Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Frontiers in Medicine

Ewa Więsik-Szewczyk¹  Donato Rigante³  Elena Bartoloni⁴  Ilenia Riccucci⁴  Benson Ogunjimi⁵  Emanuela Del Giudice⁶  Micol Frassi⁷  Elena Maria Marucco⁸  Claudia Lomater⁸  Teresa Giani⁹  Petros P. Sfikakis^1,10  Giacomo Emmi^1,11  Irene Mattioli^1,11  Paolo Sfriso^1,13  Marcello Govoni^1,15  Maria Pia Paroli^1,16  Abdurrahman Tufan^1,17  Riza Can Kardas^1,17  Alessandra Renieri^1,18  Alessandra Fabbiani^1,18  Maria Cristina Maggio^1,19  Ibrahim A. Al-Maghlouth^2,20  Claudia Fabiani^2,21  Armin Maier^2,22  Joanna Makowska^2,23  Marco Cattalini^2,24  Bruno Frediani^2,25  Alberto Balistreri^2,27  Gian Domenico Sebastiani^2,28  José Hernández-Rodríguez^3,31  Jurgen Sota^3,32  Salvatore Telesca^3,32  Carla Gaggiano^3,32  Antonio Vitale^3,32  Luca Cantarini^3,32  Valeria Caggiano^3,32  Emmanuele Guadalupi^3,32  Violetta Mastrorilli^3,33  Francesco La Torre^3,33  Fabio Cardinale^3,33  Francesca Della Casa^3,34  Gaafar Ragab^3,35  Mustafa Mahmoud Ramadan^3,36  Ayman Abdelmonem Ahmed Mahmoud^3,36  Henrique A. Mayrink Giardini^3,37  Isabele P. B. Antonelli^3,37  Heitor F. Giordano^3,37  Marília A. Dagostin^3,37  Rosa Maria Pereira^3,37  Piero Ruscitti^3,38  Ilenia Di Cola^3,38  Martina Gentile^3,38  Paola Cipriani^3,38  Giulia Cataldi^3,38  Anna Abbruzzese^3,39  Giuseppe Lopalco^3,39  Sergio Colella^3,39  Florenzo Iannone^3,39  Roberto Giacomelli^4,40  Luca Navarini^4,40 

[1] 0Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland;0Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium;0Rare Diseases and Periodic Fevers Research Centre, Università Cattolica Sacro Cuore, Rome, Italy;0Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy;1Center for Health Economics Research and Modeling Infectious Diseases, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium;1Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy;1Rheumatology and Clinical Immunology, Spedali Civili, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy;2Azienda Ospedaliera (AO) Mauriziano, Universita degli Studi di Torino, Academic Rheumatology Centre, Turin, Italy;2Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO), Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy;2Joint Academic Rheumatology Program, First Department of Propedeutic Internal Medicine, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece;3Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy;3Medical Genetics, Department of Medical Biotechnologies, University of Siena, Siena, Italy;3Rheumatology Unit, Department of Medicine, University of Padua, Padua, Italy;4Department of Medical Biotechnologies, Med Biotech Hub and Competence Center, University of Siena, Siena, Italy;4Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna - Ferrara, Department of Medical Sciences, University of Ferrara, Ferrara, Italy;4Uveitis Unit, Department of Sense Organs, Eye Clinic, Sapienza University of Rome, Rome, Italy;5Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey;5Genetica Medica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy;5University Department PROMISE “G. D'Alessandro”, University of Palermo, Palermo, Italy;6Department of Family and Community Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia;6Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy;6Rheumatology Unit, Department of Medicine, Central Hospital of Bolzano, Bolzano, Italy;7Department of Rheumatology, Medical University of Lodz, Łódź, Poland;7Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy;7Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy;8Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing, University of Antwerp, Antwerp, Belgium;8Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy;8U.O.C. Reumatologia, Ospedale San Camillo-Forlanini, Rome, Italy;9Antwerp Center for Translational Immunology and Virology, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium;9Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy;9Vasculitis Research Unit and Autoinflammatory Diseases Clinical Unit, Department of Autoimmune Diseases, Hospital Clinic of Barcelona, Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain;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 Pediatrics, Pediatric Rheumatology Center, Giovanni XXIII Pediatric Hospital, University of Bari, Bari, Italy;Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy;Internal Medicine Department, Clinical Immunology and Rheumatology Unit, Newgiza University (NGU), Giza, Egypt;Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt;Rheumatology Division, Faculdade de Medicina, Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil;Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy;Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy;Rheumatology, Immunology and Clinical Medicine Unit, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy;

关键词: autoinflammatory diseases;    precision medicine;    personalized medicine;    rare diseases;    research;    treatment;   

DOI  :  10.3389/fmed.2022.878797

来源: DOAJ

【 摘 要 】

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/.

【 授权许可】

Unknown