Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis.

ABSTRACT:

Introduction

A subject sleep diary (SSD) capturing 14 sleep parameters was developed to assess daily fluctuations in atopic dermatitis (AD)-associated sleep disturbance. This study aimed to evaluate the psychometric properties of the SSD using data including all randomized patients from the phase 3 ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials of nemolizumab in adults and adolescents (age ≥ 12 years) with moderate-to-severe AD.

Methods

Reliability, validity, and responsiveness of the SSD were evaluated, and its relationship with the single-item Sleep Disturbance Numerical Rating Scale (SD NRS) was examined using the equipercentile linking method.

Results

In ARCADIA 1 (N = 941), most SSD parameters showed good test-retest reliability (intraclass correlatio

SUBMITTER: Silverberg JI 

PROVIDER: S-EPMC11971097 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature