TEMPLATE Diagnostic tests for monitoring the treatment of wet AMD (Diagnostic tests for monitoring the treatment of wet AMD)

TEMPLATE ID	Diagnostic tests for monitoring the treatment of wet AMD
Concept	Diagnostic tests for monitoring the treatment of wet AMD
Description	Register the acquisition of the diagnostic tests contemplated in the high resolution consultation to monitor the treatment of wet AMD.
Purpose	Register the acquisition of the diagnostic tests contemplated in the high resolution consultation to monitor the treatment of wet AMD.
References
Authors	name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-29
Other Details Language	name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-29
Other Details (Language Independent)	MetaDataSet:Sample Set : Template metadata sample set Copyright: © openEHR Foundation Owner: Aitor Eguzkitza, aitor.eguzkiza@unavarra.es Speciality: Ophthalmology
Language used	en
Citeable Identifier	1013.26.119
Root archetype id	openEHR-EHR-COMPOSITION.progress_note.v1
Progress Note	Progress Note: Document used to record details of health-related events that have occurred as part of the subject's care, and/or the subject's health status, findings, opinions and plans that are current at the time of recording.
Visual acuity study	Visual acuity study: Defines the process which involves the visual acuity test and the subsequent study of results.
Procedure	Procedure: A clinical activity carried out for screening, investigative, diagnostic, curative, therapeutic, evaluative or palliative purposes.
Description
Procedure name	Procedure name: Identification of the procedure by name. Coding of the specific procedure with a terminology is preferred, where possible.
Description	Description: Narrative description about the procedure, as appropriate for the pathway step. For example: description about the performance and findings from the the procedure, the aborted attempt or the cancellation of the procedure.
Method	Method: Identification of specific method or technique for the procedure. Use this data element to record simple terms or a narrative description. If the requirements for recording the method require more complex modelling then this can be represented by additional archetypes within the 'Procedure detail' SLOT in this archetype. If the method is included in the 'Procedure name' via precoordinated codes, this data element becomes redundant.
Urgency	Urgency: Urgency of the procedure. Coding with a terminology is preferred, where possible.
Scheduled date/time	Scheduled date/time: The date and/or time on which the procedure is intended to be performed. Only for use in association with the 'Procedure scheduled' pathway step.
Final end date/time	Final end date/time: The date and/or time when the entire procedure, or the last component of a multicomponent procedure, was finished. Only for use in association with the 'Procedure performed' pathway step, and in situations where the procedure is repeated on multiple occasions before being completed or there are multiple components to the whole procedure. This may be the same as the RM time attribute for the 'Procedure completed' pathway step.
Total duration	Total duration: The total amount of time taken to complete the procedure, which may include time spent during the active phase of the procedure plus time during which the procedure was suspended. Only for use in association with the 'Procedure completed' pathway steps. >=PT0S
Procedure type	Procedure type: The type of procedure. This pragmatic data element may be used to support organisation within the user interface.
Reason	Reason: Reason that the activity or care pathway step for the identified procedure was carried out. For example: the reason for the cancellation or suspension of the procedure. Assessment of wet AMD Monitor the progression of chronic glaucoma
Comment	Comment: Additional narrative about the activity or care pathway step not captured in other fields.
Protocol
Requestor order identifier	Requestor order identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is equivalent to Placer Order Number in HL7 v2 specifications. Text Identifier
Receiver order identifier	Receiver order identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier. This is equivalent to Filler Order Number in HL7 v2 specifications. Text Identifier
Visual acuity	Visual acuity: Visual acuity is a measure of the spatial resolution of the visual processing system.
Data
Any event	Any event: Default, unspecified point in time or interval event which may be explicitly defined in a template or at run-time.
Data
Test Name	Test Name: The name of the exact visual acuity test performed. This generally represents a broad category of applied refraction. Specific refraction details can be described using 'Refractive Correction'. Details of the exact correction applied, or where multiple corrections should be captured via 'Refractive Correction'. Coded Text Pinhole visual acuity Usual corrected visual acuity Best corrected visual acuity Unaided visual acuity Text
Description	Description: An overall narrative description of the visual acuity test result.
Per Eye	Per Eye: Details of the visual field test result for each eye.
Eye Examined	Eye Examined: The eye which is being examined. Left eye Right eye Both eyes simultaneously
Absent Result	Absent Result: Details of a test result which could not be recorded. Details of reasons for an absent test result can be described in Additional Comment or Confounding Factors. Coded Text Not performed Not completed Text
Notation	Notation: Details of a visual acuity result recorded using one of the result notation formats.
