Improved patient- and caregiver-reported outcomes distinguish tacrolimus 0.03% from crisaborole in children with atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is a chronic skin disease that affects 20% of children worldwide and is associated with low patient-reported quality of life (QoL). Crisaborole (CRIS) and tacrolimus 0.03% (TAC) are Food and Drug Administration (FDA)-approved topical treatments for mild to moderate AD with similar clinical efficacy. Utilization of patient-reported outcomes (PROs) may provide meaningful data on the impact of AD treatments on patients and caregivers. This study used PROs to monitor the impact of crisaborole (CRIS) and tacrolimus 0.03% (TAC) on children with mild/moderate atopic dermatitis (AD) and caregiver burden. METHODS: This open-label study randomized 47 child-caregiver dyads to CRIS or TAC for 12 weeks. Disease severity, child quality of life (QoL), itch, pain interference, anxiety, depression, sleep, caregiver burden and caregiver QoL were assessed at baseline, 6 and 12 weeks. RESULTS: A total of 36 dyads completed the study. Children (mean age = 8.0 ± 3.9 years) had mild baseline AD and were diverse by race (39% white; 36% Black) and gender (53% males). Caregivers were mostly female (78%; mean age = 37 ± 7.6 years). Both arms improved disease severity (Eczema Area and Severity Index) from baseline to 12 weeks (CRIS = -2.4 vs. TAC = -1.9). Within-arm analyses comparing baseline to 12 weeks revealed TAC, but not CRIS, improved all child and caregiver PROs except sleep (all p < 0.05). CONCLUSIONS: Our results demonstrated that topical treatment for 12 weeks was more beneficial than 6 weeks, with TAC improving more PROs than CRIS. Future trials should implement PROs to fully understand the impact of AD treatments.

Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. METHODS: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive five weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the Inventory to Measure and Assess imaGe disturbancE-Head and Neck (IMAGE-HN). Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. RESULTS: Among 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month resulted in decreases in IMAGE-HN scores from baseline to 3 months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3 months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). CONCLUSIONS: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03831100 .

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. Methods: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive 5 weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the IMAGE-HN. Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. Results: Among 44 HNC survivors with BID, mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month decreased IMAGE-HN scores from baseline to 3-months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3-months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). Conclusions: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. Trial Registration: This trial was registered on ClinicalTrials.gov identifier NCT03831100 on February 5, 2019.

Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT ( B uilding a R enewed I ma G e after H ead & neck cancer T reatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Methods: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1- and 3-months post-intervention. Results: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). Conclusions: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. Implications for Cancer Survivors: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Trial Registration: ClinicalTrials.gov identifier: NCT03831100.

Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. METHODS: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose and delivery-matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1 and 3-month post-intervention. RESULTS: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). CONCLUSIONS: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03831100 . IMPLICATIONS FOR CANCER SURVIVORS: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID.

Excitation of "forbidden" guided-wave plasmon polariton modes via direct reflectance using a low refractive index polymer coupling layer.

A surface plasmon polariton (SPP) is an excitation resulting from the coupling of light to a surface charge oscillation at a metal-dielectric interface. The excitation and detection of SPPs is foundational to the operating mechanism of a number of important technologies, most of which require SPP excitation via direct reflectance, commonly achieved via Attenuated Total Reflection (ATR) using the Kretschmann configuration. As a result, the accessible modes are fundamentally high-loss "leaky modes," presenting a critical performance barrier. Recently, our group provided the first demonstration of "forbidden," or guided-wave plasmon polariton modes (GW-PPMs), collective modes of a MIM structure with oscillatory electric field amplitude in the central insulator layer with up to an order of magnitude larger propagation lengths than those of traditional SPPs. However, in that work, GW-PPMs were accessed by indirect reflectance using Otto configuration ATR, making them of limited applied relevance. In this paper, we demonstrate a technique for direct reflectance excitation and detection of GW-PPMs. Specifically, we replace the air gap used in traditional Otto ATR with a low refractive index polymer coupling layer, mirroring a technique previously demonstrated to access Long-Range Surface Plasmon Polariton modes. We fit experimental ATR data using a robust theoretical model to confirm the character of the modes, as well as to explore the potential of this approach to enable advantageous propagation lengths. The ability to excite GW-PPMs using a device configuration that does not require an air gap could potentially enable transformative performance enhancements in a number of critical technologies.

