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Table of Contents:

Project Coordination Updates

Project Management Updates:

We wish we could state that COVID-19 is no more, but we are retiring the name 'COVID-19 Knowledge Accelerator' and in 2023 we are now the Health Evidence Knowledge Accelerator (HEvKA).

The COKA email distribution became the HEvKA email distribution list (which will be used to send a short update each weekday and a longer summary update each weekend). We also created a HEvKA weekly email distribution list (for people who want to only receive the weekly update).

At the request of participants, we changed the scheduling of two of our active working groups.

  • Eligibility Criteria Working Group – moved to Fridays at 12-1 pm Eastern
  • Statistic Standard and Terminology Working Group – moved to Mondays at 2-3 pm Eastern

An additional Working Group created on January 31, 2023 is the “Measuring the Rate of Scientific Knowledge Transfer Working Group”. This results in a total of 14 active working groups (including Project Management). For perspective, needing to have 14 active working groups is a good thing. We are pleased to see the many accomplishments as noted below.

On January 5, 2023, the Project Management Group coordinated changes across the HEvKA daily update (email message), the HEvKA Project Page on FEvIR Platform (modified to include the agenda), and the HEvKA Project Page on HL7 Confluence (and an additional HEvKA Update Summary page on HL7 Confluence). We also started the process of canceling the prior COKA meetings and creating new HEvKA meetings (for those who want meeting invites on your calendar). You may see this continue to develop over the coming week. We then developed a suggested agenda for the next 8 days.

On January 9, 2023, the Project Management Group completed sending meeting invites for HEvKA working groups. You are welcome to join any meeting and can let us know if you want to be added to a calendar invite. We also added a GuidelineCitation Profile to the Evidence Based Medicine Implementation Guide.

On January 23, the Project Management Group reviewed many changes released today with Fast Evidence Interoperability Resources (FEvIR) Platform version 0.99.0. FEvIR™: ActivityDefinition Builder/Viewer version 0.14.0, and Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter version 3.7.1; reviewed the initial version of the Classification Profile (in the EBM IG and on FEvIR Platform) and the Adaptation Profile (in the EBM IG and on FEvIR Platform); reviewed and revised Appendix C in the developing resubmission of the Introduction to EBMonFHIR manuscript; and drafted the following for proposed presentation in FHIR DevDays:

Tutorial -- Structuring Eligibility Criteria and Cohort Definitions with FHIR

This tutorial will introduce FHIR structures for characteristic expression (e.g. definitionByTypeAndValue, definitionByCombination). There are many use cases for expressing a set of characteristics to define a group -- for example, eligibility criteria, inclusion/exclusion criteria, cohort definition, phenotype, or population.
In response to requests to support expressions of characteristics without the Expression datatype, the EvidenceVariable StructureDefinition was modified to support multiple methods of expression.
Free tooling (and Profiles) in development for human-friendly viewing and data entry of characteristics, and for sharing of characteristics and related logic expressions to match patient data against characteristics, will be introduced. 
The characteristic concept is used across Group, EvidenceVariable, and Measure Resources and there is a need to make the characteristic definitions shareable in isolation from the Resources.

On February 6, the Project Management Group was pleased to announce the publication of:

and also drafted a title for a Guidelines International Network (GIN) 2023 pre-conference course (Using technology to efficiently update and adapt guidelines) and drafted 3 aims and objectives for the course proposal:

  1. Learn the basic principles used in the application of technology to facilitate guideline content modification.
  2. Learn how efficient guideline content modification can be applied to workflows of updating guidelines and guideline adaptation.
  3. Use open tools to update or adapt a guideline (applied to your own guideline if shared ahead in structured format)

On February 13, the Project Management Group reviewed and revised improvements to the data entry form for Identifier datatype on the FEvIR Platform, and improvements to the display of Coding datatype values which now include the code system in addition to the code and display values.

On February 16, the Project Management Group applied the ResearchSubject example to the FHIR specification.

On February 20, the Project Management Group started to apply changes to the FHIR specification including:

  • breaking up research-study-classifiers CodeSystem to revert to separate code systems for each value set in ResearchStudy Resource (to match specifications needed for R5)
  • FHIR-38937 - Getting issue details... STATUS – adding search parameters for the Citation.classification element

On February 27, the Project Management Group drafted a 10-minute orientation presentation for the EuroVulcan Eligibility Criteria Connectathon Track for the EUROVULCAN Conference and Connectathon in Paris March 14th and 15th .

On March 6, the Project Management Group reviewed the many enhancements to FEvIR™: Adaptation Builder/Viewer.

On March 13, the Project Management Group prepared for a presentation on Eligibility Criteria for the EuroVulcan Connectathon occurring tomorrow.

On March 20, the Project Management Group revised the handling of Classification Profile ArtifactAssessment Resources for Citations to FHIR Resources on the FEvIR Platform to support display under Third-Party Classifiers in the Citation Viewer.

On March 27, the Project Management Group prepared the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal and continued development of creating a master index of ArtifactAssessment Resource content and Citation.citedArtifact.classification content on the FEvIR Platform. 

On March 30., the Project Management Group compiled the suggested agenda for the next 8 days:

Friday, March 31:

  • 8 am Eastern: GRADE Vocabulary Working Group – draft GRADE concept paper
  • 9 am Eastern: Risk of Bias Terminology and Tooling Working Group – continue review and addition of terms and definitions to the Scientific Evidence Code System; attention to Reporting Bias terms
  • 10 am Eastern: Communications Working Group – review progress on publications (article accepted for LHS), presentations (GIN), and website
  • 12 pm Eastern: Eligibility Criteria Working Group – Characteristic Resource modeling (valueExpression example); Cohort Definition Track for May Connectathon

Monday, April 3:

  • 8 am Eastern: Project Management – review IG preparations and FHIR Trackers
  • 9 am Eastern: Setting the SRDR Platform on FHIR Working Group – review FEvIR™: SRDR+ Project Importer and SRDR+ progress
  • 10 am Eastern: ResearchOnFHIR Working Group – continue learning about CQL
  • 2 pm Eastern: Statistic Standard and Terminology – draft SEVCO terms to match StatisticalModel Profile example

Tuesday, April 4:

  • 9 am Eastern: Measuring the Rate of Scientific Knowledge Transfer Working Group – test our method with a third RCT
  • 12 pm Eastern: FEvIR Metadata Framework Working Group – review Indexes derived from ArtifactAssessment Profiles
  • 2 pm Eastern: Research Design Working Group – prepare ‘Study Design Terminology from SEVCO’ presentation for SCT 2023 May meeting; discuss next steps for Study Design Terminology 

Wednesday, April 5:

  • 8 am Eastern: Knowledge Ecosystem Liaison Working Group – determined by participants

Thursday, April 6:

Friday, April 7:

  • 8 am Eastern: GRADE Vocabulary Working Group – Continue GRADE Vocabulary Development Methods Protocol
  • 9 am Eastern: Risk of Bias Terminology and Tooling Working Group – continue review and addition of terms and definitions to the Scientific Evidence Code System; attention to Reporting Bias terms
  • 10 am Eastern: Communications Working Group – review progress on publications, presentations, and website
  • 12 pm Eastern: Eligibility Criteria Working Group – review of Characteristic Resource and Cohort Definition Track for May Connectathon

Knowledge Ecosystem Liaison Working Group Updates:

We have collaborated with several other organizations. Active and pending coordination efforts include:

  • Frequent cross-group meetings with the Learning Health Systems Phase 1 Execution Initiative (“LHS Collaborative”) and Pain Management/Opioid Use LHS Learning Community (POLLC) have facilitated various developments. The most active or soon-to-be-actionable developments are:
    • Cultivating synergies with complementary efforts to demonstrate computable, interoperable information flow around the LHS cycle for the pain/opioid management use case, e.g., collaborating on poster presentation for upcoming MCBK meeting
    • Platform developments supporting the creation, searching, and viewing of Classifications of knowledge resources will soon be ready to provide the preliminary infrastructure for functional portals like that shown in the Learning Health Systems Portal (Demo).
    • Coordination with our Eligibility Criteria related projects (to facilitate matching patients who meet specified criteria) led to an in-progress specification of High Dosing of Single Opioid.
  • Coordination of multiple GRADE Working Group participants and related organizations with interests in standard terminology representation of GRADE vocabulary for certainty of evidence and evidence-to-decision judgments resulted in a GRADE project proposal and a new GRADE Vocabulary Working Group.
  • Coordination with the European Food Safety Authority (EFSA) and Evidence-Based Toxicology Collaboration (EBTC) led to greater understanding of technical standards and their role in supporting coordination and automation of systematic review development.
  • Coordination with Agency for Healthcare Research and Quality (AHRQ) related efforts -- Systematic Review Data Repository (SRDR), Evidence-based Practice Centers (EPCs), and the CEPI Evidence Discovery and Retrieval (CEDAR) Project – resulted in a Setting the SRDR Platform on FHIR Working Group.

On January 11, 2023, the Knowledge Ecosystem Liaison Working Group discussed plans for communication during the HL7 Work Group Meeting next week with 4 HL7 Work Groups: Biomedical Research and Regulation (BRR), Clinical Decision Support (CDS), Clinical Quality Information (CQI), and Learning Health Systems (LHS).

On January 18, 2023, the Knowledge Ecosystem Liaison Working Group reviewed and revised the 2023-01-18 EBMonFHIR/HEvKA Update to HL7 Work Groups (https://tinyurl.com/EBMonFHIR-update) presented by Joanne Dehnbostel today in the HL7 Working Group Meeting.

On January 25, the Knowledge Ecosystem Liaison Working Group introduced participants from related projects (Jerry Osheroff from Pain Management/Opioid Use LHS Learning Community (POLLC), Rachel Couban from McMaster University National Pain Center) and discussed the current plans for the Pain Center to update a 2017 guideline that was developed with the MAGICapp.  We demonstrated the use of Computable Publishing®: MAGIC-to-FEvIR Converter and discussed the development of an Adaptation Profile (in the EBM IG and on FEvIR Platform) to facilitate the many micro-changes involved in consideration of a bit of knowledge (knowledge artifact) for acceptance, rejection or modification to create a new bit of knowledge. The guideline updating process can be considered (from a technical perspective) a form of adaptation where the older guideline is the knowledge being assessed. We will consider proposing a pre-conference course for the Guidelines International Network conference to introduce how to apply computable evidence and guidance to guideline adaptation and updating. Overall, these developments can facilitate converting guideline efforts into computable guidance that can be used in a pattern shown with Towards LHSs in Action: Pain/Opioids.

On February 1, the Knowledge Ecosystem Liaison Working Group reviewed development in progress for the FEvIR™: Adaptation Builder/Viewer, and reviewed adjustments to the Towards LHSs in Action: Pain/Opioids* image summary. 

On February 8, the Knowledge Ecosystem Liaison Working Group discussed coordination of the Pain Management/Opioid Use LHS Learning Community (POLLC) efforts with multiple HEvKA-related developments, including the use of pain management/opioid use examples in our new Measuring the Rate of Scientific Knowledge Transfer Working Group efforts to measure the rate of transfer from clinical trials to clinical guidance, the Cohort Definition (Eligibility Criteria) developments being discussed with HL7 Work Groups, and potential use of the FEvIR Platform for support in updating guideline content to adapt to new evidence.

On February 15, the Knowledge Ecosystem Liaison Working Group had interesting discussions covering areas of coordination across learning health systems and cohort definition developments, metadata management interfacing with FHIR Resources, and "longitudinal CDS".

On February 22, the Knowledge Ecosystem Liaison Working Group discussed coordination of activities related to expression of Eligibility Criteria/Cohort Definitions and the new Characteristic FHIR Resource Proposal, including two Connectathons:  the EuroVulcan Eligibility Criteria Connectathon Track for the EUROVULCAN Conference and Connectathon in Paris March 14th and 15th, and a Cohort Definition Track being discussed for the May 2023 HL7 Connectathon.  We suggested identifying tool developers who want to work together between systems to exchange cohort definitions, and engaging them in Connectathon planning discussions.

On March 1, the Knowledge Ecosystem Liaison Working Group discussed three funding opportunities that relate to open ecosystems to advance standards for data, metadata, and ontologies for science, and reached out to a team member of the Human Behaviour Change Project to encourage collaboration; revised draft proposals for FAIRground Demo Submissions for the MCBK North America 2023 meeting; discussed coordination of Pain Management/Opioid Use LHS Learning Community (POLLC) participants with the Cohort Definition Track for the May 2023 HL7 FHIR Connectathon; shared a link to the FHIR for FAIR - FHIR Implementation Guide; and noted one of our team members (Janice Tufte) was named in a Forbes article titled AI-Driven Medical Care? A Health Data Reality Check.

On March 8, the Knowledge Ecosystem Liaison Working Group prepared the Cohort Definition Track page for the May 2023 HL7 FHIR Connectathon, and created a new Zulip stream for it at https://chat.fhir.org/#narrow/stream/375683-cohort-definition.

On March 15, the Knowledge Ecosystem Liaison Working Group prepared HEvKA 2022 Achievements and 2023 Plans as a high-level summary to be included in the HL7 Annual Review.

On March 22, the Knowledge Ecosystem Liaison Working Group drafted a Panel Session proposal for Guidelines International Network (GIN) 2023 Hybrid Conference in Glasgow September 19-22.

  • The draft title is “Making Science Computable: Guideline-relevant Developments from the Health Evidence Knowledge Accelerator”
  • The 5 presentations included are (drafted to be):
    • 1. Introduction to Making Science Computable, EBMonFHIR, HEvKA
    • 2. Introduction to FEvIR Platform
    • 3. Introduction to Scientific Evidence Code System
    • 4. Introduction to Recommendation Justification Builder/Viewer
    • 5. Introduction to Adaptation Builder/Viewer
  • If you would like to be a presenter in this panel, please let us know or join us in the Friday 10 am Eastern HEvKA Communications Working Group meeting to revise this Panel Session proposal for submission.

Computable Publishing LLC will be a Gold Sponsor for the HL7 International FHIR Connectathon, May 6-7, 2023 in New Orleans, LA, USA. This includes an opportunity to present two on-site 40-minute education sessions on issues of interest to Connectathon participants.  We discussed the two top candidates for these sessions:

  1. A session related to Cohort Definition efforts which may demonstrate:
    1. Characteristic FHIR Resource Proposal
    2. FEvIR™: Characteristic Builder/Viewer 
    3. FEvIR™: EvidenceVariable Builder/Viewer 
    4. Eligibility Criteria Matching Software Demonstration
    5. Eligibility Criteria Matching Software Library
  2. A session related to Statistics on FHIR which may demonstrate:
    1. FEvIR™: Evidence Builder/Viewer
    2. StatisticModel Profile (in development in Evidence Based Medicine Implementation Guide)
    3. Statistic Terminology (in development in Scientific Evidence Code System (SEVCO))
    4. Statistical formulas as Expression datatype values

On March 29, the Knowledge Ecosystem Liaison Working Group discussed the general role of the FEvIR Platform (and HEvKA efforts) in efforts across the knowledge ecosystem is to facilitate communication with structured data representing scientific knowledge (computable evidence, computable guidance, computable protocols, computable datasets). The specific tools vary with the specific type of knowledge being communicated. We viewed an example using the FEvIR™: Characteristic Builder/Viewer to create a structured representation of a characteristic for use within the context of defining care gaps for a care gap report.

Communications Working Group Updates:

On January 6, 2023, the Communications Working Group reviewed the HEvKA project page on FEvIR and the HEvKA Confluence pages with multiple changes to improve their usefulness.

