Oga Toru, Nishimura Koichi, Tsukino Mitsuhiro, Sato Susumu, Hajiro Takashi, Mishima Michiaki
Respiratory Division, Kyoto-Katsura Hospital, 17 Yamadahirao, Nishikyo-ku, Kyoto 615-8256, Japan.
Chest. 2002 Oct;122(4):1228-33. doi: 10.1378/chest.122.4.1228.
Disease-specific health status measures are characterized by higher responsiveness than generic measures and may be preferred in clinical trials. However, comparisons of responsiveness between various disease-specific measures have rarely been performed in asthma studies.
We investigated and compared the responsiveness of health status scores in asthmatic patients during treatment using three different disease-specific measures: the Juniper Asthma Quality of Life Questionnaire (AQLQ), the Living with Asthma Questionnaire (LWAQ), and the Airways Questionnaire 20 (AQ20).
We attempted to follow up 170 patients with newly diagnosed asthma over a 6-month period. Patients underwent treatment with inhaled corticosteroids in accordance with the guideline. A health status evaluation using three disease-specific measures, and pulmonary function tests were performed on the initial visit, and at 3 months and 6 months. The effect size and the standardized response mean were used as responsiveness indexes.
A total of 109 patients completed the 6-month follow-up and were then analyzed. All health status scores and FEV(1) measures improved during the first 3 months (p < 0.001). The total of the AQLQ scores showed high responsiveness indexes ranging from 1.28 to 1.46 between baseline and 3 months, and baseline and 6 months. Spearman correlation coefficients were smaller between the change in FEV(1) and the change in the LWAQ. Although the AQ20 also demonstrated high responsiveness, a ceiling effect was indicated.
The AQLQ was the most responsive measure during asthma treatment. The relationship between the change in airflow limitation and the change in the LWAQ was weaker compared to the AQLQ and the AQ20. Although the AQ20 was also responsive and its simplicity is favorable, the ceiling effect should be considered when using it.
疾病特异性健康状况测量指标的特点是比通用指标具有更高的反应性，在临床试验中可能更受青睐。然而，在哮喘研究中，很少对各种疾病特异性测量指标之间的反应性进行比较。
我们使用三种不同的疾病特异性测量指标：朱尼珀哮喘生活质量问卷（AQLQ）、哮喘生活问卷（LWAQ）和气道问卷20（AQ20），调查并比较了哮喘患者在治疗期间健康状况评分的反应性。
我们试图在6个月内对170例新诊断的哮喘患者进行随访。患者按照指南接受吸入性糖皮质激素治疗。在初次就诊时、3个月和6个月时，使用三种疾病特异性测量指标进行健康状况评估，并进行肺功能测试。效应大小和标准化反应均值用作反应性指标。
共有109例患者完成了6个月的随访并进行了分析。在最初的3个月内，所有健康状况评分和FEV（1）测量值均有所改善（p < 0.001）。AQLQ评分总和在基线与3个月之间以及基线与6个月之间显示出较高的反应性指标，范围为1.28至1.46。FEV（1）的变化与LWAQ的变化之间的斯皮尔曼相关系数较小。尽管AQ20也显示出较高的反应性，但存在天花板效应。
AQLQ是哮喘治疗期间反应性最强的测量指标。与AQLQ和AQ20相比，气流受限变化与LWAQ变化之间的关系较弱。尽管AQ20也具有反应性且其简单性有利，但在使用时应考虑天花板效应。
