Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study

Abstract

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.

Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU

“…Faster extubation and increased hospital survival, though the building blocks of long-term outcomes, no longer suffice as the sole descriptors of patient-centered outcomes. Improvements in many aspects of survivorship, including return to former quality of life, independent function, and employment, are meaningful (207). Further studies evaluating the value of patient communication with family members during and after ICU Critical Care Medicine www.ccmjournal.org e841 care and the perceptions of patients while on each of these sedatives are also needed; of note, our patient panel members described very different subjective experiences when receiving sedatives that could not be translated into guideline recommendation content.…”

Acute Respiratory Distress Syndrome as a Precursor to Post–Intensive Care Syndrome

“…Post-hospital discharge, whether in a long-term acute care hospital, skilled care facility, acute rehabilitation setting, or an ICU recovery clinic or primary care provider's office, we recommend that providers be aware of PICS and standardize their practice to identify ICU survivors and assess for functional impairments. Adapted from the core outcome measurement set for clinical research in acute respiratory failure survivors (74)(75), potential screening tests include the Hospital Anxiety and Depression scale (HADS) (76), Impact of Event Scale-Revised (IES-R) (77), and Montreal Cognitive Assessment (MoCA) (78) for anxiety, depression, post-traumatic stress disorder, and cognitive impairment, respectively. Additionally, the EuroQoL can be used as a screening test for physical function and pain (79).…”

“…Additionally, the EuroQoL can be used as a screening test for physical function and pain (79). For an objective functional assessment, the 6-minute walk test is a valid, reliable, and reproducible measure that can be followed longitudinally (74)(75). While recommended for research purposes, each of these measures are commonly used in clinical practice.…”

Hindsight and moving the needle forwards on rehabilitation trial design

“…Furthermore, the SF-36 PCS can only be measured in survivors. Accounting for death when measuring patient-reported outcomes over time is critical, especially given that both survival and quality of life are recommended core outcomes for studies of acute respiratory failure survivors 22. EPICC did not account for deaths in their analyses and use of differing data management approaches impede comparisons between trials.…”