TY  - JOUR
PY  - 2016//
TI  - Development of a pediatric adverse events terminology
JO  - Pediatrics
A1  - Gipson, Debbie S.
A1  - Kirkendall, Eric S.
A1  - Gumbs-Petty, Brenda
A1  - Quinn, Theresa
A1  - Steen, A.
A1  - Hicks, Amanda
A1  - McMahon, Ann
A1  - Nicholas, Savian
A1  - Zhao-Wong, Anna
A1  - Taylor-Zapata, Perdita
A1  - Turner, Mark
A1  - Herreshoff, Emily
A1  - Jones, Charlotte
A1  - Davis, Jonathan M.
A1  - Haber, Margaret
A1  - Hirschfeld, Steven
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - 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.<br><br>Copyright © 2017 by the American Academy of Pediatrics.<p />  <p>Language: en</p>
LA  - en
SN  - 0031-4005
UR  - http://dx.doi.org/10.1542/peds.2016-0985
ID  - ref1
ER  -