DOI: 10.1177/09622802261502150 ISSN: 0962-2802

Can discrete-time analyses be trusted for stepped wedge trials with continuous recruitment?

Hao Wang, Guangyu Tong, Heather Allore, Kelsey L. Grantham, Monica Taljaard, Fan Li

In stepped wedge cluster randomized trials (SW-CRTs), the intervention is rolled out to clusters sequentially over multiple periods. It is common practice to analyze data from SW-CRTs using linear mixed models that treat time as discrete. However, a recent systematic review found that 95.1% of cross-sectional SW-CRTs recruit individuals continuously over time. Despite the prevalence of continuous recruitment, there has been limited guidance on how to draw model-robust inference for such designs. In this article, we conduct simulation studies to examine the performance of discrete-time linear mixed models in the case of continuous recruitment designs with a continuous outcome. Specifically, we generate outcomes under a continuous-time exponential decay correlation structure with either discrete or continuous fixed period effects. We consider constant and exposure-time-dependent intervention effects, with and without random intervention effects across clusters. We then analyze the simulated data using linear mixed models under three discrete-time working correlation structures: simple exchangeable, nested exchangeable, and discrete-time exponential decay, with robust sandwich variance estimation. Our results demonstrate that discrete-time analysis often yields negligible bias and that the robust variance estimator with the Mancl and DeRouen correction consistently achieves nominal coverage and type I error rate. However, when recruitment patterns vary systematically between control and intervention periods, discrete-time analyses give slightly biased intervention effect estimates. Finally, we illustrate these findings by reanalyzing a completed SW-CRT.

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