Metric Snellen	Metric Snellen: The distance test result, recorded in Snellen format expressed in metres, where 6/6 is regarded as normal. Examples: '6/6, '6/12', '6/5' Ratio
US Snellen	US Snellen: The distance test result, recorded as Snellen visual acuity expressed in feet, where 20/20 is regarded as normal. Examples: '20/20' , '20/40', '20/18' Ratio
Decimal Snellen	Decimal Snellen: The distance test result,recorded as Sn ellen visual acuity expressed as a decimal ratio, where 1.0 is regarded as normal. Unitary
ETDRS Letters	ETDRS Letters: Visual acuity expressed using ETDRS Letters format, with a value of 100 regarded as normal. 1..120
logMar	logMar: The test result, recorded as logMar visual acuity, where a value of 0 is regarded as normal. -0.5..2
Low Vision Score	Low Vision Score: Graded scale used when patient has low levels of visual acuity. 1: NPL - No perception of light 2: PL - Perception of light 3: HM - Hand movement 4: CF - Count fingers
Letter Termination Adjustment	Letter Termination Adjustment: A line termination adjustment score applied to the visual acuity result. If the patient can read at least half of the chart line the visual acuity terminatin line is recorded as that line, with the number of letters missed on that line recorded as a negative Letter Termination Adjustment score. If the patient can read less than half of a Visual Acuity line, the previous line is recorded as the Visual Acuity result, with the number of letters seen on the following line recorded as a positive 'Letter Termination Adjustment' score. -10..10 Assumed value: 0
Derived Score	Derived Score: Visual acuity expressed as an integer score which is calculated from one or more of the other result notation formats. The original notation should be captured using 'Derived Score Original Notation' format'. Details of the algorithm used and original result format may be recorded under 'Derived Score Methodology'. >=0
Interpretation	Interpretation: The test result expressed as a qualitative term, normally coded. Example: 'Visual Acuity 20/20' or 'Jaeger 'J2' score'.
Overall Interpretation	Overall Interpretation: A term, commonly coded, expressing an overall interpretation of the visual acuity test.
Comment	Comment: Any additional narrative comment about the visual acuity test.
State
Confounding Factors	Confounding Factors: Patient circumstances which affect interpretation of the result. Often termed 'reliability' in opthalmological documentation. Examples: 'Patient was confused', 'Low light conditions'.
Refractive Correction	Refractive Correction: The specific type(s) of refractive correction applied when measuring visual acuity. Examples: 'No correction : unaided', 'Pinhole'. Spectacles Contact lenses Pinhole Autorefraction Retinoscopy
Protocol
Testing Distance	Testing Distance: The distance at which the subject's visual acuity was measured. >=0; >=0; >=0; >=0 Units: ft m cm in
Chart Method	Chart Method: The charting method used to measure visual acuity. logMar chart Snellen chart ETDRS chart Picture chart Reduced logMar Reduced Snellen Faculty of Ophthalmologists 'N' Score Jaeger 'J' Score
Chart Optotype	Chart Optotype: The style of chart optotype used to assess visual acuity. Letter Orientation Picture
Chart Scoring Algorithm	Chart Scoring Algorithm: The alogrithm used to determine the score. Single letter Whole line Last line single letter
Medical Device	Medical Device: An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.
Device name	Device name: Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device. This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available.
Type	Type: The category or kind of device. Not applicable if a category is already recorded in 'Device name'. Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers.
Description	Description: Narrative description of the medical device.
Date of manufacture	Date of manufacture: Date the device was manufactured.
Derived Score Original Notation	Derived Score Original Notation: The original visual acuity result notation from which the Derived Score was calculated. When the visual acuity result is recorded using a Derived Score, this element can be used to record the original notation format, so that it can be displayed using the original notation. US Snellen Metric Snellen Decimal Snellen ETDRS Letters Low Vision Score logMar
Derived Score Algorithm	Derived Score Algorithm: Details of the algorithm used to calculate a derived score.
Clinical image acquisition and validation NMR	Clinical image acquisition and validation NMR: Manages the acquisition and validation of diagnostic tests based on medical imaging.
Imaging examination	Imaging examination: Clinical activity about performing an imaging examination.
