Appraisal Consultation Document: Patient-education models for diabetes

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Appraisal Consultation Document

Patient-education models for diabetes

The Department of Health and the Welsh Assembly Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of patient-education models for diabetes and provide guidance on their use to the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of patient-education models for diabetes.

This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website).

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.

The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).

  • The Appraisal Committee will meet again to consider the original evidence and this Appraisal Consultation Document in the light of the views of the formal consultees.
  • At that meeting, the Committee will also consider comments made on the document by people who are not formal consultees in the appraisal process.
  • After considering feedback from the consultation process, the Committee will prepare the Final Appraisal Determination (FAD) and submit it to the Institute.
  • Subject to any appeal by consultees, the FAD may be used as the basis for the Institute's guidance on the use of the appraised technology in the NHS in England and Wales.

The key dates for this appraisal are:

Closing date for comments:Monday 2 December 2002
Second Appraisal Committee meeting: Thursday 9 January 2003

Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B.

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.
1 Appraisal Committee's preliminary views
   
1.1 It is recommended that structured patient education is made available to all people with diabetes at the time of initial diagnosis and then as required on an on-going basis, based on a formal, regular assessment of need.
1.2

There is insufficient evidence to be able to recommend specific types of education or provide guidance on the setting for or frequency of sessions. However, some principles of good practice are clear:

  • education should be provided by an appropriately trained multidisciplinary team to groups of people with diabetes, unless group work is considered unsuitable for an individual
  • sessions should be held in a location accessible to individuals, either in the community or a local diabetes centre
  • educational programmes should use a variety of teaching techniques, adapted wherever possible to meet the different needs, personal choices and learning styles of people with diabetes, and should be integrated into routine diabetes care over the longer term.
1.3 Multidisciplinary teams providing education should include, as a minimum, a diabetes specialist nurse and a dietitian. Although not formally assessed in this appraisal, input from other disciplines, such as podiatry, is recognised to be of potential value. The composition of the team and the way that members interact may vary between programmes but team functioning should be tailored to the needs of different groups of people with diabetes.
   
1.4 It is considered that the Dose Adjustment for Normal Eating (DAFNE) programme is a suitable option for individuals with type 1 diabetes, being one means of enabling people to self-manage their type 1 diabetes through an intensive, multi-dose insulin regimen that involves adjustment of insulin dose to match carbohydrate intake and lifestyle on a meal-by-meal basis.
   
1.5 It is recommended that patient-education models, particularly those for people with type 2 diabetes, are evaluated further in clinical trials in order to determine the characteristics, in terms of type, length and frequency of intervention, team composition and setting, that would maximise the impact of patient education in both the short and longer terms. Such trials should include qualitative evaluation of the educational intervention itself.



2 Clinical need and practice
   
2.1 Diabetes is a chronic metabolic disorder caused by defects in insulin secretion and action. There are two major types of diabetes: type 1 and type 2.
   
2.2 In type 1 diabetes, the pancreas makes little or no insulin because the islet b cells, which produce insulin, have been destroyed through an autoimmune mechanism. Therefore, people with type 1 diabetes usually depend on daily insulin injections to survive.
   
2.3 Type 2 diabetes results from failure of insulin production to overcome reduced tissue sensitivity to insulin (known as insulin resistance). Type 2 diabetes is a progressive disease in which insulin production declines as the disease progresses.
   
2.4 The age-standardised prevalence of diagnosed diabetes is estimated to be 2.23 per 100 males and 1.64 per 100 females. There are just over 1 million people in England and Wales with diagnosed diabetes. Of these, about 80% have type 2 diabetes (750,000 in England and 50,000 in Wales). The incidence of diabetes has been estimated at 1.7 new diagnoses per 1000 population per year (around 85,000 per year in England and 5000 per year in Wales).
   
2.5 An impaired insulin effect results in increased levels of glucose in the blood (hyperglycaemia), which can, if prolonged, cause microvascular and macrovascular damage in the body. Common complications of diabetes include visual impairment, kidney failure, angina, myocardial infarction, stroke, foot ulceration and erectile dysfunction.
   
2.6 Two large landmark studies, the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), have demonstrated the beneficial effects of maintaining good glycaemic control on the development and progression of diabetic complications in type 1 and type 2 diabetes respectively.
   
2.7 The principal goals of treatment for diabetes are to prevent acute and late complications and thus improve quality of life and avoid premature diabetes-associated death. These goals may be achieved through better control of blood glucose levels and through reductions in other macrovascular risk factors including high blood pressure.
   
