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Open Access Update

Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS): statistical analysis plan for a randomised controlled trial

Brennan C Kahan1*, Karla Diaz-Ordaz2, Kate Homer3, Dawn Carnes3, Martin Underwood4, Stephanie JC Taylor3, Stephen A Bremner1 and Sandra Eldridge1

Author Affiliations

1 Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, London E1 2AB, UK

2 Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK

3 Translational Research Unit, Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London 58 Turner St, London E1 2AB, UK

4 Warwick Clinical Trials Unit, Warwick Medical School, Gibbett Hill Road, Coventry CV4 7AL, England

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Trials 2014, 15:59  doi:10.1186/1745-6215-15-59

Published: 15 February 2014

Abstract

Background

The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial.

Methods and design

COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall analysis principles (including which participants will be included in each analysis, how results will be presented, which covariates will be adjusted for, and how we will account for clustering in the intervention group); (b) the primary and secondary outcomes, and how each outcome will be analysed; (c) sensitivity analyses; (d) subgroup analyses; and (e) adherence-adjusted analyses.

Trial registration

ISRCTN24426731

Keywords:
Statistical analysis plan; Randomised controlled trial; Self-management; Chronic musculoskeletal pain; Complex intervention