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 USA 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 prior to 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 common data elements 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.

Assessments of sensory plasticity after spinal cord injury across species

“…As part of the core SCI Common Data Elements, by the National Institute of Neurological Disorders and Stroke (NINDS), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) have become a standard clinical tool to assess sensory function [39–41]. This exam uses light touch and pinprick stimuli applied to cervical, thoracic, lumbar, and sacral dermatomes.…”

“…QST measures detection and pain thresholds of different stimulus modalities to assess sensory loss and sensory gain (e.g., allodynia, hyperalgesia) and depends on the patient’s subjective report of the perceived sensation. Included in the common data elements for SCI are both perceptual and pain threshold to cold and heat stimuli and perceptual threshold to mechanical vibration [41]. …”

The International Spinal Cord Injury Pain Extended Data Set (Version 1.0)

“…11 The ISCIPBDS was adopted by the National Institute of Health, National Institute of Neurological Disorders and Stroke (NINDS) and Common Data Elements (CDEs) as a supplemental/ highly recommended data set to be collected in clinical SCI pain research (www.commondataelements.ninds.nih.gov/SCI.aspx#tab = Data_Standards). 24 The organization of the extended data set is directly based on the pain problems identified in the basic data set and is intended to be used in research studies and be collected by researchers or health-care professionals familiar with SCI. Data should be collected by interview (or the recommended mode of administration for a specific instrument) and by clinical examination.…”

International Spinal Cord Injury Core Data Set (version 2.0)—including standardization of reporting

“…In addition, the International SCI Data Sets are integrated with the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) 29,30 , and can be downloaded from this website together with other NINDS CDEs, which may be helpful when planning SCI studies and clinical trials: https://www.commondataelements.ninds.nih.gov/SCI.aspx#tab = Data_Standards.…”