Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia.
Crit Care Med. 2019 Nov;47(11):1557-1563. doi: 10.1097/CCM.0000000000003954.
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.
A three-round modified Delphi process.
Patients, caregivers, multidisciplinary clinicians, researchers, industry partners, and research funders were included.
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.
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.
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.
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.
评估体外膜氧合支持下的急性呼吸和心脏衰竭危重症患者结局的研究显著增加。本研究旨在确定一组核心结局，这些结局对于评估静脉-动脉和静脉-静脉体外膜氧合在危重症患者中的应用的所有临床研究都是必不可少的，特别是在安全性和不良事件方面。
三轮改良 Delphi 流程。
纳入了患者、护理人员、多学科临床医生、研究人员、行业合作伙伴和研究资助者。
参与者代表了体外膜氧合的重要组织，包括体外生命支持组织、国际体外膜氧合网络、来自大容量体外膜氧合中心的临床医生，以及来自五大洲的体外膜氧合研究人员或前体外膜氧合患者。
我们使用了为制定核心结局集而推荐的标准。从文献系统评价和幸存者定性研究中确定的结局指标分别针对静脉-静脉体外膜氧合和静脉-动脉体外膜氧合，与核心结局测量在有效性试验倡议确定的领域进行映射。
第 1、2 和 3 轮调查的参与者回复率分别为 47 人的 40 人（85%）、37 人的 35 人（95%）和 69 人的 64 人（93%），参与者代表了五大洲的 10 个不同国家。在第三轮调查后，8 项结局指标在静脉-静脉体外膜氧合和静脉-动脉体外膜氧合中均达成共识。
本研究确定了评估所有评估体外膜氧合应用的研究的核心结局，包括该干预措施特有的不良事件，首次实现了结果报告的标准化。确定评估这些结局的适当测量工具是实现体外膜氧合研究综合的重要下一步。
