Handoll H H G, Goodchild L, Brealey S D, Hanchard N C A, Jefferson L, Keding A, Rangan A
Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough TS1 3BA, UK.
James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Road, Middlesbrough TS4 3BW, UK.
Bone Joint Res. 2014 Dec;3(12):335-40. doi: 10.1302/2046-3758.312.2000364.
A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.
These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received.
All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises.
In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335-40.
在外科手术干预的随机对照试验中，需要一种严谨的方法来开展、提供和记录康复治疗，以支持可靠且可用证据的产生。本文描述了在一项多中心随机对照试验中所采用的关键流程，该试验比较了成人肱骨近端骨折手术治疗与保守治疗，旨在确保为所有参与者提供高质量且可比的康复治疗。
这些流程包括制定一份关于吊带固定期间自我护理的患者信息手册，制定一份基础治疗物理治疗方案（该方案获得了提供患者护理的专科物理治疗师的投入和认可），以及确立提供家庭锻炼的预期。还设计了专门的表格，以方便可靠地报告患者接受的物理治疗护理情况。
所有这三项举措均成功实施，同时还采取了优化物理治疗记录的措施。因此，所有招募患者的参与站点都提供了吊带固定手册，所有站点都遵守物理治疗方案，且都提供了家庭锻炼。物理治疗表格的填写堪称典范，常常反映出复杂的患者护理路径。这些数据表明，两组在接受物理治疗（包括进行家庭锻炼）方面的机会均等且程度较高。
为了提高外科手术干预试验证据的有效性和相关性，并符合国际报告标准，需要仔细关注研究设计、内在康复组成部分的实施和报告。康复专家的参与对于实现这一点至关重要。引用本文：《骨与关节研究》2014年；3：335 - 40。
