title: OAE: The Ontology of Adverse Events.
abstract: BACKGROUND
  A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health.
  
  
  METHODS
  The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term 'adverse event' denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA.
  
  
  CONCLUSIONS
  OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of adverse events and of the factors (e.g., vaccinee age) important for determining their clinical outcomes.
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Yongqun
authors.initials: Y
authors.lastname: He
authors.affiliation: University of Michigan, Ann Arbor, MI, USA ; US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Sirarat
authors.initials: S
authors.lastname: Sarntivijai
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Yu
authors.initials: Y
authors.lastname: Lin
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Zuoshuang
authors.initials: Z
authors.lastname: Xiang
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Abra
authors.initials: A
authors.lastname: Guo
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Shelley
authors.initials: S
authors.lastname: Zhang
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Desikan
authors.initials: D
authors.lastname: Jagannathan
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: Luca
authors.initials: L
authors.lastname: Toldo
authors.affiliation: University at Texas Health Science Center at Houston, Houston, TX, USA.
authors.forename: Cui
authors.initials: C
authors.lastname: Tao
authors.affiliation: University at Buffalo, Buffalo, NY, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Smith
keywords: Adverse event; Design pattern; Drug; Drug adverse event; OAE; Ontology; Ontology of Adverse Events; VAERS; Vaccine; Vaccine adverse event
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