出版偏见和随机对照试验中的选择性结果报告与康复相关:文学综述
Kanako Komukai1, Sho Sugita2, Shuhei Fujimoto1
1Department of Graduate School of Public Health, Shizuoka Graduate University of Public Health, Shizuoka, Japan.
Archives of physical medicine and rehabilitation
|June 26, 2023
概括
只有13%的注册康复随机对照试验 (RCT) 发表. 在协议和发表论文之间的初级结果报告中存在显著的差异,表明康复研究中的潜在偏见.
科学领域:
- 康复研究 康复研究
- 临床试验方法论 临床试验方法论
- 出版伦理出版的伦理
背景情况:
- 发表偏见和选择性结果报告是临床研究中的关键问题.
- 评估注册协议和发表论文之间的一致性对于研究诚信至关重要.
研究的目的:
- 评估注册康复随机对照试验 (RCT) 的出版率.
- 评估注册协议和发表论文之间主要结果的一致性,以确定选择性结果报告偏差.
主要方法:
- 从UMIN,ISRCTN,ClinicalTrials.gov和MEDLINE (2013-2020) 中提取了RCT协议.
- 识别了MEDLINE的已发表论文,并将其与注册的协议相匹配.
- 比较了协议和发表论文 (摘要和主要文本) 之间的初级结果.
主要成果:
- 只有13.0% (727/5597) 的注册康复RCT协议被公布.
- 主要结果一致性在摘要中为48.7%,在协议和发表论文之间的主要文本中为72.6%.
结论:
- 康复RCT的出版率较低表明了潜在的出版偏差.
- 主要结果报告中的差异突出了公布的康复研究中选择性结果报告偏见.
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