Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
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 2.0.0-ballot 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
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).
Metadata elements in the Composition Resource that are similar to other Resources include url, identifier, version, status (which has different codes than the status used in other Resources), date, useContext, author (which uses a Reference datatype), name, title, and note.
Composition.type is required and uses a CodeableConcept datatype. Composition.category is optional and uses an array of CodeableConcept datatype.
Composition.subject is optional and uses an array of Reference to express what the composition is about. Composition.encounter is optional and uses a single Reference to an Encounter Resource (this is common in health data exchange and uncommon in science data exchange).
Composition.attester is a repeatable BackboneElement that is similar conceptually to reviewer, editor, and endorser elements used in other Resources.
Composition.custodian is optional and references an Organization Resource to represent the 'publisher' of the composition.
Composition.relatesTo is similar to Resource.relatedArtifact used in other Resources. In compositions used for scientific knowledge exchange, there is often a desire to inform the reader how to cite the composition. The relatesTo element may have an instance with a type of "cite-as" to represent how to cite the composition.
Composition.event is a repeatable BackboneElement to represent the clinical service(s) being documented and is not expected to be used commonly in the EBMonFHIR Implementation Guide.
Composition.section is a repeatable and recursive BackboneElement that contains all the content of the composition.
Identifiers of a composition section include section.title (string datatype), section.code (CodeableConcept datatype), and section.focus (Reference datatype).
Metadata about the composition section include section.author (repeatable Reference datatype) and emptyReason (CodeableConcept datatype).
The content of a section may be found in text, entry, and/or section elements.
section.entry is a repeatable Reference.
section.section is a repeatable BackboneElement and section.orderedBy is a CodeableConcept to specify the order of section entries.
section.text is a Narrative datatype used for a text summary of the section. A Narrative datatype contains 2 required elements: section.text.status coded as generated, extensions, additional, or empty and section.text.div with xhtml content.
The EvidenceReport Profile is used for a base structure (canonical resource management) for a report combining any number of Citation, Evidence, EvidenceVariable, Composition, and related Resources. The EvidenceReport Profile adds a number of extensions for metadata (versionAlgorithm, experimental, description, purpose, copyright, copyrightLabel, approvalDate, lastReviewDate, and effectivePeriod). The EvidenceReport Profile limits the number of subject elements to 1 and limits the resource types that can be referenced as the subject to Citation, Classification, EvidenceReportSubject, or ResearchStudy. The Composition.attester.mode element uses a CodeableConcept datatype and a Contributor Role Value Set is provided with preferred binding to include concepts for reviewer, editor, endorser, informant, recorder, and funder. An EvidenceReport Section Code Value Set is provided with extensible binding for the section.code elements.
The ResearchStudyDataDictionary Profile is a Profile of EvidenceReport Profile and is used for a code key for variable names in a dataset containing the observations collected in a research study. Each variable is included in a section.entry instance which references VariableDefinition Profile.
The EvidenceReportPackage Profile is used for a base structure to extend the EvidenceReport Profile with optional sections for Introduction, Discussion, Methods, References, Competing Interests, Acknowledgements, and Appendices.
The ComparativeEvidenceReport Profile is a Profile of EvidenceReportPackage and 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.
The Composition.type value is set to a "Comparative Evidence Report".
..A 'Population' section is required with entries limited to reference StudyGroup Profile.
..An 'Intervention' section is required with 2 contained sections. The 'Intervention' section may be repeated. An 'Intervention Description' section is required with entries limited to reference ExposureDefinition Profile. An 'Intervention Group' section is required with entries limited to reference ExposureGroup Profile.
..A 'Comparator' section is required with 2 contained sections. A 'Comparator Description' section is required with entries limited to reference ComparatorDefinition Profile or ExposureDefinition Profile. A 'Comparator Group' section is required with entries limited to reference ComparatorGroup Profile or ExposureGroup Profile.
..A 'Research Study' section is required with entries limited to reference ResearchStudy Resource or Citation Resource or Composition Resource.
..A 'Baseline Measures' section is optional. The 'Baseline Measures' section entry element is limited to a single instance that references BaselineMeasureReport Profile.
..A 'Participant Flow' section is optional. The 'Participant Flow' section entry element is limited to a single instance that references ParticipantFlowReport Profile.
..An 'Outcome Measures' section is optional. The 'Outcome Measures' section entry element is limited to reference OutcomeMeasureReport Profile.
..A 'Summary of Findings' section is optional. The 'Summary of Findings' section entry element is limited to reference SummaryOfFindings Profile.
The [ComparativeEvidenceSynthesisReport Profile][ComparativeEvidenceSynthesisReport] is a Profile of EvidenceReportPackage and 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.
The Composition.type value is set to a "Comparative Evidence Synthesis Report".
..A 'Population' section is required with entries limited to reference CohortDefinition Profile or ConceptualCohortDefinition Profile.
..One or more 'Intervention description' sections are required with entries limited to reference CohortDefinition Profile or ConceptualCohortDefinition Profile.
..A 'Comparator' section is required with entries limited to reference CohortDefinition Profile or ConceptualCohortDefinition Profile.
