{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T07:15:40Z","timestamp":1792134940447,"version":"4.4.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,1,26]],"date-time":"2023-01-26T00:00:00Z","timestamp":1674691200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To obtain international agreement on which outcome domains should be measured in interventional trials of genital LS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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 \u2018critical\u2019 and were discussed at the online consensus meetings. The first set of consensus meetings involved 42 participants from 12 countries. Consensus was met for \u2018symptoms\u2019 (100% agreed) and \u2018QoL \u2013 LS-specific\u2019 (92% agreed). After the second set of meetings, involving 29 participants from 12 countries, \u2018clinical (visible) signs\u2019 also met consensus (97% agreed).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljac145","type":"journal-article","created":{"date-parts":[[2023,1,27]],"date-time":"2023-01-27T03:50:27Z","timestamp":1674791427000},"page":"628-635","source":"Crossref","is-referenced-by-count":20,"title":["Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement"],"prefix":"10.1093","volume":"188","author":[{"given":"Rosalind C","family":"Simpson","sequence":"first","affiliation":[{"name":"Centre of Evidence Based Dermatology, University of Nottingham , Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gudula","family":"Kirtschig","sequence":"additional","affiliation":[{"name":"Medbase Health Centre , Frauenfeld , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Selk","sequence":"additional","affiliation":[{"name":"University of Toronto , Toronto, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"von Seitzberg","sequence":"additional","affiliation":[{"name":"The Danish Lichen Sclerosus Association , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gitte","family":"Vittrup","sequence":"additional","affiliation":[{"name":"North Denmark Regional Hospital , Hjoerring , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ione","family":"Bissonnette","sequence":"additional","affiliation":[{"name":"CNM, MSN, co-author of https:\/\/VulvovaginalDisorders.org , Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Kottner","sequence":"additional","affiliation":[{"name":"Charit\u00e9-Universit\u00e4tsmedizin , Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaclyn","family":"Lanthier","sequence":"additional","affiliation":[{"name":"Patient Representative & The Lost Labia Chronicles (https:\/\/www.lostlabia.com\/)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Stanton","sequence":"additional","affiliation":[{"name":"Patient Representative"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Foster","sequence":"additional","affiliation":[{"name":"University of Rochester , Rochester, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Promm","sequence":"additional","affiliation":[{"name":"Department of Pediatric Urology and Regensburg University , Regensburg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Augenti","sequence":"additional","affiliation":[{"name":"S. Caterina della Rosa Genital Surgery , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Lauretti","sequence":"additional","affiliation":[{"name":"S. Caterina della Rosa Genital Surgery , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7785-7465","authenticated-orcid":false,"given":"Kim S","family":"Thomas","sequence":"additional","affiliation":[{"name":"Centre of Evidence Based Dermatology, University of Nottingham , Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Core Outcomes for Research in Lichen Sclerosus (CORALS) initiative steering group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,1,26]]},"reference":[{"issue":"132","key":"2023100619300741800_ljac145-B1","article-title":"Developing core outcome sets for clinical trials: issues to consider","volume":"13","author":"Williamson","year":"2012","journal-title":"Trials"},{"issue":"39","key":"2023100619300741800_ljac145-B2","article-title":"Standardising outcomes for clinical trials and systematic reviews","volume":"8","author":"Clarke","year":"2007","journal-title":"Trials"},{"key":"2023100619300741800_ljac145-B3","author":"Core Outcome Measures in Effectiveness Trials (COMET)"},{"key":"2023100619300741800_ljac145-B4","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1038\/s41390-018-0041-9","article-title":"Developing core outcome set for women\u2019s, newborn, and child health: the CROWN Initiative","volume":"84","author":"Molloy","year":"2018","journal-title":"Pediatr Res"},{"key":"2023100619300741800_ljac145-B5","author":"The CHORD COUSIN Collaboration (C3)"},{"key":"2023100619300741800_ljac145-B6","doi-asserted-by":"crossref","first-page":"987","DOI":"10.1111\/bjd.20050","article-title":"Core outcome set implementation supported by the BJD","volume":"184","author":"Veysey","year":"2021","journal-title":"Br J Dermatol"},{"key":"2023100619300741800_ljac145-B7","doi-asserted-by":"crossref","first-page":"494","DOI":"10.1111\/bjd.12391","article-title":"Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials","volume":"169","author":"Simpson","year":"2013","journal-title":"Br J Dermatol"},{"key":"2023100619300741800_ljac145-B8","first-page":"477","article-title":"Prevalence of vulvar lichen sclerosus in a general gynecology practice","volume":"50","author":"Goldstein","year":"2005","journal-title":"J Reprod Med"},{"key":"2023100619300741800_ljac145-B9","doi-asserted-by":"crossref","first-page":"787","DOI":"10.1111\/bjd.12137","article-title":"Quality of life in Dutch women with lichen sclerosus","volume":"168","author":"Lansdorp","year":"2013","journal-title":"Br J Dermatol"},{"key":"2023100619300741800_ljac145-B10","doi-asserted-by":"crossref","first-page":"e1\u201343","DOI":"10.1111\/jdv.13136","article-title":"Evidence-based (S3) guideline on (anogenital) lichen sclerosus","volume":"29","author":"Kirtschig","year":"2015","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2023100619300741800_ljac145-B11","doi-asserted-by":"crossref","first-page":"1998","DOI":"10.1002\/ijc.30621","article-title":"Lichen sclerosus and risk of cancer","volume":"140","author":"Halonen","year":"2017","journal-title":"Int J Cancer"},{"key":"2023100619300741800_ljac145-B12","doi-asserted-by":"crossref","first-page":"1224","DOI":"10.1158\/1055-9965.EPI-16-0019","article-title":"Lichen sclerosus: incidence and risk of vulvar squamous cell carcinoma","volume":"25","author":"Bleeker","year":"2016","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2023100619300741800_ljac145-B13","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1111\/j.1479-828X.2007.00725.x","article-title":"The impact of chronic vulval pain on quality of life and psychosocial well-being","volume":"47","author":"Sargeant","year":"2007","journal-title":"Aust N Z J Obstet Gynaecol"},{"key":"2023100619300741800_ljac145-B14","first-page":"109","article-title":"Predictors of psychological well-being in a sample of women with vulval pain","volume":"54","author":"Sargeant","year":"2009","journal-title":"J Reprod Med"},{"key":"2023100619300741800_ljac145-B15","doi-asserted-by":"crossref","first-page":"909","DOI":"10.1111\/bjd.21777","article-title":"Living with vulval lichen sclerosus: a qualitative interview study","volume":"187","author":"Arnold","year":"2022","journal-title":"Br J Dermatol"},{"key":"2023100619300741800_ljac145-B16","article-title":"Topical interventions for genital lichen sclerosus","volume":"12","author":"Chi","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"2023100619300741800_ljac145-B17","doi-asserted-by":"crossref","first-page":"1236","DOI":"10.1111\/bjd.17447","article-title":"; Lichen Sclerosus Priority Setting Partnership Steering Group. 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