Transcript 20130122_ConvergenceMeeting_EHR4CR

Electronic Healthcare Record For
Clincial Research (EHR4CR)
Semantic interoperability framework
WP4
C.Daniel
INSERM UMRS 872 team 20
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
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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)
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
2
Partners
January 22, 2013
Convergence Meeting: Semantic
Interoperability for3Clinical Research &
Patient Safety in Europe
Use cases
A loosely coupled SOA, which interconnects independent
services implementing EHR4CR usage scenarios
Protocol feasibility
Patient recruitment
Clinical trial execution
Pharmacovigilance
January 22, 2013
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Leverage clinical data to design
viable trial protocols and estimate
recruitment
2
Detect patients elegible for trials &
better utilize recruitment potential
3
Re-use routine clinical data to prepopulate trial eCRFs
4
Detect adverse events &
collect/transmit relevant information
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
4
Use case 1
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Protocol feasibility
Patient care
(HL7-13606)
Patient identification
Hospital n°1
EHR
CDW
Clinical research
(CDISC)
Central queries transformed
into local queries distributed Eligibility criteria
CRO n°1
and executed overmanually formalized into central
EHRs/CDWs
queries CTMS
CDMS
(EHR4CR workbench – SHARE
data elements)
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
Hospital n°X
Protocol feasibility
EHR
CDW
Number of patients
matching eligibility
criteria
CRO n°x
CTMS
CDMS
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Use case 2
2
Patient recruitment
Patient care
(HL7-13606)
Patient identification
Hospital n°1
EHR
CDW
PSM
Clinical research
(CDISC)
Protocol content
distributed over local
CRO n°1 criteria
Protocol content +Eligibility
process step managers
manually formalized into
central queries
(including central ->local
CTMS
(EHR4CR workbench – SHARE data elements)
queries)
CDMS
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
PSM
Hospital n°X
CRO n°x
EHR
CDW
CTMS
CDMS
PSM
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Use case 2
2
Patient recruitment
Patient care
(HL7-13606)
Hospital n°1
EHR
CDW
PSM
Patient recruitment
process
Lists of eligible->screened
->recruited subjects
(protocol specific consent)
Clinical research
(CDISC)
CRO n°1
CTMS
CDMS
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
PSM
Hospital n°X
EHR
CDW
PSM
Patient recruitment
Number of recruited
subjects
CRO n°x
CTMS
CDMS
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Use case 3
3
Data capture
Patient care
(HL7-13606)
Hospital n°1
EHR
CDW
PSM
Clinical research
(CDISC)
Forms
CRO n°1
Items manually formalized
(SHARE data elements)
CTMS
CDMS
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
PSM
Hospital n°X
CRO n°x
EHR
CDW
CTMS
CDMS
PSM
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Use case 3
3
Data capture
Patient care
(HL7-13606)
Patient data capture
process
Hospital n°1
EHR
CDW
PSM
Clinical research
(CDISC)
Forms
At each visit, retrieve
query
CRO n°1
Items
manually formalized
extraction specification &
(SHARE data elements)
form(s)
for data capture
CTMS
CDMS
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
PSM
Hospital n°X
CRO n°x
EHR
CDW
CTMS
CDMS
PSM
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Use case 3
3
Data capture
Patient care
(HL7-13606)
Clinical research
(CDISC)
Hospital n°1
Data
EHR
CDW
( Recruited subjects
protocol specific consent)
PSM
CRO n°1
CTMS
CDMS
Hospital n°2
CRO n°2
EHR
CDW
CTMS
CDMS
PSM
Hospital n°X
CRO n°x
EHR
CDW
CTMS
CDMS
PSM
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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
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
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Semantic resources
EHR4CR pivot
representation
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PHARMA
Formal representation of
eligibility criteria & clinical data
(Eligibility criteria, items)
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)
(Clinical
data/documents)
“Model of meaning”
CDISC-ODM
HOSPITAL
Eligibility criteria
Between ages 18 and 56
Hemoglobin A1c value within the
diabetic range
At least 2/3 systolic blood pressure
measurements ≥ 140 mmHg
Items in eCRFs
Last known weight (kg)
Systolic Blood Pressure (mmHG)
Hypertension? Yes/No
Smoking / Non smoking ?
Frankfurt WPG2 - 20
october 2011
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
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EHR4CR Clinical Information Model
EHR4CR WP7 Meeting
Thurs 13th September 2012
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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
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EHR4CR meta data repository &
terminology (bottom up)
Scope
Execution
(Core data elements)
Eligibility criteria of clinical trials
4 CT
80 data
elements
Mappings
16
10 CT
300 data
elements
100 CT
Standardization
Semantic services
Protocol feasibility
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
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Evaluation of the semantic resources
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Oncology
Cardiovascular
and Metabolic
Total
X
Total
X
WWU
uom
Univd
un
UoG
UCL
U936
MUW
KCL*
X
HUG
Cardiovascular
Oncology
Nervous
system
disorders
Oncology
Neurology
onco
CV/Arrhythmia
s
Oncology
FAU
Disease Area
AP-HP
10 clinical trials – 11 pilot sites
23 proofs of concepts
X
3
2
3
X
2
1
X
X
X
X
X
X
X
X
2
1
X
X
X
X
X
X
X
X
3 2
3
2
1
1
2
2
X
3
2
X
3
1
4
3
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Adoption of standards
• IHE
integration/content
profiles
• Standards
– Reference
information models
(CDISC, HL7)
– ISO 11179 Meta data
repository
– ISO 21090 data types
Boolean
String
Concept
Descriptor
Physical
Quantity
Coded
Ordinal
Real
Integer
<code ='271649006'
displayName=‘Systolic blood
pressure'
codeSystem='2.16.840.1.113883.6.96
' codeSystemName='SNOMEDCT'/>
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
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
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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: [email protected]
January 22, 2013
Convergence Meeting: Semantic
Interoperability for Clinical Research &
Patient Safety in Europe
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