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

Trials

Volumn 15, Issue 1, 2014, Pages

  Kahan, Brennan C ^a   Diaz Ordaz, Karla ^b   Homer, Kate ^c   Carnes, Dawn ^c   Underwood, Martin ^d   Taylor, Stephanie J C ^c   Bremner, Stephen A ^a   Eldridge, Sandra ^a  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^d UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Chronic musculoskeletal pain; Complex intervention; Randomised controlled trial; Self management; Statistical analysis plan

Indexed keywords

ADAPTATION, PSYCHOLOGICAL; CHRONIC PAIN; CLUSTER ANALYSIS; DATA INTERPRETATION, STATISTICAL; DISABILITY EVALUATION; GROUP PROCESSES; HUMANS; MODELS, STATISTICAL; MUSCULOSKELETAL PAIN; PAIN MANAGEMENT; PAIN MEASUREMENT; RESEARCH DESIGN; SELF CARE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84894286234     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-59     Document Type: Article

References (36)

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. 3563130, 23358564.
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, 3831098, 24231458.
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, 1408309.
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, 16446108.
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, 6880820.
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, 14715402.
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, 17320338.
8. Group E. The EuroQol instrumnet: EQ-5D 1990. http://www.euroqol.org/eq-5d.
9. Statistics OfN Census 2011. 2011, http://www.ons.gov.uk/census/2011-census, Statistics OfN.
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, 3230114, 21300711.
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, 3643875, 23590245.
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, 2446464, 18556603.
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, 3444136, 22983531.
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, 22139891.
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, 23112128.
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, 24512175.
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, 15196615.
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, 12325108.
20. Turner EL, Perel P, Clayton T, Edwards P, Hernandez AV, Roberts I, et al. 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, 3589911, 22169080.
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, 3733981, 23898993.
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, 16217841.
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, 2616932.
25. Kahan BC. Bias in randomised factorial trials. Stat Med 2013, 32:4540-4549. 10.1002/sim.5869, 23733397.
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, 10913808.
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, 15977289.
28. Rubin DB. Multiple Imputation for Nonresponse in Surveys 1987, New York: John Wiley and Sons.
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, 21225900.
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, 3124925, 21259309.
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, 3904008, 24456267.
33. White IR, Thompson SG. Adjusting for partially missing baseline measurements in randomized trials. Stat Med 2005, 24:993-1007. 10.1002/sim.1981, 15570623.
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, 3538666, 23216665.
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, 19608601.
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, 3230230, 20442226.