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  • 1. NICE Issue date: [Year] of guideline clinical guideline [XX] Short title Audit support Type 2 diabetes Audit support (clinical criteria) Implementing NICE guidance 2009 NICE clinical guideline 87 Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 1 of 29
  • 2. This audit support accompanies the clinical guideline: ‘Type 2 diabetes’ (available online at www.nice.org.uk/CG87). Issue date: 2009 This is a support tool for clinical audit based on the NICE guidance. It is not NICE guidance. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties. National Institute for Health and Clinical Excellence MidCity Place, 71 High Holborn, London WC1V 6NA; www.nice.org.uk © National Institute for Health and Clinical Excellence, 2009. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of the Institute. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 2 of 29
  • 3. Using audit support The audit support document can be used to measure current practice in type 2 diabetes against the recommendations in the NICE guideline. Use it for a local audit project, by either using the whole tool or cutting and pasting the relevant parts into a local audit template. Audit criteria and standards are based on the guideline’s recommendations. The standards given are typically 100% or 0%. If these are not achievable in the short term, set a more realistic standard based on discussions with local clinicians. However, the standards given remain the ultimate objective. The data collection tool can be used or adapted for the data collection part of the clinical audit cycle by the trust, service or practice. The tool is based on the recommendations relating to clinical criteria Organisational criteria are covered in a separate document. Data may be required from a range of sources, including policy documents and patient records. Suggestions for these are indicated on the tools, although this is not an exhaustive list and they may differ in your organisation. The relevant group for this audit is adults with type 2 diabetes. Select an appropriate sample in line with your local clinical audit strategy. Whether or not the audit results meet the standard, re-auditing is a key part of the audit cycle. If your first data collection shows room for improvement, re- run it once changes to the service have had time to make an impact. Continue with this process until the results of the audit meet the standards. Links with other national priorities The audit based on this guideline should be considered in conjunction with other national priorities: • It is suggested that the audit based on this guideline is considered in conjunction with other national priorities such as the National Diabetes Audit and the audit criteria developed from ‘Depression: management of depression in primary and secondary care’ (NICE clinical guideline 23) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 3 of 29
  • 4. Clinical criteria for ‘Type 2 diabetes’ Patient education Criterion 1 Patients should receive patient education. Exceptions None Standard 100% Definitions Structured education should be offered to every person and/or their carer at and around the time of diagnosis with annual reinforcement and review. Patient education programmes should meet the criteria laid down by the Department of Health and Diabetes UK Patient Education Working Group. According to the Department of Health and Diabetes UK, structured patient education means that there is a planned course that: • has a structured, written curriculum • has trained educators • is quality assured • is audited. See organisational criterion 1 for more details. Dietary advice Patients should receive nutritional advice from a healthcare professional Criterion 2 with expertise and competencies in nutrition. Exceptions None Standard 100% Definitions None Glucose control levels The individual’s HbA1c levels should be measured at: • 2–6-monthly intervals until the blood glucose level is stable on Criterion 3 unchanging therapy • 6-monthly intervals once the blood glucose level and blood glucose- lowering therapy are stable. Exceptions None Standard 100% Definitions A measurement made at an interval of less than 3 months should be used as an indicator of direction of change, rather than as a new steady state. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 4 of 29
