Evidence
Introduction
Scope and Usage
The Evidence Resource enables the expression of the most granular form of evidence, such as the actual quantitative results of a study or scientific analysis.
Human-readable summaries of the Evidence Resource may be expressed in description, assertion, and note elements. The description element is typically used for the primary expression. The assertion element is less commonly used and is typically used for interpretive expression. The note element may be used for any number of explanatory, variant, or related comments.
The variableDefinition element is used to describe what the evidence is about. Each variable defined must be assigned a variable role which signals how that variable is used in the statistics within the Evidence Resource. The variable definition may be expressed in human-readable form (with a description element) and/or expressed in computable form by referencing Group or EvidenceVariable Resources. In general, Group Resources are used to define populations and EvidenceVariable Resources are used to define measured variables (exposures, outcomes, and covariates). The variableDefinition element allows expression of the observed variable and the intended variable. In many forms of expression the Evidence is interpreted for a specific context and recognition of both observed and intended variables is important for understanding the applicability and certainty of the evidence.
The heart of the evidence is the statistic. The statistic BackboneElement provides a machine-interpretable expression of a statistic, including the quantity; unit of measure; classification of statistic type; sample size; attributes such as confidence intervals, p values, and heterogeneity estimates; and statistic model characteristics. An Evidence Resource may contain more than one statistic, in which case each statistic matches the same combination of variable definitions.
Because a statistic can rarely be interpreted without knowing how it was obtained, the Evidence Resource enables expression of the studyDesign. For evidence derived from synthesis of evidence, the Evidence Resource enables expression of the synthesisType.
The certainty element provides a machine-interpretable expression of certainty, confidence or quality of the resource in which it is included. The certainty element can express overall certainty and certainty of any subcomponent concepts using codeable concepts from structured rating systems. The certainty element enables machine-to-machine communication of the certainty of evidence.
Boundaries and Relationships
The Evidence Resource is the central atomic component for the Evidence-related Resources. The Evidence Resource may reference multiple Group and EvidenceVariable Resources; in these cases, the Group and EvidenceVariable Resources to which an Evidence Resource points does not refer back to the Evidence. In the context of evidence synthesis, a List Resource may reference Evidence Resources where the List Resource is used to define the set of evidence being synthesized.
StructureDefinition
Elements (Simplified)
- Evidence [0..*]: - Single evidence bit
- Evidence.url [0..1]: uri Canonical identifier for this evidence, represented as a globally unique URI
- Evidence.identifier [0..*]: Identifier Additional identifier for the summary
- Evidence.version [0..1]: string Business version of this summary
- Evidence.versionAlgorithm[x] [0..1]: string, Coding extensible:version-algorithm How to compare versions
- Evidence.name [0..1]: string Name for this summary (machine friendly)
- Evidence.title [0..1]: string Name for this summary (human friendly)
- Evidence.citeAs [0..1]: markdown Display of how to cite this Evidence
- Evidence.status [1..1]: code required:publication-status draft | active | retired | unknown
- Evidence.experimental [0..1]: boolean For testing only - never for real usage
- Evidence.date [0..1]: dateTime Date last changed
- Evidence.approvalDate [0..1]: date When the summary was approved by publisher
- Evidence.lastReviewDate [0..1]: date When the summary was last reviewed by the publisher
- Evidence.author [0..*]: ContactDetail Who authored the content
- Evidence.publisher [0..1]: string Name of the publisher/steward (organization or individual)
- Evidence.contact [0..*]: ContactDetail Contact details for the publisher
- Evidence.recorder [0..*]: ContactDetail Who entered the data for the evidence
- Evidence.editor [0..*]: ContactDetail Who edited the content
- Evidence.reviewer [0..*]: ContactDetail Who reviewed the content
- Evidence.endorser [0..*]: ContactDetail Who endorsed the content
- Evidence.useContext [0..*]: UsageContext The context that the content is intended to support
- Evidence.purpose [0..1]: markdown Why this Evidence is defined
- Evidence.copyright [0..1]: markdown Intellectual property ownership, may include restrictions on use
- Evidence.copyrightLabel [0..1]: string Copyright holder and year(s)
- Evidence.relatesTo [0..*]: BackboneElement Relationships to other Resources
- Evidence.relatesTo.type [1..1]: CodeableConcept extensible:artifact-relationship-type documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
- Evidence.relatesTo.target[x] [1..1]: uri, Attachment, canonical, Reference(Resource), markdown The artifact that is related to this Evidence
- Evidence.description [0..1]: markdown Description of the particular summary
