EMS Network Data Coordinating Center

描述(由申请人提供)： 院外心肺骤停(OO-CA)和危及生命的创伤性损伤(LTI)，包括创伤性脑损伤，需要联合调查，因为它们有几个共同特征。复苏研究联盟的数据协调中心将在进行OO-CA和LTI领域的临床试验方面发挥核心作用。为此，提出了三个具体目标： 1)开发和实施一个临床试验联盟，通过向地区临床中心、赞助商和监督机构提供合作、协调、管理和支持，同时研究OOH-CA和LTI患者。 2)制定和实施程序，以快速设计和实施一系列具有最佳内部和外部有效性的高质量随机试验。 3)向研究和临床实践界迅速传播这些试验的方法和结果，以改善复苏结果。 为了实现这一目标，数据协调中心(DCC)将利用其在社区急救服务提供者、急诊医生和心脏病专家方面的丰富经验，在每个地区临床中心(RCC)积极与对OO-CA和LTI感兴趣的高素质临床医生合作。该联盟将制定和实施与OOCA和LTI相关的诊断和评估结构、过程和结果的标准定义，以表征它们的自然历史和对干预措施的反应。数据协调中心将与技术伙伴协作，加强现有的互动信息技术系统，以促进交流和发展。此外，还将利用已开发和试点测试的创新软件和手持解决方案，实施快速和无偏见的随机化方法。将采用稳健、安全和保密的数据管理和质量控制方法，为及时获取数据提供一个中央储存库，以便及时进行仔细分析。将使用多种战略来确保政策制定者、从业者和公众及时和有效地利用研究结果，以改善美国和加拿大与EMS相关的医疗保健服务。

DESCRIPTION (provided by applicant): Out-of-hospital cardiopulmonary arrest (OOH-CA) and life-threatening traumatic injury (LTI), including traumatic brain injury, warrant joint investigation since they share several common features. A Data Coordinating Center for a Resuscitation Research Consortium will play a central role in conducting clinical trials in the area of OOH-CA and LTI. In order to do so, three specific aims are proposed: 1) To develop and implement a clinical trials consortium to simultaneously study patients with OOH-CA and LTI by providing collaboration, coordination, administration and support to regional clinical centers, sponsors and oversight bodies. 2) To develop and implement procedures to rapidly design and implement a series of high-quality randomized trials that have optimal internal and external validity. 3) To rapidly disseminate the methods and the results of these trials to the research and clinical practice community so as to improve resuscitation outcomes. In order to meet this aim, the Data Coordinating Center (DCC) will draw upon its extensive experience with community emergency service providers, emergency physicians and cardiologists to actively collaborate with highly-qualified clinicians interested in OOH-CA and LTI at each regional clinical center (RCC). The Consortium will develop and implement standard definitions for diagnosis, and assessment of structure, process, and outcome related to OOH-CA and LTI to characterize their natural history, and response to interventions. The Data Coordinating Center will enhance an existing interactive information technology system in collaboration with a technology partner to facilitate communication and development. In addition, rapid and bias-free methods of randomization will be implemented by using an innovative software and handheld solution that has been developed and pilot tested. Robust, secure and confidential methods of data management and quality control will be used to provide a central repository for timely acquisition of data, so that prompt careful analyses can be conducted. Multiple strategies will be used to ensure timely and effective uptake of study results by policy makers, practitioners, and the public in order to improve EMS-related health care delivery in the United States and Canada.