检测咳嗽严重程度：一项新型、包含7项目的咳嗽严重程度患者主诉结果检测方法的开发和初步研究
2010/08/11
目的：虽然慢性和亚急性咳嗽是一大临床问题，也常是临床治疗的目标，但目前尚未有有效的咳嗽严重程度患者主诉结果（PRO）的检测工具，后者以便全面的评价临床咳嗽严重程度。咳嗽严重程度日志（CSD）是一个简单的、7个项目的日志，能满足上述要求。本试验旨在小样本的慢性或亚急性咳嗽患者中研究该方法的检测特性。
方法：39名患者（24名慢性咳嗽患者和15名亚急性咳嗽患者）参与此项为期2周的前瞻性初步研究。基线状态、第8天和第15天，患者每晚完成CSD及验证量表检测（咳嗽严重程度视觉类比量表[VAS]、莱斯特咳嗽问卷[LCQ]、美国简明健康测量量表[SF-36]、工作效率指数[WPAI]和MOS水面量表[MOS-SS]）。对第8天和第5天的变化进行全面评估。
结果：验证性因素分析支持下列3个咳嗽严重程度分量表：频率（3个项目）、强度（2个项目）和间隔（2个项目）（chi2= 10.57 (11)）。对于CSD总体评分，内部一致性(α)在第1天为0.89，第8天为0.96；再现性（组内相关系数[ICC]）在第1～8天为0.68，第8～15天为0.94。CSD总体评分与VAS（r = 0.84, P< 0.0001）、LCQ总分（r = -0.62, P< 0.0001）、分量表评分（r = -0.43, p < 0.01至 -0.60, p < 0.0001）及WPAI分量表评分（r = 0.27 (ns)至 0.51，P< 0.01）相关。SF-36或MOS-SS未见相关性。亚急性咳嗽患者随着时间其咳嗽程度显著改善(F = 3.20, P< 0.05)。
结论：结果显示，对于亚急性或慢性咳嗽的患者，有关CSD的有效性或作为研究终点，尚需大样本的研究来证实。
（陈欣审校）
Ther Adv Respir Dis. 2010 Jun 2. [Epub ahead of print]
Measuring cough severity: development and pilot testing of a new seven-item cough severity patient-reported outcome measure.
Vernon M, Leidy NK, Nacson A, Nelsen L.
United BioSource Corporation, Bethesda, MD 20814, USA.
Abstract
OBJECTIVE: Although chronic and subacute cough are clinically problematic and a target of therapeutic interventions, there are no validated cough severity patient-reported outcome (PRO) instruments for comprehensively evaluating cough severity in clinical trials. The Cough Severity Diary (CSD) is a simple, seven-item daily diary developed to meet this need. The objective of this study was to assess preliminary measurement characteristics in a small sample of patients with chronic or subacute cough.
METHODS: Thirty-nine patients (24 chronic; 15 subacute) participated in a two-week prospective pilot study. Patients completed the CSD each evening and validation instruments (cough severity visual analog scale [VAS], Leicester Cough Questionnaire [LCQ], Medical Outcomes Study 36-Item Short Form [SF-36], Work Productivity Index [WPAI], MOS Sleep Scale [MOS-SS]) at baseline, days 8 and 15, and a global rating of change at days 8 and 15.
RESULTS: Confirmatory factor analyses supported three severity subscales: frequency (three items), intensity (two items), and disruption (two items) (chi(2 )= 10.57 (11)). For the CSD total score, internal consistency (alpha) on day 1 was 0.89, and on day 8 was 0.96; reproducibility (intraclass correlation coefficients [ICC]) was 0.68 on day 1 to day 8 and 0.94 on day 8 to day 15. CSD total scores correlated with the VAS (r = 0.84, p < 0.0001), LCQ total (r = -0.62, p < 0.0001) and subscale scores (r = -0.43, p < 0.01 to -0.60, p < 0.0001), and WPAI subscale scores (r = 0.27 (ns) to 0.51, p < 0.01). No significant relationships with SF-36 or MOS-SS were found. Subacute patients showed significant improvement over time (F = 3.20, p < 0.05).
