炎症性肠病随机对照试验报告质量:系统性审查
Morris Gordon1,2, Jamal Khudr3,4, Vassiliki Sinopoulou3
1School of Medicine, University of Central Lancashire, Preston, UK MGordon@uclan.ac.uk.
BMJ open gastroenterology
|April 17, 2024
概括
大多数炎症性肠病 (IBD) 随机对照试验 (RCT) 显示存在偏差风险,这表明报告或方法可能存在问题. 虽然报告随着时间的推移而得到了改进,但对于可靠的研究,需要进一步关注减少偏见.
科学领域:
- 胃肠病学和肝病学
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 随机对照试验 (RCT) 对于在炎症性肠病 (IBD) 中基于证据的医学至关重要.
- 评估已发表的RCT中的偏差风险对于评估发现的可靠性至关重要.
- 以前的评估表明医学文献中存在潜在的偏见,需要对IBD进行专注的审查.
研究的目的:
- 系统地评估关于炎症性肠病 (IBD) 发表的随机对照试验 (RCT) 中的偏差风险.
- 识别有助于偏见的特定领域,并评估随时间推移的趋势.
- 为了将偏见风险与出版特征相关联,例如期刊影响因子和赞助.
主要方法:
- 对所有已发表的IBD RCT进行了系统的选择,没有时间限制.
- 考克兰偏见风险工具被用于评估,具有双重独立的判断.
- 使用独立的双重评级重新评估了方法质量.
主要成果:
- 在审查的563个全文出版物中,没有一个完全没有偏见.
- 只有103篇全文论文 (不包括盲目的论文) 在所有报告领域都显示出偏见的风险很低.
- 在高影响因子期刊中的RCT显示偏差风险降低,但在IF> 10 (过去5年) 的期刊中,只有6%没有偏差.
- 随着时间的推移,观察到报告趋势的改善,分配隐藏显示出显著的改善 (p=0.037).
- 较大的作者团队,全文出版物和行业/公共赞助与较低的偏见风险相关.
结论:
- 在IBD RCT中存在偏差风险,反映了其他医学专业的发现.
- 观察到的偏见可能源于报告不良,而不是仅仅是方法不良.
- 不明确的偏见风险给读者和未来的研究综合提出了重大问题.
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