Standard-based integration profiles for SALUS

Gokce B. Laleci Erturkmen, PhD A. Anil Sinaci, MSc

SRDC Software Research, Development and ConsultancyAnkara, Turkey

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SALUS: Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies (

http://www.salusproject.eu/)

• A STREP funded under Objective ICT-2011.5.3b – Tools and environments enabling the re-use of electronic health records which aims to – Enable effective integration and utilization of electronic health record

(EHR) data to improve post-market safety activities on a proactive basis

– Pilots in Lombardia Region (Italy) and Eastern Saxony (Germany)• WHO-UMC and ROCHE are actively involved in pilot studies

Partners SRDC Ltd, Turkey (coordinator) EUROREC, France WHO- UMC, Sweden OFFIS, Germany AGFA Healthcare, Belgium

ERS, Netherlands LISPA, Italy INSERM, France TUD, Germany ROCHE, Switzerland

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How SALUS extends current spontaneous reporting system to seamlessly exploit the already existing clinical data at EHRs

An ideal system for ADR surveillance would combine the strengths of case reports with those of EHRs

Use Cases• Enabling Semi-automatic Notification of Suspected ADEs and Reporting

ADEs within a Hospital– Enabling Notification of Suspected ADEs– Enabling Semi-automatic ADE Reporting

• Supporting Clinical Evaluation of a Potential Signal through Accessing the EHRs

– Characterizing the cases and contrasting them to a background population• What differs between the patients having a myocardial infarction within two weeks

of Nifedipine intake to all the other patients taking Nifedipine?

– Temporal pattern characterisation• Is there a temporal association between a drug of interest and a medical event of

interest – By comparing the actual and expected counts of events in different time periods relative

to the first prescription of a drug– Can be used for evaluating ADEs– Can be used to assess positive impacts of drugs

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• Running Exploratory Analysis Studies over EHRs for Signal Detection– Temporal association screening on EHRs

– What does the Medical Event profile look like for Nifedipine?– Are there any drugs that might be associated with causing Myocardial

Infarction?– Open ended analysis, no prior hypothesis– Generates associations that might become signals

– Manual clinical review of relevant medical history

• Using EHRs as secondary use data sources for Post Marketing safety studies– Estimate incidence rates of congestive heart failure (CHF)

in diabetic patients with a recent acute coronary syndrome (ACS) event on different diabetic medications

Use Cases

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SALUS Semantic & Technical Interoperability

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Standard-based IHE profiles for SALUS• SALUS Technical Interoperability – Subscription/Query Based Interoperability

Profiles– heterogeneous EHR systems– population based– eligible patient group (inclusion/exclusion)– continuous screening

• Related available interoperability approaches have been examined– HL7 CRFQ– From ITI: IHE RFD, From QRPH: IHE CRD

• Form based interaction, not query/subscription based, focusing on case safety reports

– From ITI: IHE XDS (MS), From PCC: IHE QED, IHE CM• Subscription/query based, yet not specialized for population based queries• Not only HL7 CCD, SALUS would support patient summaries expressed in EN13606 artefacts

– Representing eligibility queries:• HL7 HQMF queries• HL7 Study Design Message (SDM)

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Standard-based IHE profiles for SALUS

• For the subscription/query based profiles of SALUS• Extended IHE CM (subscription) and IHE QED (query)

• population based eligibility criteria• use HL7 HQMF

• Carry EN13606 EHR EXTRACTs in addition to ASTM/HL7 CCD.

