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整群随机试验中胜负统计量的样本量设计AI 解读

Composite endpoints are increasingly used in clinical trials to capture treatment effects across multiple or hierarchically ordered outcomes. Although inference procedures based on win statistics, such as the win ratio, win odds, and win difference (net benefit) have gained traction in individually randomized trials, their methodological development for cluster-randomized trials remains limited. In particular, there is no formal framework for power and sample size…

随机临床试验中有序结果胜出统计量的协变量调整AI 解读

Ordinal outcomes are common in clinical settings where they often represent increasing levels of disease progression or different levels of functional impairment. In this article, we focus on representing the average treatment effect for ordinal outcomes via intrinsic pairwise outcome comparisons captured through win estimands, such as the win ratio and win difference. Recognizing the value of baseline covariate adjustment toward enhanced precision, we first develop…

横截面阶梯楔形整群随机试验中的中介分析AI 解读

Mediation analysis has been comprehensively studied for independent data but relatively little work has been done for correlated data, especially for the increasingly adopted stepped wedge cluster randomized trials (SW-CRTs). Motivated by challenges in underlying the effect mechanisms in pragmatic and implementation science clinical trials, we develop new methods for mediation analysis in SW-CRTs. Specifically, based on a linear and generalized linear mixed models, we…