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NICE guidelines: The development process

Roger Gadsby

NICE has been very active in producing guidelines for diabetes over the past 5 years. In 2004 it published a clinical guideline on the prevention and management of foot problems, the guideline on type 1 diabetes in adults was published, as was a separate guideline on type 1 diabetes in children and young people. (NICE, 2004a; 2004b; 2004c). In March 2008 the guideline on diabetes and pregnancy was published and in May 2008 the updated guideline on type 2 diabetes was published (NICE, 2008a; 2008b).

The NICE process
When NICE commissions a guideline the work to find the evidence is undertaken by one of the national collaborating centres set up to do this. The guideline on type 2 diabetes was produced by the National Collaborating Centre for Chronic Disease at the Royal College of Physicians.

Information specialists working for the collaborating centre find and appraise the evidence which is then assessed by the Guideline Development Group (GDG) which draws up recommendations. The GDG is made up of healthcare professionals and lay representatives with an interest in the subject. Specific health economic analyses are undertaken to underpin the development of some recommendations. Once the guideline has been written in draft form it is published for stakeholder comments. These comments are then assessed and answered and the final guideline is published.

Versions of each guideline
Each guideline is published in four versions.

  • The NICE guidance, which is usually around 20–40 pages, containing all the recommendations.
  • A version of this in non-technical language for patients and carers.
  • A quick reference guide, which is usually a four-page summary – sent to every health professional in the UK.
  • A full version containing details of how the recommendations were developed and the evidence assessments on which they were based. This is usually several hundred pages long, and is published by the centre involved in its development.

Strengths of the process
The process is transparent, detailed and exhaustive. It is held in high regard by other countries who often look to NICE guidelines as the ‘gold standard’. While people may not be happy with some of the recommendations, the evidence base and the reasoning of the GDG is clearly stated in each full guideline.

Weaknesses of the process
It is a very long and time consuming process. On average it may take 12–18 months to review the evidence and write the draft guideline. There is a fixed time for the ‘evidence cut-off’. For the updated type 2 diabetes guideline this was the end of May 2007. The draft guidance was published in October 2007 for consultation and the final guideline published in May 2008, one year after the evidence cut-off.

There are processes to review a guideline around 2 years after publication, but this may mean 3 years of new evidence has accumulated before an update is considered which could affect the recommendations, and mean some are out-of-date.

Rapid update of the glycaemic element of the guideline
The evidence cut-off in May 2007 meant that issues around the possible increased risks of myocardial infarction associated with rosiglitazone were not covered in detail by the GDG, nor were the DPP-IV inhibitors. Insulin detemir was not covered either. A rapid update is being undertaken to update and expand the section on second- and third-line management of blood glucose control. In order to achieve this, the evidence on thiazolidinediones, exenatide and insulin glargine will be reconsidered. The update  will include insulin detemir, sitagliptin, vildagliptin and liraglutide, subject to these agents being licensed for use. A new GDG is being formed which will work during 2008 for a publication of this update in 2009.

Implementation of NICE guidelines
NICE has a group looking at implementation of guidelines. There has been a specific implementation guideline for diabetic foot problems, which gives details of which services should be commissioned to help ensure that recommendations are implemented. The QOF is, clearly, one of the major factors in the delivery of care, and evidence outlined in NICE guidelines underpin the clinical indicators for the QOF. The targets for blood pressure, cholesterol and HbA1c in the updated type 2 diabetes guideline differ from those of the QOF. This is understandable as the NICE targets are ‘aspirational’ whereas the QOF targets are audit standards for payment purposes.

NICE has been very active in producing guidelines for diabetes over the past 5 years. In 2004 it published a clinical guideline on the prevention and management of foot problems, the guideline on type 1 diabetes in adults was published, as was a separate guideline on type 1 diabetes in children and young people. (NICE, 2004a; 2004b; 2004c). In March 2008 the guideline on diabetes and pregnancy was published and in May 2008 the updated guideline on type 2 diabetes was published (NICE, 2008a; 2008b).

The NICE process
When NICE commissions a guideline the work to find the evidence is undertaken by one of the national collaborating centres set up to do this. The guideline on type 2 diabetes was produced by the National Collaborating Centre for Chronic Disease at the Royal College of Physicians.

Information specialists working for the collaborating centre find and appraise the evidence which is then assessed by the Guideline Development Group (GDG) which draws up recommendations. The GDG is made up of healthcare professionals and lay representatives with an interest in the subject. Specific health economic analyses are undertaken to underpin the development of some recommendations. Once the guideline has been written in draft form it is published for stakeholder comments. These comments are then assessed and answered and the final guideline is published.

Versions of each guideline
Each guideline is published in four versions.

  • The NICE guidance, which is usually around 20–40 pages, containing all the recommendations.
  • A version of this in non-technical language for patients and carers.
  • A quick reference guide, which is usually a four-page summary – sent to every health professional in the UK.
  • A full version containing details of how the recommendations were developed and the evidence assessments on which they were based. This is usually several hundred pages long, and is published by the centre involved in its development.

Strengths of the process
The process is transparent, detailed and exhaustive. It is held in high regard by other countries who often look to NICE guidelines as the ‘gold standard’. While people may not be happy with some of the recommendations, the evidence base and the reasoning of the GDG is clearly stated in each full guideline.

Weaknesses of the process
It is a very long and time consuming process. On average it may take 12–18 months to review the evidence and write the draft guideline. There is a fixed time for the ‘evidence cut-off’. For the updated type 2 diabetes guideline this was the end of May 2007. The draft guidance was published in October 2007 for consultation and the final guideline published in May 2008, one year after the evidence cut-off.

There are processes to review a guideline around 2 years after publication, but this may mean 3 years of new evidence has accumulated before an update is considered which could affect the recommendations, and mean some are out-of-date.

Rapid update of the glycaemic element of the guideline
The evidence cut-off in May 2007 meant that issues around the possible increased risks of myocardial infarction associated with rosiglitazone were not covered in detail by the GDG, nor were the DPP-IV inhibitors. Insulin detemir was not covered either. A rapid update is being undertaken to update and expand the section on second- and third-line management of blood glucose control. In order to achieve this, the evidence on thiazolidinediones, exenatide and insulin glargine will be reconsidered. The update  will include insulin detemir, sitagliptin, vildagliptin and liraglutide, subject to these agents being licensed for use. A new GDG is being formed which will work during 2008 for a publication of this update in 2009.

Implementation of NICE guidelines
NICE has a group looking at implementation of guidelines. There has been a specific implementation guideline for diabetic foot problems, which gives details of which services should be commissioned to help ensure that recommendations are implemented. The QOF is, clearly, one of the major factors in the delivery of care, and evidence outlined in NICE guidelines underpin the clinical indicators for the QOF. The targets for blood pressure, cholesterol and HbA1c in the updated type 2 diabetes guideline differ from those of the QOF. This is understandable as the NICE targets are ‘aspirational’ whereas the QOF targets are audit standards for payment purposes.

REFERENCES:

NICE (2004a) Management of type 2 diabetes: Prevention and management of foot problems. NICE, London
NICE (2004b) Type 1 diabetes: Diagnosis and management of type 1 diabetes in adults. NICE, London
NICE (2004c) Type 1 diabetes: Diagnosis and management of type 1 diabetes in children and young people. NICE, London
NICE (2008a) Diabetes in pregnancy: Management of diabetes and its complications from pre-conception to the postnatal period. NICE, London
NICE (2008b) Type 2 diabetes: the management of type 2 diabetes (update). NICE, London

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