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 2.0.0-ballot 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

: StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study - TTL Representation

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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 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 "170443"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "8" ] ;
fhir:lastUpdated [ fhir:v "2024-11-16T20:02:12.998Z"^^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>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Brian S. Alper" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact"^^xsd:anyURI ] ;
fhir:value [
a fhir:RelatedArtifact ;
fhir:type [ fhir:v "cite-as" ] ;
fhir:citation [ fhir:v "StudyEligibilityCriteria: Eligibility Criteria for Bariatric Surgery Randomized Trial (Diabetes Surgery Study) [Database Entry: FHIR Group Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 170443. Revised 2022-09-09. Available at: https://fevir.net/resources/Group/170443. Computable resource at: https://fevir.net/resources/Group/170443." ]     ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/Group/170443"^^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 "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "https://fevir.net/FOI/170443" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:name [ fhir:v "StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:date [ fhir:v "2022-09-09T10:30:50.570Z"^^xsd:dateTime] ; # 
  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:    Age 30 to 67 years at eligibility visit.    Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0%.    Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.    Willingness to accept random assignment to either treatment group.    Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.    Willingness to comply with the follow-up protocol and successful completion of the run-in.    Written informed consent. ///// Exclusion Criteria:   Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.    Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.    Cardiac stress test indicating that surgery or IMM would not be safe.    Pulmonary embolus or thrombophlebitis in the past six months.    Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.    Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.    Serum creatinine ≥ 1.5 mg/dl.    HbA1c > 14.0%."] ; # 
  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:Range ;
fhir:low [
fhir:value [ fhir:v "30"^^xsd:decimal ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ]       ] ;
fhir:high [
fhir:value [ fhir:v "67"^^xsd:decimal ] ;
fhir:unit [ fhir:v "years" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ]       ]     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ] ;
fhir:description [ fhir:v "Age 30 to 67 years at eligibility visit." ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Duration ;
fhir:value [ fhir:v "0"^^xsd:decimal ]       ] ;
fhir:text [ fhir:v "at eligibility visit" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a sct:64572001 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "64572001" ] ;
fhir:display [ fhir:v "Disease (disorder)" ]       ] [
fhir:system [ fhir:v "http://hl7.org/fhir/fhir-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Condition" ] ;
fhir:display [ fhir:v "Condition" ]       ] )     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
a sct:44054006 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "44054006" ] ;
fhir:display [ fhir:v "Diabetes mellitus type 2 (disorder)" ]       ] )     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ] ;
fhir:description [ fhir:v "Diagnosed with T2DM at least 6 months prior to enrollment" ] ;
fhir:duration [
a fhir:Duration ;
fhir:value [ fhir:v "6"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]     ]
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by CodeableConcept" ]     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
a sct:305450004 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "305450004" ] ;
fhir:display [ fhir:v "Under care of doctor (finding)" ]       ] ) ;
fhir:text [ fhir:v "under the active care of a doctor" ]     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ] ;
fhir:description [ fhir:v "under the active care of a doctor for at least the six months prior to enrollment" ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "-6"^^xsd:decimal ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ]         ] ;
fhir:high [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ]       ] ;
fhir:text [ fhir:v "for at least the six months prior to enrollment (presence throughout the range is equivalent to 'for at least the six months prior to')" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a loinc:59261-8 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "59261-8" ] ;
fhir:display [ fhir:v "Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "8"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ]     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ] ;
fhir:description [ fhir:v "HbA1c ≥ 8.0%" ]
  ] [
fhir:code [
      ( fhir:coding [
a loinc:39156-5 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "39156-5" ] ;
fhir:display [ fhir:v "Body mass index (BMI) [Ratio]" ]       ] )     ] ;
fhir:value [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "30"^^xsd:decimal ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ]       ] ;
fhir:high [
fhir:value [ fhir:v "39.9"^^xsd:decimal ] ;
fhir:unit [ fhir:v "kg/m2" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "kg/m2" ]       ]     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ] ;
fhir:description [ fhir:v "Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit." ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Duration ;
fhir:value [ fhir:v "0"^^xsd:decimal ]       ] ;
fhir:text [ fhir:v "at eligibility visit" ]     ] )
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by Reference" ]     ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Group/170442" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "CohortDefinition: Cardiovascular event" ]     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months." ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "-6"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ] ;
fhir:high [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ]       ] ;
fhir:text [ fhir:v "occurrence within the range is equivalent to 'in the past six months'" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a sct:64572001 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "64572001" ] ;
fhir:display [ fhir:v "Disease (disorder)" ]       ] [
fhir:system [ fhir:v "http://hl7.org/fhir/fhir-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Condition" ] ;
fhir:display [ fhir:v "Condition" ]       ] )     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
a sct:59282003 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "59282003" ] ;
fhir:display [ fhir:v "Pulmonary embolism (disorder)" ]       ] )     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Pulmonary embolus in the past six months." ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "-6"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ] ;
fhir:high [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ]       ] ;
fhir:text [ fhir:v "in the past six months" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
a sct:64572001 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "64572001" ] ;
fhir:display [ fhir:v "Disease (disorder)" ]       ] [
fhir:system [ fhir:v "http://hl7.org/fhir/fhir-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Condition" ] ;
fhir:display [ fhir:v "Condition" ]       ] )     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
a sct:64156001 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "64156001" ] ;
fhir:display [ fhir:v "Thrombophlebitis (disorder)" ]       ] )     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Thrombophlebitis in the past six months." ] ;
    ( fhir:timing [
fhir:contextCode [
        ( fhir:coding [
a sct:450332002 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "450332002" ] ;
fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]         ] )       ] ;
fhir:offset [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "-6"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ] ;
fhir:high [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "months" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mo" ]         ]       ] ;
fhir:text [ fhir:v "in the past six months" ]     ] )
  ] [
fhir:code [
fhir:text [ fhir:v "Defined by Reference" ]     ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Group/170441" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "CohortDefinition: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years" ]     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years." ]
  ] [
fhir:code [
      ( fhir:coding [
a loinc:718-7 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "718-7" ] ;
fhir:display [ fhir:v "Hemoglobin [Mass/volume] in Blood" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "-1"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "g/dL" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "g/dL" ]     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Significant anemia (hemoglobin 1.0 g or more below normal range)" ] ;
fhir:offset [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/characteristic-offset"^^xsd:anyURI ] ;
fhir:code [ fhir:v "LNL" ] ;
fhir:display [ fhir:v "Lower Normal Limit" ]       ] )     ]
  ] [
fhir:code [
      ( fhir:coding [
a loinc:2160-0 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2160-0" ] ;
fhir:display [ fhir:v "Creatinine [Mass/volume] in Serum or Plasma" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "1.5"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "mg/dl" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mg/dL" ]     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "Serum creatinine ≥ 1.5 mg/dl" ]
  ] [
fhir:code [
      ( fhir:coding [
a loinc:59261-8 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "59261-8" ] ;
fhir:display [ fhir:v "Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol" ]       ] )     ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "14"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "%" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ]     ] ;
fhir:exclude [ fhir:v "true"^^xsd:boolean ] ;
fhir:description [ fhir:v "HbA1c ≥ 14.0%" ]
  ] ) . #