This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). 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 |
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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": "Evidence/example-stroke-3-4half-alteplase-vs-no-alteplase-mRS0-2", "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", "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" } ] }, "studyType": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/study-type", "code": "RCT", "display": "randomized trial" } ] }, "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", "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-rating", "code": "very-low", "display": "Very low quality" } ] } ], "certaintySubcomponent": [ { "type": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-type", "code": "PublicationBias", "display": "Publication bias" } ] } ], "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-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-subcomponent-type", "code": "Inconsistency", "display": "Inconsistency" } ] } ], "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-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-subcomponent-type", "code": "Imprecision", "display": "Imprecision" } ] } ], "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-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-subcomponent-type", "code": "Indirectness", "display": "Indirectness" } ] } ], "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-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-subcomponent-type", "code": "RiskOfBias", "display": "Risk of bias" } ] } ], "rating": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/certainty-subcomponent-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.