Statement of clinical relevance
- •There is great heterogeneity in terms of the outcomes assessed in trials reporting dry mouth, highlighting the need for the development of a core outcome set. This would help in generating more comparable results across studies, improving clinical recommendations.
ABSTRACT
Objective
To develop a consensus-based core outcome set (COS) to be used in clinical trials
assessing dry mouth interventions.
Study design
Through two systematic reviews of the literature 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, May 2022 (n = 104) and ten dry mouth patients
at Cork University Dental School and Hospital, Republic of Ireland. Outcome domains
for which no consensus was reached were subsequently discussed in a second consensus
process led by a virtual Special Interest Group (SIG) of 11 oral medicine experts
from the World Workshop on Oral Medicine VIII dry mouth working group.
Results
After the two-step consensus process, consensus was reached for 12 dry mouth outcome
domains (salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, severity
of xerostomia, duration of xerostomia, overall impact of xerostomia, impact on physical
functioning, impact of hyposalivation on general health, impact on social activities,
quality of life, economic impact of dry mouth, patient satisfaction) to be included
in the final COS.
Conclusion
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.
KEY WORDS
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Article info
Publication history
Accepted:
December 28,
2022
Received in revised form:
December 26,
2022
Received:
November 2,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
