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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
    1. 5.1. Common Data Elements
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.2. Scores & Instruments
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.3. Classification
      1. Released Standard
      1. Draft Standard
      1. Deprecated Standard
    1. 5.4. Archetypes
      1. Published
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Urinanalysis (EHR Archetype) - openEHR-EHR-OBSERVATION.urinalysis.v1

- 7/10/17 - 1 form, 1 itemgroup, 18 items, 5 languages
Itemgroup: openEHR-EHR-OBSERVATION.urinalysis.v1.xml
Derived from www.openehr.org . Use to record the results of a qualitative and semi-quantitative test array performed on a sample of urine, using reagent test strips. On exposure to urine, chemical pads on the reagent test strip change colour and the test result is read by visual comparison to a color chart at specified times after exposure or by an automated device. Different commercial products carry a variety of test /reagent pads. This archetype is heavily influenced by the commonly available Multistix test strips in Australia, recording ten commonly used analytes, but is intended to be generically applicable. If requirements for other parameters become apparent to meet the requirements for other test strips then product-specific urinalysis archetypes may need to be developed.

Glasgow Coma Scale (EHR Archetype) - openEHR-EHR-OBSERVATION.glasgow_coma_scale.v1

- 7/9/17 - 1 form, 1 itemgroup, 7 items, 4 languages
Itemgroup: openEHR-EHR-OBSERVATION.glasgow_coma_scale.v1.xml
Derived from www.openehr.org . Use to record clinical responses of an adult subject of care to stimuli. It is commonly used to establish a baseline conscious state and neurological function assessment and/or to detect patients who may require immediate medical intervention. The Glasgow coma scale has three subscales E (eye), V (verbal) and M (motor). In clinical practice all three subscales are reported individually plus the 'Total score', if applicable. A recorded response for each of E, V and M is mandatory. If a response cannot be tested, then the 'Not Applicable' null flavour should be recorded; do not use the 'None' ordinal value to record a missing component. Details about the reason for not being able to test a response can be recorded in the 'Confounding factors' data element. The 'Total score' can be derived as the sum of the recorded eye, motor and verbal response scores. It is not appropriate to report a 'Total score' when one or more components are not testable because the score will be artificially low - in this situation record the EVM profile instead. The three response values are considered separately as well as their sum. The 'EVM profile' can be derived as a concatenation of each of the recorded eye, motor and verbal response scores. For example, E3 V4 M2 represents the conscious state of a subject who opens eyes to speech, utters incomprehensible sounds and has an extensor response to stimulation. The minimum possible 'Total score' value is 3 (equivalent to E1 V1 M1) and the maximum possible is 15 (equivalent to E4 V5 M6). In practical use, Glasgow coma scale is recorded as one component of clinical monitoring, using sequential and repeated point-in-time measurements. Date and time should be recorded for each measurement, as well as any factors that may influence interpretation of changes. Changes in 'Total score' or any E, V or M values may have as much clinical significance as the value recorded initially.

Blood Pressure (EHR Archetype) - openEHR-EHR-OBSERVATION.blood_pressure.v1

- 7/9/17 - 1 form, 1 itemgroup, 24 items, 10 languages
Itemgroup: openEHR-EHR-OBSERVATION.blood_pressure.v1.xml
Derived from www.openehr.org . Use to record all representations of systemic arterial blood pressure measurement, no matter which method or body location is used to record it. The archetype is intended to capture blood pressure measurements in all clinical scenarios - for example, self-measurement with a home blood pressure machine; an emergency assessment of systolic using palpation and a sphygmomanometer; measurements taken in clinical consultations or during exercise stress testing; and a series of measurements made by a machine in Intensive Care. There is a rich state model that supports interpretation of measurements through identifying patient position, exercise, confounding factors and angle of a tilt table in research. Named events have been limited to average over a 24 hour period, however templates can further constrain the default 'any event' to cater for specific requirements for blood pressure measurements such as recording Blood Pressure against specific points in time, or over a range of intervals (+/- mathematical functions).

APGAR Score (EHR Archetype) - openEHR-EHR-OBSERVATION.apgar.v1

- 7/8/17 - 1 form, 1 itemgroup, 14 items, 9 languages
Itemgroup: openEHR-EHR-OBSERVATION.apgar.v1
Derived from www.openehr.org . Allows recording of an assessment of the state of a neonate explicitly as 1, 2, 3, 5 and/or 10 minute events after birth, plus additional events as required. Usual practice is to document the Apgar score at 1 and 5 minutes; further scores can be recorded as clinically indicated. It is possible to record the Apgar score at any time after birth using this archetype. Common clinical practice is to record all 5 parameters plus the total, however this archetype allows any partial information to be recorded, if that is all that is available eg from historical data. If the total is to be calculated, it is necessary for all 5 ordinal values to be recorded. The total is the sum of the five ordinal values (min 0, max 10). It is recognised that mnemonic learning aid for APGAR is commonly taught. For example, in English: A for Appearance (skin color), P for Pulse (heart rate), G for Grimace (reflex irritability), A for Activity (muscle tone), and R for Respiration. As this is not universally applicable for all languages, it is suggested that this mnemonic can be applied by renaming the data elements within templates if desired for a specific clinical scenario.

