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• In the United States (US), COVID-19 vaccination rates among non-US-born individuals are variable, but understanding them is critical to identifying disparities. • Among over 1.5 million patients eligible for COVID-19 vaccination at 4 health systems across the US, completion of the primary vaccination series was lower in patients with a language preference other than English (62.7 %) compared with English preferring patients (63.6 %). • Though completion of the primary series was higher for non-US-born persons compared with US born persons, completion of a booster dose was lower for non-US-born persons, refugees, and patients with language preference other than English compared with their counterparts. • Requirements for COVID-19 primary vaccination for entry into the US may have played a role in the higher completion of primary COVID-19 series vaccines among refugee, immigrant and migrant populations. • The lower rate of booster uptake among newcomer populations is worthy of further attention. In the United States (US), COVID-19 vaccination rates among non-US-born individuals (i.e., refugees, immigrants, and migrants [RIM]) are variable. Understanding baseline COVID-19 vaccine coverage among these populations and determining if disparities exist is essential for quality improvement initiatives and public health interventions. Baseline COVID-19 vaccination rates for both primary series and booster doses were calculated at four health systems located in Minnesota, Colorado, and Pennsylvania participating in the Minnesota Department of Health's Center of Excellence in Newcomer Health. Patients aged ≥5 years as of 1/1/22, seen for ≥1 primary care visit during 7/1/2019–6/30/22 were included. Descriptive statistics were calculated for three measures of COVID-19 vaccine coverage during 12/14/2020–6/30/2022: 1) initiation of primary series; 2) completion of primary series; 3) completion of first booster. We calculated vaccine coverage rates for the entire population and stratified by subgroup including country of origin, refugee status, and primary language preference. We included 1,624,573 patients eligible for COVID-19 primary series vaccine and 907,749 eligible for COVID-19 booster vaccination. The percent of eligible patients who completed a COVID-19 primary series (63.4 %) and booster dose (66.2 %) were similar. Completion of the primary series was higher for non-US-born persons (72.7 %) compared with US born persons (65.4 %), similar among refugees (63.5 %) and non-refugees (63.4 %), and lower in patients with language preference other than English (62.7 %) compared with English preferring patients (63.6 %). Booster completion was lower for non-US-born persons (61.8 %), refugees (46.7 %), and patients with language preference other than English (55.3 %) compared with US-born (70 %), non-refugees (66.3 %), and English preferring patients (67.3 %) respectively. This evaluation identified disparities in COVID-19 vaccination rates among non-US-born persons and persons with a language preference other than English living in the US. Targeted outreach efforts may be beneficial in reaching these populations. [ABSTRACT FROM AUTHOR]

Novel models that improve generalist-level palliative care for cystic fibrosis (CF) are needed to address the burden of this illness. A screening-and-triage model has the potential to identify clinical problems requiring immediate follow-up by CF professionals. This study describes such a model and its immediate impact on care delivery for CF patients during a two-year period. Eligible adults completed monthly online screening for sources of distress. If results revealed one or more "indicators of concern" on two consecutive screenings, this triggered an attempted triage by a social worker. Completed triages led to prompt follow-up by CF professionals for clinical problems, if indicated. Process data were summarized and generalized linear mixed models were used to evaluate baseline patient characteristics (symptom distress, quality of life, and sociodemographics) associated with the need for prompt follow-up. A total of 1,015 monthly surveys were completed by 74 patients; 634 (66 patients) had > 1 indicators of concern; and 164 surveys (46 patients) had > 1 indicators for two consecutive surveys (e.g., global distress, pain, dyspnea, and psychological symptoms). The 164 attempted triages yielded 84 completed triages (51.2%), of which 39 (46.4%) required prompt follow-up. In multivariable analyses, older patients and those with higher symptom distress at baseline were more likely to require prompt follow-up (p <.05). Web-based screening that assesses varied domains of distress or burden can identify a subset of CF patients whose clinical problems may benefit from immediate medical or psychological attention. Additional investigations should improve screening efficiency. [ABSTRACT FROM AUTHOR]

