Project Coordination Updates:

19 people (BA, CA-D, CE , HK, HL, IK, JB, JD, KR, KS, KW, MA, PW, RC, SL, SM, TD, XC, XZ) from 9 countries (Belgium, Canada, Chile/Spain, China, Finland, Norway, Peru, UK, USA) participated this week in up to 14 active working group meetings.

On Monday, April 8, the Project Management Working Group discussed the following FHIR trackers:

https://jira.hl7.org/browse/FHIR-45094

https://jira.hl7.org/browse/FHIR-41502

https://jira.hl7.org/browse/FHIR-42885

On Monday April 8, the Setting the Scientific Record on FHIR Working Group continued to discuss the RFI Response to the NIH for Common Data Elements, created a new EvidenceVariable example on the FEvIR Platform https://fevir.net/resources/EvidenceVariable/208211 and improved the pdf for collective view. 

On Wednesday, April 10, the Communications Working Group continued to discuss the need for a contributor extension that could be applied to any resource. The Evidence Based Medicine Implementation Guide (EBM IG) would handle this contributorship.

There is currently no code in the CRediT taxonomy -- see https://jats4r.org/credit-taxonomy for data entry.

https://build.fhir.org/valueset-artifact-contribution-type.html

The group decided that the following two new artifact contribution types should be added to the above artifact contribution types:

1) computable formatting

2) data entry

 

On Friday, April 12, the Project Management Working Group created the suggested agenda for next week:

Day/Time (Eastern)

Working Group

Agenda Items

Monday 8-9 am

Project Management

FHIR changes and EBMonFHIR Implementation Guide issues

Monday 9-10 am

Setting the Scientific Record on FHIR

SRDR to FEvIR Review

Monday 10-11 am

CQL Development (a CDS EBMonFHIR sub-WG)

Evaluate the focus for this working group

Monday 2-3 pm

Statistic Terminology

Review SEVCO terms (5 terms open for vote)

Tuesday 9 am-10 am

Measuring the Rate of Scientific Knowledge Transfer

Review Initial Pilot Progress

Tuesday 2-3 pm

StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)

Create RFI Response for Common Data Elements

Tuesday 3-4 pm

Ontology Management

Review Objectives and Progress

Wednesday 8-9 am

Funding the Ecosystem Infrastructure

Review progress on product launch readiness checklist for making guidelines computable

Wednesday 9-10 am

Communications (Awareness, Scholarly Publications)

GRADE Ontology concept paper, Study Design Paper, RFI for Common Data Elements

Thursday 8-9 am

EBM Implementation Guide (a CDS EBMonFHIR sub-WG)

GIN Tech Meeting

Thursday 9-10 am

Computable EBM Tools Development

Review progress with Converter tools

Friday 9-10 am

Risk of Bias Terminology

Review SEVCO terms (3 study selection bias terms open for vote)

Friday 10-11 am

GRADE Ontology

Term development (2 Indirectness terms open for vote)

Friday 12-1 pm

Project Management

Prepare Weekly Agenda

 

SEVCO Updates:

On Monday April 8, the Statistic Terminology Working Group found that none of the 4 terms that were open for vote received enough votes to be accepted into the code system. The group worked to define one additional term, quantile. There are currently 5 terms open for vote. 

Term

Definition

Alternative Terms
(if any)

Comment for application
(if any)

absolute value

A statistic that represents the distance of a value from zero.

The | symbol is used around the value to denote the absolute value, e.g. |x|, such that if x = -3, then |x| = 3.

quantile

A statistic that represents the value for which the number of data points at or below it constitutes a specific portion of the total number of data points.

Quantile is a type of statistic but not used without specification of the portion it represents. For example, one may report a fortieth percentile (40%ile) but one does not report a percentile without specification of which percentile.

area under the ROC curve

An area under the curve where the curve is the true positive rate and the range of interest is the false positive rate.

  • AUC
  • AUROC
  • area under the receiver operating characteristic curve
  • c-statistic
  • C-statistic
  • Harrell's C
  • concordance index
  • concordance statistic

ROC stands for Receiver Operating Characteristic. The area under the ROC curve is used to assess the performance of a classifier used to distinguish between two or more groups. Another term for true positive rate is sensitivity and another term for false positive rate is 1-sensitivity.

