This implementation guidance provides guidance to support the implementation of the PRSB Diabetes Self-Management Information Standard.\u00a0General guidance is provided here. Data item specific implementation guidance can be found under the 'context' field.\u00a0PRSB has carried out a clinical safety review in accordance with DCB0129, which is detailed in the clinical safety case and accompanying Diabetes Information Standards hazard log. \n This guidance should be used in conjunction with the Risk Mitigation section.\u00a0This guidance should be used in conjunction with the final report for the Diabetes Information Standards.
\n\n 1.2 Audience
\n \n
\n This guidance is intended for anyone implementing and using the PRSB Diabetes Self-Management Information Standard. This will include health and social care professionals, IT system suppliers, developers, and implementers.\u00a0
\n 1.3 Definition and scope of the Diabetes Self-Management Information Standard\n
\n
\n 1.3.1 What the diabetes self-management information standard is:
\n \n
The set of rules and instructions governing the type of information expected within a section, cluster, record entry and element and how it is communicated is defined in the information model under the titles of Description, Cardinality, Conformance and Valuesets.\u00a0
The Diabetes Self-Management Information Standard contains the following\n information components as outlined below:There is a complex environment of systems and technology to support diabetes that need to share information and will need to conform with the information and technical standards to do so.\u00a0There are four broad groups of systems and technology increasing from the micro to macro level for example\n an app, a device, a local management system at ICS level though to a regional or national system:
\na.\u00a0\u00a0\u00a0\u00a0\u00a0lifestyle apps\u00a0for supported self-management.
\nb.\u00a0\u00a0\u00a0\u00a0\u00a0medical devices\u00a0(including self-monitoring and insulin delivery devices, Point of Care systems in hospitals and systems\n integrating data from devices e.g. Glooko)
\nc.\u00a0\u00a0\u00a0\u00a0\u00a0specialist diabetes management systems\u00a0(e.g. My Way Diabetes Health, Hicom\u2019s Diamond and Twinkle).
\nd.\u00a0\u00a0\u00a0\u00a0\u00a0non-diabetes specific health and care record and electronic prescribing and medications administration systems\u00a0(e.g. Cerner\n Millenium, Epic, EMIS, TPP SystmOne, Graphnet, Orion, Patient Centred Software, Nourish).
\nIn order for information to be shared between these systems they may need to be adapted to ensure that the information is structured and coded in alignment with the standards.\u00a0
\n2.4 Risk mitigation
\n \n
We recommend system suppliers and local implementers apply further risk mitigations when implementing the PRSB\u00a0Diabetes Self-Management Information Standard by addressing the risks that have been flagged in the clinical safety case report and hazard log for the standard.\u00a0\u00a0Suppliers and implementers should aim to reduce the risk\n scores to 2, or better, when carrying out clinical risk assessments and developing safety cases for their implementations with respect to DCB0129 and DCB0160.
\n
\n 2.5 Information governance
\n
\n Sound principles of information governance and respecting the privacy of people and their information is paramount. NHS England has published a national Information\n Governance Framework\n \u00a0that needs to be considered when planning implementation. Local agreements should be drawn up between organisations to define information requirements for communication.
2.6 Data quality
\n
\n Data quality and accuracy of coded data entry should be managed in local \u2018source\u2019 systems to ensure that information shared with people and professionals through other systems is dependent on the source data quality.\u00a0 \u00a0
2.7 Context of the information (see also Provenance Data Standard)
\n
\n It is vital for use of the data that all contextual information is maintained and should not be lost on exchange or import of information. For example, a person with diabetes self-managing their condition at home may record their own blood pressure or conduct self-monitoring of blood glucose (SMBG). They may also be using diabetes devices\n including CGM, connected insulin pens or ambulatory insulin pumps. In all cases\u00a0it is important that the full context of the information is known (where and when the measurement was done and by whom or what device). The principle, for PRSB standards, is that for clinical safety and efficacy of communications, the key contextual data described within\n the PRSB Provenance Data Standard should be shared with the message as instructed in the Diabetes Self-Management Information Standard. The principle applied in the information model is that where it is important (from a professional perspective) to know who or what device undertook the activity and who or what device recorded the that this is made\n available to the end-user of the receiving system. For every item of information shared it is important that an audit trail is recorded (even if not explicitly stated in the information model). This is set out below (see time stamp and audit trail).\u00a0
\n
\n 2.8 Provenance Data Standard
\n \n
Implementation of the Diabetes Self-Management Information Standard requires use of the PRSB Provenance Data Standard. See\u00a0Provenance data \u2013 PRSB (theprsb.org).
2.9 Time stamp and audit trail
\n
\n It is important that an audit trail is recorded for every item of information recorded or shared (even if not explicitly stated in the information model). Each record entry will need to be time stamped from the source system with date and time recorded and the identity of the person making the record. This needs to be viewable in the records\n themselves where appropriate and via a full audit trail which may be viewable by the end user to enhance transparency.
2.10 Links to other systems and records
\n
\n Effective use of the Diabetes Self-Management Information Standard will require the ability to safely link and share the information recorded by the person or their devices (initially onto proprietary apps, applications or other systems) with the person's electronic health record. How this is done is yet to be determined/ clarified with\n suppliers but may require integration with the person demographics service API where there is a legal basis to do so (see https://digital.nhs.uk/services/demographics) or other secure methods.
2.11 Coding
\n
\n The Personalised Health and Care 2020 framework for action\u00a0 ( \n https://www.gov.uk/government/publications/personalised\n -\n health\n -\n and\n -\n care\n -\n 2020\n ) recommends the use of SNOMED CT and the dictionary of medicines and devices (dm+d). Local decisions need to be made about when these codes are to be used, depending on local system functionality and plans. The current ambition is for SNOMED CT and\n dm+d to be the primary clinical coding schemes in use in the NHS.\u00a0
2.13 PRSB Support\n
\n
The PRSB support service is available for any help, enquiries or issues with the using or implementing the standards. Any feedback on the standard (including proposed changes) resulting from putting the standard into practice would also be welcome. Contact is via support@theprsb.org or Tel: 02045515225.
A description of how you communicate normally including any communication aids you use, for example a hearing aid.
\nDescribe how you would like others to engage and communicate with you, including how you would like to be addressed.
\n ", "valueSets": "Free text", "valueDomain": [{"type": "text"}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "My wellness", "implamentationGuidance": "Prompt questions: \n| \n \n \n \n \n A description covering what you are able to do, how you engage with others and how you feel on a typical day through to on a day when you are unwell or really unwell \n | \n
| \n \n \n \n \n \n
\n | \n
A description of how and when you want someone caring for you to support you.
\n\n
A description of what is also worth knowing about you for people caring or supporting you.
\n\n
Alcohol intake should be coded using only one SNOMED CT concept from the following value set:
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
219006 \u2502 Current drinker of alcohol (finding) \u2502 Descendant or self of concept.\u00a0
\n105542008 \u2502 Current non-drinker of alcohol (finding) \u2502\u00a0Descendant or self of concept.
\n783261004 \u2502 Lifetime non-drinker of alcohol (finding) \u2502\u00a0 Equal of concept.
\n371434005 \u2502 History of alcohol abuse (situation) \u2502 Equal of concept.
\n1104551000000109 \u2502\u00a0Declined to provide information about alcohol use (situation) \u2502 Equal of concept.\u00a0
\nThe following SNOMED CT concept is inactive and should not be used.\u00a0
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n228274009 \u2502 Lifetime non-drinker (finding) \u2502 Inactive concept.\u00a0Use 783261004 instead.\u00a0
\nExamination findings should be coded using only one SNOMED CT concept from the following refset:
\nSNOMED CT ID\u00a0\u00a0\u2502\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n1127601000000107 \u2502 Healthcare matters simple reference set (foundation metadata concept) \u2502 Members of this refset (including child concepts) are sufficient to support National Diabetes Audit (NDA) requirements.\u00a0
Relevant examination finding codes will generally be subtypes of the following concepts:
SNOMED CT ID\u00a0\u00a0\u2502\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n404684003 \u2502 Clinical finding (finding) \u2502 Top-level concept.
\n64572001 \u2502 Disease (disorder) \u2502 Subtype of 404684003.
Examination findings that are subtypes of the following top-level concept should be considered observations and therefore should be entered as a coded value under 'Observations record entry'.
SNOMED CT ID\u00a0\u00a0\u2502\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n363787002 \u2502Observable entity (observable entity) \u2502 Top-level concept.
\nWhere necessary additional supplementary information is permissible to\u00a0be entered as free text in the free text field to provide additional meaning to the code used. For example:
\nSNOMED CT ID\u00a0\u00a0\u2502\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n827160004 \u2502 Erythematous rash (finding) \u2502 Relevant supplementary free text information to provide additional meaning to this concept might include e.g. colour, tenderness, temperature etc.
\nIf a precoordinated concept for an examination finding is available that incorporates body site or laterality these codes may not be required, for example:
SNOMED CT ID\u00a0\u00a0\u00a0\u2502\u00a0\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
394674001 \u2502 On examination - Left diabetic foot - ulcerated (finding) \u2502 Body site and laterality codes not required.
\nSee the following link for details of the examination findings codes accepted by the National Diabetes Audit (NDA) (see https://nhs-prod.global.ssl.fastly.net/binaries/content/assets/website-assets/data-and-information/clinical-audits-and-registries/national-diabetes-audit/nda-2019-20-snomed-code-set.xlsx). Codes supporting examination findings can be found under the following 'Cluster Descriptions':
Cluster Description\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
Foot checks for people with diabetes
\nThe variable way that certain footcare assessments have been authored in SNOMED CT means that these would variously be recorded under the assessments, examination findings or observations sections of the standard depending on the hierarchy of the concept. These should be visible to the end user together and in the user-interface. For example, the PRSB consultation identified the Ipswich Touch Test * as an assessment that is being increasingly used by professionals and people with diabetes as part of their routine foot examination (see assessments). However, other clinically similar rapid footcare assessments, such as the 10g monofilament test would be recorded under the examination findings section of the standard as these are coded as clinical finding concepts in SNOMED CT. Ankle brachial pressure index (ABPI) and Toe brachial pressure index are observable entity concepts in SNOMED and would be recorded under observations.
\nSNOMED CT ID\u00a0\u00a0\u00a0\u2502\u00a0\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n299910003 \u2502 Finding of light touch (finding) \u2502 Descendants of concept for 10g monofilament outcome recorded in Examination findings
\n252059006 \u2502 Vascular measure (observable entity) \u2502 Descendants of concept for e.g., toe brachial index, ankle brachial pressure index and lower limb doppler pressures recorded in Observations.
\n1443851000000100 \u2502 Ipswich Touch Test score (observable entity) \u2502\u00a0Equal of concept recorded in Assessments or Observations.
\n763258007\u00a0\u2502\u00a0Site, Ischemia, Neuropathy, Bacterial Infection and Depth classification total score (observable entity)\u00a0\u2502\u00a0Equal of concept recorded in Assessments or Observations.
\n763004009\u00a0\u2502\u00a0University of Texas Wound Classification System grade (observable entity)\u00a0\u2502\u00a0Equal of concept recorded in Assessments or Observations.
\n763005005\u00a0\u2502\u00a0University of Texas Wound Classification System stage (observable entity)\u00a0\u2502\u00a0Equal of concept recorded in Assessments or Observations.
\n1099121000000104\u00a0\u2502\u00a0Young Townson FootSkin Hydration Scale for Diabetic Neuropathy level (observable entity)\u00a0\u2502\u00a0Equal of concept recorded in Assessments or Observations.
\n
* [See\u00a0https://doi.org/10.1111/dme.12450 ;\u00a0https://dx.doi.org/10.1016%2Fj.jcte.2021.100252]
Where required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
Where necessary additional supplementary information is permissible to\u00a0be entered as free text in the free text field to provide additional meaning to the code used. For example:
SNOMED CT ID\u00a0\u00a0\u2502\u00a0\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
827160004 \u2502 Erythematous rash (finding) \u2502 Relevant supplementary free text information to provide additional meaning to this concept might include e.g. colour, tenderness, temperature etc.
390931008 \u2502 10g monofilament sensation present (finding) \u2502 Relevant supplementary free text information to provide additional meaning to this concept might include \u201cscore = 10/10\u201d [NB: there is currently no observable entity concept for 10g monofilament test in SNOMED CT].
390932001 \u2502 10g monofilament sensation absent (finding) \u2502 Relevant supplementary free text information to provide additional meaning to this concept might include \u201cscore = 6/10\u201d indicating neuropathy. [NB: there is currently no observable entity concept for 10g monofilament test in SNOMED CT].
", "description": "Free text field to be used if no coded text available", "valueDomain": [{"type": "text", "property": [{"maxLength": "150"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Body site", "implamentationGuidance": "Body site is not required where already implied by the examination finding.This section is used to record individual observations.\u00a0
Observations are traditionally measured or 'observed' at the patient bedside as part of physical examination e.g. heart rate, blood pressure, etc. For the purposes of this standard the following are also considered to be observations (as opposed to investigation results):
~Self-monitoring of blood glucose (SMBG).
~Real-time or intermittently scanned/ 'flash' continuous glucose monitoring (CGM).\u00a0
~Monitoring of blood and urinary ketones at home.
