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教程:诊断测试准确性研究的荟萃分析统计方法。

Tutorial: statistical methods for the meta-analysis of diagnostic test accuracy studies.

机构信息

Jena University Hospital, Institute of Medical Statistics, Computer and Data Sciences, Jena, Germany.

出版信息

Clin Chem Lab Med. 2023 Jan 19;61(5):777-794. doi: 10.1515/cclm-2022-1256. Print 2023 Apr 25.

Abstract

This tutorial shows how to perform a meta-analysis of diagnostic test accuracy studies (DTA) based on a 2 × 2 table available for each included primary study. First, univariate methods for meta-analysis of sensitivity and specificity are presented. Then the use of univariate logistic regression models with and without random effects for e.g. sensitivity is described. Diagnostic odds ratios (DOR) are then introduced to combine sensitivity and specificity into one single measure and to assess publication bias. Finally, bivariate random effects models using the exact binomial likelihood to describe within-study variability and a normal distribution to describe between-study variability are presented as the method of choice. Based on this model summary receiver operating characteristic (sROC) curves are constructed using a regression model logit-true positive rate (TPR) over logit-false positive rate (FPR). Also it is demonstrated how to perform the necessary calculations with the freely available software R. As an example a meta-analysis of DTA studies using Procalcitonin as a diagnostic marker for sepsis is presented.

摘要

本教程展示了如何基于每个纳入的主要研究中可用的 2×2 表来进行诊断测试准确性研究(DTA)的荟萃分析。首先,介绍了用于敏感性和特异性荟萃分析的单变量方法。然后,描述了如何使用具有和不具有随机效应的单变量逻辑回归模型来估计敏感性。诊断比值比(DOR)用于将敏感性和特异性合并为一个单一的指标,并评估发表偏倚。最后,提出了使用精确二项式似然来描述研究内变异性和正态分布来描述研究间变异性的双变量随机效应模型,作为首选方法。基于该模型,使用回归模型对数真阳性率(TPR)对对数假阳性率(FPR)构建了综合接收者操作特征(sROC)曲线。还演示了如何使用免费的 R 软件进行必要的计算。作为一个示例,使用降钙素作为脓毒症的诊断标志物进行了 DTA 研究的荟萃分析。

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