Description
Examination name	Examination name: The name of the examination (to be) performed. Coding of the specific procedure with a terminology is preferred, where possible.
Description	Description: Narrative description about the activity or care pathway step for the identified examination, for example description about the performance and findings from the the examination, the failed attempt or the cancellation of the examination.
Reason	Reason: Reason that the activity or care pathway step for the identified examination was carried out, for example, the reason for the cancellation or suspension of the examination. DR screening Assessment of wet AMD Monitor the progression of chronic glaucoma
Anatomical location	Anatomical location: A physical site on or within the human body.
Body site name	Body site name: Identification of a single physical site either on, or within, the human body. This data element is the only mandated data point in this archetype and should be used as the primary data point to record an anatomical location with a commonly used name. It is strongly recommended that 'Body site name' be recorded as specifically as is anatomically possible. For example: record 'upper eyelid' rather than recording 'eyelid' with 'upper' as a qualifier; 'fifth rib' rather than 'rib' with a numeric qualifier. Use the other data elements for laterality, aspect, region and anatomical line to provide more detail. This data element should be coded with a terminology capable of triggering decision support, where possible - an appropriate termset for use here could comprise individual concepts or a list of precoordinated terms. Free text should be used only if there is no appropriate terminology available.
Specific site	Specific site: Additional detail using a specific region or a point on, or within, the identified body site. Use to increase precision of identification of the body site, if required. For example, the upper right quadrant or McBurney's point on the abdominal wall or interphalangeal joint of the great toe. If the 'Body site name' data element uses pre-coordinated terms that include the specific site, then this data element is redundant. Value set: terminology:Snomed?subset=Subdivision%20of%20retina&language=en-GB
Laterality	Laterality: The side of the body on which the identified body site is located. If the identified body site has no laterality, this data element should not have a value. If the 'Body site name' data element uses pre-coordinated terms that include laterality, then this data element is redundant. Left Right
Aspect	Aspect: Qualifying detail about the specific aspect of the identified body site. Use to increase precision of identification of the body site, if required. Common aspects have been included as a value set, which can be extended over time, plus a free text option. Assumes that the body is being described while in the anatomical position. For example: proximal urethra; plantar aspect of the left thumb. Multiple aspects can also be described, if required, by allowing for 0..2 occurrences. For example: a lesion may be on the left anterior/lateral (ie anterolateral) chest wall. If the 'Body site name' data element uses pre-coordinated terms that include the aspect, then this data element is redundant. Coded Text Medial Lateral Superior Inferior Anterior Posterior Proximal Distal Palmar Plantar Mid Oral Anal Text
Anatomical Line	Anatomical Line: Additional detail using theoretical lines drawn through anatomical structures used to provide a consistent reference point on the human body. Common anatomical lines have been included as a value set, which can be extended over time, plus a free text option. The additional use of this data element allows for recording of the typical position of the heart's apex beat at 5th intercostal space, left side, and mid-clavicular line. If the 'Body site name' data element uses pre-coordinated terms that include anatomical line, then this data element is redundant. Coded Text Midline Midaxillary line Anterior axillary line Posterior axillary line Mid-clavicular line Mid-pupillary line Mid-scapular line Text
Description	Description: Narrative description that can be used to further refine and support the 'Body site name'. For example: adjacent to the vermilion border; a tattoo covers the bottom half of this area.
Mydriasis application	Mydriasis application: Defines the characteristics of mydriasis procedure when carried out on a patient.
Pupil dilated	Pupil dilated: Whether or not the patient’s pupils were pharmacologically dilated for the current acquisition. Matches to DICOM (0022,000D) attribute.
Degree of dilation	Degree of dilation: The degree of the dilation in mm. Matches to DICOM (0022,000E) attribute. 0..3 mm Assumed value: 0 mm
Mydriatic delivery method	Mydriatic delivery method: The method of delivery if this should be specified (e.g. via a nebuliser or drops).
Mydriatic agent	Mydriatic agent: Chemical name of the compound used to apply midriasis. Matches to DICOM (0022,0058) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4208 (Mydriatic agent) Value set: terminology:Snomed?subset=Mydriatic%20agents&language=en-GB
Medication supply amount	Medication supply amount: Details related to the amount of a medication, vaccine or other therapeutic item to be supplied or supplied to the patient, as part of authorisation, dispensing or administration.
Amount description	Amount description: A narrative representation of the amount The amount of medication, vaccine or therapeutic good intended to be supplied or actually supplied.