The c-statistic is the area under the ROC curve calculated with the full range of possible values for true positive rate and false positive rate. Another interpretation of the c-statistic is similar without explicitly referencing the ROC curve: "The C statistic is the probability that, given 2 individuals (one who experiences the outcome of interest and the other who does not or who experiences it later), the model will yield a higher risk for the first patient than for the second. It is a measure of concordance (hence, the name “C statistic”) between model-based risk estimates and observed events. C statistics measure the ability of a model to rank patients from high to low risk but do not assess the ability of a model to assign accurate probabilities of an event occurring (that is measured by the model’s calibration). C statistics generally range from 0.5 (random concordance) to 1 (perfect concordance)." (JAMA. 2015;314(10):1063-1064. doi:10.1001/jama.2015.11082)

partial area under the ROC curve

An area under the curve where the curve is the true positive rate and the range of interest is a specified portion of the range of possible values for the false positive rate.

Area under the ROC curve is defined as an area under the curve where the curve is the true positive rate and the range of interest is the false positive rate. ROC stands for Receiver Operating Characteristic. The area under the ROC curve is used to assess the performance of a classifier used to distinguish between two or more groups. Another term for true positive rate is sensitivity and another term for false positive rate is 1-sensitivity.

area under the value-by-time curve

An area under the curve where the curve is the repeated measures of a variable over time and the domain of interest is time.

  • area under the value-time curve
  • area under the value vs. time curve
  • area under the value versus time curve

The area under the value-by-time curve is used for pharmacokinetics, pharmacodynamics, and physiological monitoring.

 

On Friday April 12, the Risk of Bias Terminology Working Group reviewed the three terms open for voting last week. The term "misapplication of study eligibility criteria" passed and was added to the code system. The two remaining terms (publication bias, bias in study selection process) were revised and reopened for voting. An additional term which was already added to the code system (study selection bias) has a new alternative term and has been reopened for voting. There are currently three risk of bias terms on the ballot. If you have voted on these terms before, please vote again as they have been revised.

Term and Voting Status

Definition

Alternative Terms
(if any)

Comment for application
(if any)

misapplication of study eligibility criteria-passed, no longer open for vote

A study selection bias due to inappropriate implementation of the study inclusion and exclusion criteria.

  • nonadherence to study eligibility criteria

study selection bias-added alternative term and reopened for vote

A selection bias resulting from factors that influence study selection, from methods used to include or exclude studies for evidence synthesis, or from differences between the study sample and the population of interest

  • bias in study selection

publication bias-revised and reopened for vote

A study selection bias in which the publicly available studies are not representative of all conducted studies.

Publication bias arises from the failure to identify all studies that have been conducted, either published (i.e., publicly available) or unpublished. The term 'studies' means evidence or research results in any form where such studies would meet the study eligibility criteria without consideration of criteria regarding the form of publication. The phrase 'publicly available studies' means the studies are available to the broad academic community and the public through established distribution channels in any form, including forms with restricted access. Established distribution channels include peer-reviewed journals, books, conference proceedings, dissertations, reports by governmental or research organizations, preprints, and study registries.

Publication bias often leads to an overestimate in the effect in favor of the study hypothesis, because studies with statistically significant positive results are more likely to be publicly available.

bias in study selection process-revised and reopened for vote

A study selection bias due to an inadequate process for screening and/or evaluating potentially eligible studies.

An adequate process for screening and evaluating potentially eligible studies should generally include at least two independent reviewers for any steps that involve subjective judgment. Any step involving subjective judgment may introduce systematic distortions into the research findings.

 

HL7 Standards Development Updates:

On Monday April 8, the CQL Development Working Group (a CDS EBMonFHIR sub-WG) discussed Clinical Cohort Definition Language (CCDL) as intermediate query format (an intermediary between FHIR and CQL expression) and sent an email to the group in Germany that works on this to see if they would like to connect. 

On Tuesday April 9, the Statistics on FHIR Working Group updated the BaselineMeasureReport profile on the FEvIR platform based on the changed FHIR specification. There were changes to the description, the categories, and the section starter. The Viewing Tool was also updated. These changes have not yet been published.

