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CC BY 4.0 · ACI open 2025; 09(02): e30-e40
DOI: 10.1055/a-2625-1046
Research Article

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

Authors

  • Danny T.Y. Wu

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    2   Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States
    3   Medical Sciences Baccalaureate Program, University of Cincinnati College of Medicine, Ohio, United States
    4   School of Design, College of Design, Architecture, Art, and Planning, University of Cincinnati, Ohio, United States
    5   Department of Computer Science, College of Engineering and Applied Sciences, University of Cincinnati, Ohio, United States
    6   Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
    7   School of Information and Library Science, University of North Carolina at Chapel Hill, North Carolina, United States

  • Manhar Suharwardy

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    3   Medical Sciences Baccalaureate Program, University of Cincinnati College of Medicine, Ohio, United States

  • Aniruddhan Ramesh

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    5   Department of Computer Science, College of Engineering and Applied Sciences, University of Cincinnati, Ohio, United States

  • Shubhra Gupta

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States

  • Chen Xin

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    4   School of Design, College of Design, Architecture, Art, and Planning, University of Cincinnati, Ohio, United States

  • Ting Zhang

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    4   School of Design, College of Design, Architecture, Art, and Planning, University of Cincinnati, Ohio, United States

  • Ching-Tzu Tsai

    1   Department of Biostatistics, Health Informatics and Data Sciences, University of Cincinnati College of Medicine, Ohio, United States
    4   School of Design, College of Design, Architecture, Art, and Planning, University of Cincinnati, Ohio, United States

  • Jenna Dawn

    6   Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

  • Michelle Faust

    6   Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

  • Adam Kushner

    6   Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Funding This study was supported by the Heart Institute at the Cincinnati Children's Hospital Medical Center.
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Erratum zu diesem Artikel:

Erratum: Agile User-Centered Design of a Clinical Research Project Management System in a Pediatric Health InstituteACI open 2025; 09(02): e41-e41
DOI: 10.1055/a-2658-0791

Abstract

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.

Keywords

research planning and conduct - interfaces and usability - workflow - evaluation - user acceptance and resistance

Protection of Human and Animal Subjects

The study was reviewed and approved by the institution's IRB (Cincinnati Children's Hospital Medical Center: 2024-0414).


Author Contributions

The first author (DW) designed and mentored the second author (MS) to survey the literature, design the study, and draft the manuscript. The third author (AR) helped draft the introduction, described the methodology, and develop the application with (SG). The designers (CX, TZ and CT) created the mockups and collected and analyzed the user feedback. JD, MF and AK helped the design and execution of the workflow analysis and usability testing as well as provided feedback to the mockups. All authors discussed the findings and helped improve the clarity and value of the manuscript.


Supplementary Material



Publikationsverlauf

Eingereicht: 27. Juni 2024

Angenommen: 11. Mai 2025

Artikel online veröffentlicht:
09. Juli 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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