Validation of two global impression questionnaires for incontinence

Validation of two global impression questionnaires for incontinence
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DOI:
10.1067/mob.2003.379
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发表时间:
2003-07-01
影响因子:
9.8
通讯作者:
Bump, RC
Bump, RC
中科院分区:
医学1区
文献类型:
--
作者:
Yalcin, I;Bump, RC

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目的:本研究的目的是评估两个全球评估问题,即患者对压力性尿失禁严重程度和改善程度的总体印象,在女性压力性尿失禁患者中的结构效度。研究设计:这是对两项双盲、安慰剂对照研究数据的二次分析,这两项研究评估了度洛西汀治疗美国主要压力性尿失禁患者(n=1133例)的疗效。评估变量包括大小便失禁发作次数、大小便失禁生活质量问卷结果、固定容量(400毫升)压力垫试验结果、患者对改善和严重程度问题的总体印象。结果:患者对严重程度问题的总体印象与大小便失禁发作次数、压力垫试验和失禁生活质量问卷结果之间的Spearman相关系数分别为0.36、0.20和-0.50(均P<.0001)。随着患者对严重程度问题严重程度的总体印象的增加,平均失禁发作频率和中位压力垫测试结果增加,平均失禁生活质量问卷结果减少。同样,患者对改善问题的总体印象回答类别与压力性尿失禁改善的三个独立指标(分别与大小便失禁发作频率、压力垫测试和大小便失禁生活质量问卷结果分别为0.49、0.33和-0.43)之间存在显著的相关性(P<.0001)。与患者对严重程度的总体印象问题、大小便失禁生活质量问卷的平均变化以及大小便失禁发作频率和压力垫试验的中位百分比变化的差异一样,患者对改善的印象问题回答类别具有非常显著的差异(P<.0001)。这些关系表明,患者对严重程度和改善问题的总体印象分别与压力性尿失禁严重程度和改善程度的三个独立指标之间存在适当和显著的关联。在严重程度和改善程度方面,问题回答与大小便失禁发作频率、压力垫测试和大小便失禁生活质量问卷测量显著相关,这分别建立了这两个全球评估问题对基线严重程度和治疗反应的结构效度。
OBJECTIVE: The purpose of this study was to assess the construct validity of two global assessment questions, the Patient Global Impression of Severity and of Improvement, in female patients with stress urinary incontinence.STUDY DESIGN: This was a secondary analysis of data from two double-blind, placebo-controlled studies that evaluated duloxetine for the treatment of predominant stress urinary incontinence in the United States (n = 1133 patients). Assessment variables included incontinence episode frequency, the Incontinence Quality of Life Questionnaire results, fixed volume (400 mL) stress pad test results, and the Patient Global Impression of Improvement and of Severity question results.RESULTS: Spearman correlation coefficients were 0.36, 0.20, and -0.50 among the Patient Global Impression of Severity question and incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire results, respectively (all P < .0001). Mean incontinence episode frequency and median stress pad test results increased and mean Incontinence Quality of Life Questionnaire results decreased with increasing Patient Global Impression of Severity question severity levels. Similarly, significant (P < .0001) correlations were observed between the Patient Global Impression of Improvement question response categories and the three independent measures of improvement in stress urinary incontinence (0.49, 0.33, and -0.43 with incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire results, respectively). As with the Patient Global Impression of Severity question, differences in mean changes for Incontinence Quality of Life Questionnaire and median percent changes for incontinence episode frequency and stress pad test among the Patient Global, Impression of Improvement question response categories were highly significant (P < .0001). These relationships indicate appropriate and significant associations between the Patient Global Impression of Severity and of Improvement questions and the three independent measures of stress urinary incontinence severity and improvement, respectively.CONCLUSION: The Patient Global Impression. of Severity and of Improvement, question responses were correlated significantly with incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire measures, which established the construct validity of these two global assessment questions for baseline severity and treatment response, respectively.