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WGM 2021-05

Evidence-Based Medicine (EBMonFHIR) and COVID-19 Knowledge Accelerator (COKA)

Brian Alper: balper@computablepublishing.com

https://docs.google.com/presentation/d/1stAoPMFfkjRKX3B7bgOIBnhpdaTQRUCI

© 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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Agenda

EBMonFHIR Introduction
COVID-19 Knowledge Accelerator Introduction
Evidence-related Developments

Evidence, EvidenceVariable, Statistic, EvidenceReport

Citation-related Developments

Citation data exchange
FAIR4FHIR and Common Metadata Framework
Relation to Library and collection of computable artifacts

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EBM-ON-FHIR INTRODUCTION

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Evidence-Based Medicine wants to be FAIR

Evidence-based medicine (EBM) is

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

FHIR enables data to be Findable, Accessible, Interoperable and Reusable (FAIR)

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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

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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?

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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.
Goal: provide interoperability for clinical research (evidence) and recommendations for clinical care

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EBMonFHIR extends FHIR to EBM data

EBMonFHIR sponsored by 3 HL7 Work Groups

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

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Fast Healthcare Interoperability Resources (FHIR)

Evidence	EvidenceVariable	EvidenceReport	Citation	Group

Source: http://build.fhir.org

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Fast Healthcare Interoperability Resources (FHIR)

Evidence	EvidenceVariable	EvidenceReport	Citation	Group

Source: http://build.fhir.org

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Fast Healthcare Interoperability Resources (FHIR)

Evidence	EvidenceVariable	EvidenceReport	Citation	Group

FHIR Resources for Evidence Expression

Primary Resources

Datatype Resources

Statistic

Source: http://build.fhir.org

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COVID-19 KNOWLEDGE ACCELERATOR INTRODUCTION

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COVID-19 Knowledge Accelerator (COKA)

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, especially with attention to COVID-19

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COKA has 10-12 active working groups

Project Management
Terminology and Ontology WG
Research Design WG
Statistic Standard and Terminology WG
Risk of Bias Terminology and Tooling WG
Common Metadata Framework WG (+ Expansion WG)
Content Citation and Classification Tools Development WG
Systematic Meta-Review Project Group (+ Supplemental WG)
Knowledge Ecosystem Liaison WG
Communications WG CDS EBM sub-WG

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COKA: How to Participate

For all of these meetings: Join Microsoft Teams Meeting
If you wish to learn more about COKA please go to Tinyurl.com/coka2020
Questions: balper@computablepublishing.com

Day	Time (Eastern)	Team
Monday	7-8 am	Project Management
Monday	9-10 am	Systematic Meta-Review Project Group
Monday	11 am-12 pm	Systematic Meta-Review Project Group Supplemental
Monday	1-2 pm	Terminology and Ontology WG
Tuesday	10-11 am	Common Metadata Framework WG
Tuesday	11 am-12 pm	Common Metadata Framework WG Expansion
Tuesday	2-3 pm	Research Design WG
Wednesday	8-9 am	Knowledge Ecosystem Liaison WG
Wednesday	9-10 am	Statistic Standard and Terminology WG
Thursday	9-10 am	Content Citation and Classification Tools Development
Thursday	4-5 pm	Project Management
Friday	9-10 am	Risk of Bias Terminology and Tooling WG
Friday	10-11 am	Communications (Awareness, Scholarly Publications)

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Tools Development

MEDLINE-to-FHIR Converter

Login first at https://fevir.net/

Go to https://fevir.net/medlineconvert

Enter a PMID and it automatically generates a FHIR Citation.

Citation Viewer and Citation Builder

Available at https://fevir.net/

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Code System Development

We are following a 13-step Code System Development Protocol to develop and maintain 4 code systems.
Step 1 (Assemble Expert Working Group)

You are welcome to join this effort -- see Invitation to join Expert Working Group. At this time, we currently have 64 people signed up from 27 countries in 6 continents.
You can sign up now with the Code System Development Intake Form to join the expert working group for any of the first 4 code systems.

