- Individual HbA1c targets should be set for patients
- Involve the patient in setting 'targets' as part of shared decision making—'no decision about me without me'
- Aim for tight glycaemic control with a target HbA1c of 6.5% in younger and/or more recently diagnosed patients
- Relax HbA1c targets if there is a significant risk of hypoglycaemia or if efforts to achieve targets have a negative impact on quality of life
- Aim for a blood-pressure target of <140/80 mmHg in patients with diabetes. If the patient has microalbuminuria or proteinuria, aim for a lower target (good practice)
- Patients should be risk stratified following foot examination—appropriate action should be taken according to clinical findings
- A foot examination should also involve an enquiry into the presence of pain, which if present may be a sign of diabetic peripheral neuropathic pain
- Although not part of the QOF, NICE guidance suggests an annual enquiry into the presence of erectile dysfunction and a prompt for this should be included in the practice's computer template.
It is clear to anyone working in the sphere of diabetes medicine that this disease is an ever-burgeoning problem. This is borne out by some recent and rather alarming data demonstrating that there is a continued rise in the prevalence of both type 1 and 2 diabetes. Figures published last year by Diabetes UK showed a diabetes prevalence of 4%, which equates to a known diagnosed population of 2.6 million people.1 This compares with a prevalence of 3.5% in 2006 with a then known diagnosed population of 2.2 million individuals.2 This unfortunate trend looks set to continue. Figures from the Association of Public Health Observatories suggest that by 2020, 8.5% of adults (3.8 million people) will have diabetes, with this figure rising to 9.5% (4.6 million people) by 2030.3
The quality and outcomes framework (QOF) was introduced as part of the new GMS contract in 2004 and helps to standardise improvements in the delivery of care, as well as offering a means by which practices are rewarded for the provision of quality healthcare. This approach is particularly important for a condition such as diabetes where well-structured and well-organised care is a key facet to managing patients successfully.4 The National Institute for Health and Care Excellence (NICE) became responsible for managing the new process for developing the clinical health improvement indicators in April 2009. This process is designed to:
- allow a transparent and independent approach
- prioritise areas for new indicator development and the retirement of old indicators
- develop and set indicators for inclusion.
The recommendations from NICE on inclusion of indicators are based on current clinical evidence and cost effectiveness.5
Diabetes in the QOF
In the 2009/10 QOF update, three diabetes indicators were introduced with new targets for glycated haemoglobin (HbA1c) of 7% (DM23), 8% (DM24), and 9% (DM25) thus replacing the older targets of 7.5% and 10%5. This essentially followed the introduction in 2009 of the revised NICE guideline for the management of type 2 diabetes, which considered an HbA1c of 6.5% as an ideal initial target.6
However, in the latest 2011/12 QOF revision, the lowest HbA1c indicator has been raised from ?7% (53 mmol/mol) to ?7.5% (58 mmol/mol). The updated indicators for glycaemic control and thresholds for payment are shown in Table 1. There have also been changes to blood-pressure targets in people with diabetes and inclusion of a risk assessment following foot screening. This article discusses these changes and the evidence behind them, and whether they are likely to lead to improved patient care.
