- HbA1c is used to diagnose diabetes, but there are important caveats that clinicians need to be aware of, and traditional measurements of glucose should be used under such circumstances
- Screening for diabetes in patients with severe mental illness is crucial as this patient group is at high risk of developing diabetes—HbA1c can be used for this purpose
- Miscoding of diabetes is common and clinicians should regularly consider whether the correct Read code has been used; failure to do this can result in clinical errors
- A requirement to identify and offer advice and treatment to patients who have diabetes and erectile dysfunction will form part of the QOF 2013/14
- Practices should begin to consider how they will incorporate an enquiry into erectile dysfunction, and subsequent assessment and treatment into their working diabetes clinics
- Clinicians should be aware of the association of testosterone deficiency with type 2 diabetes and its possible clinical impact
- Although referral to a structured education programme for patients with diabetes is not currently indicated in the QOF, clinicians should be aware of its benefits and ensure that they refer newly diagnosed patients
- Commissioners must provide structured educational programmes and ensure that these meet NICE standards.
HbA1c=glycated haemglobin; QOF=quality and outcomes framework
This article provides a summary of the changes to the diabetes indicators in the quality and outcomes framework (QOF), which came into effect from 1 April 2012, and their rationale;1 and discusses clinical areas that have been proposed as indicators for the QOF 2013/14, which at the time of going to press are still under consultation.
Diabetes in QOF 2012/2013
Use of HbA1C to diagnose diabetes
An international expert committee in 2008 stated, ‘There is no single gold standard to diagnose diabetes’, but suggested that a measure which captures chronic glucose exposure is preferable. A glycated haemoglobin (HbA1C) of ?48 mmol/mol (6.5%) is recommended as the cut-off point for diagnosing diabetes; however a value <48 mmol/mol does not exclude diabetes diagnosed during glucose tests.2-4 Both the World Health Organization (WHO)3 and the American Diabetes Association5 have endorsed the use of HbA1C for the diagnosis of diabetes.
Although MH20 in the clinical indicators for mental health does not relate specifically to the diabetes domain it is worthy of discussion because it highlights how diabetes should be diagnosed, with the use of HbA1C as the key change: ‘The percentage of patients aged 40 years and over with schizophrenia, bipolar affective disorder and other psychoses who have a record of blood glucose or HbA1C in the preceding 15 months’..1
The use of HbA1C to diagnose diabetes is preferable for patients as it avoids the need to fast and the inconvenience of performing an oral glucose tolerance test. This is of particular relevance as testing for HbA1C can be performed at the same time as the mental health review, removing the need for the patient to return to the practice for a fasting glucose test. The importance of screening this particular patient group is significant: individuals with severe mental illness are at a two- to four-fold increased risk of developing diabetes,6,7 which probably results from factors relating to poor dietary and lifestyle choices, and psychotropic medication.
Clinicians should be aware of several situations where HbA1C cannot be used to diagnose diabetes, as well as conditions that preclude its accuracy: glycated haemoglobin reflects glycaemia over the preceding 2–3 months and so may not be raised if blood glucose levels have risen rapidly; any factor that influences red-cell life span, such as pregnancy, anaemia, and renal impairment, will underestimate the true HbA1C.
Glycated haemoglobin, along with fasting and 2-hour plasma glucose levels (measured with an oral glucose tolerance test) can be used as alternative methods of determining whether a patient has diabetes.
