John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia.
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2022 Jul 5;12(7):e057790. doi: 10.1136/bmjopen-2021-057790.
The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial.
Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes.
This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.
ACTRN12619000065190.
REFORM（肌肉骨骼疾病康复）试验是一项非劣效性随机对照试验（n=210），旨在确定支持性家庭运动方案是否与面对面物理治疗一样或更好地管理某些肌肉骨骼疾病。该试验目前正在澳大利亚悉尼政府医院进行。本过程评估将与 REFORM 试验同时进行。它结合了定性和定量数据，以帮助解释试验结果，并确定在类似于 REFORM 试验的环境中推出支持性家庭运动方案的可行性。
两个理论框架为我们的过程评估方法学提供了基础：现实主义框架（背景、机制、结果）考虑了支持性家庭运动方案为何可能与面对面物理治疗一样或更好的因果假设，这些假设涉及试验的背景、机制和结果。RE-AIM 框架描述了干预措施的可及性、效果、采用、实施和维持。这两个框架将广泛用于指导使用混合方法的过程评估。例如，将从患者、医疗保健专业人员和利益相关者的访谈中获得定性数据，并收集定量数据以确定提供支持性家庭运动方案的成本和可行性。这些数据将在分析试验结果之前进行迭代分析，并与主要和次要结果的结果进行三角剖分。
本试验将根据国家卫生和医学研究委员会《人类研究伦理行为国家声明》（2018 年）和《良好临床实践注释》（CPMP/ICH-135/95）进行。2017 年 3 月 17 日，Northern Sydney Local Health District 人类研究伦理委员会（试验编号：HREC/16HAWKE/431-RESP/16/287）获得了伦理批准，并于 2020 年 2 月 4 日批准了对过程评估的修正案。过程评估的结果将通过在同行评议期刊上发表文章和在科学会议上发表演讲来传播。
ACTRN12619000065190。
