Cohort Study Design

Objectives:
•Definition of cohort design
•Design advantages and disadvantages
•Framework of cohort design
•Indications for cohort studies
•Types of cohort study designs
•Elements of cohort study
•Review of measures of disease occurrence (risk, relative risk and attributable risk)
•Potential biases and confounding effect
•Example of a cohort study

Team Members:
Ghaida Alsaeed - Doaa Walid - Hatem Alnddah - Abdulmohsen Alghannam
Team Leaders: Rawan Alwadee & Mohammed ALYousef
Revised By: Basel almeflh

Resources:
• 436 Lecture Slides + Notes

Important – Notes
 Elements of Cohort Study
Steps:
1. selection of study subjects
•A group of people without the outcome is 2. Obtaining data on exposure
identified 3. Selection of comparison groups
•Followed 4. Follow-up
•Outcome ascertainment 5. Analysis of data

Cohort
study

Types of cohort study : Strengths:

-Prospective cohort (concurrent): •Is of a particular value when the
When the cohort is assembled at the exposure is rare
present time and is followed up toward •Can examine multiple effects of a single
the future exposure
-Retrospective cohort (nonconcurrent, •Can elucidate temporal relationship
historical): between exposure and disease
A cohort is identified and assembled in
the past on the basis of existing records •If prospective, minimizes bias in the
and is “followed” to the present time ascertainment of exposure

-Mixed •Allows direct measurement of

incidence of disease in the exposed and
nonexposed groups
Cohort Study
- Term "cohort" is defined as a group of people who share a common characteristic or experience within a
defined time period (e.g., age, occupation, exposure to a drug or vaccine, pregnancy, and insured persons). You
take a group and you follow them over time
- The comparison group may be the general population from which the cohort is drawn, or it may be another
cohort of persons thought to have had little or no exposure to the substance in question, but otherwise similar.
- Cohort study is another type of analytical (observational) study.
- It is usually undertaken to obtain additional evidence to refute or support the existence of an association
between suspected cause and disease. In Cohort study there are two groups: 1- Main group 2- Comparison group.
- The objective of a cohort study is to investigate whether the incidence of an event is related to a suspected
exposure In Cohort study we measure the incidence to calculate the relative risk " ‫" اﺣﻔظﮫ ﻣﺛل اﺳﻣك‬
Steps

1- A group of people without the outcome is identified

2- Followed
3- Outcome ascertainment

Elements of Cohort Study

1. Selection of study subjects*

2. Obtaining data on exposure
3. Selection of comparison groups**
4. Follow-up
5. Analysis of data:

The data are analyzed in terms of:

1. Incidence rates of outcome among exposed and non-exposed
2. Estimation of risk

*e.g. The effect of Methotrexate (drug for rheumatoid arthritis) on

developing cardiovascular disease in Rheumatoid patients;
The exposure: is the drug / The population: is rheumatoid patients / The
outcomes: cardiovascular disease.
‫ﯾﻌﻧﻲ ﻧﺟﯾب ﻣﺟﻣوﻋﯾﺗﯾن ﻣن ﻣرﺿﻰ اﻟروﻣﺎﺗوﯾد وﺣدة ﻣﻧﮭم ﺗﺎﺧد ﻣﯾﺛﺎﺗروﻛﺳﯾت واﻟﺛﺎﻧﯾﺔ ﻣﺎ ﺗﺧد‬
‫ وھل ﻓﻌﻼ ﻓﻲ ﻋﻼﻗﺔ ﺑﯾن اﻟﻣﯾﺛﺎﺗروﻛﺳﯾت‬,‫ﻣﯾﺛﺎﺗروﻛﺳﯾت؛ وﻧﺷوف ﻣﯾن ﻣﻧﮭم ﯾﺟﯾﮫ أﻣراض اﻟﻘﻠب‬
‫واﻹﺻﺎﺑﺔ ﺑﺄﻣراض اﻟﻘﻠب؟‬

