Crawford Bruce, Stanford Richard H, Wong Audrey Y, Dalal Anand A, Bayliss Martha S
Mapi Values, Boston, MA, USA;
Patient Relat Outcome Meas. 2011 Jul;2:127-33. doi: 10.2147/PROM.S19371. Epub 2011 Jun 16.
Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR) receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) was developed to measure subject experiences with and preferences for nasal sprays.
To describe the psychometric validation of the EARNS-Q modules.
An observational study was conducted with subjects aged 18-65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM) at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22.
The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores) and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test-retest validity). Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79) and within internal consistency reliability estimates, indicating measurement of distinct constructs.
The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference for, prescription intranasal corticosteroid sprays for allergic rhinitis.
患者体验和偏好是影响变应性鼻炎（AR）患者使用鼻内皮质类固醇药物依从性的关键因素。变应性鼻炎鼻喷雾剂问卷体验（EARNS-Q）旨在衡量受试者对鼻喷雾剂的体验和偏好。
描述EARNS-Q各模块的心理测量学验证情况。
对年龄在18 - 65岁、经医生诊断为血管运动性、季节性和/或常年性变应性鼻炎且正在使用处方鼻喷雾剂的受试者进行了一项观察性研究。受试者在基线期和2周后完成EARNS-Q的体验模块以及药物治疗满意度问卷（TSQM）。在一项为期3周的随机、单盲、交叉、多中心临床研究中进行了进一步的验证分析，该研究中年龄≥18岁且有季节性AR记录的受试者接受氟尼缩松和倍氯米松治疗，并在第1天和第8天完成EARNS-Q体验模块，在第22天完成EARNS-Q偏好模块，在第8天和第22天完成TSQM。
观察性研究和临床研究分别有121名和89名受试者完成。两个模块均显示出可接受的信度（体验模块α = 0.72；偏好模块总体得分α = 0.93）和效度（组内相关系数或ICC重测效度为0.64至0.82）。体验模块和偏好模块之间的相关性中等（r = 0.39至0.79），且在内部一致性信度估计范围内，表明测量的是不同的结构。
EARNS-Q是一种患者报告结局指标，能够可靠且有效地测量受试者对变应性鼻炎处方鼻内皮质类固醇喷雾剂的体验和偏好。
