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Standard-based integration profiles for SALUS

Gokce B. Laleci Erturkmen, PhD A. Anil Sinaci, MSc SRDC Software Research, Development and Consultancy Ankara, Turkey

2013 Joint Summits on Translational Science

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

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


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
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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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Use Cases
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

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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

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

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 CDISC Study Design Model (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

Study Design for Observational Studies

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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

DEX Volume 1 is complete Volume 2 is underway Release for Public comment in May Trial Implementation in July

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

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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
Patient Name Surname Birth Date Sex Patient First name Last name Patient Firstname Surname Date of Birth Gender Date of Birth Sex


ISO/IEC 11179

Any other Metadata

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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 Metadata Federated 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

Preparing Study design links to SDTM CDEs Local for an observational Semantic MDR study Search and use CDEs from the 1 local MDR

CDISC Semantic MDR

BRIDG Semantic MDR maintains a skos:exactMatch mapping from LBORRES to Result.Value through PerformedObservationResult.val ue.Any

BRIDG Semantic MDR

Metadata Consumer

Queries federated MDR Cloud for SDTM LBORRES

Receives the URI of HITSP CDE:Result.Value

CDISC ODM Study Design Document

ODM is annotated with SDTM

Search for CCD Extraction s of the SDTM CDEs

Metadata Source implementing DEX

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XPATH of corresponding CCD element is returned

HITSP Semantic MDR

Ask for Extraction Specification of HITSP CDE:Result Value

//cda:observation[cda:templateId/@root = '2.16.840.1.113883.'] /cda:value

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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

SALUS MDR (Metadata Source) Retrieve Metadata EHR4CR (Metadata Consumer)

CDISC SHARE can be extended

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DEX Interface

Conclusion Standard-based IHE profiles for TRANSFoRm, EHR4CR, SALUS use cases
Collaborating to test IHE profiles during a joint projectathon will be a first step towards global interoperability between EHR4CR, TRANSFoRM and SALUS platforms and towards a pan-EU capability for clinical research and patient safety.

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Use case #1: Identification of populations of patients

Use case #2: Extraction of a set of individual clinical data

Use case #3: Extraction of sets of individual clinical Security & confidentiality Standards : CDISC (CDASH, Operational Design Model (ODM), Study Design Model (SDM), CSHARE, BRIDG) - HL7 (RIM, DCM, Clinical Statement model, CDA (templates e.g. CCD), 2013 Joint Summits on Translational Science 17 Vocabulary) ISO (ISO 21090, ISO 11179)

EHR4CR / TrRANSFoRM use cases SALUS use cases Clinical Research Patient Safety Protocol feasibility study Signal detection Patient recruitment IHE QRPH:Retrieve Process for Execution [RPE], Clinical Research Process Content [CRPC], Data Element Exchange [DEX] (under development) IHE PCC Query for Existing Data [QED], Care Management [CM] Case Report Form (CRF) preIndividual case safety report population (ICSR) form pre-population IHE ITI: Retrieve Form for Data Capture [RFD], IHE QRPH: Retrieve Process for Execution [RPE], Clinical Clinical Research Process Content [CRPC], Data Element Exchange [DEX] (under development) Research Document [CRD] Drug Safety Content [DSC] Retrospective observational study Use case #1+ Use case #2 Data Element Exchange [DEX] (under development) IHE ITI: XUS, CT, ATNA

Questions ?

2013 Joint Summits on Translational Science