are at higher risk of
dying. In order to draw such a conclusion, it is
necessary to undertake individual-based studies.
Mortality information in
South Africa
Aside from the problem created by under-report-
ing and misclassification of mortality inform-
ation, South African mortality data does not con-
tain useful socio-economic variables. It is there-
fore not possible to analyse mortality data
according to socio-economic class. Information
on race was previously used as a proxy measure
for socio-economic class, thus providing valuable
insights into mortality differences. However, as
from 1991, demographic information on regis-
tered deaths no longer includes race. Adequate
measures of socio-economic class (for example,
usual occupation) should be included in mortal-
ity and census information, as well as race group.
Despite these limitations, careful analyses and
interpretation of mortality data can provide
extremely valuable health care and epidemi-
ological information. Routine collection and
analysis of mortality data should become a cor-
nerstone of monitoring health status in the newly
developing Health Information System.
20 = mortality studies
EXAMPLE 20.1
The estimated cause of death profiles
for 1990: proportional mortality and
potential years of life lost (PYLL)
An analysis of the 1990 RSA death data obtained
from Central Statistical Services indicated exten-
sive under-reporting of deaths. Comparing the
number of deaths in each age group against the
census, it was estimated that only 55% of African
deaths were registered. Adjusting the African
deaths by this factor, it was estimated that there
wére 199 537 deaths in the whole of South Africa
that year, which accounted for a total loss of 4,4
million years of life. The death of a person younger
than 65 years was considered to be premature.
The estimated proportional mortality for the
top 20 causes is shown in Figure 20.5 (Bradshaw,
Laubscher, Schneider 1995). The ill-defined cat-
egory accounts for the highest proportion of 23%.
Other respiratory conditions, which include
bronchitis and chronic obstructive diseases,
account for 9,6%, and cerebrovascular disease
(stroke) accounts for 7,4% of the deaths. The over-
all death profile in South Africa reflects a com-
bination of poverty-related diseases, chronic
disease related to a Western lifestyle, and trauma.
The relative impact of the causes of death based
on the PYLL gives more weight to the deaths
which occur at younger ages than those at older
ages. For example, it can be seen from Figure 20.6
that conditions originating in the peri-natal
period contribute the largest proportion of the
total PYLL (20,3%). Implicit in any index is the
‘value of life’ at different ages. The PYLLs are
important from a public health point of view as
they can be used to identify the causes that would
have the greatest impact on the premature loss of
life. The profile suggests that public health prior-
ities in South Africa include infant mortality,
infectious diseases, violence, TB, nutritional defi-
ciencies and chronic respiratory conditions.
EXAMPLE 20.2.
Using the indirect method of estimat-
ing the infant mortality rate in Hewu,
Eastern Cape
A survey was conducted in the Hewu district of
Eastern Cape during May 1986 to obtain an esti-
mate of the infant mortality rate (IMR), as it was
known that the death and birth registers were in-
complete. Some 5 102 households were included in
193
e epidemiology applied to content areas

Sra tee CUM Cyemt LLL South Africa (1990)

(Total — 199 537 deaths)

percent
Sign/symptom ill-defined 23,33
Other respiratory 9,58
Cerebrovascular 7,35
Certain perinatal conditions 6,22
Ischaemic heart 4,86
Pulmonary circulatory 4,76
TB 4,51
Digestive cancer 3,99
Intestinal infection 3,85
Other violence 3,82
Other digestive 2,91
Endocrine/metabolism 2,90
Respiratory cancer 2,02
Genitourinary cancer 1,84
Nervous system 1,82
Other bacterial tts
Urinary system 1,52
Hypertensive 1,50
Homicide 1,49
Nutritional deficiency 1,19

10 20 30 percent

Sra em CC Ae mC Africa (1990)

(Total — 4 423 907 PYLL)

percent
Certain perinatal conditions
Sign/symptom ill-defined 14,32
Intestinal infection 10,75
Other respiratory 8,74
Other violence 5,94
TB 4,32
Nutritional deficiency 3,37
Nervous system 2,83
Pulmonary circulatory 2,61
Cerebrovascular 2.31
Homicide 2,28
Other digestive 2ohe
Other bacterial Zale
Congenital anomaly 1,79
Transport accidents 1,58
Digestive cancer 1,58
Viral 1,49
Other accidents 1,37
Endocrine/metabolism 1,16
Ischaemic heart 1,14

30 percent

194
 20 mortality studies

Figure 20.7 Number of deaths per year due to ICD codes 412 and 414 ex-
pressed as a percentage of the average number for the period 1968-1984

t
eo
Asymptomatic IHD
m

ob
©
o>
=
hw
®
>
°o
®
D
f©
ad
®
=>
wo
-
o seem Coloureds
~
Cc —~-— Asians
®
2
®D
a

Chronic IHD
am 412

21S td, (OpRTO> TiALOas oe 00 aol 82 83 84

Year

the survey, and data was collected from 7 792
women of child-bearing age. From the replies to
questions about their children born in the preced-
ing five years, it was estimated that 41 per 1 000
liveborn children died in the period 1981-1986.
Using information on all children ever born,
Brass’s indirect demographic technique indic-
ated that for the same period, the IMR ranged
from 80-100 per 1 000 live births.
The discrepancy in the estimates could be
attributed either to recall bias, or bias due to
proxy reporting (in the case of the survey), or to
the model life table being inappropriate (in the
case of the indirect estimate).
Reference:
Yach D, Katzenellenbogen J, Conradie H. ‘Ciskei infant
mortality study: Hewu district.’ South African Journal of
Science 83:416-21.
classification during the period 1968 to 1984, the
numbers of deaths for a given cause in each year
for whites, coloureds, and Asians were separately
expressed as percentages of the average number
of deaths due to that cause in that population
group over the whole period.
The graph (Figure 20.7) of the trend in the mor-
tality due to two codes related to ischaemic heart
disease (IHD) shows that between 1980 and 1983
there was a marked change in the coding practice.
The sharp drop in deaths categorized as due to
chronic IHD (ICD 412) was matched by an in-
crease in deaths due to asymptomatic IHD (ICD
414). Clearly, researchers who focus on trends
observed in mortality in one specific selected
cause, should also look at trends in all closely
related causes to ensure that observed changes
are real and not due to coding changes.

EXAMPLE 20.3
Achange in mortality coding practice
Reference:
Bradshaw D, Botha H, Joubert G, Pretorius J P, Van WykR,
in RSA Yach D. Review of South African Mortality (1984). Medical
To evaluate the consistency of the cause of death Research Council, Technical Report No 1, Parow, 1987.

195
21
Introduction
« 1993, only 43 outbreak investigations were re-
The history of epidemiology is intimately linked
with the investigation of disease outbreaks. John
Snow, an English physician, developed the prin-
ciples of outbreak investigations in his classic
research of cholera outbreaks in 19th-century
London (see Example 21.1). The terms ‘epidemic’
and ‘outbreak’ are often used interchangeably. An
epidemic is the occurrence of cases of an illness in
a community or region at a level that is clearly in
excess of the background incidence of disease for
this defined group during a particular season and
time period. (Season is included as many infec-
tious diseases show seasonal variation in inci-
dence rates.) The term ‘outbreak’ generally refers
to an epidemic which affects fewer people, is of
shorter duration, and is localized within a specific
geographical area. The Centers for Disease Con-
trol and Prevention of the USA define an outbreak
as ‘the occurrence of two or more cases which are
epidemiologically related’.
This was the case in the 1975 Marburg epidemic
that occurred in Johannesburg, in which three
cases and one death were recorded. The purpose
of investigating outbreaks is to identify factors
that are associated with the source and/or cause
of the outbreak, and are crucial to disease control
and prevention interventions. Properly con-
ducted outbreak investigations are invaluable in
evaluating reasons for failure of control pro-
grammes (such as immunization programmes),
informing public health policy, and uncovering
new risk factors (and even causal associations) in
poorly understood diseases.
Because of limited resources andalack of field
epidemiologists, relatively few outbreaks are
196
Outbreak
investigations
investigated in South Africa. Between 1960 and
ported in the South African Medical Journal
(Coetzee, Malusi, Moeti 1993), although the
number of reports of South African outbreak
investigations is greater than this if other publica-
tions, such as Epidemiological Comments and
foreign journals, are considered.
The number of cases needed before an invest-
igation is warranted depends on the nature of the
disease. In outbreaks of communicable diseases,
or of diseases which are serious in terms of
morbidity and/or mortality (for example plague,
cholera, viral haemorrhagic fever), only two or
three cases can signal the need for a full outbreak
investigation.
Although people commonly associate outbreaks
or epidemics with infectious disease, it is impor-
tant to consider the possibility that an outbreak
may be due to shared exposure to non-
infectious toxic agents (for example, outbreaks of
organophosphate poisoning in farm workers
exposed to pesticides). There are several modes
whereby a causative agent, whether infectious or
non-infectious, can be transmitted. In outbreaks
where the cause is unknown, the type of disease
symptoms will usually give some clue about the
source. For example, in outbreaks where the
symptoms are mainly gastrointestinal (such as
nausea, vomiting, or diarrhoea), the most likely
mode of transmission is through ingestion of
contaminated fluid (for example, water or milk) or
foodstuffs. In trying to determine the source of a
disease, it is important to bear in mind that
animals can play a role by acting as reservoirs of
infection (for example, rats can carry leptospirosis
and plague; several domestic and wild animals can

carry rabies), and that insects (for example, mos-
quitos carrying malaria) and arthropods (for
example, ticks carrying types of fever) can transmit
infection. The following section outlines a basic
stepwise approach to outbreak investigations.
Stepwise approach to outbreak
investigation
The efficient use of time is important in outbreak
investigations. Effective control measures should
be instituted as quickly as possible to minimize
the severity and public health impact of the
outbreak. This is best achieved by teamwork and
by following a systematic problem-orientated
approach, being logical and focused, and con-
tinually re-evaluating hypotheses as new inform-
ation comes to light. The emphasis given to the
different steps below will vary depending on the
extent to which the causative agent, the source of
exposure, and other key determinants are known
or suspected in the initial stages of the investiga-
tion. In practice, there is overlap between the
steps listed, and several steps are done concur-
rently, partially due to time constraints.
Detecting outbreaks
The most important surveillance system | is
disease notification, which is a statutory obliga-
tion on health workers to notify the health
authorities of patients with certain conditions.
However, it is likely that many outbreaks are not
detected, while others are not detected in time to
carry out a timely investigation because of delays
in reporting and failure of clinicians to notify
cases. Some diseases which have been respons-
ible for outbreaks locally were not notifiable at
the time (for example, whooping cough and
shigellosis). Laboratory-based surveillance of
microbial isolates and serology results are also
important for the detection of outbreaks, particu-
larly hospital (nosocomial) outbreaks, and out-
breaks due to non-notifiable conditions.
Confirming the diagnosis
Initial reports of disease outbreaks are sometimes
unreliable and may provide misleading inform-
ation about the causative agent. Apparent in-
creases in disease incidence may also result from
improved case detection, improved reporting,
changes in the diagnostic criteria, changes in
population size or composition, or false positive
laboratory tests.
21 ~~ outbreak investigations
These possible explanations must be consid-
ered and excluded each time a potential outbreak
has been detected. For example, a spurious out-
break of meningococcal meningitis occurred in a
rural town when a new hospital staff member
based diagnoses on microscopy of scrapings from
skin haemorrhages in suspected cases. This diag-
nostic method is particularly inaccurate, and 70%
of cases notified from this hospital turned out to
be conditions other than meningococcal menin-
gitis (Turk 1993).
Once an outbreak has been identified and
proved not to be merely an artifact of reporting or
case ascertainment, a definite diagnosis of the ill-
ness must be made. This will involve taking good
clinical histories, examining patients, and obtain-
ing laboratory test results (where appropriate and
feasible) at the outset of the investigation (see
Example 21.2).
To ensure uniformity in case detection, a case
definition should be established. The case defini-
tion should be as objective and specific as
possible while being easy to apply. It may com-
prise symptoms and signs (clinical definition)
and/or laboratory investigations (laboratory
confirmed case), depending on the disease under
investigation and access to laboratory tests.
When symptoms such as diarrhoea or fever
make up part of the definition, they need to be
clearly defined for the purposes of the invest-
igation (for example, ‘fever’ could be defined
as a sublingual temperature of at least 38,5 °C;
‘diarrhoea’ could be defined as the occurrence of
three or more stools of liquid consistency per
day for at least three successive days). If the out-
break is due to a recognized condition, reference
should be made to published case definitions
(for example, the Morbidity and Mortality
Weekly Report 1990 supplement), which serve
as a basis for standardization in comparisons
between different outbreaks.
It is useful to have a broad or lenient working
case definition (with high sensitivity) to identify
potential cases who need further evaluation (to
minimize the chance of missing cases), and to
have a more rigorous case definition (with high
specificity) for confirmed cases. It is often useful
to have an intermediate type of definition of
‘probable cases’ for suspected cases who do not
meet all the criteria for confirmed cases. For fur-
ther details on these different levels of case defini-
tion, see the Morbidity and Mortality Weekly
Report 1990 supplement.
197
e epidemiology applied to content areas
Table 21.1 Preliminary assess-
CaM Re re
investigation
41 Determine the extent of the outbreak: con-
tact hospitals, clinics, general Precuones
and/or schools.
2 Establish the causative agent if possible,
using laboratory tests if appropriate.
3 Inform all relevant authorities and get per-
mission to investigate. _ handle queries from members of the community
4 Assemblea teamof investigators.
5 Try to identify all people at risk.
_ 6 Obtain samples from the environment that
may be related to the source or transmis-
_ sion of the agent (e.g. water or food) and ~
arrange for laboratory analysis.
_ 7 Obtain any relevant lists of persons at risk
of exposure, lists of food ae yeed poi-
_soning outbreak).
8 Arrange for public relations.
9 Read up on the epidemiology of the condi-
_tion(s) being investigated once a presumpt-
_ ive diagnosis has been made. —
Preparing to investigate
Once the presence of an epidemic or outbreak
has been confirmed, a decision should be made
whether to do an outbreak investigation. This will
depend on the seriousness and public health
importance of the condition, the likelihood that
further investigation will help in effecting appro-
priate control measures, and the resources
(human and other) available to devote to the
investigation.
Once it has been decided to launch an outbreak
investigation, this decision should be acted on as
rapidly as possible. The steps outlined in Table
21.1 should be carried out as soon as possible
after receiving the outbreak notification. A multi-
disciplinary team should be assembled. The team
of investigators should include people with a
range of skills such as epidemiologist(s), micro-
biologist(s), public health physicians, and envir-
onmental health officer(s). A field manager, field-
workers, health inspectors, and data clerks (to
enter data onto computers) also need to be re-
cruited. As the people participating in outbreak
investigations usually come from a range of
health agencies and institutions, it is important to
establish good communication and co-operation
198
and a sense of teamwork at the start of the invest-
igation. A team leader should be appointed to
oversee the investigation, preferably someone
with good epidemiological skills. The people
involved in the field work should be relieved of all
other duties (if feasible) in order to devote their
time and attention to the task at hand.
Local health personnel who are familiar with
) the area and local population, and who will be
responsible for carrying out control measures,
should also be involved. A local health official
should be assigned the task of public relations to
and to provide information to the media.
Published material should be consulted once a
presumptive diagnosis has been made, including
reviews of the basic epidemiology of the condi-
tion(s) being considered, and accounts of similar
outbreak investigations. The Control of Com-
municable Diseases Manual (Benenson 1995)
is a useful resource. It lists communicable
diseases alphabetically and summarizes key in-
formation on the epidemiology and methods of
control for each condition. (It is recommended
that anyone likely to be involved in outbreak
investigations have a copy of this book in their
personal or work library.) A thorough under-
standing of the epidemiology of the disease(s)
helps investigators to ask relevant questions and
do appropriate and relevant environmental and
laboratory investigations, based on the most
likely sources and modes of spread.
Describing the outbreak
The cases which are first noticed in an outbreak
may not bea representative sample of the total
population affected. It is important to look for
further cases (which meet the broad working case
definition), in addition to those which alerted the
authorities to the presence of an outbreak. This is
because known cases may be onlya fraction of
the total, and may differ from other cases in
important attributes, which could misdirect the
course of the investigation. This is especially
important if initial reports are of hospitalized
cases, as only the most severe cases may be hos-
pitalized, and hospital cases may differ from
community cases. (For example, in measles and
whooping cough epidemics, hospitalized cases
tend to be younger and are less likely to be im-
munized than community cases.) All sources of
information which can be used to identify cases
should be considered, including records of hos-
pital admissions, clinic attendance, general prac-

titioners, school absenteeism records, disease
notifications, and death records. A decision
should be taken as to which sources to use.
A detailed description of cases is given accord-
ing to ‘person, time, and place’. This summary of
cases is useful for defining who is at risk of con-
tracting disease, as well as formulating hypo-
theses as to the likely sources of exposure, and
modes of transmission of the disease.
Person
Cases should be summarized in terms of key fac-
tors such as age, sex, occupation, ethnicity, socio-
economic status, and immunization status (as
well as other disease-specific relevant exposures).
Time
The time course of the epidemic should be stud-
ied by drawing up an epidemic curve, that is, a
histogram with the number of cases (on the Y
axis) plotted against the date of onset (on the X
axis). The shape of the epidemic curve is useful in
determining the nature of the source of infection.
A common exposure at a single point in time
(termed a ‘point source epidemic’) results in an
epidemic curve with a steep upward curve with a
well-defined peak and a relatively short time
course (Figure 21.1). In contrast to this, exposures
occurring over a period of time and conditions
which are readily spread from person to person,
are characterized by a broader, shallower epi-
demic curve, consisting of a less steep upward
curve, with one or more broad peaks occurring
over a protracted period of time. The date of any
community events which could be related to the
exposure should also be shown on the X axis of
the epidemic curve, as this may yield important
clues to the point at which infection was intro-
duced into the population. This may in turn pro-
vide clues about the source of exposure.
The epidemic curve will also show whether the
number of new cases is still on the rise or whether
it is declining, and so will help to indicate the
urgency of instituting control measures. (It is not
uncommon to find that the outbreak is already on
the decline, in which case the investigation may
be less urgent, as additional control measures
may not be needed.)
Place
Data collected should include home address, ad-
dress at work or school, location of any function
attended, and recent travel history. If the out-
break is in an institution such as a school or hos-
21 ~~ outbreak investigations
pital, or limited to a small geographic area, it is
useful to plot the spatial location of cases on a
spot map (Figure 21.2). This helps to demonstrate
clustering of cases by place and may provide clues
about the source of exposure.
The scale of the spot map will depend on the in-
vestigation and the geographical extent of the epi-
demic. If the cases are associated with an institu-
tion such as a school or hospital, they should be
plotted by location within the building (that is,
classroom or ward), and if they are confined to a
geographic area, they should be plotted on a
large-scale map showing features such as roads
and rivers. The location of potential sources of
exposure to infection, such as sources of drinking
water and ablution facilities, should be shown on
the spot map.
Ancillary environmental and microbiological
investigations
Depending on the nature’ of the outbreak and
whether or not the microbial agent responsible is
normally endemic in the population affected by
the outbreak, it is often useful to do environ-
mental and microbiological investigations to
complement epidemiologic investigations.
Evidence from environmental investigations
complements epidemiologic evidence, and, if one
is lucky, may confirm the source of infection. This
aspect of the outbreak investigation should be
overseen by someone with expertise in this kind
of investigation, such as a _ microbiologist,
hospital infection control officer, environmental
scientist, or environmental health officer.
Environmental specimens of possible sources
of infection (for example, food, drinking water,
swimming water) should be taken for micro-
biological investigation to provide evidence of the
source of exposure.
If you have access to microbiologists working in
specialized research laboratories such as the
South African Institute for Medical Research, the
National Institute for Virology, or universities
with medical schools, it may be useful (depending
on the organism under investigation) to request
that a microbiologist do specialized tests (for
example, ‘DNA fingerprinting’), using mole-
cular biology techniques, to characterize the
organism in specimens from patients and
environmental specimens. The use of ‘molecular
epidemiology’ may be useful in confirming or
refuting epidemiologic links between cases,
and in confirming environmental sources of the
outbreak strain.
199
e . epidemiology applied to content areas
Figure 21.1 Snow’s epidemic curve illustrating a point source epidemic -
a
o
a
oS
°
—
So
—
o
2
Ee
S
=
HORSAtie ecm COAT eZ eS
August
Source: Snow J. On the mode of communication of cholera. London, 1855. Reprinted in: Frost WH (ed). Snow on Cholera.
New York: Commonwealth Fund (1936).
Generating a hypothesis
The list of cases should be scrutinized for
common characteristics and exposures among
cases, as well as unusual characteristics or occur-
rences, as both can ‘provide important clues
about the source of exposure. John Snow sus-
pected that water from the Broad Street pump
was contaminated with cholera when he dis-
covered that the only case who lived a long way
away from the pump had water from it delivered
to her daily, because she liked the taste (see
Example 21.1).
Six of seven hospital-acquired Legionnaire’s
disease cases had been ventilated in intensive
care units, prompting the hypothesis that patient
ventilators were the source of infection. In
this case, the common exposures led to this
hypothesis (see Example 21.2). The descriptive
information, combined with a knowledge of
the relevant epidemiological literature of the
disease or conditions being considered, is used
to formulate hypotheses as to the most likely
source(s) of exposure and mode(s) of trans-
mission.
200
Pump handle removed
EP Labdataet aban
2 4 6 8 18 20 22 24 26 28 30
Date of onset September
Testing hypotheses
Discovering that an exposure is common among
cases does not implicate it with certainty. This
exposure may be common among non-cases as
well. It is thus necessary to do an analytical study
comparing risk factors and exposures of interest
in cases and non-cases, to help establish the most
likely source of infection. Secondary cases due to
person-to-person transmission from contact with
a known primary case should be excluded from
analytical studies designed to ascertain the
source of infection, as their inclusion will weaken
the magnitude of association with potential
sources of exposure. It is useful to consult an
epidemiologist when planning the design and
execution of hypothesis-testing studies. One of
two basic analytical study designs may be used. A
cohort design is used when the outbreak is con-
fined to a clearly defined group of people and it is
feasible to study all people at risk of becoming
cases (see Example 21.2). Point-source food
poisoning outbreaks that follow a meal or a
gathering of people are a good example of the
type of situation where it is useful to do a cohort
 21 outbreak investigations

A) =) oa®
am N el “ ” Bsi £ A] =m ° ed fe]eat & a] ” weeoecH Q ea} 6 c=)ct)& odel@ te)+ a
ie

fatal attacks ofcholera.

A study of the geographical distribution of

cholera deaths near Golden Square in London
1854 ’ showed a direct association with use of the
water pump in Broad Street.

Source: Galbraith N S, 1984.

201
e epidemiology applied to content areas
study of the entire population at risk. All people
(or as many people as possible) who ate at the
suspected place or function during the suspected
exposure period should be interviewed so that the
specific attack rate and the relative risk (rate ratio)
associated with eating each food item can be cal-
culated. A case-control design is used when it is
not possible to define or to study all people at risk
of becoming a case. The magnitude of the asso-
ciations between exposures of interest and
disease (case) status is the most important type of
evidence provided by analytical studies, and can
be used to assess which exposure is most likely to
be the source of infection. In a cohort study, this
is expressed as relative risks, while in a case-
control study, it is expressed as odds ratios.
In outbreaks in large populations or where
there is not a clearly defined group of people
among whom the majority of cases originated, it
is necessary to do a case-control study. A number
of sources may be used to select appropriate con-
trols. Suggested sources include: people attend-
ing the same health facility or family practice,
pupils from the same school(s), or people from
the same workplace or neighbourhood as the
cases. As only a sample of people with each expo-
sure of interest is studied, the rate of disease asso-
ciated with each exposure cannot be calculated,
and odds ratios are used instead of relative risks
as the measure of effect. Controls must be free of
the disease in question, and must have a similar
potential for exposure to the risk factors under
investigation as the cases.
If the disease is strongly associated with certain
characteristics such as age and sex, it may be use-
ful to match cases and controls to limit confound-
ing by these factors. Matching should only be
considered if the matching factor is strongly asso-
ciated with disease status, but the matching
factor is not itself a factor of interest. It is advis-
able to consult an epidemiologist or a biostatis-
tician if matching is used, as it is necessary to take
matching factors into account in the analysis.
In outbreaks affecting a small number of cases,
it may be useful to have more controls than cases
to improve the precision of the odds ratio estim-
ates. Up to four controls (matched or unmatched)
may be selected for each case. In outbreak invest-
igations using eithe, a case-control or cohort
design, the number of cases is often too small to
detect statistically significant associations, even
for causal exposures. However, the lack of statisti-
cal significance (p-values >0,05) should not deter
you from inferring that an exposure is causally
202
linked to disease (case) status if the magnitude of
the exposure-disease association (either the rela-
tive risk or the.odds ratio) is large in relation to
other exposures considered.
If the outbreak is due to one of the Expanded
Programme on Immunization (EPI) target dis-
eases against which infants are routinely immun-
ized (for example, poliomyelitis, measles, whoop-
ing cough), you should investigate the possibility
that the outbreak is due to inadequate vaccine
coverage and/or to vaccine failure (that is, poor
vaccine efficacy). Guidelines on carrying out vac-
cine efficacy studies in an outbreak setting are
provided in the reference by Orenstein et al
(1985), and some of these principles are illus-
trated in the reference by Coetzee et al (1994) de-
scribing an investigation of a measles outbreak in
Cape Town.
Data collection
If feasible, each case and control (or family
member of each case, if the case is a child or has
died) should be interviewed using a standardized
questionnaire. It is imperative that the method of
data collection is uniform, both among cases and
between cases and controls. For example, per-
sonal interviews of cases and telephonic inter-
views of controls could influence the replies to
questions. For the same reason, a structured stan-
dardized questionnaire is essential, as the actual
questions asked and the way they are asked may
influence answers. Items to consider in drawing
up the questionnaire are listed in Table 21.2.
Items should be selected from this list by con-
sidering what is known of the epidemiology of the
condition being investigated, omitting items
which are not potentially relevant to the invest-
igation.
Medical records are generally not a suitable
substitute for case interviews, as they tend to be
clinically orientated, and epidemiologically relev-
ant information on exposures of interest is often
omitted from the record. However, they are useful
as supplementary sources of information, espe-
cially for providing data on the results of dia-
gnostic tests and procedures.
Descriptive information should be entered
onto a computer as soon as possible in order to
create a basic list summarizing key attributes (for
example, age, sex, date of onset, area of resi-
dence) of cases. A laptop computer is useful if
available, especially if the investigation is being
done in arural area. This means that information
can be entered and analysed on the spot while the

Table 21.2 Items to consider in
outbreak investigation question-
naires
@ Symptoms (have a checklist and get a
yes/no response for each item).
Precise date of onset (rather than date of
visit to doctor or admission to hospital).
« Demographic characteristics (e.g. date of
birth, sex, home and work/school address,
ethnicity).
Places which could be related to source of
exposure and transmission to others
(household, classroom/ward, recent travel).
Time and place of contact with other cases.
Whether there is a previous history of the
disease being investigated (in conditions
where disease confers immunity against fur-
ther episodes, for example measles, whoop-
ing cough).
Immunization history (documented evidence
of immunization should be obtained).
Source(s) of drinking and bathing water.
Occupational details (especially where there
has been occupational exposure to chem-
icals or animals).
Leisure activities (for example fishing,
hiking, camping, watersports).
Animal contact.
Tick or mosquito bites (in outbreaks of
fevers).
Other disease and medication history (look-
ing especially for conditions which may lead
to increased susceptibility to the condition
under investigation).
investigation is in progress. The computer pro-
gramme Epi Info is specially designed for use in
outbreak investigations and is relatively easily
mastered by people with limited computer expe-
rience.
Implementing control measures
Once hypotheses have been tested, a decision
must be made as to the most likely causative
agent, source(s), and mode(s) of transmission, as
well as host factors (for example, lack of immu-
nization) which may have led to increased
susceptibility to the condition under investiga-
tion. This will enable recommendations to be
made on specific control strategies.
21 _~=soutbreak investigations
Recommendations should be clear and prac-
tically feasible in terms of local circumstances
and resources available. Both short- and long-
term control measures should be implemented.
Short-term measures
Measures to prevent further new cases develop-
ing include preventing exposure to the source
and/or breaking the chain of transmission. It is
often necessary to take interim control measures
based on preliminary information, before all
likely hypotheses have been tested. Any such con-
trol measures should be reconsidered during the
course of the investigation and revised in the light
of further evidence.
Long-term measures
Conclusions of the investigation should explain
why the outbreak occurred at the specific time
and place and identify weaknesses in existing sur-
veillance and preventive measures. These find-
ings should be used to draw up measures to pre-
vent similar outbreaks in the future, in the same
setting, and in other similar settings. The disease
surveillance system should be reviewed and, if
suboptimal, measures should be taken to im-
prove surveillance.
The investigation should be written up clearly
in the form of a report as soon as possible. The
report should cover the background to the invest-
igation; a description of the epidemic in terms of
person, time, and place; hypotheses considered,
with epidemiological and laboratory evidence
either supporting or refuting these hypotheses;
conclusions as to the cause, source, and mode of
transmission; and finally, recommendations for
both short- and long-term control. Copies of the
report should be submitted to the authority
requesting the investigation, local health author-
ities, and other collaborators, as well as to the
appropriate public health authorities at provin-
cial and national level.
The community in which the outbreak occur-
red should be kept informed while the invest-
igation is under way (without giving away hypo-
theses under investigation prematurely, as this
may bias the results of analytical studies), and in-
formed of the results of the investigation to allay
rumours and unnecessary fears, as well as to gain
their co-operation with control measures. The
results can be fed back to the community by
means of a presentation at a community meeting
and/or through a press release.
In concluding the investigation, consideration
203
e epidemiology applied to content areas
should be given to writing the investigation up for
publication. Publication of the findings is useful if
there is the potential for similar outbreaks in
other localities, or as a reference if innovative
epidemiological detective work and analytic
study designs were required to ‘solve’ the out-
break.
The investigation of disease outbreaks is one of
the most practical and useful applications of
epidemiology. A thorough investigation that is
clearly communicated and well documented
contributes significantly to progress in public
health delivery and clinical practice.
EXAMPLE 21.1
John Snow’s investigation of cholera
in the Broad Street area of London,
1854
In 1854, Dr John Snow investigated an outbreak of
cholera in the area around Broad Street, London.
Prior experience of cholera epidemics in 1831-2
and 1848-9 had led him to believe that cholera
was transmitted by contaminated drinking water,
but his theory did not have much support at the
time. An outbreak of cholera in his parish in 1854
gave him the opportunity to test this hypothesis.
In his initial investigation, he obtainedalist of all
reported cholera deaths in the three affected sub-
districts the week ending 2 September from the
General Register Office. He plotted them on a
street map and found remarkable clustering in
the area around the Broad Street pump (Figure
21.2). He took specimens of water from the Broad
Street pump daily and noted that the water devel-
oped a surface film and an offensive smell if left to
stand for a few days. He persuaded the parish
Board of Guardians to remove the pump handle
on 8 September to prevent further cases from this
source. A more extensive investigation in Novem-
ber that year, comprising a door-to-door survey
of all households and businesses in the area,
further implicated the Broad Street pump: of the
Broad Street residents, the cholera attack rate was
80/137 (58%) in people who were reported to
have drunk water from the Broad Street pump,
compared to 20/297 (7%) of those who did not
drink water from this source. Notable exceptions
also incriminated the pump as the source: one
case occurred in a woman who lived outside the
area, while 70 workers in a Broad Street brewery
were unaffected. Investigation revealed that the
204
woman had used water from the Broad Street
pump, and that the brewery had its own well
which supplied the workers with drinking water.
This outbreak had the characteristics of a point
source epidemic (Figure 21.1). The well in Broad
Street was no longer contaminated by the time
the pump handle was removed, as the epidemic
was almost over by this time.
Reference:
SnowJ. ‘On the mode of communication of cholera.’
London, 1855. Reprinted in: Buck C, Llopis A, Najera E,
Terris M (eds). The Challenge of Epidemiology: Issues and
Selected Readings. Washington DC: Pan American Health
Organization, 1988.
EXAMPLE 21.2
An investigation of Legionnaire’s
disease in a Johannesburg hospital
Between November 1985 and February 1986, 12
cases of Legionnaire’s disease were identified at a
Johannesburg hospital. Based on the knowledge
that the incubation period is two to 10 days, it was
determined that two cases definitely acquired the
disease in hospital, while five other cases might
have acquired the disease in hospital. Investiga-
tions were carried out to locate a hospital source.
A spot map was drawn of all hospital cases by
ward, and as water is known to bea reservoir for
L. pneumophila, the causative agent, water was
cultured from all hot water outlets in the hospital.
Although L. pneumophila was cultured in water
from three outlets, the distribution of these out-
lets did not correspond to the distribution of
cases, so they were disregarded as the source. It
was noted that six of the seven potentially hos-
pital-acquired cases had been ventilated.
Attack rates in intensive care unit (ICU) pa-
tients were calculated. according to whether or
not they had been on a ventilator. The attack rate
was 35% in ventilated patients, compared to 2%
in ICU patients who were not ventilated. This im-
plicated ventilators as the most likely source of
cases who acquired the disease in hospital, a find-
ing in keeping with known modes of transmission
of this condition.
Reference:
Strebel P M, Ramos J M, Eidelman IJ etal. ‘Legionnaires’
disease in a Johannesburg teaching hospital: Investigation
and control of an outbreak.’ South African Medical Journal
1988; 73:329-33.
22
Introduction
Childhood diseases which can be prevented by
immunization still account for considerable
morbidity and mortality in South Africa. Immun-
ization programmes aim to decrease the number
of such deaths and diseases by increasing the
immunization coverage, that is, the percentage of
the at-risk population which is immunized. It is
important that the success of such programmes is
evaluated. This can be done either by disease sur-
veillance or by determining the immunization
coverage. Disease surveillance (which entails
monitoring the incidence and distribution of
disease) serves as an indirect indicator of low
immunization coverage or poor vaccine quality.
In contrast to disease surveillance, direct assess-
ment of immunization coverage is an indicator of
programme success in reaching susceptible chil-
dren and preventing disease. Accurate immun-
ization coverage estimates have an additional
use, namely that of estimating vaccine efficacy
(using the ‘screening’ method) by comparing the
proportion of disease cases among immunized
children to the estimated coverage in the popula-
tion (Orenstein, Bernier, Dondero 1985). This
chapter will highlight methods used to assess
immunization coverage in order to direct pre-
ventative services to areas of need, and monitor
progress to the attainment of programme object-
ives.
Methods using routine data
The 1994 immunization programme review of the
Department of Health highlighted a poor under-
standing of the concept of immunization cover-
age among staff at clinics, with no standardized
Estimating
immunization
coverage
method for staff to evaluate and monitor their
progress (Department of Health 1994).
Clinic staff generally rely on costly and infre-
quent population-based survey estimates that
poorly reflect the outcome of their individual
efforts. Routine statistics of vaccine doses admin-
istered are collected by all clinics, and should be
used more effectively at this level to monitor the
success of outreach activities, and the proportion
of children who do not receive all successive
doses of each particular vaccine (drop-off). If the
quality of this data can be improved, routine re-
ports will have the advantage of providing contin-
uous and accessible information on coverage at
district or local level (Borgdorff, Walker 1988).
Administrative method
The traditional mainstay of coverage assessment
(at district and regional level) has been the rou-
tine reporting of immunizations issued, divided
by the estimated population. However, both the
numerator (doses of vaccine given) and the
denominator (usually births in an area or the es-
timated population at risk) lack reliability, with
resultant overestimation of true coverage. Values
in excess of 100% are commonly presented. Table
22.1 summarizes the sources of error.
Such coverage assessment data should be ap-
proached with healthy scepticism until proof of
validity is available. It is for this reason that other
methods of assessment and population-based
surveys are given more weight (Table 22.2).
Clinic-based coverage
An alternative approach to determining coverage
makes use of birth registers found in most clinics.
Notified births are entered into the register
205
e epidemiology applied to content areas
Table 22.1 etre of error in coverage data from vaccination returns
Numerator
@ Wasted doses (that is, doses recorded
may not equal doses given)
¢ Inaccuracy of reporting:
a) accidental
b) deliberate
Repeat vaccination (a child given two
doses of the same vaccine cannot be
distinguished from two children receiving
one dose)
chronologically and dates of vaccination entered
across the page. Any additional children not born
in the clinic catchment area are entered when
they present to the clinic for services. Children
that move out of the area are deleted from the
register. These registers are used to trace de-
faulters, but also provide a ready means of calcu-
lating clinic-specific coverage for any birth
cohort. The advantage over the administrative
method is that the numerator arises directly out
of the denominator, yielding real coverage per-
centages which cannot exceed 100% (Table 22.2).
These estimates, however, only reflect coverage
in patients who are known to the clinic, and extra-
polation to the population is possible only in
stable areas where the clinic is easily accessible to
the whole community, and is used by the whole
community.
Community-based surveys
A survey which goes into the community to deter-
mine coverage has the inherent advantage of
measuring the numerator (those immunized) and
denominator (both the immunized and non-
immunized) at the same time. Although signi-
ficantly more expensive, community-based sur-
veys can provide coverage estimates that are
more representative than those arising from rou-
tine sources (Table 22.2).
However, biases and other obstacles to accu-
rate assessment can still occur; for example:
children who are not at home at the time of the
206
Denominator
@ Census inaccuracy
¢ Underestimation of births in the target
population (the greatest error is in the most
needy areas; results in an unpredictable
_ bias) j
¢ Migration (particularly in rapidly
urbanizing areas)
The true ‘at risk’ group (should include
___ only susceptibles) is usually unknown
interview and who are therefore excluded from
the survey may represent a select group whose
immunization differs from those who are at
home;
immunization records may not always be avail-
able;
the complex study design may affect results.
EPI sampling
The Expanded Programme on Immunization
(EPI of the WHO has distinguished itself in the
application of a practical sampling technique,
uniquely designed for coverage assessment. The
EPI methodology was developed with a very spe-
cific purpose in mind — that of enabling health
service staff (as opposed to researchers) to obtain
a reliable coverage figure (a simple proportion)
(Henderson, Sundaresan 1982; Lemeshow,
Robinson 1985).
The derivation of the 30 x 7 sample (that is, 30
clusters of 7 children) was arrived at by fairly
straightforward extrapolation from simple ran-
dom sampling (see Appendix 4).
The WHO EPI manual Evaluate Vaccination
Coverage has proven extremely useful as a prac-
tical guide to the techniques involved. First, the
population is divided into convenient groups or
clusters (villages, street blocks). These divisions
are then weighted according to estimated popula-
tion size. Thirty clusters are then selected, using
simple random sampling. Within each selected
cluster, a starting point for the survey is then

