![CORALS Logo](/content/images/450x1000/6282abba8283e.jpg)
Disease State: Lichen sclerosus
Background
Genital lichen sclerosus (LS) is an inflammatory skin condition that occurs in men, women and children. It is believed to affect at least 1% of women. The prevalence in men and children is unknown. In women, 3-5% go on to develop vulval malignancy, and treatment may reduce this risk. In addition, LS impacts psychosocial and sexual well-being. Published interventional randomized controlled trials are of poor methodological quality and difficult to combine in meta-analyses. This is partly due to lack of validated and agreed upon outcome measures to assess treatment response.
CORALS is a multistakeholder collaboration led by a steering group comprised of 13 health professionals, patients and researchers.
Project Goal
CORALS aims to establish a COS (Core Outcome Set) for interventional trials in LS. To date, consensus on the core domain set has been achieved. This involved an initial 3-stage delphi consensus process to shortlist outcome domains with 199 stakeholders from over 20 countries. Subsequent virtual consensus meetings were attended by 15 patients, 21 health professionals and 6 researchers from 13 international locations.
We will now proceed to develop core instruments for the final COS.
Project Lead
Rosalind Simpson
Rosalind Simpson
![Rosalind Simpson](/content/images/450x550/6282a41561e97.jpg)
Key Project Team Members:
(see CORALS - The University of Nottingham for full details of steering group)
Patient Representatives:
Suzanne von Seitzberg
Jaclyn Lanthier
Suzanne von Seitzberg
![Suzanne von Seitzberg](/content/images/450x550/6282a54700005.jpg)
Jaclyn Lanthier
![Jaclyn Lanthier](/content/images/450x550/6282a58bb27f8.jpg)
Clinical Representatives:
Ione Bissonnette
Gudula Kirtschig
Gitte Vittrup
Amanda Selk
David Foster
Angelo Augenti
Stefano Lauretti
Martin Promm
Ione Bissonnette
![Ione Bissonnette](/content/images/450x550/62b4c9192f32c.png)
Gudula Kirtschig
![Gudula Kirtschig](/content/images/450x550/6282a775e8ed2.jpg)
Gitte Vittrup
![Gitte Vittrup](/content/images/450x550/6282a7af247a5.jpg)
Amanda Selk
![Amanda Selk](/content/images/450x550/6282a7e64a73c.jpg)
David Foster
![David Foster](/content/images/450x550/6282a88a4caf2.jpg)
Angelo Augenti
![Angelo Augenti](/content/images/450x550/6282a8de40747.jpg)
Stefano Lauretti
![Stefano Lauretti](/content/images/450x550/6282a93bee36c.jpg)
Martin Promm
![Martin Promm](/content/images/450x550/6282a992762f0.jpg)
Researchers:
Kim Thomas
Kim Thomas
![Kim Thomas](/content/images/450x550/6272d375f39a8.jpg)
C3 Methods Partner:
Jan Kottner
![Jan Kottner](/content/images/450x550/6272a1d4f11b6.jpg)
Executive Committee
Contact:
Rosalind Simpson
corals@nottingham.ac.uk
CORALS - The University of Nottingham
Publications:
Foster DC, Stockdale CK, Simpson R, Kirtschig G. Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease. J Low Genit Tract Dis. 2017;21(3):163-165.
Updated on Date May 1, 2022