CARE4Kids: Data Coordinating Core

项目摘要--数据协调核心 包括脑震荡在内的轻度创伤性脑损伤是美国儿童面临的一个紧迫的公共卫生问题。 各州。2013年，儿童中约有64万人次与脑损伤相关的急诊科就诊 只有15年以下。发生在青年时期的脑震荡比脑震荡影响更多的个体 在成人中，这些脑震荡的远端影响发生在更多的年份。理解 青年脑震荡以减轻这些伤害对寿命的影响是一个关键但未被充分研究的问题 优先考虑。尤其重要的是早中期青少年(EMA)，他们经历了持续的后 脑震荡症状(PPCS)。本提案中定义的PPC是指脑震荡后症状(PCS) 至少持续三个月。虽然只占mTBI人口的一小部分，但这些年轻人占大多数 发病率、残疾以及与教育和健康相关的费用。为了更好地了解恢复时间，当前 关于治疗和PPCS的影响，四角青年联合会(4CyC)创建了一个登记 儿童和青少年到专门诊所报告脑震荡症状。利用公共数据元素 (CDE)来自国家神经疾病和中风研究所(NINDS)，4CyC震荡登记 捕获参与者的人口统计和临床数据以及功能评估。数据协调 犹他州大学的CORE(DCC)作为4CyC震荡的数据协调中心 登记处，使其特别适合作为当前提案中的发改委。受伤间隔时间的中位数 临床访问为16天，四分位数范围为8至28天，这表明这是一种有效的方法 对于这项研究患有PPCS的儿童的建议。虽然临床因素和评估对 识别PPCS，需要了解这一结果背后的生物学机制。生物标志物 例如血液蛋白水平、神经成像和眼球运动功能可能有助于评估脑震荡症状。 以及恢复的程度。为了支持这些目标，CARE4Kids DCC提出了以下3个目标： 目标1.在方案设计、研究执行和管理、数据收集和管理方面提供援助 管理、高效的质量监测、研究报告和指标，以确保统一的血液采集 CARE4Kids网站上的样本、成像和临床数据。具体目标2.提供后勤支持 和技术专长，以协调在BioSEND收集和存储血液样本，并确保 遵守与FITBIR提交相关的数据质量和共享要求。具体目标3.至 提供生物统计学领导和专业知识，以支持CARE4儿童研究核心的分析目标 和项目。这些目标的成功实现将导致公共资源连接标准化 数据、生物样本和图像，以及PPCS的新风险分层和预测工具 脑震荡的急救。

PROJECT SUMMARY ABSTRACT – Data Coordinating Core Mild traumatic brain injury (mTBI) including concussion is a pressing public health issue for children in the United States. In 2013, there were approximately 640,000 TBI-related emergency department visits among children under 15 years alone. Concussions occurring in youth affect a greater number of individuals than concussions in adults, and the distal impact of these concussions occurs over a greater number of years. Understanding youth concussion in order to mitigate the impact of these injuries on the life span is a critical yet understudied priority. Of particular importance are early and middle adolescents (EMA) who experience persistent post- concussive symptoms (PPCS). PPCS as defined for this proposal refers to post-concussive symptoms (PCS) lasting at least three months. While a minority of the mTBI population, these youth account for the majority of morbidity, disability, and educational- and health-related costs. To better understand time to recovery, current treatments, and the impact of PPCS, the Four Corners Youth Consortium (4CYC) has created a registry of children and adolescents reporting to specialty clinics for concussion symptoms. Utilizing common data elements (CDEs) from the National Institute of Neurological Disorders and Stroke (NINDS), the 4CYC Concussion Registry captures participants' demographic and clinical data as well as functional assessments. The Data Coordinating Core (DCC) at the University of Utah has served as the Data Coordinating Center for the 4CYC Concussion Registry, making it uniquely suited to serve as the DCC in the current proposal. The median time between injury and clinic visit is 16 days with an interquartile range of 8 to 28 days suggesting this is an effective method to use for this proposal to study children suffering from PPCS. While clinical factors and assessments are useful for identifying PPCS, a need exists to understand the biological mechanisms underlying this outcome. Biomarkers such as blood protein levels, neuroimaging, and oculomotor function may help assess concussion symptoms and degrees of recovery. To support these aims, the CARE4Kids DCC proposes the following 3 aims: Specific Aim 1. To provide assistance in protocol design, study implementation and management, data collection and management, efficient quality monitoring, study reporting and metrics to ensure uniform collection of blood specimens, imaging, and clinical data across the CARE4Kids sites. Specific Aim 2. To provide logistical support and technical expertise to coordinate the collection and storage of blood specimens at BioSEND and ensure the adherence to the data quality and sharing requirements related to FITBIR submissions. Specific Aim 3. To provide biostatistical leadership and expertise to support the analytical goals of the CARE4Kids Research Cores and project. Successful implementation of these aims will result in a public resource connecting standardized data, biospecimens, and images as well as a new risk stratification and prediction tool for PPCS among concussed EMA.