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Comparison of allergies and intolerances data models Aim: to study similarities and differences between data models proposed by various countries and standards development organizations to record allergies and intolerances Information sources: HL7 Patient Care Work Group (HL7PC), HL7 Structured Documents Work Group (HL7SD), UK NHS Connecting for Health (UKCFH), UK Health & Social Care Information Centre (UKHSC), US Federal Health Information Model (FHIM), Canada Allergy Intolerance Draft Model (CAN), EU epSOS Selection of code systems for the Master Value Catalogue document (EUEP), IHTSDO Allergic state – Immune hypersensitivity disorder project document (IHTSDOPD) Domain terms and definitions Term Hypersensitivity Allergy Pseudoallergy Intolerance Condition (used in combination with hypersensitivity, allergy, pseudoallergy and intolerance) Disposition (used in combination with hypersensitivity, allergy, pseudoallergy and intolerance) Definition Objectively reproducible symptoms or signs initiated by exposure to a defined stimulus at a dose tolerated by normal persons Allergy is a type of immune-mediated hypersensitivity in which the immune response is generally directed towards a foreign antigen and which results in tissue injury, which is usually transient A nonimmune hypersensitivity generally directed towards a foreign substance, which results in tissue injury, which is usually transient A non-immunological adverse physiological sensitivity to a substance. It may be manifested by an inability to endure, withstand, absorb, or metabolize a substance (e.g. lactose). Can be a disposition or manifestation of such a disposition Source IHTSDOPD The disposition or propensity for a reaction IHTSDOPD (modified) comments Similar to adverse sensitivity, subsumes allergy, pseudoallergy and intolerance IHTSDOPD IHTSDOPD (modified) considered a type of intolerance in this document HL7PC IHTSDOPD (modified) Subsumes disposition and reaction Reaction (used in combination with hypersensitivity, allergy, pseudoallergy and intolerance) Adverse reaction The pathological process triggered by exposure to a defined stimulus in a patient with such disposition IHTSDOPD (modified) An undesirable physiological effect resulting from exposure to a substance HL7PC Subsumes reactions due to hypersensitivity, allergy, pseudoallergy and intolerance Overview This analysis uses the HL7 Patient Care Work Group (HL7PC) model as the basis for comparison, because it is the most comprehensive and most recent. The places where other models overlap with or differ from the HL7PC model are highlighted. The centerpiece of the HL7PC model is the Adverse Sensitivity to Substances Record, which documents the hypersensitivity disposition of a patient. Each hypersensitivity disposition may or may not be substantiated (or refuted) by one or more Adverse Reaction Record or Sensitivity Test Record. The following tables show the data elements in each record. Only data elements that are specific to this use case are included. Generic data elements such as date/time, patient and practitioner identifiers are omitted. Names of some data elements are modified for readability. To simplify the comparison, the data elements allocated to related entities in the HL7PC UML model are incorporated into the 3 principle records. Highlighted in red are those data elements not found in the HL7PC model. Adverse Sensitivity to Substances Record – documents disposition to adverse reactions Data element Substance Sensitivity type Certainty Description A substance is a physical material which can mean a drug or biologic, food, chemical agent, plants, animals, plastics etc. indicates whether this sensitivity is of an allergic nature or an intolerance to a substance. An allergy could be further categorized as: Confirmed - via laboratory testing or witnessed observation or other strong evidence, or Suspected (Unconfirmed) Patient reported but not further verified by Found in other models all comments UKCFH, UKHSC, FHIM, CAN UKCFH, UKHSC, CAN, FHIM Certainty is not in the HL7PC UML diagram but is mentioned in the glossary appendix clinical history, diagnostic testing or is uncertain. Criticality The potential seriousness of a future reaction. This represents a clinical judgment about the worst case scenario for a future reaction. It would be based on the severity of past reactions, the dose and route of exposure that produced past reactions, and the life-threatening or organ system threatening potential of the reaction type. Criticality is an attribute of the allergic condition, not the reaction(s). Condition status indicates the current status of the concern Substance type Drug, food, environment, vaccine etc. Probability of recurrence Probability of the reaction (allergic, adverse, intolerant) occurring IsAbsolutelyContradindic ated FHIM Not the same as severity of the reaction, because a severe reaction can be non-critical and vice versa. A Boolean flag is proposed, as gradation of criticality is deemed implausible. HL7SD, CAN, FHIM FHIM,CAN UKHSC FHIM Can this be rolled under criticality? Adverse Reaction Record – documents the observed effect resulting from exposure to a substance. Data element Substance didNotOccurFlag Reaction manifestation Severity Exposure type Description A substance is a physical material which can mean a drug or biologic, food, chemical agent, plants, animals, plastics etc. indicates that, although the patient came in contact with the substance, a reaction did not occur. indicates the specific adverse reaction that occurred. Example: Rash, Hives How severe the reaction was how the exposure occurred. Example: Vaccination, Prescription Administration, Found in other models all comments Can be used to document an exception to sensitivity to a class of drugs all HL7SD, UKHSC, CAN Type of reaction Observation method Reliability Accidental Allergic reaction or intolerance UKCFH FHIM FHIM Sensitivity Test Record – document specific sensitivity test associated with an adverse sensitivity Data element Sensitivity test Test result Evidence supporting categorization of type of reaction Description Sensitivity test performed Sensitivity test result Results of immunological or other investigations Found in other models UKCFH UKCFH UKCFH comments Can differentiate between allergic and non-allergic reactions