|Table 1: indecators for diabetes5|
|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||-||6|
|DM2||The percentage of patients with diabetes whose notes record body mass index (BMI) in the previous 15 months||-||3||40–90%|
|DM26||The percentage of patients with diabetes in whom the last IFCC-HbA1c is 59 mmol/mol (equivalent to HbA1c of 7.5% in DCCT values) or less (or equivalent test/reference range depending on local laboratory) in the preceding 15 months||DM26 replaces DM23||17||40–50%|
|DM27||The percentage of patients with diabetes in whom the last IFCC-HbA1c is 64 mmol/mol (equivalent to HbA1c of 8% in DCCT values) or less (or equivalent test/reference range depending on local laboratory) in the preceding 15 months||DM27 replaces DM24||8||40–70%|
|DM28||The percentage of patients with diabetes in whom the last IFCC-HbA1c is 75 mmol/mol (equivalent to HbA1c of 9% in DCCT values) or less (or equivalent test/reference range depending on local laboratory) in the preceding 15 months||DM28 replaces DM25||10||40–90%|
|DM21||The percentage of patients with diabetes who have a record of retinal screening in the previous 15 months||-||5||40–90%|
|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||DM29 replaces DM9||4||40–90%|
|DM10||The percentage of patients with diabetes with a record of neuropathy testing in the previous 15 months||-||3||40–90%|
|DM30||The percentage of patients with diabetes in whom the last blood pressure is 150/90 or less in the preceding 15 months||DM30 replaces DM12||8||40–71%|
|DM31||The percentage of patients with diabetes in whom the last blood pressure is 140/80 or less in the preceding 15 months||DM31 replaces DM12||10||40–60%|
|DM13||The percentage of patients with diabetes who have a record of micro-albuminuria testing in the previous 15 months (exception reporting for patients with proteinuria)||-||3||40–90%|
|DM22||The percentage of patients with diabetes who have a record of estimated glomerular filtration rate (eGFR) or serum creatinine testing in the previous 15 months||-||3||40–90%|
|DM15||The percentage of patients with diabetes with a diagnosis of proteinuria or micro-albuminuria who are treated with ACE inhibitors (or angiotensin ?? receptor blockers)||-||3||40–80%|
|DM17||The percentage of patients with diabetes whose last measured total cholesterol within the previous 15 months is ?5 mmol/l||-||6||40–70%|
|DM18||The percentage of patients with diabetes who have had influenza immunisation in the preceding 1 September to 31 March||-||3||40–85%|
IFCC=International Federation of Clinical Chemistry and Laboratory Medicine; HbA1c=glycated haemoglobin; DCCT=Diabetes Control and Complications Trial; eGFR=estimated glomerular filtration rate; ACE=angiotensin-converting enzyme
Key: Amended indicators
The increase in the lowest HbA1c indicator target from 7% to 7.5% in the 2011/2012 QOF was introduced largely because of data from the ACCORD study (Action to Control Cardiovascular Risk in Diabetes Study Group) published in 2008.7 The trial was designed to determine whether intensive therapy to target normal levels of HbA1c would reduce the risk of serious cardiovascular events in middle-aged and elderly patients with type 2 diabetes. The study participants had advanced and poorly controlled diabetes, with an average HbA1c of 8.1% on entry.
Patients in the intensive-therapy group were subjected to swift reductions in HbA1c in a fashion atypical of everyday clinical experience. There were fewer non-fatal myocardial infarctions in the intensively treated group, but there was no significant difference in the primary outcome measure (a composite of non-fatal myocardial infarction and non-fatal stroke or death from cardiovascular causes). However, and most importantly, the study was terminated early after a mean treatment period of 3.7 years due to the observation of a higher mortality rate in the intensively treated cohort.7
The more recently published ACCORD follow-up study provides analysis of data from a further 1.3 years of follow up
(i.e. 5-year outcomes of a mean of 3.7 years of intensive glucose lowering) on mortality and cardiovascular outcomes.8 Mean HbA1c levels rose from 6.4% to 7.2% in the intensive group following termination of the intervention trial. However, the same adverse trends in outcomes persisted—there was a continued increased risk of death in patients who had previously received intensive treatment. The reasons for these results remain a matter of some debate. Hypoglycaemia was believed to be the initial culprit on cessation of the intervention trial as there were higher rates of significant hypoglycaemia in the intensive group during treatment.7 However, during the post-transition period, patients in both groups were found to have similar rates of hypoglycaemia.8 As such, hypoglycaemia alone does not explain the continued higher mortality rate in intensively treated patients. Further work analysing the rapidness at which HbA1c is lowered and adverse risks of drug combinations is needed.
