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

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&#95;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&#95;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.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)