Classification of diabetes
The other change to the QOF 2012/13 relating to the diagnosis of diabetes was the replacement of DM19, ‘The practice can produce a register of all patients aged 17 years and over with diabetes mellitus, which specifies whether the patient has type 1 or type 2 diabetes’, by DM32: ‘The practice can produce a register of all patients aged 17 years and over with diabetes mellitus, which specifies the type of diabetes where a diagnosis has been confirmed’..1 This is an important change resulting from a probably unforeseen consequence of the 2006 QOF, which required diabetes to be specified as either type 1 or 2 (the rationale being to facilitate closer alignment of future indicators with NICE guidelines, which distinguish between the two diabetes subtypes). However, one study showed that this change resulted in a 22% reduction in diabetes prevalence on general practice registers, which could have resulted in an estimated 457,000 patients with diabetes being lost from existing registers.8
Misdiagnosis, misclassification, and more commonly, miscoding of diabetes can result in significant clinical errors. In 2011, NHS Diabetes and the Royal College of General Practitioners in association with the Department of Health, reviewed the coding, classification, and diagnosis of diabetes in primary care in England, and developed a useful algorithm to support accurate classification and diagnosis.9
The hardest time to specify the type of diabetes precisely is during diagnosis—the picture often becomes clearer with the passage of time. Although it is necessary to specify the precise form of diabetes, it is important to remain open minded to alternative diagnoses. This is especially important with a changing clinical picture.
Other changes to the diabetes indicators in QOF 2012/13
The number of points allocated to indicators DM2 and DM22 were reduced from three to one in QOF 2012/13.1 The QOF Advisory Committee has now suggested that these two indicators be retired in the proposed changes for 2013/14.10
A large number of QOF indicators, including several in the diabetes domain, had payment thresholds increased, reflecting a general rise in the difficulty in achieving maximum points.1
|DM32|| The practice can produce a register of all patients aged 17 years and over with diabetes mellitus, which specifies the type of diabetes where a diagnosis has been confirmed
|DM2||The percentage of patients with diabetes whose notes record body mass index in the previous 15 months||1||50–90%|
|DM26||The percentage of patients with diabetes in whom the last IFCC-HbA1C is 59 mmol/mol or less in the preceding 15 months||17||40–50%|
|DM27||The percentage of patients with diabetes in whom the last IFCC-HbA1C is 64 mmol/mol or less in the preceding 15 months||8||45–70%|
|DM28||The percentage of patients with diabetes in whom the last IFCC-HbA1cis 75 mmol/mol or less in the preceding 15 months||10||50–90%|
|DM21||The percentage of patients with diabetes who have a record of retinal screening in the preceding 15 months||5||50–90%|
|DM29||The percentage of patients with diabetes with a record of a foot examination and risk classification: 1) low risk (normal sensation, palpable pulses), 2) increased risk (neuropathy or absent pulses), 3) high risk (neuropathy or absent pulses plus deformity or skin changes or previous ulcer) or 4) ulcerated foot within the preceding 15 months||4||50–90%|
|DM10||The percentage of patients with diabetes with a record of neuropathy testing in the preceding 15 months||3||50–90%|
|DM30||The percentage of patients with diabetes in whom the last blood pressure is ?150/90 mmHg in the preceding 15 months||8||45–71%|
|DM31||The percentage of patients with diabetes in whom the last blood pressure is ?140/80 mmHg in the preceding 15 months||10||40–65%|
|DM13||The percentage of patients with diabetes who have a record of micro-albuminuria testing in the preceding 15 months (exception reporting for patients with proteinuria)||3||50–90%|
|DM22||The percentage of patients with diabetes who have a record of estimated glomerular filtration rate or serum creatinine testing in the preceding 15 months||1||50–90%|
|DM15||The percentage of patients with diabetes with a diagnosis of proteinuria or micro-albuminuria who are treated with ACE inhibitors (or ARBs)||3||45–80%|
|DM17||The percentage of patients with diabetes whose last measured total cholesterol within the preceding 15 months is ?5 mmol/l||6||40–75%|
|DM18||The percentage of patients with diabetes who have had influenza immunisation in the preceding 1 September to 31 March||3||45–85%|
Proposed indicators for QOF 2013/14
Microalbuminuria and nephropathy
Subtle changes to the wording of the indicators related to screening and treatment of microalbuminuria and diabetic nephropathy have been proposed. The current wording for DM13 states, ‘The percentage of patients with diabetes who have a record of microalbuminuria testing in the preceding 15 months (exception reporting for proteinuria)’.1 It is recommended that ‘exception reporting for proteinuria’ be removed to bring the indicator in line with NICE Clinical Guideline 87, which advises measuring the albumin:creatinine ratio, irrespective of nephropathy. 10
