Department of Urology, University of Florida, Gainesville, FL 32610-0247, USA.
Eur Urol. 2010 Jun;57(6):930-7. doi: 10.1016/j.eururo.2010.01.034. Epub 2010 Jan 26.
Robot-assisted laparoscopic prostatectomy (RALP) is displacing radical retropubic prostatectomy as the gold standard surgical approach for clinically localised prostate cancer in the United States and is also being increasingly used in Europe and other parts of the world. This trend has occurred despite the paucity of high-quality evidence to support its relative superiority to more established treatment modalities.
We performed this study to critically assess the quality of published evidence on RALP to support this major shift in practice patterns.
DESIGN, SETTING, AND PARTICIPANTS: We conducted a systematic review of the published literature through Medline and Embase (1966 to December 2008). All original research publications on RALP were included. Editorials, letters to the editor, and review articles were excluded.
Two reviewers independently performed the data abstraction using a standardised form derived from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.
Seventy-five original research publications met eligibility criteria. Fifty-five (73.3%) studies were published between 2005 and 2008, and 20 studies (26.7%) were published between 2001 and 2004. Approximately three-quarters of the studies were case series (74.7%), and only two (2.7%) randomised, controlled trials (RCT) were identified. Twelve authors cowrote 72% (54 of 75) of the published studies. Reporting of STROBE criteria ranged from 100.0% (scientific rationale/background explained) to 1.3% (consideration of sample size), with no improvement over time. The study was limited to published literature in the English language.
The published RALP literature is limited to observational studies of mostly low methodologic quality. Our findings draw into question to what extent valid conclusions about the relative superiority or equivalence of RALP to other surgical approaches can be drawn and whether published outcomes can be generalised to the broader community. There is an urgent need to raise the methodologic standards for clinical research on new urologic procedures and devices.
机器人辅助腹腔镜前列腺切除术（RALP）正在取代根治性耻骨后前列腺切除术，成为美国临床局限性前列腺癌的金标准手术方法，并且在欧洲和世界其他地区也越来越多地使用。尽管缺乏高质量的证据来支持其相对优于更成熟的治疗方式，但这种趋势已经出现。
我们进行了这项研究，以批判性地评估 RALP 发表证据的质量，以支持这种实践模式的重大转变。
设计、设置和参与者：我们通过 Medline 和 Embase（1966 年至 2008 年 12 月）对已发表的文献进行了系统回顾。所有关于 RALP 的原始研究出版物均包括在内。社论、给编辑的信和评论文章被排除在外。
两位审查员使用源自观察性研究的强化报告（STROBE）标准的标准表格独立进行数据提取。
75 篇原始研究出版物符合入选标准。55 项（73.3%）研究发表于 2005 年至 2008 年之间，20 项（26.7%）研究发表于 2001 年至 2004 年之间。大约四分之三的研究为病例系列（74.7%），仅确定了两项（2.7%）随机对照试验（RCT）。12 位作者合著了 72%（54 篇）已发表的研究。对 STROBE 标准的报告范围从 100.0%（科学原理/背景解释）到 1.3%（考虑样本量），随着时间的推移没有改进。研究仅限于英文发表的文献。
发表的 RALP 文献仅限于观察性研究，且方法学质量大多较低。我们的发现质疑了可以在多大程度上得出关于 RALP 相对于其他手术方法的相对优越性或等效性的有效结论，以及发表的结果是否可以推广到更广泛的人群。迫切需要提高新泌尿科手术和设备临床研究的方法学标准。