Amount	Amount: The amount of medication, vaccine or therapeutic good intended to be supplied or actually supplied. For example: 1, 1.5, or 0.125. >=0 (UCUM: 1)
Units	Units: The dose unit or pack unit associated with the dispense amount. For example: 'tablets', 'packs', ml'.
Duration of supply	Duration of supply: The period of time for which the medication should be dispensed or for which a suppy was dispensed. The dispenser is asked to supply sufficient quantity of medication to cover the defined period. >=P0D Units: Year Month Week Day Second
Comment	Comment: Additional narrative about the activity or care pathway step not captured in other fields.
Protocol
Start date/time	Start date/time: The start date and/or time for the procedure. This will indicate the scheduled date/time when recorded against the 'Appointment scheduled' care pathway step or the actual Start date/time in the 'Examination performed' step.
Fundoscopic examination of eyes	Fundoscopic examination of eyes: Record of clinical findings on fundoscopy of eyes
Data
Any event	Any event: *
Data
Clinical Description	Clinical Description: Descriptive overview of examination findings
Test Result	Test Result: Details of the funduscopic examination test result for each eye.
Side	Side: Determines the eye on which the test was performed.Matches to DICOM Laterality (0020,0060) attribute. Left eye Right eye
Acquisition details	Acquisition details: Details about acquisition obtained during the examination of eye fundus
Red reflex	Red reflex: True if Red Reflex is present Assumed value: false
Small pupil	Small pupil: True if during the acquisition, pupil diameter is smaller than normal (3,3mm) Assumed value: false
High refraction	High refraction: True if the refraction of the eye exceeds the range from -12D to +15D Assumed value: false
Cataract artifact	Cataract artifact: True if cataract obstructs the visualization of eye fundus Assumed value: false
Shadow artifact	Shadow artifact: True if shadow artifact is present on the border of the image Assumed value: false
Uncooperative patient	Uncooperative patient: True if patient doesn't collaborate during the image acquisition Assumed value: false
Others	Others: Other details identified during the acquisition which may affect the results from reviewing the test Value set: terminology:Snomed?subset=Complications%20on%20ophthalmic%20image%20acquisition&language=en-GB
Visualization	Visualization: Details about image quality related to ease of visualization of structures on eye fundus
Quality	Quality: Levels quantifying the quality of each acquisition, based in the ease to visualize the structures on the eye fundus 1: Quality inadequate for any diagnostic purpose 2: Unable to exclude all emergent findings 3: Only able to exclude emergent findings 4: Quality not ideal, but is possible to exclude subtle findings 5: Ideal quality
Comment	Comment: Comment, especially if not fully visualised
Structural description	Structural description: General description of the structures in the eye fundus
Optic Disc	Optic Disc: Description of optic disc
Macula	Macula: Description of macula
Retinal arteries	Retinal arteries: Description of retinal arteries
Retinal veins	Retinal veins: Description of retinal veins
Retinal background	Retinal background: Description of retinal background
Vitreous	Vitreous: Description of vitreous humour
Clinical results	Clinical results: Information of diagnostic interest obtained in the test
Other findings	Other findings: Narrative description of clinical findings not considered in the SLOT
State
Mydriatic used	Mydriatic used: True if mydriatic is used Assumed value: false
Protocol
Method	Method: Method chosen to perform the funduscopic examination Direct Indirect Contact lens biomicroscopy Non-contact lens biomicroscopy Mydriatic retinography Non-mydriatic retinography Angiography
Medical Device	Medical Device: An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.
Device name	Device name: Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device. This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available. Value set: terminology:Snomed?subset=Ophthalmic%20photography%20devices&language=en-GB
Type	Type: The category or kind of device. Not applicable if a category is already recorded in 'Device name'. Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers.
Description	Description: Narrative description of the medical device.
Unique device identifier (UDI)	Unique device identifier (UDI): A numeric or alphanumeric string that is associated with this device within a given system. Often fixed to the device as a barcode.
Manufacturer	Manufacturer: Name of manufacturer.
Date of manufacture	Date of manufacture: Date the device was manufactured.
Serial number	Serial number: Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging.
Catalogue number	Catalogue number: The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging.
Model number	Model number: The exact model number assigned by the manufacturer and found on the device label or accompanying packaging.
Batch/Lot number	Batch/Lot number: The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material.
Software version	Software version: Identification of the version of software being used in the medical device. When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development).
