论文标题

灵活的微型试验设计和样本量考虑

A Flexible Micro-Randomized Trial Design and Sample Size Considerations

论文作者

Xu, Jing, Yan, Xiaoxi, Figueroa, Caroline, Williams, Joseph Jay, Chakraborty, Bibhas

论文摘要

技术进步使得为个人提供移动健康干预措施成为可能。从这种进步中出现的一个新颖的框架是即时的适应性干预(Jitai),旨在在需要时向个人提出正确的支持。最近提出了微型试验(MRT)设计,以测试这些Jitais的近端作用。但是,现存的MRT框架仅考虑在研究开始时添加固定类别的组件。我们提出了一种灵活的MRT(FlexIMRT)设计,该设计允许在研究过程中向组件增加更多类别。拟议的设计是由Diamante研究的合作进行的,该研究学会提供短信,以鼓励糖尿病和抑郁症患者的体育锻炼。我们使用类似于纵向数据的广义估计方程的方法为FlexIMRT开发了一种新的测试统计量和相应的样本量计算器。进行了仿真研究以评估样本量计算器,并开发了计算器的R光泽应用。

Technological advancements have made it possible to deliver mobile health interventions to individuals. A novel framework that has emerged from such advancements is the just-in-time adaptive intervention (JITAI), which aims to suggest the right support to the individuals when their needs arise. The micro-randomized trial (MRT) design has been proposed recently to test the proximal effects of these JITAIs. However, the extant MRT framework only considers components with a fixed number of categories added at the beginning of the study. We propose a flexible MRT (FlexiMRT) design which allows addition of more categories to the components during the study. The proposed design is motivated by collaboration on the DIAMANTE study, which learns to deliver text messages to encourage physical activity among the patients with diabetes and depression. We developed a new test statistic and the corresponding sample size calculator for the FlexiMRT using an approach similar to the generalized estimating equation for longitudinal data. Simulation studies were conducted to evaluate the sample size calculators and an R shiny application for the calculators was developed.

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