Scientific Publications by FDA Staff

J Biopharm Stat 2013;23(4):848-55

Estimation of the common risk difference in stratified paired binary data with homogeneous stratum effect.

Zhao YD, Rahardja D

McNemar's test is commonly used to test for the risk difference between two binary variables on matched pairs. For stratified paired binary data, recently a test for the homogeneous stratum effect (HSE) has been developed. If HSE is rejected, then McNemar's test should be applied by stratum; otherwise, in this article we propose a concept of common risk difference (CRD) across the strata and derive point estimators and confidence intervals for CRD. We use a cancer study for illustration and conduct simulations to recommend point estimators and associated confidence intervals with good statistical properties.