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
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Composition</b><a name="178426"> </a><a name="hc178426"> </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">ResourceComposition "178426" Version "72" Updated "2024-04-27 17:32:10+0000" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-comparative-evidence-report.html">ComparativeEvidenceReport</a></p></div><p><b>Artifact Description</b>: This example of a ComparativeEvidenceReport Profile shows a report from a single observational study with 2 baseline measures, 2 participant flow measures, and 4 outcome measures.</p><p><b>url</b>: <a href="https://fevir.net/resources/Composition/178426">https://fevir.net/resources/Composition/178426</a></p><p><b>identifier</b>: FEvIR Object Identifier/178426</p><p><b>status</b>: final</p><p><b>type</b>: EvidenceReport <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>#EvidenceReport)</span></p><p><b>category</b>: Comparative Evidence Report <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>#ComparativeEvidenceReport "ComparativeEvidenceReport")</span></p><p><b>date</b>: 2024-04-27 17:32:10+0000</p><p><b>author</b>: </p><ul><li><span>: Brian S. Alper</span></li><li><span>: Khalid Shahin</span></li><li><span>: Joanne Dehnbostel</span></li></ul><p><b>title</b>: ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)</p><p><b>custodian</b>: <a href="Organization-118079.html">Organization/118079: Computable Publishing LLC</a> "Computable_Publishing_LLC"</p><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td><td><b>Citation</b></td><td><b>ResourceReference</b></td></tr><tr><td style="display: none">*</td><td>cite-as</td><td> </td><td>ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort) [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, Khalid Shahin, Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 178426. Revised 2024-04-27. Available at: https://fevir.net/resources/Composition/178426. Computable resource at: https://fevir.net/resources/Composition/178426.</td><td> </td></tr><tr><td style="display: none">*</td><td>derived-from</td><td> </td><td> </td><td><a href="Citation-104116.html">Citation/104116: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort</a></td></tr><tr><td style="display: none">*</td><td>composed-of</td><td>GroupAssignment <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>#GroupAssignment)</span></td><td> </td><td><a href="EvidenceVariable-183637.html">EvidenceVariable/183637: GroupAssignment: ExposureDefinition: Bariatric Surgery (RYGB, VSG, LAGB, BPD) vs. ComparatorDefinition: NOT Bariatric Surgery (RYGB, VSG, LAGB, BPD)</a> "GroupAssignment_ExposureDefinition_Bariatric_Surgery_RYGB_VSG_LAGB_BPD_vs_ComparatorDefinition_NOT_Bariatric_Surgery_RYGB_VSG_LAGB_BPD"</td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>StudyGroup: Severely Obese Adults 2018 Norwegian Cohort</b> Cohort study with baseline data of exposures from November 2005 through July 2010 and follow-up data from 2006 until death or through December 2015 at a tertiary care outpatient center, Vestfold Hospital Trust, Norway. Consecutive treatment-seeking adult patients (n = 2109) with severe obesity assessed (221 patients excluded and 1888 patients included). (1888 participants)</div>
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<div xmlns="http://www.w3.org/1999/xhtml">Bariatric surgery, mostly gastric bypass (92%) or sleeve gastrectomy (7%)</div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Title:</b> Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities</p><br/><p><b>Description:</b> The main purpose of this study is, in combination with data from the Register and Biobank study and follow-up data from the Norwegian Prescription Database, to compare the long-term effects (4-10 years) of surgical and non-surgical treatment of morbid obesity on obesity
related comorbidities by studying changes in medicine usage after treatment.
Hypotheses
1. Primary hypothesis: As compared to non-surgical treatment, bariatric surgery will be associated with higher rates of remission, and lower rates of new-onset drug treated hypertension during a follow-up period of ≤ 10 years.
