Investigating polypharmacy-related adverse events in critically ill children using electronic health records and simulated drug levels

使用电子健康记录和模拟药物水平调查危重儿童的多药相关不良事件

基本信息

  • 批准号:
    9755240
  • 负责人:
  • 金额:
    $ 16.08万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2017
  • 资助国家:
    美国
  • 起止时间:
    2017-09-13 至 2021-08-31
  • 项目状态:
    已结题

项目摘要

Polypharmacy is common in critically ill children and causes adverse events, including death. Identifying and understanding how specific drug combinations contribute to adverse events is challenging in critically ill children, requiring knowledge of drug levels and their relationships to adverse events. Although such information could be obtained from clinical trials, the execution of these trials for every drug combination is virtually impossible. Dr. Zimmerman aims to develop and evaluate an approach that combines electronic health records and simulated drug levels to identify and characterize polypharmacy-related adverse events in critically ill children. She hypothesizes that the combined approach will describe a relationship between drug levels and a specific adverse event similar to that identified through a clinical trial. This approach could then be used as a platform for evaluating safety in drug combinations frequently used in children. Dr. Zimmerman will conduct a pilot clinical trial to evaluate relationships between delirium scores and drug levels of fentanyl and dexmedetomidine in mechanically-ventilated children. She will then identify a single-center cohort from Duke electronic health records and apply PK models to predict drug levels in this population. Using advanced pharmacoepidemiologic methods, she will create statistical models to describe relationships between simulated drug levels and delirium scores. She will compare results to those obtained in the clinical trial. Finally, she will evaluate the broader applicability of the combined approach in a multicenter electronic health record cohort. Dr. Zimmerman is a pediatric intensivist with a proven commitment to patient-oriented research and a desire to acquire sophisticated skills in pharmacoepidemiologic methods. The skills achieved as a result of this proposal will facilitate the candidate's long-term career goal to advance public health by developing new methods to leverage information from large databases to increase the safety of drugs administered to critically ill children. The candidate's short-term career goals for the K23 program are to: 1) acquire knowledge and skills in optimal clinical trial design and pharmacoepidemiology; 2) develop the professional skills to successfully lead a clinical trial research team; and 3) produce preliminary data and publications to support an R01 grant application and establish a program of independent research in pediatric pharmacoepidemiology. This proposal will capitalize on unique opportunities provided by the Duke Clinical Research Institute (Smith, mentor) and the UNC epidemiology PhD program (Stürmer, PhD advisor). The mentorship team assembled is uniquely qualified, and strengths include extensive clinical research experience, internationally recognized thought leadership in trial design, clinical pharmacology, and pharmacoepidemiology; and a successful history of mentorship of junior faculty. At the conclusion of this program, Dr. Zimmerman will be well positioned to be an independent physician-scientist leading a research team.
多重用药在重症儿童中很常见,并导致不良事件,包括死亡。识别和 了解特定的药物组合如何导致不良事件在危重病患者中具有挑战性, 需要了解药物水平及其与不良事件的关系。虽然这样 信息可以从临床试验中获得,这些试验对每种药物组合的执行是 几乎不可能齐默尔曼博士的目标是开发和评估一种方法,结合电子健康 记录和模拟药物水平,以识别和表征危重患者中的多药相关不良事件 生病的孩子她假设,这种结合的方法将描述药物水平和药物浓度之间的关系。 与通过临床试验确定的不良事件相似的特定不良事件。这种方法可以作为一种 用于评估儿童常用药物组合的安全性的平台。齐默尔曼博士将进行 初步临床试验,以评估谵妄评分和芬太尼药物水平之间的关系, 右美托咪定用于机械通气儿童。然后,她将确定来自杜克的单中心队列 电子健康记录并应用PK模型来预测该人群的药物水平。使用一种高级 药物流行病学方法,她将创建统计模型来描述之间的关系 模拟药物水平和谵妄评分。她将把结果与临床试验中获得的结果进行比较。 最后,她将评估在多中心电子健康的组合方法的更广泛的适用性, 记录队列。齐默尔曼博士是一名儿科重症监护医师,致力于以患者为导向的研究 并渴望获得药物流行病学方法的复杂技能。因此获得的技能 这一建议将有助于候选人的长期职业目标,以促进公共卫生,通过开发新的 利用来自大型数据库的信息以提高给予危重患者的药物的安全性的方法 生病的孩子K23计划的候选人的短期职业目标是:1)获得知识, 最佳临床试验设计和药物流行病学方面的技能; 2)培养专业技能, 成功领导临床试验研究团队; 3)提供初步数据和出版物,以支持 R 01基金申请并建立儿科药物流行病学独立研究项目。 该提案将利用杜克临床研究所(Smith, 导师)和流行病学博士项目(Stürmer,博士顾问)。组建的导师团队是 独特的资格和优势包括广泛的临床研究经验,国际公认的 在试验设计、临床药理学和药物流行病学方面的思想领导力;以及成功的历史 对初级教员的指导。在这个项目结束时,齐默尔曼博士将处于有利地位, 一个独立的医生兼科学家领导一个研究小组。

项目成果

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Kanecia Obie Zimmerman其他文献

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