Improving Adverse Event Reporting on Cooperative Oncology Group Trials

改进肿瘤学合作组试验的不良事件报告

• 批准号: 9452250
• 负责人: Tamara Porter Miller
• 金额: $ 16.9万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-21 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9452250
• 关键词: Acute Lymphocytic Leukemia; Acute Myelocytic Leukemia; Acute Renal Failure with Renal Papillary Necrosis; Acute leukemia; Adverse effects; Adverse event; Age; Algorithms; Award; Chemotherapy-Oncologic Procedure; Child; Childhood Acute Myeloid Leukemia; Childhood Leukemia; Clinical; Clinical Data; Clinical Informatics; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Design; Common Terminology Criteria for Adverse Events; Complex; Computerized Medical Record; Creatinine; Data; Data Set; Doctor of Philosophy; Enrollment; Environment; Ethnic Origin; Family; Foundations; Gender; Goals; Gold; Hospitals; Incidence; Informatics; Knowledge; Laboratories; Learning; Malignant Childhood Neoplasm; Manuals; Medical Records; Mentors; Methods; National Cancer Institute; Natural Language Processing; Nephrotoxic; Oncology Group; Patients; Pediatric Hospitals; Pediatric Oncology; Pediatric Oncology Group; Pennsylvania; Pharmaceutical Preparations; Philadelphia; Positioning Attribute; Predictive Value; Process; Publishing; Race; Reporting; Research; Resources; Risk; Risk Factors; Safety; Sensitivity and Specificity; Supportive care; System; Testing; Texas; Text; Time; Toxicity due to chemotherapy; Training; Universities; Work; Writing; base; cancer therapy; career; chemotherapy; clinical decision-making; clinical epidemiology; cohort; epidemiology study; experience; implementation science; improved; leukemia; nephrotoxicity; novel; prospective; secondary analysis; skills; statistics; symposium

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.

项目总结/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，也称为不良事件，在全球试验中报告不足，这意味着 临床医生对不良事件发生率没有准确的认识。在当前系统中，不良事件 通过耗时的手动病历审查确定。本研究旨在开发一种系统， 使用电子病历数据捕获儿科癌症化疗的复杂不良事件 并证明该方法比现行不良事件报告系统更准确。具体 本申请的目的是：1）开发算法，以使用电子技术识别10种复杂的不良事件。 两个大型儿童医院治疗急性白血病儿童的病历数据，2）比较 该新方法的准确性，目前的系统，和3）证明电子逆向工程的实用性， 通过定义急性肾损伤的发生率和风险因素，在回答临床问题时捕获事件。 方法：本研究将使用来自1900名在北京儿童医院接受治疗的急性白血病儿童的数据。 费城（CHOP）或德克萨斯州儿童医院（TCH）从2002年到2017年。算法将 通过提取CHOP的电子病历数据识别不良事件。一旦完成， 算法将在TCH进行测试。以海图提取数据为金标准， 将确定试验不良事件报告的确定性，每种方法的相对准确性将 被比较。最后，算法将从电子医疗记录中提取肌酸酐结果，并且 急性肾损伤的发生率将根据每种白血病类型和化疗方案来确定。风险 将探讨急性肾损伤的因素。 职业目标和环境：在K 07奖的支持下，申请人Tamara P.米勒，医学博士， MSCE，将学习如何使用电子病历数据进行临床研究，获得正式的临床培训 信息学和实施科学，发展临床试验设计方面的专业知识，并提高她对 儿科肿瘤学和科学写作技能。为了完成这些培训目标，米勒博士已经组建了一个 由她的主要导师Richard Aplenc（医学博士）领导的经验丰富、互补和培养型指导团队， PhD.她的培训计划包括信息学的正式课程、辅导、国家会议和研究 进步和写作小组。她将受益于我们的资源和机会， CHOP和宾夕法尼亚大学。她的长期目标是整合新的不良事件系统， 她创建了儿科肿瘤学试验，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，过渡到她的目标 一个独立的临床研究职业生涯的重点是改善不良事件报告和支持性治疗 儿科肿瘤学的实践。