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The National Institute of Neurological Disorders and Stroke (NINDS) Updates to the Spinal Cord Injury (SCI) Common Data Element Recommendations


Collie, D.; Gay, K.; Sheikh, M.; Esterlitz, J.; Saver, J.; Warach, S.; Mendoza-Puccini, C.; Janis, S.; Group, S.V.2.0 C.D.E.W.


Common Data Element Review; Elements for Stroke; NINDS; Stroke; Version 2.0

Objective: The National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Elements (CDEs) were developed to increase the efficiency and effectiveness of clinical research study data collection, improve data quality, facilitate and accelerate data sharing across studies, and reduce study start-up time. Version 1.0 of the Stroke CDEs was posted on the NINDS CDE website in 2010 and Core Stroke CDEs were reviewed in 2015 by the Stroke Oversight Committee (OC). In January 2018, the Stroke OC recommended that Stroke CDEs undergo a comprehensive review and update to Version 2.0. Background: In August 2018, a Stroke V2.0 Working Group (WG) was established by NINDS to review all Stroke CDEs. The CDE updates will be based on developments in the field of stroke research and user feedback on existing CDEs. CDEs for subarachnoid hemorrhage and unruptured cerebral aneurysms, developed in 2017, will also be reviewed for harmonization and inclusion within Stroke. Methods: The Stroke V2.0 WG, consisting of over 50 worldwide subject matter experts, will meet regularly to review, revise and add to the existing Stroke CDEs. WG members will select and recommend instruments and assessments, and also refine and add to existing data elements from national registries and studies. The Stroke OC plans to review the project status at the 2019 International Stroke Conference, followed by a public review of proposed CDEs. Results: Stroke V2.0 CDE recommendations will span eight domains: Biospecimens, Biomarkers, and Laboratory Tests; Hospital Course and Acute Therapies; Imaging; Long-term Therapies; Medical History and Prior Health Status; Outcomes and Endpoints; Stroke Presentation and Vital Signs; and Stroke Types and Subtypes. Stroke V2.0 CDEs will be posted on the NINDS CDE website in 2019, following public review. Conclusions: The NINDS CDEs are an evolving resource that is updated as research progresses. NINDS encourages use of CDEs by the clinical research community in order to standardize the collection of research data across studies. Through the development of the Stroke V2.0 CDEs, the initiative strives to improve the utility of CDEs as a valuable starting point for stroke researchers.

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