Cohort Study

Cohort Study
Prospective (concurrent/longitudinal study):
exposure to risk factor and subsequent health
outcomes are observed after the beginning of
the study

Retrospective (historical):
utilizes info on prior exposure to risk factor
and subsequent disease status
 Cohort Study
Time

Prospective: Onset of study

Onset of study
Retrospective:
Disease

Exposed
No disease

Eligible
subjects Disease

Unexposed

No disease

Direction of inquiry
PROSPECTIVE COHORT STUDY

2008 2011 Time

Onset of study

Disabled
Very low
Apgar score
No Disabled
Newborn
infants

Disabled
Higher
Apgar score
Not Disabled

Direction of inquiry
RETROSPECTIVE COHORT
STUDY 2008 Onset of study
2009 Time

Disabled
Very low
Apgar score
Newborn
infants
Not Disabled

Disabled
Higher
Apgar score
Not Disabled

Direction of inquiry
Comparison of retro- and prospective
cohort study
Attribute Retrospective Prospective
approach approach

Information < complete > complete

< accurate > acurate
Expense Less costly More costly
Completion time Shorter Longer
 Advantages
Direct calculation of risk ratio (relative risk)
May yield info on the incidence of disease
Clear temporal relationship between exposure
and disease
Particularly efficient for study of rare
exposures
 Advantages
Can yield info on multiple outcomes of a
particular exposure
Minimize bias
Strongest observational design for establishing
cause and effect relationship
 Disadvantages
Time consuming
Often requires a large sample size
Expensive
Not efficient for the study of rare diseases
Losses of follow-up may diminish validity
Changes over time in diagnostic methods may
lead to biased results
 Disadvantages

Over 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
 Subject selection
Selection of subjects for a cohort study is
influenced by various factors :
The type of exposure under investigation
Frequency of the exposure in the population
Accessibility of subjects and the likelihood of their
continuing participation

Exposed & unexposed groups must be free of

the outcome of interest at start of the study
 Subject selection
Exposed & unexposed groups must be
similarly eligible to develope the outcome of
interest during the course of study

If some subjects already have the outcome of

interest at the onset of the study, the temporal
relationship between exposure and outcome
will be obscured.
 Subject selection
Exposed Group
Type of exposure under investigation is

critical for selection of the exposed group

Feasibility (accessible and continuous

participation)
Degree of exposure depends on the goals of

the study (exposed/unexposed, range of

exposure levels)
 Subject selection
Unexposed Group
Feasibility issues same with exposed group

Should yield a fair comparison with exposed group

Unexposed persons should be sampled from the

same (or comparable) source population as the

exposed group
Multiple comparison groups of unexposed subjects

chosen in different ways may reinforce the validity

of the findings
 Data Collection
Exposure (Independent variable)
Essential to define the exposure clearly (intensity,

duration, regularity, variability)

A subject originally satisfies the criteria for

inclusion in cohort study should not subsequently be

excluded from the analysis due to change in
exposure status during follow-up (avoid biased
conclusion).
 Data Collection
Exposure (Independent variable)
Ex.

Use of anti nausea medication during pregnancy

& subsequent risk of spontaneous abortion.
The medication may be discontinued because of
early sign of abortion. Excluding this subject from
the analysis may result in an underestimateof the
true link between use of medication and risk of
abortion.
 Data Collection
Exposure (Independent variable)
It is possible that a change in exposure status

may indicate a change in outcome status

Potential for changes in exposure status

has important implication for the frequency

of follow-up
Frequent reassessment of exposure

and outcome status required if exposure status

changes over time
 Data Collection
Response (Dependent variable)
Before start of study, imperative that the

subjects do not have the outcome (disease)

under investigation (difficult if disease
develops slowly, insidious onset,
asymptomatic till late stages)
Same surveillance in exposed and unexposed

groups
 Data Collection
Response (Dependent variable)
Sources of outcome status

Records of hospitals and physicians

Periodic exams by investigators
Accuracy and reliability of diagnosis same
between groups
Standard diagnostic protocol
ANALYSIS OF COHORT STUDIES

Outcome*
Death No death Total

Exposed A B A+B

Unexposed C D C+D

Total A+C B+D A+B+C+D

* Outcome : death/disease
 A = Exposed persons who later die
B = Exposed persons who do not die
C = Unexposed persons who later die
D = Unexposed persons who do not die

The total number of exposed persons = A + B

The total number of unexposed persons = C + D
Among exposed persons, the RISK (R) of death is
defined as :

Exposed persons who die A

R(exposed) = =
All exposed persons A+B
 Among unexposed persons, the RISK (R) of death :
Unexposed persons who die C

R (unexposed) = =
All unexposed persons C+D

R (exposed) A / (A + B)
Relative Risk (RR) = =
R (unexposed) C / (C + D)

RR = A MEASURE OF THE STRENGTH OF ASSOCIATION

BETWEEN EXPOSURE AND OUTCOME
e.g.
Table 4. Relationship between 10-minute Apgar scores and
Risk of death in the first year of life among children with birth
weights of at least 2500 g.

Death No death Total

Apgar score 42 80 122

0-3
Apgar score 43 302 345
4 -6
Total 85 382 467

Nelson KB, Ellenberg JH : Apgar scores as predictors of chronic neurologic

Disability. Pediatrics 1981; 68-36
R(exposed) = 42 / 122 = 0.344 = 34.4 %

R( less exposed) = 43/345 = 0.125 = 12.5 %

42 43
RR = = 2.8
122 345

The RR of 2.8 means that newborns at this birth weight with very
low 10 minute Apgar scores are almost 3 times more likely to die in
the first year of life

RR < 1 = protective effect

RR = 1 = no effect
RR > 1 = harmful effect of exposure
Thank you