ARCHETYPE Adverse Reaction (openEHR-EHR-EVALUATION.adverse_reaction.v5)

ARCHETYPE IDopenEHR-EHR-EVALUATION.adverse_reaction.v5
ConceptAdverse Reaction
DescriptionA harmful or undesirable effect associated with exposure to any substance or agent, including food, plants, animals, venom from animal stings or a medication at therapeutic or sub-therapeutic doses.
Use Use to record all information about adverse reactions (including allergic reactions) that are required to support direct clinical care of an individual, safe exchange of information about adverse reactions and to enable computerised knowledge-based activities such as clinical decision support and alerts. Use to provide a single place within the health record to record a range of clinical statements about adverse reactions, including: - record cumulative information about each exposure to a known substance, class of substance or agent; and - record a clinician's opinion that administration of, or exposure to, a substance or agent is absolutely contraindicated. Can also be used to record an individual's reflections on their adverse reactions. Use to record the information about an adverse reaction that might be exchanged with other systems, including as part of an adverse reaction report sent to statutory authorities. It is likely that a formal Adverse Reaction report will require additional information that will be captured in the health record using other data groups, for example medication and problem/diagnosis etc. This data group has been designed to allow recording of information about a more generic substance, class of substance or agent, and then allow more specific details to be recorded including identification of the specific substance on a per exposure basis, including links to other parts of the health record where further details may be located. Note: it is possible on second or subsequent exposures to a previously identified substance for a reaction not to occur and this data group allows for these events to be closely linked in a way that will assist in determining if the adverse reaction has been incorrectly identified. In addition, it is anticipated that in some very specific clinical situations, such as immunologist assessment or for use in clinical trials, more information about the adverse reaction may be required. Additional details can be added as cluster data groups using the ‘Further Exposure Details’ and ‘Further Reaction Details’ slots. Similarly, additional details that are required only for reporting can be added using the ‘Reporting Details’ slot. The act of recording an adverse reaction in the health record implies there is a potential hazard for the individual if they are exposed to the same substance/agent in the future - a relative contraindication. 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 anaphylaxis, the 'Absolute contraindication' data flag should be recorded as ‘True’. Note: Conversely, a statement about ‘Severity’ of propensity (with possible values such as Mild, Moderate and Severe) has deliberately not been modelled explicitly. Predicting or estimating the grade of possible severity of a future reaction is not safe to record and persist in data, except where it is absolutely clear that the risk of deliberate re-exposure is unacceptable and highly likely to cause significant harm, such as a previous manifestation of anaphylaxis, and in this case the ‘Absolute contraindication’ data flag should be used. 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 - a flag for absolute contra-indication. 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.
Misuse 1. Not to be used for recording the absence (or negative presence) of a reaction to 'any substances' or to identified substances – use the EVALUATION.exclusion family of data groups to express a positive statement of exclusion. 3. Not to be used for recording that no information was able to be obtained about the Adverse Reaction status of a patient. Use the EVALUATION.absent_information family of data group to record a positive statement of absent information about Adverse Reactions was able to be obtained, for example, if a non-cooperative patient refuses to answer questions. 5. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in administration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose, etc. 7. Not to be used for recording alerts.
Purpose To record health information that will inform a clinical assessment of the propensity of an individual for a future reaction to a substance, class of substance or agent. To record information about exposure events to a substance, building up a persisting and evolving summary over time. To record information about any adverse reaction, including: - immune mediated reactions Types I-IV (including allergic reactions and hypersensitivities), and - non-immune mediated reactions (including pseudoallergic reactions, side effects, intolerances, drug toxicities (e. g. Gentamycin), drug-drug interactions, food-drug interactions, drug-disease interactions and idiosyncratic reactions).
