Common Data Elements for Rehabilitation Research in Neurologic Disorders (NeuroRehab CDEs)

Abstract

Objective: Common data elements (CDEs) help harmonize data collection across clinical trials and observational studies, allowing for cross-study and cross-condition comparisons. Although CDEs exist for multiple clinical conditions and diseases, this work was extended only recently to neurorehabilitation research. Design: Subgroups of clinical neurorehabilitation investigators operationalized a domain definition, selected applicable CDEs from 23 existing National Institute of Neurological Disorders and Stroke (NINDS) CDE projects and National Institutes of Health (NIH) CDE repositories, and identified areas needing further development. The subgroups also reviewed public comments on the NeuroRehab-specific CDEs, which were provided from September 1, 2021 to October 7, 2021. In March 2022, version 1.0 of the NeuroRehab CDEs was completed and can be found on the NINDS CDE website: https://www.commondataelements.ninds.nih.gov/. Setting: NINDS and the Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Center for Medical Rehabilitation Research identified NeuroRehab CDEs across 12 different research domains: (1) assessments and examinations; (2) comorbid and behavioral conditions; (3) motor function; (4) treatment/intervention data: therapies; (5) treatment/intervention data: devices; (6) cognitive; (7) communication; (8) emotion/behavior/neuropsychology; (9) activities of daily living/instrumental activities of daily living; (10) quality of life; (11) participation; and (12) infant and pediatrics. Within each domain, corresponding subdomain experts identified instruments with good psychometric measurement properties. Participants: One hounded twenty experts (N=120) in rehabilitation across the 12 identified research domains and 2 cochairs with rehabilitation and measurement expertise provided oversight. Interventions: Not applicable. Main Outcome Measures: CDEs from 23 existing NINDS CDE projects and NIH CDE repositories. Results: Clinical investigators recommended NeuroRehab CDEs within 3 dimensions of the NINDS CDE classifications: Core, (Disease) Core, and Supplemental—Highly Recommended. Most measures were categorized as Supplemental—Highly Recommended; few were identified as Core or Disease Core. The subgroups also identified measurement gap areas to guide future initiatives because NeuroRehab CDEs will be developed in the future. Conclusions: These efforts are designed to accelerate rehabilitation research in neurologic disorders by allowing for cross-study and cross-condition comparisons and to encourage new CDE development.