Acta Dermato-Venereologica 99-10CompleteContent | Page 17

903 SHORT COMMUNICATION Four-week Urticaria Activity Score-7 as a Useful Patient-reported Outcome to Assess Chronic Spontaneous Urticaria: A Multicentre Study Evaluation of Adherence and Patients’ Perspective Cataldo PATRUNO 1 , Maddalena NAPOLITANO 2 , Silvia FERRUCCI 3 , Lucia BRAMBILLA 3 , Katharina HANSEL 4 , Monica CORAZZA 5 , Donatella SCHENA 6 , Caterina FOTI 7 , Paolo ROMITA 7 , Rosella GALLO 8 and Luca STINGENI 4 Section of Dermatology, Department of Health Sciences, University Magna Graecia of Catanzaro, IT-88100 Catanzaro, 2 Section of Dermatology, Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, 3 Dermatology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, 4 Section of Dermatology, Department of Medicine, University of Perugia, 5 Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, 6 Section of Dermatology and Venereology, Department of Medicine, University of Verona, 7 Department of Biomedical Science and Human Oncology, Dermatologic Clinic, University of Bari, and 8 Section of Dermatology, Department of Health Sciences, University of Genoa, Ospedale Policlinico San Martino, Genoa, Italy. E-mail: [email protected] 1 Accepted May 29, 2019; E-published May 29, 2019 Chronic spontaneous urticaria (CSU) is a condition characterized by the recurrence of itchy wheals without any specific trigger for longer than 6 weeks (1). In CSU the wheals fluctuate throughout the day. Therefore, measurement of the activity of the disease and of the ef- fectiveness of treatments is by means of patient-reported outcome (PRO) instruments, such as the Urticaria Ac- tivity Score (UAS) (2). The UAS is a quantitative daily diary that includes a once-a-day (3) or twice-a-day (4) self-evaluation score. It is used for both clinical practice and trials to assess disease activity and treatment efficacy (1). Due to the chronicity and remarkable instability of CSU, daily UAS scores are summed over one week to create the UAS7 (3). However, there is a lack of infor- mation on adherence to the instrument and the precision with which it is completed. The aim of this study was to evaluate adherence to the once-a-day UAS7 in real life, through an observational, descriptive, multicentre study on consecutive patients with CSU aged ≥18 years. MATERIALS AND METHODS All the patients were referred to 7 dermatology centres homoge- neously distributed throughout north, central, and south Italy from January 2018 to December 2018. Demographic features including sex and age were recorded. All patients started antihistamine treat­ ment for 4 weeks and were asked to record disease activity for 4 weeks using the once-a-day UAS7. The number of wheals and the intensity of pruritus were recorded and summed to create daily (0– 6) and weekly scores (0–42) (Table I). At the end of the 4 th week, patients rated the simplicity and the effort required to complete the UAS7. For this purpose, a complementary questionnaire was used regarding 5 specific items about the completion of the UAS7: difficulty, boredom, time spent, disturbance of daily activities, and whether they felt better cared for. A 1–10 scale (1–3: negative, 4–6: not sure, 7–10: positive) was used. Each patient completed the questionnaire anonymously and after the medical examination. Table I. Urticaria Activity Score (UAS) Score Number of wheals/24 h Pruritus 0 1 2 None < 20 20–50 3 > 50 or large confluent areas of wheals None Present but not annoying or troublesome Troublesome but does not interfere with daily activity or sleep Sufficiently troublesome to interfere with normal daily activity or sleep At the same time, a designated dermatologist completed a 3-item questionnaire (yes or no) for each patient, regarding: (i) possible incompleteness; (ii) interruption of compilation; and (iii) calcula- tion errors. The aim of this questionnaire was to evaluate whether the patient had correctly completed the UAS7 diary and to detect any possible errors. All parameters were analysed descriptively, using as-observed analysis. Mann–Whitney U test was used for between-group comparisons of continuous variables. Categorical variables were compared using Fisher’s exact test. A p-value < 0.01 was considered indicative of statistical significance. The study was approved by the ethics committee of each centre, and informed consent was obtained prior to the interview. RESULTS A total of 129 consecutive CSU patients (mean  ±  standard deviation (SD) age 44.8  ±  16.3 years), mostly female (87/129; 67.4%) fulfilled the enrolment criteria and completed the study. The results of the 5-item questionn- aire are reported in Table II. None of the results were statistically influenced by sex, age, geographical origin, baseline severity of disease, or response to treatment. Most patients reported that completing the UAS7 was not, or only minimally, difficult (score 1–3: 86.0%) or boring (score 1–3: 79.8%); the daily time spent to com- plete it was sufficiently brief (score 1–3: 87.6%), and daily activities were not disturbed or conditioned (score 1–3: 93.0%). In contrast, compilation of the UAS7 was reported as difficult (score 7–10: 4.7%) or boring (score 7–10: 7.8%) only in rare cases and the daily time spent was rarely long (score 7–10: 1.6%). Only one patient (0.8%) reported that completing the questionnaire Table II. Results of 5-item questionnaire administered in 129 patients with chronic spontaneous urticaria (CSU) to evaluate criticisms of Urticaria Activity Score 7 (UAS7) from the patient’s point of view using a 1–10 numeric scale a Question Was it hard? Was it boring? Did you take a long time? Did it disturb your daily activity? Did it make you feel better taken care of by the dermatologist? Not bad not good* n (%) Positive* n (%) 111 (86.0) 103 (79.8) 113 (87.6) 120 (93.0) 26 (20.2) 12 (9.3) 16 (12.4) 14 (10.8) 8 (6.2) 23 (23.4) 6 (4.7) 10 (7.8) 2 (1.6) 1 (0.8) 80 (56.4) a 1–3: negative; 4–6: not bad not good; 7–10: positive. *Statistical differences between the 3 scoring groups were significant (p  < 0.00001) for all items. This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica. Negative* n (%) doi: 10.2340/00015555-3231 Acta Derm Venereol 2019; 99: 903–904