Core-008

核心008

• 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
• 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

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.

改善产妇和儿童人口健康成果的努力需要获取可靠和及时的数据 同时适当解决与监管障碍，隐私问题，数据所有权和 技术限制。在临床与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的第一阶段来解决这些挑战。 计划目标包括1）支持孕产妇，新生儿和儿科记录的无缝整合到 建立基于人群的区域围产期研究数据存储库或数据中心，这也将使 使用单个级别标识符或地理编码地址信息链接到辅助数据集；和2） 在怀孕之前，期间和之后调查纵向寿命暴露 敏感性和健康轨迹。我们解决了监管问题[机构审查委员会（IRB） 在辛辛那提儿童医院医疗中心（CCHMC）和大学批准的协议批准 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 咨询委员会批准取消识别数据集的分布。我们获得了代表超过150,000的数据 母亲及其婴儿从2013 - 2018年从CCHMC出生，每个孩子都成功，UC Health。这些 使用研究团队构建的自动化和验证算法将数据进行地理编码和链接 技术细节和路线图，以克服几个同行评审中概述的监管挑战 出版物。跨学科伙伴关系同样使用寿命数据发表了研究结果 集成模块。一个研究团队利用该模块的地理编码能力来实施人口普查拖曳 新生儿监测代表宫内阿片类药物暴露率，新生儿戒毒综合征， 和乙型肝炎暴露。另一项团队研究评估了新生儿中抗生素使用的趋势 腹壁缺陷。对于CCTST 3.0下的生命周期数据集成模块的下一阶段，我们将： 1）通过整合额外的出生医院的电子健康记录来增加核心记录的数量 并结合了重要的统计记录； 2）扩展通过集成社会所包含的数据类型 决定因素，环境暴露和生物测量研究清单。结果，寿命数据 集成模块将继续通过额外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。