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A Valero,1 M Herdman,2,3
J Bartra,1 M Ferrer,4 I Jáuregui,5
I Dávila,6 A del Cuvillo,7 J
Montoro,8 J Mullol,9 J Sastre,10
GW Canonica,11 I Baiardini11 |
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1 Allergy Unit, Pneumology and
Respiratory Allergy, Hospital Clínic, Barcelona, Spain
2 CIBER in Epidemiology and Public Health (CIBERESP),
Spain
3 Health Services Research Unit, IMIM-Hospital del Mar,
Barcelona, Spain
4 Allergy Department, Clínica Universitaria de Navarra,
Pamplona, Spain
5 Allergology Department, Hospital de Basurto, Bilbao,
Spain
6 Immunoallergology Service, Hospital Clínico,
Salamanca, Spain
7 Clínica Dr Lobatón, Cádiz, Spain
8 Allergy Unit, Hospital La Plana, Villarreal, Spain
9 Rhinology Unit, Ear, Nose and Throat Department (ICEMEQ),
Hospital Clínic, Barcelona, Spain
10 Allergy Department, Fundación Jiménez Díaz, Madrid,
Spain
11 Allergy and Respiratory Diseases, Department of
Internal Medicine, University of Genoa, Genoa, Italy |
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Abstract |
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Objectives:
The aim of this
study was to develop
a Spanish version of
the Chronic
Urticaria Quality of
Life Questionnaire
(CU-Q2oL) and to
test its
acceptability,
reliability,
validity, and
sensitivity to
change.
Methods:
Forward and back
translation by
bilingual
translators followed
by pilot testing in
patients with
urticaria was used
to adapt the
questionnaire. The
Spanish version of
the CU-Q2oL was
self-administered
alongside the
Skindex-29 in an
observational,
longitudinal,
multicenter study.
Feasibility was
assessed by
analyzing missing
responses and
ceiling and floor
effects. Reliability
was tested by
examining
internal consistency
(Cronbach α).
Construct validity
was analyzed by
examining convergent
and discriminant
validity with the
Skindex-29 and by
evaluating the
ability of the
CU-Q2oL to
discriminate between
patients according
to a clinical
classifi cation of
severity.
Sensitivity to
change was analyzed
in a subgroup of
patients who
completed a second
visit 4 weeks after
baseline.
Results: A
total of 695
patients were
included in the
analysis. Mean (SD)
age was 42.4 (15.0)
years and 62.1% of
the sample was
female. All of the
items on the CU-Q2oL
were answered by
91.9% of the sample.
Over 15% of patients
scored at the floor
(best possible
health) on 5 of the
6 dimensions.
Cronbach α
coefficients were >
0.80 for all
dimensions of the
CU-Q2oL, and 0.86
for the overall
score.
Construct validity
was supported by
correlations between
the CU-Q2oL and the
Skindex-29, which
generally fulfilled
hypotheses, and by
the questionnaires
ability to
discriminate between
groups with
different severities
of urticaria. The
questionnaire was
sensitive to change,
with an effect size
of 1.0 for the
overall score in
patients reporting
an improvement on
the health
transition scale.
Conclusions:
The Spanish version
of the CU-Q2oL has
shown satisfactory
reliability,
validity, and
sensitivity to
change. It is
suitable for use as
an outcome measure
for chronic
urticaria patients
in clinical and
research settings.
Key words:
Chronic urticaria.
Quality of life.
Questionnaire.
Adaptation.
Validation. Spanish.
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