Development and implementation of the AIDA International Registry for patients with Behçet's disease

Antonio Vitale, Francesca Della Casa, Gaafar Ragab, Ibrahim A Almaghlouth, Giuseppe Lopalco, Rosa Maria Pereira, Silvana Guerriero, Marcello Govoni, Petros P Sfikakis, Roberto Giacomelli, Francesco Ciccia, Sara Monti, Piero Ruscitti, Matteo Piga, Claudia Lomater, Abdurrahman Tufan, Daniela Opris-Belinski, Giacomo Emmi, José Hernández-Rodríguez, Ali Şahin, Gian Domenico Sebastiani, Elena Bartoloni, Nurullah Akkoç, Özgül Soysal Gündüz, Marco Cattalini, Giovanni Conti, Gulen Hatemi, Armin Maier, Paola Parronchi, Emanuela Del Giudice, Sukran Erten, Antonella Insalaco, Francesca Li Gobbi, Maria Cristina Maggio, Farhad Shahram, Valeria Caggiano, Mohamed Tharwat Hegazy, Kazi Nur Asfina, Maria Morrone, Leandro L Prado, Rosanna Dammacco, Francesca Ruffilli, Aikaterini Arida, Luca Navarini, Ilenia Pantano, Lorenzo Cavagna, Alessandro Conforti, Alberto Cauli, Elena Maria Marucco, Hamit Kucuk, Ruxandra Ionescu, Irene Mattioli, Gerard Espinosa, Olga Araújo, Burak Karkaş, Claudia Canofari, Jurgen Sota, Ahmed Hatem Laymouna, Asma A Bedaiwi, Sergio Colella, Henrique Ayres M Giardini, Valeria Albano, Andrea Lo Monaco, George E Fragoulis, Riza Can Kardas, Virginia Berlengiero, Mohamed A Hussein, Francesca Ricci, Francesco La Torre, Donato Rigante, Ewa Więsik-Szewczyk, Micol Frassi, Stefano Gentileschi, Gian Marco Tosi, Marilia Ambiel Dagostin, Ayman Abdel-Monem Ahmed Mahmoud, Maria Tarsia, Giovanni Alessio, Rolando Cimaz, Teresa Giani, Carla Gaggiano, Florenzo Iannone, Paola Cipriani, Mariam Mourabi, Veronica Spedicato, Sara Barneschi, Emma Aragona, Alberto Balistreri, Bruno Frediani, Claudia Fabiani, Luca Cantarini, Autoinflammatory Diseases Alliance (AIDA) Network, Antonio Vitale, Francesca Della Casa, Gaafar Ragab, Ibrahim A Almaghlouth, Giuseppe Lopalco, Rosa Maria Pereira, Silvana Guerriero, Marcello Govoni, Petros P Sfikakis, Roberto Giacomelli, Francesco Ciccia, Sara Monti, Piero Ruscitti, Matteo Piga, Claudia Lomater, Abdurrahman Tufan, Daniela Opris-Belinski, Giacomo Emmi, José Hernández-Rodríguez, Ali Şahin, Gian Domenico Sebastiani, Elena Bartoloni, Nurullah Akkoç, Özgül Soysal Gündüz, Marco Cattalini, Giovanni Conti, Gulen Hatemi, Armin Maier, Paola Parronchi, Emanuela Del Giudice, Sukran Erten, Antonella Insalaco, Francesca Li Gobbi, Maria Cristina Maggio, Farhad Shahram, Valeria Caggiano, Mohamed Tharwat Hegazy, Kazi Nur Asfina, Maria Morrone, Leandro L Prado, Rosanna Dammacco, Francesca Ruffilli, Aikaterini Arida, Luca Navarini, Ilenia Pantano, Lorenzo Cavagna, Alessandro Conforti, Alberto Cauli, Elena Maria Marucco, Hamit Kucuk, Ruxandra Ionescu, Irene Mattioli, Gerard Espinosa, Olga Araújo, Burak Karkaş, Claudia Canofari, Jurgen Sota, Ahmed Hatem Laymouna, Asma A Bedaiwi, Sergio Colella, Henrique Ayres M Giardini, Valeria Albano, Andrea Lo Monaco, George E Fragoulis, Riza Can Kardas, Virginia Berlengiero, Mohamed A Hussein, Francesca Ricci, Francesco La Torre, Donato Rigante, Ewa Więsik-Szewczyk, Micol Frassi, Stefano Gentileschi, Gian Marco Tosi, Marilia Ambiel Dagostin, Ayman Abdel-Monem Ahmed Mahmoud, Maria Tarsia, Giovanni Alessio, Rolando Cimaz, Teresa Giani, Carla Gaggiano, Florenzo Iannone, Paola Cipriani, Mariam Mourabi, Veronica Spedicato, Sara Barneschi, Emma Aragona, Alberto Balistreri, Bruno Frediani, Claudia Fabiani, Luca Cantarini, Autoinflammatory Diseases Alliance (AIDA) Network

Abstract

Purpose of the present paper is to point out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients with Behçet's disease (BD). The Registry is a clinical physician-driven non-population- and electronic-based instrument implemented for the retrospective and prospective collection of real-life data about demographics, clinical, therapeutic, laboratory, instrumental and socioeconomic information from BD patients; the Registry is based on the Research Electronic Data Capture (REDCap) tool, which is thought to collect standardised information for clinical real-life research, and has been realised to change over time according to future scientific acquisitions and potentially communicate with other existing and future Registries dedicated to BD. Starting from January 31st, 2021, to February 7th, 2022, 110 centres from 23 countries in 4 continents have been involved. Fifty-four of these have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 175 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry collects baseline and follow-up data using 5993 fields organised into 16 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. The development of the AIDA International Registry for BD patients will facilitate the collection of standardised data leading to real-world evidence, enabling international multicentre collaborative research through data sharing, international consultation, dissemination of knowledge, inclusion of patients and families, and ultimately optimisation of scientific efforts and implementation of standardised care.Trial registration NCT05200715 in 21/01/2022.

Keywords: Autoinflammatory diseases; Behçet’s disease; International registry; Precision medicine; Rare diseases; Uveitis.

Conflict of interest statement

The authors declare that they have no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Worldwide distribution of the AIDA Network on February 7rd, 2022

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