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

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.

Concussed athletes walk slower than non-concussed athletes during cognitive-motor dual-task assessments but not during single-task assessments 2 months after sports concussion: a systematic review and meta-analysis using individual participant data

“…Consensus is required to establish minimum common data elements and core outcome sets for inclusion in observational studies in sports concussion dual-task research. This consensus will minimise between-study heterogeneity and facilitate meta-analysis of exploratory research 98. An improvement on current study designs to include an assessment of pre-morbid status is warranted for post-injury comparisons.…”

Cognitive Ageing in Top-Level Female Soccer Players Compared to a Normative Sample from the General Population: A Cross-sectional Study

“…Neurocognitive performance was evaluated in the players native language (92.5%) or language of their country of residency (7.5%) using the computerised neuropsychological test battery CNS Vital Signs (CNSVS). This test battery was chosen, as it is one of the core computerised neurocognitive test batteries recommended for the assessment of sport-related concussion (Broglio et al, 2018), and well established for the measurement of subtle cognitive deficits (de Oliveira & Brucki, 2014). There is evidence that CNSVS is sensitive to age-related differences over the lifespan , able to identify malingerers (Gualtieri & Hervey, 2015), and to discriminate between healthy subjects and patients with various psychological or neurological disorders (Gualtieri & Johnson, 2008;Gualtieri, Johnson, & Benedict, 2006;Iverson, Brooks, Langenecker, & Young, 2011;Meskal, Gehring, van der Linden, Rutten, & Sitskoorn, 2015).…”

Age of First Exposure to Soccer Heading and Sensory Reweighting for Upright Stance

“…Common clinical concussion assessments include tests of behavioral, cognitive, psychological and physical outcomes [23,24]. Although the first three have received considerable attention in the AFE literature, physical outcomes, such as postural control, have been understudied.…”