Dataset Information

Psychometric validation and responder definition of the sleep disturbance numerical rating scale in moderate-to-severe atopic dermatitis.

ABSTRACT:

Background

Sleep disturbance (SD) is an important part of the burden of atopic dermatitis (AD), but patient-reported outcomes that are easy to understand and interpret in the target population have been lacking. A daily, single-item, self-reported SD 11-point numerical rating scale (NRS) was recently developed to assess SD for patients with moderate-to-severe AD, but its psychometric properties have not yet been described.

Objectives

To assess the psychometric properties of the SD NRS in patients with moderate-to-severe AD.

Methods

The psychometric properties of the SD NRS were assessed using data from a phase IIb clinical trial in 218 adults with moderate-to-severe AD.

Results

Test-retest reliability of the SD NRS was substantial to almost perfect (interclass correlation 0·66-1·00) in participants who had stable SD or stable pruritus scores over 1 week. Baseline correlations were moderate to large (r > 0·30) between SD NRS and pruritus or sleep loss scores, but were small (r = -0·11 to 0·17) between SD NRS and EQ-5D-3L index and visual analogue scores, Hospital Anxiety and Depression Scale, Scoring Atopic Dermatitis, and Investigator's Global Assessment. The SD NRS could discriminate groups of participants in the expected direction according to different quality-of-life scores but not according to different clinician-reported disease severity scores. SD NRS scores significantly decreased as sleep loss, itch and quality-of-life scores improved. Analysis of meaningful change suggested a 2-5-point improvement as the initial range of responder definition in the SD NRS score.

Conclusions

The SD NRS is a reliable, valid and responsive measure of SD in adults with moderate-to-severe AD.

SUBMITTER: Puelles J

PROVIDER: S-EPMC9299666 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe intense itching associated with atopic dermatitis (AD) often causes patients to experience severe sleep disturbance. Here, we describe the results of a two-phase concept elicitation and cognitive interview study to establish the content validity of a sleep disturbance numerical rating scale (SD NRS) and a Consensus Sleep Diary adapted for adults and adolescents with moderate-to-severe AD (CSD-AD©).ResultsIn phase I, a concept elicitation conducted in 20 adults and 10 adolescents with moderate-to-severe AD revealed that the following sleep-related issues were important and relevant: nighttime awakening (87%), trouble falling asleep (73%), feeling unrested (53%), daytime fatigue or sleepiness (53%), and feeling as if they did not get enough sleep (33%). The frequency and extent of sleep disturbance varied substantially from day to day due to varying degrees of itching and flares, medication use, and changes in the weather. All participants understood the SD NRS question, with most finding it easy or very easy to understand (100% of adults and 90% of adolescents) and most understanding the anchors as intended (95% of adults, and 100% of adolescents). Most participants (94% of adults, and 90% of adolescents) indicated that they would consider a one- or two-point change meaningful on the SD NRS. The CSD-AD© was revised based on participant feedback, and tested during phase II in a convenience sample of six adults and four adolescents from phase I. The changes made to the CSD-AD© were confirmed to be relevant and understandable. All patients were able to provide an answer to each item in the CSD-AD©, and most were able to estimate the duration of nighttime awakenings, daytime naps, and dozing.ConclusionsThe study supported the content validity of the SD NRS and CSD-AD© in adults and adolescents with moderate-to-severe AD. It also emphasized the importance of using these instruments daily when assessing the benefit of a new treatment on sleep quality in this population.

Project description:IntroductionItch associated with atopic dermatitis (AD) has a profoundly negative effect on patients of all ages. Therefore, itch is a main target for AD therapeutic approaches, and treatments are perceived as beneficial when they achieve an itch reduction. In the absence of a validated scale for children aged 6-11 years that is suitable for assessing itch intensity in clinical trial settings, the Worst Itch Scale was developed.MethodsQualitative interviews, comprising concept elicitation and cognitive debriefing, were conducted to develop and evaluate the content validity of the Worst Itch Scale. Psychometric assessments used data from the LIBERTY AD PEDS phase 3 trial of dupilumab in patients aged 6-11 years with severe AD. These included test-retest reliability, construct validity, known-groups validity and responsiveness. Thresholds for clinically meaningful change were defined using anchor- and distribution-based methods.ResultsThe Worst Itch Scale consisted of two items asking about 'worst itching' experienced 'last night' and 'today'. Worst Itch Scale scores showed large, positive correlations with existing patient-reported outcome (PRO) measures of itch, and weaker correlations with clinician-reported outcome (ClinRO) measures assessing objective signs of AD. Improvements in Worst Itch Scale scores were highly correlated with improvements in other itch PROs and moderately correlated with improvements in ClinROs. The responder definition based on the primary anchor, a 1-point improvement in the Patient Global Impression of Disease, was 2.84. Supportive anchors produced response estimates ranging from 2.43 to 4.80 points.ConclusionsThe Worst Itch Scale is a fit-for-purpose (e.g. well-defined, reliable, responsive and valid) scale for evaluating worst itch intensity in children aged 6-11 years with severe AD. The within-patient threshold for defining a clinically meaningful response was a ≥ 3-4-point change in the Worst Itch Scale score.Trial registrationNCT03345914. Video: How can we reliably assess itch intensity in children 6-11 years with severe atopic dermatitis in clinical trial settings?

Project description:BackgroundAtopic dermatitis (AD) causes sleep disturbance but the epidemiology is not known.ObjectiveTo estimate the US prevalence of sleep disturbance and its impact on psychological and neurocognitive function.MethodsWe conducted a cross-sectional survey of 180 parent-child dyads with AD using stratified sampling based on disease severity (Patient Oriented Eczema Measure: mild [n = 30), moderate (n = 75) or severe (n = 75]), age, and race (White or Black or African American or other). Symptoms of sleep and psychologic health were assessed using the Patient-Reported Outcome Measurement Information System. To estimate the prevalence of sleep disturbance, we calculated weights using poststratification adjustment making marginal frequencies of AD severity, race, and age similar to marginal frequencies in the 2007 National Survey of Children's Health. Unweighted regression models examined associations with sleep disturbance.ResultsIn children age 5 to 17 years with AD, we estimated that sleep disturbance occurred in 66.9% (95% confidence interval, 53.3% to 80.5%; 3,116,305 children). The odds of severe sleep disturbance (worse than 95% of US children) were highest in moderate to severe versus mild AD (2.03 [1.00-4.10]; P = .0495; compared with 8.68 [1.82-41.49]; P = .0068). Predictors of parent proxy-reported sleep disturbance were itch intensity (adjusted β [95% confidence interval] 1.33 [0.62-2.04]) and low income (<$50,000: 6.64 [2.05-11.23]; and $50,000 to less than 100,000: 4.75 [0.35-9.14]). Controlling for disease severity, itch intensity, and significant sociodemographics-parent-proxy, reported sleep disturbance was associated with increased severity of sleep-related impairment, depression, fatigue, and anxiety, in addition to worse inattention and impulsivity. In fully adjusted models, children who self-reported sleep disturbance (T-score ≥60) had increased odds of sleep-related impairment (1.20 [1.11-1.29]), depression (1.13 [1.03, 1.24]), fatigue (1.28 [1.06-1.54]), and anxiety (1.16 [1.02-1.31]).ConclusionsSleep disturbance is a common symptom of AD. It affects about 3 million US children and is associated with neuropsychiatric impairment, including depression, anxiety, and inattention. Clinicians should screen for these symptoms in school-aged children, particularly those with moderate to severe AD.