Core Outcome Measures in Effectiveness Trials

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

General Information

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 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.

Authors:
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:
Further Study Information

Date:
Funding source(s):
None stated

Health Area

Disease Category
Rehabilitation

Disease Name
Respiratory failure

Target Population

Age Range
0 - 110

Sex
Either


Nature / type of Intervention
Any

Method(s)

Delphi process

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research
COS for practice

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