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National Institute of Neurological Disorders and Stroke Epilepsy Common Data Element Updates: Seizure Severity Instruments, Diagnostic Tools, and MRI Recommendations.


Gay, K.; Austin, J.; French, J.; Gaillard, W.D.; Shinnar, R.; Barbaro, N.; Lowenstein, D.; Sheikh, M.; Collie, D.; Esterlitz, J.; Whittemore, V.; Mendoza-Puccini, Con behalf


Diagnostic Tools; Epilepsy Common Data Elements; MRI Recommendations; NINDS; Seizure Severity Instruments

National Institute of Neurological Disorders and Stroke Epilepsy Common Data Element Updates: Seizure Severity Instruments, Diagnostic Tools, and MRI Recommendations Katelyn Gay, BS1; Joan Austin, PhD, RN, FAAN2; Jacqueline French, MD3; William D. Gaillard, MD4; Ruth Shinnar, RN, MSN5; Nicholas Barbaro, MD2; Daniel Lowenstein, MD6; Muniza Sheikh, MS, MBA1; Damon Collie, MSHS1; Joy Esterlitz, MS1; Vicky Whittemore, PhD7; M. Carolina Mendoza-Puccini, MD7 on behalf of the Epilepsy CDE Oversight Committee and Imaging Working Group 1The Emmes Company, Rockville, MD; 2Indiana University, Indianapolis, IN; 3NYU Comprehensive Epilepsy Center, New York, NY; 4Children’s National Medical Center, Washington, DC; 5Montefiore Medical Center, Bronx, NY; 6University of California, San Francisco, CA; 7National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD Objective: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project provides standardized data collection tools with consistent definitions for clinical neuroscience research. The goals of this project are to improve data collection and quality, thereby increasing efficiency with reduced study start-up time/cost and facilitating data sharing/meta-analyses. Background: Epilepsy-specific CDEs, developed in 2010, have undergone annual review and periodic updates by the Epilepsy CDE Oversight Committee (OC) to ensure they remain a current and useful resource for investigators. Feedback received during the public review of recent Epilepsy CDE updates suggested the addition of a seizure severity scale. The OC proposed adding diagnostic tools to the CDEs and revisions to the Magnetic Resonance Imaging (MRI) case report form (CRF). Design/Methods: A quality of life (QoL) subcommittee was tasked with developing CDE recommendations for instruments measuring perception of seizure severity. A literature review was conducted. Availability in English, clinical relevance, psychometric properties, respondent burden, and cost were considered in determining which instruments to recommend. The OC approved the recommendations and an additional OC subcommittee is reviewing potential epilepsy diagnostic tools to add to the CDEs. The Imaging WG will review updates to the MRI CRF. Results: The Liverpool Seizure Severity Scale 2.0 and the Seizure Severity Questionnaire V2.2 (Baseline and Follow-Up Versions) are recommended as seizure severity perception measurements in adults with epilepsy. Instrument summary documents and a summary report will be posted on the NINDS CDE website. Epilepsy diagnostic tool recommendations and updates to the MRI CRF may also be added to the Epilepsy CDEs, pending OC review. Conclusions: The Epilepsy CDEs are updated based on scientific advancements and user feedback. NINDS encourages use of the CDEs by the clinical research community to standardize data collection across studies, enabling data sharing and meta-analyses.

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