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Element name (including path)CardinalityDatatypeShort descriptionDefinitionRequirementsCommentInvariantsExample(s)Example URL
Acceptance Status
Future ExtensionsFeedback
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Concise definition for space-constrained presentationFull formal definition as narrative textWhy this element has been created -- for traceability of why and why the constraints exist as they do. This may be used to note source materials.Explanatory notes and implementation guidance about the element, how to use the data properly, exceptions to proper use, etc.These are rules for warnings or requirements for validation that will be converted to FHIR-specific logic expressions.This example is for understanding while completing this spreadsheet and is NOT part of the ElementDefinition
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description0..1markdownNatural language description of the CharacteristicA human readable narrative summarizing the Characteristic definitionNeed to be able to describe characteristics in natural language so that end users can understand the criteria.Use of this element is recommended in all cases to facilitate human inspection if questions arise regarding the structured data. Use of this element is necessary in cases with no data in any of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, or definitionByCombination elements -- an approach that may be used for Characteristics that are unable to be represented with structured data (e.g. "no subjective criteria for which participation would introduce an undue hardship")description element must have a value if no values found in any of 5 definition elements; description element should have a value"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%." or "Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial."7-0-0 in BRR meeting 2023-04-13
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note0..*AnnotationAdditional or explanatory noteA human readable narrative summarizing an additional consideration (such as a qualifier, modifier, or rationale) that is not part of the key description or definition of the characteristic."The evidence and guideline panel decision to modify the BMI threshold for Asian Americans is based on data mostly from Asian Americans not generally including Native Hawaiians and other Pacific Islanders, so it is not explicit whether the modified thresholds apply to Native Hawaiians and other Pacific Islanders. See https://diabetesjournals.org/care/article/38/1/150/37769/BMI-Cut-Points-to-Identify-At-Risk-Asian-Americans for details"6-0-0 in BRR meeting 2023-04-13
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exclude0..1booleanWhether the characteristic is an inclusion criterion or exclusion criterionAn expression of negation to be applied to the definition of the characteristic. When true, this characteristic is an exclusion criterion.This element value is applied to the value in a definition element. If true, this element prefaces the definition value with 'absence of'. This element does NOT apply to the value of the description element (i.e. the description element should include the negation concept when applicable.).if exclude element has a value, then there must be a value in definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, or definitionByCombination.description: "not an adult", exclude: true, definitionCodeableConcept.text: "adult" --or-- description: "child (minor age)", exclude: true, definitionCodeableConcept.text: "adult" --or-- description: "abnormal systolic blood pressure", exclude: true, definitionByTypeAndValue.valueRange: {low: 120 mmHg, high: 140 mmHg}6-0-0 in BRR meeting 2023-04-13
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definitionReference0..1Reference(Characteristic)Defines the characteristic using a ReferenceDefines the characteristic using a Reference Datatype which references a FHIR Characteristic Resource. In other words, this characteristic is defined by re-using a pre-existing Characteristic Resource.re-use of existing characteristic definitionsUse this definition element when the characteristic is already defined with a Resource and the Resource is referenced by an absolute path, relative path or identifierNo more than one of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, and definitionByCombination may have a value.diabetes complications is one characteristic; diabetes complications in the past 2 years is a different characteristic that may be expressed as definitionReference: {diabetes complications}, timeFromEvent: {in the past 2 years}6-0-0 in CDS meeting 2023-04-13
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definitionUri0..1uriDefines the characteristic using a URI (typically a URL)Defines the characteristic using a URI (typically a URL) to an external definition.re-use of existing characteristic definitionsUse this definition element when the characteristic is already defined with an artifact that is identified by URI. This URI is an identifier and often will be the URL (absolute path).No more than one of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, and definitionByCombination may have a value.https://phekb.org/phenotype/type-2-diabetes-mellitus6-0-0 in CDS meeting 2023-04-13
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definitionCodeableConcept 0..1CodeableConceptDefines the characteristic using a single codeable concept Defines the characteristic using a single codeable concept, using coding(s) from a terminology and/or text. re-use of existing characteristic definitions when available as codeable conceptsThis element is used when a single concept represents the entire definition of the characteristic.No more than one of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, and definitionByCombination may have a value."definitionCodeableConcept":{
"coding":[
{
"system":"http://snomed.info/sct",
"code":"305450004",
"display":"Under care of doctor (finding)"
}
],
"text":"under the active care of a doctor"
}		4-0-0 in Eligibility Criteria WG meeting 2023-04-21
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definitionByTypeAndValue 0..1BackboneElementDefines the characteristic with an attribute and its valueDefines the characteristic with an attribute (as a concept) and its value (in an appropriate datatype), potentially with modifier elements.Characteristic definition with an attribute-value pair is used across Group and EvidenceVariable Resources.This element is used when an attribute value pair is needed to express the characteristic, so one codeable concept is needed to define the attribute and a second value (codeable concept or other datatype) is needed to define the value for that attribute.No more than one of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, and definitionByCombination may have a value."definitionByTypeAndValue": {
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "59261-8",
"display": "Hemoglobin A1c/Hemoglobin.total in Blood"
}
]
},
"valueQuantity": {
"value": 14,
"comparator": ">=",
"unit": "%",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}		4-0-0 in Eligibility Criteria WG meeting 2023-04-21
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definitionByTypeAndValue.type1..1CodeableConceptThe attribute in an attribute-value pair defining the characteristicThe attribute that, coupled with the corresponding value, defines the characteristic.Need a formal way of identifying the attribute of the characteristic being described, used for characteristics defined with a single attribute."type": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "60621009",
"display": "Body mass index (observable entity) "
}
]
}		4-0-0 in Eligibility Criteria WG meeting 2023-04-21
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definitionByTypeAndValue.method 0..*CodeableConceptHow the characteristic value was determinedThe process, method, or system specifying how the characteristic value was determined.The method of determining the attribute value may not be included in the codeable concept defining the attribute, and may be necessary to fully express the characteristic definition."type": {
"coding": [
{
"system": "http://loinc.org",
"code": "1518-0",
"display": "Glucose[Mass/volume] in Serum or Plasma --2 hours post 75 g glucose PO"
}
]
},
"method": [
{
"text": "The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water."
