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

This project aims to develop a comprehensive business model and platform for reusing electronic healthcare records (EHR) data in clinical research. The objective is to support medical research while ensuring patient safety. The project is a collaborative effort involving 33 European academic and industrial partners, including 11 pharmaceutical companies and 22 public partners.

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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

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