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一项关于术前职业治疗以优化骨关节炎患者初次全髋关节置换术后恢复的可行性随机对照试验(PROOF-THR)。

A feasibility randomised controlled trial of pre-operative occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis (PROOF-THR).

作者信息

Jepson Paul, Sands Gina, Beswick Andrew D, Davis Edward T, Blom Ashley W, Sackley Catherine M

机构信息

School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, UK.

CLAHRC-EM, School of Medicine, University of Nottingham, UK.

出版信息

Clin Rehabil. 2016 Feb;30(2):156-66. doi: 10.1177/0269215515576811. Epub 2015 Mar 20.

Abstract

OBJECTIVE

To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement.

DESIGN

Single blinded feasibility randomised controlled trial, with data collection prior to the intervention, and at 4, 12, and 26 weeks following surgery.

SETTING

Recruitment from two NHS orthopaedic outpatient centres in the West Midlands, UK.

SUBJECTS

Patients awaiting primary total hip replacement due to osteoarthritis were recruited. Following pre-operative assessment, patients were individually randomised to intervention or control by a computer-generated block randomisation algorithm stratified by age and centre.

INTERVENTIONS

The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations, assessed home safety, and provided appropriate adaptive equipment. The control group received treatment as usual.

OUTCOMES

The study assessed the feasibility of recruitment procedures, delivery of the intervention, appropriateness of outcome measures and data collection methods. Health related quality of life and resource use were recorded at 4, 12 and 26 weeks.

RESULTS

Forty-four participants were recruited, 21 were randomised to the occupational therapy intervention and 23 to usual care. Analysis of 26 week data included 18 participants in the intervention group and 21 in the control. The intervention was delivered successfully with no withdrawals or crossovers; 5/44 were lost to follow-up with further missing data for participation and resource use.

CONCLUSIONS

The feasibility study provided the information required to conduct a definitive trial. Burden of assessment would need to be addressed. A total of 219 patients would be required in an efficacy trial.

摘要

目的

评估术前职业治疗干预对接受初次全髋关节置换术患者的可行性。

设计

单盲可行性随机对照试验,在干预前、术后4周、12周和26周收集数据。

地点

从英国西米德兰兹郡的两个国民保健服务(NHS)骨科门诊中心招募患者。

研究对象

招募因骨关节炎等待初次全髋关节置换术的患者。术前评估后,通过计算机生成的分层随机分组算法(按年龄和中心分层)将患者分别随机分配至干预组或对照组。

干预措施

干预组在术前接受职业治疗师的家访,职业治疗师会讨论患者的期望、评估家庭安全性并提供合适的适应性设备。对照组接受常规治疗。

观察指标

本研究评估了招募程序的可行性、干预措施的实施情况、结局指标的适宜性和数据收集方法。在术后4周、12周和26周记录健康相关生活质量和资源使用情况。

结果

共招募了44名参与者,21名被随机分配至职业治疗干预组,23名被分配至常规治疗组。对26周数据的分析纳入了干预组的18名参与者和对照组的21名参与者。干预措施成功实施,无退出或交叉情况;44名参与者中有5名失访,参与情况和资源使用方面有更多缺失数据。

结论

该可行性研究提供了开展确定性试验所需的信息。评估负担需要得到解决。疗效试验共需要219名患者。

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