National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs): Updates to the Stroke V1.0 Recommendations

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Damon Collie MSHS; Katelyn Gay BS; Muniza Sheikh MS MBA; Joy Esterlitz MS; Jeffrey L Saver MD FAHA FAAN; Steven Warach MD PhD; Clinton B Wright MD MS FAAN; M Carolina Mendoza-Puccini MD; Scott Janis PhD on behalf of the Stroke V2.0 CDE Working Group
Common Data Element (CDE); National Institute of Neurological Disorders and Stroke (NINDS)
Objective: The National Institute of Neurological Disorders and Stroke (NINDS) initiated the Common Data Element (CDE) project to provide standardized clinical research data collection formats that increase the efficiency and effectiveness of studies and reduce start-up time, as well as improve data quality and facilitate and accelerate data sharing. In 2010, Stroke-specific CDEs were published. The Stroke Oversight Committee reviewed Core CDEs in 2015, and in 2018 recommended a comprehensive review and update to Version 2.0. Background: In August 2018, the NINDS convened a Stroke V2.0 Working Group (WG) consisting of over 50 worldwide subject matter experts. The WG reviewed all current Stroke CDEs, as well as subarachnoid hemorrhage and unruptured cerebral aneurysms (SAH) CDEs for harmonization and inclusion within Stroke V2.0. Design/Methods: The Stroke V2.0 WG divided into eight domain-specific subgroups. Subgroups met regularly to review, revise and add to the existing Stroke CDEs based on stroke research developments. Updated Stroke CDE recommendations will be posted to the NINDS CDE website following an internal WG review, invited reviews by US and international organizations engaged in neurovascular research, and a public review of the draft updates. Results: The Stroke V2.0 CDE recommendations will include updated and new template case report forms, data dictionaries, instrument informational documents, and guidance documents. The updates include revisions to CDEs related to therapies, outcomes, and imaging, and will reflect the current state of science, streamline CDE recommendations, and incorporate SAH CDEs. Stroke V2.0 CDEs will be available on the NINDS CDE website in 2020. Conclusions: The NINDS CDEs are periodically revised as research progresses. Through the update of the Stroke CDEs to V2.0, the initiative strives to maintain the utility of CDEs as a valuable clinical research resource. NINDS encourages use of CDEs to standardize research data collection across studies. Support: This project is funded by HHSN271201700064C.