Development of a core outcome set for oral lichen planus: a consensus study

Background:
Oral lichen planus (OLP) is a chronic immune-mediated inflammatory condition of the oral mucosa, which can result in painful intraoral lesions with significant impact on oral function and activities of daily living. OLP is considered an oral potentially malignant disorder with an increased risk of transformation to squamous cell carcinoma reported in the literature. A lack of consensus regarding clinician and patient reported outcomes in the OLP literature has been highlighted in several publications. The development of a core outcome set (COS) for OLP would facilitate meta-analysis leading to the establishment of more robust evidence (i.e. good qualitive studies with comparable outcome measures) for the management of OLP and hence improved patient care.

Aim:
The aim of this study is to develop a COS for OLP.

Methods:
The COS will be developed using methodology reflecting the four steps outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.
Potential outcomes identified - systematic review of the literature
Further outcomes of importance - qualitative methods with key stakeholders (patients, clinicians, researchers, Federal healthcare and funding agencies, and industry)
Reviewed using a Delphi survey to select a COS
Consensus meeting to finalise the COS for OLP

Dissemination:
The COS will be disseminated via the World Workshop on Oral Medicine as part of the WONDER - World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research and by publication in peer-reviewed journals.

Contributors

The Steering Committee and External Advisory Board of the World Workshop on Oral Medicine -
Arwa Farag (Department of Oral Diagnostic Sciences, Faculty of Dentistry, King AbdulAziz University, Jeddah/ Tufts School of Dental Medicine)
Tim Hodgson (Eastman Dental Hospital, University College Hospitals NHS Foundation Trust)
Catherine Hong Hsu Ling (Faculty of Dentistry, National University of Singapore)
Siri Beier Jensen (Department of Dentistry and Oral Health, Aarhus University)
Ross Kerr (New York University College of Dentistry)
Giovanni Lodi (Department of Biomedical, Surgical and Dental Sciences Università degli Studi di Milano)
Richeal Ni Riordain (Cork University Dental School, University College Cork/ Eastman Dental Institute, University College London)
Thomas Sollecito (School of Dental Medicine University of Pennsylvania)
Martin Greenberg(School of Dental Medicine University of Pennsylvania)
Peter Lockhart (Department of Oral Medicine, Carolinas Medical Center)
Douglas Peterson (School of Dental Medicine, Neag Comprehensive Cancer Center Connecticut)

Publication

Journal: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Volume: 135
Issue: 6
Pages: 792 - 803
Year: 2023
DOI: 10.1016/j.oooo.2023.01.013

Further Study Information

Current Stage: Completed
Date: April 2020 - April 2024
Funding source(s): To be confirmed


Health Area

Disease Category: Dentistry & oral health

Disease Name: Oral lichen planus

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review

The COS will be developed using methodology reflecting the four steps outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Potential outcomes will be initially identified from a systematic review of the literature. Further outcomes of importance will be determined via qualitative methods, engaging with key stakeholders including patients, clinicians, researchers, Federal healthcare and funding agencies, and industry. The outcomes identified will subsequently be reviewed using a Delphi survey to select a COS. A face-to-face meeting with representatives from all stakeholders will be held to finalise the COS for OLP. This work will be undertaken under the direction of the World Workshop on Oral Medicine.