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HL7 Working Group Meeting

Evidence-Based Medicine on FHIR

Health Evidence Knowledge Accelerator (HEvKA) Updates

Brian S. Alper:

balper@computablepublishing.com

© 2019+ Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

2025-01-29

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Agenda

EBMonFHIR Introduction
Health Evidence Knowledge Accelerator (HEvKA) intro
SEVCO Updates
EBMonFHIR Updates
Slides are available at: https://computablepublishing.com/media

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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EBM-ON-FHIR INTRODUCTION

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence-Based Medicine is…

“the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients” (Sackett D, 1996)
“integration of clinical expertise, patient’s values and best available evidence in process of decision making related to patients health care”(Sackett D, 2002)
“integration of best research evidence with clinical expertise and patient values”(Sackett D, 2000)

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence-Based Medicine is…

“The EBM-oriented clinicians of tomorrow have three tasks:

a) to use evidence summaries in clinical practice;

b) to help develop and update selected systematic reviews or evidence-based guidelines in their area of expertise; and

c) to enroll patients in studies of treatment, diagnosis and prognosis on which medical practice is based.”(Masic 2008)

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence = Analyzed Data

Evidence = Data + Context
Evidence is often published in journals
Data in FHIR + Context in journals does not interoperate

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence

Data

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Evidence to Guidance to Action

Evidence is often published in journals
Guidance is often in decision support tools
Action can be in FHIR – but do these things interoperate?

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence

Data

Guidance

Action

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The Health Knowledge Flow we want

Data Analysis, Synthesis, and Interpretation.

EVIDENCE

Guidelines, Recommendations, Decision Aids, Decision Support

GUIDANCE

Observations and Measurements.

DATA

Healthcare (testing and intervention) decision-making and implementation

ACTION

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EBMonFHIR extends FHIR to EBM data

FHIR Resources for Evidence-Based Medicine (EBM) Knowledge Assets project (EBMonFHIR) started 2018.
The goal of EBMonFHIR is to provide interoperability (standards for data exchange) for those producing, analyzing, synthesizing, disseminating and implementing clinical research (evidence) and recommendations for clinical care (clinical practice guidelines).

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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EBMonFHIR extends FHIR to EBM data

The EBMonFHIR project (HL7 PSS-2124) is formally named FHIR Resources for Evidence-Based Medicine Knowledge Assets (EBM-on-FHIR)
EBMonFHIR sponsored by 3 HL7 Work Groups

Clinical Decision Support (CDS)
Clinical Quality Information (CQI)
Biomedical Research and Regulation (BRR)

Prior to 2020 EBMonFHIR met for one hour per week…

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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HEALTH EVIDENCE KNOWLEDGE ACCELERATOR (HEvKA) INTRODUCTION

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Health Evidence Knowledge Accelerator (HEvKA)

A virtual organization – no cost, no contracts
Open, transparent – all meetings
Engages multiple global collaborative groups, organizations, and individuals
A way for any to volunteer to accelerate development and implementation of standards for evidence exchange
The organization formerly known as COVID-19 Knowledge Accelerator (COKA)
Not an HL7 FHIR Accelerator.

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Health Evidence Knowledge Accelerator (HEvKA)

�Content and support tools for making science computable and facilitating HEvKA projects can be found on the

Fast Evidence Interoperability Resources (FEvIR) Platform https://fevir.net

The FEvIR HEvKA Project Page can be found at https://fevir.net/resources/Project/29272

The FEvIR platform includes evidence-related resources in current (R6 – CI Build) FHIR format.

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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HEvKA has 10 active working groups

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Day	Time (Eastern)	Working Group
Monday	8-9 am	Project Management
Monday	1-2 pm	Research Study Data Dictionary (a CDS EBMonFHIR sub-WG)
Tuesday	9-10 am	Measuring the Rate of Scientific Knowledge Transfer
Tuesday	2-3 pm	StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)
Wednesday	8-9 am	Making Guidelines Computable
Wednesday	9-10 am	Communications (Awareness, Scholarly Publications)
Thursday	8-9 am	EBMonFHIR Implementation Guide (a CDS EBM sub-WG)
Thursday	9-10 am	Computable EBM Tools Development
Friday	9-10 am	Statistics Terminology
Friday	10-11 am	GRADE Ontology
Friday	12-1 pm	Project Management

For all of these meetings: Join Microsoft Teams Meeting

If you wish to learn more about HEvKA please go to

https://tinyurl.com/HEvKA

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SEVCO UPDATES

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Scientific Evidence Code System (SEVCO) Updates�

Standard terminology is essential to the communication of evidence.