 

On Tuesday April 9, In the HL7 Biomedical Research and Regulation (BRR) Working Group meeting, discussion of the participant flow profile for EBM IG resulted in the suggestion, “to NOT use 'Consort' in the Profile names as these profiles will be used for retrospective studies and other studies for which CONSORT does not apply.” The full jira ticket can be viewed here: https://jira.hl7.org/browse/FHIR-44740.

 

 

On Thursday April 11, the EBM Implementation Guide Working Group (a CDS EBMonFHIR sub-WG) worked on:

Baseline Measure Report

Wrote descriptions for BaselineMeasureReport Profile of Composition Resource. These changes can be viewed using the following links : https://build.fhir.org/ig/HL7/ebm/composition.html, https://build.fhir.org/ig/HL7/ebm/StructureDefinition-baseline-measure-report.html.

Participant Flow Report

Renamed 2 Participant Flow profiles for clarity:

Profile of EvidenceVariable Resource renamed from ParticipantFlow to ParticipantFlowEvidenceVariable Profile

Profile of Evidence Resource renamed from ParticipantFlowMeasure to ParticipantFlowEvidence Profile

Created new profile:

Profile of Composition Resource named ParticipantFlowReport Profile of Composition Resource.

 

 

 

Research Development Updates:

 

On Tuesday April 9, the Measuring the Rate of Scientific Knowledge Transfer Working Group reviewed instructions for evaluating article citations. These instructions can be viewed under the heading “Investigation Description” on the project page here: https://fevir.net/radar/3

 

Knowledge Ecosystem Liaison/Coordination Updates:

 

On Tuesday April 9, the Ontology Management Working Group improved the GRADE code system translation spreadsheet including general instructions, contact information, and addition of the following columns: Translator 2, Name, Translator 2 Agreement, and language code. The order of the columns was changed so it can be filled from left to right. The group then reviewed the French translation of the GRADE certainty terms and set up the Spanish tab for the spreadsheet. The resulting spreadsheet can be viewed here: https://docs.google.com/spreadsheets/d/14wHnXAPkJmosVqEwbmUFeI5Gkn1lpN0ulZzBUXl7-5M/edit?usp=sharing

 

On Wednesday April 10, the Funding the Ecosystem Infrastructure Working Group reviewed the product launch readiness checklist for making guidelines computable which was created last week. The group also discussed which developers might be involved. The group then discussed how to distinguish the provenance between that of the computable object and that of its substantive content. We decided we need a contributor extension that could be applied to any resource. This would be a necessary requirement for the Guideline Authoring Tool. 

On Friday April 12, the GRADE Ontology Working Group discussed progress on the GRADE Ontology Concept paper which will be presented at the May 1 GRADE meeting in Miami. Thank you to everyone who helped to edit the paper.

We then reviewed the developing protocol to add language translations to the GRADE Ontology.

Finally, we reviewed the terms that were open for vote last week. Indirectness in population received only positive votes and has been added to the code system.

Indirectness in exposure received one negative vote, was revised, and is now open for vote again.

A new term, Indirectness in comparator was also defined. There are currently two terms open for vote.

If you voted for The term "indirectness in exposure" before, please vote again, as changes have been made.

The meeting was recorded and can be viewed here.

Term and Voting Status

Definition

Alternative Terms
(if any)

Comment for application
(if any)

Indirectness in population

Passed

Differences between the population-related characteristics of the evidence and the intended target application.

Indirectness in population means there are differences between the populations in the relevant research studies and the population under consideration in a question of interest.

Differences in population-related characteristics (such as disease severity, social factors, or other determinants of health) may result in differences in the estimates derived from the evidence and those that would be seen in the intended target application.

The question of interest may vary with context, such as the key considerations for a guideline or systematic review.

Indirectness in exposure

Revised and Reopened for vote

Differences between the exposure-related characteristics of the evidence and the intended target application.

  • Indirectness in intervention
  • Indirectness in exposure or intervention

Interventions are a subset of exposures intended to change outcomes.

Indirectness in exposure means there are differences between the interventions or exposures in the relevant research studies and the interventions or exposures under consideration in a question of interest.

Differences in exposure-related characteristics (such as setting, intensity, mode of delivery, timing, co-interventions, and competency of person providing the intervention) may result in differences in the estimates derived from the evidence and those that would be seen in the intended target application.

