Cohort Study

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Cohort Study

Dr. Nanees Ahmed Ismail Gad


Prof. of Public Health
Community Medicine department
Learning Objectives

 Define the concept of Cohort and cohort study


 Describe the Steps and Design a cohort study considering
its main features
 Calculate and interpret Measures of Association in
Cohort Studies
 Identify the advantages and disadvantages of cohort
design
Concept of cohort:

In Epidemiology, the term “cohort” is defined as a group of


people who share a common characteristic or experience within
a defined time period.
e.g. Pregnant diabetics is a cohort, individuals born at specific
year is a birth cohort, students of this class is a cohort. .
Definition of cohort study

“The cohort study is an observational analytical study

Objective:
 to determine the incidence of disease

 to determine whether certain exposure is associated with a


given disease (outcome)
Steps in Designing a Cohort Study:

 1- Identify the study subjects; i.e. the cohort population: A disease-free


population (or a sample of this population) is identified
 2- The baseline exposure data are assessed: sample divide into 2 groups
(exposed and non-exposed cohort groups)
 3- Follow up of individuals of this cohort are for a defined period of time
in order to record the development of the outcome(s) of interest among
exposed and non-exposed groups. Unified tools should be used for follow up.
 4- Do the data analysis: the outcomes are assessed and compared?
Basic cohort (Prospective)
design
Study population or sample
Free from disease under study
no investigator
control

Risk factor RF
Present classification on
follow-up Absent
Exposed risk factor (RF)
for period Not exposed

Yes No Yes No
D+ D- D+ D- outcome of
interest
time

Compare the frequency of outcomes in exposed persons vs. not exposed


Diagrammatic cohort Example
Non Hypertensive
males aged
between 40 - 50
years

Follow up
Smokers (>20 for 5 years Non -
cig/day) smokers

+ve +ve
-ve (not -ve (not
(Hypertensio (Hypertensio
diseased) diseased)
n) n)
Types of cohort study

► Prospective cohort study


► Retrospective cohort study
► Constructive cohort study
Prospective cohort
Exposure status is determined in the current point of time and the
outcome in the future. (Present to future)

 Example: Framingham Heart Study.


Prospective cohort

Framingham Heart Study. (https://www.framinghamheartstudy.org/) A very long cohort


 It is the most famous study from which all risk factors of noncommunicable diseases are
derived.
 The original Framingham cohort was recruited between 1948 and 1950. It consisted of
5209 cardiovascular disease-free volunteers between the ages of 29 and 62 recruited
from the moderately sized town of Framingham, Massachusetts, USA.
 The FHS had over 14,000 people from three generations, in 1971 the FHS began
enrolling the second generation cohort, comprising the children of the Original Cohort and
the spouses of the children. In 2002, the third generation cohort, comprising the
grandchildren of the Original Cohort, was initiated to additionally explore genetic
contributions to CVD
 The study found high blood pressure and high blood cholesterol to be major risk factors
for cardiovascular disease.
Prospective cohort

 Pregnant women admitted for antenatal care in an MCH center, during


winter, 2020. The shortest cohort
 They are classified into exposed to smoking (active or passive) and a group
of unexposed to smoking in the first ante-natal visit.
 The two groups were followed up (for a maximum of nine months) till labor
and the newborns were examined for congenital abnormalities or low birth
weight.
Retrospective (historical cohort study)
Exposure status is determined in the past (eg. from records)
and the outcome in current point of time. (the exposure and
outcome occurred before the study) (Past to present)

 Example: Risk of cancer from occupational exposure to ionizing


radiation: retrospective cohort study of workers. worker information was
taken from existing records,
Combination of retrospective and prospective cohort studies

• “Reconstructive Cohort Study”. The cohort that started at a point of


time in the past and continue to follow the cohort members for a period of
time from now to a time-point in the future till developing of outcomes .
(Past to present to future)

• Example: A cohort of doctors graduated in1980 is assembled from the


medical school records and followed from now 2020 to 2025 for causes of
death.
Measures of association in cohort study:
Risk (incidence):

Risk (Incidence) is the probability that an individual will develop the disease
(outcome).

It is mathematically equal to the proportion of individuals who were free from the
disease and developed the disease within a specified period.

Example: If we start with 1000 healthy Egyptian males > 40 years in 11-2010
and follow them for five years, and we find out that 50 of them developed
hypertension then, we can say that the five years risk of hypertension in this
sample/population is 5%.
A) Measure of disease frequency

Exposure Disease status


status Yes No Total
Yes a b a +b

No c d c +d

a+c b+d N (a+b+c+d)

Incidence : (Risk) is the probability that an individual will develop the


disease (outcome).