- Evidence.assertion [0..1]: markdown Declarative description of the Evidence
- Evidence.note [0..*]: Annotation Footnotes and/or explanatory notes
- Evidence.variableDefinition [0..*]: BackboneElement Description, classification, and definition of a single variable
- Evidence.variableDefinition.description [0..1]: markdown A text description or summary of the variable
- Evidence.variableDefinition.note [0..*]: Annotation Footnotes and/or explanatory notes
- Evidence.variableDefinition.variableRole [1..1]: code required:variable-role population | exposure | outcome | covariate
- Evidence.variableDefinition.roleSubtype [0..1]: CodeableConcept example:variable-role-subtype Sub-classification of the role of the variable
- Evidence.variableDefinition.comparatorCategory [0..1]: string The reference value used for comparison
- Evidence.variableDefinition.observed [0..1]: [Reference(Group](/Reference(Group), EvidenceVariable)) Definition of the actual variable related to the statistic(s)
- Evidence.variableDefinition.intended [0..1]: [Reference(Group](/Reference(Group), EvidenceVariable)) Definition of the intended variable related to the Evidence
- Evidence.variableDefinition.directnessMatch [0..1]: CodeableConcept example:directness low | moderate | high | exact
- Evidence.synthesisType [0..*]: CodeableConcept example:synthesis-type The design of the synthesis (combination of studies) that produced this evidence
- Evidence.studyDesign [0..*]: CodeableConcept extensible:study-design The design of the study that produced this evidence
- Evidence.statistic [0..*]: BackboneElement Values and parameters for a single statistic
- Evidence.statistic.description [0..1]: markdown A natural language summary of the statistic
- Evidence.statistic.note [0..*]: Annotation Footnotes and/or explanatory notes
- Evidence.statistic.statisticType [0..1]: CodeableConcept example:statistic-type Type of statistic, e.g., relative risk
- Evidence.statistic.category [0..1]: CodeableConcept Associated category for categorical variable
- Evidence.statistic.quantity [0..1]: Quantity Statistic value
- Evidence.statistic.numberOfEvents [0..1]: unsignedInt The number of events associated with the statistic
- Evidence.statistic.numberAffected [0..1]: unsignedInt The number of participants affected
- Evidence.statistic.sampleSize [0..1]: BackboneElement Count of participants in the study sample
- Evidence.statistic.sampleSize.description [0..1]: markdown Textual description of sample size for statistic
- Evidence.statistic.sampleSize.note [0..*]: Annotation Footnote or explanatory note about the sample size
- Evidence.statistic.sampleSize.numberOfStudies [0..1]: unsignedInt Number of contributing studies
- Evidence.statistic.sampleSize.numberOfParticipants [0..1]: unsignedInt Total number of participants
- Evidence.statistic.sampleSize.knownDataCount [0..1]: unsignedInt Number of participants with known results for measured variables
- Evidence.statistic.sampleSize.numberAnalyzed [0..1]: unsignedInt Total number of participants who were analayzed
- Evidence.statistic.attributeEstimate [0..*]: BackboneElement An attribute of the Statistic
- Evidence.statistic.attributeEstimate.description [0..1]: markdown Textual description of the attribute estimate
- Evidence.statistic.attributeEstimate.note [0..*]: Annotation Footnote or explanatory note about the estimate
- Evidence.statistic.attributeEstimate.type [0..1]: CodeableConcept example:attribute-estimate-type The type of attribute estimate, e.g., confidence interval or p value
- Evidence.statistic.attributeEstimate.quantity [0..1]: Quantity The singular quantity of the attribute estimate, for attribute estimates represented as single values, which may include a unit of measure
- Evidence.statistic.attributeEstimate.level [0..1]: decimal Level of confidence interval, e.g., 0.95 for 95% confidence interval
- Evidence.statistic.attributeEstimate.range [0..1]: Range Lower and upper bound values of the attribute estimate
- Evidence.statistic.attributeEstimate.attributeEstimate [0..*]: - A nested attribute estimate; which is the attribute estimate of an attribute estimate
- Evidence.statistic.modelCharacteristic [0..*]: BackboneElement An aspect of the statistical model
- Evidence.statistic.modelCharacteristic.code [1..1]: CodeableConcept example:statistic-model-code Model specification
- Evidence.statistic.modelCharacteristic.value[x] [0..1]: Quantity(SimpleQuantity), Range, CodeableConcept The specific value (when paired with code)
- Evidence.statistic.modelCharacteristic.intended [0..1]: boolean The plan for analysis
- Evidence.statistic.modelCharacteristic.applied [0..1]: boolean This model characteristic is part of the analysis that was applied, whether or not the analysis followed the plan
- Evidence.statistic.modelCharacteristic.variable [0..*]: BackboneElement A variable adjusted for in the adjusted analysis
- Evidence.statistic.modelCharacteristic.variable.variableDefinition [1..1]: [Reference(Group](/Reference(Group), EvidenceVariable)) Description and definition of the variable
- Evidence.statistic.modelCharacteristic.variable.handling [0..1]: CodeableConcept example:variable-handling-example boolean | continuous | dichotomous | ordinal | polychotomous | time-to-event | not-specified
- Evidence.statistic.modelCharacteristic.variable.valueCategory [0..*]: CodeableConcept Qualitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
