{
"description": null,
"_filename": "example/Composition-178426.json",
"package_name": "hl7.fhir.uv.ebm",
"date": "2025-03-25T22:17:24.583Z",
"meta": {
"profile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence-report" ],
"versionId": "101",
"lastUpdated": "2025-03-25T22:17:24.583Z"
},
"publisher": null,
"name": null,
"section": [ {
"code": {
"coding": [ {
"code": "introduction",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Introduction"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Introduction",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"text": "Population",
"coding": [ {
"code": "population",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Population"
} ]
},
"text": {
"div": "StudyGroup: Severely Obese Adults 2018 Norwegian Cohort 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 (nā=ā2109) with severe obesity assessed (221 patients excluded and 1888 patients included). (1888 participants)",
"status": "generated"
},
"entry": [ {
"type": "Group",
"display": "StudyGroup: Severely Obese Adults 2018 Norwegian Cohort",
"reference": "Group/178427"
} ],
"title": "Population",
"section": [ {
"code": {
"coding": [ {
"code": "screened-group",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Screened Group"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"title": "Screened Group"
}, {
"code": {
"coding": [ {
"code": "enrolled-group",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Enrolled Group"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"title": "Enrolled Group (Study Population)"
}, {
"code": {
"coding": [ {
"code": "analyzed-group",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Analyzed Group"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"title": "Analyzed Group (Study Population)"
}, {
"code": {
"coding": [ {
"code": "population-description",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Population Description"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"title": "Population Definition (Eligibility Criteria)"
} ]
}, {
"code": {
"text": "Intervention",
"coding": [ {
"code": "intervention",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Intervention"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Intervention",
"section": [ {
"code": {
"text": "Intervention Description",
"coding": [ {
"code": "intervention-description",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Intervention Description"
} ]
},
"text": {
"div": "Bariatric surgery, mostly gastric bypass (92%) or sleeve gastrectomy (7%)",
"status": "additional"
},
"entry": [ {
"type": "Group",
"display": "ExposureDefinition: Bariatric Surgery (RYGB, VSG, LAGB, BPD)",
"reference": "Group/172423"
} ],
"title": "Intervention Description"
}, {
"code": {
"text": "Intervention Group",
"coding": [ {
"code": "intervention-group",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Intervention Group"
} ]
},
"text": {
"div": "932 patients opted for bariatric surgery",
"status": "additional"
},
"entry": [ {
"type": "Group",
"display": "InterventionGroup: JAMA 2018 Norwegian cohort study Surgery cohort",
"reference": "Group/172934"
} ],
"title": "Intervention Group"
} ]
}, {
"code": {
"text": "Comparator",
"coding": [ {
"code": "comparator",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Comparator"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Comparator Section",
"section": [ {
"code": {
"text": "Comparator Description",
"coding": [ {
"code": "comparator-description",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Comparator Description"
} ]
},
"text": {
"div": "medical treatment without surgery",
"status": "additional"
},
"entry": [ {
"type": "Group",
"display": "ComparatorDefinition: NOT Bariatric Surgery (RYGB, VSG, LAGB, BPD)",
"reference": "Group/172424"
} ],
"title": "Comparator Description"
}, {
"code": {
"text": "Comparator Group",
"coding": [ {
"code": "comparator-group",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Comparator Group"
} ]
},
"text": {
"div": "956 opted for medical management without surgery",
"status": "additional"
},
"entry": [ {
"type": "Group",
"display": "ComparatorGroup: JAMA 2018 Norwegian cohort study Control cohort",
"reference": "Group/172939"
} ],
"title": "Comparator Group"
}, {
"code": {
"coding": [ {
"code": "GroupAssignment",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "GroupAssignment"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"entry": [ {
"type": "EvidenceVariable",
"display": "GroupAssignment: ExposureDefinition: Bariatric Surgery (RYGB, VSG, LAGB, BPD) vs. ComparatorDefinition: NOT Bariatric Surgery (RYGB, VSG, LAGB, BPD)",
"reference": "EvidenceVariable/312202"
} ],
"title": "Group Assignment (EvidenceVariable) Section"
} ]
}, {
"code": {
"coding": [ {
"code": "research-study",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Research Study"
} ]
},
"text": {
"div": "Title: Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities
Description: 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\nrelated comorbidities by studying changes in medicine usage after treatment.\n\nHypotheses\n1. 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 ā¤ 10 years.\n2. 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.
