Cardio-oncology care in the era of the coronavirus disease 2019 (COVID-19) pandemic: An International Cardio-Oncology Society (ICOS) statement.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has given rise to a pandemic of unprecedented proportions in the modern era because of its highly contagious nature and impact on human health and society: coronavirus disease 2019 (COVID-19). Patients with cardiovascular (CV) risk factors and established CV disease (CVD) are among those initially identified at the highest risk for serious complications, including death. Subsequent studies have pointed out that patients with cancer are also at high risk for a critical disease course. Therefore, the most vulnerable patients are seemingly those with both cancer and CVD, and a careful, unified approach in the evaluation and management of this patient population is especially needed in times of the COVID-19 pandemic. This review provides an overview of the unique implications of the viral outbreak for the field of cardio-oncology and outlines key modifications in the approach to this ever-increasing patient population. These modifications include a shift toward greater utilization of cardiac biomarkers and a more focused CV imaging approach in the broader context of modifications to typical practice pathways. The goal of this strategic adjustment is to minimize the risk of SARS-CoV-2 infection (or other future viral outbreaks) while not becoming negligent of CVD and its important impact on the overall outcomes of patients who are being treated for cancer.

Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years.

BACKGROUND: The emergence of immune-escape variants of severe acute respiratory syndrome coronavirus 2 warrants the use of sequence-adapted vaccines to provide protection against coronavirus disease 2019. METHODS: In an ongoing phase 3 trial, adults older than 55 years who had previously received three 30-µg doses of the BNT162b2 vaccine were randomly assigned to receive 30 µg or 60 µg of BNT162b2, 30 µg or 60 µg of monovalent B.1.1.529 (omicron) BA.1-adapted BNT162b2 (monovalent BA.1), or 30 µg (15 µg of BNT162b2 + 15 µg of monovalent BA.1) or 60 µg (30 µg of BNT162b2 + 30 µg of monovalent BA.1) of BA.1-adapted BNT162b2 (bivalent BA.1). Primary objectives were to determine superiority (with respect to 50% neutralizing titer [NT50] against BA.1) and noninferiority (with respect to seroresponse) of the BA.1-adapted vaccines to BNT162b2 (30 µg). A secondary objective was to determine noninferiority of bivalent BA.1 to BNT162b2 (30 µg) with respect to neutralizing activity against the ancestral strain. Exploratory analyses assessed immune responses against omicron BA.4, BA.5, and BA.2.75 subvariants. RESULTS: A total of 1846 participants underwent randomization. At 1 month after vaccination, bivalent BA.1 (30 µg and 60 µg) and monovalent BA.1 (60 µg) showed neutralizing activity against BA.1 superior to that of BNT162b2 (30 µg), with NT50 geometric mean ratios (GMRs) of 1.56 (95% confidence interval [CI], 1.17 to 2.08), 1.97 (95% CI, 1.45 to 2.68), and 3.15 (95% CI, 2.38 to 4.16), respectively. Bivalent BA.1 (both doses) and monovalent BA.1 (60 µg) were also noninferior to BNT162b2 (30 µg) with respect to seroresponse against BA.1; between-group differences ranged from 10.9 to 29.1 percentage points. Bivalent BA.1 (either dose) was noninferior to BNT162b2 (30 µg) with respect to neutralizing activity against the ancestral strain, with NT50 GMRs of 0.99 (95% CI, 0.82 to 1.20) and 1.30 (95% CI, 1.07 to 1.58), respectively. BA.4-BA.5 and BA.2.75 neutralizing titers were numerically higher with 30-µg bivalent BA.1 than with 30-µg BNT162b2. The safety profile of either dose of monovalent or bivalent BA.1 was similar to that of BNT162b2 (30 µg). Adverse events were more common in the 30-µg monovalent-BA.1 (8.5%) and 60-µg bivalent-BA.1 (10.4%) groups than in the other groups (3.6 to 6.6%). CONCLUSIONS: The candidate monovalent or bivalent omicron BA.1-adapted vaccines had a safety profile similar to that of BNT162b2 (30 µg), induced substantial neutralizing responses against ancestral and omicron BA.1 strains, and, to a lesser extent, neutralized BA.4, BA.5, and BA.2.75 strains. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04955626.).

Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.

BACKGROUND: Respiratory syncytial virus (RSV) infection causes considerable illness in older adults. The efficacy and safety of an investigational bivalent RSV prefusion F protein-based (RSVpreF) vaccine in this population are unknown. METHODS: In this ongoing, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults (≥60 years of age) to receive a single intramuscular injection of RSVpreF vaccine at a dose of 120 µg (RSV subgroups A and B, 60 µg each) or placebo. The two primary end points were vaccine efficacy against seasonal RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms. The secondary end point was vaccine efficacy against RSV-associated acute respiratory illness. RESULTS: At the interim analysis (data-cutoff date, July 14, 2022), 34,284 participants had received RSVpreF vaccine (17,215 participants) or placebo (17,069 participants). RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group (1.19 cases per 1000 person-years of observation) and 33 participants in the placebo group (3.58 cases per 1000 person-years of observation) (vaccine efficacy, 66.7%; 96.66% confidence interval [CI], 28.8 to 85.8); 2 cases (0.22 cases per 1000 person-years of observation) and 14 cases (1.52 cases per 1000 person-years of observation), respectively, occurred with at least three signs or symptoms (vaccine efficacy, 85.7%; 96.66% CI, 32.0 to 98.7). RSV-associated acute respiratory illness occurred in 22 participants in the vaccine group (2.38 cases per 1000 person-years of observation) and 58 participants in the placebo group (6.30 cases per 1000 person-years of observation) (vaccine efficacy, 62.1%; 95% CI, 37.1 to 77.9). The incidence of local reactions was higher with vaccine (12%) than with placebo (7%); the incidences of systemic events were similar (27% and 26%, respectively). Similar rates of adverse events through 1 month after injection were reported (vaccine, 9.0%; placebo, 8.5%), with 1.4% and 1.0%, respectively, considered by the investigators to be injection-related. Severe or life-threatening adverse events were reported in 0.5% of vaccine recipients and 0.4% of placebo recipients. Serious adverse events were reported in 2.3% of participants in each group through the data-cutoff date. CONCLUSIONS: RSVpreF vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (≥60 years of age), without evident safety concerns. (Funded by Pfizer; RENOIR ClinicalTrials.gov number, NCT05035212; EudraCT number, 2021-003693-31.).

SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization. METHODS: In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here. RESULTS: At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P = 0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group. CONCLUSIONS: In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19.

BACKGROUND: Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications. METHODS: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19-related hospitalization or death from any cause by day 29. RESULTS: A total of 1035 patients underwent randomization and received an infusion of bamlanivimab-etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab-etesevimab group had a Covid-19-related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, -4.8 percentage points; 95% confidence interval [CI], -7.4 to -2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab-etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19-related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001). CONCLUSIONS: Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19-related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

Safety, tolerability, pharmacodynamics and pharmacokinetics of the soluble guanylyl cyclase activator BI 685509 in patients with diabetic kidney disease: A randomized trial.

AIMS: Albuminuria is associated with abnormalities in the nitric oxide (NO)-soluble guanylyl cyclase (sGC)-cyclic guanosine monophosphate pathway. We assessed safety and efficacy of the NO-independent sGC activator BI 685509 in patients with diabetic kidney disease and albuminuria. MATERIALS AND METHODS: In this Phase Ib trial (NCT03165227), we randomized patients with type 1 or 2 diabetes, estimated glomerular filtration rate (eGFR) 20-75 mL/min/1.73 m2 and urinary albumin:creatinine ratio (UACR) 200-3500 mg/g to oral BI 685509 (1 mg three times daily, n = 20; 3 mg once daily, n = 19; 3 mg three times daily, n = 20, after final titration) or placebo (n = 15) for 28 days. Changes from baseline in UACR in first morning void (UACRFMV ) and 10-hour (UACR10h ) urine (3 mg once daily/three times daily only) were assessed. RESULTS: Baseline median eGFR and UACR were 47.0 mL/min/1.73 m2 and 641.5 mg/g, respectively. Twelve patients had drug-related adverse events (AEs; 16.2%: BI 685509, n = 9; placebo, n = 3), most frequently hypotension (4.1%: BI 685509, n = 2; placebo, n = 1) and diarrhoea (2.7%: BI 685509, n = 2; placebo, n = 0). Four patients experienced AEs leading to study discontinuation (5.4%: BI 685509, n = 3; placebo, n = 1). Placebo-corrected mean UACRFMV decreased from baseline in the 3-mg once-daily (28.8%, P = 0.23) and three-times-daily groups (10.2%, P = 0.71) and increased in the 1-mg three-times-daily group (6.6%, P = 0.82); changes were not significant. UACR10h decreased by 35.3% (3 mg once daily, P = 0.34) and 56.7% (3 mg three times daily, P = 0.09); ≥50.0% of patients (UACR10h 3 mg once daily/three times daily) responded (≥20% UACR decrease from baseline). CONCLUSIONS: BI 685509 was generally well tolerated. Effects on UACR lowering merit further investigation.

