Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot International flag

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-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: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Schauer 2014 (STAMPEDE) trial - XML Representation

Active as of 2022-05-29

Raw xml | Download



<Evidence xmlns="http://hl7.org/fhir">
  <id value="47771"/>
  <meta>
    <versionId value="10"/>
    <lastUpdated value="2023-12-06T17:48:14.614Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Evidence</b><a name="47771"> </a><a name="hc47771"> </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">ResourceEvidence &quot;47771&quot; Version &quot;10&quot; Updated &quot;2023-12-06 17:48:14+0000&quot; </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>: <code>https://fevir.net/resources/Evidence/47771</code></p><p><b>identifier</b>: FEvIR Object Identifier/47771</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_Schauer_2014_STAMPEDE_trial</p><p><b>title</b>: ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Schauer 2014 (STAMPEDE) trial</p><p><b>status</b>: active</p><p><b>date</b>: 2022-05-29 11:09:40+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: Evidence Based Medicine on FHIR Implementation Guide Code System 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: Evidence Based Medicine on FHIR Implementation Guide Code System 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 Schauer 2014 (STAMPEDE) trial [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 47771. Revised 2022-05-29. Available at: https://fevir.net/resources/Evidence/47771. Computable resource at: https://fevir.net/resources/Evidence/47771.</p></blockquote><p><b>description</b>: Mean HbA1c at 36 months in Schauer 2014 was 6.85% in Surgery group (n = 97) and 8.4% in Medical/Lifestyle group (n = 40), mean difference -1.55% (95% CI -2.28% to -0.82%)</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: 137 with uncontrolled T2DM</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/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#population &quot;population&quot;)</span></p><p><b>observed</b>: <span>: Schauer 2014 (STAMPEDE) Trial Enrollment Group</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: medical treatment</p><p><b>description</b>: Roux-en-Y gastric bypass or Sleeve Gastrectomy vs. medical treatment (intensive medical therapy)</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/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure &quot;exposure&quot;)</span></p><p><b>observed</b>: <a href="EvidenceVariable-172478.html">EvidenceVariable/172478: GroupAssignment: Roux-en-Y gastric bypass vs. medical treatment</a> &quot;GroupAssignment_Roux_en_Y_gastric_bypass_vs_medical_treatment&quot;</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: HbA1c at 36 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/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#measuredVariable &quot;measured variable&quot;)</span></p><p><b>observed</b>: <a href="EvidenceVariable-173244.html">EvidenceVariable/173244: OutcomeVariable: HbA1c at 36 months</a> &quot;OutcomeVariable_HbA1c_at_36_months&quot;</p></blockquote><p><b>synthesisType</b>: not applicable <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/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 --1.55% (95% CI -2.28% to -0.82%)</p><p><b>note</b>: Mean HbA1c at 36 months in Schauer 2014 was 6.85% in Surgery group (n = 97) and 8.4% in Medical/Lifestyle group (n = 40)</p><p><b>statisticType</b>: Mean Difference <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-statistic-type.html">StatisticStatisticType</a>#0000457)</span></p><p><b>quantity</b>: -1.55 %<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>137</td><td>137</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 -2.28% to -0.82%</td><td>Confidence interval <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C53324)</span></td><td>0.95</td><td>-2.28--0.82 %</td></tr></table></blockquote></div>
  </text>
  <url value="https://fevir.net/resources/Evidence/47771"/>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net"/>
    <value value="47771"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <version value="1.0.0-ballot"/>
  <name
        value="ComparativeEvidence_Mean_difference_in_HbA1c_between_Surgery_and_Medical_Lifestyle_groups_in_Schauer_2014_STAMPEDE_trial"/>
  <title
         value="ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Schauer 2014 (STAMPEDE) trial"/>
  <status value="active"/>
  <date value="2022-05-29T11:09:40.466Z"/>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <author>
    <name value="Brian S. Alper"/>
  </author>
  <useContext>
    <code>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="evidence-communication"/>
      <display value="Evidence Communication"/>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="ComparativeEvidence"/>
        <display value="ComparativeEvidence"/>
      </coding>
    </valueCodeableConcept>
  </useContext>
  <useContext>
    <code>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="evidence-communication"/>
