Buzoianu Manuela, Kadane Joseph B
Department of Clinical Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ 08560, USA.
Stat Med. 2008 Jun 15;27(13):2453-73. doi: 10.1002/sim.3099.
Obtaining accurate estimates of the performance of a diagnostic test for some population of patients might be difficult when the sample of subjects used for this purpose is not representative for the whole population. Thus, in the motivating example of this paper a test is evaluated by comparing its results with those given by a gold standard procedure, which yields the disease status verification. However, this procedure is invasive and has a non-negligible risk of serious complications. Moreover, subjects are selected to undergo the gold standard based on some risk factors and the results of the test under study. The test performance estimates based on the selected sample of subjects are biased. This problem was presented in previous studies under the name of verification bias. The current paper introduces a Bayesian method to adjust for this bias, which can be regarded as a missing data problem. In addition, it addresses the case of non-ignorable verification bias. The proposed Bayesian estimation approach provides test performance estimates that are consistent with the results obtained using likelihood-based approach. In addition, the paper studies how valuable the statistical findings are from the perspective of clinical decision making.
当用于评估诊断测试性能的受试者样本不能代表整个人口时,获得针对某些患者群体的诊断测试性能的准确估计可能会很困难。因此,在本文的激励示例中,通过将测试结果与金标准程序给出的结果进行比较来评估测试,金标准程序可得出疾病状态的验证结果。然而,该程序具有侵入性,且存在严重并发症的不可忽视的风险。此外,根据一些风险因素和正在研究的测试结果选择受试者接受金标准程序。基于所选受试者样本的测试性能估计存在偏差。这个问题在以前的研究中以验证偏差的名义提出。本文介绍了一种贝叶斯方法来调整这种偏差,这可以被视为一个缺失数据问题。此外,它还解决了不可忽略的验证偏差的情况。所提出的贝叶斯估计方法提供的测试性能估计与使用基于似然性的方法获得的结果一致。此外,本文从临床决策的角度研究了统计结果的价值。