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

Area of Science:

• Health Informatics
• Software Engineering
• Data Management

Background:

• Audit trails are crucial for data integrity and security in patient registries and electronic data capture (EDC) systems.
• The Open Source Registry System for Rare Diseases (OSSE) is an open-source tool for building patient registries.

Purpose of the Study:

• To develop and evaluate the usability of an initial prototype of an accessible audit trail for the OSSE.
• To identify necessary features for improving the audit trail's functionality and user experience.

Main Methods:

• Development of a new user interface for the OSSE audit trail, including list and detailed views.
• Usability evaluation using a standardized questionnaire with 15 participants, incorporating the System Usability Scale (SUS) and task-based assessments.

Main Results:

• The initial prototype achieved a SUS score of 66, indicating marginal usability and room for improvement.
• Feedback highlighted critical missing functionalities essential for effective audit trail use.

Conclusions:

• The study identified key areas for enhancing the OSSE audit trail's usability and functionality.
• Implementing the suggested features is crucial for improving user experience and data quality in patient registries.