在评估两个测量方法之间的一致性时,Requiem用于Passing-Bablok非参数回归
Bruno Mario Cesana1,2, Paolo Antonelli3
1Faculty of Medicine and Surgery, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
测量协议的Passing-Bablok回归方法是有缺陷的. 它的置信区间对于准确的等价性评估来说太宽,可能导致实验室环境中得出不正确的结论.
科学领域:
- 生物统计学 生物统计学
- 实验室医学 实验室医学
- 分析化学 分析化学
背景情况:
- 监管指南通常建议非参数的Passing-Bablok回归来评估两个测量方法之间的一致性.
- 然而,对于斜率和截面的Passing-Bablok置信区间的标准解释在统计学上不适合于等价性测试.
研究的目的:
- 为了评估非参数的Passing-Bablok回归方法在评估测量协议时的准确性.
- 在各种模拟条件下,将Passing-Bablok回归与其他回归方法 (Theil,普通最小平方,Deming) 的性能进行比较.
主要方法:
- 结构模型的详尽模拟具有不同的斜率,截面和测量误差.
- 计算四种回归技术的斜率和截面偏差.
- 使用Passing-Bablok方法评估协议百分比,并与等价值值进行比较.
主要成果:
- 通过巴布洛克回归提供了公正的估计,与德明回归可比.
- 该方法的I型错误率在接近1的斜率上接近0.05,但在0.950-1.05范围以外的斜率上明显偏离.
- 通过巴布洛克回归的置信区间往往太宽,无法达到标准的等价值值.
结论:
- 通过-巴布洛克回归置信区间的标准解释不适合进行可靠的测量协议评估.
- 宽的置信区间限制了该方法在根据人口或个人等价模型确定等价性的实用性.
- 为了在实验室环境中可靠地评估协议,可能需要使用替代的统计方法.
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