对CLSI指南EP09c"使用患者样本进行测量程序比较和偏差估计"的批判性评估
Bruno Mario Cesana1, Paolo Antonelli2, Simona Ferraro3
1Laboratory of Medical Statistics, Biometry and Epidemiology "G.A. Maccacaro", University of Milan, Milan, Italy.
Clinical chemistry and laboratory medicine
|August 17, 2024
概括
评估测量方法协议需要仔细的统计考虑. 这项研究强调了当前指导方针的局限性,并提出了用于实验室环境中准确偏差评估的替代方法.
科学领域:
- 实验室医学 实验室医学
- 生物统计学 生物统计学
- 测量科学 测量科学 测量科学
背景情况:
- 在实验室环境中,评估测量方法之间的一致性是常见的.
- 现有的指导方针,如临床和实验室标准研究所 (CLSI) EP09c,具有统计和方法方面的局限性.
- 这些局限性会导致评估测量方法的不确定性和主观性.
研究的目的:
- 批判性地审查CLSI EP09c指南,以评估测量方法协议.
- 在指南中确定缺点和未定义的方面.
- 建议改进评估系统和比例偏差的方法.
主要方法:
- 对CLSI EP09c指南的审查.
- 统计分析突出不平等差异对偏差估计的影响.
- 为实验室专业人员开发一个实用的例子.
主要成果:
- CLSI EP09c指南有限制,可以掩盖真正的偏见.
- 测量方法之间的不平等差异可能导致对偏差的误解.
- 复制对于准确估计系统和比例偏差是必要的.
结论:
- 经典的布兰德和奥尔特曼方法可能不足以计算在使用复制品时的偏差.
- 为了在实验室研究中进行强有力的协议评估,需要采用替代方法.
- 准确的偏差估计对于可靠的实验室测量比较至关重要.
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