Understanding the lived experience and unmet needs of CHILdren and young people with Lichen sclerosus and their parents/carers (CHILL)

Research questions What are the obstacles and facilitators to diagnosis and treatment adherence for children/young people with vulval lichen sclerosus (VLS) and their parents/carers? What are the unmet care, support, and information needs of children/young people with VLS and their parents/carers? What is the lived experience of children/young people with VLS and their parents/carers?

Background Vulval lichen sclerosus (VLS) is a dermatosis typically affecting the vulval and perianal skin, causing intense pruritus, dysuria, and impacting many domains of quality of life and activities of daily living such as toileting, exercising, and sitting for long periods.

VLS is considered a lifelong chronic flaring and remitting condition, requiring long-term treatment of topical corticosteroids.

Without treatment, complications include distressing loss of normal anatomy, vulval cancer, changes to sexual function, and complicated pregnancy/childbirth. Lichen sclerosus (LS) can affect anyone of any age, and VLS is estimated to affect one in 900 premenarchal girls. This study is about LS in children and young people assigned female at birth.

There is no existing literature exploring the experiences of children and young people with VLS or their parents/carers. This means there is no evidence base upon which to develop interventions or identify ways to support them.

Aims and objectives To understand the experiences and perceptions of children/young people with VLS and their parents/carers, and improve information provision to support diagnosis and treatment adherence Objectives: Recruit an ethnically diverse group of children/young people with VLS and their parents/carers Create multimedia content aimed at patients, carers, and healthcare professionals based on the findings Identify (areas for) intervention development to improve patient experience and outcomes Methods Participants in this study will be children/young people with VLS (aged 5-17) and adult primary carers of children/young people with VLS.

This will be a qualitative study using interviews and an online survey. Interviews with children will utilise play activities which aid rapport, and elicit children s experiences.

Young people can take part in interviews or, if they wish to remain anonymous, respond to an anonymous qualitative survey. Adults will participate in semi-structured interviews. Participants will be recruited through NHS secondary care clinics or through social media or support groups. Age-appropriate video recruitment material will be developed to facilitate recruitment.

Patients, carers, and the public (PPI) will be involved throughout the study.

We have four PPI representatives on the team who will attend monthly SMGs, and we will consult regularly with young people through already-existing local groups. Timeline This is a 15-month project, starting August 2024.

Months 1-3 Development of protocol and multimedia recruitment material, gain ethics approval Months 4-12 Recruitment, data collection (analysis concurrent) Months 12-15 Analysis, write-up, dissemination Anticipated impact and dissemination This will be a seminal study providing the first rigorous evidence about this patient group s experience, influencing future research funding applications, development of interventions, and service design.

As it is exploratory the impact will be determined by the findings. We will include an arts-based approach to create impact. The study will maximise findings of a funded NIHR trial comparing treatment regimens.