Module 3:

Methodology

Edosa A. (BSc, MPH, PhD Fellow)

Study Area and period
 Study setting and period
 It is related to the study area and other characteristics
which are more related to the study; write as a brief
background; Health institutions, Schools, community
(1-2 Paragraphs)
 Include map of the study site if possible
 Consider topic context into account

Write the time to which the data belongs to or the time

where the data represents the characteristics studied

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Epidemiological Study Designs
 Study designs could be
I. Exploratory/experimental
II. Observational - Analytical or
- Descriptive

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 Epidemiologic Study Designs

Experimental Observational

(RCTs)

Analytical Descriptive
(Describing patterns
of disease)
cross-sectional Cohort
Case-Control

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Choosing Epidemiologic Study
Designs

Research Method 7
idoamante07@[Link] Grimes & Schulz, 2002 (www)
 Hierarchy of Epidemiologic Study Design

 Case report (one case of unusual findings) Generate hypothesis

 Case series ( multiple case findings)

 Cross sectional studies

 Case control studies

 Cohort studies

 Randomized trial studies

Establish causality
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Epidemiologic Study Designs

Research Method 9
idoamante07@[Link] Grimes & Schulz, 2002 (www)
1. Cross-sectional study Design

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 A cross-sectional study
• Definition: A cross-sectional study is one in which
subjects are sampled irrespective of their disease status

• Is study at a particular point in time, without follow-up

• The term cross-sectional study or prevalence study

usually refers to studies at the individual level

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 A cross-sectional…
It measures prevalence at a point in time:
• attitudes, beliefs, behaviors,
• family history, genetic factors,
• existing or past health conditions, or anything else
that does not require follow-up to assess can be
studied
E.g. DHS, Population census
It is commonly used to describe the burden of disease and
its distribution

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 A cross-sectional…

The Magnitude of the event (Prevalence)

• Used to describe population characteristics,
often in terms of:
– person (who?)
– place (where?) &
– time (when?)

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 Cross-sectional…
• In a cross-sectional study, the current or historical status
of individuals is assessed and may be examined in
relation to some current or past exposure
• These studies are obviously most useful for conditions
that are not rapidly fatal, but not routinely brought to
medical attention
(e.g., Elevated blood pressure, elevated blood cholesterol,
many psychiatric disorders, diet, Sub clinical infections,
etc)

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 Cross-sectional…
 participants for a cross-sectional study are generally
chosen without previous knowledge of their
disease or exposure status,

 Such studies can be used to estimate prevalence of

both diseases and exposures

 Therefore it is used to compute prevalence ratios

and prevalence odds ratios.

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 Cross-sectional…
• the researcher has no control over the exposure of
interest (research subject), No interventions
• It involves
– identifying a defined population at a particular point
in time (target population)
– measuring a range of variables on an individual
basis
– include past and current practices/behaviors

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 Cross Sectional…
• KAP (knowledge, attitude, and practices ) study:
– KAP studies are purely descriptive and help to build up a
better understanding of the behavior of the population,
without necessarily relating this to any disease or health
outcome.
• It is a management tool: health service managers and
planners may make use of cross-sectional survey to
assess utilization and effectiveness of service
• Development of hypothesis: Hypotheses on the causes
of disease may be developed using data from cross-
sectional study survey
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 Limitation of cross-sectional study
• In cross sectional study, it is not possible to establish
cause-effect relationship (which comes first?)
• Confounding factors may not be equally distributed
between the groups being compared and this unequal
distribution may lead to bias and subsequent
misinterpretation
• Cross-sectional studies may measure current health
event.
• But Current health event may be altered by the
presence of disease
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 Limitation of…
• Recall Bias: due to errors in recalling the exposure
and possible outcome (people may forget their past
Hx)
Advantage
• Time saving /Quick result
• Relatively less costly

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 2. Case control Study
• A study that starts with the identification of persons with
the disease (or other outcome variable, the case)
of interest, and
• A suitable comparison, reference or control group of
persons without the disease
• And inquiries are made about past exposure
• We compare diseased (cases) and non-diseased (controls)
to find the level of their exposure
• Exposure status is traced back in time

