Using electronic medical record (EMR) data to examine the impact of prenatal drug exposure: Evaluating availability, accuracy and utilty of exposure information

使用电子病历 (EMR) 数据检查产前药物暴露的影响：评估暴露信息的可用性、准确性和实用性

• 批准号: 10511030
• 负责人: BETH A BAILEY
• 金额: $ 7.33万
• 依托单位: CENTRAL MICHIGAN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-25 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10511030
• 关键词: Address; Affect; Age; Alcohols; Algorithms; Biochemical; Child; Childhood; Clinical; Code; Computerized Medical Record; Data; Data Set; Data Sources; Development; Diagnosis; Drug Prescriptions; Drug Screening; Drug usage; Exposure to; Family; Frequencies; Goals; Gold; Health; Illicit Drugs; Inpatients; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10); Knowledge; Legal; Link; Longitudinal Studies; Longitudinal prospective study; Marijuana; Meconium; Medical; Methodological Studies; Methodology; Methods; Newborn Infant; Outcome; Outcome Assessment; Outpatients; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Predictive Factor; Pregnancy; Prenatal care; Prevalence; Procedures; Records; Research; Resources; Rural Community; Sensitivity and Specificity; Services; Site; System; Test Result; Testing; Time; Tissues; Tobacco; Umbilical Cord Blood; Urine; Withdrawal; Woman; Work; base; comorbidity; education resources; fetal drug exposure; fetal substance exposure; improved; in utero; individual patient; insight; interest; marijuana legalization; opioid epidemic; pediatric patients; population based; predictive modeling; prenatal exposure; prescription drug abuse; prevent; product development; prospective; racial diversity; recruit; research study; screening; socioeconomic diversity; statistics; substance use; tobacco exposure

SPECIFIC AIMS The overall goal of the proposed study is to examine the availability, accuracy, and utility of prenatal substance exposure data in the existing electronic medical records (EMR). Research on the impact of substance use during pregnancy on child outcomes has relied on large prospective, longitudinal studies to provide accurate data on exposures and outcomes. This has resulted in knowledge lagging significantly, especially problematic with the rapidly evolving opioid epidemic and recent legalization of commercial-grade marijuana. Population-based datasets have produced prevalence and more general information, but do not contain exposure information that is granular enough to reliably answer specific research questions. Individual patient EMRs contain a wealth of clinical information that can potentially be used for research purposes, however this potential related to prenatal exposures is largely unstudied. Our work, and the work of others, has demonstrated the possibilities for using EMR data to answer questions about the impact of prenatal substance exposures on child outcomes, while also highlighting the limitations and unknowns. EMRs provide the opportunity of linking pediatric outpatient records with up to three other types of EMRs (newborn inpatient record, maternal inpatient delivery record, and maternal outpatient prenatal care record), expanding available information about exposures for many patients. Our study will involve the following Specific Aims: 1. To determine exactly what exposure data is available in each of the four EMR types, with what frequency, and the congruence between exposure data sources. 2. To construct composite exposure variables from different data sources and examine the degree to which each: a) correlates with cord test results, and b) correlates with child outcomes. 3. To determine factors that predict availability, accuracy, and utility of exposure data. 4. To develop enduring study methodology materials including exposure variable coding algorithms. The study will utilize the EMRs from both a large but fairly rural community based pediatric outpatient practice, and from a large urban academic pediatric ambulatory service, which will produce substantial racial and socioeconomic diversity and will involve the two most common EMR systems in the U.S (Epic and Cerner). A minimum of 2,500 pediatric outpatients age 6 and under will be identified across the two sites for study inclusion, with at least 40% expected to have had some type of prenatal substance exposure (tobacco, alcohol, prescription drugs of abuse, and/or illicit drugs). The four EMR types examined for each participant will be the linked pediatric outpatient record, newborn inpatient record, maternal inpatient delivery record, and maternal outpatient prenatal care record. In addition to background, comorbidity, and outcomes information, any information about prenatal substance exposure will be abstracted to include: ICD-10 diagnosis and procedure codes, urine drug screens, cord blood/tissue/meconium analysis, additional biochemical testing, self- report/screening questions for drug use/exposure, lists of prescribed medications, newborn withdrawal assessment/treatment, and additional information from notes fields. Specific Aims will be evaluated with descriptive and bivariate statistics, sensitivity/specificity analyses, and predictive modeling, with the end product the development of enduring study methodology materials including exposure variable coding algorithms. If we are able to identify ways EMR data could be reliably used to not only identify pediatric patients with prenatal substance exposure, but also to develop valid exposure variables to use for research purposes, participants in studies examining the links between prenatal exposures and later outcomes could be recruited at the point of outcome assessment. This would significantly shorten the time needed to do valid studies in this field by leveraging existing data via validated methods. Study findings will also provide valuable methodological insights to inform the ultimate gold-standard prospective longitudinal studies examining the impacts of prenatal substance exposure.

