Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Group</b><a name="170443"> </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">Resource Group "170443" Version "6" Updated "2023-11-30 22:03:19+0000" </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 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>Artifact Author</b>: Brian S. Alper: </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 > 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/">SNOMED 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/">SNOMED 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>: >=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/">SNOMED CT</a>#64572001; <a href="http://hl7.org/fhir/R5/codesystem-fhir-types.html">All FHIR Types</a>#Condition "Condition")</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/">SNOMED 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/">SNOMED 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/">SNOMED CT</a>#305450004 "Under care of doctor (finding)")</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>: >=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/">SNOMED 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/">SNOMED 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> "CohortDefinition_Cardiovascular_event"</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/">SNOMED 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/">SNOMED CT</a>#64572001; <a href="http://hl7.org/fhir/R5/codesystem-fhir-types.html">All FHIR Types</a>#Condition "Condition")</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/">SNOMED 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/">SNOMED 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/">SNOMED CT</a>#64572001; <a href="http://hl7.org/fhir/R5/codesystem-fhir-types.html">All FHIR Types</a>#Condition "Condition")</span></p><p><b>value</b>: Thrombophlebitis (disorder) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED 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> "CohortDefinition_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>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>: <=-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>: >=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>: >=14 %<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p><p><b>exclude</b>: true</p></blockquote></div>
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<code value="450332002"/>
<display
value="Assessment of eligibility for clinical trial (procedure)"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="offset">
<valueRange>
<low>
<value value="-6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</valueRange>
</extension>
<extension url="text">
<valueString value="in the past six months"/>
</extension>
</extension>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64572001"/>
<display value="Disease (disorder)"/>
</coding>
<coding>
<system value="http://hl7.org/fhir/fhir-types"/>
<code value="Condition"/>
<display value="Condition"/>
</coding>
</code>
<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="59282003"/>
<display value="Pulmonary embolism (disorder)"/>
</coding>
</valueCodeableConcept>
<exclude value="true"/>
</characteristic>
<characteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description">
<valueMarkdown value="Thrombophlebitis in the past six months."/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-timing">
<extension url="contextCode">
<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="450332002"/>
<display
value="Assessment of eligibility for clinical trial (procedure)"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="offset">
<valueRange>
<low>
<value value="-6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</valueRange>
</extension>
<extension url="text">
<valueString value="in the past six months"/>
</extension>
</extension>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64572001"/>
<display value="Disease (disorder)"/>
</coding>
<coding>
<system value="http://hl7.org/fhir/fhir-types"/>
<code value="Condition"/>
<display value="Condition"/>
</coding>
</code>
<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64156001"/>
<display value="Thrombophlebitis (disorder)"/>
</coding>
</valueCodeableConcept>
<exclude value="true"/>
</characteristic>
<characteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description">
<valueMarkdown
value="Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years."/>
</extension>
<code>
<text value="Defined by Reference"/>
</code>
<valueReference>🔗
<reference value="Group/170441"/>
<type value="Group"/>
<display
value="CohortDefinition: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years"/>
</valueReference>
<exclude value="true"/>
</characteristic>
<characteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description">
<valueMarkdown
value="Significant anemia (hemoglobin 1.0 g or more below normal range)"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-offset">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/characteristic-offset"/>
<code value="LNL"/>
<display value="Lower Normal Limit"/>
</coding>
</valueCodeableConcept>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="718-7"/>
<display value="Hemoglobin [Mass/volume] in Blood"/>
</coding>
</code>
<valueQuantity>
<value value="-1"/>
<comparator value="<="/>
<unit value="g/dL"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/dL"/>
</valueQuantity>
<exclude value="true"/>
</characteristic>
<characteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description">
<valueMarkdown value="Serum creatinine ≥ 1.5 mg/dl"/>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="2160-0"/>
<display value="Creatinine [Mass/volume] in Serum or Plasma"/>
</coding>
</code>
<valueQuantity>
<value value="1.5"/>
<comparator value=">="/>
<unit value="mg/dl"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/dL"/>
</valueQuantity>
<exclude value="true"/>
</characteristic>
<characteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/characteristic-description">
<valueMarkdown value="HbA1c ≥ 14.0%"/>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="59261-8"/>
<display
value="Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol"/>
</coding>
</code>
<valueQuantity>
<value value="14"/>
<comparator value=">="/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<exclude value="true"/>
</characteristic>
</Group>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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