Unit – 1

Introduction to Research
Methodology
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March, 2024
Contents
Unit-1 Introduction to Research Methodology
• Definitions, main components, characteristics, types, and
importance of research
Questions to be answered are:-
• What is research?
• What is a health research?
• What are the Characteristics of researches?
• What are the types of researches?
• Why is research needed?

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a. Introduction to Research

• Research in the context of public health aims to provide

all aspects of information necessary for planning and
the effective implementation of services in a health
system.
• For all communities, whether affluent or poor, health
research is the top priority.

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 b. Definitions of Research
The root meaning of the word research is “search again” or
“examine carefully”.
Research is a scientific inquiry aimed at learning new facts,
testing ideas, a new way of experiencing reality, etc.
Research is the systematic collection, analysis and
interpretation of data to validate and refine an existing
knowledge, generate new knowledge and technology and
answer a certain question or solve a problem.
Research Methodology : is the specific procedures or
techniques used to identify, select, process and analyze
information about a research topic.
Science is a coherent body of knowledge composed of
research findings and tested theories for a specific
discipline.

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Definitions con…..
Science: is the systematic study of the structure and
behavior of the social and natural world through
observation and experiment or it is the pursuit and
application of knowledge and understanding of the
natural and social world based on evidence.

Technology: The application of scientific knowledge to

create devices that can solve problems or do tasks.
Technology is the application of science.

Invention: creating something entirely new product

(material), technique or service and brought to the
market.

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Definitions con…..
Innovation: Is the process of improving the existing
creations or finding new applications for the inventions.
It is improvement in someone else's invention.
Discovery: Revealing a truth that was always there or
confirming a theory or hypothesis.
Theory: A plausible and scientifically acceptable general
principle or body of principles offered to explain
phenomenon in the natural world. It can incorporate
laws, hypothesis or facts.
Exploration: It is the act of investigating or exploring
unknown regions or unfamiliar area.

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c. Main Components of Research
Main components of any research work are:
1. Preparing a research Proposal
2. Fieldwork (i.e., Data collection, Designing prototype)
3. Analyzing data & preparing a research
report (manuscript writing)

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 D. Types of Research
• The classical broad divisions of research are: Basic Research & Applied
Research
Basic research or Pure research is a scientific investigation that involves the
pursuit of knowledge for knowledge’s sake or for the pleasure of learning and
finding truth. It is necessary to generate new knowledge and technologies to
deal with major unresolved health problems. Findings are not directly useful in
practice. E.g. Genetic engineering
Applied research: is a scientific investigation conducted to generate knowledge
that will directly influence or improve practice. Its purpose is to solve problems,
to make decisions or to predict or control outcomes. Applied research is problem-
oriented, and is directed towards the solution of an existing problem. It is
necessary :to identify priority problems and to design & evaluate policies and
programs that will deliver the greatest health benefit in making optimal use of
available resources. E.g. Drug efficacy study, Treatment, diagnostic , preventive, policy,
incidence, prevalence etc
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 Classification of research…….
Classification of research based on Objectives
• Exploratory research
• Descriptive research
• Correlational research/ Observational
• Explanatory/experimental research
Classification of research based on type of data collection
• Cross-sectional research (E.g survey)
• Longitudinal research ( E.g prospective cohort study)
Another classification of Health research
• Biomedical research deals primarily with basic research involving processes at the cellular level.
• Health services research deals with issues in the environment surrounding man, which promote changes
at the cellular level.
• Behavioral research deals with the interaction of man and the environment in a manner reflecting the
beliefs, attitudes and practices of the individual in society. 9
Types of Research based on information sought
 Quantitative research
 Qualitative research
1. Quantitative research
• Is a formal, objective, systematic process in which numerical data
are used to obtain information about the world. It is used to
describe variables, examine relationships among variables, and
determine cause-and-effect interactions between variables.
• Early forms of research originated in the natural sciences such as
biology, chemistry, physics, geology etc. and is concerned with
investigating things which we could observe and measure in some
way. Such observations and measurements can be made objectively
and repeated by other researchers.
• This type of research is more concerned with questions about: how
much? how many? how often? to what extent?, etc. Data are
numbers.

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 Types of Research …
2. Qualitative research
• It is a systematic, interactive, subjective approach used to
describe life experiences and give them meaning. It
attempts to increase our understanding of why things
are the way they are in our social world and why people
act the ways they do. Data are words.
• It is concerned with developing explanations of social
phenomena. It seeks to answer questions about:
• Why people behave the way they do?
• How opinions and attitudes are formed ?
• How people are affected by the events that go on around
them?

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E. Health Research
Health Research is the application of the principles of
research on health.
• Health research has been divided in to three
overlapping divisions
1. Essential health research
2. Clinical research – Prevention, Dx, Rx, Rehabilitation
3. Biomedical research

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 Essential health research is a category of health
service research, but has elements of Clinical
research and development of technology. The
information obtained is specific to a given country
and essential for planning and monitoring health
services. E.g EDHS
 Clinical research has range of topics from studies
of the prevention and diagnosis of diseases
through new methods of treatment to care &
rehabilitation. E.g. Clinical trials on the use of new
chemotherapeutic agents.
 Biomedical research is most basic part of health
research and has more universal importance. E.g
Molecular level studies

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 Health Systems Research
• Research that supports health development has come
to be known as Health Systems Research.
• It is ultimately concerned with improving the health of a
community, by enhancing the efficiency and
effectiveness of the health system as an integral part of
the overall process of socioeconomic development.
• HSR is undertaken primarily to provide information to
support decision-making at all levels that can improve
the functioning of the health system

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F. Characteristics of Research
• It demands a clear statement of the problem
• It requires a plan (it is not aimlessly “ looking” for
something in the hope that you will come across a
solution)
• It builds on existing data, using both positive and
negative findings
• New data should be collected as required and be
organized in such a way that they answer the research
question(s)

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Essential Features of HSR
Some of the essential features of HSR are summarized
as follows:
1. HSR should focus on priority problems
2. It should be action oriented (i.e., aimed at
developing solutions)
3. An integrated & multidisciplinary approach
is required (research approaches from many
disciplines)

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Essential Features ….
4. Research should be participatory in nature (from
policy makers to community members)
5. Research must be timely
6. Emphasis should be placed on comparatively simple,
short-term research designs that are likely to yield
practical results
7. The principle of cost-effectiveness is important in
the selection of research projects. Health research
should be cost-effective.
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 Essential Features . . .
8. Results should be presented in formats most useful for
administrators, decision-makers and the community.
• A clear presentation of results with a summary of the major
findings adapted to the interests of the intended party.
• Honest discussion of practical or methodological problems
that could have affected the findings.

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 Essential Features . . .
9. Evaluation of the research undertaken - An HSR
project should not stop at finding answers to the
research questions posed, but include an assessment
of what decisions have been made based on the
results of the study. This is the ability of research
findings to influence policy, improve services and
contributes to the betterment of health.

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G. Purpose/importance or significance of Research
The broad significances of research are:
 Description
 Explanation
 Prediction
 Control or manipulation
Thus, researches are undertaken: to
validate & refine an existing knowledge,
generate new knowledge and
Technologies, and answer a certain
question or solve a problem.
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 Importance of Research…
• Description – discover new knowledge, describe existing
and clarify information for use
• Explanation – clarifying the relationship among
phenomena and variables
• Prediction – estimating the probability of an outcome in
a given situation
• Control – comes after prediction, control or manipulate
the situation to produce the desired outcome

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Importance of Research…
• Research is essential for development of scientific
knowledge that enables health care practitioners to
provide an evidence based health care.
• All together research expands evidence based practice
or scientific knowledge necessary for description,
explanation, predictions, and control of phenomenon
within a discipline (health).

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Summary of Research
Raw Facts and Figures
21 yrs 70kg man

Proportion
Information
Mean age or weight
prevalence

Knowledge
Dietary restriction improves aging

Science

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 Unit – 2
Research Proposal Writing
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March 2024
Contents
• Research Proposal Writing – 4hrs
• A research proposal, its formats, parts and why is it
needed
Questions
• What is a research proposal?
• Why is it needed?
• What is the format
• What are its parts?
• What does each part convey?

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A Research Proposal
• A research proposal is a document that presents
a plan for a project to reviewers for evaluation.
• Its purpose is to convince reviewers that you, the
researcher, are capable of successfully conducting
the proposed research project.
• It is similar to a research report, but is written
before the research project begins.

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 A Research Proposal
• A proposal has : a title, an abstract, a problem
statement, a literature review, a method or design
section, and a bibliography.
• A proposal describes the research problems and its
importance, and gives detailed account of the methods.
• It has: a plan for data collection and analysis, a
schedule of the steps to be undertaken, and
estimates of the time and budget
• It lacks result, discussion and conclusion sections.

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2. Proposal Development
Process

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Proposal Development Process/steps
A. Topic Identification and Selection
B. Formulate Statement of the problem
C. Review Literatures
D. Formulate Objectives
E. Determine/Choose Materials and Methods
• Describe study area and period
• Choose the type of Study design to be employed
• State Source population and Study population
• State Inclusion and exclusion criteria
• Decide Sampling methods to be used
• Determine Sample Size and Power
• State Variables of the study
• Give Operational definitions
• Determine Data collection methods and tools
• Ensure data quality
• Plan Data Processing and analysis techniques

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Proposal Development steps….

F. Describe Ethical considerations

G. Describe Limitations of the study
H. Give Work plan and Time
I. Propose Budget plan
J. Determine Referencing Styles

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A. Topic Identification and Selection
• Development of a research proposal is often
a cyclical process.
• It goes through a number of stages.
• If the answer to the research question is
obvious, it is a management problem that
may be solved without further research.

31
 Topic identification
 A Research Problem is an area of concern in which there
is a gap in the knowledge base needed for practice.
 How do we get the research topics? Observation during
clinical or public health practices, review of literatures
and reports, and from donors etc.
 Whether a question requires research depends on
three conditions:
1. There should be a perceived difference or discrepancy
between what it is and what it should be;
2. The reason(s) for this difference should be unclear,
and
3. There should be more than one possible and plausible
answer to the question (or solution to the problem).
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Example 1
Problem situation
• In district “ Y “ a report showed that in the first month
there were 500 children under one year old who
started immunization, but at the end of the year it
was found out that there were only 25 children who
completed their vaccination.
• Discrepancy: All the 500 children at district “ Y “
should have completed their vaccination but only 5%
out of those who started vaccination have completed.
• Problem (research) question: why only 5% of the
children completed their vaccination?

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Topic identification
• Definite answer: Out of the 1 hospital, 2 health centers
and 10 health posts found in district “Y” only 2 health
posts were functioning, the rest were closed due to
insecurity in the area.
• In the above example, assuming that all the given
information is true, there is no need of undertaking a
research, since a definite answer is obtained to the
problem situation.

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Example 2
Problem situation:
• In district “Z” (population 150,000) there are 2
health centers, 1 hospital and 15 health posts and
all of them function smoothly. However, at the
end of the year it was found that the EPI coverage
was only 25%.
• Discrepancy: Although district “Z ” had 100%
availability of health services and at least 80% of
the children should have had full vaccinations the
EPI coverage was only 25% as seen above.

