Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

<p>Abstract</p> <p>Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis o...

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Main Authors: Ivers Noah M, Halperin Ilana J, Barnsley Jan, Grimshaw Jeremy M, Shah Baiju R, Tu Karen, Upshur Ross, Zwarenstein Merrick
Format: Article
Language:English
Published: BMC 2012-08-01
Series:Trials
Subjects:
Online Access:http://www.trialsjournal.com/content/13/1/120
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author Ivers Noah M
Halperin Ilana J
Barnsley Jan
Grimshaw Jeremy M
Shah Baiju R
Tu Karen
Upshur Ross
Zwarenstein Merrick
author_facet Ivers Noah M
Halperin Ilana J
Barnsley Jan
Grimshaw Jeremy M
Shah Baiju R
Tu Karen
Upshur Ross
Zwarenstein Merrick
author_sort Ivers Noah M
collection DOAJ
description <p>Abstract</p> <p>Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.</p>
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spelling doaj.art-b7270e490d784b23bfb28628fc390f272022-12-21T23:27:03ZengBMCTrials1745-62152012-08-0113112010.1186/1745-6215-13-120Allocation techniques for balance at baseline in cluster randomized trials: a methodological reviewIvers Noah MHalperin Ilana JBarnsley JanGrimshaw Jeremy MShah Baiju RTu KarenUpshur RossZwarenstein Merrick<p>Abstract</p> <p>Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.</p>http://www.trialsjournal.com/content/13/1/120Cluster-randomized trialsBalanced allocationRestricted randomization
spellingShingle Ivers Noah M
Halperin Ilana J
Barnsley Jan
Grimshaw Jeremy M
Shah Baiju R
Tu Karen
Upshur Ross
Zwarenstein Merrick
Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
Trials
Cluster-randomized trials
Balanced allocation
Restricted randomization
title Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
title_full Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
title_fullStr Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
title_full_unstemmed Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
title_short Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
title_sort allocation techniques for balance at baseline in cluster randomized trials a methodological review
topic Cluster-randomized trials
Balanced allocation
Restricted randomization
url http://www.trialsjournal.com/content/13/1/120
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