Date of expiry	Date of expiry: Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging. This date usually applies only to single use or disposable devices.
Other identifier	Other identifier: Unspecified identifier, which can be further specified in a template or at run time. Coding of the name of the identifier with a coding system is desirable, if available.
Medical device details	Medical device details: Specific details that relate to asset management for any medical device that is designed for more than a single use.
Organisation identifier	Organisation identifier: Organisation identifier for device. May be a text string or an IEEE EUI-64 identifier. Text Identifier
Owner	Owner: Organisation responsible for the medical device.
Location	Location: Physical location where device is kept.
Network address	Network address: Network address to contact the device.
Part number	Part number: The part number of the device.
Manufacturer model name	Manufacturer model name: HL7 CDA compatible representation of device manufacture details. May be a simple string or contain simple markup e.g. for Continua PHMR reports: "Pulse Master 2000\|\|584216\|69854\|2.1\|1.1\|1.0\|" repesenting Model, Unspecified, SerialNumber, PartNumber, HardwareRevision, SoftwareRevision, ProtocolRevision, and ProdSpecGMDN.
Hardware revision	Hardware revision: The hardware revision number.
Protocol revision	Protocol revision: The protocol revision number.
Sampling frequency	Sampling frequency: The sampling frequency limits of the device. Text Quantity
Range	Range: The range limits of the device. Text Interval of Quantity
Accuracy	Accuracy: The accuracy limits of the device. Text Quantity
Resolution	Resolution: The resolution limits of the device. Text Quantity
Regulatory status	Regulatory status: Whether device is regulated or otherwise.
Date last cleaned/sterilized	Date last cleaned/sterilized: Date the device was last cleaned or sterilized.
Date last calibrated	Date last calibrated: Date the device was last calibrated.
Date last serviced	Date last serviced: The date the device was last serviced.
Formulae	Formulae: Details about formulae or algorithms used by the device in order to generate results/output.
Formula name	Formula name: Data element which is calculated or derived.
Formula	Formula: Formula used to calculate or derive the Calculated field.
Comment	Comment: Additional narrative about the device not captured in other fields.
Field angle	Field angle: Describes the optical acceptance angle of the lens used during the test 30º 45º 60º 100º 200º
Attempts	Attempts: Number of attempts before obtaining the acquisition (doesn't compute if test is repeated by a specific recognized technical failure) 1..3
(Subdivision of the retina)	(Subdivision of the retina): Subdivision of the retina identifying eye fundus image locations
(ETRDS fields)	(ETRDS fields): Subdivision of the retina based on Diabetic Retinopathy Study fields Study field 1 Study field 2 Study field 3 Study field 4 Study field 5 Study field 6 Study field 7
Mosaic and peripherals	Mosaic and peripherals: Division of the retina in quadrants + mosaic obtained from the combination of them Mosaic Central Nasal Temporal Superior Inferior
Clinical image acquisition and validation OCT	Clinical image acquisition and validation OCT: Manages the acquisition and validation of diagnostic tests based on medical imaging.
Ophthalmic tomography examination	Ophthalmic tomography examination: Record of clinical findings using optical coherence tomography with ophthalmic purposes.
Data
Any event	Any event: Default, unspecified point in time or interval event which may be explicitly defined in a template or at run-time.
Data
Clinical description	Clinical description: A term, commonly coded, expressing an overall interpretation of the OCT test.
Test result	Test result: Details of the ophthalmic tomography examination test result for each eye.
Side	Side: Determines the eye on which the test was performed.Matches to DICOM Laterality (0020,0060) attribute. Matches to DICOM Laterality (0020,0060) attribute. Left eye Right eye
Structure analyzed	Structure analyzed: The anatomic structure analyzed in this study. Matches to DICOM Anatomic Region Sequence (0008,2218) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4211 (Ophthalmic OCT Anatomic Structure Imaged). Value set: ac0001
Reference image	Reference image: Information about the image on which the position of OCT acquisitions/slices will be referenced.
Acquisition method	Acquisition method: Ophthalmic photography acquisition method chosen to obtain the reference image. Matches to DICOM Anatomic Region Sequence (0022,0015) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4202 (Ophthalmic Photography Acquisition Device). Value set: ac0003
Image type	Image type: Identifies the fundus imaging modalities obtained from the acquisition of the reference image. Corresponds to the value 4 of the DICOM image type attribute (0008,0008). RF IR AF FA ICGA
Comment	Comment: Narrative description of clinically relevant information identifiable on the reference image.
Reference image	Reference image: Image on which the position of OCT acquisitions/slices will be referenced.
Multiframe properties	Multiframe properties: Information about the slices of the retina obtained by OCT the test.
Number of frames	Number of frames: Number of slices in the study (from 1 to n). Matches to DICOM (0028,0008) attribute. >=1
OCT slice analysis	OCT slice analysis: Analysis of OCT slices considered relevant in the study.
Frame pointer	Frame pointer: Number identifying a frame among the rest in the study, to highlight its relevance on diagnosis. Matches to DICOM (0028,0009) attribute. >=1
OCT slice	OCT slice: Current slice of the retina regarding the image of reference.
Comment	Comment: Narrative description of clinically relevant information identifiable on the specific frames selected from the acquisition.
Reports	Reports: Information about image reports related to the current OCT study.
Report type	Report type: Defines the purpose of the report built from data acquired on the OCT device. OCT overview Retina exam Retina change 3D view Thickness map exam Thickness map change RNFL thickness exam RNFL thickness change RNFL thickness trend Asymmetry analysis RNFL & asymmetry analysis Posterior pole assessment Other
Report content	Report content: Which kind of graphs are included in the report. Reference image Single OCT scan OCT volume scan Retinal thickness profile Retinal thickness map RNFL thickness profile RNFL thickness map Thickness profile change Thickness map change Periapillary RNFL thickness classification Retinal average thickness Asymmetry OD-OS Hemisphere asymmetry RNFL thickness trend
Comment	Comment: Narrative description of clinically relevant information identifiable on the current report.
Report	Report: Report related to the current OCT study.
Retinal thickness	Retinal thickness: Information related to retinal thickness measurement.
Comment	Comment: Narrative description of clinically relevant information identifiable on the analysis of ophthalmic thickness measurements.
Clinical findings	Clinical findings: Every finding considered clinically relevant, found on posterior chamber of the eye. Value set: ac0002
State
Confounding factors	Confounding factors: Patient circumstances which may affect interpretation of the result.
Intraocular pressure	Intraocular pressure: Value of intraocular pressure in mmHg. Matches to DICOM (0022,000B) attribute. 0..90 mmHg (UCUM: mm[Hg])
Axial length of the eye	Axial length of the eye: Axial length of the eye in mm. Matches to DICOM (0022,0030) attribute. >=0 mm
Horizontal field of view	Horizontal field of view: The horizontal field of view in degrees. Matches to DICOM (0022,000C) attribute. Units: ° (UCUM: deg)
Contrast/Bolus	Contrast/Bolus: Information about the contrast agents administered prior to or during the acquisition. Matches to DICOM (0018,0012) attribute.
Contrast/bolus agent	Contrast/bolus agent: Identification of the contrast agent. Matches to DICOM (0018,0012) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4200 (Ophthalmic Imaging Agent). Fluorescein Indocyanine green Rose Bengal Trypan blue Methylene blue
Contrast/bolus volume	Contrast/bolus volume: Volume injected in milliliters of diluted contrast agent. Matches to DICOM (0018,1041) attribute. >=0 ml
Contrast/bolus volume ingredient concentration	Contrast/bolus volume ingredient concentration: Milligrams of active ingredient per milliliter of (diluted) agent. Matches to DICOM (0018,1049) attribute. >=0 mg/ml
Protocol
Medical Device	Medical Device: An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.
Device name	Device name: Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device. This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available. Value set: terminology:Snomed?subset=Ophthalmic%20tomography%20acquisition%20device&language=en-GB
Type	Type: The category or kind of device. Not applicable if a category is already recorded in 'Device name'. Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers.
Description	Description: Narrative description of the medical device.
Unique device identifier (UDI)	Unique device identifier (UDI): A numeric or alphanumeric string that is associated with this device within a given system. Often fixed to the device as a barcode.
Manufacturer	Manufacturer: Name of manufacturer.
Date of manufacture	Date of manufacture: Date the device was manufactured.
Serial number	Serial number: Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging.
Catalogue number	Catalogue number: The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging.
Model number	Model number: The exact model number assigned by the manufacturer and found on the device label or accompanying packaging.
Batch/Lot number	Batch/Lot number: The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material.
Software version	Software version: Identification of the version of software being used in the medical device. When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development).