  • 5. Unexplained discrepancies between HbA1c and other glucose measurements should be investigated. Criterion 4 Advice should be sought from a team with specialist expertise in diabetes or clinical biochemistry. Exceptions None Standard 100% Definitions None Self-monitoring of plasma glucose Assess at least annually: • self-monitoring skills • the quality and appropriate frequency of testing Criterion 5 • the use made of the results obtained • the impact on quality of life • the continued benefit • the equipment used. Exceptions A. Person has been in contact with the service for less than 1 year. Standard 100% Definitions None Blood-glucose-lowering therapy Metformin Metformin treatment should be started in a person who is overweight or obese, and whose blood glucose is Criterion 6 inadequately controlled by lifestyle interventions (nutrition and exercise) alone. Exceptions None Standard 100% Definitions The assessment should be tailored according to ethnic group. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 5 of 29
  • 6. Metformin should be continued if blood glucose control remains or Criterion 7 becomes inadequate and another oral glucose-lowering medication (usually a sulfonylurea) is added. Exceptions None Standard 100% Definitions None Metformin therapy should be stepped up gradually over Criterion 8 weeks to minimise risk of gastrointestinal side effects. Exceptions None Standard 100% Definitions Local clinical advice should be sought as to an appropriate timescale for this. The dose of metformin should be reviewed if the serum creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate Criterion 9 (eGFR) is below 45 ml/minute/1.73-m2. Metformin should be stopped if the serum creatinine exceeds 150 micromol/litre or the eGFR is below 30 ml/minute/1.73-m2. Exceptions None Standard 100% Definitions None Sulfonylureas A sulfonylurea should be added as second-line therapy when blood Criterion 10 glucose control remains or becomes inadequate with metformin. Exceptions None Standard 100% Definitions None A sulfonylurea should be continued if blood glucose Criterion 11 control remains or becomes inadequate and another oral glucose-lowering medication is added. Exceptions None Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 6 of 29
  • 7. A once-daily, long-acting sulfonylurea should only be Criterion 12 offered if drug concordance is a problem. Exceptions None Standard 100% Definitions None People being treated with an insulin secretagogue Criterion 13 should be educated about the risk of hypoglycaemia. Exceptions None Standard 100% Definitions None DPP-4 inhibitors (sitagliptin, vildagliptin) Criterion 14 DPP-4 inhibitor therapy should only be continued if the person has had a NEW reduction of at least 0.5 percentage points in HbA1c in 6 months. Exceptions None Standard 100% Definitions None Thiazolidinediones (glitazones) Criterion 15 Thiazolidinediones should not be commenced or continued in people NEW who have heart failure, or who are at higher risk of fracture. Exceptions None Standard 100% Definitions None Criterion 16 Thiazolidinedione therapy should only be continued if the person has had NEW a reduction of at least 0.5 percentage points in HbA1c in 6 months. Exceptions None Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 7 of 29
  • 8. Exenatide Criterion 17 GLP-1 mimetic (exenatide) therapy should be continued if the person has had a reduction of at least 1.0 percentage point in HbA1c and a weight NEW loss of at least 3% of initial body weight at 6 months. Exceptions None Standard 100% Definitions The BMI advice should be tailored for other ethnic groups. Acarbose Acarbose should only be prescribed for people unable to use other Criterion 18 glucose-lowering medications. Exceptions None Standard 100% Definitions None Insulin therapy When starting basal insulin therapy: Criterion 19 • continue with metformin and the sulfonylurea (and acarbose, if used) • review the use of the sulfonylurea if hypoglycaemia occurs. Exceptions None Standard 100% Definitions When other measures no longer achieve adequate blood glucose control (to HbA1c < 7.5% or other higher level agreed with the individual) discuss the benefits and risks of insulin therapy. When starting pre-mixed insulin therapy or mealtime plus basal insulin regimens: Criterion 20 • continue with metformin • continue the sulfonylurea initially, but review and discontinue if hypoglycaemia occurs. Exceptions None Standard 100% Definitions When other measures no longer achieve adequate blood glucose control (to HbA1c < 7.5% or other higher level agreed with the individual) discuss the benefits and risks of insulin therapy. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 8 of 29
