Family or caregiver outcomes after critical illness (FOCUS): a protocol for a core outcome set development study.

introductionFamily members of survivors of critical illness are known to experience adverse outcomes in the months following the critical care admission, which can impact their physical, social and emotional health. This protocol describes the Family or Caregiver Outcomes after critical illness (FOCUS) study, which aims to develop a core outcome set (COS) for trials involving family members of critical care patients across the continuum of care. METHODS AND ANALYSIS: A modified Delphi consensus process with researcher, clinician and patient/caregiver stakeholder groups and consensus meetings for ratification of findings, resolving uncertainty and developing an action plan for COS implementation. ETHICS AND DISSEMINATION: The FOCUS COS will inform relevant stakeholders about important outcomes for family members of critical care patients and may enhance the future design and conduct of trials in this area. This study has been approved by the University of Cambridge Psychology Research Ethics Committee. The COS will be disseminated through peer-reviewed publications and engagement with key stakeholders. TRIAL REGISTRATION NUMBER: COMET database (https://comet-initiative.org/Studies/Details/1977).