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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/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（也称为不良事件）在全球范围内的试验中报告不足，这意味着临床医生对不良事件发生率没有准确的认识。在目前的系统中，不良事件是通过耗时的人工病历审查来识别。本研究旨在开发一个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的不良事件报告系统更准确。具体的该应用程序的目标是 1) 开发算法以使用电子设备识别 10 种复杂的不良事件两家大型儿童医院接受急性白血病治疗的儿童的病历数据，2) 比较这种新方法相对于当前系统的准确性，以及 3) 证明电子逆向的实用性通过定义急性肾损伤的发生率和危险因素来捕获事件来回答临床问题。方法：本研究将使用来自儿童医院治疗的 1900 名急性白血病儿童的数据。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。一旦最终确定，算法将在 TCH 进行测试。以图表抽象数据为金标准，电子化的准确性将确定试验不良事件报告的确定和确定，并且每种方法的相对准确性将进行比较。最后，算法将从电子病历和数据中提取肌酐结果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：在本次 K07 奖项的支持下，申请人 Tamara P. Miller 医学博士， MSCE，将学习如何使用电子病历数据进行临床研究，获得正规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，并提高她的知识儿科肿瘤学和科学写作技能。为了完成这些培训目标，米勒博士组装了一个由她的主要导师 Richard Aplenc 医学博士领导的经验丰富、互补和培育的指导团队，博士。她的培训计划包括信息学、教程、全国会议和研究方面的正式课程进步和写作小组。她将受益于该公司丰富的资源和机会 CHOP 和宾夕法尼亚大学。她的长期目标是整合不良事件的新颖系统她在儿科肿瘤学试验中创建了确定性，并使用她开发的准确数据集回答临床重要问题。凭借这一奖项，米勒博士将能够顺利实现她的目标专注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。