Date of expiry	Date of expiry: Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging. This date usually applies only to single use or disposable devices.
Other identifier	Other identifier: Unspecified identifier, which can be further specified in a template or at run time. Coding of the name of the identifier with a coding system is desirable, if available.
Medical device details	Medical device details: Specific details that relate to asset management for any medical device that is designed for more than a single use.
Organisation identifier	Organisation identifier: Organisation identifier for device. May be a text string or an IEEE EUI-64 identifier. Text Identifier
Owner	Owner: Organisation responsible for the medical device.
Location	Location: Physical location where device is kept.
Network address	Network address: Network address to contact the device.
Part number	Part number: The part number of the device.
Manufacturer model name	Manufacturer model name: HL7 CDA compatible representation of device manufacture details. May be a simple string or contain simple markup e.g. for Continua PHMR reports: "Pulse Master 2000\|\|584216\|69854\|2.1\|1.1\|1.0\|" repesenting Model, Unspecified, SerialNumber, PartNumber, HardwareRevision, SoftwareRevision, ProtocolRevision, and ProdSpecGMDN.
Hardware revision	Hardware revision: The hardware revision number.
Protocol revision	Protocol revision: The protocol revision number.
Sampling frequency	Sampling frequency: The sampling frequency limits of the device. Text Quantity
Range	Range: The range limits of the device. Text Interval of Quantity
Accuracy	Accuracy: The accuracy limits of the device. Text Quantity
Resolution	Resolution: The resolution limits of the device. Text Quantity
Regulatory status	Regulatory status: Whether device is regulated or otherwise.
Date last cleaned/sterilized	Date last cleaned/sterilized: Date the device was last cleaned or sterilized.
Date last calibrated	Date last calibrated: Date the device was last calibrated.
Date last serviced	Date last serviced: The date the device was last serviced.
Formulae	Formulae: Details about formulae or algorithms used by the device in order to generate results/output.
Formula name	Formula name: Data element which is calculated or derived.
Formula	Formula: Formula used to calculate or derive the Calculated field.
Comment	Comment: Additional narrative about the device not captured in other fields.
Acquisition details on ophthalmic tomography	Acquisition details on ophthalmic tomography: Defines specific details about ophthalmic tomography studies.
Laterality	Laterality: Eye/s included in the study. Left eye Right eye Both eyes
Acquisition method	Acquisition method: Acquisition method chosen to perform the ophthalmic tomography study. It is based on the Table CID 4210 of DICOM standard. Optical Coherence Tomography Scanner Retinal Thickness Analyzer Confocal Scanning Laser Ophthalmoscope Scheimpflug Camera Scanning Laser Polarimeter Elevation-based corneal tomographer Reflection-based corneal topographer Interferometry-based corneal tomographer
Study outcome	Study outcome: Identifies the type of analyses which must be obtained from the study. Transverse image overview 3D reconstruction image analysis Video angiography Thickness analysis Thickness evolution along-time (follow-up) Thickness classification (measured vs normative) Asymmetry analysis
Predefined scan	Predefined scan: Choice among predefined settings provided by the ophthalmic tomography for scanning the eye structure.
Study type	Study type: Subject of study of the ophthalmic tomography. Angle Cornea Iris Sclera Glaucoma Retina
Predefined scans	Predefined scans: Choice of a predefined scan patterns from the device to conduct the study. Angle 1 ACA Angle 2 ACA Angle small Cornea dense Cornea large Cornea scan 08 Cornea scan 11 Cornea small Sclera dense Sclera large Sclera scan 08 Sclera scan 11 Sclera small Sclera vol. bleb Glaucoma dense Glaucoma Fast Glaucoma ONH Glaucoma P. Pole Glaucoma RNFL Retina 7 lines Retina dense Retina detail Retina fast Retina Fast HR Retina Lin HR Retina P. Pole
Custom scan	Custom scan: Description of characteristics for a personalized scan.
Scan pattern	Scan pattern: Defines the pattern used to scan structures inside the eye. Single Radial Star High speed multi-frame High resolution multi-frame
Position of scan pattern	Position of scan pattern: Eye structure in which the scan is centred. Value set: ac0001
Scan size (width or diameter)	Scan size (width or diameter): Width of the frame (or diameter in case of circle scan pattern). Units: ° (UCUM: deg)
Scan size (height)	Scan size (height): Height of the frame. Units: ° (UCUM: deg)
Distance between sections	Distance between sections: Distance between sections scanned consecutively. Units: μm (UCUM: um)
Section scans	Section scans: Number of sections included in the scan. >=1
Next step planning	Next step planning: Decision-making concerning the planning of next assessment for the diagnostic tests carried out.
