To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Reliability of BPH 3-item questionnaire
研究概览
简要总结
This study is to linguistically and psychometrically validate the translated and culturally adapted Hong Kong Chinese version of the BPH 3-item questionnaire.
详细描述
A new BPH 3-item questionnaire has recently been developed and published, and it may serve as a screening tool for male-LUTS due to symptomatic BPE. The questionnaire consists of only three items. A raw score ranging from 0 to 5 is assigned to each of the items, giving a final total score varying from 0 (no symptom) to 15 (very symptomatic). This questionnaire has been translated and validated into five different European languages and was harmonized cross-culturally for linguistic validation, followed by psychometric accuracy testing.
This new questionnaire may help rationalize more early commencement of therapy aimed at reducing the prostate size for the treatment of male LUTS due to BPE.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 - 90 years old Chinese male subjects presented with male-LUTS for at least 4 weeks
- •The subjects are able to read and fully comprehend with the content of the questionnaires
- •The subjects are willing to give informed consent for the study
排除标准
- •peak uroflow ≤4mL/sec;
- •post-void residual (PVR) ≥300 mL;
- •unable to give informed consent
- •need of clean intermittent self-catheterization / indwelling urethral catheterization at the time of enrolment;
- •Surgical treatment (e.g. TURP) of bladder outlet obstruction / symptomatic benign prostate enlargement (BPE) ≤ 3 months before entry into the study
- •clinical suspicion / presence of untreated urethral stricture and/or bladder neck stenosis,
- •clinical suspicion / presence of genitourinary cancer including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
- •uncontrolled heart failure / diabetes mellitus(DM) / hypertension(HT);
- •neuropathic bladder;
- •Currently on dialysis or in consideration for dialysis due to end stage renal disease;
- •More than 3 urinary tract infections within the last 12 months;
- •Unstable dose of diuretic within the past 3 months;
- •Has an artificial urinary sphincter;
- •Impaired mental status;
- •male-LUTS due to urinary tract infections / chronic prostatitis / chronic pelvic pain
结局指标
主要结局
Reliability of BPH 3-item questionnaire
时间窗: up to 24 weeks
Reliability was assessed by internal consistency and test-retest correlation. (ρ) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS.
Internal consistency of BPH 3-item questionnaire
时间窗: up to 24 weeks
Internal consistency was assessed by Cronbach's alpha coefficients, with \>0.7 being considered acceptable
The convergent validity of the BPH 3-item questionnaire
时间窗: up to 24 weeks
was estimated by Spearman rho (ρ) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS.
Test-retest reliability of BPH 3-item questionnaire
时间窗: up to 24 weeks
Test-retest reliability was assessed by intra-class correlation coefficient. Values between 0.6 and 0.8 indicate substantial agreement, and values over 0.8 indicate near-perfect agreement
次要结局
未报告次要终点
研究者
Chi Fai NG
Professor
Chinese University of Hong Kong