Title: Addressing a neglected area of women's health: developing diagnostic criteria for vulval lichen sclerosus.
Funder: Department of Health and Social Care

Abstract: Background Lichen sclerosus (LS) is an inflammatory vulval skin condition that affects upto 3% of women. It is a pre-malignant condition, approximately 3-5% of patients develop vulval cancer within an area of LS. The condition has considerable impact upon psychosocial and sexual well-being. This is a neglected area of women's health with late diagnosis and delayed treatment being frequently experienced. This is in part due to lack of knowledge and awareness of LS amongst the non-specialist medical community as well as lack of validated diagnostic criteria. In order to enable better diagnosis and improve care, these issues need to be addressed. Research questions to be answered What are the best diagnostic criteria (signs and symptoms) for vulval LS? Can a diagnostic tool (e.g. flowchart) be developed for use by non-specialists and patients to diagnose LS? Aims To develop and validate diagnostic criteria for vulval LS. To test implementation of diagnostic tool in primary care and during routine cervical screening visits. MethodsStage 1 (months 0-12): A three-stage electronic-Delphi consensus exercise will be performed to internationally agree the most important diagnostic criteria for LS. Participants will be a multidisciplinary expert panel including patients. Stage 2 (months 6-12): With input from healthcare professionals and patients, rewording of the agreed criteria will take place to ensure they are understood by non-specialists. Stage 3 (months 12-30): The reworded criteria will be tested in clinical practice via a multicentre diagnostic test accuracy study (cohort cross-sectional diagnostic accuracy design) involving 208 participants. Recruiting centres will be from UK and international centres. Cases will be women with a dermatologist's diagnosis of LS (reference standard). Non-cases will be women diagnosed with an alternative vulval skin condition. Index test will be diagnostic criteria agreed by the Delphi consensus panel. Multivariate logistic regression modelling will determine the best predictive model to diagnose LS. A diagnostic odds ratio will then be calculated. Stage 4 (months 30-48): An external validation study involving a further 208 participants. These will be recruited from specialist clinics in secondary care.Stage 5 (months 48-54): Development of user-friendly tool (e.g. flowchart available via a mobile app) for patients and non-experts to use to diagnose LS. Stage 6 (months 54-66): Early assessment of implementation (feasibility and practicality) of tool into primary care workflow during routine appointments and cervical screening visits.Impact and disseminationThis project will facilitate diagnosis of LS by patients and by non-specialists, enabling earlier appropriate treatment and referral. If the criteria can be successfully introduced into clinical workflow of primary care, particularly as an 'add on' during cervical screening, it can be utilised as a screening tool to pick up cases earlier. The Academic Health Services Network will support the route to become embedded in clinical practice.A robust dissemination plan including circulation of patient-friendly resources to patient groups, presentation at scientific conferences, peer reviewed publications, and social media campaigns will take place. Target groups will be health professionals, allied health professionals (including pharmacists, women's health physiotherapists) and workers in the beauty industry.

Lay abstract: The problemLichen Sclerosus (LS) is a common female genital (vulval) skin condition that impacts on daily living. Symptoms of itching and discomfort can make it difficult to sit, walk and go to the toilet. Having sex becomes painful. If not treated, LS can cause irreversible sticking together (scarring) of the vulval skin. These changes further impact on normal daily activities and quality of life. There is increased risk of cancer of the vulva in women with LS - up to 1 in 20. This is thought to occur more frequently in those who have not received adequate treatment. Whilst LS can be treated, it is often difficult to diagnose, especially for non-specialists. There are no specific checklists to guide doctors in what they should be looking for. This means that LS often goes under-recognised and undertreated. The solutionWe will create a checklist ('diagnostic criteria') to allow accurate diagnosis of LS based upon symptoms and visual changes. The checklist will be available for use by a range of health professionals (not only skin specialists) to diagnose LS as well as to help patients self-diagnose in the community.The planThe following steps will be taken to develop and test the checklist: International experts will be asked to agree a list of diagnostic criteria for LS in a consensus study. A study advisory group including patients and healthcare professionals will work together to write a Plain English description of the final list of criteria. The accuracy of the reworded LS criteria will be assessed in groups of women in the specialist outpatient clinic (diagnostic test accuracy study). The criteria will be further tested in a separate group of women in outpatient clinics (external validation). A flowchart will be developed for use by non-specialists and patients to help diagnose LS (diagnostic tool). Early work will be performed to look at the practicality of using this diagnostic tool in primary care and adding it to the national cervical screening programme. We will ensure that women of different ethnic backgrounds are included in the research as LS can appear differently depending upon skin tone. The result of this work, a diagnostic tool, needs to be relevant to women from all ethnicities.The research will be undertaken at a centre of excellence for research into skin diseases, the Centre of Evidence Based Dermatology at The University of Nottingham.Involvement of patients and the public A study advisory group including patients will be formed to help oversee this research including the following roles: Development of study protocol to ensure it is acceptable to participants. Writing the Participant Information Sheets to make certain they are easy to read and understand. Rewording final diagnostic criteria so that they can be understood by patients and the public. Contributing to reports and newsletters that will be used to share the results of this work to patients and the public. Acting as Research Champions to spread the word about this work. Impact of the workThis work will contribute to better diagnosis and earlier recognition of vulval LS. This will help patients to get the right treatment at the right time and therefore improve overall quality of life.The lead applicant will undertake specific training to develop the skills needed to complete the work and will continue to lead future research into vulval conditions on completion. She will work closely with the study advisory group and public contributors to ensure that results are widely disseminated to women, clinicians, researchers and those commissioning services.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: SKIN