Interim monitoring in sequential multiple assignment randomized trials
Interim monitoring in sequential multiple assignment randomized trials
复制标题
序贯多重分配随机试验中的中期监测
作者：
Liwen Wu;Junyao Wang;A. Wahed
一项顺序多任务随机试验（SMART）有助于同时比较多种适应性治疗策略（ats）。以往的研究已经建立了一个框架，通过逆概率加权的全局Wald检验来检验多个ats的同质性。由于在多个阶段随机化治疗的顺序性，SMARTs通常比经典临床试验更长。因此，如果观察到压倒性的疗效，增加允许早期停止的中期分析将是有益的。我们将组序贯方法引入SMARTs，以促进基于多变量卡方分布的中期监测。仿真研究表明，与经典SMART相比，所提出的SMART （IM‐SMART）临时监测在减少预期样本量的情况下保持了所需的I型误差和功率。最后，我们通过重新分析SMART评估认知行为和物理疗法对膝关节骨关节炎和共病亚综合征抑郁症状患者的影响来说明我们的方法。
A sequential multiple assignment randomized trial (SMART) facilitates the comparison of multiple adaptive treatment strategies (ATSs) simultaneously. Previous studies have established a framework to test the homogeneity of multiple ATSs by a global Wald test through inverse probability weighting. SMARTs are generally lengthier than classical clinical trials due to the sequential nature of treatment randomization in multiple stages. Thus, it would be beneficial to add interim analyses allowing for an early stop if overwhelming efficacy is observed. We introduce group sequential methods to SMARTs to facilitate interim monitoring based on the multivariate chi‐square distribution. Simulation studies demonstrate that the proposed interim monitoring in SMART (IM‐SMART) maintains the desired type I error and power with reduced expected sample size compared to the classical SMART. Finally, we illustrate our method by reanalyzing a SMART assessing the effects of cognitive behavioral and physical therapies in patients with knee osteoarthritis and comorbid subsyndromal depressive symptoms.
DOI：
10.1016/s0197-2456(03)00112-0
发表时间：
2004-02-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Rush, AJ;Fava, M;Niederehe, G
通讯作者：
Niederehe, G
影响因子：
2.1
作者：
Ertefaie, Ashkan;Wu, Tianshuang;Nahum-Shani, Inbal
通讯作者：
Nahum-Shani, Inbal