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.
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.
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DOI：
10.1007/s40279-017-0707-1
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发表时间：
2017-07
期刊：
影响因子：
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通讯作者：
CARE Consortium Investigators
中科院分区：
文献类型：
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作者：
Broglio SP;McCrea M;McAllister T;Harezlak J;Katz B;Hack D;Hainline B;CARE Consortium Investigators
轻度创伤性脑损伤(TBI)或脑震荡的自然病史仍不清楚，也没有可供临床使用的生理恢复的客观生物标志物。全美大学生体育协会(NCAA)和美国国防部(DoD)成立了震荡评估、研究和教育(CARE)联盟，以研究脑震荡后临床和神经生物学恢复的自然历史，为改善学生运动员和军事人员的伤害预防、安全和医疗服务。本文的目的是(I)描述CARE联盟的背景和驱动原理；(Ii)概述CARE联盟的政策、程序和治理的基础设施；(Iii)描述纵向6个月的临床和神经生物学研究方法；以及(Iv)描述设计和实施多中心试验时的特殊考虑因素。从2014年秋季开始，CARE联盟机构招募和招收了23,533名学生运动员和军校学生(约90%的合格学生运动员和学员；64.6%的男性，35.4%的女性)。在参与的受试者中总共诊断出1174例脑震荡，脑震荡和基线病例都保存在联邦机构间创伤性脑损伤研究(FITBIR)数据库中。挑战包括协调文职和军事机构的监管问题，实施研究程序，统一各地点和平台的神经成像方案，建设和维护关系数据库，以及数据质量和完整性监测。NCAA-DoD CARE联盟代表了对学生运动员和军事院校学生脑震荡的全面调查。富有特色的研究样本和多维方法为脑震荡科学领域的发展提供了机会，不仅在学生运动员中，而且在所有有轻微脑外伤风险的人群中。
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. 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. 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. 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.