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HL7®, FHIR® and the flame Design mark are the registered trademarks of Health Level Seven International and are used with permission.
Amsterdam, 14-16 November | @HL7 @FirelyTeam | #fhirdevdays18 | www.fhirdevdays.com
FHIR for Clinical Research
Sebastiaan Knijnenburg
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Introduction – Who am I?
• Name: Sebastiaan Knijnenburg• Background:
• MSc in Medical Informatics (& some Medicine)• PhD in pediatric oncology
• Website usability• Clinical epidemiology
• Currently Chief Technology Officer at Castor EDC
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Introduction – Who are you?
• Who has hands-on experience with FHIR?
• Who is working with clinical data?
• Who is involved in research data management?
• Who has written a scientific paper?
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The research process
Createhypothesis
Write protocol
Capture new data
Analyze data
Publish data
Write & Publish article
Adhere to regulations
Reuse existing data
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The research process is broken
Createhypothesis
Write protocol
Capture new data
Analyze data
Publish data
Write & Publisharticle
Homebrew, complex or expensive EDC tools
Manual & expensivedata linkage
(e.g. TTP)
Adhere to regulations
Reinventing the wheel in data
analysis
Incomplete reporting
Duplicationinstead of
collaboration
Heterogeneousand non-
comparableReuse
existing data
Manual and error-prone data copying
(e.g. EHR)
Not standardized and therefore not reusable
Most (academic) studies don’t comply
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How can FHIR help to advance medical research?
• Automate electronic data capture via data exchange• Improve FAIRness of data by facilitating standardization• Patient recruitment • Consent management• Device integration
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How can FHIR help to advance medical research?
• Automate electronic data capture via data exchange• Improve FAIRness of data by facilitating standardization• Patient recruitment • Consent management• Device integration
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Using FHIR for data exchange
• Research data is highly structured• Protocol defines the data requirements• Data is often already available within the EHR
• Research database is (usually) standalone• Access / Excel• One-off databases• Electronic Data Capture tools
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Using FHIR for data exchange
• High level of data duplication / transcription from EHR to research DB
• Study in Dutch UMC: • Approximately 70 FTE spent on transcribing data for research• High risk of transcription errors
• Manual data linkage often hard to achieve• (Automated) data import via FHIR
• Save time• Improve quality
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Architecture: from EHR to EDC
• Experiences with connecting three Dutch UMCs to Castor
• Started with basic resources:• Patient• Observation
• Two approaches used:• Hospital pushes FHIR messages to the outside world• Hospital allows pulling FHIIR messages from the outside world
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The push mechanism
Refresh nightly
Patientin Castor
study?
Clinical/research data warehouse
Retrieve data forpatients in studies
Create HL7 FHIR message
Send message(POST)
Receive message
yes
no
Does patient exist?no
Create record Map datato visits
yes
Update record
Broker application
Start
End
HTTPS / JSON (API)
Hospital
EDC
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The push mechanism
• Pros• Hospital has full control• Flexibility of data sources• Notifications when new data
becomes available• Custom implementations:
• C# FHIR components• MS BizTalk• Cloverleaf• Etc.
• Cons• Requires (internal) IT resources
to build and maintain• ‘Data dump’ if no negotiation
protocol in place• Recipient becomes responsible
for storage & processing• What push-interval to use?
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The pull mechanism
EHR
Lab
Etc.
MI / DWH
FHIR Server / Facade
Hospital Internet
Firewall
EDCAPIVPN HTTP GET
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The pull mechanism
• Pros• Only retrieves necessary data• ‘Live’ view of the data• Data stays at the source• All functionality of a FHIR server
available
• Cons• Access control• Pseudonymization• Requires FHIR server
implementation in the hospital
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Challenges: Identifying studies and patients
• Study management & patient enrollment differ per institute• Research data is pseudonymized• Hospital-specific implementations
• Store research pseudonyms in the EHR• Store hospital identifier in EDC system• <StudyID>:<pseudonym> as Patient ID
• Potential use for ResearchStudy and ResearchSubject resources• Clinical Research Core IG offers starting point
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Challenges: mapping incoming data
• Incoming datapoints need to be stored in the right place in the study protocol
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Study protocol
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Study forms
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Metadata mapping
• Define per data point:• Which FHIR resource (Observation)• What to store (main value)• Which CodableConcept
• Provide search tools for codes• Allows for form re-use• Effort required for standardization!
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EDC integration in the EHR
• Structured Data Capture (SDC) IG• Infrastructure to standardize and automate data capture within the EHR• See Lloyd McKenzie’s presentation from this morning
• Profiles for • Form definitions (SDC Questionnaire) • Form data (SDC Questionnaire Response)• Values sets (SDC Value Set)• Code Systems (SDC Code System)• Data Elements (SDC Data Element)
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Source: https://wiki.ihe.net/index.php/Structured_Data_Capture
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Improve FAIRness of data
• FAIR: Findable, Accessible, Interoperable, Reusable• Regarding data, metadata and infrastructure
• Defining metadata is hard for (medical) researchers
• FHIR CodeSystems at the source can greatly help
• Efforts required to harmonize used CodeSystems between hospitals/countries
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FHIR in Clinical Research
• Ample opportunities for FHIR to improve research• Data exchange, patient recruitment, consent, device integration, etc.
• Uptake in (Dutch) hospitals steadily increasing
• Metadata annotation core priority• Focus on international standards (LOINC, SNOMED, ICD, etc.)• Collaborate on (national) FHIR profiles
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What are your experiences?
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Questions?
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