Alcohol, affective atmospheres and structures of feeling in women at midlife.

Introduction: Women at midlife have increased rates of harmful drinking in many high-income countries. This cohort grew up within permissive alcohol environments that encouraged women's consumption, linking it to success, femininity, and empowerment. This research drew on notions of 'structures of feeling' and 'affective atmospheres' to explore how women at midlife describe and make sense of alcohol and drinking within their lives.

Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032.

Background: Pregnant people with coronavirus disease 2019 (COVID-19) experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnancy. We report PK and safety data for intravenous remdesivir in pregnancy.

Methods: IMPAACT 2032 was a phase 4 prospective, open-label, nonrandomized opportunistic study of hospitalized pregnant and nonpregnant women receiving intravenous remdesivir as part of clinical care.

Digital alcohol marketing and gender: A narrative synthesis.

Issues: Alcohol marketing on social media platforms is pervasive and effective, reaching wide audiences and allowing interaction with users. We know little about the gendered nature of digital alcohol marketing, including how women and men are portrayed, how different genders respond and implications for gender relations. This review aimed to identify how males, females and other genders are targeted and represented in digital alcohol marketing, and how they are encouraged to engage with digital alcohol marketing content.

Sofosbuvir-velpatasvir in children 3-17 years old with hepatitis C virus infection.

Background: The safety and efficacy of sofosbuvir-velpatasvir in children aged 3-17 years with chronic hepatitis C virus (HCV) infection of any genotype were evaluated.

Methods: In this Phase 2, multicenter, open-label study, patients received once daily for 12 weeks either sofosbuvir-velpatasvir 400/100 mg tablet (12-17 years), 200/50 mg low dose tablet or oral granules (3-11 years and ≥17 kg), or 150/37.5 mg oral granules (3-5 years and <17 kg).

Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study.

Background: Coformulated bictegravir, emtricitabine, and tenofovir alafenamide is a single-tablet regimen and was efficacious and well tolerated in children and adolescents with HIV (aged 6 years to <18 years) in a 48-week phase 2/3 trial. In this study, we report data from children aged at least 2 years and weighing 14 kg to less than 25 kg.

Methods: We conducted this open-label, multicentre, multicohort, single-arm study in South Africa, Thailand, Uganda, and the USA.

Remdesivir for COVID-19 in Hospitalized Children: A Phase 2/3 Study.

Objectives: Remdesivir decreases the risk of SARS-CoV-2 infection progressing to severe disease in adults. This study evaluated remdesivir safety and pharmacokinetics in infants and children.

Methods: This was a phase 2/3, open-label trial in children aged 28 days to 17 years hospitalized for polymerase chain reaction-confirmed SARS-CoV-2 infection.

Quality Improvement Methodology to Improve Standardized Reporting of Pediatric Thyroid Ultrasounds Using TI-RADS.

Background/purpose: The process of evaluating pediatric thyroid nodules at our institution was inconsistent with a high rate of negative biopsies raising concern of appropriate patient selection for biopsy. Our aim was to institute a standardized risk stratification reporting system for thyroid nodules to increase utilization and agreement of TI-RADS reporting at our institution.

Methods: Radiology report data were collected and analyzed as part of a quality improvement project.

Thermoresponsive Conductivity of Graphene-Based Fibers.

Smart materials are versatile material systems which exhibit a measurable response to external stimuli. Recently, smart material systems have been developed which incorporate graphene in order to share on its various advantageous properties, such as mechanical strength, electrical conductivity, and thermal conductivity as well as to achieve unique stimuli-dependent responses. Here, a graphene fiber-based smart material that exhibits reversible electrical conductivity switching at a relatively low temperature (60 °C), is reported.

Reducing Opioid Prescriptions after Common Outpatient Pediatric Urologic Surgeries: A Quality Improvement Assessment.

Unlabelled: Pediatric patients undergoing outpatient surgeries often receive prescriptions for postoperative pain, including opioid medications. As a result, the American Academy of Pediatrics formally challenged all pediatric surgeons to decrease opioid prescribing for common specialty-specific outpatient procedures at discharge. To meet this challenge, we designed a quality improvement project to decrease the average number of opioid doses administered to pediatric patients undergoing 3 common outpatient urologic surgeries: circumcision, orchiopexy, and inguinal hernia repair (IHR).

Women, alcohol consumption and health promotion: the value of a critical realist approach.

Research on women's drinking occurs in largely disparate disciplines-including public health, health promotion, psychology, sociology, and cultural studies-and draws on differing philosophical understandings and theoretical frameworks. Tensions between the aims and paradigmatic underpinnings of this research (across and within disciplines) have meant that knowledge and insight can be frequently disciplinary-specific and somewhat siloed. However, in line with the social and economic determinants of the health model, alcohol research needs approaches that can explore how multiple gender-related factors-biological, psycho-social, material, and socio-cultural-combine to produce certain drinking behaviours, pleasures and potential harms.

Both sides of the screen: Provider and patient perspective on telemedicine in pediatric surgery.

Background: There has been increased telemedicine use secondary to the COVID-19 pandemic. The objective of this study was to assess patient/parent satisfaction with their telemedicine experience, gauge provider perspective on telemedicine for the management of pediatric colorectal disease and evaluate the quality of telemedicine care being provided.

