This Program Project Grant application is a collaborative, interdisciplinary effort to characterize the neurologic, neuropsychologic, and psychosocial features of Lyme disease among persons residing in a highly endemic area of Suffolk County, New York. The application consists of four individual projects, three of which involve patients with early- and late Lyme disease in adults and children, and one which uses data collected from these projects to test hypotheses related to pathogenesis and psychosocial factors. In addition, the Program Project consists of four cores that will provide shared resources for the different projects. Core B, the Data Coordinating Center Core (DCCC), is responsible for: the coordination and flow of data across all of the Projects and Cores and is a central unit to the program project. The major goal of the DCCC is to assure that high quality data are collected from all Projects and Cores in a systematic and standardized manner. The DCCC is responsible for the epidemiologic and biostatistical aspects of each of the Projects and Cores; quality assurance; identification of the control group for Projects 2 and 3; data processing and management; data analyses and preparation of reports.
The specific aims are: 1) to serve as a collaborating center to the Program Project and to provide epidemiologic and biostatistical input to the organization, design, conduct and analysis of Projects 2, 3 and 4; 2) to coordinate the flow of data among the projects and cores; 3) to collaborate in the development of study forms, documents and protocols; 4) to develop, implement and maintain quality assurance procedures for all aspects of the projects and cores; 5) to develop and implement data management and processing procedures, including design of data entry and editing systems for data collected for each project and from each of the other Cores; 6) to prepare periodic reports for the Steering Committee and Advisory Committee to monitor recruitment and data collection; 7) to outline and perform the analyses needed to evaluate the aims of each project and collaborate in preparing publication of results; and 8) to identify a population based healthy control group for Projects 2 and 3 using random digit dialing.
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