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\begin{document}

\title{GIN McMaster Guideline Development Checklist Extension for
Computable Guidelines}



\author[1]{Chirine Chehab}%
\author[1]{Stacy Lathrop}%
\author[1]{Craig Sennabaum}%
\author[1]{Chris Harrod}%
\author[1]{James Kariuki}%
\author[1]{Derek Ritz}%
\author[1]{Maria Michaels}%
\affil[1]{Affiliation not available}%


\vspace{-1em}



  
  \date{May 21, 2024}


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\textbf{Guidelines Knowledge Level 1 (L1) Checklist~}

Our objective is to develop an extension of the widely used GIN-McMaster
Guideline Development Checklist and Tool for the Adoption and
Implementation of Computable Guidelines. This checklist extension is
intended to be used as a tool to help guideline developers develop
narrative clinical guidelines with knowledge Level 1 (L1) in clearer,
consistent, and more structured approach so that their key information
like metadata, evidence, and recommendations may be successfully
implemented by informaticists in computable formats used in clinical
decision support systems that would improve patient outcomes through
evidence-based medical practice in a learning health system based on
FAIR (Findable, Accessible, Interoperable, and Reusable) principles.
This may cover clinical practice guidelines and their related systematic
reviews, evidence reports, and supplementary data and materials.

Please provide your comments on the below L1 checklist labeled items on
the following link:
\url{https://docs.google.com/forms/d/e/1FAIpQLSfZhtHnZ4kAQxXJnGL9bgqlT4o5LCIbRewavLcKzQUPQXKcqg/viewform}

