R5 Final QA

This page is part of the FHIR Specification (v5.0.0-draft-final: Final QA Preview for R5 - see ballot notes). 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

Example Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2 (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 0-2 at 90 days in Stroke 3-4.5 hours prior (id = "example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2")

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

<Evidence xmlns="http://hl7.org/fhir">
  <id value="example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2"/> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      
      <p> 
        &quot;Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke
         3-4.5 hours prior&quot; is a comparative effect estimate.
      </p> 
  
    </div> 
  </text> 
  <url value="http://hl7.org/fhir/Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.10.3"/> 
  </identifier> 
  <name value="EffectOfAlteplaseVsNoAlteplaseOnMRS02At90DaysInStroke345HoursPrior"/> 
  <title value="Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours
   prior"/> 
  <status value="draft"/> 
  <relatedArtifact> 
    <type value="citation"/> 
    <label value="Lees 2016"/> 
    <display value="Figure 2 Lees 2016"/> 
    <citation value="Lees KR, Emberson J, Blackwell L, Bluhmki E, Davis SM, Donnan GA, et al; Stroke
     Thrombolysis Trialists’ Collaborators Group. Effects of alteplase for acute stroke
     on the distribution of functional outcomes: a pooled analysis of 9 trials. Stroke.
     2016;47:2373-2379. PMID 27507856"/> 
    <document> 
      <url value="https://doi.org/10.1161/STROKEAHA.116.013644"/> 
    </document> 
  </relatedArtifact> 
  <description value="mRS 0-2 at 90 days Odds Ratio 1.2 for Alteplase vs. No Alteplase in patients with
   acute ischemic stroke 3-4.5 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/Stroke-Thrombolysis-Trialists-2014-2016-IPD-MA-Cohort"/> 
      <type value="EvidenceVariable"/> 
      <display value="Stroke Thrombolysis Trialists’ 2014-2016 IPD-MA Cohort"/> 
    </observed> 
    <intended> 
      <reference value="Group/AcuteIschemicStroke3-4halfHours"/> 
      <type value="Group"/> 
      <display value="stroke at 3-4.5 hours"/> 
    </intended> 
    <directnessMatch> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/directness"/> 
        <code value="moderate"/> 
        <display value="Moderate quality match"/> 
      </coding> 
    </directnessMatch> 
  </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-mRS0-2-at-90days"/> 
      <type value="EvidenceVariable"/> 
      <display value="mRS 0-2 at 90 days"/> 
    </observed> 
    <intended> 
      <reference value="EvidenceVariable/example-alive-independent-90day"/> 
      <type value="EvidenceVariable"/> 
      <display value="Alive and not 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="IPD-MA"/> 
      <display value="individual patient data meta-analysis"/> 
    </coding> 
  </synthesisType> 
  <studyDesign> 
    <coding> 
      <system value="http://hl7.org/fhir/study-design"/> 
      <code value="SEVCO:01003"/> 
      <display value="randomized assignment"/> 
    </coding> 
  </studyDesign> 
  <statistic> 
    <statisticType> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/statistic-type"/> 
        <code value="C16932"/> 
        <display value="Odds Ratio"/> 
      </coding> 
    </statisticType> 
    <quantity> 
      <value value="1.2"/> 
    </quantity> 
    <sampleSize> 
      <numberOfStudies value="9"/> 
    </sampleSize> 
    <attributeEstimate> 
      <description value="95% CI 1.06 to 1.3"/> 
      <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="1.06"/> 
        </low> 
        <high> 
          <value value="1.3"/> 
        </high> 
      </range> 
    </attributeEstimate> 
  </statistic> 
  <certainty> 
    <description value="Very low certainty due to risk of bias, inconsistency, imprecision, and indirectness"/> 
    <type> 
      <coding> 
        <system value="http://hl7.org/fhir/certainty-type"/> 
        <code value="Overall"/> 
        <display value="Overall quality"/> 
      </coding> 
    </type> 
    <rating> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
        <code value="very-low"/> 
        <display value="Very low quality"/> 
      </coding> 
    </rating> 
    <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://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="no-concern"/> 
          <display value="no serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <note> 
        <text value="IST-3 had inconsistent results and contributed large proportion of data"/> 
      </note> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Inconsistency"/> 
          <display value="Inconsistency"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="serious-concern"/> 
          <display value="serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <note> 
        <text value="results derived from figure with limited data reported to support the specific
         effect estimate; derived odds ratio in figure does not match results from rates
         of mRS 0-2 reported in Supplementary Figure 3b"/> 
      </note> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Imprecision"/> 
          <display value="Imprecision"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="serious-concern"/> 
          <display value="serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <note> 
        <text value="resuts derived for 3 - 4.5 hours assume data from 0 - 6 hours is informative"/> 
      </note> 
      <type> 
        <coding> 
          <system value="http://hl7.org/fhir/certainty-type"/> 
          <code value="Indirectness"/> 
          <display value="Indirectness"/> 
        </coding> 
      </type> 
      <rating> 
        <coding> 
          <system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/> 
          <code value="serious-concern"/> 
          <display value="serious concern"/> 
        </coding> 
      </rating> 
    </subcomponent> 
    <subcomponent> 
      <note> 
        <text value="results largely influenced by IST-3 trial which was unblinded and ECASS III which
         had baseline imbalances"/> 
      </note> 
      <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://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.