NUR3163

EPIDEMIOLOGICAL STUDY
DESIGNS
 LEARNING OBJECTIVES

Identify basic study designs used in

epidemiology studies.
Define the basic differences between
descriptive, analytical, observational and
experimental epidemiology.
List the main characteristics, advantages and
disadvantages of ecologic, cross-sectional,
case-control and cohort studies.
Calculate and interpret an odds ratio, relative
risk, attributable and absolute risk
Study Design?

Direct how the investigation is

conducted
EPIDEMIOLOGIC DESIGN ANALYSIS

Measures of frequency
Ecologic, prevalence survey
Measures of association
Cross sectional, case control, cohort
Odds ratio (case control)
Relative risk/ risk ratio (cohort)

Statistical inference (all analytic studies)

P-value

Confidence limits
OVERVIEW OF
EPIDEMIOLOGIC DESIGN STRATEGIES
Descriptive studies Analytic studies

Population Observational
Ecologic Ecologic
Cross-sectional
Case control (retrospective)
Individual Cohort
(prospective/retrospective)
Case report
Case series
Interventional/Ex
Cross-sectional
(prevalence survey) perimental
Randomized controlled
trial
Field trial
Clinical trial
TIME FRAME OF STUDIES
Prospective Study - looks forward, looks to the future,
examines future events, follows a condition, concern or
disease into the future

With a prospective study

one starts with cohorts of
well individuals, and we
wait until events occurs.
time

Study begins here

TIME FRAME OF STUDIES
Retrospective Study to looks back, looks back in time
to study events that have already occurred

Looking backward is often

difficult because of recall
bias, however, the case
control studies are very
inexpensive in comparison
with prospective studies.
time

Study begins here

Strength of evidence of studies

Approach for studying

disease etiology
EPIDEMIOLOGIC DESIGN ANALYSIS

Measures of frequency
Ecologic, prevalence survey
Measures of association
Cross sectional, case control, cohort
Odds ratio (case control)
Relative risk/ risk ratio (cohort)

Statistical inference (all analytic studies)

P-value

Confidence limits
 OBSERVATIONAL ANALYTICAL
STUDIES: Measures of Association
Non-causal
association/Correlati Causal association
on
Case control
Ecologic study
(population)

Cohort
Cross sectional
studies
(individual)
Causal Association/ Relationship
One variable (exposure/ outcome) has a direct
influence on the other (exposure/ outcome).
Causation implies association, but not correlation.
Exposure (Risk factor) Outcome (Disease)
Eg:
Smoking Lung cancer
Salt intake Hypertension
Non Causal Association/
Correlation
Two variables can be related to each other without
directly affecting the values of the each other
Correlation implies association, but not causation
Eg:
The positive correlation between the number of milk
drinking and the number of peptic ulcer
If milk drinking is associated with peptic ulcer, is that
because milk causes the disease, or because ulcer
sufferers drink milk to relieve their symptoms?
Ecologic Study
A study in which at least one variable is
measured at the group (not individual) level
Eg. Study of:
Dental caries and the level of fluoride in drinking water
in a population.
Pollution level and mortality rate.

The rate of cancer incidence, the mean level of

hypertension, the average sunlight exposure at specific
geographic location.
Theoccurrence of disease is compared between groups that
have different levels of exposure
Ecologic Fallacy
The bias that may occur because an association
observed between variables on an aggregate level
does not necessarily represent the association that
exists at the individual level.
Eg.
Out of 10 people, 7(70%) have sunburned foreheads,
and 6(60%) who wear hats when they go outside.
Fallacy?
Areas with high concentrations of farm animals are also
the areas with lowest concentrations of childhood asthma.
Fallacy?
Cross-Sectional Study
A type of observational or descriptive study
(prevalence surveys)
Measures of exposure and disease are

obtained at individual level.

Starts by selecting a sample (N) from a population then
determining the distribution of exposure and disease
Not possible to determine whether the
exposure and the outcome are causally related
Data represent snapshot of information at one
point in time
Cross-Sectional StudyCont
PAST PRESENT FUTURE

CROSS SECTIONAL

PROSPECTIVE COHORT

RETROSPECTIVE COHORT

CASE CONTROL

RANDOMISED CONTROL TRIAL

Cross-Sectional Study: Uses

Prevalence Surveys
Describe population characteristics

KAP studies

Development of hypothesis
2X2 Table in Cross-Sectional Study

Disease Status Total

YES NO
Exposure A B A+B
YES
Exposure C D C+D
NO
A+C B+D
N
Case-Control Studies
Purpose
toestablish association between exposure to risk
factors and disease.
A group of individuals with the disease are selected
into the study CASES
A group of individuals who do not have the disease
is also included in the study CONTROLS
Often used in the study of rare disease
Case-Control Studies
Steps:
1. Starts with selecting case and control group.
2. Ask question from both groups regarding history of
exposure (risk factor)
3. Then compares the groups in term of exposure to
possible risk factors.
Estimate the risk using odds ratio.
Also called Retrospective Study.
Prospective VS Retrospective Cohort
PAST PRESENT FUTURE

CROSS SECTIONAL

PROSPECTIVE COHORT

RETROSPECTIVE COHORT

CASE CONTROL

RANDOMISED CONTROL TRIAL

2X2 Table in Case-Control Study

Disease Status Total

YES NO-
(Case) Control
Exposure A B A+B
YES
Exposure C D C+D
NO
A+C B+D N
 Case Control: Analysis of Data

Measure the odd of exposure based on

disease
Compared to cohort study which measure
relative risk of disease based on exposure
Odds ratio has two components;
The odds of exposure for cases
The odds of exposure for controls
Case Control: Analysis of DataCont

The odds of exposure for cases

Number of cases exposed / number of cases unexposed
given by Odds / cases = a / b
The odds of exposure for controls
Number of controls exposed / number of controls
unexposed given by Odds / controls = c / d
The estimated Odds Ratio is then Odds = ad /bc
Case Control: Analysis of DataCont
The Odds Ratio is interpreted as
OR < 1;
Odds of exposure for cases are less than those for control.
Exposure appears to reduce risk of disease.

