Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies.
Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies.
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DOI：
10.1186/1477-7525-8-131
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发表时间：
2010-11-12
影响因子：
3.6
通讯作者：
Viktrup L
中科院分区：
文献类型：
--
作者：
Angalakuditi M;Seifert RF;Hayes RP;O'Leary MP;Viktrup L
评估良性前列腺增生症影响指数(BII)的测量特性，以用于使用他达拉非治疗良性前列腺增生症(BPH)继发的下尿路症状(LUTS)的男性。剂量滴定(研究1)和剂量发现安慰剂对照(研究2)他达拉非对45岁或45岁以上患有中到重度下尿路感染(N=281；N=1053)的男性进行的研究数据被包括在这项特别后分析中。测量指标包括BII、国际前列腺症状评分(IPSS)、IPSS生活质量指数(IPSS-QOL)、LUTS综合评估问题、尿流仪测量最大尿流率(Qmax)和排空后残余尿量(PVR)。计算每次就诊时BII评分与其他指标之间的Spearman等级和Pearson相关系数。威尔科新双样本检验、t检验和一般线性建模比较了总体改善和没有改善的受试者以及服用他达拉非的受试者和安慰剂受试者的BII评分。计算BII和IPSS变化评分的效应大小、标准化反应平均数和Guyatt反应性统计量。每次就诊时BII与IPSS、IPSS-QOL高度相关，与Qmax、PVR低相关。在研究结束时，报告改善的受试者和报告没有改善的受试者(研究1和2，P<；.0001)以及服用他达拉非的受试者和服用安慰剂的受试者之间的BII有显著差异(研究1，P=.0045；研究2，P=.0064)。BII和IPSS都对变化做出了反应。结果表明，BII量表具有较好的信度，显示了BPH-LUTS患者对变化的反应性，并验证了结构效度。
To assess the measurement properties of the Benign Prostatic Hyperplasia Impact Index (BII) for use in men with Lower Urinary Tract Symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH) treated with tadalafil. Data from a dose-titration (Study 1) and a dose-finding placebo-controlled (Study 2) tadalafil studies of men 45 years of age or older with moderate to severe LUTS (N = 281; N = 1053) were included in this post-hoc analysis. Measures included the BII, International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), LUTS Global Assessment Question, uroflowmetry measure peak flow rate (Qmax) and postvoid residual volume (PVR). Spearman rank and Pearson correlation coefficients were computed between the BII score and the other measures at each visit. Wilcoxin two-sample tests, t-tests and general linear modeling compared BII scores of subjects with global ratings of improvement versus no improvement, and subjects taking tadalafil versus placebo. Effect size, standardized response mean and Guyatt's responsiveness statistic were calculated for BII and IPSS change scores. There were high correlations between BII and IPSS & IPSS-QoL and low correlations between BII and Qmax & PVR at each visit. There were significant differences in BII at the End-of-Study Visit between subjects reporting improvement versus subjects reporting no improvement (Studies 1 and 2, P < .0001) and subjects taking tadalafil versus subjects taking placebo (Study 1, P = .0045; Study 2, P = .0064). The BII and IPSS were both responsive to change. Results show that the BII is reliable, shows responsiveness to change in patients with BPH-LUTS, and demonstrates construct validity.
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影响因子：
6.6
作者：
BARRY, MJ;WILLIFORD, WO;LEPOR, H
通讯作者：
LEPOR, H
影响因子：
6.6
作者：
通讯作者：
--
影响因子：
6.6
作者：
McVary, Kevin T.;Roehrborn, Claus G.;Denes, Bela S.
通讯作者：
Denes, Bela S.
DOI：
10.1111/j.1742-1241.2007.01635.x
发表时间：
2008-01-01
影响因子：
2.6
作者：
Emberton, M.;Marberger, M.;de la Rosette, J.
通讯作者：
de la Rosette, J.
影响因子：
--
作者：
Marklund-Bau, Helen;Edell-Gustafsson, Ulla;Spangberg, Anders
通讯作者：
Spangberg, Anders