Fidelity and rigour in a global trial: Pulmonary Rehabilitation workshop for PuRe Implementation trial in primary care in LMIC settings

Introduction: PuRe1 is an individually randomised controlled Hybrid-1 implementation trial which will assess the clinical and cost effectiveness of pulmonary rehabilitation (PR) in Centre vs Home vs Usual Care groups for chronic respiratory diseases in Bangladesh, India, and Malaysia. Implementing the adapted PR intervention in the diverse resource-limited settings of the four centres presents challenges, and requires fidelity to the PR intervention, and rigorous adherence to trial processes. The PuRe workshop was aimed to ensure consistency in PR delivery through the co-creation of standardised procedures for therapists (defined in the PuRe manual), the development of patient education resources (the PuRe pack), and reaching agreement amongst investigators/researchers on trial processes (Work-Instruction). Methods: The PuRe workshop was conducted at RUSHA, CMC, Vellore in October 2024 (3-months prior to starting recruitment), attended by participants (therapists, blinded assessors, investigators/researchers) from all the PuRe Centres. Hands-on training sessions, practical demonstrations, academic discussions and consensus-building sessions were conducted using a participatory approach to prepare standardised trial documentation. Results: 18 participants attended the 3-day workshop. Working in two groups, the therapists undertook practical sessions focused on standardising performance of the primary outcome measure (Endurance Shuttle Walking Test), tailoring therapy, and exercise training for patients to ensure consistent delivery of PR across the centres. Research colleagues worked on the detailed work instruction and focused on finalising aspects of the PuRe manual (including sections on assessments, exercise training, breathing control, lifestyle, coping mechanisms, self-management, smoking and biomass, mental health and social support), and the PuRe Pack. Discussion: In addition to co-creating an agreed PR programme, undertaking training for assessing outcomes and delivering PR, discussing and finalising trial processes, the workshop reinforced the collaborative approach to designing/delivering the PuRe trial, addressing the challenges of research rigour and intervention fidelity in a multi-centre trial in low- and middle-income countries. Funding: This research is jointly funded by the UK Medical Research Council (MRC) and the UK Foreign, Commonwealth and Development Office (FCDO) under the MRC/FCDO Concordat agreement MRC MR/Y004809/1 (ISRCTN65701828). The views expressed are those of the author(s) and not necessarily those of the MRC or FCDO”.