  • 9. Insulin therapy should begin with human NPH insulin, taken at bed-time Criterion 21 or twice daily according to need. Exceptions B. Where a long-acting insulin analogue (insulin glargine) is used for a person who falls into one of the following categories: - those who require assistance from a carer or healthcare professional to administer their insulin injections - those whose lifestyle is significantly restricted by recurrent symptomatic hypoglycaemic episodes - those who would otherwise need twice-daily basal insulin injections in combination with oral glucose-lowering medications. C. Where twice-daily biphasic human insulin (pre-mix) regimens are used (once daily may be an option when initiating this therapy). D. Where pre-mixed preparations of insulin analogues rather than pre-mixed human insulin preparations are used when: - immediate injection before a meal is preferred - hypoglycaemia is a problem - there are marked postprandial blood glucose excursions. Standard 100% Definitions None Criterion 22 People on a basal insulin regimen* should be monitored for the need for NEW short-acting insulin before meals (or a pre-mixed insulin preparation). Exceptions None Standard 100% Definitions *NPH insulin or a long-acting insulin analogue (insulin detemir, insulin glargine) Criterion 23 People who are using pre-mixed insulin once or twice daily should be monitored for the need for a further injection of short-acting insulin NEW before meals or for a change to a regimen of mealtime plus basal insulin, based on NPH insulin or long-acting insulin analogues (insulin detemir, insulin glargine), if blood glucose control remains inadequate. Exceptions None Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 9 of 29
  • 10. Blood pressure management Blood pressure should be measured at least annually in a person without Criterion 24 previously diagnosed hypertension or renal disease. Exceptions None Standard 100% Definitions None If a person is on antihypertensive therapy at diagnosis: • blood pressure control and medication use should be reviewed Criterion 25 • changes should be made only if the blood pressure is poorly controlled or current medications are inappropriate because of microvascular complications or metabolic problems. Exceptions None Standard 100% Definitions None If a person is not hypertensive, does not have renal disease and their blood pressure is over the target, the measurement should be repeated at the following intervals: Criterion 26 • within 1 month if > 150/90 mmHg • within 2 months if > 140/80 mmHg • within 2 months if > 130/80 mmHg and kidney, eye or cerebrovascular damage. Exceptions None Standard 100% Definitions None Criterion 27 A blood pressure target of < 140/80 mmHg should be set. Exceptions E. Where the person has kidney, eye or cerebrovascular damage a target of < 130/80 mmHg should be set. Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 10 of 29
  • 11. If a person’s blood pressure reaches and consistently remains at, the target they should be: Criterion 28 • monitored every 4–6 months • checked for possible adverse effects of antihypertensive therapy. Exceptions F. Person has been in contact with health services for less than 4 months. Standard 100% Definitions None Cardiovascular risk estimation People should be considered to be at high premature cardiovascular risk for their age unless they: • are not overweight, tailoring this assessment according to ethnic group • are normotensive (< 140/80 mmHg in the absence of antihypertensive therapy) Criterion 29 • do not have microalbuminuria • do not smoke • do not have a high-risk lipid profile • have no history of cardiovascular disease and • have no family history of cardiovascular disease. Exceptions None Standard 100% Definitions None People not considered to be at high cardiovascular risk should have their Criterion 30 cardiovascular risk estimated annually using the UK Prospective Diabetes Study (UKPDS) risk engine. Exceptions A. Person has been in contact with the service for less than 1 year. Standard 100% Definitions See: UKPDS risk engine. Available from: www.dtu.ox.ac.uk/index.php? maindoc=/riskengine/ Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 11 of 29
