Statement of clinical relevance
-
There is a high variability in outcome domains and measures used in the assessment of xerostomia, highlighting the need to develop a core outcome set to harmonize evidence to better inform clinical decision-making for dry mouth management.
ABSTRACT
Objective
The purpose of this study was to identify all outcome domains utilized in clinical
studies of xerostomia, i.e. subjective sensation of dry mouth. This study is part
of the extended project ‘World Workshop on Oral Medicine Outcomes Initiative for the
Direction of Research (WONDER)’ to develop a core outcome set (COS) for dry mouth.
Study design
A systematic review was performed on MEDLINE, EMBASE, CINAHL and Cochrane Central
Register of Controlled Trials databases. All clinical and observational studies that
assessed xerostomia in human subjects from 2001 to 2021 were included. Information
on outcome domains was extracted and mapped to the Core Outcome Measures in Effectiveness
Trials (COMET) taxonomy. Corresponding outcome measures were summarized.
Results
From a total of 34,922 records retrieved, 688 articles involving 122,151 persons with
xerostomia were included. There were 16 unique outcome domains and 166 outcome measures
extracted. None of these domains or measures was consistently utilized across all
the studies. Severity of xerostomia and physical functioning were the two most frequently
assessed domains.
Conclusion
There is considerable heterogeneity in outcome domains and measures reported in clinical
studies of xerostomia. This highlights the need for harmonization of dry mouth assessment
in order to enhance comparability across studies and facilitate synthesis of robust
evidence for the management of patients with xerostomia.
Key words
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