对于二分结果的试验顺序分析 - 一个系统审查协议的实用指南
Sophie Juul1,2,3, Christian Gunge Riberholt4,5,6, Markus Harboe Olsen4,6
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. sophie.juul@ctu.dk.
试验序列分析 (TSA) 有常见的规划和报告错误. 本指南详细介绍了系统审查中准确的TSA的五个关键参数,以提高有效性和可重复性.
科学领域:
- 统计方法学的统计方法.
- 基于证据的医学是基于证据的医学.
- 临床试验分析临床试验分析
背景情况:
- 试验序列分析 (TSA) 对于控制随机临床试验元分析中的随机错误至关重要.
- 试验顺序分析 (METSA) 项目的重大错误和错误在大多数TSA中发现了重要的预先规划和报告缺陷.
- 这篇文章提供了一份系统审查协议的实用指南,用于规划TSA的二元化结果.
研究的目的:
- 为系统审查协议的作者提供关于计划试验序列分析 (TSA) 的实用指南.
- 解决TSA预先规划和报告中发现的常见错误和错误.
- 为了提高TSA的解释性,可重现性和有效性,需要进行系统性审查.
主要方法:
- 该指南基于TSA手册和之前的建议.
- 它结合了METSA项目的发现,该项目评估了TSA在医疗领域的使用情况.
- 专注于为二分结果规划TSA的实际考虑.
主要成果:
- 在承担TSA之前,必须在协议中定义五个基本参数.
- 这些参数包括对照组事件比例,相对风险变化,I型错误 (α),II型错误 (β) 和元分析多样性.
- 清晰地定义这些参数可以提高TSA的解释性,可复制性和有效性.
结论:
- 本指南旨在改善针对二分结果的TSA的预注册和报告.
- 它将帮助作者创建更强大的系统审查协议.
- 最终,它旨在提高随机临床试验中的元分析的质量.
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