The methodology of a “living” COVID-19 registry development in a clinical context

OBJECTIVE: The aim of this study was to describe an innovative methodology of a registry development, constantly updated for the scientific assessment and analysis of the health status of the population with COVID-19. STUDY DESIGN AND SETTING: A methodological study design to develop a multi-site, Living COVID-19 Registry of COVID-19 patients admitted in Fondazione Don Gnocchi centres started in March 2020. RESULTS: The integration of the living systematic reviews and focus group methodologies led to a development of a registry which includes 520 fields filled in for 748 COVID-19 patients recruited from 17 Fondazione Don Gnocchi centres. The result is an evidence and experience-based registry, according to the evolution of a new pathology which was not known before outbreak of March 2020 and with the aim of building knowledge to provide a better quality of care for COVID-19 patients. CONCLUSION: A Living COVID-19 Registry is an open, living and up to date access to large-scale patient-level data sets that could help identifying important factors and modulating variable for recognising risk profiles and predicting treatment success in COVID-19 patients hospitalized. This innovative methodology might be used for other registries, to be sure which the data collected is an appropriate means of accomplishing the scientific objectives planned. CLINICAL TRIAL REGISTRATION NUMBER: not applicable