Randomization-based confidence intervals for cluster randomized trials.

Content Provider	Europe PMC
Author	Rabideau, Dustin J Wang, Rui
Copyright Year	2020
Abstract	Summary In a cluster randomized trial (CRT), groups of people are randomly assigned to different interventions. Existing parametric and semiparametric methods for CRTs rely on distributional assumptions or a large number of clusters to maintain nominal confidence interval (CI) coverage. Randomization-based inference is an alternative approach that is distribution-free and does not require a large number of clusters to be valid. Although it is well-known that a CI can be obtained by inverting a randomization test, this requires testing a non-zero null hypothesis, which is challenging with non-continuous and survival outcomes. In this article, we propose a general method for randomization-based CIs using individual-level data from a CRT. This approach accommodates various outcome types, can account for design features such as matching or stratification, and employs a computationally efficient algorithm. We evaluate this method’s performance through simulations and apply it to the Botswana Combination Prevention Project, a large HIV prevention trial with an interval-censored time-to-event outcome.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC8511941&blobtype=pdf
Page Count	15
ISSN	14654644
Volume Number	22
DOI	10.1093/biostatistics/kxaa007
PubMed Central reference number	PMC8511941
Issue Number	4
PubMed reference number	32112077
Journal	Biostatistics (Oxford, England)
e-ISSN	14684357
Language	English
Publisher	Oxford University Press
Publisher Date	2021-10-01
Access Restriction	Open
Rights License	This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © The Author 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Subject Keyword	Cluster randomized trial Confidence interval Correlated data Interval-censored Permutation test Randomization-based inference
Content Type	Text
Resource Type	Article
Subject	Statistics and Probability Medicine Statistics, Probability and Uncertainty