~Other tests \u00a0which may be done by the person or the carer at home as part of their self-management. These tests provide data in real-time or near real-time and are conducted\n without the involvement of a laboratory.\u00a0
Consideration needs to be given to how this section is used in particular for devices that produce many measurements in a 24 hour period. For example, CGM devices provide between 96 (e.g. most commonly every 15 minutes by Freestyle Libre), 288 readings (e.g. every five minutes by Dexcom G6 and Metronic devices) and 1040 readings (e.g. every minute by Menarini\n Glucoday) per day (see https://doi.org/10.1177/1932296818822539).
Individual data readings may be used in the receiving system to calculate summary metrics (e.g. 2019 international consensus group list of 10 core CGM metrics (see https://doi.org/10.2337/dci19-0028)) and/ or display the data graphically (e.g. glucose readings displayed as part of the\n Ambulatory Glucose Profile (AGP).
Observations are traditionally measured or 'observed' at the patient bedside as part of physical examination. For the purposes of this standard the following are also considered to be observations (as opposed to investigation results):
\n
~Self-monitoring of blood glucose (SMBG).
~Real-time or intermittently scanned/ 'flash' continuous glucose monitoring (CGM).\u00a0
~Monitoring of blood and urinary ketones at home.
~Other tests, which may be done by the person or the carer at home as part of their self-management. These tests provide data in real-time or near real-time and are\n conducted without the involvement of a laboratory.\u00a0
Recording of device type is needed only in circumstances where this is clinically relevant (e.g. to distinguish readings from self-monitoring of blood glucose versus continuous glucose monitoring) and therefore sharing this information is not necessary for most observations (e.g., blood pressure).
\n
The following concepts relate to blood glucose monitoring devices:\u00a0
\n
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n Self-monitoring of blood glucose (SMBG):\n
\n337414009\u2502 Blood glucose meter (physical object)\u2502 Equal of concept.
\n\n Continuous glucose monitoring (CGM):\n
\n34865511000001109\u2502 Glucose interstitial fluid detection sensor (physical object) \u2502 Equal of concept. This includes both intermittently scanned (isCGM) and real time (rtCGM) continuous glucose monitors.
\n463729000 \u2502 Point-of-care blood glucose continuous monitoring system (physical object) \u2502 Equal of concept. This applies to intravascular and interstitial fluid monitors used in a hospital setting only.
\nWhere required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\n ", "description": "The coded value for device type.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Free text", "implamentationGuidance": "Where a coded value is provided this field must not be used.\u00a0Observations are traditionally measured or 'observed' at the patient bedside as part of physical examination\u00a0e.g. heart rate, blood pressure, etc. For the purposes of this standard the following are also considered to be observations (as opposed to investigation results):
~Self-monitoring of blood glucose (SMBG) using whole blood or plasma calibrated glucose meters.
~Real-time or intermittently scanned/ 'flash' continuous glucose monitoring (CGM).
~Monitoring of blood and urinary ketones.
~Other tests, which may be done by the person or the carer at home as part of their self-management.
\u00a0
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n1110521000000108 \u2502 Substance concentration of glucose in plasma (observable entity) \u2502 UTL code. Applies to readings from devices reporting molar concentration of glucose in plasma including plasma calibrated glucose meters. *
\n56991000237104\u00a0\u2502 Substance concentration of glucose in blood (observable entity) \u2502 UTL code. Applies to readings from devices reporting molar concentration of glucose in blood including whole blood calibrated blood glucose meters. *\u00a0
\n341151000000104 \u2502 Interstitial fluid glucose level (observable entity) \u2502\u00a0Applies to devices reporting molar concentration of glucose in interstitial fluid including, which may include some continuous glucose monitor (CGM) readings. For the purposes of this standard this concept is preferred to 434910001 |Interstitial fluid glucose concentration (observable entity)| although both concepts are active and neither are currently conformant with SNOMED CT Encoded Unified Test List (UTL) Editorial Principles (see https://hscic.kahootz.com/gf2.ti/f/972002/57976005.9/PDF/-/UTL_SNOMED_Editorial_Principles_v1.6.pdf) and may be superseded in future releases.
\n* Medicines and Healthcare Products Regulatory Agency (MHRA) guidance on blood glucose meters states that \u201c[i]t is essential that accurate records are kept for all aspects of blood glucose testing. This could include\u2026calibration\u2026patient results [etc]\u2026Blood glucose meter test strips generally use capillary whole blood as a sample\u2026Some blood glucose meter test strips are calibrated to give results that are comparable with laboratory glucose results, and these are termed \u2018plasma calibrated\u2019. Plasma calibrated test strips give results that are approximately 12% higher than whole blood results [(see https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/403511/Point_of_care_testing_-_blood_glucose_meters.pdf)].\u201d SNOMED CT concepts used to record results from devices should unambiguously represent what was reported as measured by the device. \u00a0Therefore device reported glucose readings from interstitial fluid and blood/ plasma (including plasma calibrated) samples should not be coded interchangeably (see also\u00a0https://dx.doi.org/10.1177%2F1932296817699637). Where these results are used for calculation of summary glucose metrics reporting molar concentrations these are given as \u2018substance concentration in capillary blood\u2019 (see summary observations section).
\nThe following is a non-exhaustive list of other codes that may be relevant to a person's diabetes self-management and should be used when sharing/ recording the corresponding observations:
\nSNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
271649006\u00a0\u2502 Systolic blood pressure (observable entity) \u2502 Vital sign. NICE care process.
271650006\u00a0\u2502 Diastolic blood pressure (observable entity) \u2502 Vital sign. NICE care process.
\n27113001\u00a0\u2502 Body weight (observable entity) \u2502 NICE care process (required to calculate BMI).
\n50373000\u00a0\u2502 Body height measure (observable entity) \u2502 Use if person standing upright. NICE care process (required to calculate BMI).
\n248334005 \u2502 Length of body (observable entity) \u2502 Use if person lying supine. NICE care process (required to calculate BMI).
\n60621009 \u2502 Body mass index (observable entity) \u2502 NICE care process.
\n446974000 \u2502 Body mass index centile (observable entity) \u2502 NICE care process.
\n896691000000102 \u2502 Child body mass index centile (observable entity) \u2502 For use in children. NICE care process.
\n364075005\u00a0\u2502 Heart rate (observable entity) \u2502 Descendants and self of concept. Vital sign.
\n386725007\u00a0\u2502 Body temperature (observable entity) \u2502 Descendants and self of concept. Vital sign.
\n86290005\u00a0\u2502 Respiratory rate (observable entity) \u2502 e.g. measured by person's carer. Vital sign.
\n431314004\u00a0\u2502 Peripheral oxygen saturation (observable entity) \u2502 Descendants and self of concept. Vital sign.
\n364589006\u00a0\u2502 Birth weight (observable entity) \u2502 Applies to child with diabetes.\u00a0
\n363812007\u2502 Head circumference (observable entity) \u2502 Descendants and self of concept. Applies to child with diabetes.
\n707205007\u00a0\u2502 Toe brachial pressure index (observable entity) \u2502 Descendants and self of concept. Applicable to diabetic foot checks.
\n446841001 \u2502 Ankle brachial pressure index (observable entity) \u2502 Descendants and self of concept.\u00a0 Applicable to diabetic foot checks.
\nSee the following link for details of the observation codes accepted by the National Diabetes Audit (NDA) (see https://nhs-prod.global.ssl.fastly.net/binaries/content/assets/website-assets/data-and-information/clinical-audits-and-registries/national-diabetes-audit/nda-2019-20-snomed-code-set.xlsx). Codes supporting examination findings can be found under the following 'Cluster Descriptions':
\nCluster Description\u00a0\u00a0\u2502\u00a0Implementation guidance
\nWhere required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nWorked example for ketones observables
\nThe following UTL results codes may be relevant for a person self-managing their diabetes at home and testing their own ketones as part of 'sick day rules' (see https://www.diabetes.org.uk/guide-to-diabetes/life-with-diabetes/illness):
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n53221000237100 \u2502 Substance concentration of ketone in blood (observable entity) \u2502 Equal of concept.
\n58621000237108 \u2502 Ordinal value of ketones in urine (observable entity) \u2502 Equal of concept.\u00a0
\nThe reporting of urinary ketones by people with diabetes may depend on the product used or local practice. For example, two products available in the UK provide report ordinal ketone results in the following ways:
\nNegative \u2502 Trace \u2502 Small \u2502 Moderate \u2502 Large \u2502 Large\u00a0
\nNot applicable \u2502 0.5 mmol/L \u2502 1.5 mmol/L \u2502 4.0 mmol/L \u2502 8.0 mmol/L \u2502 16.0 mmol/L
\nNegative \u2502 Trace \u2502 + \u2502 ++ \u2502 +++ \u2502 ++++
\nNot applicable \u2502 0.5 mmol/L \u2502 1.5 mmol/L \u2502 4.0 mmol/L \u2502 8.0 mmol/L \u2502 16.0 mmol/L
\nNB: Observable entities are the only coded values permissible\u00a0in the observations section of the standard. For example, the following codes for urinary ketone results would need to be recorded under examination findings.\u00a0
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0\u00a0\u00a0Implementation guidance\u00a0 \u00a0
167288007 \u2502 Urine ketone test = trace (finding) \u2502 Equal of concept.
\n167289004\u00a0\u2502\u00a0Urine ketone test = + (finding) \u2502 Equal of concept.
\n167290008\u00a0\u2502\u00a0Urine ketone test = ++ (finding) \u2502 Equal of concept.
\n167291007\u00a0\u2502\u00a0Urine ketone test = +++ (finding) \u2502 Equal of concept.
\n167292000\u00a0\u2502 Urine ketone test = ++++ (finding)\u2502 Equal of concept.
This does not preclude these terms being displayed to the end-user as observations as they are widely used in clinical practice. For example, ++++ ketones can be inferred from a combination of:
Observable entity\u00a0\u2502\u00a0Value\u00a0\u00a0\u2502\u00a0\u00a0UCUM\u00a0\u00a0code
\nOrdinal value of ketones in urine (observable entity)\u00a0\u2502\u00a016.0\u00a0\u2502\u00a0mmol/L\u00a0
\nPeople with diabetes may also use devices or products that report blood or urinary ketones in units of mg/dl. All results should be converted into values with units of mmol/L before sharing (see units of measure).\u00a0
\nWhether and how observations or investigations measuring the same substance (e.g. blood glucose) should be displayed together in the receiving system (e.g. electronic health record) is out of scope.\u00a0
\nThis element has a FHIR value set of observation interpretation codes (see http://hl7.org/fhir/stu3/valueset-observation-interpretation.html) that includes codes of \u2018<\u2019 for \u2018Off scale low\u2019 and \u2018>\u2019 for \u2018Off scale high\u2019 for use where the true physiological value falls outside\n the analytical range of the device providing the reading.
\nSome devices can only report results accurately within a limited range. For example, the Gluco Rx Q* Blood Glucose Monitoring System* a device used by some people with diabetes who perform their own self-monitoring of blood glucose (SMBG) that has a lower analytical range of 1.1 mmol/L (results less than this will be displayed on the device as Lo, coded in\n FHIR as \u2018<\u2019 not \u2018L\u2019 **) and an upper analytical range of 33.3 mmol/L (displaying results above this on the device as \u2018Hi\u2019, coded in FHIR as \u2018>\u2019 not \u2018H\u2019 ** ).
\n* Referenced without preference (see https://www.glucorx.co.uk/wp-content/uploads/2021/12/GlucoRX-Q-Strip-Manual.pdf).
\n** (See https://simplifier.net/packages/hl7.fhir.r4.core/4.0.1/files/78998)
\nThis record entry allows for sharing of a person's calculated glucose summary metrics calculated from \u00a0data sources including the following device types:
\n~Capillary blood glucose measured using a blood glucose meter and obtained using fingerstick testing.\u00a0
\n~Interstitial fluid glucose measured using either \"Flash\" intermittent scan (isCGM) or real-time (rtCGM) continuous glucose monitoring (CGM) devices.
\nThe elements in this section that align to the 2019 international consensus group list of 10 core CGM metrics (see https://doi.org/10.2337/dci19-0028) are listed below:
\n~Mean glucose.
\n~Glucose management indicator (GMI).
\n~Coefficient of variation (%CV).
\n~Time above range (TAR) level 2.
\n~Time above range (TAR) level 1.
\n~Time in range (TIR).
\n~Time below range (TBR) level 1.
\n~Time below range (TBR) level 2.
\nThis standard does not support sharing of the following 2019 core CGM metrics:
\n~Number of days CGM worn.
\n~Percentage of time CGM is active.
\nHowever, an approximation of the number of days the CGM device was worn and active during the reporting period could be inferred from the following elements:
\n~Reporting period (Start and end date).
\n~Percent sensor data available.
\nElements in this section that align to an earlier 2017 consensus (see https://doi.org/10.2337/dc17-1600) are listed below:
\n~Number of significant hypoglycaemic episodes.
\n~Standard deviation (of mean glucose).