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Example 2…
• Problem question: What factors influenced the low EPI
coverage in district “Z”?
Possible answers:
• Mothers might have problems for not attending in the EPI
sessions.
• The MCH, EPI, OPD, CDD, etc… programmes might not have
been integrated; hence children might have missed
opportunities in getting immunization.
• The follow up of defaulting children might not be effective and
other reasons.
Thus, the above problem situation is researchable.

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Topic selection:

Criteria for prioritizing problems for research

• Each problem that is proposed (identified) for
research has to be judged according to certain
guidelines or criteria.

• There may be several topics to choose from.

37
a) Criteria for selecting a research topic
1. Relevance: The topic you choose should be a priority
problem:
• How large or widespread is the problem?
• Who is affected?
• How severe is the problem?
• Is it the felt need of the community?
2. Avoidance of duplication: Investigate whether the
topic has been researched.
• If the topic has been researched, the results should be
reviewed to explore whether major questions that deserve
further investigation remain unanswered. If not, another
topic should be chosen.
3. Feasibility: Consider the complexity of the problem
and the resources you will require to carry out the
study.
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Criteria for selecting . . .
4. Political acceptability: It is advisable to research a
topic that has the interest and support of the
authorities. This will facilitate the smooth conduct of
the research and increases the chance that the
results of the study will be implemented.

5. Applicability of possible results and

recommendations: Is it likely that the
recommendations from the study will be applied?

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Criteria for selecting . . .
6. Urgency of data needed
• How urgently are the results needed for making a
decision? Which research should be done first and
which can be done late?
7. Ethical acceptability
• We should always consider the possibility that we may
inflict harm on others while carrying out research.
Therefore, it will be useful to review the proposed
study.

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b) Scales for rating research topics
• Relevance
1 = Not relevant
2 = Relevant
3 = very relevant
• Avoidance of duplication
1 = Sufficient information already available
2 = Some information available but major issues not covered
3 = No sound information available on which to base problem-solving
• Feasibility
1 = Study not feasible considering available resources
2 = Study feasible considering available resources
3 = Study very feasible considering available resources
• Political acceptability
1 = Topic not acceptable
2 = Topic somewhat acceptable
3 = Topic fully acceptable

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Scales for rating research topics
• Applicability
1 = No chance of recommendations being implemented
2 = Some chance of recommendations being implemented
3 = Good chance of recommendations being implemented
• Urgency
1 = Information not urgently needed
2 = Information could be used but a delay of some months would be
acceptable
3 = Data very urgently needed for decision-making
• Ethical acceptability
1 = Major ethical problems
2 = Minor ethical problems
3 = No ethical problems
 The above rating should be based on the existing data
and not on mere assumptions.

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Scales for rating research topics
Rating scale: 1 = low, 2 = medium, 3 = high
Criteria for Proposed topics
selecting a
Health problem I Health problem II Health problem III
research topic

Relevance
Avoidance of
duplication
Feasibility
Political
acceptability
Applicability
Urgency of data
needed
Ethical
acceptability
Sum 43
B. Analysis and Statement of the problem

• Was the problem adequately analyzed to include all

possible contributory factors?
• Was it clearly stated?

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Formulating the problem statement
• Key steps to problem analysis
1. Problem: is there a deviation from expectation?
2. Evidence: what is the proof that the problem is
real?
3. Impacts: why do we care?
4. Causes: what is deriving the problem
5. Recommendations: simple, just reverse the causes?

After identifying, selecting and analyzing the problem,

the next major section in a research proposal is
formulating “ statement of the problem”

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Why is it important to state and define the
problem well?
Because a clear statement of the problem:
 Is the foundation for further development of the
research proposal
 Makes it easier to find information and reports of
similar studies from which your own study design can
benefit;

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Information included in the statement of a problem
• A brief description of socioeconomic and cultural
characteristics and health status (optional).
• A more detailed description of the nature of the
problem
• basic description of the problem
• the discrepancy between what is and what it should be
• its size, distribution, and severity (who is affected, where,
since when)
• An analysis of the major factors that may influence the
problem
• A convincing argument that available knowledge is
insufficient to answer the question.
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Information included . . .
• A brief description of any solutions that have been
tried in the past, and why further research is needed.
• A description of the type of information expected to
result from the project and how this information will
be used to solve the problem
• If necessary, a short list of definitions of crucial
concepts used in the statement of the problem.

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Points for justifying the selected research problem
A health problem selected to be studied has to be justified in
terms of its:
• Being a current and existing problem which needs solution
(to fill in the information gap due to the absence of similar
studies in the given area)
• Being a widely spread problem affecting a target
population
• Effects on the health service programmes
• Being a problem which concerns the planners, policy
makers and the communities at large.
• Effects (research findings) to support decision-making at
different levels of the health delivery system.

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C. Literature Review
• The literature consists of all written sources (hard &
electronic) relevant to the topic one has selected.
• It Summarizes relevant sources and explains the
significance of that source to the research question.
Uses of literature review
 It prevents you from duplicating work that has been done
before.
 It increases your knowledge on the problem you want to
study and this may assist you in refining your "statement
of the problem".
 It gives you confidence why your particular research project
is needed.
 It gives the opportunity to be familiar with different
research methods
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Steps to writing an effective literature review:

• Gathering sources
• Evaluating sources (trusted VS grey literature)
• Synthesizing the literatures
• Writing the review
• Avoid repetitions and lengthy statements

51
Literature Review
Trusted Sources of information
• Published information (books, journals, etc.)
• Articles from national and international journals (e.g., The
EJHD, the BMJ, Nature, The Lancet, etc.)
• Computer based literature searches (E.g. MeSH Database
Indexed with PubMed)
• MeSH - medical sub-headings
• PubMed – medical publications
• Organizations (institutions)
• Clinic and hospital based data from routine activity
statistics

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Sources of information
• Local surveys, annual reports, Central Statistical Offices,
Internet
• Scientific conferences
• Statistics issued at region and district levels
• Unpublished documents (studies in related fields, reports,
etc.)
N:B Journals articles can be reputed if they are peer
reviewed and have high impact factor thus more trusted
sources of information.
There are grey literatures on Google or other websites
which are difficult to judge about. Some of them are
predatory journals which publish researches for making
money.
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Literature Review Techniques
References that are identified:
• Should first be read and skimmed

• Then summaries of the important information in each

of the references may be recorded on separate index
cards

• These should then be classified so that the information

can easily be retrieved

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Literature Review
• After collecting the required information on index
cards, the investigator should decide in which
order he/she wants to discuss previous research
findings:
• from global to local
• from broader to focused
• from past to current

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Literature review
• In conclusion, while reviewing a literature, all what is
known about the study topic should be summarized
with the relevant references.
This review should answer:
• How much is known?
• What is not known?
• What should be done based on what is lacking?

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Literature Review

• Appropriate referencing procedures should always be

followed in research proposals as well as in research
reports.
• While reviewing a literature give emphasis to both positive
and negative findings.
• Avoid any distortion of information to suit your own study
objectives.
• Avoid plagiarism

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D. Objectives
Objectives are clear, concise, declarative statements
that are expressed in the present tense.
• Objectives should be closely related to the statement of
the problem.
General and Specific Objectives:
 General objectives : aim of the study in general terms
 If we break down the general objective into smaller and
logically connected parts, then we get specific objectives.

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General and Specific Objectives
General objectives :
• In a study on missed opportunities for EPI in Addis
Ababa the general objective was:
“ to assess missed opportunities for EPI in Addis Ababa”.
Specific objectives:
• measurable statements on the specific questions to be
answered.
• Unlike the general objectives, the specific objectives
are more specific and are related to the research
problem situation.
• They indicate the variable to be examined and
measured.

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Specific objectives
Example:
• In the study of missed opportunity for EPI in Addis
Ababa the specific objectives could be:
 To find out the magnitude of missed opportunities for
children who attend OPD, MCH, CDD, etc. in Addis Ababa,
 To examine the reasons for children not being immunized
while attending the OPD, MCH, CDD, etc. services.

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Formulation of the research objectives
The formulation of objectives will help us to:
 Focus the study (narrowing it down to essentials)
 Avoid collection of data that are not strictly necessary for
understanding and solving the selected problem
 Organize the study in clearly defined parts
 The explicit formulation of study objectives is an essential
step in the planning of a study.

• It is said that “a question well-stated is a question half-

answered”, but a question that is poorly stated or unstated is
unlikely to be answered at all.

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How should we state our objectives?
We have to make sure that our objectives:
 Cover the different aspects of the problem and its
contributing factors in a coherent way and in a
logical sequence
 Are clearly expressed in measurable terms
 Are realistic considering local conditions
 Meet the purpose of the study
 Use action verbs that are specific enough to be
measured

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Examples of action verbs
• to determine
• to compare
• to verify
• to calculate
• to describe
• to find out
• to establish

63
Avoid the use of vague non-action verbs
such as;
• to appreciate
• to understand
• to study
• to believe
• to know

64
Too many specific objectives?
• One of the most important problems usually
observed among researchers (particularly
students) is the tendency of stating too
many study objectives which are not
appropriately addressed.
• It should be noted that it is on the bases of
these specific objectives that the methods,
results and discussion sections will be
presented.

65
Too many specific objectives?
• It is therefore advisable to limit the number of
specific objectives.
• In most practical situations, the number of specific
objectives should not exceed three.

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E. Materials and Methods
• Choose the type of Study design
• State Source population and Study population
• State Inclusion and exclusion criteria
• Determine Sample Size and Power
• Decide Sampling methods to be used
• State Variables of the study
• Give Operational definitions for variables
• Determine Data collection methods and tools
• Ensure Data quality
• Give Data Processing and analysis plan

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 E-1
Study Designs
Contents
 Study Designs
 Types of study designs
• Descriptive & analytic study designs
 Advantages and Limitations of study designs
Questions
• What are study designs? What are the different types
of study designs? What are the advantages and
limitations of each design?

69
Study Designs - Introduction
• Selection of a research strategy is the core of a
research design and is probably the single most
important decision the investigator has to make.

• A study may involve different study designs.

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 Classifications of Study Designs
Descriptive
Studies occurrence of problems or
diseases with respect to time, VS
place and person
Analytic
Test hypotheses on risk factors & uses a
comparison/control group

Longitudinal Cross sectional

Assessing problem over VS Studies exposure & outcome at
time a point in time

Observational Experimental
Study natural phenomena VS Investigator manipulation of treatment
or vaccine/procedure

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Selection of study design
 Depending on the existing state of knowledge about a
problem that is being studied, different types of
questions may be asked which require different study
designs.

The type of study design chosen depends on :

• The type of problem, purpose, type of exposure, or Diseases
• The knowledge already available about the problem
• Resources available for the study

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73
Epidemiological Research Designs
I. Descriptive studies
II. Analytical studies
Or
I. Observational studies
II. Experimental (Intervention) studies

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I. Descriptive Studies

75
Descriptive Studies
• Descriptive studies describe the occurrence
and distribution of problems or diseases
with respect to time, place and person.
• Descriptive studies allow the generation of
hypotheses, which can be tested by
analytical or experimental designs.