Gender, romantic relationships and sexual health in Mexico: Parents' experiences of discussion with their children.

A focus on promoting sexual health and preventing sexual violence remains largely unaddressed in most evidence-based parenting prevention programmes, despite the promise of success in addressing these topics after foundational parenting practices have been strengthened. The primary objective of this study was to understand how Mexican family and gender values shape the way families in Mexico City approach discussion of sexual health and violence with their adolescent children. The goal was to inform the development of a culturally relevant sexual health promotion and violence prevention module to add to an existing parenting intervention. During focus groups with 17 mothers and 3 fathers who had recently completed a parenting intervention, five major themes were identified: mediating messages from the outside world; the view that dads are not part of sex education; the belief that romantic relationships spell trouble; gender differences in responsibility and fear; and comfort talking about condoms. Findings indicate that caregivers adopt different approaches to education about sexual health and the prevention of sexual violence according to whether their adolescent is a boy or a girl. These differential approaches were primarily informed by cultural and contextual influences. Strategies for more overtly addressing gender relations in parenting interventions for sexual health promotion and violence prevention are discussed.

Building a nest in a storm: The impact of immigration-related stress on Latino mothers' parenting.

Latina/o immigrant mothers in the United States (U.S.) often experience discrimination, which results in deleterious impacts on their parenting practices. Because of the cumulative impact of immigration-related stress, there is a need for research aimed at identifying specific contextual stressors that have the greatest impact on Latina/o immigrant parenting. Further, given significant barriers to access mental health services, there is an urgency to comprehend how pre-existing family strengths might counteract these parenting shortcomings in Latina/o families. Accordingly, we examined in these investigation-specific pathways through which immigration-related stress affects maternal parenting practices, and how emotional and relational processes within families might act as predecessors to positive parenting practices within a context of adversity. This study is embedded within a larger program of research aimed at culturally adapting evidence-based parenting programs for low-income Latina/o immigrants. Our sample consisted of 71 Mexican-origin Latina/o mothers, residents of an urban setting in the Midwest. According to Bayesian estimated path analysis, immigration-related stress was associated with parenting stress and emotional support, while emotional support, parenting stress, and the co-parenting alliance were associated with positive parenting practices. Indirect effects demonstrate that immigration-related stress is negatively associated with positive parenting practices when mediated by parenting stress and emotional support. Current findings highlight the need to carefully examine the impact of immigration-related stress on the parenting practices of Latina/o immigrant families and the need to inform parent training interventions accordingly.

A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load.

