慢性鼻-鼻窦炎患者报告结局（CRS-PRO）量表在接受内镜鼻窦手术的 CRS 患者中的反应性和收敛有效性。
Responsiveness and convergent validity of the chronic rhinosinusitis patient-reported outcome (CRS-PRO) measure in CRS patients undergoing endoscopic sinus surgery.
机构信息
Department of Otolaryngology-Head and Neck Surgery, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
出版信息
Int Forum Allergy Rhinol. 2021 Sep;11(9):1308-1320. doi: 10.1002/alr.22782. Epub 2021 Mar 16.
BACKGROUND
The chronic rhinosinusitis patient-reported outcome (CRS-PRO) measure is a 12-item measure with previously demonstrated validity in chronic rhinosinusitis (CRS) patients receiving medical therapy. This study establishes the factor structure, responsiveness, and convergent validity of the CRS-PRO following endoscopic sinus surgery (ESS).
METHODS
Northwestern CRS Subject Registry patients had pre-ESS, 3-month (n = 111; CRS without nasal polyps [CRSsNP] = 60, CRS with nasal polyps [CRSwNP] = 51), and 6-month (n = 86; CRSsNP = 47, CRSwNP = 39) post-ESS assessments where patients completed the CRS-PRO, 22-item Sino-Nasal Outcome Test (SNOT-22), and four Patient-Reported Outcomes Measurement (PROM) Information System (PROMIS) short forms (general health measures). Patients had pre-ESS objective testing (endoscopic and radiographic assessment). Factor analysis was conducted using principal axis factoring with varimax rotation on the baseline CRS-PRO. The clinically important difference (CID) was estimated using both distribution-based and anchor-based methods.
RESULTS
Factor analysis found the CRS-PRO comprised the "rhino-psychologic," "facial discomfort," and "cough" factors, which were responsive to ESS and correlated with the other PROMs. The changes observed in the CRS-PRO at 3 months had strong correlation with the corresponding changes in SNOT-22 (r = 0.792, p < 0.0001) and moderate correlations with changes in PROMIS fatigue and sleep domains. These changes had a very large effect size (Cohen's d 1.44) comparable to the longer SNOT-22 (Cohen's d 1.41) with slightly larger effect sizes observed in CRSwNP compared to CRSsNP patients. Similar convergent validity and responsiveness were observed in the 6-month data. The CRS-PRO CID was estimated to be between 5.0 and 7.5 (midpoint 6.0) using distribution-based and anchor-based methods.
CONCLUSION
This study demonstrates the validity and responsiveness of the CRS-PRO in subjects receiving ESS.
背景
慢性鼻-鼻窦炎患者报告结局（CRS-PRO）量表是一个包含 12 个条目的量表，此前已在接受药物治疗的慢性鼻-鼻窦炎（CRS）患者中证明具有有效性。本研究旨在确定内镜鼻窦手术（ESS）后 CRS-PRO 的因子结构、反应度和收敛效度。
方法
西北 CRS 患者登记数据库的患者在 ESS 前、术后 3 个月（n = 111；非鼻息肉型 CRS [CRSsNP] = 60，鼻息肉型 CRS [CRSwNP] = 51）和术后 6 个月（n = 86；CRSsNP = 47，CRSwNP = 39）进行评估，患者在评估时完成了 CRS-PRO、22 项 Sino-Nasal Outcome Test（SNOT-22）和四个患者报告的结局测量信息系统（PROMIS）简短形式（一般健康指标）。患者在 ESS 前进行了客观测试（内镜和影像学评估）。使用基于主成分分析的主轴因子分析和 Varimax 旋转对基线 CRS-PRO 进行因子分析。使用基于分布和基于锚定的方法估计临床重要差异（CID）。
结果
因子分析发现，CRS-PRO 由“鼻-心理”、“面部不适”和“咳嗽”三个因子组成，这些因子对 ESS 有反应，并与其他 PROM 相关。3 个月时 CRS-PRO 的变化与 SNOT-22 的相应变化具有很强的相关性（r = 0.792，p < 0.0001），与 PROMIS 疲劳和睡眠领域的变化中度相关。这些变化具有很强的效应量（Cohen's d 1.44），与较长的 SNOT-22（Cohen's d 1.41）相当，在 CRSwNP 患者中观察到的效应量略大。在 6 个月的数据中也观察到了类似的收敛效度和反应度。使用基于分布和基于锚定的方法，估计 CRS-PRO 的 CID 为 5.0 到 7.5（中点为 6.0）。
结论
本研究表明，在接受 ESS 的患者中，CRS-PRO 具有有效性和反应度。
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