EUROlinkCAT protocol for a European population-based data linkage study investigating the survival, morbidity and education of children with congenital anomalies

• Main Authors: Nathalie Lelong, Babak Khoshnood, David Tucker, Mika Gissler, Maria Loane, Ingeborg Barisic, Miriam Gatt, Kari Klungsoyr, Amanda Neville, Anna Pierini, Anke Rissmann, Oscar Zurriaga, Joan K Morris, Paula Braz, Vera Nelen, Judith Rankin, Ester Garne, Sue Jordan, Anna Heino, Silvia Baldacci, Michele Santoro, Alessio Coi, Lorena Mezzasalma, Daniel Thayer, Svetlana V Glinianaia, Hermien de Walle, Guy Thys, Anna Latos-Bielenska, Aurora Puccini, Elisa Ballardini, Wladimir Wertelecki, Carlos Matias Dias, Gianni Astolfi, James Densem, Joachim Tan, Joanne Emma Given, Hugh Claridge, Abigail Reid, Liz Limb, Gillian Briggs, Nicholas Connor, Stine Kjaer Urhoj, Mads Damkjær, Christina Neergaard Pedersen, Annarita Armaroli, Ljubica Boban, L Renée Lutke, Nicole H A Siemensma-Mühlenberg, Nathalie Bertille, Makan Rahshenas, Clara Cavero Carbonell, Laia Barrachina Bonet, Laura García Villodre, Anna Jamry-Dziurla, Sonja Kiuru-Kuhlefelt, Lyubov Yevtushok, Nataliia Zymak-Zakutnia, Diana Akhmedzhanova, Lyubov Ostapchuk, Oksana Tsizh, Serhii Lapchenko, Ausenda Machado, Ana João Santos, Liliana Antunes, Hanitra Randrianaivo-Ranjatoelina, Elly Den Hond, Olatz Mokoroa Carollo, Ieuan Scanlon
• Format: Article
• Language: English
• Published: BMJ Publishing Group 2021-06-01
• Series: BMJ Open
• Online Access: https://bmjopen.bmj.com/content/11/6/e047859.full

Introduction Congenital anomalies (CAs) are a major cause of infant mortality, childhood morbidity and long-term disability. Over 130 000 children born in Europe every year will have a CA. This paper describes the EUROlinkCAT study, which is investigating the health and educational outcomes of children with CAs for the first 10 years of their lives.Methods and analysis EUROCAT is a European network of population-based registries for the epidemiological surveillance of CAs. EUROlinkCAT is using the EUROCAT infrastructure to support 22 EUROCAT registries in 14 countries to link their data on births with CAs to mortality, hospital discharge, prescription and educational databases. Once linked, each registry transforms their case data into a common data model (CDM) format and they are then supplied with common STATA syntax scripts to analyse their data. The resulting aggregate tables and analysis results are submitted to a central results repository (CRR) and meta-analyses are performed to summarise the results across all registries. The CRR currently contains data on 155 594 children with a CA followed up to age 10 from a population of 6 million births from 1995 to 2014.Ethics The CA registries have the required ethics permissions for routine surveillance and transmission of anonymised data to the EUROCAT central database. Each registry is responsible for applying for and obtaining additional ethics and other permissions required for their participation in EUROlinkCAT.Dissemination The CDM and associated documentation, including linkage and standardisation procedures, will be available post-EUROlinkCAT thus facilitating future local, national and European-level analyses to improve healthcare. Recommendations to improve the accuracy of routinely collected data will be made.Findings will provide evidence to inform parents, health professionals, public health authorities and national treatment guidelines to optimise diagnosis, prevention and treatment for these children with a view to reducing health inequalities in Europe.