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 - Funding Information:
Steven Broglio, Michael McCrea, Thomas McAllister, Jaroslaw Harezlak, and Barry Katz received funding from the NCAA and DoD to complete this investigation and to cover travel costs when speaking about this study. Brian Hainline is employed by the NCAA. Dallas Hack was formerly employed by the DoD but is currently employed by the NCAA.
Funding Information:
Contributing investigators include Scott Anderson, ATC (University of Oklahoma); Allison Brooks, MD, MPH (University of Wisconsin); Stefan Duma, PhD (Virginia Tech); Christopher Giza, MD (University of California-Los Angeles); Steven J. Svoboda, MD (United States Military Academy); and Scott Pyne, MD (United States Naval Academy). The authors would also like to thank Jody Harland, Janetta Matesan, Larry Riggen (Indiana University); Ashley Rettmann (University of Michigan); Melissa Koschnitzke (Medical College of Wisconsin); Michael Jarrett, Vibeke Brinck and Bianca Byrne (Quesgen); Thomas Dompier, Melisssa Niceley Baker, and Sara Dalton (Datalys Center for Sports Injury Research and Prevention); and the research and medical staff at each of the participating sites. This publication was made possible, in part, with support from the Grand Alliance CARE Consortium, funded by the NCAA and the DoD. The USAMRAA, Ford Detrick, MD, USA, is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Psychological Health and Traumatic Brain Injury Program under Award No. W81XWH-14-2-0151. Opinions, interpretations, conclusions and recommendations are those of the authors and are not necessarily endorsed by the DoD (DHP funds).
Publisher Copyright:
© 2017, The Author(s).
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 -