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我们应该更好地考虑新生儿随机试验中的多胎儿:方法论系统性审查
Kristy P Robledo1, Sol Libesman2, Lisa Nicole Yelland3,4
1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia kristy.robledo@sydney.edu.au.
Archives of disease in childhood. Fetal and neonatal edition
|December 9, 2024
概括
对早产婴儿的多中心试验在设计和分析中经常忽略多胎. 这一系统性审查突出了持续存在的问题,强调需要改进的方法来解释新生儿研究中的这些复杂性.
科学领域:
- 新生儿研究方法论新生儿研究方法论
- 临床试验的设计
- 生物统计学 生物统计学
背景情况:
- 涉及早产婴儿的多中心试验对于推进新生儿护理至关重要.
- 之前的审查发现了在试验设计和分析中考虑多胎儿的问题.
- 需要评估当前的做法和过去十年的改进.
研究的目的:
- 系统地审查最近针对早产婴儿的多中心试验在设计,分析和报告中如何处理多胎.
- 评估自10年前的最后一次审查以来,做法是否有所改善.
主要方法:
- 在PubMed上进行系统的文献搜索,寻找2018年6月至2023年6月期间发表的文章.
- 纳入标准:早产婴儿的多中心随机试验,报告了婴儿水平的初级结果.
- 对62项符合条件的试验进行审查,以评估是否考虑多胎产.
主要成果:
- 87%的试验在样本大小计算中没有包括多胎儿.
- 48%的试验未能在分析中考虑由于多胎出生的聚类.
- 没有任何试验报告了类内相关系数,这表明缺乏对集群效应的评估.
结论:
- 在对早产婴儿的多中心试验中,关于处理多胎产的重大挑战仍然存在.
- 在试验设计和分析中,处理多胎儿的可用统计方法往往被忽视.
- 试验人员和同行评审人员必须意识到和解决新生儿研究中的这些方法问题.
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