The National Institute of Neurological Disorders and Stroke Epilepsy Common Data Element Updates: Seizure Severity and Diagnostic Recommendations
Year of Publication
Gay, Katelyn; Austin, Joan; French, Jacqueline; Hesdorffer, Dale; Shinnar Ruth; Barbaro, Nicholas; Lowenstein, Daniel; Sheikh, Muniza; Collie, Damon; Esterlitz, Joy; Whittemore, Vicky; Mendoza-Puccini, M. Carolina on behalf of the Epilepsy CDE Oversight Committee
The National Institute of Neurological Disorders and Stroke Epilepsy Common Data Element Updates: Seizure Severity and Diagnostic Recommendations.
Common Data Element; National Institute of Neurological Disorders and Stroke Epilepsy; NINDS; Seizure Severity and Diagnostic
Rationale: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project provides standardized data collection tools for clinical neuroscience research. The goals of this project are to improve data collection and quality through the use of standardized formats with consistent data definitions, thereby increasing efficiency with reduced study start-up time and cost and facilitating data sharing/meta-analyses. Epilepsy-specific CDEs were developed in 2010 and have undergone periodic updates. The Epilepsy CDE Oversight Committee (OC) reviews and updates the Epilepsy CDEs yearly to ensure they remain a current and useful resource for investigators. In 2017, revisions were made to epilepsy etiology and seizure CDEs, and quality of life (QoL) recommendations were streamlined. These recommendations were posted for public review in 2018. Feedback suggested the addition of a seizure severity scale. The OC also discussed including diagnostic tools in the Epilepsy CDEs. Methods: The OC agreed to implement public feedback to add a seizure severity scale. A subcommittee of the QoL working group was tasked with developing CDE recommendations for instruments that measure the perception of seizure severity. A literature review was conducted using MEDLINE and CINAHL databases. Availability in English, clinical relevance, breadth and depth of psychometric properties, respondent burden and cost to administer were considered in determining which instruments were best to recommend as part of the Epilepsy CDEs. The OC reviewed and approved the recommendations of this QoL subcommittee. An additional subcommittee of the OC is reviewing potential epilepsy diagnostic tools to add to the CDEs. Results: The Liverpool Seizure Severity Scale 2.0 (LSSS 2.0) and the Seizure Severity Questionnaire (SSQ) V2.2 (Baseline and Follow-Up Versions) are recommended as measurements of seizure severity perception in adults with epilepsy. No recommendation is made at this time for the pediatric epilepsy population as there is no instrument consistently used to measure seizure severity in children. Informational documents, Notices of Copyright, and a summary report for the new Epilepsy Seizure Severity Instrument recommendations will be available on the NINDS CDE website in 2019. These recommendations will be listed within the Outcomes and Endpoints Domain/ Patient Reported Outcomes Subdomain on the website. They are Classified as Supplemental, i.e. they are commonly collected for studies but not required for use. Their use will depend on the study design and participant ability to self-report. Epilepsy diagnostic tool recommendations may be added to the Epilepsy CDEs as well, pending OC review. Conclusions: The NINDS Epilepsy CDEs are a dynamic resource for the clinical research community. Updates are made based on scientific advancements and user feedback. NINDS encourages use of the CDEs to standardize the data collection across studies, enabling data sharing and meta-analyses.