2.8

In the assessment of diabetes management, the most important outcome measures are:

  • fasting blood/plasma glucose levels
  • target blood glucose levels as measured by glycated haemoglobin (HbA1 and HbA1c), which gives an indication of blood glucose control over the previous 2-3 months - lower values represent better glucose control; the target should reflect individual needs, but HbA1c levels of between 6.5% and 7.5% are generally recommended
  • the prevention of acute episodes of hypoglycaemia and hyperglycaemia
  • a reduction in other macrovascular risk factors, such as dyslipidaemia, high blood pressure, smoking and obesity
  • short-term quality of life, adverse events and treatment tolerance
  • long-term effects on the incidence of diabetic complications, quality of life and mortality

Other relevant outcomes for educational interventions include diabetes-related knowledge, motivation and improvement in anxiety or depression, although many of these outcomes have not been formally or consistently measured in trials undertaken to date.

   
2.9 Insulin is the mainstay of treatment for type 1 diabetes. Type 2 diabetes can usually be managed through diet and exercise alone, at least in the early stages. However, it is a progressive disease, and nearly all individuals require oral antidiabetic drugs after some time. Many people with type 2 diabetes eventually need insulin to maintain satisfactory blood glucose levels. Current treatment guidelines recommend a 'step-up' policy, starting with advice on diet and exercise, adding oral antidiabetic agents, first as monotherapy and then in combination, and finally using insulin if blood glucose control deteriorates.
3 The technology
   
3.1 Education is considered to be a fundamental part of diabetes care. People with diabetes, whether they are using insulin or other means of achieving glycaemic control, have to assume responsibility for the day-to-day control of their diabetes. It is therefore critical that they understand the condition and know how to treat it, whether this is through understanding either the basis of insulin replacement therapy and how to use it optimally or how to manage their own lifestyle, including areas related to nutrition and physical activity. The aim of education for people with diabetes is to improve their knowledge and skills, enabling them to take control of their own condition and to integrate self-management into their daily lives. The ultimate goal of education is to improve: control of vascular risk factors, including blood glucose, blood lipids and blood pressure; the management of diabetes-associated complications if and when they develop; and quality of life.
   
3.2 The National Service Framework for Diabetes proposes a "supported self care service model" for diabetes and recognises the importance of education in facilitating self-management as the cornerstone of diabetes care. In addition, the expert patient programme initiative, which is now being piloted in over 50 primary care trusts, involves the introduction and evaluation of self-management training programmes for people living with long-term medical conditions including diabetes.
   
3.3 Most people with diabetes in England and Wales are offered education, at least at the time of their diagnosis. However, the length, content and style of educational options varies greatly between services; some of the educational programmes offered are unstructured, very few have been formally evaluated, and few individuals who deliver education have been formally trained for this purpose.
   
3.4 Dose Adjustment for Normal Eating (DAFNE) is a structured educational programme for people with type 1 diabetes that teaches individuals to adjust their insulin to match carbohydrate intake and lifestyle on a meal-by-meal basis, thereby allowing them dietary freedom. It is currently available in a number of diabetes centres across England as part of a national evaluation project. The programme consists of 5 days of intensive training delivered to groups of six to eight individuals on an outpatient basis. The programme is based on the Diabetes Treatment and Teaching Programmes, developed in Europe in the 1970s, and often referred to as the Geneva-Düsseldorf model of education.
   
3.5 The cost of patient education for diabetes depends on the type of programme offered. Current estimates of cost range from £66 per person attending a diabetes-centre-based teaching programme spread over 3 afternoons, to £545 for DAFNE.
4 Evidence and interpretation
   
  The Appraisal Committee considered evidence from a number of sources (see Appendix B).
   
4.1 Clinical effectiveness
   
4.1.1 Education for people with type 1 diabetes
   
4.1.1.1
Four studies were found: two randomised controlled trials (RCTs) and two controlled clinical trials (CCTs). Three of the studies tested the effect of intensified insulin treatment that included an educational component, and the other assessed the effect of education alone. The aim of intensified insulin treatment was to help individuals learn how to self-treat with generally more frequent insulin doses that were specifically related to variations in energy consumption and energy demands. The two CCTs were based on the Geneva-Düsseldorf model of patient education.
 
4.1.1.2
The trial of education alone, one of the RCTs, showed no significant difference in glycated haemoglobin HbA1, although the trial was very small (n = 37). The second RCT, the Swedish Diabetes Intervention Study (SDIS), showed a significant difference in HbA1c between groups after the 7.5?year study period and at 10?year follow-up. HbA1c levels in the intensified treatment group were 2.4% and 2.3% lower than at the start of the study (at 7.5 and 10 years, respectively); in the control group, the mean HbA1c values had decreased by 0.9% and 1.1% after 7.5 and 10 years, respectively. To put this in context, a 0.5% reduction in HbA1c can reduce long-term complications by 15-20%. The intensive-insulin-intervention groups in the two CCTs had lower levels of HbA1 at the end of the studies than the control groups (9.3% vs 12.8%, p < 0.01; 9.4% vs 12.3%, no p value provided).
   
