Analysis of Stepped-Wedge Cluster Randomized Trials when treatment effects vary by exposure time or calendar time
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处理效应随暴露时间或日历时间变化时的阶梯楔形整群随机试验分析
- 研究问题
- 阶梯楔形整群随机试验中，若处理效应随暴露时间或日历时间变化，误设效应结构会如何影响不同平均效应估计量？
- 方法与思路
- 作者比较混合效应模型中的即时效应、暴露时间平均效应和日历时间平均效应估计量，考察其在不同结构误设情景下的表现。
- 材料陈述的贡献
- 摘要称，即时效应估计在部分日历时间平均效应目标下较稳健，但混淆两种时间尺度可能产生严重偏误，甚至收敛到相反符号。
- 阅读关注点
- 应核对三种目标效应的权重定义、试验安排和混合模型设定，尤其是符号反转的条件及两种时间变化同时存在时的处理。
- 阅读边界
- 这是 arXiv 预印本，不能据此确认同行评审或期刊接收。摘要未列明稳健性结论的全部条件，也未量化各种设计下的偏误。
原文摘要
Stepped-wedge cluster randomized trials (SW-CRTs) are traditionally analyzed with models that assume an immediate and sustained treatment effect. Previous work has shown that making such an assumption in the analysis of SW-CRTs when the true underlying treatment effect varies by exposure time can produce severely misleading estimates. Alternatively, the true underlying treatment effect might vary by calendar time. Comparatively less work has examined treatment effect structure misspecification in this setting. Here, we evaluate the behavior of the mixed effects model-based immediate treatment effect, exposure time-averaged treatment effect, and calendar time-averaged treatment effect estimators in different scenarios where they are misspecified for the true underlying treatment effect structure. We show that the immediate treatment effect estimator is relatively robust to bias when estimating a true underlying calendar time-averaged treatment effect estimand. However, when there is a true underlying calendar (exposure) time-varying treatment effect, misspecifying an analysis with an exposure (calendar) time-averaged treatment effect estimator can yield severely misleading estimates and even converge to a value of the opposite sign of the true calendar (exposure) time-averaged treatment effect estimand. In this article, we highlight the two different time scales on which treatment effects can vary in SW-CRTs and clarify potential vulnerabilities that may arise when considering different types of time-varying treatment effects in a SW design. Accordingly, we emphasize the need for researchers to carefully consider whether the treatment effect may vary as a function of exposure time and/or calendar time in the analysis of SW-CRTs.