Patient Reported Outcome Measures for Salivary Function: A Systematic Review

A number of patient-reported outcome measures (PROMs) assess quality of life and symptom severity in patients with salivary gland dysfunction, but many vary in the extent of validation and domain types addressed. We identified PROMs validated to measure salivary gland function and analyzed key properties.

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A systematic review was performed using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Validated instruments with >1 item to assess salivary gland-related symptoms were included. PROMs were evaluated for developmental methodology, structure, validity, and reliability using Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria.

A total of 2059 abstracts were retrieved, and 133 full-text articles were reviewed. Sixteen PROMs assessing xerostomia (n = 7), sialadenitis (n = 4), Sjogren's syndrome (n = 2), Parkinson's-associated sialorrhea (n = 2), and oral systemic sclerosis (n = 1) were identified. Most (n = 15) were developed de novo, one was adapted from a pre-existing questionnaire. Eleven PROMs demonstrated "very good" analysis of internal consistency per COSMIN criteria, and 10 included test-retest data. Regarding content validity, four PROMs were developed with both patient and physician input, but none were rated as "adequate." All included comparisons against other questionnaires (n = 7), salivary flow rate (n = 9), and/or healthy controls (n = 3). The most rigorously developed PROM, the Xerostomia Inventory, was rated adequate in 6 out of 7 domains.

Several PROMs evaluate salivary function. The abilties of these PROMs to meet design and validation standards were variable, with notable limitations in content validity for all tools. New and updated PROMs assessing obstructive and inflammatory salivary symptoms should  utilize patient and provider input.

N/A Laryngoscope, 133:1796-1805, 2023.