Incidence among exposed: a/a+b

Incidence among non-exposed: c/c+d

Incidence among population (Ip): (a + c/(a+ b+ c+ d)


Measure of Association

1. Risk ratio or Relative risk (RR): it is a :


RR: Incidence among exposed /
a
incidence among unexposed
ab
c
For null hypothesis, Risk ratio will equal
cd
‘one’
Relative risk is a measure of the strength of the association between
exposure and outcome and indicates etiological relationship between
exposure and outcome i.e. the higher the relative risk the stronger the
etiological association.
If the relative risk = 1, the exposure is not associated with disease
If the relative risk is >1 then there is a positive association between the
exposure and the outcome and the exposure is a risk factor for that
disease.
Lastly, if the relative risk is <1, the exposure is a “protective factor”
from that disease or in other words, absence of this exposure is a risk
factor for the disease.
Example of cohort data

Total
Hypertension Free from
population
hypertension

Smokers 80 320 400


Nonsmokers 30 570 600
Total 110 890 1000
Measure of disease frequency

Incidence

• Incidence of hypertension in
smokers =80/400 =20% (0.2)
Hypertensio Total
Free from
• Incidence of hypertension in n
hypertension population
non-smokers =30/600 = 5% Smokers 80 320 400
(0.05)
Nonsmokers 30 570 600
Total 110 890 1000
• Incidence of hypertension in
the population = 110/1000= 11%
(0.11)
Measures of Association in cohort
1. The relative risk a
ab
= Incidence in the c
exposed/Incidence in the non- cd
exposed
• Relative risk in our example =
• 80/400 ÷ 30/600 Hypertensio Total
Free from
• 20/5 =4 n
hypertension population
• which means that smokers are
Smokers 80 320 400
4 times at a higher risk of
Nonsmokers 30 570 600
developing hypertension than
Total 110 890 1000
non-smokers
Measures of Association in cohort

2. Attributable risk OR Risk difference

Attributable risk (AR) is expressed as a rate not ratio

AR= is the difference between the incidence of disease among exposed - the incidence
of disease among non exposed = Risk (Exp) – Risk (Unexp) null hypothesis, Risk
difference will equal ‘zero’

AR provides information about the absolute number of cases that results from the
exposure

AR among exposed is the incidence rate of diseases among exposed individuals that can
be attributed to the exposure.

AR is expressed as cases per multiple of population ( per 100 or per 1000 or per 100000)
In our example (AR) = Incidence in
exposed – Incidence in non exposed Hypertensio Total
Free from
80/400 – 30/570 n
hypertension population
= 20 - 5 =15
Smokers 80 320 400
which means that there are excess
Nonsmokers 30 570 600
15 cases of CHD in every 100
Total 110 890 1000
smokers attributed to smoking.
Measures of Association in cohort

3. Attributable risk proportion % among exposed


Among exposed, what percent of the total risk for disease is
due to the exposure?
ARP = AR%
Incidence among exposed – incidence among non exposed
X100
incidence among exposed
ARP=20 – 5 /20 =15/20= 75%

which means that 75% of CHD among smokers are attributed


to (due to) smoking.
Measures of Association in cohort

4. Population attributable risk (PAR): PAR is the portion of the incidence


of a disease in the population (exposed and non-exposed) that is due
to exposure.

It is the incidence of a disease in the population that would be


eliminated if exposure were eliminated.

The PAR is calculated by subtracting the incidence in the unexposed


(Iu) from the incidence in total population (exposed and unexposed)
(Ip):
(Ip): (a c/(a b c d) 110/1000 = 11
PAR =11-5= 6
which means that there are excess 6 cases of CHD in every 100
population due to smoking.
Measures of Association in cohort

5. Population attributable risk percent (PAR%):


PAR% is the percent of the incidence of a disease in the population
(exposed and nonexposed) that is due to exposure.

It is the percent of the incidence of a disease in the population that


would be eliminated if exposure were eliminated.

The PAR% is calculated by dividing the population attributable risk


(PAR) by the incidence in the total population and then multiplying
the product times 100 to obtain a percentage:
6/11*100 = 54.5%
Means that 54.5% of the incidence of a disease in the
population is due to smoking and would be eliminated if
exposure were eliminated
Advantages of cohort studies:

1. Incidence rate can be calculated


2. Temporal relationship between exposure and outcome is preserved
3. Several possible outcomes related to a single exposure can be studied
e.g., effect of smoking on hypertension. Cohort over time may yield many
outcomes as myocardial infarction , stroke, lung cancer, peptic
ulcer….……..
4. Cohort studies provide a direct estimates of relative risk.
5. Free from recall bias
6. Dose-response effect can be studied
7. Suitable for examining rare exposures
Disadvantages of cohort studies:

1. Cohort studies involve a large number of people.


2. It takes a long time to complete the study.
3. Unsuitable for rare diseases or outcomes with low incidence in the
population
4. Loss of individuals (attrition) during follow-up may be due travelling
migration, death or loss of interest.
5. Expensive in term of cost and effort consumed. .
6. The study itself may change people behavior e.g. changing smoking habits.
7. With any cohort study we may be faced with ethical problems. Sometimes,
the investigator has to intervene and if possible to reduce or eliminate the
factor.
Types of bias

► Selection bias
► Follow-up bias (Migration Bias)
► Information bias (Exposure misclassification or Disease
misclassification)
Thank you
Thank you

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