Design and analysis of cluster randomized trials with time-to-event outcomes under the additive hazards mixed model.

ABSTRACT: A primary focus of current methods for cluster randomized trials (CRTs) has been for continuous, binary, and count outcomes, with relatively less attention given to right-censored, time-to-event outcomes. In this article, we detail considerations for sample size requirement and statistical inference in CRTs with time-to-event outcomes when the intervention effect parameter is specified through the additive hazards mixed model (AHMM), which includes a frailty term to explicitly account for the dependency between the failure times. First, we discuss improved inference for the treatment effect parameter via bias-corrected sandwich variance estimators and randomization-based test under AHMM, addressing potential small-sample biases in CRTs. Next, we derive a new sample size formula for AHMM an

SUBMITTER: Blaha O 

PROVIDER: S-EPMC9588628 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature