Prognostic Covariate Adjustment for Binary Outcomes Using Stratification
利用分层对二元结局进行预后协变量调整
Covariate adjustment and methods of incorporating historical data in randomized clinical trials (RCTs) each provide opportunities to increase trial power. We unite these approaches for the analysis of RCTs with binary outcomes based on the Cochran-Mantel-Haenszel (CMH) test for marginal risk ratio (RR). In PROCOVA-CMH, subjects are stratified on a single prognostic covariate reflective of their predicted outcome on the control treatment (e.g. placebo). This prognostic score…