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Title: Validation of the Italian version of the anca-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire.
Authors: Treppo E.;Isola M.;De Martino M.;Padoan R.;Giollo A.;Urban M.L.;Monti S.;Sartorelli S.;Fassio A.;Argolini L.M.;Marvisi C.;Gattamelata A.;Regola F.;Ferro F.;Cassone G.;Motta F.;Berti A.;Conticini E.;Guiducci S.;Matucci-Cerinic M.;Gullo A.L.;Manfredi A.;Frediani B.;Bortolotti R.;Selmi C.;Baldini C.;Franceschini F.;Conti F.;Caporali R.;Rossini M.;Dagna L.;Montecucco C.;Emmi G.;Schiavon F.;Salvarani C.;Quartuccio L.
Monash Health Department(s): Centre for Inflammatory Diseases at Monash Health
Institution: (Treppo, Quartuccio) Division of Rheumatology, Department of Medicine, University of Udine, Udine, Italy
(Isola, De Martino) Institute of Statistics, Department of Medicine, University of Udine, Udine, Italy
(Padoan, Giollo, Schiavon) Rheumatology Unit, Department of Medicine DIMED, University of Padua, Padova, Italy
(Urban, Emmi) Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
(Monti, Montecucco) Department of Internal Medicine and Therapeutics, Universita di Pavia, Pavia, Italy
(Monti, Montecucco) Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
(Sartorelli, Dagna) IRCCS San Raffaele Scientific Institute, Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), Milano, Italy
(Fassio, Rossini) Rheumatology Unit, University of Verona, Verona, Italy
(Argolini, Caporali) Division of Clinical Rheumatology, ASST Istituto Gaetano Pini-CTO, Milano, Italy
(Marvisi, Salvarani) Azienda USL-IRCCS di Reggio Emilia, University of Modena and Reggio Emilia, Reggio Emilia, Italy
(Gattamelata, Conti) Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Rheumatology Unit, Sapienza University of Rome, Rome, Italy
(Regola, Franceschini) Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy
(Ferro, Baldini) Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
(Cassone, Manfredi) Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy
(Motta, Selmi) Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milano, Italy
(Berti, Bortolotti) Center for Medical Sciences (CISMed), University of Trento, Rheumatology Unit, Santa Chiara Hospital, APSS, Trento, Italy
(Conticini, Frediani) Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy
(Guiducci, Matucci-Cerinic) Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Florence, Italy
(Gullo) Rheumatology Unit, Garibaldi Hospital, Catania, Italy
(Selmi) Department of Biomedical Sciences, Humanitas University, Milano, Italy
(Emmi) Centre for Inflammatory Diseases, Monash University Department of Medicine, Monash Medical Centre, Clayton, VIC, Australia
Issue Date: 28-Mar-2024
Copyright year: 2024
Publisher: Oxford University Press
Place of publication: United Kingdom
Publication information: Rheumatology Advances in Practice. 8(1) (no pagination), 2024. Article Number: Rkae001. Date of Publication: 2024.
Journal: Rheumatology Advances in Practice
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. Method(s): 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. Result(s): 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 1/4 199) had higher scores in all domains, especially in the physical function domain (P < 0.001), compared with patients not on glucocorticoid therapy (n 1/4 77). Furthermore, patients who had at least one relapse of disease (n 1/4 114) had higher scores compared with those who had never had one (n 1/4 161) in any domain (P < 0.05). Finally, nearly 30% of the patients reported work impairment. Conclusion(s): 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.Copyright © The Author(s) 2024.
Type: Article
Subjects: ANCA associated vasculitis
quality of life
Type of Clinical Study or Trial: Observational study (cohort, case-control, cross sectional, or survey)
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