}
]		https://fevir.net/resources/EvidenceVariable/331224-0-0 in Eligibility Criteria WG meeting 2023-04-21
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definitionByTypeAndValue.device 0..1Reference(DeviceDefinition | Device | DeviceMetric)Device used for determining characteristic valueThe device used for determining the characteristic value.The device used for determining the attribute value may not be included in the codeable concept defining the attribute, and may be necessary to fully express the characteristic definition.DeviceMetric Resource is equivalent to a Device Resource (referenced from DeviceMetric) and additional parameters representing the configuration or settings for the device. The DeviceMetric references the Device so there is no need to reference both from Characteristic.4-0-0 in Eligibility Criteria WG meeting 2023-04-21BM For the most part one would think that it woudl be Device Type ie DeviceDefinition (and possibly settings DeviceMetric) rather than a speficic Device instance that woudl reference for Elligibility Criteria/Cohor definition
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definitionByTypeAndValue.calculatedAs0..1ExpressionFormula used for determining characteristic valueThe mathematical formula or computational expression used to calculate the characteristic value.The formula or expression used for determining the attribute value may not be included in the codeable concept defining the attribute, and may be necessary to fully express the characteristic definition.This element (calculatedAs) is not used to fully define a characteristic with an Expression; it is only used to define the expression for how the characteristic value (in the observed instance) is calculated. Within the Expression datatype, use description element for a natural language summary of the expression, reference element for a uri or link to the expression, and/or expression element for a formal specification of the expression (coupled with the language element to specify the expression language used)."type": {"text": "estimated survival"}, "calculatedAs": {"description":"see the formula at the link", "reference":"https://www.mdcalc.com/calc/10053/binet-staging-system-chronic-lymphocytic-leukemia-cll#evidence"}6-0-0 in BRR meeting 2023-04-27
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definitionByTypeAndValue.value[x]1..1CodeableConcept | boolean | Quantity | Range | Reference() | canonical() | ExpressionThe value in an attribute-value pair defining the characteristicThe value that, coupled with the corresponding attribute, defines the characteristic.Need a formal way of identifying the value of the characteristic being described, used for characteristics defined with a single attribute, and the way of identifying the value must support many different datatypes."valueRange": {
"low": {
"value": 30,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
},
"high": {
"value": 67,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
}
}		https://fevir.net/resources/Characteristic/1119726-0-0 in BRR meeting 2023-04-27
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definitionByTypeAndValue.offset0..1CodeableConceptReference point for value defined as distance from a pointA reference point that is used, typically in conjunction with valueQuantity or valueRange, to fully specify the value as an amount or distance from the reference point.Hemoglobin concentration may have a value of 9 g/dL, or a value of 1 g/dL below the lower normal limit. The latter expression requries an 'offset' to represent the concept of the lower normal limit.6-0-0 in BRR meeting 2023-04-27
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definitionByCombination0..1BackboneElementUsed to specify how two or more characteristics are combinedDefines the characteristic as a combination of two or more characteristics.Many cohort definitions require combinations of characteristics, including component characterstics that are defined by combinations of characteristics.No more than one of definitionReference, definitionUri, definitionCodeableConcept, definitionByTypeAndValue, and definitionByCombination may have a value.All of: Age 18 yrs or older, Encounter with hospitalization for acute coronary syndrome, treatment with oral anticoagulanthttps://fevir.net/resources/Characteristic/1127256-0-0 in BRR meeting 2023-04-27
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definitionByCombination.code1..1code all-of | any-of | at-least | at-most | except-subset | statisticalUsed to specify the method of combination of characteristics.If code is "at-least" or "at-most" then threshold SHALL be used. If code is "all-of" or "any-of" then threshold SHALL NOT be used.If code is "at-least" or "at-most" then threshold SHALL be used. If code is "all-of" or "any-of" then threshold SHALL NOT be used.6-0-0 in BRR meeting 2023-05-04
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definitionByCombination.threshold0..1positiveIntProvides the value of "n" when "at-least" or "at-most" codes are usedProvides the value of "n" when "at-least" or "at-most" codes are used.If code is "at-least" or "at-most" then threshold SHALL be used. If code is "all-of" or "any-of" then threshold SHALL NOT be used.6-0-0 in BRR meeting 2023-05-04
