A patient-driven registry on Behçet's disease: the AIDA for patients pilot project

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

doi:10.3389/fmed.2023.1188021

A patient-driven registry on Behçet's disease: the AIDA for patients pilot project

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

Research output: Contribution to journal › Article

Abstract

Introduction: This 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). Methods: The 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. Results: Respondents 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 < 0.001), the presence of any major organ involvement (p < 0.031), the presence of gastro-intestinal (p < 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p < 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 < 0.001). Discussion: Preliminary 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.

Original language	English
Pages (from-to)	1-10
Number of pages	10
Journal	Frontiers in Medicine
Volume	2023
DOIs	https://doi.org/10.3389/fmed.2023.1188021
Publication status	Published - 2023

Keywords

Behçet's disease

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10.3389/fmed.2023.1188021

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Gaggiano, C., Del Bianco, A., Sota, J., Gentileschi, S., Ruscitti, P., Giacomelli, R., Piga, M., Crisafulli, F., Monti, S., Emmi, G., De Paulis, A., Vitale, A., Tarsia, M., Caggiano, V., Nuzzolese, R., Parretti, V., Fabiani, C., Lopalco, G., Maier, A., ... Cantarini, L. (2023). A patient-driven registry on Behçet's disease: the AIDA for patients pilot project. Frontiers in Medicine, 2023, 1-10. https://doi.org/10.3389/fmed.2023.1188021

@article{fe589244e98b41ec93375dcf3df91fd7,

title = "A patient-driven registry on Beh{\c c}et's disease: the AIDA for patients pilot project",

abstract = "Introduction: This 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 Beh{\c c}et{\textquoteright}s disease (BD). Methods: The project was coordinated by the University of Siena and the Italian patient advocacy organization SIMBA (Associazione Italiana Sindrome e Malattia di Beh{\c c}et), 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. Results: Respondents 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 Beh{\c c}et{\textquoteright}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 < 0.001), the presence of any major organ involvement (p < 0.031), the presence of gastro-intestinal (p < 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p < 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 < 0.001). Discussion: Preliminary 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.",

keywords = "Beh{\c c}et's disease, Beh{\c c}et's disease",

author = "Carla Gaggiano and {Del Bianco}, Alessandra and Jurgen Sota and Stefano Gentileschi and Piero Ruscitti and Roberto Giacomelli and Matteo Piga and Francesca Crisafulli and Sara Monti and Giacomo Emmi and {De Paulis}, Amato and Antonio Vitale and Maria Tarsia and Valeria Caggiano and Rossana Nuzzolese and Veronica Parretti and Claudia Fabiani and Giuseppe Lopalco and Armin Maier and Marco Cattalini and Donato Rigante and Marcello Govoni and {Li Gobbi}, Francesca and Serena Guiducci and Paola Parronchi and Achille Marino and Francesco Ciccia and Maggio, {Maria Cristina} and Emma Aragona and Elena Bartoloni and Annamaria Iagnocco and Ombretta Viapiana and Sebastiani, {Gian Domenico} and Silvana Guerriero and Antonella Insalaco and {Del Giudice}, Emanuela and Giovanni Conti and Patrizia Barone and Olivieri, {Alma Nunzia} and Antonio Brucato and Francesco Carubbi and Paola Triggianese and Angela Mauro and Tosi, {Gian Marco} and Alex Fonollosa and Giardini, {Henrique Ayres Mayrink} and Gaafar Ragab and Samar Tharwat and Jos{\'e} Hern{\'a}ndez-Rodr{\'i}guez and Sfikakis, {Petros P.} and Katerina Laskari and Anastasios Karamanakos and Gerard Espinosa and Farhad Shahram and Haner Direskeneli and Andrea Hinojosa-Azaola and Daniela Opris-Belinski and Almaghlouth, {Ibrahim A.} and G{\"u}len Hatemi and Eksin, {Mehmet Akif} and Fatos {\"O}nen and Ewa Wi{\c e}sik-Szewczyk and Nurullah Akko{\c c} and Abdurrahman Tufan and Ali {\c S}ahin and {\c S}{\"u}kran Erten and Seza Ozen and Batu, {Ezgi Deniz} and Bruno Frediani and Alberto Balistreri and Luca Cantarini",