On January 13, 2023, the Communications Working Group reviewed the feedback seeking major revisions for a JAMIA Open submission of 'Introduction to EBMonFHIR' and selected 6 conferences with open calls for presentations for additional consideration:

  1. HL7 FHIR DevDays (DevDays 2023) https://www.devdays.com/devdays-2023/ June 6-9, 2023 in Amsterdam (or Hybrid online); Proposals due Feb 1
  2. Sci-K (2023 ACM Web Conference) https://sci-k.github.io/2023/ April 30-May 4, 2023 in Austin, Texas; Proposals due Feb 6
  3. The First International Workshop on Semantics in Dataspaces (SDS 2023) https://dbis.rwth-aachen.de/SDS23/ April 30-May 1, 2023 in Austin, Texas; Proposals due Feb 6
  4. EBHC Conference 2023 https://www.ebhcconference.org/home.it-IT.html October 25-28, 2023 in Taormina, Sicily; Proposals due Feb 28
  5. SciDataCon-International Data Week (SciDataCon-IDW Salzburg 2023) https://www.scidatacon.org/IDW-2023-Salzburg/submit/ October 23-26, 2023 in Salzburg (and hybrid); Proposals due Mar 31
  6. Guidelines International Network (GIN 2023) https://g-i-n.net/conference_2023/welcome Sep 19-22, 2023 in Glasgow (or Hybrid online); Proposals due ??? (call for presentations opens Jan 17)

On January 18, 2023 an update of EBMonFHIR was given to the HL7 BRR meeting at the January Working Group Meeting

https://docs.google.com/presentation/d/1Ep0b9CM4LMC_7wgc9R6PE98xgFN0uTjC/edit#slide=id.p1

On January 20, the Communications Working Group reviewed changes to the Introduction to EBMonFHIR for resubmission for publication, and added "Review Intro to EBMonFHIR Walkthrough" to the agenda for 3 HEvKA meetings next week.

On January 27, the Communications Working Group reviewed the last set of changes to the Introduction to EBMonFHIR (and response to reviewers) for resubmission for publication.

On February 3, the Communications Working Group reminded authors who were present regarding 2 publications near ready for submission or resubmission (Intro to EBMonFHIR, Study Design Terminology) and noted the next presentation proposal deadline is February 13 for a Guidelines International Network pre-conference course. We are accelerating our developments of the FEvIR™: Adaptation Builder/Viewer to provide a compelling experience for updating or adapting guidelines and hope to have this developed far enough to submit a compelling pre-conference course (or coordinate with others producing related courses).

On February 10, the Communications Working Group made multiple revisions to prepare the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal. 

On February 17, the Communications Working Group reviewed changes to FEvIRTM: CodeSystem Viewer support listing Authors/Editors, Reviewers and Endorsers to the SEVCO Release 1.1 (https://fevir.net/sevco) and the OSF posting of the SEVCO protocol (https://osf.io/5z84p/) in preparation for submitting the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" to the Clinical Trials journal. We also reviewed three open calls for presentation proposals that we will consider in the coming weeks:

  1. EBHC Conference 2023 https://www.ebhcconference.org/home.it-IT.html October 25-28, 2023 in Taormina, Sicily; Proposals due Feb 28
  2. AMIA 2023 Annual Symposium https://amia.org/education-events/amia-2023-annual-symposium November 11-15, 2023 in New Orleans; Proposals due Mar 8
  3. Guidelines International Network (GIN 2023) https://g-i-n.net/conference_2023/welcome Sep 19-22, 2023 in Glasgow (or Hybrid online); Proposals due Apr 4

We also completed applying four changes to the FHIR specification:

On February 24, the Communications Working Group reviewed open calls for proposals and discussed developments for Cochrane, AMIA, and MCBK submissions before the early March due dates.

On March 3, the Communications Working Group submitted 3 FAIRGround Demo proposals for the MCBK meeting in May, and drafted 2 proposals (1 Panel, 1 Systems Demo) for the AMIA Annual Meeting in November.

On March 10, the Communications Working Group updated the Clinical Reasoning Module - Evidence and Statistics page in the FHIR specification for R5 to cover the full set of Resource developments and link to the EBMonFHIR project page.

On March 17, the Communications Working Group updated the HEvKA 2022 Achievements and 2023 Plans with Notes as a high-level summary to be included in the HL7 Annual Review, and submitted a Panel Presentation and Systems Demo for the American Medical Informatics Association (AMIA) Annual Meeting.

On March 24, the Communications Working Group revised the SEVCO Study Design Terminology paper to be submitted for publication by Monday. We would also like to share an announcement for the upcoming GIN North America event: Bringing Guidelines to the Digital Age:  a one-day hands-on Human-Centered Design Workshop on April 21, 2023 near Chicago.

Scientific Evidence Code System (SEVCO) Updates

 

  • All are welcome to Help Shape the Scientific Evidence Code System (SEVCO) – an open effort to define terms for the expression of study design, statistics, and risk of bias used across the communication of science. We are following a Scientific Evidence Code System Development Protocol.
    • The SEVCO Progress Update and All-Group Discussion included a presentation by Joanne Dehnbostel and open discussion with Brian Alper on April 14, 2022.  The PowerPoint can be viewed here and the meeting recording can be viewed here.
    • 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. There are currently 39 people in the Scientific Evidence Code System Expert Working Group.
  • The code system (as it is developed) can be viewed at Scientific Evidence Code System (SEVCO) -- DRAFT ONLY (Not published for current use), and anyone is welcome to comment on any term by finding the term in the Term Detail view and clicking the Comment button
  • The first version ready for release includes 75 Study Design terms and 124 Bias terms and can be viewed at https://fevir.net/sevco.
  • 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.
  • Current progress on term development includes:
    • 75 of 75 (100%) Study Design terms approved
    • 154 of 235 (66%) Bias terms approved
    • 0 of 26 Rating of Bias terms approved
    • 91 of 138 (66%) Statistic terms approved
    • 0 of 104 Statistical Model terms approved
    • 320 of 578 (55%) TOTAL terms approved

 

Research Design Working Group Updates:

This group is currently drafting an article for the peer-reviewed literature to introduce the 75 Study Design terms completed for version 1 of SEVCO. This group reached 100% agreement for these 75 terms with 42 unique people from 18 countries (an average of 12 unique people contributing to an individual term).

On January 24, 2023, the Research Design Working Group continued drafting an article titled “Study Design Terminology in the Scientific Evidence Code System (SEVCO)” for submission to the Clinical Trials journal. 

On January 31, 2023, the Research Design Working Group reviewed the submission guidelines for the Clinical Trials journal to prepare the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission. 

On February 7, the Research Design Working Group modified the primary Results table to prepare the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal. 

On February 14, the Research Design Working Group worked to finalize the manuscript describing the creation of the study design terminology, which is the first part of the Scientific Evidence Code System (SEVCO). The group discussed the acknowledgements section of the paper and will be sending out emails to more than 50 individuals to be acknowledged in the paper.

We are very thankful to all of you that volunteered your time and helped us to build this important code system. The emails should go out in the next couple of days. Please let us know if you have been involved in this process and do not receive an email. We don’t want to omit anyone as you were all integral to this successful endeavor.   

On February 21, the Research Design Working Group continue to revise the text for the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal. 

On February 28, the Research Design Working Group made adjustments to improve the Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter so it can be cited as a key example of real-world application for the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal. We also were pleased to learn that our conference proposal to present on this subject was accepted for the Society for Clinical Trials (SCT) Annual Meeting in May in Baltimore.

On March 7, the Research Design Working Group adjusted the strengths section with more comments about the FAIR Guiding Principles for the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal. 

On March 14, the Research Design Working Group adjusted the discussion section with "Opportunities for research and development" including coordinating with current projects (such as NIH initiatives) and technology-related areas of semantic search, crowdsourcing, machine learning, and natural language processing. We are hoping to submit the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" for submission to the Clinical Trials journal by the end of the week. 

On March 21, the Research Design Working Group prepared the final changes to the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" to prepare for submission to the Clinical Trials journal. 

On March 28, the Research Design Working Group SUBMITTED the manuscript "Study Design Terminology in the Scientific Evidence Code System (SEVCO)" to the Clinical Trials journal, and started drafting the outline for a presentation on “Reporting Study Design with the Scientific Evidence Code System (SEVCO): A novel community-reviewed standard vocabulary” to be presented May 23 in the Society for Clinical Trials (SCT) annual conference. 

Statistic Standard and Terminology Working Group Updates:

This group is modeling the expression of statistics in the FHIR standard and setting the shape for the Evidence Resource, as well as defining statistics terms for SEVCO, hence the group name covering ‘Standard and Terminology’.  Current efforts are related to defining measures of dispersion and there are 0 terms open for vote:

Term

Definition

Alternative Terms

Comment for application









To participate you can join the Scientific Evidence Code System Expert Working Group at https://fevir.net/resources/Project/27845.

On January 11, 2023, the Statistic Standard and Terminology Working Group discussed Regression Coefficient and, before drafting a definition, needed to review the information model (within Evidence Resource) for how the terms will be used.  We mapped out a pattern using Evidence.statistic.modelCharacteristic.code for the statistical model term (e.g. Logistic Regression) and Evidence.statistic.modelCharacteristic.attributeEstimate.type for the statistic type term (e.g. Regression Coefficient). We started the development of a StatisticalModel Profile in the Evidence Based Medicine Implementation Guide – demonstrating why this working group is named “Standard and Terminology”.

On January 18, 2023, the Statistic Standard and Terminology Working Group drafted 1 additional term (Regression Coefficient). Next week we will define terms that are Measures of Dispersion to complete the “simple” set of statistic types for initial use. We will then consider changing our overall approach for the Statistic Standard and Terminology Working Group to start developing the implementation guidance for communicating statistics in computable form, and in doing so draft additional terms for statistic types and statistical model characteristics as we use them with implementation guidance.

On January 25, the Statistic Standard and Terminology Working Group approved 3 terms (Phi coefficient, Kendall Correlation Coefficient, Goodman and Kruskal’s Gamma) and drafted 1 additional term (Measure of Dispersion). 

Next week we will define terms that are Measures of Dispersion to complete the “simple” set of statistic types for initial use. We will then change our overall approach for the Statistic Standard and Terminology Working Group to start developing the implementation guidance for communicating statistics in computable form, and in doing so draft additional terms for statistic types and statistical model characteristics as we use them with implementation guidance. We will change the weekly meeting time for this group to Tuesdays 1 pm Eastern starting with the next meeting on January 31.

On January 31, the Statistic Standard and Terminology Working Group discussed multiple nuances involved in the Evidence Resource model when representing a Range along with another statistic value (e.g. mean or median) for a dataset (combination of variables). The Range data can be modeled as additional statistic types with singular quantities (minimum observed value, maximum observed value, difference between maximum and minimum observed values). However, in common practice, the Range has been reported as an "attribute estimate" (similar to the reporting of confidence intervals) while the Range is not truly an attribute of the primary statistical estimate. There is a 'convenience factor' in reporting ranges and similar measures of dispersion (interquartile range, standard deviation) as attribute estimates but it is not technically the same thing as attributes of the statistical estimate (such as p values, confidence intervals, and credible intervals). We will continue the modeling discussion next week to determine how we think this is best handled in FHIR representation of statistics, then return to definitions of Measures of Dispersion.

On February 7, the Statistic Standard and Terminology Working Group decided to change the meeting time to Mondays 2 pm Eastern to accommodate participants whose calendars changed, found 2 terms approved (Regression Coefficient, Measure of Dispersion), discussed coordination between SEVCO and STATO, and modelled the representation of Range data in FHIR (Sample Evidence with Range) ahead of defining the Range term.

On February 13, the Statistic Standard and Terminology Working Group drafted 2 statistic terms open for vote for SEVCO.  Next week we will model how to communicate then define terms that are types of Standard Deviation.

On February 20, the Statistic Standard and Terminology Working Group found 2 terms approved (Range, Interquartile range), and used the FEvIR™: Adaptation Builder/Viewer to convert the Sample Evidence with Range to Sample Evidence with Standard Deviation and discussed the potential uses of 'Standard Deviation' terms.  We will create examples of 'Standard Deviation for Population' to model next week, then draft terms based on the modeling exercise.

On February 27, the Statistic Standard and Terminology Working Group attempted to modify the Sample Evidence with Standard Deviation to include a use case for 'Standard Deviation of Population' and conceptualized this as part of the method for sample size estimation. In attempts to represent how this would be used in real-world communications of Evidence statistics, we realized we needed to modify the example from a univariate statistic (focusing on one group) to a comparative statistic (with an effect on a continuous outcome). Next week we will revise the model for this more complex and more meaningful scenario, then draft terms based on the modelling exercise.

On March 6, the Statistic Standard and Terminology Working Group modified the Sample Evidence with Standard Deviation to model a more complex and more meaningful scenario, with changes including (1) four variable definitions (Population = Patients with diabetes, Exposure = Drug A, Reference exposure = Placebo, Measured variable = Systolic blood pressure), (2) coding the statistic type as 'Difference in means', (3) coding an attribute estimate of the statistic as 'Standard error of the difference between means', (4) adding three model characteristics to the statistic (coded as 'Two sample t-test with equal variance', 'two-tailed test', and 'individual test alpha without multiple testing adjustment', and (5) adding a fourth model characteristic as a placeholder for 'The statistical analysis plan included a sample size calculation based on the goal of hypothesis testing for a difference < - 5 mm Hg using alpha 0.05 (95% confidence interval), beta 0.2, and assumptions of a population standard deviation of 15 mm Hg in the measurement of systolic blood pressure in both treatment and reference arms'. The exercise was excellent in better understanding the relations between the Evidence Resource structure and the various terms in the Scientific Evidence Code System (SEVCO). The next modeling development we will continue next week is to create a separate Evidence Resource (StatisticalModel Profile) to represent the Statistical Analysis Plan/sample size calculation data, and how this relates to the Evidence Resource with the results of the statistical analysis.

On March 13, the Statistic Standard and Terminology Working Group copied the Sample Evidence with Standard Deviation (an example Evidence Resource to model a statistical finding with a standard deviation) and created Sample StatisticalModel Profile of Evidence Resource (an example Evidence Resource to model the statistical model–endpoint analysis plan). It took a while to express the statistical model for the specific Evidence in text (unstructured) form due to the complexity of fully expressing a statistical model.  We developed the following example to subsequently model as structured data:

H0: The null hypothesis is that the absolute value of the difference in mean systolic blood pressure between a group assigned Drug A and a second group assigned Placebo is < 5 mm Hg.

HA: The alternative hypothesis is that the absolute value of the difference in mean systolic blood pressure between a group assigned Drug A and a second group assigned Placebo is >= 5 mm Hg.

The sample size calculation is based on the unpaired, equal-variance t-test statistic, which is defined as the difference in means divided by the pooled standard error of the difference, having a t-distribution with degrees of freedom equal to the total sample size minus two, with an alpha of 0.05 and a beta of 0.2, and the assumption that the population standard deviation of the measurement of systolic blood pressure is 15 mm Hg in both groups. The test further presumes that the observed data are each normally distributed and demonstrated to have the same standard deviation.

The statistics that will be reported include the mean systolic blood pressure, standard deviation of systolic blood pressure, and sample size in each group.

In the structured data portion of the Evidence.statistic element, we retained the statisticType data (Difference in means) and retained the quantity.unit data (mm Hg) and we deleted data in quantity.value, sampleSize.numberOfParticipants, and sampleSize.knownDataCount as the results data are not available at the time of the statistical/endpoint analysis plan. Next week we will continue to revise the attributeEstimate and modelCharacteristic data in the current Sample to remove extraneous concepts and add additional details to fully specify the statistical model.

