Lesionia: a digital data management system to enhance collaborative management of epidemiological and clinical data of cutaneous leishmaniases patients.

Digital Systems for Data Management (DSDM) have become a critical cornerstone in collaborative biomedical research and clinical trials involving multiple investigators, institutions, and populations. DSDM provide unique features that ensure that data meet the standards of FAIR (Findability, Accessibility, Interoperability and Reusability). We herein present Lesionia, a DSDM designed to support the PEER518 consortium that aimed at developing new cutaneous leishmaniases (CL) diagnostics using samples and data collected from patients suspected of having CL in countries in the MENA region and West Africa. The consortium involved nine institutions across five countries: Tunisia, Morocco, Lebanon, Mali, and the USA, and informally Scientists from Algeria and Nigeria. The guidelines on the data to be collected by the clinicians and biologists during the project were used for the development of a Questionnaire that served as a basis for the implementation of a dedicated web-based DSDM.Lesionia was developed and validated for the management and the analysis of clinical and epidemiological data in the diagnosis of CL. It consists of a relational database, a web-based user interface (WUI) and a tool for experimental data handling and analysis of clinical and epidemiological data of CL cases. The platform was deployed and validated during the PEER518 project using data collected across the involved teams. Lesionia is expandable to include further collaborators, partners, and projects. It is designed for data handling from the consented patient interview and sample collection to the samples' storage and investigation. The WUI permits data entry, fetching, visualization and analysis. Rigorous controls on data entry were implemented to reduce discrepancies. It also offers a set of analysis tools that range from descriptive statistics to variable correlation analysis. Lesionia is accessible in a secure manner to all users of the consortium through a web browser.Lesionia will be a valuable tool for collaborative and integrative management of clinical and epidemiological data. It is an open-source software that can broadly serve the scientific community interested in studying, controlling, reporting, and diagnosing CL and similar cutaneous diseases.