year = "2023",

doi = "10.3389/fmed.2023.1188021",

language = "English",

volume = "2023",

pages = "1--10",

journal = "Frontiers in Medicine",

issn = "2296-858X",

publisher = "Lausanne: Frontiers Media S.A., 2014-",

}

Gaggiano, C, Del Bianco, A, Sota, J, Gentileschi, S, Ruscitti, P, Giacomelli, R, Piga, M, Crisafulli, F, Monti, S, Emmi, G, De Paulis, A, Vitale, A, Tarsia, M, Caggiano, V, Nuzzolese, R, Parretti, V, Fabiani, C, Lopalco, G, Maier, A, Cattalini, M, Rigante, D, Govoni, M, Li Gobbi, F, Guiducci, S, Parronchi, P, Marino, A, Ciccia, F, Maggio, MC, Aragona, E, Bartoloni, E, Iagnocco, A, Viapiana, O, Sebastiani, GD, Guerriero, S, Insalaco, A, Del Giudice, E, Conti, G, Barone, P, Olivieri, AN, Brucato, A, Carubbi, F, Triggianese, P, Mauro, A, Tosi, GM, Fonollosa, A, Giardini, HAM, Ragab, G, Tharwat, S, Hernández-Rodríguez, J, Sfikakis, PP, Laskari, K, Karamanakos, A, Espinosa, G, Shahram, F, Direskeneli, H, Hinojosa-Azaola, A, Opris-Belinski, D, Almaghlouth, IA, Hatemi, G, Eksin, MA, Önen, F, Więsik-Szewczyk, E, Akkoç, N, Tufan, A, Şahin, A, Erten, Ş, Ozen, S, Batu, ED, Frediani, B, Balistreri, A & Cantarini, L 2023, 'A patient-driven registry on Behçet's disease: the AIDA for patients pilot project', Frontiers in Medicine, vol. 2023, pp. 1-10. https://doi.org/10.3389/fmed.2023.1188021

TY - JOUR

T1 - A patient-driven registry on Behçet's disease: the AIDA for patients pilot project

AU - Gaggiano, Carla

AU - Del Bianco, Alessandra

AU - Sota, Jurgen

AU - Gentileschi, Stefano

AU - Ruscitti, Piero

AU - Giacomelli, Roberto

AU - Piga, Matteo

AU - Crisafulli, Francesca

AU - Monti, Sara

AU - Emmi, Giacomo

AU - De Paulis, Amato

AU - Vitale, Antonio

AU - Tarsia, Maria

AU - Caggiano, Valeria

AU - Nuzzolese, Rossana

AU - Parretti, Veronica

AU - Fabiani, Claudia

AU - Lopalco, Giuseppe

AU - Maier, Armin

AU - Cattalini, Marco

AU - Rigante, Donato

AU - Govoni, Marcello

AU - Li Gobbi, Francesca

AU - Guiducci, Serena

AU - Parronchi, Paola

AU - Marino, Achille

AU - Ciccia, Francesco

AU - Maggio, Maria Cristina

AU - Aragona, Emma

AU - Bartoloni, Elena

AU - Iagnocco, Annamaria

AU - Viapiana, Ombretta

AU - Sebastiani, Gian Domenico

AU - Guerriero, Silvana

AU - Insalaco, Antonella

AU - Del Giudice, Emanuela

AU - Conti, Giovanni

AU - Barone, Patrizia

AU - Olivieri, Alma Nunzia

AU - Brucato, Antonio

AU - Carubbi, Francesco

AU - Triggianese, Paola

AU - Mauro, Angela

AU - Tosi, Gian Marco

AU - Fonollosa, Alex

AU - Giardini, Henrique Ayres Mayrink

AU - Ragab, Gaafar

AU - Tharwat, Samar

AU - Hernández-Rodríguez, José

AU - Sfikakis, Petros P.

AU - Laskari, Katerina

AU - Karamanakos, Anastasios

AU - Espinosa, Gerard

AU - Shahram, Farhad

AU - Direskeneli, Haner

AU - Hinojosa-Azaola, Andrea

AU - Opris-Belinski, Daniela

AU - Almaghlouth, Ibrahim A.

AU - Hatemi, Gülen

AU - Eksin, Mehmet Akif

AU - Önen, Fatos

AU - Więsik-Szewczyk, Ewa

AU - Akkoç, Nurullah

AU - Tufan, Abdurrahman

AU - Şahin, Ali

AU - Erten, Şükran

AU - Ozen, Seza

AU - Batu, Ezgi Deniz

AU - Frediani, Bruno

AU - Balistreri, Alberto

AU - Cantarini, Luca

PY - 2023

Y1 - 2023

N2 - Introduction: This 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). Methods: The 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. Results: Respondents 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 < 0.001), the presence of any major organ involvement (p < 0.031), the presence of gastro-intestinal (p < 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p < 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 < 0.001). Discussion: Preliminary 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.

AB - Introduction: This 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). Methods: The 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. Results: Respondents 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 < 0.001), the presence of any major organ involvement (p < 0.031), the presence of gastro-intestinal (p < 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p < 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 < 0.001). Discussion: Preliminary 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.

KW - Behçet's disease

UR - http://hdl.handle.net/10807/257408

U2 - 10.3389/fmed.2023.1188021

DO - 10.3389/fmed.2023.1188021

M3 - Article

SN - 2296-858X

VL - 2023

SP - 1

EP - 10

JO - Frontiers in Medicine

JF - Frontiers in Medicine

ER -

A patient-driven registry on Behçet's disease: the AIDA for patients pilot project

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