Septal Perforation Quality of Life questionnaire (SEPEQOL): validation of a new instrument to assess patients undergoing endoscopic repair of a nasal septal perforation

Abstract

Abstract Purpose Nasoseptal perforations (NSP) are a clinically heterogeneous group of disorders with a wide range of available treatments. Patient-reported outcome measures (PROMs) can provide valuable insights for assessing clinical and surgical outcomes. This study aims to develop and validate a novel-specific questionnaire for patients with NSP. Methods A multi-centre prospective observational study was conducted at two tertiary referral hospitals. “Septal Perforation Quality of Life” (SEPEQOL) was developed by a committee of experts. The psychometric properties, including reproducibility, reliability, validity, and responsiveness, were assessed. Results The study included 96 symptomatic NSP patients and 30 healthy controls. SEPEQOL internal consistency was satisfactory [Cronbach´s α = 0.7843; 95% confidence interval (CI), 0.702–0.856]. Test-retest reliability was excellent, demonstrated by the absolute intraclass correlation (ICC = 0.974; 95% CI, 0.935–0.989, P-value < 0.001) and Bland-Altman plot (line bias = 1.6 ± 4.57; 95% CI -0.54–3.74, P-value < 0.001). The mean total SEPEQOL score was higher before surgery (25.16 ± 1.65) compared to 6-months after the procedure (13.72 ± 11.39), with a mean difference of 12.19 [standard deviation (SD) 10.76], P-value < 0.001. Conclusions SEPEQOL is reliable, consistent, valid, and sensitive to change over time. SEPEQOL assesses the impact of health-related quality of life on NSP and its management in clinical practice. Moreover, it is easy to apply in clinical settings with minimal burden.

Keywords

• Health-related quality of life
• Nasoseptal perforation
• Objective outcomes
• Specific quality of life questionnaire