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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-372776.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Composition 372776

version: 34; Last updated: 2025-09-02 18:37:30+0000; Language: en

Profile: ComparativeEvidenceReportExpanded

Artifact Description:

This is an example of a Comparative Evidence Report describing the QUARTET USA Randomized Controlled Trial for the EBM on FHIR Implementation Guide.

url: https://fevir.net/resources/Composition/372776

identifier: FEvIR Object Identifier/372776

status: Final

type: Comparative Evidence Report

date: 2025-09-02 18:37:30+0000

author: Joanne Dehnbostel

title: Comparative Evidence Report for QUARTET USA Trial

custodian: Computable Publishing LLC

RelatesTos

-TypeTarget[x]
*Cite As

Comparative Evidence Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 372776. Revised 2025-09-02. Available at: https://fevir.net/resources/Composition/372776. Computable resource at: https://fevir.net/resources/Composition/372776.


Source1

{
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  "id": "372776",
  "meta": {
    "versionId": "34",
    "lastUpdated": "2025-09-02T18:37:30.919Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence-report-expanded"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
      "valueMarkdown": "This is an example of a Comparative Evidence Report describing the QUARTET USA Randomized Controlled Trial for the EBM on FHIR Implementation Guide."
    }
  ],
  "url": "https://fevir.net/resources/Composition/372776",
  "identifier": [
    {
      "type": {
        "coding": [
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            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
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        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "372776",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "https://fevir.net/resources/CodeSystem/179423",
        "code": "ComparativeEvidenceReport",
        "display": "ComparativeEvidenceReport"
      }
    ],
    "text": "Comparative Evidence Report"
  },
  "date": "2025-09-02T18:37:30.919Z",
  "author": [
    {
      "display": "Joanne Dehnbostel"
    }
  ],
  "title": "Comparative Evidence Report for QUARTET USA Trial",
  "custodian": {
    "reference": "Organization/118079",
    "type": "Organization",
    "display": "Computable Publishing LLC"
  },
  "relatesTo": [
    {
      "type": "cite-as",
      "targetMarkdown": "Comparative Evidence Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 372776. Revised 2025-09-02. Available at: https://fevir.net/resources/Composition/372776. Computable resource at: https://fevir.net/resources/Composition/372776."
    }
  ],
  "section": [
    {
      "title": "Introduction Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "introduction",
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        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension.</span></p></div>"
      }
    },
    {
      "title": "Study Sample",
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        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
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      "entry": [
        {
          "reference": "Group/372797",
          "type": "Group",
          "display": "Enrolled Group for QUARTET USA Trial"
        }
      ],
      "section": [
        {
          "title": "Eligibility Criteria",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "eligibility-criteria",
                "display": "Eligibility Criteria"
              }
            ]
          },
          "text": {
            "status": "empty",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
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          "entry": [
            {
              "reference": "Group/372778",
              "type": "Group",
              "display": "Eligibility Criteria for QUARTET USA Trial"
            }
          ]
        }
      ]
    },
    {
      "title": "Intervention Group",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "intervention-group",
            "display": "Intervention Group"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "Group/375175",
          "type": "Group",
          "display": "QUARTET USA Trial Quadpill group"
        }
      ],
      "section": [
        {
          "title": "Intervention Description",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "intervention-description",
                "display": "Intervention Description"
              }
            ]
          },
          "text": {
            "status": "empty",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          },
          "entry": [
            {
              "reference": "ActivityDefinition/375159",
              "type": "ActivityDefinition",
              "display": "Quadpill once daily"
            }
          ]
        }
      ]
    },
    {
      "title": "Comparator Group",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "comparator-group",
            "display": "Comparator Group"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "Group/375182",
          "type": "Group",
          "display": "QUARTET USA Trial Control Group"
        }
      ],
      "section": [
        {
          "title": "Comparator Description",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "comparator-description",
                "display": "Comparator Description"
              }
            ]
          },
          "text": {
            "status": "empty",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
          },
          "entry": [
            {
              "reference": "ActivityDefinition/375181",
              "type": "ActivityDefinition",
              "display": "Candesartan 8 mg once daily"
            }
          ]
        },
        {
          "title": "Group Assignment (EvidenceVariable)",
          "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/375183",
              "type": "EvidenceVariable",
              "display": "GroupAssignment: Quadpill vs. Candesartan"
            }
          ]
        }
      ]
    },
    {
      "title": "Research Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "research-study",
            "display": "Research Study"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">Trial registration number: </span><a style=\"box-sizing: inherit; background-color: rgb(255, 255, 255); color: rgb(0, 113, 188); text-decoration: none; font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal;\" href=\"http://clinicaltrials.gov/show/NCT03640312\" title=\"See in ClinicalTrials.gov\">NCT03640312</a><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">.</span></p></div>"
      },
      "entry": [
        {
          "reference": "ResearchStudy/367879",
          "type": "ResearchStudy",
          "display": "Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension"
        }
      ]
    },
    {
      "title": "Methods Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "methods",
            "display": "Methods"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was &gt;130/&gt;80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. </span></p><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. </span></p></div>"
      }
    },
    {
      "title": "Baseline Characteristics",
      "code": {
        "coding": [
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            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "baseline-characteristics",
            "display": "Baseline Characteristics"
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        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. </span></p></div>"
      },
      "entry": [
        {
          "reference": "Composition/370510",
          "type": "Composition",
          "display": "Baseline Characteristics Report for QUARTET Trial"
        }
      ]
    },
    {
      "title": "Participant Flow",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "participant-flow",
            "display": "Participant Flow"
          }
        ],
        "text": "Participant Flow"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "Composition/370512",
          "type": "Composition",
          "display": "Participant Flow Report for QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Outcome Variables",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "outcome-measures",
            "display": "Outcome Measures"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "List/375184",
          "type": "List",
          "display": "Outcome Measure List for QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Outcome Findings",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "outcome-findings",
            "display": "Outcome Findings"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;\">In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. </span></p></div>"
      },
      "entry": [
        {
          "reference": "Composition/375280",
          "type": "Composition",
          "display": "Outcome Measure Report for QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Summary of Findings",
      "code": {
        "coding": [
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            "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>"
      },
      "entry": [
        {
          "reference": "Composition/397488",
          "type": "Composition",
          "display": "Summary of Findings - QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Discussion Section",
      "code": {
        "coding": [
          {
            "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\"><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": "References Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "references",
            "display": "References"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "Citation/367878",
          "type": "Citation",
          "display": "Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. (367878)"
        }
      ]
    },
    {
      "title": "Competing Interests Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "competing-interests",
            "display": "Competing Interests"
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        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "emptyReason": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code": "notstarted",
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      }
    },
    {
      "title": "Acknowledgements Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "acknowledgements",
            "display": "Acknowledgements"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "emptyReason": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code": "notstarted",
            "display": "Not Started"
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    },
    {
      "title": "Appendices Section",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "appendices",
            "display": "Appendices"
          }
        ]
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "emptyReason": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code": "notstarted",
            "display": "Not Started"
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      }
    }
  ]
}