Participants and procedures
We conducted a descriptive, cross-sectional, case-control, observational
study. AD patients were recruited from the AD outpatient clinics at the
Dermatology Departments of San Salvatore Hospital (University of
L’Aquila, Italy) from July 2020 to December 2021. Inclusion criteria for
AD patients were as follows: (i) Adult patients affected by AD according
to Hanifin’s and Rajka’s diagnostic criteria; (ii) Patients who
voluntarily signed informed consent on the study objectives; (iii)
Patients able to complete the questionnaires through a digital medium.
Exclusion criteria consisted of (i) patients affected by other cutaneous
and systemic disorders, (ii) patients with a previous diagnosis of a
psychiatric disorder or psychological symptoms, and (iii) patients being
treated with systemic drugs that interfere with sleep, excluding agents
for the treatment of AD. The control group comprised healthy individuals
without skin diseases and a prior diagnosis of psychiatric and
psychological conditions, recruited both in outpatient Dermatology
Departments and among family members of AD patients. Control
participants were matched to each AD patient for age (± 1 year) and sex,
as these two demographic factors are associated with different sleep and
psychological characteristics27–30.
The AD group underwent a clinical evaluation in which AD characteristics
were collected by experienced dermatologists using the Eczema Area and
Severity Index31 (EASI), a reliable and sensitive tool
for assessing the physical signs of AD/eczema. The total EASI score
ranges from 0 to 72, with the highest score indicating more severe
atopic dermatitis symptoms.
Subsequently, AD participants were invited to complete an online survey
via Google Forms collecting information on age, sex, self-perceived
atopic eczema severity, sleep quality and insomnia severity symptoms
using the Patient-Oriented Eczema Measure32 (POEM),
the Pittsburgh Sleep Quality Index33 (PSQI) and the
Insomnia Severity Index34 (ISI), respectively.
The (POEM) is a validated, patient-oriented assessment measure for
monitoring the severity of atopic eczema. A higher score suggests more
severe AD symptoms (range 0–28). The PSQI is a 19-item questionnaire
widely used to evaluate sleep quality. A higher total score (range
0–21) indicates more severe sleep problems. The ISI is a 7-item
clinical tool to assess insomnia severity (range 0–28). A higher score
indicates more severe insomnia symptoms. We also assessed depressive
symptoms, anxiety, and perceived stress through a set of validated
questionnaires: the Beck Depression Inventory-second
edition35 (BDI-II), the Generalized Anxiety
Disorder-736 (GAD-7), and the 10-item Perceived Stress
Scale37 (PSS-10), respectively. The BDI-II is a
21-item questionnaire used in clinical practice to evaluate depressive
symptoms (range, 0–63). A higher score denotes greater severity of
depressive symptoms. The GAD-7 is a validated 7-item questionnaire for
screening symptoms of generalized anxiety and assessing its severity in
clinical practice and research. A higher total score (range 0–21)
reflects more severe anxiety. The PSS-10 is a 10-item questionnaire
evaluating thoughts and feelings related to stressful events. A higher
total score (range 0–40) indicates more significant perceived stress.
Likewise, the control group completed an online survey in which sleep
quality, insomnia, depression, anxiety, and perceived stress were
examined using the same validated questionnaires.
The study was approved by the Institutional Review Board of the
University of L’Aquila (protocol number 35/2020). Online informed
consent was obtained from all participants, who consented to the
publication of the questionnaire results for scientific purposes.