ReferencesDerived from: <Add reference to original resource here>
Copyright© openEHR Foundation
AuthorsAuthor name: Stephen Chu
Organisation: National E-Health Transition Authority
Email: clinicalinfo@nehta.gov.au
Date originally authored: 2010-11-08
Other Details LanguageAuthor name: Stephen Chu
Organisation: National E-Health Transition Authority
Email: clinicalinfo@nehta.gov.au
Date originally authored: 2010-11-08
OtherDetails Language Independent{custodian_organisation=Ocean Informatics, references=Derived from: , original_namespace=com.oceaninformatics, original_publisher=Ocean Informatics, custodian_namespace=com.oceaninformatics, MD5-CAM-1.0.1=936BD1AD298989E23B73FAD069A36F53, build_uid=ffb60c8e-4d77-42a8-abf8-5717360af3f0, revision=5.0.0-alpha}
Keywordsreaction, allergy, allergic, adverse, event, effect, sensitivity, intolerance, hypersensitivity, side effect, toxicity, interaction, drug, food, medication, agent, substance, immune, non-immune, chemical
Lifecyclein_development
UID0ddef6b1-79de-4b08-8d2d-2ff3e3901624
Language useden
Citeable Identifier1013.1.1778
Revision Number5.0.0-alpha
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=[NCTIS-OID::1.2.36.1.2001.1001.101.102.15517], archetypeConceptDescription=A harmful or undesirable effect associated with exposure to any substance or agent, including food, plants, animals, venom from animal stings or a medication at therapeutic or sub-therapeutic doses., archetypeConceptComment=null, otherContributors=Heather Leslie, NEHTA
John Bennett, NEHTA, Australia
Rong Chen, Cambio Healthcare System, Sweden
Stephen Chu, NEHTA, Australia (Editor)
Matthew Cordell, NEHTA, Australia
David Evans, Queensland Health, Australia
Shahla Foozonkhah, Ocean Informatics, Australia
Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia
Jacquie Garton-Smith, Royal Perth Hospital and DoHWA, Australia
Sarah Gaunt, NEHTA, Australia
Andrew Goodchild, NEHTA, Australia
Heather Grain, Llewelyn Grain Informatics, Australia
Trina Gregory, cpc, Australia
Grahame Grieve, Australia
Sam Heard, Ocean Informatics, Australia
Andrew James, University of Toronto, Canada
Julie James, Blue Wave Informatics LLP, United Kingdom
Ivor Jones, Queensalnd Helath, Australia
Mary Kelaher, NEHTA, Australia
Diane Kirkham, NEHTA, Australia
Robert L'egan, NEHTA, Australia
Jobst Landgrebe, ii4sm, Switzerland
Heather Leslie, Ocean Informatics, Australia (Editor)
Hugh Leslie, Ocean Informatics, Australia
Rikard Lovstrom, Swedish Medical Association, Sweden
Sarah Mahoney, Australia
Mike Martyn, The Hobart Anaesthetic Group, Australia
David McKillop, NEHTA, Australia
Ian McNicoll, Ocean Informatics, United Kingdom
Chris Mitchell, RACGP, Australia
Stewart Morrison, NEHTA, Australia
Jörg Niggemann, Compugroup, Germany
Chris Pearce, Melbourne East GP Network, Australia
General Practice Computing Group, Australia
Camilla Preeston, Royal Australian College of General Practitioners, Australia
Margaret Prichard, NEHTA, Australia
Jodie Pycroft, Adelaide Northern Division of General Practice Ltd, Australia
Cathy Richardson, NEHTA, Australia
Robyn Richards, NEHTA - Clinical Terminology, Australia
Thilo Schuler, Australia
Peter Scott, Medical Objects, Australia
Elena Shabanova, UMMSSOft, Russian Federation
Elizabeth Stanick, Hobart Anaesthetic Group, Australia
Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore
John Taylor, NEHTA, Australia
Gordon Tomes, Australian Institute of Health and Welfare, Australia
Richard Townley-O'Neill, NEHTA, Australia
Kylie Young, The Royal Australian College of General Practitioners, Australia, originalLanguage=en, translators=, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={events=[], context=[], capabilities=[], activities=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=Reaction Reported, description=Was the adverse reaction reported to a regulatory body?, comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16379-Reaction_Reported-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16379], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, text=Adverse Reaction Report, description=Link to an Adverse Reaction Report sent to a regulatory body., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16484-Adverse_Reaction_Report-Data_Element.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16484], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0047], code=at0047, itemType=ELEMENT, level=2, text=Supporting Clinical Record Information, description=Link to further information about about the presentation and findings that exist elsewhere in the health record., comment=Examples are presenting symptoms, examination findings, diagnosis., uncommonOntologyItems={detail_docref=data_elements/NEHTA-16485-Supporting_Clinical_Record_Information-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16485], values=, extendedValues=null]], identities=[], source=[], credentials=[], state=[], items=[], contacts=[], target=[], relationships=[], description=[], ism_transition=[], content=[], details=[], other_participations=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Substance/Agent, description=Identification of a substance, agent, or a class of substance, that is considered to be responsible for the adverse reaction., comment=It is preferred that this item be coded from the Substance/Agent Values Value Domain. An agent can be a substance such as food, drug or an environmental allergen. Examples: 1. Peanut 2. Penicillin 3. Bee venom 4. Animal protein 5. Latex, uncommonOntologyItems={detail_docref=data_elements/NEHTA-15521-Substance_Agent-Data_Element.xml, coding_preferred=true, value_domain_name=Substance/Agent