OSFCOS: A core outcome set for clinical trials on oral submucous fibrosis management

Oral Submucous Fibrosis (OSF) significantly impacts oral function, quality of life and poses challenges for effective treatment evaluation due to heterogeneity in outcome reporting across clinical trials. To date, no core outcome set (COS) exists for OSF trials, leading to significant heterogeneity in outcome reporting and difficulty in comparing interventions. This study aimed to develop a COS for OSF (OSFCOS) to standardize outcome reporting in clinical trials evaluating OSF management.

The study followed COMET and COS-STAD guidelines and involved four stages: a systematic review of randomized controlled trials to identify reported outcomes; qualitative research using interviews and focus groups with OSF patients to capture patient-prioritized outcomes; a two-round Delphi survey with key stakeholders (patients, clinicians, researchers); and a consensus meeting to finalize core outcomes. Outcomes were rated using a 9-point GRADE scale, and consensus was predefined using standard thresholds.

A total of 20 outcomes were identified from systematic review and 31 from qualitative analysis. After triangulation & refinement, 16 unique outcomes were prioritized in Delphi Round 1 (n = 45). Delphi Round 2 (n = 25) rated 23 outcomes; 10 reached "consensus in." A consensus meeting with 17 stakeholders reviewed 13 outcomes and finalized 7 core outcomes for OSFCOS.

This is the first COS developed specifically for OSF that offers a robust, stakeholder-driven framework for standardized outcome reporting, comparability and enhancing data synthesis in OSF trials for better evidence generation and patient care.