Treatments for Chronic Wound Healing
Notice
We have decided to remove the current draft of the guidance document from the CMTP website, as we expect there to be some significant changes in the recommendations over the coming months. Please check back, or email info@cmtpnet.org with any questions regarding the project.
Overview
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. It is estimated that 2.8 million patients in the United States suffer from chronic wounds and that this number will grow coincident with an aging population and increasing rates of diabetes. 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.
Research on chronic wound healing technologies should be guided by a clear understanding of the research methods most relevant to producing information about chronic wound treatment. There remain a number of issues surrounding both chronic wounds and their care and treatment that have made the conduct of high quality studies challenging.
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.”
Comparative Effectiveness Research
One approach to improving research on chronic wound treatments is to provide methodological guidance for the conduct of comparative effectiveness research (CER) on chronic wound treatments. CER is defined by the Institute of Medicine as “…the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist patients, consumers, clinicians, purchasers and policy makers in making informed decisions that will improve health care at both the individual and population levels.” The evidence produced from traditional randomized clinical trials often does not address the question of which treatments work best in actual clinical practice, and the area of wound care is further impeded given that many technologies do not go through a process of randomized controlled trials for regulatory approval. CER not only addresses broad issues of what occurs in the “real world” but also the relative value of alternative treatment options. The goal of this symposium is to gather stakeholder input into the issues faced in designing research to address the relative benefit of alternative chronic wound treatments in order to establish an informed CER framework that address the needs of all decision makers involved.
CER applied to chronic wound treatment
CER in the area of chronic wounds 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.
To be most informative, CER studies in wound treatment should be designed so that they are applicable to actual wound care, both in wound care clinics and in the broader community.
