Responsiveness and convergent validity of the chronic rhinosinusitis patient-reported outcome (CRS-PRO) measure in CRS patients undergoing endoscopic sinus surgery.
Responsiveness and convergent validity of the chronic rhinosinusitis patient-reported outcome (CRS-PRO) measure in CRS patients undergoing endoscopic sinus surgery.
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DOI：
10.1002/alr.22782
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发表时间：
2021-09
影响因子：
6.4
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中科院分区：
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CRS-PRO是一项12项患者报告结局指标，先前在接受药物治疗的慢性鼻窦炎（CRS）患者中证明了有效性。本研究建立了内窥镜鼻窦手术（ESS）后CRS-PRO的因素结构、反应性和聚合效度。西北CRS受试者登记研究患者接受了ESS前、ESS后3个月（n=111; 60例CRSsNP，51例CRSwNP）和6个月（n=86; 47例CRSsNP，39例CRSwNP）评估，其中患者完成了CRS-PRO、SNOT-22和4份PROMIS简表（一般健康指标）。患者在ESS前进行客观检测（内窥镜和放射学评估）。使用主轴因子分析和方差最大旋转对基线CRS-PRO进行因子分析。使用分布和基于锚点的方法估计临床重要差异（CID）。因素分析发现，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。在3个月时在CRS-PRO中观察到的变化与SN 0 T-22中的相应变化具有强相关性（r=0.792，p<0.0001），并且与PROMIS疲劳和睡眠中的变化具有中等相关性。这些变化具有与较长SN 0 T-22（Cohen's d 1.41）相当的非常大的效应量（Cohen's d 1.44），与CRSsNP患者相比，在CRSwNP中观察到的效应量略大。在6个月数据中观察到相似的收敛效度和反应性。使用基于分布和基于锚点的方法估计CRS-PRO CID在5.0和7.5之间（中点6.0）。本研究证明了CRS-PRO在接受ESS的受试者中的有效性和反应性。
The CRS-PRO is a 12-item patient-reported outcome 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). Northwestern CRS Subject Registry patients had pre-ESS, 3-(n=111; 60 CRSsNP, 51 CRSwNP) and 6-month (n=86; 47 CRSsNP, 39 CRSwNP) post-ESS assessments where patients completed the CRS-PRO, SNOT-22, and four 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 and anchor-based methods. Factor analysis found the CRS-PRO was comprised of 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. 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 between 5.0 and 7.5 (midpoint 6.0) using distribution-based and anchor-based methods. This study demonstrates the validity and responsiveness of the CRS-PRO in subjects receiving ESS.