Validation of irritable bowel syndrome global improvement scale - An integrated symptom end point for assessing treatment efficacy
Validation of irritable bowel syndrome global improvement scale - An integrated symptom end point for assessing treatment efficacy
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DOI：
10.1023/a:1024159226274
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发表时间：
2003-07-01
影响因子：
3.1
通讯作者：
Carter, E
中科院分区：
文献类型：
--
作者：
Gordon, S;Ameen, V;Carter, E
整体改善量表 (GIS) 使用患者定义的 7 点李克特量表评估多种肠易激综合症 (IBS) 症状，范围从症状明显恶化到症状明显改善。为了评估该量表作为疗效终点的效果，我们从两项针对女性非便秘 IBS 患者的为期 12 周的随机、双盲、安慰剂对照研究中收集了数据。 GIS 反应者被定义为 IBS 症状有显着或中度改善。与无反应者相比，GIS 反应者有更多天数令人满意地控制尿急、大便更硬、每天排便次数更少以及不完全排便的天数更少。与无反应者（13% 和 11%）相比，对总体治疗感到满意或非常满意的 GIS 反应者（研究 1 和 2 中分别为 90% 和 89%）明显增多（两项研究中 r = 0.8）。 GIS 响应者对药物缓解疼痛和不适以及恢复正常活动所需的时间更加满意。我们观察到 GIS 与工作和非工作生产力损失之间存在良好的相关性。 GIS 测量与 IBS 临床终点的相关性确定了 GIS 用于测量 IBS 症状改善的有效性。 GIS 可能有助于评估未来临床试验中 IBS 干预措施的效果。
The Global Improvement Scale (GIS) assesses multiple irritable bowel syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from symptoms substantially worse to substantially improved. To evaluate the scale as an efficacy end point, data were collected from two 12-week randomized, double-blind, placebo-controlled studies of female nonconstipated IBS patients. GIS responders were defined as having substantial or moderate improvement in IBS symptoms. GIS responders had more days with satisfactory control of urgency, firmer stools, fewer stools per day, and fewer days with incomplete evacuation compared to nonresponders. Substantially more GIS responders (90% and 89% in studies 1 and 2, respectively) were satisfied or very satisfied with their treatment overall compared to nonresponders (13% and 11%) (r = 0.8 in both studies). GIS responders had greater satisfaction with medication relief of pain and discomfort and the time needed to return to usual activities. Favorable correlations between GIS and work and nonwork productivity losses were observed. Correlation of the GIS measure with IBS clinical end points establishes the validity of the GIS for measuring improvement in IBS symptoms. The GIS may be useful in assessing the efficacy of IBS interventions in future clinical trials.