Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Introduction

Official URL: http://hl7.org/fhir/uv/ebm/ImplementationGuide/hl7.fhir.uv.ebm Version: 1.0.0-ballot
Draft as of 2023-12-17 Computable Name: EBMIG

EBMonFHIR Implementation Guide

Welcome to the EBMonFHIR Implementation Guide!

The FHIR Resources for Evidence Based Medicine Knowledge Assets (‘EBMonFHIR’) Implementation Guide defines profiles and value sets for the representation of scientific knowledge. This implementation guide is intended for developers of systems using FHIR for data exchange of scientific knowledge and for authors of more specialized implementation guides in this domain.

This implementation guide covers the broad scope of representation of scientific knowledge, including (1) citations to represent identification, location, classification, and attribution for knowledge artifacts; (2) components of research study design including study eligibility criteria (cohort definitions) and endpoint analysis plans; (3) research results including the statistic findings, definition of variables for which those findings apply, and the certainty of these findings; (4) assessments of research results; (5) aggregation and synthesis of research results; (6) judgments regarding evidence syntheses and contextual factors related to recommendations; (7) recommendations; and (8) compositions of combinations of these types of knowledge. The types of interoperability covered include syntactic (Resource StructureDefinitions) and semantic (value sets).

To Learn About FHIR

This implementation guide is based on the HL7 FHIR standard. It uses terminology, notations and design principles that are specific to FHIR. Before reading this implementation guide, it’s important to be familiar with some of the basic principles of FHIR as well as general guidance on how to read FHIR specifications. Readers who are unfamiliar with FHIR are encouraged to review the following prior to reading the rest of this implementation guide.

FHIR overview

Developer’s introduction

(or Clinical introduction)

FHIR data types

Using codes

References between resources

How to read resource & profile definitions

Base resource

FHIR Validation

FHIR Versions R5 and R6

The Evidence Based Medicine on FHIR (EBMonFHIR) developed Resources (ArtifactAssessment, Citation, Evidence, and EvidenceVariable) are first ready for use in the FHIR version R5. The FHIR version R6 includes further enhancements to these Resources. This EBMonFHIR Implementation Guide is based on FHIR version R5 and adds extensions to FHIR Resources (especially Group, Evidence, and EvidenceVariable) to use the features as structured in FHIR version R6. This is expected to support smooth interoperabiltiy for EBM Resources whether implementers use R5 or R6 versions.

Resources Used in the EBMonFHIR IG

Evidence Resource

The Evidence Resource is the central atomic component for the Evidence-related Resources. The Evidence Resource provides a machine-interpretable expression of an evidence concept including the evidence variables (e.g., population, exposures, outcomes, covariates), the statistics (the quantitative results of a study or statistical analysis), and the certainty of this evidence.

Profiles of Evidence Resource include:

  • EvidenceR6 is a base for all other Evidence Profiles. Profiles of EvidenceR6 include:
    • SingleStudyEvidence
    • EvidenceSynthesisEvidence
    • NonComparativeEvidence – Profiles of NonComparativeEvidence include:
      • ComparatorOnlyEvidence
      • InterventionOnlyEvidence
      • BaselineMeasureEvidence
      • ParticipantFlow
    • ComparativeEvidence – Profiles of ComparativeEvidence include:
      • ComparativeBaselineMeasureEvidence
      • ComparativeParticipantFlow
      • NetEffectContribution
    • EndpointAnalysisPlan
    • NetEffectEstimate

EvidenceVariable Resource

The EvidenceVariable Resource describes a single variable used in a statistical analysis.

Profiles of EvidenceVariable Resource include:

  • VariableDefinition is a base for all other EvidenceVariable Profiles. Profiles of VariableDefinition include:
    • GroupAssignment
    • ParticipantFlowMeasure

Group Resource

The Group Resource represents a defined collection of entities. The group may be enumerated, meaning that there is a known quantity of group members with or without a listing of the group members. The group may be definitional, meaning there is a structured representation of the characteristics (criteria) that define membership eligiblity, or who or what matches the criteria to be considered a member of the group.

Profiles of Group Resource include:

  • GroupR6 is a base for all other Group Profiles. Profiles of GroupR6 include:
    • StudyGroup
    • ExposureGroup
    • ComparatorGroup
    • MetaanalysisStudyGroup
    • NetEffectContributions
    • CohortDefinition – Profiles of CohortDefinition include:
      • Profiles of CohortDefinition used for the inclusion and exclusion criteria of specific conceptual types of groups include StudyEligibilityCriteria (for a research study), RecommendationEligibilityCriteria (for a clinical practice guideline recommendation), SystematicReviewEligibilityCriteria (for a systematic review), MetaanalysisEligibilityCriteria (for a statistical meta-analysis), and SearchStrategy (for a literature search). These Profiles are not currently structurally different than CohortDefinition but are separated for future development in case of specialized developments for eligibility criteria.
      • ExposureDefinition, ComparatorDefinition, OutcomeDefinition, and MetaanalysisOutcomeDefinition are Profiles of CohortDefinition used for the definition of evidence variables. These Profiles are not currently structurally different than CohortDefinition but are separated for future development in case of specialized developments for variable definitions.
      • EvidenceReportSubject is used to define the subject of an EvidenceReport. A Profile of EvidenceReportSubject is:
        • ComparativeEvidenceReportSubject

Citation Resource

The Citation Resource enables reference to any knowledge artifact for purposes of identification and attribution. The Citation Resource supports existing reference structures and developing publication practices such as versioning, expressing complex contributorship roles, and referencing computable resources.

