Background:Existing data on physical rehabilitation interventions in critical illness are challenged by outcome heterogeneity that limits data synthesis and translation of research findings into clinical practice. This protocol describes the PRACTICE study to develop a core outcome set (COS) for trials of physical rehabilitation interventions delivered across the continuum of a patient’s recovery from the intensive care unit until reintegration in the community following hospital discharge.
Methods:Mixed methods will be used including: systematic reviews of quantitative and qualitative literature;qualitative interviews with patients and caregivers; a modified Delphi consensus process with researcher, clinician and patient/caregiver stakeholder groups; and consensus meetings for ratification of findings, resolving uncertainty,or developing an action plan for COS implementation.
Discussion:The PRACTICE COS will inform relevant stakeholders about important outcomes regarding physicalrehabilitation in critical illness, and may enhance the future design and conduct of trials in this area
- COS methods research
Nested methodological questions
A number of nested methodological questions will be examined during PRACTICE involving exploratory secondary analyses of the process and data set. These questions are outlined below, with further details reported in Additional file3:1. Which outcomes in the final PRACTICE COS originated from which information sources?2. How does the final PRACTICE COS feature in existing trials of physical rehabilitation in critical illness?3. How did different stakeholder groups rate outcomes?