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Biomedical Research and Regulation Work Group | Maturity Level: 2 | Trial Use | Security Category: Anonymous | Compartments: No defined compartments |
Detailed Descriptions for the elements in the ClinicalUseDefinition resource.
ClinicalUseDefinition | |||||||||
Element Id | ClinicalUseDefinition | ||||||||
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. | ||||||||
Short Display | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure | ||||||||
Cardinality | 0..* | ||||||||
Type | DomainResource | ||||||||
Summary | false | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.identifier | |||||||||
Element Id | ClinicalUseDefinition.identifier | ||||||||
Definition | Business identifier for this issue. | ||||||||
Short Display | Business identifier for this issue | ||||||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||||||
Cardinality | 0..* | ||||||||
Type | Identifier | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.type | |||||||||
Element Id | ClinicalUseDefinition.type | ||||||||
Definition | indication | contraindication | interaction | undesirable-effect | warning. | ||||||||
Short Display | indication | contraindication | interaction | undesirable-effect | warning | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Clinical Use Definition Type (Required) | ||||||||
Type | code | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.category | |||||||||
Element Id | ClinicalUseDefinition.category | ||||||||
Definition | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines". | ||||||||
Short Display | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | Clinical Use Definition Category (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.subject | |||||||||
Element Id | ClinicalUseDefinition.subject | ||||||||
Definition | The medication, product, substance, device, procedure etc. for which this is an indication. | ||||||||
Short Display | The medication, product, substance, device, procedure etc. for which this is an indication | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.status | |||||||||
Element Id | ClinicalUseDefinition.status | ||||||||
Definition | Whether this is a current issue or one that has been retired etc. | ||||||||
Short Display | Whether this is a current issue or one that has been retired etc | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | PublicationStatus (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication | |||||||||
Element Id | ClinicalUseDefinition.contraindication | ||||||||
Definition | Specifics for when this is a contraindication. | ||||||||
Short Display | Specifics for when this is a contraindication | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as contraindicating against this item. | ||||||||
Short Display | The situation that is being documented as contraindicating against this item | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Disease Symptom Procedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.diseaseStatus | |||||||||
Element Id | ClinicalUseDefinition.contraindication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic". | ||||||||
Short Display | The status of the disease or symptom for the contraindication | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Disease Status (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.comorbidity | |||||||||
Element Id | ClinicalUseDefinition.contraindication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection. | ||||||||
Short Display | A comorbidity (concurrent condition) or coinfection | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | Disease Symptom Procedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.indication | |||||||||
Element Id | ClinicalUseDefinition.contraindication.indication | ||||||||
Definition | The indication which this is a contraidication for. | ||||||||
Short Display | The indication which this is a contraidication for | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.applicability | |||||||||
Element Id | ClinicalUseDefinition.contraindication.applicability | ||||||||
Definition | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements. | ||||||||
Short Display | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | ||||||||
Cardinality | 0..1 | ||||||||
Type | Expression | ||||||||
Summary | false | ||||||||
Comments | The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element. | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the contraindication. | ||||||||
Short Display | Information about use of the product in relation to other therapies described as part of the contraindication | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | ||||||||
Definition | The type of relationship between the medicinal product indication or contraindication and another therapy. | ||||||||
Short Display | The type of relationship between the product indication/contraindication and another therapy | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Therapy Relationship Type (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy.treatment | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy.treatment | ||||||||
Definition | Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication. | ||||||||
Short Display | Reference to a specific medication, substance etc. as part of an indication or contraindication | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Therapy (Example) | ||||||||
Type | CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication | |||||||||
Element Id | ClinicalUseDefinition.indication | ||||||||
Definition | Specifics for when this is an indication. | ||||||||
Short Display | Specifics for when this is an indication | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.indication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseDefinition.indication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as an indicaton for this item. | ||||||||
Short Display | The situation that is being documented as an indicaton for this item | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Disease Symptom Procedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.diseaseStatus | |||||||||
Element Id | ClinicalUseDefinition.indication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the indication, for example "chronic" or "metastatic". | ||||||||
Short Display | The status of the disease or symptom for the indication | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Disease Status (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.comorbidity | |||||||||
Element Id | ClinicalUseDefinition.indication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection as part of the indication. | ||||||||
Short Display | A comorbidity or coinfection as part of the indication | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | Disease Symptom Procedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.intendedEffect | |||||||||
Element Id | ClinicalUseDefinition.indication.intendedEffect | ||||||||
Definition | The intended effect, aim or strategy to be achieved. | ||||||||
