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 1.0.0-ballot3 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
{
"resourceType" : "Evidence",
"id" : "267244",
"meta" : {
"versionId" : "9",
"lastUpdated" : "2025-12-11T20:35:21.032Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 267244</b></p><a name=\"267244\"> </a><a name=\"hc267244\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 9; Last updated: 2025-12-11 20:35:21+0000; Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-comparative-evidence.html\">ComparativeEvidence</a></p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/Evidence/267244\">https://fevir.net/resources/Evidence/267244</a></p><p><b>identifier</b>: FEvIR Object Identifier/267244, FEvIR Linking Identifier/NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001</p><p><b>name</b>: NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379</p><p><b>citeAs</b>: </p><div><p>Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#json.</p>\n</div><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participant who completed both treatment visits and had evaluable treatment success data.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href=\"Group-267225.html\">Group NCT03421379 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Glucagon Hydrochloride Solution</p><p><b>observed</b>: Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-267226.html\">Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: , </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Non-Inferiority</p>\n</div></blockquote><blockquote><div><p>Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)</p>\n</div></blockquote><p><b>statisticType</b>: <span title=\"Codes:\">Treatment Difference Wald's Method</span></p><p><b>quantity</b>: 0 percentage of participants</p><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Note</b></td><td><b>Type</b></td><td><b>Level</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td><blockquote><div><p>CI Number of Sides: 2-Sided</p>\n</div></blockquote></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></td><td>0.95</td><td>-1.47-1.47 percentage of participants</td></tr></table></blockquote></div>"
},
"url" : "https://fevir.net/resources/Evidence/267244",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net/FOI",
"value" : "267244",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"name" : "NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001",
"title" : "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379",
"citeAs" : "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#json.",
"status" : "active",
"author" : [
{
"name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
}
],
"publisher" : "Computable Publishing LLC",
"contact" : [
{
"telecom" : [
{
"system" : "email",
"value" : "support@computablepublishing.com"
}
]
}
],
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"description" : "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
"variableDefinition" : [
{
"note" : [
{
"text" : "All randomized participant who completed both treatment visits and had evaluable treatment success data."
}
],
"variableRole" : "population",
"intended" : {
🔗 "reference" : "Group/267225",
"type" : "Group",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379 Eligibility Criteria",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"description" : "Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution",
"variableRole" : "exposure",
"comparatorCategory" : "Glucagon Hydrochloride Solution",
"observed" : {
"display" : "Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"variableRole" : "outcome",
"observed" : {
🔗 "reference" : "EvidenceVariable/267226",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-primaryOutcome-0",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)"
}
}
],
"statistic" : [
{
"note" : [
{
"text" : "Outcome Analysis NonInferiority Type: Non-Inferiority"
},
{
"text" : "Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)"
}
],
"statisticType" : {
"text" : "Treatment Difference Wald's Method"
},
"quantity" : {
"value" : 0,
"unit" : "percentage of participants"
},
"attributeEstimate" : [
{
"note" : [
{
"text" : "CI Number of Sides: 2-Sided"
}
],
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
}
]
},
"level" : 0.95,
"range" : {
"low" : {
"value" : -1.47,
"unit" : "percentage of participants"
},
"high" : {
"value" : 1.47,
"unit" : "percentage of participants"
}
}
}
]
}
]
}