脊柱RCT中基线频率数据的特征并不表明广泛的非随机分配
Manon Malia Sydney Levayer1, Gem Rui Ping Chew2, Kyle Alexander Sheldrick3,4
1School of Biomedical Engineering, The University of Sydney, Darlington, Australia.
概括
这项研究发现,脊柱随机对照试验 (RCT) 显示没有系统欺诈的证据. 这些数据表明,主要期刊上发表的脊柱RCT使用了真正的随机分配和可靠的实验数据.
科学领域:
- 整形外科 整形外科 整形外科
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 对脊柱随机对照试验 (RCT) 潜在欺诈的担忧引发了对其可靠性的质疑.
- 确保RCT的完整性至关重要,因为它们对脊柱护理中的临床治疗决策有重大影响.
研究的目的:
- 调查在领先的脊柱期刊上发表的脊柱RCT中存在非随机基线频率数据.
- 评估脊柱RCT在指导治疗决策中的可靠性和完整性.
主要方法:
- 在PubMed的系统搜索中,从2016年1月到2020年12月,在四个主要的脊柱期刊上发表的RCT被确定为2016年1月至2020年12月.
- 使用Pearson Chi-squared测试分析了基线频率数据,以计算研究智能的p值,结果与先前麻醉学调查相比较.
主要成果:
- 在228项已识别的研究中,包括167项在分析中.
- 研究的p值通常与真正的随机实验一致.
- 虽然观察到p值略高于0.99,但这些值往往有合理的解释,整体分布与预期结果保持一致.
结论:
- 这些发现并不表明脊柱RCT中的系统欺诈行为.
- 在主要期刊上发表的脊柱RCT似乎使用了真正的随机分配和实验性数据.
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