title: Development of a Pediatric Adverse Events Terminology.
abstract: In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.
authors.affiliation: Department of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, Michigan.
authors.forename: Debbie S
authors.initials: DS
authors.lastname: Gipson
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Kirkendall
authors.affiliation: Enterprise Vocabulary Services, National Cancer Institute, and.
authors.forename: Brenda
authors.initials: B
authors.lastname: Gumbs-Petty
authors.affiliation: Enterprise Vocabulary Services, National Cancer Institute, and quinnt@mail.nih.gov.
authors.forename: Theresa
authors.initials: T
authors.lastname: Quinn
authors.affiliation: Enterprise Vocabulary Services, National Cancer Institute, and.
authors.forename: A
authors.initials: A
authors.lastname: Steen
authors.affiliation: Division of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
authors.forename: Amanda
authors.initials: A
authors.lastname: Hicks
authors.affiliation: Office of Pediatric Therapeutics, US Food and Drug Administration, Bethesda, Maryland.
authors.forename: Ann
authors.initials: A
authors.lastname: McMahon
authors.affiliation: Maintenance and Support Services Organization, Medical Dictionary for Regulatory Activities, McLean, Virginia.
authors.forename: Savian
authors.initials: S
authors.lastname: Nicholas
authors.affiliation: Maintenance and Support Services Organization, Medical Dictionary for Regulatory Activities, McLean, Virginia.
authors.forename: Anna
authors.initials: A
authors.lastname: Zhao-Wong
authors.affiliation: National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
authors.forename: Perdita
authors.initials: P
authors.lastname: Taylor-Zapata
authors.affiliation: Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Turner
authors.affiliation: Department of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, Michigan.
authors.forename: Emily
authors.initials: E
authors.lastname: Herreshoff
authors.affiliation: Neurology, Nationwide Children's Hospital, Columbus, Ohio.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts; and.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Davis
authors.affiliation: Enterprise Vocabulary Services, National Cancer Institute, and.
authors.forename: Margaret
authors.initials: M
authors.lastname: Haber
authors.affiliation: Uniformed Services University of the Health Sciences, Bethesda, Maryland.
authors.forename: Steven
authors.initials: S
authors.lastname: Hirschfeld
mesh_terms: D002648:Child; D006801:Humans; D007231:Infant, Newborn; D015931:Intensive Care, Neonatal; D007391:International Cooperation; D017063:Outcome Assessment, Health Care / Q000458:organization & administration*; D010372:Pediatrics; D009626:Terminology as Topic; D013812:Therapeutics / Q000009:adverse effects*; D018875:Vocabulary, Controlled