Brel): er Mere eelty
A comparison of three methods used in estimating immunization coverage
Method Advantages
Administrative Population-based
Clinic registers Readily available
Efficiency measure, mamage-
ment tool
EPI cluster survey Population-based
Reliable
(Adapted from a presentation by Dr P Strebel at the National EPI review seminar in Pretoria on 21 September 1994.)
directly established by further sampling (second
phase sampling). Once in the field, individual
households are selected consecutively from these
starting points by the application of a rule such as
‘next house to the right’.
However, if the population structure of the divi-
sion is very heterogeneous (that is, some are fully
immunized, others not), it may be advisable to
divide it into a greater number of smaller divi-
sions or strata (see Example 22.1).
One of the methods described in Evaluate Vac-
cination Coverage is that of going to the centre of
a village and spinning a bottle or using some
other random method for choosing a random
starting direction, and then counting the number
of houses between the central point and the out-
skirts of the settlement. The standard approach
for obtaining a starting point is to select one of the
houses in the chosen direction by means of
simple random sampling. But this house does not
have the same chance of being selected as any
other house in the village. Any homestead nearer
the centre has a much higher chance of being se-
lected than one on the outskirts of the village.
This can be understood when one realizes that
the probability of being selected is not propor-
tional to the line segment in which the house
would be found, but to the area which contains it.
There will be more cherries on the outer half of a
slice of cake, presuming that they are evenly dis-
tributed. A method has been developed to make
this approach more representative, but is beyond
22 = estimating immunization coverage
Disadvantages
Values exceed 100%
Inaccurate numerator and
denominator
Clinic population
Staff time
Expensive
Sampling bias
Lack of precision
the scope of this chapter.
Statistically speaking, children within each
cluster should be sampled randomly, and some
criticism has been levelled at EPI for its policy of
choosing households consecutively, thus intro-
ducing selection bias. Houses in a cluster are
spatially related, which could result in their occu-
pants having similar immunization status.
Since EPI coverage surveys have such specific
objectives, they cannot readily be used for pur-
poses beyond estimating a simple proportion,
and attempts at extending them without consid-
erable increase in sample size will generally suffer
from lack of statistical power.
The general economy of design, however
elegant, also implies that there is very little scope
for conclusions concerning subregions. For
example, studies in the Transkei and former Cape
Province give reliable figures for the whole region,
but say little about which specific local areas need
the greatest attention (Byarugaba 1989; Bach-
mann, Thomson, Coetzee, Klopper, Skibbe 1992).
One can increase the sample size until immuniza-
tion coverage can be determined with more pre-
cision for each subregion (or stratum) (Chapman
1990; Coetzee, Yach, Blignaut, Fisher 1990). This
is particularly important in large cities and urban
areas where high immunization coverage city-
wide may conceal pockets of low coverage that
act as foci for continuing transmission of target
diseases. For example, in peri-urban areas, the
lowest coverage areas are those with the highest
207
e epidemiology applied to content areas
Sennen ee ee ee eee ee
proportion of recent migrants (see Example 22.2).
Lot quality assurance sampling (see below) also
provides a useful method of determining sub-
region coverage status.
The EPI sampling technique was originally de-
veloped for rural areas in developing countries
and is not always ideal. Where relatively few chil-
dren of the appropriate age group are present ina
community, the standard technique of going
door-to-door may prove very tedious. In densely
populated urban and peri-urban areas, simple
random or systematic sampling is feasible. Ad-
aptations to the EPI sampling technique have
been successfully implemented, and are de-
scribed in the Examples.
A useful adjustment to the EPI sampling
methodology has been Kok’s modification used
in Kenya for dispersed populations (Kok 1986). It
uses primary school lists as a sampling frame to
target areas where children live, and then goes to
neighbouring households, so avoiding the direct
bias of selecting children who have siblings in
school. Kok’s original assumptions were the fol-
lowing:
@ the early primary school child is ‘the most
randomly and proportionally distributed regis-
tered sampling unit in the community’;
¢ school attendance should be (‘arbitrarily’) not
less than 70% (this may be a problem in isolated
rural areas of South Africa); and
@ there should not be certain groups who are
excluded from schooling.
This method, which was tested in the Machakos
district of Kenya, has proven a useful tool for EPI
internationally, and some South African re-
searchers have put it into practice.
Another modification involves the use of primi-
parous mothers for assessment of vaccination
coverage. Though the reason for choosing primi-
paras is not apparent, the method does seem to
have potential merit if extended to include all
mothers giving birth at a particular health facility.
The conditions under which this method would
give reliable results would be if the home delivery
rate was low, and follow-up excellent.
Lot Quality Assurance Sampling (LQAS)
Details of this sampling method are given in
Chapter 16. The basic principle is that a certain
number of items from a lot (batch) is tested and
the whole batch ‘rejected’ or ‘accepted’ on the
basis of the number of defectives in the chosen
items. In the case of immunization coverage, the
208
eee
items are children and the lots areas. This method
allows one to determine whether immunization
coverage in a small area is acceptable or not, but
does not estimate the actual coverage rate. It is
ideally suited for smaller urban areas where the
base population of different strata is too small for
the EPI cluster method (Rosero-Bixby, Grimaldo,
Raabe 1990; Lanata, Black 1991; Cutts 1991, 1994).
House-to-house sentinel population
investigation
In urban areas with limited resources, lack of
available expertise, and poor census data, health
services may focus on specific problem zones
where most cases of disease occur (sentinel popu-
lations). Door-to-door investigation of all chil-
dren in these defined areas can be undertaken
rapidly (as during an outbreak), or at convenient
intervals by health service staff with minimal
training. As no sampling is required and analysis
is done by hand, this approach to estimating im-
munization coverage in problem areas has
proven to be less costly than EPI cluster sample
surveys of equivalent size (Weeks, Barenzi,
Wayira 1992).
Measurement considerations
Attention must be given to fieldworker training,
questionnaire design, and definition (determina-
tion) of vaccination status. Questionnaires which
are unambiguous and generate useful variables
should be used. Variables of interest are receipt or
not of vaccination, type, number, and age at
which vaccines were received. Age should be
determined using date of birth. If date of birth is
unknown, the researcher should be aware that
there may be a preference for a given month (for
example, January) in the responses. Any age in-
accuracies could have an important effect on age-
specific immunization coverage calculations. The
training manual for EPI coverage methodology
recommends surveying children between 12 and
24 months of age as a measure of immunization
efforts over the preceding year. Information on
where vaccination took place may be useful from
amanagement point of view.
As in all studies, fieldworkers should be well
trained and motivated before data collection
begins, and periodically checked while in the
field. Careful documentation of information on
vaccination cards is vital, and workers should
know exactly what each entry means. The import-
ance of accurate recording should be empha-

sized, as should the need to encourage parents to
find cards which they have ‘temporarily mis-
placed’. The response rate should be improved by
revisiting locked dwellings at a later stage. For this
purpose, and also for quality control inspection,
the name and address of each family should be
carefully recorded.
Vaccination status can be determined by vac-
cination information on the Road to Health card,
clinic records, in some cases school records,
physical signs such as BCG scar, or a verbal report
by the respondent (usually the mother). Ignoring
the subjective verbal report clearly leads to an
underestimation of coverage in absolute terms;
yet the advantage of having a reproducible mea-
surement cannot be overemphasized. Depending
on how immunization status is defined, different
coverage estimates may be derived. In most sur-
veys, immunization coverage is estimated using
all children with vaccination information accord-
ing to a health card as the numerator and all chil-
dren as the denominator. This can be considered
a worst-case estimate (since all children for
whom a card cannot be shown are categorized as
not immunized). A best-case estimate would be
using the same numerator as above, and all chil-
dren with cards as the denominator. eee
both these figures should be reported.
Immunization data should be collected so that
coverage can be calculated for individual anti-
gens, and overall coverage for immunizations
given on time (within 28 days of due date accord-
ing to schedule). Coverage should also be calcu-
lated according to immunization status at 12
months of age, and at the time of the survey. The
standardization of coverage calculations accord-
ing to these criteria will facilitate comparisons be-
tween areas and over time (Ferrinho, Buch 1991).
Analysis
When complex sampling methods (such as clus-
ter sampling) are used, there is a need to correct
for the design effects at the analysis stage. Simple
quantities and proportions are minimally biased
by most complex designs. However, the calcula-
tion of confidence intervals depends on the
design.
Similarly, using tests and measures based on
simple random sampling — such as the chi-
square test for association and the odds ratio as a
measure of the strength of association — may
give biased results because of the complex design.
The differences can be dramatic, and it is strongly
22 _~=—sestimating immunization coverage
recommended that researchers make the effort to
familiarize themselves with the problem (Hen-
derson, Sundaresan 1982). A minor adjustment
can be made to the chi-square test that consider-
ably improves the accuracy of the test.
Work done at the MRC has concentrated on a
method called the ‘bootstrap’ technique (Rei-
nach, Groeneveld, Neethling 1990). This method
requires much computing for each data set, as it
involves numerous resamplings (with replace-
ment) from the data. Unbiased estimates of the
population variance (or any other parameter) can
be ‘obtained. Methods are now being sought to
streamline this technique.
In short, if the researcher is interested in ana-
lysing anything beyond simple coverage propor-
tions from a cluster sample, detailed statistical
assistance will be required during both design
and analysis. For more detailed information
about the methods described above, refer to
Berry and Yach (1991), and for their application in
South Africa, see Berry, Yach, Hennink 1991,
Coetzee et al 1990, and Coetzee, Ferrinho,
Reinach 1993.
Conclusion
The regular estimation of immunization coverage
by health services forms the basis of immuniza-
tion programme evaluation. Only if these es-
timates provide accurate data on specific sub-
regions can they enable programme managers to
direct preventive efforts to areas with the greatest
potential for disease transmission.
EXAMPLE 22.1
Adaptations to the EPI sampling
strategy in the Mosvold health ward
and the Free State
A study to determine vaccination coverage in
Northern KwaZulu-Natal involved the use of a
1:50 000 grid map. Numbers were allocated to
each 5 x 5,5 kilometre square in proportion to
homestead density. These figures were then used
to ensure that probability of inclusion in the study
would be proportional to population size. Sam-
"pling began at a point on the road nearest to the
centre of the square. This particular version of the
EPI-type study is very useful in rural settings with
widespread populations.
Chapman made use of a very similar method in
his survey of Free State farms to determine pri-
209
e epidemiology applied to content areas
ceria ripen | ae atin een A RR a peA
mary health care coverage and the health status
of Africans living on farms. The first stage of the
study used census data to allocate a number of
clusters to broad areas. A 1:250 000 map was used
for the second stage, but here millimetres along
vertical and horizontal axes were used for select-
ing a random starting point. The farm located
where this point fell would be visited, and dwell-
ings would be sampled consecutively, starting at
the one nearest the farmhouse. An improvement
may have been to use a more random method of
selecting the first house.
References:
Buchmann EJ, Ngesi N, Tembe R, GearJ SS, lJsselmuiden C
B. ‘Vaccination status of children aged 12-23 months in the
Mosvold health ward of KwaZulu.’ South African Medical
Journal 1987: 72:337-8.
Chapman RD. ‘The Orange Free State experience. Deter-
mining both primary health care coverage and the health
status of blacks living on farms.’ CHASA Journal 1990
1(1):30-36.
EXAMPLE 22.2
Immunization coverage estimation
adapted for use in peri-urban
settings
A study to evaluate the success of an outreach
immunization programme in Alexandra town-
ship used aerial photographs to define a sampling
frame. The whole township was divided into 108
blocks (120-150 houses each), of which 45 were
randomly selected. Within each of these blocks, a
random starting point was selected, from which
point 10 children (12-23 months old) were identi-
210
Ot OR
fied using standard EPI methodology. The larger
sample of 450 (45 clusters of 10 each) allowed for
post-sampling- stratification into formal and
informal dwellings.
Immunization coverage was lowest in children
from informal dwellings. Because the average
number of people is higher in informal dwellings,
the use of dwellings as uniform sampling units
probably resulted in under-representation of
these households.
In Khayelitsha, coverage was estimated in 12 to
23-month-old children living in three geo-
graphically distinct strata: permanent housing,
temporary housing, and a transit camp.
A sampling frame was developed by mapping
the houses in each stratum during community
surveys preceding the coverage survey. Stratified
multistage sampling selected 46 cluster starting
points, with allocation proportional to the estim-
ated number of houses per stratum. From each
starting point, 10 children were selected using
standard EPI methodology. The larger sample
size (46 clusters of 10 children each) allowed for
the estimation of stratum-specific coverage. Chil-
dren living in temporary housing had the lowest
immunization coverage, and were most likely to
be recent immigrants from the rural Eastern Cape.
References:
Coetzee DJ, Ferrinho P, Reinach S G. ‘A vaccination survey
using EPI methodology to evaluate the impact ofa child
health outreach programme in an urban area of South
Africa.’ WHO Bulletin 1993; 71(1):33-9.
Coetzee N, Yach D, Blignaut R, Fisher S A. ‘Measles vaccina-
tion coverage and its determinants in a rapidly growing peri-
urban area.’ South African Medical Journal 1990; 78:733-7.
23
Introduction
Canaries were used in bygone days to detect toxic
concentrations of carbon monoxide in mines.
Today, environmental epidemiologists are the
‘canaries’ capable of giving warning of impending
environmental disaster.
‘Fortunately, our fate is not to die as the unfor-
tunate canaries of the coal miners did, but to sing
— to call out in clear tones the nature and type of
impending health danger that threatens.’ (Gold-
smith, 1988.)
The discipline of environmental health
emerged in the 1980s, with the increasing recog-
nition that efforts at environmental improvement
and protection could have a positive effect on
disease prevention. Other than immunization
programmes, there are few health interventions
with similar opportunities for primary pre-
vention. In order to implement preventive mea-
sures, it is necessary to understand the way in
which the environment influences health.
Definition of environmental health
In its broadest context, environmental health
comprises the aspects of human health and
disease that are determined by factors in the
environment. The WHO includes in this the study
of both the direct pathological effects of chemical,
physical, and some biological agents, as well as
the (often indirect) effects on health and well-
being of the broad physical, psychological,
social, and aesthetic environment, which includes
housing, urban development, land use, and
transport.
Virtually every aspect of the environment may
Environmental
epidemiology
affect physical or mental health in some way,
either positively or negatively. An approach to the
discipline of environmental health which focuses
on environmental hazards of human origin is
useful in that it focuses on potentially remediable
problems (as opposed to, for example, ‘natural’
pollutants such as background radiation, pollens,
or climatic factors).
Environmental epidemiology is an important
tool for investigating the distribution and deter-
minants of environmental diseases in human
populations. Epidemiologists have thus been get-
ting more and more involved in evaluating the
impact of environmental pollution on human
health. Environmental health professionals are
playing an increasingly important role in environ-
mental impact assessments, and, for example, in
ensuring that health considerations are taken into
account early in the planning procedure of pro-
jects which impact on the environment.
The extremely complex nature of environ-
mental diseases places special methodological
demands on the design of studies investigating
the relationship between environmental expo-
sure and disease. For example, one is often deal-
ing with a range of non-specific ill-health effects
(some of which may only manifest themselves
after many years), and the causes may be due to
many different factors, rather than to a single
source. Considering the implications for govern-
ment and industry of instituting better control
measures and policies to regulate pollutants, it is
essential for studies to be conducted in a rigorous
and unbiased way. Specific issues relating to
exposure and outcome (effect) estimation are dis-
cussed here.
211
e epidemiology applied to content areas
The nature of environmental
diseases
Despite well-documented cases of environmental
disasters, accidents, and spills (for example,
Bhopal, where tens of thousands of people were
poisoned in 1984 by methyl isocyanates, or Spain,
where 13 000 people were poisoned in 1981 by
chemically contaminated cooking oil), the contri-
bution of environmental exposures to the causa-
tion of many diseases often goes unrecognized.
Environmental health outcomes
Types of outcomes
Outcomes (effects) in environmental health stud-
ies may include death, specific defined diseases
(for example, lung cancer), disease categories
(respiratory illnesses such as pneumonia,
asthma, and bronchitis), symptom complexes
(coughing and wheezing) and biochemical/
physiological changes which may not necessarily
result in symptoms. In fact, a whole hierarchy of
health effects may occur, ranging from minor
temporary ailments through to acute illnesses
and chronic disease, with relatively resistant and
susceptible people at either extreme of the distri-
bution. Thus there may be different exposure-
effect relationships for different subsets in the
population.
Ill-health effects of environmental exposures
may occur over a short or long period, they may
be reversible or irreversible, they may increase or
decrease over time, and they may be continuous
or temporary. Effects may be acute — for exam-
ple, they may follow quite soon after exposure
(often a single major dose) to an irritant. More
often, however, chronic disease occurs as a result
of cumulative exposure to complex mixes over
long periods. Examples include asbestos expos-
ure and mesothelioma, and radiation exposure
and leukemia. The dispersal of the population at
risk over time, and the long incubation period,
make it difficult to reconstruct exposures. For
example, cancer from exposure to asbestos may
only develop some 20 years or more after the ini-
tial exposure, during which time the original ex-
posed population may have moved and become
exposed to other risk factors. Tracing the original
population in such cases can be extremely diffi-
cult and sometimes impossible. Acute health
effects are thus usually easier to detect than
chronic health effects, which may be difficult to
relate to specific hazards or sources.
Ze,
The actual harm that can result from an expos-
ure is related both to its toxicity and the cumu-
lative dose to the target organ. The actual effective
dose is the amount of toxic material which
reaches the critical target organ in the body. It
depends on the concentration in the environ-
ment, as well as on factors related to uptake, such
as the route of entry into the body and the phys-
ical and chemical forms of the toxic substance.
Almost any chemical could cause harm if taken
into the body in sufficiently large amounts. How-
ever, in environmental health, one is often con-
cerned with those chemicals which may have
adverse health effects in small doses.
In conducting risk assessments necessary for
setting safety standards, it is particularly import-
ant to establish the nature of dose-response rela-
tionships (or exposure-response relationships).
Whilst toxicology has an important role to play,
problems involved in extrapolating from animals
to humans, and from high-dose to low-dose situ-
ations, make it necessary to rely on well-
conducted epidemiological studies.
In general, the toxic effects of pollutants can be
divided into broad classes such as acute toxicity,
chronic toxicity, cancer effects (carcinogenicity),
birth defects caused by substances (terato-
genicity), and genetic effects (mutagenicity). One
distinguishing characteristic between these cate-
gories is the fact or assumption that dose thresh-
olds exist for acute and toxic effects, but these
thresholds do not exist, or have not been demon-
strated for carcinogenic effects.
Detection of environmental health outcomes
Case detection in environmental studies can be
subject to selection bias if members of a group are
aware of their exposure status and its association
with the outcome of interest. Self-reports of
symptoms are often used as a health outcome in
studies with uncertain exposures and few or no
objectively measurable health effects. Potentially
exposed groups may report outcomes at an in-
creased rate compared to a non-exposed group,
which may result in over-reporting of cases
among the exposed group. Examples of such situ-
ations include communities worried about toxic
waste-site exposures, and office workers con-
cerned about indoor air quality. In such in-
stances, it is necessary to distinguish between
demographic and other factors known to be re-
lated to symptom reporting, over-reporting of
symptoms due to environmental worry, in-
creased symptoms due to stress caused by

environmental worry, and increased symptoms
due to environmental exposures.
Under-reporting of cases (particularly among
rural Africans in South Africa) could also produce
spurious results in environmental epidemiologic
studies, depending on which exposures and
which geographic areas are studied.
Frequently, when we talk about low-level
environmental exposure, we are concerned with
effects which may occur in a very small percent-
age of the population only. This may necessitate
very large-scale epidemiological studies. In such
cases, it may be advantageous to carry out multi-
centre or even multi-country studies. To increase
the probability of detecting a real effect in a small
population, researchers could follow the popula-
tion up for many years to accrue sufficient
person-years of risk. A further alternative is to
investigate a number of disease symptoms re-
lated to a particular exposure.
In other cases, small area studies are needed,
particularly where clusters of rare diseases are
investigated with respect to their possible links
with environmental conditions. Routine data on
health outcomes may be very limited, which
means that other data sources must be used. Also,
available data may only cover large geographical
areas, which are usually not subject to undue ex-
posure to environmental contamination from a
localized source.
Exposure estimation
General exposure issues
The validity of studies in the field of environ-
mental epidemiology depends to a large extent on
the assessment of exposure. This is one of the
most difficult areas in this type of research, due to
the problems involved in the definition and
measurement of exposure, as there will usually be
a degree of misclassification of exposure. If the
probability of misclassification is the same for
those who develop a specific disease and those
who do not, the effect will usually be to dilute the
differences between the groups.
There are two dimensions to estimating expos-
ure, namely the concentration level and the dura-
tion of exposure. In investigating acute effects,
the current exposure concentration level may be
adequate, but in studying chronic effects (after a
long exposure period, or long latency period),
past exposure concentration levels are important,
as well as the duration of exposure. For example,
23 environmental epidemiology
measurement of the pollution levels currently
emanating fromatoxic waste site will reflect the
current exposure situation, but exposure 10 years
earlier may have been quite different (because
different materials were being dumped, or be-
cause of subsequent environmental modification
and migration of the original pollutants). Prob-
lems may also arise because the measurement
technology may have changed over time, with
current technology increasingly able to measure
lower levels.
Multiple agents
A large number of causes may contribute to most
environmental diseases. The various contributing
causes (confounding factors) may obscure the
contribution of any one particular factor. For
example, the contribution of sources in the
domestic (home) environment, the local or com-
munity environment, and the regional environ-
ment (climatic zone, geographic latitude and
longitude) may need to be assessed. It is impor-
tant to assess an individual’s total exposure in the
various environments in which exposure may
take place, as well as to identify other substances
that may modify its effects.
Interactive effects
Low-level chemical exposures in particular are
often factors which play a contributory rather
than a primary role in the causation of disease.
Exposures may be interactive, resulting in a
reductive effect, an additive effect, or a synergistic
effect (where the combined effect is greater than
the sum of the individual effects). For example,
the incidence of lung cancer is very high in ura-
nium miners and asbestos workers who are
smokers, but may be less significantly elevated
among workers with similar occupational expos-
ures who are not smokers. A number of host and
environmental factors can modify the effects of
toxic substances.
Multiple sources and pathways
In environmental research, multiple sources and
pathways of exposure are frequently encountered
(Figure 23.1 illustrates the multiple sources and
pathways of lead exposure). One difficulty is the
‘general lack of knowledge about many aspects of
the behaviour of environmental pollutants. .In
order to estimate exposure accurately, it is
important to know how toxic agents enter into the
environment, whether they become dispersed or
reconcentrated, and what the pathways of human
213
e epidemiology applied to content areas
Figure 23.1 Multiple sources and pathways of exposure:
the example of lead
Direct inhalation
!
Route (2)
od
Source: Rutter M, Russell Jones R, 1983.
exposure are. Exposure to chemical substances
are normally mediated by complex environ-
mental pathways, and more than one route may
contribute to human uptake. Often one pathway
contributes the major proportion of the pollutant.
Should this critical pathway not be identified, the
multiple pathways contributing to the total ex-
posure must be carefully assessed. Adequate con-
trol measures can only be applied when the rela-
tive importance of the various routes of exposure
has been established.
Environmental monitoring
Research data is often obtained from local,
provincial, or national monitoring programmes,
which are normally carried out for regulatory pur-
poses and not for exposure-related studies. Regu-
latory environmental data is collected with the
aim of detecting peak levels to assess compliance
with standards or guidelines. Data collection is
often done at places of little relevance in terms of
human exposure. For example, an air monitor
may be placed in the immediate vicinity of a par-
ticular factory, or water quality may be monitored
214
Food
at the outlet of a sewerage works. This, however,
may have little significance in terms of people
who might actually be affected by such emissions,
since they are unlikely to live in the immediately
exposed area. On the other hand, ambient air
quality monitors may be placed at the top of
multistorey buildings where air quality may be
considerably better than at the actual breathing
level of people on the ground. Normally only a
few areas and a few substances are monitored.
What is generally required for epidemiological
studies, however, is detailed knowledge of tem-
poral and spatial variability of concentrations of
exposures. In the case of many pollutants, there is
a sharp decrease in the concentration level as one
moves away from the source. There may also be
vertical variations in the source, and, as illus-
trated in the example above, air sampling points
placed considerably above breathing level may be
safe from vandalism, but are inappropriate for
use in population exposure studies.
When variations in pollutant levels are consid-
erable (for example, in most air pollution studies),
it may be more appropriate to use personal air
samplers or filter badges rather than stationary

artigw ea Ce
Hourly mean concentrations of smoke (1g/m3)
2000
1600
1200
800
Source: Kemeny E, Ellerbeck R H, Briggs A B, 1988.
air samplers. These have the advantage of being
mobile and have the potential to measure an indi-
vidual’s total exposure. If large populations are
being monitored, however, such samplers may
not be practical on a large scale, and exposures
can be characterized at group level using station-
ary samplers.
As spatial variations in pollution levels pose
specific sampling problems in terms of where to
sample, so variations in the level of pollution over
time (for example, seasonal and daily variations)
pose problems of when and how often to sample.
Pollution levels in Soweto, for example (see
Figure 23.2), are highest in the early morning and
evening, when coal-burning activities peak. Thus
temporal variations in the level of the pollutant
will have implications for the frequency and type
of monitoring. Should measurements be made,
for example, on a continuous basis, several times
a day, once a week, monthly, or at some other
time interval? The biological variation of the
pollutant in the human system, for example,
whether or not rapid absorption and excretion
takes place, complicates the matter further.
Ultimately, the exposure data for the study must
be summarized: the choice of an appropriate
summary measure may be critical to the ultimate
understanding of the exposure. In one instance,
23 = environmental epidemiology
Dice)
12
Hour of day
the average exposure level may be important,
while in another, the use of peak values may be
more relevant (for example, in assessing noise ex-
posure). Cumulative exposures may be signific-
ant in the assessment of, for example, radiation
exposure, where multiple exposures may be
largely cumulative.
Biological monitoring
There is a growing interest and increasing re-
search into biological and biochemical markers of
exposure (for example, DNA adducts), which
should improve the effectiveness of exposure
assessments in the future. Biological monitoring
aims to estimate the level of specific chemicals at
the critical target sites where their toxic effects are
initiated. This level is the biologically effective
dose or the internal exposure level. Concentra-
tions of chemicals in body fluids or excreta may
be measured, as can effects such as mutations,
chromosomal aberrations, or sister chromatid ex-
changes induced by chemicals in cells and tissues
of exposed individuals. Blood and urine are com-
monly used for biological monitoring, as well
as hair (for example, to detect mercury or lead
concentrations), nails (arsenic), teeth, bone
(lead), faeces and breast milk (organochlorine
pesticides).
215
e epidemiology applied to content areas
Target population
In contrast to occupational epidemiology, which
focuses on young to middle-aged adult popula-
tions (predominantly male) who are relatively
healthy when they start working, environmental
epidemiology focuses on the unborn foetus, in-
fants and young children, and the elderly. Infants
and young children are at particular risk, as they
take in more of a contaminant relative to their
size than do adults, they have immature and vul-
nerable physiologies, and, because of their youth,
they have a greater probability of manifesting
long-term effects. An advantage in studying chil-
dren in environmental health studies is that they
are unlikely to be affected by common con-
founders such as smoking and occupational ex-
posure.
Certain individuals (as opposed to groups) may
be particularly sensitive or vulnerable to agents
that may be relatively harmless or trivial to most
other people. Control measures should therefore
be geared not only to people of average health,
but to the most susceptible subgroups.
Study design
In studying the relationship between exposures
and outcomes, the environmental epidemiologist
may employ a number of strategies or study de-
signs. If the exposure can be characterized, and
the outcome defined, any of the usual study de-
signs can be used.
Cross-sectional studies are usually the first ap-
proach used in assessing exposure-outcome rela-
tionships and, being exploratory in nature, have
the advantage of being able to simultaneously
investigate the relationship between several ex-
posures and many outcomes. An example would
be a study in which a questionnaire is distributed
to a cross-section of a community with questions
on the following: exposure to various environ-
mental factors (such as outdoor air pollution and
tobacco smoke, pollution in the workplace), and
various outcomes such as chronic obstructive
lung disease, asthma, and various respiratory
signs and symptoms. The disadvantage of such a
study is that it is difficult to ascertain the direction
of association of the exposures and outcomes.
Ecologic studies are also commonly used, as
they require information only at a group (rather
than individual) level with respect to disease fre-
quency and exposure. The invalid assumption of
homogeneity of exposure of individuals in an
area, the frequent absence of information about
216
confounders (for example, smoking, occupation)
and exposure and outcome data for exactly
corresponding areas, severely limit this design,
however. Studies which have relied on this design
include cancer epidemiology studies, in which,
for example, lung cancer rates in populations
were assessed in relation to air pollution levels or
smoking rates, and oesophageal cancer rates
assessed in relation to salt consumption in the
community.
’ Case-control studies can only be used when
enough is known about the outcome to properly
identify and classify cases and controls. In press-
ing environmental exposure problems, where
timeliness of findings may be important, the
case-control study, being relatively quick to con-
duct in most circumstances, may be appropriate.
Examples of case-control studies in environ-
mental epidemiology are the study of birth
defects in newborns in relation to pesticides or
radiation exposures, or pneumonia rates in chil-
dren in relation to indoor air pollution (such as
wood-burning fires).
Cohort studies may be used when enough is
known about the exposure to characterize it
effectively, or when evaluating unknown or sus-
pected outcomes. As it is possible to characterize
most exposures at least partially, cohort studies
are often the design of choice in environmental
epidemiology. They also allow a more complete
investigation of complex exposures or multiple
outcomes. Large environmental cohort studies
are currently being conducted in South Africa. An
example is the study of respiratory signs and
symptoms in a cohort of children born in Johan-
nesburg and Soweto (Yach, Cameron, Padaya-
chee, Wagstaff, Richter, Fonn 1991). These chil-
dren were regularly followed up over a period of
time, and the development of various signs and
symptoms studied in relation to various expos-
ures to factors in the home environment, such as
cooking and heating practices, overcrowding,
and smoking. Information on exposures was ob-
tained initially from mothers prior to giving birth,
and subsequently at various intervals of the chil-
dren’s development. Levels of pollution in chil-
dren’s homes were measured using personal
samplers (Von Schirnding, Mokoetle, Mathee
1994).
Another example is a study conducted in the
Western Cape of ill-health effects associated with
swimming in polluted marine waters. People
were interviewed at the beach about their swim-
ming status and other factors and subsequently

