TY - JOUR
T1 - A National Study on the Effects of Concussion in Collegiate Athletes and US Military Service Academy Members
T2 - The NCAA–DoD Concussion Assessment, Research and Education (CARE) Consortium Structure and Methods
AU - Care Consortium Investigators
AU - Broglio, Steven P.
AU - McCrea, Michael
AU - McAllister, Thomas
AU - Harezlak, Jaroslaw
AU - Katz, Barry
AU - Hack, Dallas
AU - Hainline, Brian
AU - Hoy, April
AU - Hazzard, Joseph B.
AU - Kelly, Louise A.
AU - Ortega, Justus D.
AU - Port, Nicholas
AU - Putukian, Margot
AU - Langford, T. Dianne
AU - Tierney, Ryan
AU - Campbell, Darren E.
AU - McGinty, Gerald
AU - O’Donnell, Patrick
AU - Benjamin, Holly J.
AU - Buckley, Thomas
AU - Kaminski, Thomas W.
AU - Clugston, James R.
AU - Schmidt, Julianne D.
AU - Feigenbaum, Luis A.
AU - Eckner, James T.
AU - Guskiewicz, Kevin
AU - Mihalik, Jason P.
AU - Miles, Jessica Dysart
AU - Master, Christina L.
AU - Collins, Micky
AU - Kontos, Anthony P.
AU - Bazarian, Jeffrey J.
AU - Chrisman, Sara P.D.
AU - Bullers, Christopher Todd
AU - Miles, Christopher M.
AU - Dykhuizen, Brian H.
N1 - Publisher Copyright:
© 2017, The Author(s).
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2017/7/1
Y1 - 2017/7/1
N2 - Background: The natural history of mild traumatic brain injury (TBI) or concussion remains poorly defined and no objective biomarker of physiological recovery exists for clinical use. The National Collegiate Athletic Association (NCAA) and the US Department of Defense (DoD) established the Concussion Assessment, Research and Education (CARE) Consortium to study the natural history of clinical and neurobiological recovery after concussion in the service of improved injury prevention, safety and medical care for student-athletes and military personnel. Objectives: The objectives of this paper were to (i) describe the background and driving rationale for the CARE Consortium; (ii) outline the infrastructure of the Consortium policies, procedures, and governance; (iii) describe the longitudinal 6-month clinical and neurobiological study methodology; and (iv) characterize special considerations in the design and implementation of a multicenter trial. Methods: Beginning Fall 2014, CARE Consortium institutions have recruited and enrolled 23,533 student-athletes and military service academy students (approximately 90% of eligible student-athletes and cadets; 64.6% male, 35.4% female). A total of 1174 concussions have been diagnosed in participating subjects, with both concussion and baseline cases deposited in the Federal Interagency Traumatic Brain Injury Research (FITBIR) database. Conclusions: Challenges have included coordinating regulatory issues across civilian and military institutions, operationalizing study procedures, neuroimaging protocol harmonization across sites and platforms, construction and maintenance of a relational database, and data quality and integrity monitoring. The NCAA–DoD CARE Consortium represents a comprehensive investigation of concussion in student-athletes and military service academy students. The richly characterized study sample and multidimensional approach provide an opportunity to advance the field of concussion science, not only among student athletes but in all populations at risk for mild TBI.
AB - Background: The natural history of mild traumatic brain injury (TBI) or concussion remains poorly defined and no objective biomarker of physiological recovery exists for clinical use. The National Collegiate Athletic Association (NCAA) and the US Department of Defense (DoD) established the Concussion Assessment, Research and Education (CARE) Consortium to study the natural history of clinical and neurobiological recovery after concussion in the service of improved injury prevention, safety and medical care for student-athletes and military personnel. Objectives: The objectives of this paper were to (i) describe the background and driving rationale for the CARE Consortium; (ii) outline the infrastructure of the Consortium policies, procedures, and governance; (iii) describe the longitudinal 6-month clinical and neurobiological study methodology; and (iv) characterize special considerations in the design and implementation of a multicenter trial. Methods: Beginning Fall 2014, CARE Consortium institutions have recruited and enrolled 23,533 student-athletes and military service academy students (approximately 90% of eligible student-athletes and cadets; 64.6% male, 35.4% female). A total of 1174 concussions have been diagnosed in participating subjects, with both concussion and baseline cases deposited in the Federal Interagency Traumatic Brain Injury Research (FITBIR) database. Conclusions: Challenges have included coordinating regulatory issues across civilian and military institutions, operationalizing study procedures, neuroimaging protocol harmonization across sites and platforms, construction and maintenance of a relational database, and data quality and integrity monitoring. The NCAA–DoD CARE Consortium represents a comprehensive investigation of concussion in student-athletes and military service academy students. The richly characterized study sample and multidimensional approach provide an opportunity to advance the field of concussion science, not only among student athletes but in all populations at risk for mild TBI.
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U2 - 10.1007/s40279-017-0707-1
DO - 10.1007/s40279-017-0707-1
M3 - Article
C2 - 28281095
AN - SCOPUS:85014709392
VL - 47
SP - 1437
EP - 1451
JO - Sports Medicine
JF - Sports Medicine
SN - 0112-1642
IS - 7
ER -