Stochastic analysis and modeling of pharmaceutical screw feeder mass flow rates.

Screw feeders, as the initial operation in continuous manufacturing of drug product processes, greatly influence the mass flow rate of pharmaceutical powders downstream. Existing flowsheet models can quickly simulate the average powder mass flow rate while custom Discrete Element Method models require prohibitively long times to simulate a minute of realistic, high-variance particle flow. We propose a hybrid deterministic-stochastic feeder flowsheet model that leverages time series analysis and an Autoregressive Moving Average (ARMA) model to quantify and simulate the observed non-random variation in feeder powder flow. To allow for improved process and controller design, our approach is quick-to-solve, high-variance, and has a low experimental overhead. By examining the deterministic model errors of three different volumetrically fed excipients, we demonstrate that the errors are leptokurtic, heavy-tailed, and display a linear dependence on their prior two seconds of state. These errors are all reasonably modeled by an ARMA(2,1) model and are parametrically distinct from each other. Furthermore, we show that refilling the feeder online significantly alters the error distribution, autocorrelation structure, and ARMA parameters. These findings lay the groundwork necessary to model and predict the realistic feeder dynamics of a much broader range of powders and operating conditions.

The value of the modern vascular surgeon to the health care system: A report from the Society for Vascular Surgery Valuation Work Group.

Vascular surgeons provide an important service to the health care system. They are capable of treating a wide range of disease processes that affect both the venous and arterial systems. Their presence broadens the complexity and diversity of services that a health care system can offer both in the outpatient setting and in the inpatient setting. Because of their ability to control hemorrhage, they are critical to a safe operating room environment. The vascular surgery service line has a positive impact on hospital margin through both the direct vascular profit and loss and the indirect result of assisting other surgical and medical services in providing care. The financial benefits of a vascular service line will hold true for a wide range of alternative payment models, such as bundled payments or capitation. To fully leverage a modern vascular surgeon's skill set, significant investment is required from the health care system that is, however, associated with substantial return on the investment.

Institutional Collective Action During COVID-19: Lessons in Local Economic Development.

At this point, little is known about local government responses to the economic crisis caused by COVID-19. This crisis is happening on Main Streets around the nation. This article examines how some local governments are taking collective action in partnership with other governments as well as with organizations at the local and regional levels. What is unique is that collective action is rare as it relates to traditional economic development practices, yet it is occurring and leading to offerings of multi-institutional grants and low-interest loans. However, some newer supply- and demand-side actions are the result of a lack of resources and need for expediency. Practitioners can learn about the collaborative economic development actions that governments are taking and how these partnerships can stabilize their local economies.

Influence of Megasphaera elsdenii and feeding strategies on feedlot performance, compositional growth, and carcass parameters of early weaned, beef calves.

