Development and Preliminary Validation of a New Patient-Reported Outcome Measure for Chronic Rhinosinusitis (CRS-PRO)
Development and Preliminary Validation of a New Patient-Reported Outcome Measure for Chronic Rhinosinusitis (CRS-PRO)
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DOI：
10.1016/j.jaip.2020.04.048
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发表时间：
2020-07-01
影响因子：
9.4
通讯作者：
Tan, Bruce K.
中科院分区：
文献类型：
--
作者：
Ghadersohi, Saied;Price, Caroline P. E.;Tan, Bruce K.
背景技术背景：患者报告的结果（PRO）的措施，制定和验证的患者与目前定义的表型慢性鼻窦炎（CRS）的需要，以支持临床试验在CRS.Objective：这项研究开发和检查的初步可靠性和有效性的CRS-PRO，一个新的PRO措施的CRS。通过与临床专家和45名符合当前疾病定义的CRS患者进行结构化访谈和焦点小组，21例无鼻息肉的CRS患者（CRSsNP）和24例有鼻息肉的CRS患者（CRSwNP），以确定对患者重要的项目。另选取CRS症状稳定的患者50例（CRSsNP组32例，CRSwNP组18例），评价该量表的可靠性。每个患者完成了CRS-PRO，鼻窦结果测试-22（SNOT-22），并在基线访视，然后至少7天last.RESULTS患者报告的结果测量信息系统的简短形式：后的发展过程中，21个项目被确定从物理症状，感觉障碍，心理社会影响和生活的影响的概念域。使用50例CRS患者的回答，通过消除概念上相似或高度相关的项目或平均症状严重程度较低的项目，将21个草案项目进一步细化为12个项目。12项问卷具有良好的内部一致性（Cronbach alpha，0.86）和重测信度，具有较高的组内相关系数（0.89）和Pearson相关性（r = 0.82，P
BACKGROUND: Patient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS.OBJECTIVE: This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS.METHODS: Instrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later.RESULTS: After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach alpha, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P