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cimi.adverse

The CIMI Adverse domain contains definitions for describing adverse events and adverse reactions.

ActionTaken

The action taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.

Details required An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.

AdverseEventAttribution

A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause. Adverse Event Attribution to Product or ProcedurePerformed (C1510821)

Value:  Choice required
         |  CodeableConcept should be from http://hl7.org/fhir/ValueSet/substance-code
A set of codes drawn from different coding systems, representing the same concept.
         |  Substance Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
         |  ActionPerformedStatement Abstract class representing performance of any type of action.
Certainty required The degree of confidence in a conclusion or assertion.
RouteIntoBody optional The way a substance enters an organism after contact, particularly, the route of drug administration.

AdverseEventGrade

A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system. C2985911

Value:  CodeableConcept must be from AdverseEventGradeVS
A set of codes drawn from different coding systems, representing the same concept.

AdverseEventPresenceContext

The context for an adverse event that is known, suspected, or possibly occurred.

Based On PresenceContext

AdverseEventGrade required A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system.
SeriousAdverseEvent optional Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.
Outcome must be from http://hl7.org/fhir/ValueSet/adverse-event-outcome
optional The result of performing an action or behavior, for example, an adverse reaction or new finding.
CauseCategory required Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.
AdverseEventAttribution 0 or more A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause.
ActionTaken 0 or more The action taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.
ContextCode must be from PresenceContextVS
required A code representing the ontological status of the statement, e.g., whether it exists, does not exist, is planned, etc. Attribute aligns with the SNOMED CT Situation with Explicit Context (SWEC) Concept Model context attributes: 'Finding context (attribute)' (SCTID: 408729009) and 'Procedure context (attribute)' (SCTID: 408730004). The range allowed for this attribute shall be consistent with the SNOMED CT concept model specification for SWEC.
VerificationStatus required Whether an assessment has been confirmed by testing or observation. CIMI Alignment: This attribute corresponds to FindingContext.status, but has been defined to align with FHIR. In AllergyIntolerance, the type is code.
Onset optional The beginning or first appearance of a mental or physical disorder.
Abatement optional The end, remission or resolution.
Certainty optional The degree of confidence in a conclusion or assertion.
Encounter optional A description of an interaction between a patient and healthcare provider(s) for the purpose of providing healthcare service(s) or assessing the health status of a patient.

AdverseEventPresenceStatement [Entry]

The topic (independent of context) for any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): back pain, headache, pulmonary embolism, death. An AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out. C0877248

Based On ClinicalStatement

Signed optional
         where  EntityOrRole must be a PatientOrPractitionerOrRelatedPerson
StatementTopic must be a AdverseEventTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
StatementContext must be a AdverseEventPresenceContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

AdverseEventTopic

The topic (independent of context) for any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): back pain, headache, pulmonary embolism, death. An AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out.

Based On AssertionTopic

TopicCode must be from MedDRAVS
required The concept representing the finding or action that is the topic of the statement. For action topics, the TopicCode represents the action being described. For findings, the TopicCode represents the 'question' or property being investigated. For evaluation result findings, the TopicCode contains a concept for an observable entity, such as systolic blood pressure. For assertion findings, the TopicCode contains a code representing the condition, allergy, or other item being asserted. In all cases, the TopicCode describes the topic independent of the context of the action or the finding.
AssociatedStudy optional The related clinical trial or other formal study.
FindingMethod optional The technique used to create the finding; for example, the specific imaging technique, lab test code, or assessment vehicle. CIMI Alignment: In CIMI V0.0.4, this attribute was called 'method'. The value set binding reflects CIMI's preference for LOINC codes.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.

AssociatedStudy

The related clinical trial or other formal study.

Value:  Study A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

CauseCategory

Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.

Value:  CodeableConcept must be from AttributionCategoryVS
A set of codes drawn from different coding systems, representing the same concept.

NoAdverseEventStatement [Entry]

Documentation of a situation where no adverse event has been detected or is known. No adverse event (C1963761)

Based On ClinicalStatement

StatementTopic must be a AdverseEventTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
StatementContext must be a AbsenceContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Signed optional Provenance information specific to the signing of the clinical statement.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)

SeriousAdverseEvent

Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage. C1710056

Value:  CodeableConcept must be from YesNoUnknownVS
A set of codes drawn from different coding systems, representing the same concept.

ToxicReaction [Entry]

A grade 3 or 4 adverse reaction to medication, radiation treatment, or other therapy. C0542243

Based On AdverseEventPresenceStatement

Signed optional
         where  EntityOrRole must be a PatientOrPractitionerOrRelatedPerson
StatementTopic must be a AdverseEventTopic
required Compositional and reusable grouping of clinical statement attributes that make up the clinical focus of a statement. StatementTopic class attributes are aligned with SNOMED CT Concept Model attributes when such an overlap exists. Note that this class does not include contextual attributes such as the nature of the action (ordered, proposed, planned, etc...), the nature of the patient state being described (e.g., present, suspected present, absent), and the attribution of this information (the who, when, where, how, why of the information recorded).
StatementContext must be a AdverseEventPresenceContext
required Compositional and reusable grouping of clinical statement attributes that provides the context for the topic of a clinical statement. The StatementContext class aligns with the SNOMED CT Situations with Explicit Context (SWEC) Concept Model. The StatementContext provides the expressivity required to specify that an act was performed or not performed or that a finding was asserted to be present or absent for the given subject of information. It also often holds provenance information relevant to the context of the clinical statement. It is important to note that by default the context applies to the conjunction of the attribute specified in the statement. For instance, if a clinical statement has a topic describing a rash on left arm and a context of 'absent', then the statement states that the subject of interest did not have a rash on the left arm but might have had one on the right arm.
         where  AdverseEventPresenceContext
SubjectOfInformation required The person or thing that this entry relates to, usually the Person of Record (see Entry). However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, behavior, finding, condition, wound, or intervention. CIMI alignment: SubjectOfInformation is not a Participation -- unlike CIMI. There's no action to participate in. Participant has extra unnecessary attributes, such as 'onBehalfOf'.
SourceOfInformation optional The person or entity that provided the information in the entry, e.g. the subject (patient), medical professional, family member, device or software program, as distinct from who recorded the entry.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
RecordStatus optional Concept indicating the state of this record, e.g., 'entered in error'.
Recorded optional The person who entered the order on behalf of another individual for example in the case of a verbal or a telephone order.
Cosigned 0 or more Provenance information specific to the cosigning of the clinical statement.
Verified 0 or more Provenance information specific to the verification process associated with this statement (e.g., verifier, when verified, etc.)