Statement of Clinical Relevance
- •Given considerable variability in outcomes and outcome measures to assess salivary gland hypofunction, a core outcome set would improve standardization of reporting and facilitate meta-analyses, to establish more robust evidence for the management of dry mouth and improved patient care.
Abstract
Objective
To identify all outcome measures used to assess salivary gland hypofunction (i.e.:
objective measures used to determine actual changes in saliva quantity or to assess
response to treatment of salivary gland hypofunction) and to group these into domains.
Study Design
A systematic review including clinical trials, and prospective or retrospective observational
studies involving human participants with dry mouth, with any type of intervention
where objective assessment of salivary gland hypofunction was described.
Results
Five hundred fifty-three studies involving 31,507 participants were identified. The
majority assessed both salivary gland hypofunction and xerostomia (68.7%), whilst
31.3% assessed salivary gland hypofunction alone. The majority of studies investigated
‘amount of saliva’ and the highest number of outcome measures was within the domain
‘clinical/objective signs of salivary gland hypofunction’.
Conclusions
Seven domains encompassing 30 outcome measures were identified, confirming the diversity
in outcomes and outcome measures used in research regarding salivary gland hypofunction.
Identified items will be used in conjunction with those identified regarding xerostomia
to create a COS for dry mouth quantification for use in future clinical trials, with
the overall goal of improving the standardization of reporting, leading to the establishment
of more robust evidence for the management of dry mouth and improving patient care.
Key words
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Article info
Publication history
Accepted:
December 15,
2022
Received in revised form:
November 25,
2022
Received:
November 2,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Published by Elsevier Inc.
