Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
PROSPERO registration number CRD42019152526.
- adult intensive & critical care
- rehabilitation medicine
- intensive & critical care
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Twitter @JenniferJonesAU, @SueBerney, @FILES_DC, @Griffith_DM, @LukeMcDonald_PT, @Ed_TimWalsh, @EmilyKarahalios, @Zudin_P, @LindaDenehy
Collaborators CRITICALConnect Study Investigators: Sue Berney; Michael J Berry; Linda Denehy; D Clark Files; David M Griffith; Jennifer R A Jones; Peter E Morris; Marc Moss; Amy Nordon-Craft; Zudin Puthucheary; Timothy Walsh
Contributors JRAJ, LD, SB and ZP contributed to the initial conception of the study. MJB, DCF, DMG, PEM, MM, AN-C and TW made significant subsequent contributions to the study design. JRAJ and LAM made significant contributions to the systematic literature review. IG and AK made significant contributions to the statistical analysis section. JRAJ, SB, IG, AK and LD drafted the manuscript. All authors revised the manuscript and approved the final version. The guarantor of the review is LD.
Funding This work is supported by an Austin Medical Research Foundation Project Grant. JRAJ received funding from Australian Government Research Training Program Scholarship to support her PhD studies. LD, SB and IG received funding from National Health and Medical Research Council (grant no 454717), Physiotherapy Research Foundation, Austin Medical Research Foundation and Australian and New Zealand Intensive Care Society related to this work. MM and AN-C received funding from National Institute of Nursing Research (NINR, grant no R01 NR011051) and National Heart, Lung, and Blood Institute (NHLBI, grant no K24 HL089223) from National Institutes of Health (NIH) related to this work. PEM, MJB and DCF received funding from NIH/NINR/NHLBI (grant no 1R01NR011186) related to this work. MJB received grant funding from Isagenix LLC outside the submitted work. DCF has received honoraria for consultancy from Cytovale. TW and DMG received funding from the Chief Scientist Office, Scotland (grant no CZH/4/531) related to this work. ZP has received honoraria for consultancy from Fresenius Kabi, Orion Pharmaceuticals, Lyric Pharmaceuticals, Faraday Pharmaceuticals and Nestle. The funders did not influence the study design or writing of this manuscript.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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