DEVELOPMENT AND TESTING OF A NEW MEASURE OF HEALTH-STATUS FOR CLINICAL-TRIALS IN RHINOCONJUNCTIVITIS
DEVELOPMENT AND TESTING OF A NEW MEASURE OF HEALTH-STATUS FOR CLINICAL-TRIALS IN RHINOCONJUNCTIVITIS
复制标题
DOI：
10.1111/j.1365-2222.1991.tb00807.x
复制
发表时间：
1991-01-01
影响因子：
6.1
通讯作者：
GUYATT, GH
中科院分区：
文献类型：
--
作者：
JUNIPER, EF;GUYATT, GH
本研究的目的是开发和测试健康相关的生活质量问卷的临床试验在鼻结膜炎。 鼻结膜炎生活质量问卷（RQLQ）是通过要求患者确定其生活中受鼻结膜炎影响的领域而开发的。 在一项随机、双盲试验中，对所得RQLQ的重现性、反应性和有效性进行了测试，该试验比较了常规与“按需”二丙酸倍氯米松（BDP）鼻喷雾剂治疗豚草花粉诱导的鼻结膜炎。 来自先前鼻结膜炎研究的85名患者参加了发育调查。 来自先前试验和媒体通知的60名豚草敏感患者入组临床试验。 在豚草花粉季节，定期或“根据需要”给予水性BDP（800 μ g）鼻喷雾剂。 调查显示，除了鼻结膜炎的局部症状外，患者还经历了全身症状、睡眠障碍、实际问题、活动限制和情绪问题等生活质量受损。 RQLQ包括与这些维度相关的28个问题。 RQLQ的重复给药表现出良好的重现性。 在临床试验期间，RQLQ被证明在区分常规和“按需”用药的能力方面具有响应性。 症状日记评分的变化与RQLQ评分的变化之间存在中度至强相关性，表明了有效性。 总之，在鼻结膜炎和鼻炎的临床试验中，RQLQ可能被证明是有用的健康相关生活质量的衡量标准。
The objective of this study was to develop and test a health-related quality of life questionnaire for clinical trials in rhinoconjunctivitis. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis. The resultant RQLQ was tested for reproducibility, responsiveness and validity in a randomized, double-blind trial of regular versus 'as required' aqueous beclomethasone dipropionate (BDP) nasal spray in ragweed pollen-induced rhinoconjunctivitis. Eighty-five patients from previous rhinoconjunctivitis studies participated in the developmental survey. Sixty ragweed-sensitive patients, from previous trials and media notices, were enrolled in the clinical trial. Aqueous BDP (800-mu-g) nasal spray was administered regularly or 'as required' throughout the ragweed pollen season. The survey revealed that, in addition to local symptoms of rhinoconjunctivitis, patients experienced impairment of quality of life through systemic symptoms, sleep disturbance, practical problems, activity limitations and emotional problems. The RQLQ includes 28 questions related to these dimensions. Repeated administration of the RQLQ demonstrated good reproducibility. During the clinical trial, the RQLQ proved responsive in its ability to distinguish between regular and 'as required' medication use. Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores. In conclusion the RQLQ is likely to prove useful as a measure of health-related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis.