A NEW MEASURE OF HEALTH-STATUS FOR CLINICAL-TRIALS IN INFLAMMATORY BOWEL-DISEASE
A NEW MEASURE OF HEALTH-STATUS FOR CLINICAL-TRIALS IN INFLAMMATORY BOWEL-DISEASE
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DOI：
10.1016/0016-5085(89)90905-0
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发表时间：
1989-03-01
期刊：
影响因子：
29.4
通讯作者：
TOMPKINS, C
中科院分区：
文献类型：
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作者：
GUYATT, G;MITCHELL, A;TOMPKINS, C
我们开发了一种炎症性肠病（IBD）患者主观健康状况（生活质量）的测量方法。97例IBD患者描述了他们因疾病而经历的问题;炎症性肠病问卷（IBDQ）中包括了32个最常见和最重要的项目。对61例IBD患者进行了两次评价。评估间隔一个月，在此期间进行疾病活动指数、IBDQ和许多其他问卷调查。在19名稳定患者中进行的生殖研究显示评分有所改善，但人内标准差也较小。反应性研究显示，改善或恶化的患者的评分变化较大，并表明IBDQ比一般健康状况指标更具反应性。溃疡性结肠炎患者的反应性高于克罗恩病患者。预测和观察到的IBDQ评分变化和其他指标变化之间的相关性是相似的。我们的结论是，虽然需要进一步的测试，特别是在检查IBDQ的变化和克罗恩病的活动变化之间的关系，IBDQ显示出作为IBD临床试验的健康状况的措施的承诺。
We have developed a measure of subjective health status (quality of life) for patients with inflammatory bowel disease (IBD). Ninety-seven patients with IBD described problems they had experienced as a result of the disease; the 32 most frequent and important items were included in the Inflammatory Bowel Disease Questionnaire (IBDQ). Sixty-one IBD patients were evaluated twice. One month separated the evaluations, at which disease activity indices, the IBDQ, and a number of other questionnaires were administered. Reproducibility studies in 19 stable patients showed improvement in scores, but also a small within-person standard deviation. Responsiveness studies revealed large changes in scores in patients who had improved or deteriorated and suggested that the IBDQ was more responsive than a general health status measure. Responsiveness appeared greater in patients with ulcerative colitis than in those with Crohn''s disease. Predicted and observed correlations between changes in IBDQ scores and changes in other measures were similar. We conclde that although further testing is required, particularly in examining the relation between changes in the IBDQ and changes in the activity of Crohn''s disease, the IBDQ shows promise as a measure of health status for clinical trials in IBD.