Development and Implementation of the AIDA International Registry for Patients With Undifferentiated Systemic AutoInflammatory Diseases

Abstract

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/.

Keywords: International Registry; autoinflammatory diseases; personalized medicine; precision medicine; rare diseases.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Della Casa, Vitale, Lopalco, Ruscitti, Ciccia, Emmi, Cattalini, Wiesik-Szewczyk, Maggio, Ogunjimi, Sfikakis, Tufan, Al-Mayouf, Del Giudice, Aragona, La Torre, Sota, Colella, Di Cola, Iacono, Mattioli, Jahnz-Rózyk, Joos, Laskari, Gaggiano, Abbruzzese, Cipriani, Rozza, AlSaleem, Yildirim, Tarsia, Ragab, Ricci, Cardinale, Korzeniowska, Frassi, Caggiano, Saad, Pereira, Berlengiero, Gentileschi, Guerriero, Giani, Gelardi, Iannone, Giardini, Almaghlouth, Kardas, Ait-Idir, Frediani, Balistreri, Fabiani, Rigante and Cantarini.

Figures

Figure 1

Summary of the main phases corresponding to the creation of the Registry: the preliminary phase with all the elements required to carry out the project; the development phase during which common data elements and instruments of the Registry were realized; the data collection phase following the launch of the Registry accompanied by the efforts to maintain the high quality of data entered and of the Registry according to the new scientific acquisition.

Figure 2

Country involved in the AIDA Network (update February 7th, 2022).