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.
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.
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.
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’.
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.
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Accepted: December 15, 2022
Received in revised form: November 25, 2022
Received: November 2, 2022
Publication stageIn Press Journal Pre-Proof
© 2023 Published by Elsevier Inc.