On March 20, the Statistic Standard and Terminology Working Group substantially revised the Sample StatisticalModel Profile of Evidence Resource (an example Evidence Resource to model the statistical model–endpoint analysis plan). A pseudo-code structured representation of the statistical model looks like:

description: H0: The null hypothesis is that the absolute value of the difference in mean systolic blood pressure between a group assigned Drug A and a second group assigned Placebo is <= 5 mm Hg. HA: The alternative hypothesis is that the absolute value of the difference in mean systolic blood pressure between a group assigned Drug A and a second group assigned Placebo is > 5 mm Hg. The sample size calculation is based on the unpaired, equal-variance t-test statistic, which is defined as the difference in means divided by the pooled standard error of the difference, having a t-distribution with degrees of freedom equal to the total sample size minus two, with an alpha of 0.05 and a beta of 0.2, and the assumption that the population standard deviation of the measurement of systolic blood pressure is 15 mm Hg in both groups. The test further presumes that the observed data are each normally distributed and demonstrated to have the same standard deviation. The statistics that will be reported include the mean systolic blood pressure, standard deviation of systolic blood pressure, and sample size in each group.

statisticType: coding: {system: https://fevir.net/resources/CodeSystem/27270, code: STATO:0000457, display: Difference in means}

quantity: unit: mm Hg

attributeEstimate: {description: standard error (of difference in means) with units of measure mm Hg, type: coding: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:0000063
display: Standard error of the difference between means}, quantity: unit: mm Hg}

modelCharacteristic 1: {code: text: Hypothesis testing margin, value: 5 mm Hg}

modelCharacteristic 2: {code: {system: https://fevir.net/resources/CodeSystem/27270, code: STATO:0000303, display: Two sample t-test with equal variance}, text: unpaired t-test with homogenous variance}

modelCharacteristic 3: {code: {system: https://fevir.net/resources/CodeSystem/27270, code: STATO:0000287, display: two-tailed test}

modelCharacteristic 4: {code: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:0000085, display: individual test alpha without multiple testing adjustment}, value: 0.05}

modelCharacteristic 5: {code: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:beta, display: Beta}, value: 0.2}

modelCharacteristic 6: {code: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:sample-size, display: Sample size estimation}, text: The sample size calculation is based on the unpaired, equal-variance t-test statistic, which is defined as the difference in means divided by the pooled standard error of the difference, having a t-distribution with degrees of freedom equal to the total sample size minus two, with an alpha of 0.05 and a beta of 0.2, and the assumption that the population standard deviation of the measurement of systolic blood pressure is 15 mm Hg in both groups.}

---attributeEstimate 1: {description: alpha 0.05, type: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:0000085, display: individual test alpha without multiple testing adjustment}, quantity: 0.05}
---attributeEstimate 2: {description: beta 0.2, type: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:beta, display: Beta}, quantity: 0.2}

---attributeEstimate 3: {description: assumption that the population standard deviation of the measurement of systolic blood pressure is 15 mm Hg in both groups, type: {system: https://fevir.net/resources/CodeSystem/27270, code: TBD:0000051, display: Standard deviation for population}, quantity: 15 mm Hg}

modelCharacteristic 7: {code: text: The test further presumes that the observed data are each normally distributed.}

modelCharacteristic 8: {code: text: The test further presumes that the observed data are demonstrated to have the same standard deviation.}


On March 27, the Statistic Standard and Terminology Working Group continued to refine a representation of a statistical model (endpoint analysis plan) in an Evidence Resource with Sample StatisticalModel Profile of Evidence Resource. In doing so, the following terms were used from (or added to) the draft Scientific Evidence Code System:

To complete the model representation for this example, we need to determine if any of the following 3 concepts are to be represented as terms in SEVCO, and if so where to place them:

  • allocation ratio
  • assumption that observed data are normally distributed
  • assumption that observed data have the same standard deviation

Once these 3 concepts are addressed, we will resume drafting terms for vote – but greatly informed by how the ‘whole package’ is represented in structured data.


Risk of Bias Terminology and Tooling Working Group Updates:

This group is defining terms for > 200 types of bias based on a dozen commonly used risk of bias assessment tools. In doing so, ‘Risk of Bias Tooling’ was developed resulting in the Computable Publishing®: Risk of Bias Assessment Tool (RoBAT) and Computable Publishing®: Risk of Bias Assessment Reader (RoBAR), which was further enhanced by Risk of Bias Assessment Tool (RoBAT) Usability Research (RoBATUR) and this was presented at the Ninth International Congress on Peer Review and Scientific Publication September 8-10, 2022 as Development and Pilot Test of Risk of Bias Assessment Tool for Use in Peer Review.  Current efforts are related to defining types of Reporting Bias and 4 terms open for vote are:

Term

Definition

Alternative Terms

Comment for application

Results emphasized based on statistical significance

A cognitive interpretive bias in reporting whereby results with statistical significance are given exaggerated attention.


This bias may occur in several ways. Results may be interpreted as "positive" or "conclusive" if below the significance threshold and "negative" or "inconclusive" if above the significance threshold without proper interpretation of the meaning of the significance threshold. Results may be selectively emphasized in overall summarization of the results based on whether or not they are under the significance threshold.

Pre-final publication reporting bias

A reporting bias due to publication of results or research findings that may change in subsequent reports.

  • Preliminary publication reporting bias
  • Interim publication reporting bias

One form of Pre-final publication reporting bias is the reporting of results in preprints or early versions during the peer review and publication process.

Another form of Pre-final publication reporting bias is the reporting of interim results (even if fully peer reviewed) when a study is ongoing and more data will be analyzed for the final results.

Inadequate reporting of methods

A reporting bias due to insufficient reporting of methods to determine the validity of the results.

  • Inadequate reporting to assess analytic strategy
  • Inadequate methods reporting bias


Inadequate explanation of participant withdrawals

A reporting bias due to insufficient reporting of reasons for withdrawals of participants after study enrollment.

  • Inadequate explanation of participant attrition


To participate you can join the Scientific Evidence Code System Expert Working Group at https://fevir.net/resources/Project/27845.

On January 20, the Risk of Bias Terminology and Tooling Working Group revised 1 terms (Selective comparison reporting), dropped 1 term from the Code System (Selective analysis reporting from availability bias, considered already covered by Availability bias affecting analysis selection) and drafted 1 additional term (Selective analysis reporting from repeated analyses at multiple times).

On January 27, the Risk of Bias Terminology and Tooling Working Group approved 3 terms (Selective subgroup reporting, Selective comparison reporting, Selective analysis reporting from repeated analyses at multiple times) and drafted 2 terms open for vote for SEVCO.

On February 3, the Risk of Bias Terminology and Tooling Working Group introduced our terminology tooling to several people from Europe developing terminologies related to risk assessment of chemical exposures. We then drafted 1 term for vote (Cognitive interpretive bias in reporting) and also drafted 1 more term (Interpretation of findings not addressing risk of bias) that we will continue to discuss next week.

On February 10, the Risk of Bias Terminology and Tooling Working Group found 1 term approved (Selective analysis reporting from multiple analytic models) and revised 2 terms which were re-opened for vote for SEVCO.

On February 17, the Risk of Bias Terminology and Tooling Working Group drafted 1 new term (Interpretation of results not addressing potential for bias).

On February 24, the Risk of Bias Terminology and Tooling Working Group found 2 terms approved (Selective threshold reporting bias, Cognitive interpretive bias in reporting), added a comment to the Cognitive interpretive bias in reporting term (Cognitive interpretive biases in reporting include selective theory reporting, confirmation bias, bias of rhetoric, novelty bias, popularity bias, and positive results bias.), removed 5 of those ‘subtype’ terms from the code system, and drafted 1 new term (Confirmation bias in reporting).

On March 3, the Risk of Bias Terminology and Tooling Working Group found 1 term approved (Interpretation of results not addressing potential for bias), drafted 1 new term and moved it from Reporting Bias to Analysis Bias (Reported analysis not following pre-specified analysis plan), and moved 1 term from Reporting Bias to Rating of Factor Presence (Inadequate reporting to assess analytic strategy).

On March 10, the Risk of Bias Terminology and Tooling Working Group found 2 terms approved (Reported analysis not following pre-specified analysis plan, Confirmation bias in reporting), and drafted 3 terms within Reporting Bias (Inadequate Reporting Bias, Inadequate reporting of methods, Inadequate explanation of participant withdrawals).

On March 17, the Risk of Bias Terminology and Tooling Working Group removed one proposed term from the terminology (Inadequate Reporting Bias) as SEVCO Expert Working Group feedback highlighted that it was duplicative with “Selective Reporting Bias” and “Inadequate reporting of methods” and confusing to have a separate overlapping term. We drafted 1 additional term (Pre-final publication reporting bias).

On March 24, the Risk of Bias Terminology and Tooling Working Group drafted 1 additional term (Results emphasized based on statistical significance).

Standards Development Updates

We have made numerous changes to 5 FHIR Resources that we developed (ArtifactAssessment, Citation, Evidence, EvidenceVariable, EvidenceReport) as well as the ResearchStudy Resource and RelatedArtifact Datatype. Open items are noted as FHIR Tracker items.

The HL7® Biomedical Research and Regulation (BRR) Work Group completed the proposal for an Eligibility Criteria for Clinical Trials Implementation Guide and discussed the coordination between this proposal and the Evidence Based Medicine Implementation Guide. The group will reconvene on January 26 to discuss this coordination before formal development of another Implementation Guide.

On January 26, the HL7® Biomedical Research and Regulation (BRR) Work Group discussed preparations for an Eligibility Criteria Track at the EuroVulcan Connectathon in March. We also discussed the desire to have a Characteristic Resource in FHIR.  There were a dozen participants in attendance and common consensus that a dedicated core FHIR Resource is preferable to a Profile buried in a different Resource Structure. Reasons discussed for a distinct Resource with patterns that differ from other FHIR Resource structures included:

1) The Characteristic Resource needs to be more flexible and less opinionated than other FHIR Resources because the use cases are not tightly defined within a specific domain of health data exchange.

2) Data exchange regarding characteristics need to support data exchange between systems not developed around FHIR and FHIR-based systems.

3) Data exchange regarding characteristics at times need to support the exchange of concepts with structured data to support clear human understanding without regard for the representation of concepts within FHIR-based datasets AND at times need to support the exchange of concepts with structured data to support executable functions interacting with FHIR datasets.

On January 26, the Project Management Group applied changes to the FHIR specification:

On January 30, the Project Management Working Group applied the following changes to the FHIR specification:

  • For the EvidenceVariable Resource: Allow definitionExpression to have content in addition to other characteristic.definition[xxx] methods ( FHIR-39607 - Getting issue details... STATUS )
  • Align Citation, Evidence and EvidenceVariable with CanonicalResource changes ( FHIR-40316 - Getting issue details... STATUS )

On February 1, the HL7® Clinical Decision Support (CDS) Work Group approved the following changes to the FHIR specification:

On February 2, the HL7® Biomedical Research and Regulation (BRR) Work Group discussed the Characteristic Resource, an example at https://fevir.net/resources/Characteristic/111977, and the key reasons for supporting it as a distinct FHIR Resource:

    1. Easier implementation for many who know FHIR but not a specific expression language
      1. Easier readability
      2. Easier creation of content
    2. Better digital object management at the singular characteristic/expression level
      1. Digital object identification at the singular characteristic/expression level
      2. Findability at the singular characteristic/expression level – searching for the characteristic/expression itself (e.g. when building a cohort definition and wanting to find related characteristic expressions) is different than the matching function
      3. Usage metadata management (status, experimental, copyright, etc.) at the singular characteristic/expression level
    3. Greater expressiveness of abstract concepts
      1. Representation of the concept in structured form independent of a specified expression language
      2. Representation of concepts that are not ‘computable’ like comments and explanatory notes and subjective interpretations
    4. Potential linking or data conversion conduit between forms of expression (data input for content authors, CQL expressions, human-readable expressions)


On February 2, the Project Management Working Group applied the following changes to the FHIR specification:

  • FHIR-38846 - Add title to ArtifactAssessment RESOLVED - CHANGE REQUIRED
  • FHIR-38843 - Delete EvidenceVariable.subtitle RESOLVED - CHANGE REQUIRED
  • FHIR-38844 - Add valueRange to description for offset element in EvidenceVariable RESOLVED - CHANGE REQUIRED
  • FHIR-38845 - Improve descriptions for EvidenceVariable.characteristic.timeFromEvent RESOLVED - CHANGE REQUIRED


On February 7, the HL7® Biomedical Research and Regulation (BRR) Work Group discussed the Characteristic Resource, and additional use cases included documentation of specific criteria making individual patients ineligible for a study, facilitated by having unique identifiers for each characteristic.  Groups like CDISC have substantial datasets of characteristics (or terminologies for characteristics). The more use cases we get, the better the proposal for a Characteristic Resource will be.

On February 8, the HL7® Clinical Decision Support (CDS) Work Group approved the following changes to the FHIR specification: 

  1. No change to EvidenceVariable Resource but consider ParticipantFlow Profile of Evidence in Evidence Based Medicine IG development.
  2. Correct typographical error (Agreement Acope to Agreement Scope) in codesystem-usage-context-type
  3. Change 'certain adverse events' to 'specific outcomes (e.g. adverse events)' in 2 definitions in DefinitionMethod CodeSystem
  4. Add 3 terms (see comment) to EvidenceVariableEvent CodeSystem.


On February 9, the HL7® Biomedical Research and Regulation (BRR) Work Group started drafting a Characteristic FHIR Resource Proposal.  Key portions so far include:

Scope of coverage:

The Characteristic Resource describes a characteristic, factor, trait, or criterion used in the definition of criteria for membership in a group of entities. 

Resource appropriateness:

Characteristics, often called eligibility criteria, are well understood in the business of healthcare for selection of patients for many actions such as prior authorization, clinical trial participation, and clinical decision support delivery. Distinct, reliable, unique ids are used in cases where an individual is reported to be excluded from a group based on a specific characteristic and in maintenance of a library of characteristics. Content developers defining eligibility criteria, cohort definitions, phenotype definitions, etc. will independently create, query and maintain characteristics for re-use within and across organizations. Data exchange of characteristics currently suffers from no standardization that is searchable for the specific characteristic (as distinct from searching patient data for matching the characteristic). The Characteristic Resource has 22 "core" data elements in addition to the metadata pattern elements for a canonical resource.

Expected implementations:

Anyone expressing eligibility criteria (also called cohort definitions or phenotypes) may be expected to implement. Expected implementations include clinical trial recruitment (including feasibility assessment for research sites, pre-screening potentially eligible patients, and trial eligibility confirmation), clinical decision support delivery, prior authorization, and cohort selection for real-world data collection (research to generate real-world evidence). Initial implementations expected include representation of eligibility criteria for studies registered in ClinicalTrials.gov and the 'Representation of evidence-based clinical practice guideline recommendations on FHIR' as introduced in J Biomed Inform. 2023 Feb 2;104305. doi: 10.1016/j.jbi.2023.104305 https://pubmed.ncbi.nlm.nih.gov/36738871/

In addition, the extension of FHIR to support Evidence-Based Medicine knowledge transfer introduces many researchers, systematic literature reviewers, and clinical practice guideline developers that will implement tools to find, create, revise, and communicate characteristics for eligibility criteria for original research studies, for systematic reviews, and for clinical practice guideline recommendations.

Many HL7 communities using characteristics for cohort definitions include BRR, CDS, CQI, LHS, and FHIR-I Work Groups; and CodeX, Vulcan, and Helios Accelerators.

On February 15, the HL7® Clinical Decision Support (CDS) Work Group approved the following changes to the FHIR specification: 

FHIR-37346 - Getting issue details... STATUS - Add EvidenceVariable.characteristic.instances[x], also add EvidenceVariable.characteristic.duration[x]


On February 16, the HL7® Biomedical Research and Regulation (BRR) Work Group completed the Characteristic FHIR Resource Proposal and will bring it for vote for approval on Tuesday. 

On February 21, the HL7® Biomedical Research and Regulation (BRR) Work Group approved the Characteristic FHIR Resource Proposal by unanimous (15-0-0) vote. 

