The Rare Bleeding Disorders Network

Assessing registry feasibility for common core datasets: The SATURN methodology

Recently, a position statement was published in the Orphanet Journal of Rare Diseases which describes the SATURN project’s methodology to assess the feasibility of disease registries for inclusion in a common core dataset.

SATURN (Systematic Accumulation of Treatment practices and Utilisation, Real world evidence, and Natural history data) is a project which aims to utilise existing, well-established data sources to create a common core dataset which meets the needs of various stakeholders in the osteogenesis imperfecta (OI) community. For the purposes of this article, the authors described the methodology used to assess the project’s first candidate registry, namely the Registry of OI (ROI) at the Istituto Ortopedico Rizzoli in Italy.

SATURN’s assessment methodology consists of three steps: first, registry characteristics are assessed using the Registry Evaluation and Quality Standards Tool (REQueST); secondly, a gap analysis is conducted comparing the SATURN-required core variables to those being captured in the registry’s case report form; finally, a compliance check is performed on the data exchange process according to EU regulations.

Overall, this methodology is a robust process which ensures optimal collaboration between SATURN and relevant rare disease registries. It also ensures that existing datasets on OI are being maximised to respond to the needs of all stakeholders, and ensures compliance with EMA and HTA requirements. Moving forward, this methodology can be applied to other SATURN candidate registries, as well as to inform the development of similar common core datasets in other rare disease areas.