Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Health Technol Assess. 2020 Nov;24(65):1-116. doi: 10.3310/hta24650.
Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes.
To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty.
An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study.
The trial took place in 14 NHS physiotherapy departments.
People identified as being at high risk of a poor outcome after knee arthroplasty.
A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy.
The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries.
In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold.
The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded.
This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it.
Current Controlled Trials ISRCTN13517704.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.
在英国，每年有超过 10 万例初次膝关节置换手术。大约 15-30%的患者报告结果不佳。更好的康复策略可能会改善患者报告的结果。
比较传统门诊物理治疗模式与膝关节置换术后有发生不良结局风险的患者家庭康复计划的结果。
一项个体随机、两臂对照试验，采用盲法结局评估，平行健康经济学评价和嵌套定性研究。
试验在 14 个 NHS 物理治疗部门进行。
被确定为膝关节置换术后有发生不良结局高风险的患者。
由康复助理提供的多组分家庭康复方案，并由合格治疗师进行监督，与常规门诊物理治疗进行比较。
主要结局是 12 个月时的晚期生活功能和残疾量表。次要结局包括牛津膝关节评分（一种特定于疾病的功能衡量标准）；膝关节损伤和骨关节炎结局评分；生活质量子量表；老年人身体活动量表；EuroQol-5 维度，五个等级版本；以及使用 8 字形步行测试、30 秒椅子站立测试和单腿站立测试评估的身体功能。使用参与者日记收集有关医疗服务使用情况、休假和非正式护理的信息。
共有 621 名参与者被随机分配。共有 309 名参与者被分配到 COmmunity based Rehabilitation after Knee Arthroplasty（CORKA）家庭康复计划，接受中位数为 5 次治疗（四分位间距 4-7 次）。共有 312 名参与者被分配到常规护理，接受中位数为 4 次治疗（四分位间距 2-6 次）。在家庭 CORKA 组中，有 279 名（89%）参与者和常规护理组中有 287 名（92%）参与者报告了主要结局 Late Life Function and Disability Instrument 功能总分，在 12 个月时收集。两组之间未发现具有临床或统计学意义的差异（意向治疗调整差异 0.49 分，95%置信区间-0.89 至 1.88 分；=0.48）。在随机分组后 6 或 12 个月时，两组之间在任何患者报告或身体次要结局测量中均未发现统计学显著差异。健康经济学分析发现，与常规护理相比，CORKA 干预的提供成本更低（每位参与者节省 66 英镑）。CORKA 干预的总成本（包括医疗保健成本和其他成本）低于常规护理（每位参与者节省 316 英镑）。从社会角度看，CORKA 在 30,000 英镑/QALY 的阈值下具有 75%的成本效益可能性。从更窄的健康和社会保健角度来看，CORKA 在相同的阈值下具有 43%的成本效益可能性。
干预措施持续时间短，且符合英国物理治疗的现行委托指导原则。参与者和治疗治疗师无法被蒙蔽。
这项随机对照试验发现，在膝关节置换术后康复中使用家庭康复助理提供的康复方案或传统门诊模式时，结果没有明显差异。然而，健康经济学评估发现，从社会角度来看，CORKA 家庭干预具有成本效益，且比常规护理更有效，从而更具优势，因为这组患者的带薪就业时间减少。进一步的研究可以关注识别不良结局的风险，并进一步评估一种具有成本效益的治疗方法，包括提供治疗的劳动力模式。
当前对照试验 ISRCTN82201259。
该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在 ; Vol. 24, No. 65 中全文发表。有关该项目的更多信息，请访问 NIHR 期刊库网站。
