Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
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
| Active as of 2022-09-19 |
{
"resourceType" : "Evidence",
"id" : "104098",
"meta" : {
"versionId" : "14",
"lastUpdated" : "2023-12-06T17:20:30.903Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"🔗 ,
"http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"104098\"> </a><a name=\"hc104098\"> </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 "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>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/5.5.0/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/5.5.0/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/5.5.0/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/5.5.0/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/5.5.0/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/5.5.0/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/5.5.0/CodeSystem-certainty-rating.html\">StatisticCertaintyRating</a>#low)</span></td></tr></table></div>"
},
"url" : "https://fevir.net/resources/Evidence/104098",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net",
"value" : "104098",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"version" : "1.0.0-ballot",
"name" : "ComparativeEvidence_Bypass_surgery_effects_on_Myocardial_infarction_or_stroke_in_Swedish_Obese_Subjects_SOS_study",
"title" : "ComparativeEvidence: Bypass surgery effects on Myocardial infarction or stroke in Swedish Obese Subjects (SOS) study",
"status" : "active",
"date" : "2022-09-19T21:15:57.338Z",
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
{
"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/dss"
}
]
}
],
"author" : [
{
"name" : "Brian S. Alper"
}
],
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"relatedArtifact" : [
{
"type" : "derived-from",
"document" : {
"url" : "https://jamanetwork.com/journals/jama/fullarticle/1103994"
}
},
{
"type" : "cite-as",
"citation" : "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."
}
],
"description" : "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" : "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" : "population"
}
],
"description" : "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" : "population"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "population",
"display" : "population"
}
],
"text" : "Use extension:variableRoleCode instead."
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "exposure"
},
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category",
"valueString" : "no bariatric surgery"
}
],
"description" : "bariatric surgery vs. usual care without bariatric surgery",
"note" : [
{
"text" : "exposure"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "exposure",
"display" : "exposure"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"intended" : {
🔗 "reference" : "EvidenceVariable/172427",
"type" : "EvidenceVariable",
"display" : "GroupAssignment: Bariatric Surgery vs. no bariatric surgery"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "outcome"
}
],
"description" : "nonfatal myocardial infarction or stroke",
"note" : [
{
"text" : "outcome"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "measuredVariable",
"display" : "measured variable"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/104097",
"type" : "EvidenceVariable",
"display" : "OutcomeVariable: Nonfatal myocardial infarction or stroke"
}
}
],
"synthesisType" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/synthesis-type",
"code" : "NotApplicable",
"display" : "not applicable"
}
]
},
"studyDesign" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/study-design",
"code" : "SEVCO:01002",
"display" : "Observational research"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/study-design",
"code" : "SEVCO:01011",
"display" : "Parallel cohort design"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/study-design",
"code" : "SEVCO:01014",
"display" : "Matching for comparison"
}
]
},
{
"coding" : [
{
"system" : "http://hl7.org/fhir/study-design",
"code" : "SEVCO:01028",
"display" : "Longitudinal data collection"
}
]
}
],
"statistic" : [
{
"description" : "Hazard ratio, adjusted 0.67; 95% CI 0.54 to 0.83",
"note" : [
{
"text" : "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)"
}
],
"statisticType" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
"code" : "C93150",
"display" : "Hazard Ratio"
}
]
},
"quantity" : {
"value" : 0.67
},
"numberAffected" : 359,
"sampleSize" : {
"numberOfParticipants" : 4047,
"knownDataCount" : 4047
},
"attributeEstimate" : [
{
"description" : "95% CI 0.54 to 0.83",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
}
]
},
"level" : 0.95,
"range" : {
"low" : {
"value" : 0.54
},
"high" : {
"value" : 0.83
}
}
}
],
"modelCharacteristic" : [
{
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "TBD:0000120",
"display" : "Adjustment for covariates"
}
],
"text" : "Adjusted analysis"
}
}
]
}
],
"certainty" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Overall",
"display" : "Overall certainty"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/certainty-rating",
"code" : "low",
"display" : "Low quality"
}
]
}
}
]
}
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-05-17
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