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 3-6 at 90 days in Stroke 0-3 hours prior
{
"resourceType": "Evidence",
"id": "example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <p>\n "Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior" is a comparative effect estimate.\n </p>\n\t</div>"
},
"url": "http://hl7.org/fhir/Evidence/example-stroke-0-3-alteplase-vs-no-alteplase-mRS3-6",
"identifier": [
{
"system": "urn:ietf:rfc:3986",
"value": "urn:oid:2.16.840.1.113883.4.642.10.5"
}
],
"title": "Effect of Alteplase vs No alteplase on mRS 3-6 at 90 days in Stroke 0-3 hours prior",
"status": "draft",
"relatedArtifact": [
{
"type": "citation",
"label": "Wardlaw 2014",
"display": "Analysis 1.16 from Wardlaw 2014",
"citation": "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",
"document": {
"url": "https://doi.org/10.1002/14651858.CD000213.pub3"
}
}
],
"description": "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": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "population",
"display": "population"
}
]
},
"observed": {
"reference": "EvidenceVariable/Wardlaw2014Analysis1.16.3EvidenceSet",
"type": "EvidenceVariable",
"display": "Wardlaw 2014 Analysis 1.16.3 Evidence set"
},
"intended": {
"reference": "Group/AcuteIschemicStroke0-3Hours",
"type": "Group",
"display": "stroke at 0-3 hours"
}
},
{
"variableRole": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "measuredVariable",
"display": "measured variable"
}
]
},
"observed": {
"reference": "EvidenceVariable/example-mRS3-6-at-90days",
"type": "EvidenceVariable",
"display": "mRS 3-6 at 90 days"
},
"intended": {
"reference": "EvidenceVariable/example-dead-or-dependent-90day",
"type": "EvidenceVariable",
"display": "Dead or 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": "std-MA",
"display": "summary 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": 0.65
},
"numberOfEvents": 1137,
"sampleSize": {
"numberOfStudies": 6,
"numberOfParticipants": 1779
},
"attributeEstimate": [
{
"description": "95% CI 0.54 to 0.80",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code": "C53324",
"display": "Confidence interval"
}
]
},
"level": 0.95,
"range": {
"low": {
"value": 0.54
},
"high": {
"value": 0.8
}
}
},
{
"description": "P-value = 0.000023",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code": "C44185",
"display": "P-value"
}
]
},
"quantity": {
"value": 0.000023
}
},
{
"description": "Heterogeneity I-sq = 0.0%",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code": "0000420",
"display": "I-squared"
}
]
},
"quantity": {
"value": 0,
"unit": "%",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
],
"certainty": [
{
"description": "Moderate certainty due to risk of bias",
"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": "moderate",
"display": "Moderate"
}
]
},
"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"
}
]
}
},
{
"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": "no-concern",
"display": "no serious concern"
}
]
}
},
{
"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": "no-concern",
"display": "no serious concern"
}
]
}
},
{
"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": "no-concern",
"display": "no serious concern"
}
]
}
},
{
"note": [
{
"text": "results largely influenced by IST-3 trial which was unblinded and NINDS trial which had allocation concealment not stated and 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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