To date, no disease-specific tool has been available to assess the impact of chronic rhinosinusitis with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). Therefore, the purpose of this study was to develop and validate a questionnaire specifically designed to this aim: the Nasal Polyposis Quality of Life (NPQ) questionnaire. As indicated in the current guidelines, the development and validation of the NPQ occurred in two separate steps involving different groups of patients. The questionnaire was validated by assessing internal structure, consistency, and validity. Responsiveness and sensitivity to changes were also evaluated. In the development process of NPQ an initial list of 40 items was given to 60 patients with CRSwNP; the 27 most significant items were selected and converted into questions. The validation procedure involved 107 patients (mean age 52.9 ± 12.4). NPQ revealed a five-dimensional structure and high levels of internal consistency (Cronbach's alpha 0.95). Convergent validity (Spearman' coefficient r = 0.75; p < 0.01), discriminant validity (sensitivity to VAS score), and reliability in a sample of patients with a stable health status (Interclass Coefficient 0.882) were satisfactory. Responsiveness to clinical changes was accomplished. The minimal important difference was 7. NPQ is the first questionnaire for the assessment of HRQoL in CRSwNP. Our results demonstrate that the new tool is valid, reliable, and sensitive to individual changes.
Keywords: chronic rhinosinusitis; nasal polyps; patient reported outcomes; quality of life; validation.