76
 Descriptive Studies
• A descriptive study assesses morbidity or mortality in a
population and the occurrence and distribution in
population groups by time, place and person.
• Rates, ratios and proportions are calculated as
measures of the probability of events.

77
Features of Descriptive Study
• Useful for health managers to allocate resource and to
plan effective prevention programmes.
• Useful to generate epidemiological hypothesis in the
search for disease risk factors.
• Not aimed specifically to test a hypothesis
• No attempt to gather data on controls
• Inexpensive and less time-consuming: can use
information collected routinely.
• Most common type of epidemiological study in the
medical literature.

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Types of Descriptive Studies
• Case Report
• Case Series
• Ecological Descriptive Studies
• Descriptive Cross-sectional Studies Or
Community (Population) Surveys

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 Case Report
• The case report is the type of descriptive study that gives
a detailed report of single patient.
• Example: In 1941 Gregs (An Australian Ophthalmologist)
reported a new syndrome of congenital cataract linked to
rubella in the mother during pregnancy. Clinical
observation such as this can give the first clues in the
identification of a new disease and the effect of an
exposure.

80
A Case Series
• A case series is a descriptive study that reports a series
of cases of a specific condition, or a series of treated
cases.
• Example: In the 1940s, Alton Ochenser, USA, observed
that virtually all of the patients on whom he was
operating for lung cancer gave a history of cigarette
smoking. Based on his case series observation he
hypothesized that cigarette smoking was linked with
lung cancer.
• In infectious disease epidemiology, a case series is often
used as an early means of identifying the presence of
epidemic.

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Descriptive Cross-sectional Surveys
• Descriptive cross-sectional studies entail the collection
of data on a cross-section of the population, which may
comprise the whole population or a proportion
(sample) of it.
• They provide a prevalence rate at a particular point in
time (point prevalence) or over a period of time (period
prevalence).

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Descriptive Cross-sectional Surveys
• The study population at risk is the denominator for
these prevalence rates.
• This design may also be used in health systems
research to describe ‘prevalence’ by certain
characteristics – pattern of health service utilization
and compliance – or in opinion surveys.
• A common procedure used in family planning and in
other services is the KAP survey (survey of
knowledge, attitudes and practice).

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 Advantages & disadvantages of cross sectional studies
Advantages
• They are relatively quick and
inexpensive.
• Often a good first step for a cohort
study.
• Provide prevalence information.
• Researcher has control over the
selection of study subjects.
• Researcher has control over the
measurements used.
• Can study several factors or
outcomes at one time.
• Often provides early clues for
hypothesis generation.
Disadvantages
• Does not allow the true temporal
sequence of exposure and outcome
to be ascertained, therefore unable
to shed light on cause and effect
associations.
• Potential bias in measuring
exposure.
• Potential sampling bias.
• Not feasible for rare conditions.
• Does not yield incidence or true
relative risk.
84
 Cross-sectional studies: example
ABSTRACT
Background: Commercial sex work is an occupation that makes its workers highly vulnerable to sexually
transmitted infections (STIs), including HIV especially, in border areas. Currently, there is lack of information
on unsafe sexual practice among cross-border commercial sex workers (CSWs).
Objective: to assess unsafe sexual practices and associated factors among cross-border CSWs in Mettema
Yohannis, northwest Ethiopia.
Method: A cross-sectional study triangulated with qualitative design was used. For the quantitative study,
data were collected from a systematically selected sample of 474 CSWs. Data were analyzed using the global
(sexual experiences in the last twelve months) and situational analyses (based on last sex). The
SPSS version 16.0 statistical software with multiple logistic regression was used for analyses. For the
qualitative component, seventeen in-depth interviews and four focus group discussions were carried out.
Result: The prevalence of unsafe sex during the last sexual intercourse, last seven days and last twelve
months, were 21.5%, 31.1%, 63.9%, respectively. Sex workers were more likely to practice unsafe sex with
Sudanese clients (OR=6.4, 95% CI: 3.20, 12.78) and truck drivers (OR = 4.89, 95%CI: 1.26, 18.90).
Familiarization with sexual clients was the strongest and consistently associated factor for unsafe sex both in
global and situational analyses: OR=16.76, 95%CI 8.24, 34.08 and OR=19.49, 95%CI 6.44, 58.98, respectively.
Mobile CSWs (OR =6.12 95%CI: 1.11, 33.64), working in rental houses (OR =3.72 95% CI 1.25, 11.02), duration
of exposure to sex work, educational level, monthly income and problem drinking were also significantly
associated with unsafe sex.
Conclusion: There was a high prevalence of unsafe sexual practice among cross border CSWs. It is
recommended that the Government of Ethiopia in collaboration with other organizations develop and launch
mobility friendly STI/HIV intervention programs to alleviate the vulnerability of CSWs in cross border areas.

85
Data analysis in cross-sectional studies
• Descriptive measures: rates and proportions
presented by person, place and time
• Association measures
• Odds ratio(OR)
• OR = odds of exposure among diseased/Odds of
exposure among non-diseased

86
Ecological Descriptive Studies
• When the unit of observation or analysis is an
aggregate (e.g. family, clan or school) or an ecological
unit (a village, town or country) the study becomes an
ecological descriptive study.
• Hypothesis testing is not generally an objective of the
descriptive study.
• Compare disease frequencies – among different groups
during the same period of time, or in the same
population at different points in time.

87
Ecological Study
• Does not provide individual data, rather presents
average exposure level in the community
• Correlation coefficient (r) is the measure of association
• Measures represent characteristics of the entire
population

88
Ecological Studies
• Exposure and risk factors are known only at the group
level
• Disease occurrence is at group level
• Ecologic studies are used to generate hypothesis

89
Properties of Ecological study
• Comparison of groups rather than individuals
• Missing individual information
• Low cost
• Interest in ecological effects

90
Ecological Fallacy
• Concluding that because an association
exists between exposure and disease at
the group level is therefore exits at the
individual level.
• We don’t know the link between exposure
and disease among individuals with in
each group

91
Advantages of Ecologic Studies
• Aggregate data on exposure and disease are often
publicly available
• Aggregate level data can conveniently be obtained by
researchers at a low cost
• Can be useful for evaluating the impact of community-
level interventions.
• Useful to study exposures with minimal differences
within community but differ substantially between
communities, cities, states, and countries.

92
Advantages of Ecologic Studies
 Examples of small within-community exposure
differences but large between-community differences
include:
• Quality of drinking water
• Concentration of certain air pollutants such as
ozone and fine particles
• Average fat content of diet
• Cumulative exposure to sunlight

93
Limitations of Ecological Studies
1. Inability to link exposure with outcome at
individual level.
2. Lack of ability to control potential confounders.
3. It represent average exposure levels rather
than actual values.
4. Mask non-linear relationship between exposure
and disease.
5. Ecological Fallacy

94
II. Analytical Studies
Analytical studies
• When the primary goal of a study is
establishing a relationship (association)
between a ‘risk factor’ (etiological agent)
and an outcome (disease), it is termed
analytical.

96
Analytical Studies
• Focus on identifying risk factors
• Always use comparison group
• Test hypotheses
• Relatively costly
• Less often used than descriptive studies

97
Types of Analytical studies
I. Observational Studies
II. Experimental studies

98
I. Observational Study Designs
• Observational study design is the more common
approach in public health for testing hypotheses.
• The investigator can only observe the occurrence of
disease in people who are already segregated into
groups on the basis of some exposure.
• In this kind of study, allocation into groups on the
basis of exposure to a factor is not under the control of
the investigator.

99
Types of Observational Studies
• Comparative cross-sectional studies
• Case-control Studies
• Cohort studies
• prospective and retrospective (historical)

100
Case-control Studies
• A case-control study is a type of analytic
study in which persons with a condition
("cases") and suitable comparison subjects
("controls") are identified, and then the two
groups are compared with respect to prior
exposure.
• subjects are sampled by their outcome
status.

101
Case-Control Studies
• Case-control studies are the most frequently
undertaken analytical epidemiological studies
• They are the only practical approach for
identifying risk factors for rare diseases
• They are best suited to the study of diseases
for which medical care is sought, such as
cancers

102
Case Control Study Design

Exposed
Diseased
(Cases)
Not Exposed
Target
Population
Exposed
Not Diseased
(Controls)
Not Exposed

103
Selecting Cases
• Select cases after the diagnostic criteria
and definition of the disease is clearly
established

• Study cases should be representative of

all cases

104
Selecting Cases (cont.)
• The study need not include all cases in
the population

• Cases may be located from hospitals,

clinics, disease registries, screenings,
etc.

105
Selecting Controls
• Controls should come from the same
population at risk for the disease as the
cases

• Controls should be representative of the

target population

106
Selecting Controls (cont.)
• Controls estimate the exposure rate to be
expected in cases if there were no
association between exposure and disease

• Multiple controls can be used to help add

statistical power when cases are unduly
difficult to obtain

107
Assessing Exposure
• Exposure is usually an estimate unless past
measurements are available
• It has to be assumed that the exposure
incurred at the time the disease process
began (this may not be valid)
• Exposure estimates are subject to recall
bias and interviewer bias

108
Odds Ratio (OR)
• A ratio that measures the odds of exposure for cases
compared to controls

• Odds of exposure = number exposed  number

unexposed

• OR Numerator: Odds of exposure for cases

• OR Denominator: Odds of exposure for controls

109
Calculating the Odds Ratio

Disease Status
CHD cases No CHD
(Cases) (Controls)
Exposure Smoker 112 176
Status Non- 88 224
smoker
Total 200 400
AD 112 x 224
Odds Ratio = = = 1.62
BC 176 x 88
Interpreting the Odds Ratio

The odds of exposure for cases are 1.62

times the odds of exposure for controls.
Interpreting the Odds Ratio
Those with CHD are 1.62 times more likely to be
smokers than those without CHD

or
Those with CHD are 62% more likely to be
smokers than those without CHD
Possible Sources of Bias and Error
• Information on the potential risk factor (exposure)
may not be available either from records or the
study subjects’ memories
• Information on potentially important confounding
variables may not be available either from records
or the study subjects’ memories
• Cases may search for a cause for their disease and
thereby be more likely to report an exposure than
controls (recall bias)

113
Advantages of Case-Control Studies
• Quick and easy to complete, cost effective

• Most efficient design for rare diseases

• Usually requires a smaller study population

than a cohort study

114
 Disadvantages of Case-Control Studies

• Uncertainty of exposure-disease time relationship

• Inability to provide a direct estimate of risk

• Not efficient for studying rare exposures

• Subject to biases (recall & selection bias)

115
Cohort study design
• A cohort study is an observational research design
which begins when a group of people (a cohort)
initially free of disease (outcome of interest), are
classified according to a given exposure, and then
followed up over time.
• The researcher compares whether the subsequent
development of any new cases of a disease (or other
outcome of interest) differs between the exposed and
non-exposed groups.

116
117
Types of cohort studies
• There are basically two types of cohort studies:
1. Prospective and
2. Retrospective (historical).
• The difference between the two lies in where the
starting point of the study is deemed to begin.
• In a prospective cohort study the starting point of
observation (time zero) is ‘now’, and the population
is followed into the future.

