TOWARDS AN ADVERSE EVENT REPORTING ONTOLOGY PCIRN ANNUAL GENERAL MEETING APRIL 20-21 2011 OTTAWA, ON Mélanie Courtot  and ...
Current problem <ul><li>No standard reporting system for adverse events (AE)  </li></ul><ul><li>PCIRN: Medical Dictionary ...
How to solve it <ul><li>Use of standard definitions for AE reporting </li></ul><ul><ul><li>Ensuring that adverse events fo...
Help confirm reported diagnostic <ul><li>Suggests missing information to reach unambiguous case determination </li></ul><u...
Enables complex data querying <ul><li>“ which of my patients have an AEFI involving part of the nervous system?” </li></ul>
Use of standards definitions <ul><li>Brighton collaboration </li></ul><ul><ul><li>Adopted by PHAC </li></ul></ul><ul><ul><...
Brighton publication - seizure
Brighton case definition - seizure
Computer tractable <ul><li>Domain is modeled using an ontology.  </li></ul><ul><li>Each entity is defined textually  </li>...
Enables complex data querying <ul><li>Computer can infer link such as “Encephalitis unfolds in the Nervous system” </li></ul>
Implementation in reporting systems <ul><li>Assist in confirming a reported clinical entity (e.g., seizure) at up to three...
Perspectives <ul><li>Early stage work </li></ul><ul><ul><li>Ontological issues to solve </li></ul></ul><ul><ul><li>Add mor...
Acknowledgements <ul><li>PHAC/CIHR Influenza Research Network (PCIRN) </li></ul><ul><li>IT support group: Jean-Paul Collet...
Adverse event workshop <ul><li>July 26 th  2011, Buffalo, USA </li></ul><ul><li>Co-located with International Conference o...
Sources <ul><li>The development of standardized case definitions and guidelines for adverse events following immunization....
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Towards an Adverse Event Reporting Ontology

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  • not to serve as a case definition for case finding.
  • Towards an Adverse Event Reporting Ontology

    1. 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. 2. Current problem <ul><li>No standard reporting system for adverse events (AE) </li></ul><ul><li>PCIRN: Medical Dictionary of Regulatory Activities (MedDRA) </li></ul><ul><ul><li>No definitions </li></ul></ul><ul><ul><li>No unambiguous meaning of terms </li></ul></ul><ul><li>Loss of information, low data quality </li></ul>
    3. 3. How to solve it <ul><li>Use of standard definitions for AE reporting </li></ul><ul><ul><li>Ensuring that adverse events following immunization (AEFIs) are reported in accordance to the selected guideline </li></ul></ul><ul><ul><li>Specification of signs and symptoms defining each AEFI </li></ul></ul><ul><li>Computer tractable </li></ul><ul><li>Implemented in reporting systems </li></ul>
    4. 4. Help confirm reported diagnostic <ul><li>Suggests missing information to reach unambiguous case determination </li></ul><ul><li>For example, check skin color to distinguish seizure from Hypotonic-Hyporesponsive Episode (HHE) </li></ul>
    5. 5. Enables complex data querying <ul><li>“ which of my patients have an AEFI involving part of the nervous system?” </li></ul>
    6. 6. Use of standards definitions <ul><li>Brighton collaboration </li></ul><ul><ul><li>Adopted by PHAC </li></ul></ul><ul><ul><li>300 participants from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations </li></ul></ul><ul><ul><li>Good applicability, sensitivity, and specificity </li></ul></ul><ul><ul><li>Performs well against other standards </li></ul></ul><ul><ul><li>Used within PCIRN </li></ul></ul>Kohl et al. Vaccine, 2007. Bonhoeffer et al. Vaccine, 2002. Erlewyn-Lajeunesse et al. Drug safety, 2010. Gagnon et al., Journal of allergy and clinical immunology, 2010.
    7. 7. Brighton publication - seizure
    8. 8. Brighton case definition - seizure
    9. 9. Computer tractable <ul><li>Domain is modeled using an ontology. </li></ul><ul><li>Each entity is defined textually </li></ul><ul><ul><li>Human readable definition, label </li></ul></ul><ul><li>Each entity is defined logically </li></ul><ul><ul><li>Relations to other entities </li></ul></ul><ul><li>Web Ontology Language (OWL) allows processing by computer </li></ul>
    10. 10. Enables complex data querying <ul><li>Computer can infer link such as “Encephalitis unfolds in the Nervous system” </li></ul>
    11. 11. Implementation in reporting systems <ul><li>Assist in confirming a reported clinical entity (e.g., seizure) at up to three levels of diagnostic certainty </li></ul><ul><ul><li>Checklist at data entry time </li></ul></ul><ul><li>Report on missing elements to confirm the event with some degree of certainty </li></ul><ul><li>Allow interoperability and querying on reports </li></ul>
    12. 12. Perspectives <ul><li>Early stage work </li></ul><ul><ul><li>Ontological issues to solve </li></ul></ul><ul><ul><li>Add more AEFIs </li></ul></ul><ul><li>Collaboration with Brighton </li></ul><ul><li>Discussion with Dacima to implement into their Electronic Data Capture system (Daciforms) </li></ul>
    13. 13. Acknowledgements <ul><li>PHAC/CIHR Influenza Research Network (PCIRN) </li></ul><ul><li>IT support group: Jean-Paul Collet, Victor Espinosa, Kim Marty, Lesley Sturrock, Nataliya Yuskiv, Evelyn Chan </li></ul><ul><li>PCIRN scholarship </li></ul>
    14. 14. Adverse event workshop <ul><li>July 26 th 2011, Buffalo, USA </li></ul><ul><li>Co-located with International Conference on Biomedical Ontologies </li></ul><ul><li>http://purl.org/net/aeicbo2011 </li></ul>
    15. 15. Sources <ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>

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