Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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"url" : "http://example.org/fhir/extension/recruitment-restrictions"
},
{
"url" : "http://example.org/fhir/extension/screen-failure",
"valueString" : "Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened."
}
],
"targetNumber" : 20,
"actualNumber" : 75,
"eligibility" : {
🔗 "reference" : "Group/267506",
"type" : "Group",
"display" : "M11 IGBJ Protocol Example Eligibility Criteria"
}
},
"comparisonGroup" : [
{
"linkId" : "nasal",
"name" : "Glucagon Nasal Powder",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-arm-type",
"code" : "experimental",
"display" : "Experimental"
}
]
},
"description" : "A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.",
"intendedExposure" : [
{
"reference" : "#NCT03421379-drug------glucagon-nasal-powder",
"type" : "EvidenceVariable",
"display" : "Drug: Glucagon Nasal Powder"
}
]
},
{
"linkId" : "solution",
"name" : "Glucagon Hydrochloride Solution",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-arm-type",
"code" : "active-comparator",
"display" : "Active Comparator"
}
]
},
"description" : "A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)",
"intendedExposure" : [
{
"reference" : "#NCT03421379-drug------glucagon-hydrochloride-solution",
"type" : "EvidenceVariable",
"display" : "Drug: Glucagon Hydrochloride Solution"
}
]
}
],
"objective" : [
{
"extension" : [
{
"extension" : [
{
"url" : "label",
"valueString" : "Proportion achieving treatment success"
},
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-primaryOutcome-0",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "The proportion of patients achieving treatment success defined as either an increase in PG to >70 mg/dL or an increase of >20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration."
}
},
{
"url" : "population",
"valueReference" : {
🔗 "reference" : "Group/267506",
"type" : "Group",
"display" : "M11 IGBJ Protocol Example Eligibility Criteria"
}
},
{
"url" : "interventionGroup",
"valueId" : "nasal"
},
{
"url" : "comparatorGroup",
"valueId" : "solution"
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
}
],
"name" : "Treatment success",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}
]
},
"description" : "To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%"
},
{
"extension" : [
{
"extension" : [
{
"url" : "endpoint",
"valueReference" : {
"display" : "serious adverse events (SAEs)"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "label",
"valueString" : "treatment-emergent adverse events (TEAEs)"
},
{
"url" : "endpoint",
"valueReference" : {
"display" : "treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "endpoint",
"valueReference" : {
"display" : "vital signs"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
}
],
"name" : "Safety and tolerability",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
},
"description" : "To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG"
},
{
"extension" : [
{
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-0",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-1",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-2",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-3",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
},
{
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
}
},
{
"url" : "endpoint",
"valueReference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-4",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
}
],
"name" : "To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}
]
},
"description" : "PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax"
},
{
"extension" : [
{
"extension" : [
{
"url" : "endpoint",
"valueReference" : {
"display" : "Presence of anti-glucagon antibodies"
}
}
],
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "exploratory",
"display" : "Exploratory"
}
]
},
"description" : "Explore the formation of anti-glucagon antibodies to glucagon"
},
{
"name" : "To evaluate the recovery from clinical symptoms of hypoglycemia",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/research-study-objective-type",
"code" : "exploratory",
"display" : "Exploratory"
}
]
},
"description" : "Hypoglycemia symptoms questionnaire"
}
],
"result" : [
{
"type" : "EvidenceReport",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379 Results Report",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "Results Section for NCT03421379"
}
]
}
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-22
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