Resuscitation Outcomes Consortium (ROC) Data Coordinating Center

复苏结果联盟 (ROC) 数据协调中心

• 批准号: 8240619
• 负责人: Susanne May
• 金额: $ 145万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8240619
• 关键词: Adherence; Adverse effects; Agreement; Ancillary Study; Area; California; Canada; Cardiac; Cardiopulmonary Arrest; Caring; Characteristics; Clinical; Clinical Protocols; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Collection; Communication; Communities; Conduct Clinical Trials; Continuity of Patient Care; Contract Services; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Quality; Databases; Development; Devices; Diagnosis; Disease; Eligibility Determination; Emergency Medicine; Emergency Situation; Emergency medical service; Enrollment; Ensure; Fire - disasters; Future; Goals; Guidelines; Health; Health Professional; Hospitals; Image; Individual; Information Systems; Informed Consent; Injury; Institutional Review Boards; Intervention; Investigational Drugs; Journals; Knowledge; Lead; Leadership; Life; Manuscripts; Medical; Methodology; Methods; Monitor; Natural History; Neurosurgeon; New Drug Approvals; Observational Study; Office for Human Research Protections; Online Systems; Outcome; Outcome Measure; Patient Care; Patients; Performance; Phase; Physician Executives; Physicians; Play; Policies; Policy Maker; Preparation; Process; Protocols documentation; Provider; Publications; Publishing; Qualifying; Quality Control; Randomized; Reapplication; Recruitment Activity; Registries; Research; Research Ethics; Research Personnel; Resuscitation; Review Committee; Role; Secure; Series; Site; Source; Structure; Surgeon; Training; Trauma; Traumatic Brain Injury; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Virginia; Washington; Work; Writing; base; cohort; data acquisition; data management; data sharing; design; evidence base; experience; follow-up; health care delivery; improved; innovation; meetings; member; novel therapeutic intervention; operation; patient safety; protocol development; randomized trial; repository; response; safety study; success; treatment effect; web page

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 and 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 vrith 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.

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，已联合调查，因为他们有几个共同的特点。临床 复苏研究联盟的试验中心（CTC）在开展临床研究方面发挥了核心作用。 OOH-CA和LTI领域的试验。为了改善复苏结果，CTC具有 以下目标：1）为OOHCA的临床试验提供行政和统计领导 和LTI，包括目前进行的试验的所有阶段。2)继续我们 紧急医疗服务（EMS）的护理过程和结果的观察性研究 通过Epistry Registry进行护理。3)快速设计，并实施一系列高质量的 II期和III期随机试验具有较高的内部和外部效度。 4)维持及改善一个有效率及安全可靠的资讯科技系统， 数据的收集、处理、存储和质量控制。5)带头和/或 在联合体内及时传播知识方面进行合作， 赞助商，监督机构和科学界，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。 反恐委员会将利用其与社区应急服务提供者、应急 医生和心脏病专家积极与在OOH-CA工作的高素质临床医生合作， 每个区域临床中心（RCC）的LTI研究。该中心已经并将继续作出实质性的 根据其统计数据，为临床试验设计、实施和开展的各个方面做出贡献， 行政和医疗专业知识。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。坚固、安全， 将采用保密的数据管理和质量控制方法， 及时获取数据，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。