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The analysis of continuous outcomes in multi-centre trials with small centre sizes

Pickering, Ruth M. and Weatherall, Mark (2007) The analysis of continuous outcomes in multi-centre trials with small centre sizes Statistics in Medicine, pp. 1-12. (doi:10.1002/sim.3068).

Record type: Article

Abstract

The standard analysis of clinical trials stratified by centre is to include centres as fixed effects, but if many centres contribute small numbers of patients, this approach results in a loss of power. Assuming no treatment by centre interaction, we used simulation to examine power and coverage of confidence intervals from three approaches to the analysis of continuous outcome in multi-centre trials: ignoring centres, including centres as fixed effects, and including them as random effects. The simulation incorporated eight sizes of centre effects; randomization in blocks of size 2 or 4; and two sample sizes, namely 100 and 200 patients per treatment arm in a parallel groups design. All simulated data sets included many centres with few subjects. The three different approaches were unbiased and had similar coverage. Fixed effects analysis was less powerful, particularly when centre effects were small. Incorporating block randomization with larger block size increased non-orthogonality in the design, contributing to loss of power. Where centre effects are small and recruitment in many centres is low, the approaches of ignoring centres or incorporating them as random effects have better performance than the traditional fixed effects analysis.

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More information

Submitted date: 9 August 2007
Published date: 8 October 2007
Keywords: multi-centre trials, small centres, stratification, blocking, fixed effects, random effects, inter-block information, non-orthogonality

Identifiers

Local EPrints ID: 49349
URI: http://eprints.soton.ac.uk/id/eprint/49349
ISSN: 0277-6715
PURE UUID: 26e8cc68-f4d7-43f6-a14f-f68427b05024

Catalogue record

Date deposited: 31 Oct 2007
Last modified: 17 Jul 2017 14:56

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Contributors

Author: Ruth M. Pickering
Author: Mark Weatherall

University divisions

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