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.
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Acknowledgements
The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS) or the US Government. Logistics support for this project was provided in part through NIH Contract HHSN271201200034C. The development of the NINDS SCI CDEs was made possible thanks to the great investment of time and effort of all organizing committee and WG members and members of the NINDS CDE Project team, participating from 2007 to 2014.
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The authors declare no conflict of interest.
Additional information
The members of the SCI CDE Organizing Committee and the Working Group are listed before references.
SCI CDE Organizing Committee
Joanne Odenkirchen (NINDS CDE Project Officer): National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Bethesda, MD, USA
Naomi Kleitman: NIH/NINDS, Bethesda, MD, USA (2008–2012) and Craig H. Neilsen Foundation, Encino, CA, USA (2012 to present)
Fin Biering-Sørensen: Department for Spinal Cord Injuries, Rigshospitalet and Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
Michael DeVivo: Department of Physical Medicine and Rehabilitation, University of Alabama at Birmingham, Birmingham, AL, USA
Vanessa Noonan: Rick Hansen Institute, Vancouver, British Columbia, Canada
Susan Charlifue: Craig Hospital, Englewood, CO, USA
Linda Jones: Craig H. Neilsen Foundation, Encino, CA, USA (2012 to present)
Lyn Jakeman: NIH/NINDS, Bethesda, MD, USA (2013 to present)
WORKING GROUP MEMBERS
Demographics WG
Yuying Chen (Chair): University of Alabama at Birmingham, Birmingham, AL, USA
Fin Biering-Sørensen: Department for Spinal Cord Injuries, Rigshospitalet and Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
Susan Charlifue: Craig Hospital, Englewood, CO, USA
Vanessa Noonan: Rick Hansen Institute, Vancouver, British Columbia, Canada
Peter New: Caulfield Hospital, Alfred Health, Caulfield, Victoria, Australia
Vanessa Noonan: Rick Hansen Institute, Vancouver, British Columbia, Canada
Marcel Post: University Medical Center Utrecht and De Hoogstraat, The Netherlands
Care WG
Vanessa Noonan (Chair): Rick Hansen Institute, Vancouver, British Columbia, Canada
David Berlowitz: Victorian Respiratory Support Service Department of Respiratory and Sleep Medicine, Melbourne, Australia
Fin Biering-Sørensen: Department for Spinal Cord Injuries, Rigshospitalet and Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
James S Harrop: Jefferson Medical College, Philadelphia, PA, USA
Michael Fehlings: Toronto Western Hospital, Toronto, Ontario, Canada
David W Wright: Emory University School of Medicine, Atlanta, GA, USA
Neurological outcomes WG
John Steeves (Chair): University of British Columbia and Vancouver Coastal Health, Vancouver, British Columbia, Canada
Andrew R. Blight: Acorda Therapeutics, Inc., Ardsley, NY, USA
Armin Curt: University of Zurich, University Hospital Balgrist, Zurich, Switzerland
Linda Jones: Craig H. Neilsen Foundation, Encino, CA, USA
Daniel P Lammertse: Craig Hospital, Englewood, CO, USA
Keith Tansey: Emory University and VA Medical Center, Atlanta, GA, USA
Functional outcomes WG
Kim Anderson-Erisman (Chair): The Miami Project to Cure Paralysis, Miami, FL, USA
Andrea L Behrman: Kentucky Spinal Cord Injury Research Center, University of Louisville, Louisville, KY, USA
Edelle Field-Fote: University of Miami Miller School of Medicine, Miami, FL, USA
Linda Jones: Craig H. Neilsen Foundation, Encino, CA, USA
MJ Mulcahey: Thomas Jefferson University, Philadelphia, PA, USA
Participation/QOL WG
Susan Charlifue (Chair): Craig Hospital, Englewood, CO, USA
Allen W Heinemann: Northwestern University, Chicago, IL, USA
Alan M Jette: Health & Disability Research Institute, Boston University, Boston, MA, USA
Marcel Post: University Medical Center Utrecht and De Hoogstraat, The Netherlands
Denise G Tate: University of Michigan Medical School, Ann Arbor, MI, USA
David S Tulsky: University of Michigan Medical School, Ann Arbor, MI, USA
Gale Whiteneck: Craig Hospital, Englewood, CO, USA
Electrodiagnostics WG
Keith Tansey (Chair): Emory University and VA Medical Center, Atlanta, GA, USA
Peter Ellaway: Imperial College of London, London, UK
Keith C Hayes: The University of Western Ontario, London, Ontario, Canada
John Kramer: Shepherd Center, Atlanta, GA, USA
Barry McKay: Shepherd Center, Atlanta, GA, USA
Martin Schubert: Balgrist University Hospital, Zurich, Switzerland
Arthur M Sherwood: Baylor College of Medicine, Houston, TX, USA
Imaging WG
Adam E. Flanders (Chair): Thomas Jefferson University Hospital, Philadelphia, PA, USA,
David Dungan: Radiology Imaging, Associates, PC, Englewood, CO, USA
Ralph F Frankowski: University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, USA
Daniel P Lammertse: Craig Hospital, Englewood, CO, USA
Edward D Wirth III: Asterias Biotherapeutics, Menlo Park, CA, USA
Pain WG and Psychological outcomes WG
Eva Widerström-Noga (Chair): University of Miami, Miller School of Medicine, Miami, FL, USA
Charles Bombardier: University of Washington School of Medicine, Seattle, WA, USA
Thomas N Bryce: University of Miami Miller School of Medicine, New York, NY, USA
Nanna Finnerup: Aarhus University Hospital, Aarhus, Denmark
Paul Kennedy: The Oxford Institute of Clinical Psychology Training, Oxford, UK
Mark Jensen: University of Washington, Seattle, WA, USA
John Kramer: Shepherd Center, Atlanta, GA, USA
Philip Siddall: Kolling Institute of Medical Research, The University of Sydney, Sydney, Australia
NINDS CDE Team
Joanne Odenkirchen: NINDS CDE Project Officer, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Bethesda, MD, USA
Courtney Ashton: KAI Research, Inc. (an Altarum Company), Rockville, MD, USA (2007–2012)
Stacie Grinnon: KAI Research, Inc. (an Altarum Company), Rockville, MD, USA (2007–2012)
Christina You: KAI Research, Inc. (an Altarum Company), Rockville, MD, USA (2007–2012)
Yun Lu: KAI Research, Inc. (an Altarum Company), Rockville, MD, USA (2007–2012)
Aria Lans: The EMMES Corporation, Rockville, MD, USA (2012 to present)
Sherita Ala'i: The EMMES Corporation, Rockville, MD, USA (2012 to present)
Naomi Kleitman: Program Director, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Bethesda, MD, USA (2007–2012)
Lyn Jakeman: Program Director, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Bethesda, MD, USA (2013 to present)
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Biering-Sørensen, F., Alai, S., Anderson, K. et al. Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project. Spinal Cord 53, 265–277 (2015). https://doi.org/10.1038/sc.2014.246
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DOI: https://doi.org/10.1038/sc.2014.246
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