Core Outcome Measures in Effectiveness Trials

Core Outcome Measures for Research in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation for Acute Respiratory or Cardiac Failure: An International, Multidisciplinary, Modified Delphi Consensus Study

General Information

Abstract:
OBJECTIVES: Research evaluating outcomes in critically ill patients with acute respiratory and cardiac failure supported with extracorporeal membrane oxygenation has increased significantly. The objective was to identify a core set of outcomes that are essential to include in all clinical research evaluating the use of either venoarterial or venovenous extracorporeal membrane oxygenation in critically ill patients, particularly regarding safety and adverse events. DESIGN: A three-round modified Delphi process. SUBJECTS: Patients, caregivers, multidisciplinary clinicians, researchers, industry partners, and research funders were included. SETTING: Participants represented key extracorporeal membrane oxygenation organizations, including the Extracorporeal Life Support Organization, the International Extracorporeal Membrane Oxygenation Network, clinicians from high volume extracorporeal membrane oxygenation centers, and extracorporeal membrane oxygenation researchers or former extracorporeal membrane oxygenation patients from five continents. INTERVENTIONS: We used recommended standards for the development of a core outcome set. Outcome measures identified from systematic reviews of the literature and from qualitative studies of survivors were mapped to the domains identified by the Core Outcome Measures in Effectiveness Trials initiative separately for venovenous extracorporeal membrane oxygenation and venoarterial extracorporeal membrane oxygenation. MEASUREMENTS AND MAIN RESULTS: Participant response rates were 40 of 47 (85%), 35 of 37 (95%), and 64 of 69 (93%) for survey rounds 1, 2, and 3, respectively, with participants representing 10 different countries on five continents. After the third round survey, 8 outcome measures met consensus for both venovenous extracorporeal membrane oxygenation and venoarterial extracorporeal membrane oxygenation. CONCLUSIONS: This study identified core outcomes to assess in all research evaluating the use of extracorporeal membrane oxygenation, including adverse events specific to this intervention, permitting standardization of outcome reporting for the first time. Identifying appropriate measurement instruments to evaluate these outcomes is an important next step to enable synthesis of extracorporeal membrane oxygenation research.

Authors:
Hodgson, C. L. Burrell, A. J. C. Engeler, D. M. Pellegrino, V. A. Brodie, D. Fan, E.

Publication

Journal:
Critical Care Medicine
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):
Supported, in part, by grant from the International Extracorporeal Membrane Oxygenation (ECMO) Network and The Hearts of ECMO.

Health Area

Disease Category
Heart & circulation

Disease Name
Cardiac and Respiratory Failure

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Device

Method(s)

Delphi process
Interview
Systematic review

Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research

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