Data from ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Controlled Evaluation trial) have demonstrated the benefits of intensive glycaemic control (HbA1c of 6.5% versus 7.3%) mainly through a very significant reduction in nephropathy.9 The excessive death rate from intensive control that was observed in the ACCORD trial was not observed in the ADVANCE study; there was also no difference in all-cause or cardiovascular mortality between the treatment groups in ADVANCE.9
As a result of an ageing population, nearly half of all individuals with diabetes are over the age of 65 years.10 The risk of hypoglycaemia associated with the use of certain types of oral antidiabetic medicines or insulin increases markedly with age and it can have serious consequences, particularly in the elderly. Severe hypoglycaemia can also cause emotional distress, and in some cases, increase the risk of falls and fractures11 as well as cardiovascular disease and dementia.12,13 Hypoglycaemia is a real concern for patients and can place considerable restrictions on them.
In light of all these data it is easy to understand why there has been an increase in the lowest HbA1c indicator. Striving to achieve very low levels of HbA1c in hard-to-manage individuals may pose an undesirable risk of hypoglycaemia and potentially increase the risk of early mortality. As such, leaving the targets as they were or even reducing the lowest glycaemic indicator could have exposed a significant number of high-risk patients to an overly aggressive and ultimately dangerous intervention. However, this is not the same as saying GPs should settle for an HbA1c of 7.5% in all of their patients. The UK Prospective Diabetes Study (UKPDS) follow-up study demonstrated the long-term benefits of optimising control early—the so-called metabolic memory.14 Younger patients and those who have been recently diagnosed should have dysglycaemia managed aggressively aiming for an HbA1c of 6.5% in line with NICE guidance.6 The fact that the lowest HbA1c indicator has been raised should not deflect attention from the important task of obtaining lower HbA1c targets in these important groups. Ultimately, common sense is the key. In older and high-risk patients, aim for an HbA1c of 7.5% as this represents safe practice.
Diligent weighing up will allow GPs to identify those patients who would clearly benefit from an aggressive approach to lowering of HbA1c. There are of course fears that raising the lowest HbA1c indicator will lead to a more complacent approach and impact negatively on patient care. However, I feel we are sufficiently able in primary care to decide what is the right ‘target’ for our patients.It is essential that whatever HbA1c target is chosen, it is made through a decision of shared decision making between patient and clinician.
Indicator DM9 has been replaced with DM29 (see Table 1), which covers not only the need for a foot examination to be made, but also demands that patients are risk stratified according to the clinical findings (see Table 2).5 Foot examination should be more than a tick-box exercise and it is incumbent that action is taken depending on the clinical findings. There is no reward for acting upon clinical findings with appropriate management or referral and this is an omission of the revised QOF indicators. However, risk stratification of patients should in turn result in ongoing foot-care advice (especially for those at high risk).
|Table 2: QOF indicator on risk stratification of foot complications in diabetes5|
|DM29—The percentage of patients with diabetes with a record of a foot examination and risk classification (4 points; payment stages of 40–90%):|
|Clinical findings||Risk stratification|
|1. Normal sensation, palpable pulses||Low risk|
|2. Neuropathy or absent pulses||Increased risk|
|3. Neuropathy or absent pulses plus deformity or skin changes or previous ulcer||High risk|
|4. Ulcerated foot within the preceding 15 months|
Blood pressure targets
Indicator DM12 and its target of <145/85 mmHg has been replaced by two new indicators on the percentage of patients with diabetes in whom the last blood pressure is:5
- 150/90 mmHg or less in the preceding 15 months (DM30—8 points)
- 140/80 mmHg or less in the preceding 15 months (DM31—10 points).
