Improving Adverse Event Reporting on Cooperative Oncology Group Trials

项目摘要/摘要 背景：临床试验的副作用报告描述了化疗的预期毒性。 然而，这些副作用，也被称为不良事件，在全球试验中被低估了，这意味着 临床医生对不良事件发生率没有准确的认识。在目前的系统中，不良事件是 通过耗时的手动病历审查来确定。这项研究旨在证明一种自动化的 使用电子病历(EMR)数据的不良事件识别系统比 目前的不良事件报告系统。此应用程序的具体目的是1)比较以下各项的准确性 这种使用当前系统捕获的临床试验不良事件数据的新方法，以及2)展示了 通过定义发生率和风险，电子不良事件捕获在回答临床问题中的作用 急性肾损伤的相关因素分析。 方法：本研究采用1900例儿童急性白血病患者的资料。 费城(CHOP)或亚特兰大儿童保健(CHOA)从2010年到2019年。算法有 已开发用于通过提取CHOP和Choa的EMR数据来识别不良事件。使用图表 提取数据作为金标准，基于电子病历的确定和试验不良事件的准确性 将确定报告，并比较每种方法的相对准确性。肌酸酐数据具有 从电子病历中提取，处理和分级将与肾毒性药物数据相结合， 确定每种白血病类型急性肾损伤发生率的人口统计学数据和治疗数据 以及化疗方案。本课程将探讨急性肾损伤的危险因素。 职业目标和环境：在K07补充奖的支持下，申请者Tamara P. 米勒，医学博士，MSCE，将确定使用EMR数据与传统手动操作相比的相对准确性 报告不良事件的识别。从这项工作中，申请人将学习如何使用电子病历数据 临床研究，获得实施科学和临床试验设计方面的知识，并改进HER 儿科肿瘤学知识和科学写作技能。为了完成这些培训目标，米勒博士有 组建了一个由她的主要导师Timothy领导的经验丰富、相互补充和培养的指导团队 鞭毛、dsc、mph。她已经完成了信息学的正式课程，她的培训计划包括教程， 国家会议、研究进展和写作小组。她将受益于卓越的深度 乔亚和埃默里大学的资源和机会。她的长期目标是将这部小说 她创建的不良事件确定系统用于儿科肿瘤学试验并使用准确的 她开发的数据集用于回答临床上重要的问题。有了这个奖项，米勒博士将很好地- 准备过渡到她的独立临床研究生涯目标，专注于改善不良反应 儿科肿瘤学中的事件报道和支持性护理实践。

PROJECT SUMMARY/ABSTRACT Background: The reports of side effects on clinical trials describe expected toxicities of chemotherapy. However, these side effects, also called adverse events, are globally under-reported on trials, which means that clinicians do not have an accurate sense of adverse event rates. In the current system, adverse events are identified through time-consuming, manual medical record review. This study aims to prove that an automated system of adverse event identification using electronic medical record (EMR) data is more accurate than the current adverse event reporting system. The specific aims of this application are to 1) compare the accuracy of this new method to clinical trial adverse event data captured using the current system, and 2) demonstrate the utility of electronic adverse event capture in answering clinical questions by defining the incidence and risk factors of acute kidney injury. Methods: This study uses data from 1900 children with acute leukemia treated at the Children’s Hospital of Philadelphia (CHOP) or Children’s Healthcare of Atlanta (CHOA) from 2010 through 2019. Algorithms have been developed to identify adverse events by extracting EMR data at CHOP and CHOA. Using chart abstraction data as the gold standard, the accuracy of EMR-based ascertainment and of trial adverse event reports will determined, and the relative accuracy of each method will be compared. Creatinine data that have been extracted from the EMR, processed and graded will be combined with nephrotoxic medication data, demographic data, and treatment data to determine the incidence of acute kidney injury for each leukemia type and by chemotherapy regimen. Risk factors for acute kidney injury will be explored. Career Goals and Environment: With the support of this K07 supplemental award, the applicant, Tamara P. Miller, MD, MSCE, will determine the relative accuracy of use of EMR data compared to traditional manual reporting for identification of adverse events. From this work the applicant will learn use how to use EMR data for clinical research, gain knowledge about implementation science and clinical trial design, and improve her knowledge of pediatric oncology and skills in scientific writing. To complete these training goals, Dr. Miller has assembled an experienced, complementary, and nurturing mentoring team led by her primary mentor, Timothy Lash, DSc, MPH. She has completed formal coursework in informatics and her training plan includes tutorials, national conferences, and research progress and writing groups. She will benefit from the outstanding depth of resources and opportunities at CHOA and Emory University. Her long-term goal is to integrate the novel system of adverse event ascertainment she creates into pediatric oncology trials and to use the accurate datasets she develops to answer clinically important questions. With this award, Dr. Miller will be well- positioned to transition to her goal of an independent clinical research career focused on improving adverse event reporting and supportive care practices in pediatric oncology.