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 - TTL Representation

Page standards status: Informative

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Group ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "372778"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "15" ] ;
fhir:lastUpdated [ fhir:v "2025-07-23T13:13:43.946Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as"^^xsd:anyURI ] ;
fhir:value [
a fhir:markdown ;
fhir:v "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."     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "Active" ]       ] )     ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/Group/372778"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ]       ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ]     ] ;
fhir:system [ fhir:v "https://fevir.net/FOI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "372778" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]     ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03640312 Eligibility Criteria" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:name [ fhir:v "QUARTET_Eligibility_Criteria"] ; # 
  fhir:title [ fhir:v "Eligibility Criteria for QUARTET USA Trial"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # 
  fhir:contact ( [
    ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "support@computablepublishing.com" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Inclusion Criteria:\n\n* Adults (≥18 years)\n* Spanish or English speaker.\n* 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).\n* 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.\n* 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.\n* Research grade blood pressure measurement (baseline mean) SBP\\>= 115 mmHg and DBP \\>= 60 mmHg\n\nExclusion Criteria:\n\n* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.\n* Previous diagnosis of coronary artery disease, stroke, or heart failure.\n* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \\>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)\n* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \\<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).\n* 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).\n* 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.\n* 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.\n* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.\n* Inability or unwillingness to provide written informed consent.\n* Unable to complete study procedures."] ; # 
  fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # 
  fhir:type [ fhir:v "person"] ; # 
  fhir:membership [ fhir:v "definitional"] ; # 
  fhir:combinationMethod [ fhir:v "all-of"] ; # 
  fhir:characteristic ( [
fhir:code [
      ( fhir:coding [
a sct:397669002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "397669002" ] ;
fhir:display [ fhir:v "Age" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "18"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "years" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "Adults (≥18 years)" ]
  ] [
fhir:code [
      ( fhir:coding [
a sct:365453006 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "365453006" ] ;
fhir:display [ fhir:v "Language Spoken - Finding" ]       ] )     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/codeOptions"^^xsd:anyURI ] ;
fhir:value [
a fhir:canonical ;
fhir:v "https://fevir.net/resources/ValueSet/383090"^^xsd:anyURI ;
fhir:link <https://fevir.net/resources/ValueSet/383090>         ]       ] ) ;
fhir:text [ fhir:v "Spanish or English" ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "Spanish or English speaker." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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)." ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "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)." ] ;
    ( fhir:timing [
fhir:text [ fhir:v "within the past 24 months" ]     ] )
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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." ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "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." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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." ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "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." ]
  ] [
fhir:code [
      ( fhir:coding [
a loinc:96608-5 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "96608-5" ] ;
fhir:display [ fhir:v "Systolic blood pressure mean" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "115"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "millimeters of mercury (mm Hg)" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mm[Hg]" ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "Research grade blood pressure measurement (baseline mean) SBP>= 115 mmHg" ] ;
    ( fhir:timing [
fhir:offset [
a fhir:Duration ;
fhir:value [ fhir:v "0"^^xsd:decimal ]       ] ;
fhir:text [ fhir:v "At Baseline" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a loinc:96609-3 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "96609-3" ] ;
fhir:display [ fhir:v "Diastolic blood pressure mean" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "60"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "millimeters of mercury (mm Hg)" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mm[Hg]" ]     ] ;
fhir:exclude [ fhir:v false ] ;
fhir:description [ fhir:v "Research grade blood pressure measurement (baseline mean) DBP >= 60 mmHg" ] ;
    ( fhir:timing [
fhir:text [ fhir:v "At Baseline" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a loinc:64100-1 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "64100-1" ] ;
fhir:display [ fhir:v "Contraindication" ]       ] )     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/codeOptions"^^xsd:anyURI ] ;
fhir:value [
a fhir:canonical ;
fhir:v "https://fevir.net/resources/ValueSet/383203"^^xsd:anyURI ;
fhir:link <https://fevir.net/resources/ValueSet/383203>         ]       ] ) ;
fhir:text [ fhir:v "candesartan, amlodipine, indapamide or bisoprolol" ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Known contraindication to candesartan, amlodipine, indapamide or bisoprolol." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)" ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)" ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L)." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L)." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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)." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "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)." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "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." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "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." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "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." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Inability or unwillingness to provide written informed consent." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Inability or unwillingness to provide written informed consent." ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Unable to complete study procedures." ]     ] ;
fhir:exclude [ fhir:v true ] ;
fhir:description [ fhir:v "Unable to complete study procedures." ]
  ] ) . #