Open Source Registry System for Rare Diseases (OSSE): Development and Usability Evaluation of an Initial Audit Trail Prototype.

Introduction: An audit trail is of critical importance for patient registries and electronic data capture (EDC) systems, as it ensures transparency, integrity, traceability and security of the collected data. This work demonstrates the development and usability evaluation of an initial prototype of an accessible audit trail for the Open Source Registry System for Rare Diseases (OSSE), an open source software tool for building patient registries.

Methods: The prototype comprises a new user interface with list views and detailed views to make the information stored in the audit trail of the OSSE EDC database available for users. A standardized questionnaire, including the System Usability Scale (SUS) as well as task-based section, was used to gather feedback from 15 participants with varying levels of experience in working with OSSE and patient registries.

Results: The resulting SUS score of 66 (on a scale of 0 to 100) falls within the marginal range, suggesting room for improvement in the initial prototype's usability. The survey also highlighted critical features necessary for the audit trail's functionality.

Conclusion: Several respondents noted that the lack of these functionalities led to their negative responses, emphasizing the importance of implementing these features to improve the user experience. These insights form the basis for refining the audit trail's structure and adding essential functionalities in the future to improve the overall usability and quality of OSSE.