The core provides data management and statistical services to Projects 1-5 and is an integral and essential component of the clinical projects in the study. The overall goal of Core B is to plan, implement , and monitor all data management tasks as well as to perform and interpret all statistical analyses for Projects 1 and 2 and to provide statistical analysis and data management services to Projects 3-5. Core B runs the Status Epilepticus Data System (SEDS), the central database for the clinical projects. Core B is absolutely essential to the success of the grant. The Data Management and Biostatistics Center (DMBC) appears very well integrated into the scientific projects of the grant. DMBC personnel participate in the weekly meetings of program staff. Both Dr. DeLorenzo and the DMBC staff are to be commended on the close working relationship between Core B staff and other project members. The primary database for the clinical studies, the SEDS, is maintained by the DMBC. DMBC members worked closely with clinicians and investigators to define the needed data, develop methods and forms for its collection, and develop quality control methods for the data. A rigorous review system is in place to ensure high quality data. The DMBC established a comprehensive data management system to ensure accuracy, reliability, completeness, and security of the data. Core B works with all 5 projects, but especially closely with Projects 1 and 2. Prioritization of usage is decided at the weekly meetings of the SE research team. This seems to work very effectively. The SEDS is being switched to a new computer system that will carry well into the future and should allow even better service to the component projects. The study team identified the problem with capture of cases seen in community hospitals and has instituted procedures to bring the capture of these cases to acceptable levels. Case ascertainment for cases seen in the MCV Hospital is excellent. Quality control for the data receives considerable attention. The procedures include staff training, computer checks, and weekly meetings with the staff. The project write-ups reflect the close working with the core. Analyses are specified and power of the studies is discussed. Both exploratory and confirmatory techniques are used.
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