Short Display | The intended effect, aim or strategy to be achieved | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Product Intended Use (Preferred) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.duration[x] | |||||||||
Element Id | ClinicalUseDefinition.indication.duration[x] | ||||||||
Definition | Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months). | ||||||||
Short Display | Timing or duration information | ||||||||
Cardinality | 0..1 | ||||||||
Type | Range|string | ||||||||
[x] Note | See Choice of Datatypes for further information about how to use [x] | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.undesirableEffect | |||||||||
Element Id | ClinicalUseDefinition.indication.undesirableEffect | ||||||||
Definition | An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication. | ||||||||
Short Display | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.applicability | |||||||||
Element Id | ClinicalUseDefinition.indication.applicability | ||||||||
Definition | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements. | ||||||||
Short Display | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements | ||||||||
Cardinality | 0..1 | ||||||||
Type | Expression | ||||||||
Summary | false | ||||||||
Comments | The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element. | ||||||||
ClinicalUseDefinition.indication.otherTherapy | |||||||||
Element Id | ClinicalUseDefinition.indication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the indication. | ||||||||
Short Display | The use of the medicinal product in relation to other therapies described as part of the indication | ||||||||
Cardinality | 0..* | ||||||||
Type | See ClinicalUseDefinition.contraindication.otherTherapy | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction | |||||||||
Element Id | ClinicalUseDefinition.interaction | ||||||||
Definition | Specifics for when this is an interaction. | ||||||||
Short Display | Specifics for when this is an interaction | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.interaction.interactant | |||||||||
Element Id | ClinicalUseDefinition.interaction.interactant | ||||||||
Definition | The specific medication, product, food, substance etc. or laboratory test that interacts. | ||||||||
Short Display | The specific medication, product, food etc. or laboratory test that interacts | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.interactant.item[x] | |||||||||
Element Id | ClinicalUseDefinition.interaction.interactant.item[x] | ||||||||
Definition | The specific medication, product, food, substance etc. or laboratory test that interacts. | ||||||||
Short Display | The specific medication, product, food etc. or laboratory test that interacts | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Interactant (Example) | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition)|CodeableConcept | ||||||||
[x] Note | See Choice of Datatypes for further information about how to use [x] | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.type | |||||||||
Element Id | ClinicalUseDefinition.interaction.type | ||||||||
Definition | The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction. | ||||||||
Short Display | The type of the interaction e.g. drug-drug interaction, drug-lab test interaction | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Interaction Type (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.effect | |||||||||
Element Id | ClinicalUseDefinition.interaction.effect | ||||||||
Definition | The effect of the interaction, for example "reduced gastric absorption of primary medication". | ||||||||
Short Display | The effect of the interaction, for example "reduced gastric absorption of primary medication" | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Interaction Effect (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.incidence | |||||||||
Element Id | ClinicalUseDefinition.interaction.incidence | ||||||||
Definition | The incidence of the interaction, e.g. theoretical, observed. | ||||||||
Short Display | The incidence of the interaction, e.g. theoretical, observed | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Interaction Incidence (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.management | |||||||||
Element Id | ClinicalUseDefinition.interaction.management | ||||||||
Definition | Actions for managing the interaction. | ||||||||
Short Display | Actions for managing the interaction | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | Interaction Management (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.population | |||||||||
Element Id | ClinicalUseDefinition.population | ||||||||
Definition | The population group to which this applies. | ||||||||
Short Display | The population group to which this applies | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(Group) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.library | |||||||||
Element Id | ClinicalUseDefinition.library | ||||||||
Definition | Logic used by the clinical use definition. | ||||||||
Short Display | Logic used by the clinical use definition | ||||||||
Cardinality | 0..* | ||||||||
Type | canonical(Library) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect | ||||||||
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. | ||||||||
Short Display | A possible negative outcome from the use of this treatment | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | ||||||||
Definition | The situation in which the undesirable effect may manifest. | ||||||||
Short Display | The situation in which the undesirable effect may manifest | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Undesirable Effect Symptom (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect.classification | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.classification | ||||||||
Definition | High level classification of the effect. | ||||||||
Short Display | High level classification of the effect | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Undesirable Effect Classification (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | ||||||||
Definition | How often the effect is seen. | ||||||||
Short Display | How often the effect is seen | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Undesirabl Effect Frequency (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.warning | |||||||||
Element Id | ClinicalUseDefinition.warning | ||||||||
Definition | A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'. | ||||||||
Short Display | Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.warning.description | |||||||||
Element Id | ClinicalUseDefinition.warning.description | ||||||||
Definition | A textual definition of this warning, with formatting. | ||||||||
Short Display | A textual definition of this warning, with formatting | ||||||||
Cardinality | 0..1 | ||||||||
Type | markdown | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.warning.code | |||||||||
Element Id | ClinicalUseDefinition.warning.code | ||||||||
Definition | A coded or unformatted textual definition of this warning. | ||||||||
Short Display | A coded or unformatted textual definition of this warning | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | Warning Type (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true |