过度分散泊松数据的预测区间及其在医疗和临床前质量控制中的应用

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Max Menssen, Martina Dammann, Firas Fneish, David Ellenberger, Frank Schaarschmidt
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引用次数: 0

摘要

在临床前和医疗质量控制中,利用历史控制数据来评估监测过程的稳定性或验证当前观察结果是很有意义的。一般来说,这是通过应用历史控制限(HCL)来实现的,以图形方式显示在控制图中。在许多应用中,HCL 被应用于计数数据,例如回复菌落数(艾姆斯检测法)或每位多发性硬化症患者的复发次数。计数数据可能过度分散,可能严重右偏,群集大小或其他基线量(例如,每个对照组的培养皿数量或每个患者的监测时间长度不同)也可能不同。基于准泊松假设或负二项分布,我们提出了用作 HCL 的过度分散计数数据的预测区间。可变基线量可通过偏移量来解释。此外,我们还提供了一种自举校准算法,可考虑倾斜分布并实现等尾概率。通过对八种不同的 HCL 计算方法的覆盖概率进行全面的蒙特卡洛模拟评估发现,自举校准预测区间对 1 类误差的控制效果最佳。控制图中传统使用的启发式方法(如 Shewhart c- 或 u- 图表中的限值或平均值 ± 2 SD)无法控制预先指定的覆盖概率。根据艾姆斯试验的数据和多发性硬化症患者的复发次数,展示了 HCL 的应用。建议的预测区间和自举校准算法可通过 R 软件包 predint 公开获取。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Prediction Intervals for Overdispersed Poisson Data and Their Application in Medical and Pre-Clinical Quality Control.

In pre-clinical and medical quality control, it is of interest to assess the stability of the process under monitoring or to validate a current observation using historical control data. Classically, this is done by the application of historical control limits (HCL) graphically displayed in control charts. In many applications, HCL are applied to count data, for example, the number of revertant colonies (Ames assay) or the number of relapses per multiple sclerosis patient. Count data may be overdispersed, can be heavily right-skewed and clusters may differ in cluster size or other baseline quantities (e.g., number of petri dishes per control group or different length of monitoring times per patient). Based on the quasi-Poisson assumption or the negative-binomial distribution, we propose prediction intervals for overdispersed count data to be used as HCL. Variable baseline quantities are accounted for by offsets. Furthermore, we provide a bootstrap calibration algorithm that accounts for the skewed distribution and achieves equal tail probabilities. Comprehensive Monte-Carlo simulations assessing the coverage probabilities of eight different methods for HCL calculation reveal, that the bootstrap calibrated prediction intervals control the type-1-error best. Heuristics traditionally used in control charts (e.g., the limits in Shewhart c- or u-charts or the mean ± 2 SD) fail to control a pre-specified coverage probability. The application of HCL is demonstrated based on data from the Ames assay and for numbers of relapses of multiple sclerosis patients. The proposed prediction intervals and the algorithm for bootstrap calibration are publicly available via the R package predint.

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来源期刊
Pharmaceutical Statistics
Pharmaceutical Statistics 医学-统计学与概率论
CiteScore
2.70
自引率
6.70%
发文量
90
审稿时长
6-12 weeks
期刊介绍: Pharmaceutical Statistics is an industry-led initiative, tackling real problems in statistical applications. The Journal publishes papers that share experiences in the practical application of statistics within the pharmaceutical industry. It covers all aspects of pharmaceutical statistical applications from discovery, through pre-clinical development, clinical development, post-marketing surveillance, consumer health, production, epidemiology, and health economics. The Journal is both international and multidisciplinary. It includes high quality practical papers, case studies and review papers.
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