  • 12. A full lipid profile, including high-density lipoprotein (HDL) cholesterol and triglyceride estimations, should be performed: Criterion 31 • when assessing cardiovascular risk after diagnosis • annually • before starting lipid-modifying therapy. Exceptions None Standard 100% Definitions None Management of blood lipids Statins and ezetimibe Cardiovascular risk status should be reviewed annually by assessment of cardiovascular risk factors, including features of the metabolic syndrome Criterion 32 and waist circumference, and change in personal or family cardiovascular history. Exceptions A. Person has been in contact with service for less than 1 year. Standard 100% Definitions None For people aged 40 or older: • therapy should be initiated with: Criterion 33 − generic simvastatin (to 40 mg) or − a statin of similar efficacy and cost. Exceptions G. Where cardiovascular risk from non-hyperglycaemia-related factors is low. Standard 100% Definitions None For people aged 40 or older: • if the cardiovascular risk from non-hyperglycaemia-related factors is low, cardiovascular risk should be assessed using the UKPDS risk Criterion 34 engine • simvastatin therapy (to 40 mg), or a statin of similar efficacy and cost, should be initiated if the cardiovascular risk exceeds 20% over 10 years. Exceptions None Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 12 of 29
  • 13. People on cholesterol-lowering therapy should have their lipid profile, together with other modifiable risk factors and any new diagnosis of Criterion 35 cardiovascular disease, assessed 1–3 months after starting treatment, and annually thereafter. Exceptions None Standard 100% Definitions None Criterion 36 In anyone on simvastatin the dose should be increased to 80 mg daily. Exceptions H. Total cholesterol level is below 4.0 mmol/litre. I. Low-density lipoprotein cholesterol level is below 2.0 mmol/litre. J. People who have not had an assessment 1–3 months after initiating treatment. Standard 100% Definitions None If there is a possibility of a woman becoming pregnant, statins should not Criterion 37 be used unless the issues have been discussed with the woman and agreement has been reached. Exceptions None Standard 100% Definitions None Fibrates If there is a history of elevated serum triglycerides, annual cardiovascular Criterion 38 risk assessments should include a full fasting lipid profile (including HDL cholesterol and triglyceride estimations). Exceptions None Standard 100% Definitions None Possible secondary causes of high serum triglyceride levels should be Criterion 39 assessed. Exceptions None Standard 100% Definitions Causes could include poor blood glucose control (others include hypothyroidism, renal impairment and liver inflammation, particularly from alcohol). Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 13 of 29
  • 14. A fibrate should be prescribed if triglyceride levels remain above 4.5 Criterion 40 mmol/litre. Fenofibrate should be the first-line fibrate. Exceptions None Standard 100% In some circumstances, this will be before a statin has been started because of Definitions acute need (that is, risk of pancreatitis) and because of the undesirability of initiating two drugs at the same time. Anti-thrombotic therapy Criterion 41 People should be receiving low-dose daily aspirin if they are: • aged 50 or over with blood pressure (BP) under 145/90 mmHg or • aged under 50 with significant cardiovascular risk factors. Exceptions K. People who declined to take low-dose daily aspirin. Standard 100% Definitions Low-dose daily aspirin: 75 mg. Significant cardiovascular risk factors: features of the metabolic syndrome, strong early family history of cardiovascular disease, smoking, hypertension, extant cardiovascular disease, microalbuminuria. Criterion 42 Clopidogrel should only be prescribed to people with a clear aspirin intolerance. Exceptions None Standard 100% Definitions None Kidney damage Criterion 43 The following should be carried out annually: • albumin:creatinine ratio (ACR) estimation on first-pass urine sample or spot sample if necessary • serum creatinine measurement • GFR estimate. Exceptions A. People who have been in contact with the service for less than 1 year. Standard 100% Definitions None Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 14 of 29
