Validation of the Italian version of the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire

Elena Treppo; Miriam Isola; Maria De Martino; Roberto Padoan; Alessandro Giollo; Maria Letizia Urban; Sara Monti; Silvia Sartorelli; Angelo Fassio; Lorenza Maria Argolini; Chiara Marvisi; Angelica Gattamelata; Francesca Regola; Francesco Ferro; Giulia Cassone; Francesca Motta; Alvise Berti; Edoardo Conticini; Serena Guiducci; Marco Matucci-Cerinic; Alberto Lo Gullo; Andreina Manfredi; Bruno Frediani; Roberto Bortolotti; Carlo Selmi; Chiara Baldini; Franco Franceschini; Fabrizio Conti; Roberto Caporali; Maurizio Rossini; Lorenzo Dagna; Carlomaurizio Montecucco; Giacomo Emmi; Franco Schiavon; Carlo Salvarani; Luca Quartuccio

doi:10.1093/rap/rkae001

Validation of the Italian version of the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire

Rheumatol Adv Pract. 2024 Jan 22;8(1):rkae001. doi: 10.1093/rap/rkae001. eCollection 2024.

Authors

Elena Treppo¹, Miriam Isola², Maria De Martino², Roberto Padoan³, Alessandro Giollo³, Maria Letizia Urban⁴, Sara Monti^{5

6}, Silvia Sartorelli⁷, Angelo Fassio⁸, Lorenza Maria Argolini⁹, Chiara Marvisi¹⁰, Angelica Gattamelata¹¹, Francesca Regola¹², Francesco Ferro¹³, Giulia Cassone¹⁴, Francesca Motta¹⁵, Alvise Berti¹⁶, Edoardo Conticini¹⁷, Serena Guiducci¹⁸, Marco Matucci-Cerinic¹⁸, Alberto Lo Gullo¹⁹, Andreina Manfredi¹⁴, Bruno Frediani¹⁷, Roberto Bortolotti¹⁶, Carlo Selmi^{15

20}, Chiara Baldini¹³, Franco Franceschini¹², Fabrizio Conti¹¹, Roberto Caporali⁹, Maurizio Rossini⁸, Lorenzo Dagna⁷, Carlomaurizio Montecucco^{5

6}, Giacomo Emmi^{4

21}, Franco Schiavon³, Carlo Salvarani¹⁰, Luca Quartuccio¹

Affiliations

¹ Division of Rheumatology, Department of Medicine, University of Udine, Udine, Italy.
² Institute of Statistics, Department of Medicine, University of Udine, Udine, Italy.
³ Rheumatology Unit, Department of Medicine DIMED, University of Padua, Padova, Italy.
⁴ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
⁵ Department of Internal Medicine and Therapeutics, Università di Pavia, Pavia, Italy.
⁶ Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
⁷ IRCCS San Raffaele Scientific Institute, Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), Milano, Italy.
⁸ Rheumatology Unit, University of Verona, Verona, Italy.
⁹ Division of Clinical Rheumatology, ASST Istituto Gaetano Pini-CTO, Milano, Italy.
¹⁰ Azienda USL-IRCCS di Reggio Emilia and University of Modena and Reggio Emilia, Reggio Emilia, Italy.
¹¹ Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Rheumatology Unit, Sapienza University of Rome, Rome, Italy.
¹² Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
¹³ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
¹⁴ Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.
¹⁵ Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milano, Italy.
¹⁶ Center for Medical Sciences (CISMed), University of Trento, and Rheumatology Unit, Santa Chiara Hospital, APSS Trento, Italy.
¹⁷ Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
¹⁸ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Florence, Italy.
¹⁹ Rheumatology Unit, Garibaldi Hospital, Catania, Italy.
²⁰ Department of Biomedical Sciences, Humanitas University, Milano, Italy.
²¹ Centre for Inflammatory Diseases, Monash University Department of Medicine, Monash Medical Centre, Clayton, Victoria, Australia.

Abstract

Objectives: The primary objective of this study was the translation and validation of the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire into Italian, denoted as AAV-PRO_ita. The secondary objective was to evaluate the impact of ANCA-associated vasculitis (AAV) on quality of life (QoL) and work impairment in a large cohort of Italian patients.

Methods: The study design took a prospective cohort study approach. First, the AAV-PRO was translated into Italian following the step guidelines for translations. The new AAV-PRO_ita questionnaire covered three disease domains: organ-specific and systemic symptoms and signs; physical function; and social and emotional impact. Second, Italian-speaking AAV patients were recruited from 17 Italian centres belonging to the Italian Vasculitis Study Group. Participants completed the AAV-PRO_ita questionnaire at three time points. Participants were also requested to complete the work productivity and activity impairment: general health questionnaire.

Results: A total of 276 AAV patients (56.5% women) completed the questionnaires. The AAV-PRO_ita questionnaire demonstrated a good internal consistency and test-retest reliability. Female AAV patients scored higher (i.e. worse) in all thee domains, especially in the social and emotional impact domain (P < 0.001). Patients on glucocorticoid therapy (n = 199) had higher scores in all domains, especially in the physical function domain (P < 0.001), compared with patients not on glucocorticoid therapy (n = 77). Furthermore, patients who had at least one relapse of disease (n = 114) had higher scores compared with those who had never had one (n = 161) in any domain (P < 0.05). Finally, nearly 30% of the patients reported work impairment.

Conclusion: The AAV-PRO_ita questionnaire is a new 29-item, disease-specific patient-reported outcome measuring tool that can be used in AAV research in the Italian language. Sex, glucocorticoids and relapsing disease showed the greatest impact on QoL.

Keywords: AAV-PRO; ANCA; glucocorticoids; patient-reported outcome; quality of life; questionnaire; vasculitis; work impairment.