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.

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.

Fig. 1

NCAA-DoD Grand Alliance Organizational Structure. NCAA National Collegiate Athletic Association, DoD Department of Defense, NIH National Institutes of Health

Fig. 2

Organizational structure of the CARE Consortium. Year 1 included 15 CSC institutions and 3 ARC institutions; year 2 included 21 CSC institutions and 4 ARC institutions; and year 3 included 30 CSC institutions and 6 ARC institutions. CSC schools are shown in blue and ARC schools are shown in yellow. Six sites participated in both arms of the study. NCAA National Collegiate Athletic Association, DoD Department of Defense, NIH National Institutes of Health, CARE Concussion Assessment, Research, and Education, PI principal investigator, CSC Clinical Study Core, ARC Advanced Research Core

Fig. 3

Multidimensional research approach integrating biomechanical, neurobiological, neuroimaging, genetic and clinical data elements of ARC. CARE Concussion Assessment, Research, and Education, ARC Advanced Research Core

Fig. 4

CARE ARC MRI protocol integrating multimodal imaging biomarkers of changes in brain structure and function. CARE Concussion Assessment, Research, and Education, ARC Advanced Research Core, MRI magnetic resonance imaging

Fig. 5

CARE Data Integration Pipelines. HIM Head Impact Measurement, MRI magnetic resonance imaging, HITS Head Impact Telemetry System, DICOM Digital Imaging and Communications in Medicine, QA quality assurance, QI quality improvement, QGID Quesgen identification number, CARE Concussion Assessment, Research, and Education, ARC Advanced Research Core, FITBIR Federal Interagency Traumatic Brain Research