4.1.1.3
There is evidence from the studies to suggest that severe hypoglycaemic events may be more frequent among people receiving intensified treatment, although there were apparently fewer incidents of ketoacidosis and hospitalisations among this group. Longer-term complications were reported in the SDIS study, with the intensive-insulin group experiencing fewer cases of retinopathy, nephropathy and neuropathy at the end of the study (though for neuropathy, the difference was not significant). The two CCTs assessed knowledge of diabetes and this was found to be higher in the intervention groups at the end of the studies (32 vs 24, p < 0.01; 25 vs 11, p value not provided). While increased knowledge of diabetes may reflect better ability to self-manage, there is little evidence that knowledge alone predicts better metabolic outcomes.
 
4.1.1.4
The study of DAFNE in the UK (see Section 3.4) did not meet the inclusion criteria for the Assessment Group's systematic review as there was only a concurrent control group for the first 6 months, after which time the members attended a 'delayed DAFNE' training course. However, the results of the study show that HbA1c levels fell by 1% in the first 6 months in the initial DAFNE group, and remained 0.5% lower than baseline at 12 months (p = 0.004). HbA1c levels in the control group remained constant for the first 6 months but were 0.7% lower than baseline at 12 months (that is, 6 months after the group had attended the DAFNE training course). There was no evidence to suggest that improved glycaemic control was achieved at the expense of an increase in episodes of severe hypoglycaemia. However, it should be noted that one participant in the DAFNE group was "found dead in bed" 6 months after the course; such a death is usually assumed to relate to a hypoglycaemic event. Quality of life improved significantly after DAFNE training, with 77% of patients recording an improvement in well-being and 95% recording an improvement in satisfaction with treatment.
 
4.1.1.5
In summary, only one study of a purely educational intervention was found and this did not demonstrate any beneficial effects of education, although the sample size was very small. The other three studies reviewed and the results from the DAFNE study suggest that intensive insulin treatment is effective in reducing HbA1c and complications, both in the short and long term, albeit at the possible expense of increased hypoglycaemic episodes in some individuals.
   
4.1.2 General self-management education for type 2 diabetes
   
4.1.2.1
Eight trials - six RCTs and two CCTs - were found which focused on educating individuals about a wide range of components of self-management for type 2 diabetes.
   
4.1.2.2
Only three of the studies, all RCTs, reported significant differences in HbA1c level between the intervention and control groups, with education either reducing or preventing deterioration in HbA1c levels. These three studies involved education delivered over a long period of time and therefore had the shortest time between the end of the intervention and follow-up; this overall pattern of results suggests that effects may not be long lasting, that education should be delivered over long intervals or both.
 
4.1.2.3
Significant differences in body mass index (BMI) or weight loss in favour of the education group were reported in four studies. Both CCTs reported significant differences in the use of medications, with fewer people in the education group receiving insulin or hypoglycaemic drugs at the end of the studies. Few studies recorded outcomes reflecting diabetic endpoints, and those that did showed no significant differences, although follow-up periods were too short to allow meaningful results to be obtained. Only one study reported on quality of life using a validated scale; here, quality of life was found to improve in the education group, while deteriorating in the control group. Three studies reported results for diabetes knowledge and two of these demonstrated significantly better knowledge in the intervention groups.
 
4.1.2.4
In summary, the evidence suggests that general self-management education has only a limited impact on clinical outcomes, although little long-term data were available. The effect of education on glycaemic control was more evident for longer-term interventions with shorter follow-up periods.
   
4.1.3 Focused self-management education for people with type 2 diabetes
   
4.1.3.1
Eight trials were found - seven RCTs and one CCT - which focused on one or two aspects of self-management (for example, diet and/or exercise). One RCT compared a diet intervention with a weight-loss intervention; as there were no differences in outcomes between the groups, it was not discussed further in the Assessment Report.
 
4.1.3.2
Two trials combining exercise with dietary education reported significant differences in levels of HbA1c compared with the control groups (p < 0.05 in both); in one trial, this effect was relatively long lasting (18 months). One other study combining education on diet with exercise found a significant difference in the percentage of people with HbA1c at or less than 7.0% in favour of the intervention group (p < 0.05).
 
4.1.3.3
Of the studies that reported the following outcomes, no significant differences were found in blood pressure (except in the CCT), BMI or weight, or cholesterol and triglyceride levels. One study reported significantly fewer individuals taking glucose-lowering drugs in the intervention group, whereas another study reported no significant decreases in medication use between individuals trained in weight control and those trained in self-monitoring. Only one study reported on quality of life using a validated measure, and this showed quality of life was significantly better in the group taking exercise and receiving dietary education (p < 0.05).
 