by telephone, to ascertain whether any gastro-
intestinal, respiratory, or related symptoms had
developed in the two or three days after the beach
outing. Illness rates were examined in relation to
swimmers and non-swimmers exposed to varying
degrees of water quality, assessed by various
microbiological indicators. The study will be used
to set recreational water quality standards for
South Africa (Von Schirnding, Strauss, Kfir, Ro-
bertson, Fattal, Mathee, Franck, Cabelli 1993).
Experimental studies are rarely conducted in
environmental epidemiology nowadays, except
in situations where it is possible to try out some
corrective action in reducing exposure. Such an
intervention might involve the treatment of a
water supply, or the addition of scrubbers to a
plant stack, or the removal of soil and control of
dust in mitigating environmental lead exposure.
Conclusion
Environmental epidemiology is an emerging
23 = environmental epidemiology
discipline which has undergone rapid develop-
ment in recent years because of increasing con-
cern about deteriorating environmental quality
and its effect on human health. Environmental
epidemiological studies have become increas-
ingly more sophisticated and refined, with more
emphasis and attention given to exposure assess-
ment, health outcome definition, and study
design, as discussed above. While some studies
and approaches are complex and costly to con-
duct, demanding expensive environmental and/
or biological monitoring programmes, this is not
always the case. Much progress has been made
with relatively simple ‘descriptive’ studies, which
have led to important observations and theories
about the nature of environmental exposures and
associated outcomes. It is hoped that this field of
epidemiology will continue to receive the neces-
sary support in the future, as it is critical that the
results of such research be used to form the foun-
dation of future regulatory policies.
ONE
24
Introduction
The study of occupational health dates back to
the early 17th century, with the work of Bernadino
Ramazzini. One of its distinguishing features is
the attribution of disease causation to workplace
exposures. The early stages of the discipline were
typically concerned with clinical description, and
only secondarily, if at all, with pathogenesis or the
mechanism of disease. Occupational epidemi-
ology is simply epidemiology in the context of
occupational health, and describes the distribu-
tion and determinants of disease in occupational
groupings. It is thus a basic tool of occupational
health practice. Two useful references relating to
research methods and case study material are
Checkoway, Pearce, Crawford-Brown (1989) and
Steenland (1993).
What makes occupational
epidemiology different?
Several factors peculiar to occupational health
make occupational epidemiology a topic worthy
of special mention, as distinct from general
epidemiology (Myers, Von Schirnding 1992). The
most notable of these are the following.
@ Workers form well-defined groups which lend
themselves to quantitative observation.
There is a strong focus on demonstrating asso-
ciations between exposure and effect. Expos-
ures are relatively well defined, and exposure
information is relatively easily obtained from
records or directly by measurement. Health
outcome data is likewise fairly easily obtained
from the worker group, usually by administer-
ing a detailed questionnaire interview and
218
Occupational
epidemiology
completing medical examinations, for exam-
ple, a chest X-ray and lung function tests when
the outcome is respiratory disease.
@ Ifan association is suspected or shown, this can
lead directly to preventive activity, which is re-
latively easily instituted collectively in a work-
place setting as opposed to an individual-based
curative intervention, which is typical of
clinical medicine. The chronic nature and irre-
versibility of most occupational diseases
strongly supports a preventive orientation.
For example, in the case of respiratory diseases,
chronic bronchitis and pneumoconiosis (scar-
ring of the lungs) are irreversible and usually
progressive with time. Being able to demon-
strate a causal association with dust exposure
underlines the importance of reducing dust
levels for the group as a whole as the most
effective means of preventing ill-health (see
Example 24.1).
Industrial activity is very closely linked with
vested economic, social, and political interests.
Because this is a field of social conflict in which
participants frequently have widely differing
perspectives, occupational health is a difficult
area for scientists and health professionals.
Ethical considerations related to occupational
epidemiologic findings assume particular
importance, and special codes of ethics have
existed for many years to cater for these special
needs.
Cost considerations are paramount in occupa-
tional health because those who pay the costs,
usually management, are constrained by the
need to realize profits. Workers are also
constrained by limited funds, particularly in
South Africa. There are thus strong pressures to

conduct occupational epidemiology
economically and efficiently. Negative atti-
tudes toward research are frequently encoun-
tered among industrial stakeholders.
Methodological issues in occupa-
tional epidemiology
Study design
All survey designs are used, but some are particu-
larly common and appropriate. The commonest
type of study is the cross-sectional or prevalence
study. This is particularly so in developing coun-
tries such as South Africa, where it is difficult to
retain contact with a cohort because of the in-
stability of working (often migrant) populations
with low levels of skill.
Case-control studies are also common, but
these and cohort studies are not frequently en-
countered in South Africa. One variant of the
latter is the retrospective cohort study which is
often found in occupational epidemiology, as it
meets the criterion that exposure information (in
this case, workplace records) must exist prior to
defining the historical cohort. Intervention stud-
ies are also easy to do and are becoming popular
due to increasing emphasis on evaluation .of
occupational health measures and services.
Experimental studies in most areas of occupa-
tional health are prohibited by ethical considera-
tions, although some laboratory experimentation
is done on healthy volunteers to gauge acute
effects of common occupational exposures. Some
people, however, feel that ‘experiments’ go on all
the time in the workplace in the sense that
workers are knowingly, and with legal sanction,
repeatedly exposed to known toxic and carcino-
genic substances. Two examples are the carcino-
gen asbestos and the asthma-causing agent
toluene disocyanate, to which spray painters are
exposed.
One factor that particularly strengthens survey
design in occupational epidemiology is the ready
availability of control groups. These are mostly
internal (from the same factory population) con-
trols and are generated on the basis of objective
exposure measurements. Internal controls are
generally superior to external controls, as control
and index group subjects are relatively homo-
geneous with respect to most factors other than
the exposure of interest.
The identifiable nature of the group is another
strength of occupational epidemiology. Hypo-
24 occupational epidemiology
thesis generation and testing, as well as follow-up
and evaluation of interventions, are enhanced by
this. Membership of trade unions and pension
funds is useful for tracing people.
Sampling
Sampling is mostly unnecessary due to the small
size of surveyed populations, which usually
number several hundreds, and in some cases, a
few thousand. Should it be necessary, a sampling
frame is always readily available, subject to diffi-
culties in tracing workers who have left work for
various reasons.
Measurement
The ability to characterize exposure accurately is
the great strength of occupational epidemiology.
Compared with much general epidemiology, ex-
posures are very evident. It is also usually possible
to get some measurable handle on these expos-
ures. Exposure categorization into qualitative
(yes/no), semi-quantitative (high/medium/low/
no) and quantitative variables is almost always
possible.
Exposure indices can thus be generated. This
allows quantitative risk assessments to be made
by generating measures of association between
exposure and outcome and also gradations of
association, in particular exposure-effect (con-
tinuous outcome variable) and exposure-
response (categorical outcome variable) relation-
ships.
Some caution is needed with respect to expos-
ure. Internationally, serious industrial hygiene
practices only date back a few decades, and South
Africa is particularly far behind in this regard.
Where exposure measurements are available in
industry, they often focus exclusively on high ex-
posure areas. This results from the typical indus-
trial hygiene approach, which is concerned prin-
cipally with whether environmental exposures
are below legislated occupational exposure limits.
Such compliance-oriented methods are not ideal
for accurate estimation of exposure levels.
Despite these problems, health effects abound
because exposures are usually so gross in devel-
oping countries, and may be detected relatively
easily, even in rather small groupings. Exposure
data, however imperfect, may exist in company
records, or may be reconstructed with relative
ease by performing current measurements during
unchanged production processes, or by simula-
tion of exposure conditions in different historical
phases of production.
219
e@ epidemiology applied to content areas
Precision is generally not a problem due to the
possibility of easy and repeated access to persons,
records and processes, without serious logistic
implications in taking multiple measurements.
Qualitative methods
Qualitative research is becoming increasingly
important in the workplace. It may be used to
determine perceptions of risk and to help prior-
itize problems and solutions. It may also be used
to identify sources of potential resistance to
strategies for improving occupational health
practice, as well as auditing occupational health
services. Such methods are particularly appro-
priate in the context of different workplace cul-
tures, notably those of management and workers.
Groups within the workplace may have very dif-
ferent ideas about risk and priorities. In these and
other ways, qualitative methods can help shape
what is measured and how it is measured in the
study of work-related phenomena.
Biases
Occupational studies are subject to all the same
generic biases as other epidemiologic studies.
Certain biases appear to be more specific to occu-
pational epidemiology, such as the ‘healthy
worker effect’, particularly for cross-sectional
studies. In South Africa, because unemployment
is such a problem, workers tend to stay with a job
even if it is affecting their health. Health effects in
most industries tend to be gradual and chronic
and do not lead easily to workers departing. This
is, however, just a form of the more general se-
lection bias; subjects who are part of the group se-
lected for study tend not to include those who
have left because of ill-health due to the exposure
of interest, or some other associated exposure at
work, and who are thereby lost to follow-up. The
group that is followed appears ‘healthier’ because
it consists of a disproportionate number of those
who have survived ill-health caused by the
exposure. This bias is very difficult to adjust for
and bedevils most studies, whatever the design,
where follow-up is incomplete. Another form of
this relates to the use of controls from the general
population who are by definition ‘sicker’, in that
they may not be employed or employable. Use of
such controls will dilute the effect of the pre-
sumed exposure.
Another specific problem relates to recall bias
for exposure, which may be driven in the direc-
tion of overestimation in the hope of obtaining
compensation, or in the direction of under-
220
estimation by the long induction periods charac-
teristic of most occupational diseases. This takes
on particular importance because so few longit-
udinal studies are done and there is a heavy reli-
ance on historical exposure data. Recall bias is a
form of the more general information bias.
Strong confounding biases frequently operate
in industry. There is a common tendency for
those most heavily exposed to hazards in the
workplace to have unhealthier lifestyles, which
frequently cause the same adverse health out-
comes as the workplace exposure. Workers ex-
posed to dusty workplace environments tend in
general to be heavy smokers as well. Both these
exposures cause lung diseases. Another con-
founding factor which may be associated with
dust exposure and respiratory ill-health is pre-
vious or current tuberculosis infection.
Internal validity of occupational epidemiology
studies is usually very good, while external valid-
ity or generalizability is more complicated due to
the obscure object of inference. For example, ina
community-based survey, ifa sample from a large
general population is selected and a determina-
tion made of dust and fume exposure at work,
together with respiratory symptoms and signs
and pulmonary function decreases, estimates of
the ‘true’ association in the general population
from which the sample was drawn can be deter-
mined. In occupational health, on the other hand,
an entire workforce is studied. But what do the
measures of association obtained in such a study
estimate? What is being estimated is the true
parameter of association in a hypothetical popu-
lation of all similar workers working in similar
circumstances!
Analysis
Various problems arise as a result of the relatively
small number of subjects in a typical study.
Simple stratified analysis is not practical in these
study groups if it is necessary to look beyond the
exposure (for example, dust), the outcome of
interest (for example, chronic obstructive pul-
monary disease) and one other covariate (for
example, smoking), and the number of subjects in
each stratum can thus become very small. Other
relevant factors may be age, previous tuberculosis
infection, and environmental exposure to sul-
phur dioxide or domestic fuel combustion pro-
ducts.
However, there has been substantial devel-
opment in readily available statistical modelling
methods, which allow more precise parameter

estimation from relatively sparse data than strati-
fication analysis offers.
Multivariate methods are well represented in
occupational epidemiology literature. One limita-
tion of these multivariate methods is that in-
creased precision is achieved at the expense of
possible increased bias of parameter estimates.
The choice ofa particular model always involves
assumptions about the shape of the exposure-
effect relationship, which may be incorrect,
giving rise to a biased estimate.
Indirect standardization (see Appendix 1: Stan-
dardization), which yields the Standardized
Mortality (or morbidity) ratio (SMR), is the most
frequently used comparative measure in longit-
udinal occupational mortality and cancer incid-
ence studies, because it provides a more stable
estimate when the study groups are relatively
small. This has the disadvantage that it may not
be used for comparisons between different ex-
posure categories within the study group, but
only between the index exposure category and
the standard population from which the standard
rates are drawn. This unfortunately means loss of
ability to accurately and meaningfully estimate
the exposure-outcome relationship in a situation
where categorization of workers by exposure is
possible. . Ethics
Association
Applying Bradford Hill’s criteria for establishing
causality of an association (Bradford Hill 1965),
causal interpretation is enhanced in occupa-
tional epidemiology by strong associations and
exposure-response relationships (biological gra-
dient). Additionally, because occupational
health research is efficient in terms of numbers
of subjects.and resources expended, establishing
the consistency of findings by being able to
repeat the study in other circumstances is en-
hanced. Time ordering of exposure-disease
events is usually no problem in occupational
epidemiology. It is unlikely that a lung disease
would cause someone to expose themselves to
dust — the contrary would be more likely to
apply. Biological plausibility is usually provided
by a well-developed international toxicology
database and existing theories of the mechanism
of disease causation.
On the other hand, specificity (where one
cause is uniquely responsible for one adverse
health outcome), is not a strong suit in occupa-
tional epidemiology (one notable exception is
24 occupational epidemiology
mesothelioma, which is almost exclusively
caused by asbestos). The adverse health out-
comes typically studied may be produced by
many different causative agents, both non-
occupational and occupational, in many differ-
ent industries. Lack of specificity has had some
difficult consequences for those disabled by
occupational diseases. This is partly due to the
persistence of the old-fashioned notion of indus-
trial disease having specific causation. Modern
concepts of work-related diseases that have mul-
tiple and complex etiologies have been slow to
take on in the minds of health professionals and
administrators in state departments responsible
for compensation. Attribution of risk for occupa-
tional disease to particular exposures or condi-
tions is therefore an important part of occupa-
tional epidemiology. Simple stratified analysis
can yield estimates of attributable proportion or
etiologic fraction due to the effect of the exposure
in question. This has also taken a step forward
since the advent of modern computerized statis-
tical methods for investigating the partial effects
of some occupational risk factors, while adjust-
ing for several other occupational and non-
occupational characteristics and exposures.
Ethical issues are generally more complex in
occupational epidemiology than in general epi-
demiology, and questions of confidentiality and
use of information generated are best addressed
before conducting research.
These considerations favour participatory re-
search designs and clearly understood agree-
ments, preferably in the form of written contracts,
between relevant parties at the workplace and re-
searchers. For instance, there is considerable
potential for victimization of workers, or more
subtle forms of discrimination (including job
loss) for those who participate in surveys. This
could be due to the discovery of occupational or
coincidental non-occupational illness. The re-
searcher should, however, retain a clear right to
publication of results.
The application of cost-benefit analysis raises
important questions related to the recipient of
benefits and the payer of costs. These have fre-
quently been seen as different groups — workers
pay costs and industry reaps the benefit. It is
important that cost and benefit be derived for the
same subject.
221
e@ epidemiology applied to content areas
Resources and logistical issues
Resources and funding possibilities present cer-
tain difficulties. They are more plentiful within
the private sector, but with this relative abun-
dance comes increased control over the epidemi-
ologist. In particular, there is a strong ‘negative
findings publication bias’ as opposed to the ‘posi-
tive findings publication bias’ typical of general
epidemiology. Many occupational health profes-
sionals working in industry are formally pro-
scribed by contract from publishing findings in
the scientific literature without express permis-
sion from their employers. This once again raises
ethical problems. Occupational health does not
usually enjoy a high priority with public funding
agencies, which tend to see occupational health
as a private sector responsibility, thus posing
additional difficulties for independent occupa-
tional epidemiology research.
Access to problem areas is difficult and usually
dependent on management goodwill. Where
access is not blocked by those with vested inter-
ests, a participatory research methodology can
considerably enhance the quality of data and the
interpretation of results, by tapping the implicit
knowledge of workers about exposure, the inter-
pretation of analyses, and most importantly, the
implementation of recommendations. Further-
more, participatory research methods are ideally
suited to an environment with an existing organ-
izational infrastructure (such as trade unions or
company health and safety structures) involved
in the promotion of health and the prevention of
disease. Data may be cross-validated from differ-
ent sources, and enthusiasm can be engendered
for the research process. This can help to lighten
the respondent burden, minimizing the provision
of false information, removing fear of victimiza-
tion (in the case of TB, for example), and height-
ening the possibility of efficient implementation
of recommendations.
Implementation of findings
Implementation possibilities are potentially
strong, but depend critically upon socio-eco-
nomic factors. Experience in occupational epi-
demiology provides much insight into the limits
of implementation of epidemiologic findings
generally, and highlights some of the social con-
straints upon the development of occupational
epidemiology as a science. Implementation is
institutionalized in only relatively few countries.
These countries have high degrees of social cohe-
222
sion, participative labour policies from factory
floor to parliament, and strong state involvement
in occupational epidemiology and occupational
health generally. The Scandinavian countries are
the best example, and have occupational health
systems that are light years ahead of anywhere
else. By contrast, some developed countries such
as the USA and Britain are sometimes hardly any
better than South Africa when it comes to imple-
menting occupational epidemiology knowledge.
Conclusion
The workplace has much to offer as an applica-
tion area for epidemiology. The relatively well-
controlled occupational setting, well-defined
study groups and exposures, industrial dyna-
mism and continual change provide many stimu-
lating challenges. Because of these factors, de-
spite the difficult ethical and social issues that
confront the epidemiologist, the workplace is
likely to continue to be a powerhouse of applica-
tion and development of epidemiologic method
and knowledge.
EXAMPLE 24.1
Brickfields study
Brickmaking is a dusty process with potential
adverse respiratory effects. Brick dust is addition-
ally known to contain silica which causes lung
scarring or pneumoconiosis. Until this study, no
data existed for South African brickfields, which is
fairly typical of much of South African industry. In
1985, a cross-sectional analytic study was con-
ducted on all active workers (some 560 of them) in
four brickfields in the Western Cape over a two-
week period in order to determine the relation-
ship between various dust components and res-
piratory disease in this setting.
Access for this study was gained as a result of
industrial conflict which had led to a strike. The
health survey was one of the management con-
cessions to workers who had failed to obtain wage
increases.
Workers’ perceptions were essential in helping
to design a measurement strategy for dust at
different points in the production process. Man-
agement, medical staff, and workers all had
different subjective perceptions of dustiness at
various points. Additionally, the content of offi-
cial job descriptions varied widely within the
same job category when detailed information was

obtained from workers. Details on exposures
were collected qualitatively in pilot studies so as
to ensure good quantitative measurement for the
main study.
Various components of dust in the atmosphere
of the workplace could be identified and meas-
ured, including total dust, respirable dust, and the
respirable free silica fraction. This made it pos-
sible to construct various dust exposure indices
for both current and cumulative exposures in
workplaces for which dust profiles had been
gathered. A detailed interview schedule was ad-
ministered to all workers to obtain occupational,
social, and health history data. Medical examina-
tions, chest X-rays, and lung functions tests were
performed.
Occupational exposure histories were valid-
ated against company employment records. As
workers had little sense of which exposures
caused which adverse health effects, they were
unlikely to have provided biased data leading to
false associations.
Outcome measures included continuous vari-
ables relating to lung function as well as categor-
ical variables related to X-ray findings of lung
scarring and respiratory symptoms.
Ethical problems could have arisen because
many study subjects had very poor lung function,
and if their individual results had been made
available to management in the course of the
study, they could have been discriminated
against. Therefore, before the study began, the
main stakeholders agreed that no one would be
retrenched on medical grounds, and all those
with conditions requiring medical attention
would be appropriately referred. Workers with
health problems were transferred to less dusty
work, and workers’ compensation was initiated
for deserving cases.
In this case, no one was victimized, and the
existence of a trade union representing workers
provided a safer environment for the researchers
from an ethical point of view.
During the analysis of the results, multiple
linear regression for continuous variable out-
comes provided partial correlation coefficients as
measures of the explanatory power of presump-
24 occupational epidemiology
tive causative variables (exposures), while allow-
ing for simultaneous adjustment by known or
suspected confounding factors (age, smoking).
Categorical outcomes (presence or absence of
symptoms or pneumoconiosis) were analysed by
multiple logistic regression and provided odds
ratios for dust exposure adjusted for confounding
factors.
It was possible to show that neither smoking
nor age could explain excess respiratory symp-
toms, X-ray pneumoconiosis, or decreased lung
function. After adjusting for these known causes
of ill health, there was a persistent residual effect
of dust, the magnitude of which could be deter-
mined.
Causal interpretation of the associations found
in this study between silica dust exposure in the
workplace and lung scarring was supported by
the application of Bradford Hill’s criteria — most
of which were met.
There was no immediate implementation of
findings from this research. Due to industrial ten-
sions during and after the study period, the
results were received with some hostility by man-
agement. Conflict continued and some of the
plants closed.
Nine years later, the principal author met the
group medical officer for the brick company con-
cerned at an occupational health conference and
discovered that many occupational health im-
provements had been introduced and that the
results of the study had percolated slowly and in-
directly into improved practice over time.
References:
Myers J E, Lewis P, Hofmeyr W. ‘Respiratory health of brick-
workers in Cape Town, South Africa: background, aims and
dust exposure determinations.’ Scandinavian Journal of
Work Environment and Health 1989; 15(3):180-87.
Myers J E, CornellJ E. ‘Respiratory health of brickworkers in
Cape Town, South Africa: symptoms, signs and pulmonary
function abnormalities.’ Scandinavian Journal of Work
Environment and Health 1989; 15(3):188-94.
Myers J E, Garisch D, Louw SJ. ‘Respiratory health of brick-
workers in Cape Town, South Africa: radiographic abnor-
malities.’ Scandinavian Journal of Work Environment and
Health 1989; 15(3):195-7.
223
25
Introduction
Mortality (death) statistics formed the basis upon
which population health was assessed until the
end of the 19th century, when indicators of
morbidity (illness) were introduced. These pre-
valence and incidence rates of disease provided
no insight into the severity of the conditions or
their effect on people’s lives. Thus, more recently,
the concept of morbidity has been extended to in-
corporate the personal and social consequences
of disease, and quality of life measures. So, for
example, population health can be measured
according to expected years of good quality of life
by using data from disablement studies.
Studies of disablement investigate people with
long-term functional loss, and thus focus on the
long-term consequences of the disease or injury.
The purpose of these studies is to obtain data to
assist health planners, people with disabilities
themselves, and society at large. This data pro-
vides the basis for primary prevention pro-
grammes (such as the promotion of car seat-belt
use) as well as services which enable people with
disabilities to develop their potential and im-
prove their quality of life. Despite these good
intentions, health planners, researchers, and ser-
vice providers worldwide have experienced enor-
mous problems in obtaining data which mea-
sures the consequences of disease.
The most basic research question to be asked in
epidemiological studies of disablement is, ‘What
proportion of the population is disabled?’ This
will be the main issue discussed in this chapter.
There are many clinical research questions
related to disablement and rehabilitation, but
these are not necessarily epidemiological studies
224
Disability studies
and will not be dealt with here.
Internationally, crude prevalence rates of dis-
ablement vary between 0,2% and 20%. In general,
higher rates are found in people with lower edu-
cational levels and lower occupational status, older
people, rural dwellers, and poorer people. Inter-
national variations are not necessarily due to differ-
ences in actual rates, but may be due to differing
age distributions of the populations and inconsist-
ent definitions and measurements of disablement.
The lack of a hard and fast definition of ‘dis-
ablement’ has hampered research in this field.
One difficulty is that consequences can vary in
severity. For example, one person with a walking
disability may not be able to walk at all, while
another may have trouble walking between
rooms. Another problem is the involvement of
many disciplines in the disability field, each with
its own conceptual framework, tradition, and ser-
vice. Important domains of disablement are not
always considered and reported; for example,
mobility problems may be investigated in detail
without reference to self care and work-related
problems.
Population censuses and household sample
surveys are the most common data collection
techniques used in epidemiological studies of
disablement. However, no standardized survey
design has been developed, so sampling meth-
ods, screening questions, and disability defini-
tions and assessments vary from study to study.
International classification of
impairment, disability and handicap
In an attempt to standardize the conceptual

framework and definitions of disablement, the
International Classification of Impairment, Dis-
ability and Handicap (ICIDH) was published by
the WHO in 1980 as the first step towards improv-
ing the quality of information about disablement.
It includes a fuller range of consequences of ill-
ness, injury, and other conditions that lead
people to make contact with the health care
system. While the much-used Jnternational Clas-
sification of Diseases (ICD) provides classification
of diagnosis/etiology, the ICIDH focuses on dis-
ablement and the consequences of injury, illness,
and other conditions.
The ICIDH classifies disablement into three
broad categories: impairment, disability, and
handicap. Impairment is any loss or abnormality
of psychological, physiological, or anatomical
structure or function. It is the consequence of
an illness, injury, or other condition at organ
level. Disability is any restriction or lack (result-
ing from an impairment) of ability to perform an
activity in the manner or within the range consid-
ered normal for a human being. It is concerned
with compound or integrated activities expected
of the person or of the body as a whole, as repre-
sented by tasks, skills, and behaviour. Handicap
is a disadvantage for a given individual, resulting
from an impairment or a disability, that limits or
prevents the fulfilment of a role that is normal
(depending on age, sex, social, and cultural fac-
tors) for that individual. Handicap results from an
interaction between disabled people and their
social, economic, physical, and political environ-
ment. In this chapter, the term ‘disablement’ is
used to cover all three domains discussed above.
The ICIDH provides parallel classifications
along these three axes in great detail. The se-
quence of events in the development of disable-
ment is usually:
Disease — Impairment — Disability — Handicap
FOR EXAMPLE:
Diabetes — leg amputated — walking disability —
occupational handicap
Note that a person can experience multiple
impairments, disabilities, and handicaps.
Since the first publication of the ICIDH manual in
1980, it has gradually been used in a variety of set-
tings. However, many valid criticisms have been
levelled at the classification, indicating the need
for a revision. As it stands now, its usefulness is
25 = disability studies
seriously compromised by its cumbersome
nature. It is unnecessarily complex and fails to
recommend practical and appropriate applica-
tions for clinical practice or for research. When
first published, the manual did not highlight
these shortcomings and effectively launched the
classification into a methodological vacuum.
Additionally, international disability rights groups
object to the ICIDH on the grounds that the
terminology ‘abnormality’ and ‘loss’ label dis-
abled people as ‘less than normal’.
Some of these problems are being addressed,
and a revised version is being developed in
consultation with people with disabilities, dis-
ablement workers, and researchers around the
world. A WHO Collaborating Centre for the ICIDH
has been established in the Netherlands to co-
ordinate research and other developments in this
field.
Study design :
Most epidemiological studies of disablement are
descriptive studies answering research questions
such as ‘who is disabled?’, ‘what proportion of the
population is disabled?’, and ‘what impairments
caused the disabilities?’ However, analytic de-
signs including case-control and cohort studies
can be used to answer questions related to risk
factors for disablement. An example is a study
which follows up a Cape Town birth cohort and
looks at the effect of prematurity (exposure) on
perceptual-motor performance at the age of five
years (outcome) (Coetzer 1995). Intervention
studies can assess the effectiveness of treatment
or other interventions.
Sampling
The sampling issues in disablement prevalence
studies are similar to those of all chronic diseases
of low prevalence. Because the prevalence of dis-
ablement is relatively low, sample sizes often
need to be very large so that the prevalence can be
estimated with good precision. For example, in
order to accrue 10 disabled cases, 120 people may
have to be interviewed.
Generally, larger sample sizes are needed if a
study is impairment-specific, or if impairment-
specific rates and age-specific rates are being
investigated. Younger populations will also need
larger sample sizes, because of relatively lower
prevalences.
Because of the large sample sizes needed,
random cluster sampling is a common approach
225
 e epidemiology applied to content areas
_ to obtain a representative sample. Clusters of
houses are selected and individuals within these
households are interviewed. Strictly speaking,
only one person per household should be inter-
viewed after selection from among the others in
the household by random techniques. However,
it is common for all the individuals within a
household to be studied, creating a second level
cluster (that is, the family), in that family mem-
bers are not selected independently. Given that
illnesses and disabilities may run in families, this
approach may introduce a bias. Nevertheless, the
logistical gain of boosting sample size by count-
ing all the individuals in the households often
necessitates this approach.
In Canada and New Zealand, community-
based prevalence was estimated using a national
census as the sampling frame. Everyone in the
country was asked a screening question, and a
sample of positive and negative responders to the
screening question were followed up to confirm
disability status. In the follow-up phase, a sub-
stantial proportion of positive responses con-
verted to negative, and vice versa.
In studies where only a rough estimate of the
prevalence is needed, but more details are
needed concerning needs and diagnostic/sever-
ity breakdown of the disabled in the community,
service providers can attempt to identify all the
disabled cases by compiling a disability register.
This is done by asking all key informants,
community bodies (for example, churches and
schools), and health services for the names of all
the people with disability they know of. People
with disability and their families, in turn, provide
the names of other people with disability. This
method is called networking and is excellent for
case finding, although not necessarily representa-
tive of all the people with disability in the com-
munity.
Measurement of disease
consequences
Classification
The major problems with the measurement of the
consequences of disease lie in the definitions of
disablement. As the ICIDH develops and is
routinely used in research, definitions of disable-
ment should converge with time. The conceptual
framework dividing disablement into the three
domains — impairment, disability and handicap
— is a useful one. Most studies of disablement
226
conducted in South Africa over the last five to 10
years have used this framework.
Usually the researcher needs to decide which
domain of disablement will be the primary focus
of the proposed study. Will a person be defined as
‘disabled’ if she or he has an impairment (such as
inflamed joints) or a disability (for example, a
locomotor disability) of some kind?
If, for example, a study sets out to measure dis-
ability, the research can investigate all types of
disability or focus only on one (for example, loco-
motor disability). In general, surveys with a lim-
ited focus are more common because specific
professions (such as physiotherapists), medical
areas of specialization (such as orthopaedics), or
agencies (such as the Organization for the Phys-
ically Disabled) may initiate the investigation.
Clearly a limited focus is much easier and the
screening questions (questions asked of all people
sampled in order to determine who needs to be
investigated further) need to cover limited pos-
sibilities only. Each particular disability may have
its own series of screening questions, for example,
visual disabilities (‘Is there anyone in this house-
hold who has difficulty seeing?’ plus others which
flow from this question) and locomotor disabil-
ities (‘Is there anyone in this household who has
difficulty moving?’). However, a drawback of sur-
veys with a limited focus is that sample sizes have
to be much larger to obtain precise estimates.
This is because disablement in general is an un-
common condition, and specific functional prob-
lems such as communication disorders are even
more uncommon.
Crude disablement rates alone are not a par-
ticularly useful measure. A crude rate of 12% gives
us a figure but tells us very little that could be used
in policy and service development. Impairment-
specific rates (for example, the proportion of
people in the population with amputation-
related disability) provide insight into the causes
of disablement, while age-specific rates provide
insight into the ages affected and allow for mean-
ingful comparisons between populations.
Screening questions
Disablement surveys often involve two phases: a
screening phase and a follow-up phase to confirm
the disablement status and/or ask for more
detailed information. The nature of the screening
questions and the additional questions asked
when screened positive, determine to a large
extent the prevalence found in the study.
The use of screening techniques that are