For the purposes of clarity, it has been suggested that the wording for DM15 be changed from, ‘The percentage of patients with diabetes with a diagnosis of diabetic nephropathy (clinical proteinuria) or micro-albuminuria who are treated with [angiotensin-converting enzyme] ACE inhibitors (or A2 antagonists)’ to, ‘The percentage of patients with diabetes with a diagnosis of proteinuria or micro-albuminuria who are treated with ACE inhibitors (or A2 antagonists)’.10
I am particularly pleased to see that erectile dysfunction (ED) in association with diabetes will potentially be featured in the QOF. This is a clinical area that I have previously suggested for inclusion as a QOF indicator.11 Patients do not volunteer information relating to ED frequently and helping them overcome anxieties by being open and making an enquiry about this condition would be welcome. The British Society for Sexual Medicine (BSSM) guideline defines ED as a persisting inability to attain or maintain an erection sufficient for sexual performance.12 Indicators on enquiry and subsequent assessment and treatment have been suggested—the percentage of male patients with diabetes:10
- with a record of being asked about ED in the preceding 15 months
- who have a record of ED with a record of advice and assessment of contributory factors and treatment options in the preceding 15 months.
The impact on sexual function as a long-term complication of diabetes is at last achieving a more prominent position. There are of course a huge number of issues to consider in managing any patient with diabetes—glycaemic control, lipids, and hypertension come to mind immediately, as well as ensuring patients have received annual screening for the presence of retinopathy, albuminuria, and neuropathy. Men who have either type 1 or type 2 diabetes are well known to be at significant risk of developing ED;13-16 in these individuals it often develops earlier, is more severe, and less responsive to conventional treatment.17-18
The development of sexual dysfunction has been assigned to both the vascular and neurological sequelae of diabetes, which are in turn related to the duration and severity of the disease.13,14,19 Intensive glycaemic control delays the onset and progression of microvascular complications in both type 1 and type 2 diabetes,20,21 and it follows that tighter control may result in an improvement or delayed onset of sexual complications.
Although not life threatening, ED places a significant psychological burden on the affected man and his partner, and can be a strong indicator of the presence of cardiovascular disease and should be regarded as an independent cardiovascular risk factor. Assessment of ED should include the suggested topics in Box 1.12
The management of ED begins with and demands reinforcement of the benefits of healthy eating, weight loss, and exercise. Pharmacological therapy with phosphodiesterase-5 (PDE5) inhibitors is commonly given and leads to smooth muscle relaxation, vasodilation, and penile erection.22 Individuals should be counselled carefully on how to use these medications and more importantly, recognise that they are not initiators of erection, and must be used in the context of the sexual environment.12
There is considerable evidence establishing a link between type 2 diabetes and low testosterone levels, ED, and cardiovascular disease. One study showed that 51% of men with type 2 diabetes have low testosterone levels;23 and this can be a frequent cause of treatment failure with a PDE5 inhibitor. The Androgen Deficiency in the Aging Male (ADAM) questionnaire can be used to assess the likelihood of androgen deficiency in males aged over 40 years.24
A similar risk of sexual dysfunction exists for the rate of cardiovascular and neurological complications in women; however the sexual functioning of females with diabetes has received considerably less focus both in terms of research and even more so in day to day clinical management.
Box 1: Suggestions for the assessment of erectile dysfunction in men with diabetes12
The following should be noted:
- duration of symptoms
- precipitating or predisposing factors
- any prior investigation and treatment including response to treatment
- an expression of tumescence and assessment of the presence and quality of morning erections
- an enquiry into libido ejaculatory and orgasmic dysfunction
- partner-related issues (i.e. menopause/vaginal dryness/dyspareunia)
- alcohol and smoking history.
- Focused physical examination should include:
- digital rectal examination (mandatory in presence of urinary or ejaculatory symptoms).
Box 2: Androgen Deficiency in the Aging Male (ADAM) questionnaire12
- Do you have a decrease in libido (sex drive)?
