Methodological Recomendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds
Purpose and Scope of the EGD
The purpose of this EGD is to provide specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatments 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 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.
It is estimated that 2.8 million people in the United States suffer from chronic wounds and that this number will grow coincident with an aging population and increasing rates of diabetes. Recent systematic reviews of treatments for chronic wounds have identified a number of methodological limitations in many clinical studies in the field (Lo et al., 2008; Kranke et al., 2004; Hinchcliffe et al., 2008), offering insights into potential approaches to improve the quality and relevance of evidence. In recognition of the need to improve the quality of clinical studies in this field, 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, Alliance of Wound Care Stakeholders, among others. Drawing from these and other relevant documents, CMTP developed the EGD for the Treatments for Chronic Wounds to better inform decision-makers on the design of comparative effectiveness research studies.
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 in the quality of wound care studies available for decision makers.
Providing Comments on the EGD
As with all CMTP Guidance Documents, your feedback is critical to ensuring the document reflects the best thinking on the design of chronic wound treatment studies. To make the process of providing comments as easy as possible, we have set up an online questionnaire that captures your overall opinion of the EGD, and offers space for you to provide specific changes to the wording and structure of the EGD. By using this form, we will be able to more rapidly include your recommendations into the final document.
