On anticipation effect in stepped wedge cluster randomized trials

In stepped wedge cluster randomized trials (SW-CRTs), the intervention is rolled out to clusters over multiple periods. A standard approach for analyzing SW-CRTs utilizes the linear mixed model, where the treatment effect is only present after the treatment adoption, under the assumption of no anticipation. This assumption, however, may not always hold in practice because stakeholders, providers, or individuals who are aware of the treatment adoption timing (especially when blinding is challenging or infeasible) can inadvertently change their behaviors in anticipation of the forthcoming intervention. We provide an analytical framework to address the anticipation effect in SW-CRTs and study its impact. We derive expectations of the estimators based on a collection of linear mixed models and demonstrate that when the anticipation effect is ignored, these estimators give biased estimates of the treatment effect. We also provide updated sample size formulas that explicitly account for anticipation effects, exposure-time heterogeneity, or both in SW-CRTs and illustrate their impact on study power. Through simulation studies and empirical analyses, we compare the treatment effect estimators with and without adjusting for anticipation, and provide some practical considerations.

Patient-Centered Outcomes Research Institute

Hao Wang, Xinyuan Chen, Katherine R Courtright, Scott D Halpern, Michael O Harhay, Monica Taljaard, Fan Li