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.