BACKGROUND: Based on interim analyses and modeling data, lower doses of bamlanivimab and etesevimab together (700/1400 mg) were investigated to determine optimal dose and expand availability of treatment. METHODS: This Phase 3 portion of the BLAZE-1 trial characterized the effect of bamlanivimab with etesevimab on overall patient clinical status and virologic outcomes in ambulatory patients ≥12 years old, with mild-to-moderate coronavirus disease 2019 (COVID-19), and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700/1400 mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test. RESULTS: In total, 769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients ≥65 years of age and median duration of symptoms; 4 days). By day 29, 4/511 patients (0.8%) in the antibody treatment group had a COVID-19-related hospitalization or any-cause death, as compared with 15/258 patients (5.8%) in the placebo group (Δ[95% confidence interval {CI}] = -5.0 [-8.0, -2.1], P < .001). No deaths occurred in the bamlanivimab and etesevimab group compared with 4 deaths (all COVID-19-related) in the placebo group. Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI] = -0.99 [-1.33, -.66], P < .0001) compared with those receiving placebo. Persistently high viral load at Day 7 correlated with COVID-19-related hospitalization or any-cause death by Day 29 in all BLAZE-1 cohorts investigated. CONCLUSIONS: These data support the use of bamlanivimab and etesevimab (700/1400 mg) for ambulatory patients at high risk for severe COVID-19. Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants will require continued monitoring to determine the applicability of this treatment. CLINICAL TRIALS REGISTRATION: NCT04427501.

Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.

Importance: Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19. Objective: To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19. Design, Setting, and Participants: The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020. Interventions: Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156). Main Outcomes and Measures: The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29). Results: Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment. Conclusions and Relevance: Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point. Trial Registration: ClinicalTrials.gov Identifier: NCT04427501.

From Theory to Practice: On the Ground Cultural Adaption of a Parenting Intervention for Ethnic Minority Families Involved in the Child Welfare System.

Child maltreatment is a major public health issue in the United States. In the federal fiscal year 2017, approximately 7.5 million children were referred to child welfare services (CSW) in the nation. Developmental, emotional, behavioral, and cognitive problems are prevalent among children referred to CWS. For those in foster care, temporary or permanent placement frequently introduces additional instability into a child's already chaotic life, increasing their risk for deleterious physical and mental health outcomes. Limited research exists documenting the impact of efficacious culturally adapted parent training (PT) interventions aimed at serving low-income ethnic minority families involved in CWS. The objective of this study was twofold: to explicate how a culturally adapted PT intervention for diverse families involved in CWS was perceived by participants and to better understand how interventionists adapted to families' needs. In this study, we conducted in-depth interviews with 14 parents who had completed the adapted intervention, as well as all of the interventionists providing the intervention. A thematic analysis approach was used to analyze and interpret the data. Parents indicated the positive impact that the intervention had on enhancing their parenting skills, as well as their ability to cope with the challenges associated with having a child removed by CWS. Interventionists described the gradual adaptations they implemented, in an effort to increase its cultural and contextual relevance. Research findings are relevant to the family therapy field as they increase understanding about culturally adapted PT interventions for ethnic minority families within CWS contexts.

El maltrato infantil es un gran problema de salud pública en los Estados Unidos. En el año fiscal federal 2017, se derivó a aproximadamente 7.5 millones de niños a servicios de bienestar infantil en el país. Entre los niños derivados a los servicios de bienestar infantil predominan los problemas emocionales, conductuales y del desarrollo. En los niños que están en acogida, su ubicación temporaria o permanente con frecuencia suma inestabilidad a la vida ya caótica de un niño, lo cual incrementa su riesgo de sufrir consecuencias perjudiciales en su salud mental y física. Existen escasas investigaciones que documentan los efectos de intervenciones eficaces con capacitaciones para padres culturalmente adaptadas y orientadas a asistir a familias de minorías étnicas de bajos recursos implicadas en servicios de bienestar infantil. El objetivo de este estudio fue doble: explicar cómo los participantes de una intervención con una capacitación de padres culturalmente adaptada para familias diversas implicadas en los servicios de bienestar infantil percibieron esta intervención y comprender mejor cómo los intervencionistas se adaptaron a las necesidades de las familias. En este estudio realizamos entrevistas detalladas con 14 padres que habían realizado la intervención adaptada, así como con todos los intervencionistas que llevaron a cabo la intervención. Se utilizó un método de análisis temático para analizar e interpretar los datos. Los padres indicaron el efecto positivo que tuvo la intervención en la mejora de sus habilidades de crianza, así como en su capacidad de afrontar las dificultades que surgen cuando los servicios de bienestar infantil les sacan un hijo. Los intervencionistas describieron las adaptaciones graduales que implementaron con el objetivo de aumentar su relevancia cultural y contextual. Los resultados de la investigación son relevantes para el área de la terapia familiar, ya que amplían el conocimiento sobre las intervenciones con capacitaciones para padres culturalmente adaptadas y orientadas a familias de minorías étnicas dentro del contexto de los servicios de bienestar infantil.

