Evidence Based Medicine on FHIR Implementation Guide
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This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

: ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort) - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "178426",
  "meta" : {
    "versionId" : "101",
    "lastUpdated" : "2025-03-25T22:17:24.583Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence-report"
    ]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 178426</b></p><a name=\"178426\"> </a><a name=\"hc178426\"> </a><a name=\"178426-en-US\"> </a><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\">version: 101; Last updated: 2025-03-25 22:17:24+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-comparative-evidence-report.html\">ComparativeEvidenceReport</a></p></div><p><b>Artifact Description</b>: </p><div><p>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>\n</div><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/https://fevir.net/FOI/178426</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 ComparativeEvidenceReport}\">Comparative Evidence Report</span></p><p><b>date</b>: 2025-03-25 22:17:24+0000</p><p><b>author</b>: </p><ul><li>Brian S. Alper</li><li>Khalid Shahin</li><li>Joanne Dehnbostel</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\">Computable Publishing LLC</a></p><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>Cite As</td></tr><tr><td style=\"display: none\">*</td><td/><td>Derived From</td></tr></table></div>"
  },
  "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."
    }
  ],
  "url" : "https://fevir.net/resources/Composition/178426",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
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        "text" : "FEvIR Object Identifier"
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      "system" : "urn:ietf:rfc:3986",
      "value" : "https://fevir.net/FOI/178426",
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  "status" : "final",
  "type" : {
    "coding" : [
      {
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        "code" : "ComparativeEvidenceReport",
        "display" : "ComparativeEvidenceReport"
      }
    ],
    "text" : "Comparative Evidence Report"
  },
  "subject" : [
    {
      🔗 "reference" : "Group/179633",
      "type" : "Group",
      "display" : "ComparativeEvidenceReportSubject: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)"
    }
  ],
  "date" : "2025-03-25T22:17:24.583Z",
  "author" : [
    {
      "type" : "Practitioner",
      "display" : "Brian S. Alper"
    },
    {
      "type" : "Practitioner",
      "display" : "Khalid Shahin"
    },
    {
      "type" : "Practitioner",
      "display" : "Joanne Dehnbostel"
    }
  ],
  "title" : "ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)",
  "custodian" : {
    🔗 "reference" : "Organization/118079",
    "type" : "Organization",
    "display" : "Computable Publishing LLC"
  },
  "relatesTo" : [
    {
      "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" : "cite-as"
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    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/target-reference",
          "valueReference" : {
            🔗 "reference" : "Citation/104116",
            "type" : "Citation",
            "display" : "JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort"
          }
        }
      ],
      "type" : "derived-from"
    }
  ],
  "section" : [
    {
      "title" : "Introduction",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "introduction",
            "display" : "Introduction"
          }
        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
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      "emptyReason" : {
        "coding" : [
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            "code" : "notstarted",
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        ]
      }
    },
    {
      "title" : "Population",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "population",
            "display" : "Population"
          }
        ],
        "text" : "Population"
      },
      "text" : {
        "status" : "generated",
        "div" : "<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\u2009=\u20092109) with severe obesity assessed (221 patients excluded and 1888 patients included). (1888 participants)</div>"
      },
      "entry" : [
        {
          🔗 "reference" : "Group/178427",
          "type" : "Group",
          "display" : "StudyGroup: Severely Obese Adults 2018 Norwegian Cohort"
        }
      ],
      "section" : [
        {
          "title" : "Screened Group",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "screened-group",
                "display" : "Screened Group"
              }
            ]
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          }
        },
        {
          "title" : "Enrolled Group (Study Population)",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "enrolled-group",
                "display" : "Enrolled Group"
              }
            ]
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          }
        },
        {
          "title" : "Analyzed Group (Study Population)",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "analyzed-group",
                "display" : "Analyzed Group"
              }
            ]
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          }
        },
        {
          "title" : "Population Definition (Eligibility Criteria)",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "population-description",
                "display" : "Population Description"
              }
            ]
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          }
        }
      ]
    },
    {
      "title" : "Intervention",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "intervention",
            "display" : "Intervention"
          }
        ],
        "text" : "Intervention"
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
      "section" : [
        {
          "title" : "Intervention Description",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "intervention-description",
                "display" : "Intervention Description"
              }
            ],
            "text" : "Intervention Description"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Bariatric surgery, mostly gastric bypass (92%) or sleeve gastrectomy (7%)</div>"
          },
          "entry" : [
            {
              🔗 "reference" : "Group/172423",
              "type" : "Group",
              "display" : "ExposureDefinition: Bariatric Surgery (RYGB, VSG, LAGB, BPD)"
            }
          ]
        },
        {
          "title" : "Intervention Group",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "intervention-group",
                "display" : "Intervention Group"
              }
            ],
            "text" : "Intervention Group"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">932 patients opted for bariatric surgery</div>"
          },
          "entry" : [
            {
              🔗 "reference" : "Group/172934",
              "type" : "Group",
              "display" : "InterventionGroup: JAMA 2018 Norwegian cohort study Surgery cohort"
            }
          ]
        }
      ]
    },
    {
      "title" : "Comparator Section",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "comparator",
            "display" : "Comparator"
          }
        ],
        "text" : "Comparator"
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
      "section" : [
        {
          "title" : "Comparator Description",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "comparator-description",
