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

Author:

Treppo Elena1ORCID,Isola Miriam2,De Martino Maria2,Padoan Roberto3,Giollo Alessandro3ORCID,Urban Maria Letizia4ORCID,Monti Sara56ORCID,Sartorelli Silvia7ORCID,Fassio Angelo8ORCID,Argolini Lorenza Maria9ORCID,Marvisi Chiara10,Gattamelata Angelica11,Regola Francesca12ORCID,Ferro Francesco13,Cassone Giulia14,Motta Francesca15,Berti Alvise16ORCID,Conticini Edoardo17ORCID,Guiducci Serena18,Matucci-Cerinic Marco18,Lo Gullo Alberto19ORCID,Manfredi Andreina14,Frediani Bruno17,Bortolotti Roberto16,Selmi Carlo1520,Baldini Chiara13ORCID,Franceschini Franco12,Conti Fabrizio11,Caporali Roberto9,Rossini Maurizio8,Dagna Lorenzo7,Montecucco Carlomaurizio56,Emmi Giacomo421,Schiavon Franco3,Salvarani Carlo10ORCID,Quartuccio Luca1ORCID

Affiliation:

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

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.

Publisher

Oxford University Press (OUP)

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