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。这项研究的目的是开发一种 使用电子病历数据捕获儿童癌症化疗的复杂不良事件 并证明该方法比目前的不良事件报告系统更准确。具体的 此应用程序的目标是1)开发算法来识别10个复杂的不良事件，使用电子 两家大型儿童医院治疗急性白血病儿童的病历数据，2)比较 这种新方法与现有系统相比具有更高的精确度，并且3)证明了电子反求的实用性 通过定义急性肾损伤的发生率和危险因素来回答临床问题的事件捕捉。 方法：这项研究将使用1900名儿童急性白血病患者的数据。 费城(CHOP)或德克萨斯儿童医院(TCH)从2002年到2017年。算法将是 开发用于通过在CHOP提取电子病历数据来识别不良事件。一旦敲定， 算法将在TCH接受测试。以海图摘要数据为金标准，电子地图的精确度 将确定和确定试验不良事件报告，并且每种方法的相对准确性将 被比较。最后，算法将从电子病历和 急性肾损伤的发生率将根据每种白血病类型和化疗方案进行确定。风险 本课程将探讨急性肾损伤的因素。 职业目标和环境：在K07奖项的支持下，申请者塔玛拉·P·米勒医学博士 将学习如何将电子病历数据用于临床研究，获得临床正规培训 信息学和实施科学，在临床试验设计方面发展专业知识，并提高她的知识 儿科肿瘤学和科学写作技巧。为了完成这些培训目标，米勒博士组建了一个 由她的主要导师Richard Aplenc医学博士领导的经验丰富、互补和培养的指导团队， 博士学位。她的培训计划包括信息学、教程、全国性会议和研究方面的正式课程 进步和写作小组。她将从以下卓越的资源和机会中受益 查普和宾夕法尼亚大学。她的长期目标是整合不良事件的新系统 确定她创建的儿科肿瘤学试验并使用她开发的准确数据集 回答临床上重要的问题。有了这个奖项，米勒博士将处于有利地位，向她的目标过渡 致力于改善不良事件报告和支持性护理的独立临床研究生涯 儿科肿瘤学实践。

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 develop a system that uses electronic medical record data to capture complex adverse events of chemotherapy for pediatric cancer and to prove that this method is more accurate than the current adverse event reporting system. The specific aims of this application are to 1) develop algorithms to identify 10 complex adverse events using electronic medical record data from children treated for acute leukemia at two large children's hospitals, 2) compare the accuracy of this new method to that of the current system, and 3) 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 will use data from 1900 children with acute leukemia treated at the Children's Hospital of Philadelphia (CHOP) or the Texas Children's Hospital (TCH) from 2002 through 2017. Algorithms will be developed to identify adverse events by extracting electronic medical record data at CHOP. Once finalized, the algorithms will be tested at TCH. Using chart abstraction data as the gold standard, the accuracy of electronic ascertainment and of trial adverse event reports will determined, and the relative accuracy of each method will be compared. Lastly, algorithms will extract creatinine results from the electronic medical record and the incidence of acute kidney injury will be determined 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 award, the applicant, Tamara P. Miller, MD, MSCE, will learn how to use electronic medical record data for clinical research, obtain formal training in clinical informatics and implementation science, develop expertise in 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, Richard Aplenc, MD, PhD. Her training plan includes formal coursework in informatics, tutorials, national conferences, and research progress and writing groups. She will benefit from the outstanding depth of resources and opportunities at CHOP and the University of Pennsylvania. 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.