On February 22, the HL7® Clinical Decision Support (CDS) Work Group initiated communication with the HL7® Biomedical Research and Regulation (BRR) Work Group and HL7® Learning Health Systems (LHS) Work Group to coordinate meeting during the May 2023 HL7 Working Group Meeting to discuss Characteristic modeling and the Eligibility Criteria/Cohort Definition Connectathon developments.

On February 23, the HL7® Biomedical Research and Regulation (BRR) Work Group reviewed examples of Characteristic Resource with the FEvIR™: Characteristic Builder/Viewer and notified FHIR Management Group (FMG) of the Characteristic FHIR Resource Proposal.

On February 27, the HL7® Learning Health Systems (LHS) Work Group drafted an initial proposal for a Cohort Definition Track for the May 2023 HL7 FHIR Connectathon.  Please contact us if you expect to participate and help us shape this Connectathon Track.

On March 1, the HL7® FHIR Management Group reviewed the Characteristic FHIR Resource Proposal and suggested to use the Group Resource for this purpose and asked us to conduct an analysis to answer What will it take to make Group Resource amenable to Characteristic Profile?

On March 2, the HL7® Clinical Decision Support (CDS) Work Group revised the Cohort Definition Track for the May 2023 HL7 FHIR Connectathon to include 4 System Roles (Cohort Definition Content Creation/Editing, Cohort Definition Content Viewing, Cohort Definition Content Machine Interpretation, and Repository of 'Cohort Definition Characteristics') and 2 Testing Scenarios (Expressing Cohort Definitions and Finding Cohort Definition Characteristics).

On March 6, the HL7® Learning Health Systems (LHS) Work Group posted 2023 - 05 Cohort Definition Track to the HL7 Confluence page for the January 2023 Connectathon – the May 2023 Connectathon page is not yet available. Please contact us if you expect to participate and help us shape this Connectathon Track.

On March 7, the HL7® Biomedical Research and Regulation (BRR) Work Group reviewed the developing work regarding the Characteristic FHIR Resource Proposal, a partially completed example of Acute Coronary Syndrome treated with oral antiplatelets to match the Vulcan Real World Data Implementation Guide use case, and plans for the Cohort Definition Track for the May 2023 HL7 FHIR Connectathon which will soon be moved to the May 2023 Connectathon pages.

On March 9, the HL7® Biomedical Research and Regulation (BRR) Work Group reviewed the latest proposed Characteristic Resource StructureDefinition:

-all elements from MetadataResource Interface
-description                     0..1 markdown    Natural language description of the Characteristic
-note                               0..* Annotation    Additional or explanatory note
-exclude                          0..1 boolean         If true, preface definition with absence of
-definitionReference       0..1 Reference(Characteristic)
-definitionCanonical       0..1 Reference(Characteristic)
-definitionCodeableConcept 0..1 CodeableConcept
-definitionByTypeAndValue   0..1 BackboneElement
----type                                        1..1 CodeableConcept   The type of characteristic
----method                                   0..* CodeableConcept   How the characteristic value was determined
----device                                     0..1 Reference(Device | DeviceMetric)  Device used for determining characteristic value
----value[x]                                   1..1 CodeableConcept | boolean | Quantity | Range | Reference() | canonical()
----offset                                      0..1 CodeableConcept   Reference point for valueQuantity or valueRange
-definitionByCombination   0..1 BackboneElement
----code                                      1..1 code      all-of | any-of | at-least | at-most | except-subset | statistical
----threshold                               0..1 positiveInt       Provides the value of n when at-least or at-most code is used
----characteristic                         2..* Reference(Characteristic)
-instances[x]                        0..1 Quantity | Range     Number of occurrences meeting the characteristic
-duration[x]                         0..1 Quantity | Range     Length of time in which the characteristic is met
-timeFromEvent                  0..* BackboneElement
----description                           0..1 markdown
----note                                      0..* Annotation
----event[x]                                0..1 CodeableConcept | Reference() | dateTime
----quantity                               0..1 Quantity
----range                                   0..1 Range
-executableExpression      0..* BackboneElement
----classifier                              0..* CodeableConcept
----expression                          1..1 Expression

We made further progress in creating an example to represent the Acute Coronary Syndrome (ACS) with oral antiplatelets (OAPs) cohort definition used in the Vulcan RWD IG, and replied to comments on the Cohort Definition Zulip stream at https://chat.fhir.org/#narrow/stream/375683-cohort-definition.

On March 9, the HL7® Clinical Decision Support (CDS) Sub-Work Group for LHS Connectathon Coordination added a few examples of cohort definition instances to the Cohort Definition Track page for the May 2023 HL7 FHIR Connectathon at https://confluence.hl7.org/display/FHIR/2023+-+05+Cohort+Definition

On March 16, the HL7® Biomedical Research and Regulation (BRR) Work Group and HL7® Clinical Decision Support (CDS) Sub-Work Group for LHS Connectathon Coordination reviewed examples and discussed the implementation of expressing cohort definitions with EvidenceVariable.characteristic and with a ‘Characteristic Resource’ being used for optimal modelling. Detailed discussions about expectations for the Cohort Definition Track of May 2023 FHIR Connectathon led to several people planning to follow up with developers at their institutions regarding institution-specific benefits for participating.

On March 21, the HL7® Biomedical Research and Regulation (BRR) Work Group was shown the Sample StatisticalModel Profile of Evidence Resource as an example of the developing effort to support an endpoint analysis plan (and eventually a Statistical Analysis Plan).

On March 23., the HL7® Biomedical Research and Regulation (BRR) Work Group reviewed the Acute Coronary Syndrome treated with oral antiplatelets example of ‘Characteristic Resource’ (for the Vulcan RWD IG Cohort Definition example) and revised the Acute Coronary Syndrome ICD-10 Value Set Resource referenced within this example.

On March 23., the HL7® Clinical Decision Support (CDS) Sub-Work Group for LHS Connectathon Coordination discussed coordination of the Cohort Definition Track of May 2023 FHIR Connectathon with developments of several implementers (Epic, K-Grid), the discussions on the Cohort Definition Zulip stream at https://chat.fhir.org/#narrow/stream/375683-cohort-definition, and the cross-group (HL7 BRR WG and HEvKA Eligibility Criteria WG) efforts modeling the ‘Characteristic Resource’ in preparation for analysis of what it will take to adapt the Group Resource for all the use cases for data exchange of ‘Characteristic’ and ‘CohortDefinition’ objects.

On March 29, the HL7 Clinical Decision Support Work Group discussed coordination between the Canonical Resource Management Infrastructure Implementation Guide and the Evidence Based Medicine Implementation Guide. Our current thinking is the CRMI IG will cover things like CanonicalComposition and CanonicalArtifactAssessment Profiles for the ‘computable’ and ‘publishable’ versions of ‘shareable’ knowledge artifacts while the EBM IG will develop numerous Profiles for different ‘scientific domain’ aspects of the ‘scientific’ knowledge artifacts.  

On March 30, the HL7® Biomedical Research and Regulation (BRR) Work Group reviewed the Acute Coronary Syndrome treated with oral antiplatelets example of ‘Characteristic Resource’ (for the Vulcan RWD IG Cohort Definition example) and created the Initial diagnosis of Acute Coronary Syndrome (terminology-related expression variant 2) example to demonstrate how to use an expression to define a generated value set as an alternative to creating a ValueSet Resource. In developing this model, we added Expression as a datatype to Characteristic.definitionByTypeAndValue.value[x] in the proposed Characteristic Resource StructureDefinition.

On March 30, the HL7® Clinical Decision Support (CDS) Sub-Work Group for LHS Connectathon Coordination set April 27 as the Track Kickoff time for the Cohort Definition Track of May 2023 FHIR Connectathon and discussed coordination of the cross-group projects with potential developments of creating a virtual space in the HL7 LHS WG Confluence page and/or re-organizing the HEvKA Summary Update to consolidate Cohort Development efforts distinct from other Standards Development efforts.

EBM Implementation Guide Working Group Updates:

The EBMonFHIR project is an HL7 project sponsored by the HL7 Clinical Decision Support (CDS) Work Group and co-sponsored by the HL7 Biomedical Research and Regulation (BRR) and Clinical Quality Improvement (CQI) Work Groups. The EBMonFHIR Implementation Guide Working Group is an HL7 CDS WG EBMonFHIR project sub-WG meeting to facilitate HL7 processes for standard development and further develop the EBM Implementation Guide.

The EBMonFHIR project (HL7 PSS-2124) is formally named FHIR Resources for Evidence-Based Medicine Knowledge Assets (EBM-on-FHIR) and the FHIR Management Group has approved the development of an Evidence Based Medicine Implementation Guide (EBM IG). The EBM IG repository will be maintained at https://github.com/HL7/ebm.

The specific Profiles will change as we learn the best modeling, but we are currently anticipating 38 Profiles of 9 Resources (see https://fevir.net/resources/Project/29736) including:

  • ActivityDefinition Resource -- RecommendationAction Profile
  • ArtifactAssessment Resource -- Adaptation Profile –  CertaintyOfEvidence Profile – Classification Profile -- Comment Profile – OutcomeImportance Profile – Rating Profile -- RecommendationJustification Profile -- RiskOfBias Profile
  • Citation Resource -- GuidelineCitation Profile -- RecommendationCitation Profile -- StudyCitation Profile
  • Composition Resource -- EvidenceMap Profile -- EvidenceReport Profile -- EvidenceReportConstructor Profile
  • Evidence Resource -- ComparativeEvidence Profile -- ComparatorOnlyEvidence Profile -- InterventionOnlyEvidence Profile -- NetEffectEstimate Profile -- OutcomeEvidenceSynthesis Profile -- StudyOutcomeEvidence Profile -- ParticipantFlow Profile – StatisticalCalculator Profile – StatisticalModel Profile
  • EvidenceVariable Resource -- CohortDefinition Profile – EvidenceDataset Profile -- EvidenceReportSubject Profile -- InterventionDefinition Profile -- NetEffect Profile -- OutcomeDefinition Profile– ParticipantFlowMeasure Profile -- RecommendationEligibilityCriteria Profile -- StudyEligibilityCriteria Profile – SearchStrategy Profile
  • Group Resource -- StudyGroup Profile -- StudyGroupGroup Profile
  • ImplementationGuide Resource -- ClinicalPracticeGuideline Profile
  • PlanDefinition Resource -- RecommendationPlan Profile

On January 5, 2023, the EBM Implementation Guide Working Group learned how to facilitate the development of the EBM Implementation Guide using GitHub and SUSHI, and created a StudyCitation Profile as the first Profile. Later we were also able to add a StudyEligibilityCriteria Profile (partially developed from our prior work with the Eligibility Criteria Working Group and a BRR project noted below).

On January 12, 2023, the EBM Implementation Guide Working Group discussed the pattern of 'implementation guidance' being represented in any of 6 virtual spaces (1. the core FHIR spec descriptive pages, 2. the Resource-specific descriptive page in the core FHIR spec, 3. the element-specific definition and comments in the core FHIR spec Resource page, 4. the IG descriptive pages, 5. the Profile-specific descriptive page in the IG, 6. the element-specific definition and comments in the Profile-specific page in the IG) and we need to consider this as we write the EBM IG which is a foundational base IG for others to use to develop further upon. We noted that some of the proposed Citation Resource Profiles may not be sufficiently different from the core Citation Resource that we have been improving through this effort and decided to come back to the Citation set after working on other Resources with clear distinctions among the Profiles. Next week we will review the Evidence Resource and 5 clearly distinct Profiles of it.

On January 19, 2023, the EBM Implementation Guide Working Group reviewed an implementation of the Classification Profile of ArtifactAssessment Resource (through https://fevir.net/search), made initial changes to the Classification Profile in the EBM Implementation Guide, and was introduced to FSH Online to facilitate Profile creation from the Resource StructureDefinition JSON.

On January 26, 2023,  the EBM Implementation Guide Working Group reviewed the CRMI - Canonical Resource Management Infrastructure IG project page on the HL7 CDS Confluence page and used it as a model to create the EBM - Evidence Based Medicine IG project page on the HL7 CDS Confluence page, reviewed the changes to be applied to EBMonFHIR Resources to align with CanonicalResource changes (FHIR-40316), discussed the desire for a Characteristic Resource which will change the patterns for CohortDefinition Profile of EvidenceVariable, and reviewed the Introduction to EBMonFHIR walkthrough description of an Evidence Resource.

On February 2, the EBM Implementation Guide Working Group revised the StudyOutcomeEvidence Profile http://build.fhir.org/ig/HL7/ebm/StructureDefinition-study-outcome-evidence.html to include a fixed Coding value (NotApplicable) for the synthesisType element and increase the minimum number of variableDefinition element instances from 1 to 2.  The group also questioned how to properly encode the system value for the Coding when the canonical code system URL (at terminology.hl7.org, based on FHIR R4) does not contain the term found in FHIR R5.

On February 9, the EBM Implementation Guide Working Group reviewed Evidence Resource related CodeSystem Resources that have a presence in both the FHIR Build and terminology.hl7.org (THO). Three such CodeSystems (http://terminology.hl7.org/CodeSystem/variable-role, http://terminology.hl7.org/CodeSystem/statistic-type, http://terminology.hl7.org/CodeSystem/attribute-estimate-type) appear the same content-wise. Three CodeSystems, however, have better versions in the FHIR Build (http://build.fhir.org/codesystem-directness.html, http://build.fhir.org/codesystem-synthesis-type.html, http://build.fhir.org/codesystem-certainty-rating.html) and we created UTG Change Requests to update the THO version:

UP-394 - Getting issue details... STATUS

UP-395 - Getting issue details... STATUS

UP-396 - Getting issue details... STATUS

On February 16, the EBM Implementation Guide Working Group discussed FHIR trackers to advance their progress including:


On February 23, the EBM Implementation Guide Working Group noted the addition of 4 profiles to the EBM Implementation Guide (Comment, ComparativeEvidence, ComparatorOnlyEvidence, InterventionOnlyEvidence), revised 3 profiles (RecommendationAction, CertaintyOfEvidence, OutcomeImportance), and (based on the needs for the OutcomeImportance Profile) created a FHIR change request to add ArtifactAssessment.content.quantity ( FHIR-40513 - Getting issue details... STATUS ).

On March 2, the EBM Implementation Guide Working Group revised the OutcomeImportance Profile to include ArtifactAssessment.content.quantity with quantity.comparator 0..0 and quantity.unit = "%" and a comment for quantity.value of "The value must be 0 (no importance) or a positive decimal. The value of 100 represents the importance of the reference outcome. A value greater than 100 represents exceptionally high importance that is higher than the importance of the reference outcome."

On March 9, the EBM Implementation Guide Working Group learned how to create and use Extensions in FHIR Shorthand (FSH) and discussed the expected use of InterventionOnlyEvidence and ComparatorOnlyEvidence Profiles will be to add useContext elements specific for implementation. We adjusted the EBM Implementation Guide to use the 5.0.0-draft-final FHIR version and removed differentials from multiple Profiles that are now covered by the current R5 version.  We created a Rating Profile of ArtifactAssessment and revised the OutcomeImportance Profile of ArtifactAssessment.

On March 16, the EBM Implementation Guide Working Group reviewed the CohortDefinition Profile of EvidenceVariable (being used to prepare for the Cohort Definition Track of the May Connectathon) and improved the CertaintyOfEvidence, Classification, Comment, Rating, and RecommendationJustification Profiles of ArtifactAssessment. For the Profiles of ArtifactAssessment, we required content elements to have data in many cases and we created extensible binding to Value Sets for content.type and content.classifier elements for the CertaintyOfEvidence and RecommendationJustification Profiles. For the RecommendationJustification Profile we used Value Sets with codes from the Recommendation Justification Code System developed through the EBMonFHIR/HEvKA efforts.