Addressing Immigration-Related Stress in a Culturally Adapted Parenting Intervention for Mexican-Origin Immigrants: Initial Positive Effects and Key Areas of Improvement.

Culturally adapted evidence-based parenting interventions constitute a key strategy to reduce widespread mental health disparities experienced by Latinx populations throughout the United States. Most recently, the relevance of culturally adapted parenting interventions has become more prominent as vulnerable Latinx populations are exposed to considerable contextual stressors resulting from an increasingly anti-immigration climate in the country. The current study was embedded within a larger NIMH-funded investigation, aimed at contrasting the differential impact of two culturally adapted versions of the evidence-based parenting intervention known as GenerationPMTO©. Specifically, a sample of low-income Mexican-origin immigrants was exposed either to a culturally adapted version of GenerationPMTO primarily focused on parent training components, or to an enhanced culturally adapted version in which parenting components were complemented by sessions focused on immigration-related challenges. The sample for the study consisted of 103 Mexican-origin immigrant families (190 individual parents). Descriptive analysis and generalized estimating equations (GEEs) indicated that exposure to the enhanced intervention, which included context- and culture-specific sessions, resulted in specific benefits for parents. However, the magnitude of the impact was not uniform for mothers and fathers and differed according to the type of immigration-related stress being examined (i.e., intrafamilial vs. extrafamilial stress). Overall, findings indicate the relevance of overtly addressing contextual (e.g., discrimination) and cultural challenges in culturally adapted interventions, as well as the need to increase precision according to the extent to which immigration-related stressors impact immigrant mothers and fathers in common and contrasting ways. Implications for family therapy practice and research are discussed.

Las intervenciones basadas en evidencia, dirigidas a padres y adaptadas a la cultura son una estrategia clave para reducir las desigualdades en salud mental generalizadas que las poblaciones de latin@s experimentan en los Estados Unidos. Más recientemente, la relevancia de intervenciones dirigidas a padres adaptadas a la cultura ha adquirido más peso al estar las poblaciones de latin@s expuestas a factores estresantes contextuales considerables como resultado de un ambiente cada vez más contrario a la inmigración en el país. Este estudio fue incluido dentro de una investigación de mayor escala financiada por NIMH cuyo objetivo era contrastar el impacto diferencial de dos versiones adaptadas a la cultura de la intervención basada en evidencia y dirigida a padres conocida como GenerationPMTO© . En específico, se expuso una muestra de inmigrantes de origen mexicano de bajo ingreso, o a una versión de GenerationPMTO adaptada a la cultura y enfocada principalmente en elementos de entrenamiento de padres, o a una versión reforzada adaptada a la cultura en la cual los elementos de padres se complementaron con sesiones enfocadas en retos asociados a la inmigración. La muestra para el estudio consistió de 103 familias inmigrantes de origen mexicano (190 padres individuales). Análisis descriptivos y ecuaciones de estimación generalizadas indicaron que la exposición una intervención reforzada, que incluía sesiones contextual y culturalmente específicas, generaron beneficios específicos para los padres. Sin embargo, la magnitud del impacto no fue uniforme para madres y padres y fue distinta según el tipo de estrés por inmigración examinado (p.ej., estrés intrafamiliar versus estrés extrafamiliar). En general, los hallazgos indican la relevancia de enfrentar abiertamente retos contextuales (p.ej., discriminación) y culturales en intervenciones adaptadas a la cultura, así como la necesidad de aumentar la precisión conforme a cómo los factores estresantes asociados a la inmigración afectan a madres y padres inmigrantes de la misma y diferentes maneras. Se discuten las implicaciones para la práctica e investigación de terapia familiar.

Parental Practices and Maternal Warmth as Protective Factors for Problem Behaviors in Mexican Preadolescents.