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definitionByCombination.characteristic2..*Reference(Characteristic)A characteristic that is being combinedA characteristic that is being combined with one or more other characteristics.6-0-0 in BRR meeting 2023-05-04
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instances[x]0..1Quantity | RangeNumber of occurrences meeting the characteristicNumber of occurrences meeting the characteristic.Units are set to 1.6-0-0 in BRR meeting 2023-05-04
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duration[x]0..1Quantity | RangeLength of time in which the characteristic is metLength of time in which the characteristic is met.For example, a characteristic of "having at least 6 months of experiencing dialysis at least 3 months prior to enrollment" would have a durationQuantity element to represent "at least 6 months of"Units are set to measures of time.6-0-0 in BRR meeting 2023-05-04
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timeFromEvent0..*BackboneElementTiming in which the characteristic is determinedTiming in which the characteristic is determined.The timing when the characterstic value is determined is different than the timing as frequency of occurence (instances[x]) or the duration of how long the characteristic value is present (duration[x]) or a measure of an attribute defining the characteristic (definitionByTypeAndValue).For example, a characteristic of "having at least 6 months of experiencing dialysis at least 3 months prior to enrollment" would have a timeFromEvent element to represent "at least 3 months prior to enrollment"6-0-0 in BRR meeting 2023-05-04
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timeFromEvent.description0..1markdownNatural language description of the timingA human readable narrative summarizing the timing in which the characteristic is determined.6-0-0 in BRR meeting 2023-05-04
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timeFromEvent.note0..*AnnotationAdditional or explanatory noteA human-readable string to clarify or explain concepts about the timeFromEvent.6-0-0 in BRR meeting 2023-05-04
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timeFromEvent.event[x]0..1CodeableConcept | Reference() | dateTimeThe event used as a base point (reference point) in timeThe event used as a base point (reference point) in time.Use dateTime when expressing timeFromEvent as a time point on the calendar. For example, a characteristic of "having at least 6 months of experiencing dialysis at least 3 months prior to enrollment" would have a timeFromEvent.eventCodeableConcept element to represent "enrollment" (dialysis may be represented in the characteristic.definitionCodeableConcept or characteristic.definitionByTypeAndValue element)6-0-0 in BRR meeting 2023-05-04
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timeFromEvent.quantity0..1QuantityUsed to express the observation at a defined amount of time before or after the eventUsed to express the observation at a defined amount of time before or after the event.Use value=0 to specify "At" the moment of the event. Positive values mean "after" and negative values mean "before" the event. For example, a characteristic of "having at least 6 months of experiencing dialysis at least 3 months prior to enrollment" would have a timeFromEvent.quantity element to represent "at least 3 months prior" with a value of "<= -3 months" (at least 3 months AFTER would be ">= 3 months"; 'at least BEFORE' requires a < comparator, i.e. -4 months is before -3 months)Units are set to measures of time. Units are unnecessary if value=0.6-0-0 in BRR meeting 2023-05-04
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timeFromEvent.range0..1RangeUsed to express the observation within a period before and/or after the eventUsed to express the observation within a period before and/or after the event.Use value=0 to specify "At" the moment of the event. Positive values mean "after" and negative values mean "before" the event. See additional comments under timeFromEvent.quantityUnits are set to measures of time. Units are unnecessary if value=0.6-0-0 in BRR meeting 2023-05-04
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executableExpression0..*BackboneElementAn expression plus metadataAn executable expression with or without classifier(s).When exchanging data for expression instances, there is a need to include metadata, such as classifiers of the expression, that are not found in the Expression datatype.6-0-0 in BRR meeting 2023-05-04
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executableExpression.classifier0..*CodeableConceptA categorization of the expressionA categorization of the executable expression.Examples may include use context (e.g. US-based model for race/ethnicity data exchange), technology compatibility expectations, or keywords for search support.6-0-0 in BRR meeting 2023-05-04
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executableExpression.expression1..1ExpressionAn expression that generates a valueAn expression that generates a value.6-0-0 in BRR meeting 2023-05-04
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