CASE-CONTROL STUDY

CASE-CONTROL STUDY

Obseravational and analytical studies Longitudinal studies We start knowing the effect (the disease) and we look for the risk factor/factors, in general, in a retrospective manner Case-control study types: prospective retrospective

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The design of the case-control study
exposed Sample with disease unexposed Target population exposed Sample without disease unexposed

Time
Study direction

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Selecting disease cases: patients from a hospital or a medical service

Selecting the control group: hospitalized patients suffering from another disease general population from the same town specific groups (family, friends)

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Sampling in case-control studies:

Random sample (by chance) Systematic sample Stratified sample

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The data is organised into a 2x2 contingency table

With disease

Without disease

TOTAL

Exposed to the risk factor Unexposed to the risk factor TOTAL

a
c a+c

b
d b+d

a+b
c+d a+b+c+d

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DATA ANALYSIS

Exposure odds calculation for both case and control groups: - exposure odds for cases =

a c

b - exposure odds for control group = d

ODDS RATIO (OR) =

a c ad b bc d

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INTERPRETATION

OR > 1

there is an association between exposure and disease

OR = 1
there is NO association between exposure and disease OR < 1

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STATISTICAL ANALYSIS FOR CASE-CONTROL STUDIES

The appropriate statistical test is Chi test

If the obtained p value is smaller than 0,05 (p<0.05) then we have a statistically significant result CI must not contain the value 1 (lower limit should be greater than 2)

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OR interpretation depending on CI:

If OR>1 and CI limits are close to OR, but without including the value 1, then we can state that there is a positive association between the risk factor and the disease

If OR>1 and CI includes the value 1 we can say that is NO association between exposure and disease

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ADVANTAGES:

Fast Cheap Easy to perform Requires a relatively small number of subjects It looks into more than one risk factor (more than one exposure)

Suitable for rare diseases, with a high latency period

They can determine causality, they are usefull for only one disease

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DISADVANTAGES:

Memory errors, selection errors

It doesnt allow a direct calculation of incidence

Data validation is difficult to determine

Thay cant be used for rare exposures

They study only one effect

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EXAMPLE: In an obstetrics clinic there was performed a study on the newborns between 1960 and 2000, in order to establish a possible connection between drinking alcohol during pregnancy and the apparition of the lip and maxillary cleft. During this study there were devised two groups, one of 43 newborns with lip clefs or labio-maxillo-palatine clefs and a control group with newborns without the malformation. There are no differences between the two groups (except the presence of the malformation in the cases group). There were excluded from the sample lot the patients with other malformations besides lip clefs or labio-maxillo-palatine clefs.