4.1.3.4
In summary, the evidence suggests that focused self-management education may have some effect in reducing or maintaining HbA1c levels, but has limited impact on other clinical outcomes.
   
4.1.4 Education for people with type 1 or type 2 diabetes
   
4.1.4.1
Four trials of educational interventions - three RCTs and one CCT - were found that included people with type 1 or type 2 diabetes.
 
4.1.4.2
Two studies reported significantly lower HbA1c levels in the education groups compared with the control groups at the end of the study, although there were no significant differences between the different education groups in either of these studies (intensive group education vs passive education through provision of written materials; education vs education plus social support).
 
4.1.4.3
One study focused on diet and reported no significant differences in BMI, although cholesterol levels were significantly lower in the education group. The other studies did not report on other clinical outcomes. Only one study reported on quality of life using a validated measure, and this showed quality of life was significantly better in a group receiving education and social support compared with an education-only group (p < 0.05) and a usual care group (p < 0.01). Knowledge of diabetes was assessed in two studies, and both suggested that interventions (education in one study, education and support in the other) significantly improved knowledge scores.
 
4.1.4.4
In summary, the results of these studies are similar to those that report results for type 1 and type 2 diabetes separately. There is some evidence to suggest that education may improve glycaemic control and quality of life, but little evidence about the longer-term benefits of education.
   
4.2 Cost effectiveness
   
4.2.1 Two published economic evaluations were found; both were from the USA and both were limited in their applicability and generalisability. The DAFNE Study Group submission included a detailed cost-utility analysis of DAFNE. The Assessment Group did not develop their own cost-effectiveness model but re-analysed the DAFNE model using more conservative assumptions.
   
4.2.2 Of the published evaluations, one found that a behavioural intervention addressing diet plus exercise was more cost effective than a general educational intervention in adults with type 2 diabetes, with significant improvements in quality of life at a cost of $10,870 per well year (calculated at 1986 prices). The other evaluation found that dietary self-management improved intermediate health outcomes (dietary fat consumption, saturated fat consumption, serum cholesterol) compared with usual care in adults with both type 1 and type 2 diabetes at a cost of $137 per participant.
   
4.2.3 The DAFNE cost-utility analysis compares DAFNE to conventional treatment in people with type 1 diabetes over a 10-year period. Improved metabolic control, as measured by HbA1c, is assumed to delay the onset of microvascular complications, but is conservatively assumed to have no effect on macrovascular disease. HbA1c levels are based on European trial data and are assumed to reduce by 0.9% with DAFNE sustained over a 4-year period, reducing to 0.26% thereafter. Utility values are based on those from the CODE-2 study of people with type 2 diabetes and are adjusted for patient characteristics and complications. However, the validity of extrapolating utility values from people with type 2 diabetes to those with type 1 diabetes is uncertain.
   
4.2.4 The results of the model suggest that DAFNE dominates conventional treatment (that is, it is associated with more quality-adjusted life years (QALYs) [0.11] and a net cost saving over 10 years [£2679]). DAFNE becomes cost saving after 4 years, and the results are robust to the sensitivity analyses undertaken.
   
4.2.5 The Assessment Group re-analysed the DAFNE model using more conservative assumptions, including: no effect of DAFNE on ketoacidosis; no difference in outpatient reviews; initial reduction in HbA1c of 0.53%; reduced annual probability of progression to end-stage renal disease; and reduced annual probability of first amputation. Based on these assumptions, DAFNE still dominates conventional treatment, but the net benefits (0.063 QALYs) and net cost savings (£536) are reduced.
   
4.2.6 In summary, DAFNE, and the intensified insulin treatment it inherently involves, appears to be cost effective. There is very little evidence regarding the cost effectiveness of patient education in general, but given the relatively small costs associated with educational programmes, only small improvements in terms of morbidity or health-related quality of life are needed to make educational interventions cost effective.
   
4.3 Consideration of the evidence
   
4.3.1 The Committee reviewed the evidence available on the clinical and cost effectiveness of patient-education models for diabetes, having considered evidence from people with diabetes, those who represent them, and clinical experts, on the nature of the condition and the value placed by users on the benefits of educational opportunities. It was also mindful of the need to ensure that its advice took account of the efficient use of NHS resources.
   
4.3.2 The Committee noted that many of the reviewed studies were hampered by practical limitations, were underpowered and rarely met the standards for high-quality RCTs. Length of follow-up was generally too short to detect differences in the rates of diabetic complications, and the number of withdrawals was high in many studies. The majority of studies were carried out in white British or North American populations, and there are few trials in other ethnic groups. The Committee also noted the significant number of trials that did not meet the inclusion criteria for this appraisal but that have been included in other published systematic reviews. Many of these trials did not include a control group or did not impose a requirement for long-term follow-up. In addition, the Committee noted the lack of published evidence regarding the cost effectiveness of patient-education models for diabetes and, in particular, the lack of quality-of-life information available.
   
