Validation of Patient‐Reported Outcomes Information System Sleep Disturbance and Sleep‐Related Impairment in adults with atopic dermatitis*

Lei, Donald; Yousaf, Muhammad; Janmohamed, Sherief R.; Vakharia, Paras P.; Chopra, Rishi; Sacotte, R.; Patel, Kevin R.; Singam, Vivek; Immaneni, Supriya; Kantor, Robert; Hsu, Derek Y.; Silverberg, Jonathan I.

doi:10.1111/bjd.18920

Cited by 24 publications

(24 citation statements)

References 39 publications

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“…Our questionnaire elicited details on sleep components in the preceding month. However, more detailed information in terms of a full sleep quality scale, such as the Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairment tool [ 35 ] or the full Pittsburgh Sleep Quality Index, could provide more insight and comparable scoring. In addition, we lack objective measures of sleep disturbance, such as polysomnography or consumer sleep technologies [ 36 ].…”

Section: Discussionmentioning

confidence: 99%

Colorectal Cancer Anatomical Site and Sleep Quality

Ton

Watson

Sillah

et al. 2021

Cancers

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Purpose: Sleep quality in relation to anatomic site among colorectal cancer (CRC) patients is not well understood, though discerning the relationship could contribute to improved survivorship care. Methods: We ascertained sleep quality (Pittsburgh Sleep Quality Index) and other personal characteristics within an ongoing population-based study of CRC patients identified through a cancer registry (N = 1453). Differences in sleep quality by CRC site were analyzed using chi-square and ANOVA tests. We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association of tumor site with sleep quality concerns, adjusting for patient attributes and time since diagnosis. Results: Sleeping problems were reported by 70% of CRC patients. Overall, participants with rectal (vs. colon) cancer were more likely (OR (95% CI)) to report general trouble sleeping (1.58 (1.19, 2.10)). Rectal cancer patients were also more likely than colon cancer patients to report changes in sleep patterns after cancer diagnosis (1.38 (1.05, 1.80)), and trouble sleeping specifically due to getting up to use the bathroom (1.53 (1.20, 1.96)) or pain (1.58 (1.15, 2.17)), but were less likely to report trouble sleeping specifically due to issues with breathing/coughing/snoring (0.51 (0.27, 0.99)). Conclusion: Overall, rectal cancer patients were more likely to have sleep complications compared to colon cancer patients. This suggests sleep-focused survivorship care may be adapted according to CRC site to ensure patients receive appropriate support.

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Section: Discussionmentioning

confidence: 99%

Colorectal Cancer Anatomical Site and Sleep Quality

Ton

Watson

Sillah

et al. 2021

Cancers

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“…The PROMIS Itch Short Form instruments measure how much itch interferes with HRQoL in the past 7 days across several item banks 27–29 . Patients also completed the PROMIS Sleep‐Related Impairment Short Form instrument, which measures self‐reported perceptions of impairment related to general aspects of sleep ‘in the past 7 days’ 30–32 . PROMIS instrument scores are T scores, where a higher score indicates greater impairment.…”

Section: Methodsmentioning

confidence: 99%

Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate‐to‐severe atopic dermatitis from the BREEZE‐AD7 Phase 3 randomized trial

Wollenberg

Nakahara

Maari

et al. 2021

Acad Dermatol Venereol

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Background Baricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD). Objectives To evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health‐related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient‐reported outcome (PRO) assessments in patients with moderate‐to‐severe AD previously experiencing inadequate response to TCS. Methods Adult patients with AD in BREEZE‐AD7, a Phase 3, multicentre, double‐blind trial, were randomised 1 : 1 : 1 to daily oral placebo (control) or baricitinib 4‐ or 2‐mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment‐AD (WPAI‐AD); Patient‐Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance. Results A total of 329 patients were randomised. Treatment with baricitinib 4‐mg (N = 111) or 2 mg (N = 109) plus TCS led to rapid, statistically significant improvements [vs. TCS plus placebo (N = 109)] in DLQI ≥4‐point improvement starting at Week 2 (4‐mg plus TCS, P ≤ 0.001; 2‐mg plus TCS P ≤ 0.05), change from baseline in WPAI‐AD presenteeism at Week 1 (4‐mg plus TCS, P ≤ 0.01; 2‐mg plus TCS P ≤ 0.05) and PROMIS itch interference at Week 2 (4‐mg plus TCS P ≤ 0.01). Improvements were sustained through Week 16 for baricitinib 4‐mg. Statistically significant improvements were observed at Week 16 for PBI global score (4‐mg plus TCS, P ≤ 0.001; 2‐mg plus TCS P ≤ 0.05). Conclusions Baricitinib plus TCS vs. placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks.

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“…Self‐administered questionnaires were completed by patients of the eczema clinic at an academic medical centre prior to their encounter. Questionnaires included patient‐reported severity of AD (‘Would you describe your AD or eczema as clear, almost clear, mild, moderate, or severe?’), 16 Numerical Rating Scale (NRS) for worst itch and average itch in the past 7 days (one question each, range: 0–10), Patient‐Oriented Eczema Measure (POEM) (seven questions, range: 0–28), 17–20 Dermatology Life Quality Index (DLQI; 10 questions, range: 0–30, for age ≥ 17 years), 21,22 ItchyQOL (22 questions, mean score range: 0.0–5.0), 22,23 PROMIS Sleep Disturbance (SD) and sleep‐related impairment (SRI) 8‐item SF 16,24–27 …”

Section: Methodsmentioning

confidence: 99%

Measurement properties of the product of investigator’s global assessment and body surface area in children and adults with atopic dermatitis

Silverberg

Lei

Yousaf

et al. 2020

Acad Dermatol Venereol

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BackgroundMultiple clinician‐reported outcome measures exist for atopic dermatitis (AD) severity. However, there is no gold standard for use in clinical practice.ObjectivesTo determine the measurement properties of the product of validated Investigator's Global Assessment for AD (vIGA) and body surface area (BSA) overall or divided into six categories (cBSA: 0%/0.1, <10%/10, <30%/30, <50%/50, <70%/70 and <90%/90–100%) and compare with other clinician‐reported and patient‐reported outcomes in adults and children with AD.MethodsWe performed a prospective dermatology practice‐based study using questionnaires and evaluation by a dermatologist (n = 653).ResultsvIGA*BSA and vIGA*cBSA had good convergent validity with BSA (Spearman's ρ = 0.97 and 0.93), eczema area and severity index (ρ = 0.94 and 0.92), and objective SCORAD (ρ = 0.88 and 0.89); and weak‐to‐good convergent validity with Numeric Rating Scale average itch (ρ = 0.22 and 0.22) and worst itch (ρ = 0.27 and 0.28), Patient‐Oriented Eczema Measure (ρ = 0.44 and 0.43), Dermatology Life Quality Index (ρ = 0.48 and 0.49), ItchyQOL (ρ = 0.45 and 0.46), PROMIS Sleep Disturbance (ρ = 0.46 and 0.37) and sleep‐related impairment (ρ = 0.31 and 0.31) in adults and/or children; very good discriminant validity for physician‐reported global AD severity; good responsiveness to change of severity of AD and itch; and good reliability (intraclass correlation coefficient [95% confidence interval]: 0.72 [0.60–0.81] and 0.74 [0.62–0.82]) with no floor or ceiling effects. Thresholds for interpretability bands and clinically important difference were established.ConclusionsvIGA*BSA and vIGA*cBSA scores showed good convergent and discriminant validity, reliability, responsiveness and interpretability in adults and children with AD, and were feasible for use in clinical practice. vIGA*BSA and vIGA*cBSA had slightly lower convergent validity than EASI or objective SCORAD, but might be more efficient to collect and score.

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Validation of Patient‐Reported Outcomes Information System Sleep Disturbance and Sleep‐Related Impairment in adults with atopic dermatitis*

Cited by 24 publications

References 39 publications

Colorectal Cancer Anatomical Site and Sleep Quality

Colorectal Cancer Anatomical Site and Sleep Quality

Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate‐to‐severe atopic dermatitis from the BREEZE‐AD7 Phase 3 randomized trial

Measurement properties of the product of investigator’s global assessment and body surface area in children and adults with atopic dermatitis

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