Values, value_domain_dc_id=15521}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15521], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=Absolute Contraindication, description=A flag indicating that a clinician has identified a propensity for a serious reaction upon further exposure to the substance/agent., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16073-Absolute_Contraindication-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16073], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0006], code=at0006, itemType=ELEMENT, level=2, text=Comment, description=Additional narrative about the adverse reaction not captured in other fields, including reason for flagging an absolute contraindication, instructions related to future exposure or administration of the substance/agent., comment=Used to provide additional narrative information in relation to the adverse reaction such as finding site or route of administration., uncommonOntologyItems={fsn=Adverse Reaction Comment, detail_docref=data_elements/NEHTA-15590-Adverse_Reaction_Comment-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15590], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009], code=at0009, itemType=CLUSTER, level=2, text=Reaction Event, description=Details about each adverse reaction event., comment=null, uncommonOntologyItems={detail_docref=data_groups/NEHTA-16474-Reaction_Event-Data_Group.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.102.16474], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0010], code=at0010, itemType=ELEMENT, level=3, text=Specific Substance/Agent, description=Specific identification of the substance/agent considered to be responsible for the adverse reaction event., comment=It is preferred that this item be coded from the Substance/Agent Values Value Domain. This may include a medication trade name., uncommonOntologyItems={detail_docref=data_elements/NEHTA-16349-Specific_Substance_Agent-Data_Element.xml, coding_preferred=true, value_domain_name=Substance/Agent Values, value_domain_dc_id=15521}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16349], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0011], code=at0011, itemType=ELEMENT, level=3, text=Manifestation, description=Clinical manifestation of the adverse reaction expressed as a single word, phrase or brief description., comment=It is preferred that this item be coded from the Clinical Manifestation Values Value Domain. The signs, symptoms, severity and/or certainty of the adverse reaction are relevant as it contributes towards the decision as to the immediacy and extent of treatment to be provided, as determined by a healthcare provider. Given that an adverse reaction has occurred, it is important to determine the manifestations of that reaction. Examples: 1. Itchy eyes. 2. Dysphagia. 3. Tinnitus. 4. Nausea. 5. Rash., uncommonOntologyItems={detail_docref=data_elements/NEHTA-15564-Manifestation-Data_Element.xml, coding_preferred=true, value_domain_name=Clinical Manifestation Values, value_domain_dc_id=15564}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15564], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0016], code=at0016, itemType=ELEMENT, level=3, text=Reaction Type, description=The type of reaction, as determined by the clinician., comment=It is preferred that this item be coded from the Adverse Substance Reaction Type Values Value Domain. This field is used to identify the type of adverse reaction as determined by: the signs and/or symptoms experienced by the subject of care; information provided by a relevant individual; previously documented history; and/or a clinical assessment by a healthcare provider. Examples include Immune mediated - Types I-IV (including allergy and hypersensitivity); Non-immune mediated - including pseudoallergic reaction, side effect, intolerance, drug toxicity, drug-drug interaction, food-drug interaction, drug-disease interaction and idiosyncratic reaction. Examples: 1. Allergy. 2. Idiosyncracy. 3. Interactions. 4. Intolerance / sensitivity. 5. Pseudoallergy / anaphylactoid reaction. 6. Side effects., uncommonOntologyItems={detail_docref=data_elements/NEHTA-15554-Reaction_Type-Data_Element.xml, coding_preferred=true, value_domain_name=Adverse Substance Reaction Type Values, value_domain_dc_id=15554}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15554], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0021], code=at0021, itemType=ELEMENT, level=3, text=Certainty, description=Degree of certainty, as assessed by clinician, that the specific substance/agent was the cause of the reaction., comment=It is important to know the degree of certainty of an adverse reaction to an agent/substance as there may be instances where it is not clear whether it is the active agent or a secondary component causing the problem. For example, it may be the filler in a tablet that may be the allergen rather than the active drug. Another example is where there is suspicion of a reaction which warrants recording but it has not been confirmed objectively, or where a reaction has been recorded but is subsequently discounted following further observation and/or investigation. Examples: 1. Certain. 2. Probable. 3. Unlikely., uncommonOntologyItems={fsn=Adverse Reaction Certainty, detail_docref=data_elements/NEHTA-15568-Adverse_Reaction_Certainty-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15568], values=Constraint:
Adverse Reaction Certainty Values
The set of values for the degree of confidence that the agent/substance has caused the adverse reaction.