..A 'Research Study' section is required with entries limited to reference ResearchStudy Resource or Citation Resource or Composition Resource.
..An 'Outcome Variables' section is optional with entries limited to reference [VariabletDefinition Profile][VariabletDefinition].
..A 'Results' section is optional. The 'Results' section entry element is limited to reference [OutcomeMeasureSynthesisReport Profile][OutcomeMeasureSynthesisReport].
..A 'Summary of Findings' section is optional. The 'Summary of Findings' section entry element is limited to reference SummaryOfFindings Profile.
The EvidenceMeasureReportPackage Profile is used for a base structure to extend the EvidenceReport Profile with optional relatesTo slices for Total Group, Intervention Group, Comparator Group, and Group Assignment.
The relatesTo element may include instances with type values of "depends-on", label values to identify the contextual use of specific Group Resources (such as "Intervention Group", "Comparator Group", and "Total Group"), and resourceReference values which may be limited to reference StudyGroup, ExposureGroup, or ComparatorGroup Profiles.
The relatesTo element may include instances with type values of "composed-of", label values of "Group Assignment" to identify the contextual use of specific EvidenceVariable Resources, and resourceReference values which may be limited to reference GroupAssignment Profiles.
The BaselineMeasureReport Profile is a Profile of EvidenceMeasureReportPackage and is used for an evidence report including the findings for any number of baseline measures in a research study.
The Composition.type value is set to a "Baseline Measure Report".
The relatesTo element may include instances with type values of "derived-from", label values of "Baseline Measure" to identify the contextual use of specific EvidenceVariable Resources, and resourceReference values which may be limited to reference VariableDefinition Profiles.
The section element contains one or more instances (sections) with each of these sections identified by focus (Composition.section.focus) which references a VariableDefinition Profile. Each of these focused sections contain one or more of the following sections:
..Composition.section.section[comparatorEvidence] has a section.code value for 'Evidence with comparator alone' and entries limited to a single reference of a BaselineMeasureEvidence Profile.
..Composition.section.section[interventionEvidence] has a section.code value for 'Evidence with intervention alone' and entries limited to a single reference of a BaselineMeasureEvidence Profile.
..Composition.section.section[totalGroup] has a section.code value for 'Evidence with total group' and entries limited to a single reference of a BaselineMeasureEvidence Profile.
..Composition.section.sectioncomparativeEvidence has a section.code value for 'Evidence with intervention vs. comparator' and entries limited to a single reference of a ComparativeBaselineMeasureEvidence Profile.
The ParticipantFlowReport Profile is a Profile of EvidenceMeasureReportPackage and is used for an evidence report including the counts (and proportions) for any number of participant flow measures in a research study. For example, the ParticipantFlowReport may include the data for a CONSORT Participant Flow Diagram reported with a randomized controlled trial.
The Composition.type value is set to a "Participant Flow Report".
The relatesTo element may include instances with type values of "derived-from", label values of "Participant Flow Measure" to identify the contextual use of specific EvidenceVariable Resources, and resourceReference values which may be limited to reference ParticipantFlowEvidenceVariable Profiles.
The section element contains one or more instances (sections) with each of these sections identified by focus (Composition.section.focus) which references a ParticipantFlowEvidenceVariable Profile. Each of these focused sections contain one or more of the following sections:
..Composition.section.section[comparatorEvidence] has a section.code value for 'Evidence with comparator alone' and entries limited to a single reference of a ParticipantFlowEvidence Profile.
..Composition.section.section[interventionEvidence] has a section.code value for 'Evidence with intervention alone' and entries limited to a single reference of a ParticipantFlowEvidence Profile.
..Composition.section.section[totalGroup] has a section.code value for 'Evidence with total group' and entries limited to a single reference of a ParticipantFlowEvidence Profile.
..Composition.section.sectioncomparativeEvidence has a section.code value for 'Evidence with intervention vs. comparator' and entries limited to a single reference of a ComparativeParticipantFlowEvidence Profile.
The OutcomeMeasureReport Profile is a Profile of EvidenceMeasureReportPackage and is used for an evidence report including the findings for any number of outcome measures in a research study.
The Composition.type value is set to an "Outcome Measure Report".
The relatesTo element may include instances with type values of "derived-from", label values of "Outcome Measure" to identify the contextual use of specific EvidenceVariable Resources, and resourceReference values which may be limited to reference VariableDefinition Profiles.
The section element contains one or more instances (sections) with each of these sections identified by focus (Composition.section.focus) which references a VariableDefinition Profile. Each of these focused sections contain one or more of the following sections:
..Composition.section.section[comparatorEvidence] has a section.code value for 'Evidence with comparator alone' and entries limited to a single reference of a NoncomparativeEvidence Profile.
..Composition.section.section[interventionEvidence] has a section.code value for 'Evidence with intervention alone' and entries limited to a single reference of a NoncomparativeEvidence Profile.
..Composition.section.section[totalGroup] has a section.code value for 'Evidence with total group' and entries limited to a single reference of a NoncomparativeEvidence Profile.
..Composition.section.sectioncomparativeEvidence has a section.code value for 'Evidence with intervention vs. comparator' and entries limited to a single reference of a ComparativeEvidence Profile.
