AIDA国际未分化系统性自身炎症性疾病患者注册库的建立与实施。
Development and Implementation of the AIDA International Registry for Patients With Undifferentiated Systemic AutoInflammatory Diseases.
作者信息
Della Casa Francesca, Vitale Antonio, Lopalco Giuseppe, Ruscitti Piero, Ciccia Francesco, Emmi Giacomo, Cattalini Marco, Wiesik-Szewczyk Ewa, Maggio Maria Cristina, Ogunjimi Benson, Sfikakis Petros P, Tufan Abdurrahman, Al-Mayouf Sulaiman M, Del Giudice Emanuela, Aragona Emma, La Torre Francesco, Sota Jurgen, Colella Sergio, Di Cola Ilenia, Iacono Daniela, Mattioli Irene, Jahnz-Rózyk Karina, Joos Rik, Laskari Katerina, Gaggiano Carla, Abbruzzese Anna, Cipriani Paola, Rozza Gelsomina, AlSaleem Alhanouf, Yildirim Derya, Tarsia Maria, Ragab Gaafar, Ricci Francesca, Cardinale Fabio, Korzeniowska Marcelina, Frassi Micol, Caggiano Valeria, Saad Moustafa Ali, Pereira Rosa Maria, Berlengiero Virginia, Gentileschi Stefano, Guerriero Silvana, Giani Teresa, Gelardi Viviana, Iannone Florenzo, Giardini Henrique Ayres Mayrink, Almaghlouth Ibrahim A, Kardas Riza Can, Ait-Idir Djouher, Frediani Bruno, Balistreri Alberto, Fabiani Claudia, Rigante Donato, Cantarini Luca
机构信息
Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
Department of Medical Sciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Surgery and Neurosciences, University of Siena, Siena, Italy.
出版信息
Front Med (Lausanne). 2022 Jun 10;9:908501. doi: 10.3389/fmed.2022.908501. eCollection 2022.
OBJECTIVE
This paper points out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients affected by Undifferentiated Systemic AutoInflammatory Diseases (USAIDs).
METHODS
This is an electronic registry employed for real-world data collection about demographics, clinical, laboratory, instrumental and socioeconomic data of USAIDs patients. Data recruitment, based on the Research Electronic Data Capture (REDCap) tool, is designed to obtain standardized information for real-life research. The instrument is endowed with flexibility, and it could change over time according to the scientific acquisitions and potentially communicate with other similar tools; this platform ensures security, data quality and data governance.
RESULTS
The focus of the AIDA project is connecting physicians and researchers from all over the world to shed a new light on heterogeneous rare diseases. Since its birth, 110 centers from 23 countries and 4 continents have joined the AIDA project. Fifty-four centers have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 179 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry is collecting baseline and follow-up data using 3,769 fields organized into 23 instruments, which include demographics, history, symptoms, trigger/risk factors, therapies, and healthcare information access for USAIDs patients.
CONCLUSIONS
The development of the AIDA International Registry for USAIDs patients will facilitate the online collection of real standardized data, connecting a worldwide group of researchers: the Registry constitutes an international multicentre observational groundwork aimed at increasing the patient cohort of USAIDs in order to improve our knowledge of this peculiar cluster of autoinflammatory diseases. NCT05200715 available at https://clinicaltrials.gov/.
目的
本文指出了自身炎症性疾病联盟（AIDA）国际注册库的设计、开发和部署情况，该注册库致力于收录未分化系统性自身炎症性疾病（USAIDs）患儿及成人患者的相关信息。
方法
这是一个电子注册库，用于收集USAIDs患者的人口统计学、临床、实验室、仪器检查及社会经济数据等真实世界数据。基于研究电子数据采集（REDCap）工具进行数据招募，旨在获取用于现实生活研究的标准化信息。该工具具有灵活性，可根据科学发现随时间变化，并有可能与其他类似工具进行通信；此平台确保了数据安全、质量及管理。
结果
AIDA项目的重点是连接世界各地的医生和研究人员，以全新视角审视这类异质性罕见疾病。自成立以来，来自4大洲23个国家的110个中心已加入AIDA项目。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、179名现场研究者、2名首席研究者和2名数据管理员）。该注册库正在使用23种工具中的3769个字段收集基线和随访数据，这些字段包括USAIDs患者的人口统计学、病史、症状、触发/风险因素、治疗方法及医疗信息获取情况。
结论
AIDA国际USAIDs患者注册库的开发将有助于在线收集真实的标准化数据，连接全球范围内的研究人员群体：该注册库构成了一项国际多中心观察性基础工作，旨在增加USAIDs患者队列数量，以增进我们对这类特殊自身炎症性疾病群的了解。可在https://clinicaltrials.gov/查询NCT05200715。
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