title: Concept and implementation of a study dashboard module for a continuous monitoring of trial recruitment and documentation.
abstract: 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.
authors: Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Wetterkreuz 13, 91058 Erlangen-Tennenlohe, Germany. Electronic address: dennis.toddenroth@fau.de.
authors: Dennis
authors: D
authors: Toddenroth
authors: Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Wetterkreuz 13, 91058 Erlangen-Tennenlohe, Germany. Electronic address: janakan22@googlemail.com.
authors: Janakan
authors: J
authors: Sivagnanasundaram
authors: 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. Electronic address: ulli.prokosch@imi.med.uni-erlangen.de.
authors: Hans-Ulrich
authors: HU
authors: Prokosch
authors: Medical Center for Communication and Information Technology, University Hospital Erlangen-Nuremberg, Glückstr. 11, 91054 Erlangen, Germany. Electronic address: thomas.ganslandt@uk-erlangen.de.
authors: Thomas
authors: T
authors: Ganslandt
mesh_terms: D002986:Clinical Trials as Topic; D004282:Documentation; D004526:Efficiency; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D015203:Reproducibility of Results; D012984:Software
keywords: Data management for clinical trials; Procedures for maintaining databases; Workflows for data and safety monitoring