World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a consensus study

Sven Eric Niklander; Melanie Louise Simms; Paswach Wiriyakijja; Alan Roger Santos-Silva; Michal Kuten-Shorrer; Vidya Sankar; Alexander Ross Kerr; Siri Beier Jensen; Richeal Ni Riordain; Alessandro Villa; Konstantina Delli

doi:10.1016/j.oooo.2022.12.016

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a consensus study

Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Jun;135(6):885-892. doi: 10.1016/j.oooo.2022.12.016. Epub 2023 Mar 1.

Affiliations

¹ Unit of Oral Pathology and Medicine, Faculty of Dentistry, Universidad Andres Bello, Viña del Mar, Chile. Electronic address: Sven.niklander@unab.cl.
² Department of Oral Medicine, University Dental Hospital, Cardiff, United Kingdom.
³ Department of Oral Medicine, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand; Center of Excellence in Genomics and Precision Dentistry, Chulalongkorn University, Bangkok, Thailand.
⁴ Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas (UNICAMP), Campinas, Brazil.
⁵ Eastman Institute for Oral Health, University of Rochester Medical Center, Rochester, NY, USA.
⁶ Department of Diagnostic Sciences, Tufts University School of Dental Medicine, Boston, MA, USA.
⁷ Department of Oral and Maxillofacial Pathology, Radiology and Medicine, New York University, New York, New York, USA.
⁸ Head of Department, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.
⁹ College of Medicine and Health, Cork University Dental School and Hospital, University College Cork, Cork, Ireland.
¹⁰ Oral Oncology and Dentistry, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA; Department of Orofacial Sciences University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.

PMID: 37045698
DOI: 10.1016/j.oooo.2022.12.016

Abstract

Objective: This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions.

Study design: Through 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group.

Results: After the 2-step consensus process, a consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of xerostomia, duration of xerostomia, the overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS.

Conclusions: We propose a consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Delphi Technique
Humans
Outcome Assessment, Health Care
Patient Satisfaction
Quality of Life*
Research Design
Salivary Glands
Treatment Outcome
Xerostomia* / therapy