title: Common data elements in epilepsy research: development and implementation of the NINDS epilepsy CDE project.
abstract: 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 Antiepileptic 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 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.
authors.affiliation: Department of Neurology, Emory University, Atlanta, Georgia, USA. dloring@emory.edu
authors.forename: David W
authors.initials: DW
authors.lastname: Loring
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Lowenstein
authors.forename: Nicholas M
authors.initials: NM
authors.lastname: Barbaro
authors.forename: Brandy E
authors.initials: BE
authors.lastname: Fureman
authors.forename: Joanne
authors.initials: J
authors.lastname: Odenkirchen
authors.forename: Margaret P
authors.initials: MP
authors.lastname: Jacobs
authors.forename: Joan K
authors.initials: JK
authors.lastname: Austin
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: Dlugos
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: French
authors.forename: William Davis
authors.initials: WD
authors.lastname: Gaillard
authors.forename: Bruce P
authors.initials: BP
authors.lastname: Hermann
authors.forename: Dale C
authors.initials: DC
authors.lastname: Hesdorffer
authors.forename: Steven N
authors.initials: SN
authors.lastname: Roper
authors.forename: Anne C
authors.initials: AC
authors.lastname: Van Cott
authors.forename: Stacie
authors.initials: S
authors.lastname: Grinnon
authors.forename: Alexandra
authors.initials: A
authors.lastname: Stout
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use; D003625:Data Collection / Q000592:standards* / Q000639:trends; D004827:Epilepsy / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D055825:National Institute of Neurological Disorders and Stroke (U.S.) / Q000592:standards* / Q000639:trends; D016730:Program Development / Q000592:standards*; D012107:Research Design / Q000592:standards; D014481:United States
chemical_list: D000927:Anticonvulsants