On March 23, the EBM Implementation Guide Working Group revised the CertaintyOfEvidence Profile of ArtifactAssessment to add back (remove the deletion of) workflowStatus and disposition elements. We then created a RiskOfBias Profile of ArtifactAssessment and, for binding to RiskOfBias.content.type, a Risk of Bias Type Value Set which is defined by ‘Include codes from https://fevir.net/sevco where concept is-a SEVCO:00001’. We limited the artifactReference element of the RiskOfBias Profile to reference Evidence, Composition, ResearchStudy, or Citation Resources. This completes the first pass of all 8 Profiles of ArtifactAssessment Resource. Next week we will start on Profiles of Evidence Resource.

On March 30, the 

EBM Implementation Guide Working Group created and revised multiple Profiles of Evidence including:

  • ComparativeEvidence Profile
    • Description: Profile of Evidence for Evidence Based Medicine IG. The ComparativeEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and an exposure and reference exposure that is being compared.
    • variableDefinition 3..* comment = "To report comparative evidence for a research question defined by Population, Intervention, Comparator, and Outcome (PICO), one would use four variableDefinition instances. In the 4-variable approach, the Population has variableRole of population, the Intervention has variableRole of exposure, the Comparator has variableRole of referenceExposure, and the Outcome has variableRole of measuredVariable. In some types of Comparative Evidence, where the groups being compared are not from the same Population (and thus not a PICO-style research question), the combination of Population and Intervention is expressed with the variableRole of exposure, the combination of Population and Comparator is expressed with the variableRole of referenceExposure, and the Outcome is expressed with the variableRole of measuredVariable. The 3-variable approach may be used for example to compare cats and dogs."
  • NonComparativeEvidence Profile
    • Description: Profile of Evidence for Evidence Based Medicine IG. The NonComparativeEvidence Profile is used for evidence about a single group with no comparisons between groups.
    • variableDefinition 2..*
  • InterventionOnlyEvidence Profile
    • Description: Profile of Evidence for Evidence Based Medicine IG. The InterventionOnlyEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and an exposure that is the intervention of interest in a comparative evidence. The InterventionOnlyEvidence descirbes the evidence for the intervention group.
    • variableDefinition 2..* comment = "To report intervention-only evidence for a research question defined by Population, Intervention, Comparator, and Outcome (PICO), one would use three variableDefinition instances. In the 3-variable approach, the Population has variableRole of population, the Intervention  has variableRole of exposure, the Comparator is not included in the ComparatorOnlyEvidence, and the Outcome has variableRole of measuredVariable. In some types of InterventionOnlyEvidence, where the groups being compared are not from the same Population (and thus not a PICO-style research question), the combination of Population and Intervention is expressed with the variableRole of exposure, and the Outcome is expressed with the variableRole of measuredVariable. The 2-variable approach may be used for example to compare cats and dogs."
    • useContext 1..* with an attempt to required a useContext.code = {Coding for Program} and useContext.valueCodeableConcept.text = “intervention-only-evidence” BUT WE DID NOT GET THE IG BUILD TO WORK (NEED TO LEARN HOW TO EXPRESS THIS IN FSH)
  • ComparatorOnlyEvidence Profile
    • Description: Profile of Evidence for Evidence Based Medicine IG. The ComparatorOnlyEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and an exposure that is the reference expsoure in a comparative evidence. The ComparatorOnlyEvidence descirbes the evidence for the comparator group.
    • variableDefinition 2..* comment = "To report comparator-only evidence for a research question defined by Population, Intervention, Comparator, and Outcome (PICO), one would use three variableDefinition instances. In the 3-variable approach, the Population has variableRole of population, the Intervention is not included in the ComparatorOnlyEvidence, the Comparator has variableRole of exposure, and the Outcome has variableRole of measuredVariable. In some types of ComparatorOnlyEvidence, where the groups being compared are not from the same Population (and thus not a PICO-style research question), the combination of Population and Comparator is expressed with the variableRole of exposure, and the Outcome is expressed with the variableRole of measuredVariable. The 2-variable approach may be used for example to compare cats and dogs."
    • useContext 1..* with an attempt to required a useContext.code = {Coding for Program} and useContext.valueCodeableConcept.text = “comparator-only-evidence” BUT WE DID NOT GET THE IG BUILD TO WORK (NEED TO LEARN HOW TO EXPRESS THIS IN FSH)
  • StatisticalCalculator Profile
    • Description: Profile of Evidence for Evidence Based Medicine IG. The StatisticalCalculator Profile is used for specification of the executable formula corresponding to a statistical model (for a statistical analysis plan or applied analysis)

Eligibility Criteria Working Group Updates:

Developments to support expression of structured eligibility criteria with FHIR include:

On January 6, 2023, the Eligibility Criteria Working Group discussed modeling of EvidenceVariable Resource including characteristic.definitionByTypeAndValue.valueId usage; relatedArtifact usage for “derived-from”, “transformed-with”, and “cite-as” relationship types; useContext usage for different applications of EvidenceVariable Resource creation (e.g. consolidating different natural language processing inputs into a final adjudication form for clinical application); and relations between PlanDefinition and EvidenceVariable Resources. We demonstrated the use of Eligibility Criteria Matching Software Library and FEvIR™: SoftwareScript Builder/Viewer for the representation of a ‘Characteristic Resource’.

On January 13, 2023, the Eligibility Criteria Working Group discussed the EvidenceVariable StructureDefinition and model uses of EvidenceVariable for characteristic definitions that combine other characteristic definitions, and the need for "Characteristic Resource" and the potential for meeting this need through the StudyEligibilityCriteria Profile or another related Profile.

On January 20, the Eligibility Criteria Working Group discussed the importance of creating Profiles for eligibility criteria specification (also called cohort definitions or phenotypes) and Profiles for characteristics used in building eligibility criteria specifications and supporting libraries for sharing cohort definitions and characteristics.  The characteristic concept is used across Group, EvidenceVariable, and Measure Resources and there is a need to making the characteristic definitions shareable in isolation from specific Group, EvidenceVariable, and Measure Resources. There is a concern with doing all of this as Profiles of EvidenceVariable Resource where the naming 'EvidenceVariable' would not be expected for many of the communities using characteristics for cohort definitions. With all the developments across EBMonFHIR, CDS/CQL, CodeX, Vulcan RWD, Vulcan Phenopackets, Helios, etc., there is a great need to coordinate efforts to standardize the expression of eligibility criteria/cohort definitions/authorization criteria/phenotype definitions (whatever the phrase, it is about representing a set of characteristics to define a group) -- we will propose a Characteristic Resource so this is not "buried" under a Profile of EvidenceVariable Resource.

On January 27, the Eligibility Criteria Working Group discussed a current implementation that is using an EvidenceVariable Resource for each characteristic in a set of inclusion and exclusion criteria, and then referencing these characteristics to build an EvidenceVariable Resource to represent the set of eligibility criteria. We discussed that we could simplify the EvidenceVariable Resource by reducing 5 elements (characteristic, characteristic.linkId, characteristic.description, characteristic.note, characteristic.definitionId) if we used referencing to each characteristic as a separate Resource. As a start to demonstrate this approach, we create a 'possible StructureDefinition' of a Characteristic Resource at https://fevir.net/resources/Characteristic/30934 and started to create StudyEligibilityCriteria: Characteristic Set for Bariatric Surgery Randomized Trial (Diabetes Surgery Study) (https://fevir.net/resources/Characteristic/111977) to re-create StudyEligibilityCriteria: Eligibility Criteria for Bariatric Surgery Randomized Trial (Diabetes Surgery Study) (https://fevir.net/resources/EvidenceVariable/32120) in the form of Characteristic Resources.

On February 3, the Eligibility Criteria Working Group reviewed and planned coordination with discussion occurring in HL7 Biomedical Research & Regulation (BRR) and Learning Health System (LHS) Work Groups. We also discussed information models for representing a characteristic that may be defined with a codeable concept (e.g. a SNOMED-CT term) but functionally needs to be defined by a combination of characteristics to interrogate laboratory values in FHIR-based data where the codeable concept is just a term defining the combination of laboratory test result findings.  The CodeSystem resource supports a string-based definition for each term. Mapping to a characteristic-based definition could potentially occur via an addition of definitionReference element to CodeSystem.concept to reference another resource for a structured definition, by development of a CharacteristicMap concept similar to ConceptMap for mapping terminologies, or creating a Characteristic Resource with 'any-of' combination of the two different methods for defining the characteristic.

On February 10, the Eligibility Criteria Working Group revised the EuroVulcan Eligibility Criteria Connectathon Track for the EUROVULCAN Conference and Connectathon in Paris March 14th and 15th.

On February 17, the Eligibility Criteria Working Group reviewed and made minor revisions to the Characteristic FHIR Resource Proposal and the EuroVulcan Eligibility Criteria Connectathon Track for the EUROVULCAN Conference and Connectathon in Paris March 14th and 15th.

On February 24, the Eligibility Criteria Working Group reviewed the FEvIR™: Characteristic Builder/Viewer and demonstrated the use cases for Characteristic.definitionByCombination.code = 'except-subset' and for Characteristic.expression having 0..* cardinality.

On March 3, the Eligibility Criteria Working Group added an expected participant to the Cohort Definition Track for the May 2023 HL7 FHIR Connectathon and discussed the response to the Characteristic FHIR Resource Proposal with a suggestion from FHIR Management Group to use the Group Resource for this purpose and ask of us to conduct an analysis to answer What will it take to make Group Resource amenable to Characteristic Profile?  

We desire to demonstrate specific use cases to ground the model for Characteristic expression, then use those examples to provide such an analysis. 

We discussed three possible options for making the examples: (1) a Profile of Group Resource, (2) a Profile of EvidenceVariable Resource, or (3) a 'Characteristic Resource' developed solely for the example demonstration. The group thought it was most efficient to model the ideal state for the use cases without compromise of extensions and fitting prior models designed for other purposes.

We discussed sharing phenotype expressions for use with other systems such as HDR UK Phenotype Library. Upon demonstrating an example, we found our proposed expression 0..* Expression element lacked the metadata needed to recognize the association of an expression with a specific library or for a particular purpose. Therefore, we modified our draft model for a Characteristic Resource to include executableExpression 0..* BackboneElement which includes 2 elements:  classifier 0..* CodeableConcept and expression 1..1 Expression.  Creating extensions upon extensions for this type of modeling presented a good example for the team of implementers to support our decision to develop our model in the conceptual space of a new resource before addressing how other Resources could be profiled or extended to meet the need.

On March 10, the Eligibility Criteria Working Group added a CharacteristicDefinition Extension and CohortDefinition Profile to the Evidence Based Medicine Implementation Guide. We then developed CohortDefinition instances for two of our working examples: R6 StudyEligibilityCriteria: Acute Coronary Syndrome treated with oral antiplatelets and R6 StudyEligibilityCriteria: Eligibility Criteria for Bariatric Surgery Randomized Trial (Diabetes Surgery Study).

On March 17, the Eligibility Criteria Working Group reviewed the following with multiple participants of the Vulcan FHIR Accelerator Schedule of Activities Project:


On March 24, the Eligibility Criteria Working Group completed the Acute Coronary Syndrome treated with oral antiplatelets example by creating an Oral anticoagulant value set. Because the Acute Coronary Syndrome ICD-10 Value Set created for the Initial diagnosis of Acute Coronary Syndrome Characteristic was rather complex, we discussed an alternative using a terminology-related expression language.  We created Initial diagnosis of Acute Coronary Syndrome (terminology-related expression variant) to model it, and then added Characteristic.definitionByTypeAndValue.calculatedAs to our proposed Characteristic Resource StructureDefinition:

-all elements from MetadataResource Interface
-description                     0..1 markdown    Natural language description of the Characteristic
-note                               0..* Annotation    Additional or explanatory note
-exclude                          0..1 boolean         If true, preface definition with absence of
-definitionReference       0..1 Reference(Characteristic)
-definitionCanonical       0..1 Reference(Characteristic)
-definitionCodeableConcept 0..1 CodeableConcept
-definitionByTypeAndValue   0..1 BackboneElement
----type                                        1..1 CodeableConcept   The type of characteristic
----method                                   0..* CodeableConcept   How the characteristic value was determined
----device                                     0..1 Reference(Device | DeviceMetric)  Device used for determining characteristic value

----calculatedAs                            0..1 Expression              Formula used for determining characteristic value
----value[x]                                   1..1 CodeableConcept | boolean | Quantity | Range | Reference() | canonical() | Expression

----offset                                      0..1 CodeableConcept   Reference point for valueQuantity or valueRange
-definitionByCombination   0..1 BackboneElement
----code                                      1..1 code      all-of | any-of | at-least | at-most | except-subset | statistical
----threshold                               0..1 positiveInt       Provides the value of n when at-least or at-most code is used
----characteristic                         2..* Reference(Characteristic)
-instances[x]                        0..1 Quantity | Range     Number of occurrences meeting the characteristic
-duration[x]                         0..1 Quantity | Range     Length of time in which the characteristic is met
-timeFromEvent                  0..* BackboneElement
----description                           0..1 markdown
----note                                      0..* Annotation
----event[x]                                0..1 CodeableConcept | Reference() | dateTime
----quantity                               0..1 Quantity
----range                                   0..1 Range
-executableExpression      0..* BackboneElement
----classifier                              0..* CodeableConcept
----expression                          1..1 Expression

GRADE Vocabulary Working Group Updates:

Coordination of multiple GRADE Working Group participants and related organizations with interests in standard terminology representation of GRADE vocabulary for certainty of evidence and evidence-to-decision judgments resulted in a GRADE project proposal and a new GRADE Vocabulary Working Group.

On January 6, the GRADE Vocabulary Working Group reviewed the Scientific Evidence Code System (SEVCO) project to learn about the SEVCO development protocol and the use of CodeSystem Builder/Viewer and My Ballot tools on the FEvIR Platform for SEVCO development, in anticipation of re-use of systems and experiences for planning a GRADE Vocabulary development protocol.  The group also decided to change the weekly meeting times from Fridays 8 am Eastern to Thursdays 1 pm Eastern starting on February 2.

On January 13, the GRADE Vocabulary Working Group decided to capture the effort to create a GRADE Vocabulary development protocol and produce a publication introducing a generic or base protocol for terminology development. A project page was created for Protocol Development for Terminology Development.

On January 20, the GRADE Vocabulary Working Group clarified plans to develop two distinct but related communications related to 'Protocol Development' – a detailed methodology for GRADE Vocabulary Development (and a derivative framework methodology for Terminology Development that can be used for other terminology development projects), and a project summary for the GRADE Vocabulary Development.

On January 27, the GRADE Vocabulary Working Group discussed repeating a polling of group members to find an optimal time for the weekly meetings, and discussed the benefits of a controlled vocabular for GRADE, including the value of machine-readable vocabulary specifically for GRADE - to make the GRADE vocabulary immediately available for easy use in software tools used to develop systematic reviews and guidelines.

On February 2, the GRADE Vocabulary Working Group mapped out the first 5 steps (modified from a prior 13-step protocol) for the GRADE Vocabular Development Protocol and decided to return to Friday 8 am Eastern weekly meetings after surveying the group members for an optimal meeting time.

On February 10, the GRADE Vocabulary Working Group completed mapping a 10-step protocol (derived from the SEVCO protocol) and converted the protocol to outline form for continued revision work.

