ARCHETYPE Medical device screening questionnaire (openEHR-EHR-OBSERVATION.device_screening.v0)

Name: Medical device screening questionnaire
License: http://creativecommons.org/licenses/by-sa/4.0/

ARCHETYPE ID	openEHR-EHR-OBSERVATION.device_screening.v0
Concept	Medical device screening questionnaire
Description	Series of questions and associated answers used to screen for the presence of implanted medical devices or use of assistive aids.
Use	Use to create a framework for recording answers to pre-defined screening questions about the presence of implanted devices or use of assistive aids. Common use cases include, but are not limited to: - Screening for implanted devices before an MRI test. - Checklist questions about whether the individual uses any assistive devices on admission to hospital. The initial question about any medical device use is focused on implanted devices due to the clinical safety implications, especially when undergoing imaging examinations. Examples of implanted medical devices include, but are not limited to: - cochlear implant; - pacemaker; - aneurysm clips; - joint replacement; - heart valve; - coronary stent; - bone fixation device eg screws or plates; - deep brain stimulator; or - intraocular lens. Examples of assistive aids include, but are not limited to: - wheelchair; - walking stick; - hearing aid; - reading glasses; - prosthetic limb; - braille reader; - speech generating device; or - medication organiser or dispenser. The semantics of this archetype are intentionally loose, and querying this archetype would normally only be useful or safe within the context of each specific template. In a template, each data element would usually be renamed to the specific question asked. Where value sets have been proposed for common use cases, these can be adapted for local use by using the DV_TEXT or the DV_BOOLEAN datatypes choice to match each specific use case. The EVENT structure from the reference model can be used to specify whether the questions relate to a point in time or over a period of time. Use a separate instance of the EVENT structure to distinguish between a questions related to different timeframes, such as 'ever', 'now' and in a specified interval of time - for example, the difference between "Have you ever used a hearing aid?", "Do you currently use a hearing aid?" and "Have you used a hearing aid in the past year?" The source of the information in a questionnaire response may vary in different contexts but can be specifically identified using the 'Information provider' element in the Reference Model. This archetype has been designed to be used as a screening tool or to record simple questionnaire-format data for use in situations such as a disease registry. If the screening questionnaire identifies the presence or usage of a medical device, it is recommended that the clinical system record and persist the specific details about the device using EVALUATION.device_summary.
Misuse	Not to be used to record answers to pre-defined screening questions about surgical/operative procedures when a medical device was implanted. Use the OBSERVATION.procedure_screening for this purpose. Not to be used to record answers to pre-defined screening questions about medications that have been implanted. Use the OBSERVATION.medication_screening for this purpose.
Purpose	To create a framework for recording answers to pre-defined screening questions about the presence of implanted medical devices or use of assistive devices.
References
Copyright	© openEHR Foundation
Authors	Author name: Silje Ljosland Bakke Organisation: Helse Vest IKT AS Email: silje.ljosland.bakke@helse-vest-ikt.no Date originally authored: 2021-11-15
Other Details Language	Author name: Silje Ljosland Bakke Organisation: Helse Vest IKT AS Email: silje.ljosland.bakke@helse-vest-ikt.no Date originally authored: 2021-11-15
OtherDetails Language Independent	{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=BC3DC35D69FDF6D0F376A5FCA3D2BBAD, build_uid=c92c214d-65b3-438c-86c2-040015683795, ip_acknowledgements=This artefact includes content from SNOMED Clinical Terms® (SNOMED CT®) which is copyrighted material of the International Health Terminology Standards Development Organisation (IHTSDO). Where an implementation of this artefact makes use of SNOMED CT content, the implementer must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/snomed-ct/get-snomed or info@snomed.org., revision=0.0.1-alpha}
Keywords	device, implant
Lifecycle	in_development
UID	282caf50-ac9d-4be4-a24d-134afc00336a
Language used	en
Citeable Identifier	1013.1.5844
Revision Number	0.0.1-alpha
All	Archetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Series of questions and associated answers used to screen for the presence of implanted medical devices or use of assistive aids., archetypeConceptComment=The answers may be self-reported., otherContributors=Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor) Ian McNicoll, freshEHR Clinical Informatics, UK Heather Leslie, Atomica Informatics, Australia (openEHR Editor), originalLanguage=en, translators= German: Natalia Strauch, Nina Schewe, Medizinische Hochschule Hannover, Strauch.Natalia@mh-hannover.de, schewe.nina@mh-hannover.de Norwegian Bokmål: Marit Alice Venheim, Silje Ljosland Bakke, John Tore Valand, Helse Vest IKT, Helse Vest IKT AS, Helse Bergen, marit.alice.venheim@helse-vest-ikt.no, silje.ljosland.bakke@helse-vest-ikt.no, john.tore.valand@helse-bergen.no, john.tore.valand@helse-vest-ikt.no , subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={state=[], contacts=[], details=[], description=[], content=[], provider=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0034], code=at0034, itemType=ELEMENT, level=4, text=Screening purpose, description=The reason for overall screening., comment=For example: screening prior to a Magnetic Resonance Imaging examination., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0028], code=at0028, itemType=ELEMENT, level=4, text=Any implanted medical device?, description=Presence of any implanted devices., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of: Coded Text at0031::Yes [SNOMED-CT::373066001 \| Yes] at0032::No [SNOMED-CT::373067005 \| No] at0033::Unknown [SNOMED-CT::261665006 \| Unknown] Text , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022], code=at0022, itemType=CLUSTER, level=4, text=Implanted device screening, description=Screening details about the presence of a specific implanted medical device., comment=For example: cochlear implant; pacemaker; joint replacement; heart valve; coronary stent; bone fixation device eg screws or plates; deep brain stimulator; intraocular lens; or contraceptive device., uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=1.., cardinalityText= (Cardinality: 1.., unordered), subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0004], code=at0004, itemType=ELEMENT, level=5, text=Device name, description=Name of the implanted medical device or device type being screened., comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0005], code=at0005, itemType=ELEMENT, level=5, text=Presence?, description=Presence of the implanted device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:* Coded Text at0023::Yes [The specific device is present or being used.] [SNOMED-CT::373066001 \| Yes] at0024::No [The specific device is not present or being used.] [SNOMED-CT::373067005 \| No] at0027::Unknown [It is not known whether the device is present or absent.] [SNOMED-CT::261665006 \| Unknown] Text Boolean , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0040], code=at0040, itemType=ELEMENT, level=5, text=Description, description=Narrative description about the implanted device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0050], code=at0050, itemType=ELEMENT, level=5, text=Timing, description=Indication of timing related to the implanted device., comment=The 'Timing' data element has deliberately been loosely modelled to support the myriad of ways that it can be used in questionnaires to capture when a medical device was implanted. The specific and intended semantics can be further clarified in a template. For example: the actual date and/or time; the dates when the implant was inserted or removed; the interval of time during which the implant was inserted; the implant duration; the age of the individual at the time the implant was inserted; or the duration of time since it was inserted or removed. A partial date is valid, using the DV_DATE_TIME data type, to record only a year., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of: Text Date/Time Interval of Date/Time Interval of Duration Duration , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0039], code=at0039, itemType=SLOT, level=5, text=Screening details, description=Additional details or questions about the implanted device., comment=null, uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:* openEHR-EHR-CLUSTER.device.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0022]/items[at0025], code=at0025, itemType=ELEMENT, level=5, text=Comment, description=Additional narrative about the implanted device, not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041], code=at0041, itemType=CLUSTER, level=4, text=Assistive aid screening, description=Screening details about the use of a specific assistive medical device., comment=For example: wheelchair; walking stick; hearing aid; reading glasses; prosthetic limb; braille reader; speech generating device or medication organiser., uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=1.., cardinalityText= (Cardinality: 1.., unordered), subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041]/items[at0042], code=at0042, itemType=ELEMENT, level=5, text=Aid name, description=Name of the medical device or device type being screened., comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041]/items[at0043], code=at0043, itemType=ELEMENT, level=5, text=Presence?, description=Usage of the assistive aid., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:* Coded Text at0044::Yes [The specific device is present or being used.] [SNOMED-CT::373066001 \| Yes] at0045::No [The specific device is not present or being used.] [SNOMED-CT::373067005 \| No] at0046::Unknown [It is not known whether the device is present or absent.] [SNOMED-CT::261665006 \| Unknown] Text , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041]/items[at0047], code=at0047, itemType=ELEMENT, level=5, text=Description, description=Narrative description about the assistive aid., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041]/items[at0048], code=at0048, itemType=SLOT, level=5, text=Screening details, description=Additional details or questions about the assistive aid., comment=null, uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:* openEHR-EHR-CLUSTER.device.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/events[at0002]/data[at0003]/items[at0041]/items[at0049], code=at0049, itemType=ELEMENT, level=5, text=Comment, description=Additional narrative about the assistive aid, not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], identities=[], other_participations=[], activities=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0007]/items[at0021], code=at0021, itemType=SLOT, level=2, text=Extension, description=Additional information required to extend the model with local content or to align with other reference models or formalisms., comment=For example: local information requirements; 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