Health Evidence Knowledge Accelerator (HEvKA) Daily Progress May 10-11, 2025

[Brian Alper]

Special Update from the HL7 FHIR Connectathon Evidence Based Medicine Track

 

There are no Health Evidence Knowledge Accelerator (HEvKA) meetings this week (May 12-16) as the HEvKA management team is either at the HL7 Work Group Meeting in Spain or Cochrane Africa in Kenya.

 

We had a very productive Connectathon weekend, focused on the use of FHIR for the expression of clinical trial protocols, both for the European Union Clinical Trial Information System (CTIS) and for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)  M11 working group on the Clinical electronic Structured Harmonised Protocol (CeSHarP).

 

The report out for the Evidence Based Medicine Track of the Connectathon is:

 

• What was the track trying to achieve?

• 1. Demonstrate that a EU CTIS record can be represented in a FHIR ResearchStudy Resource (with EBMonFHIR IG Profile)

• 2. Demonstrate that a EU CTIS record in FHIR can be transmitted for data exchange in the cloud

• 3. Demonstrate that an M11 report can be represented in a FHIR ResearchStudy Resource (with EBMonFHIR IG Profile)

• 4. Demonstrate added value for using FHIR to represent data for a research study covering EU CTIS and M11 report data

• List of participants

• Brian S. Alper, Computable Publishing LLC and EMA, Track Lead

• Khalid Shahin, Computable Publishing LLC, Track Lead

• Panagiotis Telonis, European Medicines Agency (EMA)

• Jimita Parekh, EMA

• Raju Rayavarapu, DNAnexus

• Martin Lucht, Roche

• Filippo Napoli, HL7 Vulcan Accelerator

• Notable achievements 

• 1. EU CTIS records (public data available from https://euclinicaltrials.eu/) successfully represented in FHIR with https://fevir.net/resources/ResearchStudy/367122 and https://fevir.net/resources/ResearchStudy/367203 (the DEUCRALIP trial) and confirmed by EMA

• including StudyEligibilityCriteria Profiles at https://fevir.net/resources/Group/367123 and https://fevir.net/resources/Group/367204 

• 2. JSON files for EU CTIS records (e.g. https://fevir.net/resources/ResearchStudy/367122#json) successfully transmitted in a Cloud technology that simulated spaces for regulatory use 

• 3. M11 report (created from a prior Vulcan UDP Connectathon) successfully represented in M11ResearchStudy Profile at https://fevir.net/resources/ResearchStudy/367214 (the DEUCRALIP trial) including reference to StudyEligibilityCriteria Profile at https://fevir.net/resources/Group/367215 

• 4. Showing the DEUCRALIP trial in FHIR with data derived from CTIS (https://fevir.net/resources/ResearchStudy/367122, #1 above) and M11 report (https://fevir.net/resources/ResearchStudy/367214, #3 above) successfully identified areas for improvements in data structure or data quality, including:

• Study acronym encoded as public title in CTIS

• sponsor protocol identifier encoded as short title in CTIS

• 28 inclusion/exclusion criteria vs. 27 inclusion/exclusion criteria (“Subjects who neither received a COVID-vaccination following EU regulations nor experienced a COVID-19 infection” handled as 2 criteria vs. 1 criterion)

• Screenshots and/or links to further information

• Screenshots for Part 1 (20+ screenshots) in EBM Track Screenshots PPT

• Ongoing effort (working group meetings) at https://fevir.net/HEvKA 

• Discovered issues / questions (if there are any)

• Coordination of M11 data elements and CTIS data elements may show data quality issues more often than data model issues

• Now what?

• 1. Change CTISRecord Profile to StudyRegistryRecord Profile in the EBMonFHIR IG

• 2. Identify the full list of CTIS data elements and map those to the StudyRegistryRecord Profile (if not captured in the sample set shown in the Connectathon 39)

• 3. for Connectathon 40 Evidence Based Medicine Track - Test the full CTIS record representation in FHIR

 

We also contributed to the Vulcan Accelerator Utilizing the Digital Protocol (UDP) Track of the Connectathon.

 

Recent releases to the FEvIR Platform include:

 

• Computable Publishing®: Guideline Authoring Tool Release 0.29.0 (May 8, 2025) provides a 'Download PDF' link in the Guideline Viewing Tool.

