Study Designs: Observational / Analytical Studies

CHP400:
Community Health Program- lI

STUDY DESIGNS
Observational / Analytical Studies
Time is Key
Research
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Present:
Present: Exposure
Disease &
Future: Disease
Methodology Exposure
Cross - section
Cohort
Case
 Case - control
Control
Studies Present: Disease
Past: Exposure
Content
 Definition and importance of Case - Control Studies

 Design
 Selecting Cases
 Selecting Controls
 Assessing Exposure: Odds Ratio (OR)
 Advantages
 Disadvantages
Research Methodology
STUDY DESIGNS
Observational Experimental
Animal
Descriptive Analytical Experiment
Case report
Case
Case
Control
control
Case series Studies Human
Intervention
Cross section Cohort Clinical trial
Ecological
STUDY DESIGNS
Case - Control Studies
Definition:
It is a type of observational analytic
epidemiologic investigation in which
subjects are selected on the basis of whether
they do or do not have the particular
disease under study.
STUDY DESIGNS
Importance:
 The most frequently undertaken analytical
epidemiological studies
 The only practical approach for identifying risk factors
for rare diseases
 They are best suited to the study of diseases for which
medical care is sought, such as cancers or hip fracture
STUDY DESIGNS
Design :
 At baseline:
 Selection of cases (disease) and controls (no

disease) based on disease status
 Exposure status is unknown
 Retrospective design – lacks temporality!

STUDY DESIGNS
Design :
Exposed
Diseased
(Cases)
Not Exposed
Target
Population
Exposed
Not Diseased
(Controls)
Not Exposed
STUDY DESIGNS
Design :

EXPOSURE OUTCOME/DISEASE
TIME
? YES
? NO
STUDY DESIGNS
Selecting Cases:
 Select cases after the diagnostic criteria and

definition of the disease is clearly established
 Selected cases should be representative of all

cases
STUDY DESIGNS
Selecting Cases:
 The study need not include all cases in the

population
 Cases may be selected from hospitals, clinics,

disease registries, screenings, etc.
STUDY DESIGNS
Selecting Cases:
 Incident cases are preferable to prevalent cases for
reducing
(a) recall bias and
(b) over-representation of cases of
long duration
 The most desirable way to obtain cases is to
include all incident cases in a defined population
over a specified period of time
STUDY DESIGNS
Selecting Controls:
 Controls should come from the same population
at risk for the disease as the cases
 Controls should be representative of the target
population
STUDY DESIGNS
Selecting Controls:
 Multiple controls can be used to add statistical
power when cases are difficult to obtain
 Using more than one control group lends
credibility to the results
 More than 3 controls for a case is usually not cost-
efficient
Selecting Controls:
Sources of cases and controls
CASES CONTROLS
All cases diagnosed in the Sample of general population
community
All cases diagnosed in a sample Non-cases in a sample of the
of the population population
All cases diagnosed in all Sample of patients in all

hospitals hospitals who do not have the
disease
All cases diagnosed in a Sample of patients in the same
single hospital hospital who do not have the
disease
Any of the above methods Spouses, siblings or associates
of cases
STUDY DESIGNS
Analysis: Odds Ratio (OR)

 A ratio that measures the odds of exposure
for cases compared to controls
 Odds of exposure = number exposed 

number unexposed
 OR Numerator: Odds of exposure for cases

 OR Denominator: Odds of exposure for
controls
STUDY DESIGNS

Disease Status
CHD cases No CHD
(Cases) (Controls)
Exposure Smoker 112 a b 176

Non- c d
Status 88 224
smoker
Total 200 400
Odds Ratio = a b
=
ad
=
112 x 224
= 1.62
c d bc 176 x 88
Interpreting the Odds Ratio (e.g)
OR<1 OR=1 OR>1
Odds of exposure Odds of Odds of exposure

Odds exposure are for cases are
for cases are less
comparison equal among greater than the
than the odds of
between cases cases and odds of exposure
exposure for
and controls controls for controls
controls
Exposure Exposure is not

Exposure
Exposure as a reduces a risk factor nor
increases
risk factor for disease risk a protective
disease risk
the disease? (Protective factor
(Risk factor)
factor)
STUDY DESIGNS

Interpreting the Odds Ratio
The odds of exposure for cases are 1.62 times the odds
of exposure for controls.
Those with CHD are 1.62 times more likely to be

smokers than those without CHD
STUDY DESIGNS
Possible Sources of Bias and Error
 Information on the potential risk factor (exposure) may not

be available:
- either from records
- or the study subjects’ memories

STUDY DESIGNS
Case - Control Studies cont.
 Cases may search for a cause for their disease and
thereby be more likely to report an exposure than
controls (recall bias)
 The investigator may be unable to determine with
certainty whether the suspected agent caused the
disease or whether the occurrence of the disease caused
the person to be exposed to the agent
STUDY DESIGNS
Case - Control Studies cont.
 Identifying and assembling a case group

representative of all cases may be unduly difficult
 Identifying and assembling an appropriate control
group may be unduly difficult
STUDY DESIGNS
Advantages:
 Quick and easy to complete, cost effective
 Most efficient design for rare diseases
 Usually requires a smaller study population

than a cohort study
 Several exposures can be studied.

STUDY DESIGNS
Disadvantages:
 Uncertainty of exposure-disease time relationship
 Inability to provide a direct estimate of risk
 Not suitable for studying rare exposures
 Subject to biases (recall & selection bias)

Summary
Case-control study:
Observational, analytic study.
Most frequently undertaken analytical studies
Quick and easy to complete, cost effective
Most efficient design for rare diseases
Subjects are selected on the basis of presence or

absence disease under study
Odds Ratio (OR)

Study Designs: Observational / Analytical Studies

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CHP400:

Community Health Program- lI

 Definition and importance of Case - Control Studies

 Selection of cases (disease) and controls (no

 Exposure status is unknown

 Retrospective design – lacks temporality!

 Select cases after the diagnostic criteria and

 Selected cases should be representative of all

 The study need not include all cases in the

 Cases may be selected from hospitals, clinics,

All cases diagnosed in all Sample of patients in all

Analysis: Odds Ratio (OR)

 Odds of exposure = number exposed 

 OR Numerator: Odds of exposure for cases

Analysis: Odds Ratio (OR)

Exposure Smoker 112 a b 176

Odds of exposure Odds of Odds of exposure

Exposure Exposure is not

Analysis: Odds Ratio (OR)

Those with CHD are 1.62 times more likely to be

Possible Sources of Bias and Error

 Information on the potential risk factor (exposure) may not

- either from records

- or the study subjects’ memories

 Identifying and assembling a case group

 Quick and easy to complete, cost effective

 Most efficient design for rare diseases

 Usually requires a smaller study population

 Several exposures can be studied.

 Inability to provide a direct estimate of risk

 Not suitable for studying rare exposures

 Subject to biases (recall & selection bias)

Most frequently undertaken analytical studies

Quick and easy to complete, cost effective

Most efficient design for rare diseases

Subjects are selected on the basis of presence or

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