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Spinal Cord. 2015 Apr;53(4):265-77. doi: 10.1038/sc.2014.246. Epub 2015 Feb 10.

Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.

Author information

1
Department of Spinal Cord Injuries, Rigshospitalet and Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
2
The EMMES Corporation, Rockville, MD, USA.
3
Miami Project to Cure Paralysis, Miller School of Medicine, University of Miami, Miami, FL, USA.
4
Craig Hospital, Englewood, CO, USA.
5
University of Alabama at Birmingham, Birmingham, AL, USA.
6
Thomas Jefferson University Hospital, Philadelphia, PA, USA.
7
Craig H. Neilsen Foundation, Encino, CA, USA.
8
Rick Hansen Institute, Vancouver, BC, Canada.
9
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
10
University of British Columbia and Vancouver Coastal Health, Vancouver, BC, Canada.
11
Emory University and Atlanta VA Medical Center, Atlanta, GA, USA.

Abstract

OBJECTIVES:

To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health.

SETTING:

International Working Groups.

METHODS:

Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before release.

RESULTS:

The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health.

CONCLUSION:

Widespread use of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained.

PMID:
25665542
PMCID:
PMC4393777
DOI:
10.1038/sc.2014.246
[Indexed for MEDLINE]
Free PMC Article

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