Release 5 Ballot
Clinical ReasoningThis page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). 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
| Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior
{
"resourceType": "Evidence",
"id": "example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">\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\t</div>"
},
"url": "http://hl7.org/fhir/Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2",
"identifier": [
{
"system": "urn:ietf:rfc:3986",
"value": "urn:oid:2.16.840.1.113883.4.642.10.3"
}
],
"title": "Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior",
"status": "draft",
"relatedArtifact": [
{
"type": "citation",
"label": "Lees 2016",
"display": "Figure 2 Lees 2016",
"citation": "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": "https://doi.org/10.1161/STROKEAHA.116.013644"
}
}
],
"description": "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": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "population",
"display": "population"
}
]
},
"observed": {
"reference": "EvidenceVariable/Stroke-Thrombolysis-Trialists-2014-2016-IPD-MA-Cohort",
"type": "EvidenceVariable",
"display": "Stroke Thrombolysis Trialists’ 2014-2016 IPD-MA Cohort"
},
"intended": {
"reference": "Group/AcuteIschemicStroke3-4halfHours",
"type": "Group",
"display": "stroke at 3-4.5 hours"
},
"directnessMatch": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/directness",
"code": "moderate",
"display": "Moderate quality match"
}
]
}
},
{
"variableRole": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "measuredVariable",
"display": "measured variable"
}
]
},
"observed": {
"reference": "EvidenceVariable/example-mRS0-2-at-90days",
"type": "EvidenceVariable",
"display": "mRS 0-2 at 90 days"
},
"intended": {
"reference": "EvidenceVariable/example-alive-independent-90day",
"type": "EvidenceVariable",
"display": "Alive and not functionally dependent at 90 days"
}
},
{
"variableRole": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "exposure",
"display": "exposure"
}
]
},
"observed": {
"reference": "EvidenceVariable/example-alteplase-for-stroke",
"type": "EvidenceVariable",
"display": "Alteplase for Stroke"
},
"intended": {
"reference": "EvidenceVariable/example-alteplase-for-stroke",
"type": "EvidenceVariable",
"display": "Alteplase for Stroke"
}
},
{
"variableRole": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "referenceExposure",
"display": "reference exposure"
}
]
},
"observed": {
"reference": "EvidenceVariable/example-no-alteplase",
"type": "EvidenceVariable",
"display": "no alteplase"
},
"intended": {
"reference": "EvidenceVariable/example-no-alteplase",
"type": "EvidenceVariable",
"display": "no alteplase"
}
}
],
"synthesisType": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/synthesis-type",
"code": "IPD-MA",
"display": "individual patient data meta-analysis"
}
]
},
"studyDesign": [
{
"coding": [
{
"system": "http://hl7.org/fhir/research-study-classifiers",
"code": "SEVCO:01003",
"display": "randomized assignment"
}
]
}
],
"statistic": [
{
"statisticType": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/statistic-type",
"code": "C16932",
"display": "Odds Ratio"
}
]
},
"quantity": {
"value": 1.2
},
"sampleSize": {
"numberOfStudies": 9
},
"attributeEstimate": [
{
"description": "95% CI 1.06 to 1.3",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code": "C53324",
"display": "Confidence interval"
}
]
},
"level": 0.95,
"range": {
"low": {
"value": 1.06
},
"high": {
"value": 1.3
}
}
}
]
}
],
"certainty": [
{
"description": "Very low certainty due to risk of bias, inconsistency, imprecision, and indirectness",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "Overall",
"display": "Overall quality"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "very-low",
"display": "Very low quality"
}
]
},
"subcomponent": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "PublicationBias",
"display": "Publication bias"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "no-concern",
"display": "no serious concern"
}
]
}
},
{
"note": [
{
"text": "IST-3 had inconsistent results and contributed large proportion of data"
}
],
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "Inconsistency",
"display": "Inconsistency"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "serious-concern",
"display": "serious concern"
}
]
}
},
{
"note": [
{
"text": "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"
}
],
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "Imprecision",
"display": "Imprecision"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "serious-concern",
"display": "serious concern"
}
]
}
},
{
"note": [
{
"text": "resuts derived for 3 - 4.5 hours assume data from 0 - 6 hours is informative"
}
],
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "Indirectness",
"display": "Indirectness"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "serious-concern",
"display": "serious concern"
}
]
}
},
{
"note": [
{
"text": "results largely influenced by IST-3 trial which was unblinded and ECASS III which had baseline imbalances"
}
],
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-type",
"code": "RiskOfBias",
"display": "Risk of bias"
}
]
},
"rating": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code": "serious-concern",
"display": "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 R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:08+1000.
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