- Do you have a lack of energy?
- Do you have a decrease in strength and/or endurance?
- Have you lost height?
- Have you noticed a decreased ‘enjoyment of life’?
- Are you sad and/or grumpy?
- Are your erections less strong?
- Have you noticed a recent deterioration in your ability to play sports?
- Are you falling asleep after dinner?
- Has there been a recent deterioration in your work performance?
If you answer ‘yes’ to number 1 or 7 or if you answer ‘yes‘ to more than three questions, you may have low testosterone.
- Morley J, Charlton E, Patrick P et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000; 49 (9): 1239–1242.
- Reproduced with kind permission from Elsevier
Possible future indicators for diabetes
It is interesting to review the indicators on the NICE menu that were not negotiated into the QOF as they will almost certainly remain on the horizon and could appear as future indicators; these include the percentage of patients:
- newly diagnosed with diabetes in the preceding 1 April to 31 March who have a record of being referred to a structured education programme within 9 months of entry on to the diabetes register
- with diabetes who have a record of a dietary review by a suitably competent professional in the preceding 15 months
- with diabetes with a record of testing of foot sensation using a 10 g monofilament or vibration (using biothesiometer or calibrated tuning fork), within the preceding 15 months.
Self-management is the method by which a patient manages and cares for their long-term condition—structured education is central to the ability of a patient to self-manage. Such education is usually given to groups of individuals, who frequently derive benefit from peer support. People with diabetes make decisions relating to various aspects of their condition on a daily basis particularly in relation to diet, medication, and exercise. The purpose of structured education is to empower people by giving them the skills to self-manage their condition, facilitating a process whereby they acquire new skills and knowledge, which results in them making their own choices. This in turn should hopefully improve metabolic control, concordance, and quality of life.
Programmes relating to self-education are a current focus of significant attention. In the UK, there are four essential components of a quality self-management education intervention:25
- structured written curriculum
- delivery by trained educators
- quality assurance process
- regular audit should be undertaken.
The most important outcome measures in the assessment of diabetes management are:25
- pre- and post-meal blood/plasma levels
- prevention of acute episodes of hypoglycaemia/hyperglycaemia
- reduction in macrovascular risk factors (i.e. smoking, lipids)
- short-term quality of life, adverse events, and treatment tolerance
- long-term effects on the incidence of diabetes complications, quality of life, and mortality.
NICE guidance has only recently made structured education a central component of care for every patient and/or carer at the time of diagnosis,26 but there is some debate as to whether the evidence supports referral to structured-education programmes, which currently have not demonstrated definite improvements in ‘hard outcomes’. The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is now a well-established educational programme for patients with type 2 diabetes, but recent outcome data have shown no difference in biomedical or lifestyle outcomes at 3 years, although there were sustained improvements in some beliefs about illness.27-29 The Expert Patient Education Versus Routine Treatment (X-PERT) programme reported significant improvements in HbA1C at 14 months in patients with type 2 diabetes, although long-term results have not been reported.30
Inclusion within the QOF of a dietary review for patients with diabetes could have huge resource implications for practices and commissioners alike. The latter would need to ensure adequate provision of dietetic services to support the likely increase in referrals.
Foot testing sensation
An important, but often poorly understood concept is that the purpose of using a monofilament is not to diagnose neuropathy, but to identify people at risk of foot ulceration. A 10 g monofilament, a calibrated tuning fork, or a biothesiometer are used to detect large-fibre neuropathy. A normal test can provide false reassurance and patients could still be at risk as they could have small fibre neuropathy resulting in loss of pain and temperature sensation. There is capacity for the nerve to repair if diagnosed early enough.31 One downside of the QOF is that it rewards activity and not process and assessing patients with the use of a monofilament is one such example. This procedure is important, but in my view, an indicator that rewards action depending on whether a patient is at low, increased, or high risk of ulceration would be more appropriate.