- Evidence.statistic.modelCharacteristic.variable.valueQuantity [0..*]: Quantity Quantitative label used for grouping values of a dichotomous, ordinal, or polychotomous variable
- Evidence.statistic.modelCharacteristic.variable.valueRange [0..*]: Range Range of quantitative labels used for grouping values of a dichotomous, ordinal, or polychotomous variable
- Evidence.statistic.modelCharacteristic.attribute [0..*]: - An attribute of the model characteristic
- Evidence.certainty [0..*]: BackboneElement Certainty or quality of the evidence
- Evidence.certainty.description [0..1]: markdown Textual description of certainty
- Evidence.certainty.note [0..*]: Annotation Footnotes and/or explanatory notes
- Evidence.certainty.type [0..1]: CodeableConcept example:certainty-type Aspect of certainty being rated
- Evidence.certainty.rating [0..1]: CodeableConcept example:certainty-rating Assessment or judgement of the aspect
- Evidence.certainty.rater [0..*]: string Individual or group who did the rating
- Evidence.certainty.subcomponent [0..*]: - A domain or subdomain of certainty
Mappings
- Evidence Mappings — 14 mapping entries
Resource Packs
list-Evidence-packs.xml
<?xml version="1.0" encoding="UTF-8"?>
<List xmlns="http://hl7.org/fhir">
<id value="Evidence-packs"/>
<status value="current"/>
<mode value="working"/>
</List>
Search Parameters
- context — token — A use context assigned to the evidence —
(Evidence.useContext.value.ofType(CodeableConcept)) - context-quantity — quantity — A quantity- or range-valued use context assigned to the evidence —
(Evidence.useContext.value.ofType(Quantity)) | (Evidence.useContext.value.ofType(Range)) - context-type — token — A type of use context assigned to the evidence —
Evidence.useContext.code - context-type-quantity — composite — A use context type and quantity- or range-based value assigned to the evidence —
Evidence.useContext - context-type-value — composite — A use context type and value assigned to the evidence —
Evidence.useContext - date — date — The evidence publication date —
Evidence.date - description — string — The description of the evidence —
Evidence.description - identifier — token — External identifier for the evidence —
Evidence.identifier - publisher — string — Name of the publisher of the evidence —
Evidence.publisher - status — token — The current status of the evidence —
Evidence.status - title — string — The human-friendly name of the evidence —
Evidence.title - url — uri — The uri that identifies the evidence —
Evidence.url - version — token — The business version of the evidence —
Evidence.version - experimental — token — Whether the Evidence is experimental —
Evidence.experimental
Examples
- evidence-example — evidence-example
- evidence-example-ASTRAL-12-alteplase-mRS3-6 — evidence-example-ASTRAL-12-alteplase-mRS3-6
- evidence-example-death-or-major-injury-reduce-parachute-vs-empty-backpack — evidence-example-death-or-major-injury-reduce-parachute-vs-empty-backpack
- evidence-example-quoted-source — evidence-example-quoted-source
- evidence-example-statistic-model-include-if — evidence-example-statistic-model-include-if
- evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6 — evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6
- evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2 — evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2
- evidence-example-stroke-alteplase-fatalICH — evidence-example-stroke-alteplase-fatalICH
- evidence-example-stroke-no-alteplase-fatalICH — evidence-example-stroke-no-alteplase-fatalICH
- evidence-examples-header — evidence-examples-header
- example-ASTRAL-12-alteplase-mRS3-6 — evidence-example-ASTRAL-12-alteplase-mRS3-6 — Risk of mRS3-6 at 90 days after Alteplase for Stroke if ASTRAL score 12
- example-death-or-major-injury-reduce-parachute-vs-empty-backpack — evidence-example-death-or-major-injury-reduce-parachute-vs-empty-backpack — Death or Major Traumatic Injury on Impact comparing intervention vs. comparator
- example-quoted-source — evidence-example-quoted-source — An example using the relatedArtifact element to quote text from the evidence source
- example-statistic-model-include-if — evidence-example-statistic-model-include-if — Statistical analysis plan with different statistical test if non-normal distribution
- example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6 — evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6 — Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior
- example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2 — evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2 — Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior
- example-stroke-alteplase-fatalICH — evidence-example-stroke-alteplase-fatalICH — Risk of fatal ICH with alteplase for stroke
- example-stroke-no-alteplase-fatalICH — evidence-example-stroke-no-alteplase-fatalICH — Risk of fatal ICH without alteplase for stroke
Mapping Exceptions
evidence-fivews-mapping-exceptions.xml
Unmapped Elements
- FiveWs.what — Unknown
- FiveWs.actor — Unknown
- FiveWs.cause — Unknown
- FiveWs.class — Unknown
- FiveWs.where — Unknown
- FiveWs.context — Unknown
- FiveWs.init — Unknown
- FiveWs.source — Unknown
- FiveWs.who — Unknown
- FiveWs.grade — Unknown
- FiveWs.planned — Unknown
- FiveWs.done — Unknown
- FiveWs.subject — Unknown