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RESEARCH: Simon Palfreyman, E Andrea Nelson, and Jonathan A Michaels Dressings for venous leg ulcers: systematic review and meta-analysis BMJ 2007; 335: 244 [Abstract] [Full text]

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Evidence controversy in wound management

Finn Gottrup   (3 March 2008)

Evidence controversy in wound management 3 March 2008
Finn Gottrup, Professor of Surgery Copenhagen Wound Healing Center, Bispebjerg Univ. Hospital, DK 2400 Copenhagen, Denmark Send response to journal: Re: Evidence controversy in wound management	Problem wounds are a significant problem for the health care system all over the world. In the industrialized world, it can be expected that almost 1-1.5% of the population constantly have a problem wound, which counts for 2-4% of the health care budget (1-3). The question is which type of intervention, which type of technology and which type of dressing materials are the best from what is available? Recent reviews have shown little or no compelling evidence of a significant difference in time to healing or percent healing between patients treated with traditional and modern dressings (4-7). In BMJ (5) a review and meta-analysis on dressings for venous leg ulcers was published in 2007. It was concluded that the type of dressing applied beneath a compression was not shown to affect ulcer healing. Reimbursement strategies in Europe are often based on evidence of this kind. Consequently traditional products like gauze and other dry wound healing dressings may be reimbursed, while not the modern dressings based on moist wound healing Modern dressing have been used for more than 25 years and the lack of evidence may raise questions of which two are especially important: 1. why has wound care research not achieved evidence on level IA of the Cochrane system and 2. is healing the only relevant end point when comparing different treatment regimens? These questions are key question in a future discussion of how to solve the evidence problem in the wound area (8). The lack of evidence is based on inadequate sample size, short follow up, non-random allocation to treatment arms, non-blinded assessment of outcomes, poor description of control and concurrent intervention etc. The main problem is the comparability of the patients, because most of the wound patients are old, fragile and are suffering of several other diseases. Furthermore is the experience and expertise gained with pharmaceutical automatically applicable to dressings (medical devices)? (9). The extended definition by Sackett et al. (10) may be more relevant in the wound area: evidence-based medicine is not restricted to randomised trials and meta-analysis, but involves exploration of al types of best external evidence with which to answer our clinical question. Prospective cohort studies may be more helpful, when cost is the major outcome of interest. Furthermore evidence based practice is only one part of the effort to provide high quality, effective treatment and care. This was shown by the French consensus group statements, which did not confirm the highest level of evidence from the literature (6) The primary end point has been a fully healed wound or time to healing. In regard to end points in a dressing evaluation other end points like protection against bacterial contamination, quality of life for patients and cost effectiveness of the dressing are of major importance. The author would propose development of appropriated scientific evaluative tools in order to make devices more efficient should be initiated. Such evaluative tools may not only be based on RTCs, but be based on study designs more appropriated in the wound area. To focus on these problems a working group consisting of wound related manufactures, economists, clinicians and other relevant persons should be established. The group should be internationally perhaps within European Union. The European Wound Management Association (EWMA) is presently setting up such a group. References 1. Dale J. Chronic ulcers of the leg: A study of the prevalence in a Scottish Community. Health Bulletin 1983; 41: 310-314. 2. Liu PY, Eriksson E, Mustoe TA. Wound healing: Practical aspects. In: Russels RC, ed. PSEF Instructial Courses. Mosby, St. Louis 1991. 3. Gottrup, F.: A specialized wound-healing center concepts: importance of a multidisciplinary department structure and surgical treatment fascilities in the treatment of chronic wounds. Am J Surg. 187 (suppl May 2004): 38S-43S, 2004 4. Bouza C, Munoz A, Amata JM. Efficacy of modern dressings in the treatment of leg ulcers: a systematic review. Wound Rep Reg 2005; 13: 218- 229. 5. Palfreyman S, Nelson EA, Michaels JA. Dressings for venous leg ulcers: systematic review and meta-analysis. BMJ 2007; 335: 244. 6. Vaneau M, Chaby G, Guillot B, Martel P, Senet P, Teot L, Chosidow O. Consensus panel recommendations for chronic and acute wound dressing. Arch Dermatol 2007; 143: 1291-1294. 7. Chaby G, Senet P, Veneau M et al. Dressings for acute and chronic wounds. A systematic review. Arch Dermatol 2007; 143: 1297-1304. 8. Gottrup F. Evidence is a challenge in wound management. Editorial. Lower Extremity Wounds. 2006; 5: 74-65. 9. Health technology assessment for medical devices in Europe – what to be considered. Position paper. Eucomed. 2001 10. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what is and what isnīt. BMJ 1996: 312: 71-72. Competing interests: None declared