Clinical Practice Guidelines
2.0.0-ballot - ballot International flag

This page is part of the Clinical Guidelines (v2.0.0-ballot: STU2 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

L1 Checklist

GIN McMaster Guideline Development Checklist Extension for Computable Guidelines

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.

           
Applicable to Guideline Developer Applicable to Informaticist/ Implementer Item Label Description Useful Resources/ Examples Further details
X* -* 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. * GIN McMaster Checklist
* IOM Guidance		  
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. * Adapting Clinical Guidelines for the Digital Age
* An Integrated Process for Co-Developing and Implementing Written and Computable Clinical Practice Guidelines
* Integrated Process tables: https://stacks.cdc.gov/view/cdc/131006An Evaluation Framework for a Novel Process to Codevelop Written and Computable Guidelines
* Evaluation framework tool: https://stacks.cdc.gov/view/cdc/131007		  
X - 3.Goal(s) Clearly articulate why a guideline development project is needed.    
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    
- 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 * FHIR Clinical Guidelines (v1.0.0) (STU 1) (hl7.org)  
X - 6.Guideline Question formulation Formulate measurable and/or observable clinical questions using the Patient/population, Intervention, Comparison, and Outcomes (PICO)      Process * Patient/population, Intervention, Comparison, and Outcomes (PICO)      Process  
X X 7.Guideline Structure Use a consistent GRADE (Grading of Recommendations Assessment, Development and Evaluation) scale that is publicly documented and linked to evidence statementsUse a structured, machine-readable format to consistently declare each recommendation and its GRADE * JATS4R
* GIN McMaster Checklist
* IOM Guidance
* EBMonFHIR - Clinical Decision Support - Confluence (hl7.org)
* Agency for Healthcare Research and Quality (AHRQ) Systematic Review Data Repository (SRDR+)		 Use the evidence-based structure and requirements for guidelines related systematic reviews, evidence reports, and supplementary data and materials.
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…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 strategiesUse 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 * https://goodwin.libguides.com/c.php?g=309484\&p=2066254 ]
* United States Core Data for Interoperability (USCDI) | Interoperability Standards Advisory (ISA) (healthit.gov)
* Value Set Authority Center (nih.gov)
Additional Resources for International Community:
* InternationalPatientSummaryIG (hl7.org)
* International Classification of Health Interventions (ICHI) (who.int)
* CDS Authoring Tool (ahrq.gov)
* FHIR Clinical Guidelines (v0.2.0) (Current) (hl7.org)
* FFT Decision Tree Example		 Define the data elements and variables that will be used when performing complex queries on available data sets and published literature.
X X 9.Guideline Update Guideline developers should have a clear versioning policy for all updates to their evidence and guidance following common version algorithms while taking into consideration the level of incorporated changes Major, Minor, and Patch.Maintain an open, transparent, and continually learning and updated system based on the latest set of evidence available. * https://semver.org/
* 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.

 

*X: Applicable, -: Not Applicable

The material on this page was developed by the GIN-NA working group and presented to the CPG-on-FHIR project team for inclusion in the CPG-on-FHIR implementation guide in support of the shared goals of creating computable clinical guideline content. This material is published at the following link: https://www.authorea.com/users/701108/articles/687733-gin-mcmaster-guideline-development-checklist-extension-for-computable-guidelines