Medication Order (EHR Archetype) - openEHR-EHR-INSTRUCTION.medication_order.v1

- 7/10/17 - 1 form, 1 itemgroup, 53 items, 3 languages
Itemgroup: openEHR-EHR-INSTRUCTION.medication_order.v1.xml
Derived from www.openehr.org . Use to record all aspects of an order of a medication, vaccine, nutritional product or other therapeutic item for an identified individual. It is intended to be used for any type of medication and related order, whether prescribed by a health professional or available for purchase 'over the counter'. The scope of this medication archetype also includes orders for vaccinations, parenteral fluids or other therapeutic goods, such as bandages, nutritional products or other items that are applied or administered to have a therapeutic effect and which have a common pattern for data recording. This archetype is designed to be used in a number of clinical contexts, including but not limited to: - a record in a clinical consultation (COMPOSITION.encounter); - a written prescription by a physician, dentist, nurse practitioner, or other designated health professional for a medication or nutritional product to be dispensed and administered (within a COMPOSITION.prescription); - an item in a current medication list, prescription or drug chart (within COMPOSITION.medication_list); and - an item in a summary document such as transfer of care (COMPOSITION.transfer_summary) or a referral (COMPOSITION.request). In many cases a medication order will be simple – typically for a single medication item with uncomplicated instructions for dispensing and administration. However this archetype is also designed to allow for more complex therapeutic orders. For example: - a reducing dose of prednisolone over a period of weeks; - titration of insulin, with dosing dependent on test results; - multiple medications prescribed simultaneously as part of a single drug regimen, such as a triple therapy for peptic ulcer; and - intravenous administration of medications or nutrition supplements, including parenteral nutrition. The archetype has therefore been designed to allow for a range of complexity, from: - simple narrative instructions for orders like 'furosemide 40mg two tablets in the morning and one at lunch' to ensure compatibility with existing systems; and - the amount of medication is usually represented in terms of a number and corresponding dose unit, however there can alternatively be a narrative statement to ensure compatibility with existing systems and coverage of all clinical scenarios; through to - structured detail for dose, route and timing to represent a fully computable specification. It has also been designed so that a single medication order structure can represent: - complex sequential medication orders using the same preparation strength to be supported within a single order structure; and - multiple medication orders can be chained in circumstances where different medications or preparations need to be given sequentially. This archetype is also suitable for ordering parenteral fluids, in care settings where it is normal practice to make these 'prescribable' items. In other settings a separate 'parenteral fluid order' may be appropriate. SLOTs containing CLUSTER archetypes have been used to represent some of the content for three reasons: - To ensure a core archetype that can be used for all the above use cases, yet allow flexibility where it is required, for example the ‘Preparation details’ SLOT where additional structured detail can be added. A candidate archetype has been suggested for Medications. It is possible that other CLUSTER archetypes may be required in future for other purposes such as complex parenteral nutrition orders; - to support archetype re-use in situations where the content has been identified as being also used in other clinical contexts, in particular the paired ACTION.medication archetype for recording actual dispensing, administration etc; and - to remove less commonly used content from the core archetype framework. Multiple orders can be represented as separate activities within this single archetype instance to carry tightly bound orders of different medications, for example, H. pylori therapy when this is not prescribed as a single pack. It should be noted that these uses subsume both the FHIR Medication Order and Medication Statement use cases. i.e this archetype is a match for both FHIR resources, used in the appropriate context.

Timed 25-Foot Walk (EHR Archetype) - openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1

- 7/10/17 - 1 form, 1 itemgroup, 11 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Timed 25-Foot Walk test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. The patient is directed to one end of a clearly marked 25-foot (7,62 m) course. Then he is instructed to walk this course as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Assistive devices (in general, customary walking devices) may be used when doing this task. Use the MSFC Manual for detailed administration instructions. The test should only be administred by a suitably trained person.

Respiration (EHR Archetype) - openEHR-EHR-OBSERVATION.respiration.v1

- 7/10/17 - 1 form, 1 itemgroup, 9 items, 6 languages
Itemgroup: openEHR-EHR-OBSERVATION.respiration.v1.xml
Derived from: www.openehr.org . Use to record the observed and measured characteristics related to spontaneous respirations in a person, including respiratory rate, depth and rhythm. Respirations are commonly recorded as one component of Vital signs - comprising Blood Pressure, Pulse, Temperature, and Oximetry. There are additional specific archetypes for each of these concepts. Respirations should be measured before feeds in neonates and young infants.

