Developing an Ontology for Randomised Controlled Trials Henry

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Developing an Ontology for Randomised Controlled Trials Henry Potts & Sanjay Modgil Design-a-Trial team,

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 l Units randomly assigned to groups,

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

Design-a-Trial Decision support software to aid inexperienced clinicians write a protocol for a randomised

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

An ontology A structure to encode data about RCTs l Used as basis for

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

History EON/GLIF-2 – for guidelines, not trials l Breast. Cancer. Proto. pont Protege. Win

History EON/GLIF-2 – for guidelines, not trials l Breast. Cancer. Proto. pont Protege. Win example – concentrating on procedural aspects l Our RCT ontology l Ongoing work by Tu, Noy etc. l

Trial_Model_Entity GLIF-2 etc. are bipartite in structure – Guideline_Model_Entity (procedural) – Reference_information l Our

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

Multiple superclasses l Protégé allows multiple superclasses – links different levels of representation –

Multiple superclasses l 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

Guideline_Model_Entity changes GLIF uses an ordinal time structure l Introduce temporal referents l l

Guideline_Model_Entity changes GLIF uses an ordinal time structure l Introduce temporal referents l l Composite steps

Reference_information changes l Activity – Compliance_procedure – Consent_procedure – Structure of Intervention_procedure l Outcome_variable

Reference_information changes l Activity – Compliance_procedure – Consent_procedure – Structure of Intervention_procedure l Outcome_variable etc.

Conclusions Copy of (mostly) documented ontology available l Aim to make it downloadable from

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