ArticleJournal of oral biology and craniofacial research
OSFCOS: A core outcome set for clinical trials on oral submucous fibrosis management.
Article in Journal of oral biology and craniofacial research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.