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Adverse reaction risk (EHR Archetype) - openEHR-EHR-EVALUATION.adverse_reaction_risk.v1

- 7/8/17 - 1 form, 1 itemgroup, 37 items, 3 languages

Itemgroup: openEHR-EHR-EVALUATION.adverse_reaction_risk.v1.xml

Derived from www.openehr.org . Use to provide a single place within the health record to document a range of clinical statements about adverse reactions, including: - record a clinical assessment of the individual’s propensity for a potential future reaction upon re-exposure; and - record cumulative information about the reaction to each exposure. Use to record information about the positive presence of the risk of an adverse reaction: - to support direct clinical care of an individual; - as part of a managed adverse reaction or allergy/intolerance list; - to support exchange of information about the propensity and events related to adverse reactions; - to inform adverse reaction reporting; and - to assist computerised knowledge-based activities such as clinical decision support and alerts. Use to record information about the risk of adverse reactions to a broad range of substances, including: incipients and excipients in medicinal preparations; biological products; metal salts; and organic chemical compounds. Adverse reaction may be: - an immune mediated reaction - Types I-IV (including allergic reactions and hypersensitivities); or - a non-immune mediated reaction - including pseudo-allergic reactions, side effects, intolerances, drug toxicities (eg to Gentamicin). In clinical practice distinguishing between immune-mediated and non-immune mediated reactions is difficult and often not practical. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient, which is better expressed by the manifestation in clinical practice. The risk of an adverse reaction event or manifestation should not be recorded without identifying a proposed causative substance or class of substance. If there is uncertainty that a specific substance is the cause, this uncertainty can be recorded using the ‘Status’ data element. If there are multiple possible substances that may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction archetype with the ‘Status’ set to an initial state of ‘Suspected’ so that adverse reaction checking can be activated in clinical systems. Once the substance, agent or class is later proven not to be the cause for a given reaction then the ‘Status’ can be modified to ‘Refuted’. This archetype has been designed to allow recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (eg Penicillins). If a class of substance is recorded then identification of the exact substance can be recorded on a per exposure basis. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios, however it permits extension of the model when additional detail is required, for example 'Reaction details', 'Exposure details', and 'Reporting details' slots. Examples of clinical situations where the extension may be required include: a detailed allergist/immunologist assessment, for reporting to regulatory bodies or use in a clinical trial. The act of recording any adverse reaction risk in a health record involves the clinical assessment that a potential hazard exists for an individual if they are exposed to the same substance/agent/class in the future – that is, a relative contraindication - and the default ‘Criticality’ value should be set to ‘Low risk’. If a clinician considers that it is not safe for the individual to be deliberately re-exposed to the substance/agent again, for example, following a manifestation of a life-threatening anaphylaxis, then the 'Criticality' data element should be amended to ‘High’. A formal Adverse Event Report to regulatory bodies is a document that will contain a broad range of information in addition to the specific details about the adverse reaction. The report could utilise parts of this Risk of adverse reaction archetype plus include additional data as required per jurisdiction. An adverse reaction or allergy/intolerance list is a record of all identified propensities for an adverse reaction for the individual upon future exposure to the substance or class, plus provides potential access to the evidence provided by details about each reaction event, such as manifestation. Valuable first-level information that could be presented to the clinician when they need to assess propensity for future reactions are: - statements about previous clinical manifestations following exposure; - source of the information/reporter; and - the ‘Criticality’ flag. Second-level information can be drawn from each exposure event and links to additional detailed information such as history, examination and diagnoses stored elsewhere in the record, if it is available. This archetype is designed as one component of the therapeutic precautions family of archetypes that need to be considered when a clinician is about to commence a new treatment, test or procedure for an individual. Links to other parts of the health record where further details may be located, such as consultation notes, is allowed by the openEHR reference model, but not modelled explicitly in this archetype. The content of this archetype is a result of a collaboration between the openEHR and HL7 FHIR communities. FHIR specific content that was included as part of the peer review process has been removed from this openEHR archetype.

Adverse reaction list (EHR Archetype) - openEHR-EHR-COMPOSITION.adverse_reaction_list.v1

- 7/8/17 - 1 form, 1 itemgroup, 3 items, 3 languages

Itemgroup: openEHR-EHR-COMPOSITION.adverse_reaction_list.v1.xml

Derived from www.openehr.org . Use to record a persistent and managed list of all previous adverse reactions (including allergies, hypersensitivities, side effects or intolerances) experienced by the subject or, alternatively, positive statements about known exclusions or actual absence of any information about adverse reactions. This list can also be utilised as a source of up-to-date adverse reaction data for exchange or as the basis for decision support. This list can include three types of archetypes that record the clinical data: - positive statements about the occurrence of actual adverse reactions experienced by the subject during their lifetime are recorded using the EVALUATION.adverse_reaction archetype; OR - a positive statement about the exclusion of any previous known adverse reactions can be recorded using the specific EVALUATION.exclusion-adverse_reaction archetype - for example: "No known adverse reactions"; OR - a positive statement about no information being available - neither known previous adverse reactions nor known exclusions - can be recorded using the EVALUATION.absence archetype. In addition a SECTION archetype can be included as an organiser that will suit local jurisdictions and clinical practice. For example: SECTION.adverse_reaction. In order for this list to be accurate and safe to use as the basis for decision support activities and for exchange, this list should ideally be curated by a clinician responsible for the health record, rather than managed automatically by the clinical system through business rules alone. While it is reasonable for clinically verified adverse reactions to be persisted over time, the same approach does not apply to statements about exclusions or absence. They should only be regarded as valid at that they are recorded. For example recording a statement that the subject is not known to be allergic to penicillin is out-of-date as soon as the clinician gives the subject a dose of penicillin and they react. This archetype is usually managed as a persistent list, however there are situations where the list may be used within episodic care and require additional attributes such as context etc to enable accurate recording. The openEHR reference model currently only allows context to be recorded within Event-based COMPOSITION archetypes. As a result, this archetype has been modelled as an Event, rather than Persistent, COMPOSITION, to allow for flexibility so that some clinical systems can safely manage Adverse Reaction Lists for episodes of care, while others will choose to implement this COMPOSITION to act in a persistent manner.

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