Department of Digestive Surgery, Rouen University Hospital, 1 rue Germont, 76031 Rouen Cedex, France.
J Gastrointest Surg. 2012 Sep;16(9):1758-67. doi: 10.1007/s11605-012-1952-0. Epub 2012 Jul 10.
The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness.
The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities.
All of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score.
The mean Jadad score was 9.7 ± 1.78. The methodological quality was insufficient in 64 RCTs (37.4 %; Jadad score <9). The mean Berdeu score was 0.36 ± 0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7 % (n = 12) of the RCTs, and research ethics committee approval was not mentioned in 14.6 % (n = 25) of the RCTs.
The reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.
随机对照试验（RCT）是评估治疗干预措施的金标准工具。方法学和伦理学方面的内容应充分报告，以使读者能够对试验的有效性和治疗效果做出明智和合理的判断。
本研究旨在评估胃肠外科随机临床试验的方法学和伦理学质量，并评估这两个质量之间的关系。
所有纳入的研究均为 2006 年至 2007 年期间在 12 种国际期刊上发表的 III 期胃肠外科随机对照临床试验。通过广泛的预定标准，对合格的研究进行识别、选择和评估。使用 Jadad 量表评估方法学质量，使用 Berdeu 评分评估伦理学质量。
Jadad 评分的平均值为 9.7±1.78。64 项 RCT（37.4%；Jadad 评分<9）的方法学质量不足。Berdeu 评分的平均值为 0.36±0.08。期刊影响因子、随机患者数量和中心数量与 Jadad 评分结果相关，期刊影响因子、行业资助和试验开始年份与 Berdeu 评分结果相关。7%（n=12）的 RCT 未获得患者的知情同意，14.6%（n=25）的 RCT 未提及研究伦理委员会的批准。
胃肠外科 RCT 的报告情况不尽如人意。在我们的研究中，方法学质量较高的试验更有可能提供有关其伦理学方面的信息。这些结果表明，需要更加关注临床研究的进行和伦理学方面的报告。参与人体临床试验的外科医生对伦理规则的掌握可以提高胃肠外科 RCT 的方法学和报告质量。