\nHow blood glucose data is shown in systems to the end user as part of the graphical user interface (GUI) is an active area of development (see https://doi.org/10.1089/dia.2020.0524) and is out of scope of this standard but it is anticipated that these metrics could be included in a dashboard that displayed individual readings as part of the ambulatory glucose\n profile (AGP) (see http://www.agpreport.org/agp/agpreports) using UK units for plasma glucose of mmol/ L. The use of electronic clinical decision support (CDS) such as active pop up alerts are widely used in proprietary and third party apps and applications for reporting data from CGM devices. It is recognised that this may also be utilised during implementation\n but a definition of CDS requirements is out of scope of this standard.\u00a0
\n ", "description": "This is a glucose metrics record entry. There may be 0 to many record entry/entries under a section. Each record entry is made up of a number of elements or data items.", "informationType": "Event.Record", "concept": [{"type": "group", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Reporting period", "implamentationGuidance": "Recording of device type is needed only in circumstances where this is clinically relevant (e.g. to distinguish readings from self-monitoring of blood glucose versus continuous glucose monitoring) and therefore sharing this information is not necessary for most observations (e.g., blood pressure).
\n
The following concepts relate to blood glucose monitoring devices:\u00a0
\n
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n Self-monitoring of blood glucose (SMBG):\n
\n337414009\u2502 Blood glucose meter (physical object)\u2502 Equal of concept.
\n\n Continuous glucose monitoring (CGM):\n
\n34865511000001109\u2502 Glucose interstitial fluid detection sensor (physical object) \u2502 Equal of concept. This includes both intermittently scanned (isCGM) and real time (rtCGM) continuous glucose monitors.
\n463729000 \u2502 Point-of-care blood glucose continuous monitoring system (physical object) \u2502 Equal of concept. This applies to intravascular and interstitial fluid monitors used in a hospital setting only.
\nWhere required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\n ", "description": "The coded value for device type.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Free text", "implamentationGuidance": "Where a coded value is provided this field must not be used.\u00a0The coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464931000000109 | Mean number of self-monitored capillary blood glucose measurements per day (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) including fingerstick tests or \u201cflash\u201d/ intermittently scanned continuous glucose monitors (isCGM).
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
", "description": "The coded value for mean daily monitoring frequency.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.This element is mandatory for data derived from a continuous glucose monitoring (CGM) device.
\nThe coded value field must contain the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~1464941000000100 | Percentage of successful data capture time to total expected continuous glucose monitoring sensor wear time using minimally-invasive continuous glucose monitoring device (observable entity)) \u2502 Applies to CGM only.
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThis metric refers to sensor failures detected by CGM devices themselves (e.g. Dexcom G6 \"Sensor failed\" screen). Currently, if a person with diabetes or their carer wishes to report CGM device sensor failures to a healthcare professional they would need to do this manually as this information is not shared from the devices themselves. This metric should be\n reported as the sum of continuous glucose monitoring sensor failures recorded/ reported by the person during the reporting period expressed as a percentage of sensors applied.
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~New code request \u2502 Number of continuous glucose monitoring device sensor failures reported by subject of record expressed as a percentage of sensors applied (observable entity) \u2502\u00a0Applies to CGM only.
\nA new code request for the above item has been submitted to NHS Digital. The FSN of the final approved code may differ. For updates or queries relating to newly submitted codes contact info@theprsb.org.
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThe table below details the required UCUM code for this element:
\nUCUM code\u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
\n% \u2502 percent ** \u2502 Percent number of sensor failures.\u2502 No specific guidance.\u00a0
\n* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
\n** Exact UCUM description.
\nFurther information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~1464671000000104 | Mean substance concentration of glucose in capillary blood using minimally-invasive continuous glucose monitoring device (observable entity) \u2502\u00a0Calculated from CGM device data.
\n~1464731000000106 | Mean substance concentration of glucose in capillary blood by self-monitoring of blood glucose using blood glucose meter (observable entity) \u2502\u00a0Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
\nSNOMED CT ID\u00a0 \u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~1464741000000102 | Standard deviation of mean substance concentration of glucose in capillary blood using minimally-invasive continuous glucose monitoring device (observable entity) \u2502\u00a0Calculated from CGM device data.
\n~1464751000000104 | Standard deviation of mean substance concentration of glucose in capillary blood by self-monitoring of blood glucose using blood glucose meter (observable entity) \u2502\u00a0Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~1464761000000101 | Coefficient of variation of mean substance concentration of glucose in capillary blood using minimally-invasive continuous glucose monitoring device (observable entity) \u2502\u00a0Calculated from CGM device data.
\n~1464771000000108 | Coefficient of variation of mean substance concentration of glucose in capillary blood by self-monitoring of blood glucose using blood glucose meter (observable entity) \u2502\u00a0Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN) \u2502\u00a0Implementation guidance
~1464791000000107 | Percentage of time above level 2 hyperglycaemic threshold to total continuous glucose monitoring time using minimally-invasive continuous glucose monitoring device (observable entity) \u2502 Calculated from CGM device data.
~1464851000000107 | Percentage of readings above level 2 hyperglycaemic threshold to total self-monitored capillary blood glucose readings using blood glucose meter (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for T/VAR level 2.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.Elements under this group are used to define the reference ranges for both times and proportions in ranges.
\nThe 2019 international consensus on time in range (see https://doi.org/10.2337/dci19-0028) outlined the following basic guidance on target ranges for people with diabetes:
\nDiabetes group \u00a0\u2502\u00a0TAR (Level 2)\u00a0\u2502\u00a0TAR (Level 1)\u00a0\u2502\u00a0TIR\u00a0\u2502\u00a0TBR (Level 1)\u00a0\u2502\u00a0TBR (Level 2)
\nType 1 or 2 \u2502 > 13.9 mmol/ L \u2502 > 10.0 mmol/ L \u2502 3.9 - 10.0 mmol/ L \u2502< 3.9 mmol/ L \u2502 < 3.0 mmol/ L
\nOptimally greater than 70% of the time (or of recorded values) the glucose levels should sit within the optimal 3.9 - 10 mmol/L target range with under 4% of the time (or recorded values) being spent below 3.9 mmol/L.
\nThe standard supports personalised glucose targets that are based on a different percentage within each range (as opposed to changing the range). For further details and guidance target ranges for older/ high risk persons and pregnant people with type 1 or type 2 diabetes (see https://doi.org/10.2337/dci19-0028).
\n\u00a0
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 385524004 \u00a0\u2502 Lower limit of reference range (qualifier value) \u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range lower bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.\u00a0
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling).
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464801000000106 | Percentage of time above level 1 hyperglycaemic threshold to total continuous glucose monitoring time using minimally-invasive continuous glucose monitoring device (observable entity) \u2502 Calculated from CGM device data.
~1464861000000105 | Percentage of readings above level 1 hyperglycaemic threshold to total self-monitored capillary blood glucose readings using blood glucose meter (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for T/VAR level 1.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.Elements under this group are used to define the reference ranges for both times and proportions in ranges.
\nThe 2019 international consensus on time in range (see https://doi.org/10.2337/dci19-0028) outlined the following basic guidance on target ranges for people with diabetes:
\nDiabetes group \u00a0\u2502\u00a0TAR (Level 2)\u00a0\u2502\u00a0TAR (Level 1)\u00a0\u2502\u00a0TIR\u00a0\u2502\u00a0TBR (Level 1)\u00a0\u2502\u00a0TBR (Level 2)
\nType 1 or 2 \u2502 > 13.9 mmol/ L \u2502 > 10.0 mmol/ L \u2502 3.9 - 10.0 mmol/ L \u2502< 3.9 mmol/ L \u2502 < 3.0 mmol/ L
\nOptimally greater than 70% of the time (or of recorded values) the glucose levels should sit within the optimal 3.9 - 10 mmol/L target range with under 4% of the time (or recorded values) being spent below 3.9 mmol/L.
\nThe standard supports personalised glucose targets that are based on a different percentage within each range (as opposed to changing the range). For further details and guidance target ranges for older/ high risk persons and pregnant people with type 1 or type 2 diabetes (see https://doi.org/10.2337/dci19-0028).
\n\u00a0
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 385524004 \u00a0\u2502 Lower limit of reference range (qualifier value) \u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range lower bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.\u00a0
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling).
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 371933006 \u2502 Upper limit of reference range (qualifier value)\u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range upper bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.\u00a0
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling).
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464781000000105 | Percentage of time in target glucose range to total glucose monitoring time using minimally-invasive continuous glucose monitoring device (observable entity) \u2502 Calculated from CGM device data.
~1464841000000109 | Percentage of readings in target range to total self-monitored capillary blood glucose readings using blood glucose meter (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for times or values in range (T/VIR).\u00a0", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.The coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 385524004 \u00a0\u2502 Lower limit of reference range (qualifier value) \u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 371933006 \u2502 Upper limit of reference range (qualifier value)\u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464831000000100 | Percentage of time below level 1 hypoglycaemic threshold to total continuous glucose monitoring time using minimally-invasive continuous glucose monitoring device (observable entity) \u2502 Calculated from CGM device data.
~1464881000000101 | Percentage of readings below level 1 hypoglycaemic threshold to total self-monitored capillary blood glucose readings using blood glucose meter (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for T/VBR level 1.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.Elements under this group are used to define the reference ranges for both times and proportions in ranges.
\nThe 2019 international consensus on time in range (see https://doi.org/10.2337/dci19-0028) outlined the following basic guidance on target ranges for people with diabetes:
\nDiabetes group \u00a0\u2502\u00a0TAR (Level 2)\u00a0\u2502\u00a0TAR (Level 1)\u00a0\u2502\u00a0TIR\u00a0\u2502\u00a0TBR (Level 1)\u00a0\u2502\u00a0TBR (Level 2)
\nType 1 or 2 \u2502 > 13.9 mmol/ L \u2502 > 10.0 mmol/ L \u2502 3.9 - 10.0 mmol/ L \u2502< 3.9 mmol/ L \u2502 < 3.0 mmol/ L
\nOptimally greater than 70% of the time (or of recorded values) the glucose levels should sit within the optimal 3.9 - 10 mmol/L target range with under 4% of the time (or recorded values) being spent below 3.9 mmol/L.
\nThe standard supports personalised glucose targets that are based on a different percentage within each range (as opposed to changing the range). For further details and guidance target ranges for older/ high risk persons and pregnant people with type 1 or type 2 diabetes (see https://doi.org/10.2337/dci19-0028).
\n\u00a0
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 385524004 \u00a0\u2502 Lower limit of reference range (qualifier value) \u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range lower bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling).
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 371933006 \u2502 Upper limit of reference range (qualifier value)\u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range upper bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.\u00a0
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling).
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nThe coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464821000000102 | Percentage of time below level 2 hypoglycaemic threshold to total continuous glucose monitoring time using minimally-invasive continuous glucose monitoring device (observable entity) \u2502 Calculated from CGM device data.
~1464871000000103 | Percentage of readings below level 2 hypoglycaemic threshold to total self-monitored capillary blood glucose readings using blood glucose meter (observable entity) \u2502 Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for T/VBR level 2.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.Elements under this group are used to define the reference ranges for both times and proportions in ranges.
\nThe 2019 international consensus on time in range (see https://doi.org/10.2337/dci19-0028) outlined the following basic guidance on target ranges for people with diabetes:
\nDiabetes group \u00a0\u2502\u00a0TAR (Level 2)\u00a0\u2502\u00a0TAR (Level 1)\u00a0\u2502\u00a0TIR\u00a0\u2502\u00a0TBR (Level 1)\u00a0\u2502\u00a0TBR (Level 2)
\nType 1 or 2 \u2502 > 13.9 mmol/ L \u2502 > 10.0 mmol/ L \u2502 3.9 - 10.0 mmol/ L \u2502< 3.9 mmol/ L \u2502 < 3.0 mmol/ L
\nOptimally greater than 70% of the time (or of recorded values) the glucose levels should sit within the optimal 3.9 - 10 mmol/L target range with under 4% of the time (or recorded values) being spent below 3.9 mmol/L.
\nThe standard supports personalised glucose targets that are based on a different percentage within each range (as opposed to changing the range). For further details and guidance target ranges for older/ high risk persons and pregnant people with type 1 or type 2 diabetes (see https://doi.org/10.2337/dci19-0028).
\n\u00a0
\nThe coded value field must contain only the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~ 371933006 \u2502 Upper limit of reference range (qualifier value)\u2502\u00a0 No specific guidance
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\nThis field is mandatory if the coded value (observable entity) is shared.
\nThis field is mandatory if the coded value (observable entity) is shared.
The table below details the required UCUM code for this element:
UCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
mmol/L \u2502 millimole per liter **\u2502 Reference range upper bound.\u2502 Molar concentration measured in mmol/L is the international standard way of measuring blood glucose used in the UK.
* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
** Exact UCUM description (US spelling)
Further information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
", "description": "\nGlucose management indicator (GMI) is supported by the 2019 consensus on CGM metrics (see https://doi.org/10.2337/dci19-0028) and a 2021 consensus report (see https://doi.org/10.1007/s00125-021-05568-3) and \"is calculated based on the average sensor glucose over the last 14 days and provides an approximation of laboratory based HbA1c, in some individuals, but it\n may be higher or lower than actual HbA1c in others.\" For further background on GMI including how to calculate it (see https://doi.org/10.2337/dc18-1581).
\nThis is calculated using either of the following equations:
\n\n OR\n
\nGMI is applicable to CGM data only.
\n ", "description": "Estimate of HbA1c using glucose management indicator (GMI), during the reporting period.The coded value field must contain the following SNOMED CT concept:
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464891000000104 | Glucose Management Indicator expressed as substance concentration ratio (observable entity) \u2502 Applies to CGM only.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for glucose management indicator (GMI).", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.The coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
SNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
~1464911000000101 | Number of clinically significant hypoglycaemic episodes recorded by continuous glucose monitoring device (observable entity) \u2502\u00a0Calculated from CGM device data.
