Evidence Based Medicine on FHIR Implementation Guide
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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

: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Evidence ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "32144"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "20" ] ;
fhir:lastUpdated [ fhir:v "2023-12-06T17:46:14.323Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence>     ] [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 32144</b></p><a name=\"32144\"> </a><a name=\"hc32144\"> </a><a name=\"32144-en-US\"> </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: 20; Last 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>url</b>: <a href=\"https://fevir.net/resources/Evidence/32144\">https://fevir.net/resources/Evidence/32144</a></p><p><b>identifier</b>: FEvIR Object Identifier/32144</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>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>author</b>: Brian S. Alper: </p><p><b>copyright</b>: </p><div><p>Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</p>\n</div><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>: </p><div><p>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>\n</div><h3>Documents</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Url</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"https://fevir.net/resources/Citation/32147\">https://fevir.net/resources/Citation/32147</a></td></tr></table></blockquote><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: Cite As</p><p><b>citation</b>: </p><div><p>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>\n</div></blockquote><p><b>description</b>: </p><div><p>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 = .01).</p>\n</div><p><b>assertion</b>: </p><div><p>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>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Bariatric Surgery Trial Enrollment Group</p>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"Group-32145.html\">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></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group assignment</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years</p><p><b>observed</b>: <a href=\"EvidenceVariable-172481.html\">GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>American Diabetes Association composite triple end point for metabolic control at 5 years <em>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:</em> 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>\n</div><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-32143.html\">OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years</a></p></blockquote><p><b>synthesisType</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/synthesis-type NotApplicable}\">not applicable</span></p><p><b>studyDesign</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 SEVCO:01003}\">randomized assignment</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: </p><div><p>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 = .01).</p>\n</div><p><b>statisticType</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/statistic-type 0000424}\">Risk Difference</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><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></td><td>0.95</td><td>0.04-0.34</td></tr></table></blockquote></div>"
  ] ; # 
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  fhir:identifier ( [
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fhir:value [ fhir:v "32144" ] ;
fhir:assigner [
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  fhir:name [ fhir:v "ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study"] ; # 
  fhir:title [ fhir:v "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:date [ fhir:v "2022-05-28T11:56:53.907Z"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # 
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  fhir:author ( [
fhir:name [ fhir:v "Brian S. Alper" ]
  ] ) ; # 
  fhir:copyright [ fhir:v "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International"] ; # 
  fhir:relatedArtifact ( [
fhir:type [ fhir:v "derived-from" ] ;
fhir:label [ fhir:v "data source" ] ;
fhir:display [ fhir:v "Diabetes Surgery Study" ] ;
fhir:citation [ fhir:v "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/." ] ;
fhir:document [
fhir:url [ fhir:v "https://fevir.net/resources/Citation/32147"^^xsd:anyURI ]     ]
  ] [
fhir:type [ fhir:v "cite-as" ] ;
fhir:citation [ fhir:v "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." ]
  ] ) ; # 
  fhir:description [ fhir:v "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 = .01)."] ; # 
  fhir:assertion [ fhir:v "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."] ; # 
  fhir:variableDefinition ( [
fhir:description [ fhir:v "Bariatric Surgery Trial Enrollment Group" ] ;
fhir:variableRole [ fhir:v "population" ] ;
fhir:observed [
fhir:reference [ fhir:v "Group/32145" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "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)" ]     ]
  ] [
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fhir:comparatorCategory [ fhir:v "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years" ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/172481" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone" ]     ]
  ] [
fhir:description [ fhir:v "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" ] ;
fhir:variableRole [ fhir:v "outcome" ] ;
fhir:observed [
fhir:reference [ fhir:v "EvidenceVariable/32143" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years" ]     ]
  ] ) ; # 
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fhir:display [ fhir:v "randomized assignment" ]     ] )
  ] ) ; # 
  fhir:statistic ( [
fhir:description [ fhir:v "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 = .01)." ] ;
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