2. Secondary hypotheses: Changes in the usage of other drugs, particularly drugs related to obesity related comorbidities, will differ significantly between patients undergoing bariatric surgery or non-surgical treatment during the follow-up period. </p><br/><p><b>Study Design:</b> Observational research (coded as: SEVCO:01002 from https://fevir.net/sevco); Parallel cohort design (coded as: SEVCO:01011 from https://fevir.net/sevco); Longitudinal data collection (coded as: SEVCO:01028 from https://fevir.net/sevco)</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml">As compared with medical patients, surgically treated patients were significantly younger with a higher BMI.</div>
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<div xmlns="http://www.w3.org/1999/xhtml">Mean age 41.2 in Surgical Group vs. 45.7 in Medical Group (p < 0.001)</div>
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<div xmlns="http://www.w3.org/1999/xhtml">Age in Medical Group (n = 956) mean 45.7 years, SD 13.5 years</div>
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<reference value="Evidence/179451"/>
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<div xmlns="http://www.w3.org/1999/xhtml">Age in Surgical Group (n = 932) mean 41.2 years, SD 10.5 years</div>
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<entry>🔗
<reference value="Evidence/179452"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[No data.]</div>
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<entry>🔗
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<display
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<title value="BMI"/>
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<div xmlns="http://www.w3.org/1999/xhtml">Mean BMI 45.4 in Surgical Group vs. 42.9 in Medical Group (p < 0.001)</div>
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<div xmlns="http://www.w3.org/1999/xhtml">BMI in Medical Group (n = 956) mean 42.9 kg/m2, SD 5.7 kg/m2</div>
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<reference value="Evidence/179458"/>
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<div xmlns="http://www.w3.org/1999/xhtml">BMI in Surgical Group (n = 932) mean 45.4 kg/m2, SD 6.2 kg/m2</div>
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<entry>🔗
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<div xmlns="http://www.w3.org/1999/xhtml">2109 patients included in baseline registry, 221 patients excluded, 1888 patients included in analysis (932 had opted for bariatric surgery, 956 had opted for medical treatment)</div>
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<display
value="ParticipantFlow: 2018 Norwegian Cohort Surgical Group Included in Analysis"/>
</entry>
</section>
<section>
<title value="Participant flow with total group"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-total-group"/>
<display value="Evidence with total group"/>
</coding>
<text value="Participant flow with total group"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">1888 patients included in analysis</div>
</text>
<entry>🔗
<reference value="Evidence/179462"/>
<type value="Evidence"/>
<display
value="ParticipantFlow: 2018 Norwegian Cohort Included in Analysis"/>
</entry>
</section>
<section>
<title value="Participant flow with intervention vs. comparator"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-vs-comparator"/>
<display value="Evidence with intervention vs. comparator"/>
</coding>
<text value="Participant flow with intervention vs. comparator"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[No data.]</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="notasked"/>
<display value="Not Asked"/>
</coding>
</emptyReason>
</section>
</section>
</section>
<section>
<title value="Outcomes"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="outcome-measures"/>
<display value="Outcome Measures"/>
</coding>
<text value="Outcomes"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[No data.]</div>
</text>
<section>
<title value="Remission of diabetes"/>
<focus>🔗
<reference value="EvidenceVariable/104117"/>
<type value="EvidenceVariable"/>
<display value="Remission of diabetes"/>
</focus>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">This example expresses the variable 'Remission of diabetes' as a dichotomous variable with a definition using both definition.concept (for a SNOMED CT term) and definition.reference which references an OutcomeDefinition Profile of Group Resource. (dichotomous variable)</div>
</text>
<section>
<title value="Outcome with comparator alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-comparator-alone"/>
<display value="Evidence with comparator alone"/>
</coding>
<text value="Outcome with comparator alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of Remission of diabetes in control group was 14.8%.</div>
</text>
<entry>🔗
<reference value="Evidence/104396"/>
<type value="Evidence"/>
<display
value="ComparatorOnlyEvidence: Remission of diabetes without bariatric surgery (Control Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-alone"/>
<display value="Evidence with intervention alone"/>
</coding>
<text value="Outcome with intervention alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of Remission of diabetes in intervention group was 57.5%.</div>
</text>
<entry>🔗
<reference value="Evidence/104401"/>
<type value="Evidence"/>
<display
value="InterventionOnlyEvidence: Remission of diabetes with bariatric surgery (Intervention Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention vs. comparator"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-vs-comparator"/>
<display value="Evidence with intervention vs. comparator"/>
</coding>
<text value="Outcome with intervention vs. comparator"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">greater likelihood of diabetes remission: AR, 57.5% vs 14.8%; RD, 42.7% [95% CI, 35.8%-49.7%], RR, 3.9 [95% CI, 2.8-5.4]
<br/>
Compared with specialized medical treatment, bariatric surgery appears to induce remission of diabetes.</div>
</text>
<entry>🔗
<reference value="Evidence/104121"/>
<type value="Evidence"/>
<display
value="ComparativeEvidence: Bypass surgery effects on Remission of diabetes in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
</section>
<section>
<title value="New onset depression"/>
<focus>🔗
<reference value="EvidenceVariable/104118"/>
<type value="EvidenceVariable"/>
<display value="New onset depression"/>
</focus>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">This example expresses the variable 'New onset depression' as a dichotomous variable with a definition using definition.reference which references an OutcomeDefinition Profile of Group Resource. (dichotomous variable)</div>
