Standard-Based Integration Profiles for Clinical Research and Patient Safety_SALUS_SRDC_Sinaci

7/28/2019 Standard-Based Integration Profiles for Clinical Research and Patient Safety_SALUS_SRDC_Sinaci

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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 Science1


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2013 Joint Summits onTranslational Science

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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-UMCand ROCHEare 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
http://www.srdc.com.tr/salus/http://www.srdc.com.tr/salus/


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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 thestrengths 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-automaticADE 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 eventofinterest

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

to thefirst prescription of a drug

Can be used for evaluating ADEs

Can be used to assesspositive 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 MyocardialInfarction?

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 Marketingsafety 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

From ITI: IHE RFD, From QRPH: IHE DSC, 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

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 DEXare possible solutions

DEX: Modular, dynamic, interoperable

Study Design for Observational Studies

DEX


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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 eligibilityand 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 inJuly


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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 ofdata elements residing in the metadata registries

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


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Patient Name

Surname

Birth Date

Sex

Patient Firstname

Surname

Date of Birth

Gender

Patient First name

Last name

Date of Birth

Sex

MDRISO/IEC11179

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&IClinical 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 SentinelCommon 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 relationsSemantic 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

Local

Semantic MDR

links to SDTM CDEs

Preparing

Study design

for anobservational

study

CDISC ODMStudy Design

Document

Search and use

CDEs from the

local MDR

Metadata Source

implementing

DEX

ODM is annotated

with SDTM

HITSP

Semantic MDR

Search forCCD

Extraction

s of the

SDTM

CDEs

BRIDG

Semantic MDR

CDISC

Semantic MDR

XPATH of corresponding

CCD element is returned

Ask for Extraction Specification of HITSP CDE:ResultValue

Receives the URI of HITSPCDE:Result.Value

Queries federatedMDR Cloud for

SDTM

LBORRES

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BRIDG Semantic MDR maintains

a skos:exactMatch mapping fromLBORRES to Result.Value

throughPerformedObservationResult.value.Any

2 3

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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DEX

Interface

Retrieve

Metadata

SALUS MDR

(Metadata Source)

EHR4CR

(Metadata Consumer)

C l i


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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.

2013 Joint Summits on Translational Science 16


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EHR4CR / TrRANSFoRM use cases

Clinical Research

SALUS use cases

Patient Safety

Use case #1:

Identification of

populations of patients

Protocol feasibility study

Patient recruitment

Signal detection

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]

Use case #2: Extraction

of a set of individual

clinical data

Case Report Form (CRF) pre-

population

Individual case safety report

(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]

Use case #3: Extractionof sets of individual

clinical

Retrospective observational studyUse case #1+ Use case #2

Data Element Exchange [DEX] (under development)

Security &

confidentiality

IHE ITI: XUS, CT, ATNA

Standards : CDISC (CDASH, Operational Design Model (ODM), Study Design Model (SDM),

CSHARE, BRIDG) - HL7 (RIM, DCM, Clinical Statement model, CDA (templates e.g. CCD),Vocabulary) ISO (ISO 21090, ISO 11179)


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Questions ?


Documents

Standard-Based Integration Profiles for Clinical Research and Patient Safety_SALUS_SRDC_Sinaci