Requiem for the Passing-Bablok nonparametric regression in assessing the agreement between two measurement methods.

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Bruno Mario Cesana, Paolo Antonelli
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引用次数: 0

Abstract

Objectives: Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is incorrect since the agreement assessment must focus on a null hypothesis of not equivalence and an alternative hypothesis of equivalence.

Methods: We exhaustively simulated appropriate structural models with several values of slope, intercept and measurement error by keeping equal variances and means of the two methods. We calculated the slope and intercept bias of four regressions: non-parametric Passing-Bablok, Theil, Ordinary Least Squares and Deming. In addition, we calculated the percentages of the agreement according to the not shareable Passing-Bablok suggestion. Furthermore, we calculated the percentages of the 95 % CI of the slope and of the intercept included within sensible equivalence thresholds for assessing the agreement.

Results: Passing-Bablok procedure gives unbiased estimates, a little more and less biased than those from Deming's regression. The percentages of rejecting the hypothesis of no-agreement, according to the wrong Passing-Bablok's approach are correctly near to 0.05 Type I error under the agreement and also for 0.990≤slopes≤1.005. However, they are too low for slopes >1.05 and <0.950.

Conclusions: The Passing-Bablok 95 % CIs are too wide for being included in sensible agreement thresholds according to a population equivalence model and, finally, this approach cannot be considered under the best agreement model of the individual equivalence.

passingbablok非参数回归评估两种测量方法之间一致性的安魂曲。
目的:监管指南推荐非参数passingbablok回归来评估实验室设置中两种测量方法之间的一致性。然而,如果斜率和截距的95% % CI分别包括1和0,则得出协议的结论是不正确的,因为协议评估必须关注不等效的零假设和等效的替代假设。方法:通过保持两种方法的方差和均值相等的方法,对斜率、截距和测量误差的若干值进行了详尽的模拟。我们计算了四种回归的斜率和截距偏差:非参数Passing-Bablok、Theil、普通最小二乘法和Deming。此外,我们根据不可共享的passingbablok建议计算了协议的百分比。此外,我们计算了斜率和截距的95% % CI的百分比,包括在评估一致性的合理等效阈值内。结果:Passing-Bablok法给出了无偏估计,与Deming回归法相比,偏大一些,偏小一些。根据错误的Passing-Bablok方法,拒绝不一致假设的百分比正确地接近于协议下的I型误差,并且0.990≤斜率≤1.005。结论:Passing-Bablok 95 % ci太宽,不能根据群体等效模型纳入合理的协议阈值,最后,该方法不能在个体等效的最佳协议模型下考虑。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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