This is the sixth article in the “DFA Guides You Through” series on Australian and International diabetic foot disease guidelines.
In the previous five sections, we have guided you through the two most important evidence-based diabetic foot disease documents available for Australian clinicians: the Australian and International guidelines. However, the journey does not end here; this is where it begins as we need to put these research recommendations into clinical practice, and look to the future. So where do we go from here?
There are three directions we will follow in this chapter: implementation of the guidelines, topics for future research, and future updates of the guidelines.
Implementation of the guidelines
Only when recommendations made in guidelines are implemented in daily clinical practice do they lead to the best outcomes in care for people with diabetic foot disease. However, little is known about the situation in Australia. Two questionnaire-based studies have been performed in Australia, one on general guideline adherence and one specifically on offloading. However, both studies used questionnaires that were not validated, and the formulation of the questions has likely resulted in over-reporting of guideline adherence. Further, response rates were relatively low, and sampling bias resulting in over-representation of adherent clinicians can be expected. Finally, only podiatrists were targeted, rather than all multidisciplinary clinicians.
Despite these limitations, both articles do provide some useful insights. The most important finding of both studies is the discrepancy between the limited use of gold standard non-removable offloading in clinical practice versus the “over-use” of mostly felted foam, for which very limited evidence is available, to offload diabetic foot ulcers. This has also been reported in other nations (e.g. America or specialized European centres). Improving offloading practices, with more frequent application of non-removable knee high devices, is one the most important areas where guidelines can be better implemented in daily clinical practice to improve outcomes for our patients.
For other aspects, such as prevention, screening, the organization of multidisciplinary foot care, or the use of dressings and advanced adjunctive therapies, we basically do not know if Australian clinicians follow the guidelines. Rather than relying on questionnaires to obtain this information, two other ways forward seem more promising.
The first is the Australian Diabetic Foot Ulcer Minimum Dataset. DFA developed this dataset in consultation with multiple stakeholders, and its use is endorsed by Australian peak bodies. If all clinicians who treat diabetic foot ulcers collect the data-items outlined in the minimum dataset, this will provide truly unique insights into the clinical practice of diabetic foot care in Australia. The dataset is not only designed to obtain diabetic foot disease outcomes such as ulcer healing, hospitalization and amputation, but also provides the opportunity to capture if care is provided in line with (inter)national guidelines.
The second way forward for Australia is the path followed by other nations such as Scotland, Belgium and Germany. These countries have created accreditation systems, where treatment of people with diabetic foot disease is only funded or reimbursed when provided by fully accredited multidisciplinary foot clinics. This system has forced clinics to either demonstrate they are providing evidence-based practice, or to stop treating people with diabetic foot disease. This is not an easy road to follow, as nicely described in these two articles, but looking at the results of these countries this may well be the best way forward for Australia as well.
In addition to these top-down approaches, bottom-up approaches should be pursued at the same time. One worthy approach, which is already described in the NHMRC guidelines, could be the creation of a “diabetic foot kit”. One kit may target foot screening and ulcer prevention, and contain the necessary equipment for evidence-based foot examinations, as well as state of the art evidence-based instruction materials. Another kit might target “first-aid ulcer treatment”, containing equipment for debridement and basic offloading. This kit should also contain instruction materials and information on multidisciplinary foot clinics for referral. These kits seem especially useful in Australia’s rural and remote areas, but may come in handy in first line health clinics in metropolitan areas as well.
Another bottom-up approach is continuous education of health care professionals involved in diabetic foot disease. With the bi-annual DFA conference (next up in September 2017), and the “What’s New in DFU” events, DFA will continue to support health professionals in keeping their knowledge up to date with the best and most recent evidence available.
The body of evidence available seems large, especially if you read the extensive NHMRC technical report or the seven IWGDF systematic reviews, but the high numbers of recommendations that are based on a low quality of evidence or expert opinion in both guidelines tell a different story. More research is needed to answer the many questions for which no evidence is currently available.
As this document is primarily aimed at clinicians, we will not extensively discuss the topics where new research is most urgently needed. However, the Australian guideline has a one page chapter (Part E) on future research topics needed, and the 5 IWGDF guidance chapters each have a “key controversies” section that describe the urgent topics for new research. Interested readers are referred to these parts of the guidelines.
Both guidelines primarily argue for more good quality, large-scale studies. A steady increase in publications on diabetic foot disease can be seen on Medline in the last 15-20 years. However, the number of randomised controlled trials published in high-impact journals does not show a similar increase. If anything, this seems to be dropping. Such studies require effort from large consortia willing to work together. It is hoped that the Diabetes Feet Australia Clinical Trials Network will stimulate this development in Australia.
Guidelines need regular updating as new evidence emerges, clinical practice changes and the methodology for guideline development improves. The IWGDF have a standard four-year update process. The next update will be produced in 2019, and this process has already begun. However, an update seems much more imperative for the Australian guideline, as it was published in 2011, based on a 2009 literature review, and a new update process to our knowledge has yet to be started.
Perhaps the most important step in the process of updating guidelines is the development of the clinical questions that form the basis of the systematic reviews. In the Australian guideline, surgical offloading, peripheral artery disease and foot infections were outside the scope of work. However, with the importance of multidisciplinary treatment (involving vascular surgeons and infectiologists as well), and the critical nature of ischemia and infection on diabetic foot ulcer outcomes, future Australian recommendations are needed to cover all bases of diabetic foot disease treatment. Further, the large number of clinical questions on risk assessment factors may be worth reconsidering. Various high-quality systematic reviews and meta-analyses are already available on this topic. While these are informative, assessment of risk alone does not lead to improved clinical outcomes, only subsequent targeted treatment does. Risk assessment based treatment is not included in any guideline and probably should be considered in future updates.
The IWGDF, on the other hand, would do well to include risk assessment factors in their new guidance documents, as this was not included in their documents apart from peripheral artery disease. Similar to the points made above, the clinical questions would be best if they include risk assessment based treatment. Another topic of debate concerns the outcome measures used to answer in these clinical questions. The IWGDF systematic reviews focus rather strictly on ulcer development, ulcer healing (primarily at 12 weeks) and some on amputation. However, some interventions (such as specific dressings) may be targeted at short-term outcomes or patient-related outcomes (such as pain reduction), and will not result in significant changes in 12 week healing outcomes. If more specific outcomes are included, more specific recommendations may be given in future.
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