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

Steven P. Broglio, Michael McCrea, Thomas McAllister, Jaroslaw Harezlak, Barry Katz, Dallas Hack, Brian Hainline, April Hoy, Louise A. Kelly, Joseph B. Hazzard, Nicholas Port, Margot Putukian, T. Dianne Langford, Ryan Tierney, Darren E. Campbell, Gerald McGinty, Patrick O’Donnell, Holly J. Benjamin, Thomas Buckley, Thomas W. Kaminski & 16 others James R. Clugston, Julianne D. Schmidt, Luis A. Feigenbaum, James T. Eckner, Kevin Guskiewicz, Jason P. Mihalik, Jessica Dysart Miles, Christina L. Master, Micky Collins, Anthony P. Kontos, Jeffrey J. Bazarian, Sara P.D. Chrisman, Christopher Todd Bullers, Christopher M. Miles, Brian H. Dykhuizen,

Research output: Research - peer-reviewArticle

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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.

LanguageEnglish (US)
Pages1-15
Number of pages15
JournalSports Medicine
DOIs
StateAccepted/In press - Mar 9 2017

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Athletes
Sports
Students
Education
Research
Brain Concussion
Databases
United States Department of Defense
Military Personnel
Natural History
Medical Students
Neuroimaging
Multicenter Studies
Biomarkers
Maintenance
Safety
Wounds and Injuries
Data Accuracy
Clinical Studies
Traumatic Brain Injury

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Physical Therapy, Sports Therapy and Rehabilitation

Cite this

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. / Broglio, Steven P.; McCrea, Michael; McAllister, Thomas; Harezlak, Jaroslaw; Katz, Barry; Hack, Dallas; Hainline, Brian; Hoy, April; Kelly, Louise A.; Hazzard, Joseph B.; Port, Nicholas; Putukian, Margot; Langford, T. Dianne; Tierney, Ryan; Campbell, Darren E.; McGinty, Gerald; O’Donnell, Patrick; Benjamin, Holly J.; Buckley, Thomas; Kaminski, Thomas W.; Clugston, James R.; Schmidt, Julianne D.; Feigenbaum, Luis A.; Eckner, James T.; Guskiewicz, Kevin; Mihalik, Jason P.; Miles, Jessica Dysart; Master, Christina L.; Collins, Micky; Kontos, Anthony P.; Bazarian, Jeffrey J.; Chrisman, Sara P.D.; Bullers, Christopher Todd; Miles, Christopher M.; Dykhuizen, Brian H.; Care Consortium Investigators.

In: Sports Medicine, 09.03.2017, p. 1-15.

Research output: Research - peer-reviewArticle

Broglio, SP, McCrea, M, McAllister, T, Harezlak, J, Katz, B, Hack, D, Hainline, B, Hoy, A, Kelly, LA, Hazzard, JB, Port, N, Putukian, M, Langford, TD, Tierney, R, Campbell, DE, McGinty, G, O’Donnell, P, Benjamin, HJ, Buckley, T, Kaminski, TW, Clugston, JR, Schmidt, JD, Feigenbaum, LA, Eckner, JT, Guskiewicz, K, Mihalik, JP, Miles, JD, Master, CL, Collins, M, Kontos, AP, Bazarian, JJ, Chrisman, SPD, Bullers, CT, Miles, CM, Dykhuizen, BH & Care Consortium Investigators 2017, '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' Sports Medicine, pp. 1-15. DOI: 10.1007/s40279-017-0707-1
Broglio, Steven P. ; McCrea, Michael ; McAllister, Thomas ; Harezlak, Jaroslaw ; Katz, Barry ; Hack, Dallas ; Hainline, Brian ; Hoy, April ; Kelly, Louise A. ; Hazzard, Joseph B. ; Port, Nicholas ; Putukian, Margot ; Langford, T. Dianne ; Tierney, Ryan ; Campbell, Darren E. ; McGinty, Gerald ; O’Donnell, Patrick ; Benjamin, Holly J. ; Buckley, Thomas ; Kaminski, Thomas W. ; Clugston, James R. ; Schmidt, Julianne D. ; Feigenbaum, Luis A. ; Eckner, James T. ; Guskiewicz, Kevin ; Mihalik, Jason P. ; Miles, Jessica Dysart ; Master, Christina L. ; Collins, Micky ; Kontos, Anthony P. ; Bazarian, Jeffrey J. ; Chrisman, Sara P.D. ; Bullers, Christopher Todd ; Miles, Christopher M. ; Dykhuizen, Brian H. ; Care Consortium Investigators. / 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. In: Sports Medicine. 2017 ; pp. 1-15
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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.",
author = "Broglio, {Steven P.} and Michael McCrea and Thomas McAllister and Jaroslaw Harezlak and Barry Katz and Dallas Hack and Brian Hainline and April Hoy and Kelly, {Louise A.} and Hazzard, {Joseph B.} and Nicholas Port and Margot Putukian and Langford, {T. Dianne} and Ryan Tierney and Campbell, {Darren E.} and Gerald McGinty and Patrick O’Donnell and Benjamin, {Holly J.} and Thomas Buckley and Kaminski, {Thomas W.} and Clugston, {James R.} and Schmidt, {Julianne D.} and Feigenbaum, {Luis A.} and Eckner, {James T.} and Kevin Guskiewicz and Mihalik, {Jason P.} and Miles, {Jessica Dysart} and Master, {Christina L.} and Micky Collins and Kontos, {Anthony P.} and Bazarian, {Jeffrey J.} and Chrisman, {Sara P.D.} and Bullers, {Christopher Todd} and Miles, {Christopher M.} and Dykhuizen, {Brian H.} and {Care Consortium Investigators}",
year = "2017",
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doi = "10.1007/s40279-017-0707-1",
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journal = "Sports Medicine",
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T1 - A National Study on the Effects of Concussion in Collegiate Athletes and US Military Service Academy Members

T2 - Sports Medicine

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 - Kelly,Louise A.

AU - Hazzard,Joseph B.

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.

AU - Care Consortium Investigators

PY - 2017/3/9

Y1 - 2017/3/9

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.

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