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在全膝关节整形术研究中的研究浪费:对已注册试验的观察性研究
Annabelle R Iken1, Michiel Schaap2, Rudolf W Poolman3,4
1Orthopedic Surgery, Leiden Universitair Medisch Centrum, Leiden, The Netherlands a.r.iken@lumc.nl.
BMJ open
|January 28, 2026
概括
在七年内公布预注册的膝关节整形术研究结果仍然是一个挑战,超过三分之一的干预试验和大多数观察研究未发表,导致研究浪费.
科学领域:
- 整形外科手术 整形外科手术
- 临床试验方法论 临床试验方法论
- 出版道德 出版道德
背景情况:
- 及时公布预先注册的研究结果对于防止研究浪费至关重要.
- 注册和公布结果之间的差异可能会阻碍科学进步.
研究的目的:
- 评估对膝关节整形术 (TKA) 研究事先注册的初级结果的及时 (7年内) 和一致的出版.
- 确定与2000年至2017年期间注册的TKA试验的发布时间和一致性相关的因素.
主要方法:
- 观察性研究分析了2000-2017年在ClinicalTrials.Gov注册的TKA试验.
- 数据来源包括临床试验.Gov,MEDLINE,Embase,科克兰图书馆,科学网络,PubMed和谷歌学者.
- 用描述性统计,卡普兰-梅尔曲线和考克斯回归来评估出版的及时性和一致性.
主要成果:
- 7年内预先注册的初级结局的公布率从2000年的0%增加到干预试验的59.6%,观察性研究的37.5%,到2017年.
- 非行业资助的干预和观察研究显示,及时和一致的出版率更高.
- 与以程序为重点和第一阶段试验相比,药物干预试验和第三阶段试验更有可能及时发表.
结论:
- 尽管有所改善,但超过三分之一的干预TKA试验和大多数观察性研究在7年时间内没有发表.
- 这种持续的出版缺口大大有助于在全膝关节整形术领域的研究浪费.
- 需要进一步努力,以确保及时传播所有注册的研究结果.
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