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选择性报告偏差对中风试验的影响:证据综合的潜在妥协 - 一项横截面研究
Xinyao Wang1,2,3, Youlin Long2,3, Na Zhang2,3
1General Practice Medical Center, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
BMC medical research methodology
|October 29, 2024
概括
对结果的选择性报告在急性缺血性中风 (AIS) 随机对照试验 (RCT) 中很常见,影响了超过60%的结果. 这种偏见,特别是结果的加法,与积极的结果和在影响较低的期刊上发表相关.
科学领域:
- 临床试验 临床试验
- 医学研究诚信 医学研究诚信
- 神经学 神经学
背景情况:
- 在随机对照试验 (RCT) 中准确报告结果对于可靠的结果解释至关重要.
- 对结果的选择性报告有利于预期的结果仍然是医学研究中经常出现的问题.
- 本研究侧重于急性缺血性中风 (AIS) RCT,以调查选择性报告的患病率和影响.
研究的目的:
- 确定在急性缺血性中风 (AIS) 随机对照试验 (RCT) 中选择性结果报告的流行率.
- 在AIS RCT中识别与选择性结果报告相关的因素.
- 评估选择性报告对AIS研究中观察到的干预效应的影响.
主要方法:
- 在MEDLINE,Embase和Cochrane图书馆系统搜索2020-2022年间发表的干预性AIS RCT.
- 纳入标准要求报告国际临床试验注册平台 (ICTRP) 主要注册表号,以便与出版物进行比较.
- 用贝叶斯的多层次物流回归来分析有助于选择性报告的因素.
主要成果:
- 在159个已识别的AIS RCT中,包括82个,报告了819个结果.
- 在72个RCT (87.8%) 和497个结局 (60.7%) 中观察到选择性报告.
- 遗漏类型的选择性报告与负面结果相关 (OR:7.39),而添加类型的选择性报告与积极结果相关 (OR:2.07) 和非顶级四分位数期刊的出版 (OR:2.48).
结论:
- 对结果的选择性报告在注册的干预AIS RCT中仍然是一个重大问题.
- 需要进一步评估,以了解选择性报告偏差对AIS RCT和随后的系统审查中报告的积极结果的影响.
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