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Objective: We conducted a qualitative study of patients’ perspectives on dry mouth outcomes to explore their personal experiences and investigate which outcomes are most important to them. This work was part of the WONDER initiative (World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research) exploring Core Outcome Measures in Effectiveness Trials.Study Design: Using a study-specific topic guide, we conducted digitally recorded, semi-structured interviews of focus groups of patients with dry mouth secondary to Sjögren syndrome and head and neck radiotherapy. We conducted interviews until data saturation had been achieved and evaluated all transcripts for accuracy before we anonymized the data.Results: Two focus groups consisting of 4 participants per group identified 4 distinct themes: (1) impact on oral health and function, (2) social isolation and withdrawal, (3) frustration with dry mouth management, and (4) limited knowledge of the medical community and lack of understanding of family and friends.Conclusions: The diversity of self-reported outcomes and the complexity of patient perceptions identified in our work may represent additional barriers to successful dry mouth management that should be considered in the design of future clinical trials.

Objectives: The parotid glands are commonly involved in primary Sjogren syndrome (pSS). The aim of this study was to assess the diagnostic accuracy of ultrasound of the parotid glands (PSGUS) compared with parotid histopathology and parotid saliva production. Study Design: We included consecutive patients suspected to have pSS. All patients underwent a full diagnostic workup according to American College of Rheumatology– European League Against Rheumatism (ACR-EULAR) criteria, including PSGUS, parotid gland biopsy, and collection of stimulated parotid saliva. For PSGUS, the average score of hypoechogenic areas in both parotid glands was applied (range 0-3). On hematoxylin and eosin (HE P < .001) and percentage of lymphocytic infiltrate (ρ = 0.575; P < .001). There was a moderate to good absolute agreement between the PSGUS and focus scores (78.5%), plasma cell shift (79.8%), LELs (81.4%), and GCs (82.7%). “Presence of hypoechogenic areas” was not very sensitive to predict focus score (69.2%), plasma cell shift (45.8%), LELs (61.5%), or GCs (34.6%). Interestingly, almost all patients with less than 25% presence of hypoechogenic areas in glandular parenchyma were also negative for GCs (98.7%). A substantial number of these patients did not have a positive focus score (81.4%), plasma cell shift (90.7%), or LELs (87.8%). There was a fair reversed correlation between PSGUS and stimulated parotid saliva flow (ρ = −0.259; P = .07). Conclusions: This is the first study comparing the diagnostic accuracy of PSGUS with histopathology and salivary secretion in detail. PSGUS and histopathology have a stronger association compared with PSGUS and parotid secretion. The specificity of PSGUS increases when the results are compared with plasma cell shift, LELs, and GCs, rather than with the focus score.

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.

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.