Tolles Juliana, Toy Jake, Bosson Nichole, Dillon David G, Donofrio-Odmann J Joelle, Menegazzi James J, Montoy Juan Carlos C, VanBuren John M, Gausche-Hill Marianne
Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA, United States.
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States.
Resusc Plus. 2025 May 28;24:100992. doi: 10.1016/j.resplu.2025.100992. eCollection 2025 Jul.
Few large randomized clinical trials (RCTs) have been conducted to inform the prehospital phase of care for out-of-hospital cardiac arrest (OHCA). We describe the development of a consortium to facilitate large-scale prehospital RCTs through a novel research collaboration, leveraging pre-existing prehospital and hospital data capture infrastructure.
We developed a consortium consisting of 173 emergency medical services (EMS) Provider Agencies and four academic "hubs." The consortium is an innovative collaboration consisting of a diverse set of EMS experts from across California and designed to overcome logistical, cost, and regulatory challenges associated with prehospital research. All participating agencies share data via a state EMS database, California EMS Information System (CEMSIS), and contribute data to the national Cardiac Arrest Registry to Enhance Survival (CARES) database. Data from CEMSIS and CARES will be linked to capture RCT outcomes. We abstracted two years of data from the CARES database to characterize the population served by the consortium and facilitate sample size calculations for future trials. We estimate that the consortium will have the ability to enroll a diverse population of patients with OHCA, at a rate of approximately 19,000 per year across all sites, for a future trial of cardiac arrest therapies.
This collaboration uses pre-existing data infrastructure to capture prehospital and hospital outcome data to facilitate large-scale prehospital RCTs for time-critical emergencies.
很少有大型随机临床试验（RCT）来指导院外心脏骤停（OHCA）的院前护理阶段。我们描述了一个联盟的发展情况，该联盟通过一种新颖的研究合作方式，利用现有的院前和医院数据采集基础设施，来推动大规模的院前RCT。
我们组建了一个由173个紧急医疗服务（EMS）提供机构和四个学术“中心”组成的联盟。该联盟是一种创新合作，由来自加利福尼亚州各地的不同EMS专家组成，旨在克服与院前研究相关的后勤、成本和监管挑战。所有参与机构通过州EMS数据库——加利福尼亚州EMS信息系统（CEMSIS）共享数据，并向国家心脏骤停登记以提高生存率（CARES）数据库提供数据。来自CEMSIS和CARES的数据将被关联起来以获取RCT结果。我们从CARES数据库中提取了两年的数据，以描述该联盟所服务的人群特征，并为未来的试验进行样本量计算。我们估计，该联盟将有能力每年在所有站点以约19000例的速度招募不同的OHCA患者群体，用于未来的心脏骤停治疗试验。
这种合作利用现有的数据基础设施来获取院前和医院结局数据，以推动针对时间紧迫的紧急情况进行大规模的院前RCT。
