This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Active as of 2022-05-29 |
{
"resourceType" : "Evidence",
"id" : "47762",
"meta" : {
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"lastUpdated" : "2023-12-06T18:56:02.603Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"🔗 ,
"http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"
]
},
"text" : {
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"47762\"> </a></p><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\">Resource Evidence "47762" Version "14" Updated "2023-12-06 18:56:02+0000" </p><p style=\"margin-bottom: 0px\">Profiles: <a href=\"StructureDefinition-comparative-evidence.html\">ComparativeEvidence</a>, <a href=\"StructureDefinition-single-study-evidence.html\">SingleStudyEvidence</a></p></div><p><b>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Evidence/47762</code></p><p><b>identifier</b>: FEvIR Object Identifier:\u00a047762</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: ComparativeEvidence_Mean_difference_in_HbA1c_between_Surgery_and_Medical_Lifestyle_groups_in_Ikramuddin_2015</p><p><b>title</b>: ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Ikramuddin 2015</p><p><b>status</b>: active</p><p><b>date</b>: 2022-05-29 11:01:10+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href=\"http://www.hl7.org/Special/committees/dss\">http://www.hl7.org/Special/committees/dss</a></p><p><b>author</b>: Brian S. Alper: </p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Evidence Communication (Details: https://fevir.net/resources/CodeSystem/179423 code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')</td><td>ComparativeEvidence <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-179423.html\">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#ComparativeEvidence)</span></td></tr><tr><td style=\"display: none\">*</td><td>Evidence Communication (Details: https://fevir.net/resources/CodeSystem/179423 code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')</td><td>SingleStudyEvidence <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-179423.html\">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#SingleStudyEvidence)</span></td></tr></table><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: derived-from</p><p><b>label</b>: data source</p><p><b>display</b>: Figure 2C</p><p><b>citation</b>: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations [Journal Article]. Contributors: Francesco Rubino, David M Nathan, Robert H Eckel, Philip R Schauer, K George M M Alberti, Paul Z Zimmet, Stefano Del Prato, Linong Ji, Shaukat M Sadikot, William H Herman, Stephanie A Amiel, Lee M Kaplan, Gaspar Taroncher-Oldenburg, David E Cummings, Delegates of the 2nd Diabetes Surgery Summit. In: Diabetes care, PMID 27222544. Published June 2016. Available at: https://pubmed.ncbi.nlm.nih.gov/27222544/.</p><blockquote><p><b>document</b></p></blockquote></blockquote><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: cite-as</p><p><b>citation</b>: ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Ikramuddin 2015 [Evidence]. Contributors: In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 47762. Revised 2022-05-29. Available at: https://fevir.net/resources/Evidence/47762. Computable resource at: https://fevir.net/resources/Evidence/47762.</p></blockquote><p><b>description</b>: Mean HbA1c at 24 months in Ikramuddin 2015 was 6.5% in Surgery group (n = 56) and 8.4% in Medical/Lifestyle group (n = 54), mean difference -1.90% (95% CI -2.78% to -1.02%)</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: 110 patients aged 30-67 years with HbA1c of at least 8%, BMI between 30 and 39.9 and T2DM for at least 6 months</p><p><b>note</b>: population</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html\">EvidenceVariableRole</a>#population "population")</span></p><p><b>observed</b>: <span>: Ikramuddin 2015 (Diabetes Surgery Study) Trial Enrollment Group</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years</p><p><b>description</b>: Roux-en-Y gastric bypass vs. medical treatment (intensive lifestyle and medical management)</p><p><b>note</b>: exposure</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html\">EvidenceVariableRole</a>#exposure "exposure")</span></p><p><b>observed</b>: <a href=\"EvidenceVariable-172481.html\">EvidenceVariable/172481: GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone</a> "GroupAssignment_Roux_en_Y_gastric_bypass_surgery_vs_Lifestyle_intensive_medical_management_intervention_alone"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: HbA1c at 24 months</p><p><b>note</b>: outcome</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html\">EvidenceVariableRole</a>#measuredVariable "measured variable")</span></p><p><b>observed</b>: <a href=\"EvidenceVariable-173246.html\">EvidenceVariable/173246: OutcomeVariable: HbA1c at 24 months</a> "OutcomeVariable_HbA1c_at_24_months"</p></blockquote><p><b>synthesisType</b>: not applicable <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-synthesis-type.html\">StatisticSynthesisType</a>#NotApplicable)</span></p><p><b>studyDesign</b>: randomized assignment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-181513.html\">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:01003)</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: mean difference -1.90% (95% CI -2.78% to -1.02%)</p><p><b>note</b>: Mean HbA1c at 24 months in Ikramuddin 2015 was 6.5% in Surgery group (n = 56) and 8.4% in Medical/Lifestyle group (n = 54)</p><p><b>statisticType</b>: Mean Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-statistic-type.html\">StatisticStatisticType</a>#0000457)</span></p><p><b>quantity</b>: -1.9 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>SampleSizes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>NumberOfParticipants</b></td><td><b>KnownDataCount</b></td></tr><tr><td style=\"display: none\">*</td><td>110</td><td>110</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Description</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>95% CI -2.78% to -1.02%</td><td>Confidence interval <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-attribute-estimate-type.html\">StatisticAttribute Estimate Type</a>#C53324)</span></td><td>0.95</td><td>-2.78--1.02 %</td></tr></table></blockquote></div>"