~1464901000000103 | Number of clinically significant hypoglycaemic episodes recorded by self-monitoring of capillary blood glucose (observable entity) \u2502\u00a0Calculated from any allowable data source where the data was collected as part of a person\u2019s self-monitoring of blood glucose (SMBG) using fingerstick testing.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
", "description": "The coded value for number of significant hypoglycaemic episodes.", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.The coded value field must contain the following SNOMED CT concept:
\nSNOMED CT ID \u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n~1464921000000107 | Mean duration of hypoglycaemic episodes in minutes (observable entity) \u2502 Applies to CGM only.\u00a0
\nWhere required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
\n"}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.
Structured assessment name should be coded using only one SNOMED CT concept that is a subtype of the following concept:
\nSNOMED CT ID\u00a0\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u00a0\u2502\u00a0\u00a0Implementation guidance
\n273249006\u00a0\u2502\u00a0Assessment scales (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nThe following list of assessment scale codes was identified during the PRSB consultation as relevant to diabetes care * and is non-exhaustive:
\n* Not all assessments identified will necessarily be appropriate for use by people with diabetes or their carers without the involvement of a healthcare professional. Included items generally had a minimum of 5% of respondents saying that they 'sometimes' or 'nearly always' used the assessment (see Diabetes Survey Report).
\nAssessment name\u00a0\u2502\u00a0SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\nHypoglycaemia awareness or fear
\nGold score\u00a0\u2502\u00a01104881000000101\u00a0\u2502\u00a0Gold Score for awareness of hypoglycaemia (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nClarke score\u00a0\u2502\u00a0838301000000106\u00a0\u2502\u00a0Clarke hypoglycaemia awareness questionnaire (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nHypoglycaemia fear survey **\u00a0\u2502\u00a0837671000000105\u00a0\u2502\u00a0Hypoglycaemia fear survey (assessment scale)\u00a0\u2502\u00a0Validated for use by people with type 1 diabetes (see https://doi.org/10.2337/dc10-1343).
\nFoot care assessments
\nSINBAD\u00a0\u2502\u00a0921741000000108\u00a0\u2502\u00a0Site, ischaemia, neuropathy, bacterial infection and depth wound classification (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nUniversity of Texas Wound Classification System\u00a0\u2502\u00a0763003003\u00a0\u2502\u00a0University of Texas Wound Classification System (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nYoung Townson FootSkin Scale\u2502\u00a0980351000000105\u00a0\u2502\u00a0Young Townson FootSkin Scale for Diabetic Neuropathy (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nIpswich touch test \u2502\u00a01443841000000103\u00a0Ipswich Touch Test (assessment scale) \u2502\u00a0No specific guidance.
\nDiabetes distress
\nDiabetes Distress Scale (DDS) 2 item **\u00a0\u2502\u00a0909401000000106\u00a0\u2502\u00a0Diabetes Distress Scale 2 item (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nDDS 17 item **\u00a0\u2502\u00a0909441000000109\u00a0\u2502\u00a0Diabetes Distress Scale 17 item (assessment scale)\u00a0\u2502\u00a0Validated for use by people with type 2 diabetes (see https://diabetesdistress.org/dd-assess-score-3).
\nT1-DDS **\u00a0\u2502\u00a01373521000000101 \u00a0\u2502\u00a0Type 1 Diabetes Distress Scale (assessment scale)\u00a0\u2502\u00a0Validated for use by people with type 1 diabetes. For rationale (see https://dx.doi.org/10.1016%2Fj.jdiacomp.2015.01.012).
\nPAID-20 **\u00a0\u2502\u00a01363131000000101\u2502\u00a0Problem Areas in Diabetes (assessment scale)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.2337/diacare.18.6.754).
\nPAID-11 **\u00a0\u2502\u00a01373391000000108\u2502\u00a0Problem Areas in Diabetes 11-item (assessment scale)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.1016/j.diabres.2019.01.026).
\nPAID-5 **\u2502\u00a01373411000000108 \u2502\u00a0Problem Areas in Diabetes 5-item (assessment scale)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.1007/s00125-009-1559-5).
\nPAID-1 **\u2502\u00a01373441000000109\u00a0\u2502\u00a0Problem Areas in Diabetes 1-item (assessment scale)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.1007/s00125-009-1559-5).
\nGeneral emotional health and wellbeing
\nWHO Well-being index \u2502 1144752009 \u2502 5-item World Health Organization Well-being Index questionnaire (assessment scale) \u2502 No specific guidance.
\nPatient Health Questionnaire (PHQ) 2 item **\u00a0\u2502\u00a0836521000000107\u00a0\u2502\u00a0Patient health questionnaire 2 (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nPHQ 4 item **\u00a0\u2502\u00a0865935003\u00a0\u2502\u00a0Patient Health Questionnaire-4 (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nPHQ 9 item **\u00a0\u2502\u00a0758711000000105\u00a0\u2502\u00a0Patient health questionnaire 9 (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nPHQ 15 item **\u00a0\u2502\u00a01065421000000105\u00a0\u2502\u00a0Patient Health Questionnaire 15 (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nHospital anxiety and depression scale (HADS)\u00a0\u2502\u00a0273524006\u00a0\u2502\u00a0Hospital anxiety and depression scale (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nGeneralised anxiety disorder (GAD) 2 item **\u00a0\u2502\u00a0836551000000102\u00a0\u2502\u00a0Generalised anxiety disorder 2 scale (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nGeneralised anxiety disorder (GAD) 7 item **\u00a0\u2502\u00a0704501007\u00a0\u2502\u00a0Generalized anxiety disorder 7 item scale (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nDiet, nutrition and eating disorders
\nMalnutrition Universal Screening Tool (MUST)\u00a0\u2502\u00a0414648004\u00a0\u2502\u00a0Malnutrition universal screening tool (assessment scale)\u00a0\u2502\u00a0Validated for use in people with type 2 diabetes. For rationale (see https://www.bapen.org.uk/pdfs/must/must_explan.pdf).
\nmSCOFF\u00a0\u2502\u00a01362371000000109\u2502\u00a0Modified Sick, Control, One, Fat, Food questionnaire (assessment scale)\u00a0\u2502\u00a0Validated in female adolescents with type 1 diabetes. For rationale (see https://doi.org/10.2337/dc13-1637).
\nDiabetes Eating Problem Survey Revised (DEPS-R) 16 item\u00a0\u2502\u00a01362831000000102 \u00a0\u2502\u00a0Diabetes Eating Problem Survey - Revised (assessment scale) \u00a0\u2502\u00a0Validated for use in youth and adolescents (see https://dx.doi.org/10.2337%2Fdc09-1890) and adults (see https://doi.org/10.1186/s40337-018-0232-0) with type 1 diabetes.
\nDiabetes self-management and quality of life
\nDiabetes Quality of Life (DQOL) questionnaire\u00a0\u2502\u00a0838221000000109\u00a0\u2502\u00a0Diabetes quality of life questionnaire (assessment scale)\u00a0\u2502\u00a0No specific guidance.
\nDiabetes Self Management Questionnaire (DSMQ) 16 item\u00a0\u00a0\u2502\u00a0New code request\u00a0\u00a0\u2502\u00a0Diabetes Self Management Questionnaire (DSMQ) 16 item (assessment scale)\u00a0\u00a0\u2502\u00a0For rationale (see\u00a0https://doi.org/10.1186/1477-7525-11-138\u00a0).
\nDiabetes Self Management Questionnaire (DSMQ-R) 27 item \u2013 revised\u00a0\u00a0\u2502\u00a0New code request\u00a0\u00a0\u2502\u00a0Diabetes Self Management Questionnaire (DSMQ-R) 27 item - revised (assessment scale)\u00a0\u00a0\u2502\u00a0For rationale (see https://doi.org/10.3389/fcdhc.2021.823046).
\nDiabetes management self-efficacy scale (DMSES) UK\u00a0\u2502\u00a01373991000000107 \u2502\u00a0Diabetes management self-efficacy scale United Kingdom 15-item (assessment scale) \u00a0\u2502\u00a0Validated for people with type 2 diabetes. For rationale (see\u00a0https://psycnet.apa.org/doi/10.1017/S1463423610000101).
\nInsulin and medication questionnaires
\nInsulin Treatment Appraisal Scale (ITAS) **\u00a0\u2502\u00a01423591000000108 \u00a0\u2502\u00a0Insulin Treatment Appraisal Scale (assessment scale)\u00a0\u2502\u00a0Validated for use in people with type 2 diabetes. For rationale (see https://dx.doi.org/10.1186%2F1477-7525-5-69 AND https://doi.org/10.1186/1477-7525-12-87).
\nMedication Adherence Report Scale (MARS) 5 item\u00a0\u2502\u00a01363071000000103 \u00a0\u2502\u00a0Medication Adherence Report Scale 5-item (assessment scale) \u00a0\u2502\u00a0For rationale (see https://dx.doi.org/10.1111%2Fbcp.14193).
\nRisk assessment tools
\nQRISK2\u00a0\u2502\u00a0763245006\u00a0\u2502\u00a0QRISK2 cardiovascular disease 10 year risk calculator (assessment scale)\u00a0\u2502\u00a0NICE recommends QRISK2 for use in people with type 2 diabetes (https://www.nice.org.uk/guidance/ng28). Use in people with type 1 is not recommended as they are already considered at high risk (see https://www.nice.org.uk/guidance/cg181).
\nQRISK3 \u2502 1085771000000100 \u2502 QRISK3 cardiovascular disease 10 year risk calculator (assessment scale) \u2502 No specific guidance.
\nPatient activation, physical activity and sleep
\nPatient Activation Measure (PAM)\u00a0\u2502713863004\u2502\u00a0Patient Activation Measure (assessment scale) | No specific guidance.
\nGPPAQ\u00a0\u2502770231000000109\u2502\u00a0General practice physical activity questionnaire (assessment scale) | No specific guidance.
\nPittsburgh sleep quality\u00a0index\u00a0\u2502 699200007\u00a0\u2502 Pittsburgh sleep quality index (assessment scale) \u2502 No specific guidance.
\nDiabetes treatment satisfaction
\nDTSQ status version\u00a0\u2502\u00a0739663003\u00a0\u2502\u00a0Diabetes Treatment Satisfaction Questionnaire status version (assessment scale) | No specific guidance.
\nDTSQ change version\u00a0\u2502739664009\u2502\u00a0Diabetes Treatment Satisfaction Questionnaire status version (assessment scale) | No specific guidance.
\nFrailty assessments
Electronic frailty index\u00a0\u25021084951000000107\u00a0\u2502\u00a0Electronic Frailty Index (assessment scale) \u2502 See\u00a0https://www.guidelines.co.uk/diabetes/type-2-diabetes-frailty-in-older-people/454600.article). Frailty is also relevant for care home residents with diabetes (see\u00a0https://www.diabetes.org.uk/resources-s3/2017-09/Care_homes_report2010_0.pdf).Electronic frailty index 2\u00a0\u2502 1423651000000101\u00a0\u2502\u00a0
Electronic Frailty Index 2 (assessment scale) \u2502 No specific guidance.
\nRockwood clinical frailty scale \u2502 445414007 \u2502 Canadian Study of Health and Aging clinical frailty scale (assessment scale) \u2502 For rationale (see https://doi.org/10.1503%2Fcmaj.050051).
\nCognition, mood and memory
\nAbbreviated mental test score (AMTS) \u2502 273255001 \u2502 Abbreviated Mental Test Score (assessment scale) \u2502 No specific guidance.
\nGeneral practitioner assessment of cognition (GPCOG) \u2502 770753000 \u2502 General Practitioner Assessment of Cognition (assessment scale) \u2502 No specific guidance.
\nMini-cog brief cognitive screening test \u2502 713262003 \u2502 Mini-Cog brief cognitive screening test (assessment scale) \u2502 No specific guidance.
\nSix item cognitive impairment test \u2502 1085141000000105 \u2502 Six Item Cognitive Impairment Test (assessment scale) \u2502 No specific guidance.
\nMini mental state examination (MMSE) \u2502 273617000 \u2502 Mini-mental state examination (assessment scale) \u2502 No specific guidance.
\nModified mini mental state examination (3MS) \u2502 273619002 \u2502 Modified mini-mental state examination (assessment scale) \u2502 No specific guidance. \u00a0
\nMontreal Cognitive Assessment (MoCA) \u2502 859351000000102 \u2502 Montreal cognitive assessment (assessment scale) \u2502 For further information (see https://www.mocatest.org/). ***
\n4AT rapid clinical test for delirium \u2502 1239191000000102 \u2502 4 A's Test for delirium and cognitive impairment (assessment scale) \u2502 No specific guidance. ***
\nConfusion assessment method (CAM) \u2502 824471000000102 \u2502 Confusion assessment method short version (assessment scale) \u2502 No specific guidance. ***
\nGeriatric depression scale (GDS) \u2502 273481004 \u2502 Geriatric depression scale (assessment scale) \u2502 Descendent or self of concept (including original long form, short form, and 4-item form scales). ***
\nAddenbrooke\u2019s cognitive examination revised (ACE-R) \u2502 445412006 \u2502 Addenbrooke's cognitive examination revised (assessment scale) \u2502 No specific guidance. ***
\nSkin integrity
\nWaterlow pressure sore risk score \u2502 278897004 \u2502 Waterlow pressure sore risk score (assessment scale) \u2502 No specific guidance.
\nMobility and activities of daily living
\nBarthel ADL index \u2502 273302005 \u2502 Barthel index (assessment scale) \u2502 Descendent or self of concept (including original, UK or modified scales).
\nInstrumental activities of daily living (I-ADL) \u2502 273534002 \u2502 Instrumental activities of daily living (assessment scale) \u2502 No specific guidance.
\nPain assessment
\nAbbey pain scale \u2502 763306003 \u2502 Abbey Pain Scale (assessment scale) \u2502 No specific guidance.
\nBPI \u2502 494711000000101 \u2502 Brief pain inventory (assessment scale) \u2502 No specific guidance.
\nBPCI \u2502 494721000000107 \u2502 Brief pain coping inventory (assessment scale) \u2502 No specific guidance.
\nPAINAD \u2502 7121000122100 \u2502 Pain Assessment in Advanced Dementia Scale (assessment scale) \u2502 No specific guidance.
\nS-LANSS \u2502 810601000000106 \u2502 Self-completed Leeds assessment of neuropathic symptoms and signs pain scale (assessment scale) \u2502 No specific guidance.
\nVAPS \u2502 273904000 \u2502 Visual analog pain scale (assessment scale) \u2502 No specific guidance.
\n
** For key diabetes assessments identified by the American Diabetes Association (see https://professional.diabetes.org/sites/professional.diabetes.org/files/media/ada_mental_health_toolkit_questionnaires.pdf).
*** For further information on some key cognitive assessments recommended by NHS England in 2014 for use in primary care in England (see https://www.england.nhs.uk/wp-content/uploads/2014/09/dementia-revealed-toolkit.pdf).
\nAssessment score should be coded using only one SNOMED CT concept that is a subtype of the following concept:
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
363787002\u00a0\u2502\u00a0Observable entity (observable entity)\u00a0\u2502\u00a0No specific guidance.
The following list of assessment score codes was identified during the PRSB consultation as relevant to diabetes care * and is non-exhaustive:
* Not all assessments identified will necessarily be appropriate for use by people with diabetes or their carers without the involvement of a healthcare professional. Included items generally had a minimum of 5% of respondents saying that they 'sometimes' or 'nearly always' used the assessment (see Diabetes Survey Report).
Assessment name\u00a0\u2502\u00a0SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
Hypoglycaemia awareness or fear
Gold score\u00a0\u2502\u00a01104871000000103\u00a0\u2502\u00a0Gold Score for awareness of hypoglycaemia (observable entity)\u00a0\u2502\u00a0No specific guidance.
Clarke score\u00a0\u2502\u00a0851981000000106\u00a0\u2502\u00a0Clarke hypoglycaemia awareness questionnaire score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Hypoglycaemia fear survey
Hypoglycaemia fear survey\u00a0**\u00a0\u2502\u00a0851971000000109\u00a0\u2502\u00a0Hypoglycaemia fear survey score (observable entity)\u00a0\u2502\u00a0Validated for use by people with type 1 diabetes (see https://doi.org/10.2337/dc10-1343).
Foot care assessments
SINBAD\u00a0\u2502\u00a0763258007\u00a0\u2502\u00a0Site, Ischemia, Neuropathy, Bacterial Infection and Depth classification total score (observable entity)\u00a0\u2502\u00a0No specific guidance.
University of Texas Wound Classification System (grade)\u00a0\u2502\u00a0763004009\u00a0\u2502\u00a0University of Texas Wound Classification System grade (observable entity)\u00a0\u2502\u00a0No specific guidance.
University of Texas Wound Classification System (stage)\u00a0\u2502\u00a0763005005\u00a0\u2502\u00a0University of Texas Wound Classification System stage (observable entity)\u00a0\u2502No specific guidance.
Young Townson FootSkin Scale\u00a0\u2502\u00a01099121000000104\u00a0\u2502\u00a0Young Townson FootSkin Hydration Scale for Diabetic Neuropathy level (observable entity)\u00a0\u2502\u00a0No specific guidance.
Ipswich touch test \u2502\u00a01443851000000100 \u2502 Ipswich Touch Test score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Diabetes distress
Diabetes Distress Scale (DDS) 2 item **\u00a0\u2502\u00a0909421000000102\u00a0\u2502\u00a0Diabetes Distress Scale 2 item score (observable entity)\u00a0\u2502\u00a0No specific guidance.
DDS 17 item **\u00a0\u2502\u00a0910931000000101\u00a0\u2502\u00a0Diabetes Distress Scale 17 item score (observable entity)\u00a0\u2502\u00a0Validated for use by people with type 2 diabetes (see https://diabetesdistress.org/dd-assess-score-3).
T1-DDS **\u00a0\u2502\u00a01373531000000104 \u00a0\u2502\u00a0Type 1 Diabetes Distress Scale total score (observable entity) \u00a0\u2502\u00a0Validated for use by people with type 1 diabetes. For rationale (see https://dx.doi.org/10.1016%2Fj.jdiacomp.2015.01.012).
PAID-20 **\u00a0\u2502\u00a01363101000000107 \u00a0\u2502\u00a0Problem Areas in Diabetes score (observable entity) \u00a0\u2502\u00a0For rationale (see https://doi.org/10.2337/diacare.18.6.754).
PAID-11 **\u00a0\u2502\u00a01368271000000101 \u00a0\u2502\u00a0Problem Areas in Diabetes 11-item score (observable entity)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.1016/j.diabres.2019.01.026).
PAID-5 **\u2502\u00a01373421000000102 \u00a0\u2502\u00a0Problem Areas in Diabetes 5-item score (observable entity) \u00a0\u2502\u00a0For rationale (see https://doi.org/10.1007/s00125-009-1559-5).
PAID-1 **\u2502\u00a01373451000000107 \u00a0\u2502\u00a0 Problem Areas in Diabetes 1-item score (observable entity)\u00a0\u2502\u00a0For rationale (see https://doi.org/10.1007/s00125-009-1559-5).
General emotional health and wellbeing
WHO Well-being index \u2502 1144665009 \u2502 5-item World Health Organization Well-being Index value (observable entity) \u2502 No specific guidance. \u00a0
Patient Health Questionnaire (PHQ) 2 item **\u00a0\u2502\u00a0836541000000100\u00a0\u2502\u00a0Patient health questionnaire 2 score (observable entity)\u00a0\u2502\u00a0No specific guidance.
PHQ 4 item **\u00a0\u2502\u00a01104961000000104\u00a0\u2502\u00a0Patient Health Questionnaire-4 score (observable entity)\u00a0\u2502\u00a0No specific guidance.
PHQ 9 item **\u00a0\u2502\u00a0720433000\u2502\u00a0Patient Health Questionnaire Nine Item score (observable entity)\u00a0\u2502\u00a0No specific guidance.
PHQ 15 item **\u00a0\u2502\u00a01065441000000103\u00a0\u2502\u00a0Patient Health Questionnaire 15 score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Hospital anxiety and depression scale (HADS)\u00a0\u2502\u00a0401319005\u00a0\u2502\u00a0Hospital Anxiety and Depression scale: anxiety score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Generalised anxiety disorder (GAD) 2 item **\u00a0\u2502\u00a0836571000000106\u00a0\u2502\u00a0Generalised anxiety disorder 2 scale score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Generalised anxiety disorder (GAD) 7 item **\u00a0\u2502\u00a0445455005\u00a0\u2502\u00a0Generalized anxiety disorder 7 item score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Diet, nutrition and eating disorders
Malnutrition Universal Screening Tool (MUST)\u00a0\u2502\u00a0444297006\u00a0\u2502\u00a0Malnutrition universal screening tool score (observable entity)\u00a0\u2502\u00a0Validated for use in people with type 2 diabetes. For rationale (see https://www.bapen.org.uk/pdfs/must/must_explan.pdf).
mSCOFF\u00a0\u2502\u00a01362261000000106 \u00a0\u2502\u00a0Modified Sick, Control, One, Fat, Food questionnaire score (observable entity) \u00a0\u2502\u00a0Validated in female adolescents with type 1 diabetes. For rationale (see https://doi.org/10.2337/dc13-1637).
Diabetes Eating Problem Survey Revised (DEPS-R) 16 item\u00a0\u2502\u00a01362751000000101 \u00a0\u2502\u00a0Diabetes Eating Problem Survey - Revised score (observable entity) \u00a0\u2502\u00a0Validated for use in youth and adolescents (see https://dx.doi.org/10.2337%2Fdc09-1890) and adults (see https://doi.org/10.1186/s40337-018-0232-0) with type 1 diabetes.
Diabetes self-management and quality of life
Diabetes Quality of Life (DQOL) questionnaire\u00a0\u2502\u00a0851991000000108\u00a0\u2502\u00a0Diabetes quality of life questionnaire score (observable entity)\u00a0\u2502\u00a0No specific guidance.
Diabetes Self Management Questionnaire (DSMQ) 16 item\u00a0\u00a0\u2502\u00a0New code request\u00a0\u00a0\u2502\u00a0Diabetes Self Management Questionnaire (DSMQ) 16 item score (observable entity)\u00a0\u00a0\u2502\u00a0For rationale (see\u00a0https://doi.org/10.1186/1477-7525-11-138\u00a0).
Diabetes management self-efficacy scale (DMSES) UK\u00a0\u2502\u00a01374011000000100 \u00a0\u2502\u00a0Diabetes management self-efficacy scale United Kingdom 15-item score (observable entity) \u2502\u00a0Validated for people with type 2 diabetes. For rationale (see\u00a0https://psycnet.apa.org/doi/10.1017/S1463423610000101).
Insulin and medication questionnaires
Insulin Treatment Appraisal Scale (ITAS) **\u00a0\u2502\u00a01423611000000100 \u00a0\u2502\u00a0Insulin Treatment Appraisal Scale total score (observable entity) ) \u2502\u00a0Validated for use in people with type 2 diabetes. For rationale (see https://dx.doi.org/10.1186%2F1477-7525-5-69 AND https://doi.org/10.1186/1477-7525-12-87).
Medication Adherence Report Scale (MARS) 5 item\u00a0\u2502\u00a01362991000000107 \u00a0\u2502\u00a0Medication Adherence Report Scale 5-item score (observable entity) \u00a0\u2502\u00a0For rationale (see https://dx.doi.org/10.1111%2Fbcp.14193).
Risk assessment tools
QRISK2\u00a0\u2502\u00a0718087004\u00a0\u2502\u00a0QRISK2 cardiovascular disease 10 year risk score (observable entity)\u00a0\u2502\u00a0NICE recommends QRISK2 for use in people with type 2 diabetes (https://www.nice.org.uk/guidance/ng28). Use in people with type 1 is not recommended as they are already considered at high risk (see https://www.nice.org.uk/guidance/cg181).
QRISK3 \u2502 1085871000000105 \u2502 QRISK3 cardiovascular disease 10 year risk calculator score (observable entity) \u2502 No specific guidance.
Patient activation, physical activity and sleep
Patient Activation Measure (PAM)\u00a0\u2013 score \u2502713644003\u00a0\u2502\u00a0Patient Activation Measure score (observable entity) | No specific guidance.
Patient Activation Measure (PAM) - level\u00a0\u2502\u00a0962851000000103\u00a0\u00a0\u2502\u00a0Patient Activation Measure Level (observable entity)\u00a0\u00a0| No specific guidance.
GPPAQ\u00a0\u2502\u00a01086511000000107\u00a0\u00a0\u2502\u00a0General Practice Physical Activity Questionnaire Physical Activity Index (observable entity)\u00a0| No specific guidance.
Pittsburgh sleep quality index\u00a0\u2502\u00a0761879005\u00a0\u2502Pittsburgh Sleep Quality Index score (observable entity)\u00a0| No specific guidance.
Diabetes treatment satisfaction
DTSQ status version\u00a0\u2502\u00a0765147009\u00a0\u2502\u00a0Diabetes Treatment Satisfaction Questionnaire status version score (observable entity)\u00a0\u00a0| No specific guidance.
DTSQ change version\u00a0\u2502 1373471000000103 \u2502\u00a0Diabetes Treatment Satisfaction Questionnaire change version\u00a0score (observable entity)\u00a0| No specific guidance.
Frailty assessments
Electronic frailty index\u00a0\u25021084961000000105\u00a0\u2502\u00a0Electronic Frailty Index score (observable entity) | See\u00a0https://www.guidelines.co.uk/diabetes/type-2-diabetes-frailty-in-older-people/454600.article). Frailty is also relevant for care home residents with diabetes (see\u00a0https://www.diabetes.org.uk/resources-s3/2017-09/Care_homes_report2010_0.pdf).
Electronic frailty index 2\u00a0\u2502 1423641000000104 \u2502\u00a0Electronic Frailty Index 2 score (observable entity) \u2502 No specific guidance.
Rockwood clinical frailty scale \u2502 763264000 \u2502 Canadian Study of Health and Aging Clinical Frailty Scale score (observable entity) \u2502 For rationale (see https://doi.org/10.1503%2Fcmaj.050051).
Cognition, mood and memory
Abbreviated mental test score (AMTS) \u2502 446840000 \u2502 Abbreviated mental test score (observable entity) \u2502 No specific guidance.
General practitioner assessment of cognition (GPCOG) \u2502 756521000000105 \u2502 General practitioner assessment of cognition score (observable entity) \u2502 No specific guidance.
Mini-cog brief cognitive screening test \u2502 713408000 \u2502 Mini-Cog brief cognitive screening test score (observable entity) \u2502 No specific guidance.
Six item cognitive impairment test \u2502 1085151000000108 \u2502 Six Item Cognitive Impairment Test total score (observable entity) \u00a0\u2502 No specific guidance.
Mini mental state examination (MMSE) \u2502 447316007 \u2502 Mini-mental state examination score (observable entity) \u2502 No specific guidance.
Modified mini mental state examination (3MS) \u2502 720485003 \u2502 Modified Mini-Mental State Examination score (observable entity) \u2502 No specific guidance. \u00a0
Montreal Cognitive Assessment (MoCA) \u2502 859371000000106 \u2502 Montreal cognitive assessment score (observable entity) \u2502 For further information (see https://www.mocatest.org/). ***
4AT rapid clinical test for delirium \u2502 1239211000000103 \u2502 4 A's Test for delirium and cognitive impairment score (observable entity) \u2502 No specific guidance. ***
Confusion assessment method (CAM) \u2502 736537001 \u2502 Confusion Assessment Method short version score (observable entity) \u2502 No specific guidance. ***
Geriatric depression scale (GDS) \u2502 273481004 \u2502 Geriatric depression scale (assessment scale) \u2502 Descendent or self of concept (including original long form, short form, and 4-item form scales). ***
Addenbrooke\u2019s cognitive examination revised (ACE-R) \u2502 711061000000109 \u2502 Addenbrooke's cognitive examination revised - score (observable entity) \u2502 No specific guidance. ***
Skin integrity
Waterlow pressure sore risk score \u2502 201221000000101 \u2502 Observation of Waterlow pressure sore risk score (observable entity) \u00a0\u2502 No specific guidance.
Mobility and activities of daily living
Barthel ADL index (original)\u2502 493451000000105 \u2502 Barthel original index of activities of daily living score (observable entity) \u2502 No specific guidance.
Barthel ADL index (modified) \u2502 443653008 \u2502 Modified Barthel index of activities of daily living score (observable entity) \u2502 No specific guidance.
Barthel ADL index (UK) \u2502 493441000000107 \u2502 Barthel United Kingdom index of activities of daily living score (observable entity) \u2502 No specific guidance.
Instrumental activities of daily living (I-ADL) \u2502 404981008 \u2502 Ability to perform instrumental activities of daily living (observable entity) \u2502 No specific guidance.
Pain assessment
Abbey pain scale \u2502 770634001 \u2502 Abbey Pain Scale score (observable entity) \u2502 No specific guidance.
BPI \u2502 443223005 \u2502 Brief pain inventory score (observable entity) \u2502 No specific guidance.
BPCI \u2502 446038006 \u2502 Brief pain coping inventory score (observable entity) \u2502 No specific guidance.
PAINAD \u2502 1091141000000107 \u2502 Pain Assessment in Advanced Dementia Scale score (observable entity) \u2502 No specific guidance.
S-LANSS \u2502 810611000000108 \u2502 Self-completed Leeds assessment of neuropathic symptoms and signs pain score (observable entity) \u2502 No specific guidance.
VAPS \u2502 443394008 \u2502 Visual analog scale pain score (observable entity) \u2502 No specific guidance.
Where required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
** For key diabetes assessments identified by the American Diabetes Association (see https://professional.diabetes.org/sites/professional.diabetes.org/files/media/ada_mental_health_toolkit_questionnaires.pdf).
*** For further information on some key cognitive assessments recommended by NHS England in 2014 for use in primary care in England (see https://www.england.nhs.uk/wp-content/uploads/2014/09/dementia-revealed-toolkit.pdf).
", "description": "The coded value for assessment score.\u00a0", "valueSets": "Subscale score should be coded using only one SNOMED CT concept that is a subtype of the following concept:
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
363787002 \u2502 Observable entity (observable entity) \u2502 No specific guidance.
Existing subscale concepts for the assessments identified as relevant to diabetes care are below:
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0
Diabetes distress score (17- item)
1374051000000101 | Diabetes Distress Scale 17 item Regimen Distress score (observable entity) |
1374031000000108 | Diabetes Distress Scale 17 item Emotional Burden score (observable entity) |
1374041000000104 | Diabetes Distress Scale 17 item Physician Distress score (observable entity) |
1374061000000103 | Diabetes Distress Scale 17 item Interpersonal Distress score (observable entity) |
Type 1 diabetes distress score
1373551000000106 | Type 1 Diabetes Distress Scale Powerlessness score (observable entity) |
1373591000000103 | Type 1 Diabetes Distress Scale Eating Distress score (observable entity) |
1373601000000109 | Type 1 Diabetes Distress Scale Physician Distress score (observable entity) |
1373561000000109 | Type 1 Diabetes Distress Scale Management Distress score (observable entity) |
1373571000000102 | Type 1 Diabetes Distress Scale Hypoglycemia Distress score (observable entity) |
1373611000000106 | Type 1 Diabetes Distress Scale Friend/Family Distress score (observable entity) |
1373581000000100 | Type 1 Diabetes Distress Scale Negative Social Perceptions score (observable entity) |
Diabetes self management questionnaire (DSMQ)
New code request | Diabetes Self Management Questionnaire (DSMQ) 16 item Eating behaviour score (Observable entity)
New code request | Diabetes Self Management Questionnaire (DSMQ) 16 item Medication taking score (Observable entity)
New code request | Diabetes Self Management Questionnaire (DSMQ) 16 item Glucose monitoring score (Observable entity)
New code request | Diabetes Self Management Questionnaire (DSMQ) 16 item Physical activity score (Observable entity)
New code request | Diabetes Self Management Questionnaire (DSMQ) 16 item Cooperation with diabetes team score (Observable entity)
Diabetes self management questionnaire \u2013 revised (DSMQ - R)
New code request | Diabetes Self Management Questionnaire \u2013 Revised (DSMQ-R) 27 item Eating behaviour score (Observable entity)
New code request | Diabetes Self Management Questionnaire \u2013 Revised (DSMQ-R) 27 item Medication taking score (Observable entity)
New code request | Diabetes Self Management Questionnaire \u2013 Revised (DSMQ-R) 27 item Glucose monitoring score (Observable entity)
New code request | Diabetes Self Management Questionnaire \u2013 Revised (DSMQ-R) 27 item Physical activity score (Observable entity)
New code request | Diabetes Self Management Questionnaire \u2013 Revised (DSMQ-R) 27 item Cooperation with diabetes team score (Observable entity)
Insulin treatment appraisal scale (ITAS)
1423621000000106 | Insulin Treatment Appraisal Scale positive appraisal score (observable entity) |
1423631000000108 | Insulin Treatment Appraisal Scale negative appraisal score (observable entity) |
General practitioner assessment of cognition (GPCOG)
756501000000101 | General practitioner assessment of cognition informant score (observable entity) |
756511000000104 | General practitioner assessment of cognition patient score (observable entity) |
Addenbrooke\u2019s cognitive examination revised (ACE-R)
711111000000108 | Addenbrooke's cognitive examination revised - attention and orientation subscore (observable entity) |
711101000000106 | Addenbrooke's cognitive examination revised - fluency subscore (observable entity) |
711081000000100 | Addenbrooke's cognitive examination revised - language subscore (observable entity) |
711091000000103 | Addenbrooke's cognitive examination revised - memory subscore (observable entity) |
711071000000102 | Addenbrooke's cognitive examination revised - visuospatial subscore (observable entity) |
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
Waterlow pressure sore risk score
201221000000101 | Observation of Waterlow pressure sore risk score (observable entity) | Descendants of concept only (including subscales for Waterlow age, sex, appetite, mobility, continence, medication, tissue malnutrition, major surgery/ trauma, neurological deficit, skin type visual risk areas and build/ weight for height scores).
Instrumental activities of daily living
Instrumental activities of daily living (I-ADL) \u2502 404981008 \u2502 Ability to perform instrumental activities of daily living (observable entity) \u2502 Relevant descendants of concept.
Where required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
** For key diabetes assessments identified by the American Diabetes Association (see https://professional.diabetes.org/sites/professional.diabetes.org/files/media/ada_mental_health_toolkit_questionnaires.pdf).
*** For further information on some key cognitive assessments recommended by NHS England in 2014 for use in primary care in England (see https://www.england.nhs.uk/wp-content/uploads/2014/09/dementia-revealed-toolkit.pdf).
", "description": "The coded value for subscale item.", "valueSets": "Where required codes are unavailable the free text field should be used and consideration given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
\n ", "description": "The coded value for the ordinal result.\u00a0", "valueSets": "SNOMED CT."}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Free text", "implamentationGuidance": "Where a coded value is provided this field must not be used.\u00a0NHS dictionary of medicines and devices (dm+d) is the recognised NHS standard for recording and sharing of medicines information (see https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/dictionary-medicines-and-devices-dmd). Contact nhsbsa.dmdenquiries@nhs.net for further information. Dm+d concepts for recording insulin must be of the actual medicinal product (AMP) type. These contain brand/ trade family name (e.g., Humulin I KwikPen), concentration (e.g., U100 [100units/ml] suspension or solution for injection), presentation type and size (e.g., 3ml cartridge or 10ml vials) and supplier name (e.g., Eli Lilly & Co Ltd). If an appropriate dm+d concept is not available, the free text entry must contain these components. For example, the following terminology aligned to the AMP would be acceptable: \u2018Humulin I 100units/ml suspension for injection 10ml vials (Mawdsley-Brooks & Company Ltd); whereas the following wording representing the generic virtual medicinal product (VMP) would not be acceptable: \u2018Insulin isophane human 100units/ml suspension for injection 10ml vials\u2019.
\nCommon examples of basal insulin types include:\u00a0
\nTrade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502Example dm+d mapped SNOMED Concept (FSN)
\n~Humulin I \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Humulin I 100units/ml suspension for injection 3ml cartridges (Sigma Pharmaceuticals Plc) (product)
\n~Insulatard \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Insulatard Penfill 100units/ml suspension for injection 3ml cartridges (Novo Nordisk Pharmaceuticals Ltd) (product)
\n~Lantus \u2502 Insulin glargine. \u2502 U100\u00a0\u2502 Lantus 100units/ml solution for injection 10ml vials (PI) (Waymade Ltd) (product)|
\n~Toujeo \u2502 Insulin glargine. \u2502 U300 \u2502 Toujeo 300units/ml solution for injection 1.5ml pre-filled SoloStar pens (Sanofi) (product)|
\n~Levemir \u2502 Insulin detemir. \u2502 U100\u00a0\u2502 Levemir FlexPen 100units/ml solution for injection 3ml pre-filled pens (Mawdsley-Brooks & Company Ltd) (product)|
\n~Tresiba \u2502 Insulin degludec.\u2502 U100 & U200 \u2502 Tresiba FlexTouch 200units/ml solution for injection 3ml pre-filled pens (Pharmaram Ltd) (product)
\nBasal insulin preparations are also available as fixed-dose combinations with other (non-insulin) medications. e.g Xultophy (Insulin degludec and Liraglutide) and Suliqua (Insulin glargine and Lixisenatide)*
\nCommon examples of bolus insulin types include:
\nTrade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502 Example dm+d mapped SNOMED Concept (FSN)
\n~Humulin S \u2502 Human soluble insulin. \u2502 U100 \u2502 Humulin S 100units/ml solution for injection 3ml cartridges (CST Pharma Ltd) (product)
\n~Novorapid \u2502 Insulin aspart. \u2502 U100\u00a0\u2502 NovoRapid FlexPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
\n~Humalog \u2502 Insulin lispro. \u2502 U100 & U200 \u2502 Humalog KwikPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
\nPremixed (biphasic) insulin injections include a combination of two insulins mixed together (rapid or medium acting insulin), given once, twice or three times a day e.g., Insuman Comb 25 (isophane insulin suspension of 25% dissolved insulin and 75% crystalline protamine insulin).**
\nFor further examples (see https://www.gloshospitals.nhs.uk/media/documents/InsulinFormulary.pdf).
\n* An example of acceptable terminology aligned to the AMP for the fixed dose combination medication Suliqua would be: \u2018Suliqua 100units/ml / 33micrograms/ml solution for injection 3ml pre-filled SoloStar pens (Sanofi)\u2019; whereas the VMP \u2018Insulin glargine 100units/ml / Lixisenatide 33micrograms/ml solution for injection 3ml pre-filled disposable devices\u2019 would not be acceptable.
\n** An example of acceptable terminology aligned to the AMP for the premixed (biphasic) insulin Insuman Comb 25 would be: \u2018Insuman Comb 25 100units/ml suspension for injection 5ml vials (Aventis Pharma)\u2019; whereas the VMP \u2018Insulin isophane biphasic human 25/75 100units/ml suspension for injection 5ml vials\u2019 would not be acceptable.
\nWhen administering insulin people with diabetes rotate their injection sites (e.g. upper arms, thighs, buttocks, abdomen) to help prevent lipohypertrophy (see https://www.diabetes.co.uk/conditions/lipohypertrophy.html) and cutaneous amyloidosis (see\n https://cks.nice.org.uk/topics/insulin-therapy-in-type-1-diabetes/management/insulin-therapy-type-1-diabetes/). NICE recommends that the person alternates between the left and right side of the body on a weekly basis. CQC guidance for providers states: \u2018When nursing or care staff administer insulin, they should record where they injected the insulin each\n time. [(see https://www.cqc.org.uk/guidance-providers/adult-social-care/diabetes-insulin-use)].\u2019
\nWhen recording the dose context of an administration of insulin, the coded value field must contain only one SNOMED CT code from the following value set:\u00a0
\nSNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n789480007 | Insulin dose (observable entity) | Parent concept.