DM31 is a tighter target for blood pressure than that set previously. Most of the evidence base for control of blood pressure relates to patients with type 2 diabetes. The aim of the UKPDS blood-pressure study was to determine whether tight control of blood pressure prevented macrovascular and microvascular complications in patients with type 2 diabetes.15 The study recruited 1148 hypertensive patients with type 2 diabetes with a mean age of 56 years and a mean blood pressure at entry of 160/94 mmHg. Patients were allocated to either tight control of blood pressure or less tight control, with a median follow up of 8.4 years. Mean blood pressure during follow up was significantly reduced in the group assigned to tight blood-pressure control (144/82 mmHg) compared with the group assigned to less tight control (154/87 mmHg) (p<0.0001). This translated into reductions in morbidity and mortality:15
- 32% reduction in diabetes-related deaths
- 44% reduction in strokes
- 37% reduction in microvascular end points.
The UKPDS post-trial monitoring results showed that the risk reductions of intensive control were lost within 2 years when control was relaxed (i.e. there is no legacy effect with regard to blood pressure control).16 The results of the blood-pressure arm of ACCORD showed no greater benefit from a strategy designed to lower systolic blood pressure to <120 mmHg compared with <140 mmHg.17
Taken as a whole, therefore the slight amendment in the revised hypertension indicator (DM31) looks justified. This also brings the QOF in line with NICE guidance, which recommends a blood pressure target of <140/80 mmHg.18
A threshold of 150/90 mmHg (DM30) remains with a maximum of 8 points available.5
In a similar fashion to the glycaemic targets, there is an important and large group of patients with diabetes in which we should not settle for the blood pressure targets set in the QOF, but instead strive for tighter control if it is safe to do so.
For those people with microalbuminuria or proteinuria, NICE recommends a target of <130/80 mmHg.18
Future revisions to the QOF
In my view, it is disappointing that the new QOF indicators do not include an enquiry into the presence of diabetic peripheral neuropathic pain (DPNP). This is a frequent complication, which occurs in up to one in six people with diabetes.19 It often presents with symmetrical pain in the legs, frequently described in emotive terms, such as sharp, stabbing, or like electric shocks, and is commonly worse at night. Clinical examination may reveal signs of sensory, motor, or autonomic dysfunction and occasionally findings of allodynia or hyperalgesia.
Diabetic peripheral neuropathic pain can be a debilitating condition that has a huge impact on a patient’s quality of life resulting in high levels of anxiety and depression in affected individuals.20 A NICE guideline is now available for the management of neuropathic pain,21 but the absence of a query into the presence of DPNP in the QOF will undoubtedly influence the rigour of the identification and management of this important complication.
Similarly no attention has been paid to erectile dysfunction (ED) in the revamped indicators. Erectile dysfunction is a common complication of diabetes and places a huge psychological burden on the patient in addition to being a strong marker for underlying cardiovascular disease. Again, the lack of inclusion for an enquiry into the presence of ED undermines the importance of this condition and probably prevents many patients accessing the support and management they require.
The updated QOF indicators for diabetes are understandable and reflect the underlying evidence base, but there are a significant proportion of patients who need to be treated more aggressively. It is important to keep this in mind as well as recognising patient groups in which it is dangerous and inadvisable to chase tighter targets. The National Diabetes Audit22 for 2009–2010 identified that an HbA1c target of ?7.5% (58 mmol/mol) was achieved by 66.5% of individuals with type 2 diabetes and only 28.2% of those with type 1 diabetes; the blood-pressure target of 140/80 mmHg was achieved by 60.7% and 69.3% of people with type 2 and type 1 diabetes, respectively. These results highlight that the revised QOF indicators for HbA1c and blood pressure could still prove hard for many patients to attain. Hopefully, the evolving NHS will allow novel and innovative ways of working to better provide the help and support for the most difficult-to-reach groups.