The question of interest may vary with context, such as the key considerations for a guideline or systematic review.

Indirectness in comparator

Newly open for vote

 

Differences between the comparator-related characteristics of the evidence and the intended target application.

  • Indirectness in control exposure
  • Indirectness in control exposure (comparator)

Comparators are exposures used as the control or reference value in comparative evidence.
Interventions are a subset of exposures intended to change outcomes.

Indirectness in comparator means there are differences between the interventions or exposures used as control exposures in the relevant research studies and the interventions or exposures used as control exposures under consideration in a question of interest.

Differences in comparator-related characteristics (such as setting, intensity, mode of delivery, timing, co-interventions, and competency of person providing the intervention) may result in differences in the estimates derived from the evidence and those that would be seen in the intended target application.

The question of interest may vary with context, such as the key considerations for a guideline or systematic review.

 

 

FEvIR Platform and Tools Development Updates:

On Thursday April 11, the Computable EBM Tools Development Working Group -reviewed Magic App Converter changes for efficiency and consistency with GRADEpro converter.

 

Releases on the FEvIR Platform:

Computable Publishing®: Fast Evidence Interoperability Resources (FEvIR) Platform is available for use now, but is “pre-release”.  The current version is 0.212.0 (April 9, 2024). 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 0.212.0 (April 9, 2024) for editors of a resource, you can compare previous versions of the JSON by going to the "Usage View" tab and click the "Show Version Differences" button. Red and Green colors are used to show changed, deleted, or added values. Orange and Yellow colors are used to show moved entries in an array. (For example, if an entry was deleted or added and all the other entries shifted as a result.) The JSON version comparison can show "Just the Differences" or the entire "Full JSON" that also includes the unchanged elements.

 

Computable Publishing®: MAGIC-to-FEvIR Converter version 0.14.0 (April 11, 2024) converts data from a MAGICapp JSON file (demo files available) to FEvIR Resources in FHIR JSON.

Release 0.14.0 (April 11, 2024) now converts much more quickly. It also creates Group resources for the population, Comparator Group, the Exposure Group, intervention definition and comparator definition. And it creates a MAGICapp-to-FHIR Conversion Report instead of a Project. It also no longer has a text field to enter a Project Name.

Quotes for thought

"Once I got into space, I was very comfortable in the universe. I felt like I had a right to be anywhere in this universe, that I belonged here as much as any speck of stardust, any comet, any planet." --Mae C. Jemison, Astronaut

"Concentrate all your thoughts upon the work at hand. The sun's rays do not burn until brought to a focus." -- Alexander Graham Bell

"Comfortable shoes and the freedom to leave are the two most important things in life." – Shel Silverstein

No man needs a vacation so much as the man who has just had one.” ― Elbert Hubbard

“My favorite machine at the gym is the vending machine.” — Caroline Rhea

 

 

 

 

To get involved or stay informed: HEvKA Project Page on FEvIR Platform, HEvKA Project Page on HL7 Confluence, or join any of the groups that are now meeting in the following weekly schedule:

 

Weekly Meeting Schedule and Link:

 

Day

Time (Eastern)

Team

Monday 

8-9 am 

Project Management

Monday

9-10 am

Setting the Scientific Record on FHIR WG

Monday 

10-11 am

CQL Development WG (a CDS EBMonFHIR sub-WG)

Monday 

2-3 pm 

Statistic Terminology WG

Tuesday

9-10 am

Measuring the Rate of Scientific Knowledge Transfer WG

Tuesday 

2-3 pm 

StatisticsOnFHIR WG (a CDS EBMonFHIR sub-WG)

Tuesday

3-4 pm

Ontology Management WG

Wednesday

8-9 am 

Funding the Ecosystem Infrastructure WG

Wednesday

9-10 am 

Communications(Awareness, Scholarly Publications) WG

Thursday

8-9 am

EBM Implementation Guide WG (a CDS EBMonFHIR sub-WG)

Thursday

9-10 am

Computable EBM Tools Development WG

Friday

9-10 am 

Risk of Bias Terminology WG

Friday

10-11 am 

GRADE Ontology WG

Friday

12-1 pm

Project Management

 

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Research and Analysis Manager, Computable Publishing LLC

 

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