We will develop a distributed network infrastructure for comparative effectiveness research that provides flexibility to participant sites in the means for data sharing. This flexibility will be implemented by allowing codification of data sharing policies - each institution will specify its own policies. The SCAlable National Network for Effectiveness Research (SCANNER) will connect diverse healthcare delivery settings with secure infrastructure that utilizes data collected at the point of care. Policies for data sharing will range from sharing of de-identified records to sharing aggregate results. Within this broad range, policies can be fine-tuned (for example, different levels of sharing for those with whom there is a DUA). When the policy specifies that data must remain at an institution, the network still could allow users outside that institution to execute queries that return summary results from simple patient counts or complex statistical procedures. The network will have a main node that manages policies, distributes queries, aggregate results, and maintains trust and security (authentication, authorization, auditing, etc). Each site will maintain a node that contains data from that site. The network will support (1) retrospective analyses, (b) prospective observational studies, (c) clinical trials, and (d) feedback to point-of- care users. Near real-time collection, analysis, dissemination of results, and feedback to the clinician will be enabled by an infrastructure that allows data to be exchanged according to policies specified by individuals and institutions. The network can scale because it is not dependent on a single trust management provider or data model, but is managed instead by a broker that assigns defined roles to selected entities.
The specific aims of this project are to (1) develop and encode policy models based on multiple stakeholders, (2) implement a scalable and secure network and analytical tools that operates across multiple settings and different IT vendors, and (3) demonstrate the use of this network by collecting data on 4 pairs of cohorts. The particular Comparative Effectiveness Research studies that will be demonstrated relate to (1) the effectiveness of co-management by pharmacists-clinicians for patients with (a) diabetes, and (b) hypertension, and (2) the effectiveness of new antiplatelet (prasugrel) and antithrombotic agents (dabigatran) as compared to their standard counterparts clopidogrel and warfarin, respectively.
Relevance SCANNER represents a novel design of an electronic infrastructure for research. The network infrastructure we propose uses data collected for clinical care and is scalable and secure. It implements policies derived from individuals and institutions, only allowing the type of data to be exchanged that are compliant with policies within a trust framework. It also implements tools for data analyses and feedback to the clinicians. Such a network will enable conduct of certain types of research studies to be conducted more efficiently and at a larger scale.
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