118
Types of cohort studies
• The exposure of interest may or may not have
occurred when the study was initiated, but the
outcome has not.
• In a retrospective the ‘starting point’, that is the point
of initial exposure occurred some time in the past and
the experience of the population is followed up to the
present time. At the time the study is initiated, both
the exposure and outcome have occurred.

119
Advantages and Disadvantages of
Cohort Studies

120
Advantages
• Relative risk can be calculated.
• Allows concluding a cause-effect relationship.
• No chance of bias being introduced due to awareness
of being sick as in encountered in case-control studies.
• Less chance for the problem of selective survival or
selective recall

121
Advantages
• Cohort studies are capable of identifying other diseases
that may be related to the same risk factor.
• Allows estimating attributable risks, thus indicating
the absolute magnitude of disease attributable to the
risk factor.
• If a probability sample is taken from the reference
population, it is possible to generalize from the sample
to the reference population

122
 Disadvantages
• Cohort studies are long-term and are thus not always
feasible; they are relatively inefficient for studying rare
conditions.
• Costly in time, personnel, space and patient follow-up.
• Sample sizes required are large, especially for infrequent
conditions.
• Attrition or loss of people from the sample or control
during the study is the major problem. The higher the
proportion lost (say beyond 10- 15%) the more serious
the potential bias.

123
Disadvantages
• There may also be attrition among investigators.
• Over a long period, many changes may occur in the environment,
among individuals or in the type of intervention, and these may
confuse the issue of association and attributable risk.
• Over a long period, study procedures may influence the behavior
of the persons investigated in such a way that the development
of the disease may be influenced accordingly (Hawthorne
effect).
• A serious ethical problem may arise when it becomes apparent
that the exposed population is manifesting significant disease
excess before the follow-up period is completed.

124
 Example of Cohort study design
Alcohol consumption and mortality from all causes, coronary heart disease, and stroke: results from a prospective cohort
study of Scottish men with 21 years of follow up
Carole L Hart, George Davey Smith, David J Hole, Victor M Hawthorne
Abstract
Objectives: To relate alcohol consumption to mortality.
Design: Prospective cohort study.
Setting: 27 workplaces in the west of Scotland.
Participants: 5766 men aged 3564 when screened in 19703 who answered questions on
their usual weekly alcohol consumption.
Main outcome measures: Mortality from all causes, coronary heart disease, stroke, and
alcohol related causes over 21 years of follow up related to units of alcohol consumed per
week.
Results: Risk for all cause mortality was similar for nondrinkers and men drinking up to 14
units a week. Mortality risk then showed a graded association with alcohol consumption
(relative rate compared with nondrinkers 1.34 (95% confidence interval 1.14 to 1.58) for
1521 units a week, 1.49 (1.27 to 1.75) for 2234 units, 1.74 (1.47 to 2.06) for 35 or more
units). Adjustment for risk factors attenuated the increased relative risks, but they remained
significantly above 1 for men drinking 22 or more units a week. There was no strong relation
between alcohol consumption and mortality from coronary heart disease after adjustment.
A strong positive relation was seen between alcohol consumption and risk of mortality from
stroke, with men drinking 35 or more units having double the risk of nondrinkers, even after
adjustment.
Conclusions The overall association between alcohol consumption and mortality is
unfavorable for men drinking over 22 units a week, and there is no clear evidence of any
protective effect for men drinking less than this.
125
 II. Experimental (Intervention) Design
• The experimental study, or clinical trial, is an
epidemiologic design that can provide data of high
quality.
• As in a cohort study, individuals are enrolled on the
basis of their exposure status: investigators themselves
allocate the exposure.
• Experiment is often neither feasible nor ethical to subject
human beings to risk factors in etiological studies thus
are not commonly done.

126
Experimental Studies
• The experimental study is the best epidemiological
study design to prove causation.
• It can be viewed as the final or definitive step in the
research process.
• The investigator has control of the subjects, the
intervention, outcome measurements, and sets the
conditions under which the experiment is conducted.
• Investigator determines who will be exposed to the
intervention and who will not.

127
Experimental Studies
• In comparative experiment one or more groups with
specific interventions is compared with a group
unexposed to interventions (clinical trials) or exposed
to the best treatment currently available.
• The effect of the new interventions on one or more
outcome variables is compared between the groups by
the use of statistical procedures.

128
The randomized clinical trial (RCT)

• The most commonly encountered experiment in health

science research, and the research strategy by which
evidence of effectiveness is measured, is the
randomized, controlled, double blind clinical trial,
commonly known as the RCT.

129
The randomized clinical trial (RCT)
• Clinical trials may be done for various purposes. Some
of the common types of clinical trials (according to
purpose) are:
a) Prophylactic trials, E.g. Immunization, contraception;
b) Therapeutic trials, E.g. Drug treatment, surgical
procedure;
c) Safety trials, E.g. Side effects of oral contraceptives and
injectables;
d) Risk-factor trials, E.g. Proving the etiology of a disease by
inducing it with the putative agent in animals, or
withdrawing the agent (E.g. Smoking) through cessation.

130
Community intervention trials (CITs)
• The major difference between Randomized Clinical
Trials and Community Intervention Trials is that the
randomization is done on communities rather than
individuals.
• Example: Testing a vaccine.
• Some communities will be randomly assigned to
receive the vaccine, while other communities will
either not be vaccinated, or will be vaccinated with a
placebo.

131
 Example of a Randomized Clinical Trial
Clinical efficacy of three common treatments in acute otitis externa in primary care: randomized
controlled trial.
Frank A M van Balen,W Martijn Smit, Nicolaas P A Zuithoff, Theo J M Verheij
Abstract
Objective: To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic
acid, and steroid and antibiotic in acute otitis externa in primary care.
Design: Randomised controlled trial.
Setting: 79 general practices, Netherlands.
Participants: 213 adults with acute otitis externa.
Main outcome measures: Primary outcome: duration of symptoms (days) according to patient diaries.
Secondary outcome: cure rate according to general practitioner completed questionnaires and
recurrence of symptoms between days 21 and 42.
Results: Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic
acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the
steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%,
respectively.
Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic
acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7,
respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively).
Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen
significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group
(0.4, 0.2 to 1.0) than in the acetic acid group.
Conclusions: Ear drops containing corticosteroids are more effective than acetic acid ear drops in the
treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear
drops are equally effective.

132
 Advantages of the experimental approach
• The ability to manipulate or assign the exposure.
• Ability to randomize subjects to experimental and
control groups.
• The ability to control confounding and eliminate sources
of spurious association.
• The ability to ensure temporality.
• The ability to replicate findings.

133
Disadvantages
• Lack of reality. In most human situations, it is impossible to
randomize all risk factors except those under examination.
• Difficulties in extrapolation.
• Ethical problems. In human experimentation, people are
either deliberately exposed to risk factors (in etiological
studies) or treatment is deliberately withheld from cases
(intervention trials).
• Difficulties in manipulating the independent variable.
• Non-representativeness of samples. Many experiments are
carried out on captive populations or volunteers, who are
not necessarily representative of the population at large.
• Experiments in hospitals (where the experimental approach
is most feasible and is frequently used) suffer from several
sources of selection bias.
134
 E-2
Sampling & Sample Size
Determination
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March 2024
Sampling - Definition:

• Sampling is a process by which some

objects or elements or events or persons
from a population are selected for study
and inferences are made about the
population.

136
 Need for Sampling:
• Study of entire population is difficult for large
populations. Study of entire population even if possible,
in certain cases, may be: time consuming, costly and not
feasible
• If sampling is done properly, accurate estimates and
inferences about population can be made.
• Sampling offers better opportunities for supervision.
• The data so obtained is likely to be more accurate than
that obtained by examining the entire population.

137
Sampling Methods or Types

There are two broad types of sampling:

1. Non-probability (non-random) sampling
2. Probability (random) sampling

138
1. Non-probability sampling
• Units or members have an unknown chance of being
included into a sample.
• Selection is non-random
• Inappropriate to generalize findings from the sample
to the population.
• Such non-probability sampling techniques includes:
a. Convenience sampling
b. Quota sampling

139
 a. Convenience Sampling
• Selection of study units that happen to be
available at the time of data collection.
• For convenience sake
• The sample so obtained is not
representative of the entire population.

140
 b. Quota sampling
• Certain number of sample units from different
categories with specific characteristics are
represented
• The investigator collect as many data in each category
of study unit as he can find until he has filled his
quota.
• As in the case of convenience sampling, the sample
obtained by quota sampling is also unrepresentative
of the entire population.

141
2. Probability Sampling Method

• A statistically designed method.

• Gives each member of a population a known
non-zero chance of being selected.
• Involves random selection.
• Results can be generalized

142
Probability Sampling Method . . .
Probability sampling method includes:
1. Simple random sampling
2. Systematic random sampling
3. Stratified random sampling
4. Cluster sampling
5. Multi-stage sampling

143
 1. Simple Random Sampling (SRS)
• The most basic method of random sampling
• Each unit in the sampling frame has an equal
chance of being selected thus
representativeness of the sample is ensured.
• However, it is costly to conduct SRS.
• Moreover, minority subgroups of interest in the
population my not be present in the sample in
sufficient numbers for study.

144
 Simple Random Sampling (SRS) ….
To select a simple random sample:
1. Make a numbered list of all the units in a
population from which you want to draw the
sample.
2. Each unit in the list should be numbered in
sequence from 1 to N (where N is the size of the
population).
3. Decide on the size of the sample.
4. Select the required sample size using:
• Lottery method, or
• Table of random numbers
• Scientific calculator or Computers
145
 2. Systematic Random Sampling
• Individuals are selected at regular intervals (for
example, every Kth) from the sampling frame.
• The first unit to be selected is taken at random from
among the first K units.
• K is the sampling interval and is determined by dividing
the total population N by the required sample n. K = N/n
• Example, a systematic sample is to be selected from
1200 students of a school. The sample size is decided to
be 100. The sampling fraction is: 1200 /100 = 12.
• K is 12

146
 Systematic Sampling ….
Merits
• Systematic sampling is usually less time consuming and
easier to perform than simple random sampling. It
provides a good approximation to SRS.
• Unlike SRS, systematic sampling can be conducted
without a sampling frame (useful in some situations
where a sampling frame is not readily available).
E.g. In patients attending a health center, where
it is not possible to predict in advance who will
be attending.

147
Systematic Sampling ….
Demerits
• If there is any sort of cyclic pattern in the ordering of
the subjects which coincides with the sampling interval,
the sample will not be representative of the population.
• Example:- list of married couples arranged with men's
names alternatively with the women's names will result
in a sample of all men or women.

148
3. Stratified Random Sampling
• Appropriate when the distribution of the characteristic
to be studied is strongly affected by certain variable
(heterogeneous population).
• Appropriate to ensure representation of minority
groups
• First stratify the whole population into groups (strata)
by the characteristic of interest (e.g. sex, geographical
area, prevalence of disease, etc)

149
 Stratified Random Sampling
• A separate sample is taken independently from each
stratum, by simple random or systematic sampling.
• The contribution of each stratum to the sample size is
propositional to the contribution of each stratum to the
total population.
• Proportional allocation - if the same sampling fraction
is used for each stratum.
• Non- proportional allocation - if a different sampling
fraction is used for each stratum or if the strata are
unequal in size and a fixed number of units is selected
from each stratum.

