Acta Dermato-Venereologica 99-10CompleteContent | Page 17
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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