reaching consensus on this topic was clearly a challenge for all experts involved.13 In the earlier projects of the IWGDF, solid scientific data were the basis for consensus, but in the present project, much more arbitrary choices had to be made.
Moreover, the design and content of a classification strongly depends on its aims, and the current system is to be used in research; a more simple system for daily clinical practice still needs to be developed.
In addition to some members of the IWGDF, all researchers who had developed an ulcer classification scheme in the past were asked to participate in a working group, with N.C.
Schaper (the Netherlands) as chairman.
The newly designed classification system has been primarily developed to char- acterise patients participating at a certain time point in a research project, usually during the inclusion phase, and should be the basis for the inclusion and exclusion criteria.16 The system, which is summarised below, aims to create a reproducible categorisation scheme; however, this assumption needs to be tested.
Therefore, the classification system needs to be validated, and indeed the process of validation has recently been started.
CONSENSUS PROCESS The international guidelines are produced by the IWGDF (Table 35.3) following a clear set of rules.
An evidence-based approach is the aim of the development of the guidelines.
The infor- mation used during this process is obtained from literature research, several Cochrane analyses and consensus statements from other documents.
However, at present, solid scientific informa- tion on many relevant topics is lacking, and the documents should be regarded as the consensus reached by a group of independent well-known experts from the different fields involved in the care of diabetic patients with foot disease.
The International Consensus was written by experts in the field, under the guidance of an editorial board.
All members of the IWGDF agreed upon the final texts after several cycles of writing, commenting and editing by the editorial board.
Subsequently, this document was endorsed by international organisations such as the World Health Organisation (WHO) and the IDF.
The three supplements on infection, wound care and classification were written by three separate working groups.
The chairman of each consensus group communicated with the editorial board of the IWGDF, which in turn was responsible for the communication with the members of the IWGDF.
The members of each group were representatives of the IWGDF and/or well-known experts in the field.
Each group was asked to produce a text that was in line with the consensus of 1999 and with other related consensus projects, such as the TransAtlantic InterSociety consensus group on peripheral arterial disease and the guidelines on diabetic foot infections of the Infectious Diseases Society of America.17 After a cycle of writing, editing and commenting by all members of the IWGDF, the texts were discussed in depth and modified during a meeting of the IWGDF in the Netherlands in 2003.
During this meeting, the three final documents were produced and subsequently agreed upon by all 62 IWGDF members, with their signatures.
Table 35.3 List of useful addresses
r Web site of the IWGDF: www.iwgdf.org r Web site of the IDF: www.idf.org/bookshop (documents and CD-ROM) r IWGDF e-mail address: karel.bakker@hetnet.nl
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390 THE INTERNATIONAL CONSENSUS ON THE DIABETIC FOOT
The consensus documents were, as stated earlier, developed by a group of independent experts, and the documents were created without any influence of pharmaceutical companies.
However, the development of the consensus and the implementation programme were greatly facilitated by the financial support given by pharmaceutical companies.
Until now, Johnson & Johnson and Dermagraft Joint Venture (Advanced Tissue Sciences/Smith & Nephew) gener- ously supported the initiative.
Furthermore, a donation was received from the Dutch EASD (European Association for the Study of Diabetes) Fund and from NovoNordisk.
In several countries, the translation of the International Consensus was supported by local pharmaceu- tical companies, which facilitated the worldwide implementation of the consensus project, as described in the next paragraph.
IMPLEMENTATION The International Consensus was originally produced as a booklet in 1999.
An interactive CD-ROM was printed in 2003, containing the original International Consensus document (1999), and the newly approved documents on infection, classification and wound healing.
Furthermore, the Spanish and French versions of the Practical Guidelines on the Management and Prevention of the Diabetic Foot were included in the CD-ROM, as well as a picture gallery and an interactive search system.
Depending upon local circumstances, the principles outlined in the documents have to be translated for local use, taking into account regional differences in socio-economics, accessi- bility to health care and cultural factors.
In almost all regions and countries, contact was made with organisations or individuals involved in diabetes care.
Local champions of the diabetic foot were recruited, resulting in a total of 82 persons (as per June 2005) as representatives of their country or region.
The International Consensus document was created in such a way that it enabled the production of translated (and if necessary adapted) versions for local use, with relatively low costs.
Moreover, in the relatively rich developing countries, national pharma- ceutical companies sponsored some of these versions, and this money was used to support the production of guidelines in some lesser developed countries.
Under guidance of the board of the IWGDF, the International Consensus was translated in 25 languages in 2005, including Russian, Chinese, Japanese and Arabic.
These translated versions were endorsed by the local diabetic organisations and were subsequently presented in most countries at national meetings on the diabetic foot.
Members of the IWGDF participated in several of these meetings and also helped to organise practical training sessions.
Subsequently, the IWGDF developed the ‘Step by Step’ programme with the aim to improve diabetic foot care in developing countries.
With the financial support of the World Diabetes Foundation, projects have been initiated in countries such as India, Sri Lanka, Bangladesh and Tanzania.
Also, an IWGDF Web site was created to inform all health care workers in the field of the diabetic foot on the consensus projects and on the current status of diabetic foot management.
In addition, more specific in- formation is provided on future meetings, and also personal experiences of people in the field are displayed as ‘Foot Notes’.
Finally, the IWGDF is, as a Consultative Section, involved in several IDF initiatives, such as the 2005 worldwide campaign on foot care.
This campaign culminated in the World Diabetes Day on this topic, with press conferences in all the IDF regions, a travelling photographic exhibition and with special issues of well-known journals specifically dedicated to this topic