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-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 "7" ] ;
fhir:lastUpdated [ fhir:v "2023-12-21T17:55:07.544Z"^^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 "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Group</b><a name=\"170443\"> </a><a name=\"hc170443\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">ResourceGroup &quot;170443&quot; Version &quot;7&quot; Updated &quot;2023-12-21 17:55:07+0000&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-study-eligibility-criteria.html\">StudyEligibilityCriteria</a></p></div><p><b>Artifact related artifact</b>: </p><p><b>Artifact Author</b>: Brian S. Alper: </p><p><b>Artifact URL</b>: <a href=\"https://fevir.net/resources/Group/170443\">https://fevir.net/resources/Group/170443</a></p><p><b>Artifact Date</b>: 2022-09-09 10:30:50+0000</p><p><b>Artifact Publisher</b>: Computable Publishing LLC</p><p><b>Artifact Copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>Artifact Contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>CombinationMethod</b>: all-of</p><blockquote><p><b>modifierExtension[http://hl7.org/fhir/StructureDefinition/artifact-status]</b></p></blockquote><p><b>identifier</b>: FEvIR Object Identifier/170443</p><p><b>type</b>: animal</p><p><b>membership</b>: definitional</p><p><b>name</b>: StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study</p><p><b>description</b>: 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 &gt; 14.0%.</p><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Age 30 to 67 years at eligibility visit.</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: 0</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: at eligibility visit</p></blockquote><p><b>code</b>: Age <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#397669002)</span></p><p><b>value</b>: 30-67</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Diagnosed with T2DM at least 6 months prior to enrollment</p><p><b>CharacteristicDurationDuration</b>: &gt;=6 months<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mo = 'mo')</span></p><p><b>code</b>: Disease (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#64572001; <a href=\"http://hl7.org/fhir/R5/codesystem-fhir-types.html\">All FHIR Types</a>#Condition &quot;Condition&quot;)</span></p><p><b>value</b>: Diabetes mellitus type 2 (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#44054006)</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: under the active care of a doctor for at least the six months prior to enrollment</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: -6-0</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: for at least the six months prior to enrollment (presence throughout the range is equivalent to 'for at least the six months prior to')</p></blockquote><p><b>code</b>: Defined by CodeableConcept <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>value</b>: under the active care of a doctor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#305450004 &quot;Under care of doctor (finding)&quot;)</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: HbA1c ≥ 8.0%</p><p><b>code</b>: Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#59261-8)</span></p><p><b>value</b>: &gt;=8 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: 0</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: at eligibility visit</p></blockquote><p><b>code</b>: Body mass index (BMI) [Ratio] <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#39156-5)</span></p><p><b>value</b>: 30-39.9</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: -6-0 months</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: occurrence within the range is equivalent to 'in the past six months'</p></blockquote><p><b>code</b>: Defined by Reference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>value</b>: <a href=\"Group-170442.html\">Group/170442: CohortDefinition: Cardiovascular event</a> &quot;CohortDefinition_Cardiovascular_event&quot;</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Pulmonary embolus in the past six months.</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: -6-0 months</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: in the past six months</p></blockquote><p><b>code</b>: Disease (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#64572001; <a href=\"http://hl7.org/fhir/R5/codesystem-fhir-types.html\">All FHIR Types</a>#Condition &quot;Condition&quot;)</span></p><p><b>value</b>: Pulmonary embolism (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#59282003)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Thrombophlebitis in the past six months.</p><blockquote><p><b>CharacteristicTiming</b></p><blockquote><p><b>url</b></p><code>contextCode</code></blockquote><p><b>value</b>: Assessment of eligibility for clinical trial (procedure) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#450332002)</span></p><blockquote><p><b>url</b></p><code>offset</code></blockquote><p><b>value</b>: -6-0 months</p><blockquote><p><b>url</b></p><code>text</code></blockquote><p><b>value</b>: in the past six months</p></blockquote><p><b>code</b>: Disease (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#64572001; <a href=\"http://hl7.org/fhir/R5/codesystem-fhir-types.html\">All FHIR Types</a>#Condition &quot;Condition&quot;)</span></p><p><b>value</b>: Thrombophlebitis (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#64156001)</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.</p><p><b>code</b>: Defined by Reference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>value</b>: <a href=\"Group-170441.html\">Group/170441: CohortDefinition: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years</a> &quot;CohortDefinition_Cancer_of_any_kind_except_basal_cell_skin_cancer_or_cancer_in_situ_unless_documented_to_be_disease_free_for_five_years&quot;</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Significant anemia (hemoglobin 1.0 g or more below normal range)</p><p><b>CharacteristicOffset</b>: Lower Normal Limit <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-characteristic-offset.html\">Characteristic Offset</a>#LNL)</span></p><p><b>code</b>: Hemoglobin [Mass/volume] in Blood <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#718-7)</span></p><p><b>value</b>: &lt;=-1 g/dL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code g/dL = 'g/dL')</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: Serum creatinine ≥ 1.5 mg/dl</p><p><b>code</b>: Creatinine [Mass/volume] in Serum or Plasma <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#2160-0)</span></p><p><b>value</b>: &gt;=1.5 mg/dl<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/dL = 'mg/dL')</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>CharacteristicDescription</b>: HbA1c ≥ 14.0%</p><p><b>code</b>: Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#59261-8)</span></p><p><b>value</b>: &gt;=14 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>exclude</b>: true</p></blockquote></div>"
