Better Wound Care Begins With Better Evidence: Outcomes of the Wound Care Evidence Summit.

Abstract

In 2022, the Alliance of Wound Care Stakeholders convened the 2-day Wound Care Evidence Summit™. The Summit brought together a multidisciplinary group of stakeholders that included payers, government agency policymakers, prominent researchers, wound care medical specialty societies, patient and clinical associations, wound care clinics, and manufacturers to discuss wound care evidence and coverage issues. The Summit focused on a wide variety of wound care topics, with an emphasis on the processes payers use to create their coverage policies and the type, quantity, and characteristics of clinical evidence payers require. The most valuable outcome of the Summit was the frank and open discourse among stakeholders, with unprecedented participation from payers and the U.S. Food and Drug Administration (FDA) on the subjects of trial design, product-approval pathways, and coverage policy determination. Stakeholders provided actionable ideas for ways to improve clinical trial research and design that will yield better evidence and ultimately better wound care. This article examines the quality, adequacy, and relevance of the existing chronic wound care research base and discusses the gaps, associated problems, and implications for clinical trial design and execution as identified by Summit participants.