| 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 statements Use 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 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 | · 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. |