Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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

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

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    <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><div style="display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 26; Last updated: 2026-08-06 10:09:23+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>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="Evidence-32144.html">Evidence ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)</a></p><p><b>identifier</b>: FEvIR Object Identifier/32144, <a href="http://terminology.hl7.org/7.5.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt 

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This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.22.28</p><p><b>version</b>: 1.0.0-ballot3</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>citeAs</b>: </p><div><p>ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Database Entry: FHIR Evidence Resource]. 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#json.</p>
</div><p><b>status</b>: Active</p><p><b>date</b>: 2022-05-28 11:56:53+0000</p><p><b>author</b>: Brian S. Alper: </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>copyright</b>: </p><div><p>Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</p>
</div><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style="display: none">*</td><td/><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/artifact-relationship-type derived-from}">Derived From</span></td><td><a href="https://fevir.net/resources/PublicationRecord/32147">https://fevir.net/resources/PublicationRecord/32147 <img src="external.png" alt="" style="vertical-align: baseline"/></a></td></tr></table><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>
</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>
</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Bariatric Surgery Trial Enrollment Group</p>
</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>
</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>
</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/sevco 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>
</div><p><b>statisticType</b>: <span title="Codes:{https://fevir.net/sevco STATO: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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