Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
National Institute for Health Research Bristol Biomedical Research Centre, University of Bristol, Bristol, UK.
Trials. 2018 Jan 23;19(1):61. doi: 10.1186/s13063-017-2391-8.
Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable.
In line with the UK Medical Research Council's recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders.
Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial.
This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.
大约 20%接受全膝关节置换术的人会在术后出现慢性疼痛，但对于管理这种类型疼痛的有效干预措施，证据有限。本文描述了一种针对膝关节置换术后慢性疼痛患者的复杂干预措施的系统开发和完善过程。该干预措施是一种包含评估门诊和进一步转诊的护理路径，必要时进行电话随访。在这项多阶段研究的设计中，我们选择专注于确保干预措施具有可操作性、可实施性和可接受性。
根据英国医学研究理事会对复杂干预措施全面开发的建议，进行了多个阶段的工作。在初步开发工作以设计干预措施之后，通过 22 名卫生专业人员的共识问卷和与 18 名医疗保健专业人员的会议讨论，对干预措施草案进行了完善。两名健康专业人员向 10 名患者提供评估门诊服务，对干预措施的实施和患者的可接受性进行了测试。通过基于正常化措施发展（NoMAD）工具的问卷，向 10 名卫生专业利益相关者评估了在随机试验背景下实施干预措施的未来实施情况。
与卫生专业人员的共识工作确保了干预措施的组成部分是适当的，并对提高干预措施提出了一些实质性的改变。干预措施实施的测试确定了一些后勤问题，随后在制定综合干预措施培训手册时进行了处理。与利益相关者的接触表明，该干预措施可以在临床环境中成功实施，并在随机试验中进行评估。
这项工作为膝关节置换术后慢性疼痛患者的复杂干预措施的开发和完善提供了信息。下一步是在多中心随机试验中评估 STAR 护理路径的临床和成本效益。
