Evidence map›Paper›PMID 40737311›Full record

ArticlePloS one2025

Development of a core outcome set for trials for management of oral submucous fibrosis (OSFCOS): A consensus study protocol.

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

Abstract read
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Shailesh M GondivkarDepartment of Oral Medicine & Radiology, Government Dental College & Hospital, Nagpur, Maharashtra, India.ORCID https://orcid.org/0000-0003-0704-7509
Monal YuwanatiDepartment of Oral Pathology & Microbiology, Saveetha Dental College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.
Sachin C SarodeDepartment of Oral Pathology & Microbiology, Dr. D.Y. Patil Dental College & Hospital, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra State, India.
Amol R GadbailDepartment of Dentistry, Government Medical College & Hospital, Nagpur, Maharashtra State, India.
Vidya LoheDepartment of Oral Medicine & Radiology, Sharad Pawar Dental College & Hospital, DMIHER (Deemed to be University), Sawangi (M), Wardha, Maharashtra State, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectiveOur aim is to create a COS (OSFCOS) for efficacy trials that look at the management OSF.

methodsAn 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 & 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.

conclusionThis 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.

Indexed as

Oral Submucous FibrosisOutcome Assessment, Health CareConsensusConsensus Statements as TopicDelphi TechniqueHumansRandomized Controlled Trials as TopicResearch DesignSystematic Reviews as TopicTreatment Outcome

Identifiers

PMID40737311
PMCPMC12309984

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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.