Reporting Adverse Events: Basis for a Common Representation

Reports of adverse events aim to monitor the status of patients in clinical trials or to provide ongoing monitoring of the safety of interventions once they are in the market. They help identify issues with treatment safety and efficacy, and allow for better education of health practitioners and the general public, ultimately allowing us to learn from our mistakes. However if such reports are to be maximally useful, the information they contain must be unambiguously shared, standardized, and accurately documented. Towards this end, we briefly review existing reporting standards and then define adverse event in a manner consistent with the use of the term in existing reporting guidelines. Novel aspects of this work include attention to the distinction between the classification of adverse events based on reporting versus the pathological process types they attempt to monitor, and integration with relevant OBO ontologies to minimize redundant definitional work as well as enable integration of adverse event reporting into the broader landscape of representation for translational medicine. Implementation of a prototype that incorporates this approach is discussed the Adverse Events Reporting Ontology (AERO).