RE: Health Evidence Knowledge Accelerator (HEvKA) Daily Progress August 30, 2024

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Brian Alper

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Sep 2, 2024, 11:05:27 AM9/2/24
to Sharon Hibay, Joanne Dehnbostel, Health Evidence Knowledge Accelerator (HEvKA)

Sharon

 

Thank you for your feedback.  FYI – reply to the HEvKA email distribution list goes to about 200 people.  I am replying to the group in case others are interested in this message.

 

For detailed discussions, there is a Risk of Bias Terminology Working Group that meets on Fridays, and there is a dedicated Scientific Evidence Code System (SEVCO) Expert Working Group email list.

 

The risk of bias terminology has 2 parts: one part with > 200 terms covers the types of bias, including selection bias, attrition bias, reporting bias, etc.  The other part covers the terms for reporting the risk of such bias.  These terms can relate to any of the types of bias, so the term “low risk of bias” could be applied to reporting bias, detection bias, etc.

 

Brian

 

 

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Brian S. Alper, MD, MSPH, FAAFP, FAMIA

CEO, Computable Publishing LLC

bal...@computablepublishing.com

 

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Making Science Machine-Interpretable
http://computablepublishing.com 

 

Lead, HEALTH EVIDENCE KNOWLEDGE ACCELERATOR

President, Scientific Knowledge Accelerator Foundation

 

Read about The Mission Change of a Lifetime

"It only takes a pebble to start an avalanche."

Schedule a meeting with me.

 

From: Sharon Hibay <shi...@advancedhealthoutcomes.com>
Sent: Monday, September 2, 2024 10:59 AM
To: Joanne Dehnbostel <jdehn...@computablepublishing.com>; Health Evidence Knowledge Accelerator (HEvKA) <HE...@computablepublishing.com>
Subject: RE: Health Evidence Knowledge Accelerator (HEvKA) Daily Progress August 30, 2024

 

Bryan & Joanne, I would recommend a slight modification to the title of each of the bias terms by adding “results” in front of the word “bias” (see the table below), as there are many types of research biases (e.g., selection, sampling, question order, confirmation, recall, non-response). Should you land on other bias level terminology, it would be my recommendation that “results” would accompany “bias”.

 

low risk of results bias

moderate risk of results bias

high risk of results bias

undetermined risk of results bias

 

 

With Kindness,

 

Dr. Sharon M. Hibay

AHO CEO and Principal

Women-Owned Small Business

(610) 248-6400

https://calendly.com/shibay

 

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From: Joanne Dehnbostel <jdehn...@computablepublishing.com>
Sent: Monday, September 2, 2024 9:13 AM
To: Health Evidence Knowledge Accelerator (HEvKA) <HE...@computablepublishing.com>
Subject: Health Evidence Knowledge Accelerator (HEvKA) Daily Progress August 30, 2024

 

 

 

Announcement: There will be no HEvKA Meetings September 2, 2024 (Labor Day in the United States)

Special participation opportunity:

 

 We need your help:

 

We are creating a grant application titled “Setting Evidence-Based Medicine on Fast Healthcare Interoperability Resources (EBMonFHIR) as the data standard for biomedical research” for PAR-23-236 Early-stage Biomedical Data Repositories and Knowledgebases (see the project page for the grant proposal) 

 

You can help in 3 ways:

 

  1. Review the current version of the grant proposal and make suggestions Research Strategy EBMonFHIR Knowledgebase.docx or any of the other pages listed in Associated Links on the project page above.
  1. Write a letter of support-- Thank you so far to Mike Hamidi (Datainterop LLC and HL7 Vulcan Accelerator), Artur Novak (Evidence Prime),  Amy Price (Dartmouth), Gustav Vella (Carelane), Allen Flynn (University of Michigan Medical School), Gabriel Rada (Epistemonikos Foundation), Gert van Valkenhoef (Cochrane) and Kevin Hobbie (ICF International) for completing PDF letters of support.
  1. Suggest citations to support statements in the text of the grant proposal (citations still needed for reference numbers 23-25, 27-28)

 

 

9 people (BA, CA-D, HK, HL, JD, KS, KW, MA, TD) participated in up to 3 active working group meetings. 