Physical examination findings (EHR Archetype) - openEHR-EHR-OBSERVATION.exam.v1

- 7/10/17 - 1 form, 1 itemgroup, 8 items, 7 languages
Itemgroup: openEHR-EHR-OBSERVATION.exam.v1.xml
Derived from www.openehr.org . Use to record details about findings on physical examination of the subject of care. This may include a narrative description of the findings, a framework in which to nest detailed CLUSTER examination archetypes, and a clinical interpretation of the findings. Examples of detailed CLUSTER examination archetypes include those that describe inspection, palpation, auscultation, percussion and movement of body systems or anatomical structures, such as CLUSTER.exam_pupils. Narrative descriptions of clinical findings from existing clinical systems may be captured using the 'Description' data element. Clinicians may sometimes want to record a summative phrase such as 'chronic otitis media' as an Interpretation of the physical examination. In the context of the physical examination archetype this should only be understood as 'physical signs are consistent with chronic otitis media'. While the summative phrase may appear to represent a diagnosis, safe and consistent querying requires a diagnosis to be recorded using the EVALUATION.problem_diagnosis archetype, even if the phrases are identical.

Paced Auditory Serial Addition Test (EHR Archetype) - openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 16 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Paced Auditory Serial Addition Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite, but may be performed independently. 61 single-digit numbers are presented to the subject one by one. During PASAT-3'' a new number is presented every three seconds, in the optional PASAT-2'' every two seconds. In each case the subject is asked to respond with the sum of the last two digits (not the running total). That is, there is a maximum of 60 possible correct sums. Use the MSFC Manual for detailed administration instructions. Prior to the recording of the actual tests at least one practice trial has to be performed (this training sequence is part of the PASAT). If less than three correct answers were given, the practice trial should be repeated (up to three times). If more than two correct answers were given, the PASAT-3'' can be administered (the patient should have understood the task sufficiently). To obtain additional information about the cognitive functions, the PASAT-2'' can be performed optionally after the 3'' test. The tests should only be administered by a suitably trained person.

Nine Hole Peg Test (EHR Archetype) - openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 18 items, 3 languages
Itemgroup: openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Nine Hole Peg Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. Both the dominant and non-dominant hand of the patient are tested twice (two consecutive trials of the dominant hand, followed by two consecutive trials of the non-dominant hand). For each trial nine pegs are picked one by one from a container, placed in the holes on a pegboard and then separately returned to the container. The subject may only use one hand at each trial, but may hold the pegboard with the free hand. This archetype covers variations of the test. According to Mathiowetz et al. (1985) an untimed practice trial should be administered prior to the timed trial for each hand. The MSFC Manual stipulates two timed trials for each hand, but no practice trial. Use the MSFC Manual or see Mathiowetz et al. (1985) for detailed administration instructions. The test should only be administered by a suitably trained person.

MSFC Score (EHR Archetype) - openEHR-EHR-OBSERVATION.msfc_score.v1

- 7/9/17 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.msfc_score.v1.xml
Derived from www.openehr.org . Use to record the MSFC Score and the reference data set, as well as links to the measured results of the three individual tests (Timed 25-Foot Walk, Nine Hole Peg Test and Paced Auditory Serial Addition Test). The MSFC Score is a computed value based on the average of each test result, adjusted to the reference population. I.e. MSFC Score = 1/3 * (Z_arm,avg. + Z_leg,avg. + Z_cognitive), where Z_x = Z-score of each test result. This score has to be computed externally, only the resulting value is to be recorded here. Use the MSFC Manual for further scoring instructions, formulas and background information.

Height (EHR Archetype) - openEHR-EHR-OBSERVATION.height.v1

- 7/9/17 - 1 form, 1 itemgroup, 5 items, 9 languages
Itemgroup: openEHR-EHR-OBSERVATION.height.v1.xml
Derived from www.openehr.org . To be used for recording the actual height or body length of an individual at any point in time. A statement identifying the physical incompleteness of the body can be recorded in the 'Confounding factors' protocol element, if required. This is the usual archetype to be used for a typical measurement of height or body length, independent of the clinical setting. Can also be used for recording an approximation of height or body length measurement in a clinical scenario where it is not possible to measure an accurate height or length - for example, measuring an uncooperative child. This is not modelled explicitly in the archetype as the openEHR Reference model allows the attribute of Approximation for any Quantity data type. At implementation, for example, an application user interface could allow clinicians to select an appropriately labelled check box adjacent to the Height data field to indicate that the recorded height is an approximation, rather than actual. In general, length measurements are recommended for children under 2 years of age and individuals who cannot stand; height measurements for all others. Ideally, height is measured standing on both feet with weight distributed evenly, heels together and both buttocks and heels in contact with a vertical back board; body length is measured in a fully extended, supine position with the pelvis flat, legs extended and feet flexed. Use to record growth and loss of height. This can currently be modelled by constraining the 'any event' to an interval in a template with associated mathematical function of increase or decrease, as appropriate.

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