• Trials · Jan 2014

    Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial

    Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial.

    • Brennan C Kahan, Karla Diaz-Ordaz, Kate Homer, Dawn Carnes, Martin Underwood, Stephanie Jc Taylor, Stephen A Bremner, and Sandra Eldridge.
    • Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, London E1 2AB, UK. b.kahan@qmul.ac.uk.
    • Trials. 2014 Jan 1;15:59.

    BackgroundThe 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 DesignCOPERS 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 RegistrationISRCTN24426731.

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