Core-008

改善孕产妇和儿童健康状况的努力需要获得可靠和及时的数据 在适当解决与监管障碍、隐私问题、数据所有权和 技术限制。在临床和翻译科学与培训中心(CCTST)2.0，我们 通过实施寿命数据集成模块的第一阶段，解决了这些挑战。 计划目标包括：1)支持将产妇、新生儿和儿科病历无缝集成到 建立一个以人口为基础的区域围产期研究数据储存库或数据中心，这也将使 使用单独的级别标识或地理编码的地址信息链接到辅助数据集；以及2) 研究孕前、孕中和孕后纵向寿命暴露对疾病的影响 易感性和健康轨迹。我们解决了监管方面的担忧[机构审查委员会(IRB) 辛辛那提儿童医院医学中心(CCHMC)和华盛顿大学批准的议定书 辛辛那提(加州大学)医疗中心]，建立了正式的数据共享协议，并召集了一个利益相关者 咨询委员会批准分发已取消识别的数据集。我们获得了超过150,000个数据 2013-2018年出生的母亲和她们的婴儿来自CCHMC、每一个孩子成功和加州大学健康。这些 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 在几个同行评审中概述的克服监管挑战的技术细节和路线图 出版物。多学科合作伙伴关系同样也发表了使用寿命数据的研究结果 集成模块。一个研究小组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、新生儿戒断综合征、 以及接触丙型肝炎。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。在CCTST 3.0下的生命周期数据集成模块的下一阶段，我们将： 1)通过整合来自其他产科医院的电子健康记录，增加核心记录的数量 并纳入生命统计记录；以及2)通过整合社会统计数据，扩大所包含的数据类型 决定因素、环境暴露和生物量研究清单。因此，寿命数据 集成模块将继续通过参与其他项目来促进围产期研究工作 CCTST社区内外的多学科团队。

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.