  • 15. Criterion 44 If ACR is abnormal: • the test should be repeated at the next two clinic visits and within 3–4 months • microalbuminuria should be confirmed if at least one of the further tests is also abnormal. Exceptions None Standard 100% Definitions Abnormal ACR = ACR > 2.5 mg/mmol for men and > 3.5 mg/mmol for women. Eye damage Criterion 45 Eye screening should be performed at or around the time of diagnosis. Exceptions None Standard 100% Definitions None Criterion 46 Eye screening should be repeated at least annually. Exceptions A. People who have been in contact with the service for less than 1 year. Standard 100% Definitions None Criterion 47 A person should be referred1 to an ophthalmologist if any of the following features are present. • Referable maculopathy: - exudate or retinal thickening within one disc diameter of the centre of the fovea - circinate or group of exudates within the macula2 - any microaneurysm or haemorrhage within one disc diameter of the centre of the fovea if associated with a best visual acuity of 6/12 or worse. • Referable pre-profilerative retinopathy: - venous beading - venous loop or reduplication - intraretinal microvascular abnormalities - multiple deep, round or blot haemorrhages. • Unexplained drop in visual acuity. Exceptions None Standard 100% 1 Patients should be referred in accordance with the National Screening Definitions Committee criteria and timelines. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 15 of 29
  • 16. 2 The macula is defined here as a circle centred on the fovea, with a diameter the distance between the temporal border of the optic disc and the fovea. Neuropathic pain Criterion 48 Neuropathic symptoms should be recorded annually. Exceptions None Standard 100% Definitions None Person-centred care Criterion 49 People should be offered: • written information about their illness or condition • written information about the treatment and care they should be offered, including the ‘Understanding NICE guidance’ booklet • written information about the service providing their treatment and care • structured education at and around the time of diagnosis with annual reinforcement and review (they should be informed that this is an integral part of diabetes care). Exceptions None Standard 100% Definitions Patients should be offered written information to help them make informed decisions about their healthcare. This should cover the condition, treatments and the health service providing care. Information should be available in formats appropriate to the individual, taking into account language, age, and physical, sensory or learning disabilities. Number of criterion Local alternatives to above criteria (to be used where other data replaced: addressing the same issue are more readily available). Exceptions Standard Definitions Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 16 of 29
  • 17. Complete one form for each patient. Patient identifier: Sex: M / F Age: Ethnicity: Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Patient education 1 1.1 Is the person receiving patient education? 1.1 (Data source: patient record) Dietary advice 2 2.1 Has the person received nutritional advice? 1.2.1 2.2 Did the healthcare professional giving the advice have expertise and competencies in nutrition? 1.2.1.1 (Data source: patient record) Glucose control levels Is the person’s blood glucose level stable? 3 3.1 1.3.2 (Data source: patient record) 3.2 The person’s levels were measured at: ……………………… …………………………… …………………………. (Data source: patient record) Are there any unexplained discrepancies 4 4.1 between HbA1c and other glucose 1.3.6 measurements? If yes, was advice sought from a team with specialist expertise in diabetes or clinical 4.2 biochemistry? (Data source: patient record) Self-monitoring of plasma glucose Have the following been assessed in the last A 5 1.4.3 12 months: 5.1 • self-monitoring skills? • the quality and appropriate frequency of 5.2 testing? 5.3 • the use made of the results obtained? 5.4 • the impact on quality of life? 5.5 • the continued benefit? • the equipment used? 5.6 (Data source: patient record) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 17 of 29
  • 18. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Blood-glucose-lowering therapy Metformin 6 6.1 Is the person receiving metformin treatment? 1.5.1 6.2 Is the person overweight or obese? 1.5.1.1/1.5.1.2 Has the person’s blood glucose been 6.3 controlled by lifestyle interventions? 1.5.1.1 (Data source: patient record) Has blood glucose remained or become 7 7.1 inadequate while the person has been receiving metformin? Has another oral glucose-lowering medication 7.2 1.5.1.3 been added? If yes to either, has metformin been 7.3 continued? (Data source: patient record) Has metformin therapy been gradually 8 8.1 stepped up over weeks? 1.5.1.4 (Data source: patient record) 9 Has: • Serum creatinine exceeded: 9.1 - 130 micromol/litre? 9.2 - 150 micromol/litre? • Estimated glomerular filtration rate (eGFR) dropped below: 9.3 - 45 ml/minute/1.73-m2? 1.5.1.5 - 30 ml/minute/1.73-m2? 