impairment-specific and limited in scope (for
example, blind, deaf, amputee) results in the
identification of the most severely affected cases,
because these cases are obviously more disabled
than those with milder functional loss. Broad-
ranging disability oriented questions concerning
functional and activity limitations such as hear-
ing, moving, and personal care activities, screen
larger proportions of the population as having a
form of disability. Following a positive response
to a screening question, most surveys request an
additional description of either the disabilities
associated with the reported impairment or the
impairments which underlie the reported disabil-
ity. These respondents may be further evaluated
by a rehabilitation specialist, such as a speech or
occupational therapist. However, many surveys
do not ask such additional questions.
The best estimate of disablement is probably
found when disability questions are used as a sur-
vey screen (for example, ‘Does anyone in this
household have difficulty walking or moving
around?’), and then followed up by impairment-
specific questions (for example, ‘What is the
reason for this difficulty?’) Handicap has not been
found to be useful as a screening device for iden-
tifying people with disability.
Other variables commonly collected
Besides asking questions related to disability
itself, surveys often ask additional wide-ranging
questions. Table 25.1 contains alist of variables
that are commonly covered.
Validation
Questionnaires are indirect measuring instru-
ments that record mostly subjectively reported
information. Reported disability and impairment
might not reflect the true level and nature of
disablement. Proxy (substitute) reporting often
worsens this problem, although in some cases
proxy reporting by a family member may be more
reliable than self-reporting by the disabled
person him or herself (for example, in the case of
a person with an intellectual disability).
The validity of the information can be im-
proved by testing the subjects either in the field or
at a foliow-up visit, or when they attend a hospital
or clinic. Validating the reported impairment may
involve a full medical examination and/or special
investigations such as X-rays and IQ testing. The
cost of such investigations may be prohibitive,
using most of the financial resources available for
the study. Alternatives to this include in-depth
25 = disability studies
Table 25.1 Variables commonly
Tite CsTeM mel ersl tae aN
Demographic
@ Age and sex
@ Place of residence (urban, rural)
¢ Highest level of education and/or training
achieved
¢@ Occupational status
¢ Details of economic activity
Marital status
Household information
@ Household environment (availability and
access to toilet, water, domestic power)
@ Number of people in household/family com-
position
¢ Dwelling type and number of rooms
Describing the disability experience
@ Additional impairments
@ Age at onset
¢@ Cause of impairment
¢ Disability status
Severity of impairment or disability
¢@ Special aids used
Services or treatment received
@ Special topics
investigation of a sub-sample of the study sample.
The sub-sample could include either only those
subjects reporting impairments (to pick up false
positives), or subjects from both (reported) im-
paired and non-impaired groups. The latter
option enables you to calculate the sensitivity and
specificity of the screening process, and is more
useful in assessing the validity of the findings.
In areas where access to and utilization of re-
habilitation services is good (this is rare in South
Africa), a review of institutional and professional
records may be a cheaper option. However,
records are often poorly designed and completed,
pointing to the need for a well-designed and co-
ordinated information system, which can be a
useful resource both for case management and
for the collection of disablement statistics.
Analyses
The use of a summarized form of the ICD is
recommended to give a classification of the
22h
e@ epidemiology applied to content areas
etiologies of the impairment(s) that is medically
meaningful and internationally comparable
(some codes may be needed for non-medical rea-
sons given, such as witchcraft). A simplified ver-
sion of the ICIDH can provide a standardized
approach to the coding and presentation of im-
pairments and disabilities.
The calculation of confidence intervals for es-
timates of the prevalence of disability is recom-
mended.
Conclusion
The major contribution of the ICIDH to popula-
tion-based disablement surveys is a conceptual
one, in that a common framework now exists as a
reference point. However, there are technical dif-
ficulties in applying concepts and categories. A
concerted effort needs to be made internationally
to develop more standardized approaches to
population-based studies.
In South Africa, there is limited population-
based disablement information to assist in plan-
ning for rehabilitation and disability support ser-
vices. Rehabilitation services are also poor in
most areas outside the major urban centres.
These two facts appear to point to a need for more
disablement surveys to provide information for
service planning. However, it is difficult, expen-
sive, and time-consuming to conduct a scientifi-
cally rigorous disablement survey. Issues of mea-
surement, large sample sizes, and validity dis-
courage widespread attempts to undertake such
studies. In many instances, large and expensive
surveys do not lead to service development or im-
provement. In such cases, the use of existing clini-
cal information is a cheaper and reasonable alter-
native. This emphasizes the need for developing
good information systems, including disability
registers, which can be consulted when needed.
Researchers and health planners need to devel-
op approaches which can be implemented
rapidly, at relatively low cost, to yield useful
results at district level. Full-scale epidemiological
surveys should only be undertaken after all the
methodological and financial issues have been
carefully considered. Such studies could be done
on a regional rather than local level, where results
can have an impact on service planning for a large
area, and can contribute towards measuring
population health according to expected years of
good quality of life.
228
EXAMPLE 25.1
The prevalence of motor disability
and impairments in Manguzi,
KwaZulu-Natal
A study was carried out to measure the preval-
ence of motor disability and impairments in the
Manguzi health ward, a rural area in KwaZulu-
Natal. An interview survey was done to determine
motor disability and a follow-up medical exami-
nation carried out for motor impairment.
A two-stage random cluster sample technique
was used, with the homestead (numbered by
malaria control officers) used as the sampling
unit. Two hundred and fifty homesteads (10% of
the total) were selected. Information collected by
trained interviewers included demographic de-
tails and the presence or absence of perceived
disabilities of each homestead member. Per-
ceived difficulties in moving and walking, and
their causes, were enquired about. A practical
field diagnosis, including a simple walking test,
was made by a trained occupational therapist.
Motor impairment was assessed by full follow-up
medical assessments, including X-rays, at a dis-
trict hospital.
Information on 52% of the sampled people was
proxy reported. A crude motor disability rate of
86/1 000 and a crude motor impairment rate of
52/1 000 was found. The commonest impairment
was osteo-arthritis of the hip, which may be the
same disease that has been reported in neigh-
bouring areas, and which is referred to as Mseleni
joint disease.
Reference:
McClaren P A, GearJ S, Irwig LM, Smit A E. ‘Prevalence of
motor impairment and disability in a rural community in
Kwazulu.’ International Journal of Rehabilitation Medicine
1987; 8:98-104.
EXAMPLE 25.2
The crude disability prevalence rate
in Mitchell’s Plain, Cape Town (1989)
A study was undertaken in 1989 to investigate the
crude disability prevalence rate in Mitchell’s
Plain, a dormitory town near Cape Town. The re-
search was initiated by the Community Occu-
pational Therapy project serving the area, in

order to broaden its service and identify disabil-
ity-related problems. A proportional stratified
cluster sampling design was used with a sample
size of 500 households. The 82% household re-
sponse rate yielded 2 424 individuals in 472
households.
During Phase 1 of the data collection, rehabili-
tation assistants interviewed a responsible adult
from each household. A census was taken of each
household and two sets of screening questions
were asked about household inhabitants. The
first question screened for all the categories of
disability (such as movement, strange behaviour,
or hearing) and also enquired about regular
treatment and appointments for health prob-
lems. If a positive response was given to any of
these questions, a second screening question
was asked about the person’s ability to perform
key activities specific for the person’s age (for
example, in the case of adults — ability to work;
in the case of children — ability to play). The
second question tended to screen out people
25 = disability studies
with mild disability who had no occupational
handicap.
All individuals (12,9%) who fell into the dis-
abled category from the first screening question
were followed up by experienced physiothera-
pists or occupational therapists, with 85% being
traced. The screening questions were repeated,
and an in-depth interview concerning disability-
related information was done on those who re-
ported to be unable or limited in the age-specific
key activities. A crude disability rate of 3,9% (95%
confidence limit 2,8% to 4,9%) was found. The
authors considered the figure of 12,9% to approx-
imate the impairment rate in the community, and
the figure of 3,9% to be the rate of moderate to
severe disability.
Reference:
Katzenellenbogen J, Joubert G, Rendall, K, Coetzee T.
‘Methodological issues in a disablement prevalence study:
Mitchells Plain, South Africa.’ Disability and Rehabilitation
1995; 17:350-57.
229
26
Introduction
The political changes that have swept South
Africa and the economic realities underlying
them have stimulated policy changes in a number
of areas. For example, in the early 1990s, there
was a shift towards primary health care and an
attempt to integrate mental health services into
primary health care. Efforts to achieve such an
integration, however, have been hampered by
numerous factors, including a lack of sound
epidemiological research in the mental health
field.
Psychiatric epidemiology could play a key role
in planning mental health services, setting up
effective training programmes for health workers,
and developing strategies to promote mental
health and prevent mental illness. It can do this
by identifying cases and risk factors for mental
health problems (particularly those amenable to
intervention), and by assessing the efficacy of
interventions to improve mental health (Yach,
Kuhn 1989).
What is different about psychiatric
epidemiology?
Part of the problem faced by any psychiatric re-
search is that psychiatric illness is often stigma-
tized and is therefore likely to be hidden from re-
searchers more often than other conditions. In
many countries, psychiatric illness is not given a
high priority, in spite of the fact that it is relatively
common, uses substantial resources, and is
socially disruptive (Dick, Spencer, Watermeyer,
Bourne, Wolff, Moyle 1978).
In psychiatry, disorders typically cannot be
230
Psychiatric
epidemiology
identified physiologically or by a predictable pat-
tern of signs and symptoms. Evidence of pathol-
ogy is often not concrete.
Many of the signs and symptoms associated
with psychiatric illness depend upon social
judgements. For example, what one person may
view as problematic social withdrawal, another
may see as appropriate reserve. Beliefs about
what is acceptable behaviour will differ in differ-
ent cultural contexts. This means that behaviour
seen to be pathological in one cultural context
may not be viewed as such in another.
A further issue that arises is the lack of agree-
ment between study subjects and researchers on
the one hand, and between psychiatric re-
searchers and clinicians on the other, about term-
inology and diagnostic labels. For example, when
some people become very agitated, unable to
concentrate, and therefore unhappy, they may
label this depression, whereas in the diagnostic
system of the psychiatrist it may be more properly
labelled anxiety. The classic example of profes-
sional inconsistency of labelling was the observa-
tion in the 1960s that schizophrenia was more
commonly diagnosed in the USA than in Britain.
This was not necessarily because of different
symptom patterns, but because conditions which
would not be called schizophrenia by British psy-
chiatrists would be classified as such by their
North American colleagues.
Later in this chapter, some of the ways in which
psychiatric epidemiologists have handled these
issues are discussed, but it is important to note
that, in psychiatry, decisions have to be culturally
and socially informed. This applies to other
branches of epidemiology as well, but it is espe-
cially necessary in psychiatric epidemiology.

Study design
Many of the psychiatric epidemiological studies
in Africa have been descriptive rather than analy-
tic, and have mainly sought to provide inform-
ation on the burden of illness by focusing on pre-
valence alone. Beyond looking at demographic
variables such as age, race, and gender, re-
searchers have rarely investigated factors asso-
ciated with the distribution of mental disorders in
the population studied. Most of the research has
also been cross-sectional, attempting to provide
‘snapshots’ of the disease status of a community
and current exposure to risk at-a single point in
time.
There have been calls for a move away from
cross-sectional descriptive to cross-sectional
analytic studies (Cooper 1984; Gillis 1987). Reeler
(1987), in particular, has stressed the need for re-
search to shift from what he calls ‘classificatory’
to ‘management’ studies, that is, studies which
can supply practical information to those who
need to make decisions. In particular, researchers
have been encouraged to obtain information on
the clinica! severity of the dysfunction, the degree
of functional impairment, current support sys-
tems, interviewees’ knowledge of the availability
srl) (lM eee ara mR
Diagnostic system
Study population
Focus of inquiry
Time factors and constraints
Type of instrument
Level of clinical skill
Prior application in study areas
Ease of analysis
26 psychiatric epidemiology
of mental health services and their prior usage
of such services, and their attitude to mental health
treatment (Cooper 1984; Links 1983; Robins 1990).
The information gained from cross-sectional
analytic studies will also facilitate the ‘graduation’
to other designs, for example, case-control stud-
ies, follow-up studies, and even experimental
studies. Such studies are needed if psychiatric
epidemiologists are to play as useful a role in the
mental health arena as epidemiologists have
played in the general health arena.
Measurement issues
Measurement of outcomes
Investigators can determine psychiatric morbid-
ity by adopting either a single or a two-stage
approach. Ina single-stage study, all the subjects
in the sample are typically interviewed by clin-
ically trained interviewers using a structured
interview, on the basis of which cases are identi-
fied. The high cost of using skilled interviewers is
a major drawback of this approach. In a two-stage
approach, a population is briefly surveyed during
the first stage by means of a rapid, simply admin-
istered, and cost-effective screening test that
mes
Options
Diagnostic and Statistical Manual of Mental
Disorders, 4th edition or International
Classification of Diseases, 10th edition
Community members, attenders at primary
health care clinics, elderly, etc.
What types of disorders are of interest and at
what levels of severity?
Time frame for inquiry (e.g. lifetime, past
month); time needed for test administration
Screening or second stage
Clinicians or trained lay interviewers
Has instrument been translated into language
of population of interest? Has it been
calibrated on that population?
Availability of computer scoring algorithms
231
e epidemiology applied to content areas
identifies possible cases. In the second stage,
‘high-risk’ individuals are re-interviewed so that
they may be confirmed as actual cases. Ifa sample
of those found to be negative on the initial screen-
ing is also re-interviewed, the second stage also
permits assessment of the validity of the screen-
ing instrument in the study population.
A number of instruments are available for
epidemiologists to ascertain the psychiatric
status of child, adolescent, and adult populations.
One of the major factors influencing the choice of
outcome measures, and hence instruments, is the
research question. Is the researcher studying a
particular age group (such as the elderly)? Is he or
she interested in studying a single type of dys-
function (such as depression) or a range of prob-
lems? Is she or he interested in whether the
person or group under study has ever experi-
enced certain kinds of problems or symptoms
(lifetime prevalence) or whether they are cur-
rently experiencing them (current prevalence)? A
number of factors influencing the choice of which
instrument to use are indicated in Table 26.1.
Various screening instruments and structured
diagnostic interviews currently used to determine
the psychiatric status of child and adult popula-
tions in developing countries are listed in tables
26.2 and 26.3. The tables also indicate the primary
application for which the instrument was de-
signed, the general focus and type of instrument
(that is, type of population to be studied and
whether the instrument is to be used for screen-
ing or a second-stage assessment), and other
issues which determine choice of instrument. For
a more detailed discussion of commonly used
psychiatric epidemiological instruments, please
refer to Bech et al (1993), Tansella, de Girolamo,
Sartorius (1992), and the WHO Division of Mental
Health (1993).
Various researchers have stressed that psy-
chiatric epidemiology needs to go beyond psy-
chiatric symptomatology in case identification.
Marsella (1992), for example, recommends that
case definition should also include psychosocial
problems such as family violence, divorce, and
racism. He argues that it may be more helpful to
examine various clinical parameters of mental
disorders and social pathologies than to focus on
diagnoses. In particular, he stresses that greater
attention should be paid to studying symptom
parameters (for example, frequency, severity, and
duration of symptoms and problem behaviours),
clinical parameters (for example, onset, course,
and outcome), and psychosocial parameters
232
(such as functional impairments, disabilities, and
handicaps).
Initiatives to- make psychiatric epidemiology
more valid have gone beyond calls for expanding
the focus of inquiry to investigating the way in
which people are classified. The traditional, cate-
gorical approach to classifying psychopathology
is coming under increasing scrutiny. An altern-
ative (though less commonly used strategy), is to
adopt a dimensional approach where the focus is
more on symptoms and symptom clusters than
individual diagnoses. Other critics (for example,
Miller and Swartz [1992]), have argued that com-
bining conventional epidemiological methods
with qualitative methods will help to overcome
the limitations of using conventional epidemi-
ological methods to investigate the depth and
complexity of psychological phenomena.
Measurement of exposures
In the mental health field, there are a number of
exposures which are associated with psychiatric
illness.
The effects of social and family arrangements
Social support and network structures may help a
person function longer and more productively
than if that person had been socially isolated.
Conversely, very stressful social or family circum-
stances may aggravate psychiatric disorders.
There is a large literature on the specific ways in
which social networks and support structures
operate, and how they affect the course of dis-
orders. The literature on what is known as ‘ex-
pressed emotion’ (EE) has shown that people
with psychiatric problems are more likely to re-
lapse in situations where members of their family
are Over-involved with them and over-critical of
them.
Part of the challenge psychiatric epidemi-
ologists face when trying to take account of the
role social and family arrangements play in affect-
ing the course of illness, lies in separating the ill-
ness itself from the factors which may affect it.
When an association is demonstrated between
social isolation and relapse, for example, it can be
because people isolate themselves as a result of
relapse, or because the social isolation has trig-
gered the relapse. We can begin to speak of isola-
tion as a risk factor for relapse only once we are
clear that the isolation is not in fact part of the ill-
ness. One way this can be done methodologically
is to demonstrate that the isolation predates any
changes in the person’s behaviour that suggest
 233
psychiatric epidemiology

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the possibility of relapse (that is, temporal rela-
tionship between outcome and exposure). The
insidious nature of onset and relapse in mental
illness, and hence the difficulty of pinpointing
onset of disease or of a particular phase in a
disease, requires very careful recording of
changes in behaviour, as well as an appreciation
of the ways in which person and context are inter-
twined.
Stressful life events
Intuitively, one might assume that unpleasant
experiences or events would contribute to the
onset or exacerbation of psychiatric disorder, and
research bears out this view.
Early work by Holmes and Rahe (1967) in the
1960s, however, demonstrated that it may not be
the quality (positive or negative) of events which
contributes to the course of disorder, but rather
the amount of change or readjustment which
events cause in people’s lives. Thus, in the many
scales that have been developed to measure life
events and life change, there are predictable
items, such as the death of a spouse and deten-
tion in jail, as well as items such as marriage, birth
of a child, and so on. There is ongoing debate
about which sorts of events can predict the course
of illness. In the case of depression, for example,
events involving loss may be more important
than in other disorders.
The same event may have different meanings
and implications for different people (Brown,
Harris 1978). The view that individuals’ personal
experience or appraisal of events is more crucial
than the events themselves has considerable
methodological implications. If a researcher is inte-
rested only in events, these can be assessed fairly
quickly using a checklist, but if appraisal is of inter-
est, then a detailed and relatively individualized in-
terview format has to be developed.
One important methodological advantage of a
reasonably in-depth interview is that, apart from
providing access to the respondent's perceptions
of events, it also helps clarify whether stressful
events occurred before or after the onset or
exacerbation of symptoms. As we have seen
before, this is a key question for developing
models of cause of disorder. A further advantage
of careful questioning in this area is that it facilit-
ates an exploration of recall bias in the reporting
of events. A depressed person, for example, may
recall many unpleasant experiences which would
not be remembered by a person who is not de-
26 psychiatric epidemiology
pressed. Recall bias can, however, be fully dealt
with in psychiatric epidemiology, as in other
branches of epidemiology, by the design of
prospective studies.
The fact that different people can experience
what are apparently the same external events in
very different ways leads the enquiry in two diver-
gent directions. The first of these concerns indi-
vidual vulnerability; the second concerns the
influence of broader cultural and social arrange-
ments on the ways in which communities under-
stand, manage, and respond to circumstances.
The following two sections will deal with these
questions.
Individual vulnerability
A person may be vulnerable to disorder on the
basis of a range of factors intrinsic to that person,
for example, the way they were brought up, phys-
ical health, stressful events, and genetic factors
(Kaplan, Sadock 1988). At first it may appear con-
ceptually difficult to separate these factors from
the disorder itself, and there may also be some
circularity in reasoning.
For example, if it can be shown that people who
are habitually suspicious are more prone than
others to a psychiatric disorder typified by exag-
gerated suspicion, have we demonstrated any-
thing at all? In spite of these difficulties, it can be
demonstrated empirically that there is no inevit-
able link between any given personality style and
psychiatric disorder.
The two dominant contemporary approaches
to classification in psychiatry (the Diagnostic and
Statistical Manual of Mental Disorders, fourth
edition, of the American Psychiatric Association,
and the International Classification of Diseases,
tenth edition, of the WHO) have attempted to
deal conceptually with separating clinical dis-
order and other factors intrinsic to the affected
person by classifying the clinical disorder on one
axis and personality disorders (and mental han-
dicap) on other axes.
The separate focus on personality disorder and
on personality style (although not uncontrover-
sial) is useful both in psychiatric epidemiology
and more especially in studies of chronic diseases
of lifestyle, where issues of behaviourial change
and adherence to treatment are vital.
Often the concern in such studies is not with
psychopathology as such, but with factors
which may contribute to disease and affect re-
covery.
235
e epidemiology applied to content areas
Broader social, economic, and cultural
influences
From an intuitive point of view, it seems logical to
suppose that rates of psychiatric disorder would
increase in proportion to actual physical hardship
experienced by people. Psychiatric epidemi-
ologists have explored the relationships between
resource allocation to groups and populations,
and psychopathology. Though the evidence is not
uniform, it does appear that there are relation-
ships between patterns of pathology and broad
socio-economic factors (Blackburn 1991; Dawes,
Donald 1994). A major challenge in such research
is to develop models capable of explaining the
mechanisms whereby broad social factors impact
on psychopathology.
The psychiatric epidemiology of apartheid —
specifically the relationship between apartheid
and mental health — can be viewed as one exam-
ple of concern about broad social factors. Surpris-
ingly little epidemiological work has systematic-
ally addressed the psychopathological effects of
apartheid (Swartz 1987). The challenges of re-
search in this area at a time of national recon-
struction in South Africa are greater than ever
before.
Other broad social factors that may influence
the mental health of populations can be seen as
intrinsically undesirable (such as war and civil
strife). Others can be viewed as broad and com-
plex social movements whose effects need to be
explored. Urbanization, for example, is a global
phenomenon leading to massive changes in
social networks and human relationships, and the
effects of urbanization on mental health are
beginning to be explored.
Part of the problem in assessing the effects of
apartheid and urbanization on mental health is
that it is very difficult to tease out particular ex-
posures for particular persons and to link these to
specific outcomes. There is also such a wide range
of experience of broad social phenomena such as
apartheid, that it is often difficult to define pre-
cisely what is meant by the term. It may be more
worthwhile from a methodological point of view
to focus more narrowly on a phenomenon which
can be measured precisely, and which can either
serve as a proxy for or be an example of a broader
social phenomenon. It is of course possible to
compare the mental health of people living under
certain social conditions with those living under
other social conditions through ecological de-
signs, but such designs are weak. For example,
some decades ago there was some interest in
236
whether South Africans as a whole suffered from
higher rates of anxiety than people elsewhere,
and an attempt was made to explain differences
in rates with reference to apartheid (Swartz 1987).
The problem with this type of analysis is that it
assumes a single causal pathway, and ignores a
whole host of other possible interpretations of the
data — including the possibility that an inter-
nationally used scale may work differently in
South Africa for cultural reasons.
_In a rapidly changing world where diversity is
experienced in every country, there has been con-
siderable interest in the effect of cultural factors
on psychopathology. Some early work in this field
was clearly racist — for example, it was once
thought that African people were incapable of
feeling depressed, as they lacked the necessary in-
sight for reflection and concern about their lives
(Littlewood, Lipsedge 1989). This flies in the face
of practically all contemporary epidemiological
evidence, which shows high rates of depression in
Africa (Littlewood, Lipsedge 1989).
The extent to which cultural arrangements
affect mental disorder, and how, is an area receiv-
ing increasing attention. There is considerable
debate, for example, on whether schizophrenia
has a better outcome in the Third World than
elsewhere, as early epidemiological evidence
seemed to suggest. These debates are part of a far
larger challenge to psychiatric epidemiology as a
whole, and this challenge is dealt with in the next
section.
Issues of validity in psychiatric
epidemiological research
Threats to the validity (accuracy) of epidemi-
ological investigations arise from failure to assess
the validity of the instruments, to calibrate them,
and to assess their reliability (repeatability). Psy-
chiatric epidemiologists have also faced diffi-
culties in finding an appropriate way to define
and measure. disorder, particularly in non-
Western settings. These difficulties demonstrate
how it is possible for a gap to exist between what
is the ‘truth’, and what is measured.
In general, the validity of,instruments may be
enhanced by conducting medical examinations
to check whether physical disorders are causing
the mental disturbance. The use of multiple
sources of data, to double check information or to
fillin gaps, also improves the quality of the data.
The validity of screening instruments can also
be enhanced by following up a certain percentage
of screen negatives, and modifying morbidity es-

timates on the basis of the number of screen nega-
tives who turn out to be cases. Reliability is as
important as validity, and it is crucial that inter-
observer reliability be established (Swanson-
Fisher, Martin 1981).
The validity of instruments developed in
Europe and North America may be compromised
by application in a new context. Researchers fre-
quently rely on cut-offs which have not been
adjusted for the population under study. This can
result in inaccurate estimates of psychiatric
morbidity.
Besides the general issues of validity, there are
at least two major threats to the validity of psychi-
atric epidemiological instruments when applied
in developing countries. The first arises from cul-
tural differences, and the second from the lang-
uage translation process.
Epidemiology is in itself a cultural enterprise,
embodying Western notions of disease and basic
Western assumptions about ways that people
function — the split between body and mind, and
between emotions and intellect, are just two exam-
ples. Psychiatric epidemiology is thus a Western
product which tends to take as a given Western
ways of seeing the world, Western classification
systems, and Western healing systems. Most
people in the world, however, do not conceptual-
ize or experience their illness in this way.
This has important consequences, the most
serious being how to judge whether behavi-
our is indeed pathological or not. When measur-
ing psychiatric morbidity, problems arise from
the confusion between culturally distinctive
behaviour and psychopathological manifesta-
tions. For example, in some African settings appa-
rent ‘hallucinations’ and ‘delusions’ may occur
even among psychiatrically healthy people and
may result from encounters with ancestors whose
influence is believed to be tangible (Gillis, Ben-
Arie, Elk, Teggin 1982).
A second and related problem stems from the
way that the specific content of a psychiatric test
may culturally influence responses. For example,
questions about experiences such as watching TV
or reading newspapers may result in biased re-
sponses, as respondents may not have access to
these objects.
Thirdly, the format of psychiatric tests may
influence responses. For example, the interrog-
ative style of most standardized tests may be
foreign to the expectations and practice of many
Africans, and verbal and non-verbal responses
may not reflect the true state of the interviewee
26 psychiatric epidemiology
(Gillis, Elk, Ben-Arie, Teggin 1982).
A number of strategies have been proposed for
handling these difficulties. Before undertaking an
epidemiological study, it is essential that re-
searchers learn about abnormal behaviour pat-
terns and the socio-cultural context within which
such behaviour occurs (Draguns 1984). This
could be achieved, for example, by conducting
anthropological studies that try to understand the
cultural context of and the reasons for specific
activities. Based upon such an anthropological
investigation, it might be useful to supplement
ingtruments by adding questions about somatic
expressions of mental illness or specific cultural
phenomena. These questions can be analysed
separately. Other strategies include using person-
nel familiar with subtle cultural nuances as inter-
viewers or interpreters, asking subjects to explain
some of their responses, rating a symptom as
negative whenever there is any doubt about it
being positive, conducting physical examinations
to make allowances for the influence of physical
health on mental status, and modifying the con-
tent of certain questions to make them more rele-
vant to interviewees’ everyday experience.
Translation of psychological tests into African
languages can also affect the validity of epidemi-
ological studies. This occurs primarily because
languages differ in the way they express inner dis-
tress such as depression and anxiety (Swartz,
Ben-Arie, Teggin 1985). The first step in reducing
the threat to validity cdused by the translation
process is to translate the instrument in such a
way that the concept behind each item is ade-
quately conveyed, incorporating local idioms of
distress and, if necessary, asking a series of sep-
arate questions rather than a single question. The
second step is to get someone to do an independ-
ent translation back into the original language.
The third step is to straighten out the differences
between the original and the back-translation.
Another set of strategies can be applied during
the interview. Where interpreters are used, they
should preferably be from a similar cultural back-
ground to the respondents. They should be fluent
in the interviewee’s language, have mental health
expertise, and be skilled in the use of the instru-
ment in question. The interview process should be
constantly monitored by evaluating the relevance
of answers and observing interviewee’s non-verbal
behaviour. It may even be necessary to ask inter-
viewees to paraphrase some questions to deter-
mine how they understand them, or to rephrase
‘difficult’ questions using standard alternatives.
Basil
e@ epidemiology applied to content areas
It will therefore be helpful to conduct pilot
studies comparing the results with assessments
made by clinicians, comparing the distribution of
scores between normal and patient samples, and
to pre-test the translation. The validity of an
instrument in a cross-cultural setting may also be
assessed by conducting formal statistical assess-
ment (for example, factor analysis) comparing
scores obtained in a cross-cultural setting and
studies elsewhere.
Psychiatric epidemiology in the
primary health care context
General approach
Following the Alma Ata declaration, there has
been increasing interest and emphasis on inte-
grating mental health services into primary
health care (PHC). This has important implica-
tions for psychiatric epidemiology. What does it
mean to integrate mental health services into pri-
mary health care? At one important level, it
means treating obvious or known cases of mental
disorder as far as possible at the primary level and
in an integrated way. At another, though, it means
rethinking the ways in which we understand
health and illness behaviour (that is, the ways in
which people interpret, respond to, and act on
their experiences of ill health) and reorientating
PHC programmes to accommodate these factors.
Anyone with clinical experience in any area of
health care will be familiar with patients whose
behaviour does not easily fit with the health care
system. These may include people who come for
help when no physical problem can be found,
people who experience pain and discomfort out
of proportion to their pathophysiology, people
who do not take medication as prescribed, people
who continue with lifestyles which are bad for
their health, people who abuse their bodies with
cigarettes, alcohol, and addictive drugs, parents
who seem to have their children’s best interests at
heart, but who fail to do what is necessary to keep
the children healthy, and so on. The list is endless.
The AIDS epidemic has convinced many sceptical
health care professionals that serious attention
must be given to psychosocial factors as part of
any primary health care programme.
Psychiatric epidemiology has much to offer any
health worker or researcher in the quest to under-
stand and influence patterns of health and illness.
Psychiatric epidemiology is, however, narrowly
understood and is sometimes thought to focus
238
only on major recognized psychiatric illnesses
(such as schizophrenia) and major affective dis-
orders (disorders of mood). These illnesses are
important in the public health field, as they are
distressing, and may be chronic and place a
burden of care on family and community mem-
bers and the health services. However, psychiatric
epidemiology should and does go beyond the
study of the major psychiatric conditions. It is
often stated that psychological factors are
responsible for much of the work that has to be
done at primary health care level. The implication
(spoken or unspoken) is that these factors waste
primary health care resources. The first task of an
approach to psychiatric epidemiology at this level
is to sort out a series of questions about psycho-
logical factors in primary health care, and to
decide which of these questions is relevant to the
setting being studied.
A central question which has been asked in psy-
chiatric epidemiology concerns the paths people
follow on their journey to becoming known psy-
chiatric patients. Table 26.4, reproduced from
Goldberg and Huxley (1992), shows that in Britain
not all people who suffer from mental disorder
(defined as having an episode lasting at least two
weeks in a calendar year) consult primary care
services, and that there is a progressive filtering
by which people become users of mental illness
services and, even more rarely, psychiatric in-
patients.
Of central importance in Goldberg and Huxley’s
work are two observations.
Not everyone suffering from mental disorder
comes to the attention of mental illness ser-
vices, or even to the attention of the health ser-
vices in general.
The process whereby one becomes a patient in
mental illness services depends only partly on
the symptoms from which one suffers.
As Goldberg and Huxley note, the filters between
different levels in their model depend partly on
how people who experience symptoms under-
stand and act on them (illness behaviour), clini-
cian competence (ability to detect disorder), and
patterns of referral and resources available (fefer-
ral to mental illness services and admission to
psychiatric hospitals).
- In order to tease out the different contributors
of paths to psychiatric care and status as a psychi-
atric patient, we need to be able to answer ques-
tions both about what constitutes a psychiatric
 26 psychiatric epidemiology

A series of studies which demonstrate many of

Table 26.4 Five levels and four
Te LCL AY
Level 1: The community
(illness behaviour)
Level 2: Total mental morbidity — attenders
in primary care
(ability to detect disorder)
the issues involved in thinking about psychiatric
epidemiology in relation to primary health care,
and which also address some other questions
raised in this chapter, were undertaken as part of
1st filter
the Mamre Community Health Project (Miller,
Swartz 1990; Reynolds, Swartz 1993; Rumble,
Swartz, Parry, Zwarenstein [in press]; Swartz,
Miller 1991). A brief discussion of those studies is
2nd filter
given below, for illustrative purposes.

