Anderson Kathryn M, Doulaveris Georgios, Bennett Carrie, Mol Ben W, Berghella Vincenzo
Department of Obstetrics and Gynecology, Warren Alpert Medical School, Brown University, Providence, RI (Dr Anderson).
Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, New York City, NY (XX Doulaveris).
Am J Obstet Gynecol MFM. 2023 May;5(5):100889. doi: 10.1016/j.ajogmf.2023.100889. Epub 2023 Feb 17.
The number of retracted articles in peer-reviewed journals is increasing within the field of obstetrics. The most common reason for article retraction is scientific misconduct. Unfortunately, article retraction often occurs years after publication, allowing inaccurate data to be widely distributed to readers. There exists a great need for validated screening criteria for obstetric journals to use when reviewing randomized controlled trials for scientific misconduct.
This study aimed to compare retracted obstetric randomized controlled trials with nonretracted randomized controlled trials with regard to their inclusion of 7 quality metrics: prospective trial registration, trial registration number, ethics approval statement, name of the approving committee, statement of informed consent, adherence to the Consolidated Standards of Reporting Trials guidelines, and a data sharing statement.
Obstetric randomized controlled trials retracted between 1995 and 2021 identified through Retraction Watch were compared with nonretracted randomized controlled trials published between 2018 and 2020 with regard to inclusion of the 7 quality metrics. The main outcome was the difference in prospective trial registration. Secondary outcomes were the percentage of individual criteria met and the screening performance of quality criteria in predicting article retraction.
A total of 150 randomized controlled trials were identified, of which 14 (9.3%) were retracted and 136 (90.7%) nonretracted. Retracted randomized controlled trials were less likely than nonretracted randomized controlled trials to be prospectively registered (14.3% vs 80.1%; P<.001). The median number of quality criteria met was lower for retracted randomized controlled trials (3 vs 6; P<.01). Using a cutoff of ≤4 criteria was associated with 85.7% (95% confidence interval, 57.2-98.2) sensitivity and 92.0% (95% confidence interval, 86.2-96.0) specificity in distinguishing the retracted randomized controlled trials from nonretracted studies.
Retracted obstetric randomized controlled trials were less likely to include the 7 quality metrics required on submission by most top obstetrics and gynecology journals.
在妇产科学领域，同行评审期刊中撤稿文章的数量正在增加。文章撤稿最常见的原因是学术不端行为。不幸的是，文章撤稿往往在发表数年之后才发生，这使得不准确的数据得以广泛传播给读者。在评审随机对照试验是否存在学术不端行为时，妇产科学期刊非常需要经过验证的筛选标准。
本研究旨在比较撤稿的产科随机对照试验与未撤稿的随机对照试验在7项质量指标方面的情况，这7项指标包括前瞻性试验注册、试验注册号、伦理批准声明、批准委员会名称、知情同意声明、是否遵循《报告试验的统一标准》指南以及数据共享声明。
通过Retraction Watch识别出1995年至2021年间撤稿的产科随机对照试验，并与2018年至2020年间发表的未撤稿随机对照试验在7项质量指标方面进行比较。主要结果是前瞻性试验注册方面的差异。次要结果是各项标准符合的百分比以及质量标准在预测文章撤稿方面的筛选性能。
共识别出150项随机对照试验，其中14项（9.3%）被撤稿，136项（90.7%）未撤稿。撤稿的随机对照试验进行前瞻性注册的可能性低于未撤稿的随机对照试验（14.3%对80.1%；P<0.001）。撤稿的随机对照试验符合质量标准的中位数较低（3项对6项；P<0.01）。使用≤4项标准的临界值在区分撤稿的随机对照试验与未撤稿研究时，敏感性为85.7%（95%置信区间，57.2 - 98.2），特异性为92.0%（95%置信区间，86.2 - 96.0）。
撤稿的产科随机对照试验纳入大多数顶级妇产科期刊投稿时所需的7项质量指标的可能性较小。
