title: Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Spinal Cord Injuries, Rigshospitalet and Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
authors: F
authors: F
authors: Biering-Sørensen
authors: The EMMES Corporation, Rockville, MD, USA.
authors: S
authors: S
authors: Alai
authors: Miami Project to Cure Paralysis, Miller School of Medicine, University of Miami, Miami, FL, USA.
authors: K
authors: K
authors: Anderson
authors: Craig Hospital, Englewood, CO, USA.
authors: S
authors: S
authors: Charlifue
authors: University of Alabama at Birmingham, Birmingham, AL, USA.
authors: Y
authors: Y
authors: Chen
authors: University of Alabama at Birmingham, Birmingham, AL, USA.
authors: M
authors: M
authors: DeVivo
authors: Thomas Jefferson University Hospital, Philadelphia, PA, USA.
authors: A E
authors: AE
authors: Flanders
authors: Craig H. Neilsen Foundation, Encino, CA, USA.
authors: L
authors: L
authors: Jones
authors: Craig H. Neilsen Foundation, Encino, CA, USA.
authors: N
authors: N
authors: Kleitman
authors: The EMMES Corporation, Rockville, MD, USA.
authors: A
authors: A
authors: Lans
authors: Rick Hansen Institute, Vancouver, BC, Canada.
authors: V K
authors: VK
authors: Noonan
authors: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
authors: J
authors: J
authors: Odenkirchen
authors: University of British Columbia and Vancouver Coastal Health, Vancouver, BC, Canada.
authors: J
authors: J
authors: Steeves
authors: Emory University and Atlanta VA Medical Center, Atlanta, GA, USA.
authors: K
authors: K
authors: Tansey
authors: Miami Project to Cure Paralysis, Miller School of Medicine, University of Miami, Miami, FL, USA.
authors: E
authors: E
authors: Widerström-Noga
authors: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
authors: L B
authors: LB
authors: Jakeman
mesh_terms: D022126:Access to Information; D000068456:Clinical Studies as Topic; D065709:Common Data Elements; D032921:Consensus; D006801:Humans; D020407:Internet; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D012107:Research Design; D013119:Spinal Cord Injuries / Q000175:diagnosis / Q000473:pathology / Q000503:physiopathology / Q000628:therapy; D014481:United States