van der Molen Thys, Willemse Brigitte W M, Schokker Siebrig, ten Hacken Nick H T, Postma Dirkje S, Juniper Elizabeth F
Department of General Practice, University of Groningen, Groningen, The Netherlands.
Health Qual Life Outcomes. 2003 Apr 28;1:13. doi: 10.1186/1477-7525-1-13.
The new Global Obstructive Lung Disease (GOLD) guidelines advice to focus treatment in Chronic Obstructive Pulmonary Disease (COPD) on improvement of functional state, prevention of disease progression and minimization of symptoms. So far no validated questionnaires are available to measure symptom and functional state in daily clinical practice. The aim of this study was to develop and validate the Clinical COPD Questionnaire (CCQ).
Qualitative research with patients and clinicians was performed to generate possible items to evaluate clinical COPD control. Thereafter, an item reduction questionnaire was sent to 77 international experts. Sixty-seven experts responded and the 10 most important items, divided into 3 domains (symptoms, functional and mental state) were included in the CCQ (scale: 0 = best, 6 = worst).
Cross-sectional data were collected from 119 subjects (57 COPD, GOLD stage I-III; 18 GOLD stage 0 and 44 (ex)smokers). Cronbach's alpha was high (0.91). The CCQ scores in patients (GOLD 0-III) were significantly higher than in healthy (ex)smokers. Furthermore, significant correlations were found between the CCQ total score and domains of the SF-36 (rho = 0.48 to rho = 0.69) and the SGRQ (rho = 0.67 to rho = 0.72). In patients with COPD, the correlation between the CCQ and FEV1%pred was rho =-0.49. Test-retest reliability was determined in 20 subjects in a 2-week interval (Intra Class Coefficient = 0.94). Thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of the CCQ.
The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD. Data support the validity, reliability and responsiveness of this short and easy to administer questionnaire.
新的全球阻塞性肺疾病（GOLD）指南建议，慢性阻塞性肺疾病（COPD）的治疗应侧重于改善功能状态、预防疾病进展以及使症状最小化。到目前为止，在日常临床实践中尚无经过验证的问卷可用于测量症状和功能状态。本研究的目的是开发并验证临床COPD问卷（CCQ）。
对患者和临床医生进行了定性研究，以生成用于评估临床COPD控制情况的可能条目。此后，向77位国际专家发送了一份条目精简问卷。67位专家做出了回应，CCQ纳入了分为3个领域（症状、功能和精神状态）的10个最重要条目（量表：0 = 最佳，6 = 最差）。
收集了119名受试者的横断面数据（57例COPD患者，GOLD I - III期；18例GOLD 0期患者以及44名（曾）吸烟者）。克朗巴哈系数较高（0.91）。患者（GOLD 0 - III期）的CCQ得分显著高于健康（曾）吸烟者。此外，还发现CCQ总分与SF - 36的各领域（rho = 0.48至rho = 0.69）以及圣乔治呼吸问卷（SGRQ）（rho = 0.67至rho = 0.72）之间存在显著相关性。在COPD患者中，CCQ与FEV1%预计值之间的相关性为rho = - 0.49。在20名受试者中以2周为间隔测定了重测信度（组内相关系数 = 0.94）。36名有或无COPD的吸烟者在戒烟2个月后CCQ有显著改善，表明CCQ具有反应性。
CCQ是专门为测量COPD患者的临床控制情况而开发的自填式问卷。数据支持了这份简短且易于使用的问卷的有效性、可靠性和反应性。