Step 2 (Identify common tools): 25 tools and systems identified for the code systems to support.
Step 3 (Draft terms): 485 non-redundant concepts identified to support the 25 tools and systems.
Step 4 (Identify relevant ontologies): We have 27 eligible Ontologies Identified for Code System Development.
Step 5 (Ontology mapping) is underway. 9 ontologies mapped so far, 18 to go.

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Code System Development

We are following a 13-step Code System Development Protocol to develop and maintain 4 code systems.
Step 6 (Draft preferred term, alternative terms, definition)
Step 7 (Accept if 100% agreement from Expert Working Group [EWG] voting)
Step 8 (Revise from EWG suggestions and accept if 100% agreement)
Step 9 (Deliberate with group discussion and accept if 80% agreement)
Step 10 (Collaborate with ontologies that provide majority of contribution to agreed codes)
Step 11 (Publish the code system)
Step 12 (Support implementation and revise as needed)
Step 13 (Support ongoing maintenance with continuous application of steps 1-12)

18 Terms have reached 100% agreement as of May 24, 2021.

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Steroids for COVID-19 �Systematic Meta-Review Goals

Determine consistency of findings and judgments across SRs of steroid Tx for COVID-19
Determine the most current accurate findings
Document the findings in computable resources for efficient updating and dissemination

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�Steroids for COVID-19 �Systematic Meta-Review data capture�

Population specification

Intervention/Comparator spec

Outcome specification

Statistic type

Statistic quantity/value

Sample size

Statistic attributes/model

Certainty rating system used

Certainty ratings (by SR)

ROB assessment of SR (ROBIS)

Developments to come

Create data entry support (Systematic Review Results Reporter)
Create FHIR Resources for

Group
EvidenceVariable
Evidence
EvidenceReport

Create system to be notified when changes occur

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Evidence-Related Developments

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Evidence Exchange Efforts in Connectathon

Charité - Universitätsmedizin Berlin presented draft Evidence, EvidenceVariable and Group Resources to express evidence from meta-analysis and net effect estimates.
Extensive discussion adjusted how to fit the EBMonFHIR model and how to adjust the EBMonFHIR model to better fit this function.

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EvidenceVariable Resource Changes

Multiple changes to improve EvidenceVariable Resource

https://jira.hl7.org/browse/FHIR-32645 Reference(Any)

https://jira.hl7.org/browse/FHIR-32646 characteristic.type

https://jira.hl7.org/browse/FHIR-32647 characteristicCombination

any-of

all-of

at-least-n

net-effect

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Evidence Exchange Efforts in Connectathon

We created “COKA-EBM Clinical Outcomes in ACTT-1 Remdesivir RCT EvidenceReport” at https://fevir.net/resources/EvidenceReport/156

supported with

9 Evidence Resources
7 EvidenceVariable Resources
2 Group Resources
1 ActivityDefinition Resource

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EvidenceReport Resource

Discussion of EvidenceReport Resource vs. profile of Composition Resource

https://jira.hl7.org/browse/FHIR-31867
https://confluence.hl7.org/display/FHIR/EvidenceReport+FHIR+Resource+Proposal
Discussion continues with SD WG in Thursday 10 am weekly meetings

relatesTo and RelatedArtifact harmonization

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Statistic (and OrderedDistribution)

These Datatypes are only used in Evidence Resource
Discussion of removing these datatypes

https://jira.hl7.org/browse/FHIR-31866
https://jira.hl7.org/browse/FHIR-31564
Absorb Statistic into backbone element in Evidence
Remove distribution element from Evidence

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Citation-Related Developments

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Citation Resource

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Citation Exchange Results (Connectathon)

MITRE Corporation successfully loaded 2 Citation Resources onto FEvIR.net and they were viewed in Citation Viewer

Plans discussed to exchange classifiers to 2 Citation Resources for the same cited artifact

