
ABSTRACT Objective Patient perspectives have become an important aspect of healthcare evaluation. To measure health related quality of life (HRQoL), it is essential to apply well‐researched HRQoL instruments. Current instruments for chronic sialadenitis have limitations and, thus, we created a new disease‐specific HRQoL tailored for chronic sialadenitis. Methods COSMIN guidelines were followed. Initially, a preliminary 24‐item questionnaire was created. Untreated patients ( n = 126) were recruited to complete the preliminary questionnaire alongside the generic HRQoL instrument, 15D. ENT specialists evaluated the severity of the disease and the disability caused by the disease. Additionally, a control group of healthy adults was recruited for comparison. Based on patients' responses, items were reduced using predefined criteria, and the final instrument was validated with statistical analyses. Cronbach's α was used to measure internal consistency, and the intraclass correlation coefficient (ICC) was used to measure test–retest reliability. Results The most suitable recall period was 3 months. With statistical analyses, the number of items was reduced to 14, leading to the creation of the final instrument, the Chronic Sialadenitis Outcome Test 14, CSOT‐14. CSOT‐14 had good internal consistency (Cronbach's α = 0.871) and test–retest reliability (ICC = 0.911), and it differentiated patients from healthy controls. Conclusions A novel instrument for chronic sialadenitis, CSOT‐14, that clearly differentiated patients from healthy controls was created and validated. The instrument can be used in daily clinical practice for patients with chronic sialadenitis. Level of Evidence 2.
Male, Adult, Reproducibility of Results, Middle Aged, Severity of Illness Index, Sialadenitis, Surveys and Questionnaires, Case-Control Studies, Chronic Disease, Quality of Life, Humans, Female, Comprehensive Otolaryngology, Aged
Male, Adult, Reproducibility of Results, Middle Aged, Severity of Illness Index, Sialadenitis, Surveys and Questionnaires, Case-Control Studies, Chronic Disease, Quality of Life, Humans, Female, Comprehensive Otolaryngology, Aged
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