Introduction: This article points out the design, methods, development and deployment of the international registry promoted by the AutoInflammatory Disease Alliance (AIDA) Network with the aim to define and assess paediatric and adult patients with immune-mediated scleritis. Methods: This registry collects both retrospective and prospective real-world data from patients with non-infectious scleritis through the Research Electronic Data Capture (REDCap) tool and aims to promote knowledge and real-life evidence from patients enrolled worldwide; the registry also allows the collection of standardised data, ensuring the highest levels of security and anonymity of patients’ data and flexibility to change according to scientific acquisitions over time. The communication with other similar registries has been also ensured in order to pursue the sustainability of the project with respect to the adaptation of collected data to the most diverse research projects. Results: Since the launch of the registry, 99 centres have been involved from 20 countries and four continents. Forty-eight of the centres have already obtained a formal approval from their local ethics committees. At present, the platform counts 259 users (95 principal investigators, 160 site investigators, 2 lead investigators, and 2 data managers); the platform collects baseline and follow-up data using 3683 fields organised into 13 instruments, including patient’s demographics, history, symptoms, trigger or risk factors, therapies and healthcare utilization. Conclusions: The development of the AIDA International Registry for patients with non-infectious scleritis will allow solid research on this rare condition. Real-world evidence resulting from standardised real-life data will lead to the optimisation of routine clinical and therapeutic management, which are currently limited by the rarity of this ocular inflammatory condition.

Development and implementation of the AIDA international registry for patients with non-infectious scleritis / Della Casa, F.; Vitale, A.; Pereira, R. M.; Guerriero, S.; Ragab, G.; Lopalco, G.; Cattalini, M.; Mattioli, I.; Parronchi, P.; Paroli, M. P.; Del Giudice, E.; Gaggiano, C.; Dagostin, M. A.; Albano, V.; Soliman, M. M.; Colella, S.; Nascimbeni, G.; Sota, J.; Antonelli, I. P. B.; Alessio, G.; Caggiano, V.; Tufan, A.; Amin, R. H.; Tarsia, M.; Ghanema, M.; Iannone, F.; Ricci, F.; La Torre, F.; Wiesik-Szewczyk, E.; Conticini, E.; Gentileschi, S.; Dammacco, R.; Cimaz, R.; Frediani, B.; Abbruzzese, A.; Ruscitti, P.; Tosi, G. M.; Giordano, H. F.; Conforti, A.; Balistreri, A.; Rigante, D.; Cantarini, L.; Fabiani, C.. - In: OPHTHALMOLOGY AND THERAPY. - ISSN 2193-6528. - (2022). [10.1007/s40123-022-00466-2]

Development and implementation of the AIDA international registry for patients with non-infectious scleritis

Paroli M. P.;Del Giudice E.;
2022

Abstract

Introduction: This article points out the design, methods, development and deployment of the international registry promoted by the AutoInflammatory Disease Alliance (AIDA) Network with the aim to define and assess paediatric and adult patients with immune-mediated scleritis. Methods: This registry collects both retrospective and prospective real-world data from patients with non-infectious scleritis through the Research Electronic Data Capture (REDCap) tool and aims to promote knowledge and real-life evidence from patients enrolled worldwide; the registry also allows the collection of standardised data, ensuring the highest levels of security and anonymity of patients’ data and flexibility to change according to scientific acquisitions over time. The communication with other similar registries has been also ensured in order to pursue the sustainability of the project with respect to the adaptation of collected data to the most diverse research projects. Results: Since the launch of the registry, 99 centres have been involved from 20 countries and four continents. Forty-eight of the centres have already obtained a formal approval from their local ethics committees. At present, the platform counts 259 users (95 principal investigators, 160 site investigators, 2 lead investigators, and 2 data managers); the platform collects baseline and follow-up data using 3683 fields organised into 13 instruments, including patient’s demographics, history, symptoms, trigger or risk factors, therapies and healthcare utilization. Conclusions: The development of the AIDA International Registry for patients with non-infectious scleritis will allow solid research on this rare condition. Real-world evidence resulting from standardised real-life data will lead to the optimisation of routine clinical and therapeutic management, which are currently limited by the rarity of this ocular inflammatory condition.
2022
autoinflammatory diseases; clinical management; inflammatory ocular diseases; innovative biotechnologies; international registry; personalised medicine; precision medicine; rare diseases
01 Pubblicazione su rivista::01a Articolo in rivista
Development and implementation of the AIDA international registry for patients with non-infectious scleritis / Della Casa, F.; Vitale, A.; Pereira, R. M.; Guerriero, S.; Ragab, G.; Lopalco, G.; Cattalini, M.; Mattioli, I.; Parronchi, P.; Paroli, M. P.; Del Giudice, E.; Gaggiano, C.; Dagostin, M. A.; Albano, V.; Soliman, M. M.; Colella, S.; Nascimbeni, G.; Sota, J.; Antonelli, I. P. B.; Alessio, G.; Caggiano, V.; Tufan, A.; Amin, R. H.; Tarsia, M.; Ghanema, M.; Iannone, F.; Ricci, F.; La Torre, F.; Wiesik-Szewczyk, E.; Conticini, E.; Gentileschi, S.; Dammacco, R.; Cimaz, R.; Frediani, B.; Abbruzzese, A.; Ruscitti, P.; Tosi, G. M.; Giordano, H. F.; Conforti, A.; Balistreri, A.; Rigante, D.; Cantarini, L.; Fabiani, C.. - In: OPHTHALMOLOGY AND THERAPY. - ISSN 2193-6528. - (2022). [10.1007/s40123-022-00466-2]
File allegati a questo prodotto
File Dimensione Formato  
Della Casa_Development and_2022.pdf

accesso aperto

Note: https://link.springer.com/article/10.1007/s40123-022-00466-2
Tipologia: Versione editoriale (versione pubblicata con il layout dell'editore)
Licenza: Creative commons
Dimensione 282.69 kB
Formato Adobe PDF
282.69 kB Adobe PDF

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1617863
Citazioni
  • ???jsp.display-item.citation.pmc??? 6
  • Scopus 9
  • ???jsp.display-item.citation.isi??? 9
social impact