Development of a Pediatric Adverse Events Terminology

Area of Science:

• Pediatric Health and Safety
• Biomedical Informatics
• Clinical Research Terminology

Background:

• Established in 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Terminology Harmonization Initiative aimed to standardize pediatric research data.
• A coalition formed the Pediatric Terminology Adverse Event Working Group in 2013 to create standardized terminology for international pediatric adverse event (AE) reporting.

Purpose of the Study:

• To develop a comprehensive and standardized terminology for pediatric adverse events (AEs).
• To facilitate the acquisition and sharing of knowledge across pediatric clinical research, practice, and safety reporting.

Main Methods:

• A multinational group of pediatric specialists and biomedical terminology experts collaborated.
• Developed a working definition of AEs and reviewed concepts from 16 pediatric clinical domains.
• Tested the AE terminology in hospital readmissions and neonatal intensive care unit (NICU) settings.

Main Results:

• The resulting AE terminology includes over 1000 pediatric diseases, disorders, and clinical findings.
• Demonstrated proof-of-concept utility in hospital readmissions and NICU settings.
• The terminology is integrated with established biomedical terminologies and available via the National Cancer Institute's Enterprise Vocabulary Services.

Conclusions:

• The developed AE terminology offers a standardized, temporally focused resource for pediatric health and disease.
• Its compatibility with existing terminologies and availability for unrestricted use promote adoption in diverse settings.
• The terminology is designed for ongoing refinement through user feedback and continued use.