{"title":"纵向推论对不可忽略性的贝叶斯二阶敏感性:抗抑郁药临床试验数据的应用。","authors":"Elahe Momeni Roochi, Samaneh Eftekhari Mahabadi","doi":"10.1515/ijb-2022-0014","DOIUrl":null,"url":null,"abstract":"<p><p>Incomplete data is a prevalent complication in longitudinal studies due to individuals' drop-out before intended completion time. Currently available methods via commercial software for analyzing incomplete longitudinal data at best rely on the ignorability of the drop-outs. If the underlying missing mechanism was non-ignorable, potential bias arises in the statistical inferences. To remove the bias when the drop-out is non-ignorable, joint complete-data and drop-out models have been proposed which involve computational difficulties and untestable assumptions. Since the critical ignorability assumption is unverifiable based on the observed part of the sample, some local sensitivity indices have been proposed in the literature. Specifically, Eftekhari Mahabadi (Second-order local sensitivity to non-ignorability in Bayesian inferences. Stat Med 2018;59:55-95) proposed a second-order local sensitivity tool for Bayesian analysis of cross-sectional studies and show its better performance for handling bias compared with the first-order ones. In this paper, we aim to extend this index for the Bayesian sensitivity analysis of normal longitudinal studies with drop-outs. The index is driven based on a selection model for the drop-out mechanism and a Bayesian linear mixed-effect complete-data model. The presented formulas are calculated using the posterior estimation and draws from the simpler ignorable model. The method is illustrated via some simulation studies and sensitivity analysis of a real antidepressant clinical trial data. Overall, the numerical analysis showed that when repeated outcomes are subject to missingness, regression coefficient estimates are nearly approximated well by a linear function in the neighbourhood of MAR model, but there are a considerable amount of second-order sensitivity for the error term and random effect variances in Bayesian linear mixed-effect model framework.</p>","PeriodicalId":50333,"journal":{"name":"International Journal of Biostatistics","volume":" ","pages":""},"PeriodicalIF":1.2000,"publicationDate":"2023-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bayesian second-order sensitivity of longitudinal inferences to non-ignorability: an application to antidepressant clinical trial data.\",\"authors\":\"Elahe Momeni Roochi, Samaneh Eftekhari Mahabadi\",\"doi\":\"10.1515/ijb-2022-0014\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Incomplete data is a prevalent complication in longitudinal studies due to individuals' drop-out before intended completion time. 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引用次数: 0
摘要
在纵向研究中,由于个体在预期完成时间之前退出,数据不完整是一个普遍的并发症。目前可用的通过商业软件分析不完整纵向数据的方法,最多依赖于辍学的可忽略性。如果潜在的缺失机制是不可忽略的,则在统计推断中产生潜在的偏差。为了消除drop-out不可忽略时的偏差,提出了联合完整数据和drop-out模型,该模型涉及计算困难和不可检验的假设。由于临界可忽略性假设无法根据样本的观测部分进行验证,因此文献中提出了一些局部敏感性指标。具体地说,Eftekhari Mahabadi(二阶局部灵敏度对贝叶斯推理的不可忽略性)。Stat Med 2018;59:55-95)提出了一种用于横断面研究贝叶斯分析的二阶局部灵敏度工具,与一阶工具相比,其处理偏倚的性能更好。在本文中,我们的目标是将该指标扩展到具有辍学的正常纵向研究的贝叶斯灵敏度分析。该指标基于退出机制的选择模型和贝叶斯线性混合效应完整数据模型驱动。给出的公式是用后验估计计算的,并从更简单的可忽略模型中得出。通过模拟研究和对真实抗抑郁药物临床试验数据的敏感性分析来说明该方法。总体而言,数值分析表明,当重复结果存在缺失时,回归系数估计可以通过MAR模型邻域的线性函数近似地逼近,但贝叶斯线性混合效应模型框架中误差项和随机效应方差存在相当大的二阶敏感性。
Bayesian second-order sensitivity of longitudinal inferences to non-ignorability: an application to antidepressant clinical trial data.
Incomplete data is a prevalent complication in longitudinal studies due to individuals' drop-out before intended completion time. Currently available methods via commercial software for analyzing incomplete longitudinal data at best rely on the ignorability of the drop-outs. If the underlying missing mechanism was non-ignorable, potential bias arises in the statistical inferences. To remove the bias when the drop-out is non-ignorable, joint complete-data and drop-out models have been proposed which involve computational difficulties and untestable assumptions. Since the critical ignorability assumption is unverifiable based on the observed part of the sample, some local sensitivity indices have been proposed in the literature. Specifically, Eftekhari Mahabadi (Second-order local sensitivity to non-ignorability in Bayesian inferences. Stat Med 2018;59:55-95) proposed a second-order local sensitivity tool for Bayesian analysis of cross-sectional studies and show its better performance for handling bias compared with the first-order ones. In this paper, we aim to extend this index for the Bayesian sensitivity analysis of normal longitudinal studies with drop-outs. The index is driven based on a selection model for the drop-out mechanism and a Bayesian linear mixed-effect complete-data model. The presented formulas are calculated using the posterior estimation and draws from the simpler ignorable model. The method is illustrated via some simulation studies and sensitivity analysis of a real antidepressant clinical trial data. Overall, the numerical analysis showed that when repeated outcomes are subject to missingness, regression coefficient estimates are nearly approximated well by a linear function in the neighbourhood of MAR model, but there are a considerable amount of second-order sensitivity for the error term and random effect variances in Bayesian linear mixed-effect model framework.
期刊介绍:
The International Journal of Biostatistics (IJB) seeks to publish new biostatistical models and methods, new statistical theory, as well as original applications of statistical methods, for important practical problems arising from the biological, medical, public health, and agricultural sciences with an emphasis on semiparametric methods. Given many alternatives to publish exist within biostatistics, IJB offers a place to publish for research in biostatistics focusing on modern methods, often based on machine-learning and other data-adaptive methodologies, as well as providing a unique reading experience that compels the author to be explicit about the statistical inference problem addressed by the paper. IJB is intended that the journal cover the entire range of biostatistics, from theoretical advances to relevant and sensible translations of a practical problem into a statistical framework. Electronic publication also allows for data and software code to be appended, and opens the door for reproducible research allowing readers to easily replicate analyses described in a paper. Both original research and review articles will be warmly received, as will articles applying sound statistical methods to practical problems.