150
Stratified Random Sampling

151
Stratified Sampling:
Merit
• The representativeness of the sample is improved.
• Adequate representation of minority subgroups of
interest can be ensured by stratification and by varying
the sampling fraction between strata as required.
Demerit
• sampling frame for the entire population has to be
prepared separately for each stratum.

152
 4. Cluster Sampling
• The selection of groups of study units (clusters) instead
of the selection of study units individually
• The sampling unit is a cluster and the sampling frame is
a list of clusters.
• It is based on the assumption that the characteristic to
be studied is uniformly distributed throughout the
reference population, which may not always be the case.

153
Cluster Sampling …
Procedure
• The population of interest is divided into a number of
relatively small sub-divisions or clusters (e.g. districts,
villages, institutions, cities etc.).
• Clusters are randomly selected
• All the units in the selected clusters are studied
N:B It is preferable to select a large number of small
clusters rather than a small number of large clusters.

154
 Cluster Sampling …
Merit
• A list of all the individual study units in the reference
population is not required. It is sufficient to have a list
of clusters.
Demerit
• It is based on the assumption that the characteristic to
be studied is uniformly distributed throughout the
reference population, which may not always be the
case.

155
5. Multi-Stage Sampling
• This method is appropriate when the reference
population is large and widely scattered.
Zone 
Woreda 
 Kebele 
 Household
• Selection is done in stages until the final sampling unit
(e.g., households or persons) are arrived at.
• The primary sampling unit (PSU) is the sampling unit
(usually large size) in the first sampling stage.
• The secondary sampling unit (SSU) is the sampling
unit in the second sampling stage. etc.
• Example - The PSUs could be kebeles and the SSUs
could be households.

156
Multi-Stage Sampling…
Merit - Cuts the cost of preparing sampling frame
Demerit - Sampling error is increased compared with a
simple random sample.
• Multistage sampling gives less precise estimates than
simple random sampling for the same sample size, but
the reduction in cost usually far outweighs this, and
allows for a larger sample size.
• That is, a design effect need to be considered.

157
Errors in Sampling
• When we take a sample, our results will not exactly
equal the correct results for the whole population. That
is, our results will be subject to errors. This error has
two components.
• Sampling error (i.e., random error)
• Non Sampling error (i.e., bias)
• What are the errors to be confronted with when
taking a random sample?

158
 1. Sampling Error (Random Error)
• A sample is a subset of a population. Because of this
characteristic of samples, results obtained from them
cannot reflect the full range of variation found in the
larger group (population). This type of error, arising
from the sampling process it self, is called sampling
error, which is a form of random error.
• Random error consists of random deviations from the
true value, which can occur in any direction.
• Sampling error can be minimized by increasing the size
of the sample.
• When the sample size (n) equals the size of the target
population (N), sampling error equals zero.
159
 2. Non-Sampling Error (Bias)
• Bias consists of systematic deviations from the true
value, always in the same direction

• There are several possible sources of bias in sampling

(resulting from incompleteness of the sampling frame) :
• Accessibility bias,
• Volunteer bias,
• Recall bias,
• Information bias,
• self-reporting bias, non-response bias etc.
• It is possible to eliminate or reduce the non-sampling error (bias) by
careful design of the sampling procedure and by taking care of the
errors that may arise during data collection and analysis and not by
increasing the sample size.

160
 Non-Sampling Error (Bias)
• The best- known source of bias is NON-RESPONSE BIAS.
• Non-response bias refers to failure to obtain information on
some of the subjects included in the sample to be studied
• Non-response should be kept to a minimum. E.g. below 15%
of the sample
• There are several ways to deal with this problem and reduce
the possibility of bias:
• Data collection tools (questionnaires) have to be pre-
tested.
• If non-response is due to absence of subjects repeated
attempts.
• Including contingency for non-response.
161
 Conclusion
• Bias, like chance (random error) and confounding,
should always be considered as a possible alternative
explanation of any observed statistical association,
whether positive, inverse or null.
• Unlike chance and confounding, which can be taken into
account in the analysis through the use of appropriate
statistical techniques, bias is most effectively dealt with
through careful design and meticulous conduct of a
study.

162
Sample Size Determination
 Sample Size Determination
 How many people do we need in our sample?
 In planning any investigation we must decide how many
people need to be studied in order to answer the study
objectives.

 If the study is too small we may fail to detect important

effects, or may estimate effects too imprecisely. If the
study is too large then we will waste resources.

 In general, it is much better to increase the accuracy of

data collection (by improving the training of data
collectors and data collection tools) than to increase the
sample size after a certain point.

164
Sample Size Determination
The eventual sample size is usually a
compromise between what is desirable and
what is feasible.
The feasible sample size is determined by the
availability of resources.
It is also important to remember that resources
are not only needed to collect the information,
but also to analyze it.

165
 Sample Size Determination
• In order to calculate the required sample size, one has
to know the following facts:
• The reasonable estimate of the key proportion to be
studied. If you cannot guess the proportion, take it as
50%.

• The degree of accuracy required. That is, the allowed

deviation from the true proportion in the population as a
whole. It can be within 1% to 5%, etc.
• The confidence level required, usually specified as 95%.

166
 Facts in sample size calculation . . .
• The size of the population that the sample is to
represent. If it is more than 10,000 the precise
magnitude is not likely to be very important; but if the
population is less than 10,000 then a smaller sample
size may be required.

• The difference between the two sub-groups and the

value of the likelihood or the power that helps in
finding a statistically significant difference.

167
 Estimating a proportion in cross-sectional studies
• the minimum sample size required, for a very large
population (N>10,000) is:
n = Z2. p(1-p) / w2
Example 1
A. p = 0.26 , w = 0.03 , Z = 1.96 ( i.e., for a 95% C.I.)
n = (1.96)² (.26 × .74) / (.03)2 = 821.25 ~ 822
• Thus , the study should include at least 822 subjects.

168
Estimating a Proportion
B. If the above sample is to be taken from a relatively
small population (say N = 3000), the required
minimum sample will be obtained from the above
estimate by making some adjustment
nf = no/1+(no/N)
= 821.25 / (1+ (821.25/3000)) = 644.7
= 645 subjects

169
 Estimating a proportion - Example 2
• A hospital administrator wishes to know what
proportion of discharged patients are unhappy with the
care received during hospitalization . If 95% Confidence
interval is desired to estimate the proportion within 5%,
how large a sample should be drawn?
n = Z2. p(1-p) / w2 =(1.96)2(.5 ×.5)/(.05)2 =384.2 ~ 385 patients

• NB: If you don’t have any information about P, take it

as 50% and get the maximum value of PQ which is 1/4
(i.e., 25%).

170
 Estimating a mean
• The same approach is used but with SE = δ/n
• The required (minimum) sample size for a very large
population is given by :
n = Z2.δ 2 / w2
• Example – 3. A health officer wishes to estimate the mean
serum cholesterol in a population of men. From previous
similar studies a standard deviation of 40 mg/100ml was
reported. If he is willing to tolerate a marginal error of up to
5 mg/100ml in his estimate, how many subjects should be
included in his study ? (α=5%, two sided)
a) If the population size is assumed to be very large, the
required sample size would be:
n = (1.96)2 (40)2 / (5)2 = 245.86 ~ 246 persons

171
Comparing two proportions (cohort, Cross-sectional)
n (in each region) = f(α,β) (p1q1 + p0 q0 ) / (p1 - p0 )²
n = (Zα +Zβ)² . (p1q1 + p0 q0 ) / (p1 - p0 )²
α = type I error (level of significance)
β = type II error ( 1- β = power of the study)
Power = the probability of getting a significant result
f (α, β) =10.5, when the power = 90% and the level of
significance = 5%
P1 = expected rate of disease in the exposed group
P0 = expected rate of disease in the non-exposed
group
172
 Sample Size calculation

• Example – 4. The proportion of nurses leaving the health

service is compared between two regions. In one region
30% of nurses is estimated to leave the service within 3
years of graduation. In other region it is probably 15%.

173
Solution
• The required sample to show, with a 90% likelihood
(power), that the percentage of nurses is different in
these two regions would be: (assume a confidence
level of 95%)
n each = (1.28+1.96)2 ((.3x.7) +(.15 x.85)) / (.30 - .15)2 = 158
• If 10% is added for non-response and other
contingencies,
n each = 158 + 16 = 174
• Therefore, 174 nurses are required in each region.

174
Comparing Exposure frequency in Case-Control Studies
n (in each region) = f(α,β) (p1q1 + p0 q0 ) / (p1 - p0 )²
α = type I error (level of significance)
β = type II error ( 1- β = power of the study)
Power = the probability of getting a significant
result
P1 = expected proportion of the exposure in the
diseased group
P0 = expected proportion of the exposure in the
non- diseased group

175
Comparing Mean between Groups

• In cross-sectional or experimental studies

n = 2(SD)2 x (Z1-α/2 + Zβ)² / (mean1 – mean2 )²

Where:
SD = expected standard deviation of the
measure in the population

176
E-3 Variables - Definitions:
• A variable is a characteristic of a person, object,
or phenomenon that can take on different values.
• Because in the health research we often look for
associations, it is important to make a distinction
between dependent and independent variables.
Both the dependent and independent variables
together with their operational definitions (when
necessary) should be stated.

177
Variables - Definitions:
• The variable that is used to describe or measure the
problem under study is called the dependent variable.
• The variables that are used to describe or measure the
factors that are assumed to influence the problem are
called independent variables.
• Background variables (characteristics) - In almost
every study involving human subjects, background
variables, such as, age, sex, educational status,
monthly family income, marital status and religion will
be included.

178
Dependent and Independent Variables
• For example, in a study of relationship between
smoking and lung cancer, "suffering from lung cancer"
(with the values yes, no) would be the dependent
variable and smoking , age, Sex would be the
independent variable.
Dependent variable: Suffering from lung cancer (yes/no)
• Yes = 1
• No = 0
Independent variables:
• Age (years)
• Sex (M=1, F=2)
• Smoking (no=0, less than a packet/day = 1, one to two
packets/day = 2 , more than two packets/day = 3)
179
Operational Definitions of Variables

• Note that the different values of many of the

variables can easily be determined.
• However, for some variables it is sometimes not
possible to find meaningful categories unless the
variables are made operational with precise
indicators.
• Operationally defining variables means that you
make them measurable.

180
Operational Definitions of Variables
• The researcher may need to review the literature to find
out what definitions have been used by other
researchers, so that he can standardize his definitions
and thus be able later to easily compare his findings
with those of the other studies.
• The variables to be studied are selected on the basis of
their relevance to the objectives of the investigation.
• The initial list is usually too long. It has to be pruned
to facilitate the collection and processing of the data.

181
Operational Definitions of Variables
• Once the variables are selected, each of them should
be clarified. There are two aspects to be considered.
• Clear definition of variables in terms of
objectively measurable facts i.e., operational
definition
• The scale of measurement to be used in data
collection.
• Unless the variables are clearly and explicitly defined,
there can be no assurance that, if the study is
performed by a different investigator, or repeated by
the same investigator, similar findings would be
obtained.

