Abstracts

Rationale: To assist investigators conducting clinical studies and accelerate data sharing, the NINDS with its contractor, KAI Research, Inc., continues to foster the Common Data Element (CDE) Project, an initiative to harmonize data collection across studies. At the past two American Epilepsy Society Annual Meetings, the Project convened a Working Group of experts in epilepsy clinical research to advise the Institute on the development of Epilepsy CDEs and accompanying resources. The initial development phase of the Epilepsy CDEs is almost complete and the CDEs will be posted to the NINDS CDE Website (http://www.commondataelements.ninds.nih.gov/) for public use in July 2010. Methods: The forty-member Epilepsy CDE Working Group (WG) divided into subgroups who met periodically to identify and define elements for the data domains of: comorbidities, neurological examination, anti-epileptic treatments, seizures and syndromes, surgery and pathology, neuropsychology, quality of life, imaging, and electrophysiology. The CDE recommendations drafted by the subgroups were then vetted through the full WG. The resulting recommendations include the following resources: Catalog of approximately 550 Epilepsy CDEs with detailed specifications for each CDE; Library of 20 customizable case report form (CRF) modules; List of about 60 standardized instruments with explanations of when each instrument is recommended for use, a summary of the instrument s strengths and weaknesses, and additional references. Version 0.0 of the Epilepsy CDEs was posted on the NINDS CDE Website for public review in June 2010. During the public review period select organizations and the larger epilepsy clinical research community will be asked to provide feedback about the Epilepsy CDEs. Then the Epilepsy CDE WG will have a chance to review the comments received during public review, make revisions to the Epilepsy CDEs, and finalize Version 1.0. Version 1.0 of the Epilepsy CDEs will then be published on the NINDS CDE Website by the end of July 2010. Results: The poster presentation will provide an update about the status of Version 1.0 of the Epilepsy CDEs, including: Report of those researchers who have already begun to use the Epilepsy CDE; Examples of how feedback from the research community was used to improve the Epilepsy CDEs; Explanation of how the CDEs, CRF modules, and recommended instruments can be used by a clinical study; and Summary of next steps to ensure the Epilepsy CDEs meet the evolving needs of epilepsy researchers. Conclusions: The NINDS strongly encourages investigators conducting epilepsy clinical studies to use the Epilepsy CDEs and to submit their comments about them via the NINDS CDE Website. The best way to ensure the Epilepsy CDEs are useful tools and the CDE Project accomplishes its goals is to continuously revise and add to the CDEs based upon the feedback of researchers.