Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
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
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<lastUpdated value="2024-11-16T20:02:12.998Z"/>
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<name value="Brian S. Alper"/>
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<citation
value="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."/>
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<display value="Accession ID"/>
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<name
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<status value="active"/>
<date value="2022-09-09T10:30:50.570Z"/>
<publisher value="Computable Publishing LLC"/>
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<description
value="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%."/>
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<coding>
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<code value="450332002"/>
<display
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<offsetDuration>
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<text value="at eligibility visit"/>
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<code value="64572001"/>
<display value="Disease (disorder)"/>
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<coding>
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<code value="Condition"/>
<display value="Condition"/>
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<coding>
<system value="http://snomed.info/sct"/>
<code value="44054006"/>
<display value="Diabetes mellitus type 2 (disorder)"/>
</coding>
</valueCodeableConcept>
<exclude value="false"/>
<description
value="Diagnosed with T2DM at least 6 months prior to enrollment"/>
<durationDuration>
<value value="6"/>
<comparator value=">="/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</durationDuration>
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<characteristic>
<code>
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<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="305450004"/>
<display value="Under care of doctor (finding)"/>
</coding>
<text value="under the active care of a doctor"/>
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<exclude value="false"/>
<description
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<code value="450332002"/>
<display
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<high>
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<code value="mo"/>
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</offsetRange>
<text
value="for at least the six months prior to enrollment (presence throughout the range is equivalent to 'for at least the six months prior to')"/>
</timing>
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<characteristic>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="59261-8"/>
<display
value="Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol"/>
</coding>
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<comparator value=">="/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
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<exclude value="false"/>
<description value="HbA1c ≥ 8.0%"/>
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<code>
<coding>
<system value="http://loinc.org"/>
<code value="39156-5"/>
<display value="Body mass index (BMI) [Ratio]"/>
</coding>
</code>
<valueRange>
<low>
<value value="30"/>
<system value="http://unitsofmeasure.org"/>
</low>
<high>
<value value="39.9"/>
<unit value="kg/m2"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg/m2"/>
</high>
</valueRange>
<exclude value="false"/>
<description
value="Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit."/>
<timing>
<contextCode>
<coding>
<system value="http://snomed.info/sct"/>
<code value="450332002"/>
<display
value="Assessment of eligibility for clinical trial (procedure)"/>
</coding>
</contextCode>
<offsetDuration>
<value value="0"/>
</offsetDuration>
<text value="at eligibility visit"/>
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<code>
<text value="Defined by Reference"/>
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<valueReference>🔗
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<type value="Group"/>
<display value="CohortDefinition: Cardiovascular event"/>
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<exclude value="true"/>
<description
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<timing>
<contextCode>
<coding>
<system value="http://snomed.info/sct"/>
<code value="450332002"/>
<display
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<unit value="months"/>
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<high>
<value value="0"/>
<unit value="months"/>
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<code value="mo"/>
</high>
</offsetRange>
<text
value="occurrence within the range is equivalent to 'in the past six months'"/>
</timing>
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<characteristic>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64572001"/>
<display value="Disease (disorder)"/>
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<code value="Condition"/>
<display value="Condition"/>
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<coding>
<system value="http://snomed.info/sct"/>
<code value="59282003"/>
<display value="Pulmonary embolism (disorder)"/>
</coding>
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<exclude value="true"/>
<description value="Pulmonary embolus in the past six months."/>
<timing>
<contextCode>
<coding>
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<code value="450332002"/>
<display
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<unit value="months"/>
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<code value="mo"/>
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<high>
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<unit value="months"/>
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<code value="mo"/>
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<text value="in the past six months"/>
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<characteristic>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="64572001"/>
<display value="Disease (disorder)"/>
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<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"/>
<description value="Thrombophlebitis in the past six months."/>
<timing>
<contextCode>
<coding>
<system value="http://snomed.info/sct"/>
<code value="450332002"/>
<display
value="Assessment of eligibility for clinical trial (procedure)"/>
</coding>
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<valueReference>🔗
<reference value="Group/170441"/>
<type value="Group"/>
<display
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<exclude value="true"/>
<description
value="Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years."/>
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<characteristic>
<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"/>
<description
value="Significant anemia (hemoglobin 1.0 g or more below normal range)"/>
<offset>
<coding>
<system value="http://hl7.org/fhir/characteristic-offset"/>
<code value="LNL"/>
<display value="Lower Normal Limit"/>
</coding>
</offset>
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<characteristic>
<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"/>
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<exclude value="true"/>
<description value="Serum creatinine ≥ 1.5 mg/dl"/>
</characteristic>
<characteristic>
<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"/>
<description value="HbA1c ≥ 14.0%"/>
</characteristic>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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