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Electronic Healthcare Record For Clincial Research (EHR4CR) Semantic interoperability framework. WP4 C.Daniel INSERM UMRS 872 team 20. Objective, scope Executive Summary. Objectives EHR4CR platform for reusing EHR data in order to support medical research

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Electronic Healthcare Record For Clincial Research (EHR4CR) Semantic interoperability framework


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    1. Electronic Healthcare Record For Clincial Research (EHR4CR)Semantic interoperability framework WP4 C.Daniel INSERM UMRS 872 team 20 Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    2. Objective, scope Executive Summary • Objectives • EHR4CR platform for reusing EHR data in order to support medical research • Comprehensive business model for governance, acceptance, adoption and sustainability • Duration & budget: 4 years – 7 Mons Euros (+ in kind contribution) • Partners: 33 European academic and industrial partners • 11 Pharmaceutical Companies (members of EFPIA) • 22 Public Partners (Academia, Hospitals and SMEs) Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    3. Partners Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    4. Use cases A loosely coupled SOA, which interconnects independent services implementing EHR4CR usage scenarios Protocol feasibility • Leverage clinical data to design viable trial protocols and estimate recruitment 1 • Detect patients elegible for trials & better utilize recruitment potential 2 Patient recruitment • Re-use routine clinical data to pre-populate trial eCRFs 3 Clinical trial execution • Detect adverse events & collect/transmit relevant information 4 Pharmacovigilance Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    5. Use case 1Protocol feasibility 1 Patient care (HL7-13606) Clinical research (CDISC) Patient identification Central queries transformed into local queries distributed and executed over EHRs/CDWs Hospital n°1 Eligibility criteria manually formalized into central queries (EHR4CR workbench – SHARE data elements) CRO n°1 EHR CDW CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS CRO n°x Hospital n°X Protocol feasibility Number of patients matching eligibility criteria CTMS CDMS EHR CDW

    6. Use case 2Patient recruitment 2 Patient care (HL7-13606) Clinical research (CDISC) Patient identification Protocol content distributed over local process step managers (including central ->local queries) Hospital n°1 Protocol content +Eligibility criteria manually formalized into central queries (EHR4CR workbench – SHARE data elements) CRO n°1 EHR CDW PSM CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS PSM CRO n°x Hospital n°X CTMS CDMS EHR CDW PSM

    7. Use case 2Patient recruitment 2 Patient care (HL7-13606) Clinical research (CDISC) Patient recruitment process Lists of eligible->screened ->recruited subjects (protocol specific consent) Hospital n°1 CRO n°1 EHR CDW PSM CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS PSM CRO n°x Patient recruitment Number of recruited subjects Hospital n°X EHR CDW CTMS CDMS PSM

    8. Use case 3Data capture 3 Patient care (HL7-13606) Clinical research (CDISC) Forms Items manually formalized (SHARE data elements) Hospital n°1 CRO n°1 EHR CDW PSM CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS PSM CRO n°x Hospital n°X CTMS CDMS EHR CDW PSM

    9. Use case 3Data capture 3 Patient care (HL7-13606) Clinical research (CDISC) Patient data capture process At each visit, retrieve query extraction specification & form(s) for data capture Forms Items manually formalized (SHARE data elements) Hospital n°1 CRO n°1 EHR CDW PSM CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS PSM CRO n°x Hospital n°X CTMS CDMS EHR CDW PSM

    10. Use case 3Data capture 3 Patient care (HL7-13606) Clinical research (CDISC) Hospital n°1 CRO n°1 Data (Recruited subjects protocol specific consent) EHR CDW PSM CTMS CDMS Hospital n°2 CRO n°2 EHR CDW CTMS CDMS PSM CRO n°x Hospital n°X EHR CDW CTMS CDMS PSM