具体目标 这项研究的总体目标是检查产前检查的可用性、准确性和实用性。 现有电子病历（EMR）中的物质暴露数据。 关于怀孕期间药物使用对儿童结局影响的研究依赖于大的前瞻性， 纵向研究，以提供关于暴露和结果的准确数据。这导致了知识 严重滞后，特别是阿片类药物流行迅速演变和最近的合法化问题， 商用大麻基于人口的数据集产生了流行率和更普遍的 信息，但不包含足够细粒度以可靠地回答特定 研究问题。个体患者的EMR包含大量的临床信息， 然而，就研究目的而言，这种与产前接触有关的可能性基本上没有得到研究。我们的工作， 其他人的工作，已经证明了使用EMR数据来回答有关 产前物质暴露对儿童结局的影响，同时也强调了限制和 未知数EMR提供了将儿科门诊记录与多达三种其他类型的 EMR（新生儿住院记录、产妇住院分娩记录和产妇门诊产前护理 记录），扩大了许多患者暴露的可用信息。 我们的研究将涉及以下具体目标： 1.为了准确地确定四种EMR类型中每种类型的暴露数据， 频率，以及暴露数据源之间的一致性。 2.从不同的数据源构建复合暴露变量，并检查 其中每一个：a）与脐带测试结果相关，和B）与儿童结果相关。 3.确定预测暴露数据可用性、准确性和实用性的因素。 4.开发持久的研究方法材料，包括暴露变量编码 算法 该研究将利用来自大型但相当农村的社区儿科门诊实践的EMR， 和一个大型的城市学术儿科门诊服务，这将产生大量的种族和 这将涉及美国两个最常见的EMR系统（Epic和Cerner）。一 两个研究中心将确定至少2，500名6岁及以下的儿科门诊患者进行研究 包括，至少有40%的人预计有某种类型的产前物质暴露（烟草，酒精， 滥用处方药和/或非法药物）。为每个参与者检查的四种EMR类型将是 链接儿科门诊记录、新生儿住院记录、产妇住院分娩记录和产妇 门诊产前护理记录。除了背景、合并症和结局信息外， 关于产前物质暴露信息将被抽象为包括：ICD-10诊断和程序 代码、尿液药物筛查、脐带血/组织/胎粪分析、附加生化检测、自我检测 药物使用/暴露的报告/筛选问题、处方药列表、新生儿戒断 评估/治疗以及注释字段中的其他信息。具体目标将通过以下方式进行评估： 描述性和双变量统计、敏感性/特异性分析和预测建模， 开发持久的研究方法材料，包括暴露变量编码 算法 如果我们能够确定EMR数据不仅可以可靠地用于识别儿科患者， 产前物质暴露，而且还开发有效的暴露变量用于研究目的， 可以招募参与研究产前暴露与后期结果之间联系的人员， 在结果评估方面。这将大大缩短在这方面进行有效研究所需的时间。 通过有效的方法利用现有的数据。研究结果还将提供有价值的方法 为最终的黄金标准前瞻性纵向研究提供信息的见解， 物质暴露。