Clinical Practice Guidelines (CPG) on EBMonFHIR
1.0.2 - qa-preview

This page is part of the CPG-on-EBMonFHIR Implementation Guide (1.0.2).

Clinical Practice Guidelines (CPG) on EBMonFHIR

Official URL: https://www.netzwerk-universitaetsmedizin.de/fhir/cpg-on-ebm-on-fhir/ImplementationGuide/de.netzwerk-universitaetsmedizin.ebm-cpg Version: 1.0.2
Draft as of 2024-10-21 Computable Name: CPGonEBMonFHIR

Summary

This implementation guide describes an approach to using evidence-based medicine on FHIR (EBMonFHIR) in combination with FHIR Clinical Guidelines to represent evidence-based clinical practice guidelines including the evidence upon which the recommendations are based. The approach is based on the PICO (population, intervention, comparator, outcome) framework and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

This implementation guide is based on FHIR R5 (5.0.0).

The following elements are required to represent a clinical practice guideline recommendation for automated clinical decision support systems:

Name FHIR Base Resource Description References
Recommendation PlanDefinition Representation of a single guideline recommendation. Recommendation Plan, Guideline Citation, Recommendation Citation.
Recommendation Plan PlanDefinition Description of a recommended intervention addressed in a specific guideline recommendation. Intervention Activities specified in the guideline recommendation; Recommendation Eligibility Criteria defining the group of patients to which the recommendation applies to; Recommendation Justification providing the justification of the recommendation; Guideline Citation, Recommendation Citation.
Recommendation Action ActivityDefinition Definition of an activity that is part of an intervention in the context of a clinical practice guideline recommendation. -
Recommendation Eligibility Criteria EvidenceVariable Description of the population to which a specific guideline recommendation applies. -

The following profiles are used to represent the evidence upon which a clinical practice guideline recommendation is based:

Name FHIR Base Resource Description References
Study Outcome Evidence Evidence Evidence statistics generated from a single study or systematic review regarding a clinical question. Study Eligibility Criteria, Intervention Definition, Outcome Definition, Study Citation
Study Eligibility Criteria EvidenceVariable Intended definition of the patient group for which evidence or was generated or evidence synthesis was performed. -
Study Cohort Group Actual composition of the patient group for which the evidence was generated. -
Outcome Evidence Synthesis Evidence A single evidence for an outcome from an evidence synthesis (e.g., meta-analysis). Evidence Synthesis Cohorts, Evidence Data Set
Evidence Synthesis Cohorts Group Actual composition of the patient group for which evidence synthesis was performed. -
Intervention Definition EvidenceVariable Definition of an intervention or comparison with respect to which evidence was generated. -
Outcome Definition EvidenceVariable Definition of the outcome for which evidence was generated. -
Evidence Data Set EvidenceVariable Definition of the outcome used as the observed measured variable for an evidence synthesis. -
Outcome Evidence Evidence Evidence statistics generated from a single study or systematic review regarding a clinical question. Study Eligibility Criteria, Intervention Definition, Outcome Definition, Study Citation
Study Eligibility Criteria EvidenceVariable Definition of the patient group for which evidence was generated. -

The following profiles are used to represent the assessment of evidence which justify the recommendation:

Name FHIR Base Resource Description References
Recommendation Justification ArtifactAssessment Rating of the recommendation given all evidence for all considered outcomes. Recommendation Plan, Certainty of Evidence Rating, Net Effect Estimate
Certainty of Evidence Rating ArtifactAssessment Rating of the evidence for individual outcomes. Outcome Evidence
Net Effect Estimate EvidenceVariable Description of the net effect of a guideline recommendation. (Expected) Outcomes of a guideline recommendation.

Additionally, the following profiles are used to bundle recommendations and resources:

Name FHIR Base Resource Description References
Clinical Practice Guideline Composition Composition of several individual guideline recommendations Recommendation Plan, Guideline Citation
Guideline Bundle Bundle Bundle of all resources of a single clinical practice guideline. All other resources in this IG.

The following diagram provides an overview of the different profiles used in this implementation guide and their relationship:

FHIR Structure Overview

Study Outcome Evidencea Study Eligibility Criteria Outcome Evidence Synthesis Study Cohort Evidence Synthesis Cohorts Intervention Definition Outcome Definition Evidence Data Set Study Citation Certainty of Evidence Rating Net Effect Estimate Recommendation Justification Recommendation Plan Recommendation Action Recommendation Eligibility Criteria Recommendation Citation Guideline Citation

Reprinted from Journal of Biomedical Informatics, Lichtner, G., Alper, B. S., Jurth, C., Spies, C., Boeker, M., Meerpohl, J. J., & von Dincklage, F. (2023). “Representation of evidence-based clinical practice guideline recommendations on FHIR”. 2023., with permission from Elsevier. DOI: https://doi.org/10.1016/j.jbi.2023.104305. Journal homepage: https://www.sciencedirect.com/journal/journal-of-biomedical-informatics.

Detailed

The following diagram provides a more detailed view on the important fields of the profiles and their relationships. For a consistent detailed view, please visit the pages of the individual profiles.

In short, a single guideline recommendation describes a specific group of patients (the “population”), for which a certain treatment (or the absence from treatment) is recommended (the “intervention”). As the guideline recommendations are based on meta-analyses of clinical studies, the expected outcome of the recommended intervention on the patients may also be encoded. This additionally allows to specify the net effect of the recommendation by weighting the individual outcomes by their relative importance. For more information on the net effect, see Alper, B. S. et al. Defining certainty of net benefit: a GRADE concept paper. BMJ Open 9, e027445 (2019).


Examples

Multiple recommendations represented in the here shown format can be found at the CODEX+ CELIDA Recommendations repository.

  • The EBMonFHIR project is currently developing an EBM Implementation Guide aimed at representing computable knowledge for guideline recommendations (and others).
  • The CODEX+ CELIDA project has developed an execution engine for applying the recommendations to patient data in OMOP Common Data Model format..

Publication

Lichtner, G., Alper, B. S., Jurth, C., Spies, C., Boeker, M., Meerpohl, J. J., & von Dincklage, F. (2023). “Representation of evidence-based clinical practice guideline recommendations on FHIR”. Journal of Biomedical Informatics (2023). https://doi.org/10.1016/j.jbi.2023.104305.

Authors

  • Gregor Lichtner (University Medicine Greifswald)
  • Brian Alper (Computable Publishing LLC, Scientific Knowledge Accelerator Foundation)
  • Falk von Dincklage (University Medicine Greifswald)
  • Carlo Jurth (Charité – Universitätsmedizin Berlin)
  • Claudia Spies (Charité – Universitätsmedizin Berlin)
  • Martin Boeker (Medical Center rechts der Isar, Technical University of Munich)
  • Joerg Meerpohl (Medical Center & Faculty of Medicine, University of Freiburg; Cochrane Germany)