182
 E-4
Types of Data & Methods of
Data Collection
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March 2024
Types of Data
What are data?
• Data are raw facts and figures.
• Statistical data are results of measurements
or observations of any statistical study on
what are called variables.
• A variable is a characteristic or an attribute
of a person, an object, etc.

184
Data Types & Nature

What are the types of data?

• Quantitative VS Qualitative data
• Primary VS Secondary data
• Numerical VS Categorical (Quantitative)

185
Primary and Secondary data

• Primary data is directly obtained from the

respondents or from the collecting
organization like CSA
• Secondary data: are obtained from the
secondary sources including various
organizations, books, reports, journals etc.

186
Quantitative Data
• Quantitative data are mainly of two types: Categorical
and Numerical data
• Quantitative data are also classified as numerical
discrete and numerical continuous data.
• Numerical discrete data occur when the observations
are integers that correspond with a count of some sort.
• Examples : Family size, the number of heart beats
within a specified time interval , parity and gravidity
(a mother’s history of number of births and
pregnancies), etc.

187
 Numerical Continuous data
• The scale with the greatest degree of quantification.
• Each observation theoretically lies along a continuum.
• One is not restricted in principle to particular values
such as the integers of the discrete scale. The restricting
factor is the degree of accuracy of the measuring
instrument.
• Most clinical measurements, such as blood pressure,
serum cholesterol level, weight, height, age.

188
Qualitative Data

• Qualitative data are summary of

respondents own words, ideas,
opinions, views, beliefs,
• Are recorded in tapes, written on note
books.

189
Data Collection Activities

• Data Collection tools preparation and testing

• Interviewers training
• Actual data collection

190
Methods of Data Collection

• Depending on the type of variable and the objective

of the study, different data collection methods can be
employed.
• Data collection techniques allow us to systematically
collect data from people, objects, phenomenon and
about the setting in which they occur.

191
Data Collection Techniques
• In the collection of data, we have to be systematic.
• If data are collected haphazardly, it will be difficult to
answer our research questions in a conclusive way.
• Data collection methods are classified as primary
method and secondary method.

192
Choice of Data Collection Method depends on
• Objective of the study
• Variables of the study and nature of data
• Design of the study
• Educational background of respondents
• Place of data or location
• Time available for data collection
• Infrastructure availability
• Degree of accuracy
• Topic sensitivity
193
 Methods of Data Collection
1. The primary method constitutes obtaining data by
any of the following ways:
a) Observing (measurement using instruments or behavior)
b) Interviewing (Face-to-face, Telephone)
c) Administering written questionnaires (self-administered
interviews, Postal or mail)

d) Focus group discussions

• The data obtained by the above techniques are called
primary data.

194
 Data Collection Data Collection Tools
Techniques
Using available information Checklist; data compilation forms

Observing Eyes and other senses; pen, paper;

watch; scales; microscope,
machines, etc
Interviewing Interview schedule; checklist;
questionnaire; tape recorder

Administering written Questionnaire

questionnaires

Focus group discussions FGD guide, Tape recorder, video

195
Methods of Data Collection
2. Secondary method is a method by which we obtain
data from the records of institutions or health
facilities that are collected as part of their routine
duties.
a) Using available information (record review)

196
Secondary Data
• Analysis of the information routinely collected by
health facilities/other institutes for a defined purpose
usually not for this research.
• Use of key informants is an important technique to
gain access to available information.
• Other sources of available data – newspapers,
published case histories,… etc.
• Medical records
• Vital records (birth, death)

197
Advantages of Secondary Data

• Cheaper and available quickly

• Usually available for long time periods,
therefore useful in time series analyses
• Often can be used to target primary data
collection
• The only source of data for past events

198
Disadvantages of Secondary Data
• Available data are rarely perfect for your research
needs
• Reliability and validity problems may be present
• Risk of breach of confidentiality exists
• Record quality is inconsistent, often impossible to read
• Information not uniformly reported
• Difficult to retrieve compared to automated records

199
 A. Observation
• Observation is a technique that involves systematically
selecting, watching and recording behavior and
characteristics of living beings, objects or phenomena.
• Observation of measuring instruments
• Observation of behavior can be:
• Participant observation
• Non-participant observation

200
Observation
• Gives more accurate information
• Checks on the information collected through
interviews.
• As they are time consuming, they are most often used
in small scale studies
• Can also be made on objects
E.g.- the presence or absence of latrines and the state
of cleanliness may be observed

201
Administering Interviews
Interviewer-administered
• By telephone
• In person (Face – to-Face interview)
• Ideal Length - 20–30 minutes
Self-administered
• Individually
• In groups
• By mail
• Internet or email
• Ideal Length - 15–20minutes
Combinations of Techniques
• Self-administered with interviewer instructions
• Mail with telephone follow-up

202
Interviewer Administered
• Oral questioning of respondents, either
individually or as a group.
• Answers can be recorded by writing them
down or by tape-recording the responses,
or a combination of them.

203
Interviewer administered
A. High degree of flexibility (unstructured)
• Usually used when studying sensitive issues or when
the researcher has little understanding of the
problem
• Is frequently applied in exploratory studies
• The sequence of topics should be determined by the
flow of discussion

204
Interviewer administered
B. Low degree of flexibility (Structured)
• Useful when the researcher is relatively
knowledgeable about expected answers or When the
number of respondents being interviewed is relatively
large.
• Questionnaires may be used with a fixed list of
questions in a standard sequence, which have mainly
fixed or pre-categorized answers

205
Interviewer administered
• A questionnaire is always used
• Produces high response rate
• Can be used for illiterate people
• Allows clarification of questions
• Produce less honest response compared with self
administered questionnaires
• Prone to interviewer and social desirability biases

206
Self-administered Questionnaire
• Gathering all or part of the respondents in one place at
one time and administering questionnaire
• Sending questionnaires by mail
• Hand-delivering questionnaires to respondents and
collecting them later

207
Self administered….
• Less costly compared with interviewing technique
• Can be used for large sample size with ease
• Useful when issue is sensitive
• Yields less response rate due to incompleteness
• Respondents must be literate

208
Focus group discussions (FGDs)
• FGDs allow a group of informants to freely
discuss a certain subject with the guidance of
a facilitator or reporter.
• Group discussion of 8-12 persons guided by a
facilitator.
• The group members talk freely and
spontaneously about a certain topic.
• The purpose of an FGD is to obtain in-depth
information on concepts, perceptions, and
ideas of the group.

209
Conducting a FGD
• Participants should have a similar (homogeneous)
background in relation to the issue studied
• Free communication and interaction should be
encouraged.
• Discussion guide - a written list of topics to be
covered, formulated as a series of open-ended
questions.
• One should act as a "facilitator" for the focus group
and one as a "recorder” or note maker.

210
Bias in Data Collection

• BIAS in information collection is a distortion,

which results in the information not being
representative of the true situation.

211
Possible Sources of Bias in Data Collection
1. Defective instruments
• Fixed or closed questions on topics about which too little is
known;
• weighing scales which are not standardized.
2. Observer bias
• Problems on watching out and recording
3. Selection bias
• Recruitment problems (volunteers)
4. Social desirability bias
5. Effect of interviewer on informant

212
Data Quality Assurance
• Standardization of instruments
• Training of data collectors
• Good preparation, pre-testing the
questionnaire
• Supervision
• Use of different sources for comparison
• Calibration of measuring instruments
• Automation of measurements

213
 E-5
Developing Data Collection
Tools
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March 2024
 Developing Data Collection Tools
• Questionnaires are frequently used as instruments for
recording of data or information (data collection) in
epidemiological studies.
• A QUESTIONNAIRE contains different forms of
questions, personal characteristics (subject
identification, reference code or number, data collector
identification & Signature, date, time & place), and
other relevant information such as title & purpose of the
study, consent form, instructions,, and a THANK YOU!
statement for the respondent at the last line of last
page.
Developing Data Collection Tools

• Questions may take two general forms: they may be

“open ended” questions, which the subject answers in
his own words or “closed ended” questions, which are
answered by choosing from a number of fixed
alternative responses.
Types of Questionnaires & Questions
• Structured Questionnaires: contains close-ended questions with
fixed response categories.
• A checklist is a type of structured questionnaire that is used to
collect measurement and observation data.
Example
1. Have you ever conducted a research as a principal
investigator?
a) Yes
b) No (Never)
c) I don’t remember/ No answer/ Don’t Know
2. If the answer for Q1 above is “yes” which type of research
design/s you have employed?
a) Descriptive cross-sectional
b) Comparative cross-sectional
c) Case-control
d) Prospective Cohort
e) Retrospective cohort
f) Randomized clinical trials
g) If other …….. Specify __________________
Types of Questionnaires & Questions
• Semi-structured Questionnaires: contains close-
ended questions with fixed response categories and
few open-ended questions
Example
1. Do you like to do research?
a) Yes
b) No
c) No answer
2. If answer is ‘No’ for Q1 above would you explain the
reasons why don’t like to do research?
___________________________________________
___________________________________________
___________________________________________
Types of Questionnaires & Questions
• Unstructured Questionnaires or interview or discussion
guides: contains few open ended-questions. They are
used in qualitative research design.
Example
1. Would you explain to me your concerns about quality of
education nowadays?
_______________________________________
_______________________________________
_______________________________________
2. Tell me more how you compare the current situation
with previous?
_______________________________________
_______________________________________
_______________________________________
Use and Design of a Questionnaire
• Good design is essential to gather accurate and
reliable information.
• The aim is to obtain information in a systematic
manner in accordance with pre-determined and
standardized criteria and methods. This allows valid
comparisons to be made between the attributes of
different groups of study subjects.
• It is always important that questions are precise and
unambiguous, and clear instructions are given to the
interviewer or subject, as appropriate, on how to
interpret questions, how to record answers, and how to
proceed through the questionnaire.
Principles of Questionnaire Design
• Aim of the study

