Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2022-09-19 |
<Evidence xmlns="http://hl7.org/fhir">
<id value="104098"/>
<meta>
<versionId value="14"/>
<lastUpdated value="2023-12-06T17:20:30.903Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"/>
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<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Evidence</b><a name="104098"> </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">Resource Evidence "104098" Version "14" Updated "2023-12-06 17:20:30+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>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Evidence/104098</code></p><p><b>identifier</b>: FEvIR Object Identifier: 104098</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: ComparativeEvidence_Bypass_surgery_effects_on_Myocardial_infarction_or_stroke_in_Swedish_Obese_Subjects_SOS_study</p><p><b>title</b>: ComparativeEvidence: Bypass surgery effects on Myocardial infarction or stroke in Swedish Obese Subjects (SOS) study</p><p><b>status</b>: active</p><p><b>date</b>: 2022-09-19 21:15:57+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>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: derived-from</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: Bypass surgery effects on Myocardial infarction or stroke in Swedish Obese Subjects (SOS) study [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 104098. Revised 2022-09-19. Available at: https://fevir.net/resources/Evidence/104098. Computable resource at: https://fevir.net/resources/Evidence/104098.</p></blockquote><p><b>description</b>: Bariatric surgery was associated with a reduced number of cardiovascular deaths (28 events among 2010 patients in the surgery group vs 49 events among 2037 patients in the control group; adjusted hazard ratio [HR], 0.47; 95% CI, 0.29-0.76; P = .002). The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (199 events among 2010 patients) than in the control group (234 events among 2037 patients; adjusted HR, 0.67; 95% CI, 0.54-0.83; P < .001). -- Extrapolated from this data the outcome of Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group and 171 out of 2010 patients in the surgery group, and the adjusted HR for total events is assumed to apply (adjusted HR 0.67, 95% CI 0.54 to 0.83)</p><p><b>assertion</b>: Compared with usual care, bariatric surgery was associated with reduced number of cardiovascular deaths and lower incidence of cardiovascular events in obese adults.</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Inclusion criteria were age 37 to 60 years and a body mass index of at least 34 in men and at least 38 in women. All in Sweden.</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/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#population "population")</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: no bariatric surgery</p><p><b>description</b>: bariatric surgery vs. usual care without bariatric surgery</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/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure "exposure")</span></p><p><b>intended</b>: <a href="EvidenceVariable-172427.html">EvidenceVariable/172427: GroupAssignment: Bariatric Surgery vs. no bariatric surgery</a> "GroupAssignment_Bariatric_Surgery_vs_no_bariatric_surgery"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: nonfatal myocardial infarction or stroke</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/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#measuredVariable "measured variable")</span></p><p><b>observed</b>: <a href="EvidenceVariable-104097.html">EvidenceVariable/104097: OutcomeVariable: Nonfatal myocardial infarction or stroke</a> "OutcomeVariable_Nonfatal_myocardial_infarction_or_stroke"</p></blockquote><p><b>synthesisType</b>: not applicable <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-synthesis-type.html">StatisticSynthesisType</a>#NotApplicable)</span></p><p><b>studyDesign</b>: Observational research <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-study-design.html">Study Design</a>#SEVCO:01002)</span>, Parallel cohort design <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-study-design.html">Study Design</a>#SEVCO:01011)</span>, Matching for comparison <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-study-design.html">Study Design</a>#SEVCO:01014)</span>, Longitudinal data collection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-study-design.html">Study Design</a>#SEVCO:01028)</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: Hazard ratio, adjusted 0.67; 95% CI 0.54 to 0.83</p><p><b>note</b>: The event rates are calculated from the reported total (fatal and nonfatal events) minus the fatal events. Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group and 171 out of 2010 patients in the surgery group, and the adjusted HR for total events is assumed to apply (adjusted HR 0.67, 95% CI 0.54 to 0.83)</p><p><b>statisticType</b>: Hazard Ratio <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-statistic-type.html">StatisticStatisticType</a>#C93150)</span></p><p><b>quantity</b>: 0.67</p><p><b>numberAffected</b>: 359</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>4047</td><td>4047</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 0.54 to 0.83</td><td>Confidence interval <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C53324)</span></td><td>0.95</td><td>0.54-0.83</td></tr></table><h3>ModelCharacteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Adjusted analysis <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>#TBD:0000120 "Adjustment for covariates")</span></td></tr></table></blockquote><h3>Certainties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Rating</b></td></tr><tr><td style="display: none">*</td><td>Overall certainty <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#Overall)</span></td><td>Low quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-certainty-rating.html">StatisticCertaintyRating</a>#low)</span></td></tr></table></div>
</text>
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<identifier>
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<display value="Accession ID"/>
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<text value="FEvIR Object Identifier"/>
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<system value="https://fevir.net"/>
<value value="104098"/>
<assigner>
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<version value="1.0.0-ballot"/>