Profiles of Citation Resource include:

  • JournalArticleCitation
  • BookCitation
  • BookPartCitation
  • DatabaseCitation
  • DatabaseEntryCitation
  • DatasetCitation
  • PreprintCitation
  • SoftwareCitation
  • WebPageCitation

ArtifactAssessment Resource

The ArtifactAssessment Resource provides one or more comments, classifiers or ratings about a Resource and supports attribution and rights management metadata for the added content.

Profiles of ArtifactAssessment Resource include:

  • Comment
  • Classification
    • DateAsRating Profile is a Profile of Classification
  • Rating
  • CertaintyOfEvidence
  • RiskOfBias
  • RecommendationJustification
  • OutcomeImportance
  • CompositeRating
  • Adaptation
    • Comparison Profile is a Profile of Adaptation

Composition Resource

The Composition Resource is a structure for grouping information for purposes of persistence and attestability. The Composition Resource provides the basic structure for a FHIR document. The full content of the document is expressed using a Bundle Resource containing the Composition and its entries (which are references to other FHIR Resources).

Profiles of Composition Resource include:

  • EvidenceReport is used for a base structure (canonical resource management) for a report combining any number of Citation, Evidence, EvidenceVariable, EvidenceReport, and related Resources. Profiles of EvidenceReport include:
    • ComparativeEvidenceReport is used for an evidence report including the study group, exposure, comparator, and findings for any number of outcomes comparing the exposure to the comparator in the study group.
    • Guideline is used for the composition of a clinical practice guideline and may be tightly related to use of the Recommendation Profile for related content.
    • Recommendation is used for the composition of a recommendation (such as that from a clinical practice guideline) and may be tightly related to a RecommendationPlan Profile of PlanDefinition and a RecommendationJustification Profile of ArtifactAssessment.
    • SummaryOfFindings is used for an evidence report combining Evidence and EvidenceVariable Resources, organized around VariableDefinition (Profile of EvidenceVariable), to represent the summary of findings of comparative evidence.
    • SummaryOfNetEffect is used for an evidence report combining ArtifactAssessment, Evidence, and EvidenceVariable Resources, organized around VariableDefinition (Profile of EvidenceVariable), to represent the summary of net effect contributions of comparative evidence, adjusted for the relative importance of outcomes.
    • EvidenceMap is used for an organized listing of Resources used to generate EvidenceReport instances.
    • M11Report is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.

Other Resources

Other Resources and Other Profiles used in the EBMonFHIR Implementation Guide include:

  • ResearchStudy Resource
  • CodeSystem Resource including a Profile of:
    • DataDictionary used for a code key for variable names in a dataset.
  • ActivityDefinition Resource including a Profile of:
    • RecommendationAction used for a recommendation from a clinical practice guideline.
  • PlanDefinition Resource including Profiles of:
    • RecommendationPlan used for the implementable representation of a recommendation (such as that from a clinical practice guideline). RecommendationPlan is developed to match the CPGonFHIR related Implementation Guidance.
    • SoaPlanDefinition used for the representation of a schedule of activities that is often includes with a research study protocol. SoaPlanDefinition is in development related to efforts to support the M11Report Profile.
  • Library Resource including Profiles of:
    • SearchResults used to represent search results, such as for a systematic review. The subjectReference element is limited to reference a SearchStrategy Profile.
    • SystematicReviewIncludedStudies used to represent the subset of search results of a systematic review which meet the inclusion criteria. The subjectReference element is limited to reference a SystematicReviewEligibilityCriteria Profile.
    • SystematicReviewExcludedStudies used to represent the subset of search results of a systematic review which did not meet the inclusion criteria. The subjectReference element is limited to reference a SystematicReviewEligibilityCriteria Profile.
  • List Resource including Profiles of:
    • EvidenceList used provide a list of Evidence Resources. EvidenceList is used to represent a group of evidence for the population for an EvidenceSynthesisEvidence using a summary data meta-analysis approach and is referenced from a MetaanalysisStudyGroup. The entry element is repeatable and limited to reference an Evidence Resource.
    • NetEffectContributionList used provide a list of Evidence Resources (NetEffectContribution Profile). NetEffectContributionList is used to represent a group of evidence for the population for a NetEffectEstimate (Profile of Evidence) using a net effect analysis approach and is referenced from a NetEffectContributions (Profile of Group). The entry element is repeatable and limited to reference a NetEffectContribution Resource.
    • OutcomeList used provide a list of outcomes. OutcomeList is referenced in the EvidenceReportSubject Profile as a way to define the set of outcomes that an EvidenceReport is about. The entry element is repeatable and limited to reference an OutcomeDefinition Profile or a VariableDefinition Profile.

Dependencies and Statements

Dependencies

IGPackageFHIRComment
.. Evidence Based Medicine on FHIR Implementation Guidehl7.fhir.uv.ebm#1.0.0-ballotR5
... HL7 Terminology (THO)hl7.terminology.r5#5.3.0R5Automatically added as a dependency - all IGs depend on HL7 Terminology
... FHIR Extensions Packhl7.fhir.uv.extensions.r5#1.0.0R5Automatically added as a dependency - all IGs depend on the HL7 Extension Pack

Cross Version Analysis

Global Profiles

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.