OSSE Unravelled - Supporting registry research with easy-to-use, quality-assured open-source software

• Applicant: Dr. Jessica Vasseur
• Subject Area: Medical Informatics and Medical Bioinformatics
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 528705165

Background: OSSE (Open Source Registry System for Rare Diseases) is an existing software framework to create and operate disease-specific patient registries. It consists of several software modules, including the OSSE EDC for web-based electronic data capture and central repositories for metadata-based definition of data elements and registry forms. Since its initial release in 2016, OSSE has been used and continuously developed in several research projects and patient registries. Overall Objective: Due to limited resources, many OSSE features are tailored to a specific registry and often require implementation by an IT specialist. This project will therefore address and improve the usability and accessibility of key features in order to facilitate the setup and use of OSSE-based patient registries for users without an IT background. Work Plan, Form Display Logic: First, we will develop a user interface to define the OSSE Form Display Logic, referring to the conditional display of data elements depending on user input. Currently, this is implemented through a JavaScript object and usually handled by IT specialists. Together with users of existing OSSE patient registries, we will develop and evaluate a user interface for configuring and implementing the logic definitions. This interface may also be extended to other form modifications, such as registry-specific calculations. By allowing users to modify their forms via a user interface rather than code, we aim to improve the usability of OSSE in terms of the flexible and easily accessible setup of a patient registry. Audit trail: Secondly, we will make the OSSE audit trail, currently only accessible in the database, available to users in the OSSE EDC. This new user interface will be based on requirements gathered from users of existing OSSE patient registries. The existing audit trail will be extended to the registry configuration and data provenance. In this context, we will provide a separate test and production area within the same OSSE instance, allowing users to formally version a registry configuration regarding the imported forms. This enhancement aims to improve both the usability of OSSE and the quality of the collected data. Test environment: Through the ongoing modularisation of the OSSE EDC, which aims to reduce the complexity of the overall software architecture, we will make OSSE more accessible to a wider community of software developers. In order to foster cross-team collaboration and future open source development, we will develop and provide testing procedures, documentation, and a standardised testing and demonstration environment. Thus, we will not only facilitate the future development and accessibility of OSSE but also enhance the overall quality and reliability of the software. Conclusion: Ultimately, these improvements will help to ensure the acceptance and usability of OSSE by a wider community of researchers seeking to build patient registries and software developers.

• DFG Programme: Research Grants
• Co-Investigator: Jens Göbel