\n789497001 \u2502 Insulin dose calculated by insulin to carbohydrate ratio (observable entity) \u2502 This codes for a carbohydrate coverage bolus insulin dose.
\n789499003 \u2502 Insulin dose at breakfast calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a a carbohydrate coverage bolus insulin dose at breakfast.
\n789498006 \u2502 Insulin dose at lunch calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at lunch.
\n789500007 \u2502 Insulin dose at evening meal calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at evening meal.
\nNew code request \u2502 Insulin dose at other calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at other times.
\n789495009\u2502Insulin dose calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose.
\nNew code request \u2502Insulin dose at breakfast calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose at breakfast.
\n789484003\u2502Insulin dose at lunch calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at lunch.
\n865982005\u2502Insulin dose at evening meal calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at evening meal.
\nNew code request \u2502Insulin dose at snack time calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at other (snack) times.
\n870499003 \u2502 Basal insulin infusion rate (observable entity) \u2502 Use if recording a basal insulin infusion dose.
\nThe fact an insulin dose was basal can be ascertained by medication name (brand name) if delivered by multiple daily injection (MDI). 'Basal' insulin delivered by pump (either continuous subcutaneous insulin infusion (CSII) or continuous intraperitoneal insulin infusion (CIPII)) uses an infusion of rapid acting insulin as a basal analogue and therefore to identify the dose as basal should be recorded using this concept (SCTID:870499003).
\nA new code request for the above items has been submitted to NHS Digital. The FSN of the final approved code may differ. For updates or queries relating to newly submitted codes contact info@theprsb.org.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
The PRSB consultation defined a preliminary consensus around the following time blocks for recording data related to calculation and administration of insulin boluses:
\nTime block \u2502\u00a0Description\u00a0\u2502\u00a0Implementation guidance
\nBreakfast.\u2502 Any bolus administered between 05.30 and 10.29. \u2502 E.g., the bolus dose at breakfast.
\nLunch.\u2502 Any bolus administered between 10.30 and 15.29. \u2502 E.g., the bolus at lunch.
\nEvening meal.\u2502 Any bolus administered between 15.30 and 22:59. \u2502 E.g., the bolus dose at evening meal.
\nOther.\u2502 Any bolus administered between 23.00 and 05.29 \u2502 E.g., the bolus dose at other (snack) times. This includes overnight.
\nThis element supports the recording of the following types of administered insulin dose:
\n\n Basal insulin injections:\n
\nBasal insulin (delivered by multiple daily injection (MDI) as part of a basal, basal/ bolus or basal plus regimen). Basal insulin is usually administered as a reproducible dose (either as two injections of 12 hour insulin or one injection of a 24+ hour insulin). For an overview of basal insulin therapy (see https://doi.org/10.1111/dom.14552 AND see\n https://doi.org/10.1002/pdi.1846).
\n\n Bolus insulin injections:\n
\n~Bolus insulin delivered either by multiple daily injection (MDI) as part of a basal/ bolus or basal plus regimen.
\nBolus insulin is commonly administered along with a meal by people with diabetes in relation to carbohydrate content of a meal and ambient glucose level at the time of the meal and is therefore potentially very variable and is thus easiest recorded in relation to the variables which determine this (i.e., insulin to carbohydrate ratio and insulin sensitivity\n factor).
\n\n Premixed insulin injections: \n
\nA combination of two insulins mixed together (rapid or medium acting insulin), given once, twice or three times a day.
\n\n Basal insulin infusions:\n
\nBasal insulin when delivered by pump therapy is either a continuous subcutaneous infusion of rapid acting insulin (CSII) or continuous intraperitoneal infusion of rapid acting insulin (CIPII). The minimum required dosing elements to support the recording of basal insulin delivered by CSII / CIPII are Dose context (coded value) and Dose administered (start date/\n time, end date / time, value, units of measure).
\n\n Bolus insulin infusions:\n
\nModern insulin pumps have features that allow bolus insulin to be administered in up to four different ways (See https://doi.org/10.1177%2F193229680900300631), which are outlined in the table below (as applied in software-based recording). For manual bolus dose recording (where a person is not using a pump or connected insulin pens) summary data is expected to be\n recorded in the usual insulin dosing section.
\n\n Recording pump delivered bolus insulin:\n
\n\n Name \u2502 Synonym(s)\u00a0\u2502 Description \u2502 Implementation guidance \u2502 Minimum required dosing elements\n
\n~Single short bolus. \u2502 Standard bolus; quick/ fast/ easy bolus. \u2502 Bolus dose is infused/ injected all at once. \u2502 Applies to both injected and pump boluses. \u2502 One record entry of: Medication name (coded value), Dose context (coded value), Dose administered (value, units of measure, administration data and time).
\n~Two boluses. \u2502 Split bolus. \u2502 A percentage of the bolus dose (e.g. 50%) is given immediately and remainder is delivered all at once a period of time later (e.g. 30 minutes later). \u2502 Can apply to both injected and pump boluses. \u2502Two record entries of: Medication name (coded value), Dose context (coded value), Dose administered (value, units of measure,\n administration data and time).
\n~Extended bolus. \u2502 Bolus dose is delivered as an infusion over a period of time (e.g. 3 hours)\u2502 Applies to insulin pumps only. \u2502One record entry of: Medication name (coded value), Dose context (coded value), Dose administered (Start date/ time, end date / time, value, units of measure).
\n~Combination bolus \u2502 Multi-wave bolus; dual wave bolus. \u2502 A proportion of the bolus is delivered immediately (e.g 70%) and the rest is delivered as an extended bolus (e.g. 30%) over a period of time (e.g. infusion over 2 hours)\u2502 Applies to insulin pumps only.\u00a0 \u2502 Two record entries: one for a single short bolus and one for an extended bolus.
\nFurther information on CSII bolus types can be found in the following pump user guide (see https://www.accu-chek.com/download/file/fid/16301), which is referenced for illustrative purposes only without preference).
\n ", "description": "Details of dose administered.", "concept": [{"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.This field is mandatory if the coded value (observable entity) is shared.
\nThe table below details the required UCUM code for this element where the medication administered is an insulin (either as a single short bolus or infusion):
\nUCUM code \u00a0* \u2502\u00a0Description of the unit\u00a0\u2502\u00a0Parent PRSB Element\u00a0\u2502\u00a0Implementation guidance
\n[IU] \u2502 international unit **\u2502 Dose administered \u2502 Dose given as a single short bolus. Systems must display 'unit(s)' or 'international unit(s)' without abbreviation.***
\n[IU]/h \u2502 international unit per hour\u2502 Dose administered \u2502 Dose given as an infusion. Systems must display 'unit(s) per hour' or 'international unit(s) per hour' without abbreviation.***
\n* UCUM codes are mixed case American Standard Code for Information Interchange (ASCII) text.
\n** Exact UCUM description.
\n*** 'Overdose of insulin due to abbreviations or incorrect device' is on the NHS Never Events list (see https://www.england.nhs.uk/wp-content/uploads/2020/11/2018-Never-Events-List-updated-February-2021.pdf), which includes where 'overdose' refers to when:
\n~'a patient is given a 10-fold or greater overdose of insulin because the words 'unit' or 'international units' are abbreviated; such an overdose was given in a care setting with an electronic prescribing system.'
\nThe words 'unit(s)' [the norm] and 'international unit(s)' should not be abbreviated when displayed in systems implementing the standard.
\nFurther information including a full specification on the Unified Code for Units of Measure (UCUM) is available (see unitsofmeasure.org).
\nSNOMED CT.
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Insulin carbohydrate ratio", "implamentationGuidance": "
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Insulin sensitivity factor", "implamentationGuidance": "
\u00a0
\n\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Correction target", "implamentationGuidance": "
The person's correction target for the bolus dose administered. This includes entries for the correction target for breakfast, lunch, evening meal, or other times.
\n
\n
\n
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}]}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "*", "mro": "R", "name": "Comment", "implamentationGuidance": "This free text comment applies to an individual dose of any medication.
As a medicine insulin must be prescribed and dispensed (and therefore coded) as a brand name. For further information (see https://bnf.nice.org.uk/guidance/guidance-on-prescribing.html).
NHS dictionary of medicines and devices (dm+d) is the recognised NHS standard for recording and sharing of medicines information (see https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/dictionary-medicines-and-devices-dmd). Contact nhsbsa.dmdenquiries@nhs.net for further information. Dm+d concepts for recording insulin must be of the actual medicinal product (AMP) type. These contain brand/ trade family name (e.g., Humulin I KwikPen), concentration (e.g., U100 [100units/ml] suspension or solution for injection), presentation type and size (e.g., 3ml cartridge or 10ml vials) and supplier name (e.g., Eli Lilly & Co Ltd). If an appropriate dm+d concept is not available, the free text entry must contain these components. For example, the following terminology aligned to the AMP would be acceptable: \u2018Humulin I 100units/ml suspension for injection 10ml vials (Mawdsley-Brooks & Company Ltd); whereas the following wording representing the generic virtual medicinal product (VMP) would not be acceptable: \u2018Insulin isophane human 100units/ml suspension for injection 10ml vials\u2019.
Common examples of basal insulin types include:\u00a0
Trade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502Example dm+d mapped SNOMED Concept (FSN)
~Humulin I \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Humulin I 100units/ml suspension for injection 3ml cartridges (Sigma Pharmaceuticals Plc) (product)
~Insulatard \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Insulatard Penfill 100units/ml suspension for injection 3ml cartridges (Novo Nordisk Pharmaceuticals Ltd) (product)
~Lantus \u2502 Insulin glargine. \u2502 U100\u00a0\u2502 Lantus 100units/ml solution for injection 10ml vials (PI) (Waymade Ltd) (product)
~Toujeo \u2502 Insulin glargine. \u2502 U300 \u2502 Toujeo 300units/ml solution for injection 1.5ml pre-filled SoloStar pens (Sanofi) (product)
~Levemir \u2502 Insulin detemir. \u2502 U100\u00a0\u2502 Levemir FlexPen 100units/ml solution for injection 3ml pre-filled pens (Mawdsley-Brooks & Company Ltd) (product)
~Tresiba \u2502 Insulin degludec.\u2502 U100 & U200 \u2502 Tresiba FlexTouch 200units/ml solution for injection 3ml pre-filled pens (Pharmaram Ltd) (product)
Basal insulin preparations are also available as fixed-dose combinations with other (non-insulin) medications. e.g Xultophy (Insulin degludec and Liraglutide) and Suliqua (Insulin glargine and Lixisenatide)*
Common examples of bolus insulin types include:
Trade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502 Example dm+d mapped SNOMED Concept (FSN)
~Humulin S \u2502 Human soluble insulin. \u2502 U100 \u2502 Humulin S 100units/ml solution for injection 3ml cartridges (CST Pharma Ltd) (product)
~Novorapid \u2502 Insulin aspart. \u2502 U100\u00a0\u2502 NovoRapid FlexPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
~Humalog \u2502 Insulin lispro. \u2502 U100 & U200 \u2502 Humalog KwikPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
Premixed (biphasic) insulin injections include a combination of two insulins mixed together (rapid or medium acting insulin), given once, twice or three times a day e.g., Insuman Comb 25 (isophane insulin suspension of 25% dissolved insulin and 75% crystalline protamine insulin).**
For further examples (see https://www.gloshospitals.nhs.uk/media/documents/InsulinFormulary.pdf).
* An example of acceptable terminology aligned to the AMP for the fixed dose combination medication Suliqua would be: \u2018Suliqua 100units/ml / 33micrograms/ml solution for injection 3ml pre-filled SoloStar pens (Sanofi)\u2019; whereas the VMP \u2018Insulin glargine 100units/ml / Lixisenatide 33micrograms/ml solution for injection 3ml pre-filled disposable devices\u2019 would not be acceptable.
** An example of acceptable terminology aligned to the AMP for the premixed (biphasic) insulin Insuman Comb 25 would be: \u2018Insuman Comb 25 100units/ml suspension for injection 5ml vials (Aventis Pharma)\u2019; whereas the VMP \u2018Insulin isophane biphasic human 25/75 100units/ml suspension for injection 5ml vials\u2019 would not be acceptable.
", "description": "The insulin name. May only be a brand name.", "concept": [{"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Coded value", "implamentationGuidance": "When recording the dose context of an administration of insulin, the coded value field must contain only one SNOMED CT code from the following value set:\u00a0
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
789480007 | Insulin dose (observable entity) | Parent concept.
789497001 \u2502 Insulin dose calculated by insulin to carbohydrate ratio (observable entity) \u2502 This codes for a carbohydrate coverage bolus insulin dose.
789499003 \u2502 Insulin dose at breakfast calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a a carbohydrate coverage bolus insulin dose at breakfast.
789498006 \u2502 Insulin dose at lunch calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at lunch.
789500007 \u2502 Insulin dose at evening meal calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at evening meal.
New code request \u2502 Insulin dose at other calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at other times.
789495009\u2502Insulin dose calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose.
New code request \u2502Insulin dose at breakfast calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose at breakfast.
789484003\u2502Insulin dose at lunch calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at lunch.
865982005\u2502Insulin dose at evening meal calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at evening meal.
