在药物与非药物干预中进行证据综合的数据提取错误:交叉试验的研究协议
Yi Zhu1,2,3, Pengwei Ren4, Suhail A R Doi5
1MOE Key Laboratory of Population Health Across Life Cycle (Anhui Medical University), No. 81 Meishan Road, Hefei, Anhui, China.
数据提取错误在药物试验中更常见. 这项交叉试验将比较药物和非药物干预措施之间的错误率,以改善研究综合和指导方针.
科学领域:
- 临床研究方法论 临床研究方法论
- 证据综合 证据综合
- 医疗保健中的数据管理
背景情况:
- 数据提取对于研究合成至关重要,但错误很普遍.
- 与非药物干预试验相比,在药物干预试验中观察到数据提取错误的发生率更高.
- 了解这些差异对于完善基于证据的医学指南,实践和政策至关重要.
研究的目的:
- 调查药品和非药品随机对照试验 (RCT) 之间的数据提取错误率的潜在变化.
- 提供经验证据,可以为系统审查和元分析提供数据提取的最佳实践.
主要方法:
- 一个交叉,多中心,调查者盲目的试验,涉及90名研究生.
- 参与者将在随机序列中对10个制药RCT和10个非制药RCT进行数据提取.
- 错误率将在细胞,研究和参与者层面在双重检查过程之前和之后进行评估,并使用通用线性混合效应模型进行分析.
主要成果:
- 主要结果是比较药品和非药品干预组之间的数据提取错误率在双重检查之前.
- 二次结果包括在双重检查过程后的错误率.
- 小组分析将探讨审核员经验和提取时间对错误率的影响.
结论:
- 预计这项试验将提供有关数据提取错误率差异的重要证据.
- 结果将有助于开发改进的数据提取策略和更强大的系统审查指南.
- 结果将对提高各种医学领域证据综合的质量和可靠性产生影响.
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