Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

Hallas, Sarah (Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK) ; Nelson, Andrea (School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK) ; O'Meara, Susan (Kleijnen Systematic Reviews Ltd, York, UK) ; Adderley, Una (School of Healthcare, University of Leeds, Leeds, UK) ; Meskell, Pauline (University of Limerick, Limerick, Ireland) ; Nixon, Jane (School of Medicine, University of Leeds, UK) ; O'Loughlin, Aonghus (National University of Ireland Galway, Galway, Ireland ; University Hospital Galway, Galway, Ireland ; Bon Secours Hospital, Galway, Ireland) ; Probst, Sebastian (Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland ; University Hospital Geneva, Geneva, Switzerland) ; Tawfick, Wael (National University of Ireland Galway, Galway, Ireland ; University Hospital Galway, Galway, Ireland) ; Wild, Thomas (University Medical Center Hamburg-Eppendorf, Germany ; University of Applied Science Anhalt, Germany ; Clinic of Dermatology, Immunology and Allergology, Medical Center Dessau, Medical University Brandenburg, Theodor Fontane, Medical Center Dessau, Germany) ; Gethin, Georgina (National University of Ireland Galway, Galway, Ireland)

Background : A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important 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 the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. 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. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. Aim : The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. Methods : Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Article Type:
HEdS - Genève
Aucun institut
7 p.
Published in:
Journal of tissue viability
Numeration (vol. no.):
2021, to be published
Appears in Collection:

Note: The status of this file is: restricted

 Record created 2021-04-15, last modified 2021-05-03

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