Improving Adverse Event Reporting on Cooperative Oncology Group Trials

点击翻译按钮获取中文摘要

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 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.