OR = 1;
Odds of exposure for cases are the same as those for control.
Exposure does not appear to be a risk factor.

OR > 1;
Odds of exposure for cases are more than those for
control.
Exposure appears to increase risk of disease.
Case-control study of relationship between chili pepper
consumption and gastric cancer risk

Chili pepper Cases of Controls

consumption gastric cancer
YES A = 204 B = 552

NO C = 9 D = 145

OR = AD / CB = (204)X(145)(9)X(552) = 5.92

Thus, chili pepper eaters have 5.92 X risk of developing

gastric cancer compared to non-eaters.
Cohort Studies
A group of subjects, selected to represent the
population of interest, is studied over time.
Information is collected about the outcome of

interest and exposure to risk factors.

Subjects are disease-free at the outset of the

study.
At distinct point of time, data are collected
relating to health outcomes and exposure to
risk factors.
Cohort Studies: Steps
Begins with exposed and non-exposed persons who
do not have the disease.
The study sample is drawn only from individuals at
risk of developing the outcome.
Individuals are followed through time until some of
them develop the disease.
Compare the rate of the outcome for the exposed
group to the rate of the outcome for the non-
exposed group.
Prospective VS Retrospective Cohort

Prospective cohort studies

Studiescarried out from present time into future.
Can be tailored to collect specific exposure data

Retrospective (historical) cohort studies

Look at medical events from some time point in the
past up to the present time.
Prospective VS Retrospective Cohort
PAST PRESENT FUTURE

CROSS SECTIONAL

PROSPECTIVE COHORT

RETROSPECTIVE COHORT

CASE CONTROL

RANDOMISED CONTROL TRIAL

2X2 Table in Cohort Study

Disease Disease Total

YES NO
Exposure A B A+B
YES
Exposure C D C+D
NO
A+C B+D N
Cohort: Analysis of Data
Risk Ratio/ Relative Risk
measure of the extend those exposed getting the
disease compared to the non-exposed group
[a / (a+ b)] / [ c / c + d)]
Interpreting Relative Risk
Calculation obtained from cohort
study
Absolute risk
Involvespeople who contact disease due to an
exposure
= a/a+b

Attributable risk
The amount of disease that can be attributed to
a certain exposure.
= (a/a+b) (c/c+d)
Attributable Risk for an Exposed
Group
 Analysis: Measure association

Relative risk and odds ratio are important as measures

of the strength of association
Important for deriving causal inference
Attributable risk is a measure of how much disease risk is
attributed to a certain exposure
Useful in determining how much disease can be prevented
Therefore:
Relative risk is valuable in etiologic studies of disease
Attributable risk is useful for Public Health guidelines and
planning
Advantages and disadvantages of
different study design

1. Discuss the advantages and the

disadvantages of cross-sectional studies
,case report/ series, case-control studies,
cohort studies and experimental studies.
2. Divide 5 groups (11-12 members)
3. Presentation on 29/9 (Just 1-2 slides)
4. Create 3 questions related to the study
designs
 DESCRIPTIVE STUDIES VS
ANALYTICAL STUDIES
DESCRIPTIVE STUDIES ANALYTICAL STUDIES

Used when little is known about Used when insight about various
the disease aspects of disease is available

Rely on preexisting data Rely on development of new

data (prospective)
Who, where, when
Why

Illustrates potential associations Evaluates the causality of

associations
Develop hypothesis
test hypothesis
 ANALYTICAL STUDIES:
Observational Vs Experimental
OBSERVATIONAL
STUDIES
No manipulation of study factors
No randomization of subjects.
Observe the pattern of exposure
and disease in the population.
Descriptive studies: cross-
sectional studies to generate
hypothesis.
Analytical studies: ecologic
studies, case-control studies and
cohort studies, to test
hypothesis.
EXPERIMENTAL
STUDIES
Manipulate the study factor or
the exposure and see the
outcome.
Randomize the study subjects:
subjects receiving exposure is
by chance not by choice.
Experimental study: Animal
studies, clinical trials, effect of
intervention.
Ethical consideration
Selection of Study
ASSIGNMENT
You are required to select public health literature
and write an appraisal of the article focusing on its
research process.
You are expected to read the article and searched
out additional information relating to the study
design or topic of discussion.
You should briefly introduce the article, focusing on
the key methodologic issues.
ASSIGNMENTcont
Your appraisal should include:
Research Problem
Literature Review
Variables
Hypotheses
Design
Sample
Data Collection
Ethical Considerations
Data Analysis
Discussion and Interpretation of Findings
Application to Nursing Practice
ASSIGNMENTcont
You can use this appraisal checklist:
http://www.casp-uk.net/casp-tools-checklists

http://joannabriggs.org/research/critical-appraisal-
tools.html