Health Economics and Outcomes Research of Wound Care: Overview of Methodology.

To provide an overview of comparative effectiveness research (CER) methodology and discuss the challenges of health economics and outcomes research (HEOR) in wound care. Narrative description of HEOR methodology with supporting references. With the increasing costs of clinical trials, the use of observational studies in a real-world setting will be essential. Wound care clinicians should understand the importance of proper methods for conducting CER studies. Propensity score methods and marginal structural modeling can create a "quasi-randomized" environment for measuring wound closure and can help drive informed decision-making. In wound care, a paucity of HEOR information is available with great reluctance to use this information by payers, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and other agencies. Furthermore, a limited amount of high-quality retrospective data to measure wound care outcomes exist. The U.S. Wound Registry is one of few data sources that accurately reports on outcomes for all wound types and is a Qualified Clinical Data Registry. Several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting. Using CER and cost-effectiveness studies succinctly needs to be incorporated if progress is to be made in improving wound care outcomes and reducing cost.