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) - XML Representation

Active as of 2022-05-28

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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><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="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/6.0.2/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 

This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: 

Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.

This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.22.10</p><p><b>version</b>: 2.0.0-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>: </p><div><p>Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</p>
</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>
</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>
</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>
</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>org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code</b>: population</p><p><b>description</b>: </p><div><p>Bariatric Surgery Trial Enrollment Group</p>
</div><p><b>note</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>org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code</b>: exposure</p><p><b>org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category</b>: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years</p><p><b>description</b>: </p><div><p>Group assignment</p>
</div><p><b>note</b>: exposure</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>org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code</b>: outcome</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>note</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>
</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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