• For ADE Reporting (ICSR)• QED, DSC or IHE DEX are possible solutions• DEX: Modular, dynamic, interoperable

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IHE DEX

• For the reuse of EHRs for clinical research– E.g. CCD CDASH annotated ODM

• Can be achieved through existing IHE profiles – RFD, CRD, Redaction– The problem: one size fits all – XSLT mappings

• Power of an MDR– apply mappings earlier in the process

• During the form design, data elements of the form have already been mapped to the corresponding elements in the EHR export

– The MDR to maintain the exact correspondences between the research and healthcare data elements

• DEX is to support study feasibility, patient eligibility and recruiting, adverse event reporting, retrospective observational studies as well as case report form pre-population

– existing standards for patient summaries – ASTM/HL7 CCD

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IHE DEX – Actors and Transactions

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Retrieve Metadata [QRPH-Y1]

This transaction is used by the Metadata Consumer to retrieve the metadata of a selected Data Element from the Metadata Repository. The Metadata Consumer has previously obtained the UUID of the Data Element she is looking by means outside of the scope of this transaction

DEX •Volume 1 is complete•Volume 2 is underway•Release for

•Public comment in May•Trial Implementation in July

Semantic Metadata Registry (MDR)• Data within each system is stand-alone and not interoperable

– “have a common understanding of the meaning and descriptive characteristics (e.g. representation) of data”

• Metadata for Semantic Interoperability– annotate the information models of different systems

• with the same set of data elements residing in the metadata registries

– early approach: bottom-up• takes root from several other disciplines like linguistics, compilers etc…

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MDRISO/IEC 11179

Any other Metadata

Disparate Data Elements, Content Models• There are many different efforts to define Data Elements, and binding them to actual

data sources (like CCD documents)• Examples:

– Health Information Technology Standards Panel (HITSP) has defined the C154: Data Dictionary Component

• HITSP C83 marks the elements in CCD document with the corresponding HITSP C154 data elements

– The Federal Health Information Model (FHIM) develops a common Computationally Independent Model (CIM) for EHRs

– GE/Intermountain Healthcare Clinical Element Models (CEM) – The Transitions of Care Initiative (ToC) maintains the S&I Clinical Element Data Dictionary

(CEDD) • Mappings to I2B2, PopMedNet, HQuery implementations, FHIM Model, HITSP C154 when possible

– available in separate excel sheets, PDFs…

– CDISC SDTM, CDASH– Mini Sentinel Common Data Model (CDM) – I2B2 data model – Observational Medical Outcomes Project (OMOP) Common Data Model (CDM)

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Linked MetadataFederated Semantic MDRs

• Maintain & Manage– Data Elements– the relations between Data Elements– the components of Data Elements– the relations between the components of Data Elements

• Different Data Elements from different Content Models– their relations and mappings are managed semantically

• A set of Data Elements with lots of relations – Semantic Resource Set– The relations can be through the LOD cloud – Linked Metadata!

• The relations may point to native representations of the Content Models– Extraction Specification

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An example Execution in SALUS

LocalSemantic MDR

links to SDTM CDEs

Preparing Study design

for an observational

study

CDISC ODMStudy Design

Document

Search and use CDEs from the local MDR

Metadata Source implementing

DEX

ODM is annotated with SDTM

HITSPSemantic MDR

Search for CCD

Extractions of the SDTM CDEs

BRIDGSemantic MDR

CDISCSemantic MDR

XPATH of corresponding CCD element is returned

Ask for Extraction Specification of HITSP CDE:”ResultValue”

Receives the URI of HITSP CDE:“Result.Value”

Queries federated MDR Cloud for

SDTM “LBORRES”

1

BRIDG Semantic MDR maintains a skos:exactMatch mapping from

LBORRES to “Result.Value” through

“PerformedObservationResult.value.Any”

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4

5

6

7

//cda:observation[cda:templateId/@root = '2.16.840.1.113883.10.20.1.31'] /cda:value

Metadata Consumer

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Participation to a projectathon?Using DEX?

• SALUS is implementing a semantic MDR for the semantic interoperability• Semantic MDR can implement IHE DEX in order to provide

– extraction specifications during ICSR Reporting– population of data collection sets for eligible patients during observational studies

• SALUS – EHR4CR collaboration through DEX

• CDISC SHARE can be extended…

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Retrieve Metadata

SALUS MDR(Metadata Source)

EHR4CR(Metadata Consumer)