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 Case Control

Exposed Not Exposed Not

exposed Exposed

past

Have the Have no the

disease of the disease of the
interest interest
(Cases) (Controls)
Retrospective nature

Present

General population
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 Case Control

• A case-control study is designed to help determine

if an exposure is associated with an outcome
• Case-control study is always retrospective because
it starts with an outcome then traces back to
investigate exposures

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 Case Control
• The relationship of an attribute to the disease is
examined by comparing the
Case (diseased) those with the outcome of
interest &
Control(non diseased) those without of
outcome of interest
• Case and control must be comparable in all aspects
except their exposure status to the suspected
determinant of the disease i.e.
• Controls must be comparable to cases in every aspects except
that they do not have the disease
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 Case…
• Preferably controls are drawn from the same
population as the cases
There are two basic types of case-control studies:
A/ Non-matched case-control study
In this study design, the number of controls does
not necessarily equal the number of cases
For example, we may enroll 105 cases and 178
controls

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For a simple non-matched case control study, the
data can be summarized in a 2 × 2 table as below :
Cases(Number) Controls(Number)
Exposed A B
Not exposed C D

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 Case…
B/ Matched case control
• The study has linked a case to a control based on
matching of one or more variables
• The summary table will differ for a matched case-
control study
• Let's look at an example. Suppose we plan to match
cases to controls by gender and age (+ 5 years). We
first identify the following case:

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 Case…

In a matched study, we enroll controls based upon some

characteristic(s) of the case
For example, we might match the sex or to the age of the control
to the sex or age of the case
The idea in matching is to match upon a potential confounding
variable in order to remove their confounding effect
There are two basic types of matched designs:
One-to-one matching (i.e., one case to one control) and
One case to ‘n’ controls (n = 2-4 controls)

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 Case…
• Matching should be considered only for risk factors
whose confounding effects need to be controlled for
• Common examples of matching variables
(confounding factors): age, sex, level of education,
wealth (income), marital status, race
• Matching all confounding variables is not efficient
and almost impossible in practice.
• Besides, matching all confounding variables could
lead to overmatching and thus to less precise
estimates

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 Case…
Analysis of a matched case control study design
• only discordant pairs are used
• A discordant pair occurs when the exposure status
of case is different than the exposure status of the
control
Analysis: include conditional logistic regression
(conditioned upon the matching)

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Matched pairs

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 Case…
• Concordance is based upon exposure status
• In a matched case-control study, the cell counts
represent pairs, not individuals
• In the statistical analysis, only the discordant pairs are
important
• Cells B and C contribute to the odds ratio in a matched
design
• Cells A and D do not contribute to the odds-ratio.
• If the risk for disease is increased due to exposure, C
will be greater than B
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 Basic procedures
1. Identify cases:- people who are with the disease of
interest
2. Select controls (non cases): in the people who have not
developed that disease
3. Compare the magnitude of the exposure of cases with
non cases

4. Draw inferences about the underlying exposure that led

to differences in characteristics of cases and controls

OR = odds of diseased in cases/odds of diseased in

controls
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 Total a+c b+d
Odds of exposure in diseased = a/c or a:c
Odds of exposure in not-diseased = b/d
Odds of disease in exposed = a/b or a:b
Odds of disease in unexposed = c/d
OR Exposure = a/c ÷ b/d = a/c x d/b = ad/cb Results are
OR Disease = a/b ÷ c/d = a/b x d/c = ad/bc the same

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 Case…
Sources of cases
1. Hospital (health institutions)
easy and inexpensive to conduct minimize recall bias
but it is prone for selection bias
2. Population (community)based
• Cost –more expensive
• More recall bias
• Minimal selection bias

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 Advantages of Case-Control Studies

- Relatively cheap, easy and quick studies (than cohort

& experimental)
- Multiple exposures can be examined
- Suitable when randomization is unethical
(like alcohol and pregnancy outcome)

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 Disadvantages of Case-Control Studies

