Core Outcomes for Research in Lichen Sclerosus (CORALS)
Lichen sclerosus (LS) is a chronic genital condition which can cause significant symptoms, interferes with day to day life and has a substantial impact on quality of life.
The Core Outcomes for Research in Lichen Sclerosus (CORALS) project will establish the most important outcomes to measure in future trials of genital lichen sclerosus.
A recording of the project group meeting held in September 2021 is available to watch online.
Progress to date
In 2021 we completed 3 rounds of the CORALS surveys. A huge thank you to everyone that participated!
Two virtual sessions were held in January 2022 to vote upon the final 'core domains' for future lichen sclerosus research studies. Further meetings took place in May/June 2022 where we concluded the process of agreeing core outcome domains. The international community of patients and their carers, health professionals and researchers, have concluded that all future lichen sclerosus clinical trials should measure SIGNS, SYMPTOMS and QUALITY OF LIFE in their outcomes. Please see our full published report in the British Journal of Dermatology.
We have now begun the process of determining which instruments should be used for these domains. Each domain will have its own group to lead the work needed to complete the process. Please see below for further details.
• Signs – working group composition in progress
• Symptoms – working group led by Professor Catherine Leclair and Dr Erin Foster
• Quality of Life – working group composition in progress
Opportunity to Take Part
We aim to involve a mixture of patients, patient representatives, health professionals and researchers from across the world in the development of the lichen sclerosus core outcome set. If you would like to become involved in the CORALS project, please email email@example.com.
Participant Information Sheets
We have produced these participant information sheets in several different languages.
Why are we doing this project?
Published randomised controlled trials of treatments for LS use different ways of measuring response to treatments (outcomes). This prevents the results of trials from being combined. If trial results were combined, we would have stronger evidence on which to base treatment making decisions. The CORALS project aims to obtain international agreement on what aspects of disease (‘domains’) should be measured in clinical trials of LS. These core domains will subsequently inform an international ‘core outcome set’ for use in all future LS trials.
What will the research involve?
In this project we will:
1. Review the most up to date literature for lichen sclerosus to see what aspects of disease (‘domains’) have been measured previously. We will create a long list of domains.
2. Obtain consensus from international stakeholders (including patients, health professionals, researchers, journal editors, industry representatives) via an online survey on the most important of these domains to create a short list.
3. At a face-to-face meeting, agree the final outcome domains which are considered to be ‘core’ to all future trials of lichen sclerosus.
What will happen with the results?
The results of this work will be used to prepare the next steps of Core Outcome Set development. For each of the agreed core outcome domains, it needs to be established how best to measure the domain. Outcome measurement instruments therefore need to be selected. Once the final Core Outcome Set has been agreed, the hope is that researchers will use it in all studies for Lichen Sclerosus (researchers can still add in other outcomes if they wish). If all future studies have standardised outcomes in this way, their results can be combined and it will be easier to determine which treatments are best.
The results will be shared through networks with patient and professional groups, as well as presentation at conferences and publication in scientific journals.
Who is funding the project?
Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement Rosalind C Simpson, Gudula Kirtschig, Amanda Selk, Suzanne von Seitzberg, Gitte Vittrup, Ione Bissonnette, Jan Kottner, Jaclyn Lanthier, Chris Stanton, David Foster, Martin Promm, Angelo Augenti, Stefano Lauretti, Kim S Thomas, British Journal of Dermatology, Volume 188, Issue 5, May 2023, Pages 628–635,
Steering Group BiographiesProtocol
If you would like more information please contact us.
- UK Dermatology Trials Network (UK DCTN) (funders)
- International Society for study of Vulvovaginal Disease (ISSVD)
- British Society for Study of Vulval Disease (BSSVD)