Resuscitation Outcomes Consortium (ROC) Data Coordinating Center

描述（由申请人提供）：由于院外心肺骤停（OOH-CA）和危及生命的创伤性损伤（LTI）（包括创伤性脑损伤）具有几个共同特征，因此对其进行了联合研究。复苏研究联盟的临床试验中心（CTC）在OOH-CA和LTI领域的临床试验中发挥了核心作用。以改善复苏结局为目标，CTC有以下目标：1）为OOHCA和LTI的临床试验提供行政和统计领导，包括目前进行的试验的所有阶段。2)通过Epistry注册中心继续我们对紧急医疗服务（EMS）护理过程和结局的观察性研究。3)快速设计和实施一系列高质量的II期和III期随机试验，具有高的内部和外部效度。4)维护和改进一个高效、安全的信息技术系统，用于数据的收集、处理、存储和质量控制。5)与申办者、监督机构和科学界一起，在联盟内及时传播知识方面发挥领导作用和/或进行合作，从而改善复苏结果。6)为OOH-CA和LTI的临床试验提供方法学领导。CTC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）从事OOH-CA或LTI研究的高素质临床医生合作。中心已经并将继续根据其统计、管理和医学专业知识，为临床试验设计、实施和开展的各个方面做出实质性贡献。数据协调中心将加强现有的互动信息技术系统，以促进通信和发展。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，以确保及时有效地向决策者，从业人员和公众传播研究结果，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, have been jointly investigated since they share several common features. The Clinical Trial Center (CTC) for a Resuscitation Research Consortium has played a central role in conducting clinical trials in the areas of OOH-CA and LTI. With the goal of improving resuscitation outcomes, the CTC has the following aims: 1) To provide administrative and statistical leadership for clinical trials in OOHCA an d LTI including all phases of currently conducted trials. 2) To continue our observational study of care processes and outcomes for emergency medical services (EMS) care through the Epistry registry. 3) To rapidly design, and implement a series of high-quality Phase II and Phase III randomized trials that have high internal and external validity. 4) To maintain and improve an efficient and secure information technology system for collection, processing, storage, and quality control of the data. 5) To take the lead and/or collaborate regarding timely dissemination of knowledge within the consortium, with sponsors, oversight bodies, and the scientific community, thereby improving resuscitation outcomes. 6) To provide methodological leadership for clinical trials in OOH-CA and LTI. The CTC will draw upon its extensive experience with community emergency service providers, emergency physicians and cardiologists to actively collaborate with highly-qualified clinicians working in OOH-CA or LTI research at each regional clinical center (RCC). The Center has and will continue to make substantial contributions to all aspects of clinical trial design, implementation and conduct based on its statistical, administrative and medical expertise. The Data Coordinating Center will enhance an existing interactive information technology system to facilitate communication and development. 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 dissemination of study results to policy makers, practitioners, and the public in order to improve EMS-related health care delivery in the United States and Canada.