Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement.

BACKGROUND: Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life (QoL). It causes progressive anatomical changes and a potential risk of cancer. Published randomized controlled trials are of varying methodological quality and difficult to combine in meta-analyses. This is partly due to lack of agreed outcome measures to assess treatment response. Identification of core outcome sets (COSs), which standardize key outcomes to be measured in all future trials, is a solution to this problem. OBJECTIVES: To obtain international agreement on which outcome domains should be measured in interventional trials of genital LS. METHODS: Recommended best practice for COS domain development was followed: (i) identification of potential outcome domains: a long list was generated through an up-to-date LS literature search, including information collected during the LS priority-setting partnership; (ii) provisional agreement of outcome domains: a three-stage multi-stakeholder international electronic-Delphi (e-Delphi) consensus study; (iii) final agreement of outcome domains: online consensus meeting with international stakeholders including anonymized voting. RESULTS: In total, 123 participants (77 patients, 44 health professionals, 2 researchers) from 20 countries completed three rounds of the e-Delphi study. Eleven outcome domains were rated as 'critical' and were discussed at the online consensus meetings. The first set of consensus meetings involved 42 participants from 12 countries. Consensus was met for 'symptoms' (100% agreed) and 'QoL - LS-specific' (92% agreed). After the second set of meetings, involving 29 participants from 12 countries, 'clinical (visible) signs' also met consensus (97% agreed). CONCLUSIONS: The international community has agreed on three key outcome domains to measure in all future LS clinical trials. We recommend that trialists and systematic reviewers incorporate these domains into study protocols with immediate effect. CORALS will now work with stakeholders to select an outcome measurement instrument per prioritized core domain.

The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial.

INTRODUCTION: Lichen sclerosus (LS) can affect sexuality and quality of life (QoL). OBJECTIVE: The aim of the study was to evaluate the impact of psychosexual counseling in women with LS. MATERIALS AND METHODS: One hundred fifty-eight women 18 years or older, newly diagnosed with LS, and referred to North Denmark Regional Hospital from January 2018 to November 2019 were included. The women were randomized in a 1:1 ratio to usual care or an intervention group receiving usual care and up to 8 individual consultations with a specialist in sexual counseling. Spouses or partners were encouraged to participate. The women filled out the questionnaires Female Sexual Function Index (FSFI), Dermatology Life Quality Index, and the WHO-5 Well-Being Index at baseline and after 6 months. RESULTS: The controls presented a mean score of 14.8 ± 8.7 and the intervention group presented a mean score of 12.8 ± 8.9 at FSFI. At follow-up, the controls had an FSFI score of 15.2 ± 9.2 and the intervention group revealed an FSFI score of 18.3 ± 9.5. Both groups experienced improved sexual functioning and for the intervention group the increase was significant ( p < .001).At baseline, the Dermatology Life Quality Index mean score was 8.9 ± 5.6 for the control group and 9.3 ± 6.1 for the intervention group. At follow-up, the controls revealed a score of 8.6 ± 5.5 and the intervention group a score of 6.8 ± 5.8. The intervention group reached a significantly higher degree of QoL than the controls ( p = .008). CONCLUSIONS: Psychosexual counseling has a significant impact on sexual functioning and QoL in women with LS.