Development of a Core Outcome Set for Use in Research Evaluations of Interventions Used for Venous Leg Ulceration

Background: Venous leg ulceration is a recurring condition causing pain, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified that the outcomes important to all stakeholders are not always reported. Research has also identified that there are a large number of different outcomes being reported, impacting synthesis of results, and clinical decision-making. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. Aim: To develop a core outcome set for research evaluations of interventions used for venous leg ulceration. Methods: 1) A scoping review identified the outcome domains and outcomes that have been reported in randomised controlled trials and qualitative research. 2) eDelphi consensus study on the outcome domains. 3) eDelphi consensus study on the outcomes. Results: 1) The scoping review identified 807 different outcomes that have been reported in the venous leg ulcer randomised controlled trials included in the review. Fifteen outcomes were identified from qualitative studies. 2) Ten outcome domains were rated as core by participants in the consensus study. 3) The consensus study on the outcomes refined the outcome domains to produce a core outcome domain set comprising of 5 outcome domains. Eleven outcomes were rated as core by participants in the consensus study. Conclusion: A core outcome domain set and a set of 11 candidate outcomes have been developed. The development of a core outcome set has the potential to reduce research waste, improve the utility of trials, reduce outcome reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based guidelines.