EPIDEMIOLOGIC STUDY

DESIGNS- OBSERVATIONAL
 Epidemiological studies

Epidemiological
study designs

Observational- Experimental-
Descriptive RCTs (individual&
Analytic community)
Clinical trials
ANOTHER CLASSIFICATION?
 Case series

Individuals
Cross-sectional
Descriptive
Populations Correlational

Epidemiological studies
Case control

Observational
Prospective
Cohort
Analytical Retrospective

Intervention Clinical trials

 Descriptive Studies
• Describe the general characteristics of the
distribution of a disease
– Person
– Place
– Time
• Correlational Studies
• Case Reports and Case Series
• Cross-Sectional Surveys
 So why proceed to an analytical study?

Often when we need to answer the following type of

questions:
• What is the source of infection for an outbreak of
diarrhoeal disease?
• What are the risk factors for neonatal tetanus?
• What factors are associated with increased mortality for
persons with measles?
• Does smoking cause lung cancer?

Analytical epidemiology
 Analytic epidemiology
• Attempts to provide the why? and how? of
health related events.
• Observational studies
– Case control studies
– Cohort studies
• Experimental studies
 Case control studies
• Aetiologic studies in which comparison are
made between individuals who have a disease,
cases and individuals who do not, controls
 Case-Control Study

Exposure
Disease
? (Case)

? No disease
(Control)

Retrospective Nature
 Major Steps in case-control study
• Define and select cases
• Select controls
• Ascertain exposures
• Compare exposure in cases and controls
–proportions/odds ratios ....
• Test any differences for statistical
significance
 What (Who) is a control ?
• A “case” AMAP except that they do not have
the disease (outcome).
• Must have same opportunity for exposure as
a case
• Must be subject to same inclusion&
exclusion criteria.
• No one control group is optimal for all
situations
• Scientific, economic and practical
considerations
 Principles of Control Selection
• From same study base (target population)
as cases
• Selected independently of exposure status!!
• If they had developed illness, they would
have been a case
• Comparable information to cases
 General Population Controls

• Advantages
– If all cases in general population known
– direct calculation of risk
• Disadvantages
– Cost
– Sampling frame
 Neighborhood Controls
• Advantages:
– Inexpensive,efficient
– Matched for potentially confounding variables
• Disadvantages
– Exposure related to neighborhood
– Potential bias
 Hospital Controls
• Advantages:
– Convenient
– Come from same catchment area
• Disadvantages:
– Control disease may be linked to exposure
– Hospitalized controls differ from general
population
 Friend Controls
• Advantages
– Convenient
• Disadvantages
– Bias
– Friends may share same exposure
 Analysis in Case Control Studies
 No calculation of rates
 Proportion of exposure
 Distribution of cases and controls according to exposure
in a case control study

Cases Controls

Exposed a b

Not exposed c d

Total a+c b+d

% exposed a/(a+c) b/(b+d)

Odd’s exposed a/c b/d

 Distribution of cases and controls according to consumption of bottled
water in a case-control study

Cases Controls

20 5
Bottled water

No bottled water
5 20

Total 25 25
% exposed 20/25=80% 5/25=20%

Odds exposed a/c=4 b/d=0.25

 Intuitively….

If the frequency of exposure is higher among

the cases than the controls,

then the incidence will probably be higher

among the exposed than the non-exposed.
 Distribution of cases and controls according to exposure in a case-
control study

Cases Controls
Exposed a b

c d
Not exposed
a+c b+d
Total

Odds Exp = a/c Odds Exp =

b/d
Cases Controls

a/c axd
Odds ratio (OR) =
a/(a+c) OR
b/d bxc
Distribution of cases and controls according to bottled water consumption in a
case-control study

Cases Controls

Exposed 20 5

Not exposed 5 20

25 25
Total

Odds Exp = Odds Exp =

Cases 20/5 Controls 5/20
20/5 20 x 20
a/(a+c) = = 16
Odds ratio (OR) = 5x5
5/20
 Strengths of Case Control Studies
• Rare diseases
• Multiple exposures
• Rapid, no latency period
• Small sample size
• Low cost
• No ethical problems
 Limitations of Case-control Studies
• No calculation of rates and risks
• Selection of controls difficult
• Not suitable for rare exposures
• Problems with recall
 Classical examples of case control studies
• Cigarette Smoking & lung cancer
• Drugs (Thalidomide) & congenital
malformation
• Maternal smoking & congenital
malformation
• Radiation & leukemia
• Oral Contraceptives & Hepatocellular cancer
Cohort study
 Definition of cohort
• A cohort was a 300- 600 man unit in the Roman
army
• A group of people marching through time from an
exposure to one or more outcomes
• The studies follow up two or more groups from
exposure to outcome
• The goal is usually to measure incidence
 Cohort identification
• A cohort can be defined by
– Population (single cohort with internal
comparison group)
– Exposure status (double cohort which consists
of exposed and unexposed groups)
• A cohort can be fixed or dynamic
– Fixed is defined by an event that has already
occurred and no new members can be added
– In dynamic members can come in and out
 Cohort identification
• Cohorts can be identified through

– Geographical area- e.g. Framingham study,

– Distinct and measurable exposures e.g.

studies of survivors of the Japanese atomic
bombs, Gay men
– Ease of follow up – e.g. British physicians
study, Nurses health study,
 Classification
• Prospective (concurrent)
– Cohort is assembled, baseline exams and data
collected for purpose of study

• Retrospective (historical)
– Cohort is assembled in the past on the basis of
records . Some data might be missing

• Bidirectional (mixed)
– Includes both elements
 Prospective cohort study
Investigator
begins study
here
Retrospective cohort studies
Information needs
to be available on Investigator
this population begins study
here
 Steps in conducting cohort studies
• Identify a cohort
• Determine exposure status at baseline
• Follow up over time
• Ascertain whether outcomes have
occurred at intervals or at the end
• Analyze data
 Analysis in cohort
• The unit of study is the individual
• Goal is to calculate incidence
– Cumulative incidence provided there is no loss to
follow up (censoring) or competing risks
– Incidence density – makes use of person time at risk
contributed by each individual
• Once incidence (I) is calculated for exposed and non-
exposed Relative Risk (RR) can then be calculated
• RR = I exposed/ I un-exposed
• One RR is obtained one can also get Attributable risk
(AR), PAR, etc
 Distribution of illness according to
exposure in a cohort study

ILL NOT ILL Risk

b a+b
a
a
Exposed a+b

Not exposed c d c+d c

c+d

Relative risk = Risk exposed / Risk not exposed

 Presentation of cohort data:
2x2 table

ill not ill

ate ham 49 49 98

did not eat

4 6 10
ham
Classical example: foodborne outbreak (cohort = all people who attended a
wedding for example)

ill not ill / Total Incidence

ate ham 49 49 98 50 %

did not
4 6 10 40 %
eat ham

Relative risk 50% / 40% = 1.25

 Strengths
• Allows for the study of rare exposures
• Allows for the measure of incidence
• Allows for the study of multiple outcomes of a single
exposure
• Allows for clearer description of the exposure- disease
time relationship
• Less prone to selection bias
• Less bias from outcome ascertainment if done
prospectively
 Limitations
• Prone to loss to follow up ( migration, refusal to
participate, withdrawals and deaths from competing
risks)
• If prospective costly and time consuming
• Inefficient for rare diseases
• Differential bias over time (exposures can change over
time)
• Exposure can change over time
• Multiple exposures = difficult
Classical Examples of cohort study
• 1951 study of smoking & lung cancer (Doll &
Hill)
• Framingham heart study (1948)