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

Kahan, Brennan C; Diaz-Ordaz, Karla; Homer, Kate; Carnes, Dawn; Underwood, Martin; Taylor, Stephanie Jc; Bremner, Stephen A; Eldridge, Sandra; (2014) Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial. Trials, 15 (1). 59-. ISSN 1745-6215 DOI: https://doi.org/10.1186/1745-6215-15-59

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.

Additional Information

Item Type	Article
Faculty and Department	Faculty of Epidemiology and Population Health > Dept of Medical Statistics
PubMed ID	24528484
ISI	333470000001
Related URLs	OA Location