Core Outcomes for Research in Lichen Sclerosus (CORALS)

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.

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.

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.