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;2:119-26. doi: 10.2147/PROM.S19195. Epub 2011 Jun 16.
Allergic rhinitis affects 10%-20% of the US population. Its chronic nature, combined with patients' perceptions of safety/efficacy, administration, and sensory attributes of nasal sprays (corticosteroids), impact patient adherence to therapy. The purpose of this study was to develop a measure of experience with and preference for corticosteroid therapy for treatment of allergic rhinitis.
Questionnaire development was conducted through qualitative research including concept elicitation and content testing in 153 patients with allergic rhinitis. Patient focus groups (n = 66), in conjunction with content confirmation and saturation in additional groups (n = 87), provided research data. A literature-based conceptual framework was incorporated into the interview guide. An iterative process of data collection, analysis, and theory development yielded the conceptual framework.
Consistent comments from the focus groups combined with those from cognitive debriefing interviews led to the incorporation of 14 finalized attributes into the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) items. Between the first and second cognitive debriefing interviews, researchers revised the EARNS-Q for retesting. Face and content validity tests indicated that the items, responses, and instructions were understood by study participants. The EARNS-Q is comprised of two modules that measure patient experience with nasal sprays (experience module), and patient preference for a nasal spray relative to another (preference module).
The EARNS-Q accurately measured patient experience with and preference for nasal sprays used in treating allergic rhinitis. A potential application of this questionnaire may be as a patient-reported outcomes endpoint in clinical trials of intranasal corticosteroids in patients with allergic rhinitis.
变应性鼻炎影响着10% - 20%的美国人口。其慢性特征，再加上患者对鼻喷雾剂（皮质类固醇）的安全性/有效性、给药方式及感官特性的认知，会影响患者对治疗的依从性。本研究的目的是开发一种衡量变应性鼻炎患者使用皮质类固醇治疗的体验及偏好的方法。
通过定性研究来设计问卷，包括对153例变应性鼻炎患者进行概念引出和内容测试。患者焦点小组（n = 66），连同其他小组（n = 87）的内容确认和饱和度分析，提供了研究数据。一个基于文献的概念框架被纳入访谈指南。数据收集、分析和理论发展的迭代过程产生了概念框架。
焦点小组的一致意见与认知反馈访谈的意见相结合，使得14个最终属性被纳入变应性鼻炎鼻喷雾剂体验问卷（EARNS - Q）项目。在第一次和第二次认知反馈访谈之间，研究人员对EARNS - Q进行了修订以便重新测试。表面效度和内容效度测试表明研究参与者理解了项目、回答和说明。EARNS - Q由两个模块组成，一个测量患者使用鼻喷雾剂后的体验（体验模块），另一个测量患者相对于另一种鼻喷雾剂对某一种鼻喷雾剂的偏好（偏好模块）。
EARNS - Q准确地测量了变应性鼻炎患者使用鼻喷雾剂的体验和偏好。该问卷的一个潜在应用可能是作为变应性鼻炎患者鼻内皮质类固醇临床试验中患者报告的结局终点。
