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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

Hodgson, Carol L. PhD1; Burrell, Aidan J. C. MD1,2; Engeler, Daniel M. PharmSci(Hon)1; Pellegrino, Vincent A. MD2; Brodie, Daniel MD3; Fan, Eddy MD, PhD4,5 on behalf of the International ECMO Network

doi: 10.1097/CCM.0000000000003954
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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.

1Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

2Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia.

3Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital, New York, NY.

4Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.

5Department of Medicine, University Health Network and Sinai Health System, Toronto, ON, Canada.

This work was performed at the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.

Drs. Hodgson, Brodie, and Fan conceived of the study. All authors designed the study and assisted with data acquisition and interpretation. All authors drafted and revised the article for intellectual content. All authors approved the final version and are accountable for the accuracy and integrity of the data.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

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

Dr. Hodgson reports grants from Hearts of ECMO and the Heart Foundation of Australia during the conduct of the study. Dr. Pellegrino received funding from Xenios. Dr. Brodie reports receiving research support from ALung Technologies, personal fees from Baxter, anticipated personal fees from BREETHE, unpaid advising for Hemovent, and he disclosed off-label product use of ECMO. Dr. Fan is supported by a New Investigator Award from the Canadian Institutes of Health Research and has received personal fees from Abbott, ALung Technologies, and MC3 Cardiopulmonary outside the submitted work. The remaining authors have disclosed that they do not have any conflicts of interest.

For information regarding this article, E-mail: carol.hodgson@monash.edu

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