Author:
Vitale Antonio,Della Casa Francesca,Lopalco Giuseppe,Pereira Rosa Maria,Ruscitti Piero,Giacomelli Roberto,Ragab Gaafar,La Torre Francesco,Bartoloni Elena,Del Giudice Emanuela,Lomater Claudia,Emmi Giacomo,Govoni Marcello,Maggio Maria Cristina,Maier Armin,Makowska Joanna,Ogunjimi Benson,Sfikakis Petros P.,Sfriso Paolo,Gaggiano Carla,Iannone Florenzo,Dagostin Marília A.,Di Cola Ilenia,Navarini Luca,Ahmed Mahmoud Ayman Abdelmonem,Cardinale Fabio,Riccucci Ilenia,Paroli Maria Pia,Marucco Elena Maria,Mattioli Irene,Sota Jurgen,Abbruzzese Anna,Antonelli Isabele P. B.,Cipriani Paola,Tufan Abdurrahman,Fabiani Claudia,Ramadan Mustafa Mahmoud,Cattalini Marco,Kardas Riza Can,Sebastiani Gian Domenico,Giardini Henrique A. Mayrink,Hernández-Rodríguez José,Mastrorilli Violetta,Więsik-Szewczyk Ewa,Frassi Micol,Caggiano Valeria,Telesca Salvatore,Giordano Heitor F.,Guadalupi Emmanuele,Giani Teresa,Renieri Alessandra,Colella Sergio,Cataldi Giulia,Gentile Martina,Fabbiani Alessandra,Al-Maghlouth Ibrahim A.,Frediani Bruno,Balistreri Alberto,Rigante Donato,Cantarini Luca
Abstract
ObjectiveAim of this paper is to present the design, construction, and modalities of dissemination of the AutoInflammatory Disease Alliance (AIDA) International Registry for patients with systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease (AOSD), which are the pediatric and adult forms of the same autoinflammatory disorder.MethodsThis Registry is a clinical, physician-driven, population- and electronic-based instrument implemented for the retrospective and prospective collection of real-world data. The collection of data is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain evidence drawn from routine patients' management. The collection of standardized data is thought to bring knowledge about real-life clinical research and potentially communicate with other existing and future Registries dedicated to Still's disease. Moreover, it has been conceived to be flexible enough to easily change according to future scientific acquisitions.ResultsStarting from June 30th to February 7th, 2022, 110 Centers 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 4449 fields organized into 14 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access.ConclusionsThis international Registry for patients with Still's disease will allow a robust clinical research through collection of standardized data, international consultation, dissemination of knowledge, and implementation of observational studies based on wide cohorts of patients followed-up for very long periods. Solid evidence drawn from “real-life” data represents the ultimate goal of this Registry, which has been implemented to significantly improve the overall management of patients with Still's disease. NCT 05200715 available at https://clinicaltrials.gov/.