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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-02-10

AUTHORS

F Biering-Sørensen, S Alai, K Anderson, S Charlifue, Y Chen, M DeVivo, A E Flanders, L Jones, N Kleitman, A Lans, V K Noonan, J Odenkirchen, J Steeves, K Tansey, E Widerström-Noga, L B Jakeman

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. More... »

PAGES

265-277

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  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/sc.2014.246

    DOI

    http://dx.doi.org/10.1038/sc.2014.246

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1029946419

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/25665542


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