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Short Description

The primary focus is exchange of complex eligibility criteria (inclusion and exclusion criteria) for research cohorts, clinical trials, and clinical care recommendations. 

Long Description

Using the characteristic backbone element of the Group resource to express criteria is well established but the approach has limitations for complex criteria.

The Evidence-Based Medicine on FHIR project group (co-sponsored by CDS, CQI and BRR WGs) developed EvidenceVariable Resource to express complex characteristics defining evidence variables. In a separate BRR track focusing on a review of inclusion / exclusion criteria, discussion on the need to express complex characteristics converged on EvidenceVariable.

With a desire to describe eligibility criteria using Group Resource but a demand for handling many complex characteristics and combinations of characteristics, we will explore adapting the EvidenceVariable Resource to structure such content, easily referenced from a Group Resource.

Type

Test the design of a Resource

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group  

BRR (EBMonFHIR Project)

Track Lead(s)

Track Lead Email(s)

balper@computablepublishing.com; gustav.vella@healex.systems; kshahin@computablepublishing.com

Related Tracks

FHIR Version

Current build

Specification(s) this track uses

Other resources 

Review of inclusion / Exclusion Criteria in FHIR (Link to BR&R Pages on this topic)

Examples and Comparison of Approaches

Suggested Additions and Changes to EvidenceVariable


  • Terminology Servers this track users? N/A
  • Specific Terminology Code Systems and Value Sets needed for this track? N/A

Artifacts of focus

Expected participants / Actual Participants

We expect both implementers and specifiers to take part:

  • Computable Publishing LLC, Healex (Gustav Vella, Martin Döge), Firely, 3 Research Hospitals

Actual Participants

  • Brian Alper (Computable Publishing LLC)
  • Gustav Vella (Healex)
  • Khalid Sahin (Computable Publishing LLC)
  • Joanne Dehnbostel (Computable Publishing LLC)
  • Lorenz Rosenau (Universitätsklinikum Schleswig-Holstein / Universität zu Lübeck )
  • Martin Doege (Healex)
  • Gregor Lichtener (Universitätsmedizin Greifswald)
  • Harold Lehmann
  • Henrich Krämer
  • Robert Dingwell
  • Rana Cook
  • Bret Eathorne
  • Darell Woelk

Zulip stream

https://chat.fhir.org/#narrow/stream/197019-EBMonFHIR

Track Kick Off Call

Pre-connectathon Track Orientation

Thursday April 21st 12 Eastern 

https://hl7-org.zoom.us/j/95147253604


If you missed the call you can listen to the recording here: https://hl7-org.zoom.us/rec/share/DmcDxJ06V6jbHr4d2ZO1o8t9ClzHvqV2oCeohr9YEPCuJXsUSe7XEUVkEHGEIk5J.ycDF5gsjM37yU7a-?startTime=1650557099000

Track Details

Scenario:

Expressing Eligibility Criteria

Action:

Select complex eligibility criteria (e.g. from research studies described at ClinicalTrials.gov) and express using EvidenceVariable Resource.

Success Criteria:  

Track participants are able to express eligibility criteria with satisfactory degree of granularity.

Bonus point:

Track participants are able to interpret eligibility criteria expressed by other participants.

TestScript(s): None

Security and Privacy Considerations: None



Draft agenda:

Tuesday, May 3

9:00-10:00 – Day 1 Orientation to EvidenceVariable resource and Eligibility Criteria IG

10:00-12:00 – Working Session 1 - create Eligibility Criteria instances

1:00-3:30 – Working Session 2 - review feedback for IG changes

3:30-4:00 – Day 1 Wrap-up (Summarize achievements, obstacles, next day plans)

Wednesday, May 4

9:00-10:00 – Day 2 Welcome Session - Review Bariatric Surgery examples of Eligibility Criteria

10:00-12:00 – Working Session 1 - create examples of characteristic instances for documentation for each datatype

1:00-2:00 – Implementation Preview - presentation on conversion of EvidenceVariable to CQL, FHIR search, AQL

2:00-2:45 – Day 2 Wrap-up - review feedback for IG changes, consider decision flow chart

3:00-4:00 – Eligibility Criteria track report out  – prepare the presentation

4:30-4:40 - Eligibility Criteria track report out