9.4 (Data source: patient record) Has the metformin: 9.5 • been stopped? • been reduced in dosage? 9.5 (Data source: patient record/drug chart) Sulfonylureas Has blood glucose control stayed or become 10 10.1 inadequate while on metformin? Has another oral glucose-lowering medication 1.5.2.2 10.2 been added to the metformin treatment? (Data source: patient record/drug chart) Is the person’s blood glucose control 11 11.1 1.5.2.3 inadequate? Has another oral glucose-lowering 11.2 `medication been added? Has the sulfonylurea been continued? 11.3 (Data source: patient record) Is drug concordance a problem for the 12 12.1 person? If yes, have they been offered a daily, long- 1.5.2.5 12.2 acting sulfonylurea? (Data source: patient record/drug chart) Has the person been educated about the risk 13 13.1 of hypoglycaemia? 1.5.2.6 (Data source: patient record) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 18 of 29
  • 19. DPP-4 inhibitors (sitagliptin, vildagliptin) Is the person receiving DPP-4 inhibitor 14 1.6.1.4 therapy? If yes, have they had a reduction of at least 0.5 percentage points in HbA1c in 6 months? Thiazolidinediones (glitazones) Is the person being prescribed a 15 15.1 thiazolidinedione? 15.2 Does the person have heart failure? Has the person’s fracture risk been 15.3 1.6.2.4 assessed? Is the person at higher risk of fracture? 15.4 (Data source: patient record/drug chart) Are they receiving thiazolidinedione? 16 16.1 1.6.2.6 Has the person has had a reduction of at least 0.5 percentage points in HbA1c in 6 months)? Exenatide Is exenatide being prescribed? 1.6.3.2 (Data source: drug chart) If yes, has the person has had: • a reduction of at least 1.0 percentage 17 17.1 points in HbA1c in 6 months • weight loss of at least 3% of initial body weight at 6 months? Acarbose Is acarbose being prescribed? 18 18.1 (Data source: drug chart) 1.5.4.1 If yes, is the person unable to use other 18.2 glucose-lowering medications? Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 19 of 29
  • 20. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Insulin therapy Has the person been started on basal insulin 19 19.1 1.7.1 therapy? Is the person receiving: 19.2 • metformin? 1.7.1.1/ 1.7.1.2/ 19.3 • sulfonylurea? 1.7.1.3 19.4 • an alpha-glucosidase inhibitor? Did hypoglycaemia occur after the basal 19.5.1 insulin therapy started? 1.7.1.1 If yes, was there a change in the use of the 19.5.2 sulfonylurea? 20 Has the person recently started: 20.1 • pre-mixed insulin therapy? 1.7.1.2 20.2 • mealtime plus basal insulin regimens? Did insulin therapy begin with human NPH B / C / D 21 21.1 1.7.2.3 insulin taken: • at bed time? • twice daily? If the person is on a basal insulin regimen, have they been monitored for the need for: 22 1.7.2.6 22.1 • short-acting insulin before meals 22.1 • pre-mixed insulin preparation? If the person is using pre-mixed insulin once 23 23.1 or twice daily, are they being monitored for 1.7.2.7 the need for: • a further injection of short-acting insuling before meals • a change to a regimen of mealtime plus basal insulin based on NPH insulin analogues if blood glucose remains inadequate Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 20 of 29
  • 21. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Blood pressure management 24 24.1 Has the person’s blood pressure been measured within the last year? 1.8.1 24.2 Has the person been diagnosed with hypertension or renal disease? 25 If the person was on antihypertensive therapy at diagnosis: • was blood pressure control and medication 25.1 use reviewed? • If yes: 25.2 - was the blood pressure poorly 1.8.2 controlled? 25.3 - are current medications inappropriate because of microvascular complications or metabolic problems? (Data source: patient record) 26 If the person is not hypertensive, were subsequent measurements repeated at the following intervals: 26.1 • within 1 month if > 150/90 mmHg? 1.8.3 26.2 • within 2 months if > 140/80 mmHg? 26.3 • within 2 months if > 130/80 mmHg and kidney, eye or cerebrovascular damage? (Data source: patient record) If the person has kidney, eye or 27 27.1 E cerebrovascular damage, was a target < 130/80 mmHg set? 1.8.6 27.2 If no, was a target of < 140/80 mmHg set? (Data source: patient record) 28 If the person’s blood pressure reached and F consistently remained at the target were they: • monitored every 4–6 months? 28.1 1.8.13 28.2 • checked for possible adverse effects of antihypertensive therapy? (Data source: patient record) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 21 of 29
