TOWARDS AN ADVERSE EVENTREPORTING ONTOLOGYPCIRN ANNUAL GENERAL MEETINGAPRIL 20-21 2011OTTAWA, ON Mélanie Courtot and Ryan Brinkman on behalf of the PCIRN IT support group
Current problem No standard reporting system for adverse events (AE) PCIRN: Medical Dictionary of Regulatory Activities (MedDRA) No definitions No unambiguous meaning of terms Loss of information, low data quality
How to solve it Use of standard definitions for AE reporting Ensuring that adverse events following immunization (AEFIs) are reported in accordance to the selected guideline Specification of signs and symptoms defining each AEFI Computer tractable Implemented in reporting systems
Help confirm reported diagnostic Suggests missing information to reach unambiguous case determination For example, check skin color to distinguish seizure from Hypotonic- Hyporesponsive Episode (HHE)
Enables complex data querying “which of my patients have an AEFI involving part of the nervous system?”
Use of standards definitions Brighton collaboration Adopted by PHAC 300 participants from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations Bonhoeffer et al. Vaccine, 2002. Good applicability, sensitivity, and specificity Kohl et al. Vaccine, 2007. Performs well against other standards Erlewyn-Lajeunesse et al. Drug safety, 2010. Used within PCIRN Gagnon et al., Journal of allergy and clinical immunology, 2010.
Computer tractable Domain is modeled using an ontology. Each entity is defined textually Human readable definition, label Each entity is defined logically Relations to other entities Web Ontology Language (OWL) allows processing by computer
Enables complex data querying Computer can infer link such as “Encephalitis unfolds in the Nervous system”
Implementation in reporting systems Assist in confirming a reported clinical entity (e.g., seizure) at up to three levels of diagnostic certainty Checklist at data entry time Report on missing elements to confirm the event with some degree of certainty Allow interoperability and querying on reports
Perspectives Early stage work Ontological issues to solve Add more AEFIs Collaboration with Brighton Discussion with Dacima to implement into their Electronic Data Capture system (Daciforms)
Acknowledgements PHAC/CIHR Influenza Research Network (PCIRN) IT support group: Jean-Paul Collet, Victor Espinosa, Kim Marty, Lesley Sturrock, Nataliya Yuskiv, Evelyn Chan PCIRN scholarship
Adverse event workshop July 26th 2011, Buffalo, USA Co-located with International Conference on Biomedical Ontologies http://purl.org/net/aeicbo2011
Sources The development of standardized case definitions and guidelines for adverse events following immunization. Kohl et al. Vaccine, Volume 25, Issue 31, 1 August 2007, Pages 5671-5674 The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI) Bonhoeffer et al., Vaccine Volume 21, Issues 3-4, 13 December 2002, Pages 298-302 Diagnostic Utility of Two Case Definitions for Anaphylaxis: A Comparison Using a Retrospective Case Notes Analysis in the UK. Erlewyn-Lajeunesse et al., Drug Safety, 2010 Jan 1; Vol. 33 (1), pp. 57-64. Safe vaccination of patients with egg allergy with an adjuvanted pandemic H1N1 vaccine. Gagnon et al., Journal of allergy and clinical immunology, 2010; Vol. 126, pp 317.