Toddenroth Dennis, Sivagnanasundaram Janakan, Prokosch Hans-Ulrich, Ganslandt Thomas
Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Wetterkreuz 13, 91058 Erlangen-Tennenlohe, Germany.
Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Wetterkreuz 13, 91058 Erlangen-Tennenlohe, Germany; Medical Center for Communication and Information Technology, University Hospital Erlangen-Nuremberg, Glückstr. 11, 91054 Erlangen, Germany.
J Biomed Inform. 2016 Dec;64:222-231. doi: 10.1016/j.jbi.2016.10.010. Epub 2016 Oct 18.
The difficulty of managing patient recruitment and documentation for clinical trials prompts a demand for instruments for closely monitoring these critical but unpredictable processes. Increasingly adopted Electronic Data Capture (EDC) applications provide novel opportunities to reutilize stored information for an efficient management of traceable trial workflows. In related clinical and administrative settings, so-called digital dashboards that continuously visualize time-dependent parameters have recently met a growing acceptance. To investigate the technical feasibility of a study dashboard for monitoring the progress of patient recruitment and trial documentation, we set out to develop a propositional prototype in the form of a separate software module.
After narrowing down functional requirements in semi-structured interviews with study coordinators, we analyzed available interfaces of a locally deployed EDC application, and designed the prototypical study dashboard based on previous findings. The module thereby leveraged a standardized export format in order to extract and import relevant trial data into a clinical data warehouse. Web-based reporting tools then facilitated the definition of diverse views, including diagrams of the progress of patient accrual and form completion at different granularity levels. To estimate the utility of the dashboard and its compatibility with current workflows, we interviewed study coordinators after a demonstration of sample outputs from ongoing trials.
The employed tools promoted a rapid development. Displays of the implemented dashboard are organized around an entry page that integrates key metrics for available studies, and which links to more detailed information such as study-specific enrollment per center. The interviewed experts commented that the included graphical summaries appeared suitable for detecting that something was generally amiss, although practical remedies would mostly depend on additional information such as access to the original patient-specific data. The dependency on a separate application was seen as a downside. Interestingly, the prospective users warned that in some situations knowledge of specific accrual statistics might undermine blinding in a subtle yet intricate fashion, so ignorance of certain patient features was seen as sometimes preferable for reproducibility.
Our proposed study dashboard graphically recaps key progress indicators of patient accrual and trial documentation. The modular implementation illustrates the technical feasibility of the approach. The use of a study dashboard might introduce certain technical requirements as well as subtle interpretative complexities, which may have to be weighed against potential efficiency gains.
临床试验中患者招募和文档管理的困难促使人们需要用于密切监测这些关键但不可预测过程的工具。越来越多地采用电子数据采集（EDC）应用程序，为重新利用存储的信息以高效管理可追溯的试验工作流程提供了新机会。在相关的临床和行政环境中，最近所谓的数字仪表盘不断可视化时间相关参数，越来越受到认可。为了研究用于监测患者招募和试验文档进展的研究仪表盘的技术可行性，我们着手开发一个单独软件模块形式的命题原型。
在与研究协调员进行半结构化访谈以缩小功能需求后，我们分析了本地部署的EDC应用程序的可用接口，并根据先前的发现设计了原型研究仪表盘。该模块利用标准化导出格式，以便将相关试验数据提取并导入临床数据仓库。基于网络的报告工具随后促进了不同视图的定义，包括不同粒度级别上患者入组和表格填写进度的图表。为了评估仪表盘的实用性及其与当前工作流程的兼容性，我们在展示正在进行试验的样本输出后采访了研究协调员。
所使用的工具促进了快速开发。已实施仪表盘的显示围绕一个入口页面组织，该页面整合了可用研究的关键指标，并链接到更详细的信息，如每个中心的特定研究入组情况。受访专家评论说，所包含的图形摘要似乎适合检测总体上是否存在问题，尽管实际补救措施大多取决于其他信息，如获取原始患者特定数据。对单独应用程序的依赖被视为一个缺点。有趣的是，潜在用户警告说，在某些情况下，特定入组统计信息的知晓可能会以微妙但复杂的方式破坏盲法，因此有时为了可重复性，对某些患者特征的无知被视为更可取。
我们提出的研究仪表盘以图形方式概括了患者入组和试验文档的关键进展指标。模块化实现说明了该方法的技术可行性。使用研究仪表盘可能会引入某些技术要求以及微妙的解释复杂性，这可能需要与潜在的效率提升进行权衡。
