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A Framework for Parametric Time-Varying Treatment Effects in Multiple Intervention Stepped Wedge Design Clinical Trials in the Presence of Non-Uniform Cluster-Period Correlation Structures

非均匀簇期相关下多干预阶梯楔形试验的参数化时变效应框架

Stepped wedge design (SWD) trials typically assume that treatment effects are immediate following implementation, but this assumption is often unrealistic in pragmatic settings where effects evolve over exposure time. This impact is further complicated in multiple-intervention stepped wedge designs (M-SWDs), due to their complex crossover patterns. Existing work has addressed time-varying treatment effects for main effects at the analysis stage using nonparametric…

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A generalized multiple-intervention stepped wedge design framework for treatment effect estimation in the presence of non-uniform cluster-period correlation structures

非均匀簇—时期相关下多干预阶梯楔形设计的统一框架

Existing power and design methods for multiple-intervention stepped wedge designs (M-SWDs) typically assume exchangeable cluster-period correlation, despite evidence that correlation often decays over time. Misspecification of this correlation structure can substantially distort variance estimation and power, particularly for treatment interaction effects. We develop a unified covariance framework for M-SWDs that separates intracluster correlation from an explicit…

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