PDF(Pubmed)
Abstract：
OBJECTIVE: Longitudinal patient tolerability data collected as part of randomized controlled trials are often summarized in a way that loses information and does not capture the treatment experience. To address this, we developed an interactive web application to empower clinicians and researchers to explore and visualize patient tolerability data.
METHODS: We used adverse event (AE) data (Common Terminology Criteria for Adverse Events) and patient-reported outcomes (PROs) from the NSABP-B35 phase III clinical trial, which compared anastrozole with tamoxifen for breast cancer-free survival, to demonstrate the tools. An interactive web application was developed using R and the Shiny web application framework that generates Sankey diagrams to visualize AEs and PROs using four tools: AE Explorer, PRO Explorer, Cohort Explorer, and Custom Explorer.
RESULTS: To illustrate how users can use the interactive tool, examples for each of the four applications are presented using data from the NSABP-B35 phase III trial and the NSABP-B30 trial for the Custom Explorer. In the AE and PRO explorers, users can select AEs or PROs to visualize within specified time periods and compare across treatments. In the cohort explorer, users can select a subset of patients with a specific symptom, severity, and treatment received to visualize the trajectory over time within a specified time interval. With the custom explorer, users can upload and visualize structured longitudinal toxicity and tolerability data.
CONCLUSIONS: We have created an interactive web application and tool for clinicians and researchers to explore and visualize clinical trial tolerability data. This adaptable tool can be extended for other clinical trial data visualization and incorporated into future patient-clinician interactions regarding treatment decisions.
METHODS: We used adverse event (AE) data (Common Terminology Criteria for Adverse Events) and patient-reported outcomes (PROs) from the NSABP-B35 phase III clinical trial, which compared anastrozole with tamoxifen for breast cancer-free survival, to demonstrate the tools. An interactive web application was developed using R and the Shiny web application framework that generates Sankey diagrams to visualize AEs and PROs using four tools: AE Explorer, PRO Explorer, Cohort Explorer, and Custom Explorer.
RESULTS: To illustrate how users can use the interactive tool, examples for each of the four applications are presented using data from the NSABP-B35 phase III trial and the NSABP-B30 trial for the Custom Explorer. In the AE and PRO explorers, users can select AEs or PROs to visualize within specified time periods and compare across treatments. In the cohort explorer, users can select a subset of patients with a specific symptom, severity, and treatment received to visualize the trajectory over time within a specified time interval. With the custom explorer, users can upload and visualize structured longitudinal toxicity and tolerability data.
CONCLUSIONS: We have created an interactive web application and tool for clinicians and researchers to explore and visualize clinical trial tolerability data. This adaptable tool can be extended for other clinical trial data visualization and incorporated into future patient-clinician interactions regarding treatment decisions.
摘要：
目的：作为随机对照试验的一部分收集的纵向患者耐受性数据通常以一种丢失信息且无法获取治疗经验的方式进行总结。为了解决这个问题，我们开发了一个交互式网络应用程序,使临床医生和研究人员能够探索和可视化患者的耐受性数据.
方法：我们使用了NSABP-B35III期临床试验的不良事件（AE）数据（不良事件通用术语标准）和患者报告结果（PRO）。将阿那曲唑与他莫昔芬的无乳腺癌生存率进行了比较，演示工具。使用R和ShinyWeb应用程序框架开发了一个交互式Web应用程序，该框架使用四个工具生成Sankey图以可视化AE和Pro：AEExplorer，PROExplorer,队列探险家，和自定义资源管理器。
结果：为了说明用户如何使用交互式工具，使用来自自定义浏览器的NSABP-B35III期试验和NSABP-B30试验的数据，提供了四个应用程序中每个应用程序的示例。在AE和PRO探险家中，用户可以选择AE或PRO在指定的时间段内可视化，并比较不同的治疗。在队列探险家中，用户可以选择具有特定症状的患者子集，严重程度,和接受的治疗，以在指定的时间间隔内随时间的轨迹可视化。有了自定义浏览器，用户可以上传和可视化结构化的纵向毒性和耐受性数据。
结论：我们为临床医生和研究人员创建了一个交互式网络应用程序和工具，以探索和可视化临床试验耐受性数据。该适应性工具可以被扩展用于其他临床试验数据可视化,并且被结合到关于治疗决策的未来患者-临床医生交互中。
方法：我们使用了NSABP-B35III期临床试验的不良事件（AE）数据（不良事件通用术语标准）和患者报告结果（PRO）。将阿那曲唑与他莫昔芬的无乳腺癌生存率进行了比较，演示工具。使用R和ShinyWeb应用程序框架开发了一个交互式Web应用程序，该框架使用四个工具生成Sankey图以可视化AE和Pro：AEExplorer，PROExplorer,队列探险家，和自定义资源管理器。
结果：为了说明用户如何使用交互式工具，使用来自自定义浏览器的NSABP-B35III期试验和NSABP-B30试验的数据，提供了四个应用程序中每个应用程序的示例。在AE和PRO探险家中，用户可以选择AE或PRO在指定的时间段内可视化，并比较不同的治疗。在队列探险家中，用户可以选择具有特定症状的患者子集，严重程度,和接受的治疗，以在指定的时间间隔内随时间的轨迹可视化。有了自定义浏览器，用户可以上传和可视化结构化的纵向毒性和耐受性数据。
结论：我们为临床医生和研究人员创建了一个交互式网络应用程序和工具，以探索和可视化临床试验耐受性数据。该适应性工具可以被扩展用于其他临床试验数据可视化,并且被结合到关于治疗决策的未来患者-临床医生交互中。
