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Developing an Ontology for Randomised Controlled Trials

This project, led by Henry Potts and Sanjay Modgil at University College London, focuses on creating an ontology for Randomised Controlled Trials (RCTs). RCTs, the gold standard in clinical research, involve the random assignment of units into groups for comparison. Our ontology encodes essential data about RCTs, pivotal for developing the Design-a-Trial decision support software, aiding inexperienced clinicians in protocol writing. This structured approach facilitates understanding of trial-level concepts and integrates guidelines and procedural aspects into a cohesive framework.

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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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