Abstract

Treatment of hard-to-heal wounds involves a holistic approach for choosing between available treatment options. However, evidence for informing these choices is sparse, introducing uncertainty into decisions about the optimum treatment pathways that reflect the vast heterogeneity in this patient population. This paper discusses the existing clinical and health economic literature in order to provide insight into sources of uncertainty in the evaluation of the holistic approach to management of the hard-to-heal wounds, and how this uncertainty can be appropriately reflected in research. We identified three key sources of uncertainty in the evaluation of chronic wound treatments, namely heterogeneity in aetiology and patient populations, heterogeneity in treatment pathways, and challenges around capturing all relevant outcomes. Reflecting these complexities requires sophisticated modelling of treatment sequencing and long-term outcomes. The paper discusses how the scope specification, scenario analyses, and sensitivity analyses can be used to fully characterise analytical uncertainty.

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