http://hl7.org/fhir/uv/ebm/Composition/397488
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  last updated:
    v: 2025-09-03T12:20:32.624Z
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text:
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    v: Outcome Sample Size Result Without Treatment Result With Treatment (Observed) Result With Treatment (Calculated) Effect Estimate Certainty of Evidence What this means Systolic blood pressure at 12 weeks 62 participants, 60 analyzed, 53 without missing data [No summary statement.] [No summary statement.] [No summary statement.] difference in means -4.5 mm Hg (95% confidence interval -10.82 mm Hg to 1.32 mm Hg) [No summary statement.] [No summary statement.] Diastolic blood pressure at 12 weeks 62 participants, 60 analyzed, 53 without missing data [No summary statement.] [No summary statement.] [Not a proportion.] difference in means -4.92 mm Hg (95% confidence interval -8.58 mm Hg to 0.27 mm Hg) [No summary statement.] [No summary statement.] Medication Adherence at 12 weeks 62 participants, 53 without missing data 70% 65.6% 46.33% odds ratio 0.37 (95% confidence interval 0.19 to 2.08) [No summary statement.] [No summary statement.] Hypertension Control at 12 weeks 62 participants, 60 analyzed, 53 without missing data 54.17% 65.52% 77.11% odds ratio 2.85 (95% confidence interval 0.94 to 8.59) [No summary statement.] [No summary statement.] Add-on Amlodipine at 6 weeks 62 participants, 60 analyzed, 62 without missing data, 22 events 53.33% 18.75% 51.25% odds ratio 0.92 (95% confidence interval 0.02 to 0.41) [No summary statement.] [No summary statement.] Adverse event free and hypertension control at 12 weeks 62 participants, 53 analyzed, 53 without missing data, 13 events 33.33% 17.24% 29.33% odds ratio 0.83 (95% confidence interval 0.22 to 3.16) [No summary statement.] [No summary statement.]
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  text:
    v: Summary of Findings
date:
  v: 2025-09-03T12:20:32.624Z
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title:
  v: Summary of Findings - QUARTET USA Trial
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    v: Summary of Findings - QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 397488. Revised 2025-09-03. Available at: https://fevir.net/resources/Composition/397488. Computable resource at: https://fevir.net/resources/Composition/397488.
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      v: EvidenceVariable/375202
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Hypertension Control at 12 weeks
section:
  title:
    v: Sample Size
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: sample-size
      display:
        v: Sample Size
  text:
    status:
      v: generated
    div:
      v: 62 participants, 60 analyzed, 53 without missing data
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397480
    reference:
      v: Evidence/397480
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Result Without Treatment
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-comparator-alone
      display:
        v: Result with comparator alone
  text:
    status:
      v: generated
    div:
      v: 54.17%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379737
    reference:
      v: Evidence/379737
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Hypertension Control at 12 weeks in QUARTET USA Trial Control Group
section:
  title:
    v: Result With Treatment--Observed
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone
      display:
        v: Result with intervention alone
  text:
    status:
      v: generated
    div:
      v: 65.52%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379736
    reference:
      v: Evidence/379736
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Hypertension Control at 12 weeks in QUARTET USA Trial Quadpill group
section:
  title:
    v: Result With Treatment--Derived
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone-calculated
      display:
        v: Result with intervention alone (calculated)
    text:
      v: result with intervention with calculated value derived from the control group and effect estimate
  text:
    status:
      v: empty
    div:
      v: [No data.]
section:
  title:
    v: Effect Estimate
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-vs-comparator
      display:
        v: Result with intervention vs. comparator
  text:
    status:
      v: generated
    div:
      v: odds ratio 2.85 (95% confidence interval 0.94 to 8.59)
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397480
    reference:
      v: Evidence/397480
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Certainty of Evidence
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: certainty-of-evidence
      display:
        v: Certainty of Evidence
  text:
    status:
      v: empty
    div:
      v: [No certainty rating found.]
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397480
    reference:
      v: Evidence/397480
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Assertion
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423

v: assertion

v: Assertion

status:
  v: empty
div:
  v: [No assertion provided.]

l: http://hl7.org/fhir/uv/ebm/Evidence/397480
reference:
  v: Evidence/397480
type:
  v: Evidence
  l: Evidence
display:
  v: Evidence for Results for Hypertension Control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan

