SummaryBackgroundModerate‐to‐severe atopic dermatitis (AD) is a chronic disease characterized by intense, persistent and debilitating itch, resulting in sleep deprivation, signs of anxiety and depression, impaired quality of life and reduced productivity. The Peak Pruritus Numerical Rating Scale (NRS) was developed and validated as a single‐item, patient‐reported outcome (PRO) of itch severity.ObjectivesTo describe the content validity and psychometric assessment (test–retest reliability, construct validity, known‐groups validity, sensitivity to change) of the Peak Pruritus NRS, and to derive empirically a responder definition to identify adults with a meaningful change in itch.MethodsContent validity was assessed through in‐depth patient interviews. Psychometric assessments used data from phase IIb and phase III dupilumab clinical trials and included test–retest reliability, construct validity, known‐groups validity and sensitivity to change in patients with moderate‐to‐severe AD.ResultsInterview participants indicated that the Peak Pruritus NRS was a relevant, clear and comprehensive assessment of itch severity. Peak Pruritus NRS scores showed large, positive correlations with existing PRO measures of itch, and weak or moderate correlations with clinician‐reported measures assessing objective signs of AD. Peak Pruritus NRS score improvements were highly correlated with improvements in other itch PROs, and moderately correlated with improvements in clinician‐reported measures assessing objective signs of AD. The most appropriate threshold for defining a clinically relevant, within‐person response was ≥ 2–4‐point change in the Peak Pruritus NRS.ConclusionsThe Peak Pruritus NRS is a well‐defined, reliable, sensitive and valid scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD.
Thick GaN bars with ͓112 គ 0͔ orientation have been sliced from GaN boules grown on freestanding films by hydride vapor phase epitaxy ͑HVPE͒ in the ͓0001͔ direction. High-resolution x-ray diffraction and transmission electron microscopy have been used to study the structural quality and defect distribution in the material in comparison to heteroepitaxially grown thick HVPE-GaN films grown in the ͓112 គ 0͔ direction on ͑11 គ 02͒-plane sapphire. It is demonstrated that while the heteroepitaxial material possesses a high density of stacking faults and partial dislocations, leading to anisotropic structural characteristics, the ͑112 គ 0͒-plane bulk GaN, sliced from boules, exhibits low dislocation density and narrow rocking curves with isotropic in-plane character.
The Impact of Weight on Quality of Life‐Lite (IWQOL‐Lite) is widely used in evaluations of weight‐loss interventions, including pharmaceutical trials. Because this measure was developed using input from individuals undergoing intensive residential treatment, the IWQOL‐Lite may include concepts not relevant to clinical trial populations and may be missing concepts that are relevant to these populations. An alternative version, the IWQOL‐Lite Clinical Trials Version (IWQOL‐Lite‐CT), was developed and validated according to the US Food and Drug Administration's (FDA's) guidance on patient‐reported outcomes. Psychometric analyses were conducted to validate the IWQOL‐Lite‐CT using data from two randomized trials (NCT02453711 and NCT02906930) that included individuals with overweight/obesity, with and without type 2 diabetes. Additional measures included the SF‐36, global items, weight and body mass index. The IWQOL‐Lite‐CT is a 20‐item measure with two primary domains (Physical [seven items] and Psychosocial [13 items]). A five‐item Physical Function composite and Total score were also supported. Cronbach's alpha and intraclass correlation coefficients exceeded 0.77 at each time point; patterns of construct validity correlations were consistent with hypotheses; and scores demonstrated treatment benefit. The IWQOL‐Lite‐CT is appropriate for assessing weight‐related physical and psychosocial functioning in populations commonly targeted for obesity clinical trials. Qualification from the FDA is being sought for use of the IWQOL‐Lite‐CT in clinical trials to support product approval and labelling claims.
The temperature-dependent electrical characteristics of Schottky rectifiers fabricated with a SiO2 field plate on a freestanding n− gallium nitride (GaN) substrate were reported in the temperature range of 298–473K. The Schottky barrier heights evaluated from forward current-voltage measurement revealed an increase of Schottky barrier height and series resistance but a decrease of ideality factor (n) with increasing temperature. However, the Schottky barrier heights evaluated from capacitance-voltage measurement remained almost the same throughout the temperature range measured. The Richardson constant extrapolated from ln(J0∕T2) vs 1∕T plot was found to be 0.029Acm−2K−2. A modified Richardson plot with ln(J0∕T2) vs 1∕nT showed better linearity, and the corresponding effective Richardson constant was 35Acm−2K−2. The device showed a high reverse breakdown voltage of 560V at room temperature. The negative temperature coefficients were found for reverse breakdown voltage, which is indicative of a defect-assisted breakdown.
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