• Question selection

• Question wording or Language

• Question sequence

• Response options

• Questionnaire structure
 Principles of Questionnaire Design
• Aim of the study – it is essential that aims of the
study are clear and precise.
• Question selection – all questions necessary to fulfill the
aims of the study should be included. Equally questions
that are not directly relevant to the aims must be
rigorously excluded.
• Question wording/Language – the wording of
questions must be intelligible to all subjects and
unambiguous.
 Principles of Questionnaire Design
• Question sequence – the order in which questions are
asked needs to be carefully planned. It should be logical,
interesting and economical.
• Response options – the types of response being
sought must be explicitly set out (discrete options or
open-ended answers).
• Questionnaire structure – the structure and the
layout of the questionnaire must be designed to
facilitate its completion and analysis of data.
 Content of the Questionnaire
a) Briefing
• This should provide a short statement indicating:
• The auspices and purpose of the study
• How subjects (cases & controls) have been solved
• The procedure being followed (interview or self-completion)
• The right of subjects to decline to participate or answer
specific questions
• Arrangements for safeguarding confidentiality
• The subjects signed consent to participate, when
appropriate
Content of the Questionnaire
b) Identification
• Subject’s name and address
• Subject identification number
c) Personal characteristics
• The data recorded will depend on the nature and
purpose of the study, but usually includes:
• Title of the survey and subject identification number
• Date, time and place of interview and name of
interviewer
• Age, gender, marital status, occupation, social data
relevant to the purpose of the study (e.g. education,
income, family size, housing).
 In Questionnaire Design Remember to:
a. Use familiar and appropriate language
b. Avoid abbreviations, double negatives, etc.
c. Avoid two elements to be collected through one question
d. Pre-code the responses to facilitate data processing
e. Avoid embarrassing and painful questions
f. Watch out of ambiguous questions
g. Avoid language that suggests a response (leading
questions)
h. Start with simpler questions
i. Ask the same questions to all respondents
 In Questionnaire Design Remember to:
j. Provide ‘other’ or ‘don’t know’ options where
appropriate
k. Give the unit of measurement for continuous variables
(years, months, kgs etc)
l. For open-ended questions, provide sufficient space for
the response
m. Arrange questions in logical sequence
n. Provide complete training for interviewers
o. Pretest the questionnaire on 20-50 respondents in actual
field situations
p. Include “thank you” after the last question
Sample Questionnaire Design
Assignment
• Prepare a questionnaire having both open and close-
ended questions on the following topics
• diarrhea prevalence among Under 5 children
• ANC Utilization among 15-49 years women
• Malaria prevalence and incidence in a given area
• Assessment of nutritional status on less than 14 years
 E-6
Data Processing, Analysis
and Presentation
Ebrahim Muktar (MPH, Ast. Prof Public Health)
WKU, March 2024
Data Processing
• Data processing refers to data entry onto a
computer, and data checks and correction.
• The aim of this process is to produce a relatively
‘clean’ data set which may be imported into a
statistical package.

230
Data entry
• Data entry concerns the transfer of data from a
questionnaire to a computer file.
• Before this takes place, the data must be checked for
errors, information that needs coding must be coded
and missing values must be dealt with.
• Computers are reliable, portable, computationally
powerful and easy to use. However, they give you what
you give them. Computer scientists refer to this
principle as GIGO: Garbage In, Garbage Out.

231
Data coding

• For computers to work their magic they must

be able to read your data. In general
computers are at their best with numbers.
• Some statistical packages cannot analyze
alphabetic codes, some cannot understand
open ended responses, you must translate
variables through the process called “coding”.

232
Data coding
• Coding is assigning a separate (non-overlapping)
numerical code for separate answers and missing
values. For example, instead of using ‘Male’ and
‘Female’ for the variable Sex, it can be indicated as 1 =
Male and 2 = Female.
• Missing values occur when measurements were not
taken, or respondents did not answer questions.
Ideally, a code should be chosen to denote a missing
value (e.g. a code ‘9’ or ’99’ or ’999’ is often used
missing values).

233
Data Cleaning
• Once the survey data have been gathered, they need
to be entered onto a computer data file and checked
for errors, impossible values and inconsistencies that
may be due to coding or data entry errors.
• No matter how carefully the data have been entered
some errors are inevitable.
• Errors can result from incorrect reading, incorrect
coding, incorrect typing, etc.

234
Data Analysis
• It is a usual practice to give much time to
questionnaire design and data collection and not
give any thought to the analysis stage.
• However, it is important to establish early on the exact
data type of the main outcome measures (scales of
measurement)
• The data type in turn determines which type of
statistical test is most appropriate
• This in turn has implications for the required sample
size.

235
 Data Analysis
• Once the data have been entered, it is
necessary to check for errors
• If you are satisfied that the data entered onto
the computer are correct, you will probably
start your analysis by requesting basic
(simple) frequencies (including mean,
standard deviation, etc.).
• The next stage is to request cross-tabulations or
contingency tables

236
Data Analysis

• Following the presentation of descriptive

statistics, there appears a need to apply
some statistical tests (in most research
activities)
• It is important to understand that the most
appropriate statistical test depends on the
type of study design, nature of variables
(especially, the outcome variable), etc.

237
 Three Steps of Data Analysis
Univariate analysis
Step 1: Examine the distribution of each individual
variable
Bivariate analysis
Step 2: Describe association between pairs of variables
(only two variables)
Multivariate analysis
Step 3: Use a statistical model called Regression (Linear or
logistic) to examine the relationship between multiple
independent variables & a dependent variable

238
Univariate Analysis
• Univariate analysis is the process of describing the
sample by examining and summarizing the
distribution of each individual variable.

• Can be used for all variables, regardless of level of

measurement

• It is also useful to make the researcher familiar with

variables
• It can also be used to test variables for fulfilling
assumptions

239
Frequency Distribution
• Most basic and usually done for categorical variables
is frequency Distribution.
• A frequency distribution shows how many cases
correspond to each attribute of a variable.
• It is like a “tally” or “count” process of a categorical
variable.
• It also can have proportion (Percent)

240
Descriptive Statistics
• Describing data in a clear and informative manner
using:
• Measures of central tendency and dispersion
• Mean, Median and Mode
• Variance, Standard Deviations, CV, Quartiles & IQR
• Proportions, percentages, etc.
• Tabular presentations
• Graphical presentations

241
Presentation of Results
• For data to be more easily appreciated and to draw
quick comparisons, it is often useful to arrange the
data in the form of a table, or in one of a number of
different graphical forms.

242
 Graphical presentation of data
• The main purpose of statistical methods is to reduce the
size of statistical data and to render them easily
intelligible. To attain this objective the methods of
classification, tabulation, averages & percentages are
generally used.
• But the method of diagrammatic representation is
probably simpler and more easily understandable.
• A graph is a method of showing quantitative data.
When correctly drawn it allows the reader to obtain
rapidly an over-all grasp of the material presented.

243
Types of diagrams (graphs)
Among the kinds of diagrams in common use are:
1. Line diagram (graph) – trends over time
2. Bar diagram (graph) – compare categorical data
3. “Pie” chart – compare groups in one categorical variable
4. Histogram – reveal distribution of a single N. continuous
5. ‘Box and whisker’ plots – show variability
6. Scatter plots – show relationship of two continuous variables

244
Choice of Tables vs. Graphs
• Quantity of Data
• Large - graphs
• Small - tables
• Objectives
• Precise - tables
• Clear and easy - Graphs
• Graphs - where impact is more important than the
fine detail of the values given.

245
 Bivariate Analysis
• Bivariate analysis is the second step in analysis
• It is analysis made to test presence of
relationship between two variables.
• Describes presence of association between two
variables
• Answers the question: Is there a relationship
between these two variables?

246
Possible combination
• There are three possible combination pairs of variable
types,

Combination between:

1. Two qualitative (categorical) variables

2. Two quantitative variables

247
 Two qualitative variables
• This is when the dependent and the independent
variables are categorical
• The statistics can be done
• Manually,
• Statcalc of EPI-info,
• logistic regression in SPSS.
• Chi square is the usual test of statistics for checking the
presence of association but does not provide the
magnitude of the association.

248
Two quantitative variables
• When the two variables are continuous and
symmetrically distributed, we use:
a. Simple linear regression
• weight and height
• house rent and income
b. Pearson’s correlation
• Measures the degree of linear correlation between
two variables (e.g. X and Y).

249
 Calculating Measures of Associations

Case
Indices of Risk
Yes No
Absolute Risk = a/a+b
Yes a b a+b
Relative Risk = a/a+b/c/c+d Exposure
No c d c+d
Odds Ratio = ad/bc

Risk Difference = a/a+b - c/c+d Total a+c b+d N

250
Exercises
Asthma No Asthma
symptoms symptoms Total

Exposed 48 151 199

Not exposed 16 114 130

251
Multivariate Analysis
• Multivariate analysis refers to the analysis of
data that takes into account a number of
explanatory variables and one outcome
variable simultaneously.
• It allows for the efficient estimation of
measures of association while controlling for
a number of confounding factors.

252
Multivariate Analysis
• All types of multivariate analyses involve the
construction of a mathematical model to describe the
association between independent and dependent
variables.
• A large number of multivariate models have been
developed for specialized purposes, each with a
particular set of assumptions underlying its
applicability.

253
Summary on data processing, analysis & presentation

Data Processing
• Checking for completeness, Sorting, Entering
in to a computer, coding, cleaning or Editing
Data Presentation or Report writing
• Using words description or narration,
presenting categorical or numerical
descriptive summaries
• Using frequency tables, diagrams such as bar
graphs, pie-charts, histograms, distribution
curves, box and whisker plots, scatter plots

254
Summary on data processing, analysis & presentation

Data Analysis – can be done manually on

data master sheet or by computers
• Counting frequencies, calculating rates, ratios
and proportions
• Computing descriptive numerical summaries:
averages, variances, coefficient of variations
• Descriptive cross tabulations are used
• Calculating measures of associations (OR,
RR), correlation coefficients, measures of
statistical significance by confidence intervals
and P-values
• Testing hypothesis (for comparative studies)
using analytic cross tabulations

255
F. Health Research Ethics
• Ethics is the branch of philosophy that
deals with distinctions between right and
wrong-with the moral consequences of
human actions.

256
Health Research Ethics
• Health Research Ethics is a Scientifically rationalized,
substantiated and supported code of moral principles &
practices with respect to design or formulation,
implementation, and dissemination of any health
research undertaking.
• It may be legally enforced or not.

257
Health Research Ethics

• Health research studies should be judged

ethically on three sets of criteria:
1. Ethical principles
2. Ethical rules and,
3. Scientific criteria

258
Basic Ethical Principles
1. Respect for autonomy
• a norm of respecting the decision-making capacities of
autonomous persons.
• Respect for autonomy of research participants
• Protection of research participants with impaired or diminished autonomy
• Paternalism (making decisions to the best interest of the persons by
governing body)
2. Non- malficence
• a norm of avoiding the causation of harm. Minimizing risks
3. Beneficence
• a group of norms for providing benefits and balancing benefits
against risks and costs. Maximizing benefits
4. Justice
• a group of norms for distributing benefits, risks, and costs fairly.

259
Respect for autonomy
Autonomy has diverse meanings:
• Self governance or determination
• Privacy
• Individual choice
• Freedom of the will

260
Respect for autonomy
• Protection of persons with diminished and impaired
abilities:
• children and adolescents, Persons with disability (mental
impairments); Persons in confinement (e.g. prisoners).
• A person of diminished autonomy is in some respect
controlled by others or incapable of deliberating or
acting on the basis of his/her desires and plans.
• Special protection to avert undue subjection as well as
having lawful guardians on their behalf.
• Paternalism is indicated if one has impaired autonomy.

261
Ethical Rules
• Veracity : all study subjects should be told the truth.
There is no justification for lying.
• Privacy- limited access to an individual and to
information about that person
• Confidentiality - how access to and use of private
information is structured
• Fidelity: keeping our promises and avoiding negligence
with information.
• Informed Consent

262
Ethical or Moral rules
1. tell the truth
2. respect the privacy of others
3. protect confidential information
4. obtain consent
5. when asked, help others make important
decisions

263
Informed Consent Process
a. Recruitment
b. Explanation of research
c. Confirmation of understanding
d. Signing of agreement

264
Confidentiality
• If research subject authorizes release of the
information to others, then there is no violation of
rights or confidentiality
• Personal or group data, if disclosed to third parties,
may cause harm or distress.
• Investigators should make arrangements for
protecting the confidentiality of such data
• When personal identifiers remain on records used for
a study, investigators should explain why this is
necessary and how confidentiality will be protected.

