Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
RATIONALE:

Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in measurement instruments used, creating barriers to synthesizing study data.

OBJECTIVES:

To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge.

METHODS:

A three-round modified Delphi consensus process with 77 participants (47% female, 55% outside USA), including clinical researchers from >16 countries across 6 continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for 7 consensus-derived outcomes plus 1 recommended outcome.

MEASUREMENTS AND MAIN RESULTS:

Response rates were 91%-97% across the 3 rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and SF-36v2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both Hospital Anxiety and Depression Scale, and Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus for exclusion. The following measures did not reach the threshold for consensus, but achieved the highest scores for their respective outcomes: Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute walk test (physical function).

CONCLUSIONS:

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

Aim:
To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge.

Authors:
Needham DM, Sepulveda KA, Dinglas VD, Chessare CM, Aronson Friedman L, Bingham Iii CO, Turnbull AE

Publication

Journal:
American Journal of Respiratory & Critical Care Medicine
Volume:
Issue:
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Lungs & airways

Disease Name
Respiratory failure

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Delphi process

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Funders
Researchers

Study Type

Recommended outcome measures (measurement)

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