Common Data Elements for Rehabilitation Research in Neurological Disorders (NeuroRehab CDEs).
Noelle E Carlozzi, M Carolina Mendoza-Puccini, Sue Marden, Deborah Backus, Linda Bambrick, Carolyn Baum, Jonathan F Bean, Steven C Cramer, Theresa Hayes Cruz, Anne Deutsch, Kimberly Frey, Katelyn Gay, James E Graham, Robert K Heaton, Shannon Juengst, Claire Z Kalpakjian, Allan J Kozlowski, Catherine E Lang, Jon Pearlman, Adam Politis, Sharon Ramey, Elizabeth Rasch, Angelle M Sander, Heidi Schambra, Marcia J Scherer, Beth S Slomine, Elizabeth W Twamley, Steven L Wolf, Allen W Heinemann
Author Information
Noelle E Carlozzi: University of Michigan Medical School, Ann Arbor, Michigan. Electronic address: carlozzi@med.umich.edu.
M Carolina Mendoza-Puccini: National Institute of Neurological Disorder and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland.
Sue Marden: National Center for Medical Rehabilitation Research (NCMRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.
Deborah Backus: Shepherd Center, Atlanta, Georgia.
Linda Bambrick: National Institute of Neurological Disorder and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland.
Carolyn Baum: Washington University in St. Louis, St. Louis, Missouri.
Jonathan F Bean: Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts, New England GRECC, VA Boston Healthcare System, Boston, MA; and Spaulding Rehabilitation, Boston, MA.
Steven C Cramer: University of California Los Angeles and California Rehabilitation Institute, Los Angeles, California.
Theresa Hayes Cruz: National Center for Medical Rehabilitation Research (NCMRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.
Anne Deutsch: Shirley Ryan AbilityLab and Northwestern University Chicago, Illinois; and RTI International, Research Triangle Park, North Carolina.
Katelyn Gay: The Emmes Company, LLC, Rockville, Maryland.
James E Graham: Colorado State University, Fort Collins, Colorado.
Robert K Heaton: University of California San Diego, La Jolla, California.
Shannon Juengst: University of Texas Southwestern Medical Center, Dallas, Texas and TIRR Memorial Hermann, Houston, Texas.
Claire Z Kalpakjian: University of Michigan Medical School, Ann Arbor, Michigan.
Allan J Kozlowski: Mary Free Bed Rehabilitation Hospital, Grand Rapids, Michigan.
Catherine E Lang: Washington University in St. Louis, St. Louis, Missouri.
Jon Pearlman: University of Pittsburgh, Pittsburgh, Pennsylvania.
Adam Politis: Office of the Director, National Institutes of Health, Bethesda, Maryland.
Sharon Ramey: Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, Virginia.
Elizabeth Rasch: Office of the Director, National Institutes of Health, Bethesda, Maryland.
Angelle M Sander: Baylor College of Medicine and TIRR Memorial Hermann, Houston, Texas.
Heidi Schambra: NYU Langone Health and NYU Grossman School of Medicine, New York, New York.
Marcia J Scherer: Institute for Matching Person and Technology, Webster, New York and Department of Physical Medicine and Rehabilitation, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Beth S Slomine: Kennedy Krieger Institute, Baltimore, Maryland and John Hopkins University School of Medicine.
Elizabeth W Twamley: University of California San Diego, La Jolla, California; VA San Diego Healthcare System, San Diego, CA.
Steven L Wolf: Emory University School of Medicine, Dept. Rehab Medicine, Atlanta, Georgia.
Allen W Heinemann: Northwestern University, Shirley Ryan AbilityLab, Chicago, Illinois.
OBJECTIVE: Common data elements (CDEs) help harmonize data collection across clinical trials and observational studies, allowing for cross-study and cross-condition comparisons. While 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 NIH CDE repositories, and identified areas needing further development. The subgroups also reviewed public comments on the NeuroRehab specific CDEs, which were provided from 01 September 2021 to 07 October 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 (NICHD)/National Center for Medical Rehabilitation Research (NCMRR) 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: 120 experts in rehabilitation across the 12 identified research domains and two Co-Chairs with rehabilitation and measurement expertise provided oversight. INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: CDEs from 23 existing NINDS CDE projects and NIH CDE repositories RESULTS: Clinical investigators recommended NeuroRehab CDEs within three 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 as NeuroRehab CDEs are developed in the future. CONCLUSIONS: These efforts are designed to accelerate rehabilitation research in Neurological Disorders by allowing for cross-study and cross-condition comparisons and to encourage new CDE development.
