Objective: A core outcome set (COS) is the minimum agreed-on data set required to be measured in interventional trials. To date, there is no COS for oral lichen planus (OLP). This study describes the final consensus project that brought together the results of the previous stages of the project to develop the COS for OLP.
Study design: The consensus process followed the Core Outcome Measures in Effectiveness Trials guidelines and involved the agreement of relevant stakeholders, including patients with OLP. Delphi-style clicker sessions were conducted at the World Workshop on Oral Medicine VIII and the 2022 American Academy of Oral Medicine Annual Conference. Attendees were asked to rate the importance of 15 outcome domains previously identified from a systematic review of interventional studies of OLP and a qualitative study of OLP patients. In a subsequent step, a group of OLP patients rated the domains. A further round of interactive consensus led to the final COS.
Results: The consensus processes led to a COS of 11 outcome domains to be measured in future trials on OLP.
Conclusion: The COS developed by consensus will help reduce the heterogeneity of outcomes measured in interventional trials. This will allow future pooling of outcomes and data for meta-analyses. This project showed the effectiveness of a methodology that could be used for future COS development.
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)
Disease Category: Dentistry & oral health
Disease Name: Oral lichen planus
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- 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.