Psychiatric epidemiology in practice: the

Level 3: Mental disorders identified bydoc-
tors (‘Conspicuous Psychiatric Mor-
3rd filter
(referral to mental illness services)
Level 4: Total morbidity — mental illness ser-
Ath filter
(admission to psychiatric beds)
Level 5: Psychiatric in-patients
(Source: Goldberg D, Huxley P 1980, 1992)
case and about behaviour of patients and practi-
tioners in the context of the particular resources
available to them. Equally important is the observa-
tion that a very substantial proportion of people
who suffer from episodes of mental illness will not
come into contact with health services at all, or, if
they do, they will not be perceived to be suffering
from mental illness. In some cases, the person who
presents at a PHC service may bearelative experi-
encing the burden of living with a person who is far
more symptomatic, but who will not use services at
all. For example, a person could be very withdrawn
and suspicious, and therefore unlikely to use any
services at all. This withdrawal and suspicion could
place a great burden ona relative or someone else
in the household, who would then go for help be-
cause of their own distress.
A further implication of the Goldberg and
Huxley model is that many people suffering from
distressing symptoms need never become psy-
chiatric patients as such. This does not neces-
sarily make their experience any less distressing
or important as a focus for concern on the part of
health service planners and epidemiologists.
Looking at the psychiatric epidemiology of
primary health care can provide ways of under-
standing not only disorders in themselves, but
issues in service provision as well.
Mamre Community Health Project
The Mamre Community Health Project, a collab-
orative enterprise between the people of Mamre,
the University of Cape Town, and the Medical Re-
search Council, was established in 1986 as an
opportunity for epidemiological research and to
improve the health of Mamre (see also Example
3.2). The project is unusual, as it has had alarge
psychological component from early on in the
project’ history.
In 1986, a community-wide survey was under-
taken of health status in Mamre. The researchers
were interested in getting an idea of the preval-
ence of psychiatric disorders in Mamre. Wishing
to use a term for psychiatric illness that was
acceptable to the community, they asked re-
spondents in a pilot study whether they suffered
from their ‘nerves’. A very large number of
women answered yes — far more than could ever
conceivably have been psychiatric patients
according to what is known of the expected
number of patients in any given community. As a
result, the question was modified to ask whether
people had been treated for their nerves in the
past year. Roughly 2,9% of respondents answered
in the affirmative, with a male:female ratio of
approximately 1:3. At this point, psychologists
were asked to join the project team.
Using the Goldberg and Huxley (1992) model,
psychologists were able to explore not only
mental disorder itself, but also important factors
concerning its identification and management.
The questions asked at each level and filter, and
the ways in which these were addressed, are
shown in Table 26.5. Some details of the research
strategy have been omitted and altered slightly in
order to maintain conceptual clarity.
There is no psychiatric inpatient facility ip
Mamre, so only the filter to this level of care — and
not details about the actual care received — was
studied. It would have been impossible to survey
all residents of Mamre who were in hospital else-
239
e@ epidemiology applied to content areas
where (especially in Cape Town) at any given time
to assess directly, for example, level of care
received.
The various studies in Mamre allowed for a
spectrum of questions to be addressed in a wide
Pre) (wes Cr Cr Creamy Ly) the Mamre eT
Project as an application of the Goldberg and Huxley method
QUESTION
Level 1: Mental illness in the community
How common is psychiatric morbidity in the
Mamre community?
First filter: illness behaviour
What factors lead people in Mamre with
psychiatric morbidity to approach primary
health care facilities for help?
Level 2: Total psychiatric morbidity in primary care
What proportion of people from Mamre using
primary health care services suffer from
psychiatric symptoms?
Second filter: Detection of disorder
To what extent do primary health care personnel
detect psychiatric symptoms, and what are
some of the factors affecting this detection
pattern?
Level 3: Conspicuous psychiatric morbidity
What proportion of people making use of PHC
services are recognized by practitioners as
having psychiatric morbidity?
Third filter: Referral to psychiatrists
What factors (apart from detection of disorder)
contribute to PHC practitioners’ decisions to
refer to psychiatric services?
Level 4: Total psychiatric patients
Who are the known psychiatric patients in
Mamre, and what are the characteristics and
needs of themselves and their families?
240
range of ways, both quantitatively and qualit-
atively. The issues of validity so central to assess-
ment in psychiatric epidemiology were especially
clear in the cross-sectional, community-based
survey, which is described briefly.
LAG Prey
‘RESEARCH STRATEGY
Community-based random survey (cross-
sectional) Note: some methodological issues
raised by this study are discussed below
i) Questions about illness behaviour in the
random survey;
ii) Qualitative study of ‘nerves’ amongst known
psychiatric patients
Cross-sectional survey of psychiatric morbidity
amongst all people from Mamre using
primary health care services both in the village
and in the large neighbouring town
i) Rating sheets filled in by primary health care
personnel on all people assessed during
the cross-sectional survey, and comparison
of their ratings with scores obtained on a
standard instrument
ii) Semi-structured interviews with primary
health care personnel about their approach
to identifying psychiatric morbidity
Rating scales mentioned above
i) Interviews with PHC practitioners
ii) Review of records of known psychiatric
patients in Mamre =
i) Review of the records and register kept by
the psychiatric sister who deals with Mamre
ii) Survey of all known psychiatric patients and
their families

Table 26.5 (continued) Research strategy used tnthe N eree Community
Health Project as an application of the Goldberg and Huxley method:
Fourth filter: Admission to psychiatric beds
What factors play a role in determining whether
Mamre residents are admitted to psychiatric
hospitals in Cape Town?
Level 5: Psychiatric in-patients |
There is no psychiatric in-patient facility in Mamre,
so only the filter to this level of care was studied.
Randomly selected adults were assessed
using the Self-Reporting Questionnaire (SRQ) as
a first-stage screen, and the Present State Exam-
ination (PSE-9) as the second-stage criterion.
Demographic, health care utilization, and sub-
stance abuse data were also collected. Using the
PSE-9 CATEGO Index of Definition of 5, the
weighted prevalence of psychiatric morbidity
was 27,1%, the majority of cases being given a
tentative diagnosis of depressive or anxiety dis-
order. Even though the ‘CATEGO’ algorithm was
initially chosen as a standard for assessing
whether a person met the criteria for classifica-
tion as a case of psychiatric morbidity, it
became clear that this was not appropriate, as a
substantial proportion of cases were identified
by CATEGO as having paranoid disorders. It
emerged on careful re-analysis of the data that
what may be culturally appropriate ways of ex-
plaining disorder in Mamre (such as believing
that it was caused by the bad deeds of others)
was being rated as part of a paranoid syndrome
on the PSE. It was therefore necessary to rein-
terpret this type of phenomenon in the light of
knowledge of local cultural beliefs. The SRQ’s
weighted sensitivity and specificity were 49%
and 82% respectively. Sensitivity was therefore
very low, and further research on criterion va-
lidity of the SRQ in South Africa is needed. Over-
all, the SRQ correctly identified 67% of cases
and non-cases. No demographic variables pre-
dicted psychiatric morbidity, but there was an
indirect link between morbidity and primary
health care utilization. In summary, the study
provides useful information about prevalence,
and important lines of enquiry regarding the
refinement of psychiatric epidemiological
26 psychiatric epidemiology
i) Detailed admission histories of all known
psychiatric patients, coupled with interviews
regarding access to psychiatric resources
ii) Intervention study of the effect of a support
group on rates of re-admission to psychiatric _
hospitals
«
methods in South Africa (Rumble, Swartz, Parry,
Zwarenstein, [in press]).
Conclusion '
Psychiatric epidemiology in South Africa (and in
the developing world generally) is at an exciting
stage. Methodologically, designs that have been
used up to this point have been rather unsophist-
icated. Part of the challenge now is to move to
more sophisticated designs, including those
which assess the efficacy of interventions. Metho-
dologically, much remains to be done in South
Africa in terms of developing psychiatric epi-
demiology in the direction of analytical and inter-
vention studies. Questions of validity are also cru-
cial to consider.
Concerned as it is with the difficult-to-measure
but crucial realities of people’s daily lives, psychi-
atric epidemiology has been forced to grapple
with how one makes as accurate an assessment of
those lives as possible. Many of the issues which
face psychiatric epidemiology are therefore rel-
evant to epidemiology in general. One of the most
important of these is the need for epidemiology to
be informed by local practices.
Modern psychiatric epidemiology is taking in-
creasing account of the reality that there are
many perspectives on disorder and its treatment.
Its methods are being combined with qualitative
and anthropological approaches, as we have
seen. It is also important, however, to recognize
the extent to which psychiatric epidemiology’s
engagement with a diverse world has helped
focus our attention on the nature of the epidemi-
ological enterprise itself.
241
@ epidemiology applied to content areas
EXAMPLE 26.1
Psychiatric disorders in two African
villages
Probably the most cited psychiatric epidemi-
ological research study in Africa is one conducted
by John Orley in Uganda and reported by him and
John Wing in an article published in 1979. Dr
Orley, a British-trained psychiatrist, had carried
out extensive anthropological and ethnographic
field work in East Africa for five years prior to the
study.
Study objective: To determine the nature and
extent of psychiatric problems in two African
villages using a standard system of defining,
eliciting, and recording symptoms.
@ Design: A cross-sectional study.
@ Sample: 206 residents of two rural villages in
Uganda. Subjects included adult residents in all
homesteads along selected village paths.
Instrument: A brief (48-item) form of the Pre-
sent Status Examination (PSE-9) which was
translated into Luganda by a Ugandan medical
student. Another Ugandan then retranslated
Reference:
Orley J, Wing JK. ‘Psychiatric disorders in two African vil-
lages.’ Archives of General Psychiatry 1979; 36:513-20.
242
the Luganda back into English and modifica-
tions were made to the original translation. The
translated version was then used in a psychi-
atric department in Kampala to test it against
clinical judgement. Questions that did not elicit
answers relevant to the symptoms they were
designed to illuminate were modified. Later, a
pilot study involving 25 respondents was car-
ried out in a rural area.
Procedures: All interviews were carried out by
Dr Orley, assisted by a research assistant (a
man from the area). A physical examination
was also undertaken to rule out malaria and
other problems which might underlie psychi-
atric symptomatology.
@ Results: 27% of the men and 24% of the women
were found to have psychiatric disorders at the
threshold level and above. Five percent had
definite psychiatric disorders. Most of these
conditions were depressive, but hypomanic
and anxiety states were also represented. A
large number of respondents had both depres-
sive disorders and anxiety states.
2i
Introduction
Anthropometric studies are carried out to deter-
mine the nutritional status and growth patterns of
a group or groups. This can be done to identify
individuals who are under- or overnourished, or
to investigate the relationship between nutri-
tional status and some disease outcome (for
example, obesity as a risk factor for heart disease,
or undernutrition as a risk factor for infectious
disease or poor school performance). Anthropo-
metric studies can also be used to monitor or
evaluate the effect of nutrition intervention pro-
grammes, for example, supplementary feeding.
Repeated assessments can establish whether the
overall nutrition situation is improving or deteri-
orating, and whether existing nutritional pro-
grammes should be modified. The standard of
nutrition reflects quality of life and, less directly,
socio-economic development. In children, one
normally identifies the poorly nourished and
growth retarded as a risk group, whereas in adults
obesity is considered a risk factor.
Assessing the nutritional status of
children
Nutritional indicators
Definition
Age, height, and weight can be used to determine
nutritional status in children, since these three
measurements form the following indicators:
@ height for age;
weight for age;
@ weight for height.
Anthropometric
studies
In determining height and weight it is essential
that the measurements are made in a standard-
ized way, meaning that the instruments (for
example, scales) as well as observers must be
standardized (see Appendix 2). Age should be cal-
culated using date of birth (obtained from, for
example, a Road to Health card) and date of
examination. In cases where an accurate birth-
date is not available, it is appropriate to use the
weight for height indicator rather than the two
age-related indicators. Because children vary
considerably with regard to the onset of puberty,
these nutritional indicators should not be used
for children over the age of 10.
Reference population and cutpoints
Each child’s age, height, and weight are deter-
mined and compared with values obtained from a
reference population. The most often used refer-
ence standard is the data collected on a broad
cross-section of normal American children by the
United States National Center for Health Stat-
istics (NCHS), which has also been tabulated by
the WHO. Some researchers object to the use of
the American data as a reference, because chil-
dren elsewhere may differ anthropometrically
from American children, not because of nutri-
tional status, but due to other factors, such as
genetics. For example, even well-nourished
Japanese children in the USA and Chinese chil-
dren in Hong Kong are shorter than American
children on average. However, the American data
is generally accepted as the important inter-
national reference standard.
For the reference population, percentiles have
been calculated by sex and age (in years and
months). For example, for girls aged five years,
243
e@ epidemiology applied to content areas
the NCHS-tabulated 3rd percentile of weight for
age is 14 kg; that is, in the reference population,
only 3% of girls aged five weighed 14 kg or less. If
we examine a girl of five and find that she weighs
13,5 kg, we would say that she falls ‘below the 3rd
percentile weight for age’. By referring to the
reference population, we can determine which
children or what proportion of children are
undernourished. Different definitions of under-
nutrition exist; often the 3rd percentile or the 5th
percentile are used as the cut-off level below
which undernutrition is diagnosed. More re-
cently, the Nutrition Unit of the WHO has recom-
mended the use of the median (the 50th per-
centile) minus 2 x standard deviation as the cut-
off. (The values given by this cutpoint are similar
to those obtained when using the 3rd percentile.)
In the WHO publication Measuring Change in
Nutritional Status (1983), various percentiles, as
well as the median minus selected multiples of
the standard deviation, are tabulated for the
NCHS reference population. A researcher can
thus manually look up a cut-off point and classify
an individual child on that basis. The data has
also been computerized, and a computer pro-
gramme, Epi Info, can be used to categorize chil-
dren or summarize anthropometric data. A
child’s growth can thus be monitored by plotting
his or her weight at consecutive ages, for example.
This is commonly done at well-baby clinics,
where weights are plotted on the child’s Road to
Health chart (Figure 27.1 shows the chart for the
Birth-to-ten project). In this way, any faltering in
weight can be detected and prompt action taken.
Not only children who fall below the 3rd _per-
centile, but any child who shows a decline in
weight for age, is seen as possibly being at risk.
Another measure which is sometimes used is
that of the percentage of expected value for a
given indicator. For a given age or sex, the median
of the indicator in the reference population is
taken as the expected value, and the observed
value can thus be expressed as a percentage of
expected value. The five-year-old girl has an
expected weight for age of 17,7 kg (that is, the
median weight for age for a five-year-old girl is
17,7 kg), so her weight of 13,5 kg is 76,3% of
expected. In this context, 80% of expected is often
used as the cut-off level below which undernutri-
tion is diagnosed.
Obesity in children receives less attention than
undernutrition because of uncertainties about the
long-term dangers of childhood obesity. Obesity
can be defined as a weight for height which is 20%
244
above the expected on the NCHS tables. Gross
childhood obesity is associated with orthopaedic
problems and overweight with psychological prob-
lems. Most fat babies lose their fat in childhood, but
obese children tend to become obese adults.
Interpretation
The three indicators each reflect a different
aspect of nutrition. A child who is low on height
for age is stunted and has a history of undernutri-
tion (that is, chronic undernutrition). If this child
has a normal weight for height, it is currently
being normally fed. Weight for height reflects cur-
rent nutritional status. A child could have a low
weight for age if it is stunted (has low height for
age) or thin (has low weight for height) or both.
Other measures of nutritional status
Mid-upper arm circumference can be used as an
indicator of wasting. Mild to moderate cases of
malnutrition will not be detected by this
measurement, but under famine conditions it is a
good measure to use. In some research studies,
skinfold thicknesses are also measured. (Head
circumference is generally used to measure brain
growth, not nutritional status.)
Assessing the nutritional status of
adults
To be able to define obesity accurately, one needs
to be able to measure body fat. Body fat can be
measured by the seldom-used technique of
underwater weighing, which is costly and cum-
bersome. More easily measurable characteristics
therefore have to be used as indicators of body
fat. Many studies have been conducted to assess
the value of skinfold thicknesses and various
weight-height relationships as predictors of body
fat. Skinfold measurements (biceps, triceps, sub-
scapular, and suprailiac) have generally been
found to correlate well with body fat measured by
underwater weighing, and formulae exist for con-
verting skinfold thicknesses to an estimate for
body fat. For accurate determinations of skinfold
measurements, researchers need to use standard-
ized callipers, and to be well-trained in the
methodology for these measurements, as meas-
urement variation is often large. Age- and sex-
specific reference data for skinfold thicknesses is
available from the Health and Nutritional Exam-
ination Survey (HANES) of the United States.
The indicator most often used to assess the
nutritional status of adults, however, is the Body
 245
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e@ epidemiology applied to content areas
Mass Index (BMI), also known as the Quetelet
index. To be able to calculate this index, we need
to determine a subject’s height and weight (once
again ensuring that this is done in a standardized
way).
BML is defined as: weight (in kg)
height (in m) x height (in m)
BMI values can be categorized into undernour-
ished (women with BMI <19, men with BMI <20),
normal (women with BMI 19-<24, men with BMI
20-<25), overweight (women with BMI 24-<30,
men with BMI 25-<30) and obese (BMI 30 or more
for both sexes).
The distribution of fat over the body is also
important when assessing the nutritional status
of adults. Individuals can have a gynoid shape (fat
is localized in the lower part of the body; pear-
shaped) or an android shape (fat is localized in
the upper part of the body; apple-shaped). These
different shapes have been found to be associated
with different diseases. So, for example, people
with an android shape are more at risk for
diabetes, ischaemic heart disease, and hyperten-
sion. Measurements of waist, hip, buttocks, and
thigh circumference can be used to determine
which shape an individual has.
Conclusion
Nutritional status is both an important risk factor
and health outcome to measure and monitor.
Strict guidelines on how measurements are made
and interpreted have te be followed to ensure that
valid results and conclusions are drawn.
EXAMPLE 27.1
Nutritional status of children aged
12-23 months in Alexandra township
To evaluate the nutritional status of children aged
12-23 months in Alexandra township, a commu-
nity survey was conducted in April 1990. Cluster
sampling was used to select 450 children. Weight
was measured to the nearest 0,1 kg in under-
clothes only. Scales were calibrated to zero before
a child was weighed. Height was measured to the
nearest 0,1 cm, using standard WHO methods. To
calculate age, date of birth was taken from the
Road to Health card or obtained from the mother.
Measurements were made by experienced
observers.
Nearly half the children had chronic malnutri-
tion (fell below the third percentile height for
246
age): 44,3% of the boys and 44,1% of the girls.
However, less than 4% of the boys and girls
showed signs of acute malnutrition (fell below
third percentile of weight for height). It was found
that significantly more children from informal
dwellings had chronic malnutrition than children
from formal dwellings: 53,2% compared to 39,5%.
To determine the reliability of the measure-
ments, a random sample of 45 children were
measured and weighed again. Poor reliability was
found, possibly due to the difficulty of measuring
children aged 12-23 months in informal settle-
ments.
Weight for age results were compared with in-
formation routinely documented on master cards
at the Alexandra Health Care Centre well-baby
clinic from June 1990 to December 1990. This
source indicated that 5,5% of children were below
the third percentile of weight for age, compared
to 17,7% of the boys and 9,3% of the girls in the
community survey. The researchers concluded
that this may indicate that the health centre is not
reaching those children in greatest need.
Recommendations made for nutrition pro-
gramme development include that an evaluation
should be made of who attends the health ser-
vices, and how to attract those in greatest need.
Furthermore, health workers should be trained to
measure anthropometry accurately.
Reference:
Coetzee DJ, Ferrinho P. ‘Nutritional status of Alexandra
township. Clinic-based data and a community survey.’
South African Medical Journal 1994; 84(7):413-15.
EXAMPLE 27.2
A profile of obesity in arural and
urban black population in the Free
State
In a random sample of households in a rural
region of the Free State and an urban area, vari-
ous risk factors for coronary heart disease were
investigated in participants aged 25 years and
older. Obesity was one of the risk factors. Two
doctors performed all anthropometric measure-
ments which included height, weight, waist and
hip circumference. All measurements were
done following strict guidelines, and techniques
were periodically standardized. In the age
strata, the following percentages of female
respondents were found to be obese (BMI 30 or
more):
 27 anthropometric studies

FEMALES 25-34 years, to 20,4% in the urban males aged

Rural Urban 55-64 years. The mean waist:hip ratio of women
Age stratum % obese stratum % obese in both groups and for all age groups exceeded
group size size 0,8, which is seen as the cutoff value for an
increased risk of, for example, ischaemic heart
25-34 142 27,5% 105 31,1%
disease. Whether this cutoff value holds for this
35-44 110 41,8% 126 42,9%
population must still be established.
45-54 99 42,4% 105 54,3%
55-64 102 49,0% 68 47,1%
Reference:
65+ 121 31,4% 64 42,2%
Mollentze W F, Moore AJ, Steyn AF, Joubert G, Steyn K,
Oosthuizen G M, Weich DJ V. ‘Coronary heart disease risk
The percentage of male respondents who were
factors in a rural and urban Orange Free State black popula-
obese ranged from 3,9% in the urban males aged tion.’ South African Medical Journal 1995; 85(2):90-96.

247
28
Introduction
In the case of health outcomes for which there
is no ‘agent’ responsible, epidemiologists com-
monly investigate people’s lifestyle, habits, or
environment. Researchers investigate these
factors firstly to describe them in the popula-
tion, and secondly to determine if there is a re-
lationship between a factor and a health out-
come.
Dietary intake, which is intricately bound
with environment, socio-economic status and
culture, is one such ‘lifestyle’ factor which is
often investigated. In epidemiology, the saying
‘You are what you eat’ is translated into the
questions ‘What do you eat (exposure)?’ and
‘What is your health status (outcome)?’
Thus, in epidemiology, dietary studies (also
known as food consumption studies) are car-
ried out in order to collect diet information at a
national, institutional, household, or individual
level. It is important to have national informa-
tion on the per capita food consumption, the
availability of food, and the trends for these
over the years, so that national food and nutri-
tional planning and policy formulation can take
place. At the individual level, food consump-
tion data is needed to: assess the adequacy of
dietary intake of free-living or institutionalized
respondents; expose differences in the diet or
eating pattern of experimental versus control
participants; determine relationships between
dietary components and disease states; moni-
tor diet as a variable in a research project; and
to intervene in a study population. Methods for
the collection of per capita food availability at a
national level, or dietary studies at household
or institutional level, will not be discussed here.
248
Assessment of
dietary intake
Methods of data collection in dietary
studies
There are several methods available for the
assessment of food intake at the individual level
(for example, weighed record method, 24-hour
recall method). Various factors, such as the pur-
pose of the study (to obtain qualitative food in-
take data or nutrient intake quantified in grams
and milligrams), qualities of the study population
(for example, age, literacy level), and availability
of resources (interviewers, scales for weighing
food portions), determine the choice of method.
The advantages and disadvantages of each
method should be weighed against the priorities
of the study when making a final choice (Table
28.1). The methods for assessing food intake can
be divided into two basic categories:
¢ recording of data at the time of eating
@ recall of food eaten in the past (immediate,
recent or distant past).
Recording of data at the time of eating
Weighed records
All food and drinks are to be accurately weighed
or measured, and recorded on record sheets for
the duration of the dietary study (for example,
seven days or 30 days). Each respondent needs to
be equipped with a scale, as ordinary kitchen
scales are not accurate enough. Research-quality
scales, however, are very expensive. Weighing
and recording absolutely everything taken at
mealtimes and between meals place a heavy
burden on the respondents, and the longer the
period of record-keeping, the more respondents
tend to simplify their diets. Only literate, very
 28 assessment of dietary intake

Ces eMC eC rCR cere icra t ty

dietary data collection at individual level

Method Main Main Researcher nutri- Data as

advantages disadvantages tional background Foods Nutrients
RECORDS
Weighed Very accurate Expensive. NEEDED — for
record Heavy burden detailed instruc-
on respondent. tions on weighing v v
Limited sample size. and recording and
Respondent literacy to check records.
essential.
Simplification of diet
by respondent.
Estimated No special equip- Heavy burden NEEDED — to train
record ment needed on respondent. and instruct on
Simplification of recording and v v
diet by respondent. how to quantify.
Respondent literacy
essential and thus 4
leads to under-
representation of
people with low
intelligence/education.
RECORDS Very precise Combination of the NEEDED — as
COMBINED above. above, and to
WITH DIRECT : check records and v v
CHEMICAL samples.
ASSESSMENT
RECALLS
24-Hour Low burden on Relies on memory. NEEDED — to
recall respondent. One recall not interview and/or
Low refusal rate. representative of train interviewers, ¥ Y
Takes little time. individual's intake to quantify intake.
Suitable for large — only for groups
numbers. of >50.
Does not repre-
sent usual intake.
Underestimation
of intake.
Quantified Low burden on Experienced inter- NEEDED — for the
food respondent. viewer required. interview, designing
Usual pattern Long interview. the questionnaire, ¥ Y
frequency
determined. Heavy demands to quantify intake.
Large numbers on interviewer.
possible. Overestimation
of intake.
Food Low burden on Not suitable NEEDED — for
frequency respondent. for nutrient designing the
calculations. questionnaire. v —
(qualitative) Classify respon-
dents in gross
frequency categories.

249
e@ epidemiology applied to content areas
dedicated people qualify as suitable respondents.
Because onlya select group of respondents are
suitable, random sampling cannot be done and
the representativeness of samples is usually
limited.
The researcher needs to train the respondent
and give detailed instructions on the weighing
and recording of foods and drinks taken, as well
as training on how to deal with combined dishes
such as ‘potjiekos’, samp and beans, pizza,
samoosas, and how to manage recording of meals
not eaten at home. Records need to be checked
often (daily in some studies).
Estimated records
All foods and drinks are to be recorded on record
sheets in terms of household measures (such as
spoon- or cupfuls), or in dimensions (for exam-
ple, one meat patty, 8 cm diameter, 1 cm thick).
The researcher needs to train the respondent on
how to quantify food intake. In addition, written
instructions are usually part of the record sheets.
Records are usually kept for seven days, but the
period is determined by the purpose of the study.
For example, for representative information on
nutrients for which intake can vary greatly
depending on food choice (such as vitamin A or
cholesterol), nine days or 28 days of record-keep-
ing might be necessary. The estimated record
method puts a lesser burden on the respondent
than the weighed record method.
In some studies, duplicate portions of all foods
eaten are to be assembled by the respondent for
chemical assessment of the nutrient content of
the total food intake. Respondents find it difficult
to dispose of valued food items such as alcoholic
drinks, cake, steak, and slabs of chocolate in such
a way!
Recall of food eaten in past
24-hour recall
Instead of writing down dietary intake on record
sheets, the respondent is interviewed on all food
intake for the previous day, that is, a 24-hour
period. The interviewer needs to be experienced
and must use visual aids to assist the respondent
in quantifying food intake. These can include
food models, real food, and spoons of varying
sizes.
This method relies on the memory of the
respondent and intake is usually underestimated.
‘Yesterday’s’ intake is not representative of an
individual’s usual intake, and dietary study re-
250
search methodology indicates that data from at
least 50 respondents is needed to describe the
‘usual’ intake-for a group. Thus subgroups (for
example, age or sex groups), have to have at least
50 participants. More than one 24-hour recall by
the same respondent, for example, for two week-
days and one weekend day, cancel some of the
disadvantages of the method.
Quantified food frequency
The interviewer has a structured questionnaire,
and the respondent recalls how often and in what
quantities the foods listed were eaten over a
specified period of time; for example, the last
month, three or six months, or the last year. This
is a long interview which needs an experienced
interviewer. Visual aids are used to assist in quan-
tifying intake. In a Western-type mixed diet, this
method tends to overestimate intake because the
wide variety of different foods means that a large
number of foods is recorded. Respondents are
usually unable to compensate in their reporting
for substitution (where some foods replace others
during a specified time period). The quantified
food frequency gives a better indication of usual
food intake than the 24-hour recall. The re-
searcher needs insight into the eating habits of
the research population, to ensure that often-
used foods are included in the questionnaire.
Food frequency method (qualitative food intake
data)
The interviewer uses a structured questionnaire
to fill in the number of times specific food items
were eaten over a specified period of time. The
quantity of food eaten is not asked. Such inform-
ation can be used to monitor respondents’ dietary
intake in a study (for example, data to prove that
diet changed or remained unchanged during an
experiment), or to expose differences in the fre-
quency of intake between groups, for example
age, sex, Or experimental groups. Data from this
method cannot be used to calculate intake of nu-
trients.
Dietary histories
The term ‘dietary history method’ is often used,
sometimes incorrectly. According to interna-
tional definition, a dietary history consists of a
combination of a 24-hour recall with a meal pat-
tern (that is, how many food intake periods per
day, and what foods are usually consumed at each
of these periods) over an extended period of time
with food quantities specified in household

measures, as well as a checklist of foods usually
consumed.
Important aspects of data collection
In dietary studies it is important to take note of
the following aspects.
@ Respondents must be trained to keep records.
Correct reading of the scale and the discipline
not to estimate a weight are of crucial import-
ance in the weighed record method. For the es-
timated record method, respondents need to
be taught in how much detail to record and
how quantities should be estimated and
recorded.
@ The training of the interviewers for the recall
methods must be standardized. It is of great
importance that quantifying of intake is ‘stan-
dardized’ if more than one interviewer is used.
This implies training the fieldworkers together,
with food models and real food available to
visualize quantities, and to reach mutual
definitions, even if these definitions apply only
to one specific study (for example, the size ofa
‘medium’ apple, or a ‘heaped’ spoonful).
Validity and reproducibility
Several articles have been published reviewing
the limitations of the various methods for assess-
ing food consumption. There is no ‘gold standard’
for the validation of dietary study methods. One
method may be compared with another method
(relative validity), or a new method may be
validated against an external criterion such as a
biological marker. Repeatability (measuring the
same subject under the same conditions) is influ-
enced by the day-to-day variation in the subject’s
food intake, as well as by seasonal variation and
other factors.
Calculation of intake
Dietary data is usually presented either in terms
of food intake or nutrient intake. The exception is
the qualitative food frequency method, where in-
take is not quantified and nutrient intake thus
cannot be calculated.
Calculation in terms of foods
This, in its simplest form, involves counting (by
hand or computer) of the frequency with which
specific foods are eaten. Computer programmes
have been developed at the National Research
Programme for Nutritional Intervention of the
Medical Research Council by which the number
28 assessment of dietary intake
of portions (portion size specified) of foods eaten
from the five basic food groups (milk, meat and
alternatives, vegetables and fruit, cereals, and
fats) can be calculated. For example, these could
calculate that children under five are taking only
215 ml milk daily, compared to the recommenda-
tion of 500 ml milk daily, or that adults are having
two portions of vegetables and fruit daily instead
of the recommended minimum of four portions.
Calculation in terms of nutrients
For this, one needs information on food composi-
tion. This can be obtained by chemical analysis
(depending on the aim of the study, but not often
done, as it is very expensive) or from food com-
position tables (commonly used). Food composi-
tion tables usually give the amount of nutrients in
a specified amount of food, for example, per 100 g
of food. There are 3 g protein and 120 mg calcium
in 100 g milk, for example. The Medical Research
Council has compiled Food Composition Tables
from American, British, and (where available)
South African food composition data. In the 1991
version of the Food Composition Tables, only
18% were South African values.
Dietary data can be analysed by hand, but this is
very cumbersome. The quality of the results is at
risk because so many calculations need to be made.
Dietary data can also be analysed by computer; and
programmes such as SAS can be used. For comput-
erization, dietary intake data needs to be coded.
The MRC Food Quantities Manual is very useful for
converting food reported in household measures
into grams of food consumed. Two software pack-
ages for personal computers, containing the MRC
food composition database, are available. Food-
finder is a nutrient analysis programme which can
be used for small scale research, while Foodfundi
Professional is a nutrient analysis and counselling
programme for the therapeutic consultant. For
more information on these products, contact the
authors.
Standards for interpretation of
dietary data
Food intake, expressed in number of portions
consumed from different food groups, can be
- compared with recommendations for healthy
eating, to describe adequacy of the diet. Nutrient
data can be compared with recommendations for
energy, protein, vitamin, and mineral intake.
South Africa does not have its own recommenda-
tions for these, but uses those of the United States
251
e@ epidemiology applied to content areas
of America (the US Recommended Dietary Allow-
ances [RDA], revised 1989), or the WHO (1985), or
Britain (1991). Cut-off points such as <75%, <67%,
<50%, >=100% and >=120% of the standard are
used to describe the adequacy of nutrient intake.
South Africa has its own dietary guidelines for
the prevention of coronary heart disease: less
than 30% of energy should come from fat, and
carbohydrate should contribute at least 55% of
energy.
Conclusion
Several methods are available to assess dietary
intake. Data can be described in terms of foods or
nutrients, and standards for evaluation are avail-
able. Dietary studies are not easy to execute or to
analyse; therefore, where evaluation of the diet
seems to be an essential part of a study protocol,
it is recommended that:
adietitian, knowledgeable in dietary research
methodology, is included as part of the re-
search team;
abaseline period (usually at least two weeks),
during which respondents follow their usual
diet, is included in dietary intervention studies
in order to provide for the placebo effect;
@ depending on the design of the study, a refer-
ence group is included in dietary intervention
studies to provide for possible influences such
as the placebo effect and seasonal variation on
the outcome of the study.
EXAMPLE 28.1
Use of the 24-hour dietary recall
method in the BRISK study
In the Coronary Risk Factor study on the African
population in the Cape Peninsula (BRISK), diet-
ary information was collected on children and
adults in order to describe dietary patterns in
these groups, and to investigate their eating pat-
tern as a potential coronary risk factor. The 24-
hour recall method was used, and the interviewers
were senior professional nursing sisters, fluent in
the vernacular.
The deciding factors in the choice of method
were the large sample size (n = 1 500); the short
interview time available; the low respondent
literacy rate anticipated; and the site of data col-
lection (home interviews meant that plates,
spoons, and other containers were likely to be
available to assist in quantifying food intake).
252
Intensive training of the interviewers was
spread over five days and conducted by dietitians.
Included in the training were general aspects of
interviewing techniques; awareness of the subtle
differences in foods (for example, full cream, low
fat, skim milk; butter, brick margarine, tub mar-
garine); awareness of food preparation methods
and ways of quantifying food intake, including
the use of food models to describe volume or size
of portions.
The information was coded bya trained coder
with knowledge of the scope of the food composi-
tion tables, and punched into a mainframe com-
puter for analysis. The results provided a profile
of the dietary pattern in an urban African com-
munity.
References
Bourne LT, Langenhoven M L, Steyn K, Jooste P L,
LaubscherJ A, Van der Vyver E. ‘Nutrient intake in the
urban African population of the Cape Peninsula, South
Africa. The Brisk Study.’ Central African Journal of
Medicine 1993; 39:238-47.
Bourne LT, Langenhoven M L, Steyn K, Jooste PL,
NesamvuniA E, Laubscher]J A. ‘The food and meal pattern
in the urban African population of the Cape Peninsula,
South Africa; the Brisk Study.’ Central African Journal of
Medicine 1994; 40:140-48.
Bourne LT, Langenhoven M L, Steyn K, Jooste P L,
Laubscher J A, Bourne D E. ‘Nutritional status of 3-6 year-
old African children in the Cape Peninsula.’ East African
Medical Journal 1994; 71:695-702.
EXAMPLE 28.2
24-hour dietary recall: coding food
intake for analysis
To code food intake data, food codes from the
MRC Food Composition Tables database are
used. The MRC Food Quantities Manual is used to
translate food intake in household measures into
grams of food.
Time | Whatfood Howwas How much
ofday| anddrink it prepared was eaten
2 slices
(10 cm thick)
hard (brick) | 2 level teaspoons
lcup
1 medium
Food codes
brown bread = 4002
brick margarine = 6508
 28 assessment of dietary intake

full cream milk = 0006 b Day of the week: Monday = 1; Tuesday = 2; etc.
apple = 7001 c Meal of the day e.g. breakfast = 1; in-between =
2Petc;
Computer coding sheets containing 80 blocks d The last block is used for the card number. If
per line can be used, or a special coding sheet (see more than 80 spaces are required for coding
example below) can be used. one meal, the identification line is repeated on
the next coding sheet and the card number will
CODING SHEET then be 2.
a a a e e b c d e Additional information can be coded, for exam-
4 0 0 2 0 0 6 0 ple, gender, experimental period, type of diet,
6 5 0 8 0 0 1 0 etc.
0 0 0 6 0 2 5 0
7 0 0 1 0 1 5 0 Second to 10th line:
In each line, the first four blocks are used for the
Explanation: food code and the last four blocks for the amount
The first line of the coding sheet can be used for of food eaten.
identification, e.g.: This information can then be computerized for
a First three or more blocks: code number of analysis of the data.
study respondent;

