Background
Xerostomia refers to the subjective complaint of oral dryness, while salivary gland hypofunction (SGH) refers to an objective limitation in the quantity of saliva produced. The complaint of dry mouth which includes both conditions is common; with the reported prevalence of both xerostomia and SGH being as high as 40% in some published studies. SGH may be as a result of an underlying systemic disease and it is a known adverse effect of over 500 medications. Quality and quantity of saliva is important in maintaining the health of the hard and soft tissues of the oral cavity. The reduced quality of life reported in patients with dry mouth indicates its impact beyond the confines of the oral cavity. There are currently no standardised outcome measures for the assessment of dry mouth and no strong evidence to support any topical or systemic interventions available. The development of a core outcome set (COS) for dry mouth would facilitate meta-analysis leading to the establishment of more robust evidence (good quality studies with comparable results) for the management of dry mouth and hence improved patient care.
Aim
The aim of this study is to develop a COS for dry mouth.
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 from a systematic review of the literature
Further outcomes of importance - qualitative methods, engaging with key stakeholders including patients, clinicians, researchers, Federal healthcare and funding agencies, and industry.
Delphi survey to select a COS.
Consensus meeting to finalise the COS for dry mouth
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.
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: Dry mouth
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- 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
Brief description of 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 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 dry mouth. This work will be undertaken under the direction of the World Workshop on Oral Medicine.