Protocolson FHIR –exchanging study designs with EHR systems

PHUSE Research On FHIR Group

DS04 – US Connect

Protocols on FHIR – exchanging study designs with EHR systems

Schedule of Activities• What is HL7 FHIR®?• What has previously been done?• What can be done with the Schedule of Activities?• What benefits will this provide?• What's next?

Research on FHIR: Protocol

What is HL7?Founded in 1987, Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services.


What is HL7 FHIR?FastHealthcareInteroperabilityResources


• FHIR is a new specification based on emerging industry approaches, but informed by years of lessons around requirements, successes and challenges gained through defining and implementing HL7 v2, HL7 v3 and the RIM, and CDA.

https://www.hl7.org/fhir/overview.html

What is HL7 FHIR®?FastHealthcareInteroperabilityResources


• Core focus on Healthcare• Healthcare and Research differ in their

approaches– What is captured– How it is captured– How it is reported

• Healthcare data is Research data and Research data is Healthcare data



• Intended for exchange• No assumptions about how the data is

maintained internally• Uses common standards for exchange

(REST)• Searchable• Versioned• Pathways to and from FHIR to CDA,

OMOP and SDTM



• A set of extensible well-defined, generic representational artifacts for healthcare data (Base Resources)

• System independent• Clear semantics• Links, references, external value lists• Resources have lifecycle management

through stability designations; from 0 through to Normative

FHIR® Resource Patient - Content


http://hl7.org/fhir/patient.html

http://hl7.org/fhir/patient.html

What has been done?


Mapping• CDISC EHR to CDASH• FHIR to CDISC Joint Mapping

Implementation Guide (BR&R)

How will the SoA on FHIR help?• Better data integration experience

• Better cost tracking

• Reusing integrated systems


• Observations that pertain to research activities are linked

• Activities explicitly linked to trial protocols as well as invoicing systems

• EHR Systems have integrations that can be utilized– Patient Calendar (e.g. Epic MyCharts)– Workflow management systems– Facilities management systems

How will the SoA on FHIR help?• Integrated process tracking

• Discoverability

• Provenance/Traceability


• Query the EHR for status of activities

• Deployed SoA can be found directly within the EHR

• Patient load can be inferred directly

• Relationships between Resources and Attributes are traceable

What can be done with the Schedule of Activities (SoA)?• The SoA is a key part of the Protocol• It describes what happens and when


Planned Activities

Encounters

• It doesn't specify "how" – activities take place and observations are recorded.

The how matters - FHIR® Workflow Activities


FHIR Resources for SoA Specification

ResearchStudy PlanDefinition ActivityDefinition

Specifies a study'sdetails as definedin the protocol

(such as title, phase, condition,principal investigator, armetc.)

Details pre-defined groups of actions

(such as those required by a study as presented in the SoA)

Describes an activity or task

(to be undertaken as part of the study data collection, e.g. collect vital signs)

protocol action


Overall Design Capabilities – Definition and Execution

ResearchStudy PlanDefinition ActivityDefinitionprotocol action

CarePlan ServiceRequestbasedOn

basedOninstantiatesCanonical

ServiceRequest

basedOn


Proposed StudyDefinition


PlanDefinition defines the interrelationships of steps and the rules around their execution

ActivityDefinition defines an activity to be performed as a single step


hasM

embe

r

based

On

based

On • Walk all the way down from the ResearchStudy to the Observation

• Traceability– Why a procedure was done– Who did the procedure?– When did they do it?– What was the outcome?

• The Observation is linked to the Patient(through the subject attribute) and the Patient is linked to the ResearchStudy(through the ResearchSubject)

hasM

embe

r


Outcomes for the Project• Using the CDISC Pilot Project (Eli-Lilly H2Q-MC-LZZT) as a ‘digital twin’

– Have ODM, Protocol, CSR, Data assets• Build out the SOA in a systematic way

– Sample ResearchStudy– Schedule of Planned Visits– Schedule of Planned Visits plus one Activity– Schedule of Planned Visits with repeated Activities– Schedule of Planned Visits with multiple Activities– Full SoA for the H2Q-MC-LZZT

• Publication of FHIR Bundles for each checkpoint so anyone can pick it up and run with it.

• Development of an Implementation Guide for Schedules of Activities


FHIR ® Implementation Guides• A set of rules of how a particular interoperability or standards problem is solved -

typically through the use of FHIR resources. This resource is used to gather all the parts of an implementation guide into a logical whole and to publish a computable definition of all the parts.

• Example Scenarios– Do we need new Resources for the SOA Use case?

• StudyArm as a derivative of a Group– Do we need to extend/specialise existing resourses?

• StudyVisitDefinition as an extension of PlanDefinition to include study specific attributes such as Planned Study Day, Study Day Window

• Published as part of the HL7 FHIR® build process


FHIR ® Implementation Guides

https://phuse-org.github.io/fhir-schedule-of-activities-ig/


What is next?• Finalising the sample resources for the H2Q-MC-LZZT study• Pattern/Code for alignment between CDISC Operational Data Model (ODM) and

SoA FHIR archetypes.• Support HL7 Project Vulcan

– Participating in HL7 FHIR® Connectathons– Delivery of the Implementation Guide

• Education– Teaching Research about FHIR– Teaching Healthcare about Research


http://www.hl7.org/vulcan/


http://www.hl7.org/vulcan/

Thanks and Join Us!• Current status and deliverables are available:

– Advance Hub: https://bit.ly/38PwEP8• We need more people

– Learn about HL7 FHIR®– Learn about FHIR Shorthand (FSH)

• Contact Wendy ([email protected]) for an invite


Protocolson FHIR –exchanging study designs with EHR systems

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