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Source1

{
  "resourceType": "Evidence",
  "id": "32144",
  "meta": {
    "versionId": "21",
    "lastUpdated": "2025-10-11T10:55:17.578Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence",
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/single-study-evidence"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code": "active",
            "display": "Active"
          }
        ]
      }
    }
  ],
  "url": "https://fevir.net/resources/Evidence/32144",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "32144",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study",
  "title": "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)",
  "citeAs": "ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Database Entry: FHIR Evidence Resource]. 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#json.",
  "status": "active",
  "date": "2022-05-28T11:56:53.907Z",
  "author": [
    {
      "name": "Brian S. Alper"
    }
  ],
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "copyright": "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International",
  "relatesTo": [
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier",
          "valueCodeableConcept": {
            "text": "data source"
          }
        }
      ],
      "type": "derived-from",
      "targetAttachment": {
        "url": "https://fevir.net/resources/Citation/32147",
        "title": "Diabetes Surgery Study 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/."
      }
    }
  ],
  "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).",
  "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.",
  "variableDefinition": [
    {
      "description": "Bariatric Surgery Trial Enrollment Group",
      "variableRole": "population",
      "observed": {
        "reference": "Group/32145",
        "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)"
      }
    },
    {
      "description": "Group assignment",
      "variableRole": "exposure",
      "comparatorCategory": "Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years",
      "observed": {
        "reference": "EvidenceVariable/172481",
        "type": "EvidenceVariable",
        "display": "GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone"
      }
    },
    {
      "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",
      "observed": {
        "reference": "EvidenceVariable/32143",
        "type": "EvidenceVariable",
        "display": "OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years"
      }
    }
  ],
  "synthesisType": [
    {
      "coding": [
        {
          "system": "http://terminology.hl7.org/CodeSystem/synthesis-type",
          "code": "NotApplicable",
          "display": "not applicable"
        }
      ]
    }
  ],
  "studyDesign": [
    {
      "coding": [
        {
          "system": "https://fevir.net/sevco",
          "code": "SEVCO:01003",
          "display": "randomized assignment"
        }
      ]
    }
  ],
  "statistic": [
    {
      "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": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000424",
            "display": "risk difference"
          }
        ]
      },
      "quantity": {
        "value": 0.19
      },
      "numberAffected": 15,
      "sampleSize": {
        "numberOfStudies": 1,
        "numberOfParticipants": 120,
        "knownDataCount": 98
      },
      "attributeEstimate": [
        {
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
                "code": "C53324",
                "display": "Confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": 0.04
            },
            "high": {
              "value": 0.34
            }
          }
        }
      ]
    }
  ]
}