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

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 four stakeholder groups relevant to clinical research evaluating postdischarge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations.

Aim

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.

Contributors

Turnbull, Alison E.; Sepulveda, Kristin A.; Dinglas, Victor D.; Chessare, Caroline M.; Bingham, Clifton O.; Needham, Dale M.

Publication

Journal: Critical Care Medicine
Volume: 45
Issue: 6
Pages: 1001 - 1010
Year: 2017
DOI: https://doi.org/10.1097/CCM.0000000000002435

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Supported, in part, by the National Heart, Lung, and Blood Institute (R24HL111895). Dr. Bingham also receives support through a Methods Award from the Patient Centered Outcomes Research Institute (SC14-11402-10918) and the Rheumatic Diseases Research Core Center Human Subjects Core funded by the National Institutes of Arthritis and Musculoskeletal and Skin Diseases (National Institutes of Health P30-AR053503). Dr. Turnbull's institution received funding from the National Heart, Lung, and Blood Institute (NHLBI). Dr. Needham's institution received funding from the NIH/NHLBI, Gordon & Betty Moore Foundation, NIH, and National Health and Medical Research Council (Australia). All authors received support for article research from the National Institutes of Health (NIH).


Health Area

Disease Category: Rehabilitation

Disease Name: Respiratory failure

Target Population

Age Range: 20 - 110

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process