Comparative Outcomes Management with Electronic Data Technology(COMET)Study

描述（由申请人提供）：拟议的使用电子数据技术的比较结果管理（COMET）研究的第一阶段包括开发新的电子数据网络基础设施，该基础设施将有望在位于斯坦福大学、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）之间访问和共享临床和研究数据。这种新的、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CCs中的每一个都能够收集纵向数据内容。然而，建立如此重要的关系需要在规范阶段处理多个组件。为了在多个机构的临床和研究部门之间正确地发展对数字和物理内容的安全、身份验证、许可和合规的数据访问和共享的规范和实现目标，需要将18个基本组件放入并发敏捷进化开发中。发展彗星网所涉及的组成部分包括建立一个包含下列特点的信息系统：通过互联网络的单点访问；一个不断发展的、可定制的本体映射到由临床中心的信息学基础设施组成的各种数据模型、数据库实例和数据元素收集并存档的现有变量；一个直观的联邦查询工具，为各种研究和临床用例生成结果集；当需要进行进一步分析时，启动转移数字或物理标本样本的请求程序；所有临床中心通用的程序；请求和传输程序，使数字和物理内容的合规、授权和认证的交换和共享得以实现并记录下来；HIPAA合规;还有开源软件。另一个阶段是收集来自一项比较有效性试验的数据，该试验评估了正压通气（PAP）与口腔矫治（OA）治疗在改善超重/肥胖阻塞性睡眠呼吸暂停（OSA）患者高血压和心血管功能异常方面的作用，OSA是一种非常普遍的睡眠相关呼吸障碍。该项目的比较有效性部分是一项新颖的多中心单盲（数据收集者）双臂随机平行组比较试验。该研究旨在确定PAP与OA治疗在主要为女性、超重/肥胖OSA合并高血压患者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群体、不同的患者合并症和疾病严重程度、不同的设备和测试类型，并纵向连接从该比较有效性试验中收集的前瞻性信息。从该试验中收集的数据将用于测试信息学基础设施。

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.