The Guideline Profile is a Profile of EvidenceReportPackage and is used for the composition of a clinical practice guideline and may be tightly related to use of the Recommendation Profile for related content.
The Composition.type value is set to a "Guideline".
The Guideline Profile will have 1 to 6 section element instances with any of the following section.code concepts: Introduction, Recommendations, Text, Methods, Acknowledgements, and Appendices. The Recommendations section will have entries which are constrained to reference the Recommendation Profile.
The Recommendation Profile is a Profile of EvidenceReportPackage and 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.
The Composition.type value is set to a "Recommendation".
The Recommendation Profile will have 1 or more section element instances with any of the following section.code concepts: Recommendation Specification (required), Discussion (optional), Evidence (optional), Justification (optional), and Considerations (optional).
..The Recommendation Specification section is required and contains sections with section.code concepts for Recommendation Statement, Ratings, Population, Action, and Opposite Action.
..The Discussion section may contain sections for text-based summaries.
..The Evidence section may contain sections for text-based summaries and may contain entries referencing ArtifactAssessment, Evidence, or Composition Resources.
..The Justification section may contain sections for text-based summaries and may contain entries referencing ArtifactAssessment Resources (RecommendationJustification Profile).
..The Considerations section contains sections with section.code concepts for Summary, Subgroup Considerations, Implementation Considerations, Monitoring Considerations, Competing Interests, and Research Considerations.
The SummaryOfFindings Profile is a Profile of EvidenceReport and 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.
The Composition.type value is set to a "Summary of Findings".
The SummaryOfFindings Profile has 1 'Column Headers' section and 1 or more 'Summary of findings entry for a single outcome' sections. Each 'Summary of findings entry for a single outcome' section has a focus element (section.focus) which references a VariableDefinition Profile. Each of these sections has the same set of section.section.code patterns to provide the following contained sections:
An 'Outcome Measure' section is required for the 'Column Headers' section and optional for the 'Summary of findings entry for a single outcome' sections. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference a single VariableDefinition Profile.
A 'Sample Size' section is optional.
A 'Result with comparator alone' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference a single ComparatorOnlyEvidence Profile.
A 'Result with intervention alone' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference a single InterventionOnlyEvidence Profile.
A 'Result with intervention alone (calculated)' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference up to 2 Resources using ComparatorOnlyEvidence Profile or ComparativeEvidence Profile.
A 'Result with intervention vs. comparator' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference a single ComparativeEvidence Profile.
A 'Certainty of Evidence' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries may reference ComparativeEvidence Profile or CertaintyOfEvidence Profile.
An 'Assertion' section is optional. If used in the 'Summary of findings entry for a single outcome' section, entries are limited to reference a single ComparativeEvidence Profile.
The SummaryOfNetEffect Profile is a Profile of EvidenceReportPackage and 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.
The Composition.type value is set to a "Summary of Net Effect Contributions".
The SummaryOfNetEffect Profile has 1 'Column Headers' section, 1 or more 'Summary of net effect contributions entry for a single outcome' sections, and may have a 'Net Effect Estimate' section. Each 'Summary of net effect contributions entry for a single outcome' section has a focus element (section.focus) which references a VariableDefinition Profile. Each of these sections and the 'Column Headers' section has the same set of section.section.code patterns to provide the following contained sections:
An 'Outcome Measure' section is required for the 'Column Headers' section and optional for the 'Summary of net effect contributions entry for a single outcome' sections. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single VariableDefinition Profile.
An 'Outcome Desirability' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single OutcomeImportance Profile.
A 'Relative Importance' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single OutcomeImportance Profile.
A 'Result with comparator alone' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single ComparatorOnlyEvidence Profile.
A 'Evidence Results for the intervention exposure only' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single InterventionOnlyEvidence Profile.
A 'Result with intervention alone (calculated)' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference up to 2 Resources using ComparatorOnlyEvidence Profile or ComparativeEvidence Profile.
A 'Result with intervention vs. comparator' section is optional. If used in the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single ComparativeEvidence Profile.
A 'Net Effect Contribution' section is required. In the 'Summary of net effect contributions entry for a single outcome' section, entries are limited to reference a single NetEffectContribution Profile.
The 'Net Effect Estimate' section, if used, is limited to a single entry which references a NetEffectEstimate Profile.
The EvidenceMap Profile is a Profile of EvidenceReport and is used for an organized listing of Resources used to generate EvidenceReport instances.
The Composition.type value is set to a "EvidenceMap".
The EvidenceMap Profile provides 11 optional sections with a suggested section.code.coding value and limitations of resource type for section.entry values. The 11 sections are:
The M11Report Profile is a Profile of EvidenceReport and 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.
The Composition.type value is set to a "Clinical Trial Protocol" and "CeSHarP Report".
The M11Report Profile contains 15 sections with highly detailed instructions and is shared in the EBMonFHIR Implementation Guide for initial development and coordination with the base structures in the EBMonFHIR Implementation Guide. There will likely be a future 'M11 Report' Implementation Guide developed by a different but coordinated group.
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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