| Resum: |
Background: The daily diary Urticaria Activity Score (UAS) and its weekly score (UAS7) are widely used to assess signs and symptoms in patients with chronic spontaneous urticaria (CSU). The objective of this study was to assess the psychometric properties of a Spanish version of the once-daily UAS. Methods: Observational study in patients ≥18 years old receiving usual care for CSU (daily or almost daily occurrence of generalized hives or angioedema for ≥6 weeks). Patients were included consecutively and completed the UAS, EQ-5D, and the Chronic Urticaria Quality of Life scale (CU-QoL) at two study visits 6 weeks apart. On each occasion, the UAS was completed once-daily for 7 consecutive days to be able to calculate the UAS7 score. Psychometric properties of reliability, construct validity, and responsiveness were assessed. The Minimal Important Difference (MID) was estimated for the UAS7 using anchor- and distribution-based approaches. Results: Data from 166 patients was available for analysis (mean age 49 years, 65. 7% female). Floor (5. 4% of patients with the lowest possible score) and ceiling (1. 2%) effects were low; 15% of patients had missing values. Internal consistency and test-retest reliability were good (Cronbach's alpha of 0. 83 and an ICC of 0. 84, respectively). Convergent validity was demonstrated through the pattern of correlations with the EQ-5D and CU-QoL and known groups' validity was demonstrated by the instrument's ability to discriminate between patients with different overall levels of urticaria severity, with between-group effect-sizes (ES) ranging from 0. 36 to 1. 19. The UAS7 proved responsive to change with effect sizes ranging from 0. 3 to 1. 52 in patients reporting improvement or deterioration in overall urticaria status. The MID for the UAS7 score was estimated at 7-8 points, on a scale of 0-42. Conclusions: The Spanish version of the UAS score has demonstrated a robust psychometric performance in patients with CSU managed in conditions of usual care. It can therefore be considered a suitable instrument to assess disease activity in clinical practice in Spanish-speaking patients. The Spanish version's reliability and validity are similar to those reported for other language versions of the once- and twice-daily variants of the UAS. |
| Nota: |
Dr. Jauregui has acted as a paid consultant or medical writer for Novartis, FAES Farma, and Pfizer Spain, and has received speaker honorarium from MSD Spain and FAES Farma. Dr. Gimenez-Arnau is on the scientific advisory board of Uriach Pharma, Genentech, and Novartis, has received research grants from Uriach Pharma and Novartis, and is a speaker for Uriach Pharma, Novartis, Genentech, Menarini, GSK, and MSD. Michael Herdman received payment from Novartis, Spain for his work on this study. Dr. Bartra has served as consultant to Novartis, Faes Farma, and Hal Allergy, and has received lecture fees from Novartis, Stallergenes, UCB, Thermofisher, Menarini, and Chiesi. Dr. Labrador-Hornillo has acted as a paid consultant for Novartis and Shire, has received speaking honorarium from Novartis and Shire and received grant support from Thermofisher. Dr. Ortiz de Frutos has acted as a paid consultant for Novartis and has received research grants from Astellas and Leo Pharmaceuticals. Dr. Silvestre has acted as a paid consultant for Novartis. Dr. Sastre has served as consultant to Thermofisher, MSD, Sanofi, Novartis, Faes Farma, Genentech, Roche and GSK, has been paid lecture fees by Novartis, GSK, Stallergenes, UCB, Thermofisher, and has received grant support from Thermo-fisher, GSK and ALK-Abello. Dr. Velasco has acted as a paid consultant for Novartis. Dr. Ferrer is on the scientific advisory board and is a speaker for Novartis and FAES Farma, has served on the scientific advisory board for Genentech, has received research grants from Novartis, and has received speaker honorarium from MSD, Novartis, FAES and GSK. Dr. Valero has served as a consultant to Faes Farma, Chiesi, Orion Pharma, MSD, Novartis, UCB, Uriach Pharma, GSK, Stallergenes, has received lecture fees from Novartis, GSK, Stallergenes, Chiesi, Leti, and Thermofisher, and has received grant support from Novartis, Faes Farma, and Uriach Pharma. |
visitant ::
identificació
(Institut Hospital del Mar d'Investigacions Mèdiques)