• Clinical trial participation is not equitable across people with cystic fibrosis (CF). • Self-study is a valuable tool for reducing disparities in CF clinical trial participation. • Tailored approaches to recruitment and referrals can increase diversity in CF clinical trials. Clinical trials are a necessary tool for evaluating the effectiveness of newly developed treatments and interventions for cystic fibrosis (CF). Prior work demonstrated a proportional underrepresentation of people with CF (pwCF) identifying as part of a minoritized racial or ethnic group in clinical trials. In order to establish a baseline for improvement efforts, we undertook a center-level self-study to evaluate if the racial and ethnic backgrounds of pwCF participating in clinical trials at our CF Center in New York City reflect our overall patient diversity (N = 200; 55 pwCF identifying as part of a minoritized racial or ethnic group and 145 pwCF identifying as non-Hispanic White). A smaller proportion of pwCF identifying as part of a minoritized racial or ethnic group participated in a clinical trial as compared to pwCF identifying as non-Hispanic White (21.8% vs. 35.9%, P = 0.06). A similar trend was present for pharmaceutical clinical trials (9.1% vs. 16.6%, P = 0.3). When limiting the study population to the pwCF most likely to be eligible for a CF pharmaceutical clinical trial, a larger proportion of pwCF identifying as part of a minoritized racial or ethnic group participated in a pharmaceutical clinical trial as compared to pwCF identifying as non-Hispanic White (36.4% vs. 19.6%, P = 0.2). No pwCF identifying as part of a minoritized racial or ethnic group participated in an offsite clinical trial. Efforts to improve the racial and ethnic diversity of pwCF in clinical trials, both onsite and offsite, will require a shift in how recruitment opportunities are identified and communicated to pwCF. [ABSTRACT FROM AUTHOR]

Background: Zanubrutinib is a next-generation, selective Bruton tyrosine kinase inhibitor with efficacy in relapsed chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). We compared zanubrutinib with bendamustine-rituximab to determine its effectiveness as frontline therapy in patients with CLL or SLL.Methods: We conducted an open-label, multicentre, phase 3 study at 153 academic or community hospitals in 14 countries and regions. Eligible patients had untreated CLL or SLL requiring treatment as per International Workshop on CLL criteria; were aged 65 years or older, or 18 years or older and had comorbidities; and had an Eastern Cooperative Oncology Group performance status score of 0-2. A central interactive web response system randomly assigned patients without del(17)(p13·1) to zanubrutinib (group A) or bendamustine-rituximab (group B) by sequential block method (permutated blocks with a random block size of four). Patients with del(17)(p13·1) were enrolled in group C and received zanubrutinib. Zanubrutinib was administered orally at 160 mg twice per day (28-day cycles); bendamustine at 90 mg/m2 of body surface area on days 1 and 2 for six cycles plus rituximab at 375 mg/m2 of body surface area the day before or on day 1 of cycle 1, and 500 mg/m2 of body surface area on day 1 of cycles 2-6, were administered intravenously. The primary endpoint was progression-free survival per independent review committee in the intention-to-treat population in groups A and B, with minimum two-sided α of 0·05 for superiority. Safety was analysed in all patients who received at least one dose of study treatment. The study is registered with ClinicalTrials.gov, NCT03336333, and is closed to recruitment.Findings: Between Oct 31, 2017, and July 22, 2019, 590 patients were enrolled; patients without del(17)(p13·1) were randomly assigned to zanubrutinib (group A; n=241) or bendamustine-rituximab (group B; n=238). At median follow-up of 26·2 months (IQR 23·7-29·6), median progression-free survival per independent review committee was not reached in either group (group A 95% CI not estimable [NE] to NE; group B 28·1 months to NE). Progression-free survival was significantly improved in group A versus group B (HR 0·42 [95% CI 0·28 to 0·63]; two-sided p<0·0001). The most common grade 3 or worse adverse event was neutropenia (27 [11%] of 240 patients in group A, 116 [51%] of 227 in group B, and 17 [15%] of 111 patients in group C). Serious adverse events occurred in 88 (37%) of 240 patients in group A, 113 (50%) of 227 patients in group B, and 45 (41%) of 111 patients in group C. Adverse events leading to death occurred in 11 (5%) of 240 patients in group A, 12 (5%) of 227 patients in group B, and three (3%) of 111 patients in group C, most commonly due to COVID-19 (four [2%] of 240 patients in group A), diarrhoea, and aspiration pneumonia (two each [1%] of 227 patients in group B).Interpretation: Zanubrutinib significantly improved progression-free survival versus bendamustine-rituximab, with an acceptable safety profile consistent with previous studies. These data support zanubrutinib as a potential new treatment option for untreated CLL and SLL.Funding: BeiGene. [ABSTRACT FROM AUTHOR]

