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.
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 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.

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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

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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

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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)

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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.

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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

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Case Control Study Design

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

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

• Study cases should be representative of

all cases

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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

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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

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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

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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)

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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)

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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.

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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.

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 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.

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 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.
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