Objectives
To identify the core âdomainsâ (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge.
Design
A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review: 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers, that rated the importance of 19 preliminary outcome domains, and 2) results from a qualitative study of acute respiratory failure survivorsâ outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey.
Setting
Web-based surveys of participants representing 4 stakeholder groups relevant to clinical research evaluating post-discharge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and US federal research funding organizations.
Interventions
None.
Measurements and Main Results
Survey response rates were 97% and 99% in Round 1 and Round 2 respectively. There were 7 domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function.
Conclusion
This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.