Calculating sample size for a

case-control study
Statistical Power
Statistical power is the probability of
finding an effect if its real.
Factors Affecting Power
1. Size of the effect
2. Standard deviation of the characteristic
3. Bigger sample size
4. Significance level desired

Sample size calculations
Based on these elements, you can write
a formal mathematical equation that
relates power, sample size, effect size,
standard deviation, and significance
level.
Calculating sample size for a case-
control study: binary exposure
Use difference in proportions formula
formula for difference in
proportions
2
2 1
2
/2
) (p
) Z )( 1 )( (
)
1
(
p
Z p p
r
r
n

Sample size in the
case group
Represents the
desired power
(typically .84 for
80% power).
Represents the
desired level of
statistical
significance
(typically 1.96).
A measure of
variability (similar to
standard deviation)
Effect Size
(the difference
in proportions)
r=ratio of
controls to cases
Example
How many cases and controls do you
need assuming
80% power
You want to detect an odds ratio of 2.0 or
greater
An equal number of cases and controls
(r=1)
The proportion exposed in the control
group is 20%
Example, continued
2
2 1
2
/2
) (p
) Z )( 1 )( (
)
1
(
p
Z p p
r
r
n

For 80% power, Z

=.84
For 0.05 significance level, Z

=1.96
r=1 (equal number of cases and controls)
The proportion exposed in the control group is 20%

To get proportion of cases exposed:

1 ) 1 (
exp
exp
exp

OR p
ORp
p
controls
controls
case
33 .
20 . 1
40 .
1 ) 1 0 . 2 )( 20 (.
) 20 (. 0 . 2
exp

case
p
Average proportion exposed = (.33+.20)/2=.265

Example, continued
181
) 20 . 33 . (
) 96 . 1 84 )(. 265 . 1 )( 265 (.
2
2
2

n
2
2 1
2
/2
) (p
) Z )( 1 )( (
)
1
(
p
Z p p
r
r
n

Therefore, n=362 (181 cases, 181 controls)

Calculating sample size for a case-
control study: continuous exposure
Use difference in means formula
formula for difference in
means
Sample size in the
case group
Represents the
desired power
(typically .84 for
80% power).
Represents the
desired level of
statistical
significance
(typically 1.96).
Standard deviation
of the outcome
variable
Effect Size
(the difference
in means)
2
2
/2
2
) ifference (
) Z (
)
1
(
d
Z
r
r
n

r=ratio of
controls to cases
Example
How many cases and controls do you need
assuming
80% power
The standard deviation of the characteristic you
are comparing is 10.0
You want to detect a difference in your
characteristic of 5.0 (one half standard deviation)
An equal number of cases and controls (r=1)
Example, continued
For 80% power, Z

=.84
For 0.05 significance level, Z

=1.96
r=1 (equal number of cases and controls)
=10.0
Difference = 5.0

2
2
/2
2
) ifference (
) Z (
)
1
(
d
Z
r
r
n

Example, continued
Therefore, n=126 (63 cases, 63 controls)

63 ) 84 . 7 ( 2 ) 2 (
) 5 (
) 84 . 7 ( 10
) 2 (
2
2
2
n
2
2
/2
2
) ifference (
) Z (
)
1
(
d
Z
r
r
n