EMS Network Data Coordinating Center

描述（由申请人提供）： 院外心肺骤停（OOH-CA）和危及生命的创伤性损伤（LTI），包括创伤性脑损伤，值得联合调查，因为它们有几个共同的特点。复苏研究联盟的数据协调中心将在OOH-CA和LTI领域的临床试验中发挥核心作用。为此，提出了三个具体目标： 1)开发和实施临床试验联盟，通过向区域临床中心、申办者和监督机构提供协作、协调、管理和支持，同时研究OOH-CA和LTI患者。 2)开发和实施程序，以快速设计和实施一系列具有最佳内部和外部效度的高质量随机试验。 3)将这些试验的方法和结果迅速传播给研究和临床实践界，以改善复苏结局。 为了实现这一目标，数据协调中心（DCC）将利用其与社区急救服务提供者、急诊医生和心脏病专家的丰富经验，积极与每个区域临床中心（RCC）对OOH-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诊断的标准定义，以及与OOH-CA和LTI相关的结构，过程和结果的评估，以表征其自然史和对干预措施的反应。数据协调中心将与一个技术伙伴合作，加强现有的互动信息技术系统，以促进通信和发展。此外，还将使用已开发和试点测试的创新软件和手持解决方案，实施快速和无偏倚的随机化方法。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，以便能够迅速进行仔细分析。将采用多种策略，以确保决策者，从业人员和公众及时有效地吸收研究结果，以改善美国和加拿大的EMS相关医疗保健服务。

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.