中国神经外科随机对照试验:试验实施和完成的动态
Tao Liu1,2, Mingqi Liu1,2, Zhuang Sha1,2
1Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin , China.
Neurosurgery
|October 5, 2023
概括
中国神经外科在随机对照试验 (RCT) 中取得了重大进展,尽管样本大小和功率计算需要改进. 在中国,COVID-19大流行对RCT的设计和质量影响极小.
科学领域:
- 神经外科 神经外科
- 基于证据的医学是基于证据的医学.
- 临床试验中的临床试验.
背景情况:
- 神经外科越来越依赖于基于证据的实践,特别是随机对照试验 (RCT).
- 缺乏对中国对神经外科RCT贡献的系统评估.
- 在COVID-19大流行之前和期间,了解中国神经外科RCT的变化是有限的.
研究的目的:
- 对中国神经外科RCT特征进行详细检查和全面分析.
- 在COVID-19大流行之前和期间评估RCT特征的差异.
- 调查影响中国神经外科RCT质量和趋势的因素.
主要方法:
- 在PubMed,科学网,Embase和Cochrane图书馆的数据库中进行全面的搜索,直到2023年3月.
- 纳入标准要求影响因子高于0.
- 检查设计和质量参数,并对疫情前和疫情期间的时间进行比较 (2020年1月之前与之后).
主要成果:
- 分析了91个神经外科RCT,主要关注血管疾病 (47.3%) 和创伤 (18.7%).
- 超过一半的人使用综合报告试验标准 (CONSORT) 图 (69.2%),大多数人比较非手术治疗 (63.7%).
- 较大的试验显示出更好的质量,但显著的疗效试验往往缺乏功率计算;随着时间的推移,CONSORT的使用和结果规范性增加了. 疫情对设计和质量影响最小,但可能阻碍了完成.
结论:
- 尽管面临挑战,但中国的神经外科医生在进行RCT方面取得了进展.
- 样本大小和功率计算中的缺陷需要注意.
- 提高神经外科RCT设计的严谨性,合理性和完整性是必不可少的.
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