A Core Outcome Set for Research in Patients on Extracorporeal Membrane Oxygenation

Abstract

Objectives: A core set of outcomes have been identified and published, which are essential to include in all clinical research evaluating the use of extracorporeal membrane oxygenation in critically ill patients, particularly regarding safety and adverse events. The purpose of this international modified Delphi study was to determine which measurement tools and the timing of measurement should be selected for the core outcome set for research evaluating patients receiving extracorporeal membrane oxygenation.

Design: This was a two-round international, multidisciplinary web-based, modified Delphi study.

Patients: Participants were identified from the International Extracorporeal Membrane Oxygenation Network and the Extracorporeal Life Support Organization, including consumers, multidisciplinary clinicians, researchers and industry partners.

Measurements: Measurement tools and the timing of measurement were identified from a systematic review of the literature and clinical trials registrations. The primary outcome was the percentage of respondents who completed each survey and indicated that a measurement tool as well as the timing of the measurement should "always" be included in a core outcome set.

Main results: Participant response rates were 46 of 65 (71%) and 40 of 46 (87%) for rounds one and two, respectively, with participants representing, researchers, consumers, and industry partners from 15 countries over five continents. Seven measurement tools were identified for the core outcome set of patients on extracorporeal membrane oxygenation.

Conclusions: This study has identified appropriate measurement instruments and the timing of measurement to include in the core outcome set for research evaluating patients receiving extracorporeal membrane oxygenation. This was an important final step to standardize and synthesize research efforts internationally.