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

Q1 Medicine

Journal of oral biology and craniofacial research Pub Date : 2026-03-01 Epub Date: 2026-02-13 DOI:10.1016/j.jobcr.2026.101421

Shailesh M. Gondivkar , Amol R. Gadbail , Monal Yuwanati , Vidya Lohe , Sachin Sarode

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引用次数: 0

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.

查看原文本刊更多论文

OSFCOS：口腔黏膜下纤维化治疗临床试验的核心结局集。

背景：口腔粘膜下纤维化（OSF）显著影响口腔功能和生活质量，并且由于临床试验结果报告的异质性，对有效治疗评估提出了挑战。迄今为止，没有OSF试验的核心结局集（COS），导致结果报告的显著异质性和比较干预措施的困难。本研究旨在建立OSF评估标准（OSFCOS），以规范评估OSF管理的临床试验结果报告。方法：该研究遵循COMET和COS-STAD指南，分为四个阶段：对随机对照试验进行系统评价，以确定报告的结果；定性研究采用访谈和焦点小组与OSF患者，以获取患者优先的结果；对主要利益相关者（患者、临床医生、研究人员）进行两轮德尔菲调查；并召开一次共识会议，最终敲定核心成果。使用9分GRADE量表对结果进行评分，并使用标准阈值预先确定共识。结果：系统评价共获得20个结果，定性分析获得31个结果。经过三角化和细化，16个独特的结果在Delphi Round 1中被优先考虑（n = 45）。Delphi Round 2 （n = 25）评估了23个结果；达成“共识”有17个利益攸关方参加的协商一致会议审查了13项成果，并最终确定了OSFCOS的7项核心成果。结论：这是第一个专门为OSF开发的COS，为标准化结果报告、可比性和增强OSF试验中的数据综合提供了一个强大的、利益相关者驱动的框架，以更好地提供证据和患者护理。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of oral biology and craniofacial research Medicine-Otorhinolaryngology

CiteScore

4.90

自引率

0.00%

发文量

133

审稿时长

167 days

期刊介绍： Journal of Oral Biology and Craniofacial Research (JOBCR)is the official journal of the Craniofacial Research Foundation (CRF). The journal aims to provide a common platform for both clinical and translational research and to promote interdisciplinary sciences in craniofacial region. JOBCR publishes content that includes diseases, injuries and defects in the head, neck, face, jaws and the hard and soft tissues of the mouth and jaws and face region; diagnosis and medical management of diseases specific to the orofacial tissues and of oral manifestations of systemic diseases; studies on identifying populations at risk of oral disease or in need of specific care, and comparing regional, environmental, social, and access similarities and differences in dental care between populations; diseases of the mouth and related structures like salivary glands, temporomandibular joints, facial muscles and perioral skin; biomedical engineering, tissue engineering and stem cells. The journal publishes reviews, commentaries, peer-reviewed original research articles, short communication, and case reports.