title: A National Study on the Effects of Concussion in Collegiate Athletes and US Military Service Academy Members: The NCAA-DoD Concussion Assessment, Research and Education (CARE) Consortium Structure and Methods.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: NeuroTrauma Research Laboratory, University of Michigan Injury Center, University of Michigan, 401 Washtenaw Ave, Ann Arbor, MI, 48109, USA. broglio@umich.edu.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Broglio
authors.affiliation: Departments of Neurosurgery and Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: McCrea
authors.affiliation: Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: McAllister
authors.affiliation: Department of Epidemiology and Biostatistics, Indiana University, Bloomington, IN, USA.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Harezlak
authors.affiliation: Department of Biostatistics, Indiana University, Indianapolis, IN, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Katz
authors.affiliation: National Collegiate Athletic Association, Indianapolis, IN, USA.
authors.forename: Dallas
authors.initials: D
authors.lastname: Hack
authors.affiliation: National Collegiate Athletic Association, Indianapolis, IN, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Hainline
mesh_terms: D000293:Adolescent; D000328:Adult; D056352:Athletes; D001265:Athletic Injuries; D001924:Brain Concussion / Q000175:diagnosis* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008889:Military Personnel; D016134:Organizational Policy; D009938:Organizations; D013178:Sports Medicine; D013334:Students; D014495:Universities / Q000458:organization & administration*