Departments of Surgery (Urology), McGill University, Montreal, Canada.
BJU Int. 2013 Mar;111(3):419-26. doi: 10.1111/j.1464-410X.2012.11401.x. Epub 2012 Aug 29.
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Results from well designed randomized controlled trials usually provide the strongest evidence possible in favour of one medical intervention over another. For this reason, it is of paramount importance to conduct such trials in bladder cancer, where randomized trials are lacking, in particular to answer questions that have so far confounded us or to investigate the efficacy of new diagnostic tools or interventions. This study provides a demographic analysis of randomized controlled trials published in bladder cancer between the years of 1995 and 2010, with only 238 articles identified. Less than one-third of these reported a statistical power calculation, and only 8% were double-blinded. With many publications inaccurately labelled as randomized trials, we reveal the scarcity of trials performed over the given time period, even compared with other cancers with similar incidence, and highlight the need for more well designed trials to be conducted.
To demographically examine randomized controlled trials (RCTs) that have been conducted in bladder cancer over a predefined time period.
Various techniques have been described to detect RCTs using different databases. We searched the MEDLINE database by crossing the heading 'Urinary bladder neoplasms' with the MeSHs 'Clinical trial$.mp. OR clinical trial.pt. OR random:.mp. OR tu.xs.' between 1995 and 2010. For the RCTs identified, analysis was performed on each RCT, placing particular emphasis on modality of intervention, cohort size, principal author, region, journal type, disease status, histology, blinding, number of centres involved, performance of a statistical power calculation, accrual status and trial support.
Of 5002 RCT bladder cancer papers retrieved over the given period, only 238 represented actual RCTs after manual appraisal. More than half of the RCTs investigated medical and surgical therapies (54.2%), and only half had a sample size of >100 patients. A small percentage of studies were double-blinded (8.0%), and there was an almost equal distribution of multicentre vs single centre trials (54.6% vs 45.4%). More studies were conducted in Europe (61.3%) than the rest of the world combined, with urologists principally the lead investigators in the majority (72.3%). Most studies were conducted on patients with urothelial carcinoma (97.1%), with less than one-third reporting a statistical power calculation (31.5%).
Only 238 RCTs were published for bladder cancer between 1995 and 2010. RCTs are under-utilized in bladder cancer. More trials need to be designed with larger sample sizes in order to optimize diagnostic and treatment strategies for patients with bladder cancer.
在医学领域，随机对照试验（RCT）通常被认为是评估干预措施效果的金标准。然而，对于膀胱癌这种常见的疾病，随机对照试验的数量相对较少。
对过去某一时间段内发表的膀胱癌随机对照试验进行人口统计学分析。
我们使用不同的数据库描述了各种检测 RCT 的技术。我们在 1995 年至 2010 年间，通过将“膀胱癌”主题词与“临床试验$”和“随机$”进行交叉搜索，在 MEDLINE 数据库中进行了搜索。对于识别出的 RCT，我们对每个 RCT 进行了分析，特别强调了干预方式、队列大小、主要作者、地区、期刊类型、疾病状态、组织学、盲法、涉及的中心数量、统计效能计算的执行情况、入组状态和试验支持。
在给定的时间段内，共检索到 5002 篇膀胱癌 RCT 论文，经过人工评估，只有 238 篇是真正的 RCT。超过一半的 RCT 研究了医疗和手术治疗（54.2%），只有一半的 RCT 样本量大于 100 例。只有一小部分研究是双盲的（8.0%），并且多中心和单中心试验的分布大致相同（54.6%对 45.4%）。欧洲（61.3%）的研究数量多于其他地区的总和，泌尿科医生是大多数研究的主要研究者（72.3%）。大多数研究都是针对尿路上皮癌患者进行的（97.1%），只有不到三分之一的研究报告了统计效能计算（31.5%）。
1995 年至 2010 年期间，仅发表了 238 篇膀胱癌 RCT。膀胱癌 RCT 的应用不足。为了优化膀胱癌患者的诊断和治疗策略，需要设计更多具有更大样本量的试验。