Study Design: 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)
",
"status": "generated"
},
"entry": [ {
"type": "ResearchStudy",
"display": "Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities",
"reference": "ResearchStudy/208285"
} ],
"title": "Research Study"
}, {
"code": {
"coding": [ {
"code": "methods",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Methods"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Methods Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"text": "Baseline Measures",
"coding": [ {
"code": "baseline-measures",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Baseline Measures"
} ]
},
"text": {
"div": "As compared with medical patients, surgically treated patients were significantly younger with a higher BMI. Mean age 41.2 in Surgical Group vs. 45.7 in Medical Group (p < 0.001). Mean BMI 45.4 in Surgical Group vs. 42.9 in Medical Group (p < 0.001).",
"status": "additional"
},
"entry": [ {
"type": "Composition",
"display": "Baseline Measure Report: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"reference": "Composition/312203"
}, {
"type": "List",
"display": "BaselineVariablesList: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"reference": "List/312201"
} ],
"title": "Baseline Measures"
}, {
"code": {
"text": "Participant Flow",
"coding": [ {
"code": "participant-flow",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Participant Flow"
} ]
},
"text": {
"div": "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)",
"status": "additional"
},
"title": "Participant Flow"
}, {
"code": {
"text": "Outcomes",
"coding": [ {
"code": "outcome-measures",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Outcome Measures"
} ]
},
"text": {
"div": "Risk of Remission of diabetes in control group was 14.8%. Risk of Remission of diabetes in intervention group was 57.5%. 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]
Compared with specialized medical treatment, bariatric surgery appears to induce remission of diabetes.
Risk of New onset depression in control group was 6.5%. Risk of New onset depression in intervention group was 8.9%. 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].
Compared with specialized medical treatment, bariatric surgery may slightly increase the incidence of depression.
Risk of Treatment with opioids in control group was 15.8%. Risk of Treatment with opioids in intervention group was 19.4%. 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].
Compared with specialized medical treatment, bariatric surgery may slightly increase the use of opioids.
Risk of additional GI surgical procedure in control group was 15.5%. Risk of additional GI surgical procedure in intervention group was 31.3%. 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]).
Compared with specialized medical treatment, bariatric surgery appears to increase the rate of additional gastrointestinal surgical procedures.",
"status": "additional"
},
"entry": [ {
"type": "Composition",
"display": "Outcome Measure Report: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"reference": "Composition/318262"
}, {
"type": "List",
"display": "OutcomeVariablesList: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"reference": "List/312205"
} ],
"title": "Outcomes"
}, {
"code": {
"coding": [ {
"code": "summary-of-findings",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Summary of Findings"
} ]
},
"text": {
"div": "[No data.]
",
"status": "empty"
},
"title": "Summary of Findings",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"coding": [ {
"code": "discussion",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Discussion"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Discussion Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"coding": [ {
"code": "references",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "References"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "References Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"coding": [ {
"code": "competing-interests",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Competing Interests"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Competing Interests Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"coding": [ {
"code": "acknowledgements",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Acknowledgements"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Acknowledgements Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
}, {
"code": {
"coding": [ {
"code": "appendices",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "Appendices"
} ]
},
"text": {
"div": "[No data.]",
"status": "empty"
},
"title": "Appendices Section",
"emptyReason": {
"coding": [ {
"code": "notstarted",
"system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"display": "Not Started"
} ]
}
} ],
"type": "{:coding [{:system \\\"https://fevir.net/resources/CodeSystem/179423\\\", :code \\\"ComparativeEvidenceReport\\\", :display \\\"ComparativeEvidenceReport\\\"}], :text \\\"Comparative Evidence Report\\\"}",
"experimental": null,
"resourceType": "Composition",
"title": "ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"package_version": "1.0.0-ballot2",
"author": [ {
"type": "Practitioner",
"display": "Brian S. Alper"
}, {
"type": "Practitioner",
"display": "Khalid Shahin"
}, {
"type": "Practitioner",
"display": "Joanne Dehnbostel"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
"valueMarkdown": "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."
} ],
"custodian": {
"type": "Organization",
"display": "Computable Publishing LLC",
"reference": "Organization/118079"
},
"status": "final",
"id": "0fabfbab-9510-4d50-a584-0944e4deae85",
"kind": null,
"url": "https://fevir.net/resources/Composition/178426",
"identifier": [ {
"type": {
"text": "FEvIR Object Identifier",
"coding": [ {
"code": "ACSN",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"display": "Accession ID"
} ]
},
"value": "https://fevir.net/FOI/178426",
"system": "urn:ietf:rfc:3986",
"assigner": {
"display": "Computable Publishing LLC"
}
} ],
"relatesTo": [ {
"type": "cite-as",
"extension": [ {
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/target-markdown",
"valueMarkdown": "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 2025-03-01. Available at: https://fevir.net/resources/Composition/178426. Computable resource at: https://fevir.net/FLI/DocumentForComposition178426."
} ]
}, {
"type": "derived-from",
"extension": [ {
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/target-reference",
"valueReference": {
"type": "Citation",
"display": "JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort",
"reference": "Citation/104116"
}
} ]
} ],
"version": null,
"subject": [ {
"type": "Group",
"display": "ComparativeEvidenceReportSubject: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
"reference": "Group/179633"
} ]
}