Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds

This Effectiveness Guidance Document (EGD) provides specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous disease-related ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds. This is the second in a series of EGDs that CMTP has developed in the area of wound care. In August 2009, CMTP issued an EGD entitled, “Devices for Local Treatments of Chronic Wounds.” This EGD replaces the earlier version. The final version of this present EGD was released in the fall of Fall 2012.

Approximately 2.8 million people in the United States suffer from chronic wounds, and this number will increase as the population ages, and as the rates of diabetes increase. Recent systematic reviews of treatments for chronic wounds have identified a number of methodological limitations in many clinical studies on chronic wounds, and have offered insights into approaches to improve the quality and relevance of evidence. In recognition of the need to improve study quality, a number of organizations have recently produced recommendations for the conduct of clinical research for chronic wounds, including AdvaMed, the World Union of Wound Healing Societies, the European Wound Management Association, and the Alliance of Wound Care Stakeholders, among others. Drawing from these and other relevant documents, CMTP developed this EGD on the treatment of chronic wounds to better inform decision-makers on the design of comparative effectiveness research studies.  Significant input was obtained from key stakeholders during our CER Methods for the Treatment of Chronic Wounds Symposium, held in Baltimore in July 2010.

The ten recommendations contained in this EGD are intended to reflect the types of evidence that would be useful to patients, clinicians, guideline developers, payers and other “post-regulatory” decision makers in making health care decisions at the individual and population level. While incorporating all ten recommendations in future study design is highly desirable, it is recognized that may not always be feasible. Incorporating at least some of these recommendations in future studies would substantively advance the quality of wound care studies available for decision makers.

Documents

Effectiveness Guidance Document (pdf) (1.55 MB)
Technical Working Group Members (pdf) (270.8 kB)

For more information, contact Rachael Moloney.