Physiotherapy Department, The University of Melbourne, Parkville, Victoria, Australia
Physiotherapy Department, Division of Allied Health, Austin Health, Heidelberg, Victoria, Australia.
BMJ Open. 2020 May 4;10(5):e035613. doi: 10.1136/bmjopen-2019-035613.
The number of inconclusive physical rehabilitation randomised controlled trials for patients with critical illness is increasing. Evidence suggests critical illness patient subgroups may exist that benefit from targeted physical rehabilitation interventions that could improve their recovery trajectory. We aim to identify critical illness patient subgroups that respond to physical rehabilitation and map recovery trajectories according to physical function and quality of life outcomes. Additionally, the utilisation of healthcare resources will be examined for subgroups identified.
This is an individual participant data meta-analysis protocol. A systematic literature review was conducted for randomised controlled trials that delivered additional physical rehabilitation for patients with critical illness during their acute hospital stay, assessed chronic disease burden, with a minimum follow-up period of 3 months measuring performance-based physical function and health-related quality of life outcomes. From 2178 records retrieved in the systematic literature review, four eligible trials were identified by two independent reviewers. Principal investigators of eligible trials were invited to contribute their data to this individual participant data meta-analysis. Risk of bias will be assessed (Cochrane risk of bias tool for randomised trials). Participant and trial characteristics, interventions and outcomes data of included studies will be summarised. Meta-analyses will entail a one-stage model, which will account for the heterogeneity across and the clustering between studies. Multiple imputation using chained equations will be used to account for the missing data.
This individual participant data meta-analysis does not require ethical review as anonymised participant data will be used and no new data collected. Additionally, eligible trials were granted approval by institutional review boards or research ethics committees and informed consent was provided for participants. Data sharing agreements are in place permitting contribution of data. The study findings will be disseminated at conferences and through peer-reviewed publications.
CRD42019152526.
针对危重症患者的不确定疗效的物理康复随机对照试验的数量正在增加。有证据表明,可能存在一些危重症患者亚组,他们可能受益于有针对性的物理康复干预措施,这些措施可以改善他们的康复轨迹。我们旨在确定对物理康复有反应的危重症患者亚组,并根据身体功能和生活质量结果绘制康复轨迹。此外,还将检查为确定的亚组使用医疗保健资源的情况。
这是一项个体参与者数据荟萃分析方案。对在急性住院期间为危重症患者提供额外物理康复治疗的随机对照试验进行了系统文献回顾,评估了慢性疾病负担,最低随访期为 3 个月,测量基于表现的身体功能和健康相关生活质量结果。在系统文献回顾中检索到的 2178 条记录中,有两位独立审查员确定了四项符合条件的试验。邀请符合条件的试验的主要研究者将他们的数据贡献到这项个体参与者数据荟萃分析中。将评估偏倚风险(针对随机试验的 Cochrane 偏倚风险工具)。将总结纳入研究的参与者和试验特征、干预措施和结果数据。荟萃分析将采用一个阶段模型,该模型将考虑到研究之间的异质性和聚类。将使用链式方程进行多重插补,以解决缺失数据问题。
这项个体参与者数据荟萃分析不需要伦理审查,因为将使用匿名参与者数据,并且不会收集新数据。此外,合格的试验已获得机构审查委员会或研究伦理委员会的批准,并为参与者提供了知情同意。已经签订了数据共享协议,允许数据的贡献。研究结果将在会议上和通过同行评审的出版物中进行传播。
CRD42019152526。