Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6.xml

Clinical Decision Support Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

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

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Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior (id = "example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6")

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

<Evidence xmlns="http://hl7.org/fhir">
  <id value="example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6"/> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> 
        &quot;Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3
         hours prior&quot; is a comparative effect estimate.
      </p> 
  </div> 
  </text> 
  <url value="Evidence/example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6"/> 
  <title value="Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior"/> 
  <status value="draft"/> 
  <relatedArtifact> 
  <type value="citation"/> 
  <label value="Wardlaw 2014"/> 
  <display value="Analysis 1.16 from Wardlaw 2014"/> 
  <citation value="Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke.
     Cochrane Database Syst Rev. 2014 Jul 29(7):CD000213. PMID 25072528"/> 
  <url value="https://doi.org/10.1002/14651858.CD000213.pub3"/> 
  </relatedArtifact> 
  <description value="mRS 3-6 at 90 days Odds Ratio 0.65 for Alteplase vs. No Alteplase in patients with acute
   ischemic stroke 0-3 hours prior"/> 
  <variableDefinition> 
    <variableRole> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/> 
        <code value="population"/> 
        <display value="population"/> 
      </coding> 
    </variableRole> 
    <observed> 
      <reference value="EvidenceVariable/Wardlaw2014Analysis1.16.3EvidenceSet"/> 
      <type value="EvidenceVariable"/> 
      <display value="Wardlaw 2014 Analysis 1.16.3 Evidence set"/> 
    </observed> 
    <intended> 
      <reference value="Group/AcuteIschemicStroke0-3Hours"/> 
      <type value="Group"/> 
      <display value="stroke at 0-3 hours"/> 
    </intended> 
  </variableDefinition> 
  <variableDefinition> 
    <variableRole> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/> 
        <code value="measuredVariable"/> 
        <display value="measured variable"/> 
      </coding> 
    </variableRole> 
    <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> 
  </variableDefinition> 
  <variableDefinition> 
    <variableRole> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/> 
        <code value="exposure"/> 
        <display value="exposure"/> 
      </coding> 
    </variableRole> 
    <observed> 
      <reference value="EvidenceVariable/example-alteplase-for-stroke"/> 
      <type value="EvidenceVariable"/> 
      <display value="Alteplase for Stroke"/> 
    </observed> 
    <intended> 
      <reference value="EvidenceVariable/example-alteplase-for-stroke"/> 
      <type value="EvidenceVariable"/> 
      <display value="Alteplase for Stroke"/> 
    </intended> 
  </variableDefinition> 
  <variableDefinition> 
    <variableRole> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/> 
        <code value="referenceExposure"/> 
        <display value="reference exposure"/> 
      </coding> 
    </variableRole> 
    <observed> 
      <reference value="EvidenceVariable/example-no-alteplase"/> 
      <type value="EvidenceVariable"/> 
      <display value="no alteplase"/> 
    </observed> 
    <intended> 
      <reference value="EvidenceVariable/example-no-alteplase"/> 
      <type value="EvidenceVariable"/> 
      <display value="no alteplase"/> 
    </intended> 
  </variableDefinition> 
  <synthesisType> 
    <coding> 
      <system value="http://terminology.hl7.org/CodeSystem/synthesis-type"/> 
      <code value="std-MA"/> 
      <display value="summary data meta-analysis"/> 
    </coding> 
  </synthesisType> 
  <studyType> 
    <coding> 
      <system value="http://terminology.hl7.org/CodeSystem/study-type"/> 
      <code value="RCT"/> 
      <display value="randomized trial"/> 
    </coding> 
  </studyType> 
  <statistic> 
    <statisticType> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/statistic-type"/> 
        <code value="C16932"/> 
        <display value="Odds Ratio"/> 
      </coding> 
    </statisticType> 
    <quantity> 
      <value value="0.65"/> 
    </quantity> 
    <numberOfEvents value="1137"/> 
    <sampleSize> 
      <numberOfStudies value="6"/> 
      <numberOfParticipants value="1779"/> 
    </sampleSize> 
    <attributeEstimate> 
      <description value="95% CI 0.54 to 0.80"/> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/> 
          <code value="C53324"/> 
          <display value="Confidence interval"/> 
        </coding> 
      </type> 
      <level value="0.95"/> 
      <range> 
        <low> 
          <value value="0.54"/> 
        </low> 
        <high> 
          <value value="0.8"/> 
        </high> 
      </range> 
    </attributeEstimate> 
    <attributeEstimate> 
      <description value="P-value = 0.000023"/> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/> 
          <code value="C44185"/> 
          <display value="P-value"/> 
        </coding> 
      </type> 
      <quantity> 
        <value value="0.000023"/> 
      </quantity> 
    </attributeEstimate> 
    <attributeEstimate> 
      <description value="Heterogeneity I-sq = 0.0%"/> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/> 
          <code value="0000420"/> 
          <display value="I-squared"/> 
        </coding> 
      </type> 
      <quantity> 
        <value value="0"/> 
        <unit value="%"/> 
        <system value="http://unitsofmeasure.org"/> 
        <code value="%"/> 
      </quantity> 
    </attributeEstimate> 
  </statistic> 
  <certainty> 
    <description value="Moderate certainty due to risk of bias"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
        <code value="Overall"/> 
        <display value="Overall quality"/> 
      </coding> 
    </type> 
    <rating> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
        <code value="moderate"/> 
        <display value="Moderate"/> 
      </coding> 
    </rating> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
          <code value="PublicationBias"/> 
          <display value="Publication bias"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
          <code value="Inconsistency"/> 
          <display value="Inconsistency"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
          <code value="Imprecision"/> 
          <display value="Imprecision"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
          <code value="Indirectness"/> 
          <display value="Indirectness"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <note> 
        <text value="results largely influenced by IST-3 trial which was unblinded and NINDS trial which had
         allocation concealment not stated and baseline imbalances"/> 
      </note> 
      <type> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-type"/> 
          <code value="RiskOfBias"/> 
          <display value="Risk of bias"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="serious-concern"/> 
          <display value="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.