Comparative Outcomes Management with Electronic Data Technology(COMET)Study

电子数据技术比较结果管理（COMET）研究

• 批准号: 8029335
• 负责人: Clete A Kushida
• 金额: $ 830.99万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8029335
• 关键词: Comparative; Outcomes; Management; Electronic; Data

DESCRIPTION (provided by applicant): The first phase of the proposed Comparative Outcomes Management with Electronic Data Technology (COMET) Study includes the development of a new electronic data network infrastructure that will prospectively enable access to and the sharing of clinical and research data between four Clinical Centers (CCs), located at Stanford University, University of Pennsylvania, University of Wisconsin-Madison, and Harvard University. The development of this new, broad, scalable, and sustainable electronic data network will enable the collection of longitudinal data content by each of the four CCs. However, the establishment of a relationship of this magnitude requires that multiple components be addressed during the specification phase. There are 18 essential components needed to be placed into concurrent agile evolutionary development in order to properly evolve specification and implementation goals of secure, authenticated, permissioned, and compliant data access to and sharing of digital and physical content among the clinical and research arms of multiple institutions. The components involved in development of the COMET network include creation of an informatics system that incorporates the following features: single-point access via the Internet; an evolving, customizable ontology mapped to existing variables collected by, and archived in, a wide variety of data models, database instances, and data elements comprising the informatics infrastructures of the clinical centers; an intuitive, federated query tool to produce result sets for a variety of research and clinical use cases; a request procedure to initiate the transfer of digital or physical specimen samples when they are needed for further analysis; procedures common to all clinical centers; request and transfer procedures enabling and logging the compliant, authorized, and authenticated exchange and sharing of digital and physical content; HIPAA compliance; and open-source software. The other phase is the collection of data from a comparative effectiveness trial evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA), a highly prevalent sleep-related breathing disorder. The comparative effectiveness component of the proposed project is a novel multicenter single-blind (data collectors) two-arm randomized parallel group comparative trial. It is designed to determine the relative efficacy and differential degree of benefit of PAP versus OA therapy with respect to cardiovascular risk in predominantly female, overweight/obese OSA patients with hypertension. The electronic network infrastructure developed through COMET will link the prospective information collected from this comparative effectiveness trial via multiple CCs, diverse patient and research participant populations, different patient comorbidities and disease severities, various equipment and test types, and longitudinally across several patient visits. The data collected from this trial will be used to test the informatics infrastructure. PUBLIC HEALTH RELEVANCE: We plan to develop an electronic network that will enable the transfer of information from various hospitals and medical centers, patients and research subjects, different types and severity of medical problems, various equipment and test types, and across several patient visits. This network will allow physicians and scientists to access comprehensive information about their patients and research subjects, and the sharing of this information across several academic institutions may ultimately lead to improvement in medical outcomes. We also plan to conduct a study evaluating two common treatments for obstructive sleep apnea (OSA), a highly prevalent sleep-related breathing disorder, and we anticipate that this study will provide comparative data for determining the effectiveness of these treatments in reducing cardiovascular risk in a population at high risk for cardiovascular disease, and will enhance clinical decision making in determining the optimal treatment strategies for patients with OSA.

描述（由申请人提供）：拟议的电子数据技术比较结局管理（COMET）研究的第一阶段包括开发新的电子数据网络基础设施，该基础设施将前瞻性地实现位于斯坦福大学、宾夕法尼亚大学、威斯康星大学麦迪逊分校和哈佛大学的四个临床中心（CC）之间的临床和研究数据访问和共享。这一新的、广泛的、可扩展的和可持续的电子数据网络的发展将使四个协调中心的每一个都能够收集纵向数据内容。然而，建立这种规模的关系需要在规范阶段处理多个组件。需要将18个基本组件放入并行敏捷演进开发中，以适当地演进规范和实现目标，即在多个机构的临床和研究部门之间安全、认证、许可和合规地访问和共享数字和物理内容。COMET网络的开发所涉及的组成部分包括创建一个信息系统，该系统具有以下特点：通过互联网进行单点访问;一个不断发展的、可定制的本体论，该本体论映射到由各种数据模型、数据库实例和数据元素收集并存档的现有变量，这些数据模型、数据库实例和数据元素包括临床中心的信息基础设施;直观的联合查询工具，用于为各种研究和临床用例生成结果集;请求程序，用于在需要进一步分析时启动数字或物理标本样本的传输;所有临床中心通用的程序;请求和传输程序，实现并记录数字和物理内容的合规、授权和认证交换和共享;符合HIPAA;以及开源软件。另一个阶段是从一项比较有效性试验中收集数据，该试验评估了气道正压通气（PAP）与口腔矫治器（OA）治疗在改善患有阻塞性睡眠呼吸暂停（OSA）的超重/肥胖患者的高血压和心血管功能异常方面的效果，OSA是一种高度流行的睡眠相关呼吸障碍。拟议项目的比较有效性部分是一项新的多中心单盲（数据收集者）双臂随机平行组比较试验。其目的是确定PAP与OA治疗在主要为女性、超重/肥胖OSA伴高血压患者中心血管风险方面的相对疗效和获益差异程度。通过COMET开发的电子网络基础设施将通过多个CC、不同的患者和研究参与者人群、不同的患者合并症和疾病严重程度、各种设备和测试类型，以及纵向跨越多个患者访视，将从该比较有效性试验中收集的前瞻性信息联系起来。从本试验中收集的数据将用于测试信息学基础设施。 公共卫生关系：我们计划开发一个电子网络，该网络将能够传输来自不同医院和医疗中心、患者和研究对象、不同类型和严重程度的医疗问题、各种设备和测试类型以及多个患者访问的信息。该网络将使医生和科学家能够获得有关其患者和研究对象的全面信息，并且在几个学术机构之间共享这些信息可能最终导致医疗结果的改善。我们还计划进行一项研究，评估阻塞性睡眠呼吸暂停（OSA）的两种常见治疗方法，OSA是一种高度流行的睡眠相关呼吸障碍，我们预计这项研究将提供比较数据，以确定这些治疗方法在降低心血管疾病高危人群心血管风险方面的有效性，并将增强临床决策，以确定OSA患者的最佳治疗策略。

项目成果

The COMET Sleep Research Platform.

COMET 睡眠研究平台。

• DOI: 10.13063/2327-9214.1059
• 发表时间: 2014
• 期刊: EGEMS (Washington, DC)
• 作者: Nichols,DeborahA;DeSalvo,Steven;Miller,RichardA;Jónsson,Darrell;Griffin,KaraS;Hyde,PamelaR;Walsh,JamesK;Kushida,CleteA
• 通讯作者: Kushida,CleteA