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J Neurotrauma. 2018 Dec 1;35(23):2776-2783. doi: 10.1089/neu.2018.5643. Epub 2018 Jul 23.

National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations.

Author information

1
1 University of Michigan , Ann Arbor, Michigan.
2
2 University of Pittsburgh , Pittsburgh, Pennsylvania.
3
3 Baylor College of Medicine and the Michael E. DeBakey VA Medical Center, Houston, Texas.
4
4 University of Calgary , Calgary, Alberta, Canada .
5
5 University of Utah School of Medicine , Salt Lake City, Utah.
6
6 Concussion Center at Emerson Hospital, Concord, Massachusetts.
7
7 Swiss Concussion Center, University of Zurich , Zurich, Switzerland .
8
8 University of Sheffield , Sheffield, United Kingdom .
9
9 Montreal Children's Hospital, McGill University Health Center , Montréal, Québec, Canada .
10
10 Children's National Health System, Washington, DC.
11
11 UCLA Brain Injury Research Center, Steve Tisch BrainSPORT Program, University of California , Los Angeles, California.
12
12 Centre for Neuro Skills , Encino, California.
13
13 SUNY Jacobs School of Medicine and Biomedical Sciences, University at Buffalo , Buffalo, New York.
14
14 Albert Einstein College of Medicine and Montefiore Medical Center , Bronx, New York.
15
15 The Mind Research Network, University of New Mexico , Albuquerque, New Mexico .
16
16 Indiana University School of Medicine , Indianapolis, Indiana.
17
17 Medical College of Wisconsin , Milwaukee, Wisconsin.
18
18 The Research Institute at Nationwide Children's Hospital , Columbus, Ohio.
19
19 Princeton University , Princeton, New Jersey.
20
20 San Camillo-Forlanini Hospital, Rome, Italy .
21
21 Kennedy Krieger Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
22
22 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
23
23 The International Concussion and Head Injury Research Foundation , London, United Kingdom .
24
24 Children's Hospital of Eastern Ontario Research Institute , Ottawa, Ontario, Canada .
25
25 The Emmes Corporation, Rockville, Maryland.
26
26 National Institute of Neurological Disorders and Stroke (NINDS) Bethesda, Maryland.

Abstract

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.

KEYWORDS:

assessment tools; clinical outcomes; clinical research; common data elements; data sets; traumatic brain injury

PMID:
29717643
PMCID:
PMC6247979
[Available on 2019-12-01]
DOI:
10.1089/neu.2018.5643

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