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Abstract Details

National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs): Updates to the Stroke V1.0 Recommendations
Cerebrovascular Disease and Interventional Neurology
P4 - Poster Session 4 (5:30 PM-6:30 PM)
4-001
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.
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.
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. 
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.
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.
Authors/Disclosures
Katelyn E. Gay (The Emmes Company, LLC)
PRESENTER 		Ms. Gay has received personal compensation for serving as an employee of The Emmes Company, LLC.
No disclosure on file
Muniza Sheikh (The Emmes Company, LLC) Ms. Sheikh has received personal compensation for serving as an employee of The Emmes Company.
Joy R. Esterlitz (The Emmes Corp) No disclosure on file
Jeffrey L. Saver, MD, FÂ鶹´«Ã½Ó³»­ (UCLA Health) Dr. Saver has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Saver has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stryker. Dr. Saver has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerenovus. Dr. Saver has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boehringer Ingelheim (prevention only). Dr. Saver has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Medical Association. Dr. Saver has received stock or an ownership interest from Rapid Medical.
Steven Warach, MD, PhD (Dell Medical School, The University of Texas at Austin) Dr. Warach has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. The institution of Dr. Warach has received research support from State of Texas. Dr. Warach has received publishing royalties from a publication relating to health care.
Clinton B. Wright, MD, FÂ鶹´«Ã½Ó³»­ (NINDS) An immediate family member of Dr. Wright has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Wright has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Abali Milne Kalil. Dr. Wright has received publishing royalties from a publication relating to health care. An immediate family member of Dr. Wright has received personal compensation in the range of $500-$4,999 for serving as a surveyor with ASTRO.
No disclosure on file
Scott Janis, PhD (NINDS Office of Clinical Research) No disclosure on file