Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Introduction

Official URL: http://hl7.org/fhir/uv/ebm/ImplementationGuide/hl7.fhir.uv.ebm Version: 1.0.0-ballot2
IG Standards status: Draft Maturity Level: 1 Computable Name: EBMIG
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44

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 Continuous Integration Build of 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 R5-based links prior to reading the rest of this implementation guide. For changes that are in development for the next version of FHIR (R6), use the Continuous Integration Build of FHIR to find related content.

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

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:

  • SingleStudyEvidence
  • EvidenceSynthesisEvidence
  • NonComparativeEvidence – Profiles of NonComparativeEvidence include:
    • ComparatorOnlyEvidence
    • InterventionOnlyEvidence
    • BaselineMeasureEvidence
    • ParticipantFlowEvidence
  • ComparativeEvidence – Profiles of ComparativeEvidence include:
    • ComparativeBaselineMeasureEvidence
    • ComparativeParticipantFlowEvidence
    • NetEffectContribution
  • StatisticModel – A Profile of StatisticModel is:
    • 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
    • ParticipantFlowEvidenceVariable
    • DichotomousIntendedOutcome

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 definitional groups include StudyEligibilityCriteria (for a research study) and RecommendationEligibilityCriteria (for a clinical practice guideline recommendation). These Profiles are not currently structurally different than CohortDefinition but are separated for future development in case of specialized developments for eligibility criteria.
    • ConceptualCohortDefinition – Profiles of ConceptualCohortDefinition include:
      • Profiles of ConceptualCohortDefinition used for the inclusion and exclusion criteria of specific conceptual groups include SystematicReviewEligibilityCriteria (for a systematic review) and MetaanalysisEligibilityCriteria (for a statistical meta-analysis). These Profiles are not currently structurally different than ConceptualCohortDefinition but are separated for future development in case of specialized developments for eligibility criteria.
      • ConceptualExposureDefinition, ConceptualComparatorDefinition, OutcomeDefinition, and MetaanalysisOutcomeDefinition are Profiles of ConceptualCohortDefinition used for the definition of evidence variables. These Profiles are not currently structurally different than ConceptualCohortDefinition but are separated for future development in case of specialized developments for variable definitions.
      • SearchStrategy (for a literature search)
      • 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:
    • ResearchStudyDataDictionary is used for a code key for variable names in a dataset containing the observations collected in a research study.
    • 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.
    • EvidenceReportPackage is used for a base structure to extend the EvidenceReport Profile with optional sections for Summary, Introduction, Discussion, Methods, References, Competing Interests, Acknowledgements, and Appendices. Profiles of EvidenceReportPackage 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.
      • ComparativeEvidenceSynthesisReport is used for an evidence report including the intended population, intended exposure, intended comparator, and findings for any number of outcomes comparing the exposure to the comparator with observed study group, observed exposure group, and observed comparator group unique for each outcome.
      • 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.
      • 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.
    • EvidenceTableReportPackage is used for a base structure to extend the EvidenceReport Profile with Results sections where each results section instance has a focus on a measured variable and a reproducible structure to represent evidence about that measured variable for different groups. Profiles of EvidenceTableReportPackage include:
      • BaselineMeasureReport is used for an evidence report including the findings for any number of baseline measures in a research study.
      • ParticipantFlowReport is used for an evidence report including the counts (and proportions) for any number of participant flow measures in a research study.
      • OutcomeMeasureReport is used for an evidence report including the findings for any number of outcome measures in a research study.
      • 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.

Other Resources

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

  • ResearchStudy Resource
    • CTISRecord used for a scientific study record in the European Union Clinical Trial Information System (EU CTIS), a research study registry of the European Union (EU).
    • M11ResearchStudy used to add extensions for use with an M11 Report.
    • SystematicReview used for a research study that involves investigation of research studies.
  • 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:
    • BaselineVariablesList is used to provide a list of EvidenceVariable Resources which represent baseline measures.
    • EvidenceList is used to 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.
    • OutcomeVariablesList is used to provide a list of EvidenceVariable Resources which represent outcome measures.
    • ParticipantFlowVariablesList is used to provide a list of EvidenceVariable Resources which represent participant flow measures.

