Power calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint

Abstract

A popular design choice in public health and implementation science research, stepped wedge cluster randomized trials (SW-CRTs) are a form of randomized trial whereby clusters are progressively transitioned from control to intervention, and the timing of transition is randomized for each cluster. An important task at the design stage is to ensure that the planned trial has sufficient power to observe a clinically meaningful effect size. While methods for determining study power have been well-developed for SW-CRTs with continuous and binary outcomes, limited methods for power calculation are available for SW-CRTs with censored time-to-event outcomes. In this article, we propose a stratified marginal Cox model to account for secular trend in cross-sectional SW-CRTs, and derive an explicit expression of the robust sandwich variance to facilitate power calculations without the need for computationally intensive simulations. Power formulas based on both the Wald and robust score tests are developed and compared via simulation, generally demonstrating superiority of robust score procedures in different finite-sample scenarios. Finally, we illustrate our methods using a SW-CRT testing the effect of a new electronic reminder system on time to catheter removal in hospital settings. We also offer an R Shiny application to facilitate sample size and power calculations using our proposed methods.

Mary M. Ryan

Assistant Professor
mary [dot] ryan [at] wisc [dot] edu

My research interests include group sequential design and clinical trials, with applications in Alzheimer’s Disease biomarker discovery, as well as pragmatic and cluster randomized trials.