Psychometric validation of the severity of chronic cough diary, leicester cough questionnaire, and a cough severity visual analogue scale in patients with refractory chronic cough.

IF 2.9 Q2 HEALTH CARE SCIENCES & SERVICES
Andrew Trigg, Nathan Clarke, Christoph Gerlinger, Ulrike Krahn, Adam Gater, Claudia Haberland
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引用次数: 0

Abstract

Background: Refractory chronic cough (RCC) is commonly reported in primary care and associated with significant morbidity. Patient-reported outcome (PRO) measures are important for evaluating the efficacy of antitussive medications for RCC in clinical trials from the patient-perspective. Psychometric properties of Severity of Chronic Cough Diary (SCCD) Cough Severity and Cough Frequency, Leicester Cough Questionnaire (LCQ) Total and Physical Domain and Cough Severity Visual Analogue Scale (VAS) scores using data from a 12-week Phase 2b trial evaluating the efficacy of eliapixant in patients with RCC (NCT04562155) are reported.

Results: Quality of completion for the SCCD, LCQ and Cough Severity VAS across the study was high, no ceiling or floor effects were observed at baseline. Internal consistency for LCQ Total and Physical domain scores was also high (Cronbach's alpha = 0.939 and 0.806, respectively). SCCD Cough Frequency and Cough Severity, LCQ Total and Physical domain, and Cough Severity VAS scores demonstrated strong test-retest reliability (Intraclass correlation coefficient ≥ 0.848) among participants defined as stable between Week 3 and Week 4 according to Patient Global Impression of Severity (PGI-S) ratings and Awake Cough Count readings. Construct validity was supported by known-groups comparisons, with large differences (effect sizes 1.99-4.16) observed between groups categorized according to PGI-S ratings and objective Awake Cough Counts. Ability to detect improvement was supported by large effect sizes (≥0.8) observed for mean changes in SCCD, LCQ and Cough Severity VAS scores from baseline to Week 12 among participants classified as 'improved' according to PGI-S/PGI-C ratings and Awake Cough Counts. Triangulated thresholds (score range) for meaningful within-patient improvement based on anchor-based assessments were -0.82 for SCCD Cough Frequency (0-4), -0.69 for SCCD Cough Severity (0-4), 2.36 for the LCQ Total (3-21), 0.77 for the LCQ Physical (1-7) and -17.73 for the Cough Severity VAS (0-100) scores.

Conclusion: Findings support the reliability, validity and responsiveness of the newly developed SCCD Cough Frequency and Severity items as fit-for-purpose PRO measures of cough frequency or severity for use in drug development programs within RCC. The LCQ Total, LCQ Physical Domain and Cough Severity VAS also exhibit acceptable measurement properties for use in this population.

难治性慢性咳嗽患者慢性咳嗽日记、莱斯特咳嗽问卷和咳嗽严重程度视觉模拟量表的心理测量学验证
背景:难治性慢性咳嗽(RCC)在初级保健中经常被报道,并与显著的发病率相关。在临床试验中,患者报告的预后(PRO)指标对于从患者角度评估抗咳药物治疗RCC的疗效非常重要。本文报道了慢性咳嗽日志(SCCD)咳嗽严重程度和咳嗽频率、莱斯特咳嗽问卷(LCQ)总域和物理域以及咳嗽严重程度视觉模拟量表(VAS)评分的心理测量特性,这些数据来自一项评估埃利哌ixant对RCC (NCT04562155)患者疗效的12周2b期试验。结果:SCCD、LCQ和咳嗽严重程度VAS的完成质量在整个研究中都很高,在基线时没有观察到上限或下限效应。LCQ总分和Physical domain得分的内部一致性也较高(Cronbach’s alpha分别为0.939和0.806)。SCCD咳嗽频率和咳嗽严重程度、LCQ总分和物理域以及咳嗽严重程度VAS评分显示,根据患者整体严重程度印象(PGI-S)评分和清醒咳嗽计数读数,在第3周至第4周被定义为稳定的参与者中,测试重测可靠性强(类内相关系数≥0.848)。已知组比较支持结构效度,根据PGI-S评分和客观清醒咳嗽计数进行分类的组之间存在较大差异(效应值1.99-4.16)。根据PGI-S/PGI-C评分和清醒咳嗽计数,从基线到第12周,SCCD、LCQ和咳嗽严重程度VAS评分的平均变化观察到的大效应量(≥0.8)支持检测改善的能力。基于固定点评估的患者内部有意义改善的三角化阈值(评分范围)为:SCCD咳嗽频率(0-4)-0.82,SCCD咳嗽严重程度(0-4)-0.69,LCQ总分(3-21)2.36,LCQ物理(1-7)0.77,咳嗽严重程度VAS(0-100)评分-17.73。结论:研究结果支持新开发的SCCD咳嗽频率和严重程度项目作为RCC药物开发项目中咳嗽频率或严重程度的适合用途的PRO测量的可靠性,有效性和响应性。LCQ总分、LCQ物理域和咳嗽严重程度VAS在该人群中也显示出可接受的测量特性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Patient-Reported Outcomes
Journal of Patient-Reported Outcomes Health Professions-Health Information Management
CiteScore
3.80
自引率
7.40%
发文量
120
审稿时长
20 weeks
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