2S
29
Introduction
Until recently, community dentistry in South Africa
was viewed as a ‘do-good’ discipline that lacked the
seriousness of more urgent primary health care
projects. Due to the ‘mildness’ of oral health condi-
tions, oral health is often neglected, even though
dental caries constitute one of the most common
preventable diseases in South Africa.
However, dental epidemiology has instilled in
community dentistry the tools with which to
measure oral or dental disease, as well as a more
rigorously scientific approach. The key issue in
dental epidemiology is that of measurement, and
this chapter will focus on this.
Measurement of oral disease
The measurement of oral (dental) diseases and
health status is undertaken by clinicians and dental
epidemiologists in both qualitative and quantita-
tive terms. The dental clinician examines and
measures dental diseases at the individual level,
focusing on a patient’s oral condition and then
choosing a treatment plan in the best interests of
that patient. The dental epidemiologist, however,
measures dental status and dental conditions at a
particular point in time in the general population.
This point judgement requires standardized crite-
ria which differentiate between clinical and
epidemiological examination, as clinical investiga-
tions rely necessarily on subjective judgement. The
principal focus of oral epidemiology has been the
measurement of oral disease in the following areas.
Dental caries (tooth decay)
Periodontal disease
— gingivitis (gum disease)
254
Measurements
in dental
epidemiology
— periodontitis (advanced chronic gum disease)
Oral mucosal diseases including oral cancer
— Oral-facial complex cancer
— Oral disease of the soft tissues of the mouth,
including aphthous ulcers, candida infections
(thrush), lichen planus and leucoplakia
Dentofacial anomalies
— malocclusion of teeth and jaws (crooked or
misaligned teeth)
— enamel opacities and fluorosis (teeth
stained due to high fluoride intake)
¢ Social dental indicators
The international system of tooth identification is
used in the measurement of oral diseases. The
first digit specifies the quadrant of the mouth and
the second the actual tooth. The permanent den-
tition is allocated first digits of 1 to 4, while the
primary dentition is given first digits of 5 to 8. The
teeth are thus numbered as follows:
maxilla
primary dentition: 55 54535251 6162636465
permanent: 18 171615141312 21 22 23 24 25 26
27 28
mandible
permanent: 48 47 46 45 44 43 42 41 3132333435
36 37 38
primary: 85 84 83 82 81 7172737475
Use of indices
In order to standardize and have common criteria
for recording dental diseases, dental clinicians
have created indices which measure traits and
conditions in the mouth so that these can be
numerically described.
Russell (1956) has defined an index as ‘numeri-

cal value describing the relative status of a popu-
lation on a graduated scale with definite upper
and lower limits, which is designed to permit and
facilitate comparison with other population clas-
sified by the same criteria and methods.’
Measurement of dental caries
Dental caries indices
The criteria and methodology for the diagnosis of
dental caries and the definition of related treat-
ment needs of individual teeth are well defined
(WHO, 1987). Four indices are commonly used to
measure prevalence, incidence, and severity of
dental caries. They are:
@ DMFT for permanent teeth
@ DMEFS for permanent teeth surfaces
¢@ dmft for primary teeth
¢@ dmfs for primary teeth surfaces.
DMFT
The DMFT index measures the status of perma-
nent teeth in young people and adults. Each tooth
in the mouth is examined using set criteria, and
teeth are classified as decayed (D), missing (M),
filled (F), or sound. The sum of decayed, missing,
and filled teeth gives the DMFT score for the indi-
vidual. DMFT scores can thus range from zero to
32 units. Teeth which are unerupted are not
scored as missing, but described as unerupted
teeth, and thus not reflected in the score.
In epidemiological surveys on a population, each
individual’s DMFT score is obtained and a mean
value with standard deviation or standard error is
calculated for the population. Distribution of
scores often deviates from the normal, and the
median, 25th, and 75th percentiles should then be
used as summary statistics.
DMFS
The DMEFS index measures the status of each tooth
surface of permanent dentition. It is computed in
the same way as the DMFT, except that the unit of
measurement is the surface of the tooth rather than
the tooth itself. In the adult permanent dentition, a
total of 144 surfaces is recorded for this index: five
surfaces per tooth, except for the canines and inci-
sors which have only four. Thus, it is possible to have
a DMES score ranging from zero to a maximum of
144. Any new lesion or filling can be identified and
progression recorded. This index is therefore more
sensitive than the DMFT, and is able to reveal small-
er changes in caries progression. The increased re-
cording units of this index allow for more variability
in the individual and mean scores, thus affecting the
29 measurements in dental epidemiology
standard deviation and standard error.
The DMFS index is increasingly being used, as it
allows for the monitoring and evaluation of trends
in the distribution and progression of dental caries,
and can therefore be used as a tool to evaluate the
quality of care. The index indicates the distribution
of-either caries incidence or treatment on each
tooth and surface in an individual’s mouth. Dental
planners are currently using the measures of this
index to plan future needs for oral health care, and
as a quality assurance measure.
dinft
This is an index for primary teeth and is recorded in
a similar way to the DMFT except that it is only used
for children of five years and under. The index can
range from zero to amaximum of 20.
dmfs
The dmfs measures the status of each tooth surface in
the primary dentition. This score can range from zero
to 88. Recording of dmfs and dmft from the age of six
years and upwards is problematic, as it is difficult to
ascertain whether a primary tooth has been exfoliat-
ed or extracted when looking at missing teeth.
Comments on dental caries indices
These indices record past caries history and treat-
ment received by individuals. Certain difficulties are
experienced when allocating scores to extracted teeth
(teeth that are missing) due to caries, as the tooth loss
may be due to periodontal disease. The DMFT index
reaches a saturation in older age groups, thus pre-
venting registration of further attack. When using the
DMEFS index, the allocation of a score to extracted
teeth is a problem as the tooth may have been at-
tacked on one surface only, even though its extraction
score is four or five surfaces (depending on the tooth
type). The other disadvantage of the indices is that
each tooth is scored the same regardless of the severi-
ty of the lesion. The index merely notes whether a
tooth or surface of a tooth is decayed, filled, or miss-
ing. The indices do not differentiate between arrested
caries and active caries, or between small lesions
detected clinically or by radiographs. Furthermore,
occlusal caries have become difficult to diagnose
clinically because of the impact of fluorides on teeth.
There is recent evidence that the diagnosis of secon-
dary caries along the wall lesion in restored teeth is
difficult to make. It is only certain when there is sub-
sequent tooth cavitation of the filling or tooth.
Caries indices give an indication of past and treat-
ment experience. In longitudinal studies, they can be
used to measure the rate of caries attack and, in clini-
cal studies and preventive programmes, the efficacy
of preventive agents (toothpaste, for example).
255
e epidemiology applied to content areas
Periodontal health
Periodontal health is the general term describing
the status of the periodontal tissues, which
include the gingiva, gingival and connective
tissue attachments. The measurement of peri-
odontal health is based on two broad categories:
1 oral cleanliness
2 disease related to the gingiva and periodontium.
To measure these categories, clinicians and dental
epidemiologists have formulated indices to
measure the extent and severity of the dirt (plaque)
in the mouth, and the inflammatory conditions of
gingivitis and periodontitis. These indices are either
reversible or irreversible. Recent developments in
measurement of periodontal disease include a
composite index which provides a measure for
severity and treatment need.
Measurement of plaque and debris
The measurement of cleanliness has been record-
ed by several indices, but the two most common
are the Simplified Oral Hygiene Index (OHI-S)
and the Plaque Index (PI).
Plaque Index (PI) by Silness and Loé, 1964
The Plaque Index is a relatively crude index suit-
able for epidemiological studies to determine oral
cleanliness. It is frequently used to demonstrate
the effectiveness of oral hygiene measures in
tooth-brushing programmes for children and for
reinforcing oral hygiene promotion among adults
at individual or group levels.
The most important consideration in the index is
the measurement of the thickness of plaque (sticky
dirt or debris on teeth) along the gingival margin area
on all four surfaces of each tooth. The plaque index is
computed for all surfaces — mesial, distal, facial, and
palatal — on all or selected teeth, or specific areas of
teeth. To reveal plaque, a light source, gentle drying
of the teeth and gingiva, a dental mirror, and probe
are required. Plaque is not stained. The PI is aggre-
gated by scoring each of the four surfaces of the
selected teeth from zero to three, and then adding
the scores and dividing by the number of teeth. The
score from zero to three is in an ordinal scale, and the
categories describe the differences in presence of
plaque on the surfaces.
0 = tooth surface is clean with no visible plaque
1 = tooth surface looks clean but plaque can be
removed from its gingival third with a sharp
explorer
2 = visible plaque
Q ll tooth surface covered with abundant
plaque
256
Other plaque and calculus indices
There are numerous other indices which measure
plaque (debris).and calculus (calcified plaque) in
the mouth. Most of these indices are used by clin-
icians for measuring specific objectives. The
epidemiologist, however, requires an index which
is rapid and easy to use, and may therefore opt for
the WHO recommendation of recording soft
deposits and calculus visible to the naked eye as
present or absent.
The clinician in private practice may want to
take a more detailed record, and will therefore use
more sensitive indices suited to individual use,
namely the Hygiene Index and the Simplified Oral
Hygiene Index.
The Simplified Oral Hygiene Index (OHI-S)
The Simplified Oral Hygiene Index (OHI-S)
(Greene, Vermillion 1960) is an index which
measures the extent of debris (plaque) and calcu-
lus (tartar) on the surfaces of individual teeth.
One component measures the extent of plaque
on the surfaces of teeth. Each designated tooth
surface is assigned a score of 0 to 3, expressing the
extent of debris on the tooth.
A second component measures the extent of
visible calculus above the gum margin that is
present on the same teeth surfaces measured for
plaque. These scores also range from 0to 3.
The mean debris and calculus scores for each
patient are determined by adding the individual
score and dividing by the number of surfaces exam-
ined. The patient’s individual OHI-S is obtained by
adding the mean debris and calculus scores.
The examination is limited to six permanent
tooth surfaces: the labial surface of the upper right
central incisor (tooth 21), the labial surface of the
lower left central incisor (tooth 41), the buccal
surfaces of the upper first permanent molars (teeth
16 and 26), and the lingual surfaces of the lower first
permanent molars (teeth 36 and 46).
Measurement of gingivitis and
periodontitis
Gingivitis
Gingivitis is the inflammation of the gingiva char-
acterised by redness, swelling, and pain. The
condition is reversible with good oral hygiene and
effective plaque control. Gingivitis is measured by
the use of different gingivitis indices. The most
commonly used is the Gingival Index of Loé
(1967). Dental epidemiologists use the Gingival
Index (GI) in conjunction with the Plaque Index.

Gingival Index (Loé 1967)
This index involves numerical scoring of four
areas — mesial, distal, facial/buccal, and lingual —
of selected teeth. It is a partial recording system;
six teeth are selected for examination, namely 16,
12, 24, 34, 42, and 46. The scores from the four
areas are added together and averaged to give the
Gl for the tooth; these are in turn added and
divided by the number of teeth measured to
express a mean for the individual. The score is
attributed according to the following criteria:
0 = normal gingiva; no bleeding on probing
1 = mild inflammation, slight change in colour,
slight alteration of gingival surface, no
bleeding
2 = moderate inflammation, erythema, swelling
3 = severe inflammation, severe erythema and
swelling, tendencies towards spontaneous
haemorrhage, some ulceration.
Periodontal disease
Periodontitis is the inflammation of the perio-
dontium resulting in deep pocketing, loss of
attachment and tooth mobility, and loss of func-
tion of the tooth. The use of indices to determine
the severity of periodontitis, the degree of inflam-
mation, and the destruction of supporting struc-
ture (attachment loss) must be evaluated. There
are a variety of periodontal indices, the most
useful of which are described here.
The Periodontal Disease Index of
Ramfjord (1959)
This is the most common and useful index for
epidemiological studies. The system is based on
partial recording of six: typical teeth commonly
known as the Ramfjord teeth: 16, 21, 24, 36, 41,
and 44. If one of these teeth is missing, the tooth
distal to the missing tooth may be substituted.
The measurement of periodontal pocketing is
carried out using a special probe (University of
Michigan O) calibrated from zero to > 9 mm. The
criteria for the scoring of the PDI are:
0 = noinflammation, no alteration of gingiva
1 = mild to moderate gingivitis at some location
on the gingival margin
2 = mild to moderate gingivitis of the entire
gingival margin surrounding the tooth
3 = advanced gingivitis with severe erythema,
ulceration, and spontaneous bleeding
4 = upto3mm ofattachment loss, measured
from the cemento-enamel junction
5 = 3-6mm of attachment loss
6 = more than 6 mm attachment loss
29 measurements in dental epidemiology
The PDI thus contains a gingivitis index in scores
1, 2, and 3, and a measure of attachment loss
independent of gingivitis in scores 4, 5, and 6.
Community Periodontal Index of Treatment
Needs (CPITN)
The WHO and the International Dental Feder-
ation (FDI) have recommended the use in epide-
miological surveys of a periodontal index which
measures both the level of periodontal disease
and the need for treatment. This index is known
as the Community Periodontal Index of Treat-
ment Needs (CPITN).
Three indicators of periodontal status are mea-
sured in this assessment:
1 presence or absence of gingival bleeding
2 supra- or subgingival calculus
3 periodontal pockets, subdivided into shallow —
(4-5 mm) and deep (6+ mm).
A specially designed periodontal probe with a 0,5
mm ball tip is used, bearing a black band which is
between 3,5 mm and 5,5 mm from the ball tip.
The mouth is divided into sextants defined by
teeth numbers 18-14, 13-23, 24-28, 38-34, 33-43,
and 44-48. A sextant should be examined only if
there are two or more teeth present which are not
indicated for extraction. When only one tooth
remains in a sextant, it should be included in the
adjacent sextant.
For adults aged 20 years and over, the teeth to be
examined are: 17, 16, 11, 26, 27, 47, 46, 31, 36, and
37. The two molars in each posterior sextant are
paired for recording and if one is missing, there is
no replacement. If no index teeth or tooth is pres-
ent in a sextant qualifying for examination, all the
remaining teeth in that sextant are examined.
For young people up to the age of 19 years, only six
teeth are used: 16, 11, 26, 36, 31, and 46. This modifi-
cation is made to avoid classifying the deepened
crevices associated with eruption as periodontal
pockets (false pockets). For the same reason, when
assessing children younger than 15 years, recording
of pockets should not be attempted; only calculus
and bleeding should be considered.
The WHO recommends that a special probe
should be used for ‘sensing’ to determine pocket
_ depth and to detect subgingival calculus and
bleeding responses. The results are recorded with
the highest scores in the appropriate box in
descending order of severity as follows:
4 = pocket6+mm
3 = pocket4or5mm
2 = calculus present
200
e epidemiology applied to content areas
1 = bleeding present
0 = healthy
The CPIIN assesses the status of the gingiva, oral
debris, attachment loss, and periodontal pockets.
This gives a composite assessment of the periodon-
tal status of the individual. From this, it can be de-
termined whether an individual requires complex
treatment for the management of pockets; oral
hygiene instruction and scaling to remove calculus
in case of moderate pockets; oral hygiene instruction
alone when the only signs are bleeding on probing,
orno treatment when none of the above is found.
The index is quick and easy to use, especially in
large epidemiological surveys. The data may be
expressed as frequencies and mean values for the
various variables. However, some researchers hold
the view that the use of the CPITN index overesti-
mates the treatment needs within a population, as
the treatment strategies are based on one-to-one
operator to patient strategy. Furthermore, if these
treatment need results are used for planning
purposes, the resources apparently required would
be in excess of what most service providers would
be able to afford.
Measurement of oral mucosal
diseases
The WHO has developed several guides for the
measurement of oral diseases. Two guides are of
special interest for the collection and reporting of
data for oral mucosal diseases in a standardized
form: the International Classification of Diseases:
Application to Dentistry and Stomatology (ICD-
DA) (WHO, 1978) and the Guide to Epidemiology
and Diagnosis of Oral Mucosal Disease and Con-
ditions (WHO, 1980). The prevalence and incidence
of oral conditions are expressed as simple counts
that may be turned into rates and proportions using
an appropriate and standardized denominator.
Classification of common oral mucosal
diseases
1. Carcinoma (140-149 of ICD-DA)
2. Leucoplakia (528.6X, 523.84)
2.1 Homogeneous: lesions that are uniformly
white
2.2 Non-homogeneous: lesions in which part of
the lesion is white and part appears
reddened.
. Erythroplakia (528.70)
Leukokeratosis nicotina palati (528.72)
. Lichen planus (698.00 —- 697.09)
. Oral submucous fibrosis (528.80)
. Acute herpetic gingivastomatitis (054.20)
258
8. Candididias (112.00 —09)
9. Recurrent oral aphthae (528.20)
Most epidemiological data of the oral-facial
complex is further classified according to the
origin, site, and type of lesions. Recent trends in
the diagnosis of these conditions have empha-
sised the need to look at the risk factors when
measuring the prevalence of the diseases
(Johnson, 1994).
‘ Currently, more than 80% of oral cancers are of
the squamous cell type, which is the third most
common type of cancer in the developing world.
The standardized age incidence rate between 1988-
1992 in South Africa for oral pharyngeal cancer was
25,8 per 100 000 (Hille, Shear, Sitas [in press]).
Assessment of malocclusion and
dentofacial anomalies
The WHO (1977, 1987) has noted that there is no
universally accepted method for the recording of
dentofacial anomalies that are of significance to
the public health planner, although there are
numerous methods to measure anomalies for the
individual based on treatment needs. Attempts
have been made by the WHO (1987) and the FDI
(1982) to develop measures which would be able
to measure occlusal traits of populations.
Diagnostic classification
Angle’s classification (1899) is the best known of this
type of diagnosis, and has been refined to include
incisor classification for grading the severity of the
anomaly between the two arches (mandibular and
maxilla) in the mouth. This classification has limita-
tions, as it essentially records a diagnosis of a trait
that deviates from the norm, without indicating
treatment need.
The WHO (1987), in its pathfinding survey
manual, recommends a simple categorization of
malocclusion. Two levels of anomaly are distin-
guished: very slight (a twisted or tilted tooth or slight
crowding); or spacing and other anomalies that are
generally regarded as having an unacceptable effect
on facial appearance, or which cause significant
reduction in masticatory or speech function.
The FDI (1982) has recommended the assess-
ment of occlusal traits to determine the prevalence
of malocclusion and dental irregularities and to
estimate the treatment needs of a population, to
enable basic planning of orthodontic services. The
examination is to be made on children with perma-
nent teeth, as some of the minor problems of occlu-
sion in the stage of development are self-correcting.

The occlusal traits recorded refer to spacing and/or
crowding of anterior teeth, the measurement of
maxillary/mandibular overjet and overbite, and
anterior/posterior relationship of the molars. The
traits give a composite picture which determines
treatment need, and which can be recorded.
Treatment need indices
Two occlusal indices have been developed to assess
treatment need (Index of Orthodontic Treatment
Need or IOTN) and the standard of treatment
needed (Peer Assessment Rating or PAR Index).
The IOTN assesses and ranks malocclusion in
terms of the significance of various occlusal traits
for individual’s dental health and _ perceived
aesthetic impairment. The purpose of the index is
to identify those individuals who would most likely
benefit from orthodontic treatment.
The PAR Index consists of a scoring system and
a ruler that allows analysis of a study cast in
approximately two minutes. The PAR Index pro-
vides a single summary score for overall align-
ment and occlusion.
Both indices are in use in industrialized coun-
tries where the demand for orthodontic treat-
ment in the public and private oral health services
is high. However, there has been limited use of
these indices in developing countries, because of
fiscal and human resource constraints.
Comments on the assessment of malocclusion
Approaches to the diagnosis and treatment of mal-
occlusion have two distinct pathways. The ortho-
dontist dealing with the individual is primarily
concerned with the minute functional capacity and
aesthetic appearance of teeth. The public dental
health planner is concerned with an assessment of
the prevalence of malocclusion in the general
population, and concerned with major dentofacial
anomalies which affect gross appearance and func-
tion. The additional problem in an acceptable
approach to treatment need indices is the whole
question of perception of need and occlusal dishar-
mony by both the individual and the dental profes-
sional. In developing countries where human,
financial, and physical resources are limited, ortho-
dontic treatment has a very low priority.
Assessment of other conditions
Measurement of fluorosis
The universal use of fluorides at the individual
and community level has indicated the need for
assessment of enamel opacities. The most
common conditions measured are:
29 measurements in dental epidemiology
@ fluorosis
enamel hypoplasia
enamel opacities
¢ intrinsic staining.
Dental fluorosis is a hypoplasia of the dental
enamel caused by excessive ingestion of fluoride
during the period of tooth calcification. The
degreee of hypoplasia depends on the quantity of
fluoride ingested during the period of calcifica-
tion. The degree of hypoplasia can range from a
barely noticeable condition to severe and ugly
brown staining, with pitted and even flaking
enamel. For purposes of quantitative recording of
the various degrees of severity of defects of
enamel due to fluoride ingestion, several indices
have been developed. These are:
Dean’s dental Fluorosis Index
@ Al-Alous Modified Fluorosis Index
@ Modified Fluorosis Index of Fejekov-Thylstrup
¢@ Community Fluorosis Index.
Depending on the objectives of the study, differ-
ent indices may be used. More details of each
index can be found in the dental literature.
Social dental indicators
The majority of dental indices measure the
morbidity and mortality of dental diseases, and
do not include the social and psychological
impact of dental disease in the assessment of
dental status. As we know, the WHO (1978) has
provided a definition of health which extends
beyond the absence of disease and incorporates
both social and psychological aspects of health.
Jago (1977) and Cushing (1985) have advocated
the development of social dental indicators which
incorporate the clinical and social characteristics
of dental experiences and self-assessment of oral
health. Socio-dental indicators would be able to
meet the needs of patients as well as clinicians.
Trends in oral health
Dental caries have declined significantly in a
number of developed countries (Downer 1993).
Some of the reasons for the decline have been
given as increased use of fluorides, improved oral
hygiene measures, and reduction in sugar
consumption. The prevalence and severity of
dental caries in developing countries continue to
increase; for example, the prevalence rate among
city dwellers in some African cities was between
51% to 93% (Manji, 1991). In South Africa, the
259
e epidemiology applied to content areas
mean DMFT for 12-year-olds is 1,7, with a preva-
lence of caries of 26% (du Plessis, 1989). This is
considered low according to WHO indicators for
this age group.
Recent findings from longitudinal studies
support the concept that periodontal destruction
proceeds in random bursts at specific sites, and
demonstrate that some individuals have a higher
risk of attachment loss. There is further evidence
that cigarette smoking is a significant risk factor in
causation of dental disease, and there is evidence
of HIV-associated periodontal disease. Periodontal
disease has become more prevalent and severe in
populations in developing countries, especially in
Asia and Africa. CPITN data from the NOHS in
South Africa (1989) shows that gingivitis is ubiqui-
tous in lower socio-economic groups.
260
Conclusion
Oral diseases can be measured as simple counts
and expressed as rates and ratios for prevalence
and incidence measures, if only trends in oral
diseases need to be obtained. More detailed and
advanced indices have been devised by dental
epidemiologists to measure the severity and extent
of oral diseases. Recent trends have included
composite indices that measure treatment needs
(CPITN), types of treatment, and the effects of
preventive measures given to individuals and
communities.
30
Introduction
This chapter aims to introduce the reader to
health economics. In doing so, it will show how
the supply and demand for health care differs
from that for most other goods, and it will high-
light the economic objectives of health care. It will
also describe methodologies for economic evalu-
ation. This includes the identification of the
inputs and outputs of health interventions, an
introduction to the costing of these interventions,
and an explanation of how the results from epi-
demiological studies can be used in economic
evaluation.
Economics involves the analysis of trade-offs
between scarce resources. Decisions on how best
to use available resources are made daily at the
national, sectoral, and household level. In par-
ticular, evaluating the potential costs and benefits
of choosing one alternative over another — the
opportunity cost — is important to economic
thought.
The relatively new discipline of health eco-
nomics applies economic principles to health
care settings. Because good health is an integral
part of individual and national wellbeing, eco-
nomic principles are applied to establish how
best to allocate scarce resources to achieve im-
proved health status. Studies in the economics of
health have investigated questions such as what
proportion of a nation’s resources should be de-
voted to health, how a nation’s health expendi-
ture should be allocated, and how the mix be-
tween private and public health care provision
can be optimized.
Many countries see health as a valuable invest-
ment. A nation’s economic development and pro-
Health
economics
ductive capacity are intrinsically linked to the
health of its population. Poor health can impose
economic hardship on individuals, households,
and nations. The economic costs of ill health in-
clude loss of days worked, loss of income, de-
creased productivity, the opportunity cost of
medical services, and a fall in savings. Studies
have shown that in some African countries, pro-
ductivity of workers could be increased by as
much as 20% if morbidity rates were reduced
(World Bank 1993). This holds tremendous impli-
cations for a country’s Gross Domestic Product.
Effective antenatal and well-baby interventions,
and adequate childhood nutrition have a signi-
ficant impact on an individual’s health and well-
being over the entire lifespan. In economic terms,
this translates into a population that is more pro-
ductive and less of a liability on health care re-
sources.
Conversely, economic hardship at the indi-
vidual and national level can result in poor health.
Ahousehold’s health status is affected by the food
consumed, the source of drinking water, self-care
practices, access to health services and medica-
tion, and education levels. Many of these are
related to level of income. Changes in the nature
of a nation’s economy (such as a decline in eco-
nomic growth or a shift in production patterns)
can also affect health status adversely. Other eco-
nomic phenomena that affect a nation’s health
status include the extent to which it offers social
welfare programmes and safety nets for the poor,
its income distribution, the percentage of the
population’s income spent on basic necessities
such as food, and the unemployment rate. Hence,
the overall economic development of the country
has a direct effect on the health of its population.
261
e@ epidemiology applied to content areas
This explains why health can be considered an
investment commodity or good.
The health care market
In order to undertake economic evaluations of
health interventions, we must understand the
nature of the health care market. Health, like
other products or goods, has buyers and sellers,
or consumers and providers. However, health is
fundamentally different from other commodities
bought and sold in the marketplace. The way this
difference is perceived by the various stake-
holders affects the functioning of a nation’s
health care market, as well as debates concerning
access and equity.
In the ideal marketplace, consumer and pro-
ducer decisions are triggered by price mech-
anisms. Price is the measure of how much income
a consumer is willing to sacrifice for a good, and
determines a producer’s decision regarding how
much ofa product he or she is willing and able to
supply. In order for the combination of consumer
and producer decisions to work well, or for a
market to be perfectly competitive, the market
must fulfill certain criteria outlined in Table 30.1.
The health care market, for the most part, does
not operate according to the theory of perfect
competition. This ‘market failure’ in the health
sector, where certain conditions are not met, im-
plies that there is an inefficient allocation of
health care resources. The special nature of the
health care market is contrasted with perfect
competition in Table 30.1. This illustrates the
extent to which the government needs to inter-
vene in the market to rectify instances where the
market fails to achieve efficiency and societal
objectives. The nature and extent of such inter-
vention can be determined by economic evalu-
ations.
The health care market’s failure to conform to
the criteria of perfect competition has many
implications. For example, risk and uncertainty
results in the development of insurance markets.
As the need and cost of health care generally
cannot be predicted (criterion 3), individuals may
try to protect themselves against the unknown by
purchasing health insurance. Health insurance
gives rise to two potential problems in the health
care market: moral hazard and adverse selection.
Many argue that insured patients present little
incentive to their doctors (or themselves) to eco-
nomize on health care. This potential to over-
supply and/or overuse services (moral hazard)
262
contributes to market failure.
In order to minimize the unpredictability of
demand, insurance companies are likely to select
the youngest, healthiest members of society as
clients. Those who are chronically ill, unable to
afford premiums, or considered to be high risk,
tend to be excluded. This phenomenon of ad-
verse selection further skews the workings of the
health care market.
Economic objectives of health care
Efficiency
The principle of efficiency in health economics
addresses whether limited resources are being
used in the best possible way. It also determines
whether resources are used in a way that achieves
the best value for money. Three types of efficiency
can be assessed in health economics.
The first is technical efficiency, which looks for
combinations of the fewest possible resources or
inputs needed to meet the objectives of a service
or programme. For example, it would determine
various combinations of the least number of staff,
equipment, supplies, etc, needed to treat 500 out-
patients a day at a clinic.
The second is economic efficiency, which
establishes the least cost combination of inputs
needed to achieve a desired output — treatment
of 500 clinic outpatients in this example. Cost-
effectiveness analyses and cost-utility analyses
assess technical and economic efficiency.
Third is allocative efficiency, which looks at the
health system as a whole and determines whether
pursuing a certain policy or programme is worth-
while in the first place. Next it assesses whether
services are being provided at least cost and
whether economies of scale (the most appro-
priate level of service at the lowest cost) have been
achieved. (Cost-benefit analysis, described
below, does this.) For all of these models, detailed
information on the inputs and outputs of a pro-
gramme is needed.
Effectiveness
Health planners seek measures of effectiveness to
establish whether health care interventions
achieve their stated objectives, while health eco-
nomists use measures of effectiveness in cost
effectiveness analyses to assess efficiency. Health
economists depend on epidemiologists for in-
formation about the effect of health interven-
tions. Firstly, they need to confirm that the inter-
ventions they are evaluating are effective. Health

Table 30.1 The health care market contrasted Te
Re OEE ted
CRITERIA FOR PERFECT
COMPETITION —
a Many buyers
Self-interest (producers
seek to maximize profits and
consumers seek to maximize
satisfaction gained from
consuming a good or utility)
Predictability of need and
cost
Full information regarding
the product
The ability of the consumer
to assess fully the benefits
and opportunity cost of a
product — consumer
sovereignty
- Ahomogeneous product
There are many sellers and
they can easily enter and
leave the health care market
(no barriers to entry)
No substantial fall in unit
costs with larger-scale pro-
duction — or no significant
economies of scale — that
would encourage monopolies
No spillover effects
(externalities) resulting
from production or
consumption
30 health economics
Paes
THE HEALTH CARE MARKET
There is often a sole purchaser of health care (a monopsonist);
i.e. the state, large enterprise, or insurance companies.
Consumers may not always seek to maximize utility; those who
require health care may be unwilling or unable to seek it. Thus,
health is sometimes considered a merit good; one which warrants
government intervention to ensure that it is not under-consumed.
ll-health is often unforseeable, and hence the demand for health
care and the related costs are difficult to predict.
The supplier of health care usually holds a monopoly on
information, which limits competition and may encourage
monopolistic behaviour.
Health workers have greater understanding and access to
information than the patient, and thus are directly involved in the
patient’s decision to consume health care. This confers monopoly
powers on the provider and hinders the consumer's ability to make
an informed choice of provider. This hinders consumer sovereignty.
Neither health care nor its suppliers (public, private, NGOs)
are homogeneous.
The long training period for health professionals and professional
licensing bodies create barriers to easy entry into the health
care market.
Several components of health care provision lead to economies
of scale and natural monopolies. Cases in which only a few
suppliers exist (such as hospitals and pharmaceutical
companies) negate perfect competition.
When health interventions affect society at large, rather than just
the individual receiving care, they are considered public goods.
Externalities (spillover effects) are benefits or costs that have
important implications for economic analysis. Being treated for
gonorrhoea, for example, benefits not only the persons involved,
but also decreases their sexual partners’ chances of getting
the disease. If society is better off because it knows that the sick
are being well cared for, this is a spillover effect of health care
(a caring externality).
263
@ epidemiology applied to content areas
interventions are deemed effective when they
result in improved health status.
In epidemiology, the evaluation of effectiveness
can involve the measurement of health outputs or
outcomes resulting from an environmental
change or a specific health care intervention.
Whereas epidemiology compares the outcomes
of various interventions, an economic evaluation
of effectiveness compares the cost of these out-
comes. The results from various epidemiological
studies (such as randomized control trials and
case-control studies) that measure effect are used
for this type of economic evaluation. For exam-
ple, the value of resources put into health care can
be compared with indicators of effectiveness such
as a change in blood pressure or years of life
gained. Thus, indicators of effectiveness link the
results of epidemiological studies to economic
analyses of efficiency.
Note that effectiveness (that is, it works) does not
automatically mean that an intervention is efficient
(it works and is the best value for money). However,
technical, economic, and allocative efficiency are
contingent on effectiveness.
Equity
When assessing the economic objectives of health
care, we must ask to what extent the allocation of
health care is equitable and reflects society’s will.
While equity is usually a specified policy for health in
most countries, it is not a straightforward notion.
Most simply put, it questions whether some mem-
bers of society are willing to sacrifice some health
gain in exchange fora ‘fairer’ distribution of health
gain for all.
There are two dimensions of equity to consider.
Horizontal equity means equal treatment of
equals; this would require that all those with similar
health care needs be given equal opportunity to
access and treatment. For example, in South Africa,
there has been much debate on how to ensure that
in each province everyone has equal access to PHC.
Vertical equity means unequal treatment for un-
equals; it implies equality in service utilization and
positive discrimination towards those who are less
willing or able to use health services. Thus, those
with greater needs (more severe illnesses, inability
to pay, and so on) would obtain concessional
access. For example, more resources for TB preven-
tion and control might be directed toward an area
with a very high prevalence of TB, or lower-income
groups may have their treatment and transport to
the services subsidized.
264
In general, if resources are not being allocated
to those with the greatest needs, the efficiency of
the service is reduced. This is an important issue
to consider in a decision-making or policy con-
text. Thus the situation in South Africa has not
only been inequitable, but inefficient. In this con-
text, an intervention that is technically efficient is
also equitable. Any attempt to extend services to
those in greatest need will improve the efficiency
of the health care system.
If the goal is equity of access and utilization of
health services, efficient use of scarce resources
may have to be sacrificed for equity gains. While a
100% immunization rate is an equitable goal, a
slightly lower rate of 90% may be more efficient. A
lot of resources would have to be used to achieve
the last 10 percent. Both national governments
and local health policy-makers are faced with
such trade-offs between equity and efficiency.
These decisions at the margins are often the focus
of health care debate.
Economic evaluation
Economic evaluation considers two components
of the production process for any given activity,
namely inputs and outputs. Inputs are resources
such as labour and equipment that are put into
producing goods and services, in this case health
care. Outputs are the results of production, while
the process describes the transforming of inputs
into outputs — the final result of the production
process. In economics, the relationship between
these components is analysed within the frame-
work of the production function, which repre-
sents the relationship between inputs and out-
puts. The production function would indicate
that the output of one cured TB patient is de-
pendent on (or a function of) the interaction be-
tween inputs such as staff, medicines, and equip-
ment.
The health sector presents special problems for
economic analysis because it does not produce
simple units of output, but several different types
of outputs simultaneously. Health cannot be
expressed as a simple variable; thus various
output measures are expressed as a proxy for
‘health’. Moreover, a number of different inputs
are used in the production of health; these can
often be difficult to identify and quantify. The fol-
lowing sections on inputs and outputs will pro-
vide researchers with some useful tools to use in
economic evaluation.