title:
  v: Results for Add-on Amlodipine at 6 weeks
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: summary-of-findings-entry-for-a-single-outcome
    display:
      v: Summary of findings entry for a single outcome
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/375203
  reference:
    v: EvidenceVariable/375203
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Add-on Amlodipine at 6 weeks
section:
  title:
    v: Outcome Measure
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: outcome-measure
      display:
        v: Outcome Measure
  text:
    status:
      v: generated
    div:
      v: Add-on Amlodipine at 6 weeks
  entry:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/375203
    reference:
      v: EvidenceVariable/375203
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Add-on Amlodipine at 6 weeks
section:
  title:
    v: Sample Size
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: sample-size
      display:
        v: Sample Size
  text:
    status:
      v: generated
    div:
      v: 62 participants, 60 analyzed, 62 without missing data, 22 events
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397479
    reference:
      v: Evidence/397479
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Result Without Treatment
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-comparator-alone
      display:
        v: Result with comparator alone
  text:
    status:
      v: generated
    div:
      v: 53.33%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379740
    reference:
      v: Evidence/379740
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Add-on Amlodipine at 6 weeks in QUARTET USA Trial Control Group
section:
  title:
    v: Result With Treatment--Observed
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone
      display:
        v: Result with intervention alone
  text:
    status:
      v: generated
    div:
      v: 18.75%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379739
    reference:
      v: Evidence/379739
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Add-on Amlodipine at 6 weeks in QUARTET USA Trial Quadpill group
section:
  title:
    v: Result With Treatment--Derived
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone-calculated
      display:
        v: Result with intervention alone (calculated)
    text:
      v: result with intervention with calculated value derived from the control group and effect estimate
  text:
    status:
      v: empty
    div:
      v: [No data.]
section:
  title:
    v: Effect Estimate
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-vs-comparator
      display:
        v: Result with intervention vs. comparator
  text:
    status:
      v: generated
    div:
      v: odds ratio 0.92 (95% confidence interval 0.02 to 0.41)
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397479
    reference:
      v: Evidence/397479
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Certainty of Evidence
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: certainty-of-evidence
      display:
        v: Certainty of Evidence
  text:
    status:
      v: empty
    div:
      v: [No certainty rating found.]
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397479
    reference:
      v: Evidence/397479
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Assertion
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423

v: assertion

v: Assertion

status:
  v: empty
div:
  v: [No assertion provided.]

l: http://hl7.org/fhir/uv/ebm/Evidence/397479
reference:
  v: Evidence/397479
type:
  v: Evidence
  l: Evidence
display:
  v: Evidence for Results for Add-on Amlodipine at 6 weeks in GroupAssignment: Quadpill vs. Candesartan

title:
  v: Results for Adverse event free and hypertension control at 12 weeks
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: summary-of-findings-entry-for-a-single-outcome
    display:
      v: Summary of findings entry for a single outcome
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/375278
  reference:
    v: EvidenceVariable/375278
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Adverse event free and hypertension control at 12 weeks
section:
  title:
    v: Outcome Measure
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: outcome-measure
      display:
        v: Outcome Measure
  text:
    status:
      v: generated
    div:
      v: Adverse event free and hypertension control at 12 weeks
  entry:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/375278
    reference:
      v: EvidenceVariable/375278
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Adverse event free and hypertension control at 12 weeks
section:
  title:
    v: Sample Size
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: sample-size
      display:
        v: Sample Size
  text:
    status:
      v: generated
    div:
      v: 62 participants, 53 analyzed, 53 without missing data, 13 events
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397478
    reference:
      v: Evidence/397478
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Result Without Treatment
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-comparator-alone
      display:
        v: Result with comparator alone
  text:
    status:
      v: generated
    div:
      v: 33.33%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379743
    reference:
      v: Evidence/379743
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in QUARTET USA Trial Control Group
section:
  title:
    v: Result With Treatment--Observed
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone
      display:
        v: Result with intervention alone
  text:
    status:
      v: generated
    div:
      v: 17.24%
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/379742
    reference:
      v: Evidence/379742
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in QUARTET USA Trial Quadpill group
section:
  title:
    v: Result With Treatment--Derived
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-alone-calculated
      display:
        v: Result with intervention alone (calculated)
    text:
      v: result with intervention with calculated value derived from the control group and effect estimate
  text:
    status:
      v: empty
    div:
      v: [No data.]
section:
  title:
    v: Effect Estimate
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: result-with-intervention-vs-comparator
      display:
        v: Result with intervention vs. comparator
  text:
    status:
      v: generated
    div:
      v: odds ratio 0.83 (95% confidence interval 0.22 to 3.16)
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397478
    reference:
      v: Evidence/397478
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Certainty of Evidence
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: certainty-of-evidence
      display:
        v: Certainty of Evidence
  text:
    status:
      v: empty
    div:
      v: [No certainty rating found.]
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/397478
    reference:
      v: Evidence/397478
    type:
      v: Evidence
      l: Evidence
    display:
      v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan
section:
  title:
    v: Assertion
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423

v: assertion

v: Assertion

status:
  v: empty
div:
  v: [No assertion provided.]

l: http://hl7.org/fhir/uv/ebm/Evidence/397478
reference:
  v: Evidence/397478
type:
  v: Evidence
  l: Evidence
display:
  v: Evidence for Results for Adverse event free and hypertension control at 12 weeks in GroupAssignment: Quadpill vs. Candesartan