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Presentation Title - PUB: National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) Recommendations: Project Overview and Recent Updates.


Sheikh, M.; Collie, D.; Edun, I.; Feldman, R.; Franklin, A.; Gay, K.; Johnson, R.; Spector, I.; Esterlitz, J.; Mendoza-Puccini, C.


Common Data Element (CDE); NINDS; Project Overview and Recent Updates

National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) Recommendations: Project Overview and Recent Updates. Authors: Muniza Sheikh, MS, MBA1; Damon Collie, MSHS1; Ilar Edun, BA1; Robin Feldman, MBA1; Andrew Franklin, BA1; Katelyn Gay, BS1; Rebecca Johnson, PhD1; Ian Spector, MPS1; Joy Esterlitz, MS1; M. Carolina Mendoza-Puccini, MD2 1The Emmes Company, Rockville, MD; 2The National Institute of Neurological Disorders and Stroke, Bethesda, MD Objective: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project develops data standards for neuroscience clinical research. This CDE initiative provides data collection frameworks in a consistent format via the NINDS CDE website. The project goals are to promote harmonized data definitions, data sharing and aggregation, efficiency of research studies, and data quality. The project strives to be a collaborative effort by involving additional National Institutes of Health (NIH) institutes, other federal agencies, non-profit organizations, academic institutions, and national organizations. NINDS encourages CDE use by the clinical research community and seeks user feedback to continually improve CDE resources. Background: The NINDS CDE project was initiated in 2006 to assist new and established clinical investigators conducting neurological research. Over 18,000 CDEs and 1,400 template case report forms and instrument recommendations have been developed across 24 disorders. Since 2011, there have been over 187 papers published that mention and/or cite the NINDS CDEs or the NINDS CDE website. Design/Method: Disorder-specific CDE recommendations are developed by working groups (WGs) and maintained by oversight committees. Both groups are comprised of industry researchers, clinicians, allied health professionals, and patient advocates. WG recommendations are developed using the diverse subject matter expertise of its members across research domains. NINDS has recently collaborated with National Library of Medicine, Centers for Disease Control and Prevention, and American Academy for Cerebral Palsy and Developmental Medicine to jointly develop CDEs for Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH), Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and Cerebral Palsy (CP), respectively. CDE availability and use is promoted through peer-reviewed publications and at national and international conferences using exhibits, posters, and presentations, where participants learn the importance of the CDEs and how to navigate the NINDS CDE website. Results: Recent updates have been recommended to the CP, Epilepsy, Friedreich’s ataxia, Multiple Sclerosis, ME/CFS, Spinal Cord Injury, and SAH CDEs based on subject matter expert review and user feedback. The Stroke CDEs are undergoing a comprehensive update, resulting in a version 2.0 to be posted in 2020. CDEs for two new disorder areas, Pain and Rehabilitation, are in development in collaboration with the NIH Help End Addiction Long-Term (HEAL) initiative and the National Institute of Child Health and Human Development.

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