Updates to the National Institute of Neurological Disorders and Stroke (NINDS) Spinal Cord Injury (SCI) Common Data Element Recommendations
Year of Publication
Feldman, Robin; Spector, Ian; Sheikh, Muniza; Esterlitz, Joy; Jakeman, Lyn B; Mendoza-Puccini, M Carolina; Noonan, Vanesa on behalf of the NINDS Spinal Cord Injury CDE Oversight Committee
International Spinal Cord Society 59th Annual Scientific Virtual Meeting
International Spinal Cord Society 59th Annual Scientific Virtual Meeting; National Institute of Neurological Disorders and Stroke (NINDS) Spinal Cord Injury Common Data Element
Introduction: As part of a continuing review, the NINDS Spinal Cord Injury (SCI) Common Data Element (CDE) project convened the SCI CDE Oversight Committee (OC) in March 2018 to update the SCI CDEs and the International SCI Data Sets. Comprised of subject matter experts from domestic and international research, industry, and patient advocates the NINDS SCI CDE OC periodically reviews the SCI CDEs based on recommendations and feedback to make decisions regarding suggested corrections and updates. This review ensures that the SCI CDEs remain a current and useful tool for investigators and their research teams. Methods: Version 1.0 of the adult SCI and pediatric SCI CDEs were posted to the NINDS CDE website in 2014 and 2016, respectively, with an OC update in 2016 as well. In 2018, the SCI OC began a comprehensive review of the SCI CDE recommendations by domain and evaluated whether the current CDE or measure classifications were still accurate; considered new CDEs or measures to recommend for inclusion; and indicated a context for use for those measures classified as Supplemental–Highly Recommended. The SCI OC also developed and systematically applied classification criteria to facilitate their review and recommendations of the SCI CDEs. Results: Following review of 87 SCI measures, the SCI OC determined that eight should be reclassified from Exploratory to Supplemental, one from Exploratory to Supplemental Highly – Recommended, 11 from Supplemental to Exploratory, two from Supplemental to Supplemental – Highly Recommended, and five from Supplemental – Highly Recommended to Supplemental. The SCI OC also recommended the inclusion of three new measures, the Spinal Cord Ability Ruler, the Mini-Balance Evaluation Systems Test (MiniBESTest), and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD), and the removal of six measures, THAQ, ABLE Scale, Berlin Questionnaire, FOSQ, Infant Sleep Questionnaire and the OSA-18. Summary documents of these 87 SCI measures were posted on the NINDS CDE website in Spring 2020 for public review. The finalized versions will be available on the website in late Summer 2020. Of the 1,882 SCI CDEs, 69 were downgraded from Supplemental to Exploratory and 5 were upgraded from Supplemental to Supplemental – Highly Recommended. Finally, of the 28 International SCI Data Sets, the SCI OC reclassified three from Supplemental to Exploratory, four from Supplemental to Supplemental – Highly Recommended and one from Supplemental – Highly Recommended to Supplemental. The recommended updates to the SCI CDEs and International SCI Data Sets will also be reviewed by the research community prior to finalizing. Conclusions: The NINDS encourages the use of CDEs for clinical research in neuroscience. The SCI OC is working with the NINDS and SCI organizations to promote the uptake and use of the SCI CDEs.