ICHP Researcher Helps NICHD Develop Terminology for Pediatric Adverse Events
A researcher with the University of Florida’s Institute for Child Health Policy (ICHP) is working to ensure that child health policymakers, researchers, clinicians and other stakeholders all speak the same language when describing and classifying pediatric adverse events, such as a drug overdose.
Amanda Hicks, Ph.D., recently served on an international team of child health researchers convened by the National Institute of Child Health and Human Development (NICHD) to develop a terminology for adverse events in pediatric research and clinical care. The group’s groundbreaking work, published in the January 2017 issue of Pediatrics, provides scientists and clinicians with an important tool to improve pediatric patient safety and quality of care.
Hicks, an assistant professor of biomedical informatics in the Department of Health Outcomes & Policy (HOP) and ICHP, said the coalition, called the Pediatric Adverse Event Terminology Working Group (PAETWG), formed in 2013 to develop a common, readily accessible, dynamic working vocabulary for describing and cataloging adverse events that occur for any reason in children from birth through early adulthood. The terminology, available through the NICHD, the National Cancer Institute’s Enterprise Vocabulary Services (EVS), and the Medical Dictionary for Regulatory Activities (MedDRA), was designed to be integrated with other resources and accessible to all.
Children are particularly vulnerable to experiencing harm associated with adverse events, such as a drug overdose, because the stages of a child’s physical development can influence disease progression and vice versa, according to Hicks.
“Adjusting drug dosages to a child’s weight or selecting devices based on a child’s size can actually precipitate an adverse event,” said Hicks, whose research focuses on developing and evaluating the resources that computers use to understand the relationships among words, concepts and categories. These models, called “semantic networks,” can support machine reasoning with language, data and text. The NICHD coalition defines an adverse event as “an untoward medical occurrence or an unfavorable and unintended sign, symptom or illness that occurs in the context of exposure to a product either as part of an investigation of a product or during use of a marketed product.”
Hicks said the NICHD convened the coalition to address a lack of consistency in the terminology used to describe pediatric adverse events.
“Although a number of organizations have developed systems for classifying and describing adverse events, it is crucial to have an internationally accessible resource devoted to pediatrics,” she said. Because there was no official terminology to describe adverse events in children, it is possible that many events often went undetected by researchers, clinicians and policymakers working to document, understand and prevent them. Moreover, a common terminology facilitates integrating pediatric adverse event data that are collected in different studies at different study sites.
To help with the undertaking, the group recruited 62 subject matter experts from Australia, Canada, Italy, the United Kingdom and the United States with backgrounds in clinical care, research, safety reporting, regulatory activities, epidemiology, or informatics. The coalition then spent 18 months reviewing, developing, classifying and testing some 1,223 terms and definitions covering a broad range of health conditions. The team developed highly specific definitions that were flexible enough to be used internationally and in both high- and low-resource environments.