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12 Education in the Management of the Foot in Diabetes Kate Radford, Susan Chipchase and William Jeffcoate
INTRODUCTION It is invariably recommended that people with diabetes should be offered education about preventive foot care, and this should be repeated at intervals , most frequently for those at greatest risk.
While there is no disputing this principle, it is based on a number of assumptions.
Thus, it assumes that such education will result in a significant change in behaviour and that this in turn will lead to a reduction in the incidence of foot problems.
It also assumes that the content of the information to be taught is established, as well as its optimal mode of delivery.
In practice, the evidence base is extremely thin and the only aspect of education that is beyond dispute is that people with diabetes should be told that foot ulcers may occur, and that they should do their best to look after their feet in order to prevent them.
There is a pressing need for further work to be done in order to establish the structure and content of educational programmes, as well as their cost-effectiveness.
Such work should determine the extent to which education is best directed at the patient or at the professional.
It should also investigate who should do the teaching, how often, what is taught and what methods should be used.
The question of educating the educators should be addressed.
Without formal evaluation, the implementation of detailed prevention programmes may consume resources that might be better directed at the more effective management of the established foot ulcer.
EVIDENCE FOR THE EFFECTIVENESS OF EDUCATION Education might be used in primary prevention (in those who have never had a foot problem), in secondary prevention (prevention of recurrence) and in the management of established ulcers. Evidence of effectiveness might be either direct (reduction in incidence of ulcers or amputation) or indirect (using surrogate end points such as knowledge and foot care behaviour).
The Foot in Diabetes, 4th Edition. Edited by Andrew J.M. Boulton, Peter R. Cavanagh and Gerry Rayman. C 2006 John Wiley & Sons, Ltd. ISBN: 0-470-01504-7
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144 EDUCATION IN THE MANAGEMENT OF THE FOOT IN DIABETES
Primary Prevention Reduced incidence of ulcers and amputation
Intensive education with follow-up contact and reminders over 12 months led to a weakly sig- nificant reduction (OR 0.41; CI 0.16, 1.00) in incidence of new ulcers in a relatively socially disadvantaged, predominantly female, group of patients with type 2 diabetes in Indianapolis, although the study was not large enough to demonstrate an equivalent effect on amputations.1 McCabe and colleagues2 undertook a larger, but incompletely randomised study (in the sense that all those at high risk were allocated to the intervention group) in Liverpool, United King- dom, and found that the introduction of an integrated foot care programme did not reduce new foot ulcers in high-risk patients, although there was a significant reduction ( p < 0.01) in the incidence of major amputation.
In two randomised studies of educational interventions covering multiple aspects of diabetes care, neither Rettig and colleagues3 nor Bloomgarden et al.4 found any reduction in the incidence of foot problems after 12 and 18 months, respec- tively.
Similarly, Ronnemaa et al.5 found that education did not lead to a reduction in ulcer incidence after 12 months, while Hamalainen and colleagues6 found no benefit of education in low-risk patients in a study involving 7-year follow-up
Surrogate end points
Of those studies listed above, which were also designed to assess foot care knowledge and behaviour, there was a significant improvement in the intervention group in three,3,5,6 while there was no change in one.4 Corbett7 reported that one-to-one education resulted in a significant improvement in knowledge ( p <0.03) and foot care behaviour ( p <0.01) at 3 months, while Mazzuca et al.8 found no effect at 1 year.
In a small study comparing a low-intensity (1-h foot care advice) with a high-intensity (general diabetes education programme followed by 9-h foot care teaching over 4 weeks) programme, there was marked ( p <0.001) difference in foot care knowledge and behaviour over the succeeding 6 months.9 This was associated with a fall ( p <0.001) in the incidence of active foot ‘problems requiring treatment’ , although almost all of these ‘problems’ appear to have been abnormalities of nail and skin other than ulceration.
In a study exploring different educational interventions, Kruger and Guthrie10 reported improved health care behaviour at 6 months in both intervention groups.
Pieber and colleagues also reported a reduced prevalence of callus and nail abnormalities following general diabetes education of low-risk patients managed in the community.11
Secondary Prevention Reduced incidence of ulcers and amputation
Malone and colleagues12 randomised 203 patients who had been admitted to hospital with foot problems (ulcer, infection or amputation) to either receive or not a single, hour-long education session that included display of graphic visual images. They found that the intervention group had a threefold and highly significant reduction in both new ulceration (OR 0.28; CI 0.13, 0.59) and amputation (OR 0.32; CI 0.14, 0.71). We have been unable to identify any other studies of education in secondary prevention.
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ISSUES TO BE ADDRESSED IN PLANNING AN EDUCATION PROGRAMME 145
Management of Established Ulcers A recent (and very large) study from Chennai reported that of 1259 patients at previous high risk and who presented with foot ulcers, healing occurred in 82% who were judged (retrospectively and in an unspecified way) to have adhered to foot and ulcer care advice, compared to 50% of those who did not.13 There have been no other specific studies of the effect of education on established ulcers, although it could be assumed that one benefit of a pre-emptive education programme might be that those who later develop an ulcer would be empowered to seek expert help earlier.
Early self-referral may be associated with an improved outcome, and this may be the explanation for the reduced incidence of amputation in the otherwise neutral study by McCabe et al.,2 as well as the apparently startling reduction in amputation reported by Malone and colleagues12 and the reduced healing time reported by Griffiths and Wieman.14
CONCLUSIONS CONCERNING THE PUBLISHED LITERATURE A recent Cochrane systematic review15 drew attention to the paucity of good-quality research in the area.
Published trials of interventions were often poorly designed and described.
The content and style of the education delivered varied widely.
Even the better designed studies were too small and therefore insufficiently powered to detect true effects.
There is, therefore, a danger of both a Type I error (concluding that an intervention is effective when it is not) and a Type II error (concluding that is not effective when it is).
There is also a very real risk of a Type III error16 , whereby an intervention that is shown to be ineffective when evaluated in isolation and as part of a formal trial may yet be effective in practice when it is delivered as part of a coordinated multidisciplinary programme.
Moreover, it should be recognised that the effectiveness of any education programme is critically dependent on the availability of complementary clinical services.
Thus, a programme that emphasises the importance of seeking immediate expert advice will be ineffective if such advice is not available.
Valk et al.15 concluded that the evidence to suggest that patient education per se reduces the incidence of both foot ulcers and amputations was weak and inconclusive.
While an education programme may increase knowledge or awareness, this does not necessarily result in changes in foot care skills or behaviour, or in clinically significant benefit.
Moreover, the effectiveness of educational measures appears to be generally short term.6,9 It is clear that there is a need for more high-quality randomised controlled trials, based on modern concepts of educational practice.
These trials should explore the content and methodology of education programmes, as well as seek to define both their effectiveness and cost benefit.17
ISSUES TO BE ADDRESSED IN PLANNING AN EDUCATION PROGRAMME Aim The aim of the intervention is to induce a change of behaviour, which will result in a lower incidence of, or improved outcome from, diabetic foot disease.