Establishing effective diagnostic criteria for vulval lichen sclerosus: a diagnostic test accuracy study
Vulval lichen sclerosus
407 consecutive women (≥18 years of age) who have been referred to a skin specialist by their GP with a vulval skin complaint will be identified by the usual care team from clinic lists. Patients will then be sent the patient information sheet and expression of interest form ahead of their appointment at the specialist clinic. Patients will have the opportunity to discuss all aspects of the study and provide consent either at the appointment or in advance. Once the participant has consented, the research team will ask some demographic and clinical questions, and then both the patient’s managing clinician and a second health professional who is blinded to the clinician's diagnosis will conduct separate vulval examinations. At one site (Nottingham), participants may be examined by a third blinded health professional. Optional clinical photographs will also be taken of the patient's LS condition. This will all occur in a single study visit that will last approximately 30 minutes. This information will be uploaded by the research site to the online database (REDCap) and the results will be analysed to assess the diagnostic accuracy of the criteria (from a previous electronic-Delphi consensus study registered at: https://www.nottingham.ac.uk/research/groups/cebd/documents/ls-protocol.pdf). The 17 expert-agreed diagnostic criteria are: • Changes in the anatomy of the genital area • Response to topical corticosteroids • Whiteness • Itch • Burying of the clitoral area • Absence of vaginal involvement • Fissuring • Crinkly skin • Bruising/bleeding under the skin • Fissuring at the back entrance to the vagina • Pain/soreness unrelated to sexual activity • Pain/soreness related to sexual activity • Skin thickening • Loss of skin stretchiness • Erosions • Irritation • Perianal fissure
1. Female 2. >=18 years of age 3. New presentation to a specialist clinic (secondary care or community hub) with a vulval skin complaint
1. Inability to provide informed consent 2. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva 3. More than 2 weeks since initial consultation from managing clinician