SEVCO is an open effort to define terms for the expression of

study design,
statistics, and
risk of bias

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Scientific Evidence Code System (SEVCO) Updates�

The SEVCO code system (in FHIR resource form) can be viewed as it is being developed Scientific Evidence Code System (SEVCO) -- DRAFT ONLY (Not published for current use),
Anyone is welcome to comment on any term by finding the term in the Term Detail view and clicking the Comment button

https://fevir.net/27270

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Scientific Evidence Code System (SEVCO) Updates

To join the Scientific Evidence Code System Expert Working Group to vote on the terms and definitions in this code system, just go to the Scientific Evidence Code System (SEVCO) Project Page and click the Join the Group button.
Members of the Expert Working Group can vote on any term that is open for voting in the Term Detail view and clicking the Vote button, or by viewing all terms open for vote at Computable Publishing®: My Ballot.

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Scientific Evidence Code System (SEVCO) Updates

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SEVCO Release 2.0 is now published with 486 terms at https://fevir.net/sevco.

SEVCO suggested to THO as an external terminology.

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EBMonFHIR UPDATES

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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EBMonFHIR Implementation Guide

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Planning version 1.0.0-ballot2 for May Ballot

This version uses R6 base.

87 Profiles, 24 Extensions, 3 ValueSets, about 400 Examples

Prep for Ballot: Examples for systematic reviews, DichotomousIntendedOutcome, EvidenceVariable extensions; Moving terminologies to THO; RESTRUCTURE EvidenceTableReportPackage and derivatives

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Research Study Data Dictionary

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ResearchStudyDataDictionary Profile of Composition

Many changes to EvidenceVariable: definitionModifier, conditional, classifier, dataStorage, timing, period, constraint, missingDataMeaning, unacceptableDataHandling

ResearchStudyDataDictionary Working Group meets Mondays at 1-2 pm Eastern

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ResearchStudy R6 Prep

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Elements for finding ResearchStudy Resources:

--focus
--condition
--keyword
--? outcomeCode

Defining the variables
--recruitment
--comparisonGroup (modified with target/actual/elig/observed)
--objective.outcomeMeasure (Estimand framework)

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CDS R6 Prep

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ArtifactAssessment: 9 changes from R6 prep review, Applied
Citation: 21 changes from R6 prep review, Applied
Evidence: 36 changes from R6 prep review, Approved

EvidenceVariable: in review with ResearchStudyDataDictionary WG
EvidenceReport: to be deprecated
Evidence and Statistics: Clinical Reasoning page changes, Proposed

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RelatedArtifact changes

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RelatedArtifact Datatype (and elements using it) to be deprecated
Corollary changes proposed for 6 Resources

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RelatedArtifact changes for Evidence

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Add Evidence.citeAs[x] 0..1 markdown | canonical(Citation) | uri
Add Evidence.citation 0..* CitationInformation
Add Evidence.dependency[x] 0..* canonical(Any) | Reference(Any)
Add Evidence.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add Evidence.documentation[x] 0..* Attachment | Reference(DocumentReference)
Add Evidence.justification[x] 0..* markdown | uri | Attachment | canonical(Composition) | Reference(ArtifactAssessment | Composition)
Add Evidence.partOf[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Evidence.replaces[x] 0..* canonical(Evidence) | Reference(Evidence) | uri
Add Evidence.replacedWith[x] 0..* canonical(Evidence) | Reference(Evidence) | uri
Add Evidence.specificationOf[x] 0..1 markdown | Attachment | uri

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RelatedArtifact changes for EvidenceVariable

