electronic healthcare record for clincial research (ehr4cr) semantic interoperability framework
Post on 03-Feb-2016
55 Views
Preview:
DESCRIPTION
TRANSCRIPT
Electronic Healthcare Record For Clincial Research (EHR4CR)
Semantic interoperability framework
WP4C.Daniel
INSERM UMRS 872 team 20
January 22, 2013 1Convergence Meeting: Semantic
Interoperability for Clinical Research & Patient Safety in Europe
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 Europe2January 22, 2013
Partners
Convergence Meeting: Semantic Interoperability for Clinical Research &
Patient Safety in Europe3January 22, 2013
Use cases
Protocol feasibility
Convergence Meeting: Semantic Interoperability for Clinical Research &
Patient Safety in Europe4January 22, 2013
11Leverage clinical data to design viable trial protocols and estimate recruitment
Patient recruitment 22Detect patients elegible for trials & better utilize recruitment potential
Clinical trial execution 33Re-use routine clinical data to pre-populate trial eCRFs
Pharmacovigilance 44Detect adverse events & collect/transmit relevant information
A loosely coupled SOA, which interconnects independent services implementing EHR4CR usage scenarios
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 1Protocol feasibility
5
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
Eligibility criteria manually formalized into central
queries (EHR4CR workbench – SHARE data elements)
11
Patient identificationCentral queries transformed
into local queries distributed and executed
over EHRs/CDWs
Protocol feasibilityNumber of patients matching eligibility
criteria
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 2Patient recruitment
6
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
Protocol content +Eligibility criteria manually formalized into central
queries (EHR4CR workbench – SHARE data elements)
22
PSM
PSM
PSM
Patient identificationProtocol content
distributed over local process step managers(including central ->local
queries)
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 2Patient recruitment
7
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
22
PSM
PSM
PSM
Patient recruitment process
Lists of eligible->screened->recruited subjects
(protocol specific consent)
Patient recruitmentNumber of recruited
subjects
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 3Data capture
8
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
FormsItems manually formalized
(SHARE data elements)
33
PSM
PSM
PSM
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 3Data capture
9
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
FormsItems manually formalized
(SHARE data elements)
33
PSM
PSM
PSM
Patient data capture process
At each visit, retrieve query extraction specification &
form(s) for data capture
Clinical research (CDISC)
CRO n°1
Patient care(HL7-13606)
Hospital n°1
CTMSCDMS
Use case 3Data capture
10
EHRCDW
Hospital n°2
Hospital n°X
EHRCDW
EHRCDW
CRO n°2
CTMSCDMS
CRO n°x
CTMSCDMS
PSM
PSM
PSM
Data( Recruited subjects
protocol specific consent)
33
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 eligibility determination
and data capture
Convergence Meeting: Semantic Interoperability for Clinical Research &
Patient Safety in Europe11January 22, 2013
Semantic resources
Frankfurt - WPG2 - 20
october 201112
Items in eCRFsLast known weight (kg)Systolic Blood Pressure (mmHG)Hypertension? Yes/NoSmoking / Non smoking ?
Items in eCRFsLast known weight (kg)Systolic Blood Pressure (mmHG)Hypertension? Yes/NoSmoking / Non smoking ?
Eligibility criteriaBetween ages 18 and 56Hemoglobin A1c value within the diabetic rangeAt least 2/3 systolic blood pressure measurements ≥ 140 mmHg
Eligibility criteriaBetween ages 18 and 56Hemoglobin A1c value within the diabetic rangeAt least 2/3 systolic blood pressure measurements ≥ 140 mmHg
PHARMA(Eligibility criteria, items)
HOSPITAL (Clinical
data/documents)
Clinical data/documentAgeCardiovascular disease
•HBP•Angor•Cardiac failure
SBP (mmHG)Weight (kg)Tabacco ? yes/noHemoglobin A1c
Clinical data/documentAgeCardiovascular disease
•HBP•Angor•Cardiac failure
SBP (mmHG)Weight (kg)Tabacco ? yes/noHemoglobin A1c
EHR4CR pivot representation
“Model of meaning”Formal representation of
eligibility criteria & clinical data
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 13
EHR4CR Clinical Information Model
EHR4CR WP7 Meeting Thurs 13th September 2012 14
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 15
100 CT
EHR4CR meta data repository & terminology (bottom up)
16
Scope(Core data elements)
Mappings
10 CT300 data elements
10 CT300 data elements
4 CT80 data
elements
4 CT80 data
elements
Eligibility criteria of clinical trials
Execution
Standardization
Semantic servicesProtocol feasibility
Convergence Meeting: Semantic Interoperability for Clinical Research &
Patient Safety in Europe17January 22, 2013
Evaluation of the semantic resources 10 clinical trials – 11 pilot sites
23 proofs of concepts
18
Adoption of standards• IHE
integration/content profiles
• Standards– Reference information
models (CDISC, HL7)– ISO 11179 Meta data
repository– ISO 21090 data types
BooleanBoolean StringString
Physical QuantityPhysical Quantity RealReal
IntegerInteger
Concept Descriptor
Concept Descriptor
<code ='271649006' displayName=‘Systolic blood pressure' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMEDCT'/>
Coded OrdinalCoded Ordinal
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 Europe20January 22, 2013
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 Europe21January 22, 2013
top related