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Editorial
Hindsight and moving the needle forwards on rehabilitation trial design
  1. Bronwen Connolly1,2,3,4,5,
  2. Linda Denehy5
  1. 1 Lane Fox Clinical Respiratory Physiology Research Centre, London, UK
  2. 2 NIHR Biomedical Research Centre, Guy’s and St. Thomas’ NHS Foundation, London, UK
  3. 3 King’s College London, London, UK
  4. 4 Centre for Human and Aerospace Physiological Sciences, King’s College London, London, UK
  5. 5 Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Professor Linda Denehy, Department of Physiotherapy, The University of Melbourne, Melbourne, Vic 3010, Australia; %E2%80%83%E2%80%83%E2%80%83%E2%80%83%E2%80%83l.denehy{at}unimelb.edu.au

https://doi.org/10.1136/thoraxjnl-2017-210588

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    Hindsight: the ability to understand, after something has happened, what should have been done or what caused the event.1

    The first randomised controlled trials (RCTs) of physical rehabilitation in critically ill patients in the intensive care unit (ICU) were published nearly 10 years ago demonstrating favourable results and heralding a groundswell of clinical and research activity in the field.2 3 Ensuing RCTs continued to investigate the peri-ICU period4 5 but additionally mapped the rehabilitation pathway to include post-ICU discharge on the ward6 and community7 8 and across the continuum of care.9 However, this impressive body of literature has challenged a transformation in clinical practice. Recent studies have failed to show a difference in primary outcome,4 5 but is this truly failure of interventions to demonstrate effect or failure of intervention delivery within an appropriately designed study? Hindsight is a valuable perspective to interpret this premise. Triallists need to pre-empt advances in knowledge and understanding of the topic in order to future-proof their research. It is easy to lament what could have been done differently. Acknowledging this, these trials have contributed greatly to our current understanding of the intricacies of design, conduct and evaluation of trials of complex rehabilitation interventions in critical care.

    Against this backdrop, Wright and colleagues present their Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC) study, a multicentre RCT investigating intensive versus standard physical rehabilitation therapy in the ICU.10 This is the first UK trial of its kind, recruiting 308 participants to receive either intervention (target 90 min per day) or control (target 30 min per day) physical rehabilitation treatment. The primary outcome was health-related quality of life measured using the Physical Component Summary (PCS) of the Short-Form-36 (SF-36) at 6 months. Intention-to-treat analysis revealed no difference between groups, mean …

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    Footnotes

    • Contributors Both authors contributed equally to the design, drafting and revision of this manuscript and agreed the final version for submission.

    • Funding BC is funded by an National Institute for Health Research (NIHR) Postdoctoral Fellowship (2015-08-015) and is supported by the NIHR Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.

    • Disclaimer The views expressed are those of the authors and are not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Provenance and peer review Commissioned; externally peer reviewed.

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