R6 Ballot (1st Draft)
Clinical ReasoningThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw Turtle (+ also see Turtle/RDF Format Specification)
Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
[a fhir:Evidence ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n <p>\n "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.\n </p>\n \n </div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "cds" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2"^^xsd:anyURI] ; #
fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.10.3" ]
] ) ; #
fhir:name [ fhir:v "EffectOfAlteplaseVsNoAlteplaseOnMRS02At90DaysInStroke345HoursPrior"] ; #
fhir:title [ fhir:v "Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; #
fhir:contact ( [
fhir:telecom ( [
fhir:system [ fhir:v "url" ]
] )
] ) ; #
fhir:relatedArtifact ( [
fhir:type [ fhir:v "citation" ] ;
fhir:label [ fhir:v "Lees 2016" ] ;
fhir:display [ fhir:v "Figure 2 Lees 2016" ] ;
fhir:citation [ fhir:v "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" ] ;
fhir:document [
fhir:url [ fhir:v "https://doi.org/10.1161/STROKEAHA.116.013644"^^xsd:anyURI ]
]
] ) ; #
fhir:description [ fhir:v "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"] ; #
fhir:variableDefinition ( [
fhir:variableRole [ fhir:v "population" ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/Stroke-Thrombolysis-Trialists-2014-2016-IPD-MA-Cohort" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Stroke Thrombolysis Trialists’ 2014-2016 IPD-MA Cohort" ]
] ;
fhir:intended [
fhir:reference [ fhir:v "Group/AcuteIschemicStroke3-4halfHours" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "stroke at 3-4.5 hours" ]
] ;
fhir:directnessMatch [
fhir:coding ( [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/directness"^^xsd:anyURI ] ;
fhir:code [ fhir:v "moderate" ] ;
fhir:display [ fhir:v "Moderate quality match between observed and intended variable" ]
] )
]
] [
fhir:variableRole [ fhir:v "outcome" ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/example-mRS0-2-at-90days" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "mRS 0-2 at 90 days" ]
] ;
fhir:intended [
fhir:reference [ fhir:v "EvidenceVariable/example-alive-independent-90day" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Alive and not functionally dependent at 90 days" ]
]
] [
fhir:variableRole [ fhir:v "exposure" ] ;
fhir:comparatorCategory [ fhir:v "No Alteplase" ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/example-group-assignment-alteplase-for-stroke-vs-no-alteplase" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Group Assignment: Alteplase for Stroke vs No Alteplase" ]
]
] ) ; #
fhir:synthesisType [
fhir:coding ( [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/synthesis-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "IPD-MA" ] ;
fhir:display [ fhir:v "individual patient data meta-analysis" ]
] )
] ; #
fhir:studyDesign ( [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/study-design"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01003" ] ;
fhir:display [ fhir:v "randomized assignment" ]
] )
] ) ; #
fhir:statistic ( [
fhir:statisticType [
fhir:coding ( [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/statistic-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C16932" ] ;
fhir:display [ fhir:v "Odds Ratio" ]
] )
] ;
fhir:quantity [
fhir:value [ fhir:v "1.2"^^xsd:decimal ]
] ;
fhir:sampleSize [
fhir:numberOfStudies [ fhir:v "9"^^xsd:nonNegativeInteger ]
] ;
fhir:attributeEstimate ( [
fhir:description [ fhir:v "95% CI 1.06 to 1.3" ] ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C53324" ] ;
fhir:display [ fhir:v "Confidence interval" ]
] )
] ;
fhir:level [ fhir:v "0.95"^^xsd:decimal ] ;
fhir:range [
fhir:low [
fhir:value [ fhir:v "1.06"^^xsd:decimal ]
] ;
fhir:high [
fhir:value [ fhir:v "1.3"^^xsd:decimal ]
]
]
] )
] ) ; #
fhir:certainty ( [
fhir:description [ fhir:v "Very low certainty due to risk of bias, inconsistency, imprecision, and indirectness" ] ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Overall" ] ;
fhir:display [ fhir:v "Overall certainty" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "very-low" ] ;
fhir:display [ fhir:v "Very low quality" ]
] )
] ;
fhir:subcomponent ( [
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "PublicationBias" ] ;
fhir:display [ fhir:v "Publication bias" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "no-concern" ] ;
fhir:display [ fhir:v "no serious concern" ]
] )
]
] [
fhir:note ( [
fhir:text [ fhir:v "IST-3 had inconsistent results and contributed large proportion of data" ]
] ) ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Inconsistency" ] ;
fhir:display [ fhir:v "Inconsistency" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious-concern" ] ;
fhir:display [ fhir:v "serious concern" ]
] )
]
] [
fhir:note ( [
fhir:text [ fhir:v "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" ]
] ) ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Imprecision" ] ;
fhir:display [ fhir:v "Imprecision" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious-concern" ] ;
fhir:display [ fhir:v "serious concern" ]
] )
]
] [
fhir:note ( [
fhir:text [ fhir:v "resuts derived for 3 - 4.5 hours assume data from 0 - 6 hours is informative" ]
] ) ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Indirectness" ] ;
fhir:display [ fhir:v "Indirectness" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious-concern" ] ;
fhir:display [ fhir:v "serious concern" ]
] )
]
] [
fhir:note ( [
fhir:text [ fhir:v "results largely influenced by IST-3 trial which was unblinded and ECASS III which had baseline imbalances" ]
] ) ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "RiskOfBias" ] ;
fhir:display [ fhir:v "Risk of bias" ]
] )
] ;
fhir:rating [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious-concern" ] ;
fhir:display [ fhir:v "serious concern" ]
] )
]
] )
] )] . #
# -------------------------------------------------------------------------------------
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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot1 generated on Mon, Dec 18, 2023 15:17+1100.
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