通过目标试验仿真方法进行观察性分析:一种方法学系统性审查
Noémie Simon-Tillaux1,2, Guillaume L Martin2, David Hajage2
1Office of Biostatistics and Epidemiology, Gustave Roussy, Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France simon.noemie@ymail.com.
BMJ open
|November 12, 2024
概括
许多模拟目标试验的研究未能指定它们,从而增加了偏差风险. 在观察性研究中指定目标试验与较少的方法问题和较低的偏差有关.
科学领域:
- 流行病学 流行病学
- 生物统计学 生物统计学
- 卫生研究方法论 卫生研究方法论
背景情况:
- 目标试验模拟提高了透明度,并减少了观察性研究中的偏见.
- 评估目标试验模拟的质量对于可靠的真实世界证据至关重要.
研究的目的:
- 评估模拟研究中目标试验的规范性.
- 检查目标试验及其观察模拟之间的一致性.
- 评估模拟目标试验的观察分析中偏差风险.
主要方法:
- 按照PRISMA指南进行的方法论系统审查.
- 搜索了MEDLINE和20个一般/专业期刊 (2021年1月~2022年7月).
- 包括声明模拟随机试验的研究;评估协议组件,一致性和偏差风险 (ROBINS-I).
主要成果:
- 审查了100项研究;24%没有指定目标试验.
- 只有40%的人详细介绍了所有目标试验协议组件.
- 在46%的特定试验中发现了目标试验和仿真之间的一致性.
- 28%的研究存在严重偏差风险; 41%的研究存在时间零错位.
- 指定目标试验的研究显示,时间零问题 (39%对52%) 和严重偏差 (26%对33%) 的比例较低.
结论:
- 很大一部分模拟目标试验的研究缺乏对原始试验的明确规范.
- 在真实随机试验的模拟中,不一致性很明显.
- 指定目标试验似乎与观察性研究中的方法问题和偏见减少有关.
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