Genesis of the prevention guidelines project

In December 2006, the Wound Healing Society published the Treatment Guidelines for Pressure, Arterial, Venous and Diabetic Ulcers in this Journal (Wound Repair & Regeneration 2000; 14: 645–710). The project was initiated, funded, and supported by the Wound Healing Foundation, an organization that shares with the Wound Healing Society the goal of enhancing the quality of care of patients suffering from any type of wounds. As recounted earlier, four work groups gave selflessly of their time to complete the Treatment Guidelines project in a timely manner. Their efforts were crowned by the above mentioned publication, which has become in short time a standard reference for the most comprehensive and up-to-date scientific exposé on the state of the art. At the completion of the project, two issues became evident: the need to update the guidelines on a regular basis, a task entrusted by the Wound Healing Society to Dr. Martin Robson, and the void in the realm of prevention of chronic wounds. Clinicians and health care providers are keenly aware of how much easier it is to prevent an ulcer than treat one; furthermore, all have had the disappointment of seeing a wound that was carefully and painstakingly nursed to healing recur in short time. Before the groups had a chance to disband, I gave them the challenge of providing a further set of guidelines on prevention of chronic wounds. To a person, all groups rose to the challenge, recognizing the void and need for such an exposition. The only personnel change occurred in the Pressure Ulcer Group, leadership for the prevention guidelines being assumed by Joyce K. Stechmiller, PhD ARNP, who is a member of the Pressure Ulcer Working group and who also has a special interest in prevention. The work groups again have fully delivered on their assigned tasks. Drafts of the prevention guidelines were formulated using the same format and parameters as the treatment guidelines. As previously, the chronic wounds chosen for prevention guideline development were venous, diabetic, arterial, and pressure ulcers. Consensus was the order of the day and was maintained throughout: in the broad and comprehensive research of existing literature; in the make-up of work groups to include all specialties, disciplines, professional degrees, and societies (various clinical fields such as dermatology, endocrinology, vascular surgery, plastic surgery, podiatry, geriatrics, nursing, dietetics/nutrition, rehabilitative services, and prosthetics were all represented); in the application of the Delphi process in that the vast majority of the group had to be in agreement with any pronouncement or recommendation; and finally, in the seeking of input from all interested parties, societies, and industry at a publicly held forum during the Annual Meeting of the Wound Healing Society in April 2007 in Tampa, FL. Characteristically, there is a lack of any “agenda” in the final product, as no industrial or other interest group approval or funding was sought. The charge to each panel was to develop guidelines for the best wound prevention measures as supported by evidence from the literature. To formulate these evidence-based guidelines, a common methodology was agreed upon by all four panels. Previous guidelines, meta-analyses, PubMed, MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews, recent review articles of treatment of the ulcer under consideration, and the Medicare/CMS consensus of usual treatment of chronic wounds were all reviewed for evidence. Guidelines were formulated, underlying principle(s) enumerated, and evidence references listed and coded. The code abbreviations for evidence citations were as follows: In addition to human clinical studies, these current guidelines also encompass well-controlled animal studies that present proof of principle, especially when a clinical series corroborated the laboratory results, have been cited. It is also clear that principles that have been validated for one type of chronic wound often are applicable to other chronic wounds. Because of these variations, a different system was used to grade the evidence weight supporting a given guideline. The strength of evidence supporting a guideline is listed as Level I, Level II, or Level III. The guideline evidence levels are: Level I: Meta-analysis of multiple randomized clinical trials (RCTs) or at least two RCTs supporting the intervention of the guideline. Another route would be multiple laboratory or animal experiments with at least two significant clinical series supporting the laboratory results. Level II: Less than Level I, but at least one RCT and at least significant clinical series or expert opinion papers with literature reviews supporting the intervention. Experimental evidence that is quite convincing but not yet supported by adequate human experience is included. Level III: Suggestive data of proof-of-principle, but lacking sufficient evidence such as meta-analysis, RCT, or multiple clinical series. NB: The recommendation in the guideline can be positive or negative at the proposed level. Each of the specific ulcer prevention guidelines is designed as a stand-alone document, so there is repetition of some treatment principles and guidelines among the various documents. As these Prevention Guidelines are being published, I again wish to thank the Wound Healing Foundation for its support. My sincerest thanks go also to all panel members who have worked so hard to produce these remarkable documents. Lastly, I think these guidelines represent a call to action to all scientists, clinicians, health care providers, industry members involved in this field and government funding agencies: the need for more hard data is clear and these data cannot be acquired unless all interested groups lock arms and work toward this goal.