</text>
<section>
<title value="Outcome with comparator alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-comparator-alone"/>
<display value="Evidence with comparator alone"/>
</coding>
<text value="Outcome with comparator alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of New onset depression in control group was 6.5%.</div>
</text>
<entry>🔗
<reference value="Evidence/104395"/>
<type value="Evidence"/>
<display
value="ComparatorOnlyEvidence: New onset depression without bariatric surgery (Control Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-alone"/>
<display value="Evidence with intervention alone"/>
</coding>
<text value="Outcome with intervention alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of New onset depression in intervention group was 8.9%.</div>
</text>
<entry>🔗
<reference value="Evidence/104400"/>
<type value="Evidence"/>
<display
value="InterventionOnlyEvidence: New onset depression with bariatric surgery (Intervention Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention vs. comparator"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-vs-comparator"/>
<display value="Evidence with intervention vs. comparator"/>
</coding>
<text value="Outcome with intervention vs. comparator"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">greater risk of new-onset depression: AR, 8.9% vs 6.5%; RD, 2.4% [95% CI, 1.3%-3.5%], RR, 1.5 [95% CI, 1.4-1.7]
<br/>
Compared with specialized medical treatment, bariatric surgery may slightly increase the incidence of depression.</div>
</text>
<entry>🔗
<reference value="Evidence/104155"/>
<type value="Evidence"/>
<display
value="ComparativeEvidence: Bypass surgery effects on New onset depression in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
</section>
<section>
<title value="Treatment with opioids"/>
<focus>🔗
<reference value="EvidenceVariable/104119"/>
<type value="EvidenceVariable"/>
<display value="Treatment with opioids"/>
</focus>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">This example expresses the variable 'Treatment with opioids' as a dichotomous variable with a simple definition using definition.concept.text (dichotomous variable)</div>
</text>
<section>
<title value="Outcome with comparator alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-comparator-alone"/>
<display value="Evidence with comparator alone"/>
</coding>
<text value="Outcome with comparator alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of Treatment with opioids in control group was 15.8%.</div>
</text>
<entry>🔗
<reference value="Evidence/104394"/>
<type value="Evidence"/>
<display
value="ComparatorOnlyEvidence: Treatment with opioids without bariatric surgery (Control Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-alone"/>
<display value="Evidence with intervention alone"/>
</coding>
<text value="Outcome with intervention alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of Treatment with opioids in intervention group was 19.4%.</div>
</text>
<entry>🔗
<reference value="Evidence/104402"/>
<type value="Evidence"/>
<display
value="InterventionOnlyEvidence: Treatment with opioids with bariatric surgery (Intervention Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention vs. comparator"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-vs-comparator"/>
<display value="Evidence with intervention vs. comparator"/>
</coding>
<text value="Outcome with intervention vs. comparator"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">greater risk of treatment with opioids: AR, 19.4% vs 15.8%, RD, 3.6% [95% CI, 2.3%-4.9%], RR, 1.3 [95% CI, 1.2-1.4]
<br/>
Compared with specialized medical treatment, bariatric surgery may slightly increase the use of opioids.</div>
</text>
<entry>🔗
<reference value="Evidence/104156"/>
<type value="Evidence"/>
<display
value="ComparativeEvidence: Bypass surgery effects on Treatment with opioids in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
</section>
<section>
<title value="Additional GI surgical procedure"/>
<focus>🔗
<reference value="EvidenceVariable/104120"/>
<type value="EvidenceVariable"/>
<display value="Additional GI surgical procedure"/>
</focus>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">This example expresses the variable 'Additional GI surgical procedure' as a dichotomous variable with a simple definition using definition.concept.text (dichotomous variable)</div>
</text>
<section>
<title value="Outcome with comparator alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-comparator-alone"/>
<display value="Evidence with comparator alone"/>
</coding>
<text value="Outcome with comparator alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of additional GI surgical procedure in control group was 15.5%.</div>
</text>
<entry>🔗
<reference value="Evidence/104385"/>
<type value="Evidence"/>
<display
value="ComparatorOnlyEvidence: Additional GI surgical procedure without bariatric surgery (Control Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention alone"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-alone"/>
<display value="Evidence with intervention alone"/>
</coding>
<text value="Outcome with intervention alone"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Risk of additional GI surgical procedure in intervention group was 31.3%. 292 out of 932 observed with percentage of: 31.3%</div>
</text>
<entry>🔗
<reference value="Evidence/104398"/>
<type value="Evidence"/>
<display
value="InterventionOnlyEvidence: Additional GI surgical procedure with bariatric surgery (Intervention Group) in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
<section>
<title value="Outcome with intervention vs. comparator"/>
<code>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="evidence-with-intervention-vs-comparator"/>
<display value="Evidence with intervention vs. comparator"/>
</coding>
<text value="Outcome with intervention vs. comparator"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">Surgical patients had a greater risk for undergoing at least 1 additional gastrointestinal surgical procedure (AR, 31.3% vs 15.5%; RD, 15.8% [95% CI, 13.1%-18.5%]; RR, 2.0 [95% CI, 1.7-2.4]).
<br/>
Compared with specialized medical treatment, bariatric surgery appears to increase the rate of additional gastrointestinal surgical procedures.</div>
</text>
<entry>🔗
<reference value="Evidence/104157"/>
<type value="Evidence"/>
<display
value="ComparativeEvidence: Bypass surgery effects on Additional GI surgical procedure in JAMA 2018 Norwegian cohort study"/>
</entry>
</section>
</section>
</section>
</Composition>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-05-16
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