Friday, April 19, 2024
4/19/2024
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.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