Diagnostic report request	Diagnostic report request: Request for a diagnostic report involving the study of specific diagnostic tests.
Request	Request: Current Activity.
Description
Service requested	Service requested: Identification of the service requested. This is often coded with an external terminology. Remote assessment of wet AMD Review of AMD state at the retinologist's office
Description of service	Description of service: A detailed narrative description of the service requested.
Reason for request	Reason for request: A short description of the reason for the request. This is often coded with an external terminology. Completed the diagnostic tests necessary for assessment Patient not responding to treatment
Reason description	Reason description: A narrative description explaining the reason for request.
Intent	Intent: Stated intent of the request by the referrer.
Urgency	Urgency: Urgency of the request. Emergency Urgent Routine
Date &/or time service required	Date &/or time service required: The date and time that the service should be performed or completed.
Latest date service required	Latest date service required: The latest date that is acceptable for the service to be completed.
Protocol
Requestor Identifier	Requestor Identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is also referred to as Placer Order Identifier.
Receiver identifier	Receiver identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier.
Request status	Request status: The status of the request for service as indicated by the requester. Status is used to denote whether this is the initial request, or a follow-up request to change or provide supplementary information.
Service request	Service request: Request for a health-related service to be supplied by a healthcare provider or agency. For example equipment request.
Request	Request: Description of the requested service.
Description
Service name	Service name: Identification of the service requested, by name. Coding of the 'Service name' with a coding system is desirable, if available. Follow-up schedule for the treatment of wet AMD Repeat anti-VEGF injection to treat wet AMD
Service type	Service type: Category of service requested. For example: hospital vs home care delivery.
Description	Description: Narrative description of the service requested. Follow-up comprised by VA, NMR, OCT tests
Reason for request	Reason for request: A short phrase describing the reason for the request. Coding of the 'Reason for request' with a coding system is desirable, if available.
Reason description	Reason description: Narrative description about the reason for request.
Intent	Intent: Description of the intent for the request. For example a referral with the intent of having specialist care take over the care of the patient, or advice on how to proceed with an investigation or treatment. This data element allows multiple occurrences to enable multiple choice selection in user interface. Stable state of wet AMD Progressive state of wet AMD
Urgency	Urgency: Urgency of the request for service. Specific definitions of emergency and urgent will vary between clinical contexts, clinical systems and the nature of the request itself, so have not be defined in this archetype. If explicit timing is required then the Service period should be clearly stated. Coded Text Emergency Urgent Routine Text
Service due	Service due: The date/time, or acceptable interval of date/time, for provision of the service. In practice, clinicians will often think in terms of ordering services as approximate timing, for example: review in 3 months, 6 months or 12 months. As clinical systems need more exact parameters to operate on, this '3 months' will usually be converted to an exact date 3 months from the date of recording and stored using this data element.
Service period start	Service period start: The date/time that marks the beginning of the valid period of time for delivery of this service. This date/time is the equivalent to the earliest possible date for service delivery. For example: sometimes a certain amount of time must pass before a service can be performed, for example some procedures can only be performed once the patient has stopped taking medications for a specific amount of time.
Service period expiry	Service period expiry: The date/time that marks the conclusion of the valid period of time for delivery of this service. This date/time is the equivalent to the latest possible date for service delivery or to the date of expiry for this request. For example: a service may be required to be completed before another event, such as scheduled surgery.
Indefinite?	Indefinite?: The valid period for this request is open ended and has no date of expiry. Record as TRUE to record explicity that the request has no expiry date.
Protocol
Requestor Identifier	Requestor Identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is also referred to as Placer Order Identifier.
Receiver identifier	Receiver identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier.
Request status	Request status: The status of the request for service as indicated by the requester. Status is used to denote whether this is the initial request, or a follow-up request to change or provide supplementary information.
Other contributors	Jose Andonegui, Complejo hospitalario de Navarra (CHN), jose.andonegui.navarro@cfnavarra.es; Luis Serrano, Universidad Pública de Navarra (UPNA), lserrano@unavarra.es; Jesús D. Trigo, Universidad Pública de Navarra (UPNA), jesusdaniel.trigo@unavarra.es