Establishing Effective Diagnostic Criteria for Lichen Sclerosus (SHELLS)
Lichen Sclerosus (LS) is a common female genital (vulval) skin condition which can cause significant symptoms, interferes with daily living, and has a substantial impact on quality of life.
The James Lind Alliance Lichen Sclerosus Priority Partnership which was led by Dr Rosalind Simpson to completion in 2018, involved over 960 patients and health professionals to internationally agree the ‘Top 10’ research priorities for LS. ‘What is the best way to diagnose lichen sclerosus’ was a shared priority voted 2nd within the overall ‘Top 10’, and this is what we aim to address in the SHELLS study.
So far, an e-Delphi consensus study has been undertaken, wherein a group of international experts have agreed the diagnostic criteria for lichen sclerosus that will allow the accurate diagnosis of LS based upon symptoms and visual changes. The accuracy of this will be tested in the next part of the research (SHELLS) with participants across specialist vulval outpatient clinics. By the end of this study, 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.
Study objectives
Primary objective:
- Test expert-agreed vulval LS diagnostic criteria in UK clinical practice using a cross-sectional diagnostic accuracy study involving patients with vulval skin disorders.
Secondary objectives:
- Develop a training manual to be used alongside the diagnostic tool to support its use.
- Assess feasibility and understanding of the implementation of the tool in primary care.
Opportunity to take part
The SHELLS project involves close collaboration with patients and the public. A study advisory group including patients will oversee this research and help inform decision making throughout the project. They will help with several roles such as development of the study protocol, writing of the participant information sheets, rewording the final diagnostic criteria so they can be understood by patients and the public, and contributing to reports and newsletter that will be used to share results and spread the word about this work.
If you would like to become involved in the SHELLS project, please get in touch.
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Research Progress
Current Stage:
Open to recruitment
The SHELLS study is open to recruitment!
We are now in the process of continuing to open all of our research sites across the UK.
We have finished preparing the study documents and gained ethics approvals. This included the protocol, consent forms and participant information sheets, which our study advisory group provided their valuable support and feedback with.
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Key information
Why are we doing this project?
Lichen sclerosus can be 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. There is increased risk of cancer of the vulva in women with LS and this is thought to occur more frequently in those who have not received adequate treatment. The SHELLS project aims to develop a checklist of diagnostic criteria to help a range of health professionals to diagnose LS as well as to help patients self-diagnose in the community.
What will the research involve?
- 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.
- Current Stage (2024-2026) - The accuracy of the reworded LS criteria will be assessed in groups of women in the specialist outpatient clinic (diagnostic test accuracy study).
- 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.
What will happen with the results?
This project will contribute to better diagnosis and earlier recognition of vulval LS. This will help patients get the right treatment at the right time and therefore improve overall quality of life.
The results will be widely disseminated to women, clinicians, researchers and those commission services. The results will be shared through networks with patient and professional groups, as well as presentations at conferences and publication in scientific journals.
Who is funding the project?
The National Institute for Health and Care Research is funding this research project as part of an advanced research fellowship.