**Comparison group can be one of two ether General

population or Internal comparison group.
‫ﯾﻌﻧﻲ ﻟو طﺑﻘﻧﮭﺎ ﻋﻠﻰ اﻟﻣﺛﺎل إﻟﻲ ﻗﺑل ﯾﻌﺗﺑر اﻧﺗﯾرﻧﺎل؛ ﻷن ﻛل اﻟﻘروﺑﯾن ﻣرﺿﻰ‬
‫ ﺑﯾﻧﻣﺎ ﻟو ﻗروب ﻣرﺿﻰ روﻣﺎﺗوﯾد واﻟﻘروب اﻵﺧر ﻣن ﻋﺎﻣﺔ اﻟﻧﺎس ھﻧﺎ‬،‫روﻣﺎﺗوﯾد‬
.‫ﯾﻌﺗﺑر ﺟﯾﻧﯾرال‬
!The internal is better
 Disease Total
Cohort
1. Incidence rates: Yes No
who developed the disease over
the total. Exposed to a putative a b a+b
Among exposed= a/a+b etiologic factor
Among non-exposed= c/c+d Non exposed to a putative c d c+d
etiologic factor

Disease Total
Cohort
2. Relative risk (RR) = a/(a+b) /c/(c+d) Yes No
The Incidence of exposed over the
Exposed to a putative a b a+b
incidence of non-exposed.
etiologic factor
Non exposed to a putative c d c+d
etiologic factor

Disease Total
Cohort
Yes No
3. Attributable risk (AR)= is the
difference in the disease rates in Exposed to a putative a b a+b
exposed and unexposed individuals etiologic factor
Non exposed to a putative c d c+d
etiologic factor

• Q: When the event of interest is a newly developed disease, what we should do with the
prevalent cases?

• Incidence can be estimated as the number of events

occurring during the follow-up period divided by the
number of subjects in the cohort at baseline minus
one-half of the losses

• 4/[1000-(1/2 X 7)] = 4.01/1000

• In this example,
• 1000 people started the study and followed up
• 4 eventually have the outcome “ events “
• 7 lost to follow up “ see the arrows “
• Incidence = number of outcome / (number of subjects started the study - 0.5
* number of subjects who lost to follow up )
• The subjects are classified according to their exposure
status

• Then, the incidence of the outcome of interest

(usually a disease) is ascertained and compared across
exposure categories

Example
• Calculate the incidence of disease in exposed
3 / 500 - ( 0.5 * 4 ) = 0.006

• Calculate the incidence of disease in unexposed

1 / 500 – ( 0.5 * 3 ) = 0.002

• Calculate the relative risk (risk ratio)

0.006 / 0.002 = 3 There is association because it is > 1

• > 1 There is association

• < 1 Protective role

• = 1 No risk nor Protection

➢ An important assumption for the calculation of incidence in a cohort study is that individuals who are lost to
follow-up are similar to those who remain under observation
Types of cohort studies
Three types of cohort studies have been distinguished on the basis of the time of occurrence of disease in
relation to the time at which the investigation is initiated and continued:
1. Prospective cohort studies (concurrent): forward

When the cohort is assembled at the present time and is followed up toward the future
2. Retrospective cohort studies (nonconcurrent, historical):backward **

A cohort is identified and assembled in the past on the basis of existing records and is “followed” to the

present time
** Don’t get confused with Retrospective and case control, even we go back in time we still looking for the exposure first !!

3. A combination of retrospective and prospective cohort studies

Strengths
• Is of a particular value when the exposure is rare

• Can examine multiple effects of a single exposure

• Can elucidate temporal relationship between exposure and disease

• If prospective, minimizes bias in the ascertainment of exposure

• Allows direct measurement of incidence of disease in the exposed and nonexposed groups

Limitations
• Is inefficient of the evaluation of rare diseases “ the best design for rare diseases CASE CONTROL “

• If prospective, can be extremely expensive and time consuming

• If retrospective, requires the availability of adequate records

• Validity of the results can be seriously affected by losses to follow-up “ especially if the losses are in one group more
than other or all of the losses are sharing the same demographic characteristics “
 Advantages and disadvantages of cohort studies

Advantages Disadvantages
Incidence, Relative Risk and Attributable Risk It involves a large number of people
can be calculated.
Several possible outcomes related to It takes a long time to complete the study and
exposure can be studied simultaneously. obtain results. And very expensive.
You can calculate many outcomes
It provides a direct estimate of relative risk. It is unusual to lose a substantial proportion of
the original cohort.

