Cross-cultural adaptation of the Italian Chronic Rhinosinusitis Patient-Reported Outcome. Questionnaire

Objective: The Chronic Rhinosinusitis Patient-Reported Outcome (CRS-PRO) is a validated 12-item tool for assessing symptom burden in chronic rhinosinusitis (CRS). Although cross-culturally validated in other languages, there is no Italian version. This study aimed to translate, adapt, and validate the CRS-PRO for Italian-speaking patients. Methods: We conducted a prospective multicentre study in 5 Italian otolaryngology centres (Jan 2024 - Aug 2025). Translation and adaptation followed International Society for Pharmacoeconomics and Outcomes Research guidelines. Participants were adults with CRS without polyps (CRSsNP), with polyps (CRSwNP), and healthy controls. Psychometric testing included internal consistency (Cronbach's α, McDonald's ω), test-retest reliability (Intraclass Correlation Coefficient, ICC), Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) factor analyses, and construct validity. Results: A total of 118 participants were enrolled (controls = 32, CRSsNP = 40, CRSwNP = 46). Internal consistency was moderate (Cronbach's α = 0.669) but excellent (McDonald's ω = 0.946). Reliability was high (ICC = 0.92). EFA supported a two-factor solution (physical, psychological), explaining 73.4% of the total variance. CFA confirmed this model (CFI = 0.978, TLI = 0.972, SRMR = 0.109), with strong interfactor correlation (r = 0.93). CRSwNP patients reported the highest burden. Conclusions: The Italian CRS-PRO showed strong reliability, validity, and factorial structure, supporting its clinical and research use.