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
Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
Front Med (Lausanne). 2022 Apr 7;9:878797. doi: 10.3389/fmed.2022.878797. eCollection 2022.
Aim 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.
This 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.
Starting 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.
This 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. NCT05200715 available at https://clinicaltrials.gov/.
本文旨在介绍自身炎症性疾病联盟（AIDA）国际注册中心针对系统性幼年特发性关节炎（sJIA）和成人起病的斯蒂尔病（AOSD）患者的设计、构建及数据传播方式，这两种疾病分别是同一自身炎症性疾病的儿童和成人形式。
该注册中心是一种临床的、由医生主导的、基于人群和电子的工具，用于回顾性和前瞻性收集真实世界数据。数据收集基于研究电子数据采集（REDCap）工具，旨在获取来自常规患者管理的证据。标准化数据的收集旨在带来关于真实临床研究的知识，并有可能与其他现有的和未来致力于斯蒂尔病的注册中心进行交流。此外，它的设计足够灵活，能够根据未来的科学进展轻松改变。
从2022年6月30日至2022年2月7日，来自4大洲23个国家的110个中心参与其中。其中54个中心已获得当地伦理委员会的批准。目前，该平台有290名用户（111名主要研究者、175名现场研究者、2名首席研究者和2名数据管理员）。该注册中心使用4449个字段，这些字段被组织成14种工具来收集基线和随访数据，包括患者的人口统计学信息、病史、临床表现和症状、触发因素/风险因素、治疗方法和医疗服务获取情况。
这个针对斯蒂尔病患者的国际注册中心将通过收集标准化数据、国际咨询、知识传播以及基于长期随访的大量患者队列开展观察性研究，实现强有力的临床研究。从“真实生活”数据中得出的可靠证据是该注册中心的最终目标，其设立是为了显著改善斯蒂尔病患者的整体管理。可在https://clinicaltrials.gov/查询NCT05200715。
