AB1359 Translation, cultural adaptation and validation of the italian version of the bild: the bildit. (12th June 2018) - Santoni, A.
Abstract : Background: Evaluation of organ damage is one of the most important assessments in SLE patients; the SLICC/DI is a physician –driven instrument widely used to assess organ damage in SLE. Patient-reported outcomes (PROs), self-assessments that are not being interpreted by a clinician, are gaining a central role as outcome measures. Among these, the Brief Index of Lupus Damage (BILD) is a patient-reported instrument for the assessment of organ damage in SLE. 1 Objectives: The aims of the present study are translation, cultural adaptation and validation of an Italian version of the BILD. Methods: The process of translation and cultural adaptation followed published guidelines. 2 The final version of the questionnaire (BILDit) was pretested in a group of 30 SLE patients to evaluate acceptability, comprehension and feasibility. The validity of the BILDit was evaluated by its administering to consecutive patients attending the outpatients clinic or the inpatients wards. The external validity was tested toward the SLICC/DI scored by a physician blinded to the BILDit results. Correlation with other PROMs (FACIT, SF-36) was also tested. In a subgroup of 30 patients the questionnaire was administered twice at 2 weeks interval to assess their reliability. Results: A total of 166 SLE patients participated to the study (93.4% female, 97% Caucasian); mean age (±standard deviation) at enrollment was 45.4 years±13, mean disease duration resulted 14.3±10 years. Overall, disease activity at enrollment as expressed by the SLEDAI score resulted quite low (median SLEDAI 2, IQR 0–4) and 27.3% of patients presented an active disease (SLEDAI >4). At least one organ damage according with the SLICC/DI was present in 111 patients (56.35%) with a median score of 2 (IQR1–4). In the pilot test, 80% of patients answered to all the questions; 93% of the patient declared no difficulty in completing the questionnaire and the median time required resulted 5 min. 3–5 BILDit showed very high reliability (test-retest α >0.8). The BILDit scores in our sample showed a strong positive correlation with SLICC/DI (rho=0.69; p<0.001); by comparing the single BILDit and SLICC/Di items, we found a significant concordance for all but retinopathy and cerebrovascular disease that resulted underestimate by patients. BILDit scores showed a positive linear relation with age (p<0.01)and disease duration (p<0.01); in a multivariate analysis, a significant inverse correlation was found between BILDit scores and FACIT scores (p<0.01) and with both physical and mental components of the SF-36 (p<0.01). Conclusions: BILDit demonstrated to be acceptable, comprehensible, feasible and reliable in our routine clinical setting; it also showed good correlation with physician's driven instruments and quality of life measures. The BILDit can be considered a useful screening tool for the assessment of organ damage as perceived from the patient's point of view before the standard visit. References: [1] Yazdany, J. et al. The Brief Index of Lupus Damage (BILD): A patient-reported measure of damage in SLE. Arthritis Care Res. 2011; 63, 1170–1177. [2] Guillemin F. et al. Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines. Journal of Clinical Epidemiology1993; 46: 1417–1432 Disclosure of Interest: None declared