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Xiaoxi Yan

Publications and source records attributed to Xiaoxi Yan.

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A Flexible Micro-Randomized Trial Design and Sample Size Considerations

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.

stat.ME

A Novel Approach To Assess Dynamic Treatment Regimes Embedded In A Smart With An Ordinal Outcome

Sequential multiple assignment randomized trials (SMARTs) are used to construct data-driven optimal intervention strategies for subjects based on their intervention and covariate histories in different branches of health and behavioral sciences where a sequence of interventions is given to a participant. Sequential intervention strategies are often called dynamic treatment regimes (DTR). In the existing literature, the majority of the analysis methodologies for SMART data assume a continuous primary outcome. However, ordinal outcomes are also quite common in clinical practice. In this work, first, we introduce the notion of generalized odds ratio (GOR) to compare two DTRs embedded in a SMART with an ordinal outcome and discuss some combinatorial properties of this measure. Next, we propose a likelihood-based approach to estimate GOR from SMART data, and derive the asymptotic properties of its estimate. We discuss alternative ways to estimate GOR using concordant-discordant pairs and two-sample U-statistic. We derive the required sample size formula for designing SMARTs with ordinal outcomes based on GOR. A simulation study shows the performance of the estimated GOR in terms of the estimated power corresponding to the derived sample size. The methodology is applied to analyze data from the SMART+ study, conducted in the UK, to improve carbohydrate periodization behavior in athletes using a menu planner mobile application, Hexis Performance. A freely available Shiny web app using R is provided to make the proposed methodology accessible to other researchers and practitioners.

stat.ME

Multi-Level Micro-Randomized Trial: Detecting the Proximal Effect of Messages on Physical Activity

Technological advancements in mobile devices have made it possible to deliver mobile health interventions to individuals. A novel intervention framework that emerges from such advancements is the just-in-time adaptive intervention (JITAI), where it aims to suggest the right support to the individual "just in time", when their needs arise, thus having proximal, near future effects. The micro-randomized trial (MRT) design was proposed recently to test the proximal effects of these JITAIs. In an MRT, participants are repeatedly randomized to one of the intervention options of various in the intervention components, at a scale of hundreds or thousands of decision time points over the course of the study. However, the extant MRT framework only tests the proximal effect of two-level intervention components (e.g. control vs intervention). In this paper, we propose a novel version of MRT design with multiple levels per intervention component, which we call "multi-level micro-randomized trial" (MLMRT) design. The MLMRT extends the existing MRT design by allowing multi-level intervention components, and the addition of more levels to the components during the study period. We apply generalized estimating equation type methodology on the longitudinal data arising from an MLMRT to develop the novel test statistics for assessing the proximal effects and deriving the associated sample size calculators. We conduct simulation studies to evaluate the sample size calculators based on both power and precision. We have developed an R shiny application of the sample size calculators. This proposed design is motivated by our involvement in the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) study. This study uses a novel mobile application, also called "DIAMANTE", which delivers adaptive text messages to encourage physical activity.

stat.ME