The National Institute of Neurological Disorders and Stroke (NINDS) Updates to the Spinal Cord Injury (SCI) Common Data Element Recommendations
Publication Type
Presentation
Year of Publication
2019
Authors
Feldman, Robin; Joseph, Kristen; Sheikh, Muniza; Esterlitz, Joy; Noonan, Vanessa; Jakeman, Lyn B; Mendoza-Puccini, M. Carolina; NINDS Spinal Cord Injury CDE Oversight Committee
Keywords
The National Institute of Neurological Disorders and Stroke (NINDS) Updates to the Spinal Cord Injury (SCI) Common Data Element Recommendations
Abstract
Objective(s): 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.
Background: The NINDS SCI CDE OC is comprised of subject matter experts from domestic and international research, industry, and patient advocates. To ensure that the SCI CDEs remain a current and useful tool for investigators, the Oversight Committee periodically reviews the SCI CDEs based on recommendations and feedback to make decisions regarding suggested corrections and updates.
Design/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 reviewed 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.
Results: Following review of eighty-seven SCI measures, the SCI OC determined that eight should be reclassified from Exploratory to Supplemental. The OC also recommended for inclusion five measures as Exploratory: Spinal Cord Ability Ruler, Mini-Balance Evaluation Systems Test (MiniBESTest), Medical Outcomes Study Sleep Scale, PROMIS Sleep Disturbance, and PROMIS Sleep-Related Impairments. Of the 1,882 SCI CDEs, the Anal canal voluntary contraction indicator CDE was reclassified from Supplemental to Core; 34 were upgraded from Supplemental to Supplemental – Highly Recommended; and 22 were downgraded from Supplemental to Exploratory. Recommended updates will be reviewed prior to finalizing.
Conclusions: NINDS encourages the use of CDEs for clinical research in neuroscience. To ensure that the SCI CDEs remain current, they are periodically updated by the SCI Oversight Committee based on research advances and user input.