Enhancing Medication Safety in Children with Polypharmacy Using Parent-Reported Symptom Assessments

使用家长报告的症状评估提高多药治疗儿童的用药安全

• 批准号: 9293759
• 负责人: James A Feinstein
• 金额: $ 16.51万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293759
• 关键词: Adult; Adverse Drug Experience Report; Adverse drug event; Adverse effects; Antiepileptic Agents; Area; Biometry; Caring; Cerebral Palsy; Characteristics; Child; Child health care; Childhood; Clinic; Clinical; Colorado; Conduct Clinical Trials; Consequentialism; Data; Data Analyses; Detection; Disease; Emergency Situation; Emergency department visit; Ensure; Environment; Equipment and supply inventories; Evaluation; Event; Evolution; Exhibits; Exposure to; Functional disorder; Goals; Growth; Health; Health Services Research; Healthcare; Home environment; Hospitalization; Impairment; K-Series Research Career Programs; Knowledge; Laboratories; Lead; Life; Marketing; Measurable; Medicaid; Medical; Medical Records; Mentors; Monitor; Neurologic; Noise; Outcomes Research; Outpatients; Parents; Patient Self-Report; Patients; Pattern; Pediatric Hospitals; Pediatrics; Persons; Pharmaceutical Cares; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacologic Substance; Pharmacy Schools; Physicians; Polypharmacy; Population; Positioning Attribute; Prevalence; Prospective cohort study; Public Health; Reporting; Reproducibility; Research; Research Project Grants; Research Support; Retrospective cohort study; Risk; Safety; Savings; Science; Scientist; Signal Transduction; Specialist; Symptoms; System; Training; Universities; Visit; associated symptom; career; complex chronic conditions; design; dosage; experience; health care service utilization; high risk; high risk population; improved; innovation; novel therapeutics; patient oriented; patient safety; professor; prospective; safety practice; skills; success; surveillance study

PROJECT SUMMARY/ABSTRACT An increasing number of children with medical complexity are exposed to polypharmacy in the ambulatory setting and take multiple high-risk medications daily. Polypharmacy can lead to serious adverse drug events (ADEs). The most vulnerable children with medical complexity exhibit a multitude of symptoms and have impairments that make the self-report of ADEs unfeasible, severely limiting the conduct of clinical trials and post-marketing drug surveillance studies to detect ADEs. Dr. James Feinstein’s overarching hypothesis is that repeated parent-reported symptom assessments (PRSA) before and after medication changes will provide clinically pertinent information, improve ADE signal detection, and enhance medication safety. This patient- oriented mentored career development award is designed to support the transition of James Feinstein, MD, MPH, an Assistant Professor of Pediatrics at the University of Colorado, into an independent clinician-scientist and to achieve his long-term career goal of becoming a national leader in pediatric polypharmacy and medication safety research. His short-term career goals are to (1) study factors involved in the escalation of polypharmacy and (2) implement a prospective PRSA system to guide and monitor pharmaceutical care for high-risk children. Dr. Feinstein will complete additional didactic and experiential training in 3 key areas necessary for his success: (1) pharmacoepidemiology and pharmacovigilance; (2) quantitative longitudinal data analysis; and (3) the design and conduct of prospective cohort studies. The University of Colorado Anschutz Medical Campus provides a unique research environment to conduct pediatric polypharmacy research, supported by collaborative research partnerships between the Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), The Skaggs School of Pharmacy and Pharmaceutical Sciences, and the Children’s Hospital Colorado Special Care Clinic for children with medical complexity. Dr. Feinstein’s renowned team of research mentors, Dr. Allison Kempe (health services research), Dr. Robert Valuck (pharmacoepidemiology), Dr. Chris Feudtner (children with complex chronic conditions), and Dr. Diane Fairclough (biostatistics), will guide completion of the proposed training and research plan. To achieve his short-term career goals, Dr. Feinstein proposes three research projects that will contribute to the implementation of a PRSA system to evaluate children with polypharmacy for medication- related issues. The specific aims are to conduct: (1) a retrospective cohort study to quantify annual polypharmacy and factors associated with escalation of polypharmacy; (2) a cross-sectional evaluation of symptoms in children with polypharmacy using PRSAs to advance our understanding of signal-to-noise and signal detection challenges; and (3) a prospective cohort study to assess whether using PRSAs prior to and after medication changes detects known ADEs. This innovative proposal could provide evidence to support the use of PRSA more broadly for the evaluation of other therapies in vulnerable children with medical complexity.

项目总结/摘要 越来越多的儿童与医疗复杂性暴露于多种药物在门诊 并每天服用多种高危药物。多药治疗可导致严重的药物不良事件 （ADE）。最脆弱的儿童与医疗复杂性表现出多种症状， 使ADE自我报告不可行的损伤，严重限制了临床试验的开展， 用于检测ADE的上市后药物监测研究。詹姆斯·范斯坦博士的首要假设是 在药物变化前后重复的家长报告的症状评估（PRSA）将提供 临床相关信息，改善ADE信号检测，提高用药安全性。这个病人- 定向指导职业发展奖旨在支持詹姆斯范斯坦，医学博士， 从科罗拉多大学儿科学助理教授转变为独立的临床科学家 并实现他的长期职业目标，成为全国领先的儿科综合用药， 药物安全性研究。他的短期职业目标是（1）研究参与升级的因素， 多药治疗和（2）实施前瞻性PRSA系统来指导和监测药物护理 高危儿童。Feinstein博士将在3个关键领域完成额外的教学和体验培训 他的成功所必需的：（1）药物流行病学和药物警戒;（2）定量纵向 数据分析;（3）前瞻性队列研究的设计和实施。科罗拉多大学 安舒茨医学院提供了一个独特的研究环境，进行儿科多药 研究，由成人和儿童联盟之间的合作研究伙伴关系支持， 健康结果研究和交付科学（ACCORDS），药学院斯卡格斯和 科罗拉多儿童医院特殊护理诊所， 复杂性费恩斯坦博士著名的研究导师团队，艾利森肯普博士（卫生服务 Robert Valuck博士（药物流行病学）、Chris Feudtner博士（复杂慢性 条件）和Diane Fairclough博士（生物统计学）将指导完成拟议的培训， 研究计划。为了实现他的短期职业目标，范斯坦博士提出了三个研究项目， 促进实施PRSA系统，以评估患有多种药物治疗的儿童- 相关问题。具体目的是：（1）进行回顾性队列研究， 多药治疗和与多药治疗升级相关的因素;（2）多药治疗的横断面评价 使用PRSA的儿童多药治疗的症状，以促进我们对信噪比的理解， 信号检测挑战;和（3）前瞻性队列研究，以评估是否使用PRSA之前和 在药物变化后检测到已知的ADE。这一创新建议可以提供证据支持 更广泛地使用PRSA来评估具有医学复杂性的弱势儿童的其他疗法。