Core-008

核心008

基本信息

批准号：
10613566
负责人：
JAMES E. HEUBI
金额：
$ 10.14万
依托单位：
UNIVERSITY OF CINCINNATI
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-14 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10613566
关键词：
Address Agreement Algorithms Antibiotics Birth Censuses Child Childhood Clinical Sciences Communities Data Data Set Defect Disease susceptibility Electronic Health Record Environmental Exposure Equipment and supply inventories Goals Grant Health Hepatitis C Hospitals Individual Infant Institutional Review Boards Link Longevity Medical center Mothers Neonatal Neonatal Abstinence Syndrome Newborn Infant Outcome Ownership Pediatric Hospitals Peer Review Perinatal Phase Privacy Protocols documentation Publications Publishing Records Research Training Translational Research Universities Vital Statistics abdominal wall clinical center data de-identification data hub data integration data repository data sharing improved multidisciplinary opioid exposure population based population health post pregnancy programs social determinants trend

项目摘要

Efforts to improve maternal and child population health outcomes require access to reliable and timely data while appropriately addressing challenges related to regulatory barriers, privacy issues, data ownership, and technical limitations. In the Center for Clinical and Translational Science and Training (CCTST) 2.0, we addressed these challenges with the implementation of the first phase of the Lifespan Data Integration Module. Program goals included 1) supporting seamless integration of maternal, neonatal, and pediatric records to establish a population-based, regional perinatal research data repository, or data hub, which would also enable linkage to ancillary data sets using individual level identifiers or geocoded address information; and 2) investigating longitudinal lifespan exposures before, during, and after pregnancy that impact disease susceptibility and health trajectories. We addressed regulatory concerns [Institutional Review Board (IRB) protocol approval granted at Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati (UC) Medical Center], established formalized data sharing agreements, and convened a stakeholder advisory board to approve distributions of de-identified data sets. We acquired data representing over 150,000 mothers and their infants born from 2013-2018 from CCHMC, Every Child Succeeds, and UC Health. These data were geocoded and linked using automated and validated algorithms built by the study team with technical details and a roadmap for overcoming regulatory challenges outlined in several peer-reviewed publications. Multidisciplinary partnerships have likewise published results of studies using the Lifespan Data Integration Module. One study team leveraged the module’s geocoding capability to implement census tractlevel neonatal surveillance representing rates of intrauterine opioid exposure, neonatal abstinence syndrome, and hepatitis C exposure. Another team study evaluated trends in antibiotic use among newborns with abdominal wall defects. For the next phase of the Lifespan Data Integration Module under CCTST 3.0, we will: 1) increase the volume of core records by integrating electronic health records from additional birth hospitals and incorporate vital statistics records; and 2) expand the types of data contained through integration of social determinants, environmental exposures, and a biospecimen research inventory. As a result, the Lifespan Data Integration Module will continue to catalyze perinatal research efforts through engagement of additional multidisciplinary teams, both within and external to the CCTST community.

改善孕产妇和儿童人口健康结果的努力需要获得可靠和及时的数据同时妥善解决与监管障碍、隐私问题、数据所有权等相关的挑战在临床和转化科学与培训中心 (CCTST) 2.0 中，我们通过实施寿命数据集成模块第一阶段解决了这些挑战。计划目标包括 1) 支持孕产妇、新生儿和儿科记录的无缝集成，以建立一个以人口为基础的区域围产期研究数据库或数据中心，这也将使使用单独级别标识符或地理编码地址信息链接到辅助数据集；以及 2) 纵向调查怀孕前、怀孕期间和怀孕后影响疾病的终生暴露情况我们解决了监管问题[机构审查委员会（IRB）。方案获得辛辛那提儿童医院医疗中心 (CCHMC) 和辛辛那提大学的批准辛辛那提（UC）医疗中心]，建立了正式的数据共享协议，并召集了利益相关者顾问委员会批准分发去识别化数据集。我们获取了超过 150,000 个数据。来自 CCHMC、Every Child Succeeds 和 UC Health 的 2013 年至 2018 年出生的母亲及其婴儿。使用研究团队构建的自动化且经过验证的算法对数据进行地理编码和链接几个同行评审中概述的技术细节和克服监管挑战的路线图多学科合作伙伴也同样发表了使用寿命数据的研究结果。集成模块。一个研究团队利用该模块的地理编码功能来实施人口普查区域级别。新生儿监测代表宫内阿片类药物暴露率、新生儿戒断综合征、另一项团队研究评估了新生儿中抗生素使用的趋势。对于 CCTST 3.0 下的寿命数据集成模块的下一阶段，我们将： 1) 通过整合更多出生医院的电子健康记录来增加核心记录的数量并纳入生命统计记录；2) 通过整合社会信息扩大所包含的数据类型决定因素、环境暴露和生物样本研究清单，从而得出寿命数据。整合模块将继续通过更多参与来促进围产期研究工作 CCTST 社区内部和外部的多学科团队。