Methods: A cross sectional study was performed at a single institution from March 2020-February 2021.

Ledipasvir-sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy.

Objectives: In children with hematological malignancies, chronic hepatitis C virus (HCV) infection has been associated with more rapid liver disease progression and higher risk of malignancy relapse due to chemotherapy interruption. We evaluated the safety and efficacy of ledipasvir-sofosbuvir for 12weeks in these patients.

Methods: In a phase 2, open-label study, at one site in Egypt, patients ages 12-<18years with chronic HCV genotype 1 or 4 infection undergoing maintenance chemotherapy for hematological malignancies received ledipasvir-sofosbuvir (90 mg/400 mg) once daily for 12weeks.

Sofosbuvir-velpatasvir-voxilaprevir in adolescents 12 to 17 years old with HCV infection.

Background And Aims: Sofosbuvir-velpatasvir-voxilaprevir is a pangenotypic regimen for chronic HCV infection. In the USA and Europe, sofosbuvir-velpatasvir-voxilaprevir once daily for 12 weeks is indicated for adults who previously received an HCV NS5A inhibitor. In Europe, sofosbuvir-velpatasvir-voxilaprevir is also indicated in the absence of prior HCV direct-acting antiviral (DAA) therapy as an 8-week or 12-week regimen.

Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials.

Background & Aims: The effect of race on routinely available noninvasive tests of fibrosis is incompletely understood. This study evaluated the performance of noninvasive tests among white and Asian patients in the STELLAR trials (NCT03053050 and NCT03053063), which evaluated selonsertib in patients with advanced (F3-F4) fibrosis due to nonalcoholic steatohepatitis (NASH).

Methods: Baseline liver biopsies were centrally read using the NASH Clinical Research Network system, and 4 noninvasive tests (Nonalcoholic fatty liver disease fibrosis score [NFS], Fibrosis-4 index [FIB-4], Enhanced Liver Fibrosis test [ELF], and liver stiffness by vibration-controlled transient elastography) were measured.

Alcohol and drinking within the lives of midlife women: A meta-study systematic review.

Background: A range of societal changes have created positive and encouraging environments for women's alcohol use. Within this context, in Western countries there is evidence of rising rates of alcohol consumption and related harms among midlife and older women. It is timely and important to explore the role of alcohol in the lives of midlife women to better understand observed data trends and to develop cohort specific policy responses.

The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis.

Background & Aim: Fibrosis is an independent predictor of death in nonalcoholic steatohepatitis (NASH). We assessed the associations between histologic and noninvasive tests (NITs) for fibrosis with clinical and patient-reported outcomes (PROs) in advanced NASH.

Methods: Patients with advanced NASH (NASH Clinical Research Network stage F3 or F4) were enrolled in 4 multinational clinical trials of simtuzumab and selonsertib.

The Diagnostic Error Index: A Quality Improvement Initiative to Identify and Measure Diagnostic Errors.

Objective: To develop a diagnostic error index (DEI) aimed at providing a practical method to identify and measure serious diagnostic errors.

Study Design: A quality improvement (QI) study at a quaternary pediatric medical center. Five well-defined domains identified cases of potential diagnostic errors.

Fatigue and Pruritus in Patients with Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: The Impact on Patient-Reported Outcomes.

Fatigue and pruritus are common in patients with chronic liver diseases of all etiologies, but clinical awareness is mostly restricted to those with cholestatic liver diseases. We assessed the impact of fatigue and pruritus on patient-reported outcomes (PROs) of patients with advanced nonalcoholic steatohepatitis (NASH). Specifically, PROs (Short Form-36, Chronic Liver Disease Questionnaire-NASH, Euro-Qol 5 Dimension, and Work Productivity and Activity Impairment instruments) were assessed at baseline in patients with histologically confirmed bridging fibrosis (F3) or compensated cirrhosis (F4) due to NASH enrolled in STELLAR 3 and 4.

Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials.

Background & Aims: Apoptosis signal-regulating kinase 1 (ASK1) plays a key role in hepatocyte injury, inflammation, and fibrosis in non-alcoholic steatohepatitis (NASH). We evaluated the safety and antifibrotic effect of selonsertib, a selective inhibitor of ASK1, in patients with advanced fibrosis due to NASH.

Methods: We conducted 2 randomized, double-blind, placebo-controlled, phase III trials of selonsertib in patients with NASH and bridging fibrosis (F3, STELLAR-3) or compensated cirrhosis (F4, STELLAR-4).

Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.

Purpose: Ledipasvir/sofosbuvir and sofosbuvir/velpatasvir have been approved worldwide for the treatment of chronic hepatitis C virus (HCV) infection. Although both have been approved in China, there are currently no data on their pharmacokinetic profiles in Chinese individuals. Two studies investigated the pharmacokinetic properties, safety, and tolerability of ledipasvir/sofosbuvir and sofosbuvir/velpatasvir, respectively, in healthy Chinese subjects.

A diagnostic time-out to improve differential diagnosis in pediatric abdominal pain.

Background: Pediatric abdominal pain is challenging to diagnose and often results in unscheduled return visits to the emergency department. External pressures and diagnostic momentum can impair physicians from thoughtful reflection on the differential diagnosis (DDx). We implemented a diagnostic time-out intervention and created a scoring tool to improve the quality and documentation rates of DDx.