ssizeEpiInt.default1 {powerSurvEpi}R Documentation

Sample Size Calculation Testing Interaction Effect for Cox Proportional Hazards Regression with two covariates for Epidemiological Studies (Both covariates should be binary)

Description

Sample size calculation testing interaction effect for Cox proportional hazards regression with two covariates for Epidemiological Studies. Both covariates should be binary variables. The formula takes into account the correlation between the two covariates.

Usage

ssizeEpiInt.default1(power, theta, psi, p00, p01, p10, p11, alpha = 0.05)

Arguments

power postulated power.
theta postulated hazard ratio.
psi proportion of subjects died of the disease of interest.
p00 proportion of subjects taking values X_1=0 and X_2=0, i.e., p_{00}=Pr(X_1=0,mbox{and}, X_2=0).
p01 proportion of subjects taking values X_1=0 and X_2=1, i.e., p_{01}=Pr(X_1=0,mbox{and}, X_2=1).
p10 proportion of subjects taking values X_1=1 and X_2=0, i.e., p_{10}=Pr(X_1=1,mbox{and}, X_2=0).
p11 proportion of subjects taking values X_1=1 and X_2=1, i.e., p_{11}=Pr(X_1=1,mbox{and}, X_2=1).
alpha type I error rate.

Details

This is an implementation of the sample size calculation formula derived by Schmoor et al. (2000) for the following Cox proportional hazards regression in the epidemoilogical studies:

h(t|x_1, x_2)=h_0(t)exp(β_1 x_1+β_2 x_2 + gamma (x_1 x_2)),

where both covariates X_1 and X_2 are binary variables.

Suppose we want to check if the hazard ratio of the interaction effect X_1 X_2=1 to X_1 X_2=0 is equal to 1 or is equal to exp(gamma)=theta. Given the type I error rate α for a two-sided test, the total number of subjects required to achieve a power of 1-β is

n=frac{(z_{1-α/2}+z_{1-β})^2delta}{[log(theta)]^2 psi},

where psi is the proportion of subjects died of the disease of interest,

delta=frac{1}{p_{00}}+frac{1}{p_{01}}+frac{1}{p_{10}} +frac{1}{p_{11}},

and p_{00}=Pr(X_1=0,mbox{and}, X_2=0), p_{01}=Pr(X_1=0,mbox{and}, X_2=1), p_{10}=Pr(X_1=1,mbox{and}, X_2=0), p_{11}=Pr(X_1=1,mbox{and}, X_2=1).

Value

The ssize of the test.

References

Schmoor C., Sauerbrei W., and Schumacher M. (2000). Sample size considerations for the evaluation of prognostic factors in survival analysis. Statistics in Medicine. 19:441-452.

See Also

ssizeEpiInt.default0, ssizeEpiInt2

Examples

  # Example at the end of Section 4 of Schmoor et al. (2000).
  # p00, p01, p10, and p11 are calculated based on Table III on page 448
  # of Schmoor et al. (2000).
  ssizeEpiInt.default1(power = 0.8227, theta = 3, psi = 139 / 184,
    p00 = 50/184, p01 = 21 / 184, p10 = 78 / 184, p11 = 35 / 184,
    alpha = 0.05)
  

[Package powerSurvEpi version 0.0.5 Index]