Centre of Evidence Based Dermatology
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Core Outcomes for Research in Lichen Sclerosus (CORALS)

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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.

If you would like to participate in CORALS, please complete this really short survey to express your interest
 
 

Participant Information Sheets

We have produced these participant information sheets in several different languages.

 
 


Key Information

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?
This study is funded by a pump-priming award from the UK Dermatology Clinical Trials Network (UK DCTN).
 

 

Steering Group BiographiesProtocol
If you would like more information please contact us.

 

Partner Organisations

  • UK Dermatology Trials Network (UK DCTN) (funders) 
  • International Society for study of Vulvovaginal Disease (ISSVD)
  • British Society for Study of Vulval Disease (BSSVD)

Centre of Evidence Based Dermatology

The University of Nottingham
King's Meadow Campus
Lenton Lane
Nottingham, NG7 2NR


telephone: +44 (0) 115 823 1048
email:cebd@nottingham.ac.uk