Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Centre for Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Trials. 2021 Jul 20;22(1):467. doi: 10.1186/s13063-021-05362-x.
Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, remains the same pre- to post-operatively, and in some instances declines. The PEP-TALK trial evaluates the effects of a group-based, behaviour change intervention on physical activity following a THR or TKR.
PEP-TALK is an open, phase III, pragmatic, multi-centre, parallel, two-arm, two-way superiority randomised controlled trial investigating the effectiveness of usual care plus a behaviour change therapy compared with usual care alone following primary THR or TKR. The primary outcome is the UCLA Activity Score at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes measured at 6 months and 12 months after randomisation include the UCLA Activity Score, Lower Extremity Functional Scale, Oxford Hip/Knee Score, Numerical Rating Scale for Pain, Generalised Self-Efficacy Scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale, EuroQoL EQ-5D-5L index and EQ-VAS and complications or adverse events. Full details of the planned analysis approaches for the primary and secondary outcomes, as well as the planned sensitivity analyses to be undertaken due to the COVID-19 pandemic, are described here. The PEP-TALK study protocol has been published previously.
This paper provides details of the planned statistical analyses for the PEP-TALK trial. This is aimed to reduce the risk of outcome reporting bias and enhance transparency in reporting.
International Standard Randomised Controlled Trials database, ISRCTN Number: 29770908 . Registered on October 2018.
全髋关节置换术（THR）和全膝关节置换术（TKR）是两种非常成功的矫形手术，可以减轻骨关节炎患者的疼痛。先前的证据表明，体力活动充其量在术前和术后保持不变，在某些情况下甚至会下降。PEP-TALK 试验评估了基于小组的行为改变干预对 THR 或 TKR 后体力活动的影响。
PEP-TALK 是一项开放、三期、实用、多中心、平行、双臂、双向优效随机对照试验，研究了在初次 THR 或 TKR 后，常规护理加行为改变治疗与单纯常规护理相比的效果。主要结局是随机分组后 12 个月的 UCLA 活动评分，将使用线性混合效应模型进行分析。次要结局包括随机分组后 6 个月和 12 个月的 UCLA 活动评分、下肢功能量表、牛津髋关节/膝关节评分、疼痛数字评分量表、一般自我效能感量表、Tampa 运动恐惧量表、医院焦虑和抑郁量表、EuroQoL EQ-5D-5L 指数和 EQ-VAS 以及并发症或不良事件。本文详细描述了主要和次要结局的计划分析方法，以及由于 COVID-19 大流行而计划进行的敏感性分析。PEP-TALK 研究方案先前已发表。
本文提供了 PEP-TALK 试验计划统计分析的详细信息。这旨在降低结局报告偏倚的风险，并提高报告的透明度。
国际标准随机对照试验数据库，ISRCTN 编号：29770908。于 2018 年 10 月注册。
