在随机临床试验中发表后的研究完整性问题:文学范围审查
Patrick F W Chien1, Mohamad A Elsuity2,3, Mosab M Rashwan4
1Department of Obstetrics and Gynecology, RCSI and UCD Malaysia Campus, Penang, Malaysia.
概括
本范围审查检查了随机临床试验 (RCT) 中的出版后完整性问题. 调查结果突出了研究透明度的差距,强调需要多方利益相关者达成共识,以解决RCT的完整性问题.
科学领域:
- 医学研究 医学研究
- 临床试验 临床试验
- 研究诚信研究诚信
背景情况:
- 在随机临床试验 (RCT) 中,出版后处理完整性问题存在重大挑战.
- 现有的文献显示,关于这些问题的管理,存在争议.
研究的目的:
- 进行一个范围的系统审查,绘制在RCT中关于出版后完整性问题的现有文献.
- 确定与出版后RCT完整性相关的关键领域和具体问题.
主要方法:
- 在多个数据库中进行了全面的搜索,包括PubMed,Scopus,Cochrane图书馆和谷歌学者.
- 无论语言,文章类型或出版日期如何,研究都被选中,直到2022年11月.
- 数据的提取和表格是双重进行的,由第三个审核员进行验证.
主要成果:
- 包含了89项研究,截面研究是最常见的 (38.2%).
- 确定的主要领域包括一般的完整性问题 (23.6%),期刊政策 (28.1%),编辑和同行评审过程 (9.0%),以及对未来研究的建议 (29.2%).
- 发现了显著的差距,特别是关键评估指导和调查流程.
结论:
- 审查确定了有关出版后RCT完整性的各种领域和问题,以及关键差距.
- 迫切需要多方利益相关者达成共识,以制定具体的指导方针,以解决RCT发布后的完整性问题.
- 提高研究透明度需要所有参与研究生命周期的利益相关者的协作努力.
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