Musculoskeletal Research Unit, University of Bristol Medical School, Bristol, UK
NIHR Bristol Biomedical Research Centre, Bristol, UK.
BMJ Open. 2024 Mar 20;14(3):e078785. doi: 10.1136/bmjopen-2023-078785.
To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.
Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.
Two National Health Service (NHS) secondary care hospitals in England and Wales.
Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0-28 on the Sleep Condition Indicator questionnaire.
The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.
The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.
Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.
This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.
ISRCTN14233189.
测试一项针对全膝关节置换术患者的新型术前定制睡眠干预的随机对照试验（RCT）的可行性。
采用 1:1 随机分组、嵌入式定性研究的可行性双臂两中心 RCT。
英格兰和威尔士的两家国家卫生服务（NHS）二级保健医院。
从全膝关节置换术候补名单中确定的术前成年患者，其睡眠受到干扰，定义为睡眠状况指标问卷得分为 0-28。
REST 干预措施是由扩展范围从业者（ESP）提供的术前定制睡眠评估和行为干预包，并在干预后 4 周进行电话随访。所有参与者都接受了参与 NHS 医院提供的常规护理。
主要目的是评估进行全面试验的可行性。患者报告的结果在基线、术前 1 周和术后 3 个月进行评估。为确定可行性而收集的数据包括合格患者的数量、招募率和干预依从性。定性工作通过对 ESP 和患者的访谈，探讨了研究过程和干预措施的可接受性。
向 378 名患者寄出了筛查包，57 名患者被随机分组。在随机分组的患者中，20 名在研究时间内接受了手术。随机分配到干预组的 28 名参与者中有 25 名参加了预约。术前完成了 40/57（70%）的参与者的随访结局测量，术后完成了 15/57（26%）的参与者的随访结局测量。在完成结局测量的参与者中，除了疼痛 DETECT：基线时 86%完整，术前时 72%完整，术后时 67%完整外，所有时间点的结局测量数据完成率均为 80%或更高。访谈表明，大多数参与者认为研究过程和干预措施是可以接受的。
这项可行性研究表明，对流程和设计进行一些修改后，评估 REST 干预的临床和成本效益的 RCT 是可行的。
ISRCTN81035234。
