DOP037 The V-Sync study: Validation of the synchronization of the ENEIDA and UR-CARE registry
Authors: Burisch PhD- DMSc J , Drobne D , Pouillon L , Gisbert J P , Casanova M J , Domenech E , Ciria M M 
Published: January 2025

Background

European Crohn’s and Colitis Organisation [ECCO] to facilitate daily clinical practice and research studies in inflammatory bowel disease (IBD)1,2. The ENEIDA registry, promoted by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU), aims to facilitate the prospective collection of clinical data of interest for clinical care practice3.

Recently, a significant milestone was achieved by synchronizing these two databases, aimed at harmonizing and enhancing clinical data collection, streamlined research, and more effectively conducting translational studies. This synchronization allows for a unified approach to IBD data management among different countries, thereby facilitating comprehensive data analysis and improved patient care strategies.

The aim of the V-SYNC study is to validate the synchronization between the databases, ensuring data integrity, consistency, and compatibility across both platforms. Furthermore, to draw learnings for future synchronization efforts between existing (national) databases and UR-CARE.

Methods

In a data comparison step, 100 patient data subsets will be randomly selected from the ENEIDA and URCARE databases, comprising 50 Crohn’s disease and 50 ulcerative colitis cases with complete datasets. Each group will be stratified by disease duration (&lt;5 years or ≥5 years) and advanced therapy initiation. Key variables such as demographics, diagnosis, treatment history, outcomes, and follow-up data will be compared. Validation metrics, including concordance rates, correlation coefficients, and discrepancy analysis, will assess data consistency, with only patients having complete datasets included.

In a functional testing step, usability tests will verify effective query and retrieval of synchronized data. Additionally, 10 quality of care queries will be applied to both registries to check for consistent results. These queries evaluate metrics such as advanced therapy usage, pre-treatment screenings, osteoporosis/osteopenia diagnosis, IBD and primary sclerosis cholangitis management, postoperative outcomes, biologic therapy responses, and smoking status.

Results

Data subsets from both registries are currently being exported and the validation is expected to be finalised by 2024.

Conclusion

Successful validation of the ENEIDA and URCARE database synchronization will set a precedent for data harmonization in IBD research, leading to improved data management practices, more accurate research findings, and ultimately better patient outcomes. This study will provide a framework for future synchronization efforts across other clinical and research databases.

References

1. European Crohn’s and Colitis Organisation [ECCO]. United Registries for Clinical Assessment and Research. 2017. Available at: https://www.ecco-ibd.eu/science/ur-care.html [Accessed July 6, 2024].

2. Burisch J, Gisbert JP, Siegmund B, et al. Validation of the "United Registries for Clinical Assessment and Research" [UR-CARE], a European Online Registry for Clinical Care and Research in Inflammatory Bowel Disease. J Crohns Colitis 2018;12:532–537.

3. Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol 2020;43:551–558.