This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.

Objectives To identify the core “domains” (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 survivors’ 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.

RationaleClinical trials of interventions aimed at the families of intensive care unit (ICU) patients have proliferated but recruitment for these trials can be challenging.ObjectivesTo evaluate a strategy for recruiting families of patients currently being treated in an ICU using limited human resources and time-varying daily screening over 7 consecutive daysMethodsWe screened the Johns Hopkins Hospital medical ICU census 7 days per week to identify eligible family members. We then made daily, in-person attempts to enroll eligible families during a time-varying 2-hour enrollment period until families declined participation, consented, or were no longer eligible.Measurements and main resultsThe primary outcome was the proportion of eligible patients for whom ≥1 family member was enrolled. Secondary outcomes included enrollment of legal healthcare proxies, the consent rate among families approached for enrollment, and success rates for recruiting at different times during the day and week. Among 284 eligible patients, 108 (38%, 95% CI 32%-44%) had ≥1 family member enrolled, and 75 (26%, 95% CI 21%-32%) had their legal healthcare proxy enrolled. Among 117 family members asked to participate, 108 (92%, 95% CI 86%-96%) were enrolled. Patients with versus without an enrolled proxy were more likely to be white (44% vs. 30%, P = .02), live in a zip code with a median income of ≥$100,000 (15% vs. 5%, P = .01), be mechanically ventilated (63% vs. 47%, P = .01), die in the ICU (19% vs. 9%, P = .03), and to have longer ICU stays (median 5.0 vs. 1.8 days, P<.001). Day of the week and time of day were not associated with family presence in the ICU or consent rate.ConclusionsFamily members were recruited for more than one third of eligible patients, and >90% of approached consented to participate. There are important demographic differences between patients with vs without an enrolled family member.