Global, multilingual, physician-invited, patient-completed digital registry enabling pre-consultation engagement and...

Lower limb venous diseases are prevalent chronic conditions that require standardized, efficient, and patient-centered clinical assessment across diverse healthcare settings. Despite increasing digitalization of healthcare, scalable multilingual digital infrastructures capable of supporting standardized pre-consultation data collection and physician-validated real-world evidence generation remain limited. We conducted a global, cross-sectional observational study, using an innovative physician-invited/patient-completed digital registry, designed to enable pre-clinical engagement. The registry was conceived as a modular, multilingual digital infrastructure, allowing individuals to include clinical data prior to any physician encounter who will then validate the already acquired information, while also completing the healthcare professional part· We assessed geographic reach, usability, engagement in data completion, and cross-sectional associations between demographic, clinical factors and disease stage, defined as CEAP clinical class and Venous Clinical Severity Score (VCSS). 6457 patients from 59 countries from Africa, Asia, Europe, North and South America enrolled in the registry before their first specialist consultation. Completion of all the required data was achieved by 1355 patients from 12 countries. Among participating physicians, the platform usability was rated as easy in 94.2% of responses, while its overall usefulness was rated as high or very high in 76.6% of responses. Privacy concerns were expressed in 17% of cases. Cross-sectional analyses identified risk factor profiles associated with CEAP class ≥ 4 and VCSS ≥ 8·5. These stage-associated profiles differed from those previously reported, reflecting the need for a detailed integration of appropriately collected real-world data in venous disease investigations. A global, multilingual, physician-invited/patient-completed digital registry may facilitate earlier patient engagement and has the potential to support more efficient care pathway, moreover across linguistic contexts, with more timely data capture. This registry provides a scalable digital infrastructure for standardized patient- and physician-validated data collection across multiple countries, with potential applicability to multidisciplinary clinical practice and research. Such infrastructure may facilitate earlier and broader diagnostic insights, including for conditions beyond the initial reason for care seeking, and provide a robust foundation for machine learning, reducing reliance on synthetic datasets and supporting scalable, equitable digital health innovation across medical specialties.