Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.

In a cluster-randomized trial (CRT), the number of participants enrolled often varies across clusters. This variation should be considered during both trial design and data analysis to ensure statistical performance goals are achieved. Most methodological literature on the CRT design has assumed equ...

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Autores principales: Denghuang Zhan, Liang Xu, Yongdong Ouyang, Richard Sawatzky, Hubert Wong
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:a9f4636810ba404eab2f8661d02863482021-12-02T20:08:53ZMethods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.1932-620310.1371/journal.pone.0255389https://doaj.org/article/a9f4636810ba404eab2f8661d02863482021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255389https://doaj.org/toc/1932-6203In a cluster-randomized trial (CRT), the number of participants enrolled often varies across clusters. This variation should be considered during both trial design and data analysis to ensure statistical performance goals are achieved. Most methodological literature on the CRT design has assumed equal cluster sizes. This scoping review focuses on methodology for unequal cluster size CRTs. EMBASE, Medline, Google Scholar, MathSciNet and Web of Science databases were searched to identify English-language articles reporting on methodology for unequal cluster size CRTs published until March 2021. We extracted data on the focus of the paper (power calculation, Type I error etc.), the type of CRT, the type and the range of parameter values investigated (number of clusters, mean cluster size, cluster size coefficient of variation, intra-cluster correlation coefficient, etc.), and the main conclusions. Seventy-nine of 5032 identified papers met the inclusion criteria. Papers primarily focused on the parallel-arm CRT (p-CRT, n = 60, 76%) and the stepped-wedge CRT (n = 14, 18%). Roughly 75% of the papers addressed trial design issues (sample size/power calculation) while 25% focused on analysis considerations (Type I error, bias, etc.). The ranges of parameter values explored varied substantially across different studies. Methods for accounting for unequal cluster sizes in the p-CRT have been investigated extensively for Gaussian and binary outcomes. Synthesizing the findings of these works is difficult as the magnitude of impact of the unequal cluster sizes varies substantially across the combinations and ranges of input parameters. Limited investigations have been done for other combinations of a CRT design by outcome type, particularly methodology involving binary outcomes-the most commonly used type of primary outcome in trials. The paucity of methodological papers outside of the p-CRT with Gaussian or binary outcomes highlights the need for further methodological development to fill the gaps.Denghuang ZhanLiang XuYongdong OuyangRichard SawatzkyHubert WongPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0255389 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Denghuang Zhan
Liang Xu
Yongdong Ouyang
Richard Sawatzky
Hubert Wong
Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
description In a cluster-randomized trial (CRT), the number of participants enrolled often varies across clusters. This variation should be considered during both trial design and data analysis to ensure statistical performance goals are achieved. Most methodological literature on the CRT design has assumed equal cluster sizes. This scoping review focuses on methodology for unequal cluster size CRTs. EMBASE, Medline, Google Scholar, MathSciNet and Web of Science databases were searched to identify English-language articles reporting on methodology for unequal cluster size CRTs published until March 2021. We extracted data on the focus of the paper (power calculation, Type I error etc.), the type of CRT, the type and the range of parameter values investigated (number of clusters, mean cluster size, cluster size coefficient of variation, intra-cluster correlation coefficient, etc.), and the main conclusions. Seventy-nine of 5032 identified papers met the inclusion criteria. Papers primarily focused on the parallel-arm CRT (p-CRT, n = 60, 76%) and the stepped-wedge CRT (n = 14, 18%). Roughly 75% of the papers addressed trial design issues (sample size/power calculation) while 25% focused on analysis considerations (Type I error, bias, etc.). The ranges of parameter values explored varied substantially across different studies. Methods for accounting for unequal cluster sizes in the p-CRT have been investigated extensively for Gaussian and binary outcomes. Synthesizing the findings of these works is difficult as the magnitude of impact of the unequal cluster sizes varies substantially across the combinations and ranges of input parameters. Limited investigations have been done for other combinations of a CRT design by outcome type, particularly methodology involving binary outcomes-the most commonly used type of primary outcome in trials. The paucity of methodological papers outside of the p-CRT with Gaussian or binary outcomes highlights the need for further methodological development to fill the gaps.
format article
author Denghuang Zhan
Liang Xu
Yongdong Ouyang
Richard Sawatzky
Hubert Wong
author_facet Denghuang Zhan
Liang Xu
Yongdong Ouyang
Richard Sawatzky
Hubert Wong
author_sort Denghuang Zhan
title Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
title_short Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
title_full Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
title_fullStr Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
title_full_unstemmed Methods for dealing with unequal cluster sizes in cluster randomized trials: A scoping review.
title_sort methods for dealing with unequal cluster sizes in cluster randomized trials: a scoping review.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/a9f4636810ba404eab2f8661d0286348
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AT richardsawatzky methodsfordealingwithunequalclustersizesinclusterrandomizedtrialsascopingreview
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