目的:鼻中隔穿孔(NSP)是一组临床异质性疾病,具有广泛的可用治疗方法。患者报告的结果测量(PROM)可以为评估临床和手术结果提供有价值的见解。本研究旨在开发和验证针对NSP患者的新型特定问卷。
方法:在两家三级转诊医院进行了一项多中心前瞻性观察研究。“间隔穿孔生活质量”(SEPEQOL)由专家委员会制定。心理测量属性,包括再现性,可靠性,有效性,和响应能力,被评估。
结果:该研究包括96名NSP症状患者和30名健康对照。SEPEQOL内部一致性令人满意[Cronbachα=0.7843;95%置信区间(CI),0.702-0.856]。重测可靠性非常好,通过绝对组内相关性(ICC=0.974;95%CI,0.935-0.989,P值<0.001)和Bland-Altman图(线偏倚=1.6±4.57;95%CI-0.54-3.74,P值<0.001)证明。手术前平均总SEPEQOL评分(25.16±1.65)高于手术后6个月(13.72±11.39),平均差为12.19[标准偏差(SD)10.76],P值<0.001。
结论:SEPEQOL是可靠的,一致,有效,对时间变化敏感。SEPEQOL评估了与健康相关的生活质量对NSP及其临床实践管理的影响。此外,这是很容易适用于临床设置与最小的负担。
OBJECTIVE: 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.