  ] ; # 
  fhir:extension ( [
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 "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Brian S. Alper" ]     ]
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fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/combination-method"^^xsd:anyURI ] ;
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  ] ) ; # 
  fhir:modifierExtension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-status"^^xsd:anyURI ] ;
fhir:value [ fhir:v "active" ]
  ] ) ; # 
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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"^^xsd:anyURI ] ;
fhir:value [ fhir:v "170443" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:type [ fhir:v "animal"] ; # 
  fhir:membership [ fhir:v "definitional"] ; # 
  fhir:name [ fhir:v "StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study"] ; # 
  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:characteristic ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Age 30 to 67 years at eligibility visit." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( 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:url [ fhir:v "offset"^^xsd:anyURI ] ;
fhir:value [
a fhir:Duration ;
fhir:value [ fhir:v "0"^^xsd:decimal ]         ]       ] [
fhir:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ fhir:v "at eligibility visit" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
fhir:code [
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fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "397669002" ] ;
fhir:display [ fhir:v "Age" ]       ] )     ] ;
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fhir:low [
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fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ]       ] ;
fhir:high [
fhir:value [ fhir:v "67"^^xsd:decimal ] ;
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fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ]       ]     ] ;
fhir:exclude [ fhir:v "false"^^xsd:boolean ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Diagnosed with T2DM at least 6 months prior to enrollment" ]     ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-duration-duration"^^xsd:anyURI ] ;
fhir:value [
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 [
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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" ]       ] )     ] ;
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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 ]
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fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "under the active care of a doctor for at least the six months prior to enrollment" ]     ] [
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fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
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a fhir:CodeableConcept ;
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fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
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fhir:display [ fhir:v "Assessment of eligibility for clinical trial (procedure)" ]           ] )         ]       ] [
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fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ]           ] ;
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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:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ 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:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "HbA1c ≥ 8.0%" ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( 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:url [ fhir:v "offset"^^xsd:anyURI ] ;
fhir:value [
a fhir:Duration ;
fhir:value [ fhir:v "0"^^xsd:decimal ]         ]       ] [
fhir:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ fhir:v "at eligibility visit" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( 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:url [ fhir:v "offset"^^xsd:anyURI ] ;
fhir:value [
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:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ fhir:v "occurrence within the range is equivalent to 'in the past six months'" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Pulmonary embolus in the past six months." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( 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:url [ fhir:v "offset"^^xsd:anyURI ] ;
fhir:value [
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:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ fhir:v "in the past six months" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Thrombophlebitis in the past six months." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "contextCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( 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:url [ fhir:v "offset"^^xsd:anyURI ] ;
fhir:value [
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:url [ fhir:v "text"^^xsd:anyURI ] ;
fhir:value [ fhir:v "in the past six months" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing"^^xsd:anyURI ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ 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: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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Significant anemia (hemoglobin 1.0 g or more below normal range)" ]     ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-offset"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( 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: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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Serum creatinine ≥ 1.5 mg/dl" ]     ] ) ;
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:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "HbA1c ≥ 14.0%" ]     ] ) ;
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 ]
  ] ) . #