Abstract Details

Title Stroke Version 2.0 Common Data Element (CDE) Review: Updates to the National Institute of Neurological Disorders and Stroke (NINDS) CDEs for Stroke

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 3-017

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, NINDS established a Stroke V2.0 Working Group (WG) 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. Unruptured cerebral aneurysms and subarachnoid hemorrhage CDEs, developed in 2017, will also be reviewed for harmonization and inclusion within Stroke.

Design/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 refine and add to existing data elements from national registries and studies.

Results The Stroke OC plans to review the project status at the 2019 International Stroke Conference, followed by a public review of proposed CDEs. Stroke V2.0 CDEs will be posted on the NINDS CDE website in 2019.

Conclusions The NINDS CDEs are an evolving resource that is updated as research progresses. NINDS encourages use of CDEs by the clinical research community 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.

Authors/Disclosures
Robin S. Feldman (Emmes Company, LLC) PRESENTER	No disclosure on file
	No disclosure on file
Katelyn E. Gay (The Emmes Company, LLC)	Ms. Gay has received personal compensation for serving as an employee of The Emmes Company, LLC.
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, FAAN (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.
	No disclosure on file

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