CONCLUSIONS: Results suggest that the CSD is ready for further testing in larger naturalistic studies or as an exploratory endpoint in clinical trials of patients with subacute or chronic cough.
Ther Adv Respir Dis. 2010 Jun 2. [Epub ahead of print]
方法：39名患者（24名慢性咳嗽患者和15名亚急性咳嗽患者）参与此项为期2周的前瞻性初步研究。基线状态、第8天和第15天，患者每晚完成CSD及验证量表检测（咳嗽严重程度视觉类比量表[VAS]、莱斯特咳嗽问卷[LCQ]、美国简明健康测量量表[SF-36]、工作效率指数[WPAI]和MOS水面量表[MOS-SS]）。对第8天和第5天的变化进行全面评估。
结果：验证性因素分析支持下列3个咳嗽严重程度分量表：频率（3个项目）、强度（2个项目）和间隔（2个项目）（chi2= 10.57 (11)）。对于CSD总体评分，内部一致性(α)在第1天为0.89，第8天为0.96；再现性（组内相关系数[ICC]）在第1～8天为0.68，第8～15天为0.94。CSD总体评分与VAS（r = 0.84, P< 0.0001）、LCQ总分（r = -0.62, P< 0.0001）、分量表评分（r = -0.43, p < 0.01至 -0.60, p < 0.0001）及WPAI分量表评分（r = 0.27 (ns)至 0.51，P< 0.01）相关。SF-36或MOS-SS未见相关性。亚急性咳嗽患者随着时间其咳嗽程度显著改善(F = 3.20, P< 0.05)。
结论：结果显示，对于亚急性或慢性咳嗽的患者，有关CSD的有效性或作为研究终点，尚需大样本的研究来证实。
（陈欣审校）
Ther Adv Respir Dis. 2010 Jun 2. [Epub ahead of print]
Measuring cough severity: development and pilot testing of a new seven-item cough severity patient-reported outcome measure.
Vernon M, Leidy NK, Nacson A, Nelsen L.
United BioSource Corporation, Bethesda, MD 20814, USA.
Abstract
OBJECTIVE: Although chronic and subacute cough are clinically problematic and a target of therapeutic interventions, there are no validated cough severity patient-reported outcome (PRO) instruments for comprehensively evaluating cough severity in clinical trials. The Cough Severity Diary (CSD) is a simple, seven-item daily diary developed to meet this need. The objective of this study was to assess preliminary measurement characteristics in a small sample of patients with chronic or subacute cough.
METHODS: Thirty-nine patients (24 chronic; 15 subacute) participated in a two-week prospective pilot study. Patients completed the CSD each evening and validation instruments (cough severity visual analog scale [VAS], Leicester Cough Questionnaire [LCQ], Medical Outcomes Study 36-Item Short Form [SF-36], Work Productivity Index [WPAI], MOS Sleep Scale [MOS-SS]) at baseline, days 8 and 15, and a global rating of change at days 8 and 15.
RESULTS: Confirmatory factor analyses supported three severity subscales: frequency (three items), intensity (two items), and disruption (two items) (chi(2 )= 10.57 (11)). For the CSD total score, internal consistency (alpha) on day 1 was 0.89, and on day 8 was 0.96; reproducibility (intraclass correlation coefficients [ICC]) was 0.68 on day 1 to day 8 and 0.94 on day 8 to day 15. CSD total scores correlated with the VAS (r = 0.84, p < 0.0001), LCQ total (r = -0.62, p < 0.0001) and subscale scores (r = -0.43, p < 0.01 to -0.60, p < 0.0001), and WPAI subscale scores (r = 0.27 (ns) to 0.51, p < 0.01). No significant relationships with SF-36 or MOS-SS were found. Subacute patients showed significant improvement over time (F = 3.20, p < 0.05).
CONCLUSIONS: Results suggest that the CSD is ready for further testing in larger naturalistic studies or as an exploratory endpoint in clinical trials of patients with subacute or chronic cough.
Ther Adv Respir Dis. 2010 Jun 2. [Epub ahead of print]
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