Background Cystic fibrosis (CF) causes high illness burden. Screening may identify patients who could potentially benefit from interventions for symptoms or other sources of distress. We evaluated the feasibility of a web-based system for routine monitoring. Methods Adult CF patients enrolled in a study of palliative care service delivery completed web-based assessments every 30 days on global distress, physical and psychological symptom distress, and the perceived benefits of discussing advance care planning (ACP) with CF clinicians. Feasibility was assessed by the rate of survey completion, survey reminders, and missed surveys during a 9-month rolling enrollment period. Results Of 74 participants (47.3% women, 94.4% white), 36.7% had comorbid diabetes, and 56.9% had an FEV1% predicted score of 40–69. In total, patients completed 456 (80.6%) of 566surveys every 30 days over the assessment period. Sixty-five (87.8%) completed 405 (79.7%) of 508 surveys online and 9 (12.2%) completed 51 (88.0%) of 58 surveys using a combination of online, telephone, and mail-based methods. Many surveys were completed without reminders (online: 261 [64.4%] of 405; combined methods: 29 [56.9%] of 51), with 166 (36.4%) surveys requiring 1 or more reminders. Further, 23.0% (17) of patients noted elevated global distress; 20.3% (15) endorsed physical symptom distress, 12.2% (9) had psychological distress, and 58.1% (43) reported that discussing ACP would be beneficial. Conclusions Repeated web-based screening for symptom distress and ACP preferences is feasible in adult CF patients. Future studies should assess the system's generalizability and staff resources when implementing reminders and non-web methods of completion. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the probability of target attainment (PTA) of various anidulafungin dosing regimens against Candida spp. in patients with acute leukaemia. A Monte Carlo simulation was performed using a previously published population pharmacokinetic model. The following dosing scenarios were evaluated: 200 mg loading dose (LD) on Day 1 then 100 mg daily (manufacturer's recommended dosing regimen); 200 mg LD on Day 1 then 100 mg every 48 h (q48 h); and 200 mg q48 h, 200 mg every 72 h (q72 h) and 300 mg q72 h. For each dosing regimen, free drug concentrations were calculated to evaluate the effect of 99% protein binding. The PTA at various pharmacodynamic (PD) targets was determined as the percentage of subjects who achieved a free drug area under the plasma concentration–time curve over the minimum inhibitory concentration ratio (ƒAUC/MIC) or a free drug maximum plasma concentration over the minimum inhibitory concentration ratio (ƒ C max /MIC) above the PD targets. PTA expectation values were then calculated for each dosing regimen. The currently recommended dosing regimen of anidulafungin was not optimal for invasive candidiasis in patients with acute leukaemia. Alternate dosing strategies with higher doses and extended dosing intervals (intermittent dosing) achieved better target attainment. This is the first study to optimise therapy with anidulafungin using Monte Carlo simulation. These results provide a rationale in support of future clinical investigation of intermittent dosing of anidulafungin. [ABSTRACT FROM AUTHOR]

Abstract: The regional distribution of wall thickness and failure properties in human abdominal aortic aneurysm (AAA) was explored. Three unruptured and one ruptured AAA were harvested as a whole during necropsy. Thickness was measured at about every 1.5cm2 wall surface area for an average of 100 measurement sites per AAA. Multiple longitudinally oriented rectangular specimen strips were cut at various locations from each AAA for a total of 48 strips. The strips were subjected to uniaxial extension until failure. Wall thickness varied regionally and between AAA from as low as 0.23mm at a rupture site to 4.26mm at a calcified site (median=1.48mm). Wall thickness was slightly lower in the posterior and right regions. The failure tension (ultimate) of specimen strips varied regionally and between AAA from 5.5N/cm close to a blister site in the ruptured AAA to 42.3N/cm at the undilated neck of a 4cm diameter unruptured AAA (median=14.8N/cm). Failure stress (ultimate) varied from 33.6 to 235.1N/cm2 (median=126.6N/cm2). There was no perceptible pattern in failure properties along the circumference. Failure tension of specimen strips at or close to blisters was mostly low. The rupture site in the ruptured aneurysm had the lowest recorded wall thickness of 0.23mm with only slightly higher readings within a 1cm radius. The failure tension of the specimen strip close to the rupture site was low (11.1 N/cm) compared to its neighborhood in the ruptured aneurysm. [Copyright &y& Elsevier]

Abstract: Background:: Topical retinoids are one of the most effective classes of topical drugs used to treat acne vulgaris.The effects of the gel formulation of the topical retinoid tazarotene have been widely reported, but few data on the cream formulation are available. Objective:: The primary aim of the 2 studies reported in this article was to determine the effects of tazarotene0.1 % cream in patients with facial acne vulgaris. Methods:: Two randomized, double-blind, parallel-group studies were performed. The first was conducted at 14 investigational sites across the United States, and the second took place at 15 sites, with 5 of these providing blood samples for analysis of tazarotenic acid. In both studies, patients aged ≥12 years with facial acne vulgaris were randomized to receive tazarotene or vehicle cream QD for 12 weeks. Lesion counts (noninflammatory, inflammatory, and total) and overall clinical and global assessments were made at weeks 0 (baseline), 4, 8, and 12. Adverse events (AEs) were monitored throughout the study In one of the studies, therapeutic drug monitoring was performed at weeks 4 and 8 in members of the study population who gave consent for blood withdrawal. Results:: Eight hundred forty-seven patients were enrolled in the 2 studies (430 males, 417 females; mean age,19 years; age range, 11–52 years [1 patient was entered into the study at age 11 years, in violation of the protocol]). At 12 weeks, the median percentage changes from baseline in all 3 lesion counts were significantly lower with tazarotene than with vehicle (all, P < 0.001), as were the overall clinical and global responses (both, P < 0.001). Treatment-related AEs whose incidence was higher with tazarotene than with vehicle included desquamation, dry skin, erythema, a burning sensation on the skin, and skin irritation (all, P < .001) and pruritus (P < 0.01); most (83%–98%) were mild or moderate. Systemic exposure to tazarotenic acid was limited (mean, <0.1 ng/mL) and did not increase with time. Conclusions:: In these 2 studies in adolescent and adult patients with facial acne vulgaris, tazarotene 0.1%cream QD for 12 weeks was effective and well tolerated. Systemic exposure to tazarotenic acid was limited. [Copyright &y& Elsevier]

Background: It is difficult and expensive to use surveys to obtain the repeatable information that is needed to understand and monitor tobacco prevalence rates and to evaluate cessation interventions among various subgroups of the population. Therefore, the electronic medical record database of a large medical group in Minnesota was used to demonstrate the potential value of that approach to accomplish those goals. Methods: The relevant variables for all medical group patients aged 18 and over were extracted from the record from a 1-year period. Rates of smoking prevalence were computed for the entire population as well as for those with various characteristics and combinations of characteristics of interest to tobacco-cessation advocates. These prevalence rates were also adjusted to control for the other characteristics in the analysis. Results: From March 2006 to February 2007, there were 183,982 unique patients with at least one office visit with a clinician, and a record of their tobacco-use status (90%). Overall, 19.7% with recorded status were tobacco users during this year, as were 24.2% of those aged 18–24 years, 16.0% of pregnant women, 34.3% of those on Medicaid, 40.0% of American Indians, 9.5% of Asians, and 8.5% of those whose preferred language was other than English. Combining characteristics allowed greater understanding of those differences. Conclusions: Although there are limitations in these data, the level of detail available for this large population and the ease of repeat analysis should greatly facilitate targeted interventions and evaluation of the impact. [Copyright &y& Elsevier]