The Risk of Bias Terminology Working Group found that the term open for voting this week (rating of bias risk) passed with a vote of 7-0. The group then discussed which terms should be used for this rating and viewed the terms that are included in the common rating tools for this purpose including the GRADE approach. The following terms (low risk of bias, moderate risk of bias, high risk of bias, undetermined risk of bias) were chosen, defined, and are open for voting. There are currently 4 risk of bias terms open for voting. 

 

Term

Definition

Alternative Terms

(if any)

Comment for application

(if any)

A qualitative assessment that there is a low likelihood and potential impact of systematic distortion in research results.

An assessment of low risk of bias means there are no serious concerns for bias.

A qualitative assessment that there is some likelihood and potential impact of systematic distortion in research results, but this likelihood and potential impact is neither low nor high.

  • some concerns for risk of bias
  • medium risk of bias

As opposed to the term undetermined risk of bias, the term 'moderate risk of bias' expresses a positive assertion of concern.

A qualitative assessment that there is a high likelihood and potential impact of systematic distortion in research results.

  • serious risk of bias

An assessment of high risk of bias means there are serious concerns for bias.

A qualitative assessment that there is insufficient information to make a qualitative assessment regarding the likelihood and potential impact of systematic distortion in research results.

As opposed to the term moderate risk of bias, the term 'undetermined risk of bias' does not express a positive assertion of concern.

 

The GRADE Ontology Working Group found that the term Incoherence passed with a vote of 10-0.  The other terms open for voting (Plausible opposing confounding and Large effect) were refined and reopened for voting as shown below. 

 

Term

Definition

Alternative Terms

(if any)

Comment for application

(if any)

Confounding that may influence the effect in the opposite direction of the observed effect.

  • Reverse confounding
  • Opposing residual confounding
  • Plausible opposing residual confounding

The effect of confounding may be suspected or observed.

 

Opposing confounding is defined as confounding having the effect in the opposite direction of the observed effect. For interpretation in the context of rating the certainty of evidence, opposing confounding may be defined as confounding such that the effect would not lie on one side of a specified threshold or within a specified range.

 

In the context of rating the certainty of evidence (which is defined as the confidence that the true value of the measure being estimated lies on one side of a specified threshold or within a specified range), the domain of 'Plausible opposing confounding' is only considered when the observed effect lies on one side of a specified threshold or within a specified range. If the observed effect were not in the specified area of interest, then the consideration of plausible opposing confounding would not be relevant.

 

When rating the certainty of evidence from observational (or non-randomized) studies and when the summary effect of all plausible confounding is considered to be opposing confounding, then one may rate up the certainty of evidence.

An effect size that is substantially far from the null.

  • Large magnitude of effect
  • Large effect size

If the effect is reported with a risk ratio, hazard ratio, or other relative measure for which a value of 1 means a null effect, then a 'large effect' may be considered for any value substantially greater than 1 (e.g. > 2) or any value substantially lesser than 1 (e.g. < 0.5).

 

When rating the certainty of evidence from observational (or non-randomized) studies and the effect size is sufficiently large that it cannot be plausibly explained by residual confounding and there are no other serious concerns, then one may rate up the certainty of evidence.

 

The Project Management Working Group created the agenda for all meetings in September including the HEvKA presentations during the Global Evidence Summit in Prague. 

 

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

Review data standard funding proposal and Authoring Tools progress

Monday 2-3 pm

Statistic Terminology

Review SEVCO terms (1 term open for vote, z-score)

Tuesday 9 am-10 am

Measuring the Rate of Scientific Knowledge Transfer

Scientific Knowledge Accelerator Foundation Board meeting, review Global Evidence Summit presentations

Tuesday 2-3 pm

StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)

Estimand representation in ResearchStudy Resource, develop Evidence Report example

Wednesday 8-9 am

Making Guidelines Computable

Create example with Guideline Authoring Tool; poster for Global Evidence Summit

Wednesday 9-10 am

Communications (Awareness, Scholarly Publications)

Global Evidence Summit Posters, Special Session, MCBK lightning talks

Thursday 8-9 am

EBM Implementation Guide (a CDS EBMonFHIR sub-WG)

QA Report, Profile descriptions

Thursday 9-10 am

Computable EBM Tools Development

Review progress with Authoring tools

Friday 9-10 am

Risk of Bias Terminology

Review SEVCO risk of bias terms (1 term open for vote, rating of bias risk)