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Citation Resource Changes

Multiple changes to value sets to support Citation Resource

https://jira.hl7.org/browse/FHIR-32322

Changes include real-world example needs (e.g. adding code-repository and restricted to ArticleUrlType value set)
Changes include mapping to Dublin Core Metadata Initiative standard (e.g. adding coverage to CitedArtifactClassificationType value set)
https://jira.hl7.org/browse/FHIR-31600

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Citation Boundaries (vs. Provenance)

https://jira.hl7.org/browse/FHIR-31973
The Provenance Resource is used to track the contributions to a resource as it occurs, especially for purposes of confirming authenticity and trust. Citation.citedArtifact.contributorship is used to report the attribution of contributions to the cited artifact, especially for purposes of recognition and acknowledgement, but is not directly reporting the data to support authenticity of the contributions.�

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Citation Boundaries (vs. DocumentReference)

https://jira.hl7.org/browse/FHIR-31600
The DocumentReference Resource is described as a reference to a document of any kind for any purpose. As the DocumentReference Resource was developed for healthcare data exchange it is modeled to support individualized provenance, security, and artifact relationships as often needed in this context. The Citation Resource was developed for the reference to knowledge artifacts commonly used in scientific and scholarly communication so is modeled to support identification, attribution, classification, status tracking, and representation (summary) of the citation.

�

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Common Metadata Framework and FAIR4FHIR�

FAIR = Findable, Accessible, Interoperable, Reusable

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Common Metadata Framework and FAIR4FHIR�

Categorizing metadata to help mobilize computable biomedical knowledge

https://onlinelibrary.wiley.com/doi/10.1002/lrh2.10271
Findability – Type, Domain, Purpose, Identification
Accessibility – Location
Interoperability – CBK-to-CBK relationships, Technical
Reusability – Authorization and rights management, Preservation, Integrity
Trustability – Provenance, Evidence basis, Evidence from use

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Common Metadata Framework and FAIR4FHIR�

Specifying metadata to help mobilize computable biomedical knowledge

This is the NEXT BIG STEP
For each metadata category:

What data elements? – for each data element:

What datatype(s)?
What number of instances (cardinality)?
What terminologies?
What constraints?

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Common Metadata Framework and FAIR4FHIR�

FAIRness for FHIR Project

https://confluence.hl7.org/pages/viewpage.action?pageId=91991234

FAIRness for FHIR project is working on an FHIR4FAIR IG

How FAIRness of data can be improved by adopting FHIR
http://build.fhir.org/ig/HL7/fhir-forfair/

Hope for September Connectathon testing of IG

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Common Metadata Framework and FAIR4FHIR�

Which FHIR Resource to use as basis for FAIRification with FHIR

Library
Citation
ResearchStudy

Most promising resources are in R5
SOA WG voted for:

Submit NIB for FAIR4FHIR IG for Sep 2021 referencing R4B and special treatment of Citation (in R5)
Propose to CDS and FMG that the Citation Resource in R4B be replaced with the Citation Resource in R5

Can Citation be changed in R4B now? Will need to discuss with FMG

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Citation and Library

Relation to Library and collection of computable artifacts

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QUESTIONS/NEXT STEPS

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Citation Exchange Next Steps

Adjust value sets for Citation Resource.
Complete development of Citation Builder and Citation Viewer on fevir.net to facilitate human-friendly editing and viewing with conversion to/from FHIR Citation json
Explore FHIR operations for “Exchange Classifiers” function.
Explore FHIR Subscription Framework for notifications function.
Consider when to start IG development.

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Evidence-related Next Steps

Complete structure changes to EvidenceVariable Resource.
Explore FHIR operations for “Evidence” functions.
Explore FHIR Subscription Framework for notifications function.
Consider when to start IG development.

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Questions/Important Links

FHIR Specification (R5 Continuous integration build): http://build.fhir.org/
Track Confluence: https://confluence.hl7.org/pages/viewpage.action?pageId=97458212
JIRA: https://jira.hl7.org/projects/FHIR/issues
FHIR Chat: https://chat.fhir.org/
COKA page: https://confluence.hl7.org/pages/viewpage.action?pageId=97468919
Questions/Comments, email 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.

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