神经临床护理随机临床试验中的效果大小和事件率估计:系统性审查的协议
Gentle Sunder Shrestha1,2, Nuanprae Kitisin3,4, Phil Talbot5
1Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
BMJ open
|December 25, 2025
概括
在神经临床护理试验中高估效应大小导致研究不足. 本系统审查评估了已发表的随机临床试验中这些估计的准确性,以改善未来的研究设计.
科学领域:
- 临床试验 临床试验
- 神经临界护理是指神经临界护理.
- 生物统计学 生物统计学
背景情况:
- 准确的效果大小和事件率估计对于随机临床试验 (RCT) 中的样本大小计算至关重要.
- 在涉及重症患者的试验中,对这些参数的高估是常见的,这可能导致研究不足和假阴性结果增加.
- 这种系统的高估还没有在神经临床护理试验中得到系统的评估.
研究的目的:
- 系统地审查涉及重症神经病患者的已发表的RCT.
- 为了确定这些试验中效应大小和事件率估计的准确性.
- 识别与估计准确性相关的因素.
主要方法:
- 从2015年起发表的涉及成年重症神经病患者的RCT的系统综述.
- 包括报告二进制或时间到事件结果的RCT,具有优越性设计.
- 由两个独立的审稿人进行数据提取;用于聚合的随机效应模型;使用后勤和多变量线性回归进行分析.
主要成果:
- 效应大小和事件率估计的准确性将通过比较估计值与观察值来评估.
- 将评估估计准确度与否定虚假假设之间的关联.
- 小组分析将探讨期刊影响因子,样本大小和偏差风险的影响.
结论:
- 结果将为神经临床护理RCT中更准确的样本大小计算提供信息.
- 提高估计准确度可以提高研究能力,减少假负结果.
- 这一审查将为未来神经临床护理试验设计提供基于证据的建议.
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