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

Frontiers in Medicine

Derya Yildirim²  Rik Joos³  Bruno Frediani⁴  Claudia Fabiani⁵  Gaafar Ragab⁷  Rosa Maria Pereira⁷  Katerina Laskari⁸  Benson Ogunjimi⁸  Francesca Ricci⁹  Donato Rigante^1,11  Petros P. Sfikakis^1,12  Valeria Caggiano^1,13  Abdurrahman Tufan^1,14  Carla Gaggiano^1,14  Luca Cantarini^1,15  Virginia Berlengiero^1,16  Djouher Ait-Idir^1,17  Maria Tarsia^1,17  Sulaiman M. Al-Mayouf^1,17  Alberto Balistreri^1,18  Silvana Guerriero^1,18  Teresa Giani^1,19  Emanuela Del Giudice^2,20  Viviana Gelardi^2,21  Emma Aragona^2,22  Francesco La Torre^2,23  Ibrahim A. Almaghlouth^2,24  Riza Can Kardas^2,25  Jurgen Sota^2,26  Marcelina Korzeniowska^2,26  Giacomo Emmi^2,27  Karina Jahnz-Rózyk^2,27  Ewa Wiesik-Szewczyk^2,28  Micol Frassi^2,28  Antonio Vitale^2,29  Stefano Gentileschi^2,29  Anna Abbruzzese^2,29  Moustafa Ali Saad^2,29  Sergio Colella^2,29  Florenzo Iannone^2,29  Alhanouf AlSaleem^3,30  Francesco Ciccia^3,30  Irene Mattioli^3,30  Francesca Della Casa^3,31  Marco Cattalini^3,32  Fabio Cardinale^3,32  Gelsomina Rozza^3,33  Piero Ruscitti^3,33  Daniela Iacono^3,33  Ilenia Di Cola^3,34  Giuseppe Lopalco^3,34  Henrique Ayres Mayrink Giardini^3,34  Paola Cipriani^3,34  Maria Cristina Maggio^3,35 

[1] Infectious Diseases Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium;0Department of Pediatrics King Faisal Specialist Hospital and Research Center Riyadh, Riyadh, Saudi Arabia;0Department of Pediatrics, Antwerp University Hospital, Edegem, Belgium;0Research Laboratory, Biodiversity, Biotechnology, Environment and Sustainable Development, Department of Biology, Faculty of Sciences, M'Hamed Bougara University, Boumerdes, Algeria;1Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy;;1Center for Health Economics Research and Modeling Infectious Diseases (CHERMID), Vaccine &1Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt;2Department of Rheumatology, Ziekenhuis Netwerk Antwerpen, Berchem, Belgium;2Faculty of Medicine, Newgiza University (NGU), Giza, Egypt;2Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy;3Department of Life Sciences and Global Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy;3KidZ Health Castle, Universitair Ziekenhuis Brussel, Jette, Belgium;3Rheumatology and Clinical Immunology, Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy;4Joint Academic Rheumatology Program, National and Kapodistrian University of Athens Medical School, Athens, Greece;4Rare Diseases and Periodic Fevers Research Centre, Università Cattolica del Sacro Cuore, Rome, Italy;4Rheumatology Division, Hospital das Clinicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil;5Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey;5Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy;6Department of Ophthalmology and Otolaryngology, University of Bari, Bari, Italy;6King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia;7Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, ASST G. Pini-CTO, University of Milan, Milan, Italy;7Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Polo Pontino, Italy;8Division of Gastroenterology, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy;8Rheumatology Unit, Department of Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia;9College of Medicine Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia;9Department of Pediatrics, Pediatric Rheumatology Center, Ospedale “Giovanni XXIII”, AOU Consorziale Policlinico, Bari, Italy;Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy;Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland;Department of Medical Sciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Surgery and Neurosciences, University of Siena, Siena, Italy;Department of Precision Medicine, Università Degli Studi Della Campania Luigi Vanvitelli, Napoli, Italy;Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy;Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy;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;University Department PROMISE “G. D'Alessandro”, University of Palermo, Palermo, Italy;

关键词: autoinflammatory diseases;    personalized medicine;    precision medicine;    rare diseases;    International Registry;   

DOI  :  10.3389/fmed.2022.908501

来源: DOAJ

【 摘 要 】

ObjectiveThis 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).MethodsThis 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.ResultsThe 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.ConclusionsThe 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. NCT 05200715 available at https://clinicaltrials.gov/.

【 授权许可】

Unknown