CARE4Kids: Data Coordinating Core

项目摘要摘要-数据协调核心

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.