Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot3
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot3
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-ballot3 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
| Page standards status: Informative |
{
"resourceType" : "Group",
"id" : "438155",
"meta" : {
"versionId" : "25",
"lastUpdated" : "2026-07-23T13:49:34.467Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-eligibility-criteria"
]
},
"language" : "en",
"text" : {
"status" : "empty",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>[No data.]</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
"valueMarkdown" : "CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS [Database Entry: FHIR Group Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 438155. Revised 2026-07-23. Available at: https://fevir.net/resources/Group/438155. Computable resource at: https://fevir.net/resources/Group/438155#json."
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-author",
"valueContactDetail" : {
"name" : "Brian S. Alper, MD, MSPH"
}
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact",
"valueRelatedArtifact" : {
"type" : "derived-from",
"resourceReference" : {
"reference" : "Group/438152",
"type" : "Group",
"display" : "CTIS2025-523977-40-00 Eligibility Criteria"
}
}
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/artifact-relatedArtifact",
"valueRelatedArtifact" : {
"type" : "supports",
"resourceReference" : {
"reference" : "ResearchStudy/438151",
"type" : "ResearchStudy",
"display" : "Changes in Coronary Plaque Composition By Semaglutide Use in Diabetic Patients With Acute Coronary Syndrome: A Randomized Optical Coherence Tomography Trial - ARMYDA - 10 study"
}
}
},
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
"code" : "active",
"display" : "Active"
}
]
}
}
],
"url" : "https://fevir.net/resources/Group/438155",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net/FOI",
"value" : "438155",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"name" : "ARMYDA_Eligibility_Criteria",
"title" : "CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS",
"publisher" : "Computable Publishing LLC",
"contact" : [
{
"telecom" : [
{
"system" : "email",
"value" : "support@computablepublishing.com"
}
]
}
],
"description" : "This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"type" : "person",
"membership" : "definitional",
"combinationMethod" : "all-of",
"characteristic" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "64572001",
"display" : "Disease (disorder)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "44054006",
"display" : "Diabetes mellitus type 2 (disorder)"
}
]
},
"exclude" : false,
"description" : "Diagnosis of T2DM"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "64572001",
"display" : "Disease (disorder)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "401314000",
"display" : "Acute non-ST segment elevation myocardial infarction (disorder)"
}
]
},
"exclude" : false,
"description" : "Non-ST-segment elevation ACS"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)"
},
"exclude" : false,
"description" : "Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel"
},
"exclude" : false,
"description" : "Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "397669002",
"display" : "Age"
}
]
},
"valueQuantity" : {
"value" : 40,
"comparator" : ">=",
"unit" : "years",
"system" : "http://unitsofmeasure.org",
"code" : "a"
},
"exclude" : false,
"description" : "Age ≥40 years"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Signed informed consent."
},
"exclude" : false,
"description" : "Signed informed consent."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "64572001",
"display" : "Disease (disorder)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "10633002",
"display" : "Acute congestive heart failure (disorder)"
}
]
},
"exclude" : true,
"description" : "Acute heart failure"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://loinc.org"
}
],
"text" : "Estimated glomerular filtration rate"
},
"valueQuantity" : {
"value" : 30,
"comparator" : "<",
"unit" : "mL/min/1.73 m²"
},
"exclude" : true,
"description" : "Renal dysfunction (estimated GFR <30 mL/min/1.73 m²)"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "71388002",
"display" : "Procedure (procedure)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "108241001",
"display" : "Dialysis procedure (Procedure)"
}
]
},
"exclude" : true,
"description" : "Renal dysfunction (on dialysis)"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "64572001",
"display" : "Disease (disorder)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "75694006",
"display" : "Pancreatitis (disorder)"
}
]
},
"exclude" : true,
"description" : "History of pancreatitis."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "High risk of pancreatitis."
},
"exclude" : true,
"description" : "High risk of pancreatitis."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Severe gastroparesis requiring therapy <6 months prior to randomization."
},
"exclude" : true,
"description" : "Severe gastroparesis requiring therapy <6 months prior to randomization."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Active malignancy or history of neuroendocrine tumors."
},
"exclude" : true,
"description" : "Active malignancy or history of neuroendocrine tumors."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Hypersensitivity or contraindications to semaglutide or its excipients."
},
"exclude" : true,
"description" : "Hypersensitivity or contraindications to semaglutide or its excipients."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "76625-3",
"display" : "Alanine aminotransferase [Enzymatic activity/volume] in Blood"
}
]
},
"valueQuantity" : {
"value" : 2,
"comparator" : ">",
"unit" : "upper limit of normal",
"system" : "http://hl7.org/fhir/characteristic-offset",
"code" : "UNL"
},
"exclude" : true,
"description" : "Severe hepatic dysfunction (ALT >2× upper limit of normal)."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "1920-8",
"display" : "Aspartate aminotransferase [Enzymatic activity/volume] in Blood"
}
]
},
"valueQuantity" : {
"value" : 2,
"comparator" : ">",
"unit" : "upper limit of normal",
"system" : "http://hl7.org/fhir/characteristic-offset",
"code" : "UNL"
},
"exclude" : true,
"description" : "Severe hepatic dysfunction (AST >2× upper limit of normal)."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "1975-2",
"display" : "Total Bilirubin in Serum or Plasma (measured by mass/volume, e.g., mg/dL)"
}
]
},
"valueQuantity" : {
"value" : 1.5,
"comparator" : ">",
"unit" : "upper limit of normal",
"system" : "http://hl7.org/fhir/characteristic-offset",
"code" : "UNL"
},
"exclude" : true,
"description" : "Severe hepatic dysfunction (total bilirubin >1.5× upper limit of normal)."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study."
},
"exclude" : true,
"description" : "Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "64572001",
"display" : "Disease (disorder)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "420422005",
"display" : "Ketoacidosis due to diabetes mellitus (disorder)"
}
]
},
"exclude" : true,
"description" : "Patients with diabetic ketoacidosis"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/fhir-types",
"code" : "MedicationRequest",
"display" : "MedicationRequest"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://www.nlm.nih.gov/research/umls/rxnorm",
"code" : "1991302",
"display" : "semaglutide"
}
]
},
"exclude" : true,
"description" : "Use of semaglutide at screening within 30 days prior to randomization."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",
"valueBoolean" : false
}
],
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Inability to provide informed consent."
},
"exclude" : true,
"description" : "Inability to provide informed consent."
}
]
}
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-07-27
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change