Content area
Full Text
Spinal Cord (2015) 53, 265277& 2015 International Spinal Cord Society All rights reserved 1362-4393/15 http://www.nature.com/sc
Web End =www.nature.com/sc
REVIEW
Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project
F Biering-Srensen1, S Alai2, K Anderson3, S Charlifue4, Y Chen5, M DeVivo5, AE Flanders6, L Jones7, N Kleitman7, A Lans2, VK Noonan8, J Odenkirchen9, J Steeves10, K Tansey11, E Widerstrm-Noga3 and LB Jakeman9
Objectives: To develop a comprehensive set of common data elements (CDEs), data denitions, 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 nal 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 Classication 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.
Spinal Cord (2015) 53, 265277 doi:http://dx.doi.org/10.1038/sc.2014.246
Web End =10.1038/sc.2014.246; published online 10 February 2015
INTRODUCTIONThere has been increasing interest in developing common data elements (CDEs) to facilitate start-up of clinical studies and to enable improved coordination, sharing and analyses of research data.14
Across the neuroscience community, this endeavor has been guided in large part by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH).5 The NINDS CDE Project began in 2006 and has resulted in development...