4.3.3 Despite the limitations of the studies, the Committee was convinced of the importance of patient education in helping to improve glycaemic control and quality of life, while reducing the rate of complications associated with diabetes. The Committee also recognised that, given the relatively small costs of education, only small improvements in terms of morbidity or quality of life would be needed to make educational programmes cost effective.
   
4.3.4 On the balance of the evidence available, the Committee concluded that all individuals with diabetes should be offered structured patient education at the time of initial diagnosis and as required on an on-going basis, based on a formal, regular assessment of need. In this context, structured patient education is defined as being a planned and graded programme of education that is comprehensive in scope, flexible in content, responsive to an individual's clinical and psychological needs, and adaptable to his or her educational and cultural background.
   
4.3.5

The Committee noted that the lack of a consistent relationship between outcomes and type, length and frequency of intervention, team composition, and setting, particularly in studies involving people with type 2 diabetes, made it difficult to identify the characteristics that would make an educational programme successful. It was therefore unable to provide recommendations on specific approaches to education. However, the Committee was convinced by the anecdotal evidence supporting:

  • a multidisciplinary approach to education with appropriate training provided to the educators
  • the use of group education sessions which enable individuals to serve as support for one another, and are generally less costly and allow staff to use the time they devote to patient education more efficiently
  • the provision of educational opportunities in an accessible location, which could include both community- and diabetes-centre-based settings
  • the value of educational programmes based on a variety of learning techniques, adapted to meet the varying needs of people with diabetes and integrated into routine diabetes care over the longer term.

In order to determine the characteristics that would maximise the impact of patient education, further evaluation in clinical trials and qualitative studies is recommended.

   
4.3.6 The Committee considered the DAFNE programme to be one means by which people with type 1 diabetes can manage their diabetes, and that it would be particularly useful for those in whom an intensive, multi-dose insulin regimen is being used or considered. Although the DAFNE study did not meet the inclusion criteria for the systematic review, the Committee noted that the study was specifically designed to test the feasibility of introducing the Geneva-Düsseldorf model of education into the UK setting. As such, the DAFNE study meets the good practice criteria set out by the Medical Research Council for the evaluation of complex interventions.
5 Proposed recommendations for further research
   
5.1 The DAFNE evaluation has been expanded and extended for a further 12 months to include seven more centres and up to 1000 participants, with the aim of learning more about implementation issues across the NHS. Work is also under way to develop a new DAFNE programme for children with type 1 diabetes and for adults with type 2 diabetes.
   
5.2 The paucity of high-quality trials of the effectiveness of patient-education models for diabetes reveals a need for more research. Further research should involve RCTs with designs based on explicit hypotheses and educational theory and that include a range of outcomes evaluated after long follow-up intervals. Further qualitative research should be used to identify the characteristics of education that are most important for different stages of the disease and that best match different cultural and social needs.
6 Preliminary views on the resource impact for the NHS
   
  This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible.
   
6.1 Successful implementation of structured educational programmes will depend on the availability of an appropriately trained workforce. Evidence submitted to the Committee suggests that there is a shortage of both diabetes specialist nurses and dietitians. There will also be a need for rigorous training for all educators in the principles of both diabetes and education, and while some accredited training programmes exist, others will need to be developed. To enable future developments in patient education to be fully evaluated, trusts need to establish robust audit and quality-assurance processes.
   
6.2 The impact of patient education for diabetes on the NHS budget will depend on the epidemiology of the target population and the cost of the educational programme offered. For type 2 diabetes, the impact of this guidance will vary at a local level depending on the extent to which structured education programmes are already available. Although there are significant numbers who are eligible for education, the cost of providing group education is relatively inexpensive and would be offset by reduced healthcare costs brought about by improved glycaemic control.
   
6.3

In the submission from the DAFNE study group, it is estimated that 113,500 and 6700 people with type 1 diabetes in England and Wales respectively would be suitable for DAFNE, with a further 5513 and 324 newly diagnosed patients becoming eligible each year. These figures are based on the following assumptions:

  • a prevalence rate of type 1 diabetes of 0.366 per 100 people and an incidence rate of 0.017 per 100 people
  • 80% of people with type 1 diabetes being suitable for DAFNE
  • an adult population of 38.7 million and 2.3 million in England and Wales respectively.
   
