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

Area of Science:

• Rehabilitation Medicine
• Clinical Trials Methodology
• Pain Management

Background:

• Chronic musculoskeletal pain affects a significant portion of the population, leading to disability.
• Self-management interventions are crucial for managing persistent pain conditions.
• The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial investigates a specific group-based self-management course.

Purpose of the Study:

• To outline the comprehensive statistical analysis plan for the COPERS trial.
• To ensure rigorous evaluation of the group-based self-management course's effectiveness.
• To provide a transparent methodology for analyzing pain-related disability reduction.

Main Methods:

• The COPERS trial is a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial.
• The analysis plan covers overall principles, outcome definitions, covariate adjustment, and handling of clustering.
• Specific statistical methods for primary, secondary, sensitivity, subgroup, and adherence-adjusted analyses are detailed.

Main Results:

• This article focuses on the analysis plan, not the trial results.
• The plan details how primary outcomes (pain-related disability) and secondary outcomes will be assessed.
• Methods for handling missing data and potential biases are described.

Conclusions:

• A robust statistical analysis plan is essential for the valid interpretation of randomised controlled trial findings.
• This plan ensures the COPERS trial's results will be rigorously analyzed.
• The findings will inform the effectiveness of group-based self-management for chronic musculoskeletal pain.