Despite the increase in publication of literature on wound care, the need to build wound care evidence remains a challenge. In previous editorials,1,2 we have described the importance of rethinking evidence-based practice from reliance on only randomized controlled trials (RCTs) to encompassing the concepts of Sackett et al.3,4 Sackett et al3,4 defined evidence-based medicine (EBM) as experimental evidence, expert knowledge, and patient preference. Along with the World Union of Wound Healing Societies, we believe that the EBM concept includes the judicious use of expert opinion or knowledge, patient preference from the patient and families experience with illness, and the best available scientific evidence.
In wound care, there is a lack of well-designed RCTs to answer key clinical questions. Not all clinical questions can be answered by RCTs and different research designs are appropriate depending on the research question. Systematic reviews and meta-analyses often conclude that further studies are required. These studies often include idealized patients who do not have coexisting medical conditions or pharmacotherapy that can impair wound healing. Such reviews do not consider other levels of evidence. Experts need to review the other levels of evidence, consider the systematic reviews and meta-analyses, and utilize their own personal experience to develop a consensus of best practices.3,4
A consensus of expert knowledge is important to represent the perspective of professionals from nursing, medicine, and allied health fields. Recommendations also need to consider patient preference and limitations of the healthcare system. The article, "Skin Changes at End of Life (SCALE)," published in the June issue of Advances in Skin & WoundCare,5 illustrates a key consensus process.
The SCALE document is an exemplar of how the consensus building process can be used to build wound care evidence. Within the wound care community, discussion of the clinical reality of skin changes in persons at the end of life has not kept pace with the evidence base for this important concept. The SCALE article was developed from the evidence-informed consensus of a panel of individuals (Table 1) who reviewed the scientific evidence, debated the key concepts, and then produced a series of statements to summarize the available information. These preliminary draft statements were published in an international journal6, distributed electronically, and presented as poster/presentations at conferences throughout the world to elicit the broadest response and input from the wound care community globally. A modified Delphi process was then utilized to fine-tune the statements. Each panel member electronically voted on individual statements, indicating that he/she strongly agreed, somewhat agreed, somewhat disagreed, or strongly disagreed with the statement. For the statement to be forwarded to distinguished external reviewers, 80% of the panel members had to accept the statement. If consensus is not reached, the statement needs to be modified based on the participants' comments for improvement. Once consensus is achieved, the same process can be repeated for a group of international reviewers (Table 2). The final published article5 represents the independent collective approval of more than 80 key thought and content leaders from different professions and different countries and cultural backgrounds worldwide. The results support a universal realization that skin changes do occur at the end of life. These changes may be unavoidable, and as the body declines, skin integrity will be compromised. If we are going to call this phenomenon skin failure, we need a definition with associated research evidence. Not all experts agree on a definition of skin failure,7 and we do need research to determine when the skin changes are reversible or irreversible and the best way to treat patients considering comfort and patient preference.
R. Gary Sibbald, BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, MAPWCA, Toronto, Ontario, Canada
Elizabeth A. Ayello, PhD, RN, ACNS-BC, CWON, MAPWCA, FAAN, New York, New York
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