 

• Fast Evidence Interoperability Resources (FEvIR®) Platform Release 0.300.1 (May 11, 2025) fixes a bug to enable replacing relatedArtifact entries with relatesTo entries for Evidence, EvidenceVariable, ArtifactAssessment, Citation, and ResearchStudy Resources.

 

• FEvIR®: ValueSet Builder-Viewer Release 0.12.1 (May 11, 2025) removes the creation of a relatedArtifact extension for "cite-as" data in preference of a citeAs extension from the Evidence Based Medicine on FHIR Implementation Guide.

 

• FEvIR®: ValueSet Builder-Viewer Release 0.13.0 (May 12, 2025) provides direct links to terms from the Scientific Evidence Code System (SEVCO) when the compose.include value is https://fevir.net/sevco.

 

 

Quote for thought:  "Remember, there's no such thing as an unrealistic goal-just unrealistic time frames." -Donald J. Trump

 

To get involved or stay informed: HEvKA Project Page on FEvIR Platform, HEvKA Project Page on HL7 Confluence, View a consolidated list of presentations, videos, posters, journal articles, and book chapter mentions related to HEvKA, COKA, EBMonFHIR and the FEvIR Platform at https://ComputablePublishing.com/media.

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[Brian Alper]

Special Update from the HL7 Work Group Meeting

 

There are no Health Evidence Knowledge Accelerator (HEvKA) meetings this week (May 12-16) as the HEvKA management team is either at the HL7 Work Group Meeting in Spain or Cochrane Africa in Kenya.

 

We had a productive two days at the Work Group Meeting so far, making new connections, especially related to clinical research efforts in Austria, Germany, and France.  Numerous FHIR changes were applied to ResearchStudy and ResearchSubject Resources.

 

The Evidence Based Medicine on FHIR Implementation Guide Ballot results are in.  Overall the feedback was ‘Affirmative’ with some suggested improvements, mainly for simplification.  The one ‘Negative’ feedback (where ‘Negative’ just means we need to resolve the issue for Ballot Reconciliation) was that we need more descriptive information, such as a page walking through a randomized trial and how all the parts can be entered into FHIR Resources.  This is a very good suggestion to improve the Implementation Guide, and will become a major focus for EBMonFHIR IG Work Group meetings.

 

Recent releases to the FEvIR Platform include:

 

• Fast Evidence Interoperability Resources (FEvIR®) Platform Release 0.302.0 (May 13, 2025) suppresses the display of "1" when used to represent the units of a Quantity datatype, handles the canonical URL for Resources using an artifact-url extension when creating the URL for the Computable Resource in the generation of citation summaries (citeAs data), and provides a 'Sort Element Order' button in the JSON View to resort the JSON elements in the order following the FHIR StructureDefinition.

 

• Computable Publishing®: Risk of Bias Assessment Reader (RoBAR) Release 0.4.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• Fast Evidence Interoperability Resources (FEvIR®) Platform Release 0.301.0 (May 12, 2025) adds a StudyRegistryRecord Profile of ResearchStudy Resource to be consistent with the Evidence Based Medicine on FHIR Implementation Guide.

 

• FEvIR®: ValueSet Builder-Viewer Release 0.13.0 (May 12, 2025) provides direct links to terms from the Scientific Evidence Code System (SEVCO) when the compose.include value is https://fevir.net/sevco.

 

• FEvIR®: Adaptation Builder-Viewer Release 0.24.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• FEvIR®: Classification Builder-Viewer Release 0.11.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• FEvIR®: Comment Builder-Viewer Release 0.7.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• FEvIR®: Comparison Builder-Viewer Release 0.7.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• FEvIR®: Group (Cohort Definition) Builder-Viewer Release 0.36.0 (May 13, 2025) changes Group.characteristic.instancesQuantity to Group.characteristic.instancesUnsignedInt to match changes to the FHIR R6 specification.

 

• FEvIR®: Rating Builder-Viewer Release 0.8.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

• FEvIR®: Recommendation Justification Builder-Viewer Release 0.31.0 (May 13, 2025) supports automatic revision and display of citeAs data.

 

 

Quote for thought:  ‘Interoperability needs to be a “framework” and not a “straightjacket” for how we do things.’ –Eric Holderman

 

To get involved or stay informed: HEvKA Project Page on FEvIR Platform, HEvKA Project Page on HL7 Confluence, View a consolidated list of presentations, videos, posters, journal articles, and book chapter mentions related to HEvKA, COKA, EBMonFHIR and the FEvIR Platform at https://ComputablePublishing.com/media.