      <display value="Evidence Communication"/>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="SingleStudyEvidence"/>
        <display value="SingleStudyEvidence"/>
      </coding>
    </valueCodeableConcept>
  </useContext>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <relatedArtifact>
    <type value="derived-from"/>
    <label value="data source"/>
    <display value="Figure 2C"/>
    <citation
              value="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
           value="https://diabetesjournals.org/care/article/39/6/861/29305/Metabolic-Surgery-in-the-Treatment-Algorithm-for"/>
    </document>
  </relatedArtifact>
  <relatedArtifact>
    <type value="cite-as"/>
    <citation
              value="ComparativeEvidence: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups in Schauer 2014 (STAMPEDE) trial [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 47771. Revised 2022-05-29. Available at: https://fevir.net/resources/Evidence/47771. Computable resource at: https://fevir.net/resources/Evidence/47771."/>
  </relatedArtifact>
  <description
               value="Mean HbA1c at 36 months in Schauer 2014 was 6.85% in Surgery group (n = 97) and 8.4% in Medical/Lifestyle group (n = 40), mean difference -1.55% (95% CI -2.28% to -0.82%)"/>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="population"/>
    </extension>
    <description value="137 with uncontrolled T2DM"/>
    <note>
      <text value="population"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="population"/>
        <display value="population"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
    <observed>
      <type value="Group"/>
      <display value="Schauer 2014 (STAMPEDE) Trial Enrollment Group"/>
    </observed>
  </variableDefinition>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="exposure"/>
    </extension>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category">
      <valueString value="medical treatment"/>
    </extension>
    <description
                 value="Roux-en-Y gastric bypass or Sleeve Gastrectomy vs. medical treatment (intensive medical therapy)"/>
    <note>
      <text value="exposure"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="exposure"/>
        <display value="exposure"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
    <observed>🔗 
      <reference value="EvidenceVariable/172478"/>
      <type value="EvidenceVariable"/>
      <display
               value="GroupAssignment: Roux-en-Y gastric bypass vs. medical treatment"/>
    </observed>
  </variableDefinition>
  <variableDefinition>
    <extension
               url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
      <valueCode value="outcome"/>
    </extension>
    <description value="HbA1c at 36 months"/>
    <note>
      <text value="outcome"/>
    </note>
    <variableRole>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
        <code value="measuredVariable"/>
        <display value="measured variable"/>
      </coding>
      <text value="Use extension:variableRoleCode instead."/>
    </variableRole>
    <observed>🔗 
      <reference value="EvidenceVariable/173244"/>
      <type value="EvidenceVariable"/>
      <display value="OutcomeVariable: HbA1c at 36 months"/>
    </observed>
  </variableDefinition>
  <synthesisType>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/synthesis-type"/>
      <code value="NotApplicable"/>
      <display value="not applicable"/>
    </coding>
  </synthesisType>
  <studyDesign>
    <coding>
      <system value="https://fevir.net/resources/CodeSystem/181513"/>
      <code value="SEVCO:01003"/>
      <display value="randomized assignment"/>
    </coding>
  </studyDesign>
  <statistic>
    <description value="mean difference --1.55% (95% CI -2.28% to -0.82%)"/>
    <note>
      <text
            value="Mean HbA1c at 36 months in Schauer 2014 was 6.85% in Surgery group (n = 97) and 8.4% in Medical/Lifestyle group (n = 40)"/>
    </note>
    <statisticType>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/statistic-type"/>
        <code value="0000457"/>
        <display value="Mean Difference"/>
      </coding>
    </statisticType>
    <quantity>
      <value value="-1.55"/>
      <unit value="%"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="%"/>
    </quantity>
    <sampleSize>
      <numberOfParticipants value="137"/>
      <knownDataCount value="137"/>
    </sampleSize>
    <attributeEstimate>
      <description value="95% CI -2.28% to -0.82%"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
          <code value="C53324"/>
          <display value="Confidence interval"/>
        </coding>
      </type>
      <level value="0.95"/>
      <range>
        <low>
          <value value="-2.28"/>
          <unit value="%"/>
          <system value="http://unitsofmeasure.org"/>
          <code value="%"/>
        </low>
        <high>
          <value value="-0.82"/>
          <unit value="%"/>
          <system value="http://unitsofmeasure.org"/>
          <code value="%"/>
        </high>
      </range>
    </attributeEstimate>
  </statistic>
</Evidence>