A MEASURE OF QUALITY-OF-LIFE FOR CLINICAL-TRIALS IN CHRONIC LUNG-DISEASE
A MEASURE OF QUALITY-OF-LIFE FOR CLINICAL-TRIALS IN CHRONIC LUNG-DISEASE
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DOI：
10.1136/thx.42.10.773
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发表时间：
1987-10-01
期刊：
影响因子：
10
通讯作者：
CHAMBERS, LW
中科院分区：
文献类型：
--
作者：
GUYATT, GH;BERMAN, LB;CHAMBERS, LW
由于肺功能、运动能力和功能状态或生活质量之间的关系一般较弱，因此在临床试验中开发了一份自我报告问卷来确定治疗对生活质量的影响。100名慢性气流受限患者被问及他们的疾病如何影响他们的生活质量，以及他们的症状和限制有多重要。采用最常用、最重要的条目编制问卷，评价四个维度：呼吸困难、疲劳、情绪功能、患者S对疾病的控制感(掌握)。通过对处于稳定状态的患者重复给药测试，重复性很好：所有四个维度的变异系数都小于12%。通过向13名患者在药物治疗优化前后以及另外28名患者在参加呼吸康复计划前后进行问卷调查，测试了对变化的敏感度。在这两种情况下，在所有四个维度上都注意到了巨大的、统计上显著的改善。问卷得分的变化与肺活量值、运动能力以及患者和医生的全球评级的变化相关。由此可见，该问卷具有较高的准确性、效度和响应性。因此，它可以作为临床试验中生活质量的一种有用的疾病特异性指标。
Since the relationships between pulmonary function, exercise capacity, and functional state or quality of life are generally weak, a self report questionnaire has been developed to determine the effect of treatment on quality of life in clinical trials. One hundred patients with chronic airflow limitation were asked how their quality of life was affected by their illness, and how important their symptoms and limitations were. The most frequent and important items were used to construction a questionnaire evaluating four dimensions: dyspnoea, fatigue, emotional function, and the patient''s feeling of control over the disease (mastery). Reproduciblity, tested by repeated administration to patients in a stable condition, was excellent: the coefficient of variation was less than 12% for all four dimensions. Responsiveness (sensitivity to change) was tested by administering the questionnaire to 13 patients before and after optimisation of their drug treatment and to another 28 before and after participatin in a respiratory rehabilitaton programme. In both cases large, statistically significant improvements in all four dimensions were noted. Changes in questionnaire score were correlated with changes in spirometric values, exerices capacity, and patients'' and physicians'' global ratings. Thus it has been shown that the questionnaire is precise valid, and responsive. It can therefore serve as a useful disease specific measure of quality of life for clinical trials.