随机对照试验报告患者报告的结果,研究组之间没有显著差异,可能容易产生不合理的结论 - 一个系统性审查
Antti Saarinen1, Oskari Pakarinen2, Matias Vaajala3
1Department of Orthopaedics and Traumatology, Turku University Hospital, Finland.
Journal of clinical epidemiology
|March 1, 2024
概括
患者报告结果测量 (PROM) 的上限效应在骨科随机对照试验 (RCT) 中很常见,可能掩盖组之间的真实差异,并导致错误的结论.
科学领域:
- 整形外科的研究研究.
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 患者报告结果指标 (PROM) 的上限效应可能导致临床研究中的错误结论.
- 这一问题在随机对照试验 (RCT) 中尤其重要,因为缺乏观察到的差异可能是由于测量限制而不是真正的平衡.
研究的目的:
- 调查骨科RCT中与上限效应相关的错误的来源.
- 为了确定在PROM得分没有显著差异的研究中的上限效应的频率.
- 评估上限效应如何抑制治疗组之间的可检测差异.
主要方法:
- 在十大骨科期刊 (2012-2022) 中发表的RCT的系统综述.
- 纳入标准:研究报告没有显著的PROM差异,并使用参数统计数据.
- 通过分析超出PROM尺度的患者比例来模拟上限效应.
主要成果:
- 在查2343.3之后,包括了190项研究.
- 在74%的研究 (140/190) 中观察到显著的上限效应.
- 模拟数据表明,由于上限效应,在17%的研究中 (33/190) 潜在的群体差异被掩盖了.
结论:
- PROM仪器和研究群体之间的不匹配是常见的,增加了虚假"没有差异"发现的风险.
- 上限效应代表了在RCT中解释PROM数据的重大潜在错误来源.
- 研究人员应该仔细考虑PROM的适用性,以避免掩盖治疗效果.
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