A patient-driven registry on Behçet’s disease: the AIDA for patients pilot project
Authors: Gaggiano Carla , Del Bianco Alessandra , Sota Jurgen , Gentileschi Stefano , Ruscitti Piero , Giacomelli Roberto , Piga Matteo , Crisafulli Francesca , Monti Sara , Emmi Giacomo , De Paulis Amato , Vitale Antonio , Tarsia Maria , Caggiano Valeria , Nuzzolese Rossana , Parretti Veronica , Fabiani Claudia , Lopalco Giuseppe , Maier Armin , Cattalini Marco , Rigante Donato , Govoni Marcello , Li Gobbi Francesca , Guiducci Serena , Parronchi Paola , Marino Achille , Ciccia Francesco , Maggio Maria Cristina , Aragona Emma , Bartoloni Elena , Iagnocco Annamaria , Viapiana Ombretta , Sebastiani Gian Domenico , Guerriero Silvana , Insalaco Antonella , Del Giudice Emanuela , Conti Giovanni , Barone Patrizia , Olivieri Alma Nunzia , Brucato Antonio , Carubbi Francesco , Triggianese Paola , Mauro Angela , Tosi Gian Marco , Fonollosa Alex , Giardini Henrique Ayres Mayrink , Ragab Gaafar , Tharwat Samar , Hernández-Rodríguez José , Sfikakis Petros P. , Laskari Katerina , Karamanakos Anastasios , Espinosa Gerard , Shahram Farhad , Direskeneli Haner , Hinojosa-Azaola Andrea , Opris-Belinski Daniela , AlMaghlouth Ibrahim A. , Hatemi Gülen , Eksin Mehmet Akif , Önen Fatos , Więsik-Szewczyk Ewa , Akkoç Nurullah , Tufan Abdurrahman , Şahin Ali , Erten Şükran , Ozen Seza , Batu Ezgi Deniz , Frediani Bruno , Balistreri Alberto , Cantarini Luca 
Published: June 2023

IntroductionThis paper describes the creation and preliminary results of a patient-driven registry for the collection of patient-reported outcomes (PROs) and patient-reported experiences (PREs) in Behçet’s disease (BD).MethodsThe project was coordinated by the University of Siena and the Italian patient advocacy organization SIMBA (Associazione Italiana Sindrome e Malattia di Behçet), in the context of the AIDA (AutoInflammatory Diseases Alliance) Network programme. Quality of life, fatigue, socioeconomic impact of the disease and therapeutic adherence were selected as core domains to include in the registry.ResultsRespondents were reached via SIMBA communication channels in 167 cases (83.5%) and the AIDA Network affiliated clinical centers in 33 cases (16.5%). The median value of the Behçet’s Disease Quality of Life (BDQoL) score was 14 (IQR 11, range 0–30), indicating a medium quality of life, and the median Global Fatigue Index (GFI) was 38.7 (IQR 10.9, range 1–50), expressing a significant level of fatigue. The mean Beliefs about Medicines Questionnaire (BMQ) necessity-concern differential was 0.9 ± 1.1 (range – 1.8–4), showing that the registry participants prioritized necessity belief over concerns to a limited extent. As for the socioeconomic impact of BD, in 104 out of 187 cases (55.6%), patients had to pay from their own pocket for medical exams required to reach the diagnosis. The low family socioeconomic status (p &lt; 0.001), the presence of any major organ involvement (p &lt; 0.031), the presence of gastro-intestinal (p &lt; 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p &lt; 0.001) were associated to a higher number of accesses to the healthcare system. Multiple linear regression showed that the BDQoL score could significantly predict the global socioeconomic impact of BD (F = 14.519, OR 1.162 [CI 0.557–1.766], p &lt; 0.001).DiscussionPreliminary results from the AIDA for Patients BD registry were consistent with data available in the literature, confirming that PROs and PREs could be easily provided by the patient remotely to integrate physician-driven registries with complementary and reliable information.