<name
value="ComparativeEvidence_Bypass_surgery_effects_on_Myocardial_infarction_or_stroke_in_Swedish_Obese_Subjects_SOS_study"/>
<title
value="ComparativeEvidence: Bypass surgery effects on Myocardial infarction or stroke in Swedish Obese Subjects (SOS) study"/>
<status value="active"/>
<date value="2022-09-19T21:15:57.338Z"/>
<publisher value="HL7 International / Clinical Decision Support"/>
<contact>
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<telecom>
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<value value="http://www.hl7.org/Special/committees/dss"/>
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<author>
<name value="Brian S. Alper"/>
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<copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
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<url value="https://jamanetwork.com/journals/jama/fullarticle/1103994"/>
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<type value="cite-as"/>
<citation
value="ComparativeEvidence: Bypass surgery effects on Myocardial infarction or stroke in Swedish Obese Subjects (SOS) study [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 104098. Revised 2022-09-19. Available at: https://fevir.net/resources/Evidence/104098. Computable resource at: https://fevir.net/resources/Evidence/104098."/>
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<description
value="Bariatric surgery was associated with a reduced number of cardiovascular deaths (28 events among 2010 patients in the surgery group vs 49 events among 2037 patients in the control group; adjusted hazard ratio [HR], 0.47; 95% CI, 0.29-0.76; P = .002). The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (199 events among 2010 patients) than in the control group (234 events among 2037 patients; adjusted HR, 0.67; 95% CI, 0.54-0.83; P < .001). -- Extrapolated from this data the outcome of Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group and 171 out of 2010 patients in the surgery group, and the adjusted HR for total events is assumed to apply (adjusted HR 0.67, 95% CI 0.54 to 0.83)"/>
<assertion
value="Compared with usual care, bariatric surgery was associated with reduced number of cardiovascular deaths and lower incidence of cardiovascular events in obese adults."/>
<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="population"/>
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<description
value="Inclusion criteria were age 37 to 60 years and a body mass index of at least 34 in men and at least 38 in women. All in Sweden."/>
<note>
<text value="population"/>
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<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="population"/>
<display value="population"/>
</coding>
<text value="Use extension:variableRoleCode instead."/>
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<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="exposure"/>
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<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category">
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<description
value="bariatric surgery vs. usual care without bariatric surgery"/>
<note>
<text value="exposure"/>
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<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="exposure"/>
<display value="exposure"/>
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<text value="Use extension:variableRoleCode instead."/>
</variableRole>
<intended>🔗
<reference value="EvidenceVariable/172427"/>
<type value="EvidenceVariable"/>
<display
value="GroupAssignment: Bariatric Surgery vs. no bariatric surgery"/>
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</variableDefinition>
<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="outcome"/>
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<description value="nonfatal myocardial infarction or stroke"/>
<note>
<text value="outcome"/>
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<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/104097"/>
<type value="EvidenceVariable"/>
<display
value="OutcomeVariable: Nonfatal myocardial infarction or stroke"/>
</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="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01002"/>
<display value="Observational research"/>
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</studyDesign>
<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01011"/>
<display value="Parallel cohort design"/>
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</studyDesign>
<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01014"/>
<display value="Matching for comparison"/>
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<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01028"/>
<display value="Longitudinal data collection"/>
</coding>
</studyDesign>
<statistic>
<description value="Hazard ratio, adjusted 0.67; 95% CI 0.54 to 0.83"/>
<note>
<text
value="The event rates are calculated from the reported total (fatal and nonfatal events) minus the fatal events. Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group and 171 out of 2010 patients in the surgery group, and the adjusted HR for total events is assumed to apply (adjusted HR 0.67, 95% CI 0.54 to 0.83)"/>
</note>
<statisticType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/statistic-type"/>
<code value="C93150"/>
<display value="Hazard Ratio"/>
</coding>
</statisticType>
<quantity>
<value value="0.67"/>
</quantity>
<numberAffected value="359"/>
<sampleSize>
<numberOfParticipants value="4047"/>
<knownDataCount value="4047"/>
</sampleSize>
<attributeEstimate>
<description value="95% CI 0.54 to 0.83"/>
<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="0.54"/>
</low>
<high>
<value value="0.83"/>
</high>
</range>
</attributeEstimate>
<modelCharacteristic>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="TBD:0000120"/>
<display value="Adjustment for covariates"/>
</coding>
<text value="Adjusted analysis"/>
</code>
</modelCharacteristic>
</statistic>
<certainty>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="Overall"/>
<display value="Overall certainty"/>
</coding>
</type>
<rating>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/certainty-rating"/>
<code value="low"/>
<display value="Low quality"/>
</coding>
</rating>
</certainty>
</Evidence>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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