{
"description": "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).",
"_filename": "example/Evidence-32144.json",
"package_name": "hl7.fhir.uv.ebm",
"statistic": [ {
"quantity": {
"value": 0.19
},
"sampleSize": {
"knownDataCount": 98,
"numberOfStudies": 1,
"numberOfParticipants": 120
},
"description": "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).",
"statisticType": {
"coding": [ {
"code": "0000424",
"system": "http://terminology.hl7.org/CodeSystem/statistic-type",
"display": "Risk Difference",
"version": "4.4.0",
"userSelected": true
} ]
},
"numberAffected": 15,
"attributeEstimate": [ {
"type": {
"coding": [ {
"code": "C53324",
"system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"display": "Confidence interval"
} ]
},
"level": 0.95,
"range": {
"low": {
"value": 0.04
},
"high": {
"value": 0.34
}
}
} ]
} ],
"date": "2022-05-28T11:56:53.907Z",
"meta": {
"profile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence", "http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence" ],
"versionId": "20",
"lastUpdated": "2023-12-06T17:46:14.323Z"
},
"publisher": "HL7 International / Clinical Decision Support",
"name": "ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study",
"copyright": "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International",
"type": null,
"experimental": null,
"resourceType": "Evidence",
"variableDefinition": [ {
"note": [ {
"text": "population"
} ],
"observed": {
"type": "Group",
"display": "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)",
"reference": "Group/32145"
},
"extension": [ {
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode": "population"
} ],
"description": "Bariatric Surgery Trial Enrollment Group",
"variableRole": {
"text": "Use extension:variableRoleCode instead.",
"coding": [ {
"code": "population",
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"display": "population"
} ]
}
}, {
"note": [ {
"text": "exposure"
} ],
"observed": {
"type": "EvidenceVariable",
"display": "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone",
"reference": "EvidenceVariable/172481"
},
"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": "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years"
} ],
"description": "Group assignment",
"variableRole": {
"text": "Use extension:variableRoleCode instead.",
"coding": [ {
"code": "exposure",
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"display": "exposure"
} ]
}
}, {
"note": [ {
"text": "outcome"
} ],
"observed": {
"type": "EvidenceVariable",
"display": "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years",
"reference": "EvidenceVariable/32143"
},
"extension": [ {
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode": "outcome"
} ],
"description": "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",
"variableRole": {
"text": "Use extension:variableRoleCode instead.",
"coding": [ {
"code": "measuredVariable",
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"display": "measured variable"
} ]
}
} ],
"title": "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)",
"package_version": "1.0.0-ballot",
"author": [ {
"name": "Brian S. Alper"
} ],
"synthesisType": {
"coding": [ {
"code": "NotApplicable",
"system": "http://terminology.hl7.org/CodeSystem/synthesis-type",
"display": "not applicable"
} ]
},
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "cds"
} ],
"status": "active",
"id": "a078cb8b-3124-4e60-81e3-d97c9e36bb78",
"kind": null,
"url": "https://fevir.net/resources/Evidence/32144",
"identifier": [ {
"type": {
"text": "FEvIR Object Identifier",
"coding": [ {
"code": "ACSN",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"display": "Accession ID"
} ]
},
"value": "32144",
"system": "https://fevir.net",
"assigner": {
"display": "Computable Publishing LLC"
}
} ],
"version": "1.0.0-ballot",
"relatedArtifact": [ {
"type": "derived-from",
"label": "data source",
"display": "Diabetes Surgery Study",
"citation": "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/.",
"document": {
"url": "https://fevir.net/resources/Citation/32147"
}
}, {
"type": "cite-as",
"citation": "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."
} ],
"studyDesign": [ {
"coding": [ {
"code": "SEVCO:01003",
"system": "https://fevir.net/resources/CodeSystem/181513",
"display": "randomized assignment"
} ]
} ],
"contact": [ {
"name": "HL7 International / Clinical Decision Support",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/dss",
"system": "url"
} ]
} ],
"assertion": "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."
}