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Author Notes:

Correspondence: David W. Loring, Ph.D., Department of Neurology, Emory University, 101 Woodruff Circle, Suite 6000, Atlanta, GA 30322, (404) 727-4116, dloring@emory.edu

Subject:

Keywords:

  • Research
  • Epilepsy
  • National Institute of Neurological Disorders and Stroke

Common Data Elements in Epilepsy Research: Development and Implementation of the NINDS Epilepsy CDE Project

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Journal Title:

Epilepsia

Volume:

Volume 52, Number 6

Publisher:

, Pages 1186-1191

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Summary The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience-related clinical research. CDEs are intended to standardize aspects of data collection, decrease study start-up time, and provide more complete, comprehensive, and equivalent data across studies within a particular disease area. Therefore, CDEs will simplify data sharing and data aggregation across NINDS-funded clinical research, and where appropriate, facilitate the development of evidenced-based guidelines and recommendations. Epilepsy-specific CDEs were established in nine content areas: (1) Antiepileptic Drugs (AEDs) and Other Antepileptic Therapies (AETs), )2) Comorbidities, (3) Electrophysiology, (4) Imaging,(5) Neurological Exam, (6) Neuropsychology,(7) Quality of Life, (8) Seizures and Syndromes, and (9) Surgery and Pathology. CDEs were developed as a dynamic resource that will accommodate recommendations based on investigator use, new technologies, and research findings documenting emerging critical disease characteristics. The epilepsy-specific CDE initiative can be viewed as part of the larger international movement toward “harmonization” of clinical disease characterization and outcome assessment designed to promote communication and research efforts in epilepsy. It will also provide valuable guidance for CDE improvement during their further development, refinement, and implementation. This article describes the NINDS CDE Initiative, the process used in developing Epilepsy CDEs, and the benefits of CDEs for the clinical investigator and NINDS.

Copyright information:

© 2011 International League Against Epilepsy

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