New code request \u2502Insulin dose at snack time calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at other (snack) times.
870499003 \u2502 Basal insulin infusion rate (observable entity) \u2502 Use if recording a basal insulin infusion dose.
The fact an insulin dose was basal can be ascertained by medication name (brand name) if delivered by multiple daily injection (MDI). 'Basal' insulin delivered by pump (either continuous subcutaneous insulin infusion (CSII) or continuous intraperitoneal insulin infusion (CIPII)) uses an infusion of rapid acting insulin as a basal analogue and therefore to identify the dose as basal should be recorded using this concept (SCTID:870499003).\u00a0
A new code request for the above items has been submitted to NHS Digital. The FSN of the final approved code may differ. For updates or queries relating to newly submitted codes contact info@theprsb.org.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
The PRSB consultation defined a preliminary consensus around the following time blocks for recording data related to calculation and administration of insulin boluses:
Time block \u2502\u00a0Description\u00a0\u2502\u00a0Implementation guidance
Breakfast.\u2502 Any bolus administered between 05.30 and 10.29. \u2502 E.g., the bolus dose at breakfast.
Lunch.\u2502 Any bolus administered between 10.30 and 15.29. \u2502 E.g., the bolus at lunch.
Evening meal.\u2502 Any bolus administered between 15.30 and 22.59. \u2502 E.g., the bolus dose at evening meal.
Other.\u2502 Any bolus administered between 23.00 and 05.29 \u2502 E.g., the bolus dose at other (snack) times. This includes overnight.
", "description": "\n\n
\n
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Time of day", "implamentationGuidance": "
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Usual insulin carbohydrate ratio", "implamentationGuidance": "
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Usual insulin sensitivity factor", "implamentationGuidance": "
\n
\n
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Usual correction target", "implamentationGuidance": "
\n
\n
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Summary medication metrics", "implamentationGuidance": "Implementation guidance under this section refers to insulin summary metrics.", "description": "Summary metrics for medication administered.\u00a0", "concept": [{"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "*", "mro": "R", "name": "Insulin metrics record entry", "implamentationGuidance": "
The coded value field must contain the following SNOMED CT code:
\n
\n
\n \n SNOMED CT ID\u00a0 \u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n
\n \n \n
261000004 \u2502 Closed loop (qualifier value) \u2502 No specific guidance.\u00a0
\n
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.
The coded value field must contain only one SNOMED CT concept from the following value set:\u00a0
\nSNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
\n859291000000102\u2502 Changing infusion set (procedure) \u2502 Equal of concept.
\nNew code request \u2502 Changing infusion patch pump (procedure)\u00a0\u2502 Equal of concept.
\n"}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.
"}, {"type": "item", "minimumMultiplicity": "1", "maximumMultiplicity": "1", "mro": "M", "name": "Value", "implamentationGuidance": "This field is mandatory if the coded value (observable entity) is shared.
\n
\n
\u00a0
\u00a0\u00a0
\nAs a medicine insulin must be prescribed and dispensed (and therefore coded) as a brand name. For further information (see https://bnf.nice.org.uk/guidance/guidance-on-prescribing.html).
NHS dictionary of medicines and devices (dm+d) is the recognised NHS standard for recording and sharing of medicines information (see https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/dictionary-medicines-and-devices-dmd). Contact nhsbsa.dmdenquiries@nhs.net for further information. Dm+d concepts for recording insulin must be of the actual medicinal product (AMP) type. These contain brand/ trade family name (e.g., Humulin I KwikPen), concentration (e.g., U100 [100units/ml] suspension or solution for injection), presentation type and size (e.g., 3ml cartridge or 10ml vials) and supplier name (e.g., Eli Lilly & Co Ltd). If an appropriate dm+d concept is not available, the free text entry must contain these components. For example, the following terminology aligned to the AMP would be acceptable: \u2018Humulin I 100units/ml suspension for injection 10ml vials (Mawdsley-Brooks & Company Ltd); whereas the following wording representing the generic virtual medicinal product (VMP) would not be acceptable: \u2018Insulin isophane human 100units/ml suspension for injection 10ml vials\u2019.
Common examples of basal insulin types include:\u00a0
Trade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502Example dm+d mapped SNOMED Concept (FSN)
~Humulin I \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Humulin I 100units/ml suspension for injection 3ml cartridges (Sigma Pharmaceuticals Plc) (product)
~Insulatard \u2502 Human isophane insulin/ NPH. \u2502 U100 \u2502 Insulatard Penfill 100units/ml suspension for injection 3ml cartridges (Novo Nordisk Pharmaceuticals Ltd) (product)
~Lantus \u2502 Insulin glargine. \u2502 U100\u00a0\u2502 Lantus 100units/ml solution for injection 10ml vials (PI) (Waymade Ltd) (product)
~Toujeo \u2502 Insulin glargine. \u2502 U300 \u2502 Toujeo 300units/ml solution for injection 1.5ml pre-filled SoloStar pens (Sanofi) (product)
~Levemir \u2502 Insulin detemir. \u2502 U100\u00a0\u2502 Levemir FlexPen 100units/ml solution for injection 3ml pre-filled pens (Mawdsley-Brooks & Company Ltd) (product)
~Tresiba \u2502 Insulin degludec.\u2502 U100 & U200 \u2502 Tresiba FlexTouch 200units/ml solution for injection 3ml pre-filled pens (Pharmaram Ltd) (product)
Basal insulin preparations are also available as fixed-dose combinations with other (non-insulin) medications. e.g Xultophy (Insulin degludec and Liraglutide) and Suliqua (Insulin glargine and Lixisenatide)*
Common examples of bolus insulin types include:
Trade family group\u00a0\u2502\u00a0Generic\u00a0\u2502\u00a0Concentration\u00a0\u2502 Example dm+d mapped SNOMED Concept (FSN)
~Humulin S \u2502 Human soluble insulin. \u2502 U100 \u2502 Humulin S 100units/ml solution for injection 3ml cartridges (CST Pharma Ltd) (product)
~Novorapid \u2502 Insulin aspart. \u2502 U100\u00a0\u2502 NovoRapid FlexPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
~Humalog \u2502 Insulin lispro. \u2502 U100 & U200 \u2502 Humalog KwikPen 100units/ml solution for injection 3ml pre-filled pens (Ethigen Ltd) (product)
Premixed (biphasic) insulin injections include a combination of two insulins mixed together (rapid or medium acting insulin), given once, twice or three times a day e.g., Insuman Comb 25 (isophane insulin suspension of 25% dissolved insulin and 75% crystalline protamine insulin).**
For further examples (see https://www.gloshospitals.nhs.uk/media/documents/InsulinFormulary.pdf).
* An example of acceptable terminology aligned to the AMP for the fixed dose combination medication Suliqua would be: \u2018Suliqua 100units/ml / 33micrograms/ml solution for injection 3ml pre-filled SoloStar pens (Sanofi)\u2019; whereas the VMP \u2018Insulin glargine 100units/ml / Lixisenatide 33micrograms/ml solution for injection 3ml pre-filled disposable devices\u2019 would not be acceptable.
** An example of acceptable terminology aligned to the AMP for the premixed (biphasic) insulin Insuman Comb 25 would be: \u2018Insuman Comb 25 100units/ml suspension for injection 5ml vials (Aventis Pharma)\u2019; whereas the VMP \u2018Insulin isophane biphasic human 25/75 100units/ml suspension for injection 5ml vials\u2019 would not be acceptable.
", "description": "The insulin name. May only be a brand name.", "concept": [{"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Coded value", "implamentationGuidance": "When recording the dose context of an administration of insulin, the coded value field must contain only one SNOMED CT code from the following value set:\u00a0
SNOMED CT ID\u00a0\u2502\u00a0Fully specified name (FSN)\u00a0\u2502\u00a0Implementation guidance
789480007 | Insulin dose (observable entity) | Parent concept.
789497001 \u2502 Insulin dose calculated by insulin to carbohydrate ratio (observable entity) \u2502 This codes for a carbohydrate coverage bolus insulin dose.
789499003 \u2502 Insulin dose at breakfast calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a a carbohydrate coverage bolus insulin dose at breakfast.
789498006 \u2502 Insulin dose at lunch calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at lunch.
789500007 \u2502 Insulin dose at evening meal calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at evening meal.
New code request \u2502 Insulin dose at other calculated by insulin to carbohydrate ratio (observable entity) \u2502 This code applies for a carbohydrate coverage bolus insulin dose at other times.
789495009\u2502Insulin dose calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose.
New code request \u2502Insulin dose at breakfast calculated by insulin sensitivity factor (observable entity) \u2502 This code applies for a high blood sugar correction bolus insulin dose at breakfast.
789484003\u2502Insulin dose at lunch calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at lunch.
865982005\u2502Insulin dose at evening meal calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at evening meal.
New code request \u2502Insulin dose at snack time calculated by insulin sensitivity factor (observable entity)\u2502 This code applies for a high blood sugar correction bolus insulin dose at other (snack) times.
870499003 \u2502 Basal insulin infusion rate (observable entity) \u2502 Use if recording a basal insulin infusion dose.
The fact an insulin dose was basal can be ascertained by medication name (brand name) if delivered by multiple daily injection (MDI). 'Basal' insulin delivered by pump (either continuous subcutaneous insulin infusion (CSII) or continuous intraperitoneal insulin infusion (CIPII)) uses an infusion of rapid acting insulin as a basal analogue and therefore to identify the dose as basal should be recorded using this concept (SCTID:870499003).\u00a0
A new code request for the above items has been submitted to NHS Digital. The FSN of the final approved code may differ. For updates or queries relating to newly submitted codes contact info@theprsb.org.
Where required codes are unavailable consideration should be given to the submission of a new code request to UK SNOMED CT request submission portal (see https://isd.digital.nhs.uk/rsp/user/guest/home.jsf). Contact info@thePRSB.org for further information.\u00a0
The PRSB consultation defined a preliminary consensus around the following time blocks for recording data related to calculation and administration of insulin boluses:
Time block \u2502\u00a0Description\u00a0\u2502\u00a0Implementation guidance
Breakfast.\u2502 Any bolus administered between 05.30 and 10.29. \u2502 E.g., the bolus dose at breakfast.
Lunch.\u2502 Any bolus administered between 10.30 and 15.29. \u2502 E.g., the bolus at lunch.
Evening meal.\u2502 Any bolus administered between 15.30 and 22.59. \u2502 E.g., the bolus dose at evening meal.
Other.\u2502 Any bolus administered between 23.00 and 05.29 \u2502 E.g., the bolus dose at other (snack) times. This includes overnight.
", "description": "\n\n
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\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Time of day", "implamentationGuidance": "
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Modal insulin carbohydrate ratio", "implamentationGuidance": "
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Modal insulin sensitivity factor", "implamentationGuidance": "
\n
\n
\u00a0
\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Modal correction target", "implamentationGuidance": "
\n
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\u00a0\u00a0
\n", "valueDomain": [{"type": "string", "property": [{"maxLength": "10"}]}]}]}]}]}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Medication item entry", "description": "All medications and devices that can be prescribed to be entered via this Medication item entry. Handles details of continuation / addition / amendment of admission medications.", "informationType": "Event.Record", "concept": [{"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "*", "mro": "R", "name": "Medical devices entry", "implamentationGuidance": "
337414009\u2502 Blood glucose meter (physical object)\u2502 Equal of concept.
\nContinuous glucose monitoring (CGM):
\n34865511000001109\u2502 Glucose interstitial fluid detection sensor (physical object) \u2502 Equal of concept. This includes both intermittently scanned (isCGM) and real time (rtCGM) continuous glucose monitors.
\n463729000 \u2502 Point-of-care blood glucose continuous monitoring system (physical object) \u2502 Equal of concept. This applies to intravascular and interstitial fluid monitors used in a hospital setting only.
\nFHIR value set : - Confidentiality\n
\n "}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Class", "description": "The document type e.g. report, summary, images, treatment plan, patient preferences, workflow", "valueSets": "Free text.", "valueDomain": [{"type": "text", "property": [{"maxLength": "150"}]}]}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Document title", "description": "The title of the document.", "valueSets": "Free text", "valueDomain": [{"type": "text", "property": [{"maxLength": "150"}]}]}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Document name", "description": "The name of the document. This should align to the PRSB document naming standard. Where the document is a KOS document this field (designated typeCode) is used to carry the DICOM Imaging procedure: This attribute shall be populated by the XDS-I Imaging Document Source from a code in the Procedure Code Sequence (0008,1032) of the performed procedure\n with which the document is associated. Values may be found in a suitable DICOM browser", "valueSets": "SNOMED CT: - As per the https://theprsb.org/wp-content/uploads/2018/11/Clinical-document-indexing-standards_NHS-Scotland.pdf \n "}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Document MIME type", "description": "MIME type of the document e.g. application, pdf, audio, jpeg", "valueSets": "Free text", "valueDomain": [{"type": "text"}]}, {"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Comments", "description": "Comments associated with the document.", "valueSets": "Free text", "valueDomain": [{"type": "text", "property": [{"maxLength": "150"}]}]}, {"type": "group", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Additional information required for images.", "description": "Additional information required for images.", "informationType": "Event.Record", "concept": [{"type": "item", "minimumMultiplicity": "0", "maximumMultiplicity": "1", "mro": "R", "name": "Image procedure", "description": "The procedure used to capture the image", "valueSets": "Free text