  • 22. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Cardiovascular risk estimation 29 29.1 Do the following apply to the person (if none apply, they should not be considered to be at high premature cardiovascular risk for their age): 29.1.1 • overweight? 29.1.2 • not normotensive? - hypertensive? - hypotensive? 1.9.1 29.1.3 • has macroalbuminuria? 29.1.4 • smokes? 29.1.5 • has high-risk lipid profile? 29.1.6 • has history of cardiovascular disease? 29.1.7 • has family history of cardiovascular disease? (Data source: patient record) 30 30.1 Is the person indicated as being at high cardiovascular risk? (Data source: patient record) 30.2.1 If not, have they had their risk estimated using the UKPDS1 risk engine? 1.9.2 (Data source: patient record) 30.2.2 Dates of the last two estimates? A (Data source: patient record) 31 31.1 Has a full lipid profile been performed: 31.1.1 • after diagnosis when cardiovascular risk was assessed? 1.9.4 31.1.2 • annually? 31.1.3 • before starting lipid-modifying therapy? (Data source: patient record) 1 UK Prospective Diabetes Study Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 22 of 29
  • 23. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Management of blood lipids Statins and ezetimibe 32 Was cardiovascular risk status reviewed by assessment of cardiovascular risk factors, including: 32.1.1 • features of the metabolic syndrome? 32.1.2 • waist circumference? 32.1.3 • a change in personal or family 32.1.4 1.10.1.1 cardiovascular history? (Data source: patient record) Dates of the last two reviews: 32.2.2 1. A 32.2.3 2. 33 If the person is aged 40 or over, was therapy G 1.10.1.2/ 33.1 initiated with a generic simvastatin? 1.10.1.3 33.2 If yes, was the dose up to 40 mg? If no, was a statin used of 33.3 - similar efficacy 33.4 - similar cost (Data source: patient record) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 23 of 29
  • 24. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. 34 If the person is aged 40 or over: 1.10.1.3 34.1 Is the cardiovascular risk from non- hyperglycaemia-related factors low? 34.2 If yes, has risk been assessed using the UKPDS risk engine? (Data source: patient record) 34.3 Does the cardiovascular risk exceed 20% over 10 years? 34.4 If yes, have either of the following been initiated: 34.4.1 • simvastatin therapy? 34.4.2 - if yes, was the dose up to 40 mg? • A statin of 33.4.3 - similar efficacy 33.4.4 - similar cost used? (Data source: patient record) 35 35.1 Is the person on cholesterol-lowering therapy? 35.2 Have the following been assessed: 1–3 months Annually after diagnosis 35.2.1 • lipid profile? 1.10.1.4 35.2.2 • other modifiable risk factors? 35.2.3 • new diagnosis of cardiovascular disease? (Data source: patient record) 36 36.1 Is the person on simvastatin? 36.1.1 If yes, has the dose been increased to 80 mg H / I / J daily? (Data source: patient record/drug chart) 37 37.1.1 If the person is female, is there a possibility of 1.10.1.5 her becoming pregnant? 37.1.2 Is she receiving a statin? 37.1.3 If yes, is there evidence that the statin was started following discussion with the person? (Data source: patient record) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 24 of 29
  • 25. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Fibrates Is there a history of elevated serum 38 38.1 triglycerides? If yes, is there evidence of annual cardiovascular risk assessments, including: 38.1.1 • full fasting lipid profile? 1.10.2.1 38.1.2 • HDL cholesterol? • triglyceride estimations? 38.1.3 (Data source: patient record) 39 39.1 Have possible secondary causes of high serum triglyceride levels been assessed? 1.10.2.2 (Data source: patient record) Are the person’s triglyceride levels above 40 40.1 4.5 mmol/litre? 40.2 If yes, has a fibrate been prescribed? 1.10.2.3 Was fenofibrate the first or only fibrate 40.3 prescribed? (Data source: patient record/drug chart) Anti-thrombotic therapy 41 If the person is taking low-dose daily aspirin, K are they: • aged 50 or over with BP under 41.1 145/90 mmHg? 1.11.1/1.11.2 41.2 • aged under 50 with significant cardiovascular risk factors? (Data source: patient record/drug chart) 42 42.1 If the person is prescribed clopidogrel, do they 1.11.3 have an intolerance to aspirin? (Data source: patient record/drug chart) Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 25 of 29