Changes from first ballot

The Implementation Guide has changed substantially by using a FHIR R6 base instead of a FHIR R5 base.

In addition, new Profiles include BaselineMeasureReport, BaselineVariablesList, ComparativeEvidenceSynthesisReport, ConceptualCohortDefinition, ConceptualComparatorDefinition, ConceptualExposureDefinition, DichotomousIntendedOutcome, EvidenceReportPackage, EvidenceTableReportPackage, M11ResearchStudy, OutcomeMeasureReport, OutcomeVariablesList, ParticipantFlowReport, ParticipantFlowVariablesList, ResearchStudyDataDictionary, SystematicReview, and VariablesList. Removed Profiles include DataDictionary, EvidenceMap, and EvidenceR6. Some Profiles were renamed, such as ParticipantFlowMeasure was renamed ParticipantFlowEvidenceVariable.

New Extensions include AdditionalLanguage, CiteAs, EvidenceVariableCLassifier, EvidenceVariableConditional, EvidenceVariableConstraint, EvidenceVariableDataCleaning, EvidenceVariableDataStorage, EvidenceVariableDefinitionModifier, EvidenceVariableHandlingDetail, EvidenceVariableMissingData, EvidenceVariablePeriod, RelatesToWithQuotation, RelatesTo, RelativeOutcomeImportance, ResearchStudyComparisonGroupEligibility, ResearchStudyExcludedStudy, ResearchStudyIncludedStudy, ResearchStudyNumberOfStudiesIdentified, ResearchStudyNumberOfStudiesIncluded, ResearchStudyOutcomeMeasure, ResearchStudyResultAsComposition, ResearchStudySaeReportingMethod, ResearchStudySearchStrategy, ResearchStudySponsorConfidentialityStatement, ResearchStudyStudyAmendment, ResearchStudySystematicReviewEligibilityCriteria, TargetAttachment, TargetCanonical, TargetMarkdown, TargetReference, and TargetUri. Many of these extensions are temporary and provided to support elements that will be available in the latest R6 build version of FHIR but are not available for the IG builder.

Acknowledgements

This Implementation Guide was made possible by the thoughtful contributions of many, including but not limited to the following people and organizations:

  • Brian S. Alper, MD, MSPH, FAAFP, FAMIA, FGIN, Computable Publishing LLC (US) - Editor
  • Khalid Shahin, Computable Publishing LLC (US) - Committer
  • Joanne Dehnbostel, MS, MPH, Computable Publishing LLC (US)
  • Health Evidence Knowledge Accelerator (HEvKA)
  • Scientific Knowledge Accelerator Foundation
  • Clinical Decision Support (CDS) Work Group
  • Clinical Quality Information (CQI) Work Group
  • Biomedical Research and Regulation (BRR) Work Group
  • Structured Documents (SD) Work Group
  • Guidelines International Network Technology Working Group (GINTech)
  • Muhammad Afzal, PhD, FHEA, Birmingham City University (England)
  • Rachel Couban, McMaster University (Canada)
  • Christopher M. Enright, Computable Publishing LLC (US)
  • Sophie Klopfenstein, MD, Berlin Institute of Health at Charité – Universitätsmedizin Berlin (Germany)
  • Bhagvan Kommadi, MS, Capri Global Capital Ltd. (India)
  • Ilkka Kunnamo, MD, PhD, Duodecim Publishing Company (Finland)
  • Harold Lehmann, MD, PhD, Johns Hopkins University (US)
  • Gregor Lichtner, PhD, Universitätsmedizin Greifswald (Germany)
  • Matthias Löbe, IMISE, Universität Leipzig (Germany)
  • Bryn Rhodes, Smile Digital Health (US)
  • Karen A. Robinson, PhD, Johns Hopkins University (US)
  • Mario Tristan, IHCAI Institute (Costa Rica)
  • Janice Tufte, Hassanah Consulting (US)
  • Yunwei Wang, MITRE (US)
  • Kenneth J. Wilkins, PhD, National Institutes of Health, National Institute of Diabetes & Digestive & Kidney Diseases (NIH/NIDDK) (US)

Dependencies and Statements

Dependencies

Cross Version Analysis

Global Profiles

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.