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Example Evidence/example-ASTRAL-12-alteplase-mRS3-6 (XML)

Clinical Decision Support Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw XML (canonical form + also see XML Format Specification)

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Risk of mRS3-6 at 90 days after Alteplase for Stroke if ASTRAL score 12 (id = "example-ASTRAL-12-alteplase-mRS3-6")

<?xml version="1.0" encoding="UTF-8"?>

<Evidence xmlns="http://hl7.org/fhir">
  <id value="example-ASTRAL-12-alteplase-mRS3-6"/> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      
      <p> 
        &quot;Risk of mRS3-6 at 90 days after Alteplase for Stroke if ASTRAL score
         12&quot; is a univariate risk estimate (non-comparative evidence).
      </p> 
  
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="cds"/> </extension> 
  <url value="http://hl7.org/fhir/Evidence/example-ASTRAL-12-alteplase-mRS3-6"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.10.2"/> 
  </identifier> 
  <name value="RiskOfMRS36At90DaysAfterAlteplaseForStrokeIfASTRALScore12"/> 
  <title value="Risk of mRS3-6 at 90 days after Alteplase for Stroke if ASTRAL score 12"/> 
  <status value="draft"/> 
  <publisher value="HL7 International / Clinical Decision Support"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      </telecom> 
  </contact> 
  <relatedArtifact> 
    <type value="citation"/> 
    <label value="Cooray 2016 Validation Study"/> 
    <display value="External Validation of the ASTRAL and DRAGON Scores for Prediction of Functional
     Outcome in Stroke."/> 
    <citation value="Cooray C, Mazya M, Bottai M, Dorado L, Skoda O, Toni D, Ford GA, Wahlgren N, Ahmed
     N. External Validation of the ASTRAL and DRAGON Scores for Prediction of Functional
     Outcome in Stroke. Stroke. 2016 Jun;47(6):1493-9. Epub 2016 May 12. PMID 27174528"/> 
    <document> 
      <url value="https://doi.org/10.1161/STROKEAHA.116.012802"/> 
    </document> 
  </relatedArtifact> 
  <description value="5.3% risk of mRS 3-6 at 90 days"/> 
  <variableDefinition> 
    <variableRole value="population"/> 
    <observed> 
      <reference value="Group/ASTRAL-Cooray-validation-cohort-and-received-alteplase"/> 
      <type value="Group"/> 
      <display value="ASTRAL validation cohort and received alteplase"/> 
    </observed> 
    <intended> 
      <reference value="Group/ASTRAL-12-and-received-alteplase"/> 
      <type value="Group"/> 
      <display value="patients 0-4.5 hours after acute ischemic stroke onset with ASTRAL score = 12 and
       received alteplase"/> 
    </intended> 
  </variableDefinition> 
  <variableDefinition> 
    <description value="functionally dependent or dead at 3 months"/> 
    <variableRole value="outcome"/> 
    <observed> 
      <reference value="EvidenceVariable/example-mRS3-6-at-90days"/> 
      <type value="EvidenceVariable"/> 
      <display value="mRS 3-6 at 90 days"/> 
    </observed> 
    <intended> 
      <reference value="EvidenceVariable/example-dead-or-dependent-90day"/> 
      <type value="EvidenceVariable"/> 
      <display value="Dead or functionally dependent at 90 days"/> 
    </intended> 
    <directnessMatch> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/directness"/> 
        <code value="high"/> 
        <display value="High quality match between observed and intended variable"/> 
      </coding> 
    </directnessMatch> 
  </variableDefinition> 
  <studyDesign> 
    <coding> 
      <system value="http://hl7.org/fhir/study-design"/> 
      <code value="SEVCO:01016"/> 
      <display value="Uncontrolled cohort design"/> 
    </coding> 
  </studyDesign> 
  <statistic> 
    <description value="5.3% risk"/> 
    <statisticType> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/statistic-type"/> 
        <code value="C44256"/> 
        <display value="Proportion"/> 
      </coding> 
      <text value="derived proportion"/> 
    </statisticType> 
    <quantity> 
      <value value="0.0525"/> 
    </quantity> 
    <sampleSize> 
      <note> 
        <text value="number of participants describes number in the total study sample, known data count
         describes number in study sample with ASTRALscore = 12, total number of events
         describes number of participants with ASTRAL score = 12 and outcome of mRS 3-6
         at 90 days"/> 
      </note> 
      <numberOfParticipants value="36131"/> 
    </sampleSize> 
  </statistic> 
  <certainty> 
    <type> 
      <coding> 
        <system value="http://hl7.org/fhir/certainty-type"/> 
        <code value="Overall"/> 
        <display value="Overall certainty"/> 
      </coding> 
    </type> 
    <rating> 
      <coding> 
        <system value="http://hl7.org/fhir/certainty-rating"/> 
        <code value="high"/> 
        <display value="High quality"/> 
      </coding> 
    </rating> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="RiskOfBias"/> 
          <display value="Risk of bias"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <description value="Estimated risk from validation calibration plot consistent with predicted risk;
       observed risk in subgroup with ASTRAL score = 12 consistent with validation calibration
       plot"/> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Inconsistency"/> 
          <display value="Inconsistency"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Indirectness"/> 
          <display value="Indirectness"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <description value="Narrow confidence interval"/> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Imprecision"/> 
          <display value="Imprecision"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="PublicationBias"/> 
          <display value="Publication bias"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
  </certainty> 
</Evidence> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.