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

TY - JOUR

T1 - Common data elements for spinal cord injury clinical research

T2 - a National Institute for Neurological Disorders and Stroke project

AU - Biering-Sørensen, F

AU - Alai, S

AU - Anderson, K.

AU - Charlifue, S

AU - Chen, Y.

AU - DeVivo, M

AU - Flanders, A E

AU - Jones, L

AU - Kleitman, N

AU - Lans, A

AU - Noonan, V K

AU - Odenkirchen, J

AU - Steeves, J

AU - Tansey, K

AU - Widerström-Noga, E

AU - Jakeman, L B

PY - 2015/4/15

Y1 - 2015/4/15

N2 - 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.

AB - 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.

KW - Access to Information

KW - Clinical Studies as Topic

KW - Common Data Elements

KW - Consensus

KW - Humans

KW - Internet

KW - National Institute of Neurological Disorders and Stroke

KW - Research Design

KW - Spinal Cord Injuries

KW - United States

U2 - 10.1038/sc.2014.246

DO - 10.1038/sc.2014.246

M3 - Review

C2 - 25665542

SN - 1362-4393

VL - 53

SP - 265

EP - 277

JO - Spinal Cord

JF - Spinal Cord

IS - 4

ER -