Abstracts

Rationale: To assist investigators in reducing study start-up time and introduce efficient data collection standards across clinical studies, NINDS, with KAI Research, Inc. (KAI), continues work on the Common Data Element (CDE) Project. At the AES 2008 Annual Meeting, the Project staff convened a Working Group (WG) of experts in clinical epilepsy to advise the Institute on the development of CDEs and accompanying materials for epilepsy research. It is important to note that the CDE Project is not seeking to define the complete universe of epilepsy variables at this time; rather, it is aiming to identify elements that will be useful across most epilepsy studies. Methods: To develop the epilepsy CDEs, the WG divided into subgroups to focus on identifying and defining data elements in the domains of: - Comorbidities - Neurological Examination - Anti-Epileptic Drugs (AEDs) and other Anti-Epileptic Treatments (AETs) - Seizures and Syndromes - Surgery and Pathology - Neuropsychology - Quality of Life - Imaging - Electrophysiology. The WG members serve on either one or two subgroups. The subgroups began meeting by teleconference in April 2009 and will continue to hold calls every four to six weeks through the summer of 2009 to define the CDEs for their domains and to recommend, as relevant, standardized, validated instruments for epilepsy research. Results: The final products from each subgroup will include: dictionary of epilepsy CDEs, template data collection form(s), and a list of recommended standardized instruments. At the AES 2009 Annual Meeting the WG will work to finalize Version 1.0 of the epilepsy CDEs and make the materials available for public review and use. Examples of these materials will be presented as part of this update. Conclusions: The products created through the above process will be posted to the NINDS CDE Web site at www.nindscommondataelements.org. Members of the epilepsy research community at large will be invited to review, utilize, and comment on the proposed CDEs and accompanying materials. The epilepsy CDEs will be periodically reviewed and updated based on feedback from the epilepsy community and changes in the epilepsy clinical research landscape.