TY - JOUR
T1 - National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations
AU - Broglio, Steven P.
AU - Kontos, Anthony P.
AU - Levin, Harvey
AU - Schneider, Kathryn
AU - Wilde, Elisabeth A.
AU - Cantu, Robert C.
AU - Feddermann-Demont, Nina
AU - Fuller, Gordon W.
AU - Gagnon, Isabelle
AU - Gioia, Gerard A.
AU - Giza, Christopher
AU - Griesbach, Grace S.
AU - Leddy, John J.
AU - Lipton, Michael L.
AU - Mayer, Andrew R.
AU - McAllister, Thomas W.
AU - McCrea, Michael
AU - McKenzie, Lara B.
AU - Putukian, Margot
AU - Signoretti, Stefano
AU - Suskauer, Stacy J.
AU - Tamburro, Robert
AU - Turner, Michael
AU - Yeates, Keith O.
AU - Zemek, Roger
AU - Ala'I, Sherita
AU - Esterlitz, Joy
AU - Gay, Katelyn
AU - Bellgowan, Patrick S.F.
AU - Joseph, Kristen
N1 - Funding Information:
Dr. Kontos receives research support in the form of research grants from General Electric-National Football League (NFL), ElMindA, Ltd, and Abbott Labs, outside the submitted work. Dr. Wilde receives research support in the form of grants from Brain-scope, Inc., outside the submitted work. Dr. Cantu serves as a Senior Advisor to the NFL Head Neck and Spine Committee, as Vice President and Chair for the Scientific Advisory Committee of the National Operating Committee on Standards for Athletic Equipment, and Co-Founder, Medical Director for the Concussion Legacy Foundation. Dr. Cantu receives royalties from the Houghton Mifflin Harcourt and is a Legal Expert Opinion for the National Collegiate Athletic Association (NCAA), National Hockey League, etc., outside the submitted work. Dr. Gioia receives personal fees from Behavior Rating Inventory of Executive Function as a test author, outside the submitted work. Dr. Giza received research support in the form of research grants from NINDS, NCAA, U.S. Department of Defense, philanthropic support, unrestricted funds and research grants from University of California, Los Angeles (UCLA) Steve Tisch BrainSPORT; Easton Labs for Brain Injury, and UCLA BIRC, and a research grant from Neural Analytics (NINDS Small Business Innovation Research grant), during the conduct of the study; and received research support in the form of research grants from Avanir, and other forms of support as a consultant for Neural Analytics 2015-2016 and NFL-Neuro Care Program, National Hockey League Players’ Association, National Hockey League, Major League Soccer, outside the submitted work. He further reports receiving book royalties from Blackwell Publishing, outside the submitted work. Dr. Tamburro receives research support in the form of grants from the U.S. Food and Drug Administration Office of Orphan Product Development Program, non-financial support from Ony, and royalties from Springer Publishing, outside the submitted work. Dr. Yeates receives research support in the form of grants from the Canadian Institutes of Health Research, the National Institutes of Health, and book royalties from Guilford Press and Cambridge University Press, outside the submitted work.
Funding Information:
The funding source for this project is the U.S Army Medical Research and Materiel Command’s Combat Casualty Care Research Program and NIH contracts HHSN271201700064C and HHSN271201200034C. The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS) or the U.S. government. The development of the NINDS SRC CDEs was made possible thanks to the great investment of time and effort of Working Group members and the members of the NINDS CDE Project team participating from 2016 to present. In addition, we are grateful for the input provided during the public review period.
Publisher Copyright:
© Copyright 2018, Mary Ann Liebert, Inc., publishers.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Through a partnership with the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, and Department of Defense, the development of Sport-Related Concussion (SRC) Common Data Elements (CDEs) was initiated. The aim of this collaboration was to increase the efficiency and effectiveness of clinical research studies and clinical treatment outcomes, increase data quality, facilitate data sharing across studies, reduce study start-up time, more effectively aggregate information into metadata results, and educate new clinical investigators. The SRC CDE Working Group consisted of 32 worldwide experts in concussion from varied fields of related expertise divided into three Subgroups: Acute (<72 h post-concussion), Subacute (3 days-3 months post-concussion) and Persistent/Chronic (>3 months post-concussion). To develop CDEs, the Subgroups reviewed various domains, then selected from, refined, and added to existing CDEs, case report forms and field-tested data elements from national registries and funded research studies. Recommendations were posted to the NINDS CDE Website for Public Review from February 2017 to April 2017. Following an internal Working Group review of recommendations, along with consideration of comments received from the Public Review period, the first iteration (Version 1.0) of the NINDS SRC CDEs was completed in June 2017. The recommendations include Core and Supplemental-Highly Recommended CDEs for cognitive data elements and symptom checklists, as well as other outcomes and end-points (e.g., vestibular, oculomotor, balance, anxiety, depression), and sample case report forms (e.g., injury reporting, demographics, concussion history) for domains typically included in clinical research studies. The NINDS SRC CDEs and supporting documents are publicly available on the NINDS CDE website www.commondataelements.ninds.nih.gov. Widespread use of CDEs by researchers and clinicians will facilitate consistent SRC clinical research and trial design, data sharing, and metadata retrospective analysis.
AB - Through a partnership with the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, and Department of Defense, the development of Sport-Related Concussion (SRC) Common Data Elements (CDEs) was initiated. The aim of this collaboration was to increase the efficiency and effectiveness of clinical research studies and clinical treatment outcomes, increase data quality, facilitate data sharing across studies, reduce study start-up time, more effectively aggregate information into metadata results, and educate new clinical investigators. The SRC CDE Working Group consisted of 32 worldwide experts in concussion from varied fields of related expertise divided into three Subgroups: Acute (<72 h post-concussion), Subacute (3 days-3 months post-concussion) and Persistent/Chronic (>3 months post-concussion). To develop CDEs, the Subgroups reviewed various domains, then selected from, refined, and added to existing CDEs, case report forms and field-tested data elements from national registries and funded research studies. Recommendations were posted to the NINDS CDE Website for Public Review from February 2017 to April 2017. Following an internal Working Group review of recommendations, along with consideration of comments received from the Public Review period, the first iteration (Version 1.0) of the NINDS SRC CDEs was completed in June 2017. The recommendations include Core and Supplemental-Highly Recommended CDEs for cognitive data elements and symptom checklists, as well as other outcomes and end-points (e.g., vestibular, oculomotor, balance, anxiety, depression), and sample case report forms (e.g., injury reporting, demographics, concussion history) for domains typically included in clinical research studies. The NINDS SRC CDEs and supporting documents are publicly available on the NINDS CDE website www.commondataelements.ninds.nih.gov. Widespread use of CDEs by researchers and clinicians will facilitate consistent SRC clinical research and trial design, data sharing, and metadata retrospective analysis.
KW - assessment tools
KW - clinical outcomes
KW - clinical research
KW - common data elements
KW - data sets
KW - traumatic brain injury
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U2 - 10.1089/neu.2018.5643
DO - 10.1089/neu.2018.5643
M3 - Article
C2 - 29717643
AN - SCOPUS:85053208756
SN - 0897-7151
VL - 35
SP - 2776
EP - 2783
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
IS - 23
ER -