Development of the Chronic Sialadenitis Outcome Test-14 for Chronic Sialadenitis.

Abstract

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. 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. 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. 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.