{
  "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",
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  "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": [ {
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          "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
          "display": "Confidence interval"
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      "level": 0.95,
      "range": {
        "low": {
          "value": 0.04
        },
        "high": {
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  "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": "Computable Publishing LLC",
  "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": [ {
    "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"
    },
    "description": "Bariatric Surgery Trial Enrollment Group",
    "variableRole": "population"
  }, {
    "observed": {
      "type": "EvidenceVariable",
      "display": "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone",
      "reference": "EvidenceVariable/172481"
    },
    "description": "Group assignment",
    "variableRole": "exposure",
    "comparatorCategory": "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years"
  }, {
    "observed": {
      "type": "EvidenceVariable",
      "display": "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years",
      "reference": "EvidenceVariable/32143"
    },
    "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": "outcome"
  } ],
  "title": "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)",
  "package_version": "1.0.0-ballot2",
  "author": [ {
    "name": "Brian S. Alper"
  } ],
  "synthesisType": {
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      "system": "http://terminology.hl7.org/CodeSystem/synthesis-type",
      "display": "not applicable"
    } ]
  },
  "extension": [ {
    "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to",
    "extension": [ {
      "url": "type",
      "valueCode": "derived-from"
    }, {
      "url": "targetUri",
      "valueUri": "https://fevir.net/resources/Citation/32147"
    }, {
      "url": "targetMarkdown",
      "valueMarkdown": "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/."
    } ]
  }, {
    "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to",
    "extension": [ {
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      "valueCode": "cite-as"
    }, {
      "url": "targetMarkdown",
      "valueMarkdown": "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."
    } ]
  } ],
  "status": "active",
  "id": "d1f707a0-5e19-4551-a2d9-5eb4038908b7",
  "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"
    }
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  "version": null,
  "studyDesign": [ {
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      "code": "SEVCO:01003",
      "system": "https://fevir.net/sevco",
      "display": "randomized assignment"
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  "contact": [ {
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      "value": "support@computablepublishing.com",
      "system": "email"
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  } ],
  "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."
}