Donovan J L, Peters T J, Abrams P, Brookes S T, de aa Rosette J J, Schäfer W
Department of Social Medicine, University of Bristol, United Kingdom.
J Urol. 2000 Dec;164(6):1948-55.
The International Continence Society (ICS) ICSmale questionnaire was devised to provide a thorough evaluation of the occurrence and bothersomeness of lower urinary tract symptoms and their impact on the lives of men with benign prostatic disease. This report completes the developmental work on the questionnaire, producing the concise short form instrument, ICSmaleSF, with a valid, reliable and scientifically justified scoring system.
Two data sets were used. The short form version of the questionnaire was devised and initially evaluated using data on men with uncomplicated lower urinary tract symptoms who were involved in the CLasP randomized controlled trial comparing laser therapy with transurethral prostatic resection and conservative management or monitoring without active intervention. External validation of the scoring system was undertaken using data from phase II of the ICS benign prostatic hyperplasia (BPH) study, an observational study of outcome in men with lower urinary tract symptoms related to benign prostatic enlargement. All patients completed the developmental version of the ICSmale questionnaire. Parallel analysis on the CLasP data set identified items that were responsive to change or highly problematic, allowing other redundant and overlapping items to be eliminated. Factor analysis and Cronbach's alpha coefficients were used to examine the clustering of items. Regression models were used to investigate the validity of followup scores within and across treatment groups in the CLasP and ICS/BPH studies.
The questionnaire, which originally comprised 22 items, was shortened to 11 items in the 2 distinct factors of voiding (ICSmaleVS) and incontinence (ICSmaleIS) symptoms. Cronbach's alpha coefficients were high at 0.76 for ICSmaleVS and 0.78 for ICSmaleIS. A simple additive score was calculated by adding the 5 items in ICSmaleVS and 6 in ICSmaleIS. ICSmaleVS and ICSmaleIS detected expected improvement in the laser therapy and transurethral prostatic resection groups, and stability in the conservative management group within CLasP. Similarly each subscore but particularly ICSmaleVS was sensitive to differences in the outcome of the range of treatments in the ICS/BPH study. While frequency and nocturia were highly problematic and sensitive to change individually, they did not load into the other main factors or correlate with each other. It is suggested that these symptoms should be evaluated separately with the additional inclusion of a single item measure of the impact of lower urinary tract symptoms on daily life.
The ICSmaleSF represents a comprehensive, concise, valid and reliable instrument for evaluating men with lower urinary tract symptoms. Unlike other questionnaires in the field it contains subscores for the domains of voiding and incontinent symptoms as well as the separate consideration of frequency, nocturia and impact on daily life. We hope that it will become the tool of choice for the comprehensive evaluation of treatment of men with lower urinary tract symptoms associated with benign prostatic disease.
国际尿控协会（ICS）男性问卷旨在全面评估下尿路症状的发生情况、困扰程度及其对良性前列腺疾病男性患者生活的影响。本报告完成了该问卷的研发工作，生成了简明的简化版工具ICSmaleSF，并配有有效、可靠且具有科学依据的评分系统。
使用了两个数据集。问卷的简化版经设计后，最初利用参与CLasP随机对照试验的单纯下尿路症状男性患者的数据进行评估，该试验比较了激光治疗与经尿道前列腺切除术以及保守治疗或不进行积极干预的监测情况。评分系统的外部验证采用了ICS良性前列腺增生（BPH）研究第二阶段的数据，这是一项对与良性前列腺增生相关的下尿路症状男性患者结局的观察性研究。所有患者均完成了ICS男性问卷的研发版本。对CLasP数据集进行的平行分析确定了对变化有反应或问题较大的项目，从而得以剔除其他冗余和重叠的项目。采用因子分析和克朗巴哈系数来检验项目的聚类情况。使用回归模型来研究CLasP和ICS/BPH研究中治疗组内及组间随访评分的有效性。
该问卷最初包含22个项目，在排尿（ICSmaleVS）和尿失禁（ICSmaleIS）症状这两个不同因素中缩短为11个项目。ICSmaleVS的克朗巴哈系数为0.76，ICSmaleIS的为0.78，均较高。通过将ICSmaleVS中的5个项目和ICSmaleIS中的6个项目相加计算出一个简单的累加分数。ICSmaleVS和ICSmaleIS在CLasP中检测到激光治疗组和经尿道前列腺切除组有预期的改善，保守治疗组情况稳定。同样，在ICS/BPH研究中，每个子分数，尤其是ICSmaleVS，对一系列治疗结局的差异很敏感。虽然尿频和夜尿问题较大且各自对变化敏感，但它们未归入其他主要因素，彼此之间也无相关性。建议应分别评估这些症状，并额外纳入一项关于下尿路症状对日常生活影响的单项测量。
ICSmaleSF是一种用于评估下尿路症状男性患者的全面、简明、有效且可靠的工具。与该领域的其他问卷不同，它包含排尿和尿失禁症状领域的子分数，以及对尿频、夜尿和对日常生活影响的单独考量。我们希望它将成为全面评估与良性前列腺疾病相关的下尿路症状男性患者治疗情况的首选工具。
