Keoghane S R, Lawrence K C, Jenkinson C P, Doll H A, Chappel D B, Cranston D W
Department of Urology, Churchill Hospital, Oxford, United Kingdom.
Urology. 1996 Jan;47(1):43-7. doi: 10.1016/s0090-4295(99)80380-x.
To evaluate the sensitivity to change of outcome measures in a double-blind randomized controlled trial of transurethral resection of the prostate (TURP) and contact laser prostatectomy.
A total of 152 patients were randomized to TURP or contact laser prostatectomy using the Surgical Laser Technology (SLT) system. Preoperative data were obtained using a self-administered questionnaire containing the American Urological Association (AUA-7) symptom score, the bothersome score (benign prostatic hyperplasia impact index), and the Short Form-36 health status questionnaire (SF-36). Follow-up was at 1 and 3 months. Effect size scores were calculated to indicate the extent of change from baseline to follow-up.
Data were available on 148 patients: 72 received laser therapy and 76 received TURP. Mean change in AUA-7 score at 3 months was 7.3 in the laser arm, compared with 11.9 in the TURP arm (P < 0.05). Furthermore, substantial change was detected in both groups on the bothersome score. However, very few significant differences in SF-36 dimension scores from baseline to 3 months were detected.
The SF-36 at both baseline and follow-up indicated a similar level of health status as that reported in the general population. Subsequently, the measure did not improve on any dimensions. Our data support the claim of some researchers that shorter disease-specific indices are vital to the evaluation of treatment regimens in clinical trials, especially when the general health of the patients is similar to that of the population.
在一项经尿道前列腺切除术（TURP）和接触式激光前列腺切除术的双盲随机对照试验中，评估结局指标对变化的敏感性。
总共152例患者使用外科激光技术（SLT）系统随机分为接受TURP或接触式激光前列腺切除术。术前数据通过一份自我管理问卷获得，该问卷包含美国泌尿外科学会（AUA - 7）症状评分、困扰评分（良性前列腺增生影响指数）和简短健康调查问卷（SF - 36）。随访时间为1个月和3个月。计算效应大小评分以表明从基线到随访的变化程度。
148例患者有可用数据：72例接受激光治疗，76例接受TURP。激光治疗组3个月时AUA - 7评分的平均变化为7.3，而TURP组为11.9（P < 0.05）。此外，两组在困扰评分上均检测到显著变化。然而，从基线到3个月，SF - 36维度评分几乎没有检测到显著差异。
基线和随访时SF - 36均表明健康状况水平与一般人群报告的相似。随后，该指标在任何维度上均未改善。我们的数据支持一些研究人员的观点，即较短的疾病特异性指标对于评估临床试验中的治疗方案至关重要，尤其是当患者的总体健康状况与人群相似时。
