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FHIR Connectathon 27

Evidence-Based Medicine/COVID-19 Knowledge Accelerator Track Orientation

Brian 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.

2021-05-11

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Agenda

EBMonFHIR Introduction
COVID-19 Knowledge Accelerator Introduction
EBM/COKA related Resources and Tools
FHIR Connectathon Overview
Getting Ready for Connectathon
Evidence-Based Medicine/COKA Track Overview
Questions/Next Steps

© 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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FHIR IS MAKING HEALTH DATA FAIR

Fast Healthcare Interoperability Resources (FHIR) is an HL7 standard for electronic data exchange
FHIR enables data to be Findable, Accessible, Interoperable and Reusable (FAIR)
FHIR solves long-intractable problems of sharing health data
Resources (the R in FHIR) is the technical HOW
HL7 standards development process is the human HOW

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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”

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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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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

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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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EBM/COKA RELATED RESOURCES AND TOOLS

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COKA Activities – all 4 components

Contextualized application for each instance

Specific content and people

Common format for how data elements are expressed

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Common vocabulary and code systems

Terminology

FHIR Citation Resource
FHIR EvidenceReport Resource
FHIR Evidence Resource

FHIR EvidenceVariable Resource
FHIR Group Resource
FHIR Statistic Resource [Datatype]

Study Design Code System
Statistic Code System

Statistic Type Code System

Statistic Model Code System
Certainty Code System
Risk of Bias Code System

Citation Repository Tools

MEDLINE-to-FHIR Converter

Citation Viewer
Citation Builder
Clinical Trial Results Reporter
Systematic Review Results Reporter

COVID-19 Knowledge Accelerator
Liaised network initiatives:

AHRQ ACTS COVID-19 Data-to-Evidence-to-Action Collaborative
COVID-END
FAIRness for FHIR

Systematic Meta-Review Project:

Steroid therapy for COVID-19

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COKA Activities – all 4 components

Contextualized application for each instance

Specific content and people

Common format for how data elements are expressed

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Common vocabulary and code systems

Terminology

FHIR Citation Resource
FHIR EvidenceReport Resource
FHIR Evidence Resource

FHIR EvidenceVariable Resource
FHIR Group Resource
FHIR Statistic Resource [Datatype]

Study Design Code System
Statistic Code System

Statistic Type Code System

Statistic Model Code System
Certainty Code System
Risk of Bias Code System

Citation Repository Tools

MEDLINE-to-FHIR Converter

Citation Viewer
Citation Builder
Clinical Trial Results Reporter
Systematic Review Results Reporter

COVID-19 Knowledge Accelerator
Liaised network initiatives:

AHRQ ACTS COVID-19 Data-to-Evidence-to-Action Collaborative
COVID-END
FAIRness for FHIR

Systematic Meta-Review Project:

Steroid therapy for COVID-19

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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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Citation Resource

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COKA Activities – all 4 components

Contextualized application for each instance

Specific content and people

Common format for how data elements are expressed

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Common vocabulary and code systems

Terminology

FHIR Citation Resource
FHIR EvidenceReport Resource
FHIR Evidence Resource

FHIR EvidenceVariable Resource
FHIR Group Resource
FHIR Statistic Resource [Datatype]

Study Design Code System
Statistic Code System

Statistic Type Code System

Statistic Model Code System
Certainty Code System
Risk of Bias Code System

Citation Repository Tools

MEDLINE-to-FHIR Converter

Citation Viewer
Citation Builder
Clinical Trial Results Reporter
Systematic Review Results Reporter

COVID-19 Knowledge Accelerator
Liaised network initiatives:

AHRQ ACTS COVID-19 Data-to-Evidence-to-Action Collaborative
COVID-END
FAIRness for FHIR

Systematic Meta-Review Project:

Steroid therapy for COVID-19

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Contextualized application for each instance

Specific content and people

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Terminology

Share changes to shape FHIR resources for evidence communication

Join an Expert Working Group for Code System Development

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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 63 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 Progress

Code System	Current Status
Risk of Bias	13 commonly used tools or systems mapped. There are now 257 draft terms in the Risk of Bias and Safeguard Code System 2021 Feb 12.
Statistic Type	4 commonly used tools or systems mapped. There are now 109 draft terms in the simplified Statistic Type Code System concept list.
Statistic Model	2 commonly used tools or systems mapped. There are now 77 draft terms in the simplified Statistic Model Code System concept list.
Study Design	6 commonly used tools or systems mapped. There are now 56 draft terms in the simplified Study Design Code System concept list.

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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)

15 Terms have reached 100% agreement as of May 10, 2021.

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COKA Activities – all 4 components

Contextualized application for each instance

Specific content and people

Common format for how data elements are expressed

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Common vocabulary and code systems

Terminology

FHIR Citation Resource
FHIR EvidenceReport Resource
FHIR Evidence Resource

FHIR EvidenceVariable Resource
FHIR Group Resource
FHIR Statistic Resource [Datatype]

Study Design Code System
Statistic Code System

Statistic Type Code System

Statistic Model Code System
Certainty Code System
Risk of Bias Code System

Citation Repository Tools

MEDLINE-to-FHIR Converter

Citation Viewer
Citation Builder
Clinical Trial Results Reporter
Systematic Review Results Reporter

COVID-19 Knowledge Accelerator
Liaised network initiatives:

AHRQ ACTS COVID-19 Data-to-Evidence-to-Action Collaborative
COVID-END
FAIRness for FHIR

Systematic Meta-Review Project:

Steroid therapy for COVID-19

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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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COKA Activities – all 4 components

