超越通常的意义:随机对照试验的脆弱性指数在顶级的一般骨科期刊中
Mohammad Poursalehian1, Mahdi Sahebi, Mahboobeh Tajvidi
1From the Joint Reconstruction Research Center, Tehran University of Medical Sciences, Tehran, Iran (Poursalehian, Sahebi, Tajvidi, and Sabaghian), the Students' Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran (Sahebi), the Student Research Committee, Faculty of Medicine, Abadan University of Medical Sciences, Abadan, Iran (Tajvidi), the School of Medicine, Iran University of Medical sciences, Tehran, Iran (Sabaghian), the Orthopedic Surgery Research Center (OSRC), Sina University Hospital, Tehran University of Medical Sciences, Tehran, Iran (Asgari), the Department of Orthopaedic Surgery, Nationwide Children's Hospital, Columbus, OH (Tabaie), the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (Bhandari), the Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada (Bhandari), and the International Center for Limb Lengthening, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, MD (Hoveidaei).
具有二分结果的骨科随机对照试验 (RCT) 比具有连续结果的试验更脆弱. 这种脆弱性,特别是对于微不足道的结果,与小样本大小和少数事件有关,影响结果的可靠性.
科学领域:
- 整形外科手术 整形外科手术
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 像P值这样的标准统计指标不充分评估随机对照试验 (RCT) 结果的可靠性.
- 脆弱性指数,包括脆弱性指数 (FI),反向脆弱性指数 (RFI) 和持续脆弱性指数 (CFI),为试验结果稳定性提供了更可靠的衡量标准.
- 使用这些指数评估骨科RCT的稳定性对于解释研究结果至关重要.
研究的目的:
- 评估在主要期刊上发表的骨科随机对照试验 (RCT) 结果的稳定性.
- 使用已建立的脆弱性指数 (FI,RFI,CFI) 来比较二分法和连续结果的脆弱性.
- 确定导致骨科研究结果脆弱的因素.
主要方法:
- 进行了2019年至2023年期间在前五个一般骨科期刊中发表的RCT的系统审查.
- 数据提取集中在脆弱性指数 (FI,RFI,CFI) 和160个RCT的相关措施上.
- 索引是使用既定方法计算的,采用样本大小调整.
主要成果:
- 只有一个RCT明确报告了脆弱性指数.
- 有意义的二分结果的脆弱性指数 (FI) 中位数为5 (样本大小142).
- 微不足道二分结果的中位逆脆弱性指数 (RFI) 为3 (样本大小为100),中位持续脆弱性指数 (CFI) 为13 (样本大小为86.5).
- 与连续结果相比,二元结果表现出更大的脆弱性,特别是那些结果微不足道的结果.
结论:
- 骨科RCT中的连续结果不如二分化结果那么脆弱.
- 微不足道的二分论结果特别脆弱,通常是由于样本规模小和结果事件有限.
- 纳入脆弱性指数可以提高RCT发现的可靠性,特别是在考虑患者退休时.
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