Agile User-Centered Design of a Clinical Research Project Management System in a Pediatric Health Institute.

Background: Project management is crucial in academic hospitals due to the intensive involvement in research and clinical trials. Designing an application in a user-centered and workflow-compatible manner can prevent issues arising from hospital's limited resources and various risks (e.g., financial risk and ethical misconduct). Objectives: This study aimed to (1) develop a hybrid method combining user-centered design (UCD) and agile software development (ASD) principles, (2) apply the hybrid model to develop a Clinical Research Project Management System (CRPMS), (3) assess the usability of the CRPMS and iteratively refine the application. Materials and Methods: A CRPMS was developed following the UCD and ASD principles and supported by a research core in a pediatric heart institute. In Phase 0, semi-structured interviews were conducted to understand processes and bottlenecks. In Phase 1, the project management and budgeting sections of the CRPMS were simultaneously developed. In Phase 2, the Principal Investigator dashboard and the intake section of the CRPMS were developed. Usability evaluation metrics included the System Usability Scale (SUS), Single Ease Question, and severity scores. Results: In Phase 1, the average SUS score was 88.65. There were 126 usability issues and 68 were considered high severity due to the SUS score cutoff (>1.5). In Phase 2, the average SUS score was 87.1. All of the 71 usability issues were addressed during the iterative refinements. Conclusion: A workflow-compatible and highly user-friendly CRPMS was developed by employing a hybrid Agile UCD model. Future work includes continuing development and expanding the CRPMS within and outside the institute.