265
Means of Ensuring Confidentiality
• Omitting information that might lead to identification
of individual subjects
• Limiting access to the data by any means
• Unlinked information - Refers to information that can
not be linked, associated or connected with the person
to whom it refers.
• Linked information:
• Anonymous – when the information can not be linked to
the person to whom it refers except by a code or other
means known only to that person, and the investigator
can not know the identity of that person.

266
Principle of Non-Maleficence
• Minimizing harm-considerations
• Respect for local priorities and resource use
• Avoid stigmatization, prejudice, economic loss
• Propose measures against eminent risks during the
study
• Avoid harmful publicity
• Respect local social and cultural norms
• Disclosure of conflict of interest

267
G. Work plan (Project Management) -
• Personnel, job descriptions, training
• Schedule (timetable)- provide actual dates for
each activity
• Onset, data collection, analysis, write-up
• Use a GAANT Chart
H. Budget (itemize all direct costs in Ethiopian
Birr)
• Personnel, materials, travel, contingency, etc.
• Using tables

268
I. References:
• There are different styles to choose from: Vancouver
style uses numbered list and Harvard style uses author
and date.
•Referencing styles
Examples - Journal articles
1. Alene GD. Harmful traditional health practices: a
cross-sectional survey among under-five children in
Dembia district, North-west Ethiopia. Ethiop.J.Health
Biomed Sci. 2010; 2(2):83-93.
2. You CH, Lee KY, Chey RY, Menguy R.
Electrogastrographic study of patients with
unexplained nausea, bloating and vomiting.
Gastroenterology. 1980;79(2):311-4.
269
References: Example
From a book
3. Rang HP, Dale MM, Ritter JM, Moore PK.
Pharmacology. 5th ed. Edinburgh: Churchill
Livingstone; 2003.
Chapter in a book
4. Kloos H. The Physical and Biotic Environment. In:
Zein A. Zein and Kloos H, eds.The Ecology of Health
and Disease in Ethiopia. Westview Press, 1993;27-
39.

270
References:
Internet
5. Safe Motherhood Fact sheet. Good quality maternal
health services. 2002, [Cited December 2008];
• Available from:
http://safemotherhood.org/facts_and_figures/mater
nal_healt_html

271
 Unit – 5
Major Components of a
Research Proposal
Major Components of a Research Proposal
 Title and cover page
 Acknowledgements
 Abstract
 Table of contents
I. Introduction
 Statement of the research problem
 Literature review: knowledge pertinent to the study
 Significance of the proposed work
II. Objectives of the study
 General and Specific objectives
 Hypotheses

273
III. Materials and methods
 Study design
 Study area (Setting)
 Population (Source and study population)
 Inclusion and exclusion criteria
 Sample size and power calculation
 Sampling procedure (methods)
 Variables
 Operational definitions
 Data collection methods
 Validity and Reliability
 Data analysis
 Ethical considerations
III. Limitations of the study
IV. Work plan (project management)
V. Budget (itemize all direct costs in Ethiopian Birr)
VI. References
VII. Appendices
274
Summary of the Major Components of a Proposal
Title and cover page
• The cover page should contain the title, the names of
the authors with their academic ranks and positions,
the institution and the month and year of submission
of the proposal.
• The title could consist of a challenging statement or
question, followed by an informative subtitle covering
the content of the study and indicating the area where
the study will be undertaken.

275
Acknowledgements
• It is good practice to thank those who supported you
technically or financially in the development of your
research proposal. Also, your employer who has
allowed you to invest time during the development of
your proposal

276
Abstract:
• Summary of the proposal which should include:
Background, Objectives, Methods, Time schedule
and the Total cost.
Table of contents:
• A table of contents is essential. It provides the
reader a quick overview of the major sections of
your research proposal, with page references, so
that one can go through the proposal in a
different order or skip certain sections.

277
I) Introduction
1. Statement of the research problem
• Background and definition of the problem of the study
• Why the proposed study is important, etc.
2. Literature review
• knowledge pertinent to subject under study
3. Significance of the proposed work
• Specific statements on the significance of the results of the
study should be given.
• Where to use the results; who to make use of the results;
what for the result would be used; and other details related
with the usefulness of the end results of the study.

278
Conceptual Framework

• Conceptual framework – gives an

overall view of the interrelationship
(interdependence) of variables

279
 II) Objective of the study
 General objective: aim of the study in general terms
 Specific objectives: measurable statements on the
specific questions to be a answered
• The objectives should meet purpose of the study.
• They should be phrased clearly, unambiguously
and very specifically in measurable terms.
 Hypotheses

280
III) Materials and Methods
• Type of study (study design)
• Population & area (source & study population)
• Describe the study areas and populations
• Mapping and numbering of the study area
• Accessibility (provide background information, travel, time,
etc..)
• Inclusion and exclusion criteria

281
Materials and methods
• Sample size and power calculation
• Sampling procedure (methods) to be used
• Type of data (variables to be collected)
• Operational definitions of variables
• Data collection methods and tools
• Data collection and coding forms should be appended to
protocol
• Validity and Reliability
• Training , quality control, data entry and clean-up

282
Materials and methods
• Data analysis
• Frequencies, rates, other parameters
• Statistical software packages and tests to be used
• Data presentation (dummy tables to be appended)
• Ethical considerations:
• rights and welfare of the subjects and method of obtaining
their informed consent
• Pre-test or pilot study:
• allows us to identify potential problems in the proposed
study

283
IV) Work plan (Project Management) -
• Personnel, job descriptions, training
• Schedule (timetable)- provide actual dates for
each activity
• Onset, data collection, analysis, write-up
• Use a GAANT Chart
V) Budget (itemize all direct costs in Ethiopian
Birr)
• Personnel, materials, travel, contingency, etc.
• Using tables

284
VI) References:
•Referencing styles
Examples - Journal articles
1. Alene GD. Harmful traditional health practices: a
cross-sectional survey among under-five children in
Dembia district, North-west Ethiopia. Ethiop.J.Health
Biomed Sci. 2010; 2(2):83-93.
2. You CH, Lee KY, Chey RY, Menguy R.
Electrogastrographic study of patients with
unexplained nausea, bloating and vomiting.
Gastroenterology. 1980;79(2):311-4.

285
References: Example
From a book
3. Rang HP, Dale MM, Ritter JM, Moore PK.
Pharmacology. 5th ed. Edinburgh: Churchill
Livingstone; 2003.
Chapter in a book
4. Kloos H. The Physical and Biotic Environment. In:
Zein A. Zein and Kloos H, eds.The Ecology of Health
and Disease in Ethiopia. Westview Press, 1993;27-
39.

286
References:
Internet
5. Safe Motherhood Fact sheet. Good quality maternal
health services. 2002, [Cited December 2008];
• Available from:
http://safemotherhood.org/facts_and_figures/mater
nal_healt_html

287
VII) Appendices:
• Data collection and coding forms
• Dummy tables for data presentation
• Letters of support (cooperation)

288
 Unit – 6
Research Report Writing
& Critical Appraisal of a
Scientific Paper
Writing a Research Report
• Research is not complete until the results are
presented to the stakeholders or partners of the
research and are submitted for publication in peer-
reviewed and reputed scientific literature.
• Writing a good report may take much time and effort
• The most difficult task is usually the preparation of the
draft report
• The report should be easily intelligible.

290
Writing a Research Report
• A good research report requires:
• clarity of language,
• a logical presentation of facts and inferences,
• the use of easily understood tables and charts, and
• an orderly arrangements of the report as a whole.
• It should not be lengthy than is necessary.
• The report normally follows the outline of the research
proposal and makes use of most of the materials
prepared for the proposal.

291
Conventional Outline of Research Report
 Title and cover page
 Abstract (Summary)
 Acknowledgements
 Table of contents
 List of Tables, Figures
 Acronyms (optional)
1. Introduction
 Focus on the research problem of the study followed by most
relevant literature review
 Brief description of significance of the study
2. Objectives of the study
 General and Specific objectives

292
Outline of Research Report…
3. Materials and methods
 Study design and Study area
 Source and study population
 Sample size and power calculation
 Sampling procedure used
 Variables and Operational definitions
 Data collection methods, instruments , personnel
 Data analysis procedures & statistical tests applied
 How ethical clearance & consent obtained

293
Outline of Research Report…

4. Results
 Presentation and descriptions of findings using
words, numbers, facts, summary figures :
rates, proportions, in tables and graphs
 Statistical significance tests and associations
findings using P-values, RRs, ORs, 95% CI
estimates,
 Do not discuss or explain the results, present as
it is

294
Outline of Research Report…
4. Discussion
 Do not repeat the results
 Discuss most pertinent findings
 Compare findings with other similar studies that support
or contradict your own
 Discuss the limitation of the study and
 Tell whether findings could be generalized
 Avoid conflict of interests
5. Conclusions and Recommendations
6. References
7. Annexes or Appendices

295
 Unit – 7

Appraisal of a research proposal

and scientific paper
Critical Appraisal – Definitions
• Critical appraisal is "the process of carefully and
systematically examining research to judge its
trustworthiness, and its value and relevance in a
particular context.
• Critical appraisal can be defined as the "...application
of rules of evidence to a study to assess the validity of
the data, completeness of reporting, methods and
procedures, conclusions, compliance with ethical
standards, etc.

297
Critical Appraisal – Concepts
• Critical appraisal is a systematic process through which
the strengths and weaknesses of a research study can
be identified.
• This process enables the reader to assess the study's
usefulness and whether its findings are trustworthy.
• Critical appraisal is an essential step in the process of
putting research into practice.

298
Components of Critical Appraisal
• The most important component of critical appraisal is
careful assessment of the study design; and
evaluation of the statistical methods used,
interpretation of the findings and potential conflicts
of interest are also essential.
• Finally, consideration of the importance of the research
to one's own patients

299
Critical Appraisal of a Proposal
1. Is the study's research question relevant?
2. Does the proposed study will add anything new?
3. Is the study design appropriate for the research question?
4. Is the sample size adequate (large enough) to be generalized?
5. Do the proposed study methods will minimize potential sources of
bias?
6. Are the planned data collection procedures appropriate?
7. Are appropriate statistical analyses techniques planned?
8. Is the estimates of the time and budget feasible ?
9. Can the results be applicable to public health practice?
10. Are there any conflicts of interest?
11. Is the principal investigator an expert/knowledgeable ?

300
Critical Appraisal of a Published Research
1. Is the Study's Research Question Relevant?
2. Does the Study Add Anything New?
3. What Type of Research Question Does the Study Pose?
4. Was the Study Design Appropriate for the Research Question?
5. Did the Study Methods Address the Key Potential Sources of
Bias?
6. Was the Study Performed in Line with the Original Protocol?
7. Does the Study Test a Stated Hypothesis?
8. Were the Statistical Analyses Performed Correctly?
9. Do the Data Justify the Conclusions?
10. Are There any Conflicts of Interest?
301