                "display" : "Comparator Description"
              }
            ],
            "text" : "Comparator Description"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">medical treatment without surgery</div>"
          },
          "entry" : [
            {
              🔗 "reference" : "Group/172424",
              "type" : "Group",
              "display" : "ComparatorDefinition: NOT Bariatric Surgery (RYGB, VSG, LAGB, BPD)"
            }
          ]
        },
        {
          "title" : "Comparator Group",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "comparator-group",
                "display" : "Comparator Group"
              }
            ],
            "text" : "Comparator Group"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">956 opted for medical management without surgery</div>"
          },
          "entry" : [
            {
              🔗 "reference" : "Group/172939",
              "type" : "Group",
              "display" : "ComparatorGroup: JAMA 2018 Norwegian cohort study Control cohort"
            }
          ]
        },
        {
          "title" : "Group Assignment (EvidenceVariable) Section",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "GroupAssignment",
                "display" : "GroupAssignment"
              }
            ]
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          },
          "entry" : [
            {
              🔗 "reference" : "EvidenceVariable/312202",
              "type" : "EvidenceVariable",
              "display" : "GroupAssignment: ExposureDefinition: Bariatric Surgery (RYGB, VSG, LAGB, BPD) vs. ComparatorDefinition: NOT Bariatric Surgery (RYGB, VSG, LAGB, BPD)"
            }
          ]
        }
      ]
    },
    {
      "title" : "Research Study",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "research-study",
            "display" : "Research Study"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<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\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 ≤ 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. </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>"
      },
      "entry" : [
        {
          🔗 "reference" : "ResearchStudy/208285",
          "type" : "ResearchStudy",
          "display" : "Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities"
        }
      ]
    },
    {
      "title" : "Methods Section",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "methods",
            "display" : "Methods"
          }
        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
      "emptyReason" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "notstarted",
            "display" : "Not Started"
          }
        ]
      }
    },
    {
      "title" : "Baseline Measures",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "baseline-measures",
            "display" : "Baseline Measures"
          }
        ],
        "text" : "Baseline Measures"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">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 &lt; 0.001). Mean BMI 45.4 in Surgical Group vs. 42.9 in Medical Group (p &lt; 0.001).</div>"
      },
      "entry" : [
        {
          🔗 "reference" : "Composition/312203",
          "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" : "List/312201",
          "type" : "List",
          "display" : "BaselineVariablesList: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)"
        }
      ]
    },
    {
      "title" : "Participant Flow",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "participant-flow",
            "display" : "Participant Flow"
          }
        ],
        "text" : "Participant Flow"
      },
      "text" : {
        "status" : "additional",
        "div" : "<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>"
      }
    },
    {
      "title" : "Outcomes",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "outcome-measures",
            "display" : "Outcome Measures"
          }
        ],
        "text" : "Outcomes"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">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]<br/>Compared with specialized medical treatment, bariatric surgery appears to induce remission of diabetes.<br/><br/>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].<br/>Compared with specialized medical treatment, bariatric surgery may slightly increase the incidence of depression.<br/><br/>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].<br/>Compared with specialized medical treatment, bariatric surgery may slightly increase the use of opioids.<br/><br/>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]).<br/>Compared with specialized medical treatment, bariatric surgery appears to increase the rate of additional gastrointestinal surgical procedures.</div>"
      },
      "entry" : [
        {
          🔗 "reference" : "Composition/318262",
          "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" : "List/312205",
          "type" : "List",
          "display" : "OutcomeVariablesList: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)"
        }
      ]
    },
    {
      "title" : "Summary of Findings",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "summary-of-findings",
            "display" : "Summary of Findings"
          }
        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "emptyReason" : {
        "coding" : [
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            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "notstarted",
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        ]
      }
    },
    {
      "title" : "Discussion Section",
      "code" : {
        "coding" : [
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            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "discussion",
            "display" : "Discussion"
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        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
      "emptyReason" : {
        "coding" : [
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            "code" : "notstarted",
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        ]
      }
    },
    {
      "title" : "References Section",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "references",
            "display" : "References"
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        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
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            "code" : "notstarted",
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        ]
      }
    },
    {
      "title" : "Competing Interests Section",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "competing-interests",
            "display" : "Competing Interests"
          }
        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
      },
      "emptyReason" : {
        "coding" : [
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            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "notstarted",
            "display" : "Not Started"
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        ]
      }
    },
    {
      "title" : "Acknowledgements Section",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "acknowledgements",
            "display" : "Acknowledgements"
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        ]
      },
      "text" : {
        "status" : "empty",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
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      "emptyReason" : {
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