On February 17, the GRADE Vocabulary Working Group summarized a simple listing of 103 terms (noted from our prior efforts at https://fevir.net/resources/CodeSystem/27833) for the initial draft scope of the GRADE Vocabulary:

  • 18 Certainty of Evidence Domain terms - Overall certainty, Risk of bias, Inconsistency, Indirectness (5 types), Imprecision, Publication bias, Dose response gradient, Plausible confounding, Large effect, Direct effect estimate, Indirect effect estimate, Incoherence, Intransitivity
  • 5 Certainty of Evidence Rating terms - High certainty, Moderate certainty, Low certainty, Very low certainty, No evidence
  • 12 Certainty of Evidence Domain Rating terms - no serious concern, serious concern, very serious concern, extremely serious concern, present, absent, no change to rating, reduce rating -1, reduce rating -2, reduce rating -3, increase rating +1, increased rating +2
  • 2 Recommendation Domain terms - Strength of Recommendation, Direction of Recommendations
  • 6 Recommendation Rating terms - Strong, Weak, For, Against, Good practice statement, Recommendation to use intervention only in research
  • 16 Decision Factor terms - Problem Importance, Desirable Effects, Undesirable Effects, All critical and important effects, Values Variability, Balance of Effects, Resources Required, Cost-effectiveness, Equity, Acceptability, Feasibility, Test Accuracy, Test's Effects, Natural Course (Prognosis), Intervention Effects (Management Effects), Link between Test results and Management
  • 24 Decision Factor Rating terms - 10 ‘magnitude rating’ terms, 4 ‘variability rating’ terms, 5 ‘direction of effect rating’ terms, 5 ‘cost rating’ terms

On February 24, the GRADE Vocabulary Working Group discussed the distinctions between developing manuscripts for publications as GRADE concept papers or GRADE guidance papers (with formal protocols defined by the GRADE Working Group) and developing machine-interpretable structured terminologies to represent the GRADE Vocabulary.

On March 3, the GRADE Vocabulary Working Group decided to prioritize the drafting of 'Developing a structured vocabulary for GRADE: a GRADE concept paper' for presentation at the GRADE Working Group meeting in Split, Croatia in May.

On March 10, the GRADE Vocabulary Working Group discussed the objectives of 'Developing a structured vocabulary for GRADE: a GRADE concept paper' to be drafted by May 10 for presentation at the GRADE Working Group meeting in Split, Croatia in May. The concept paper should include an explanation of what a structured vocabulary is, the benefits of a structured vocabulary, how (in general terms) we expect to develop a structured vocabulary, and examples of a structured representation of a GRADE vocabulary term.

On March 17, the GRADE Vocabulary Working Group drafted the outline and key concepts for 'Developing a structured vocabulary for GRADE: a GRADE concept paper'.

On March 24, the GRADE Vocabulary Working Group discussed the key examples to demonstrate the value for 'Developing a structured vocabulary for GRADE: a GRADE concept paper'.  One example is "Indirectness" where representation of "Indirectness in population definition" and "Indirectness in intervention definition" may be subtypes with value in structured form.  For example, one may wish to search for evidence with no indirectness in population definition (exact match for the population) but accept modest indirectness in intervention definition (allowed for related interventions), or conversely search for evidence for the exact intervention of interest in related-but-different populations. Another example is "Certainty of evidence" which may differ when "noncontextualized" (such as in the report of a systematic review) from when "contextualized" (such as in a guideline panel assessment for a specific recommendation). One may wish to search for Moderate-to-high certainty evidence from systematic reviews or Low-to-high certainty evidence used in guidelines. If you have any clinically relevant examples for these concepts, please share—we would like to find examples that are easy to understand and compelling.

Platform Development Updates

  • The Fast Evidence Interoperability Resources (FEvIR) Platform is set up to support a hub for data exchange using the HL7® FHIR® standard. (FHIR is the registered trademark of Health Level Seven International (HL7) and the use does not constitute endorsement by HL7.)
    • The FEvIR Platform is available for use now, but is “pre-release”.  The current version is 0.117.2 (March 20, 2023). Viewing resources is open without login.  Signing in is free and required to create content (which can then only be edited by the person who created the content).
    • Release notes can be found at https://fevir.net/resources/Project/29394.
    • Release 0.113.1 (March 13, 2023) adds line wrapping to the display of data using Expression datatype.
    • Release 0.114.0 (March 14, 2023) applies the startCollapsed mode to Identifier data entry within Reference-specific data entry, adds spacing between contributor names in the auto-generated "How to Cite" citation summaries for FEvIR Platform resources, and adds "Update the Resource to refresh How to Cite information if the content has changed." in the How to Cite section in Builder tools.
    • Release 0.115.0 (March 15, 2023) changes the "Add Resource JSON" button on the FEvIR Start Page to a "Create New Resource" button; supports human-friendly data entry for a resource title, selection of a resource type, and optional selection of a profile type (for selected resource types); and upon clicking the "Submit" button creates a new Resource on the FEvIR Platform with the user entering the Resource-specific/Profile-specific Builder tool.
    • Release 0.116.0 (March 15, 2023) displays helper text with Resource and Profile choices in the data entry form for "Create New Resource" and revises some backend platform functions to improve performance.
    • Release 0.117.0 (March 16, 2023) reorganizes the buttons to access tools on the FEvIR Start Page and adds organizing labels (Builder Tools, Converter Tools, Specialized Tools), revises the Active HEvKA Projects list on the FEvIR Start Page, and provides a link on the FEvIR Start Page to View All Projects.
    • Release 0.117.1 (March 17, 2023) corrects the "Create New Resource" tool to use the CohortDefinition Profile as an option when EvidenceVariable Resource is selected.

    • Release 0.117.2 (March 20, 2023) uses Citation.useContext elements for FEvIR Platform Use to coordinate with Classification Profile classifications of Resources on the FEvIR Platform.

  • FEvIR™ API Release 0.1.0 (December 21, 2022) supports 2 interactions:
    • 1 -- a GET request with input of a single FEvIR Object Identifier (FOI) and an authentication token and response of the selected Resource as a JSON object.
    • 2 -- a GET request with input of a single ClinicalTrials.gov record identifier (NCTId) and an authentication token and response of the ClinicalTrials.gov record data as a FHIR Bundle Resource.
  • The FEvIR Platform has 17 Builder Tools that are available when logged in, and 23 Viewer Tools that are available without logging in.
    • Builder Tools enable creation of a FHIR Resource without any working knowledge of FHIR or JSON.
    • Viewer Tools enable human-friendly viewing of a FHIR Resource. Views may include outline representation of the JSON and/or specialized views based on the resource type.
    • FEvIR™: ActivityDefinition Builder/Viewer version 0.17.0 (March 13, 2023) creates and displays an ActivityDefinition Resource.
      • Release 0.17.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: Adaptation Builder/Viewer version 0.19.0 (March 13, 2023) creates and displays an ArtifactAssessment Resource with an Adaptation Profile.
      • Release 0.19.0 (March 13, 2023) adds automatic creation of a related artifact element with a citation for the resource upon resource updating.
    • FEvIR™: Characteristic Builder/Viewer version 0.4.0 (March 17, 2023) creates and displays a Characteristic Resource.
      • Release 0.3.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating, and improves the vertical spacing between items in the Description column of tables.
      • Release 0.4.0 (March 17, 2023) replaces the expression 0..* element with and executableExpression 0..* BackboneElement (classifier 0..* CodeableConcept, expression 1..1 Expression) to support metadata exchange associated with Expression data exchange.
    • FEvIR™: Citation Builder/Viewer version 1.18.0 (March 20, 2023) creates and displays a Citation Resource.
      • Release 1.17.0 (March 14, 2023) adds JSON Outline to the Navigation menu and enables editing and display of Citation Metadata for date, purpose, copyright, effectivePeriod, relatedArtifact, and note elements for the Citation Resource.
      • Release 1.18.0 (March 20, 2023) displays Use Context data in the Citation Metadata under FEvIR Platform use:, converts Citation.classification data regarding FEvIR Platform use to Citation.useContext data regarding FEvIR Platform use, supports display of Third-Party Classifiers when such classifications are based on Citation.citedArtifact.classification.artifactAssessment referencing an ArtifactAssessment Resource on the FEvIR Platform, and supports display of Third-Party Classifiers when such classifications are based on Classification Profiles of ArtifactAssessment on the FEvIR Platform which are classifications of the cited artifact FOI when the Use Context of FEvIR Platform use is a FHIR Resource.
    • FEvIR™: Classification Builder/Viewer version 0.3.0 (March 13, 2023) creates and displays an ArtifactAssessment Resource with a Classification Profile.
      • Release 0.3.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: CodeableConcept Element Builder version 0.6.2 (April 13, 2022) creates FHIR JSON for a CodeableConcept datatype.
    • FEvIR™: CodeSystem Builder/Viewer version 0.33.0 (March 10, 2023) creates and displays code system terms (concepts) in a CodeSystem Resource.
      • Release 0.33.0 (March 10, 2023) adds How to Cite, Metadata, Classifiers, and JSON Outline sections to the Navigation Menu, adds the automatic How-to-Cite generation to the CodeSystem Builder, and supports the metadata pattern editing and viewing features.
    • FEvIR™: Comment Builder/Viewer version 0.3.0 (March 13, 2023) creates and displays an ArtifactAssessment Resource with a Comment Profile.
      • Release 0.3.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: Composition Viewer version 0.5.0 (September 20, 2022) displays a Composition Resource.
    • FEvIR™: Evidence Builder/Viewer version 0.25.0 (March 13, 2023) creates and displays an Evidence Resource.
      • Release 0.24.0 (March 8, 2023) reorganizes the Navigation Menu for the Evidence Viewer and adds How to Cite, Metadata, and Classifiers sections; and provides a fully functioning Evidence Builder in the Text View, including use of SEVCO terms for Evidence.studyDesign, Evidence.statistic.statisticType, and Evidence.statistic.attributeEstimate.type elements.
      • Release 0.25.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: Evidence Report Viewer version 0.8.4 (December 23, 2021) displays an Evidence Report Resource.
    • FEvIR™: EvidenceVariable Builder/Viewer version 0.20.1 (March 17, 2023) displays an EvidenceVariable Resource.
      • Release 0.20.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating with the CharacteristicDefinition Builder, and adds automatic creation of a related artifact element with a citation for the resource upon resource updating with the EvidenceVariable Builder.
      • Release 0.20.1 (March 17, 2023) corrects the "CharacteristicDefinition Builder" to become a CohortDefinition Builder and use the CohortDefinition Profile of EvidenceVariable Resource.
    • FEvIR™: Group (Population/Sample) Builder/Viewer version 0.14.0 (May 26, 2022) creates and displays a Group Resource.
    • FEvIR™: PlanDefinition Builder/Viewer version 0.1.0 (March 13, 2023) creates and displays a PlanDefinition Resource.
      • Release 0.1.0 (March 13, 2023) introduces FEvIR™: PlanDefinition Builder/Viewer to provide a human-friendly summary of a PlanDefinition Resource. The initial Builder supports editing metadata elements in the Text View.
    • FEvIR™: Project Builder/Viewer version 0.42.1 (March 20, 2023) creates and displays a “Project” Resource (which is not a FHIR Resource).
      • Release 0.42.0 (March 13, 2023) adds automatic creation of a related artifact element with a citation for the resource upon resource updating.
      • Release 0.42.1 (March 20, 2023) creates Citation.useContext data instead of Citation.classification data for FEvIR Platform use for Citations created from the Project page.
    • FEvIR™: Questionnaire Viewer version 0.4.0 (November 16, 2022) displays a Questionnaire Resource.
    • FEvIR™: QuestionnaireResponse Builder version 0.3.1 (February 28, 2022) creates a QuestionnaireResponse Resource. The tool displays the Questionnaire based on the Questionnaire Resource (FHIR JSON) with a human-friendly interactive form for data entry.
    • FEvIR™: Rating Builder/Viewer version 0.3.0 (March 13, 2023) creates and displays an ArtifactAssessment Resource with a Rating Profile.
      • Release 0.3.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: Recommendation Justification Builder/Viewer version 0.19.0 (March 13, 2023) creates and displays a RecommendationJustification Profile of an ArtifactAssessment Resource.
      • Release 0.19.0 (March 13, 2023) adds automatic creation of a related artifact element with a citation for the resource upon resource updating.
    • Computable Publishing®: Recommendation Viewer version 0.9.0 (January 3, 2022) displays a Recommendation Resource. The ‘Recommendation Resource’ is an earlier prototype.
    • FEvIR™: Research Study Viewer version 0.3.0 (February 28, 2023) displays a ResearchStudy Resource.
      • Release 0.3.0 (February 28, 2023) sets the expand/collapse features for the JSON Outline in Text View to start in expanded mode.
    • FEvIR™: Resource Viewer version 0.7.1 (November 7, 2022) displays a Text View of JSON in outline form without the JSON format to any Resource on the FEvIR Platform without a specialized Viewer.
    • Computable Publishing®: SchemaElement Builder/Viewer version 0.4.0 (June 28, 2022) creates and displays a SchemaElement Resource. The ‘SchemaElement Resource’ is a prototype developed to support the Common Metadata Framework project and is not planned for development as a FHIR Resource.
    • FEvIR™: SoftwareScript Builder/Viewer version 0.7.0 (March 13, 2023) creates and displays a SoftwareScript Resource (a method of sharing code scripts).
      • Release 0.7.0 (March 13, 2023) removes the needs for double updating to update How to Cite data upon resource updating.
    • FEvIR™: ValueSet Builder/Viewer version 0.7.0 (March 10, 2023) creates and displays a ValueSet Resource.
      • Release 0.7.0 (March 10, 2023) adds How to Cite, Metadata, Classifiers, and JSON Outline sections to the Navigation Menu, adds the automatic How-to-Cite generation to the CodeSystem Builder, and supports the metadata pattern editing and viewing features.
  • The FEvIR Platform has 7 Specialized Tools.
    • Computable Publishing®: Evidence Report Generator version 0.7.1 (February 22, 2023) automatically generates one or more Composition Resources with EvidenceReport Profile. (You can test it with Project 104063.)
      • Release 0.7.0 (January 24, 2023) sorts Evidence Reports of Net Effect Contributions by Health Impact values from highest (largest benefit) to lowest (largest harm), and corrects the format of the Composition Resource produced to include the Health Impact contribution as a string instead of a number.
      • Release 0.7.1 (February 22, 2023) adjusts the Evidence Report Generator to use the canonical URLs for the relevant Profiles from the Evidence Based Medicine Implementation Guide. 
    • FEvIR™: My Ballot version 0.5.0 (November 18, 2022) is used to facilitate the Scientific Evidence Code System (SEVCO) development.
    • Computable Publishing®: Portal View version 0.17.2 (March 21, 2022) provides an organized list of resources associated with a project. For now, the only ‘Portal View’ displayed is the Learning Health Systems Portal (Demo).
    • Computable Publishing®: Recommendations Table Viewer version 0.9.0 (March 21, 2022) is a concept demonstration. This concept demonstration shows a collection of computable recommendations derived from manual review of online guideline publications AND review of structured data from GRADEpro and MAGICapp software systems.
    • Computable Publishing®: Risk of Bias Assessment Reader (RoBAR) version 0.3.0 (November 16, 2022) provides a human-friendly of a Risk of Bias Assessment created by the Risk of Bias Assessment Tool (RoBAT).
    • Computable Publishing®: Risk of Bias Assessment Tool (RoBAT) version 0.16.0 (November 18, 2022) creates a report for a complete risk of bias assessment.
    • FEvIR™: SRDR+ Project Importer version 0.2.1 (March 6, 2023) retrieves all project data from SRDR+, creates a Project on the FEvIR Platform, loads all the FHIR Resources associated with the Project to the FEvIR Platform, and associates all the loaded FHIR Resources with the Project.
      • Release 0.2.0 (February 27, 2023) displays 'All project information loaded as FHIR Resources will be publicly available.' and fixes a bug in project title display.
      • Release 0.2.1 (March 6, 2023) increases the timeout period to load large SRDR+ Projects and fixes a bug related to changing the SRDR+ API token.
  • Eligibility Criteria Matching Software Library Release 0.1.0 establishes a MatchCheckLibrary folder (not currently accessible outside of the FEvIR Platform) to store JavaScript files specifically used for the Eligibility Criteria Matching Software Demonstration, supports calling these functions from this folder when "Check for Match 2" is called in the Eligibility Criteria Matching Software Demonstration, and provides copies of the code scripts (as code strings and base64Binary strings) in SoftwareScript Resources.
  • Eligibility Criteria Matching Software Library Release 0.2.0 (December 27, 2022) establishes a GitHub repository to share downloadable files.