Friday 10-11 am

GRADE Ontology

Review GRADE terms (Plausible opposing confounding, Large effect, Incoherence)

Friday 12-1 pm

Project Management

September agenda; Review NIH PAR-23-236 R24 Early-stage Biomedical Data Repositories and Knowledgebases

 

 

To join any of these meetings use the following link for a Microsoft Teams Meeting:

 

 

For the week of September 2 (No meetings on Labor Day which is Monday, September 2):

 

Day/Time (Eastern)

Working Group

Agenda Items

Sep 3 Tuesday 9 am-10 am

Measuring the Rate of Scientific Knowledge Transfer

review Global Evidence Summit presentation

Sep 3 Tuesday 2-3 pm

StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)

review SEVCO poster for Global Evidence Summit, Estimand representation in ResearchStudy Resource

Sep 4 Wednesday 8-9 am

Making Guidelines Computable

Refine example with Guideline Authoring Tool; GINTech agenda for Global Evidence Summit

Sep 4 Wednesday 9-10 am

Communications (Awareness, Scholarly Publications)

Global Evidence Summit Posters, Special Session

Sep 5 Thursday 8-9 am

EBM Implementation Guide (a CDS EBMonFHIR sub-WG)

QA Report, Profile descriptions

Sep 5 Thursday 9-10 am

Computable EBM Tools Development

Review progress with Authoring tools

Sep 6 Friday 9-10 am

Risk of Bias Terminology

Review SEVCO risk of bias terms (4 terms open for vote)

Sep 6 Friday 10-11 am

GRADE Ontology

Review GRADE terms (Plausible opposing confounding, Large effect)

Sep 6 Friday 12-1 pm

Project Management

CANCELLED for travel to Global Evidence Summit

 

 

For the week of September 9 (no HEvKA meetings as many are in Global Evidence Summit in Prague):

 

Day/Time (Central European)

Presentation/Meeting Type

Presentation/Meeting Title

Sep 10 Tuesday 11-12:30 am

Special Session

Using technology to make the Evidence Ecosystem more efficient and effective: global collaborations for interoperability

Sep 11 Wednesday 7:30-8:30 am

Working Group

GINTech

Sep 11 Wednesday 12:30-2 pm

Poster

P29 GINTech: Making Guidelines Computable

Sep 12 Thursday 12:30-2 pm

Poster

P86 The GRADE Ontology Project

Sep 13 Friday 10:04-10:11 am

Oral Presentation

How to Measure the Rate of Knowledge Transfer from Clinical Trials to Clinical Practice Guidance

Sep 13 Friday 12-1:30 pm

Poster

P25 Scientific Evidence Code System (SEVCO): a common language for communicating evidence

Sep 14 Saturday 9 am-5 pm

GRADE Working Group

agenda includes GRADE Ontology update

 

 

For the week of September 16:

 

Day/Time (Eastern)

Working Group

Agenda Items

Sep 16 Monday 11 am-12 pm

Project Management

FHIR changes and EBMonFHIR Implementation Guide issues

Sep 16 Monday 9-10 am

Setting the Scientific Record on FHIR

Review data standard funding proposal and Authoring Tools progress

Sep 16 Monday 2-3 pm

Statistic Terminology

Review SEVCO terms (1 term open for vote, statistical inference paradigm)

Sep 17 Tuesday 9 am-10 am

Measuring the Rate of Scientific Knowledge Transfer

project planning

Sep 17 Tuesday 2-3 pm

StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)

develop Evidence Report example

Sep 18 Wednesday 8-9 am

Making Guidelines Computable

Review feedback from Global Evidence Summit

Sep 18 Wednesday 9-10 am

Communications (Awareness, Scholarly Publications)

HL7 WGM EBMonFHIR presentations

Sep 19 Thursday 8-9 am

EBM Implementation Guide (a CDS EBMonFHIR sub-WG)

QA Report, Profile descriptions

Sep 19 Thursday 9-10 am

Computable EBM Tools Development

Review progress with Authoring tools

Sep 20 Friday 9-10 am

Risk of Bias Terminology

Review SEVCO risk of bias terms ( rating of bias risk)

Sep 20 Friday 10-11 am

GRADE Ontology

Review GRADE terms

Sep 20 Friday 12-1 pm

Project Management

CANCELLED for travel to HL7 Work Group Meeting

 

 

for the week of September 23:

 

No HEvKA meetings as many will participate in HL7 FHIR Connectathon and Work Group Meeting.