6.4

The budget impact calculation also makes the following assumptions:

  • the 'stock' of eligible people will be trained within 10 years
  • each of the ten existing DAFNE centres can train a further 1.5 new centres each year
  • each centre trains 120 patients per year
  • each centre costs £64,500 per year to run, with an initial capital investment of £9000.
6.5 The results suggest that in England,160 centres could be established by 2005 to train those people who are currently eligible, with 46 centres required from 2014 to maintain a steady state of provision. The maximum cumulative capital required would be £19 million in 2006/7. The roll out would be self-financing by 2009 and would potentially generate savings of £500 million by 2020. In Wales, nine centres could be established by 2006 to train those people who are currently eligible, with three centres required from 2015 to maintain a steady state. The maximum cumulative capital required would be £1 million in 2007/8. The roll out would be self-financing by 2010 and would potentially generate savings of £28 million by 2020.
7 Proposals for implementation and audit
   
  This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1.
   
7.1 NHS organisations and all clinicians who provide care for people with diabetes, including general practitioners, practice nurses, consultants treating people with diabetes, diabetes specialist nurses and dietitians, should review local practice and policies regarding education for people with diabetes to take account of the guidance set out in Section 1.
   
7.2 Local guidelines or care pathways that refer to the care of people with diabetes should incorporate the guidance in Section 1.
   
7.3 NHS Trusts, Local Health Groups and general practices should ensure that responsibility is clearly defined for offering and providing educational programmes for people with diabetes and for considering referral of people with type 1 diabetes to the DAFNE programme.
   
7.4

Arrangements should be made in NHS organisations for:

  • multidisciplinary teams, including at least a diabetes specialist nurse and a dietitian, to be available to provide structured education for people with diabetes
  • the teams to receive appropriate training
    - in the use of a variety of teaching techniques to meet the different needs, personal choices and learning styles of people with diabetes
    - in the assessment of individuals' learning needs
  • sessions to be provided to groups of individuals in an accessible location.
 
7.5
To measure compliance locally with the guidance, the following criteria can be used. Further details on suggestions for audit are presented in Appendix C.
 
7.5.1

A person who is initially diagnosed as having diabetes is offered structured education that is:

  • provided by an appropriately trained multidisciplinary team
  • provided to groups of people with diabetes, unless group work is considered unsuitable for an individual
  • held in a location accessible to individuals who want to participate
  • based on the use of a variety of teaching techniques
  • integrated into routine diabetes care over the long term.
7.5.2
A person with diabetes is assessed formally and regularly for his or her needs for education on managing diabetes and further education that is consistent with the specifications in 7.5.1 is offered to meet the needs identified.
 
7.5.3
The DAFNE programme is considered as an option for a person with type 1 diabetes.
   
7.6 Local clinical audits on the care of people with diabetes could also include criteria for the management of diabetes based on the standards in the National Service Framework for Diabetes.
8 Related guidance
   
8.1

The Institute has issued guidance on the use of rosiglitazone and pioglitazone for diabetes. All issued guidance and details of appraisals and guidelines in progress are available on the NICE website (www.nice.org.uk).

  • National Institute for Clinical Excellence (2000) Guidance on rosiglitazone for type 2 diabetes mellitus. NICE Technology Appraisal Guidance No. 9. London: National Institute for Clinical Excellence.
  • National Institute for Clinical Excellence (2001) Guidance on the use of pioglitazone for type 2 diabetes mellitus. NICE Technology Appraisal Guidance No. 21. London: National Institute for Clinical Excellence.
   
8.2

The Institute is also publishing a series of guidelines on the management of type 2 diabetes:

  • National Institute for Clinical Excellence (2002) Management of type 2 diabetes: retinopathy - screening and early management. Inherited Clinical Guideline E. London: National Institute for Clinical Excellence.
  • National Institute for Clinical Excellence (2002) Management of type 2 diabetes: renal disease - prevention and early management. Inherited Clinical Guideline F. London: National Institute for Clinical Excellence.
  • National Institute for Clinical Excellence (2002) Management of type 2 diabetes: management of blood glucose. Inherited Clinical Guideline G. London: National Institute for Clinical Excellence.
  • National Institute for Clinical Excellence (2002) Management of type 2 diabetes: management of blood pressure and blood lipids. Inherited Guideline H. London: National Institute for Clinical Excellence.
8.3

The following technology appraisals and clinical guidelines are part of the Institute's ongoing work programme:

  • technology appraisal on long-acting insulin analogues: due to be issued late 2002
  • technology appraisal on insulin pumps: due to be issued early 2003
  • clinical guideline on management of type 2 diabetes: foot care (update of an existing guideline published by the Royal College of General Practitioners): due to be issued late 2003
  • clinical guideline on type 1 diabetes: diagnosis and management of type 1 diabetes in primary and secondary care: due to be issued early 2004.
9 Proposed date for review of guidance
   
  The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review.
   
