LAUSR.org creates dashboard-style pages of related content for over 1.5 million academic articles. Sign Up to like articles & get recommendations!

Estimation of conditional power for cluster-randomized trials with interval-censored endpoints.

Photo from wikipedia

Cluster-randomized trials (CRTs) of infectious disease preventions often yield correlated, interval-censored data: dependencies may exist between observations from the same cluster, and event occurrence may be assessed only at intermittent… Click to show full abstract

Cluster-randomized trials (CRTs) of infectious disease preventions often yield correlated, interval-censored data: dependencies may exist between observations from the same cluster, and event occurrence may be assessed only at intermittent study visits. This data structure must be accounted for when conducting interim monitoring and futility assessment for CRTs. In this article, we propose a flexible framework for conditional power estimation when outcomes are correlated and interval-censored. Under the assumption that the survival times follow a shared frailty model, we first characterize the correspondence between the marginal and cluster-conditional survival functions, and then use this relationship to semiparametrically estimate the cluster-specific survival distributions from the available interim data. We incorporate assumptions about changes to the event process over the remainder of the trial-as well as estimates of the dependency among observations in the same cluster-to extend these survival curves through the end of the study. Based on these projected survival functions we generate correlated interval-censored observations, and then calculate the conditional power as the proportion of times (across multiple full-data generation steps) that the null hypothesis of no treatment effect is rejected. We evaluate the performance of the proposed method through extensive simulation studies, and illustrate its use on a large cluster-randomized HIV prevention trial. This article is protected by copyright. All rights reserved.

Keywords: conditional power; interval censored; cluster randomized; cluster; randomized trials

Journal Title: Biometrics
Year Published: 2020

Link to full text (if available)


Share on Social Media:                               Sign Up to like & get
recommendations!

Related content

More Information              News              Social Media              Video              Recommended



                Click one of the above tabs to view related content.