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Epidemiologic Study Designs

Epidemiologic Study Designs

CaseControl
study

Crosssectional
study

Hierarchy of Epidemiological Study Designs

Hierarchy of Epidemiological Study Designs

Cross-sectional
studies
Case-Control
studies

Strength of evidence
Strongest

Weakest

Meta-analysis of RCT
Randomized Controlled Trials
Community Intervention Design
Quasi Experimental design
Meta-analysis of observational st.
Cohort Design
Cross-sectional design
Case-Control design
Case series
Case report

Case-Control Studies

Synonyms

Retrospective study
Case reference study
Case comparison study
Case history study

Definition
An epidemiological approach in
which the researchers start by
picking up cases (with disease) and
controls (without the disease) and
finds out the presence of particular
exposure which he/she thinks is a
risk factor and compares the two
groups as regards the presence of
exposure

Design of a Case-control study

Advantages
Inexpensive, requires only a few subjects gives
quick results
Well suited for diseases which have a long latent
period (e.g. cancers, AIDS, MI, CVA etc.)
Well suited for an outcome which is rare
Well suited for conditions in which medical care is
usually sought
Helps in examining multiple etiologic factors - once
we have the cases of the disease, we can take
history of all the factors that we feel may be risk
factors
Reasonably good for diseases that have a
relatively rapid onset and are usually hospitalized
(e.g. most of the acute infections; injuries etc.)

Disadvantages
Not a good method for studying rare exposures
Does not give any idea of incidence or
prevalence; it only gives us a measure of Odds
Ratio (OR)
Particularly prone to various forms of selection
and information biases, particularly survivorship
Bias, Recall Bias and observers bias.
Temporal Relationship is usually only a matter
of conjecture but not a proof

Designing and Conducting


a Case-Control study
1. Specify the total population and actual (Study)
population
2. Specify the major study variables and their
scales of measurement
3. Calculate the sample size
4. Specify the selection criteria of cases
5. Specify the selection procedure of controls
6. Specify the procedures of measurement and
specially take care to ensure validity and reliability
7. Do a pilot study
8. Conduct the study
9. Analysis of data

1: Specify total population and


actual (Study) population
Gives us an complete idea of study
population
Cases and controls should represent
the same population

2: Specify the major study variables


& their scales of measurement
Outcome Variable: Dichotomous scale
i.e disease present or absent
Exposure Variable: Particular cause
associated with disease
Scales of measurement of exposure
variable: Dichotomous
Potential confounding Factors: Through
literature and expert discussion

3: Calculate the Sample Size


Z

1-/2

+z

1-

)2 * p

*q
n=
----------------------------(p1 - p0)2

where, n = minimum sample size for each group;


Z 1-/2 = value of alpha error; z 1-= value of beta
error; For the usual situation when alpha error =
0.05 two tailed, the value is 1.96 and for beta
error = 0.20, it is 0.84; P0= Proportion of those
without the exposure who are likely to develop
the outcome (in a prospective study) or
Proportion of those without the outcome who are

4: Specify the selection criteria of


cases
Diagnostic Criteria:
Clear-cut (Preferably by expert bodies)

State inclusion and exclusion criteria:

Inclusion criteria had a reasonable chance of exposure


Exclusion criteria no exposure

Source of cases:

Hospitals, OPDs, General Practitioners, community

Incident or Prevalent cases:

Newly occurring or already having disease


Incident cases are better

Methods of Sampling:

Systematic random sampling


Simple random sampling

5: Specify the selection procedure


of controls
Source :
hospital based or population based
Advantages and Disadvantages

Exclusion / Inclusion Criteria:


same as for cases

Number of controls per case:


At least 1 control per case

Number of Control groups:


Usually one group
Two groups can improve validity like hospital and
community

Matching:
list out all confounding factors, as well as universal
confounding factor age, sex etc.

6: Specify the procedures of


measurement
Selection and information biases
Specially take care to ensure validity
and reliability
Questionnaire

7: Do a Pilot Study
Pre-testing of part of a sample
In order to improve the actual
studys quality and efficiency
Can reveal deficiencies in the design
of a proposed study
Bias can be avoided

8: Conduct the Study


Validity
Anemia:

Reliability
Check for variations due to
Observer
Subjects
Instruments and techniques

9: Analysis of Data
Calculate
Odds Ratio with 95% Confidence Interval
Testing of Hypothesis
Use Chi-square test or t test depending
upon variable
Control confounding variable through
stratified analysis with Mantel-Hanszel
technique or Multiple logistic Regression
Pair-matched study use McNemars
Chi-square, OR, 95% CI of OR.

Odds ratio
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

Calculating the Odds Ratio


Disease Status
No CHD
CHD
cases (Controls
)
Exposur Smoker (Cases)
112
176
e
Non88
224
Status smoker
Total
200
400
Odds
Ratio

AD
BC

112 x 224
176 x 88

= 1.62

Estimate of OR
OR<1

OR=1

Odds of
Odds of
Odds
exposure for exposure
compariso
cases are
are equal
n between less than the
among
cases and
odds of
cases and
controls
exposure for
controls
controls
Exposure
Exposure
reduces
Particular
as a risk
disease
exposure is
factor for
risk
not a risk
the
factor
(Protective
disease?
factor)

OR>1
Odds of
exposure
for cases are
greater than
the odds of
exposure for
controls
Exposure
increases
disease risk
(Risk factor)

Interpreting the Odds Ratio

The odds of exposure for


cases are 1.62 times the odds
of exposure for controls.

or

Interpreting the Odds Ratio

Those with CHD are 1.62 times more likely to


be smokers than those without CHD

or
Those with CHD are 62% more likely to be
smokers than those without CHD

Classical Case-Control studies