- The new indicators do much to align the QOF with NICE guidance, but do not mirror it exactly
- The relaxation of the glycaemic control target DM23 (now DM26) is likely to help reduce the prescription of expensive new medications and insulins for diabetes
- The tighter blood-pressure targets are unlikely to be a significant cost pressure as they reflect NICE guidance and most types of antihypertensive medication are now available as generics with low acquisition costs
- Local formularies can identify the most cost-effective drugs
- Practices could choose from the following as part of achieving the new national quality and productivity prescribing indicators for QOF:
- antidiabetic drugs prescribed as metformin and sulfonylureas
- insulins prescribed as detemir and glargine.
- Diabetes UK. Diabetes in the UK 2010: key statistics on diabetes. London: Diabetes UK, 2010.
- Diabetes UK. Reports and statistics. Diabetes prevalence 2006 (Oct 2006). www.diabetes.org.uk/Professionals/Publications-reports-and-resources/Reports-statistics-and-case-studies/Reports/Diabetes_prevalence_2006/
- Holman N, Forouhi N, Goyder E, Wild S. The Association of Public Health Observatories (APHO) diabetes prevalence model: estimates of total diabetes prevalence for England, 2010–2030. Diabet Med 2011; 28 (5): 575–582.
- Coppell K, Anderson K, Williams S et al. The quality of diabetes care: a comparison between patients enrolled and not enrolled on a regional diabetes register. Prim Care Diabetes 2011; 5 (2): 131–137.
- British Medical Association. NHS Employers. Quality and outcomes framework guidance for GMS contract 2011/12. London: BMA, NHS Employers, 2011. Available at: www.bma.org.uk/employmentandcontracts/independent_contractors/quality_outcomes_framework/qofguidance2011.jsp
- National Institute for Health and Care Excellence. Type 2 diabetes: newer agents. Clinical Guideline 87. London: NICE, 2009. Available at: www.nice.org.uk/guidance/CG87
- Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein H, Miller M, Byington R et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358 (24): 2545–2559.
- Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein H, Miller M, Genuth S et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med 2011; 364 (9): 818–828.
- ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358 (24): 2560–2572.
- Rosenstock J. Management of type 2 diabetes mellitus in the elderly: special considerations. Drugs Aging 2001; 18 (1): 31–44.
- Schweizer A, Dejager S, Foley J et al. Clinical experience with vildagliptin in the management of type 2 diabetes in a patient population ?75 years: a pooled analysis from a database of clinical trials. Diabetes Obesity Metab 2011; 13 (1): 55–64.
- Desouza C, Salazar H, Cheong B et al. Association of hypoglycemia and cardiac ischemia: a study based on continuous
monitoring. Diabetes Care 2003; 26 (5): 1485–1489.
- Whitmer R, Karter A, Yaffe K et al. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009; 301 (15): 1565–1572.
- Holman R, Paul S, Bethel M et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359 (15): 1577–1589.
- UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317 (7160): 703–713.
- UK Prospective Diabetes Study Group. Long-term follow-up after tight control of blood pressure in type 2 diabetes N Engl J Med 2008; 359 (15): 1565–1576.
- ACCORD Study Group, Cushman W, Evans G, Byington R et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362 (17): 1575–1585.
- The National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical guideline for management in primary and secondary care (update). London: Royal College of Physicians, 2008. Available at: www.nice.org.uk/guidance/CG66
- Daousi C, MacFarlane I, Woodward A et al. Chronic painful neuropathy in an urban community: a controlled comparison of people
with and without diabetes. Diabet Med 2004; 21 (9): 976–982.
- Jain R, Jain S, Raison C, Maletic V. Painful diabetic neuropathy is more than pain alone: examining the role of anxiety and depression as mediators and complicators. Curr Diab Rep 2011; May 25 (Epub ahead of print).
- National Institute for Health and Care Excellence. Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings. Clinical Guideline 96. London: NICE, 2010. Available at: www.nice.org.uk/guidance/CG96
- The NHS Information Centre, National Diabetes Audit Executive Summary. National diabetes audit executive summary 2009–2010. The NHS Information Centre for Health and Social Care, 2011. Available at: www.ic.nhs.uk/nda G