type: exampleresource: Evidenceexample: evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2
Evidence Example: evidence-example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2
Narrative
"Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 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-3-4half-alteplase-vs-no-alteplase-mRS0-2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>
"Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior" 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"/>
<relatesTo>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/artifact-relationship-type" />
<code value="cites" />
<display value="Cites" />
</coding>
</type>
<targetMarkdown value="Figure 2 Lees 2016 <b>Citation:</b> 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 <b>URL:</b> https://doi.org/10.1161/STROKEAHA.116.013644"/>
</relatesTo>
<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 value="population"/>
<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 between observed and intended variable"/>
</coding>
</directnessMatch>
</variableDefinition>
<variableDefinition>
<variableRole value="outcome"/>
<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 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="IPD-MA"/>
<display value="individual patient 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="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://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="very-low"/>
<display value="Very low 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>
<note>
<text value="IST-3 had inconsistent results and contributed large proportion of data"/>
</note>
<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="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://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="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://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="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://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>