AB0627 Evaluation of internal consistency, feasibility, and reliability of the Italian version of ANCA-associated vasculitis patient-reported outcome (AAV-PRO_ita) questionnaire: preliminary results from a multicenter study on a large cohort of Italian patients

Abstract

BackgroundThe ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire is a 29-item disease-specific PRO measure for AAV[1]. The Italian version of the AAV-PRO questionnaire (AAV-PRO_ita) was translated in collaboration with Oxford and Bristol University (UK) and was preliminarily tested on a single-center Italian cohort[2].ObjectivesThe main objective of this multicentric study was to assess the internal consistency, feasibility, and reliability of the AAV-PRO_ita in a large cohort of Italian AAV patients. The secondary objective was to investigate the clinical characteristics of AAV patients associated with AAV-PRO_ita domains.MethodsThe AAV-PRO_ita is describes the following disease domains: (1) organ-specific and systemic symptoms and signs (SSS); (2) physical function (PF); (3) social and emotional impact (SEI). In this study, Italian-speaking AAV patients were recruited from Italian Centres (N=13) with a large experience in the diagnosis and treatment of systemic vasculitis, belonging to the Vasculitis Study Group of the Italian Society of Rheumatology. Inclusion criteria were: a confirmed diagnosis of GPA, MPA, or EGPA; ANCA positivity in at least once occasion or biopsy-proven AAV; and age ≥18 years old. Participants completed the AAV-PRO_ita at three different time-points: baseline, after 5-7 days, and at month 3.Results229 AAV-patients (56.3% women) with a median age of 61 (IQR 51-72) were recruited and completed the questionnaires. The subtype of AAV was mainly GPA (131, 57.2%), followed by EGPA (58, 25.3%), and MPA (40, 17.5%). Median BVASv3 at baseline was 0 (IQR 0-3), whereas the median BVASv3 at the onset of disease was 14 (IQR 9-20). Participants had a median duration of disease of 67 (IQR 24-126) months. Patients who experienced at least one relapse, one hospitalization, and one severe infection were 40.2%, 53.3%, and 24%, respectively. 83% of the patients were on immunosuppressant therapy and 71.6% were still receiving glucocorticoids (GC).AAV-PRO_ita questionnaire had good internal consistency (Cronbach’s Alpha range 0.81-0.93) and good test-retest reliability (ICCs range 0.93-0.96). Item response rates were high overall (maximum 0.87% missing data), supporting the feasibility of the questionnaire.Concerning the domains of the questionnaire, female AAV patients scored higher (i.e. worse) in all three domains, especially in the SEI domain (p-value<0.001). Older participants (≥65 years) scored higher in the PF domain (p-value<0.05) in all three times of self-completions of the questionnaire. The ongoing treatment also influenced the results. In fact, patients on GC showed higher scores in the PF domain (p-value=0.003) and SEI domain (p-value=0.021). The VDI value seemed to be related to AAV-PRO_ita scores more than disease duration or disease activity, especially in the SSS domain (ρ>0.3, p-value<0.001). Conversely, subtype of AAV did not influence the item scores.ConclusionThe AAV-PRO_ita questionnaire is a new 29-item, disease-specific PRO measure for use in AAV in the Italian language. It is a self-administered Italian questionnaire with good internal consistency, feasibility, and reliability. AAV-PRO_ita proved to be a useful tool to explore the AAV patient’s perception of quality of life, and it could become an important way of measuring the unmet needs of AAV patients.References[1]Robson, J.C. et al. Validation of the ANCA-Associated Vasculitis Patient-Reported Outcomes (AAV-PRO) Questionnaire. Ann. Rheum. Dis.2018, 77, 1157–1164, doi:10.1136/annrheumdis-2017-212713.[2]Treppo, E.; Palese, A.; Vita, S.D.; Quartuccio, L. AB0392 PRELIMINARY VALIDATION OF THE ITALIAN VERSION OF ANCA-ASSOCIATED VASCULITIS PATIENT-REPORTED OUTCOME (AAV-PRO_ita) QUESTIONNAIRE: FATIGUE AND CHRONIC PAIN AS UNMET NEEDS BY CURRENT TREATMENTS. Ann. Rheum. Dis.2021, 80, 1224–1224, doi:10.1136/annrheumdis-2021-eular.2123.AcknowledgementsWe thank the Italian Study Group on Systemic Vasculitis.Disclosure of InterestsNone declared

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

“…These findings had not been investigated in the previous validation study of the English questionnaire [ 6 ]. Conversely, in the validation study of the English questionnaire [ 6 ] and in the preliminary evaluation of our questionnaire [ 12 ], older participants (≥65 years old) had higher scores in the PF domain ( P < 0.05), and younger participants (<65 years old) showed a trend of higher scores in the SEI domain; however, these data were not confirmed by our final results. The VDI and BVASv3 did not appear to be related to the AAV-PRO_ita scores ( r < 0.3, i.e.…”

Patient-reported outcomes in ANCA-associated vasculitis: a cross-sectional study to explore the interactions between patients’ and physicians’ perspectives

“…This study examined the association between the domains of the AAV-PRO instrument, other outcome measures, and clinical variables in 70 patients with AAV from Mexico. Preliminary studies have validated the AAV-PRO instrument in other populations [ 21 ]. Table 4 summarizes the results of the present study and the validation studies of the AAV-PRO.…”

“…Twenty-four of the 26 male patients (92%) completed the IIEF-5 questionnaire. Overall, the median score was 20 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). According to the cutoff values, 17 (70.8%) of men had some degree of erectile dysfunction (in 12 of them it was mild to moderate and in 5 it was severe).…”

Unmet needs in ANCA-associated vasculitis: Physicians’ and patients’ perspectives

“…Hence, the AAV-PRO can guarantee for the patients that their perspective on the disease is represented in the study on AAV (100, 104). The effort to make AAV-PRO more useful and available in the clinical practice is ongoing: AAV-PRO has been translated in 14 languages and it has been validated in order to be incorporated into clinical trials (97, [105][106][107]. Recently, a preliminary Italian work that translated and evaluated the AAV-PRO questionnaire showed that: a) AAV-PRO scores related with VDI value more than disease duration or activity; b) higher scores belonged to women in all domains, especially in ones concerning social and emotional impact; c) therapy with GC has impact on the physical function domain (105).…”

“…The effort to make AAV-PRO more useful and available in the clinical practice is ongoing: AAV-PRO has been translated in 14 languages and it has been validated in order to be incorporated into clinical trials (97, [105][106][107]. Recently, a preliminary Italian work that translated and evaluated the AAV-PRO questionnaire showed that: a) AAV-PRO scores related with VDI value more than disease duration or activity; b) higher scores belonged to women in all domains, especially in ones concerning social and emotional impact; c) therapy with GC has impact on the physical function domain (105). These data are confirmed by a comparative Greek study (108) reporting that in AAV, QoL correlated more strongly with organ damage and less with disease activity, unlike in patients with rheumatoid arthritis, in whom QoL correlated with both disease activity and damage.…”