血管外科的选择性出版:已终止和未发表的随机临床试验的特点
Mary A Binko1, Katherine M Reitz2, Rabih A Chaer2
1School of Medicine, University of Pittsburgh, Pittsburgh, PA.
Annals of vascular surgery
|June 13, 2023
概括
停止和未发表的随机临床试验 (RCT) 在血管外科手术中很常见. 行业资金与完成的RCT的出版物减少有关,这突显了透明报告的必要性.
科学领域:
- 医学研究 医学研究
- 临床试验 临床试验
- 血管外科 血管外科
背景情况:
- 暂停和未发表的随机临床试验 (RCT) 普遍存在,导致出版偏见和知识损失.
- 在血管外科研究中选择性出版的程度尚不清楚.
研究的目的:
- 确定在2010年至2019年期间注册的血管手术RCT的终止和发布率.
- 确定与已完成RCT发表相关的因素.
主要方法:
- 从2010年1月1日到2019年10月31日,在ClinicalTrials.gov上注册的血管外科RCT的系统审查.
- 试验被归类为已完成或已停止,基于招生状态和试验结束.
- 通过使用ClinicalTrials.gov,PubMed和Google Scholar,在试验完成后的30个月内评估了出版状态.
主要成果:
- 在血管外科手术中,有22.2%的RCT被中止,其中一个常见的原因是入学率不高.
- 80.0%的中止试验和25.0%的完成试验仍未发表.
- 工业融资与已完成的RCT公布的可能性较低 (OR=0.18) 显著相关.
- 有相当多的参与者 (4,788) 参与了没有公开结果的试验.
结论:
- 大约25%的注册血管手术RCT被中止,25%的完成试验没有发表.
- 行业赞助的试验表明,同行评审出版的可能性降低.
- 对于所有血管外科RCT,无论资金来源或完成状态如何,都需要改善对结果的报告.
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