    11. Semantic resources • Common EHR4CR clinical information model/meta data repository • A unique global as view schema of the heterogeneous EHRs/CDWs distributed over different pilot sites across Europe. • Shared core data elements • Common EHR4CR terminology • Integrate a range of clinical terminologies that are needed to collectively encode the variety of clinical entities (including observations , procedures, substance administration, etc) represented in the EHR4CR information model. • Query expansion and some degree of terminological reasoning • Query extraction specification for eligibilitydetermination and data capture Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    12. Semantic resources EHR4CR pivot representation“Model of meaning” Formal representation of eligibility criteria & clinical data PHARMA (Eligibility criteria, items) HOSPITAL (Clinical data/documents) Eligibility criteria Between ages 18 and 56 Hemoglobin A1c value within the diabetic range At least 2/3 systolic blood pressure measurements ≥ 140 mmHg CDISC-SDM • Clinical data/document • Age • Cardiovascular disease • HBP • Angor • Cardiac failure • SBP (mmHG) • Weight (kg) • Tabacco ? yes/no • Hemoglobin A1c HL7 CDA (e.g. CCD) Items in eCRFs Last known weight (kg) Systolic Blood Pressure (mmHG) Hypertension? Yes/No Smoking / Non smoking ? CDISC-ODM Frankfurt - WPG2 - 20 october 2011

    13. EHR4CR Clinical Information Model • Material : “source” models • BRIDG model & HL7 v3 models (HL7 RCRIM WG) • «StudyDesign» and «A_SupportingClinicalStatementUniversal» models • I2b2 model • Method: Model-driven engineering • Transforming HL7 v3 models in UML models and adapt these models to the purpose and scope of the EHR4CR project • Multidimensional EHR4CR Information Model (ISO 21090 datatypes) • Standardized data elements (pre-processed eligibility criteria of 10 clinical trials) • Tooling: Open Medical Development Framework (OMDF) [Ouagne10] EHR4CR WP7 Meeting Thurs 13th September 2012

    14. EHR4CR Clinical Information Model EHR4CR WP7 Meeting Thurs 13th September 2012

    15. EHR4CR meta data repository & terminology (top down) • Material • Reference document templates (e.g. CCD, CDA templates) • Reference terminologies • Patient care: clinical findings, test results, labs, or medications, etc. • Clinical research (MedDRA, CDASH/ Ontology of Clinical Research) • Method & Tooling • We used Bioportal to upload terminologies • from UMLS (SNOMED CT, LOINC, ICD-10 codes, etc.) • from other sources (e.g for ATC or PathLex) • We developed a data element/value set editor to build a core data element repository EHR4CR WP7 Meeting Thurs 13th September 2012

    16. EHR4CR meta data repository & terminology (bottom up) Scope (Core data elements) Execution Eligibility criteria of clinical trials 10 CT 300 data elements 4 CT 80 data elements 100 CT Mappings Standardization

    17. Semantic servicesProtocol feasibility Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    18. Evaluation of the semantic resources 10 clinical trials – 11 pilot sites23 proofs of concepts

    19. Adoption of standards • IHE integration/content profiles • Standards • Reference information models (CDISC, HL7) • ISO 11179 Meta data repository • ISO 21090 data types String Boolean Concept Descriptor Coded Ordinal Physical Quantity Real Integer <code ='271649006' displayName=‘Systolic blood pressure' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMEDCT'/>

    20. Semantic interoperability issues • Building/maintaining semantic resources • Sharing core data elements (CDISC SHARE) • Representing consistently complex clinical information models (clinical data structures templates, data elements) including clinical context • Antibiograms, anatomic pathology cancer checklists (histologic type, grade, TNM, tumor size, etc) • Supporting the mapping process between pivot/local information models & terminologies • Semantic services • Clinical research • Formal representation of eligibility criteria & eCRF • Mapping medical concepts in eligibility criteria/eCRFs including highly pre-coordinated terms to standard reference terminologies • Representing temporal constraints • Patient care • Mapping local data structures and/or interface terminologies to pivot models Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

    21. Project Information • Project website : http://www.ehr4cr.eu/ • Publications • Ouagne D, Hussain S, Sadou E, Jaulent MC, Daniel C. The Electronic Healthcare Record for Clinical Research (EHR4CR) information model and terminology. Stud Health Technol Inform. 2012;180:534-8 • El Fadly A, Rance B, Lucas N, Mead C, Chatellier G, Lastic PY, Jaulent MC, Daniel C. Integrating clinical research with the Healthcare Enterprise: from the RE-USE project to the EHR4CR platform. J Biomed Inform. 2011 Dec;44 Suppl 1:S94-102. • Contact information WP4: Christel.daniel@crc.jussieu.fr Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe