Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: Eligibility Criteria for QUARTET USA Trial - XML Representation

Page standards status: Informative

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<Group xmlns="http://hl7.org/fhir">
  <id value="372778"/>
  <meta>
    <versionId value="15"/>
    <lastUpdated value="2025-07-23T13:13:43.946Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria"/>
  </meta>
  <text>
    <status value="empty"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
  </text>
  <extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as">
    <valueMarkdown
                   value="Eligibility Criteria for QUARTET USA Trial [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 372778. Revised 2025-07-23. Available at: https://fevir.net/resources/Group/372778. Computable resource at: https://fevir.net/resources/Group/372778#json."/>
  </extension>
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    <valueContactDetail>
      <name
            value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
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             url="http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status">
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        <system
                value="http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"/>
        <code value="active"/>
        <display value="Active"/>
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  <url value="https://fevir.net/resources/Group/372778"/>
  <identifier>
    <type>
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        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net/FOI"/>
    <value value="372778"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value value="NCT03640312 Eligibility Criteria"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <name value="QUARTET_Eligibility_Criteria"/>
  <title value="Eligibility Criteria for QUARTET USA Trial"/>
  <status value="active"/>
  <publisher value="Computable Publishing LLC"/>
  <contact>
    <telecom>
      <system value="email"/>
      <value value="support@computablepublishing.com"/>
    </telecom>
  </contact>
  <description
               value="Inclusion Criteria:

* Adults (≥18 years)
* Spanish or English speaker.
* Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).
* Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.
* Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.
* Research grade blood pressure measurement (baseline mean) SBP\&gt;= 115 mmHg and DBP \&gt;= 60 mmHg

Exclusion Criteria:

* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.
* Previous diagnosis of coronary artery disease, stroke, or heart failure.
* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \&gt;300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)
* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \&lt;50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).
* Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
* Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.
* Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.
* Inability or unwillingness to provide written informed consent.
* Unable to complete study procedures."/>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <type value="person"/>
  <membership value="definitional"/>
  <combinationMethod value="all-of"/>
  <characteristic>
    <code>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="397669002"/>
        <display value="Age"/>
      </coding>
    </code>
    <valueQuantity>
      <value value="18"/>
      <comparator value="&gt;="/>
      <unit value="years"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="a"/>
    </valueQuantity>
    <exclude value="false"/>
    <description value="Adults (≥18 years)"/>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="365453006"/>
        <display value="Language Spoken - Finding"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <extension url="http://hl7.org/fhir/StructureDefinition/codeOptions">
        <valueCanonical value="https://fevir.net/resources/ValueSet/383090"/>
      </extension>
      <text value="Spanish or English"/>
    </valueCodeableConcept>
    <exclude value="false"/>
    <description value="Spanish or English speaker."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
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    <valueCodeableConcept>
      <text
            value="Previous documentation of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse)."/>
    </valueCodeableConcept>
    <exclude value="false"/>
    <description
                 value="Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse)."/>
    <timing>
      <text value="within the past 24 months"/>
    </timing>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks."/>
    </valueCodeableConcept>
    <exclude value="false"/>
    <description
                 value="Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose."/>
    </valueCodeableConcept>
    <exclude value="false"/>
    <description
                 value="Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose."/>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="96608-5"/>
        <display value="Systolic blood pressure mean"/>
      </coding>
    </code>
    <valueQuantity>
      <value value="115"/>
      <comparator value="&gt;="/>
      <unit value="millimeters of mercury (mm Hg)"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="mm[Hg]"/>
    </valueQuantity>
    <exclude value="false"/>
    <description
                 value="Research grade blood pressure measurement (baseline mean) SBP&gt;= 115 mmHg"/>
    <timing>
      <offsetDuration>
        <value value="0"/>
      </offsetDuration>
      <text value="At Baseline"/>
    </timing>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="96609-3"/>
        <display value="Diastolic blood pressure mean"/>
      </coding>
    </code>
    <valueQuantity>
      <value value="60"/>
      <comparator value="&gt;="/>
      <unit value="millimeters of mercury (mm Hg)"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="mm[Hg]"/>
    </valueQuantity>
    <exclude value="false"/>
    <description
                 value="Research grade blood pressure measurement (baseline mean) DBP &gt;= 60 mmHg"/>
    <timing>
      <text value="At Baseline"/>
    </timing>
  </characteristic>
  <characteristic>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="64100-1"/>
        <display value="Contraindication"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <extension url="http://hl7.org/fhir/StructureDefinition/codeOptions">
        <valueCanonical value="https://fevir.net/resources/ValueSet/383203"/>
      </extension>
      <text value="candesartan, amlodipine, indapamide or bisoprolol"/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Known contraindication to candesartan, amlodipine, indapamide or bisoprolol."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or &gt;300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)"/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or &gt;300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR &lt;50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L)."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR &lt;50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L)."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods)."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods)."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Inability or unwillingness to provide written informed consent."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description
                 value="Inability or unwillingness to provide written informed consent."/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Defined by CodeableConcept"/>
    </code>
    <valueCodeableConcept>
      <text value="Unable to complete study procedures."/>
    </valueCodeableConcept>
    <exclude value="true"/>
    <description value="Unable to complete study procedures."/>
  </characteristic>
</Group>