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. 2. 3. 4. Size of the effect Standard deviation of the characteristic Bigger sample size 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 casecontrol study: binary exposure

Use difference in proportions formula

formula for difference in Represents the proportions

Sample size in the case group

r=ratio of controls to cases

desired power (typically .84 for 80% power).

r 1 ( p)(1 p)(Z Z/2 ) n( ) 2 r (p1 p2 )

A measure of variability (similar to standard deviation) Effect Size (the difference in proportions)

Represents the desired level of statistical significance (typically 1.96).

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
r 1 ( p)(1 p)(Z Z/2 ) n( ) 2 r (p1 p2 )

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:
pcaseexp ORpcontrols exp pcontrols exp (OR 1) 1
pcaseexp 2.0(. 20 ) .40 .33 (. 20 )( 2.0 1) 1 1.20

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

Example, continued
r 1 ( p)(1 p)(Z Z/2 ) n( ) 2 r (p1 p2 )
2

(. 265 )(1 .265 )(. 84 1.96 ) n2 181 2 (.33 .20 )

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

Calculating sample size for a casecontrol study: continuous exposure

Use difference in means formula

formula for difference in means

Sample size in the case group

r=ratio of controls to cases

Represents the desired power (typically .84 for 80% power).

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

Represents the desired level of Standard deviation Effect Size of the outcome (the difference statistical significance variable in means) (typically 1.96).

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

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

Example, continued
r 1 ( Z Z/2 ) n( ) 2 r (difference)
2
2

10 (7.84 ) 2 n ( 2) (2) 2 (7.84 ) 63 2 (5)

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