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0012], code=at0012, itemType=ELEMENT, level=3, text=Reaction Description, description=Narrative description of the reaction., comment=Examples: 1. Itchy eyes. 2. Dysphagia. 3. Tinnitus., uncommonOntologyItems={detail_docref=data_elements/NEHTA-15563-Reaction_Description-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15563], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0027], code=at0027, itemType=ELEMENT, level=3, text=Onset of Reaction, description=Record of the date and/or time of the onset of the reaction., comment=The date or date and time that the specific Reaction commenced. Sometimes, the date or age at which a person reacts to an agent is a relevant to understanding a condition, or to determining appropriate treatment. Often, this will be an approximate, self-reported age, date or datetime. Examples: (Please see), uncommonOntologyItems={fsn=Reaction Onset Date, detail_docref=data_elements/NEHTA-15507-Reaction_Onset_Date-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.15507], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0028], code=at0028, itemType=ELEMENT, level=3, text=Duration of Reaction, description=Length of duration of the reaction., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16352-Duration_of_Reaction-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16352], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0029], code=at0029, itemType=SLOT, level=3, text=Additional Reaction Detail, description=Additional detail about the reaction, including anatomical location., comment=null, uncommonOntologyItems={detail_docref=data_groups/NEHTA-16150-Additional_Reaction_Detail-Data_Group.xml, spec_id=108}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.102.16150.9.1], values=Include:
openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations
Exclude:
All not explicitly included archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0018], code=at0018, itemType=ELEMENT, level=3, text=Exposure Description, description=Description about exposure to the substance/agent., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16477-Exposure_Description-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16477], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0020], code=at0020, itemType=ELEMENT, level=3, text=Earliest Exposure, description=Record of the date and/or time of the earliest or initial exposure to the substance/agent., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16372-Earliest_Exposure-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16372], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0025], code=at0025, itemType=ELEMENT, level=3, text=Duration of Exposure, description=Length of duration of exposure., comment=Used to describe the length of exposure to substance/agent triggering a specific reaction event., uncommonOntologyItems={detail_docref=data_elements/NEHTA-16373-Duration_of_Exposure-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16373], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0019], code=at0019, itemType=SLOT, level=3, text=Additional Exposure Detail, description=Additional detail about exposure/s for this reaction event, including structured medication amount information., comment=null, uncommonOntologyItems={detail_docref=choices/NEHTA-16478-Additional_Exposure_Detail-Choice.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.105.16478], values=Include:
openEHR-EHR-CLUSTER.amount.v1 and specialisations Or
openEHR-EHR-CLUSTER.timing.v1 and specialisations Or
openEHR-EHR-CLUSTER.medication_admin.v1 and specialisations
Exclude:
All not explicitly included archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0040], code=at0040, itemType=ELEMENT, level=3, text=Clinical Management Description, description=Description about the clinical management provided., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16482-Clinical_Management_Description-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16482], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0031], code=at0031, itemType=ELEMENT, level=3, text=Multimedia, description=Inclusion of any multimedia file to support the recording of the reaction event., comment=An example is a photo of a rash or presentation with angioneurotic oedema., uncommonOntologyItems={detail_docref=data_elements/NEHTA-16376-Multimedia-Data_Element.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_MULTIMEDIA, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16376], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0041], code=at0041, itemType=SLOT, level=3, text=Reporting Details, description=Further details required for reporting to regulatory bodies., comment=null, uncommonOntologyItems={detail_docref=choices/NEHTA-16631-Reporting_Details-Choice.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.105.16631], values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Comment, description=Further comment about the reaction event., comment=null, uncommonOntologyItems={fsn=Adverse Reaction Event Comment, detail_docref=data_elements/NEHTA-16483-Adverse_Reaction_Event_Comment-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16483], values=, extendedValues=null]], provider=[]}, topLevelItems={protocol=ResourceSimplifiedHierarchyItem [path=ROOT_/protocol[at0042], code=at0042, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=1..*, subCardinalityText=, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null], data=ResourceSimplifiedHierarchyItem [path=ROOT_/data[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=1..*, subCardinalityText=, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=Reaction Reported, description=Was the adverse reaction reported to a regulatory body?, comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16379-Reaction_Reported-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16379], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, text=Adverse Reaction Report, description=Link to an Adverse Reaction Report sent to a regulatory body., comment=null, uncommonOntologyItems={detail_docref=data_elements/NEHTA-16484-Adverse_Reaction_Report-Data_Element.xml}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16484], values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0047], code=at0047, itemType=ELEMENT, level=2, text=Supporting Clinical Record Information, description=Link to further information about about the presentation and findings that exist elsewhere in the health record., comment=Examples are presenting symptoms, examination findings, diagnosis., uncommonOntologyItems={detail_docref=data_elements/NEHTA-16485-Supporting_Clinical_Record_Information-Data_Element.xml}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=[NCTIS-OID::1.2.36.1.2001.1001.101.103.16485], values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]