Diabetic peripheral neuropathic pain
A large observational study undertaken in northwest England revealed a prevalence of diabetic peripheral neuropathic pain (DPNP) of 21% in patients with diabetes;32 it was more prevalent in those who were female, had type 2 diabetes, or were of south-Asian origin.32 Other data show that DPNP is both under reported and under treated.33 Inclusion of an indicator on DPNP would be welcome in view of its prevalence and the significant impact it has on a patient’s quality of life.34,35
I believe on the whole that the QOF has led to an improvement in diabetes care as it has for other long-term conditions. It is imperative however that it does not serve as an exercise in data recording. One negative aspect of the QOF is that it does not reward the care process. A prime example of this is the need to stratify a patient with diabetes as being at low, increased, or high risk of ulceration; however the clinician is not rewarded for instigating appropriate clinical management when needed. With many practice nurses performing diabetes reviews, it is important that the introduction of new indicators does not further increase time pressures, leading to a reduction in care and less focus on, for example, glycaemic control, hypertension, and lipids—QOF needs to be more than a tick-box exercise.
- Although still subject to consultation, several changes are likely to be imposed on the QOF in the future
- These include patient referral to a structured education programme within 9 months of diagnosis for all patients, which will require CCGs to ensure that sufficient places are available to meet demand
- The shift to HbA1C as the means of diagnosing diabetes is increasing detection rates, and commissioners will need to respond to the rise in patient numbers and consult with public health colleagues to model likely future demand for education programmes
- CCGs will have a duty to promote continual quality improvement in primary care and should investigate variations in QOF achievement among its practices to identify possible causes and compare these with other markers, such as amputation rates
- Increased QOF payment thresholds, screening for erectile dysfunction, and the rising prevalence of diabetes will place pressure on prescribing budgets, and the use of glucose testing strips; a review of formularies for diabetes medicines will be required to mitigate the potentially increased costs.
QOF=quality and outcomes frameworks; CCG=clinicial commissioning group; HbA1C=glycated haemoglobin
- British Medical Association. NHS Employers. Quality and outcomes framework 2012/13. London: BMA, NHS Employers, 2012. Available at: bma.org.uk/practical-support-at-work/contracts/independent-contractors/qof-guidance
- Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 2003; 26 Suppl 1: S5–S20.
- World Health Organization. Use of glycated haemoglobin (HbA1C) in the diagnosis of diabetes mellitus. Abbreviated report of a WHO consultation. Geneva: WHO, 2011. Available at: www.who.int/diabetes/publications/report-hba1c_2011.pdf
- Diabetes UK website. New diagnostic criteria for diabetes. www.diabetes.org.uk/About_us/Our_Views/Care_recommendations/New_diagnostic_criteria_for_diabetes_/?print=2 (accessed 23 January 2013).
- American Diabetes Association. Standards of medical care in diabetes—2010. Diabetes Care 2010; 33 Suppl 1: S11–S61.
- Dixon L, Weiden P, Delahanty J et al. Prevalence and correlates of diabetes in national schizophrenia samples. Schizophr Bull 2000; 26 (4): 903–912.
- Lamberti J, Crilly J, Maharaj K et al. Prevalence of diabetes mellitus among outpatients with severe mental disorders receiving atypical antipsychotic drugs. J Clin Psychiatry 2004; 65: 702–706.
- Hippisley-Cox J, O’Hanlon S. Identifying patients with diabetes in the QoF—two steps forward, one step back. Rapid response to: Tanne J. Diabetes, not obesity, increases risk of death in middle age. BMJ 2006; 333: 672.
- NHS Diabetes, Royal College of General Practitioners. Getting it right: improving the classification, diagnosis and coding of diabetes. Factsheet 34. NHS Diabetes, RCGP, 2011.
- National Institute for Health and Care Excellence. Summary of recommendations for the NICE menu and recommendations for the retirement of indicators. London: NICE, 2012. Available at: www.nice.org.uk/media/1E3/79/QOFACJune12SummaryRecommendations.pdf
- Downie P. Management and treatment of diabetes, erectile dysfunction and hypogonadism. Diabetes and Primary Care 2009; 11 (6): 354–357.
