Improving the Evidence Base in Oral medicine

Abstract

Improving the Evidence Base in Oral Medicine Background: Oral medicine is a specialty that cares for patients with conditions of the oral and perioral region. A common group of these conditions are the oro-mucosal diseases which can cause oral ulceration with a wide spectrum of severity for patients leading to potentially significant morbidity and reduction in quality of life. Many of these conditions have no definitive treatment or cure, and as such the aim of management is to improve the patient’s condition whilst minimising risk from the treatments given. Evidence based practice is the cornerstone of clinical care. A systematic review of randomised controlled trials with meta-analyses of data, is highest level of evidence available, however, the issue of heterogeneity of outcome measures is often noted and meta-analyses are rarely achieved. To improve this, the development of core outcomes sets has been suggested. Through consensus of relevant stakeholders (including patients, clinicians, and researchers), an agreed set of outcomes is developed. This set of outcomes will then be measured in all future trials for a particular condition – the aim being to reduce heterogeneity and allow for meta- analyses. Objectives: To evaluate the evidence base of the management of four oral ulcerative conditions (Recurrent Aphthous Stomatitis (RAS), Oral Ulcers in Bechet’s Disease, Oral Mucous Membrane Pemphigoid, Oral Pemphigus Vulgaris) and to develop a core outcome set for use in interventional trials for RAS using an interactive consensus process Settings: Systematic reviews were carried out as part of the Cochrane Collaboration (Recurrent Aphthous Stomatitis (RAS) and Behçet’s Disease) and World Workshop of Oral Medicine (WWOM) (Pemphigus Vulgaris (PV), Mucous Membrane Pemphigoid (MMP)) Patient involvement in core outcome set development took place at the University of Manchester, UK in 2014. Consensus process, informed by the patient input and systematic reviews, took place at the British Society of Oral Medicine (BSOM) in Leeds, UK in 2015 Participants: Patients with a diagnosis of RAS who were attending the oral medicine department in Manchester, were involved in the patient information meeting. Delegates at the BSOM meeting attended the consensus process, including oral medicine specialists, dentists, dental hygienists, dental nurses and research academics. Design: Mixed methods, including systematic reviews, patient involvement and interactive consensus via clicker technology. Results: The four systematic reviews reported heterogeneity of outcomes and no meta-analyses were possible. The RAS patients identified six important outcomes for inclusion. Systematic review of 73 interventional randomised controlled trials for RAS revealed a total of 313 individual outcomes. This number was reduced to 22 by removing duplication and grouping similar outcomes into domains. Consensus process led to further agreement on the inclusion of 13 outcomes for the COS Conclusion: Interventional trials for oral conditions should adopt the use of a core outcome set so that future systematic reviews and meta-analyses can be carried out to provide clinicians with higher quality evidence base than is currently possible due to the heterogeneity of outcome measure used in trials. This project demonstrates a new process for gaining consensus for COS which avoids the need for large scale postal Delphi processes. With ongoing improvements in interactive online programmes, consensus processes will be easier to arrange and will allow for greater and wider participation.

Date of Award	1 Aug 2022
Original language	English
Awarding Institution	The University of Manchester
Supervisor	Tanya Walsh (Supervisor), Anne-Marie Glenny (Supervisor) & Paul Brocklehurst (Supervisor)