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心理测量验证和有意义的变化新鼻多症症状日记的门

Vivian H Shih¹, Ashley F Slagle², Cristina Ivanescu³

¹AstraZeneca, Gaithersburg, MD, USA.

The Annals of otology, rhinology, and laryngology

|June 5, 2023

概括

鼻多症症状日记 (NPSD) 有效地测量了具有鼻多症 (CRSwNP) 症状的慢性鼻炎. 它的分数证明了对评估治疗效果的临床试验的可靠性和有效性.

科学领域:

耳鼻喉科耳鼻喉科耳鼻喉科
临床试验临床试验
患者报告的结果

背景情况:

慢性鼻炎与鼻多重症 (CRSwNP) 显著影响患者的生活质量.
准确可靠的症状评估工具对于评估CRSwNP的试验疗法至关重要.

研究的目的:

为了评估四个鼻多症症状日记 (NPSD) 衍生得分的心理特征.
为了确定CRSwNP症状评估的NPSD得分的可靠性,有效性和响应性.
在临床试验中为NPSD得分建立有意义变化值 (MCT).

主要方法:

评估了三个单项评分 (鼻塞评分[NBS],鼻塞评分[NCS],难以嗅觉评分[DSS]) 和总症状评分 (TSS) 的心理特征.
分析了3期临床试验中518名严重CRSwNP患者的数据.
可靠性,有效性 (融合和已知组),以及检测变化的能力,使用既有方法和比较PROs (如SNOT-22) 进行了评估.

主要成果:

总症状评分 (TSS) 显示出强大的内部一致性 (Cronbach α = .88) 和测试重试可靠性 (> .80).
所有四个NPSD得分都显示出与SNOT-22 (r = .70) 的良好收有效性和已知组有效性.
NPSD得分对临床变化敏感,已建立MCT以改善 (1.0分为NBS,NCS,DSS;4.0分为TSS).

结论:

这四个NPSD衍生得分是可靠的,有效的,适合在临床试验中评估CRSwNP症状改善.
这些得分,与已建立的MCT一起,可以支持研究治疗的症状改善评估.
该NPSD是CRSwNP研究和临床实践的宝贵工具.

关键词:

慢性鼻炎与鼻多重构成开发工具开发工具开发工具有意义的变化值.患者报告的结果衡量措施.心理测量特性心理测量属性

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Self-Report Tests of Personality

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Self-report inventories are objective personality assessments that use multiple-choice items or numbered scales, typically ranging from 1 (strongly disagree) to 5 (strongly agree). They are often called Likert scales after Rensis Likert. These inventories are widely used due to their ease of administration and cost-effectiveness. One of the most prominent examples is the Minnesota Multiphasic Personality Inventory (MMPI), initially developed in the 1940s to assess abnormal personality traits.