A progress report on criteria for including patients in research studies

Chairman
N.C.Schaper, Maastricht, The Netherlands

 

Members working group:
K. van Acker, Antwerpen, Belgium
J. Apelqvist, Lund/Malmö, Sweden
D. Armstrong, Tucson, USA
A.J.M. Boulton, Miami, USA/Manchester, UK
H. Connor, Hereford, UK
M.E. Edmonds, London, UK
R.G. Frykberg, Des Moines, USA
K.G. Harding, Cardiff, UK
W.J. Jeffcoate, Nottingham, UK
G. Reiber, Seattle, USA

In 2000 the Editorial Board was given the task of guiding the consensus process on research classification on behalf of the IWGDF, which in the meantime had become a consultative section of the International Diabetes Federation (IDF). After consultation with the American
Diabetes Association (ADA) it was decided that the IWGDF would formulate a classification scheme only for research purposes and the ADA would formulate a classification scheme for daily practice. These two initiatives would be developed in close collaboration.


The aims of a research classification system were defined in a preparatory meeting of the
Editorial Board with the Steering Committee (in January 2001). Moreover, the procedures for developing such a system were described and a timeframe was established. In the autumn of 2001, all experts who had developed an ulcer classification scheme in the past were invited for a consensus meeting. In this meeting the backbone of a system to classify diabetic foot ulcers for research purposes was developed. In particular all experts agreed that a research classification scheme should include the five items of the PEDIS system. In this PEDIS system Perfusion, Extent / size, Depth / tissue loss, Infection and Sensation should be categorised in each patient. For each category a strict grading system was developed and defining this grading system in unambiguous terms, which are applicable in clinical research, was the greatest challenge. This system was further refined in a meeting in Hungary, 2002, with a number of external experts, including the chairmen of the consensus groups.

The current text in which the received comments of 41 IWGDF members were incorporated was finalised after a meeting of the Editorial Board May 2003. This 4th version was sent to all experts involved in the consensus process and was presented as a progress report during the Consensus/Implementation meeting. This report was extensively debated and was modified during the consensus meeting. Subsequently the document was approved by all IWGDF members present. Moreover, it was decided that the current system has to be validated first before it can be published as a formal IWGDF consensus document.

 

Content Diabetic foot ulcer classification system for research purposes
- The Consensus process
- Background and aims of the ulcer research classification
- The structure of the ulcer research classification
- Validation