Rhinology and Skull Base Surgery Unit, Otorhinolaryngology Department, La Paz University Hospital, Madrid, Spain.
Rhinology and Skull Base Surgery Unit, Otorhinolaryngology Department, Ramón y Cajal University Hospital, Madrid, 28034, Spain.
Head Face Med. 2024 Sep 2;20(1):46. doi: 10.1186/s13005-024-00451-z.
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.
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.
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.
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.
鼻中隔穿孔（NSP）是一组具有广泛治疗选择的临床表现异质性疾病。患者报告的结局测量（PROM）可提供评估临床和手术结果的有价值的见解。本研究旨在为 NSP 患者开发和验证一种新的专用问卷。
在两家三级转诊医院进行了一项多中心前瞻性观察研究。“鼻中隔穿孔生活质量”（SEPEQOL）由专家委员会制定。评估了心理测量特性，包括可重复性、可靠性、有效性和反应性。
研究纳入了 96 例有症状的 NSP 患者和 30 名健康对照者。SEPEQOL 的内部一致性令人满意[Cronbach 的α=0.7843；95%置信区间（CI）为 0.702-0.856]。测试-重测可靠性极好，表现为绝对组内相关系数（ICC=0.974；95%CI，0.935-0.989，P 值<0.001）和 Bland-Altman 图（线偏差=1.6±4.57；95%CI-0.54-3.74，P 值<0.001）。手术前的平均总 SEPEQOL 评分（25.16±1.65）高于手术后 6 个月（13.72±11.39），平均差异为 12.19[标准差（SD）10.76]，P 值<0.001。
SEPEQOL 可靠、一致、有效，并且随着时间的推移变化敏感。SEPEQOL 评估了健康相关生活质量对 NSP 及其在临床实践中的管理的影响。此外，它在临床环境中易于应用，负担最小。