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Add EvidenceVariable.citeAs[x] 0..1 markdown | canonical(Citation) | uri
Add EvidenceVariable.citation 0..* CitationInformation
Add EvidenceVariable.dependency[x] 0..* canonical(Any) | Reference(Any)
Add EvidenceVariable.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add EvidenceVariable.documentation[x] 0..* Attachment | Reference(DocumentReference)
Add EvidenceVariable.justification[x] 0..* markdown | uri | Attachment | canonical(Composition) | Reference(ArtifactAssessment | Composition)
Add EvidenceVariable.partOf[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add EvidenceVariable.replaces[x] 0..* canonical(EvidenceVariable) | Reference(EvidenceVariable) | uri
Add EvidenceVariable.replacedWith[x] 0..* canonical(EvidenceVariable) | Reference(EvidenceVariable) | uri
Add EvidenceVariable.specificationOf[x] 0..1 markdown | Attachment | uri

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RelatedArtifact changes for ResearchStudy

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Add ResearchStudy.citeAs[x] 0..1 markdown | canonical(Citation) | uri
Add ResearchStudy.citation 0..* CitationInformation
Add ResearchStudy.dependency[x] 0..* canonical(Any) | Reference(Any)
Add ResearchStudy.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add ResearchStudy.documentation[x] 0..* Attachment | Reference(DocumentReference)
Add ResearchStudy.justification[x] 0..* markdown | uri | Attachment | canonical(Composition) | Reference(ArtifactAssessment | Composition)
Add ResearchStudy.partOf[x] 0..* canonical(ResearchStudy) | Reference(ResearchStudy) | uri
Add ResearchStudy.replaces[x] 0..* canonical(ResearchStudy) | Reference(ResearchStudy) | uri
Add ResearchStudy.replacedWith[x] 0..* canonical(ResearchStudy) | Reference(ResearchStudy) | uri
Add ResearchStudy.specificationOf[x] 0..1 markdown | Attachment | uri
Add ResearchStudy.amends[x] 0..* canonical(ResearchStudy) | Reference(ResearchStudy) | uri
Add ResearchStudy.amendedWith[x] 0..* canonical(ResearchStudy) | Reference(ResearchStudy) | uri

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RelatedArtifact changes for ArtifactAssessment

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Change ArtifactAssessment.citeAs[x] 0..1 markdown | canonical(Citation) | uri
Add ArtifactAssessment.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add ArtifactAssessment.replaces[x] 0..* Reference(ArtifactAssessment) | uri
Add ArtifactAssessment.replacedWith[x] 0..* Reference(ArtifactAssessment) | uri
Add ArtifactAssessment.specifcationOf[x] 0..1 markdown | Attachment | uri
Add ArtifactAssessment.content.justification[x] 0..* markdown | uri | Attachment | canonical(Composition) | Reference(Any)

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RelatedArtifact changes for Composition

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Add Composition.citeAs[x] 0..1 markdown | canonical(Citation) | uri
Add Composition.dependency[x] 0..* canonical(Any) | Reference(Any)
Add Composition.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add Composition.partOf[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Composition.replaces[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Composition.replacedWith[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Composition.specificationOf[x] 0..1 markdown | Attachment | uri
Add Composition.amends[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Composition.amendedWith[x] 0..* canonical(Composition) | Reference(Composition) | uri

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RelatedArtifact changes for Citation

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Add Citation.dependency[x] 0..* canonical(Any) | Reference(Any)
Add Citation.derivedFrom[x] 0..* canonical(Any) | Reference(Any) | uri
Add Citation.documentation[x] 0..* Attachment | Reference(DocumentReference)
Add Citation.partOf[x] 0..* canonical(Composition) | Reference(Composition) | uri
Add Citation.replaces[x] 0..* canonical(Citation) | Reference(Citation) | uri
Add Citation.replacedWith[x] 0..* canonical(Citation) | Reference(Citation) | uri
Add Citation.specificationOf[x] 0..1 markdown | Attachment | uri
Add Citation.amends[x] 0..* canonical(Citation) | Reference(Citation) | uri
Add Citation.amendedWith[x] 0..* canonical(Citation) | Reference(Citation) | uri
Change Citation.citedArtifact.relatesTo.resource to Citation.citedArtifact.relatesTo.url 0..1 uri
Create related-artifact-type CodeSystem and ValueSet for Required binding for relatesTo.type