A systematic review of outcome measures evaluating treatment efficacy in vulval lichen sclerosus and evaluation of patients' priorities

Abstract

Vulval lichen sclerosus (VLS) is an inflammatory skin disease characterised by itching, apareunia, loss of vulval architecture and scarring. Heterogeneity in outcome reporting precludes comparison between treatments. This study aimed to systematically review outcome measures used to evaluate the efficacy of VLS treatments and present patients' treatment priorities. This review followed the PRISMA guidelines using a registered protocol (PROSPERO: CRD42022356738). Multiple databases were searched, along with grey literature on Clinicaltrials.gov, European Union Clinical Trials and International Standard Randomised controlled trial (RCT) registries. All RCTs assessing any treatment for VLS were eligible for inclusion. A total of 775 patients were assessed across 21 RCTs. The assessment tools reported outcomes in the following domains: patient‐reported symptoms assessed with one validated scale in 12 studies and seven non‐validated scales in nine studies; sexual function with validated female sexual function index and female sexual distress scale in two studies and two non‐validated scales in two studies; quality of life with three validated scales in three studies and clinician‐reported objective outcomes with two validated scales in three studies and six non‐validated scales in fourteen studies. Histological changes were assessed in 10 studies and tissue biomechanics in one study. We also carried out an online survey completed by 809 women with VLS to assess their research and disease treatment priorities and identified validated outcome measures to assess these. There is high variability in assessing treatment outcomes for VLS. We identified validated assessment tools which could be implemented in VLS studies to evaluate the effectiveness of treatments.