检测咳嗽严重程度:来自慢性咳嗽患者和文献的观点
2009/05/27
背景:要想从患者角度评价咳嗽的严重程度以及获得临床试验的治疗疗效,需有一项有效、可靠的评价工具。本文将患者对咳嗽严重程度的看法作为研究的第一步,以此制定一个新的患者自评结果(patient-reported outcome, PRO)检测法用于临床试验。
方法:本研究为焦点群体访谈研究,研究对象来源于美国临床内科确诊的慢性咳嗽患者。通过半结构化的焦点群体访谈指导,收集患者关于咳嗽严重程度和症状特征的相关信息。对数据进行编码,区分咳嗽严重程度的概念和名称。
结果:研究共分有3个焦点群体访谈组(n=22; 6名男性; 平均年龄66.1±12.9)。病因包括GERD、哮喘、支气管炎、鼻后滴漏及其他。咳嗽严重程度由以下三个指标判定:咳嗽频率、咳嗽程度和对睡眠/日常活动的打断。除单发咳嗽外,所有组患者将咳嗽描述为无法控制的发作。咳嗽的紧迫性被认为是即将发生咳嗽的重要标志,属于咳嗽频率范畴。患者还认为白天活动和晚间睡眠障碍也是咳嗽严重程度的标志。此外,患者还描述了咳嗽严重程度的变异性。
结论:研究结果显示,患者根据咳嗽的频率、强度和对睡眠/日常活动的打断来描述咳嗽的严重程度,因此,在评价咳嗽的严重性和治疗效果时应该纳入上述三个指标。
(刘国梁 审校)
Vernon M,et al. Cough. 2009 Mar 19;5(1):5. [Epub ahead of print]
Measuring cough severity: perspectives from the literature and from patients with chronic cough.
ABSTRACT:
BACKGROUND: In order to assess severity of cough from patients’ perspectives and capture the effects of treatment in clinical trials, a measurement tool must show evidence of validity and reliability. The purpose of this study was to characterize cough severity from patients’ perspectives as the initial step in the development of a new patient-reported outcome (PRO) measure for use in clinical trials.
METHODS: This focus groups study included patients with clinician confirmed chronic cough recruited from a large internal medicine clinic in the US. A semi-structured focus group guide was designed to elicit information about patients’ experiences with cough severity and their characterization of symptoms. The focus group data were coded to identify concepts and terminology of cough severity.
RESULTS: Three focus groups were conducted [n=22; 6 male; mean age 66.1 (+/-12.9)]. Etiology included GERD, asthma, bronchitis, post-nasal drip, and other. Three domains of cough severity were identified: frequency, intensity, and disruption. In addition to a single cough, participants in all focus groups described coughing in uncontrollable paroxysms they called "fits," "bouts," "spells," or "episodes." The urge to cough, described as an important sign of impending cough, was considered a component of cough frequency. Participants also described daytime activity and nighttime sleep disruption as an indication of cough severity. Finally, participants described variability in cough severity.
CONCLUSION: Results suggest that patients describe cough severity in terms of frequency, intensity, and disruptiveness, indicating these 3 domains should be addressed when evaluating cough severity and outcomes of treatment.
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