 

Computable EBM Tools Development Working Group Updates:

Example projects to demonstrate parts of ‘Evidence And Guidance Linked Expressions’ (EAGLEs) include:

The current attention of this group is review of approaches to facilitate data entry for many different datatypes with automated conversion to FHIR. 

On January 5, 2023, the Computable EBM Tools Development Working Group reviewed the FEvIR™ API, FEvIR API Documentation, Bariatric Surgery Decision Example of Implementation Tools (and demonstration of creating Evidence Reports from FHIR Resources), Eligibility Criteria Matching Software Demonstration, Eligibility Criteria Matching Software Library, FEvIR™: SoftwareScript Builder/Viewer, and FEvIR™: ActivityDefinition Builder/Viewer, and prepared Apollo Accelerator members with this introduction ahead of FHIR training that occurs next week.

On January 12, 2023, the Computable EBM Tools Development Working Group reviewed and refined the specifications for display of boolean, date, and dateTime datatypes using the FEvIR™: ActivityDefinition Builder/Viewer.

On January 19, 2023, the Computable EBM Tools Development Working Group reviewed and refined the user experience for searching on the FEvIR Platform (https://fevir.net/search) using the Classification Profile of ArtifactAssessment Resource, and reviewed the Computable Publishing®: MAGIC-to-FEvIR Converter to determine next steps for related developments.

On January 26, 2023, the Computable EBM Tools Development Working Group confirmed the FEvIR™ API was functioning well for external use, discussed the importance and handling of the OutcomeImportance Profile of ArtifactAssessment for individualized clinical decision support applications, confirmed interest in a Guidelines International Network pre-conference course to facilitate guideline updating and adaptation with the Adaptation Profile of ArtifactAssessment, reviewed changes to the FEvIR Platform over the past week, and added ATC and Nordic Article Number (Vnr) code systems to selected elements in the FEvIR™: ActivityDefinition Builder/Viewer.

On February 2, the Computable EBM Tools Development Working Group reviewed and advanced the FEvIR™: Adaptation Builder/Viewer.

On February 9, the Computable EBM Tools Development Working Group discussed desires for collaboration with MAGICapp that may include individualized access to the data via API (similar in modeling to the FEvIR™: SRDR+ Project Importer in development) and conversion of the data to FHIR Resources associated with a project (as available with Computable Publishing®: MAGIC-to-FEvIR Converter).

On February 16, the Computable EBM Tools Development Working Group reviewed and advanced the FEvIR™: Adaptation Builder/Viewer and discussed the FEvIR™: SRDR+ Project Importer in development.

On February 23, the Computable EBM Tools Development Working Group reviewed and advanced the FEvIR™: Adaptation Builder/Viewer with a suggestion to auto-detect the datatype of object elements for easier management.

On March 2, the Computable EBM Tools Development Working Group developed the FEvIR™: Rating Builder/Viewer.

On March 9, the Computable EBM Tools Development Working Group reviewed the many developments across the FEvIR Platform, FEvIR™: Adaptation Builder/Viewer, FEvIR™: Characteristic Builder/Viewer, and FEvIR™: Evidence Builder/Viewer.

On March 16, we made major improvements to the FEvIR Start Page and are pleased to announce:

Fast Evidence Interoperability Resources (FEvIR) Platform Release 0.117.0 (March 16, 2023) reorganizes the buttons to access tools on the FEvIR Start Page and adds organizing labels (Builder Tools, Converter Tools, Specialized Tools), revises the Active HEvKA Projects list on the FEvIR Start Page, and provides a link on the FEvIR Start Page to View All Projects.

On March 23, the Computable EBM Tools Development Working Group reviewed many changes to the Fast Evidence Interoperability Resources (FEvIR) Platform with special interest in FEvIR™: Citation Builder/Viewer, FEvIR™: Classification Builder/Viewer, FEvIR™: Evidence Builder/Viewer, and FEvIR™: PlanDefinition Builder/Viewer. We also added Ilkka Kunnamo of Duodecim Publishing Company Ltd. to our Panel Session proposal in development for Guidelines International Network (GIN) 2023 Hybrid Conference in Glasgow September 19-22.

FEvIR Metadata Framework Working Group Updates:

A project page for the Common Metadata Framework project is available at https://fevir.net/resources/Project/29201

Following a publication of Categorizing metadata to help mobilize computable biomedical knowledge (by a working group within the Mobilizing Computable Biomedical Knowledge (MCBK) Standards Working Group), we started a Common Metadata Framework Working in February 2021.

We took many turns working out models for a Common Metadata Framework (simplifying our overall approach and improving the FHIR standard and various tools along the way).  Some of the approaches we developed include:

  • Specifying Metadata to MCBK spreadsheet defining 138 data elements for the specification of 13 metadata categories to communicate the Findability, Accessibility, Interoperability, Reusability, and Trustability (FAIR+T) of knowledge artifacts
  • Mapping the “COKA MCBK Common Metadata Framework” to multiple crosswalks of metadata schemas created by various Research Data Alliance (RDA) working groups
  • Creation of a ‘SchemaElement Resource’ structure to describe an element in any schema and map it to elements in other schema, and then
    • Creation of about 10,000 SchemaElement Resources to document portions of FHIR, ClinicalTrials.gov, and Research Information Systems (RIS) schemas and > 1,000 map elements within some of these SchemaElement Resources to document conversions between these schemas
    • Creation of 146 SchemaElement Resource instances to fully specify all the Common Metadata Framework elements, and mapping to and from 55 RIS SchemaElement Resource instances
  • Creation of a ‘Common Data Structure’ for more efficient specification of 40 datatypes for the Common Metadata Framework (most are linked from https://fevir.net/FLI/CommonDataStructureArtifact), and mappings to and from the Common Data Structure with RIS and FHIR Citation structures

We refocused this Working Group on the metadata structures used and shared on the FEvIR Platform as a real-world implementation and practical application.  An initial step was the creation of a Classification Profile of ArtifactAssessment Resource.

On January 10, 2023, the Common Metadata Framework Working Group added Profiles to the developing Evidence Based Medicine Implementation Guide, including:


Classification

Profile of ArtifactAssessment for Evidence Based Medicine IG. The Classification Profile is used for classifier tags that may be created independently from Resource creators and may be used for search indexes.

ParticipantFlow

Profile of Evidence for Evidence Based Medicine IG. The ParticipantFlow Profile is used for counts of completion and reasons for non-completion of participation in a research study.

Participant Flow Measure

Profile of EvidenceVariable for Evidence Based Medicine IG. The ParticipantFlowMeasure Profile is used to describe outcome measures for completion and reasons for non-completion of participation in a research study.

The Research Design Working Group reviewed the ParticipantFlow Profile Demonstration to view examples of the ParticipantFlow and ParticipantFlowMeasure Profiles.

On January 17, 2023, the Common Metadata Framework Working Group developed proof-of-concept code in preparation for using Classification Profiles of ArtifactAssessment Resource as a search index on the FEvIR Platform.

On January 24, 2023, the Common Metadata Framework Working Group became the FEvIR Metadata Framework Working Group to reflect the change in focus from a generalized framework for metadata across platforms to focus on the specific metadata framework applied to the FEvIR Platform. Today we applied changes to the FEvIR Platform related to complex data operations in which data is managed as both a string and a number in inter-related contexts. In one instance, in responding to community feedback to sort Summary of Net Effect Contributions to list the benefits then the harms, we used the value of the net effect contribution (positive if benefit, negative if harm) for the sorting. We learned the data value needed to be a number for net effect calculations but needed to be a string for proper FHIR compliance when reported in a Narrative datatype for the Composition Resource. In another instance, we discovered that our data entry fields for number-type data worked fine on Google Chrome but users on Firefox were able to enter non-numeric data and have their data erased. We learned that the data input uses a string datatype (TextField data entry) even if the output is set to type='number' so we applied RegEx-based checks of the data input for use in browsers that do not handle it automatically. 

On January 31, the FEvIR Metadata Framework Working Group identified a bug in the FEvIR Platform code that was producing and interpreting profiles as a string datatype instead of an array of string datatype (in Resource.meta.profile) and applied bug fixes necessary for proper functioning of the Classification Builder/Viewer, Comment Builder/Viewer, Adaptation Builder/Viewer, and FEvIR Search tools.

On February 7, the FEvIR Metadata Framework Working Group reviewed developments for the FEvIR™: Adaptation Builder/Viewer.

On February 14, the FEvIR Metadata Framework Working Group reviewed developments for the FEvIR™: Adaptation Builder/Viewer, tackling challenges in recursive processing.

On February 21, the FEvIR Metadata Framework Working Group identified the proper canonical URLs for Profiles defined by the Evidence Based Medicine Implementation Guide (http://build.fhir.org/ig/HL7/ebm/artifacts.html), added a Comment Profile to the EBM IG, and modified the FEvIR Platform (Adaptation, Classification, Comment, and Recommendation Justification Builder/Viewer tools) to use the canonical URLs in meta.profile values for corresponding Resources.

On February 28, the FEvIR Metadata Framework Working Group facilitated last-minute changes to the FHIR Build before code freeze for the R5 version, and adjusted FEvIR Platform handling of metadata pattern elements with expectations for array form in the FHIR specification. We also developed a major function gain in FEvIR™: Characteristic Viewer which now shows the details of Inclusion Criteria and Exclusion Criteria for a Characteristic Resource defined by a combination of characteristics – see https://fevir.net/resources/Characteristic/111977 for an example.

On March 7, the FEvIR Metadata Framework Working Group reviewed and refined multiple changes to the FEvIR Platform to support more efficient data entry for metadata elements (MetadataResource interface elements).

On March 14, the FEvIR Metadata Framework Working Group improved the data entry for Reference datatype and applied editing and viewing of multiple MetadataResource interface elements to the Citation Builder/Viewer.  The Citation Builder/Viewer has a specialized Citation Metadata section to distinguish the metadata for the Citation Resource from the metadata for the cited artifact (which may also be a FHIR Resource).

On March 21, the FEvIR Metadata Framework Working Group thanks Bryn Rhodes for a ‘guest visit’ to help orient us to the Canonical Resource Management Infrastructure Implementation Guide and we discussed various strategies for coordinating these concepts with the Evidence Based Medicine Implementation Guide (in development) and with the FEvIR Platform.

On March 28, the FEvIR Metadata Framework Working Group continued development of a Classification Index for the FEvIR Platform, pulling Classification data from each of ArtifactAssessment Resources with Classification Profile and Citation.citedArtifact.classification element instances.

Setting the SRDR Platform on FHIR Working Group Updates:

The Agency for Healthcare Research and Quality (AHRQ) maintains a Systematic Review Data Repository (SRDR), and efforts are underway to convert the data in this SRDR to FHIR format. The Setting the SRDR Platform on FHIR Working Group facilitates the data conversion to FHIR and collaborative developments between the SRDR-Plus Platform, the FEvIR Platform, and potentially the AHRQ Evidence-based Practice Centers (EPCs) and the CEPI Evidence Discovery and Retrieval (CEDAR) Project.

On January 9, 2023, the Setting the SRDR Platform on FHIR Working Group reviewed concepts in the application of FHIR Questionnaire and QuestionnaireResponse Resources, including Questionnaire.useContext to relate the Questionnaire to a specific Project, and skip logic and nested items within the Questionnaire. We also reviewed the FEvIR™ API and Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter and discussed strategies to facilitate SRDR users to add a Project ID on the FEvIR Platform and retrieve all the project data in FHIR Resources.

On January 23, the Setting the SRDR Platform on FHIR Working Group reviewed the initial pre-release view of FEvIR™: SRDR+ Project Importer and were pleased to demonstrate retrieval of FHIR JSON content from SRDR+ in response to sending a Project ID and a SRDR+ API token.

On January 30, the Setting the SRDR Platform on FHIR Working Group confirmed the initial FEvIR™: SRDR+ Project Importer is correctly returning the SRDR project FHIR Resources as a Bundle and is limited to projects for which the user is the project owner. We discussed changes to the API response to include project id, project title, and selected project attributes. Next steps will be to convert each Resource in the Bundle to an entry on the FEvIR Platform and associated the Resources with a Project entry on the FEvIR Platform.

On February 6, the Setting the SRDR Platform on FHIR Working Group reviewed the Classification Profile http://build.fhir.org/ig/HL7/ebm/StructureDefinition-classification.html of ArtifactAssessment Resource and discussed how it is the optimal model for data exchange where the classification data is generated by persons other than the data being classified.  This is a common use case for SRDR+ including the project-specific screening classifications of Citations which are not project-specific. There is also a desire to share such classifications between SRDR+ and PICO Portal, so we may use this Working Group time to further develop the Classification Profile.

On February 13, the Setting the SRDR Platform on FHIR Working Group reviewed the format of responses from the SRDR+ API with project data, created an example FEvIR Project Page for SRDR+ projects to define the desired output (https://fevir.net/resources/Project/112344), and wrote the specifications for a function to convert the SRDR+ API response to an individualized FEvIR Project Page linking to all the project FHIR Resources on the FEvIR Platform.

On February 20, the Setting the SRDR Platform on FHIR Working Group reviewed the FEvIR™: SRDR+ Project Importer which is still in development and with the initial release accepts an SRDR+ Project ID and API token, then creates a Project page on the FEvIR Platform with links to all the associated project data in FHIR Resources on the FEvIR Platform.  We looked at an initial project and identified improvements to apply to FHIR Questionnaire Resources for the project.

On February 27, the Setting the SRDR Platform on FHIR Working Group applied changes to the FEvIR™: SRDR+ Project Importer including the addition of 'All project information loaded as FHIR Resources will be publicly available.' on the first page, and displaying the Project Title with the initial display of the resulting Project page.

On March 6, the Setting the SRDR Platform on FHIR Working Group discussed models for the use of Questionnaire Resource to represent data collection forms for systematic reviews in which questionnaire items are specific to study arms. One idea suggested is to create an EvidenceVariable Resource for each study arm, then create a separate QuestionnaireResponse for each study arm set of responses with a Questionnaire item to identify the study arm with valueReference. The group also reviewed the FEvIR™: SRDR+ Project Importer to identify some bug fixes.

On March 13, the Setting the SRDR Platform on FHIR Working Group established the functionality of the FEvIR™: SRDR+ Project Importer by a participant importing their own test project. We also explored the "How to Cite" feature on the FEvIR Platform which autogenerates citations for Resources on the FEvIR Platform and includes these citations as relatedArtifact entries in the resource JSON, and the "How to Cite" feature in edit mode in selected resource types that provides the JSON for a full Citation Resource.

On March 20, the Setting the SRDR Platform on FHIR Working Group discussed the use of ArtifactAssessment Resource for the “labels” of abstract evaluation processing during systematic review screening, and we showed how the Classification Profile could use content.type, content.classifier, and content.author elements to manage the full set of “labels” across multiple raters. We demonstrated how these “labels” could then be viewed with the Citation Viewer. We also discussed how to use additional elements within ArtifactAssessment Resources to support AI/ML applications.

