Concerns about Data Integrity of 22 Randomized Controlled Trials in Women's Health
Concerns about Data Integrity of 22 Randomized Controlled Trials in Women's Health
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DOI：
10.1055/s-0041-1727280
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发表时间：
2021-05-18
影响因子：
2
通讯作者：
Mol, Ben W.
中科院分区：
文献类型：
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作者：
Liu, Yizhen;Thornton, Jim G.;Mol, Ben W.
目的在对产后出血的回顾性研究中，发现同一作者在同一时间、同一地点针对同一种情况进行的随机对照试验（RCT），其基线特征差异较大。研究设计我们对艾哈迈德·M.博士发表的所有随机对照试验的数据完整性进行了重点分析。魔法。我们检查了这些研究的临床逻辑，并对试验之间的基线特征和结局进行了成对比较。我们使用数学方法来评估基线特征的分布是否与chance.Results相一致2015年3月至2019年12月，Maged博士发表了22项RCT（n = 3，722）。每个中心每月随机分配的受试者中位数为32例（范围= 1-89）。15项研究未注册或回顾性注册，其中1项研究在发表后1年注册。一项研究在所述研究期结束前提交发表。这些研究中有许多不寻常的发现，包括生物学上不可信的事件，例如七项研究中胎龄和出生体重之间没有关联，三项试验之间的体重指数非常不同，这些试验在同一家医院同时进行，主题相同，以及不太可能发生的事件，例如有限的参与者脱落。其中一篇论文包含大量文本重复，数据与来自不同医院的不同作者组发表的一篇论文相同，两篇论文同时提交。所有22项试验的基线特征的数学分析表明，至少有一些报告的基线特征是不太可能的结果，适当的randomization.Conclusion我们的分析22随机对照试验的博士Maged建议潜在的数据完整性问题，至少在其中一些。我们建议期刊根据出版伦理委员会的指导方针进行调查。本文中演示的程序可能有助于在未来尝试验证已发表的随机对照试验的真实性时评估数据完整性。
Objective During a review on postpartum hemorrhage, we identified randomized controlled trials (RCTs) of one author conducted at the same time and place for the same condition, with large differences in baseline characteristics. We assessed the data integrity of the RCTs of this author.Study Design We undertook a focused analysis of the data integrity of all RCTs published by Dr. Ahmed M. Maged. We examined the studies for clinical logic and made pairwise comparisons of baseline characteristics and outcomes between trials. We used mathematical methods to assess whether the distribution of baseline characteristics was compatible with chance.Results Between March 2015 and December 2019, Dr. Maged published 22 RCTs ( n = 3,722). The median number of participants randomized per center per month was 32 (range = 1-89). Fifteen studies were either not or retrospectively registered, with one study registered 1 year after publication. One study was submitted for publication prior to the completion of the described study period. There were many unusual findings in the studies, including biologically implausible occurrences such as the absence of an association between gestational age and birthweight in seven studies and very different body mass index between three trials, which ran at the same time in the same hospital on the same topic as well as unlikely occurrences such as limited participant drop outs. One paper contained considerable text duplication and identical data to that in a paper published by a different author group from a different hospital, with both papers submitted at the same time. Mathematical analysis of the baseline characteristics of all 22 trials indicated that at least some of the reported baseline characteristics were unlikely to be the result of proper randomization.Conclusion Our analyses of the 22 RCTs of Dr. Maged suggest potential data integrity issues in at least some of them. We suggest that journals investigate according to the Committee on Publication Ethics guidelines. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.