\par\null\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
Applicable to Guideline Developer{} & Applicable to Informaticist/
Implementer{} & Item Label{} & Description{} & Useful Resources/
Examples{} & Further details{}\tabularnewline
X\textsuperscript{*}{} & -\textsuperscript{*} & 1. Policy{} & Provide a
link with a persistent identifier to public documentation of standards
used by the organization to develop their guidelines, including the
organization's methods and procedures, including how it established
transparency, composes its guideline development group, manages
conflicts of interest, and its evidence review, rating of evidence, peer
review, update, data management, and distribution/publishing policies.{}
& \selectlanguage{ngerman}·~~~~~~
\href{https://drive.google.com/drive/folders/1kFhyum_ezBAHqmAYKk43ptdySCP1ruXc}{GIN
McMaster Checklist}{} ·~~~~~~
\href{https://drive.google.com/drive/folders/1kFhyum_ezBAHqmAYKk43ptdySCP1ruXc}{IOM
Guidance}{} &\tabularnewline
X{} & - & 2.Scope{} & Clearly articulate the scope of the guideline
development project, including who the guidelines are for, what clinical
domains they cover, and where they may be practiced.{} & \selectlanguage{ngerman}·~~~~~~
\href{https://journals.lww.com/ajmqonline/fulltext/2023/09002/adapting_clinical_guidelines_for_the_digital_age_.2.aspx}{Adapting
Clinical Guidelines for the Digital Age}{} ·~~~~~~
\href{https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476601/}{An
Integrated Process for Co-Developing and Implementing Written and
Computable Clinical Practice Guidelines}{} ·~~~~~~ Integrated Process
tables:\url{https://stacks.cdc.gov/view/cdc/131006}\href{https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476596/}{An
Evaluation Framework for a Novel Process to Codevelop Written and
Computable Guidelines}{} ·~~~~~~ Evaluation framework
tool:\url{https://stacks.cdc.gov/view/cdc/131007}{} &\tabularnewline
X{} & - & 3.Goal(s){} & Clearly articulate why a guideline development
project is needed.{} & &\tabularnewline
X{} & X{} & 4.Contributor(s){} & Ensure the involvement of
informaticists and implementation scientists in the guideline's
development panel.{} Provide contact information for guideline
developers, informaticists, and other involved stewards{} &
&\tabularnewline
- & X{} & 5.Knowledge Levels Requirements{} & Provide a clear, strong,
and tangible definition of the requirements of each guidelines knowledge
levels starting with the executable knowledge level 4 (L4) to be able to
understand what is needed at L1 and be most useful{} & \selectlanguage{ngerman}·~~~~~~
\href{https://hl7.org/fhir/uv/cpg/documentation-approach-06-01-levels-of-knowledge-representation.html\#:~:text=\%E2\%80\%9CLevels\%E2\%80\%9D\%20of\%20Knowledge\%20Representation\%20Framing\%201\%20Approach\%20The,Semi-structured\%20...\%204\%20Structured\%20...\%205\%20Executable\%20}{FHIR
Clinical Guidelines (v1.0.0) (STU 1) (hl7.org)}{} &\tabularnewline
X{} & - & 6.Guideline Question formulation{} & Formulate measurable
and/or observable clinical questions using the
\href{https://www.cochranelibrary.com/en/about-pico}{Patient/population,
Intervention, Comparison, and Outcomes
(PICO)}~~~~~\href{https://www.cochranelibrary.com/en/about-pico}{Process}{}
& \selectlanguage{ngerman}·~~~~~~
\href{https://www.cochranelibrary.com/en/about-pico}{Patient/population,
Intervention, Comparison, and Outcomes
(PICO)}~~~~~\href{https://www.cochranelibrary.com/en/about-pico}{Process}{}
&\tabularnewline
X{} & X{} & 7.Guideline Structure{} & Use a consistent
\href{https://www.gradeworkinggroup.org/}{GRADE}(Grading of
Recommendations Assessment, Development and Evaluation) scale that is
publicly documented and linked to evidence statements{} Use a
structured, machine-readable format to consistently declare each
recommendation and its GRADE{} & \selectlanguage{ngerman}·~~~~~~
\href{https://jats4r.org/}{JATS4R~}{} ·~~~~~~
\href{https://drive.google.com/drive/folders/1kFhyum_ezBAHqmAYKk43ptdySCP1ruXc}{GIN
McMaster Checklist}{} ·~~~~~~
\href{https://drive.google.com/drive/folders/1kFhyum_ezBAHqmAYKk43ptdySCP1ruXc}{IOM
Guidance}{} ·~~~~~~
\href{https://confluence.hl7.org/display/CDS/EBMonFHIR}{EBMonFHIR -
Clinical Decision Support - Confluence (hl7.org)}{} ·~~~~~~
\href{https://www.ahrq.gov/cpi/about/otherwebsites/srdr.ahrq.gov/index.html}{Agency
for Healthcare Research and Quality (AHRQ) Systematic Review Data
Repository (SRDR+)}{} &
\href{https://docs.google.com/document/d/1sHNuICuXuiWFH1iSFLkUhea0YpDWjY33/edit?usp=drive_link\&ouid=110694559203203173816\&rtpof=true\&sd=true}{Use
the evidence-based structure and requirements for guidelines related
systematic reviews, evidence reports, and supplementary data and
materials}.{}\tabularnewline
X{} & X{} & 8.Documentation requirements per recommendation{} & Identify
and use common data elements and variables while writing your
recommendation in order to implement it in conformance with your
real-world requirements and health outcomes.{} ~ Formulate guidance for
each recommendation using the same necessary data elements, value sets,
and measures used to develop them from PICO questions.{} Understand data
to model, define, and map those data elements through the entire
learning health system for the particular topic / disease / drug /
screening / etc\ldots{}{} Consider and formulate the care pathways for
implementing each recommendation when there is sufficiently clear
evidence to confidently do so.{} ~ Clearly articulate possible care
options, along with the known variables and contexts using the heuristic
theory of decision-making, often implemented as fast-and-frugal (FFT)
decision trees since they are linked to signal detection theory,
evidence accumulation theory, and a threshold model of decision-making,
which, in turn, allows quantitative analysis of the accuracy of clinical
management strategies{} Use an existing application,~ template, or other
tool to facilitate the generation of individual statements that can be
executed to these algorithms. For example: If (x AND y OR z)~ is true:
make N recommendation. x, y, z statements should be easy to find within
the narrative, and should be documented clearly{} & \selectlanguage{ngerman}·~~~~~~
\url{https://goodwin.libguides.com/c.php?g=309484\&p=2066254} {]}{}
·~~~~~~
\href{https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi}{United
States Core Data for Interoperability (USCDI) \textbar{}
Interoperability Standards Advisory (ISA) (healthit.gov)}{} ·~~~~~~
\href{https://vsac.nlm.nih.gov/}{Value Set Authority Center (nih.gov)}{}
Additional Resources for International Community:{} ·~~~~~~
\href{https://hl7.org/fhir/uv/ips/2019Sep/}{InternationalPatientSummaryIG
(hl7.org)}{} ·~~~~~~
\href{https://www.who.int/standards/classifications/international-classification-of-health-interventions}{International
Classification of Health Interventions (ICHI) (who.int)}{} ·~~~~~~
\href{https://cds.ahrq.gov/authoring/documentation\#CDS_Authoring_Tool_User_Guide}{CDS
Authoring Tool (ahrq.gov)}{} ·~~~~~~
\href{https://hl7.org/fhir/uv/cpg/methodology-case-study.html}{FHIR
Clinical Guidelines (v0.2.0) (Current) (hl7.org)}{} ·~~~~~~ FFT Decision
Tree \href{https://pubmed.ncbi.nlm.nih.gov/29484787/}{Example}{} &
Define the data elements and variables that will be used when performing
complex queries on available data sets and published
literature.{}\tabularnewline
X{} & X{} & 9.Guideline Update{} & Guideline developers should have a
clear versioning policy for all updates to their evidence and guidance
following common
\href{https://www.hl7.org/fhir/valueset-version-algorithm.html}{version
algorithms} while taking into consideration the level of incorporated
changes \href{https://semver.org/}{Major, Minor, and Patch}.{} Maintain
an open, transparent, and continually learning and updated system based
on the latest set of evidence available.{} & \selectlanguage{ngerman}·~~~~~~
\url{https://semver.org/}{} ·~~~~~~
\url{https://www.hl7.org/fhir/valueset-version-algorithm.html}{} & Each
version shall have a persistent identifier for transparency in the
historical record, and that each version can be linked across all other
versions of that document through clearly communicated related
publications in each document and its indexed metadata.{}\tabularnewline
\bottomrule
\end{longtable}

\textsubscript{*X: Applicable, -: Not Applicable}

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