Dataset Information

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 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.

SUBMITTER: Kahan BC

PROVIDER: S-EPMC3930300 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Kahan Brennan C BC Diaz-Ordaz Karla K Homer Kate K Carnes Dawn D Underwood Martin M Taylor Stephanie Jc SJ Bremner Stephen A SA Eldridge Sandra S

Trials 20140215

<h4>Background</h4>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.<h4>Methods and design</h4>COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall ana ...[more]

PMID: 24528484

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Project description:BackgroundExercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.MethodsWalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.DiscussionThe WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.Trial registrationWalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

Project description:BackgroundPersistent pelvic pain is pain sensed in or around the pelvis and is often associated with negative cognitive, behavioral, sexual, and emotional consequences. The lack of interprofessional persistent pelvic pain management programs that address the complex interplay of biopsychosocial factors result in lengthy wait times and negative health outcomes. Limited access to evidence informed self-management educational resources contributes to poor coping strategies. Evidence shows that self-management education and strategies support patients while they wait for care. However, very few studies explore the patient's lived experience of participating in an online educational program designed for persistent pelvic pain.ObjectivesThis study aims to understand the experience of women with persistent pelvic pain participating in an online, self-management education program ("Pelvic Pain Empowered Management" program) while awaiting care at an interprofessional pelvic pain clinic.DesignA descriptive qualitative approach was used to explore the experiences of women participating in an online educational program designed for cis women with persistent pelvic pain.MethodsWe conducted semi-structured interviews with 11 women, transcribed the data verbatim using NVivo software (NVivo 12, QSR International Pty Ltd.), and analyzed inductively using previously established methods.ResultsWe identified four main themes relevant to women's experiences of the program: (1) the program shaped expectations around upcoming pelvic pain appointments, (2) the program content is relevant and resonates with people with lived experience of persistent pelvic pain, (3) the program enhanced understanding of persistent pelvic pain, and (4) the program empowered people with skills and strategies to better manage their persistent pelvic pain.ConclusionOur findings highlight how self-directed online patient education can be leveraged while persistent pelvic pain patients wait for care to support them in setting expectations around care and in engaging in pain self-management.

Project description:IntroductionPersistent non-cancer pain affects one in five adults and is more common in Māori-the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), access to PMPs is poor due to long waiting lists. Although online-delivered PMPs enhance access, none have been codesigned with patients or compared with group-based, in-person PMPs. This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a cocreated, culturally appropriate, online-delivered PMP (iSelf-help) compared with in-person PMP in reducing pain-related disability.Methods and analysisMixed-methods, using a modified participatory action research (PAR) framework, involving three phases. Phase I involved cocreation and cultural appropriateness of iSelf-help by PAR team members. Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. Adults (n=180, age ≥18 years) with persistent non-cancer pain eligible for a PMP will be recruited and block randomised (with equal probabilities) to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help participants will participate in two 60-minute video-conferencing sessions weekly for 12 weeks with access to cocreated resources via smartphone application and a password-protected website. The control participants will receive group-based, in-person delivered PMP. Primary outcome is pain-related disability assessed via modified Roland Morris Disability Questionnaire at 6 months post intervention. Secondary outcomes include anxiety, depression, stress, pain severity, quality of life, acceptance, self-efficacy, catastrophising and fear avoidance. Data will be collected at baseline, after the 12-week intervention, and at 3 and 6 months post intervention. We will conduct economic analyses and mixed-method process evaluations (Phase IIA).Ethics and disseminationThe Health and Disability Ethics Committee approved the study protocol (HDEC18/CEN/162). Phase III involves dissemination of findings guided by the PAR team as outcomes become apparent.Trial registration numberACTRN 12619000771156.

Dataset Information

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

Background

Methods and design

Trial registration

Publications

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

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