Yuchen Wang, Luke Fostvedt, Jessica Wojciechowski, Donald Irby, Timothy Nicholas
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引用次数: 0
摘要
PoissonERM 是一个 R 软件包,用于对二元结果进行暴露-反应(ER)分析,以确定暴露与不良事件(AE)发生之间的关系。虽然泊松回归可以用 glm() 实现,但 PoissonERM 提供了一种简单的方法来半自动化整个分析,并以 R markdown (Rmd) 文件的形式生成简短报告,其中包括基本的分析细节和简要结论。PoissonERM 使用用户控制脚本中的信息处理所提供的数据集,并生成每个终点(每种 AE)的暴露指标、协变量和事件计数的汇总表/图。在检查了每个 AE 的发病率、相关性和每个协变量的缺失值后,就会根据所提供的规格为每个终点建立暴露-反应模型。PoissonERM 可以灵活地在建模过程中纳入并比较多种尺度变换。根据单变量模型的 p 值或偏差(Δ D $$ \Delta D $$)选择最佳暴露指标。如果在控制脚本中指定了协变量搜索,则使用后向消除法建立最终模型。PoissonERM 会在每个终点的最终模型建立过程中识别并避免高度相关的协变量。使用外部(模拟)暴露指标数据预测事件发生率是 PoissonERM 的一项附加功能,有助于了解与特定剂量方案相关的事件发生率。清理后的数据、模型开发和预测的汇总输出保存在工作文件夹中,可使用 Rmd 编译成 HTML 报告。
Automated Poisson regression exposure–response analysis for binary outcomes with PoissonERM
PoissonERM is an R package used to conduct exposure–response (ER) analysis on binary outcomes for establishing the relationship between exposure and the occurrence of adverse events (AE). While Poisson regression could be implemented with glm(), PoissonERM provides a simple way to semi-automate the entire analysis and generate an abbreviated report as an R markdown (Rmd) file that includes the essential analysis details with brief conclusions. PoissonERM processes the provided data set using the information from the user's control script and generates summary tables/figures for the exposure metrics, covariates, and event counts of each endpoint (each type of AE). After checking the incidence rate of each AE, the correlation, and missing values in each covariate, an exposure–response model is developed for each endpoint based on the provided specifications. PoissonERM has the flexibility to incorporate and compare multiple scale transformations in its modeling. The best exposure metric is selected based on a univariate model's p-value or deviance () as specified. If a covariate search is specified in the control script, the final model is developed using backward elimination. PoissonERM identifies and avoids highly correlated covariates in the final model development of each endpoint. Predicting event incidence rates using external (simulated) exposure metric data is an additional functionality in PoissonERM, which is useful to understand the event occurrence associated with certain dose regimens. The summary outputs of the cleaned data, model developments, and predictions are saved in the working folder and can be compiled into a HTML report using Rmd.