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

Abstract：

: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.

journal_name

Trials

journal_title

Trials

authors

Ivers NM,Halperin IJ,Barnsley J,Grimshaw JM,Shah BR,Tu K,Upshur R,Zwarenstein M

doi

10.1186/1745-6215-13-120

subject

Has Abstract

pub_date

2012-08-01 00:00:00

pages

120

issn

1745-6215

pii

1745-6215-13-120

journal_volume

13

pub_type

杂志文章,评审

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