Identifying outcomes reported in trials of interventions in venous leg ulceration for a core outcome set development: A scoping review.

Background: Venous leg ulceration is a chronic, recurring, condition causing significant patient morbidity. Randomised controlled trials evaluating treatments for venous leg ulceration provide evidence for clinical decision-making. For trial findings to be useful, outcomes measured need to be clinically meaningful, and consistently and fully reported across trials. A core outcome set is an agreed and standardised set of outcomes which should be, as a minimum, reported in all trials for a given indication.

Aim: To identify the outcome domains and outcomes reported in trials of interventions for venous leg ulceration.

Methods: A scoping review of the literature was carried out. Randomised controlled trials within Cochrane systematic reviews looking at venous leg ulceration interventions and qualitative studies exploring venous leg ulceration were included.

Results: The review identified 807 outcomes from randomised controlled trials and 15 outcomes from qualitative studies, and these were grouped into 11 outcome domains: healing, patient reported symptoms, clinician reported symptoms, carer reported symptoms, life impacts, clinical signs, clinical measurement, performance of the intervention, resource use (supplies and clinician time) and adverse events. The outcome domain 'healing' included 111 outcomes, 'symptoms' 109, 'life impacts' 30, 'clinical signs' 88, 'clinical measurement' 184, 'performance of the intervention' 58, 'resource use' 52 and 'adverse events' 190.

Conclusion: The scoping review identified a large number of outcomes (n = 822) across 11 related outcome domains, supporting the need for a core outcome set.