On March 27, the Setting the SRDR Platform on FHIR Working Group identified and discussed multiple issues to improve the FHIR output from the SRDR+ API, including:

  • Avoiding an API crash when missing certain types of data
  • Specifying the expected datatype for answers to questionnaire items in Questionnaire.item.type
  • Use of QuestoinnaireResponse Resource for the data representing completed questionnaires
  • Use of ArtifactAssessment Resource (and Classificaiton Profile) for the “labels” of abstract evaluation processing during systematic review screening
  • Use of RelatedArtifact Datatype to share PDF attachments for full-text

Research Development Updates

Scientific Knowledge Accelerator Foundation Updates:

On January 31, the Scientific Knowledge Accelerator Foundation Board of Directors discussed the development of metrics to measure the pace of scientific knowledge transfer. We decided to target two concepts for initial metric development:

  1. For systematic reviews, time from publication (date) to citation in 2 or more independently published guidelines, clinical reference, clinical education, or clinical decision support artifacts
  2. For clinical trials, time from publication (date) to citation in 2 or more independently published systematic reviews, guidelines, clinical reference, clinical education, or clinical decision support artifacts

We decided to start the Measuring Rate of Scientific Knowledge Transfer Working Group as a weekly HEvKA meeting on Tuesdays at 9 am Eastern. The last Tuesday of each month will be used for the Board of Directors meeting.

On February 28, the Scientific Knowledge Accelerator Foundation Board of Directors reviewed the progress of the Measuring Rate of Scientific Knowledge Transfer Working Group and discussed three upcoming collaborative grant opportunities (let us know if you would like to participate in any of them):

  1. National Science Foundation (NSF) Pathways to Enable Open-Source Ecosystems (POSE)
  2. NIH Accelerating Data and Metadata Standards in the Environmental Health Sciences (R24 Clinical Trial Not Allowed)
  3. NIH Notice of Intent to Publish a Funding Opportunity Announcement for Accelerating Behavioral and Social Science through Ontology Development and Use (U01) – for this, we considered, once the Study Design Terminology in SEVCO paper is submitted for publication, to focus development of additional Study Design terms for behavioral and social science needs.

On March 28, the Scientific Knowledge Accelerator Foundation Board of Directors reviewed grant opportunities (NIH U01 Accelerating Behavioral and Social Science through Ontology Development and Use, NIEHS Accelerating Data and Metadata Standards, NSF Pathways to Enable Open-Source Ecosystems (POSE), NLM Research Grants in Biomedical Informatics and Data Science). For the NLM opportunity, we drafted first-draft Specific Aims for a 4-year project:

  • Year 1) Translate original research results (effect estimates/statistical findings and variable definitions), from studies used in pre-existing meta-analyses (at snapshot time 1), into FHIR. Validate reliable translation/transformation of original research results into computable evidence.
  • Year 2) Translate search strategies, from pre-existing meta-analyses, into FHIR. Validate precision and recall of computable searches.
  • Year 3) Translate statistical analysis plans for pre-existing meta-analyses into FHIR. Validate that automated processing of computable evidence in FHIR reliably reproduces the meta-analysis results.
  • Year 4) Update the meta-analyses with automated support using data available at snapshot time 2. Validate reliable reproduction of the updated (cumulative) meta-analyses.


Measuring the Rate of Scientific Knowledge Transfer Working Group Updates:

An additional Working Group created on January 31, 2023 is the “Measuring Rate of Scientific Knowledge Transfer Working Group”.  A Project page for the Measuring the Rate of Scientific Knowledge Transfer Working Group can be found at https://fevir.net/resources/Project/112280.

On February 7, the Measuring the Rate of Scientific Knowledge Transfer Working Group created a Project page at https://fevir.net/resources/Project/112280 and suggested 3 definitions for interpretation of "Time from publication of clinical trial report to citation in 2 or more independently published systematic reviews, guidelines, clinical reference, clinical education, or CDS artifacts.":

  1. Publication of a clinical trial report will be defined as any record of results being made publicly available.  This may occur through journal publication, preprint publication, trial registry report with results, or regulatory document.
  2. Independently published systematic reviews, guidelines, clinical reference, clinical education, or CDS artifacts means the authors of these outlets do not overlap with each other or with the authors of the clinical trial.
  3. Citation in an independently published report means that the clinical trial results are incorporated into the Results of the report and not just the Introduction and Discussion (if the report has focused Results).

For an initial effort to document data for such a measure we use the Krebs 2018 clinical trial:

  1. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial [Journal Article]. Contributors: Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. In: JAMA, PMID 29509867. Published March 06, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29509867/. 

Based solely on PubMed 'Cited by" mapping we captured informative dates to include:

StateActual/ExpectedStart
published-final-formActual2018-03-06
use-in-guideline-PMC7067148Actual2020-03-30
possible-use-in-SR-PMC8506236Expected2021-10-12
use-in-guideline-PMC9639433Actual2022-11-04
use-in-guideline-PMC9484571Actual2022-09-08

On February 14, the Measuring the Rate of Scientific Knowledge Transfer Working Group repeated the effort to document data for such a measure with the Portenoy 2012 clinical trial:

  1. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial [Journal Article]. Contributors: Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. In: The journal of pain, PMID 22483680. Published May 2012. Available at: https://pubmed.ncbi.nlm.nih.gov/22483680/. 

We captured informative dates to include:

StateActual/ExpectedStart
published-final-formActual2012-04-12
published-results-CTgovActual2011-06-17
possible-use-in-SR-PMID26809975Expected2016-02
use-in-SR-PMC5520783Actual2017-03-22
use-in-SR-PMC5879974Actual2018-02-05
use-in-SR-PMID26103030Actual2015-06-23

Learnings from this second pass include:

1) The clinical trial was published in 2012 but the clinical trial results were posted to ClinicalTrials.gov in 2011 and this was not obvious from the journal-published clinical trial report.

2) A key systematic review (published in 2015) was not found in the PubMed "Cited By" search. Subsequently follow-up with NLM confirmed that PubMed "Cited By" data is limited and not reliable for a core method.

Next week we will explore other citation mapping databases, such as SCOPUS and Web Of Knowledge.

On February 21, the Measuring the Rate of Scientific Knowledge Transfer Working Group evaluated the first article (Krebs 2018) using Web of Science and found an additional use in a guideline with publication July 3, 2019, thus reducing the 'time to 2 published uses' from 4.5 years to 2 years.  There was not an obvious method to limit the list of citing articles to systematic reviews and guidelines.

On March 7, the Measuring the Rate of Scientific Knowledge Transfer Working Group evaluated the first article (Krebs 2018) using Web of Science (expanded to include more databases) and SCOPUS and found an additional use in a systematic review with publication of November 16, 2018, thus reducing the 'time to 2 published uses' from 2 years to 1 year 4 months. Both database approaches had about 500 citations and both were able to sort the citations in chronological order and supported 'search within results' to limit to mentions of 'systematic' or 'guideline' in the title/abstract (using Web of Science) or as associated keywords (using SCOPUS). Next week we will repeat the analysis with the same search databases using the Portenoy 2012 clinical trial to select a search database for our initial protocol.

On March 14, the Measuring the Rate of Scientific Knowledge Transfer Working Group re-evaluated the Portenoy 2012 clinical trial using the PubMed "Cited By" search and was able to obtain full-text access to one of the identified systematic reviews and confirm this article included the trial. So the estimated "time to 2 published uses" for the Portenoy 2012 clinical trial is currently 4.5 years, similar to the Krebs 2018 article at this stage.  We documented the protocol for using Web of Science and SCOPUS and will use it next week to see if we again reduce this time measure.

On March 21, the Measuring the Rate of Scientific Knowledge Transfer Working Group re-evaluated the Portenoy 2012 clinical trial using Web of Science and SCOPUS. With Web of Science, we identified an additional systematic review published 2014-03-07, shortening the “time to 2 published uses” from 4.5 years to 4 years. With SCOPUS, we found this systematic review and also identified a “systematic review” published 2014-04-23 (https://pubmed.ncbi.nlm.nih.gov/24760158/), shortening the “time to 2 published uses” to 2 years 10 months. The latter item (found with a ‘systematic review’ filter in SCOPUS but not Web of Science) is not a traditional systematic review, but it did include a systematic search and presented results for the context of guiding clinical practice.

We discussed changing "For clinical trials, time from publication (date) to citation in 2 or more independently published systematic reviews, guidelines, clinical reference, clinical education, or clinical decision support artifacts" to "For clinical trials, time from publication (date) to citation in 2 or more independently published systematically derived reports intended to guide clinical practice (e.g. systematic reviews, guidelines, clinical reference, clinical education, or clinical decision support artifacts)"

For this approach we would define:

  • "systematically derived" means that there is a specification of search sources and inclusion criteria
  • "intended to guide clinical practice" means the report is created with a primary intention of informing or guiding clinical practice (or informing decision makers who are developing clinical practice guidance)

For next week we will repeat our efforts with a new sample clinical trial:

Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection.

Brunelli SM, Van Wyck DB, Njord L, Ziebol RJ, Lynch LE, Killion DP. J Am Soc Nephrol. 2018 Apr;29(4):1336-1343. doi: 10.1681/ASN.2017080870. Epub 2018 Feb 22. PMID: 29472415


ResearchOnFHIR Working Group Updates:

We are currently working through the HL7 FHIR-based tools and initiatives to support clinical research project, evaluating the findings of a scoping review of 203 tools and a systematic review of 49 published uses of FHIR for clinical research.

On January 23, 2023, the ResearchOnFHIR Working Group continued the review of one article:

  1. Toward cross-platform electronic health record-driven phenotyping using Clinical Quality Language [Journal Article]. Contributors: Brandt PS, Kiefer RC, Pacheco JA, Adekkanattu P, Sholle ET, Ahmad FS, Xu J, Xu Z, Ancker JS, Wang F, Luo Y, Jiang G, Pathak J, Rasmussen LV. In: Learning health systems, PMID 33083538. Published October 2020. Available at: https://pubmed.ncbi.nlm.nih.gov/33083538/. 

and added 2 related links to the Project Page:

https://cql.hl7.org/01-introduction.htmlCQL Introduction
https://build.fhir.org/fhirpath.htmlFHIRPath Introduction

Due to the high importance of understanding CQL for multiple projects (especially related to Eligibility Criteria work), we are now using the ResearchOnFHIR Working Group time to review FHIRPath and CQL introductions in detail.

On January 30, the ResearchOnFHIR Working Group reviewed the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ through section 4 and will continue with section 5 (Functions) next week.

On February 6, the ResearchOnFHIR Working Group reviewed Sections 5.1-5.3 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about functions related to existence (criteria matching), filtering, projection (mapping data to changes based on that data), and subsetting.

On February 13, the ResearchOnFHIR Working Group reviewed Sections 5.4-5.10 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about functions related to combining, conversion, string manipulation and other string functions, math, tree navigation, trace, and getting current date/time values.

On February 20, the ResearchOnFHIR Working Group reviewed Sections 6.1-6.3 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about operations related to equality (and equivalence), comparison, and type (is resourceType, as datatype).

On February 27, the ResearchOnFHIR Working Group reviewed Sections 6.4-6.7.1 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about operations related to collections, Boolean logic, and math.

On March 6, the ResearchOnFHIR Working Group reviewed Sections 6.7-7 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about operations related to Date/Time arithmetic, operator precedence, and the FHIRPath aggregate function. The group recognized the potential with the FHIRPath aggregate function to encode statistical formulas and we discussed how this could be applied. Within the EBM Implementation Guide, we already have 4 EvidenceVariable Profiles that can be used for the representation of the dataset (EvidenceDataset) or the contributing variables to a dataset (StudyEligibilityCriteria, InterventionDefinition, OutcomeDefinition), and we have an Evidence Profile (StatisticalModel) that can be used for expression of the 'statistical analysis plan' to be applied to the dataset. We conceptualized an additional Evidence Profile (StatisticalCalculator) that could include an extension with an Expression datatype to provide the executable formula for conducting the statistical analysis.

On March 13, the ResearchOnFHIR Working Group reviewed Sections 8.1-8.6 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about lexical elements including whitespace, comments, literals, symbols, keywords, and identifiers.

On March 20, the ResearchOnFHIR Working Group reviewed Sections 8.7-12.3 of the FHIRPath IG at https://build.fhir.org/ig/HL7/FHIRPath/ learning about case-sensitivity, environment variables, types (models) and reflection, type safety and strict evaluation, and formal specifications. This completes our walkthrough of the FHIRPath IG and we will resume learning about CQL next week.

On March 27, the ResearchOnFHIR Working Group reviewed Chapter 1 (Introduction) of Clinical Quality Language (CQL) Release 1 and the introduction portion of Chapter 2 Author’s Guide, briefly reviewing the CQL Structure Diagram and an example library ChlamydiaScreening_CQM version '2'.

Additional Information

Quotes for Thought:

  • "Success is peace of mind, which is a direct result of self-satisfaction in knowing you made the effort to become the best of which you are capable." --John Wooden

  • "The reward for work well done is the opportunity to do more" --Jonas Salk
  • "Look in your disappointments for the resolve to transform your experiences into solutions." --Bryant H. McGill
  • "The thing that is really hard, and really amazing, is giving up on being perfect and beginning the work of becoming yourself." --Anna Quindlen

Monthly Participation:

  • For January 2023 – 37 people (AI, AS, AYL, BA, BK, BM, CE, ES, GL, GV, HL, IK, IR, JD, JJ, JL, JM, JO, JT, JV, KOB, KP, KR, KS, KW, MA, MD, MH, MT, NA, NO, PW, RC, RL, SS, YG, YW) from 8 countries (Canada, Costa Rica, Finland, Germany, India, Taiwan, UK, USA) participated in up to 56 active working group meetings.

  • For February 2023 – 31 people (AI, BA, BM, CE, CS, GHM, GL, GV, HL, IK, IR, JD, JJ, JO, JR, JT, KOB, KP, KR, KS, KW, MA, MH, MT, NO, PR-S, PW, RC, RL, SS, YW) from 8 countries (Canada, Costa Rica, Finland, Germany, Norway, Taiwan, UK, USA) participated this month in up to 60 active working group meetings.

To get involved or stay informed:

You can learn more at the HEvKA Project Page on FEvIR Platform or HEvKA Project Page on HL7 Confluence, or join any of the groups that are now meeting in the following weekly schedule:

Weekly Meeting Schedule

Day

Time (Eastern)

Working Group

Monday 

8-9 am 

Project Management

Monday

9-10 am

Setting the SRDR Platform on FHIR

Monday 

10-11 am

ResearchOnFHIR

Monday 2-3 pmStatistic Standard and Terminology
Tuesday9-10 amMeasuring the Rate of Scientific Knowledge Transfer

Tuesday

12 pm-1 pm

FEvIR Metadata Framework

Tuesday 

2-3 pm 

Research Design

Wednesday

8-9 am 

Knowledge Ecosystem Liaison

Thursday

8-9 am 

EBM Implementation Guide (a CDS EBM sub-WG)

Thursday

9-10 am

Computable EBM Tools Development

Thursday 

4-5 pm 

Project Management

Friday 

8-9 am

GRADE Vocabulary

Friday

9-10 am 

Risk of Bias Terminology and Tooling

Friday

10-11 am 

Communications (Awareness, Scholarly Publications)

Friday

12-1 pm 

Eligibility Criteria


To join any of these meetings:


________________________________________________________________________________

Join Microsoft Teams Meeting

+1 929-346-7156   United States, New York City (Toll)

Conference ID: 324 918 025#

Local numbers

Meeting support by ComputablePublishing.com

________________________________________________________________________________

Email balper@computablepublishing.com if you would like to be added (or removed) to any of the specific meeting invites or to the HEvKA Distribution List email.  You are welcome to join any meeting at any time whether you have signed up or not.   The HEvKA Distribution List receives daily progress update emails.  This weekly progress update email is also shared with the Scientific Evidence Code System Expert Working Group email distribution list.



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