title: Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial.
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
  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.
  
  
  BACKGROUND
  ISRCTN24426731.
authors: Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, London E1 2AB, UK. b.kahan@qmul.ac.uk.
authors: Brennan C
authors: BC
authors: Kahan
authors: Karla
authors: K
authors: Diaz-Ordaz
authors: Kate
authors: K
authors: Homer
authors: Dawn
authors: D
authors: Carnes
authors: Martin
authors: M
authors: Underwood
authors: Stephanie Jc
authors: SJ
authors: Taylor
authors: Stephen A
authors: SA
authors: Bremner
authors: Sandra
authors: S
authors: Eldridge
mesh_terms: D000223:Adaptation, Psychological; D059350:Chronic Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D016000:Cluster Analysis; D003627:Data Interpretation, Statistical; D004185:Disability Evaluation; D006126:Group Processes; D006801:Humans; D015233:Models, Statistical; D059352:Musculoskeletal Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D012107:Research Design; D012648:Self Care / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome