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Background: Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments. Methods: Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12–17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale's psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods. Results: Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data. Conclusions: The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients. Key summary points: • The Sleep-Loss Scale is a novel rating scale for assessing the impact of itch on sleep in atopic dermatitis (AD). • A mixed-methods approach was used to explore the content validity and psychometric properties of the Sleep-Loss Scale. • Qualitative results supported sleep loss as a common experience in AD and indicated that the Sleep-Loss Scale was relevant, appropriate, and interpreted as intended. • Quantitative results demonstrated the Sleep-Loss Scale is valid, reliable, and able to detect change. • The Sleep-Loss Scale was found to be fit-for-purpose for use in clinical trials of AD treatments among moderate-to-severe patients. [ABSTRACT FROM AUTHOR]

Introduction: Atopic dermatitis is associated with intense itch, which has been shown to cause sleep disruption that significantly impacts the lives of patients with atopic dermatitis. Despite this, little is known about its burden to the healthcare system and society. This study aimed to quantify the economic burden of itch-related sleep loss in moderate-to-severe atopic dermatitis in the UK. Methods: A literature-based decision-analytic model was developed from a healthcare payer and societal perspective. The model quantifies the economic burden by linking the severity of itch to the number of days of sleep disruption. The model captures the direct costs of healthcare resource utilization and treatment alongside the indirect costs of productivity loss from absenteeism and presenteeism at work over a 5-year time horizon. The patient population considered was patients aged ≥ 15 years with moderate-to-severe atopic dermatitis and itch-related sleep disruption. Results: The model estimated that itch-related sleep disruption as a result of moderate-to-severe atopic dermatitis would affect an average of 821,142 people over the time horizon (2022 to 2026). This translates into an average net economic burden of £3.8 billion (£4687 per patient), with an average of 172 million days being affected by sleep disruption per year in the UK. The greatest contributor to the annual average net economic burden was productivity loss from absenteeism and presenteeism, each accounting for 34%. The direct costs (treatment costs and healthcare resource use) accounted for 32% of the net economic burden. The results showed a high and gradually increasing economic burden over the 5-year time horizon. Conclusions: Sleep disruption has a high economic burden and reducing itch may provide substantial direct and indirect savings. Quantifying the economic burden of itch-related sleep loss may provide support for analyses to inform public health policies for treatment of atopic dermatitis, particularly within the moderate-to-severe level. [ABSTRACT FROM AUTHOR]

Background: Pruritus, or itch, is a key symptom of atopic dermatitis (AD); as such, mitigating itch is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Pruritus Numeric Rating Scale (Pruritus NRS), a novel single-item scale for assessing itch severity in clinical trials of AD treatments. Methods: In this mixed-methods study, qualitative interviews were conducted with 21 people with moderate-to-severe AD (n = 15 adult, n = 6 adolescent) to develop a conceptual model of the patient experience in AD and explore the content validity of the Pruritus NRS. Data collected daily from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess the Pruritus NRS' psychometric performance, including reliability, construct validity, and responsiveness. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods. Results: Qualitative findings highlighted the importance of itch in AD, including severity, persistence, frequency, and daily life interference. Patient debriefing of the Pruritus NRS indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported overall good psychometric properties. MWPC was defined as a 3-point improvement in Pruritus NRS score, a finding supported by qualitative data. Conclusions: The Pruritus NRS provides a valid and reliable patient-reported measure of itching severity in patients with moderate-to-severe AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in this population. Trial Registration: ClinicalTrials.gov identifier, NCT03443024. [ABSTRACT FROM AUTHOR]

Introduction: Real-world disease management of atopic dermatitis (AD) is hampered by a lack of consistency between providers that treat AD regarding assessment of severity, disease activity, and quality of life. Variability and inconsistency in documentation makes it difficult to understand the impact of AD. This study summarizes AD-related symptoms and concerns captured in unstructured qualitative provider notes by healthcare providers during visits with patients with AD. Methods: Provider notes were obtained for patients with AD (n = 133,025) from a USA-based ambulatory electronic health records system. The sample included both children (n = 69,551) and adults at least 18 years of age (n = 63,474) receiving treatment from a variety of specialties including primary care, dermatology, and allergy/immunology. Key skin-related words were identified from a review of a sample of notes and natural language processing (NLP) was applied to determine the frequency of the keywords and bigram patterns. Results: Provider notes largely focused on symptoms (primarily itch) and symptom relief rather than the impact of AD on work or lifestyle. Despite the known relationship between itch and skin pain, neuralgia was not widely documented. Compared to primary care providers, dermatologists' and allergist/immunologists' notes had more documentation of symptom-related issues. Personal and work/life burden issues were not widely documented regardless of specialty. Conclusion: The topics documented in case notes by healthcare providers about their patients with AD focus largely on symptoms and, to a lesser extent, treatment, but do not reflect the burden of AD on patients' lives. This finding highlights a potential care gap that warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Pyoderma gangrenosum (PG) is an uncommon but severe extra-intestinal manifestation (EIM) of inflammatory bowel disease (IBD). The incidence and risk factors for PG are disputed. Aims: To assess the incidence of PG and identify factors associated with PG in IBD patients. Methods: A search of electronic databases (Ovid and PubMed) was conducted between 1966 and 2019. Studies that calculated the incidence of PG in IBD patient cohorts were included. Patient demographics, IBD subtype, and EIM presence were recorded. A review of our institutional database of 1057 IBD patients was conducted. A multivariate regression model and meta-analysis were conducted to identify risk factors for PG. A random effects model was used to combine the data of included studies. Results: Fourteen studies were included in addition to 1057 IBD patients and 26 PG cases from the Louisville cohort. In total, there were 379 cases of PG in the cumulative cohort of 61,695 IBD patients. The PG incidence in individual studies ranged from 0.4 to 2.6%. In the institutional cohort, ocular EIMs and a permanent stoma were significant risk factors for PG. In the meta-analysis, PG was associated with female gender (RR = 1.328, 95% CI 1.161–1.520), Crohn's disease (RR = 1.193, 95% CI 1.001–1.422), erythema nodosum (RR = 9.281, 95% CI 6.081–14.164), and ocular EIM (RR = 4.55, 95% CI 3.04–6.81). There was study heterogeneity when assessing IBD subtype, ocular, and joint EIMs. Conclusions: There are conflicting data on the incidence and risk factors for PG. This meta-analysis confirms an association between PG and female gender, Crohn's disease, erythema nodosum, and ocular EIM that have been described in smaller studies. [ABSTRACT FROM AUTHOR]