  • 26. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Kidney damage Have the following been carried out in the last 43 A year: • ACR estimation on first-pass urine sample 43.1 or spot sample if necessary? 1.12.3 43.2 • serum creatinine measurement? 43.3 • GFR estimate? 44 44.1 If ACR is abnormal: • was the test repeated: 44.2 - at the following two clinic visits? 1.12.4 44.3 - within 3–4 months? • was microalbuminuria confirmed if at least 44.4 one of the further tests was also abnormal? Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 26 of 29
  • 27. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Eye screening Was eye screening performed at or around 45 45.1 the time of diagnosis? 1.13.1 46 46.1 Was the eye screening repeated annually? A Were there features of referable maculopathy 47 47.1 including: 47.1.1 • exudate or retinal thickening within one disc diameter of the centre of the fovea? • circinate or group of exudates within the 47.1.2 macula? • any microaneurysm or haemorrhage within one disc diameter of the centre of 47.1.3 the fovea if associated with a best visual acuity of 6/12 or worse? Were there features of referable pre- 47.2 1.13.9 profilerative retinopathy, including: 47.2.1 • venous bleeding? 47.2.2 • venous loop or reduplication? 47.2.3 • intraretinal microvascular abnormalities? • multiple deep, round or blot 47.2.4 haemorrhages? Was there an unexplained drop in visual 47.3 acuity? If yes to any of the above, was the person 47.4 referred to an ophthalmologist? (Data source: patient record/referral form) Neuropathic pain Have neuropathic symptoms been recorded 48 48.1 1.14.2.1 annually? Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 27 of 29
  • 28. Crite- Data NICE NA/ rion item Criterion Yes No guideline exceptions no. no. ref. Person-centred care 49 Was the person offered written information Patient-centred about: care 49.1 • their illness or condition 49.2 • the treatment and care they should be offered 49.3 − including the ‘Understanding NICE guidance’ booklet 49.4 • the service providing their treatment and care Was the person offered structured education at and around the time of diagnosis with annual reinforcement and review. (Data source: patient records) Data collection completed Exception codes: A – Person has been in contact with health service for less than 1 year. B – Where a long-acting insulin analogue (insulin glargine) is used for a person who falls into one of the following categories: − those who require assistance from a carer or healthcare professional to administer their insulin injections − those whose lifestyle is significantly restricted by recurrent symptomatic hypoglycaemic episodes − those who would otherwise need twice-daily basal insulin injections in combination with oral glucose-lowering medications. C – Where twice-daily biphasic human insulin (pre-mix) regimens are used (once daily may be an option when initiating this therapy). D – Where pre-mixed preparations of insulin analogues rather than pre-mixed human insulin preparations are used when: – immediate injection before a meal is preferred – hypoglycaemia is a problem – there are marked postprandial blood glucose excursions. E – Person has kidney, eye or cerebrovascular damage and a target of < 130/80 mmHg was set. F – Person has been in contact with health service for less than 4 months. G – Cardiovascular risk from non-hyperglycaemia-related factors is low. H – Total cholesterol level is below 4.0 mmol/litre. I – Low-density lipoprotein cholesterol is below 2.0 mmol/litre. J – Person has not had an assessment 1–3 months after initiating treatment. K – Person declined to take low-dose daily aspirin. Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 28 of 29
  • 29. Further information Click here for further information on reporting and monitoring the audit of NICE guidance in your organisation. Supporting implementation NICE has developed tools to help organisations implement the clinical guideline on Type 2 diabetes (listed below). These are available on our website (www.nice.org.uk/CG87). • Costing tools • Slides highlighting key messages for local discussion. • Audit support for monitoring local practice (this document). A practical guide to implementation, ‘How to put NICE guidance into practice: a guide to implementation for organisations’, is also available on our website (www.nice.org.uk/usingguidance/implementationtools). The guidance You can download the guidance documents from www.nice.org.uk/CG87. For printed copies of the quick reference guide or ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk and quote N1863 (quick reference guide) and/or N1864 (‘Understanding NICE guidance’). Audit support: Clinical (NICE clinical guideline 87) Type 2 diabetes (2009) Page 29 of 29