{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T15:17:37Z","timestamp":1774279057226,"version":"3.50.1"},"reference-count":20,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T00:00:00Z","timestamp":1753833600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>The effectiveness of oral submucous fibrosis (OSF) treatment is currently assessed with a broad range of clinical outcome measures. This heterogeneity complicates study comparison, synthesis of results, and evidence-based clinical practice guideline development. A core outcome set (COS) is a set of agreed, standardized outcomes that will be measured and reported across all clinical trials for a particular condition.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Objective<\/jats:title>\n<jats:p>Our aim is to create a COS (OSFCOS) for efficacy trials that look at the management OSF.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Methods<\/jats:title>\n<jats:p>An initial list of the potentially relevant outcomes will be drawn by a systematic review of randomized controlled trials focused on OSF treatment. An e-Delphi process will be done to obtain agreement among important stakeholders. The stakeholders will consist of OSF patients, members of the Indian Academy of Oral Medicine &amp; Radiology, the representatives from the Indian Dental Association, clinical researchers, and other oral health specialists. Participants will be asked to rate the importance of each outcome on a structured online questionnaire. Participants will also be allowed to propose new outcomes in Round 1. Feedback and the aggregated scores will be given in later rounds to guide re-rating. If after the second round, there is still no consensus, a third round will be taken.Final consensus on outcome inclusion will be determined based on predefined criteria.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>This protocol outlines a structured, inclusive approach to developing a core outcome set for OSF. The finalized OSFCOS will be made publicly available to guide outcome selection in clinical trials, improve the quality of systematic reviews, and support evidence-based clinical recommendations for the treatment of OSF.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0325158","type":"journal-article","created":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T17:35:33Z","timestamp":1753896933000},"page":"e0325158","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["Development of a core outcome set for trials for management of oral submucous fibrosis (OSFCOS): A consensus study protocol"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0704-7509","authenticated-orcid":true,"given":"Shailesh 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