Responsiveness of symptom scales for interstitial cystitis
Responsiveness of symptom scales for interstitial cystitis
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DOI：
10.1016/j.urology.2005.07.014
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发表时间：
2006-01-01
期刊：
影响因子：
2.1
通讯作者：
Kusek, JW
中科院分区：
文献类型：
--
作者：
Propert, KJ;Mayer, RD;Kusek, JW
目标。在间质性膀胱炎(IC)患者的临床试验中，评估复合量表对随时间变化的反应性。IC的症状测量包括O‘Leary-Sant症状和问题指数和威斯康星大学间质性膀胱炎问卷，以及测量疼痛/不适、紧迫感和排尿频率等单个症状域的量表。这些数据来自间质性膀胱炎临床试验小组进行的随机临床试验。参与者符合国家卫生研究院-国家糖尿病研究所以及消化和肾脏疾病IC的标准，并报告至少中度疼痛和频率。主要终点是24周时患者报告的全球反应评估(GRA)。次要终点包括三个综合指数，疼痛/不适和紧迫感，以及24小时频率。通过将症状评分的变化与GRA定义的反应类别进行比较来评估反应性。在原始试验的121名受试者中，有94名数据完整。根据GRA的衡量，这三个综合指数对受试者随时间的改善都很敏感。O‘Leary-Sant指数变化1.2个点，威斯康星州IC库存变化3.1个点，对应于GRA的一个类别变化。个别症状也有反应。6项结果指标的变化具有较高的相关性。这三种综合症状量表对IC患者随时间的变化具有反应能力。这些指标提供了对症状变化的重要洞察力，并被推荐作为未来IC临床试验的次要终点。还应考虑针对个别症状领域的其他终点，以帮助评估效果机制。
Objectives. To evaluate the responsiveness of composite scales to change over time in a clinical trial of patients with interstitial cystitis (IC). The measurement of symptoms in IC includes the O'Leary-Sant Symptom and Problem Indexes and the University of Wisconsin Interstitial Cystitis Inventory and scales that measure the individual symptom domains of pain/discomfort, urgency, and voiding frequency.Methods. The data were derived from a randomized clinical trial conducted by the Interstitial Cystitis Clinical Trials Group. Participants met the National Institutes of Health-National Institute for Diabetes, and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency. The primary endpoint was a patient-reported global response assessment (GRA) at 24 weeks. Secondary endpoints included the three composite indexes, pain/discomfort and urgency, and 24-hour frequency. Responsiveness was assessed by comparing symptom score changes against response categories defined by the GRA.Results. Of the 121 subjects in the original trial, 94 with complete data were included. All three composite indexes were sensitive to subject improvement over time as measured by the GRA. A 1.2-point change in the O'Leary-Sant indexes and a 3. 1-point change in the Wisconsin IC inventory corresponded to a one-category change in the GRA. Individual symptoms were also responsive. The correlation was high among the changes in the six outcome measures.Conclusions. The three composite symptom scales are responsive to change over time in patients with IC. These indexes provide important insight into symptom changes and are recommended as secondary endpoints in future clinical trials of IC. Additional endpoints addressing individual symptom domains should also be considered to aid in the evaluation of effect mechanisms.