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 2022-05-28 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Evidence ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "32144"] ; # fhir:meta [ fhir:versionId [ fhir:v "20" ] ; fhir:lastUpdated [ fhir:v "2023-12-06T17:46:14.323Z"^^xsd:dateTime ] ; ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence> ] [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"32144\"> </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 "32144" Version "20" 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>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Evidence/32144</code></p><p><b>identifier</b>: FEvIR Object Identifier: 32144</p><p><b>version</b>: 1.0.0-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>: Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</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>: Diabetes Surgery Study</p><p><b>citation</b>: 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><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: 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></blockquote><p><b>description</b>: 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><p><b>assertion</b>: 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><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Bariatric Surgery Trial Enrollment Group</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><p><b>observed</b>: <a href=\"Group-32145.html\">Group/32145: 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> "StudyGroup_Bariatric_Surgery_Trial_Enrollment_Group"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years</p><p><b>description</b>: Group assignment</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>observed</b>: <a href=\"EvidenceVariable-172481.html\">EvidenceVariable/172481: GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone</a> "GroupAssignment_Roux_en_Y_gastric_bypass_surgery_vs_Lifestyle_intensive_medical_management_intervention_alone"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: American Diabetes Association composite triple end point for metabolic control at 5 years *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 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><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-32143.html\">EvidenceVariable/32143: OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years</a> "OutcomeVariable_American_Diabetes_Association_composite_triple_end_point_for_metabolic_control_at_5_years"</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>: 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>: 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><p><b>statisticType</b>: Risk Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (StatisticStatisticType[4.4.0]#0000424)</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>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>0.04-0.34</td></tr></table></blockquote></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "cds" ] ] ) ; # fhir:url [ fhir:v "https://fevir.net/resources/Evidence/32144"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net"^^xsd:anyURI ] ; fhir:value [ fhir:v "32144" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] ) ; # fhir:version [ fhir:v "1.0.0-ballot"] ; # fhir:name [ fhir:v "ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study"] ; # fhir:title [ fhir:v "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)"] ; # fhir:status [ fhir:v "active"] ; # fhir:date [ fhir:v "2022-05-28T11:56:53.907Z"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ] ] ) ] ) ; # fhir:author ( [ fhir:name [ fhir:v "Brian S. Alper" ] ] ) ; # fhir:copyright [ fhir:v "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International"] ; # fhir:relatedArtifact ( [ fhir:type [ fhir:v "derived-from" ] ; fhir:label [ fhir:v "data source" ] ; fhir:display [ fhir:v "Diabetes Surgery Study" ] ; fhir:citation [ fhir:v "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/." ] ; fhir:document [ fhir:url [ fhir:v "https://fevir.net/resources/Citation/32147"^^xsd:anyURI ] ] ] [ fhir:type [ fhir:v "cite-as" ] ; fhir:citation [ fhir:v "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." ] ] ) ; # fhir:description [ fhir:v "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)."] ; # fhir:assertion [ fhir:v "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."] ; # fhir:variableDefinition ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ; fhir:value [ fhir:v "population" ] ] ) ; fhir:description [ fhir:v "Bariatric Surgery Trial Enrollment Group" ] ; ( fhir:note [ fhir:text [ fhir:v "population" ] ] ) ; fhir:variableRole [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "population" ] ; fhir:display [ fhir:v "population" ] ] ) ; fhir:text [ fhir:v "Use extension:variableRoleCode instead." ] ] ; fhir:observed [ fhir:reference [ fhir:v "Group/32145" ] ; fhir:type [ fhir:v "Group"^^xsd:anyURI ] ; fhir:display [ fhir:v "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)" ] ] ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ; fhir:value [ fhir:v "exposure" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category"^^xsd:anyURI ] ; fhir:value [ fhir:v "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years" ] ] ) ; fhir:description [ fhir:v "Group assignment" ] ; ( fhir:note [ fhir:text [ fhir:v "exposure" ] ] ) ; fhir:variableRole [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "exposure" ] ; fhir:display [ fhir:v "exposure" ] ] ) ; fhir:text [ fhir:v "Use extension:variableRoleCode instead." ] ] ; fhir:observed [ fhir:reference [ fhir:v "EvidenceVariable/172481" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone" ] ] ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code"^^xsd:anyURI ] ; fhir:value [ fhir:v "outcome" ] ] ) ; fhir:description [ fhir:v "American Diabetes Association composite triple end point for metabolic control at 5 years *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 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" ] ; ( fhir:note [ fhir:text [ fhir:v "outcome" ] ] ) ; fhir:variableRole [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/variable-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "measuredVariable" ] ; fhir:display [ fhir:v "measured variable" ] ] ) ; fhir:text [ fhir:v "Use extension:variableRoleCode instead." ] ] ; fhir:observed [ fhir:reference [ fhir:v "EvidenceVariable/32143" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years" ] ] ] ) ; # fhir:synthesisType [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/synthesis-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "NotApplicable" ] ; fhir:display [ fhir:v "not applicable" ] ] ) ] ; # fhir:studyDesign ( [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:01003" ] ; fhir:display [ fhir:v "randomized assignment" ] ] ) ] ) ; # fhir:statistic ( [ fhir:description [ fhir:v "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)." ] ; fhir:statisticType [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/statistic-type"^^xsd:anyURI ] ; fhir:version [ fhir:v "4.4.0" ] ; fhir:code [ fhir:v "0000424" ] ; fhir:display [ fhir:v "Risk Difference" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.19"^^xsd:decimal ] ] ; fhir:numberAffected [ fhir:v "15"^^xsd:nonNegativeInteger ] ; fhir:sampleSize [ fhir:numberOfStudies [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:numberOfParticipants [ fhir:v "120"^^xsd:nonNegativeInteger ] ; fhir:knownDataCount [ fhir:v "98"^^xsd:nonNegativeInteger ] ] ; ( fhir:attributeEstimate [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C53324" ] ; fhir:display [ fhir:v "Confidence interval" ] ] ) ] ; fhir:level [ fhir:v "0.95"^^xsd:decimal ] ; fhir:range [ fhir:low [ fhir:value [ fhir:v "0.04"^^xsd:decimal ] ] ; fhir:high [ fhir:value [ fhir:v "0.34"^^xsd:decimal ] ] ] ] ) ] ) . #
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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