Inputs
Economics assesses the different combinations of
inputs in terms of their effect on output. This may
include determining the impact on output of
changing the relative proportions of labour and
equipment, assessing the impact on output of
changing the amount of one input while keeping
others constant, or establishing the cheapest and
most efficient way to produce a service.
While some inputs (such as personnel num-
bers, equipment, and drugs) are relatively easy to
quantify, other inputs that go into producing
optimal health care (such as socialization, cul-
ture, networks of friends, workmates and care-
givers, personal preferences, as well as clinic care)
are less easy to quantify. While an ideal economic
evaluation would incorporate all components of
the production process, the focus is usually on the
quantifiable ones below.
In order to conduct an economic appraisal of
goods and services that make up the delivery and
utilization of health care, one must assess their
cost. While the everyday notion of cost and the
understanding used in economics are not all that
different, certain important distinctions must be
noted between lay terminology and strict eco-
nomic usage of the term.
Identifying costs
Economic cost is generally seen in terms of sacri-
ficing something. This may be money, time, or
another good. The value of sacrificing one good
for another is termed the opportunity cost. If one
considers the choice, for example, between buy-
ing a new dialysis machine or extending measles
immunization coverage to a further 500000
people for the same amount of money, the oppor-
tunity cost of the extended coverage is the dialysis
machine conceded.
The total cost of a good or service is the sum
total of all costs that contribute to its production.
The total cost of providing an immunization ser-
vice for a given area, for example, includes
salaries, equipment for and maintenance of the
refrigeration system, the immune sera, buildings,
and many other aspects of the service. Total cost
comprises fixed and variable costs.
It is important to distinguish between fixed
costs and variable costs. Fixed costs (often refer-
red to as ‘overheads’) tend to remain constant
regardless of the quantity of output. A hospital,
for example, will have a number of relatively fixed
costs (buildings, rental, equipment, etc), inde-
pendent of the number of patients seen. Variable
30 health economics
costs, on the other hand, will vary depending on
the number of patients and procedures. Exam-
ples of variable costs are syringes, sutures, or
swabs. ,
A classification of costs often used in financing
and budgeting exercises is capital and recurrent
costs. Capital costs (many of which are fixed
costs) refer to resources whose lifespan is greater
than one year. They include the cost of buildings,
vehicles and equipment, and staff training. The
value of capital goods is calculated based on their
current replacement cost. This cost can be
divided over their projected lifespan and adjusted
using a suitable discount rate. In this way, capital
costs can be added to operating or recurrent costs
in annual budgets or financial statements to show
total costs. Recurrent costs refer to those things
purchased regularly or used within a fiscal year.
Among others, these include staff salaries, sup-
plies, operation, and maintenance. An example of
a budget for a PHC clinic is Shown in Table 30.2.
The costs discussed above form part of the in-
trinsic cost of manufacturing a good and/or pro-
viding a service. Such costs incurred in provision
of health care are termed direct costs. Direct costs
may also include government grants, donations,
volunteer time, and costs to the consumer (pa-
tient) such as user fees, medication, and travel to
and from the clinic.
Pel Ceetee eeUe mile
a PHC clinic: an example
‘Personnel =
Supplies
_ Vehicle maintenan
—Inservicetrainng =
_ Other operating costs _
e@ epidemiology applied to content areas
However, the patient often has further costs not
directly related to the provision of the good or ser-
vice itself. These indirect costs borne outside the
health sector and incurred not only by patients,
but also by others, may include time lost from
work, or the consumption of something else fore-
gone. For example, the process of having one’s
child immunized against measles includes wait-
ing time (an opportunity cost) and subjective
costs, which are often intangible and difficult to
measure. The economic value of these subjective
costs (pain, changes in normal daily activity,
mobility, apprehension, anxiety, and decreased
social performance) are included in the category
of indirect costs. The section below on Quality
Adjusted Life Years (QALYs) looks at these issues
in detail.
Table 30.3 gives an example of a breakdown of
direct and indirect costs. In this case, it shows the
direct costs (hospital, TB, drugs, outpatients) of
HIV/AIDS in Lesotho from 1994-8. Indirect costs
are expressed as the value of productive years of
life lost as a result of AIDS morbidity and mortal-
ity.
. The social cost or benefit of any one interven-
tion is the sum of the cost or benefit to the indi-
vidual and any additional cost or benefit to
society. Since these additional benefits may be
quite extensive, and market mechanisms do not
peel CmecLUMO ae mcrae
Creel aeRh a) ge
Hospital — TOTAL
1994 |2545 843 [4186546 |87616
1098)4683798 |5800651 [161900
1996 |7 703489 |7 525332 |268717
1997 14 603 169 |9 255 230 |409606
1998 | 16 263 122 |10 891 143/580 967 |1078870
*Value of potential years of life lost in monetary terms
Source: McMurchy D, 1994
266
reflect their presence, government intervention
may be warranted. For example, if fees are set at
market rates, individuals with gonorrhoea may
well decide not to go to a STD clinic. Given the
implications of this, a good case could be made
for state subsidization of such services. Some
commodities or services would otherwise not be
produeéed at all, whereas others would be pro-
duced on an inappropriate scale. It is important
to consider these if we seek to reflect the true cost
or benefit of an intervention.
Measures of cost
To ascertain the unit cost or average cost of an
immunization service, for example, one must
divide the total cost by the number of immuniza-
tions done. For a given number of immuniza-
tions, this establishes the average or mean cost
per immunization.
The marginal cost of a service or good is the
cost of producing (or providing) one extra unit of
that good or service. One does net use fixed costs
(for example, buildings) in determining the mar-
ginal cost, but looks exclusively at changes in vari-
able costs. The marginal cost of extending im-
munization coverage to one more person may be
small (if that person lives on a route that is already
covered by the service), or large (if that individual
lives some distance away from the normal route
mes odie
patient | Direct COSTS
Discounted | *PYLL Direct +
Indirect
|294 365 7114369 |6240676 | 24441810 | 30682486
|445500 | 11091850 |9017793 | 45553460 | 54571 253
|630673 | 16128211 | 12 311 611 | 75875013 | 88186624
|844902 | 22112907 | 15 794 932 | 115 718 702 : 131 513 634
28 814 102 | 19 209 401 | 164 094 254 | 183 303 655

taken). This cost is an important one to consider
when assessing whether to expand or contract a
service.
It is often difficult to calculate the marginal cost
unless detailed data is available. The researcher
could calculate the additional cost of extending a
service to a group of people (for example, an addi-
tional 100 patients) rather than calculating the
cost of immunizing one more person. This is
called incremental cost. Calculating the cost of
extending an immunization service to a rural
village not previously covered will give one the
incremental cost of providing this service. The
incremental unit cost (incremental cost divided
by village population) can be used as an altern-
ative to the marginal cost.
Acosting framework: tools and tips for economic
evaluation
In undertaking a formal costing study of a given
service, all costs must be taken into considera-
tion. There are a number of accessible texts that
address the process of costing (for example,
Creese, Parker [n.d.]), and only a brief overview
will be given here.
Identify all elements involved in the interven-
tion being evaluated
This is achieved most easily by charting all
activities that are part of a given health care
delivery process (for example, a clinic or an
immunization service). Costs may need to be
broken down into detailed categories: what, for
example, are the instruments needed, as well as
the staff, building, equipment and vehicle
requirements for immunizing the inhabitants
of a district against measles? What are the direct
and indirect costs to the patient? A useful
checklist derived from Luce and Elixhauser
(1990) is the following:
— direct personal costs: overheads, staff
salaries, appliances, medication, transporta-
tion, rehabilitation, etc;
— direct non-personal costs: support services,
research and development, health education,
surveillance and control, etc;
— indirect costs (wages and time): lost
productivity, income and leisure time, home
caregivers, childcare, etc;
— indirect costs (intangible): psychosocial costs,
pain, changes in daily living patterns, etc.
@ Identify the possible alternatives to the inter-
vention being evaluated
30 ~=health economics
This is particularly important ifan economic
evaluation that compares different treatment
options is to be carried out. Alternatives can be
identified from the clinical literature, in discus-
sions with experts in the field, and from present
providers of a given service. It may be necessary
to construct a number of possible alternative
models for a given service. Note that this step
may be unnecessary if one is simply costing an
intervention and a formal economic evaluation
is not to be carried out.
Assemble data and calculate/estimate costs
involved
Sources for cost data may include accounts,
budgets, patient folders, management inform-
ation, staff employment records. In some cases,
only total cost data are available and it may be
necessary to estimate costs based on the best
information available (staffinterviews might be
useful). A way of minimizing imprecision is to
discount for future costs, and to conduct sensi-
tivity analyses (see pp. 270, 272).
@ Exclude costs
Some costs (for example, externalities) may be
irrelevant to the analysis performed, or too
expensive or time-consuming to collectina
comprehensive way. The analyst needs to
decide what to include in the costing on the
basis of its feasibility and likely implications.
For example, he or she: might decide to exclude
indirect costs when costing a primary health
care clinic.
Allocate money values to the costs
While charges may be equivalent to costs ina
perfect market, this is rarely so in the health
care sector where cross-subsidization, shifting
of costs (by transfer payments), and imperfect
market forces skew charges significantly. Bear-
ing this in mind, it is often feasible to use a
given charge as a proxy for cost, unless it is
evident that the error produced is substantial. A
more accurate alternative consists of calcu-
lating total cost by adding together the costs of
all components in the production process. This
is particularly relevant in studies of the public
sector where fees are unequal to costs.
@ Beware of double counting
A common error made in costing exercises is
counting the same cost twice under different
headings. For example, the cost of medication
267
e@ epidemiology applied to content areas
may have been entered both as a user charge
(to the patient) and in terms of its cost to the
clinic (procurement, storage, preparation,
dispensing, administration, monitoring, treat-
ment for adverse effects, etc). This will result in
an inflated total cost. A similar error can be
made by allocating the same cost both to direct
and indirect costs columns.
Discounting
The implementation and impact of a health inter-
vention is likely to occur over time. Thus, we are
likely to compare its costs and benefits over a
number of years. If we must choose between two
or mote services or’projects, the net benefits of
each should be compared. It is necessary to use
discounting in such an economic evaluation, in
order to account for society’s desire for short-
term results. Discounting deflates the value of
money in the future to account for this positive
time preference. As*the net benefits across all
years are compared in terms of their value at the
time of evaluation, discounting then favours
those projects that provide them sooner. The pre-
sent value of net benefits is determined using a
formula (Luce, Elixhauser 1990) which utilizes the
discount rate available from the Reserve Bank.
Discounting should not be perceived as an
adjustment for inflation.
Shadow pricing @ premature infants could be used as a proxy for the
Price often does not reflect economic or oppor-
tunity cost adequately. For example, the price of
goods purchased from abroad may not reflect
their real value if the exchange rate is over-valued.
Economic distortions such as tariffs, subsidies,
import and export taxes also distort price. Like-
wise, the wage rate may not reflect the true value
of labour: A limited number of doctors, repres-
ented by a professional body, may drive the price
of their labour above its market value. Conversely,
if the state is the sole purchaser (monopsonist) of
nurses’ labour, it may keep wages below their true
market value. Ultimately, the value of labour
should be assessed based on its availability
(elasticity).
Shadow pricing allows prices to be adjusted to
reflect their true economic value. In the case of
labour, if there is high involuntary unemploy-
ment, the shadow price of unskilled labour may
approach zero. If, on the other hand, there is a
limited supply of highly skilled labour, the
shadow price would represent the opportunity
cost of that individual’s labour if he or she were
268
employed elsewhere in the health sector. Further-
more, shadow pricing can also be used to reflect
the social cost of an intervention.
Outputs
Output indicators aim to measure changes in
health status. No indicator is without short-
comings, and all are value-laden and difficult to
measure. In economic evaluations of health care
interventions, these indicators are weighed
against the cost of the programme or service.
Putting value on human life
A common approach used to establish the value
of an intervention places a monetary value on
human life. Often this is measured in terms of
years of life gained. These monetary values can be
used to measure ‘benefits’ in cost-benefit ana-
lysis. In general, there are three methods com-
monly used to value life and well-being (Mooney
1992):
The implied values approach takes into con-
sideration the value that the government or soci-
ety attaches to well-being or a life saved. These
costs can be implied from the marginal cost of a
preventative intervention or from the cost of
introducing life-saving high technology.
Measurements are based on existing policies and
value systems. For example, the marginal cost to
the state of expanding neonatal intensive care for
value of an infant’s life.
The human capital approach equates the value
of life to an individual’s lifetime productive capa-
city measured in terms of his or her income earn-
ings. Specifically, this is average discounted
labour costs adjusted according to the country’s
employment rate.
Finally, the consumer’s willingness to pay
places a value on the amount she or he is pre-
pared to pay to reduce the risk of mortality or
morbidity. The value of a health intervention is
thus based on the amount that the consumer is
willing to pay for it.
All three of these approaches are proxies and
each presents its own set of problems. The
human capital approach equates life to livelihood
and fails to encompass those who are not form-
ally employed. The implied values approach,
which uses the cost of mortality-reducing inter-
ventions introduced by the public sector as a
proxy for society’s value of life, is based on the
values of current decision-makers (McQuire,
Henderson, Mooney 1992). The ‘willingness to

pay’ approach may be the most economically
sound because it assumes consumer sovereignty,
but there are shortcomings in this approach.
Health status indicators
Health status indicators are valuable when com-
paring health status both across time and cross-
sectionally. Mortality and morbidity rates are the
most frequently used measures of health output.
These indicators are vague and those working in
the health field have sought to find more precise
ones. These include: disease-specific measure-
ments which quantify clinical change (for exam-
ple, changes in cholesterol levels); measures of
dysfunction (number of productive working days
lost to illness or inability to perform certain tasks);
health profiles which give individuals a rating in
identified health ‘domains’ according to levels of
disability and distress (such as the Nottingham
Health Profile); and global health indicators
which measure states of health (utilities) relative
to each other on an interval scale of 0-1 (death —
perfect health).
Quality adjusted life years (QALYs)
The health status indicators covered above are
limited by their inability to measure the effect of
the duration of ill health. One methodology that
attempts to account for this is the QALY or the
Quality Adjusted Life Year. In this model, the
number of years of life gained from a medical
intervention are adjusted to account for quality of
life — disability and distress levels. This is espe-
cially relevant to medical interventions that have
the potential to incapacitate the patient. Like the
global health indicators mentioned above, this
model depends on a single index to value levels of
health, and measures quality on a scale of 0-1
using health rating scales (Kind, Rosser, Williams
1983), time trade-offs between disability and
years of life, or ‘standard gamble’ — the trade-off
between chronic illness and the chance of death
due to a potentially hazardous treatment (Tor-
rance 1987). QALYs extend beyond global health
indicators to weight the index relative to years of
life gained. Ultimately, this approach can be used
to measure the trade-off between being relatively
healthy over a short period of time against being
in poor health over a long period of time. It can
also be used to assess the relative impact of differ-
ent health interventions when the costs of these
interventions are expressed in terms of the
number of QALYs they produce.
30 health economics
This model has been criticised because it is
based on trade-off decisions usually made under
hypothetical situations; it looks exclusively at the
movement from good health to bad; its valuations
assume that an additional year of suffering is
equivalent to the previous one; and QALYs do not
measure externalities associated with health care.
Nonetheless, the introduction of QALYs into
health economics represents an attempt to in-
corporate intangible costs into the discipline.
Disability adjusted life years (DALYs)
DALYs were developed by the World Bank to
measure the burden of disease (World Bank
1993). They measure the potential years of life lost
due to disability or death ata given age. While
they are similar to QALYs, they explicitly include
disease type (using disease-specific severity
weightings), focus exclusively on disability, and
are weighted for age based on the individual’s
predicted productive value. Many of the criti-
cisms of QALYs are equally applicable to DALYs.
DALYs have also been faulted for giving an age
weighting based solely on the individual’s
assumed productive capacity, without taking into
account other socio-cultural variables.
Economic evaluation methods
The economic evaluation of health-related inter-
ventions looks at how inputs relate to outputs, or
the complete production function. Essentially, it
compares costs to consequences. Good cost and
epidemiological data is crucial to economic
evaluation. The results of this type of evaluation
are only as good as the information used. De-
cision-makers need to make decisions on how to
derive maximum benefit from a fixed budget.
Economic evaluation is one tool that may provide
a framework for these choices.
A number of types of economic evaluation
exist. Different ones are appropriate for different
contexts, and they differ from one another in the
extent of their analysis and .their evaluation of
outcome. Four methods are briefly described
below. Cost-minimization analysis is used to find
the least costly way of implementing a project-or
programme. Cost-benefit analysis is used to
determine whether a programme should be,intro-
duced or not. And cost-effectiveness and cost-
utility analyses compare programmes to deter-
mine which produces the desired outcome at the
least cost. In cost-utility analysis, the outcome is
expressed in terms of QALYs.
269
e epidemiology applied to content areas
Cost-minimization analysis
Cost-minimization analysis is based on the
assumption that a programme or project is in-
trinsically worthwhile, and does not attempt to
evaluate alternative programmes. Rather, it is
used to establish which of two or more inter-
ventions that have similar outputs costs the least
or is technically more efficient. The marginal and
average costs associated with an intervention are
calculated to assess the least costly means of
achieving programme goals and optimum service
levels.
Cost-benefit analysis
Cost-benefit analysis (CBA) is an economic evalu-
ation tool which measures costs and benefits
exclusively in monetary terms. It allows for com-
parison of various options for achieving a pro-
gramme objective, or of different possible health
interventions (allocative efficiency). In assessing
whether an intervention is worthwhile, the results
of a CBA will determine whether benefits out-
weigh the costs. Most CBAs concentrate on direct
net benefits. However, indirect benefits (such as
the value of increased production resulting from
the programme), and intangible benefits which
reflect a change in health status (such as reduced
pain and suffering), can also be included. Since
most health programmes are implemented over a
given time period and contain hidden and dis-
torted costs, discounting and shadow pricing
should be used where applicable. Because health
outcomes are not easily measured in monetary
terms, CBA has proven most useful in measuring
the direct net benefits of an intervention in terms
of resource savings. The human capital approach
is most often used to establish indirect benefit.
Willingness to pay and implied values are used
less often, although improved methods of deter-
mining willingness to pay have led to a shift back
to the use of cost-benefit analysis in assessing
outcomes. Such an analysis could compare the
cost of a renal dialysis with the value of the life
saved. The value of the life could be determined
by the amount the individual would pay for the
intervention.
Cost-effectiveness analysis
Cost-effectiveness analysis (CEA) is a tool used for
comparing alternative uses of resources that
achieve similar outcomes. In CEA, only costs are
expressed in monetary terms in the evaluation of
an intervention; benefits are usually expressed in
natural units, such as mortality, morbidity, or
270
years of life gained. Results are expressed in terms
of a ratio, such as costs per unit of output (for
example, cost per fully immunized child) or the
effect per monetary unit (for example, number of
fully immunized children per R1 000). A given
project can be deemed efficient if it maximizes
benefit achieved under a given budget or min-
imizes the cost of reaching a given objective.
Cost-utility analysis
Cost-utility analysis (CUA) was adapted from
cost-effectiveness analysis to measure the effects
of a programme or project in terms of utility or
satisfaction gained from receiving the interven-
tion (a quality-adjusted outcome). Like CEA, it
maintains a focus on cost minimization or effect
maximization, but allows for comparison across
different medical fields and through time. Results
are usually expressed in terms of cost per QALY.
As aresult, this method allows the effectiveness of
one type of treatment to be assessed against
another treatment for the same ailment, and
incorporates more than one measure of outcome.
CUA is also used to judge different health inter-
ventions relative to each other and compares
these by assessing marginal cost per QALY
gained. QALY league tables are used for this pur-
pose. For example, it may be found that the mar-
ginal cost per QALY gained from providing renal
dialysis is R20 000, while that of providing renal
transplants is R10 000. This may carry policy
implications.
Table 30.4 summarizes the four methodologies
for economic evaluation described above. It illus-
trates the units of measurement used for inputs
(costs) and for consequences (outputs, effects, or
outcomes).
Sensitivity analysis
There is uncertainty in all economic analyses.
Given that precise data is often unavailable and a
number of assumptions have to be made in the
process of evaluation, it is necessary to test the
sensitivity of the results to changes in these
assumptions. For example, one might test the
impact of increasing and/or decreasing certain
costs by a given percentage, or of quantifying out-
puts in a different manner. Sensitivity analysis
gives a base estimate high and low parameters. It
can also indicate whether results depend on a
particular assumption and are therefore incon-
Clusive, or whether changing certain assumptions
has little effect on results. Thus, sensitivity analy-
sis will give some indication as to the level of
 30 =health economics

detail necessary in a study. In some cases, results
may be reliable using fairly rough data, whereas
in other cases more specific indicators are neces-
sary.
Conclusion
One must bear in mind that not all costs are easily
quantifiable, and may have effects which are not
purely financial. Economic evaluations are also
not free of the analyst’s value judgements. They
require co-operation between clients, health
workers, health managers, epidemiologists, and
economists. Furthermore, evaluations are costly
and time-consuming and are not presently used
extensively in the health sector outside of narrow
fields such as the evaluation of pharmaceuticals.
Therefore, the results of economic evaluation
should be seen as no more than atool for de-
cision-makers. In the provision of health care,
there is a need for a balanced interplay between
economic appraisal and considerations of equity,
ethics, and political expediency. While evaluation
studies may reflect the most efficient path to
follow, they do not necessarily provide the most
equitable solutions. Their value stems mostly
from the fact that they ‘make health care planning
comprehensive rather than partial, systematic
rather than piecemeal, and value judgements
explicit rather than implicit’ (McQuire, Hender-
son, Mooney 1992).
EXAMPLE 30.1
Economic impact of the AIDS
epidemic in SA
This study assesseds the direct and indirect costs
of AIDS to South Africa. Direct costs included
direct personal costs (such as hospitalization and
drugs for HIV/AIDS patients) and non-personal
costs (testing, research, and prevention pro-
grammes). Direct personal costs were estimated
using a hypothetical model for utilization of
health care resources at each stage of the disease.
The major cost component of this section was

pel (me tm Ce Tame ete Pent in economic

evaluations

Type of economic Measurement of Consequences Measurement of

evaluation costs consequences

Cost minimization Rand, $ etc. Identical None

Cost effectiveness Rand, $ etc. Single effect, common Natural units — e.g.
to the alternatives but years of life gained,
achieved to different units of blood pressure
degrees reduction

Cost-benefit Rand, $ etc. Single or multiple effects, Rand, $ etc.

not necessarily common
to alternatives

Common effects may be

achieved to different
degrees

Cost-utility Rand, $ etc. Single or multiple effects, Quality adjusted

not necessarily common years of life
to alternatives

Common effects may be

achieved to different
degrees

271
e@ epidemiology applied to content areas
found to be hospitalization. The model generated
cost estimates for the public and private sectors
and for the country as a whole. Non-personal
costs were calculated based on estimates of the
total number of HIV tests conducted, and the
total annual cost of research and education. It
was estimated that the direct cost (both personal
and non-personal) of HIV/AIDS to South Africa in
1995 would be between R4713 million and
R10 007 million. Indirect costs were based on the
total number of work years lost. The indirect cost
of HIV/AIDS for 1995 was estimated at R1 887
million (after the figures were adjusted for a 50%
replacement rate of disabled labour). The study
then went on to predict the economic impact of
HIV/AIDS on GNP; it found a 0,12% loss of earn-
ings for 1995 and a 1,5% loss of earnings by 2005.
Thereafter, various scenarios of service mix were
simulated to establish their impact on costs. The
study concluded that AIDS could have a profound
impact on health care resources, seriously hinder
economic growth in the medium term, and pro-
duce numerous other indirect costs. The results
of such a costing exercise can be used to show
policy-makers the importance of early preventa-
tive measures and can assist them with their long-
term financial plans.
Reference:
Broomberg, J, Steinberg M, Masobe P, Behr G. ‘The Eco-
nomic Impact of the AIDS Epidemic in South Africa’ in Bar-
nett T, Blaikie P (eds). AIDS in Africa; Its Present and Future
Impact, London: Belhaven Press 1992.
EXAMPLE 30.2
Costs and benefits of vaccination
programme for Hib disease
In this study, the researchers conducted a cost-
benefit analysis to measure the hypothetical
272
benefits of a vaccine for Haemophilus influenzae
type B infection (Hib) in the 1992 Cape Town
birth cohort (n = 46 537). The risk of disease over a
five-year period was calculated to be 666 to
100 000 births. Net benefits are the difference be-
tween the costs of using or not using a HibTITER.
Costs were the sum of direct medical costs (per-
sonal and non-personal) and indirect costs. The
bulk of direct benefits (avoidable disease costs)
were the hospitalization of patients with menin-
gitis, pneumonia, and septicaemia. Indirect costs
and benefits were measured using the human
capital and willingness to pay approaches. Costs
and benefits were discounted through time at a
rate of 2%. Unvaccinated disease patterns and
vaccine efficacy data were compiled from clinical
data. Sensitivity analyses were conducted on a
number of assumptions; coverage was assessed at
85%, 90% and 95%. The value of life estimates and
the discount rate chosen were found to have the
greatest impact on the model's results. Net bene-
fit was measured as the difference between cost of
disease averted and the cost of the vaccination
programme itself. It was estimated that the costs
of introducing the vaccine to the 1992 Cape Town
birth cohort would have been R8,3 million, while
the economic cost of Hib disease was projected at
R10,7 million to R11,8 million. Had the vaccine
been introduced, the net benefit (costs saved)
would have ranged from R2,4 million to R3,5 mil-
lion. This example shows how economic evalu-
ation can be used to motivate for a particular
health intervention. It can be used to show that
even if the costs upfront appear to be substantial,
the cost of doing nothing may be greater.
Reference:
Hussey, GD, Lasser M L, Reekie W D. ‘The costs and benefits
ofa vaccination programme for Haemophilus influenza type
B disease.’ Southern African Medical Journal 1995; 85(1):
20-25.

appendix 1: Standardization
(adjustment) of rates
If a variable (for example, age or sex) is related to
the outcome of interest, and the two or more
populations which are to be compared regarding
the outcome differ with respect to the distribu-
tion of that variable, one needs to standardize or
adjust rates before they can be compared. This ap-
pendix refers to standardization with respect to
age distribution — a similar approach would be
used to standardize for sex or age and sex.
Standardization can take the form of direct or
indirect standardization, depending on the type of
information that is available for the populations.
To perform direct standardization, the research-
er needs age-specific rates for each population, as
well as a standard or reference age distribution. An
example is provided in Table 1. For each popula-
tion, the standardized rate is calculated by multi-
plying each age-specific rate with the number of
persons in the standard distribution who are in that
age category, adding these values, and finally divid-
ing by the number of people in the standard popu-
lation. One could also multiply each age-specific
rate with the proportion of the standard population
which falls in that age category, and then add these
‘weighted’ age-specific rates. Adjusted rates are
thus obtained by mathematical manipulation of
category-specific rates (in this case age-specific
rates) and provide hypothetical summary (overall)
rates for purposes of comparison.
As a standard distribution, the researcher can
use the age distribution of either of the popula-
tions of interest, their joint distribution, or some
other standard, such as the World Standard. The
standardized rates obtained do, of course, depend
on which standard is used. Thus, applying the age-
specific rates of two populations to various stan-
dards can lead to varying conclusions.
There are many criticisms of standardization,
precisely because it summarises. Researchers
often pay little attention to the informative cate-
gory-specific rates, focusing only on the stan-
dardized rate. No single summary rate can reflect
the richness of category-specific rates, but if there
are many categories, it may be difficult to make
useful deductions based on these rates.
Indirect standardization is used when catego-
ry-specific rates are not available for one or more
of the populations of interest. For this standard-
ization method, the researcher uses the crude
number of cases in each of the populations (the
appendix
‘observed’ number), the category distribution of
the two populations (for example, age distribu-
tion) and the category-specific rates of a standard
population (which could be one of the popula-
tions being compared, if the information is avail-
able). By multiplying each category-specific rate
of the standard population with the number of
people in the matching category of the popula-
tion of interest and then adding these, one
obtains the ‘expected’ number of cases in the
population. By dividing the observed by the
expected number of cases, one has calculated a
standardized morbidity (or mortality) ratio for
that population. (This is also described in Chapter
20: Mortality studies.)
A word of caution about indirect standardiza-
tion: one uses the category distribution of each
population (which may be vastly different) to
calculate that population’s expected number of
cases. This method has therefore also been called
the ‘changing base method’. When one compares
standardized morbidity ratios, one is thus actual-
ly comparing measures based on differing stan-
dards. Direct standardization (or the ‘fixed base
method’) involves the comparison of measures
based on the same standard, and thus represents
the true essence of standardization.
Besides comparing rates in different popula-
tions, standardization can also be used if the
researcher has done a study on a sample in which
the proportion of the sample in each stratum (for
example, age group) does not correspond to the
proportion of the target population in each
stratum (that is, one does not have a proportional
stratified sample). Often strata of equal size are
included in a sample (for example, 100 subjects
for each age group), and this distribution does not
reflect the population composition. Crude preva-
lences or rates found in such samples could be
very distorted because of the unrealistic age
distribution. In these cases, one has to adjust the
stratum-specific rates to obtain the overall rate in
the population. Table 2 provides an example.
appendix 2: Standardization
of observers and instruments
To ensure that good quality measurements are
taken, the observers (measurers) as well as the
measuring instruments need to be standardized
(that is, they should be adjusted to agree with a
measuring standard). The observers have to be
trained thoroughly in the proper methods of using
23
epidemiology: a manual for south africa

gel) (ewRT rea eer elpece Cm emae A Ml

Timaom eit d yity

Group A
Age group Population size Proportion of Number of deaths Mortality rate
population in in age group in age group
age group

Under 25 18 000 0,45 90 0,005

25 to 49 10 000 0,25 50 0,005
50 to 69 6 000 0,15 210 0,035
70+ 6 000 0)15 270 0,045
Total 40 000 1,00 620 0,0155

Group B
Age group Population size Proportion of Number of deaths Mortality rate
population in in age group in age group
age group

Under 25 5 000 0:25 5 0,004

25 to 49 5 000 0,25 10 0,002
50 to 6 5 000 0,25 150 0,030
70+ 5 000 0,25 200 0,040
Total 20 000 1,00 365 0,018
The crude death rate in Group A is 0,0155 (or 15,5 Younger people tend to have a lower mortality
per 1 OOO), and in Group B 0,018 (or 18 per rate than older people. We therefore decide to
1 000). However, from the age-specific mortality standardize to a reference population, say one
rates, itis clear that the rates in Group A are with an age structure as follows (where the age
consistently higher than in Group B. From the distribution is indicated by the proportion in each
population figures, it can be seen that Group A is age group):
clearly a younger population than Group B.

Under 25 0,30 of population

25 to 49 years 0,30
50 to 69 years 0,20
70+ 0,20

The standardized rate for Group A is then

0,005 x 0,30 + 0,005 x 0,30 + 0,035 x 0,20 + 0,045 x 0,20 = 0,019 (19 per 1 000)
and for Group B
0,001 x 0,30 + 0,002 x 0,30 + 0,030 x 0,20 + 0,040 x 0,20 = 0,015 (15 per 1 000)

the instruments. For example, the WHO (1983) stip-
ulates that crown to heel lengths of children under
two years of age should be determined using a
wooden length-board in the following way:
‘The infant is laid on the board, which is itself
on a flat surface. The head is positioned firmly
against the fixed headboard, with the eyes looking
vertically. The knees are extended, usually by firm
pressure applied by an assistant, and the feet are
flexed at right angles to the lower legs. The
upright sliding footpiece is moved to obtain firm
274
contact with the heels and the length read to the
nearest 0,1 cm.’
After such training, and before field work starts,
the consistency and accuracy of the observers’
readings should be investigated. Each observer
should make repeat measurements on some sub-
jects. These subjects should be similar to those who
will be measured in the study. In this way, one can
determine whether an observer measures consis-
tently. However, a consistent observer may be
measuring consistently incorrectly (for example,
 appendix

consistently reading weight too heavy).

