Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
<Evidence xmlns="http://hl7.org/fhir">
<id value="33244"/>
<meta>
<versionId value="37"/>
<lastUpdated value="2025-03-03T20:40:42.910Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-synthesis-evidence"/>
</meta>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to">
<extension url="type">
<valueCode value="derived-from"/>
</extension>
<extension url="targetUri">
<valueUri
value="https://diabetesjournals.org/care/article/39/6/861/29305/Metabolic-Surgery-in-the-Treatment-Algorithm-for"/>
</extension>
<extension url="targetMarkdown">
<valueMarkdown
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/."/>
</extension>
</extension>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to">
<extension url="type">
<valueCode value="supported-with"/>
</extension>
<extension url="targetReference">
<valueReference>🔗
<reference value="Citation/33089"/>
<type value="Citation"/>
<display
value="Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations-Citation"/>
</valueReference>
</extension>
</extension>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to">
<extension url="type">
<valueCode value="cite-as"/>
</extension>
<extension url="targetMarkdown">
<valueMarkdown
value="ComparativeEvidence: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis [Database Entry: FHIR Evidence Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 33244. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/33244. Computable resource at: https://fevir.net/resources/Evidence/33244#json."/>
</extension>
</extension>
<url value="https://fevir.net/resources/Evidence/33244"/>
<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="urn:ietf:rfc:3986"/>
<value value="https://fevir.net/FOI/33244"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<name value="MeanDiffA1c2016metaAnalysis"/>
<title
value="ComparativeEvidence: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis"/>
<status value="active"/>
<date value="2022-05-28T12:01:55.472Z"/>
<publisher value="Computable Publishing LLC"/>
<contact>
<telecom>
<system value="email"/>
<value value="support@computablepublishing.com"/>
</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="EvidenceSynthesisEvidence"/>
<display value="EvidenceSynthesisEvidence"/>
</coding>
</valueCodeableConcept>
</useContext>
<copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
<description
value="effect estimate for differences in mean HbA1c at study end point between Surgery and Medical/Lifestyle groups -1.14% (95% CI -1.57% to -0.71%) in meta-analysis of 15 trials with 1,067 participants"/>
<note>
<text
value="summary derived from Figure 2C as data not reported in the text"/>
</note>
<variableDefinition>
<description
value="Patients with type 2 diabetes *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 observed element can reference a Group Resource that represents an actual group of studies included and has a quantity. The quantity would be the number of members (number of studies), and the characteristic can be code 'Member of' and valueReference EvidenceList with an EvidenceList that can reference the Evidence Resources representing the individual study results. This meta-analysis included 15 studies. The intended element (if desired) can reference a Group Resource that expresses the population of studies intended for evidence application through structured characteristics. The structured characteristics could be used to express the SR eligibility criteria for participants (i.e. included studies). The included trials included patients with T2D, including mainly individuals with BMI ≥35 kg/m2 (the most commonly used threshold for traditional bariatric surgery) as well as some patients with BMI <35 kg/m2 (range 25–35 kg/m2)."/>
<variableRole value="population"/>
<observed>🔗
<reference value="Group/33395"/>
<type value="Group"/>
<display
value="MetaanalysisStudyGroup: Study results included in Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis"/>
</observed>
<intended>🔗
<reference value="Group/175766"/>
<type value="Group"/>
<display
value="MetaanalysisEligibilityCriteria: Mean difference in HbA1c effect of bariatric surgery in type 2 diabetes and elevated BMI in 2016 meta-analysis"/>
</intended>
</variableDefinition>
<variableDefinition>
<description
value="Any of 4 bariatric surgery procedures (Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Laparoscopic Adjustable Gastric banding, Biliopancreatic Diversion) vs. Medical/lifestyle interventions *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:* As the control group (observed reference exposure) was defined differently in each trial, the intended reference exposure is described as the absence of the intended exposure (Bariatric Surgery)."/>
<variableRole value="exposure"/>
<comparatorCategory value="no bariatric surgery"/>
<intended>🔗
<reference value="EvidenceVariable/172427"/>
<type value="EvidenceVariable"/>
<display
value="GroupAssignment: Bariatric Surgery vs. no bariatric surgery"/>
</intended>
</variableDefinition>
<variableDefinition>
<description
value="Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point"/>
<variableRole value="outcome"/>
<observed>🔗
<reference value="EvidenceVariable/46025"/>
<type value="EvidenceVariable"/>
<display
value="OutcomeVariable: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point"/>
</observed>
</variableDefinition>
<synthesisType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/synthesis-type"/>
<code value="std-MA"/>
<display value="summary data meta-analysis"/>
</coding>
</synthesisType>
<studyDesign>
<coding>
<system value="https://fevir.net/sevco"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</coding>
</studyDesign>
<statistic>
<description
value="mean difference in HbA1c -1.14% (95% CI -1.57% to -0.71%)"/>
<note>
<text
value="random-effects model, heterogeneity tau-squared 0.63; chi-squared 200.88, df 14 (p < 0.00001), I-squared 93%"/>
</note>
<note>
<text value="test for overall effect z = 5.20 (p < 0.00001)"/>
</note>
<statisticType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/statistic-type"/>
<code value="0000457"/>
<display value="Mean Difference"/>
</coding>
<text
value="A mean of values in which each value is the subtraction of one quantity from another."/>
</statisticType>
<quantity>
<value value="-1.14"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</quantity>
<sampleSize>
<description
value="15 studies with 1067 participants contributing to analysis"/>
<numberOfStudies value="15"/>
<numberOfParticipants value="0"/>
<knownDataCount value="1067"/>
</sampleSize>
<attributeEstimate>
<description value="95% CI -1.57% to -0.71%"/>
<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="-1.57"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="-0.71"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</attributeEstimate>
<attributeEstimate>
<description value="z = 5.20"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</coding>
<text value="Z-score"/>
</type>
<quantity>
<value value="5.2"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<description value="p < 0.00001"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.00001"/>
<comparator value="<"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<description value="Tau squared = 0.63"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000421"/>
<display value="Tau squared"/>
</coding>
</type>
<quantity>
<value value="0.63"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<description
value="Chi square for homogeneity 200.88, df 14 (p < 0.00001)"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</coding>
<text value="Chi square for homogeneity"/>
</type>
<quantity>
<value value="200.88"/>
</quantity>
<attributeEstimate>
<description value="degrees of freedom (df) = 14"/>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</coding>
<text value="Degrees of Freedom"/>
</type>
<quantity>
<value value="14"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<description value="p < 0.00001"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.00001"/>
<comparator value="<"/>
</quantity>
</attributeEstimate>
</attributeEstimate>
<attributeEstimate>
<description value="I-squared = 93%"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000420"/>
<display value="I-squared"/>
</coding>
</type>
<quantity>
<value value="93"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</quantity>
</attributeEstimate>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="metaAnalysis"/>
<display value="Meta-analysis"/>
</coding>
</code>
</modelCharacteristic>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="effectsRandom"/>
<display value="Random-effects"/>
</coding>
</code>
</modelCharacteristic>
</statistic>
</Evidence>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot2. Generated 2025-03-28
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