描述包括在骨科手术系统评论中的试验中的随机化
Matthew Tang1, Kimberley K Lun2, Adriane M Lewin1,3
1School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia.
Bone & joint open
|December 3, 2024
概括
系统性审查中的许多骨科手术试验缺乏足够的随机化,增加了偏差风险. 改善随机对照试验和系统审查的进行对于可靠的患者护理证据至关重要.
科学领域:
- 整形外科手术 整形外科手术
- 基于证据的医学 基于证据的医学
- 临床试验方法论 临床试验方法论
背景情况:
- 随机对照试验 (RCT) 的系统审查对于患者护理决策至关重要.
- 有关骨科手术RCT随机化的质量存在担忧.
- 这项研究评估了骨科手术系统综述中的随机化试验的质量.
研究的目的:
- 评估随机对照试验 (RCT) 随机对照试验的质量,包括在专注于整形外科手术的系统性审查中.
- 确定该领域不充分的随机化和错误分类研究的流行情况.
主要方法:
- 在PubMed,Embase和Cochrane图书馆系统搜索2022年整形外科手术系统评论.
- 分析了100个评论的随机样本;所有包含的RCT都使用Cochrane风险偏差-2工具进行了评估,用于随机序列生成.
- 收集关于RCT和系统审查特征的数据,以探索随机化质量的关联.
主要成果:
- 在917个独特的RCT中,只有40.8%具有足够的随机化;6.7%是不充分的,而44.7%缺乏信息.
- 7.9%的纳入研究是观察性研究,被错误标记为RCT.
- 出版年份,作者专业知识和期刊影响因子等因素与适当的随机化相关.
- 45%的系统性审查包含至少一个不够随机的RCT或错误分类的观察性研究.
结论:
- 有关证据表明,在系统性审查中,骨科手术RCT的随机化质量不佳.
- 不充分的随机化和研究设计的错误分类造成了大量的偏差风险.
- 进行RCT和系统审查的改进是必要的,以确保临床实践的可靠证据.
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