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