Epidemiological Study Designs And

Measures Of Risks
(2)
 Objectives of the Lecture
• To describe observational study designs
• To describe experimental study designs and
clinical trials
• Calculation and interpretation of measures of
risk
 Case stud.

Descriptive stud.

Surveys
Non intervention
stud.
(Observational)
Ecological
(correlational)

Analytical stud.
Cross-sectional
(Prevalence)

Study designs

Case con. Stud.

Randomized control (case-reference)
Trials (Clinical trials)

Intervention stud. Cohort stud.

(Experimental) Non-randomized (Follow-up)
trials
(Quasi-experimental
study)
 Cohort Study
• Cohort study is type of analytical studies.
• Distinguishing features:
A. Cohort identified before appearance
of disease under investigation.
B. Study groups observed over period of
time to determine frequency of the
disease.
C. Study proceeds forward from cause to
effect.
Cohort study is undertaken to support the existence
of association between suspected cause and disease

A major limitation of cross-sectional surveys and case-

control studies is difficulty in determining if exposure or
risk factor preceded the disease or outcome.
Cohort Study

Key Point:

Presence or absence of risk factor is

determined before outcome occurs.
Concept of cohort:
Cohort in epidemiology defined as a group of
people who share a common characteristic or
experience with in defined period time.
longitudinal
Prospective studies
Forward looking study I
Incidence study
starts with people free of disease
assesses exposure at “baseline”
assesses disease status at “follow-up”
• Indications of cohort studies:
When there is good evidence of exposure and
disease.
When exposure is rare but incidence of
disease is higher among exposed
When follow-up is easy, cohort is stable
When ample funds are available
If attrition of study population can minimized.
Design of a Cohort Study
 Time

Direction of inquiry

Disease
Exposed
People No disease
population
without the
disease Disease
Not
exposed
No disease
 Framework of a cohort study
• General consideration to be taken:
1. Cohorts must be free from the disease under study.
2. Both groups should be equally susceptible to the
disease under study.
3. Both groups should be comparable in all possible
variables.
4. Diagnostic & eligibility criteria must be defined
beforehand.
• Elements of a cohort study
1. Selection of study subjects.
2. Obtaining data on exposure.
3. Selection of comparison groups.
4. Follow up.
5. Analysis.
 Selection of study subjects
General population
Whole population in an area
A representative sample
Special group of population
Select group
occupation group / professional group (Dolls study )
Exposure groups
Person having exposure to some physical, chemical or biological
agent
e.g. X-ray exposure to radiologists
 Obtaining data on exposure
Personal interviews / mailed questionnaire
Reviews of records
Dose of drug, radiation, type of surgery etc
Medical examination or special test
Blood pressure, serum cholesterol
Environmental survey

By obtaining the data of exposure we can classify

cohorts as
Exposed and non exposed and
By degree exposure we can sub classify cohorts
 Selection of comparison group
Internal comparison •
Only one cohort involved in study –
Sub classified and internal comparison done –
External comparison •
More than one cohort in the study for the purpose of –
comparison
e.g. Cohort of radiologist compared with ophthalmologists –
Comparison with general population rates •
If no comparison group is available we can compare the –
rates of study cohort with general population.
Cancer rate of uranium miners with cancer in general –
population
 Follow-up
To obtain data about outcome to be determined •
(morbidity or death)
Mailed questionnaire, telephone calls, personal interviews –
Periodic medical examination –
Reviewing records –
Surveillance of death records –
Follow up is the most critical part of the study –
Some loss to follow up is inevitable due to death •
change of address, migration, change of occupation.
Loss to follow-up is one of the draw-back of the •
cohort study.
 ANALYSIS

Calculation of incidence rates among exposed •

and non exposed groups

Estimation of risk •
 Incidence rates of outcome
Disease Status Framework •
Yes No Total

a b a+b
Study
Yes
Exposure cohort

Status
c d c+d
No Comparison
cohort

a+c b+d N
 Incidence rate

Among exposed = A/(A+B)

Among non- exposed = C/(C+D)

• After the end of follow up , if
• Incidence of disease in exposed (A/(A +B) >
in non-exposed(C/(C+D) this suggest
disease & factor are associated.
• Cohort studies are frequently referred to as
prospective .
2. Estimation of risk( outcome ):
A. Relative risk.

RR=incidence of diseases in exposed

incidence of diseases in non- exposed
RR measure strength of association.
RR>1 mean positive association.
B. Attributable risk: is the difference in
incidence rates between exposed & non-
exposed.

AR=I.R(exposed)-I.R(non-exp) *100
I.R(exposed)
Smoking Lung cancer Total

YES NO

YES 70 6930 7000

NO 3 2997 3000

73 9927 10000

Find out RR and AR for above data

Incidence of lung cancer among smokers •
70/7000 = 10 per 1000
Incidence of lung cancer among non-smokers •
3/3000 = 1 per thousand
RR = 10 / 1 = 10
(lung cancer is 10 times more common among
smokers than non smokers)
AR = 10 – 1 / 10 X 100
= 90 %
(90% of the cases of lung cancer among smokers are
attributed to their habit of smoking)
• TYPES OF COHORT STUDIES

1. PROSPECTIVE COHORT S.
2. RETROSPECTIVE COHORT S.
3. COMBINATION
1.Prospective cohort studies:(current)
In which outcome has not yet occurred at the
time of investigation begins.

