Power Analysis for Stepped Wedge Trials with Two Treatments

TL;DR

This paper develops a linear mixed model for stepped wedge trials with two treatments, deriving power calculation methods and analyzing how design features influence statistical power for main and interaction effects.

Contribution

It introduces a novel linear mixed model for SWDs with two treatments and provides closed-form solutions for power analysis, extending existing methods beyond single-treatment designs.

Findings

Derived closed-form solutions for standard errors of treatment effects.

Analyzed impact of design features on power for main and interaction effects.

Applicable to various design structures including repeated cross-sectional and cohort designs.

Abstract

Stepped wedge designs (SWDs) are designs for cluster randomized trials that feature staggered, unidirectional cross-over, typically from a control to a treatment condition. Existing literature on statistical power for SWDs primarily focuses on designs with a single treatment. However, SWDs with multiple treatments are being proposed and conducted. We present a linear mixed model for a SWD with two treatments, with and without an interaction between them. We derive closed form solutions for the standard errors of the treatment effect coefficients for such models along with power calculation methods. We consider repeated cross-sectional designs as well as open and closed cohort designs and different random effect structures. Design features are examined to determine their impact on power for main treatment and interaction effects.