Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as NeuroRehab Core, NeuroRehab [Disease] Core, or NeuroRehab Supplemental–Highly Recommended (NeuroRehab Classification Definitions)
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
NeuroRehab Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for NeuroRehab study start-up
NeuroRehab Highlight Summary: Overview of all NeuroRehab-specific CDE recommendations as they appear on the website
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
In the Form Search below, select a Subdisease for your NeuroRehab study to view the CDEs for those types of studies.
The default setting for Subdisease is ‘Any’ and will return results for all Subdiseases.
NeuroRehab Comprehensive includes all CDE recommendations.
NeuroRehab General includes all CDE recommendations that are not disease specific.
All other Subdiseases include recommendations specific to existing NINDS CDE project disorders.
Overview
The National Institute of Neurological Disorders and Stroke (NINDS), in partnership with the National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) formed the Common Data Elements for Rehabilitation Research in Neurological Disorders (NeuroRehab) Working Group (WG) in 2020. Chairs were appointed to lead the overall WG and the twelve domain-specific subgroups: Assessments and Examinations; Comorbid and Behavioral Conditions; Motor Function; Treatment/Intervention Data: Devices; Treatment/Intervention Data: Therapies; Cognitive; Communication; Emotion Behavior Neuropsychology; Activities of Daily Living; Quality of Life; Participation; Infant Pediatrics. Subgroups met from October 2020 to July 2021 to develop their recommendations. See the roster for list of members by subgroup.
Neurorehabilitation (i.e., neurological rehabilitation) refers to a supervised program by an interdisciplinary team of health professionals (e.g., physiatrists, neuropsychologists, physical therapists) that is designed for individuals with diseases, trauma, or disorders of the nervous system. Neurorehabilitation can often improve function, reduce symptoms, and improve the well-being/health-related quality of life of individuals through active and dynamic processes and therapies. (Adapted from Johns Hopkins Medicine, 2021. Neurological Rehabilitation. Accessed 22Feb2021 from https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/neu....)
The goal of the NeuroRehab v1.0 CDE project is to create a centralized resource of existing NINDS CDEs for neurorehabilitation researchers and determine areas for future development.
This project aligns with the existing NINDS CDE subdomain framework with some harmonization of subdomains. The working group focused their review on existing NINDS CDE recommendations to determine what is relevant to neurorehabilitation research. During the initial phase of the project, additional existing CDEs from other NIH-supported CDE efforts were also reviewed.
Additionally, v1.0 was limited to those instruments and CDE recommendations considered essential for all NeuroRehab studies (NeuroRehab Core), essential for disease-specific NeuroRehab studies (NeuroRehab [Disease] Core) or essential based on certain conditions or study types in NeuroRehab research (NeuroRehab Supplemental - Highly Recommended). Core CDEs for studies in infant and pediatric populations were also identified.
During the review, subgroups identified gap areas for their domains in the existing NINDS/NIH CDEs. These gap areas include new instruments, CDEs and subdomains, as well as Supplemental or Exploratory recommendations. For some subgroups, the existing NINDS/NIH CDEs relevant to their purview were limited. Identified gap areas will inform the direction of future work.
Roster
Members of the NeuroRehab CDE Working Group by subgroup, current members of the Steering Committee and the NINDS/NICHD CDE Team are listed below.
Please see the Overview tab for additional project background and timeline information.
Publications
A publication related to the NeuroRehab CDE initiative will be written at a later date. The citation for this publication will be included on this site as soon as it is available.
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.