Chronic Wound Treatment
Chronic wounds are commonly defined as wounds that do not heal within an expected time frame, or have proceeded through healing without the accompanying expected improvement in functional outcomes. Venous diseases, diabetes, and pressure ulcers are the source of most chronic wounds, all impacting quality of life and incurring high health care costs. Significant uncertainty remains about the value of many therapies for chronic wounds, in part due to lack of high quality research studies comparing alternative treatments and treatment strategies.
The lack of high quality studies and standard study methodologies for assessing chronic wound therapies has been noted by several recent systematic reviews conducted in both Europe and the United States. The 2008 Cochrane Collaboration Review concluded, “Trials comparing TNP [Topical Negative Pressure] with alternative treatments for chronic wounds have methodological flaws and data do demonstrate a beneficial effect of TNP on wound healing however more, better quality research is needed.”
CER Applied to Chronic Wound Treatment
One approach to improving research in the area of chronic wounds is to provide methodological guidance for the conduct of comparative effectiveness research (CER) on chronic wound treatments. This is particularly challenging due to the major and widespread gaps in knowledge in this clinical area as well as the proliferation of treatments. The goals of CER include identifying the range of therapies being used in chronic wound care, and which therapies serve as clinically relevant alternatives for different wound etiologies and patient populations. Traditional RCTs often do not include the comparators of most importance to decision makers, so this is a crucial goal of CER. In addition, CER should be based on clinically-relevant outcomes that address the primary concerns of patients, clinicians, payers and policy makers, moving beyond outcomes primarily of interest to regulators. Finally, to be most informative, CER studies in chronic wound treatment should be designed so that they are applicable to actual wound care, both in wound care clinics and in the broader community.
CER Methods Symposium
The Comparative Effectiveness Research Methods for the Treatment of Chronic Wounds Conference took place on July 20, 2010 in Baltimore, MD. The goal of the conference was to gather the input of stakeholders on the issues faced in designing research to address the relative benefit of alternative treatments for chronic wounds in order to establish an informed CER framework that addresses the needs of all the decision makers involved. For this symposium, CMTP and the Angiogenesis Foundation assembled a globally diverse group representing a rich variety of stakeholder perspectives, including representatives from the government sector, academia, product developers, health care providers, insurers/payers, the advocacy community, and participants that self-identified as “other,” including two participants from Cochrane Wounds Review Group Editors. Outcomes of the symposium included summaries of various stakeholders’ perspectives on the evidence gaps and discussions on topics such as alternatives to randomized controlled trials and the use of comparators in designing CER studies. Discussions at this meeting laid the foundation for the development of an Effectiveness Guidance Document on the Treatment of Chronic Wounds.
Click here for the July 20th, 2010 Meeting Summary (pdf) (1.56 MB)