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Clinical Decision Support Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No 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 \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\n </div>" }, "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "cds" }], "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" }], "name" : "EffectOfAlteplaseVsNoAlteplaseOnMRS02At90DaysInStroke345HoursPrior", "title" : "Effect of Alteplase vs No alteplase on mRS 0-2 at 90 days in Stroke 3-4.5 hours prior", "status" : "draft", "publisher" : "HL7 International / Clinical Decision Support", "contact" : [{ "telecom" : [{ "system" : "url", "value" : "http://www.hl7.org/Special/committees/dss" }] }], "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" : "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 between observed and intended variable" }] } }, { "variableRole" : "outcome", "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" : "exposure", "comparatorCategory" : "No Alteplase", "observed" : { "reference" : "EvidenceVariable/example-group-assignment-alteplase-for-stroke-vs-no-alteplase", "type" : "EvidenceVariable", "display" : "Group Assignment: Alteplase for Stroke vs 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/study-design", "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://hl7.org/fhir/certainty-type", "code" : "Overall", "display" : "Overall certainty" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/certainty-rating", "code" : "very-low", "display" : "Very low quality" }] }, "subcomponent" : [{ "type" : { "coding" : [{ "system" : "http://hl7.org/fhir/certainty-type", "code" : "PublicationBias", "display" : "Publication bias" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/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://hl7.org/fhir/certainty-type", "code" : "Inconsistency", "display" : "Inconsistency" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/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://hl7.org/fhir/certainty-type", "code" : "Imprecision", "display" : "Imprecision" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/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://hl7.org/fhir/certainty-type", "code" : "Indirectness", "display" : "Indirectness" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/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://hl7.org/fhir/certainty-type", "code" : "RiskOfBias", "display" : "Risk of bias" }] }, "rating" : { "coding" : [{ "system" : "http://hl7.org/fhir/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.
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