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

Abstract

Objectives The primary objective of this study is 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 is to evaluate the impact of AAV on Quality of Life(QoL) and work impairment in a large cohort of Italian patients. Methods The study design employs 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 covers 3 disease domains: (a)organ-specific and systemic symptoms and signs(SSS); (b)physical function(PF); and (c)social and emotional impact(SEI). Secondly, 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 3 different time-points. Additionally, participants were also requested to complete the WPAI: GH. 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(ie worse) in all 3 domains, especially in the SEI domain(p-value < 0.001). Patients on GC therapy(n = 199) had higher scores on all domains, especially in the PF domain(p-value < 0.001), compared with patients without GC 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) on any domains(p-value < 0.05). Finally, nearly 30% of the patients reported work impairment. Conclusions The AAV-PRO_ita questionnaire is a new 29-item, disease-specific PRO measuring tool which can be used in AAV research in the Italian language. Gender, GCs and relapsing disease showed the greatest impact on QoL.

Systemic vasculitis: one year in review 2024

“…Studies have demonstrated the influence of factors such as sex, GC therapy, and disease history (e.g. disease duration, previous relapses) on patients' perception of their disease (118)(119)(120). Furthermore, since AAV is a multisystemic disorder, managing comorbidities, both pre-existing and subsequent to the diagnosis of AAV, is crucial (121).…”