1. TOWARDS AN ADVERSE EVENT
REPORTING ONTOLOGY
PCIRN ANNUAL GENERAL MEETING
APRIL 20-21 2011
OTTAWA, ON
Mélanie Courtot and Ryan Brinkman on behalf of the
PCIRN IT support group
2. 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
3. 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
4. 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)
5. Enables complex data querying
“which of my patients have an AEFI involving part
of the nervous system?”
6. 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.
9. 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
10. Enables complex data querying
Computer can infer link such as “Encephalitis unfolds
in the Nervous system”
11. 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
12. 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)
13. 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
14. Adverse event workshop
July 26th 2011, Buffalo, USA
Co-located with International Conference on
Biomedical Ontologies
http://purl.org/net/aeicbo2011
15. 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.