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

应对持续性疼痛,自我管理有效性研究(COPERS):一项随机对照试验的统计分析计划

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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.

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