Global Medical Affairs, Immunology and Inflammation Development, Sanofi, Chilly-Mazarin, France.
Patient-Centered Outcome Assessment, RTI Health Solutions, Research Triangle Park, North Carolina, U.S.A.
Laryngoscope. 2022 May;132(5):933-941. doi: 10.1002/lary.29766. Epub 2021 Aug 26.
OBJECTIVES/HYPOTHESIS: The 22-item Sinonasal Outcome Test (SNOT-22) is a validated chronic rhinosinusitis health-related quality-of-life outcome (HRQoL) measure; however, SNOT-22 domains have not been validated specifically for chronic rhinosinusitis with nasal polyps (CRSwNP).
Validation of SNOT-22 domain structure, using data from 3 randomized, placebo-controlled, double-blinded, multicenter clinical trials of dupilumab in adults with moderate-to-severe CRSwNP.
Preliminary dimensional structure was derived by exploratory factor analyses of SNOT-22 data from a phase 2 trial (NCT01920893) of dupilumab for the treatment of CRSwNP. Data from 2 phase 3 clinical trials (NCT02912468 and NCT02898454) were then used for confirmatory factor analysis, and evaluated for reliability, construct validity, and responsiveness. In all three trials, the SNOT-22 was administered electronically on a tablet and trial participants were required to answer all items.
Factor analysis supported five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. Correlations between domains were moderate to high, ranging from 0.53 (Nasal-Emotion) to 0.88 (Function-Sleep). Construct validity was mostly supported; relationships with other measures were almost always in the intended direction and magnitude. Internal consistency reliability also confirmed questionnaire structure with strong Cronbach's alpha values (all >0.80). Moderate-to-high correlations were observed between change in SNOT-22 domain scores and other study patient-reported outcome measures, along with large effect-size estimates (≥0.7), demonstrating responsiveness of the Nasal, Sleep, and Function domains. Emotion and Ear/Facial domains had small-to-moderate effect sizes.
Psychometric analyses support the validity, reliability, and responsiveness of five domains of SNOT-22 (Nasal, Ear/Facial, Sleep, Function, and Emotion) for assessing symptoms and impact on HRQoL in patients with CRSwNP. Laryngoscope, 132:933-941, 2022.
目的/假设：22 项鼻鼻窦结局测试（SNOT-22）是一种经过验证的慢性鼻-鼻窦炎健康相关生活质量结局（HRQoL）的衡量标准；然而，SNOT-22 各领域尚未专门针对伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）进行验证。
使用来自 3 项随机、安慰剂对照、双盲、多中心临床试验的数据，对成人中重度 CRSwNP 患者使用度普利尤单抗治疗进行 SNOT-22 领域结构的验证。
通过对度普利尤单抗治疗 CRSwNP 的 2 期试验（NCT01920893）的 SNOT-22 数据进行探索性因素分析，得出初步的维度结构。然后使用来自 2 项 3 期临床试验（NCT02912468 和 NCT02898454）的数据进行验证性因素分析，并评估可靠性、结构有效性和反应性。在所有 3 项试验中，SNOT-22 通过平板电脑进行电子管理，试验参与者需要回答所有项目。
因素分析支持 5 个领域：鼻腔、耳部/面部、睡眠、功能和情绪。领域之间的相关性为中度至高度，范围从 0.53（鼻腔-情绪）到 0.88（功能-睡眠）。结构有效性得到了大部分支持；与其他测量方法的关系几乎总是朝着预期的方向和幅度。内部一致性可靠性也证实了问卷结构，具有很强的克朗巴赫阿尔法值（均>0.80）。SNOT-22 各领域评分的变化与其他研究患者报告的结局测量指标之间存在中度至高度相关性，且效应量估计值较大（≥0.7），表明鼻腔、睡眠和功能领域具有反应性。情绪和耳部/面部领域的效应量较小到中等。
心理测量学分析支持 SNOT-22 的 5 个领域（鼻腔、耳部/面部、睡眠、功能和情绪）的有效性、可靠性和反应性，用于评估 CRSwNP 患者的症状和对 HRQoL 的影响。《喉镜》，132：933-941，2022。
