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.
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January 2017
Special Article|
January 01 2017
Development of a Pediatric Adverse Events Terminology
Debbie S. Gipson, MD;
Debbie S. Gipson, MD
aDepartment of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, Michigan;
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Eric S. Kirkendall, MD;
Eric S. Kirkendall, MD
bCincinnati Children’s Hospital Medical Center, Cincinnati, Ohio;
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Brenda Gumbs-Petty, MD;
Brenda Gumbs-Petty, MD
cEnterprise Vocabulary Services, National Cancer Institute, and
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Theresa Quinn, BS;
cEnterprise Vocabulary Services, National Cancer Institute, and
Address correspondence to Theresa Quinn, BS, RN, Enterprise Vocabulary Services, 11300 Rockville Pike, Suite 1100, Rockville, MD 20852. E-mail: quinnt@mail.nih.gov
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A. Steen, MD;
A. Steen, MD
cEnterprise Vocabulary Services, National Cancer Institute, and
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Amanda Hicks, PhD;
Amanda Hicks, PhD
dDivision of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas;
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Ann McMahon, MD;
Ann McMahon, MD
eOffice of Pediatric Therapeutics, US Food and Drug Administration, Bethesda, Maryland;
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Savian Nicholas, MD;
Savian Nicholas, MD
fMaintenance and Support Services Organization, Medical Dictionary for Regulatory Activities, McLean, Virginia;
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Anna Zhao-Wong, MD;
Anna Zhao-Wong, MD
fMaintenance and Support Services Organization, Medical Dictionary for Regulatory Activities, McLean, Virginia;
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Perdita Taylor-Zapata, MD;
Perdita Taylor-Zapata, MD
gNational Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland;
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Mark Turner, MBChB;
Mark Turner, MBChB
hInstitute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom;
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Emily Herreshoff, BA;
Emily Herreshoff, BA
aDepartment of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, Michigan;
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Charlotte Jones, MD;
Charlotte Jones, MD
iNeurology, Nationwide Children’s Hospital, Columbus, Ohio;
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Jonathan M. Davis, MD;
Jonathan M. Davis, MD
jDepartment of Pediatrics, The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts; and
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Margaret Haber, BA;
Margaret Haber, BA
cEnterprise Vocabulary Services, National Cancer Institute, and
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Steven Hirschfeld, MD
Steven Hirschfeld, MD
kUniformed Services University of the Health Sciences, Bethesda, Maryland
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Address correspondence to Theresa Quinn, BS, RN, Enterprise Vocabulary Services, 11300 Rockville Pike, Suite 1100, Rockville, MD 20852. E-mail: quinnt@mail.nih.gov
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
Pediatrics (2017) 139 (1): e20160985.
Article history
Accepted:
October 11 2016
Citation
Debbie S. Gipson, Eric S. Kirkendall, Brenda Gumbs-Petty, Theresa Quinn, A. Steen, Amanda Hicks, Ann McMahon, Savian Nicholas, Anna Zhao-Wong, Perdita Taylor-Zapata, Mark Turner, Emily Herreshoff, Charlotte Jones, Jonathan M. Davis, Margaret Haber, Steven Hirschfeld; Development of a Pediatric Adverse Events Terminology. Pediatrics January 2017; 139 (1): e20160985. 10.1542/peds.2016-0985
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