- Hackett G, Kell P, Ralph D et al. British Society for Sexual Medicine guidelines on the management of erectile dysfunction. J Sex Med 2008; 5: 1841–1865.
- Brown J, Wessells H, Chancellor M et al. Urologic complications of diabetes. Diabetes Care 2005; 28 (1): 177–185. Available at: care.diabetesjournals.org/content/28/1/177.long
- Fedele D, Bortolotti A, Coscelli C et al. Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici. Int J Epidemiol 2000; 29 (3): 524–531.
- Klein R, Klein B, Lee K et al. Prevalence of self-reported erectile dysfunction in people with long-term IDDM. Diabetes Care 1996; 19 (2): 135–141.
- De Berardis G, Franciosi M, Belfiglio M et al. Erectile dysfunction and quality of life in type 2 diabetic patients: a serious problem too often overlooked. Diabetes Care 2002; 25 (2): 284–291.
- Corona G, Mannucci E, Forti G, Maggi M. Hypogonadism, ED, metabolic syndrome and obesity: a pathological link supporting cardiovascular diseases. Int J Androl 2009; 32 (6): 587–598.
- Lewis R, Fugl-Meyer K, Bosch R et al. Epidemiology/risk factors of sexual dysfunction. J Sex Med 2004; 1 (1): 35–39.
- Rhodenet E, Ribeiro E, Riedner C. Glycosylated haemoglobin levels and the severity of erectile function in diabetic men. BJU Int 2005; 95: 615–617.
- [No authors listed]. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352: 837–853.
- Wan P, Lau J, Chalmore T. Meta-analysis of effects of intensive blood glucose control on the late diabetic complications of type 1 diabetes. Lancet 1993; 341 (8856): 877–890.
- Lau D, Kommu S, Mumtaz F et al. The management of phosphodiesterase-5 (PDE5) inhibitor failure. Current Vascular Pharmacology 2006; 4 (2): 89–93.
- Kapoor D, Aldred H, Clark S, Channer K et al. Clinical and biochemical assessment of hypogonadism in men with type 2 diabetes: correlations with bioavailable testosterone and visceral adiposity. Diabetes Care 2007; 30 (4): 911–917.
- Morley J, Charlton E, Patrick P et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000; 49 (9): 1239–1242.
- National Institute for Health and Care Excellence. Guidance on the use of patient-education models for diabetes. NICE Technology Appraisal 60. London: NICE, 2003. Available at: www.nice.org.uk/guidance/TA60
- National Institute for Health and Care Excellence website. Diabetes in adults quality standard. London: NICE, 2011. Available at: www.nice.org.uk/guidance/QS6
- Diabetes education and self management for ongoing and diagnosed (DESMOND) website. www.desmond-project.org.uk
- Davies M, Heller S, Skinner T et al. Effectiveness of the diabetes education and self-management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes. Cluster
randomised controlled trial. BMJ 2008; 336: 491.
- Khunti K, Gray L, Skinner T et al. Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care. BMJ 2012; 344: e2333.
- Deakin T, Cade J, Williams R, Greenwood D. Structured patient education: the diabetes X-PERT Programme makes a difference. Diabet Med 2006; 23 (9): 944–954.
- Abbott C, Malik R, van Ross E et al. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011; 34 (10): 2220–2224.
- Petropoulos I, Fadavi H, Asghar O at al. Diabetic neuropathy: Review of diagnosis and management. Diabetes Primary Care 2010; 12 (3): 165–174.
- Daousi C, MacFarlane I, Woodward A et al. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med 2004; 21 (9): 976–982.
- Gore M, Brandenburg N, Hoffman D et al. Burden of illness in painful diabetic peripheral neuropathy: the patients’ perspectives. J Pain 2006; 7 (12): 892–900.
- Armstrong D, Chappell A, Le T et al. Duloxetine for the management of diabetic peripheral neuropathic pain: evaluation of functional outcomes. Pain Med 2007; 8 (5): 410–418. G