type: exampleresource: Evidenceexample: evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6
Evidence Example: evidence-example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6
Narrative
"Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior" is a comparative effect estimate.
Example XML
<?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>
"Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior" is a comparative effect estimate.
</p>
</div>
</text>
<url value="http://hl7.org/fhir/Evidence/example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.10.5"/>
</identifier>
<name value="EffectOfAlteplaseVsNoAlteplaseOnMRS36At90DaysInStroke03HoursPrior"/>
<title value="Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior"/>
<status value="draft"/>
<relatesTo>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/artifact-relationship-type" />
<code value="cites" />
<display value="Cites" />
</coding>
</type>
<targetMarkdown value="Analysis 1.16 from Wardlaw 2014 <b>Citation:</b> 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 <b>URL:</b> https://doi.org/10.1002/14651858.CD000213.pub3"/>
</relatesTo>
<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 value="population"/>
<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 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>
</variableDefinition>
<variableDefinition>
<variableRole value="exposure"/>
<comparatorCategory value="No Alteplase"/>
<observed>
<reference value="EvidenceVariable/example-group-assignment-alteplase-for-stroke-vs-no-alteplase"/>
<type value="EvidenceVariable"/>
<display value="Group Assignment: Alteplase for Stroke vs No Alteplase"/>
</observed>
</variableDefinition>
<synthesisType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/synthesis-type"/>
<code value="std-MA"/>
<display value="summary data meta-analysis"/>
</coding>
</synthesisType>
<studyDesign>
<coding>
<system value="https://fevir.net/sevco"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</coding>
</studyDesign>
<statistic>
<statisticType>
<coding>
<system value="https://fevir.net/sevco"/>
<code value="STATO:0000182"/>
<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 certainty"/>
</coding>
</type>
<rating>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/certainty-rating"/>
<code value="moderate"/>
<display value="Moderate quality"/>
</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>