TY - JOUR
T1 - Development and implementation of the AIDA International Registry for patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis syndrome
AU - Della Casa, Francesca
AU - Vitale, Antonio
AU - Cattalini, Marco
AU - La Torre, Francesco
AU - Capozio, Giovanna
AU - Del Giudice, Emanuela
AU - Maggio, Maria Cristina
AU - Conti, Giovanni
AU - Conti, Giorgio
AU - Alessio, Maria
AU - Ogunjimi, Benson
AU - Ragab, Gaafar
AU - Emmi, Giacomo
AU - Aragona, Emma
AU - Giani, Teresa
AU - Lopalco, Giuseppe
AU - Parronchi, Paola
AU - Shahram, Farhad
AU - Verrecchia, Elena
AU - Ricci, Francesca
AU - Cardinale, Fabio
AU - Di Noi, Silvia
AU - Nuzzolese, Rossana
AU - Lubrano, Riccardo
AU - Patroniti, Serena
AU - Naddei, Roberta
AU - Sabato, Vito
AU - Hussein, Mohamed A.
AU - Dotta, Laura
AU - Mastrorilli, Violetta
AU - Gentileschi, Stefano
AU - Tufan, Abdurrahman
AU - Caggiano, Valeria
AU - Hegazy, Mohamed Tharwat
AU - Sota, Jurgen
AU - Almaghlouth, Ibrahim A.
AU - Ibrahim, Amr
AU - Wiȩsik-Szewczyk, Ewa
AU - Ozkiziltas, Burcugul
AU - Grosso, Salvatore
AU - Frassi, Micol
AU - Tarsia, Maria
AU - Pereira, Rosa Maria R.
AU - Taymour, Maged
AU - Gaggiano, Carla
AU - Colella, Sergio
AU - Fabiani, Claudia
AU - Morrone, Maria
AU - Ruscitti, Piero
AU - Frediani, Bruno
AU - Spedicato, Veronica
AU - Giardini, Henrique A. Mayrink
AU - Balistreri, Alberto
AU - Rigante, Donato
AU - Cantarini, Luca
PY - 2022
Y1 - 2022
N2 - Objective: Aim of this paper is to illustrate the methodology, design, and development of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to patients with the Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome. Methods: This is a physician-driven, population- and electronic-based registry proposed to gather real-world demographics, clinical, laboratory, instrumental and socioeconomic data from patients suffering from PFAPA syndrome. Data recruitment is realized through the on-line Research Electronic Data Capture (REDCap) tool. This registry is thought to collect standardized information for clinical research leading to solid real-life evidence. The international scope and the flexibility of the registry will facilitate the realization of cutting-edge study projects through the constant updating of variables - as required by future scientific acquisitions - and the possible merging and transfer of data between current and future registries devoted to this disease. Results: One hundred and twelve centers have already been involved from 23 countries and 4 continents starting from August 24th, 2021, to March 21st, 2022. Fifty-five out of 112 have already obtained the formal approval from their local Ethics Committees. At current, the platform counts 287 users (108 principal investigators, 179 site investigators, 2 lead investigators, and 2 data managers). The registry collects retrospective and prospective data using 3845 fields organized into 24 instruments, including PFAPA patient’s demographics, medical histories, symptoms, triggers/risk factors, therapies, and impact on the healthcare systems. Conclusions: The development of the AIDA International Registry for patients with PFAPA syndrome will enable the on-line collection of standardized data prompting real-life studies through the connection of worldwide groups of physicians and researchers. This project can be found on https://clinicaltrials.gov NCT 05200715
AB - Objective: Aim of this paper is to illustrate the methodology, design, and development of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to patients with the Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome. Methods: This is a physician-driven, population- and electronic-based registry proposed to gather real-world demographics, clinical, laboratory, instrumental and socioeconomic data from patients suffering from PFAPA syndrome. Data recruitment is realized through the on-line Research Electronic Data Capture (REDCap) tool. This registry is thought to collect standardized information for clinical research leading to solid real-life evidence. The international scope and the flexibility of the registry will facilitate the realization of cutting-edge study projects through the constant updating of variables - as required by future scientific acquisitions - and the possible merging and transfer of data between current and future registries devoted to this disease. Results: One hundred and twelve centers have already been involved from 23 countries and 4 continents starting from August 24th, 2021, to March 21st, 2022. Fifty-five out of 112 have already obtained the formal approval from their local Ethics Committees. At current, the platform counts 287 users (108 principal investigators, 179 site investigators, 2 lead investigators, and 2 data managers). The registry collects retrospective and prospective data using 3845 fields organized into 24 instruments, including PFAPA patient’s demographics, medical histories, symptoms, triggers/risk factors, therapies, and impact on the healthcare systems. Conclusions: The development of the AIDA International Registry for patients with PFAPA syndrome will enable the on-line collection of standardized data prompting real-life studies through the connection of worldwide groups of physicians and researchers. This project can be found on https://clinicaltrials.gov NCT 05200715
KW - PFAPA syndrome
KW - Registry
KW - PFAPA syndrome
KW - Registry
UR - http://hdl.handle.net/10807/221446
U2 - 10.3389/fped.2022.930305
DO - 10.3389/fped.2022.930305
M3 - Article
SN - 2296-2360
VL - 2022
SP - 1
EP - 10
JO - Frontiers in Pediatrics
JF - Frontiers in Pediatrics
ER -