title: An approach for utilizing clinical statements in HL7 RIM to evaluate eligibility criteria.
abstract: The HL7 RIM (Reference Information Model) is a commonly used standard for the exchange of clinical data and can be employed for integrating the patient care and clinical research domains. Yet it is not sufficiently well specified to ensure a canonical representation of structured clinical data when used for the automated evaluation of eligibility criteria from a clinical trial protocol. We present an approach to further constrain the RIM to create a common information model to hold clinical data. In order to demonstrate our approach, we identified 132 distinct data elements from 10 rich clinical trails. We then defined a taxonomy to (i) identify the types of data elements that would need to be stored and (ii) define the types of predicate that would be used to evaluate them. This informed the definition of a pattern used to represent the data, which was shown to be sufficient for storing and evaluating the clinical statements required by the trials.
authors.affiliation: Dept. of Informatics, School of Natural and Mathematical Sciences, King's College London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Bache
authors.affiliation: Assistance Publique - Hôpitaux de Paris & INSERM, U1142, Paris, France.
authors.forename: Christel
authors.initials: C
authors.lastname: Daniel
authors.affiliation: Centre for Health Informatics and Multiprofessional Education, University College London, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: James
authors.affiliation: Assistance Publique - Hôpitaux de Paris & INSERM, U1142, Paris, France.
authors.forename: Sajjad
authors.initials: S
authors.lastname: Hussain
authors.affiliation: Health Informatics Centre, University of Dundee, Scotland.
authors.forename: Mark
authors.initials: M
authors.lastname: McGilchrist
authors.affiliation: Dept. of Primary Care and Public Health Sciences, King's College London, UK.
authors.forename: Brendan
authors.initials: B
authors.lastname: Delaney
authors.affiliation: Dept. of Informatics, School of Natural and Mathematical Sciences, King's College London, UK.
authors.forename: Adel
authors.initials: A
authors.lastname: Taweel
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D057286:Electronic Health Records / Q000592:standards*; D004608:Eligibility Determination / Q000592:standards*; D057208:Health Level Seven / Q000592:standards*; D016247:Information Storage and Retrieval / Q000592:standards; D038622:Internationality; D017410:Practice Guidelines as Topic; D009626:Terminology as Topic; D018875:Vocabulary, Controlled