Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Update

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

Authors: Brennan C Kahan, Karla Diaz-Ordaz, Kate Homer, Dawn Carnes, Martin Underwood, Stephanie JC Taylor, Stephen A Bremner, Sandra Eldridge

Published in: Trials | Issue 1/2014

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
Carnes D, Taylor SJ, Homer K, Eldridge S, Bremner S, Pincus T, Rahman A, Underwood M: Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS). BMJ Open. 2013, 3: e002492-CrossRefPubMedPubMedCentral
2.
Carnes D, Homer K, Underwood M, Pincus T, Rahman A, Taylor SJ: Pain management for chronic musculoskeletal conditions: the development of an evidence-based and theory-informed pain self-management course. BMJ Open. 2013, 3: e003534-10.1136/bmjopen-2013-003534.CrossRefPubMedPubMedCentral
3.
Von Korff M, Ormel J, Keefe FJ, Dworkin SF: Grading the severity of chronic pain. Pain. 1992, 50: 133-149. 10.1016/0304-3959(92)90154-4.CrossRefPubMed
4.
Nicholas MK: The pain self-efficacy questionnaire: taking pain into account. Eur J Pain. 2007, 11: 153-163. 10.1016/j.ejpain.2005.12.008.CrossRefPubMed
5.
Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983, 67: 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
6.
McCracken LM, Vowles KE, Eccleston C: Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004, 107: 159-166. 10.1016/j.pain.2003.10.012.CrossRefPubMed
7.
Osborne RH, Elsworth GR, Whitfield K: The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns. 2007, 66: 192-201. 10.1016/j.pec.2006.12.002.CrossRefPubMed
8.
9.
10.
White IR, Horton NJ, Carpenter J, Pocock SJ: Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011, 342: d40-10.1136/bmj.d40.CrossRefPubMedPubMedCentral
11.
Kahan BC, Morris TP: Assessing potential sources of clustering in individually randomised trials. BMC Med Res Methodol. 2013, 13: 58-10.1186/1471-2288-13-58.CrossRefPubMedPubMedCentral
12.
Andridge RR, Shoben AB, Muller KE, Murray DM: Analytic methods for individually randomized group treatment trials and group-randomized trials when subjects belong to multiple groups. Stat Med. 2014, doi: 10.1002/sim.6083
13.
Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL: Individually randomized group treatment trials: a critical appraisal of frequently used design and analytic approaches. Am J Public Health. 2008, 98: 1418-1424. 10.2105/AJPH.2007.127027.CrossRefPubMedPubMedCentral
14.
Kahan BC, Morris TP: Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ. 2012, 345: e5840-10.1136/bmj.e5840.CrossRefPubMedPubMedCentral
15.
Kahan BC, Morris TP: Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012, 31: 328-340. 10.1002/sim.4431.CrossRefPubMed
16.
Kahan BC, Morris TP: Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects?. Stat Med. 2013, 32: 1136-1149. 10.1002/sim.5667.CrossRefPubMed
17.
Kahan BC: Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how?. BMC Med Res Methodol. 2014, 14: 20-10.1186/1471-2288-14-20.CrossRefPubMedPubMedCentral
18.
Hernandez AV, Steyerberg EW, Habbema JD: Covariate adjustment in randomized controlled trials with dichotomous outcomes increases statistical power and reduces sample size requirements. J Clin Epidemiol. 2004, 57: 454-460. 10.1016/j.jclinepi.2003.09.014.CrossRefPubMed
19.
Pocock SJ, Assmann SE, Enos LE, Kasten LE: Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002, 21: 2917-2930. 10.1002/sim.1296.CrossRefPubMed
20.
Turner EL, Perel P, Clayton T, Edwards P, Hernandez AV, Roberts I: Covariate adjustment increased power in randomized controlled trials: an example in traumatic brain injury. J Clin Epidemiol. 2012, 65: 474-481. 10.1016/j.jclinepi.2011.08.012.CrossRefPubMed
21.
Kahan BC, Morris TP: Adjusting for multiple prognostic factors in the analysis of randomised trials. BMC Med Res Methodol. 2013, 13: 99-10.1186/1471-2288-13-99.CrossRefPubMedPubMedCentral
22.
Royston P, Altman DG, Sauerbrei W: Dichotomizing continuous predictors in multiple regression: a bad idea. Stat Med. 2006, 25: 127-141. 10.1002/sim.2331.CrossRefPubMed
23.
Campbell H, Dean CB: The consequences of proportional hazards based model selection. Stat Med. 2013, 10.1002/sim.6083
24.
Freeman PR: The performance of the two-stage analysis of two-treatment, two-period crossover trials. Stat Med. 1989, 8: 1421-1432. 10.1002/sim.4780081202.CrossRefPubMed
25.
26.
Raab GM, Day S, Sales J: How to select covariates to include in the analysis of a clinical trial. Control Clin Trials. 2000, 21: 330-342. 10.1016/S0197-2456(00)00061-1.CrossRefPubMed
27.
Shuster JJ: Diagnostics for assumptions in moderate to large simple clinical trials: do they really help?. Stat Med. 2005, 24: 2431-2438. 10.1002/sim.2175.CrossRefPubMed
28.
Rubin DB: Multiple Imputation for Nonresponse in Surveys. 1987, New York: John Wiley and SonsCrossRef
29.
White IR, Royston P, Wood AM: Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011, 30: 377-399. 10.1002/sim.4067.CrossRefPubMed
30.
Carpenter JR, Goldstein H, Kenward MG: REALCOM-IMPUTE software for multilevel multiple imputation with mixed response types. J Stat Softw. 2011, 45 (5): [epub]
31.
Andridge RR: Quantifying the impact of fixed effects modeling of clusters in multiple imputation for cluster randomized trials. Biom J. 2011, 53: 57-74. 10.1002/bimj.201000140.CrossRefPubMedPubMedCentral
32.
Morris TP, Kahan BC, White IR: Choosing sensitivity analyses for randomised trials: principles. BMC Med Res Methodol. 2014, 14: 11-10.1186/1471-2288-14-11.CrossRefPubMedPubMedCentral
33.
White IR, Thompson SG: Adjusting for partially missing baseline measurements in randomized trials. Stat Med. 2005, 24: 993-1007. 10.1002/sim.1981.CrossRefPubMed
34.
Hardt J, Herke M, Leonhart R: Auxiliary variables in multiple imputation in regression with missing X: a warning against including too many in small sample research. BMC Med Res Methodol. 2012, 12: 184-10.1186/1471-2288-12-184.CrossRefPubMedPubMedCentral
35.
Emsley R, Dunn G, White IR: Mediation and moderation of treatment effects in randomised controlled trials of complex interventions. Stat Methods Med Res. 2010, 19: 237-270. 10.1177/0962280209105014.CrossRefPubMed
36.
Sussman JB, Hayward RA: An IV for the RCT: using instrumental variables to adjust for treatment contamination in randomised controlled trials. BMJ. 2010, 340: c2073-10.1136/bmj.c2073.CrossRefPubMedPubMedCentral
Metadata
Title
Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS): statistical analysis plan for a randomised controlled trial
Authors
Brennan C Kahan
Karla Diaz-Ordaz
Kate Homer
Dawn Carnes
Martin Underwood
Stephanie JC Taylor
Stephen A Bremner
Sandra Eldridge
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-59

Other articles of this Issue 1/2014

Trials 1/2014 Go to the issue

Study protocol

Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care

Study protocol

MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial

Study protocol

Comparison of posterior foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the cervical spine: study protocol for a randomized controlled trial (ForaC)

Study protocol

Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial

Study protocol

One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675

Study protocol

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial