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Research Article|Articles in Press

World Workshop on Oral Medicine VIII: Development of a Core Outcome Set for Dry Mouth: A Systematic Review of Outcome Domains for Xerostomia.

Published:March 06, 2023DOI:https://doi.org/10.1016/j.oooo.2023.01.012

      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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