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Abstract Background Vulval lichen sclerosus (VLS) is a high-burden, under-researched chronic skin disease. It is characterised by itching, pain, sexual dysfunction and poor quality of life. Up to 70% of patients develop fibrosis and vulval architectural changes. The only evidence-based treatment includes topical steroids. New potential surgical treatments include autologous fat transfer (AFG) and platelet-rich plasma (PRP) injections but high-level evidence supporting these treatments is sparse. Aims To identify patients’ research priorities and evaluate the acceptability of AFG and PRP as treatments for VLS and design a trial co-produced by patients. Methods One-to-one interviews, focus groups and online questionnaires were used to investigate patients’ research priorities, acceptability of treatments, preferred outcome assessment tools, views on a sham procedure and trial design. Results A focus group (n=18) and an online patient survey (n=809) identified the top research priorities: changes to vulval anatomy, emotional impact on intimate relationships, inability to have penetrative intercourse and pain during intercourse. Patients reported poor quality of life and said that addressing these would be life-changing. Ninety-nine percent of patients agreed that this trial should be performed and 73% were willing to take part if a sham procedure was used. A patient advisory group (n=5) has been created to co-produce the trial. Conclusion VLS is a complex disease with no core outcome set. Patient co-production is a keystone to a successful trial design and ensures that research is aligned with patients’ priorities. This research defines the key priorities of research into current surgical interventions for VLS.
Jasionowska et al. (Fri,) studied this question.