OAE: The Ontology of Adverse Events

Abstract

BackgroundA 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.DescriptionThe 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.ConclusionOAE 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.

Linking MedDRA®-Coded Clinical Phenotypes to Biological Mechanisms by the Ontology of Adverse Events: A Pilot Study on Tyrosine Kinase Inhibitors

“…The ontology is built and expanded on a case-by-case basis. The expansion of OAE with TKI/mAb-associated AEs is a result of this process (9, 10, 17). With the focus on TKI/mAb-associated AEs, we have successfully added 844 new AEs terms to OAE, most of which are cardiovascular disorders AEs or related terms.…”

“…We recruited the help of clinicians with expertise in cardiotoxicity to determine the proper classification of terms before they were inserted into the ontology structure. A complete description of the methods have been detailed in the previously published work by He et al (10). …”

“…The Ontology of Adverse Events (OAE), previously known as Adverse Event Ontology – AEO (8, 9), is a community-based open source ontology that supports the representation and analysis of clinical adverse event phenotypes (10). In the OAE, an adverse event is considered a pathological bodily process (a class defined as an occurrent in the Basic Formal Ontology (BFO) (11)) and is described as an unpleasant or unexpected clinical phenotype that occurs after a medical treatment.…”

“…Therefore, OAE semantically captures the relationships of AEs to the medical intervention leading to the occurrence of AEs, and provides a possible framework to link clinically reported drug AEs to the underlying mechanisms (10). The expansion and further development of OAE described here allows it to be used to explore mechanisms for drug-associated AEs as defined by MedDRA ® terms.…”

MedDRA® automated term groupings using OntoADR: evaluation with upper gastrointestinal bleedings

“…Other ontologies have been described for adverse events: OAE (Ontology of adverse events) [29] and AERO (Adverse event reporting ontology) [30], that may be useful in the field of pharmacovigilance. AERO proposes an alternative approach to the identification of case reports describing anaphylaxis using the Automatic Brighton Classification (ABC) tool [31]; its scope is therefore limited and MedDRA terms are not formally described according to relations we propose such as finding site, abnormal morphology.…”