Dose response ratios can also be calculated. Selection of comparison groups which are
representative of the exposed and unexposed
segments of the population is a limiting factor.

Since comparison groups are formed before There may be changes in the standard
disease develops, certain forms of bias can methods or diagnostic criteria of the disease.
be minimized like mis-classification.

Framework of a cohort study

In contrast to case control studies which proceed from "effect to cause", the basic approach in cohort studies is to
work from "cause to effect“

Case control is the opposite to Cohort So in Cohort, there is a group of ppl who don’t have the disease
Case control > we start from the disease but they are Exposed to Risk factor.
Cohort > we start from Exposure or risk factor The main purpose of Cohort is to measure the association between
E.g. you recruited 100 patients and you want to study the the risk factor or exposure and the disease, and we want to see will
risk of smoking, dose the researcher start from the this risk factor lead to a certain disease or not.
outcomes (disease) or start from the Exposure?
If they start with the exposure it is Cohort
If they start with the disease it is Case-Control

So here you follow them

over time to see, how
many who are exposed
develop the disease, and
how many who are not
exposed develop the
disease

Schematic diagram of the design of cohort studies

4. Indications for cohort

studies:
1. When there is good evidence of an association or causal relationship between exposure and disease.*
2. When exposure is rare, but the incidence of disease high among exposed, e.g. special exposure groups like
those in industries, or exposure to X-rays.
3. When attrition of study population can be minimized, e.g. follow-up is easy, cohort is stable, cooperative
and easily accessible.
4. When ample funds and time are available. * e.g. Does eating too much sugar increase the risk of diabetes?
Does drinking too coffee cause heart disease?
Difference between Cohort and Case-Control Study :

Case-Control Cohort
The key
of any
Proceeds from "effect to cause" Proceeds from "cause to effect" question
if you
Starts with the disease Starts with people exposed risk factor or have a
suspected cause scenario
in the
Tests whether the suspected cause occurs Tests whether disease .occurs more
exam .
more frequently in those with the disease frequently in those exposed, than in those
than among those without the disease not similarly exposed

Involves fewer number of subjects Involves larger number of subjects

Yields relatively quick results Long follow-up period often needed,

involving delayed results
Suitable for the study of rare diseases Inappropriate when the disease or exposure
under investigation is rare
Generally yields only estimate RR or OR Yields incidence rates, RR and AR

CANNOT yield information about diseases CAN yield information about more than one
other than that selected for study disease outcome

Potential Biases: main biases with Cohort

study
1. Non response > no response from people, so the results will be underestimated > false results > error.
2. Loss to follow up with time > Long time > people may die or refuse to continue. The main problem in cohort.
3. Measurement errors in exposure > errors in the tools of measurement.

Confounding Effect
o Confounding is a distortion (inaccuracy) in the estimated
measure of association that occurs when the primary
exposure of interest is mixed up with some other factor
that is associated with the outcome.

o In the figure, the primary goal is to ascertain the strength of

association between physical inactivity and heart disease.

o Age is a confounding factor because it is associated with the

exposure (meaning that older people are more likely to be
inactive), and it is also associated with the outcome
(because older people are at greater risk of developing
heart disease). For a confounding factor, It is important to associate
or link with both the exposure and the outcomes.
Summary
•Cohort studies are observational in nature and are useful in comparing risks in subgroups of populations
within a specific time frame
•Availability of data from previous years can lead to less expensive estimates for Risk, RR, and AR, using a
retrospective cohort study
•Prospective Cohort studies are expensive in time and resources, in addition to estimates of Risk, RR and
AR , provide a causal link between risk factors and disease/other outcomes e.g. cancer.

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Female slides

Example of Cohort
Study:

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