Resuscitation Outcomes Consortium (ROC) Data Coordinating Center

描述(申请人提供)：院外心肺骤停(OHO-CA)和危及生命的创伤性损伤(LTI)，包括创伤性脑损伤，已经被联合调查，因为它们有几个共同的特征。复苏研究联盟的临床试验中心(CTC)在OO-CA和LTI领域的临床试验中发挥了核心作用。为了改善复苏结果，CTC有以下目标：1)为OuchA和LTI的临床试验提供行政和统计领导，包括目前正在进行的所有阶段的试验。2)继续通过Epistry注册对紧急医疗服务(EMS)护理的护理过程和结果进行观察性研究。3)快速设计和实施一系列具有较高内、外部效度的高质量二期和三期随机试验。4)维护和完善有效和安全的信息技术系统，以收集、处理、存储和控制数据。5)牵头和/或与赞助商、监督机构和科学界合作，在联合体内及时传播知识，从而改善复苏结果。6)为ONG-CA和LTI的临床试验提供方法学指导。CTC将利用其在社区急救服务提供者、急救医生和心脏病专家方面的丰富经验，积极与每个地区临床中心(RCC)从事OOCA或LTI研究的高素质临床医生合作。该中心已经并将继续以其统计、管理和医疗专业知识为基础，为临床试验设计、实施和实施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，以促进交流和发展。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，以便及时进行仔细分析。将采用多种策略确保及时有效地向决策者、从业者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。复苏结果联盟(ROC)将为院外心肺骤停和危及生命的创伤性损伤领域的临床试验提供行政领导。该联盟是由美国和加拿大的9个地区性临床中心组成的集团。(摘要结束) 简历：在这一出色的应用中，数据协调中心建议提供管理领导，维护和使用Epistry中的观察数据，设计和实施临床试验，维护和改进高效和安全的信息技术，并领导复苏结果联盟(ROC)的知识传播。这一应用的优势在于它对院外心肺骤停和危及生命的创伤性损伤的潜在影响、疾病控制中心的基础设施、统计专业知识以及出色的数据收集和管理。有几个担忧降低了人们的热情。这些问题包括：1)缺乏随机数据，2)没有讨论主要挑战以及发展协调委员会如何克服这些挑战，3)缺乏共同的PI和领导计划。此外，审查员认为，礼宾培训和认证应由信息和通信技术中心进行，而不是由个别地点进行。此外，有很多关于丢失数据的讨论，以及需要找到丢失的人口数据的方法的结论。这些问题和其他问题降低了最终的影响得分。总体而言，DCC被发现对中华民国做出了重大贡献。

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. The Resuscitation Outcomes Consortium (ROC) will provide administrative leadership for clinical trials in the area of out-of-hospital cardiopulmonary arrest and life-threatening traumatic injury. The Consortium is a group of 9 regional clinical centers within the United States and Canada. (End of Abstract) Resume: In this excellent application the data coordinating center proposes to provide administrative leadership, maintain and use observational data in the Epistry, design and implement clinical trials, maintain and improve an efficient and secure information technology, and lead in knowledge dissemination for the resuscitation outcomes consortium (ROC). The strengths of this application were its potential impact on out-of-hospital cardiopulmonary arrest and life-threatening traumatic injury, the DCC's infrastructure, the statistical expertise and the excellent data collection and management. There were several concerns that lowered enthusiasm. These included: 1) A lack of randomized data, 2) No discussion of major challenges and how the DCC overcame them and 3) The lack of a Co-PI and leadership plan. In addition, reviewers felt that protocol training and certification should be done by DCC and not by individual sites. Also, there was much discussion about missing data and the conclusion that a way was needed to locate missing demographic data. These and other issues lowered the final impact score. Overall, the DCC was found to have contributed significantly to ROC.