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• الفرضية
Study Design
1. Select cases of disease:
• Newly diagnosed cases
• In one or more hospitals, clinics,
medical centers
• Cases identified should be
representative of disease status in the
community
Study Design (Cont.(
2. Select a control group:
• Patients within the same medical care
facility
• A sample of general population
• Friends or acquaintances
• Fellow employees
• Neighbours
• Family members
Control group
• Involves sampling:
– A sample of patients in the same hospital
where cases were selected
– A sample of the general population in a
community
3. Ensure comparability of cases & controls,
e.g., of same age, sex, socioeconomic status
to reduce bias (error(
Study Design (Cont.(
4. Collect information about exposure:
• Interviews with cases and controls
• Hospital records
• Employment records
Study Design (Cont.(
Exposure +ve Cases
Exposure -ve
Exposure +ve Controls
Exposure -ve
In the Past <---------- Onset of Study
Study Design (Cont.(
5. Data analysis:
• Determine presence or absence of exposure
in cases & controls
• Construct 2X2 table
• Measure the association between exposure
and disease, i.e.,
• The measure of association is called Odds
Ratio (OR(
5. Data analysis
Disease
Cases Controls Total
+ve a b a+b
exposure
- ve c d c+d
-------------------------------
Total a+c b+d a+b+c+d
5. Data analysis (2X2 Table(
• In a cohort study: relative risk or RR (the measure of
association( =
a
------
a+b
-------------
c
--------
c+d
• In the general population “a” is very small relative to
“b”. Similarly, “c” ” is very small relative to “d”.
• Thus, In the general population: a/a+b ~ a/b and
c/c+d ~ c/d . Consequently the formula reduces to:
a/b ad
----- = ---- = odds ratio (OR(
c/d bc
5. Data analysis (2X2 Table(
a/c ad
=--------- = ----
b/d bc
Study Design (Cont.(
6. Interpret the results:
• Positive association
• No association
• Negative association
Study Design (Cont.(
6. Interpret the results
• If the proportion of exposed among the
cases of disease is the same as the
proportion of exposed among the control
group, then the OR will be one. Therefore:
• If the OR is 1 = there is no association
• If the OR is >1 = there is a + ve assoc., I.e.
Exposure causes disease
• If the OR is <1 = there is a - ve assoc. , I.e.
Exposure protects from disease
Study Design (Cont.(
6. Interpret the results
• Interpretation of a + ve association:
• If the OR is bet. 1 - 1.9 = weak assoc.
• If the OR is bet. 2 - 3.9 = moderate assoc.
• If the OR is bet. > 4 = strong assoc.
Case-control Study (Example(
Smoking & Lung Cancer
• 100 men with lung cancer and 100 controls,
of similar age & sex, are interviewed
regarding smoking history.
• Hypothesis: Cigarette smoking is associated
with development of lung cancer.
• Among the cases 80 were smokers & among
the controls 30 were smokers.
• Q. Is there any association between smoking
and lung cancer? (Show your 2X2 table &
calculations(
Case-control Study (Example(
Smoking & Lung Cancer
Disease
Cases Controls Total
Smok.+ve 80 30
exposure
Smok.- ve 20 70
-------------------------------
Total 100 100
Case-control Study (Example(
Smoking & Lung Cancer
ad 80 x 70 5600
• Odds ratio (OR( = --- = ---------- = ------
bc 30 x 20 600
= 9.3
• Interpretation:
• This a + ve association
• The risk of lung cancer in smokers is 9.3
times compared to nonsmokers
• It is a strong association OR > 3.9
• Therefore most probably smoking causes
lung cancer
Case-control Study
Advantages & Disadvantages
(1( Advantages:
• Relatively inexpensive
• Relatively quick results
• Smaller number of subjects
• Suitable for rare disease
• Ethical problems minimal
Case-control Study
Advantages & Disadvantages
(2( Disadvantages:
• Problems of selecting appropriate
control group
• Problems of comparability
• Incomplete information
• Biased recall
• Yields only estimated relative risk
(OR(
Case-control Study
Examples
• Cancer(of various sites( & Atomic
Bomb explosion
• Lung cancer & cigarette smoking
• Congenital malformations & drugs in
early pregnancy
• Leukemia & exposure to radiation
• Liver cancer & hepatitis B
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