Therefore, measurements made by each observer BE (ese Wetec
ea ieee Berl
iiyls
must be compared with those of an accepted to the population age structure
standard to investigate accuracy of measure-
ment. The standard is commonly the training In a study to determine the prevalence of hyper-
instructor or the fieldworker supervisor. Annex 1 tension in Mamre residents aged 15 years and
of the WHO publication Measuring change in older, it was decided to include all inhabitants
nutritional status (1983) outlines methods of older than 45 years, as a service to the commun-
analysis of such repeated measurements to deter- ity. Samples were drawn from the younger age
mine consistency and accuracy. Even from a groups. The resulting sample is thus clearly much
simple listing of the different measurements, one older than the Mamre population.
should get an indication whether there are prob-
lems with their quality, and whether these are due Sample Population
to carelessness, or whether measurements are Males Females Males Females
consistently wrong. Similar investigations of
measurement quality can be done during the 13;6% 10:4: SD 25532.5
data collection phase. 15.5 1474 24,5 23,0
All measuring instruments have to be standard- f9,3° 18,6 17,4 18,2
ized before each measuring session, especially if 22,f 22,4 LO2 Of
instruments are handled roughly in the field, and 16;6.. 19,0 G35 0°78
moved around. So, for example, the weight record- LO4 15,054 Bees
ed by the scales should be compared with a known 100% 100% 100% 100%
weight. All scales should give the same reading
The prevalence of hypertension in the females
when measuring the same standard weight. If no
in the age groups was
standard weights are available, one could, for
example, use a 10 litre plastic bottle filled with 15-24 1,4 45-54 35,3
water, which will weigh 10 kg. The weights used for 25-34 bid 55-64 49,2
standardization should fall within the range of 35-44 14,5 65+ 56,9
weights being measured in the study. All scales The crude prevalence of hypertension among
should be moved to the zero point before each females in the sample is 29,8% whereas the
measurement. When choosing a measuring instru- age-adjusted prevalence for females is 16,3%
ment, one should take into account the ease with
which it can be used, as well as its accuracy. Many (1,4x 0,325 + 5,1x0,23+ 14,5x0,182 +
researchers feel, for example, that ordinary bath- 35,3 x 0,107 + 49,2 x 0,078 + 56,9 x 0,078)
room scales should not be used since they become Source: Hoffman M, Joubert G. ‘Mamre hypertension
inaccurate over time. study.’ Medical Research Council: Unpublished data 1990.

appendix 3: Derivation of the stated value for p. It so happens that a proportion of

30 x 7 EPI sample
With some mathematical manipulation, a formula
for sample size can be calculated.
n= 24d
with n the sample size, z the normal deviate (1,96), p
the expected proportion, q = 1-p, and d the required
precision (half the width of the confidence interval).
One factor here is the ‘precision’ or the degree to
which data centres (groups) around asingle point. If
this is given as, say, 0,1, the implication is that at a
95% level of confidence, any estimate will not fall
further than 10 percentage points away from the
0,5 (50%) requires the greatest sample size for a given
precision, and this proportion is thus used in the
calculations. The required sample size for simple
random sampling is 96.
The design effect in a complex sampling design
is the ratio of the variance of the estimated para-
meter under the design to that under a simple
random sampling design of the same sample size.
The design effect of a cluster sample is usually
less than 2, meaning that the cluster sample size
need seldom be more than double that of a simple
random sample. This gives a figure of 192. Thirty is
a large enough number of clusters for most statisti-
cal tests to apply, and so it was thought that a
sample of 30 clusters with 7 children was adequate.
219
epidemiology: a manual for south africa

appendix 4: Random number table

08939 53632 41345 65379 20165 32576 13967 90616 17995 92422
92578 23668 08801 39792 59541 SO 58830 60923 36068 68101
83994 91054 90377 22776 23263 34593 98191 77811 83144 98563
43080 71414 40760 01831 44145 48387 93018 22618 98547 87716
39372 ~ 46789 26381 37186 85684 79426 05395 17538 56671 82181
83046 58644 04452 98912 53406 30224 00687 32099 86414 29590
99808 32539 96961 88917 60847 64826 41332 64557 15354 Las
28478 70870 68912 75644 33648 21097 23745 52593 01849 37760
09916 19651 28659 95093 12626 19919 05879 56003 83100 94572
19537 66067 20569 28808 87722 67059 12851 73573 25776 92500
23013 (05574 26320 07754 09642 88068 41626 57139 68199 94938
55838 80585 80967 60540 34528 62310 63106 17843 39104 74036
92279 87344 93556 75233 09394 79265 91047 32891 77925 71530
27850 23IS2 89336 26026 52130 78544 02090 05645 15060 39550
01760 54605 11794 79312 69728 04554 99775 57659 47981 68954
81889 70751 87501 88247 41966 57574 67745 88304 20118 25964
74722 14654 15425 60665 25162 04987 03467 75915 24282 62456
56196 75068 ' 44643 92240 51651 79743 13598 63901 61020 91003
96842 62021 00543 45073 65545 87612 35765 26079 34589 72821
25619 98328 59393 71401 93871 20611 78830 87477 15390 05044
91746 05084 04781 82933 54564 80986 94843 40178 87483 63288
92384 84706 76778 98313 98875 08427 60687 88272 83448 06237
86390 62208 95735 14535 25591 22730 06059 31786 36181 31016
60458 83606 57510 92609 38061 94881 26736 06489 98303 31419
03783 39922 05489 73630 92379 91602 18193 84741 44704 05558
31011 36035 37113 98362 56149 51634 04468 62096 32361 35301
20555 05621 48728 41776 12101 96615 70781 55151 93876 66892
56466 36766 12400 43510 49456 05140 85736 68155 37306 10438
26875 67304 61950 65962 38223 35676 70043 99178 64677 95457
90648 84770 OZ OL 93814 27760 22232 83545 01183 55188 20482
26197 72840 01264 52019 00739 36259 10905 39097 36437 66743
72522 34445 D3 Io 13840 97262 59007 78685 41044 38103 59216
12370 ‘41270 36290 46307 51230 90614 82613 80148 37371 02895
81028 60112 31415 47478 02131 85480 93699 92876 13958 47867
61573 38634 77650 18189 10283 97999 95442 90657 84963 93863
98511 46300 91199 30492 62159 98525 31710 03540 35844 83200
76606 10834 75548 30779 54744 26450 66001 57949 53685 00567
20237 16311 15733 47599 43998 35594 17577 85113 52487 48900
21022 86025 26951 87480 82317 06580 98627 32536 07573 52612
47512 11564 41777 46581 03492 01722 78900 57901 37307 02727
80598 59041 28861 41793 91007 69907 00376 73086 35132 53014
01892 34226 88327 21926 36607 22307 04376 25491 13563 51955
89657 70349 15176 57916 10911 44218 67108 04678 24097 02476
97983 65616 11841 80504 76452 34176 16986 94328 13091 29592
59727 92033 14654 59622 25844 18460 78162 02832 13528 55683
12340 72894 26303 01771 73895 27432 99536 50328 06141 83886
48049 33318 67463 04914 22316 89663 37132 15825 60759 22131
85953 16537 25639 05004 99269 50577 10036 05022 39800 93605
03426 78111 37828 23967 03350 04397 96227 37787 60680 23993
Source: Fleiss, 1981

276

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Section B: Epidemiological research methods
and protocol development
4 Planning a research project
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Further reading
Abrahamson J H. Survey methods in community medicine
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5 Literature review
Further reading
Sackett D L, Haynes RB, Guyatt G H, Tugwell P. Clinical
epidemiology:A basic science for clinical medicine (2nd
edn). Chapters 11, 12 and 13. Boston: Little, Brown and
Co. 1991.
6 Setting objectives for research
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Centre (Canada) and World Health Organization (Geneva)
19Q1:
7 Study design
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LilienfeldA M, Lilienfeld D. Foundations of epidemiology
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Rothman KJ. Modern epidemiology New York: Little, Brown
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Sackett D L, Haynes RB, Guyatt GH, Tugwell P. Clinical
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8 Sampling
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2
 epidemiology: a manual for south africa
Sackett D LS. ‘Bias in analytic studies.’ Journal of Chronic
Diseases. 1979; 32:51-3.
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Biernacki P, Waldorf D. ‘Snowball sampling: Problems and
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9 Datacollection and measurement
Further reading
AbrahamsonJ H. Survey methods in community medicine
(4th edn). Edinburgh: Churchill Livingstone 1990.
Joubert G, Hoffman M. ‘Data quality in a community health
survey — the experience with the Mamre Community
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RezlerA G. The assessment ofattitudes. WHO/EDUC/712/
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Sackett D LS. ‘Bias in analytic studies.’
Journal of Chronic Diseases 1979; 32:51-63.
Woodward CA, Chambers LW. Guide to questionnaire
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Canadian Public Health Association 1980.
10 Other issues to consider in the protocol
Further reading
MRC News. Special issue: Compilation of articles of general
interest 1989; 20(5). (This issue contains articles on, for
example, how to write scientific papers, how to present
research results visually, the roles of authors and editors,
and ethical issues in publishing research.)
Also refer to references and further readings given for Chapter
3 and those given in Section C.
Section C:Data presentation, analysis,
and interpretation
11 An introduction to data presentation, analy-
sis, and interpretation
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Mollentze W F, Joubert G. ‘Coronary risk factor study of
black rural and urban populations in the Free State.’
University of the Orange Free State 1994. Unpublished
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Further reading
Altman D G. Practical statistics for medical research. London:
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John Wiley 1981.
Fleiss J L. Statistical methods for rates and proportions.
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Greenland S. ‘Randomisation, statistics and causal inference. ,
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Hoaglin D C, Mosteller F, Tukey JW. Understanding robust
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Hosmer D W, Lemeshow S. Applied logistic regression.
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Rosner B. Fundamentals of biostatistics. Boston:
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Rothman KJ. Modern epidemiology. New York:
Little, Brown and Co. 1986.
Siegel S. Non-parametric statistics for the behavioural
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Tufte E R. The visual display ofquantitative information.
Connecticut: Graphics Press 1983.
12 Integrating epidemiological concepts
References
Ahlbom A, Norell S. Introduction to modern epidemiology.
Chestnut Hill: Epidemiology Resources Inc. 1990.
Further reading
Breslow NE, Day NE. Statistical methods in cancer research.
Volume II— The design and analysis of cohort studies.
Oxford: Oxford University Press 1987.
HulleyS B, Cummings SR (eds). Designing clinical research.

Baltimore: Williams and Wilkins 1988.
Kahn HA. An introduction to epidemiologic methods.
New York: Oxford University Press 1983.
KelseyJ,Thompson WP, Evans A S. Methods in observation-
al epidemiology. New York: Oxford University Press 1986.
McMahon B, Pugh T F. Epidemiology principles and
methods. Boston: Little, Brown and Co. 1970.
Rothman KJ. Modern epidemiology. Boston: Little, Brown
and Co. 1986.
Schlesselman J J. Case-control studies. Design, conduct,
analysis. New York: Oxford University Press 1982.
Section D: Common approaches in epidemiology
13 The use of routinely available data in
epidemiological studies
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14 Disease surveillance
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15 Health systems research (HSR)
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Goldberg D, Huxley P. Mental illness in the community.
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Goldberg D, Huxley P. Common mental disorders:
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Holmes TH, Rahe RH. ‘The Social Readjustment Rating
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epidemiology: a manual for south africa
Miller T, Swartz L. ‘Access to psychiatric resources: The case
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Newton J. Preventing mental illness in practice. London:
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‘Rumble S, Swartz L, Parry C D H, Zwarenstein M.
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Swanson-Fisher R W, Martin CJ. ‘Standardized interviews in
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Swartz L, Miller T. “Minor psychiatric disability and primary
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Swartz L. ‘Transcultural psychiatry in South Africa. Part II.’
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Swartz L, Ben-Arie O, Teggin AF. ‘Subcultural delusions and
hallucinations: Comments on the present State
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Tafari S, Aboud F E, Larson C P. ‘Determinants of mental
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Tansella M, de Girolamo G, Sartorius N. Annotated bibliog-
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27 Anthropometric studies
Further reading
Bray GA. ‘Definition, measurement and classification of the
syndromes of obesity.’ International Journal of Obesity
1978; 2:99-112.
Frisancho AR. ‘Newnorms of upper limb fat and muscle
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Keys A. ‘Overweight, obesity, coronary heart disease and
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Kibel MA, Wagstaff A (eds). Child health for all: Amanual
for Southern Africa. Cape Town: Oxford University Press
199e ‘i
Steyn K, Fourie J, RossouwJ E, Langenhoven M L, Joubert G,
Chalton D O. ‘Anthropometric profile of the coloured
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Womersley J, Durnin J VGA. ‘A comparison of the Skinfold
286
method with extent of “overweight” and various weight-
height relationships in the assessment of obesity.’
British Journal of Nutrition 1977; 38:271-84.
World Health Organization. Measuring change in nutritional
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28 Assessment of dietary intake
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Department of Health. Report on Health and Social Subjects
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Food and Nutrition Board, National Academy of Sciences —
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Bingham SA. ‘The dietary assessment of individuals;
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29 Measurements in dental epidemiology
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30 Health economics
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Appendix 4
Reference
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287
epidemiology: a manual for south africa
copyright acknowledgements
The editors and publisher acknowledge with thanks permis-
sion to reproduce copyright material in this book. Every effort
has been made to trace copyright holders, but where this has
proved impossible, the editors and publisher would be grateful
for any information which would enable them to amend inad-
vertent omissions in future editions.
Tuberculosis clinic card designed for hand analysis, taken
from: Dick K, Youngleson S M. ‘The design ofa case register for
tuberculosis. A pilot study in the southwestern Cape’. South
African Medical Journal 1994; 84:621-3. Printed by courtesy of
the authors.
Checklist for statistical review, taken from: Gardner M J,
Altman DG (eds). ‘Statistics with confidence — confidence
intervals and statistical guidelines’. London: British Medical
Journal 1989. Printed by courtesy of BMJ Publishing Group.
Adaptation of a hand[{drawn map of Khayelitsha, taken from:
Pick, W M, etal. ‘A study of the effects of urbanisation on the
health of women in Khayelitsha, Cape Town. Working paper
288
No 1: rationale and methods.’ Cape Town: Department of
Community Health, UCT 1990. Printed by courtesy of the
authors.
Rifkin’s framework for assessing participation in projects,
taken from: Rifkin S B, Muller F, Bichmann W. ‘Primary health
care: on measuring participation’. Social Science and Medicine
1988; 26:931—40. Printed by courtesy of the authors.
Revised problem analysis diagram of factors contributing to
high defaulter rate among TB patients, taken from: Varkevisser
C M, Pathmanathan I, Brownlee A. Designing and Conducting
HSR Projects. HSR Training Series, Vol 2 Part 1. International
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International Development Research Center.
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error on the precision and validity of measures of effect, taken
from: BothaJ L, Yach D. ‘Epidemiological research methods.
Part II. Descriptive studies’. South African Medical Journal
1986; 70:769. Printed by courtesy of the Medical Association of
South Africa.
 index

index causation of disease 10-12

guidelines for establishing 12
models of multiple causation 11-12
A necessary cause 10-11
sufficient cause 10-11
active surveillance 142 cause of death
problems in 145 determining 189-90
adult mortality 189 profiles (study of) 193
age-specific fertility rate 20 census data 19
age-specific mortality rates 187 Centre for Epidemiological Research in Southern Africa
AIDS research (CERSA) 8
assessment of economic impact of epidemic 271-2 CERSA see Centre for Epidemiological Research in Southern
KAPB surveys in schools 174-5 Africa
setting objectives for 63 childhood mortality rate 189
analysis cholera outbreak (London, 1854).204
in disability studies 227-8 classification (of disablement) 224-5, 226
in occupational epidemiology 220-1 closed questions 83
analytic studies 64, 66-7 cluster sampling 77-8
different types of 67-9 CME see comparative mortality factor
for testing hypothesis 200-2 coding 86-7, 180
objectives of 61 cohort studies 69, 202, 216-17
anthropometric studies 243-7 Commission on Health Research for Development (1990) 5
examples of 246-7 communal versus individual consent 31
for adults 244-6 communication 167
for children 243-4 community (definition of) 34
arithmetic mean 108-9 community health see public health
association 221 community health worker project (evaluating) 181
attitudes, measurement of 171 community indicators 162
attributable risk 117-18 community intervention trials 70
attribution theory 169 community oriented primary care (COPC) 7
community participation 34-40, 166-7
application of 34-7
criterion for ranking 39
bar graphs 106-8 definition of 34
before-after studies 71 evaluation of 37-40
behaviours, measurement of 171 example of study with 43-6
beliefs, measurement of 171 factors and components for evaluation of 38
in health projects 35, 37-40
bias .
in programmes 34-5
in case-control studies 68
in KAPB survey sampling 172 in research 35-7 :
Community Periodontal Index of Treatment Needs (CPITN)
in occupational epidemiology 220
257-8
in research process 51-3
community studies 164-8
in sampling 79-81
data collection for 165
information 128-30
dealing with community in 166-7
selection 127-8
examples of 167-8
types of 127
fieldworkers and 165-6
validity and 126-30
sampling for 164-5
biological monitoring 215
community-based surveys 206-8
birth rate 16
comparative mortality factor (CMF) 188-9
births data
confidence intervals 113-14, 115
sources and limitations of 135, 136
confidentiality 32
used for estimating immunization coverage 205-6
conflicts of interest 33
bivariate plot 106, 107, 121
confounders 119
block chart 109
consent 31, 32
BMI see Body Mass Index
content analysis 180
Body Mass Index (BMI) 244-6
content validity 92
box plot 104, 105-6 control measures 203-4
budget 96, 97 COPC see community oriented primary care
correlation 120
c . cost-benefit analysis 270
cost-effectiveness analysis 270
case definition 197 cost-minimization analysis 270
case-control studies 68-9, 162, 202, 216, 219 costs
case-referent studies see case-control studies framework for evaluating 267-8
categorical variables 101-2, 108 identifying 265-6
and honesty in graphical display 110 measuring 266-8
graphical display of 106-8 cost-utility analysis 270

289
epidemiology: a manual for South Africa

CPITN see Community Periodontal Index of Treatment methods of data collection in 248-51
Needs national level 248
criteria-related validity 92 validity and reproducibility of 251
cross-sectional analytic studies 67-8, 216, 219 disability, classification of 224-5
example of 222-3 Disability Adjusted Life Years (DALY) 23, 190, 269
crude rates 18 disability prevalence (studies to determine) 228-9
birth 20 disability studies 224-9
death (mortality) 20, 187 examples of 228-9
culture 237 variables included in 227
cumulative incidence 16-17 disclosure 31
discounting 268
D disease surveillance 140-6
definition of 140
for detecting outbreaks 197
DALY see Disability Adjusted Life Years
" history of 140
data analysis 87-9, 95-7, 101-23
main purpose of 141
by computer 87-9
methods of 141-4
by hand 87, 88
problems in 144-5
checking data before 102-3
to determine immunization coverage 205
commonly used 116-22
uses of 140-1
exploratory 103-8
DMFS/dmfs index 255
for estimating immunization coverage 209
DMFT/dmft index 255
in KAPB surveys 172
dummy tables 95
summarizing 108-111
what to consider when choosing appropriate 116
data capture sheet 87
data checking procedure 102
data collection 82-94 ecologic studies 71-2, 193, 216
for estimating immunization coverage 208-9 economic evaluation 264-9
for qualitative research 177-9 examples of studies 271-2
in community studies 165 measurement of costs and consequences 271
in dietary studies 48-51 methods of 269-71
in outbreak investigation 202-3 economic objectives 262-4
issues related to 93-4 effectiveness 262-4
methods of 84, 177-9 efficiency 262
quality of data 89-93 ENHR see essential national health research
using questionnaires for 82-9 environmental diseases
data distribution (types of) 104-6 causes of 213
data interpretation 101-23 nature of 212-13
data management 95-7 environmental epidemiology 211-17
data presentation 101-23 environmental health
guidelines for 122
assessment of exposure 213-15
data quality 89-93
definition of 211
data types 89-90
environmental health outcomes 212-13
death rates 16
detection of 212-13
demographic indicators (for South Africa) 22
types of 212
demographic processes 20-2
environmental investigations 199
demographic transition 22-3
environmental monitoring 214
demography 19-23
dental caries (measurement of) 255
EPI see Expanded Programme on Immunization
EPI30x7 sample 206, 275
dental epidemiology (measurements in) 254-60
deontological theories 27 epidemic (definition of) 196
dependency ratio 19, 22 epidemic curve 199, 200
depth interviews 177 epidemiological concepts, integrating 124-30
examples of use of 181 epidemiological triangle 11
descriptive statistics 108 epidemiologist, role of 6
descriptive studies 64, 66 epidemiology 5-6
objectives of 61 analytic 5
diabetes, late-onset (prevalence of) 167-8 definition of 5
diagnostic interviews 232, 233-4 descriptive 5
dietary data discipline of 5-6
calculation of 251 future of 8-9
collection of 248-51 in South Africa (history of) 6-8
interpretation of 251-2 ofa disease 5
dietary histories 250-1 Epidemiology Society of Southern Africa (ESSA) 8
dietary studies 248-53 equity 264
examples of 252-3 ESSA see Epidemiology Society of Southern Africa
individual level 248, 249 essential national health research (ENHR) 5

290
 index

ethical principles (in research) 27-34 contrasted with perfect competition situation 263
ethical reasoning health care system 148
ethics and 26-7 economic evaluation of 264-9
examples of ethical dilemmas to stimulate 42 ways of looking at 151
process of 28 health economics 261-72
ethical review (of research) 33-4 health indicators 23-4
ethical theory 27, 28 key mortality rates used as 189
ethics 25-6, 96 proposed by WHO 24
and data collection 93 selection of for monitoring population health 24
and ethical reasoning 26-7 sources of data for 23
and occupational epidemiology 221 uses of 23-4
examples of ethically unacceptable research 26 health insurance 262
guidelines for action 96 health services data
in clinical trials 70 sources and limitations of 135, 137
issues of in epidemiological research 314 study of in provinces 138-9
ethics review committees 33 health status indicators 269
evaluation 147 health system 147-8
Expanded Programme on Immunization (EPI) 158-60 Health Systems Research (HSR) 147-57
sampling method used in 206-8, 209-10 approach of 152
experimental studies 64, 66, 69-71, 217, 219 characteristics of 152
exploratory data analysis 103-8 examples of questions for 153
exposure, more than two levels of 118-19 examples of studies in 155-7
exposure estimation 213-15 integrated view of 151-3
methodology of 152-3
F tips for conducting 153-5
health-related behaviour 169 ’
face validity 92 height for age 243-4
family planning services (REA of) 162-3 hepatitis B reporting system 146
feedback 33 histogram 106
fertility 20 hospital care (observations of levels of) 184
fertility rate 16 house-to-house sentinel population investigation 208
field supervision 94 HSR see Health Systems Research
field trials 70 hypothesis 62
fieldworkers (in community studies) 165-6 generating a 200
fluorosis (measurement of) 259 testing a 200-2
focus group interviews 177-8 hypothesis (significance) testing 114-15
follow-up studies see cohort studies
food consumption studies see dietary studies

G ICIDH see International Classification of Impairment,

Disability and Handicap
general fertility rate 20 IFCH see Institute of Family and Community Health
geographic variation, determining 190 immunization coverage, estimating 205-10
geometric mean 110 analysis 209
Gingival Index 257 comparison of three methods used in 207
gingivitis (measurement of) 256-7 examples of 209-10
Gluckman Commission see National Health Service in peri-urban settings 210
Commission (1944) measurement considerations 208-9
graphical display (of data) 103-8 using community-based surveys 206-8
categorical variables 106-8 using routine data 205-6
honesty in 110 impairment, classification of 224-5
numerical variables 103-6 implementation (of epidemiological findings) 40-2, 222
growth patterns see anthropometric studies facilitating 41-2
growth rate (population) 20 obstacles to 41
IMR see infant mortality rate
incidence 15-18
incidence density see incidence rate
handicap (classification of) 224-5 incidence rate 17
haphazard sampling see non-random (haphazard) sampling incident cases 15-16
Health Belief Model 169 counting 18
health care inconsistent validity 93
components of 148 Index of Orthodontic Treatment Need (IOTN) 259
economic objectives of 262-4 index person 90
elements which can be evaluated 150-1 indices
goals of 149-51 for dental caries 255
health care delivery (stages of) 148-9 for dental diseases 254-5
health care market 262 for fluorosis 259

291
epidemiology: a manual for South Africa
for gingivitis and periodontitis 256-8
for malocclusion 259
for periodontal health 256
individual interviews 84
infant mortality (profile of) 168
infant mortality rate IMR) 20
indirect method of estimating (example of) 193-5
used as indicator of health 189
information bias 128-30
informed consent 31, 32
inputs (health care system) 149, 265-8
Institute of Family and Community Health (IFCH) 7
International Classification of Impairment, Disability and
Handicap (ICIDH) 225
intervention studies 219
examples of 184
see also experimental studies
interviewers 93
IOTN see Index of Orthodontic Treatment Need
Ithuseng VHW evaluation 44, 45, 46
J
judgement sampling 78
K missed opportunities studies 162
KAP gap 169
KAP surveys 169-70
KAPB surveys 169-75
characteristics measured by 171-2
criticism of 172-4
description of 170
examples of surveys 174-5
history of 169-70
issues specific to 172
predicting practice with 172-3
problems of in developing countries 174
reliability and validity of 173
simplistic approaches to ] 73-4
steps in conducting 170
uses of 170
knowledge, measurement of 171
L
laboratory-based surveillance 143
legal considerations 96
Legionnaire’s disease investigation 204
life expectancy 20-2
life table analysis 189, 192
literature
finding the 54-5
reading the 55
systematizing and summarizing 55
literature review 54-5
for outbreak investigation 198
writing up 55
logistics (of occupational epidemiology) 222
Lot Quality Assurance Sampling (LQAS) 160, 208
LQAS see Lot Quality Assurance Sampling
mailed questionnaires 84
malaria control programme 144
malocclusion and dentofacial anomalies (measurement of)
292
258-9
Mamre Community Health Project
community participation and 43-4
research strategy used in 239-41
matching 68-9, 202
measles immunization (REA to assess) 163
measurement 82
in dental epidemiology 254-60
in disability studies 226-7
in occupational epidemiology 219-20
in psychiatric epidemiology 231-8
of exposures 232-6
of outcomes 231-2
. sources of error in 90
validity of 236-8
measurement bias 127
measurement instruments 82
factors affecting choice of 222
measures of strength of association 116-18
measures of variability 111
median 105, 109
microbiological investigations 199
migration 22
misclassification 128-30
differential 129-30
non-differential 128-9
mode 110
molecular epidemiology 199
morbidity data, sources and limitations of 134, 136-7
mortality 20-2
mortality coding practice (study of) 195
mortality data, sources and limitations of 134, 135-6
mortality rates 16, 136
determining 187-93
mortality studies 187-95
examples of 193-5
determining trends over time 190-2
in South Africa 193
issues in 187-93
mortality surveillance 161
multiple linear regression 120-2
multiple pathways 213-14
multiple sources 213-14
multivariate analysis 120-2
N
: National Health Service Commission (1944) 6-7
natural history of disease 13-14
networking see snowballing (networking)
non-random (haphazard) sampling 78-9
Normal (Gaussian) distribution 113
notifiable disease reporting 142-3, 177
notifiable diseases 143
null hypothesis 114
numerical variables 102, 108-11
and honesty in graphical display 110
graphical display of 103-6
nutritional indicators (for children) 243-4
nutritional status see anthropometric studies; dietary studies
Oo
observational studies 64-5, 66
occupational epidemiology 218-23
ethics and 221
 index
etcee

examples of study in 222-3 psychiatric epidemiology in 238-41

implementation of findings in 222 roots of 6
methodological issues in 219-21 primary prevention 14
resources and logistical issues in 222 primordial prevention 14
unique aspects of 218-19 principle of autonomy 28-9
odds ratio 117 principle of beneficence 29-30
open-ended questions 83 principle of justice 30-1
oral health (trends in) 259-60 principle of non-malevolence 29-30
oral (mucosal) disease principle of respect for persons 28
classification of 258 probability distributions 113
measurement of 254, 258 probability sampling see random sampling
outbreak (definition of) 196 processes (delivery of health care) 149
outbreak investigations 196-204 proportional mortality 136
describing the outbreak 198-9 Proportional Mortality Ratio (PMR) 190
examples of 204 proportional stratified sampling 76
person, time and place 199 proxy consent 31
preliminary assessment 198 proxy response 90
preparing to investigate 198 psychiatric epidemiology 230-42
step-by-step approach to 197-204 example of research study 242
outbreak surveillance 144 in practice 239-41
outcomes (health system) 149 in primary health care context 238-41
outputs (health care system) 149, 268-9 issues of validity of research in 236-8
over-reporting 212-13 unique aspects of 230
psychiatric illness
P example of study of 242
exposures associated with 232-6
paired observations 118 levels and filters in 239, 240-1 *
PAR see Peer Assessment Rating Index public health 4-5
parameter 111
research 5
publish (obligation to) 33
parametric versus non-parametric methods 115-16
purposive sampling 77
partial disclosure 31
p-value 114, 115
participant observation 178-9
PYLL see potential years of life lost
participatory research 35-7
passive surveillance 141-2
problems in 144-5 Q
PDI see Periodontal Disease Index
Peer Assessment Rating Index (PAR) 259 QALYS see Quality Adjusted Life Years
periodontal disease (measurement of) 257 qualitative data 176
Periodontal Disease Index (PDI) 257 qualitative methodology 176-84
periodontal health 256 advantages and disadvantages of 181
PHC see primary health care examples of use of 181-4
Pholela 6 issues regarding 1277-81
pictionnaire 45 philosophy underlying 176
pie charts 106-8 uses of 176
pilot study 89 qualitative methods 176
Plaque Index (PI) 256 qualitative research 176
PMR see Proportional Mortality Ratio advantages and disadvantages of 181
examples of 181-4
point prevalence see prevalent cases
in the workplace 220
policy development 148-9
methodological issues in 179-81
cycle 41
methods of data collection for 177-9
population composition 19-20
outline of process (example) 182
population data, sources and limitations of 134, 136 uses of 176
population parameters, estimating 111-16 Quality Adjusted Life Years (QALYs) 269
population pyramid 19-20, 21 quality health care 147, 149-51
potential years of life lost (PYLL) 190 quality of research 33
practice, measurement of 171 quartiles 105-6
preceding birth technique 161 questionnaires 82-9
precision 124 analysing 86-7
predicted validity 92-3 development 83-9
prediction see hypothesis for KAPB surveys 172, 173
prevalence 15-18 for outbreak investigations 202-3
rate 17, 17-18 formulating questions for 83-6
prevalent cases 17 layout and design of 86, 172, 208
counting 18 pictionnaire 45
prevention of disease 12-15 piloting 89
at different stages 14, 15 used in psychiatric epidemiology 233-4
primary health care (PHC) Quetlet index see Body Mass Index

293
epidemiology: a manual for South Africa

analysing 116-18
R measures of 15-19
road to health card 245
random number table 276
routine surveillance 142-3
random sampling 75-8
problems in 145
randomized controlled clinical trials 70
routinely available data
range 111
examples of use of 137-9
rapid environmental health assessment 160-1
for estimating immunization coverage 205-6
rapid epidemiological assessment (REA) 158-63
mortality data 135-6
broad types of 158-62
types, sources, and limitations of 134-5
family planning services study 162-3
using 133-5
measles immunization study 163
uses of 158
rapid ethnographic assessment 160 Ss
rates 15
calculating 15, 16 sample 74
comparison of 18-19 sample size 80-1
key 16 estimates yielded by increasing 125
REA see rapid epidemiological assessment formula for 275
recall bias 127 statistical significance, strength of association and 118
relative mortality rates 188-9 study design, precision of estimates and 124-5
relative risk 116-17 sampling 74-81
reliability (measurement) 90, 91 bias in 79-8, 127
improving and evaluating 92-3 EPI 206-8
of KAPB surveys 172, 173 example of strategy to eliminate bias in 81
report writing 98, 203 for disability studies 225-6
research 3-4 in community studies 164-5
applied 3 in KAPB surveys 172
basic (fundamental) 3 in occupational epidemiology 219
country-specific 5 in qualitative studies 180
global health 5 LQAS 208
public health 5 non-random (haphazard) 78-9
reasons for conducting 4 random 75-8
research diaries 179 techniques for REA 158-62
research hypothesis 62 sampling frame 75
research objectives, setting 56-63 for community study 164
examples of 62-3 sampling units 75
specific 61-2 for community study 164
research problem, identifying and analysing 56-8, 59, 60, 61 scales of measurement 86
research process 49 scatter plot 121
bias in 51-3 screening techniques 226-7
planning phase of 49-53 secondary prevention 14
researchers’ patterns of emotions during 53
selection bias 127-8
research project, probable stakeholders in 166
self-administered questionnaire 82-3
research protocol see study protocol
sensitivity analysis 270-1
research questions 64
sentinel surveillance 143-4, 161
developing 83-6
problems in 145
for health systems research 153-4
formulating 56-63 shadow pricing 268
in disability studies 226-7 significance level 114
in KAPB surveys 171 simple linear regression 120
methods of questioning 82-3 simple random sampling 75, 77
research report Simplified Oral Hygiene Index (OHI-S) 256
qualities of a good 98 smoking (KAPB survey regarding) 175
structure of 98 SMR see standardized mortality ratio
research team 49-50 snowballing (networking) 79
- for outbreak investigation 198 social dental indicators 259
researcher control 64-5 Social Learning Theory 169
researchers, emotional state of 53 social psychological theories 169
(see also fieldworkers; research team) socio-cultural context 174
resources 96 special surveillance programmes 144
for occupational epidemiology 222 problems in 145
respiratory disease specific rates 18
health survey 44 specificity 221
occupational study 222-3 specimens (use for other purposes) 32-3
Rifkin’s framework 38 spot map 199, 201
risk difference 117 standard deviation 111
risk factors 10-11 standard error 112-13, 124

294
 index

standardization (adjustment) 19, 273-5 ' tally sheet 46

direct 273, 274 target population 74 ;
indirect 221, 273, 275 in environmental epidemiology 216
of observors and instruments 273-5 targeted sampling 79
of rates 188, 273 TB (tuberculosis)
standardized mortality rates 188 photo novel 182-4
standardized mortality ratio (SMR) 188-9 study of patient compliance in treatment 137-8
statistic (definition of) 111 telephone surveys 84
statistical concepts 101 tertiary prevention 14
statistical hypothesis 62, 114 theoretical memos 180
statistical review, checklist for 123 total fertility rate 20
statistical significance 115, 118 training 93-4, 180-1, 208-9
stem and leaf plot 104-5 translation 93, 174, 237
stratification 119-20 24-hour recall 250
stratified cluster sampling 77 Typeland Il error 114 \
stratified random sampling 75-7 a
strength of association 118
structured interviews 83
U
study
implementation objectives of 62 under-5 mortality rates 20, 189
statement of purpose or aim of 58-61 under-reporting 144-5
study base 65-6 in environmental studies 213
study design 64-73 in hepatitis B notifications 146
and comparison group 65 unstructured interview 83
and research control 64-5 urbanization 22
and research questions 64 utilitarian theory 27
and study base 65-6
and temporal sequence of exposure and outcome 65 Vv
commonly used 66-73
considerations 125-6 vaccination programme for hypothetical disease 272
for disability studies 225 vaccination status 209
in environmental epidemiology 216-17 vaccine efficacy, estimating 205, 206
in occupational epidemiology 219 validation 227
in psychiatric epidemiology 231 validity 124
matching research topics to 72-3 and bias 126-30
study protocol 50-3 value (of human life) 268-9
checklist for a 52 variables 101-2
contents of a 50-1 types of 101
major headings in a 50 verbal autopsies 161-2
study (target) population see target population
study types 66 WwW
matching research topics to 72-3
summary rates (mortality) 187-8 weight for age 243-4
summary statistics 108 weight for height 243-4
surveillance methods for REA 161-2 (see also disease ‘why game’ 56-7
surveillance) written versus oral consent 32
survey of records 84
systematic sampling 78

T
table shells see dummy tables

295
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wu
 Health care workers and medical students often find epidemiology
dauntingly abstract, even though it provides a vital background to
the work they do. This comprehensive manual provides an acces-
sible introduction to epidemiology and its application in primary
health care. The basic principles and tools are clearly explained and
applied to a wide range of specific topics — from psychiatric to
environmental epidemiology.

This updated manual offers:

ae ereninnnurtehielte guidance on the skills necessary

to demystify epidemiological research and study
» a Strong emphasis on the practical application of
epidemiology to field situations
» examples of research that highlight local health issues
the multidisciplinary approach and knowledge of a
wide range of South African experts
clear guidelines on how to write protocols and
manage statistics
numerous helpful figures and graphs.

This clear and accessible book will be invaluable not only to medical
students and professionals, but also to all others interested in
epidemiology, or in current and future health trends in South Africa.

ISBN 0-19-571308-7

9 "780195 il