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Developing an Ontology for Randomised Controlled Trials

Developing an Ontology for Randomised Controlled Trials. Henry Potts & Sanjay Modgil Design-a-Trial team, University College London. Randomised controlled trials. ‘Gold standard’ in clinical research

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Developing an Ontology for Randomised Controlled Trials

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  1. Developing an Ontology for Randomised Controlled Trials Henry Potts & Sanjay Modgil Design-a-Trial team, University College London

  2. Randomised controlled trials • ‘Gold standard’ in clinical research • Units randomly assigned to groups, in which intervention(s) are compared to a control and an outcome measured • Not restricted to medicine (agricultural products, advertising, archaeological conservation)

  3. Design-a-Trial • Decision support software to aid inexperienced clinicians write a protocol for a randomised controlled trial (RCT) • Critiquing, pre-emption, natural language generation, ... • Back-end: Prolog; user interface: Visual Basic • http://www.design-a-trial.net

  4. An ontology • A structure to encode data about RCTs • Used as basis for Design-a-Trial v.2 [Sanjay’s talk] • Propose as an Interlingua for other trial software

  5. History • EON/GLIF-2 • for guidelines, not trials • BreastCancerProto.pont ProtegeWin example • concentrating on procedural aspects • Our RCT ontology • Ongoing work by Tu, Noy etc.

  6. Trial_Model_Entity • GLIF-2 etc. are bipartite in structure • Guideline_Model_Entity (procedural) • Reference_information • Our ontology is tripartite • add Trial_Model_Entity • Allows representation of trial-level concepts • Trial architecture, Outcomes, Interventions, Randomisation, ...

  7. Multiple superclasses • Protégé allows multiple superclasses • links different levels of representation • crossing Guideline_Model_Entity vs. Trial_Model_Entity divide • ties Outcome_measure to an Action_Step Thanks to... Samson Tu for this paradigm shift

  8. Guideline_Model_Entity changes • GLIF uses an ordinal time structure • Introduce temporal referents • Composite steps

  9. Reference_information changes • Activity • Compliance_procedure • Consent_procedure • Structure of Intervention_procedure • Outcome_variableetc.

  10. Conclusions • Copy of (mostly) documented ontology available • Aim to make it downloadable from the web site and write up for publication • DaT going into commercial development

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