Epidemiological Study Design

(Quantitative)

By:

Wubareg Seifu (MPH, Assistant Professor)

School of Public Health

Department of Epidemiology

December, 2024

Email: [email protected]
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 Session Objective
• Discus the study design selection parameters.
• Describe the difference between observational and
interventional study design
• Describe the basic concepts of descriptive studies
• Describe the indication for each designs
• Identify common bias associated with each design
• Describe the limitations and strength study designs
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 Study Design
• Specific plan or protocol for conducting a study which

enables the researcher to translate the conceptual

hypothesis in to operational.

• Study design is the arrangement of conditions for the

collection and analysis of data to provide the most
accurate answer to a question in the most economical
way.
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 Study design tells about
• What we are going to achieve from the study
• Who are going to be our study participants
• How we are going to select study participants
• How many study participants we need
• What kind of data collection methods we will use
• How we are going to analyze our data

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Types of Epidemiological Study
Designs

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Evidence of Hierarchy of Epidemiological Study
Design

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 Selection Criteria of Study Design

• Objective of the study

• Feasibility issue
• Status of existent knowledge
• Technical know how
• Availability of study participants
• The level of ethical concerns

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Descriptive or Analytical Study Design

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Descriptive Study Design

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 Descriptive study Designs
• Descriptive studies are usually the first phase of an
epidemiological investigation.
• These studies are concerned with observing the distribution
of disease and health related characteristics in human
populations.
• Such studies basically ask the questions of what, who,
where, and when.
• Useful for generating new hypothesis (provides clues to
disease etiology).
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Descriptive Studies

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 Types of Descriptive Study Designs

INDIVIDUALS (study unit)

studies on individual bases
--- Case reports
--- Case series
--- Cross sectional surveys
POPULATIONS (GROUPS)
Studies on population bases
--- Ecologic/correlation/ aggregate studies
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Cross Sectional Study

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 Types of Cross Sectional Studies

• Descriptive cross sectional/Survey

• Analytical cross sectional (comparative cross

sectional studies)

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Cross Sectional Study as
Descriptive Study Design

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When to conduct Descriptive
Cross Sectional Studies?

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Example of Descriptive Cross Sectional Design

Objective:
• To estimate the magnitude of antenatal care service
utilization among pregnant women in a certain
city, 2022
Study Design:
• Population based household cross sectional study
Result:
• 35% of women attended ANC during their 1st
trimester
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Possible research topics for cross section

• Proportion of mother who gave birth at hospital

• Prevalence of acute malnutrition

• MCH service utilization

• Vaccination coverage in X-woreda

• Prevalence of smoking among college students

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 Home take reading assignment

• Case reports
• Case series
• Ecological (aggregate) studies

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 Exercises
State the Appropriate Descriptive Study Design
1: The prevalence and associated factors of stunting in Somali
region
2: Occurrence of new vector borne disease in Somali region
3: The relationship between obesity and diabetes mellitus in
Africa since 2000
4: Prevalence of smoking after a new sanction imposed by the
federal government in Ethiopia
5: The proportion of mothers who gave birth at health facility
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Analytical Observational
Study Design

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Analytical studies definition

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 Analytical Study Design

• Is smoking a risk factor for cancer?

• Is fatty diet a risk for DM?

• Is knowledge affects ANC utilization?

• What is the effect of this drug?

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 Types of Analytical Observational Designs

• Analytical Cross Sectional

• Case Control design

• Cohort study design

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Observational Studies

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 Analytical cross sectional study design

• The outcome and the exposure status is measured

at the same time.

• Used to examine data at one point in time.

• It can estimate proportion of outcome of interest.

• It can also identify possible risk factors

associated with the outcome of interest.
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Analytical Cross-Sectional Design

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 Issues in the design of cross-sectional surveys

• Choosing a representative sample

– Probabilistic sampling techniques

• Adequate sample size estimation

– Prevalence
– Factors

• Potential bias in cross-sectional studies

– Non response bias
– Recall bias
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 Advantage
• Short term
• Fewer resources required
• More easily controlled
• Design less complex
• Provide relationship between attributes of disease and
characteristics of various groups,
• Data is useful for planning of health services and medical
programs
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Common Limitation of Descriptive Designs

• Recall bias
• Needs large sample size
• Capture prevalent rather than incident
• Can not establish cause effect
relationship
 Can’t establish cause effect relationship

• Depression and alcohol abuse

– depression causes alcoholism

Or
Chicken and egg dilemma

– alcoholism causes depression?

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Case Control Design

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General Framework of Case-Control Studies

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General Framework of Case Control Design

2010 2022

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Measures of association in
Case Control Design

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 Advantage of Case Control design
• Quick and easy to complete, cost effective

• Most efficient design for rare diseases

• Usually requires a smaller study population than

a cohort study
• Can identify multiple risk factor for a singe
disease

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Rare diseases and Case Control Design
• Forsyth and colleagues used a case control study to
assess whether aspirin use in the setting of viral illness
among children is associated with Reye’s syndrome, a
deadly disease.
• Over an 18-month period only 24 cases were identified
from 108(USA) and 20(Canada) Hospitals.

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 Limitation of Case Control
• Uncertainty of exposure-disease time relationship

• Case-control studies are limited to examining one

outcome.

• Inability to provide a direct estimate of risk

• Not efficient for studying rare exposures

• It can be difficult to find a suitable control group

• Subject to biases (recall & selection bias)

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 Home take reading

• Matching in case control study

– Unmatched case control

– Matched case control

• Sources of cases and controls

– Community based

– Facility based

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 Reflection

• What are the parameters to select study

design?

• What is the difference between descriptive

and analytical study design?

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 Cohort Study Design
(longitudinal, follow up study)

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Cohort Study Design

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General Framework of Cohort Study design

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Types of Cohort Studies

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 Prospective Cohort Design

2023 2025

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Retrospective Cohort

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 Indication for Retrospective Cohort
• Occupational exposures
• Uranium miners
• Asbestos workers
• Military staffs

• Outbreak investigation
• Food borne outbreaks (population at risk known)

• Atomic bomb blasts

• Birth defects
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Measures of Association

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 Advantage of Cohort Design
• 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

• Selection and information biases are decreased

• Multiple outcomes can be studied

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 Disadvantage of Cohort Design
• Lengthy and expensive
• Needs large sample size
• Not appropriate for rare diseases
• Loss to follow up
• Resource intensive
• Incomplete data
• Recall bias
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Group Discussion

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2. Experimental /Intervention
Studies

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 Feature of Intervention studies
1. Radom allocation to RX and control group

2. Placebo effect

3. Blinding technique
– Single blinding

– Double blinding

– Triple blinding
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Randomization Implication

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 Blinding

• Preventing key persons involved in the study

from knowing which treatment a subject is
receiving.
• In respect of this, there are essentially three
groups of people involved in trials that can be
blinded.

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Level of blinding

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Placebo Effect

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 Types of Experimental study
1. Randomized controlled clinical trial (RCT)

2. Field trial

3. Community trial

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RCT

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 Measures of association
• The association b/t exposure & a disease is measured
by calculating the Relative (risk) ratio (as in cohort
study).

• Association is measured directly.

Incidence of disease among exposed

RR =
Incidence of disease among non-exposed
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 Limitations

– Time consuming and relatively very expensive

– Loss to follow up

– Volunteer bias

– Ethical issues are given high consideration.

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Decision Tree of Study Design

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