NICE GUIDELINE: TYPE 2 DIABETES Prevention and Management of Foot Problems The National Institute of Clinical Excellence (NICE) published an updated guideline in January 2004.9 A previous foot care guideline had been published in the year 2000 under the auspices of the Royal College of General Practitioners, Royal College of Physicians, Royal College of Nursing and British Diabetic Association (now Diabetes UK).
It was developed utilising the NICE methodology for guideline development.
A number of research studies published since the previous guideline have informed the con- clusions for the new guideline.
It can be downloaded from the NICE Web site www.nice.org.uk, and is available in a full version, a patient version and a quick reference guide.
The quick ref- erence guide was sent to all GPs in England and Wales.
The main recommendations have gradings of level A to level D.
Level A is directly based on category 1 evidence (meta-analysis of randomised controlled trials (RCTs), or at least one RCT).
Level B is directly based on category 2 evidence (at least one study without
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randomisation or at least one other type of quasi-experimental study) or extrapolated from category 1 evidence.
Level C is directly based on category 3 evidence (evidence from non- experimental descriptive studies, such as comparative studies, correlation studies and case, control studies) or extrapolated from category 1, 2 or 3 evidence.
Level D is directly based on category 4 evidence (evidence from expert committee reports or opinions and/or clinical experience of respected authors).
Some of the recommendations concerning education are drawn from the NICE 2003 ap- praisal of patient education models for diabetes.
The initial recommendations are for a simple screening examination for risk factors for diabetic foot ulceration as part of the annual review process for everyone with diabetes.
The recommendation is (1) examination of the feet and lower legs for any foot deformity; (2) palpation of foot pulses; (3) testing of foot sensation using 10-g nylon monofilament or vibration; and (4) inspection of footwear.
The evidence level for this recommendation is given as level A.
These items link to indicators 9 and 10 of the diabetes quality framework of the new GP contract, in which quality points are awarded for the percentage of people with diabetes with a record of the presence or absence of foot pulses, and the percentage of people with a record of neuropathy testing in their records.
The guidelines state that patients who have any of the above abnormalities detected, and do not have an active foot ulcer, should be referred to the local foot protection team for further assessment.
This team with expertise in protecting the foot would typically contain podiatrists, orthotists and foot care specialists.
They would assess patients as being either at high risk or at increased risk of foot ulcers.
Those found to be at high risk need management and frequent review (1, 3 monthly).
The following items are included in each review: (1) inspection of the patient’s feet; (2) a review of the need for vascular assessment; (3) an evaluation of the provision and appropri- ateness of intensified foot care education, specialist footwear and insoles, and skin and nail care.
Those found to be at increased risk of foot ulceration should be reviewed every 3, 6 months as follows: (1) review the need for vascular assessment; (2) evaluate footwear; (3) provide enhanced foot care education.
In most practices, about one third of people with diabetes will have some abnormal- ity giving them some degree of increased foot ulcer risk.
These individuals need referral to the foot protection programme.
The remaining approximately two thirds of the prac- tice population will have no at-risk features, and just need re-screening at their next annual review.
The other major recommendations of relevance to primary care are those dealing with the management of someone newly presenting with foot care emergencies.
These are defined as new ulceration, swelling and discolouration.
Such emergencies need to be referred to a multidisciplinary foot care team within 24 h.
This is defined as a team of highly trained specialist podiatrists and orthotists, nurses with training in dressing diabetic foot wounds and diabetologists with expertise in lower limb complications.
The evidence level for this recommendation is given as level D.
The expectation would be that as a minimum the team should (1) investigate and treat vascular insufficiency; (2) initiate and supervise wound management, using dressings and debridement and systemic antibiotics for cellulitis or bone infection as indicated; (3) ensure an effective means of distributing foot pressures, including specialist footwear, orthotics and casts; and (4) try to achieve optimal blood glucose levels and control of risk factors for cardiovascular disease.
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IMPLICATIONS OF THE NICE GUIDELINES FOR PRIMARY CARE 125
IMPLICATIONS OF THE NICE GUIDELINES FOR PRIMARY CARE It used to be said that all people with diabetes needed referral for podiatric assessment.
This resulted in many people with diabetes and normal feet attending the podiatry services, which often became overwhelmed.
The recommendations of the new guideline mean that the one third of people with diabetes who need the expertise of the podiatry service should be able to get it, and those who have normal feet can have basic foot care advice in the practice and can cut their own toenails or have them cut by a carer.
It may require a reorganisation of local podiatry services, but many already are providing a community-based foot protection programme.
This guideline provides support to get them developed in areas where it is not yet happening.
Some hospitals already have multidisciplinary foot care teams.
Others as yet do not.
The guideline should encourage and provide impetus for their development.
If the NICE guideline is followed, it seems highly likely to improve the outcome for patients in the primary care setting.
The messages of the guideline are simple.
It outlines a brief screening examination in primary care, the fulfilment of which will earn quality points in the new GP contract; patients who screen positive should be referred for further assessment and education to a foot protection programme; anyone newly presenting with a foot emergency should be referred to a multidisciplinary foot care team within 24 h.
The guideline should also provide support for service improvement in areas where foot care services are underdeveloped.
The quick reference guide version of the guideline contains a clear and helpful ‘pathway of care’ algorithm which outlines the clinical decisions that need to be made at each stage of the pathway.
There is also a patient guide that can be used by people with diabetes to help understand foot problems and what sort of care they should expect for their feet.
The guideline development process involved the critical review of over 300 papers and stud- ies to underpin the evidence base for the recommendations.
The full draft guideline of nearly 200 pages (including appendices)9 provides a wealth of information and analysis for those with a special interest.
However, the quick reference guide contains all the simple messages that if fully implemented across the country would undoubtedly reduce the number of amputations in people with diabetes.
Testing Neuropathy in Primary Care The quality and outcomes framework of the new GP contract does not specify which method of testing for neuropathy should be used in primary care, but only that a patient should have a record of a neuropathy test.
The NICE report states that there is a good evidence base for the use of the biothesiometer and the 10-g nylon monofilament to detect neuropathy.9 The monofilament is easy to use, light, reproducible10 and cheap compared to the biothesiometer, which often weighs 2.5 kg, requires a power source and costs around £400.11 The assessment of vibration using the 128-Hz tuning fork is much less reliable as a test for neuropathy.
The NICE report states that identification of neuropathy, based on insensitivity to a 10-g nylon monofilament, is convenient and appears cost-effective9 (recommendation level C).
The 10-g nylon monofilament seems to have become the neuropathy test that is used in foot care screen- ing in primary care in the United Kingdom.
Not all 10-g nylon monofilaments generate 10 g of force, and so it important to use the most reliable ones.
All current monofilaments do
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Table 10.1 The procedure for testing neuropathy with the 10-g monofilament
r Bend the monofilament a couple of times at the beginning of each clinic before you use it.
This removes any residual stiffness. r Explain what you are doing to the patient and apply the monofilament on a sensitive area of the skin, e.g. inside the forearm. r Ask the patients to close their eyes and say ‘yes’ every time they feel you touch their feet no matter how lightly they perceive the touch. r Place the monofilament at 90◦ to the skin surface and slowly push the monofilament until it has bent approximately 1 cm.
This should take 0.5 s.
Do not jab the skin with the monofilament. r Hold the monofilament in position for 1, 2 s and then slowly release the pressure over 1, 2 s, until the monofilament is straight.
At this point remove the monofilament from contact with the skin. r Repeat the procedure for all testing sites on both feet and record the findings. r If during this test you obtain areas where the patient does not respond, repeat the test at the same site twice more, and if there is still no response record a negative response.