2.Retrospective cohort S.(historical)

factors occurred before start of investigation.
 3. Combination of retrospective &
prospective :
• The cohort is identified from past records &
is assessed of date for the outcome. The
same cohort is followed up prospectively
into future for further assessment of
outcome.
Advantages & disadvantages of cohort
studies:
• Advantages:
1. calculate incidence rate.
2. can study several outcomes related to
exposure simultaneously.
3. provide direct estimate of relative risk.
4. can calculate dose-response ratios.
5. can minimized certain bias.
• Disadvantages:

1. Takes long time.

2. Certain administrative problems are
inevitable (loss of fund, experienced s).
3. Selection of comparison groups is limiting
factor.
4. Changes in standard methods or
diagnostic criteria.
5. Are expensive.
6. Usual lose a substantial proportion of the
original cohort.
7. Study may affect people behavior.
8. Ethical problems.
 Differences between cohort & case –
control studies:
Case control study cohort study
1.proceed from ( effect to Proceed from(cause to
cause) effect)

2.starts with disease Starts from risk factor

3.test if suspected cause Test if disease occur
occur more in diseased more in exposed than
than non-diseased. non-exposed.
Case control study Cohort study

4.involves fewer number Involves large number of

of subjects subjects

5.relatively get quick Long follow up lead to

results delayed results.

6.suitable for study of Inappropriate in rare

rare diseases diseases or exposure.

7.yields only estimate of Yields incidence rate, RR

RR(odds ratio) as well as AR

8.relatively inexpensive expensive

 Experimental Study Designs

In experimental studies the researcher

manipulates a situation and measures its effect
after that

Type:
1- Randomized control trials
2- Non-randomized trials
 1) RANDOMIZED CONTROLLED TRIALS

Those trials are used for assessment of methods

of treatment and prevention.

They include:
- intervention
- control groups and
- randomization
 Features of Randomized control trials
1- Manipulation:
The researcher does some intervention (Example
provision of new drug) to one of the study groups.
2- Control:
The researcher introduces one or more control groups
to compare with the experimental group
3- Randomization:
Each subject have an equal chance of being allocated to
either of the two groups( study and comparison
groups)
 Steps
1. Drawing a protocol.
2. Selecting comparison & experimental groups
3. Randomization.
4. Manipulation (intervention).
5. Follow up.
6. Assessment of the outcome.
 RANDOMIZATION

 Randomization is the statistical procedure by

which the participants are allocated into groups
usually called study & control groups to receive
or not to receive intervention.
 RANDOMIZATION

 Randomization ensures that the investigator

has no control over the allocation of the
participants to either the study or control
group, thus eliminating the selection bias.

 Randomization is best done by using

statistical random table.
 MANIPULATION
 Manipulation or intervention is usually done by
application or withdrawal of the suspected
factor e.g. drugs, vaccine or dietary factor.

 This manipulation creates an independent

variable (drug, or new procedure) which effect is
then determined by the measurement of the
final outcome which is the dependent variable
e.g. incidence of disease, recovery.
 FOLLOW UP
 This includes examination of the study &
control groups subjects at defined intervals of
time in standard manner under the same
conditions in the same time frame till the final
assessment.

 The main difficulties in the follow up process

include: Attrition from:- death, migration,
displacement and loss of interest etc
 ASSESSMENT
The final assessment of the trial is carried in
terms of:
 Positive results:
These include the benefits of the
experimental study such as reduced incidence of
the disease or severity of the disease, cost of
health services or other appropriate outcome.
 Negative results:
These include the severity & frequency of side-
effects and complications.

 The incidence of positive/negative results is

compared in both groups and the differences
are tested statistically.
2- Non-randomized trials
 a. QUASI-EXPERIMENTAL STUDY DESIGNS

• At least one of the characteristics of the true

experiment is missing (RANDOMIZATION OR
CONTROL GROUP)

• Example: effect of health education of the level of

participation of village population in an
immunization campaign.
 Blinding.

Blinding is carried in three ways:

1. Single blind trial:

The participant is not aware whether he
belongs to the study or control group.
2. Double blind trial:
Neither the doctor nor the participant is aware
of the group allocation and treatment received.

3. Triple-blind trial:
The participant, the investigator & the person
analyzing the data are all blind.
This is the ideal but double-blinding is the most
commonly used.
 DISADVANTAGES OF EXPERIMENTAL STUDIES

• They are costly.

• Ethical problems.
• Feasibility is difficult.
 Summary

• What are the different study designs

• Enumerate measures of the risk

Thanks