9.1 It is proposed that the guidance on this technology is reviewed in February 2006.
David Barnett
Chairman, Appraisal Committee
October 2002
Appendix A. Appraisal Committee members
 
NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chair, vice-chair and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches.
 
Committee members are asked to declare any interests in the technology to be appraised. If there is a conflict of interest, the member is excluded from participating further in that appraisal.
 
The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declaration of interests, are posted on the NICE website.
 
Dr Jane Adam
Radiologist, St. George's Hospital, London
 
Professor R L Akehurst
Dean, School of Health Related Research, Sheffield University
 
Dr Sunil Angris
General Practitioner, Waterhouses Medical Practice
 
Professor David Barnett (Chairman)
Professor of Clinical Pharmacology, University of Leicester
 
Professor Sir Colin Berry
Retired Professor of Morbid Anatomy & Histopathology, The Royal London Hospital
 
Dr Shiela Bird
MRC Biostatistics Unit, Cambridge
 
Professor John Brazier
Health Economist, University of Sheffield
 
Professor Rosamund Bryar
Professor of Comminity and Primary Care Nursing, St Bartholomew School of Nursing and Midwifery
 
Professor Martin Buxton
Director of Health Economics Research Group, Brunel University
 
Professor Mike Campbell
Statistician, Institute of General Practice & Primary Care, Sheffield
 
Dr Karl Claxton
Health Economist, University of York
 
Professor Sarah Cowley
Professor of Community Practice Development, Kings College, London
 
Dr Mike Davies
Consultant Physician, University Department of Medicine and Metabolism, The Manchester Royal Infirmary
 
Professor Jack Dowie
Health Economist, London School of Hygiene & Tropical Medicine, London
 
Dr Paul Ewings
Statistician, Taunton & Somerset NHS Trust
 
Professor Terry Feest
Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit, and Chairman of the UK Renal Registry
 
Professor Gary A Ford
Professor of Pharmacology of Old Age / Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust
 
Mrs Sue Gallagher
Former Chief Executive, Merton, Sutton and Wandsworth Health Authority
 
Dr Trevor Gibbs
Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline
 
Sally Gooch
Director of Nursing, Mid-Essex Hospital Services Trust
 
Mr John Goulston
Director of Finance, Barts and London NHS Trust
 
Professor Trisha Greenhalgh
Professor of Primary Health Care, University College London
 
Miss Linda Hands
Clinical Reader in Surgery, University of Oxford
 
Professor Philip Home
Professor of Diabetes Medicine, University of Newcastle
 
Dr Terry John
General Practitioner, The Firs, London
 
Ruth Lesirge
Lay Representative; previously Director, Mental Health Foundation
 
Dr George Levvy
Lay Representative; Chief Executive, Motor Neurone Disease Association
 
Dr Gill Morgan
Chief Executive, NHS Confederation
 
Professor Miranda Mugford
Health Economist, University of East Anglia
 
Mr M Mughal
Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust
 
Mr James Partridge
Lay Representative, Chief Executive, Changing Faces
 
Siân Richards
General Manager, Cardiff Local Health Board
 
Professor Philip Routledge
Professor of Clinical Pharmacology, University of Wales
 
Dr Rhiannon Rowsell
Medical and Regulatory Affairs Director, AstraZeneca UK Ltd
 
Dr Stephen Saltissi
Consultant Cardiologist, Royal Liverpool University Hospital
 
Professor Andrew Stevens (Vice-Chairman)
Professor of Public Health, University of Birmingham
 
Professor Ray Tallis
Consultant Physician, Hope Hospital, Salford
 
Dr Cathryn Thomas
General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham
 
Professor Mary Watkins
Professor of Nursing, University of Plymouth
 
Dr Norman Waugh
Senior Lecturer and Public Health Consultant, University of Southampton
 
Dr David Winfield
Consultant Haematologist, Royal Hallamshire Hospital
Appendix B. Sources of evidence considered by the Committee
 
The following documentation and opinion was made available to the Committee:
 
A.

Assessment Report prepared by the Southampton Health Technology Assessment Centre:

Patient education models for diabetes, 22 August 2002, Rapid Reviews Team, Southampton Health Technology Assessment Centre, University of Southampton

B.

Manufacturer/sponsor submissions from:

  • DAFNE study group
C.

Professional/specialist group submissions from::

  • British Dietetic Association
  • Diabetes UK
  • Guideline Development Group (ScHARR)
  • Primary Care Collaborating Centre, ScHARR, University of Sheffield
  • Royal College of Nursing
  • Royal College of Physicians (on behalf of Royal College of Physicians, the Specialist Care Section of Diabetes UK, and the Association of British Clinical Diabetologists)
D.

