Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
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 2022-05-28 |
{
"resourceType" : "Evidence",
"id" : "32144",
"meta" : {
"versionId" : "20",
"lastUpdated" : "2023-12-06T17:46:14.323Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"🔗 ,
"http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"32144\"> </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 "32144" Version "20" Updated "2023-12-06 17:46:14+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/32144</code></p><p><b>identifier</b>: FEvIR Object Identifier:\u00a032144</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study</p><p><b>title</b>: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)</p><p><b>status</b>: active</p><p><b>date</b>: 2022-05-28 11:56:53+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><p><b>copyright</b>: Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</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>: Diabetes Surgery Study</p><p><b>citation</b>: Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study [Journal Article]. Contributors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, Avis J Thomas, John E Connett, John P Bantle, Daniel B Leslie, Qi Wang, William B Inabnet, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J Billington. In: JAMA, PMID 29340678. Published January 16, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29340678/.</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: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 32144. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/32144. Computable resource at: https://fevir.net/resources/Evidence/32144.</p></blockquote><p><b>description</b>: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P\u2009=\u2009.01).</p><p><b>assertion</b>: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Bariatric Surgery Trial Enrollment Group</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>: <a href=\"Group-32145.html\">Group/32145: 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011)</a> "StudyGroup_Bariatric_Surgery_Trial_Enrollment_Group"</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>: Group assignment</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>: American Diabetes Association composite triple end point for metabolic control at 5 years *NOTE: note.text is used artificially to support the EBMonFHIR Implementation Guide and the following content would more properly be found in a note.text element:* The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years</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-32143.html\">EvidenceVariable/32143: OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years</a> "OutcomeVariable_American_Diabetes_Association_composite_triple_end_point_for_metabolic_control_at_5_years"</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>: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P\u2009=\u2009.01).</p><p><b>statisticType</b>: Risk Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (StatisticStatisticType[4.4.0]#0000424)</span></p><p><b>quantity</b>: 0.19</p><p><b>numberAffected</b>: 15</p><h3>SampleSizes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>NumberOfStudies</b></td><td><b>NumberOfParticipants</b></td><td><b>KnownDataCount</b></td></tr><tr><td style=\"display: none\">*</td><td>1</td><td>120</td><td>98</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Level</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</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>0.04-0.34</td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "cds"
}
],
"url" : "https://fevir.net/resources/Evidence/32144",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net",
"value" : "32144",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"version" : "1.0.0-ballot",
"name" : "ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study",
"title" : "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)",
"status" : "active",
"date" : "2022-05-28T11:56:53.907Z",
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
{
"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/dss"
}
]
}
],
"author" : [
{
"name" : "Brian S. Alper"
}
],
"copyright" : "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International",
"relatedArtifact" : [
{
"type" : "derived-from",
"label" : "data source",
"display" : "Diabetes Surgery Study",
"citation" : "Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study [Journal Article]. Contributors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, Avis J Thomas, John E Connett, John P Bantle, Daniel B Leslie, Qi Wang, William B Inabnet, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J Billington. In: JAMA, PMID 29340678. Published January 16, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29340678/.",
"document" : {
"url" : "https://fevir.net/resources/Citation/32147"
}
},
{
"type" : "cite-as",
"citation" : "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 32144. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/32144. Computable resource at: https://fevir.net/resources/Evidence/32144."
}
],
"description" : "Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P\u2009=\u2009.01).",
"assertion" : "In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.",
"variableDefinition" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "population"
}
],
"description" : "Bariatric Surgery Trial Enrollment Group",
"note" : [
{
"text" : "population"
}
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"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "population",
"display" : "population"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "Group/32145",
"type" : "Group",
"display" : "120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011)"
}
},
{
"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" : "Group assignment",
"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"
}
],
"description" : "American Diabetes Association composite triple end point for metabolic control at 5 years *NOTE: note.text is used artificially to support the EBMonFHIR Implementation Guide and the following content would more properly be found in a note.text element:* The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years",
"note" : [
{
"text" : "outcome"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "measuredVariable",
"display" : "measured variable"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/32143",
"type" : "EvidenceVariable",
"display" : "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years"
}
}
],
"synthesisType" : {
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{
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"code" : "NotApplicable",
"display" : "not applicable"
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"studyDesign" : [
{
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "SEVCO:01003",
"display" : "randomized assignment"
}
]
}
],
"statistic" : [
{
"description" : "Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P\u2009=\u2009.01).",
"statisticType" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
"version" : "4.4.0",
"code" : "0000424",
"display" : "Risk Difference",
"userSelected" : true
}
]
},
"quantity" : {
"value" : 0.19
},
"numberAffected" : 15,
"sampleSize" : {
"numberOfStudies" : 1,
"numberOfParticipants" : 120,
"knownDataCount" : 98
},
"attributeEstimate" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
}
]
},
"level" : 0.95,
"range" : {
"low" : {
"value" : 0.04
},
"high" : {
"value" : 0.34
}
}
}
]
}
]
}
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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