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关于连接组织疾病随机试验的出版时间和时间延迟出版偏差
Denis Mongin1, Barbara Russo1, Alejandro Brigante2
1Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
ACR open rheumatology
|July 13, 2023
概括
结合组织疾病 (CTD) 随机对照试验 (RCT) 的发布时间正在改善. 尽管许多CTD-RCT在两年后发表,但没有发现时间延迟出版偏差.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 出版物 科学科学 出版物
背景情况:
- 随机对照试验 (RCT) 对于医学知识的进步至关重要,特别是在风湿病学中.
- 了解结合组织疾病 (CTD) 发表时间表对于评估研究影响和效率至关重要.
- 发表偏见,即研究结果影响出版速度的偏见,可以扭曲科学记录.
研究的目的:
- 确定涉及CTD的RCT从完成到出版的时间.
- 确定影响这些出版时间表的因素.
- 调查研究结果的意义是否会影响出版速度 (时间延迟出版偏差).
主要方法:
- 对在Clinicaltrials.gov (2000-2016) 注册的CTD进行干预性,2/3,3,或4期RCT的分析.
- 纳入标准要求在研究完成后5年内公布.
- 使用多变量线性回归来分析与出版时间相关的因素,包括结果的意义.
主要成果:
- 包括62个RCT,主要是系统性狼和系统性硬化症的3期药理治疗试验.
- 出版的中位时间为28个月;35%的人报告了统计学上显著的初级结果.
- 在研究期间,出版时间减少,没有发现出版速度与结果意义,资金,期刊影响因子或试验复杂性之间的联系.
结论:
- 很大一部分CTDs-RCTs在完成后两年多发布.
- 在这个队列中没有发现时间滞后出版偏差的证据.
- 近年来,CTDs-RCTs的发布时间表已经有所改善.
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