Resuscitation Outcomes Consortium (ROC) Data Coordinating Center

复苏结果联盟 (ROC) 数据协调中心

基本信息

批准号：
8787766
负责人：
Susanne May
金额：
$ 649.8万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-01 至 2018-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8787766
关键词：
Adherence Adverse effects Agreement 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 Coordinating Center Data Files Data Quality Databases Development Devices Diagnosis Disease Eligibility Determination Emergency Department Physician 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 Letters 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 Play Policies Policy Maker Preparation Principal Investigator 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 experience follow-up health care delivery improved innovation meetings member novel therapeutic intervention operation patient safety programs protocol development randomized trial repository response safety study success treatment effect trial design web page

项目摘要

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.

描述（由申请人提供）：院外心肺停滞（OOH-CA）和威胁生命的创伤性损伤（LTI），包括脑损伤，因为它们具有多个共同特征，因此已经共同研究了。复苏研究联盟的临床试验中心（CTC）在OOH-CA和LTI领域进行临床试验方面发挥了核心作用。为了改善复苏结果，CTC的目的是：1）为OOHCA和OOHCA和LTI的临床试验提供行政和统计领导力，包括当前进行试验的所有阶段。 2）继续我们通过ePrions登记中心的护理过程和紧急医疗服务（EMS）护理结果的观察性研究。 3）快速设计并实施一系列具有高内部和外部有效性的高质量II期和III期随机试验。 4）维护并改善了一个有效且安全的信息技术系统，用于收集，处理，存储和质量控制数据。 5）与赞助商，监督机构和科学界有关及时传播知识的及时传播知识，从而提高复苏结果。 6）为OOH-CA和LTI的临床试验提供方法论领导。 CTC将借鉴其与社区紧急服务提供商，急诊医师和心脏病专家的丰富经验，以与在每个区域临床中心（RCC）中在OOH-CA或LTI研究中工作的高度合格的临床医生积极合作。该中心已经并且将继续根据其统计，行政和医学专业知识，对临床试验设计，实施和行为的各个方面做出重大贡献。数据协调中心将增强现有的交互式信息技术系统，以促进通信和发展。强大的，安全和机密的数据管理和质量控制方法将用于提供及时获取数据的中央存储库，以便可以及时进行仔细的分析。将使用多种策略来确保将研究结果及时传播给政策制定者，从业者和公众，以改善美国和加拿大与EMS相关的医疗保健提供。