 

For the week of September 30:

 

Day/Time (Eastern)

Working Group

Agenda Items

Sep 30 Monday 8-9 am

Project Management

FHIR changes and EBMonFHIR Implementation Guide issues

Sep 30 Monday 9-10 am

Setting the Scientific Record on FHIR

Review Authoring Tools progress

Sep 30 Monday 2-3 pm

Statistic Terminology

Review SEVCO terms (statistical inference paradigm)

Oct 1 Tuesday 9 am-10 am

Measuring the Rate of Scientific Knowledge Transfer

Scientific Knowledge Accelerator Foundation Board meeting

Oct 1 Tuesday 2-3 pm

StatisticsOnFHIR (a CDS EBMonFHIR sub-WG)

develop Evidence Report example

Oct 2 Wednesday 8-9 am

Making Guidelines Computable

Review progress with Guideline Authoring Tool

Oct 2 Wednesday 9-10 am

Communications (Awareness, Scholarly Publications)

publications, presentations, website

Oct 3 Thursday 8-9 am

EBM Implementation Guide (a CDS EBMonFHIR sub-WG)

QA Report, Profile descriptions

Oct 3 Thursday 9-10 am

Computable EBM Tools Development

Review progress with Authoring tools

Oct 4 Friday 9-10 am

Risk of Bias Terminology

Review SEVCO risk of bias terms ( rating of bias risk)

Oct 4 Friday 10-11 am

GRADE Ontology

Review GRADE terms

Oct 4 Friday 12-1 pm

Project Management

Prepare weekly agenda

 

Releases on the FEvIR Platform:

Computable Publishing®: Comparative Evidence Report Viewing Tool  version 0.31.0 (August 30, 2024) displays a Composition Resource with a ComparativeEvidenceReport Profile.

Release 0.31.0 (August 30, 2024) no longer displays “No human-readable text added.” when a section Narrative text element is empty.

Computable Publishing®: EvidenceReportPackage Viewing Tool version 0.3.0 (August 30, 2024)  displays an EvidenceReportPackage Profile of a Composition Resource.

Release 0.3.0 (August 30, 2024) no longer displays “No human-readable text added.” when a section Narrative text element is empty.

Computable Publishing®: Guideline Viewing Tool version 0.20.0 (August 30, 2024) displays a Guideline Profile of a Composition Resource

Release 0.20.0 (August 30, 2024) no longer displays “No human-readable text added.” when a section Narrative text element is empty.

Computable Publishing®: M11 Report Viewing Tool  version 0.18.0 (August 30, 2024) displays an M11Report Profile of a Composition Resource.

Release 0.18.0 (August 30, 2024) no longer displays “No human-readable text added.” when a section Narrative text element is empty.

Computable Publishing®: Recommendation Authoring Tool version 0.25.0 (August 30, 2024) creates a Composition Resource with a Recommendation Profile and the associated Resources for a structured representation of a recommendation.

Release 0.25.0 (August 30, 2024) supports autogeneration of the Narrative summary from the first entry reference in the Population section in the Recommendation Specification section; display of the title, description, combination method, and inclusion and exclusion criteria from the Group Resource defining the Population in the Population section in the Recommendation Specification section in the Recommendation Viewing Tool; and no longer displays “No human-readable text added.” when a section Narrative text element is empty.

Computable Publishing®: Summary Of Findings Viewing Tool 0.28.0 (August 30, 2024)  displays a Composition Resource with a SummaryOfFindings Profile.

Release 0.28.0 (August 30, 2024) no longer displays “No human-readable text added.” when a section Narrative text element is empty.

 

Quote for Thought:

“September’s here,
Time to get into gear,
But before we do,
One last hullabaloo”--author unknown






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 

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)

Wednesday

8-9 am 

Making Guidelines Computable 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

 

To join any of these meetings:

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Joanne Dehnbostel MS, MPH

Research and Analysis Manager, Computable Publishing LLC

 

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