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

• Type of Material: Article
• Authors: David W Loring, Emory University; Daniel H. Lowenstein, University of California San Francisco; Nicholas M. Barbaro, University of California San Francisco; Brandy E. Fureman, National Institute of Neurological Disorders and Stroke; Joanne Odenkirchen, National Institute of Neurological Disorders and Stroke; Margaret P. Jacobs, National Institute of Neurological Disorders and Stroke; Joan K. Austin, Indiana University; Dennis J. Dlugos, University of Pennsylvania; Jacqueline A. French, New York University; William Davis Gaillard, George Washington University; Bruce P. Hermann, University of Wisconsin Madison; Dale C. Hesdorffer, Columbia University; Steven N. Roper, University of Florida; Anne C. Van Cott, University of Pittsburgh; Stacie Grinnon, KAI Research Inc.; Alexandra Stout, KAI Research Inc.
• Language: English
• Date: 2011-06
• Publisher: Wiley: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2011 International League Against Epilepsy
• Final Published Version (URL): http://onlinelibrary.wiley.com/doi/10.1111/j.1528-1167.2011.03018.x/abstract;jsessionid=8E25E6962F62D34921B12FF7CF722A4B.d04t04
• Title of Journal or Parent Work: Epilepsia
• ISSN: 0013-9580
• Volume: 52
• Issue: 6
• Start Page: 1186
• End Page: 1191
• Keywords: Epilepsy; National Institute of Neurological Disorders and Stroke; Research
• Research Categories: Biology, Neuroscience

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.