The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases
Authors: Gaggiano Carla , Vitale Antonio , Tufan Abdurrahman , Ragab Gaafar , Aragona Emma , Wiesik-Szewczyk Ewa , Ait-Idir Djouher , Conti Giovanni , Iezzi Ludovica , Maggio Maria Cristina , Cattalini Marco , Torre Francesco La , Lopalco Giuseppe , Verrecchia Elena , Paulis Amato de , Sahin Ali , Insalaco Antonella , Sfikakis Petros P. , Marino Achille , Frassi Micol , Ogunjimi Benson , Opris-Belinski Daniela , Parronchi Paola , Emmi Giacomo , Shahram Farhad , Ciccia Francesco , Piga Matteo , Hernández-Rodríguez José , Pereira Rosa Maria R. , Alessio Maria , Naddei Roberta , Olivieri Alma Nunzia , Giudice Emanuela Del , Sfriso Paolo , Ruscitti Piero , Gobbi Francesca Li , Kucuk Hamit , Sota Jurgen , Hussein Mohamed A. , Malizia Giuseppe , Jahnz-Różyk Karina , Sari-Hamidou Rawda , Romeo Mery , Ricci Francesca , Cardinale Fabio , Iannone Florenzo , Casa Francesca Della , Natale Marco Francesco , Laskari Katerina , Giani Teresa , Franceschini Franco , Sabato Vito , Yildirim Derya , Caggiano Valeria , Hegazy Mohamed Tharwat , Marzo Rosalba Di , Kucharczyk Aleksandra , Khellaf Ghalia , Tarsia Maria , Almaghlouth Ibrahim A. , Laymouna Ahmed Hatem , Mastrorilli Violetta , Dotta Laura , Benacquista Luca , Grosso Salvatore , Crisafulli Francesca , Parretti Veronica , Giordano Heitor F. , Mahmoud Ayman Abdel-Monem Ahmed , Nuzzolese Rossana , Musso Marta De , Chighizola Cecilia Beatrice , Gentileschi Stefano , Morrone Mirella , Cola Ilenia Di , Spedicato Veronica , Giardini Henrique A. Mayrink , Vasi Ibrahim , Renieri Alessandra , Fabbiani Alessandra , Mencarelli Maria Antonietta , Frediani Bruno , Balistreri Alberto , Tosi Gian Marco , Fabiani Claudia , Lidar Merav , Rigante Donato , Cantarini Luca 
Published: September 2022

Objective

The present manuscript aims to describe an international, electronic-based, user-friendly and interoperable patient registry for monogenic autoinflammatory diseases (mAIDs), developed in the contest of the Autoinflammatory Diseases Alliance (AIDA) Network.

Methods

This is an electronic platform, based on the Research Electronic Data Capture (REDCap) tool, used for real-world data collection of demographics, clinical, laboratory, instrumental and socioeconomic data of mAIDs patients. The instrument has flexibility, may change over time based on new scientific acquisitions, and communicate potentially with other similar registries; security, data quality and data governance are corner stones of the platform.

Results

AIDA project will share knowledge and expertise on mAIDs. Since its start, 118 centers from 24 countries and 4 continents have joined the AIDA project. Fifty-nine centers have already obtained the approval from their local Ethics Committees. Currently, the platform counts 337 users (122 Principal Investigators, 210 Site Investigators, 2 Lead Investigators, and 3 data managers). The Registry collects baseline and follow-up data using 3,748 fields organized into 21 instruments, which include demographics, patient history, symptoms, trigger/risk factors, therapies, and healthcare information for mAIDs patients.

Conclusions

The AIDA mAIDs Registry, acts both as a research tool for future collaborative real-life studies on mAIDs and as a service to connect all the figures called to participate. On this basis, the registry is expected to play a pivotal role in generating new scientific evidence on this group of rare diseases, substantially improving the management of patients, and optimizing the impact on the healthcare system. NCT 05200715 available at https://clinicaltrials.gov.