CARE4Kids: Data Coordinating Core

CARE4Kids：数据协调核心

• 批准号: 10203599
• 负责人: LAWRENCE Joseph COOK
• 金额: $ 44.57万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-08 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10203599
• 关键词: Adherence; Adolescent; Adult; Affect; Algorithms; Biological; Biological Markers; Biometry; Blood; Blood Proteins; Blood Specimen Collection; Blood specimen; Brain Concussion; Child; Clinic; Clinic Visits; Clinical; Clinical Data; Clinical Research; Collection; Common Data Element; Data; Data Collection; Data Coordinating Center; Development; Distal; Education; Emergency department visit; Enrollment; Ensure; Goals; Health; Image; Individual; Informatics; Injury; Leadership; Logistics; Longevity; Measures; Methods; Minority; Monitor; Morbidity - disease rate; National Institute of Neurological Disorders and Stroke; Neuropsychology; Outcome; Participant; Phase; Population; Post-Concussion Syndrome; Protocols documentation; Public Health; Recovery; Registries; Reporting; Research; Research Support; Resources; Risk; Site; Surveys; Symptoms; System; Technical Expertise; Text; Text Messaging; Time; Traumatic Brain Injury; United States; Universities; Utah; Youth; biomarker development; cohort; concussive symptom; cost; data management; data quality; data sharing; data standards; design; disability; endophenotype; experience; imaging biomarker; medical specialties; mild traumatic brain injury; neurobehavioral; neuroimaging; oculomotor; predictive marker; prospective; risk prediction; risk stratification; symptom cluster; tool

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.

项目摘要摘要-数据协调核心 包括脑震荡在内的轻度创伤性脑损伤（mTBI）是美国儿童面临的一个紧迫的公共卫生问题。 States. 2013年，约有64万名儿童因TBI而到急诊科就诊 15岁以下发生在青年的脑震荡比脑震荡影响更多的人 在成年人中，这些脑震荡的远端影响发生在更长的时间内。理解 为了减轻这些伤害对寿命的影响， 要务特别重要的是早期和中期青少年（EMA）谁经历持续的后， 脑震荡症状（PPCS）。本提案定义的PPCS是指脑震荡后症状（PCS） 持续至少三个月。虽然这些年轻人占mTBI人口的少数，但他们占大多数。 发病率、残疾以及与教育和健康有关的费用。为了更好地了解恢复时间，当前 治疗，以及PPCS的影响，四角青年联盟（4CYC）已经创建了一个登记册， 儿童和青少年因脑震荡症状到专科诊所就诊。利用共同数据元素 （CDE）来自国家神经疾病和卒中研究所（NINDS），4CYC脑震荡登记处 获取参与者的人口统计学和临床数据以及功能评估。数据协调 核心（DCC）在犹他州大学已担任数据协调中心的4CYC脑震荡 书记官处，使其特别适合担任目前提案中的发展协调委员会。受伤之间的平均时间 临床访视时间为16天，四分位数范围为8至28天，表明这是一种有效的方法 研究患有PPCS的儿童的建议。虽然临床因素和评估对于 为了识别PPCS，需要了解这种结果背后的生物学机制。生物标记 如血液蛋白水平、神经成像和眼功能可以帮助评估脑震荡症状 恢复的程度。为了支持这些目标，CARE 4Kids DCC提出了以下3个目标： 目标1。在方案设计、研究实施和管理、数据收集和 管理、有效的质量监测、研究报告和指标，以确保统一的血液采集 CARE 4Kids研究中心的标本、成像和临床数据。具体目标2。提供后勤支助 和技术专业知识，以协调血液标本在BioSEND的采集和储存，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。到 提供生物统计领导和专业知识，以支持CARE 4Kids研究核心的分析目标 和项目。这些目标的成功实施将导致公共资源连接标准化 数据，生物标本和图像，以及一个新的风险分层和预测工具，PPCS中 脑震荡