Simmental-Angus calves [n = 135; 72 steers and 63 heifers; body weight (BW) = 212.4 kg ± 36.1] were early weaned (~5 mo) to evaluate multiple feeding regimens (conventional vs. aggressive energy diets ± Megasphaera elsdenii NCIMB 41125 (M. elsdenii culture (MEC); Lactipro Advance; MS Biotec Inc., Wamego, KS) in order to elucidate the optimal development strategy. Objectives were measured by tracking the effects of caloric density and oral drenching of growing phase performance and subsequent carcass traits. The 72-d experiment featured three groups: 1) control (CON), fed exclusively a 35% roughage diet; 2) aggressive (AGR), fed a blend of a 10% and 35% roughage diets; 3) MEC, fed the same diet as AGR and drenched with 50 mL of M. elsdenii NCIMB 41125 on day 1. A subset of calves (n = 45) was equipped with wireless rumination tags (Allflex Flex Tag; SCR Engineers, Ltd; Netanya, Israel), which logged daily rumination and general activity. Skeletal growth variables were assessed by measuring wither and hip height pretrial and posttrial. Ultrasonography provided additional resolution concerning growing phase compositional gain, which was later verified by carcass data collection. Data were analyzed as a nested analysis of variance with BW and gender serving as blocking factors. The increased caloric density of the diets administered to MEC and AGR calves resulted in greater average daily gain and gain:feed values compared with CON even during the first 21 d of diet acclimation (P ≤ 0.05). Additional fiber concentration of CON diets led to increased rumination times in 9 of the 10 wk of trial (P ≤ 0.10). No differences amongst treatments were detected for skeletal variables or ultrasound 12th rib fat. Cattle fed CON diets posted 3.4% inferior BW at the end of the growing period trial and a 3.8% reduction in hot carcass weight (HCW), reinforcing the theory that intensifying caloric intake during the growing phase does not compromise future feedlot performance. Ultrasound marbling scores for MEC-treated cattle were 19° greater than AGR treated cattle (P ≤ 0.05) at the end of the growing phase trial. Nearly the exact same advantage (22°) was observed in the cooler 5 mo later (P = 0.42). Implying MEC metabolically imprinted cattle to favor marbling development. It appears that maximizing dietary caloric density in light-weight calves does not adversely affect the growth curve, while oral dosing of MEC during the growing period may be a precursor for enhanced quality grade.

Impact of Body Mass Index on Outcomes of Autogenous Fistulas for Hemodialysis Access.

BACKGROUND: The prevalence of obesity is increasing in the United States. The treatment of end-stage renal disease (ESRD) via hemodialysis spans the spectrum of body mass index (BMI). This study examines the impact of BMI on outcomes of autogenous fistulas for hemodialysis access in a large population-based cohort of patients. METHODS: A retrospective study of all patients in the prospectively maintained United States Renal Database System who initiated hemodialysis between 2007 and 2014 was performed. Chi-squared test, t-tests, Kaplan-Meier estimates, log-rank tests, multivariable logistic and Cox regression analysis were employed to evaluate access maturation, interventions, patency, and mortality. RESULTS: There were 300,778 patients studied. Of these, 9,394 (3.1%) were underweight, 87,351 (29.1%) were normal weight, 86,101 (28.6%) were overweight, 57,047 (19%) were obese class I, 31,077 (10.3%) were obese class II, and 29,808 (9.9%) were obese class III. There was no significant difference in maturation for patients who were underweight (adjusted hazard ratio [aHR] 0.97, 95% CI 0.89-1.06, P = 0.48), overweight (aHR 1.01, 95% CI 0.97-1.05, P = 0.66), obese class I (aHR 1.05, 95% CI 0.99-1.09, P = 0.22), or obese class II (aHR 1.01, 95% CI 0.94-1.05, P = 0.98 relative to normal weight. However, there was a 6% decrease in maturation for obese class III patients (aHR 0.94, 95% CI 0.89-0.99, P = 0.02) compared to normal weight patients. Primary (aHR 0.93, 95% CI 0.91-0.96, P < 0.001), primary assisted (aHR 0.90, 95% CI 0.88-0.93, P < 0.001), and secondary patency (aHR 0.89, 95% CI 0.86-0.92, P < 0.001) were lower for underweight compared to normal weight patients. There was 8%, 10%, and 7% decrease in primary (aHR 0.92, 95% CI 0.90-0.93, P < 0.001), primary assisted (aHR 0.90, 95% CI 0.88-0.92, P < 0.001), and secondary patency (aHR 0.93, 95% CI 0.91-0.94, P < 0.001) respectively for patients in obese class III compared to patients with normal weight. There was an increase in patient survival with increasing BMI. CONCLUSIONS: In this population-based cohort of hemodialysis-dependent patients, severe obesity was associated with a decrease in fistula maturation. Extremes of BMI were associated with lower patency, but higher BMI was associated with better patient survival. Obese patients nearing ESRD might require earlier referral for arteriovenous fistula (AVF) placement in order to allow for maturation and AVF use at incident hemodialysis.

Hemodynamic events during carotid stenting are associated with significant periprocedural stroke and adverse events.

BACKGROUND: There are limited data on the impact of carotid angioplasty and stenting (CAS)-related changes in blood pressure, heart rate, and preprocedural medications on periprocedural stroke in contemporary, real-world practice. This study evaluates the risk attributable to the CAS-related hemodynamic events and the impact preprocedural medications have on mitigating this risk in a large, population-based cohort. METHODS: We studied all patients in the Vascular Quality Initiative who underwent CAS between January 2006 and December 2016. Kaplan-Meier, multivariable logistic, and Cox regression analyses were used to evaluate the impact of periprocedural hypertension, hypotension, bradycardia, and medication use on immediate periprocedural stroke (IPPS), 30-day, and 1-year stroke. RESULTS: Of the 13,698 CAS procedures studied, 1239 (9.1%), 1824 (13.3%), and 1333 (9.7%) patients experienced periprocedural hypertension, hypotension, and bradycardia, respectively. IPPS was 3.2% vs 2.1% vs 0.65% (P < .001), comparing patients with periprocedural hypertension vs hypotension vs normotension and 1.4 vs 1.0% (P = .19) for bradycardic vs nonbradycardic patients. Periprocedural hypertension was associated with a four-fold increase in IPPS (adjusted odd ratio [aOR], 3.97; 95% confidence interval [CI], 2.63-5.99; P < .001). periprocedural hypotension and bradycardia were associated with 5.5-fold (aOR, 5.56; 95% CI, 3.24-9.52; P < .001) and 2.3-fold (aOR, 2.31; 95% CI, 1.26-4.25; P = .007) increases in IPPS among patients with carotid symptoms. There was 76% decrease in IPPS for patients who did not experience a periprocedural hemodynamic event (aOR, 0.24; 95% CI, 0.16-0.35; P < .001). Unlike preprocedural beta-blockers and angiotensin-converting enzyme inhibitors, prophylactic antibradyarrhythmic agents conferred a 58% reduction in IPPS among patients with carotid symptoms (aOR, 0.42; 95% CI, 0.23-0.78; P = .006). The periprocedural hemodynamic events were also associated with 7.7-fold increase in myocardial infarction (aOR, 7.70; 95% CI, 4.77-12.45; P < .001), a 2.2-fold increase in 30-day mortality (aOR, 2.24; 95% CI, 1.61-3.12; P < .001), and a 16% increase in length of stay (aOR, 1.16; 95% CI, 0.04-2.28; P = .042). The occurrence of these hemodynamic events is higher in patients with prior cardiac disease and the difference in periprocedural outcomes extended to 1 year. CONCLUSIONS: Periprocedural hemodynamic events are associated with an increase in periprocedural stroke, myocardial infarction, death, and length of stay. Periprocedural hypertension in all patients; hypotension and bradycardia in patients with symptomatic carotid disease are associated with significant increase in IPPS. Prophylactic antibradyarrhythmic agents are associated with decrease in bradycardia and IPPS. These results heighten the need to anticipate and promptly address these CAS-related hemodynamic events, especially in susceptible patients.

Multi-scale modeling of early-stage morphology in solution-processed polycrystalline thin films.

A model is introduced for treating early-stage nucleation, growth kinetics, and mesoscale domain structure in submonolayer polycrystalline films prepared by solution-phase processing methods such as spin casting, dip coating, liquid-based printing, and related techniques. The model combines a stochastic treatment of nucleation derived from classical nucleation theory with deterministic computation of the spatiotemporal dynamics of the monomer concentration landscape by numerical solution of the two-dimensional diffusion equation, treating nuclei as monomer sinks. Results are compared to experimental measurements of solution-processed submonolayer tetracene films prepared using a vapor-liquid-solid deposition technique. Excellent agreement is observed with most major kinetic and structural film characteristics, including the existence of distinct induction, nucleation, and growth regimes, the onset time for nucleation, the number of domains formed per unit area, and the micron- to millimeter-scale spacing statistics of those domains. The model also provides a detailed description the dynamically-evolving monomer concentration landscape during film formation as well as quantities derived from it, such as time- and position-dependent domain nucleation and growth rates.