Expert perspectives from:

  • Dr Helen Cooper, Lecturer in Health Care Education, University of Liverpool
  • Dr John Day, Consultant Physician Emeritus, The Ipswich Hospital NHS Trust
  • Mr Tim Sanders, Patient Representative
  • Mrs Susan Dunnigan, Patient Representative
  • Dr Wendy Gatling, Consultant Physician, Poole Hospital NHS Trust
  • Mr Steven Sexton, Patient Representative
  • Mr Simon O'Neill, Patient Representative, Head of Care Developments, Diabetes UK
Appendix C. Detail on criteria for audit of the use of continuous subcutaneous insulin infusion for diabetes
 
Possible objective for an audit
 
An audit on patient education for diabetes could be carried out to ensure that structured education is offered to all people with diabetes.
 
Possible patients to be included in an audit
 
  • all people who are newly diagnosed with diabetes in a given time period, for example, in the last 6 months or year

  • a reasonable sample of people who have been previously diagnosed with diabetes; for example, 10% or 25% of people stratified by age group, either in a general practice or in a diabetes service offered by a specialist consultant or diabetes specialist nurse, who have had the diagnosis of diabetes for a specified time period (for example, 6 months or 1 year)

  • all people with type 1 diabetes currently registered in a general practice or being seen by a consultant specialising in diabetes.
Measure to be used as a basis for an audit
 
The measure that could be used in an audit of education for people who are newly diagnosed with diabetes is as follows.
Criterion Standard Exception Definition of Terms

1.The person is offered structured education that is consistent with all of the following:

a. provided by an appropriately trained multidisciplinary team

b. provided to a group of people with diabetes

c. held in a location that is accessible to the individuals involved

d. uses a variety of teaching techniquese. is integrated into routine diabetes care over the longer term.

e. is intergrated into routine diabetes care over the longer term.

100% of people newly diagnosed with diabetes. A. For 1b, group work is considered unsuitable for an individual.

For audit purposes, clinicians will have to agree locally on what constitutes structured education and how the offer of education to a person who has diabetes is documented.

A multidisciplinary team is defined as a minimum of a diabetes specialist nurse and a dietitian. The training required will have to be defined locally for audit purposes.

Teams will have to agree locally on the individuals for whom it is considered that group work is unsuitable, and how to audit whether a variety of teaching techniques is being used and whether education is being integrated into routine diabetes care over the longer term.

For audit purposes, the individuals involved should be asked if the location used for the structured education is accessible.

The measures that could be used in an audit of education for people who have previously been diagnosed with diabetes are as follows.

Criterion Standard Exception Definition of Terms
1. The person is assessed formally and regularly for his or her needs for education on managing diabetes.
100% of people who have an established diagnosis of diabetes. None. For audit purposes, clinicians will have to agree locally on what constitutes a formal assessment of a person's needs for education and how regularly the assessment is to be carried out.

2. The person is offered further structured education to meet his or her identified educational needs that is consistent with all of the following:

a. provided by an appropriately trained multidisciplinary team

b. provided to a group of people with diabetes

c. held in a location that is accessible to the individuals involved

d. uses a variety of teaching techniquese. is integrated into routine diabetes care over the longer term

e. is intergrated into routine diabetes care over the longer term.

100% of people who have an established diagnosis of diabetes. A. Formal, regular assessment has not identified any need for further education.

B. For 1b, group work is considered unsuitable for an individual.

For audit purposes, clinicians will have to agree locally on what constitutes structured education and how the offer of education to a person who has diabetes is documented.

A multidisciplinary team is defined as a minimum of a diabetes specialist nurse and a dietitian. The training required will have to be defined locally for audit purposes.

Teams will have to agree locally on the individuals for whom it is considered that group work is unsuitable, and how to audit whether a variety of teaching techniques is being used and whether education is being integrated into routine diabetes care over the longer term.

For audit purposes, the individuals involved should be asked if the location used for the structured education is accessible.

The measure that could be used in an audit of education for people with type 1 diabetes is as follows.

Criterion Standard Exception Definition of Terms
1. The person is considered for referral to a DAFNE programme. 100% of people with type 1 diabetes. A. The person is unable to participate in the programme.

B. There is no DAFNE programme currently available in the area.
For audit purposes, clinicians will have to agree locally on how consideration for referral to a DAFNE programme is documented.
Calculation of compliance with the measures
 
Compliance with the measure described in the table is calculated as follows:
 

Number of patients whose care is consistent with the criterion plus the number of patients who meet any exception

 

  X 100

Number of patients to whom the measure applies

 
 
 
 
Clinicians should review the findings of measurement, identify if practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.

This page was last updated: 30 March 2010

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.