Contextualized application for each instance

Specific content and people

Common format for how data elements are expressed

Schema

Common interfaces (UIs and APIs) and data transformations

Tooling

Common vocabulary and code systems

Terminology

FHIR Citation Resource
FHIR EvidenceReport Resource
FHIR Evidence Resource

FHIR EvidenceVariable Resource
FHIR Group Resource
FHIR Statistic Resource [Datatype]

Study Design Code System
Statistic Code System

Statistic Type Code System

Statistic Model Code System
Certainty Code System
Risk of Bias Code System

Citation Repository Tools

MEDLINE-to-FHIR Converter

Citation Viewer
Citation Builder
Clinical Trial Results Reporter
Systematic Review Results Reporter

COVID-19 Knowledge Accelerator
Liaised network initiatives:

AHRQ ACTS COVID-19 Data-to-Evidence-to-Action Collaborative
COVID-END
FAIRness for FHIR

Systematic Meta-Review Project:

Steroid therapy for COVID-19

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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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FHIR CONNECTATHON OVERVIEW

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What’s to be gained by attending a FHIR Connectathon?

Join a community of FHIR users
Develop and test your system and use of the standard
Demonstrate what’s possible
Refine the FHIR Specification

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Participant Opportunities

Join in the community

Bring questions and share your challenges
Help others by sharing your knowledge

Raise questions that identify hot topics
Record your results
What happens at Connectathon stays at Connectathon

It’s OK to fail

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GETTING READY FOR CONNECTATHON

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Getting Ready for Connectathon

Review the HL7 Connectathon 27 webpage to learn more about Connectathon, all the tracks, and find your focus

We recommend participating fully in only one track

Register for Connectathon and select your track in the Pre-Connectathon Survey (i.e., Evidence-Based Medicine)

Early-bird rates: $175 for members and $275 for non-members
After April 23: $275 for members and $400 for non-members

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Getting Ready for Connectathon

Visit the EBM/COKA Track Page for more information

Connect with your track lead in advance
Join the Track Zulip Chat: https://chat.fhir.org/#narrow/stream/237951-COVID-19-Knowledge.20Accelerator

Attend weekly COKA Meetings

Meeting Details: https://confluence.hl7.org/pages/viewpage.action?pageId=97468919

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EVIDENCE-BASED MEDICINE/COKA TRACK OVERVIEW

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Track Description

Demonstrate data exchange using Evidence, EvidenceVariable, Group and EvidenceReport resources to communicate clinical trial and systematic review findings.
Demonstrate data exchange using Citation Resource to communicate location of computable biomedical knowledge artifacts.
Overcome the gap in the flow from the creation of evidence (research results, data analysis) to synthesis of evidence to inform decision support.

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Track Objectives

Orient newcomers to EBM-related resources and tools
Develop reference implementations for data exchange.
Develop new implementations for system-specific data exchange.
Test the design (schema) and terminologies (code systems) of EBM-related FHIR Resources.
Adjust EBM-related FHIR Resources if needed.

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Track Agenda/Schedule

Tuesday, May 18, 2021:

9:30-11:30 am GMT: Working Session for Citation Resource exchange
12:00-2:00 pm GMT: Working Session for Evidence and EvidenceVariable Resource exchange
3:00-4:00 pm GMT: Review and Adjustment from working sessions
4:00-6:00 pm GMT: second Working Session for Citation Resource exchange

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Track Agenda/Schedule

Wednesday, May 19, 2021:

9:30-11:30 am GMT: second Working Session for Evidence and EvidenceVariable Resource exchange
12:00-1:00 pm GMT: second check-in and resource review
1:00-3:00 pm GMT: Open working session for all scenarios
3:30-4:30 pm GMT: Review of Track Accomplishments

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Track Participant Roles

Citation Manager - a system that aggregates citation data for articles and documents
Systematic Review Developer - a system that supports the selection of articles (inclusion/exclusion decision), data extraction, evidence synthesis, and reporting of findings
Evidence Variable Classifier - a system that describes the evidence variables (e.g. populations, exposures, and outcomes)
Evidence Classifier - a system that describes the evidence (evidence variables, statistics and certainty) in computable form

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Track Scenario 1

Share a list of selected research articles about COVID-19

Action: The Citation Manager will transmit a list of selected research articles as a bundle of Citation Resources.
Success Criteria: A different Citation Manager will reliably display the list of selected research articles.
Bonus point: Transfer of multiple identifiers related to an article that were not previously used in the Citation Manager (for example CORD-19 unique ID)

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Track Scenario 2

Share a list of selected computable biomedical knowledge artifacts (CBKs)

Action: The Citation Manager will transmit a list of selected CBKs as a bundle of Citation Resources.
Success Criteria: A different Citation Manager will reliably display the list of selected CBKs.
Bonus point: Transfer of multiple classifiers related to a CBK that were not previously used in the Citation Manager (for example “the CBK is an executable app”)

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Track Scenario 3

Create computable expressions for the evidence variables related to COVID-19 clinical research

Action: The Evidence Variable Classifier will create EvidenceVariable Resources expressing the population, exposures and outcomes for a clinical research article.
Success Criteria: Valid EvidenceVariable Resources are understood and agreed by other Evidence Variable Classifiers
Bonus point: Association of EvidenceVariable Resources with EvidenceReport Resources and Evidence Resources.

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Track Scenario 4

Create computable expressions for the evidence (statistical summary of findings) related to COVID-19 clinical research

Action: The Evidence Classifier will create Evidence Resources for a clinical research article.
Success Criteria: Valid Evidence Resources are understood and agreed by other Evidence Classifiers
Bonus point: Association of Evidence Resources with EvidenceReport Resources and EvidenceVariable Resources.

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QUESTIONS/NEXT STEPS

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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/
Registration: http://www.hl7.org/events/fhir/connectathon/2021/05
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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