},
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"value" : "47762",
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],
"version" : "1.0.0-ballot",
"name" : "ComparativeEvidence_Mean_difference_in_HbA1c_between_Surgery_and_Medical_Lifestyle_groups_in_Ikramuddin_2015",
"title" : "ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Ikramuddin 2015",
"status" : "active",
"date" : "2022-05-29T11:01:10.770Z",
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
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"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
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],
"author" : [
{
"name" : "Brian S. Alper"
}
],
"useContext" : [
{
"code" : {
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-communication",
"display" : "Evidence Communication"
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"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "ComparativeEvidence",
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{
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"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"relatedArtifact" : [
{
"type" : "derived-from",
"label" : "data source",
"display" : "Figure 2C",
"citation" : "Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations [Journal Article]. Contributors: Francesco Rubino, David M Nathan, Robert H Eckel, Philip R Schauer, K George M M Alberti, Paul Z Zimmet, Stefano Del Prato, Linong Ji, Shaukat M Sadikot, William H Herman, Stephanie A Amiel, Lee M Kaplan, Gaspar Taroncher-Oldenburg, David E Cummings, Delegates of the 2nd Diabetes Surgery Summit. In: Diabetes care, PMID 27222544. Published June 2016. Available at: https://pubmed.ncbi.nlm.nih.gov/27222544/.",
"document" : {
"url" : "https://diabetesjournals.org/care/article/39/6/861/29305/Metabolic-Surgery-in-the-Treatment-Algorithm-for"
}
},
{
"type" : "cite-as",
"citation" : "ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Ikramuddin 2015 [Evidence]. Contributors: In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 47762. Revised 2022-05-29. Available at: https://fevir.net/resources/Evidence/47762. Computable resource at: https://fevir.net/resources/Evidence/47762."
}
],
"description" : "Mean HbA1c at 24 months in Ikramuddin 2015 was 6.5% in Surgery group (n = 56) and 8.4% in Medical/Lifestyle group (n = 54), mean difference -1.90% (95% CI -2.78% to -1.02%)",
"variableDefinition" : [
{
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{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
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],
"description" : "110 patients aged 30-67 years with HbA1c of at least 8%, BMI between 30 and 39.9 and T2DM for at least 6 months",
"note" : [
{
"text" : "population"
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"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "population",
"display" : "population"
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],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
"type" : "Group",
"display" : "Ikramuddin 2015 (Diabetes Surgery Study) Trial Enrollment Group"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "exposure"
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{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category",
"valueString" : "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years"
}
],
"description" : "Roux-en-Y gastric bypass vs. medical treatment (intensive lifestyle and medical management)",
"note" : [
{
"text" : "exposure"
}
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"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "exposure",
"display" : "exposure"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/172481",
"type" : "EvidenceVariable",
"display" : "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "outcome"
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"description" : "HbA1c at 24 months",
"note" : [
{
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{
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"code" : "measuredVariable",
"display" : "measured variable"
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"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/173246",
"type" : "EvidenceVariable",
"display" : "OutcomeVariable: HbA1c at 24 months"
}
}
],
"synthesisType" : {
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{
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"code" : "NotApplicable",
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"studyDesign" : [
{
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "SEVCO:01003",
"display" : "randomized assignment"
}
]
}
],
"statistic" : [
{
"description" : "mean difference -1.90% (95% CI -2.78% to -1.02%)",
"note" : [
{
"text" : "Mean HbA1c at 24 months in Ikramuddin 2015 was 6.5% in Surgery group (n = 56) and 8.4% in Medical/Lifestyle group (n = 54)"
}
],
"statisticType" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
"code" : "0000457",
"display" : "Mean Difference"
}
]
},
"quantity" : {
"value" : -1.9,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"sampleSize" : {
"numberOfParticipants" : 110,
"knownDataCount" : 110
},
"attributeEstimate" : [
{
"description" : "95% CI -2.78% to -1.02%",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
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"level" : 0.95,
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"value" : -2.78,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
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"high" : {
"value" : -1.02,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
]
}
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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