- Selection of case and control is tiresome

- Subject to bias (selection, recall, misclassification)
- Direct incidence estimation is not possible
- Temporal relationship is not clear
- Multiple outcomes cannot be studied

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 3. Cohort Study designs

An approach to studying disease incidence and risk

factors:
Approach:
1. Start with a population at risk (a batch of population)
2. Measure characteristics at baseline
3. Follow-up the population (with out the event) over time
4. Compare the rate of events (incidence) among with &
without the exposure status

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 Cohort Studies

(A) Diseased
People Exposed Not diseased
Population without
disease (B) Not Diseased
exposed
Not disease

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 Cohort Study..
Population -Can be large or small
Time - Can be long or short
Scope - Can be simple or elaborate
For rare out comes, it needs many people and/or lengthy
follow-up
May have to decide what characteristics to measure long
in advance

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 Prospective cohort study

Disease
Exposure Study starts occurrence

time

Disease
Study starts Exposure occurrence

time
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 Retrospective cohort studies

Disease
Exposure Study starts
occurrence

time

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 Presentation of cohort data:
Population at risk

Does HIV infection increase risk of developing TB

among a population of drug users?

(follow up
2 years) Population Cases

HIV + 215 8
HIV - 215 1

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 Presentation of cohort data:
Person-years at risk

Tobacco smoking and lung cancer, England

& Wales, 1951
Person-years Cases

Smoke 42,800 133 (0.31%)

Do not smoke 42,800 3 (0.007%)

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 Advantages of Cohort Studies
• Can establish population-based incidence
• Accurate relative risk (risk ratio) estimation
• Can examine rare exposures (asbestos & lung cancer)
• Temporal relationship can be inferred (prospective design)
• Time-to-event analysis is possible
• Can be used where randomization is not possible
• Magnitude of a risk factor’s effect can be quantified
• Decreases selection and information biases
• Multiple outcomes can be studied for each exposure (smoking
& lung cancer, larynx cancer)
• Exposure status can be determined before disease detection

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 Disadvantages of Cohort Studies
• Lengthy and expensive
• May require very large samples
• Not suitable for rare diseases
• Not suitable for diseases with long-latency
• Unexpected environmental changes may influence the
association
• High non-response, migration and loss-to-follow-up
biases

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4. Experimental study design

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 4. Experimental…
• The subjects in the study who actually receive
the treatment of interest are called the treatment
group
• The subjects who receive no treatment are
called the comparison group ( control group)
• In an experiment, we are interested in the effect
of treatment on outcome of interest

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 [Link]…

Before considering an experimental design, you

need to ask yourself the following questions:
• Is it possible/feasible to apply random selection
to assign people to treatment and control group?
• Is the process of random selection into
experimental and control groups ethical and
legal?
e.g. pregnant mother and alcohol drinking etc
(fetal alcoholic syndrome)
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 4. Experimental …
There are certain procedures you need to follow:
• First randomly select a treatment & control group
• Both, treatment & control groups must come from the
same population,
• Both groups should have about the same number of
subjects in them,
• As a general rule, not less than 25 subjects in each group

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 4. Experimental …
• The experiment is complete when you take a final
measure, called the post test,
• Your findings should be interpreted primarily from
differences in a post test score between experimental
and control groups
• Use the blind experiment: subjects don't know
which group they're in, the experimental or control
group
• These precautions help protect your study from the
Hawthorne and the Placebo Effect

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 4. Experimental …

• The Hawthorne effect refers to the tendency of

subjects to act differently when they know they are being
studied, especially if they think they have been singled
out from some experimental treatment
• The Placebo effect refers to the tendency of some
subjects to think they are "cured" or sufficiently treated
when they know about the research
• (A tendency to report favorable response to any therapy
regardless of its physiologic efficacy of the Rx )

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 [Link]…
Advantages
• Randomized Controlled Trials (RCTs)
– the “gold standard” of research designs
– provides most convincing evidence of relationship
between exposure and effect
Disadvantages
• Very expensive
• it may be unethical, for example, to assign persons
to certain treatment or comparison groups

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Thank you!

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