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The National Institute of Neurological Disorders and Stroke Updates to the Epilepsy Common Data Elements: MRI, Diagnostic Tools, and Surgery & Pathology Recommendations.


Gay, K.; Barbaro, N.; French, J.; Gaillard, W.; Collie, D.; Sheikh, M.; Mendoza-Puccini, C.; Whittemore, V.; Groups, E.C.D.E.Oversi


Diagnostic Tools; Epilepsy Common Data Elements; NINDS; Stroke Updates; Surgery & Pathology

The National Institute of Neurological Disorders and Stroke Updates to the Epilepsy Common Data Elements: MRI, Diagnostic Tools, and Surgery & Pathology Recommendations Katelyn Gay, BS1; Nicholas Barbaro, MD2; Jacqueline French, MD3; William D. Gaillard, MD4; Damon Collie, MSHS1; Muniza Sheikh, MS, MBA1; M. Carolina Mendoza-Puccini, MD5; Vicky Whittemore, PhD5 on behalf of the Epilepsy CDE Oversight Committee and Working Groups 1The Emmes Company, Rockville, MD; 2UT Health Austin, Austin, TX; 3NYU Comprehensive Epilepsy Center, New York, NY; 4Children’s National Medical Center, Washington, DC; 5National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD Rationale: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project develops data standards for clinical research in neurological disorders. This project seeks to harmonize data collection, foster collaboration through data sharing and analysis, increase efficiency of clinical studies, and improve data quality and integrity. Epilepsy-specific CDEs were developed in 2010. The Epilepsy CDE Oversight Committee (OC) reviews the Epilepsy CDEs yearly and recommends updates as needed based on scientific advancements and user feedback. The OC has identified the need for updates to the MRI and Surgery & Pathology case report forms (CRFs) and the addition of epilepsy diagnostic tools. Methods: The Imaging and Surgery & Pathology Working Groups (WGs) were convened in 2019 to update the MRI and Surgery & Pathology CRFs, respectively. The Imaging WG modifications to the MRI CRF focus on improving usability in studies. The Surgery & Pathology WG updates will include new technological advances made since the development of the original version of the CRF. The OC is reviewing existing instruments for epilepsy diagnosis to determine which should be added to the Epilepsy CDE recommendations. The OC will review and approve the recommendations of these WGs and reach a consensus on the diagnostic tools before they are posted to the NINDS CDE website. Results: Revised CRFs and data dictionaries for the MRI and Surgery & Pathology CRFs will be posted on the NINDS CDE website once the changes have been finalized. The CRFs are template modules that may be downloaded and modified for use in studies. Data dictionaries provide details including the definition, suggested question text, permissible values, NINDS CDE classification, population, and input restrictions for each data element. Informational documents will be posted for the diagnostic tools selected by the OC. These documents include information such as how to access the instrument, the NINDS CDE classification, a short description, scoring, and references. The CDEs will be classified following the NINDS CDE convention of Core (required), Supplemental – Highly Recommended (essential based on certain conditions or study types), Supplemental (commonly collected but not required), and Exploratory (require further validation but are reasonable to use). Conclusions: The NINDS Epilepsy CDEs are updated periodically so that they remain a current and useful tool for investigators engaged in clinical neuroscience research. NINDS encourages the use of CDEs by the clinical research community to standardize study data collection which facilitates data sharing/cross study comparisons, data aggregation, and meta-analyses.

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