Evidence map›Paper›PMID 40785501›Full record

ArticleStatistical methods in medical research2025

Selecting the optimal longitudinal cluster randomized design with a continuous outcome: Parallel-arm, crossover, or stepped-wedge.

Jingxia Liu, Fan Li, Siobhan Sutcliffe, Graham A Colditz

Abstract read
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Article in Statistical methods in medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Jingxia LiuDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.ORCID 0000-0002-9434-7907
Fan LiDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.ORCID 0000-0001-6183-1893
Siobhan SutcliffeDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.
Graham A ColditzDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA.

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI TIMOTHY J. EBERLEIN · 2001 to 2026
$128.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Washington University Implementation Science Center for Cancer Control (WU-ISCCC)P50CA244431 · NCI · WASHINGTON UNIVERSITY · PI BROWNSON, ROSS C, COLDITZ, GRAHAM A. · 2019 to 2023
$8.0M
NCATS NIH HHS UL1 TR002345NCI NIH HHS P30 CA091842NCI NIH HHS P50 CA244431
6 · The paper itself

Abstract

The optimal designs (ODs) for parallel-arm longitudinal cluster randomized trials, multiple-period cluster randomized crossover (CRXO) trials, and stepped wedge cluster randomized trials (SW-CRTs), including closed-cohort and repeat cross-sectional designs, have been studied separately under a cost-efficiency framework based on generalized estimating equations (GEEs). However, whether a global OD exists across longitudinal designs and randomization schedules remains unknown. Therefore, this research addresses a critical gap by comparing OD feature across complete longitudinal cluster randomized trial designs with two treatment conditions and continuous outcomes. We define the OD as the design with either the lowest cost to obtain a desired level of power or the largest power given a fixed budget. For each of these ODs, we obtain the optimal number of clusters and the optimal cluster-period size (number of participants per cluster per period). To ensure equitable comparisons, we consider the GEE treatment effect estimator with the same block exchangeable correlation structure and develop OD algorithms with the lowest cost for each of six study designs. To obtain OD with the largest power, we summarize the previous and propose new OD algorithms and formulae. We suggest using the number of treatment sequences

Indexed as

Randomized Controlled Trials as TopicResearch DesignCluster AnalysisCross-Over StudiesHumansLongitudinal StudiesModels, StatisticalBlock exchangeable correlation structurecluster randomized crossoveroptimal design under a budgetary constraintparallel-arm longitudinal cluster randomized trialstepped wedge cluster randomized trials

Identifiers

PMID40785501
PMCPMC13251621

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.