Doulaveris Georgios, Vani Kavita, Saccone Gabriele, Chauhan Suneet P, Berghella Vincenzo
Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (Drs Doulaveris and Vani).
Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (Drs Doulaveris and Vani).
Am J Obstet Gynecol MFM. 2022 Jan;4(1):100509. doi: 10.1016/j.ajogmf.2021.100509. Epub 2021 Oct 14.
There has been an increasing number of randomized controlled trials published in obstetrics and maternal-fetal medicine to reduce biases of treatment effect and to provide insights on the cause-effect of the relationship between treatment and outcomes.
This study aimed to identify obstetrical randomized controlled trials published in top weekly general medical journals and monthly obstetrics and gynecology journals, to assess their quality in reporting and identify factors associated with publication in different journals.
The 4 weekly medical journals with the highest 2019 impact factor (New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ), the top 4 monthly obstetrics and gynecology journals with obstetrics-related research (American Journal of Obstetrics & Gynecology, Ultrasound in Obstetrics & Gynecology, Obstetrics & Gynecology, and the BJOG: An International Journal of Obstetrics and Gynaecology), and the American Journal of Obstetrics & Gynecology Maternal-Fetal Medicine were searched for obstetrical randomized controlled trials in the years 2018 to 2020. The primary outcome was the number of obstetrical randomized controlled trials published in the obstetrics and gynecology journals vs the weekly medical journals and the percentage of trials published, overall and per journal. The secondary outcomes included the proportion of positive vs negative trials overall and per journal and the assessment of the study characteristics of published trials, including quality assessment criteria.
Of the 4024 original research articles published in the 9 journals during the 3-year study period, 1221 (30.3%) were randomized controlled trials, with 137 (11.2%) randomized controlled trials being in obstetrics (46 in 2018, 47 in 2019, and 44 studies in 2020). Furthermore, 33 (24.1%) were published in weekly medical journals, and 104 (75.9%) were published in obstetrics and gynecology journals. The percentage of obstetrical randomized controlled trials published ranged from 1.5% to 9.6% per journal. Overall, 34.3% of obstetrical trials were statistically significant or "positive" for the primary outcome. Notably, 24.8% of the trials were retrospectively registered after the enrollment of the first study patient. Trials published in the 4 weekly medical journals enrolled significantly more patients (1801 vs 180; P<.001), received more often funding from the federal government (78.8% vs 35.6%; P<.001), and were more likely to be multicenter (90.9% vs 42.3%; P<.001), non-United States based (69.7% vs 49.0%; P=.03), and double blinded (45.5% vs 18.3%; P=.003) than trials published in the obstetrics and gynecology journals. There was no difference in study type (noninferiority vs superiority) and trial quality characteristics, including pretrial registration, ethics approval statement, informed consent statement, and adherence to the Consolidated Standards of Reporting Trials guidelines statement between studies published in weekly medical journals and studies published in obstetrics and gynecology journals.
Approximately 45 trials in obstetrics are being published every year in the highest impact journals, with one-fourth being in the weekly medical journals and the remainder in the obstetrics and gynecology journals. Only about a third of published obstetrical trials are positive. Trials published in weekly medical journals are larger, more likely to be funded by the government, multicenter, international, and double blinded. Quality metrics are similar between weekly medical journals and obstetrics and gynecology journals.
在妇产科学和母胎医学领域，发表的随机对照试验数量不断增加，以减少治疗效果的偏差，并深入了解治疗与结果之间关系的因果联系。
本研究旨在识别发表于顶级综合性医学周刊和妇产科学月刊上的产科随机对照试验，评估其报告质量，并确定与在不同期刊上发表相关的因素。
检索了2018年至2020年间，2019年影响因子最高的4种综合性医学周刊（《新英格兰医学杂志》《柳叶刀》《美国医学会杂志》和《英国医学杂志》）、4种发表产科相关研究的顶级妇产科学月刊（《美国妇产科学杂志》《妇产科超声》《妇产科学》和《英国妇产科杂志：国际妇产科学杂志》）以及《美国妇产科学杂志·母胎医学》上的产科随机对照试验。主要结果是在妇产科学期刊与综合性医学周刊上发表的产科随机对照试验数量，以及总体和各期刊上发表试验的百分比。次要结果包括总体和各期刊上阳性试验与阴性试验的比例，以及对已发表试验的研究特征评估，包括质量评估标准。
在为期3年的研究期间，9种期刊发表的4024篇原创研究文章中，1221篇（30.3%）为随机对照试验，其中137篇（11.2%）为产科随机对照试验（2018年46篇，2019年47篇，2020年44篇）。此外，33篇（24.1%）发表于综合性医学周刊，104篇（75.9%）发表于妇产科学期刊。各期刊上发表的产科随机对照试验百分比在1.5%至9.6%之间。总体而言，34.3%的产科试验主要结果在统计学上具有显著意义或为“阳性”。值得注意的是，24.8%的试验在纳入首位研究患者后进行回顾性注册。发表于4种综合性医学周刊的试验纳入的患者明显更多（1801例对180例；P<0.001），获得联邦政府资助的频率更高（78.8%对35.6%；P<0.001），更有可能是多中心试验（90.9%对42.3%；P<0.001）、非美国本土试验（69.7%对49.0%；P=0.03）以及双盲试验（45.5%对18.3%；P=0.003）。综合性医学周刊上发表的试验与妇产科学期刊上发表的试验在研究类型（非劣效性与优效性）以及试验质量特征方面没有差异，包括预试验注册、伦理批准声明、知情同意声明以及是否遵循《报告试验的统一标准》指南声明。
每年约有45项产科试验发表于影响因子最高的期刊，其中四分之一发表于综合性医学周刊，其余发表于妇产科学期刊。仅约三分之一已发表的产科试验为阳性。发表于综合性医学周刊的试验规模更大，更有可能由政府资助，为多中心、国际性和双盲试验。综合性医学周刊与妇产科学期刊的质量指标相似。