Epidemiological estimates indicate that approximately 12% of children and adolescents in Mexico are in clinical ranges for psychological disorders. Low-income families in need of psychological support generally encounter understaffed and sometimes inefficient public health services and thus, families frequently constitute the primary source of support for individuals affected by mental health disorders. Empirical studies in the Mexican context have demonstrated that positive parental practices are associated with positive developmental outcomes and low levels of problem behaviors for both children and adolescents. This study aims to identify if such practices act as protective factors for problem behaviors in 306 Mexican students in 4th, 5th, and 6th grades from 3 public elementary school s in Mexico City. Practices of maternal autonomy and communication as well as maternal warmth were found to significantly diminish internalizing and externalizing problem behaviors, while parental involvement and communication only reduced externalizing problem behaviors. Findings have implications for social welfare programs that target positive youth development and supportive parenting.

Enfermedad carotídea aterosclerosa y enfermedad de sustancia blanca en sujetos sin historia de infarto cerebral o isquemia cerebral transitoria.

INTRODUCTION: Atherosclerotic carotid artery disease (CAD) is a major risk factor for cerebrovascular disease. OBJECTIVE: To analyze the association of major vascular risk factors with atherosclerotic CAD and white matter disease (WMD) in patients without a history of ischemic stroke. METHOD: Risk factors were assessed with carotid examination using Doppler duplex ultrasound. Cases with a history cerebral infarction or transient ischemic attack were not included. Subjects had brain magnetic resonance imaging scans available and those with large-artery ischemic lesions were excluded. Multivariate models were constructed for the prediction of atherosclerotic CAD, significant carotid stenosis, atheroma burden and WMD. RESULTS: One-hundred and forty-five subjects were assessed (60.7% were females, mean age was 73 years). Atherosclerotic CAD was documented in 54.5%, carotid stenosis ≥ 50% in 9.0%, > 6 atheroma plaques in 7.6%, and periventricular or subcortical WMD in 28.3% (20.6% had atherosclerotic CAD and WMD concurrently). Risk factors independently associated with atherosclerotic CAD were age and hypertension; hypertension was associated with ≥ 50% carotid stenosis; age was associated with > 6 atheroma plaques; and age, diabetes and hypertension were associated with WMD. Obesity was not associated with any of the analyzed independent variables. CONCLUSIONS: In asymptomatic subjects without a history of ischemic stroke, age and hypertension were the most important risk factors for macrovascular disease. Diabetes mellitus was associated with microvascular disease. Obesity alone was not a major determinant of CAD or WMD.

INTRODUCCIÓN: La enfermedad carotídea aterosclerosa (ECA) es un factor de riesgo importante para enfermedad vascular cerebral. OBJETIVO: Analizar la asociación entre factores de riesgo vascular mayores con ECA y leucopatía cerebral en pacientes sin historia de ictus isquémico. MÉTODO: Se evaluaron factores de riesgo en sujetos con exploración de carótidas mediante ultrasonografía Doppler dúplex. No se incluyeron casos con historia de infarto cerebral o ataque isquémico transitorio. Los sujetos contaron con resonancia magnética cerebral y se excluyeron aquellos con lesiones isquémicas de grandes vasos. Se construyeron modelos multivariable para la predicción de ECA, estenosis carotídea significativa, carga de ateromas y leucopatía cerebral. RESULTADOS: Se estudiaron 145 sujetos (60.7 % mujeres, edad de 73 años). Se documentó ECA en 54.5 %, estenosis carotídea ≥ 50 % en 9 %, carga de placas de ateroma > 6 en 7.6 % y leucopatía periventricular o subcortical en 28.3 % (20.6 % tenían concurrentemente ECA y leucopatía). Los factores asociados independientemente con ECA fueron edad e hipertensión; con estenosis ≥ 50 %, hipertensión; con cargas de ateromas > 6 placas, edad; con leucopatía, edad, diabetes e hipertensión. La obesidad no se asoció con las variables independientes analizadas. CONCLUSIONES: En los sujetos asintomáticos sin historia de ictus isquémico, la edad y la hipertensión fueron los factores de riesgo más importantes para enfermedad macrovascular. La diabetes mellitus se asoció con enfermedad microvascular. La obesidad por sí sola no fue un determinante mayor de ECA o leucopatía cerebral.

Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate the long-term effect of thermoablative fractional CO2 laser (TACO2L) as an alternative treatment for early stages of stress urinary incontinence (SUI) in postmenopausal women with genitourinary syndrome of menopause. METHODS: A total of 161 postmenopausal patients (age 53.38 ± 5.1 years, range 45-65 years) with a clinical diagnosis of mild SUI were prospectively enrolled in the study. Patients received one treatment with TACO2L every 30-45 days, each treatment comprising four sessions, followed in all patients by a yearly treatment session at 12, 24 and 36 months. SUI was evaluated using the International Continence Society 1-h pad test and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TACO2L treatment. RESULTS: TACO2L treatment was associated with a significant improvement in ICIQ-UI SF scores and 1-h pad weight test at 12 months (both p < 0.001), 24 months (both p < 0.001) and 36 months (both p < 0.001). Improvements were maintained for up to 36 months without the need for any further intervention. The results were confirmed by significant histological changes related to trophic restoration of the vagina, responsible for extrinsic and intrinsic mechanisms involved in urinary continence. CONCLUSIONS: Our results suggest that TACO2L is an efficient and safe novel treatment strategy in patients with mild SUI. Further investigation to confirm the long-term results presented here is still warranted.

Knowledge about emergency dental trauma management among school teachers in Colombia: A baseline study to develop an education strategy.

BACKGROUND/AIM: Dental trauma in school populations has a high frequency and school teachers are often close to the place where such injuries occur. However, many studies have confirmed the lack of knowledge as to how to act in these cases. The aim of this study was to determine the knowledge in regard to dental trauma of school teachers in Colombia. MATERIALS AND METHODS: A multicentre, descriptive cross-sectional study was performed in 251 schools using a stratified randomized sampling. A structured hard copy survey was personally delivered to 2390 school teachers in the selected schools. The survey contained questions related to work experience, teaching level and demographic data, as well as questions related to their knowledge of and attitude towards emergency dental trauma management. RESULTS: The response rate was 96%. Most of the school teachers (95%) had never received training related to dental trauma, although 35% had witnessed at least 1 case. Of 2296 school teachers surveyed, only 5.8% would have replanted an avulsed tooth. An association was found between work experience and appropriate management of an avulsed tooth. No significant differences were found in regard to school location (city), school type (private/public), gender and school teachers' education level. CONCLUSIONS: The knowledge of school teachers in Colombia about emergency dental trauma management is inadequate. The findings strongly suggest a need for an education strategy with the involvement of the government, dentistry schools and private organizations.

Dialysis Arteriovenous Fistula Failure and Angioplasty: Intimal Hyperplasia and Other Causes of Access Failure.

The arteriovenous fistula (AVF) is the preferred hemodialysis access type because it has better patency rates and fewer complications than other access types. However, primary failure remains a common problem impeding AVF maturation and adding to patients' morbidity and mortality. Juxta-anastomotic (or inflow) stenosis is the most common reason leading to primary failure, and percutaneous transluminal angioplasty continues to be the gold-standard treatment with excellent success rates. Intimal hyperplasia (IH) has been traditionally blamed as the main pathophysiologic culprit, but new evidence raises doubts regarding the contribution of IH alone to primary failure. We report a 64-year-old man with a 2-stage brachiobasilic AVF that was complicated by failure 4 months after creation. An angiogram showed multiple juxta-anastomotic and midfistula stenotic lesions. Percutaneous transluminal angioplasty was successful in assisting maturation and subsequently cannulating the AVF for hemodialysis treatment. We failed to identify the underlying cause of stenosis because biopsy specimens from fistula tissue obtained at the time of transposition revealed no occlusive IH. This case emphasizes the need for additional research on factors contributing to AVF failure besides IH and highlights the need for more therapeutic options to reduce AVF failure rate.

Different Strokes for Different Folks? Contrasting Approaches to Cultural Adaptation of Parenting Interventions.

Relevant achievements have been accomplished in prevention science with regard to disseminating efficacious parenting interventions among underserved populations. However, widespread disparities in availability of parenting services continue to negatively impact diverse populations in high-income countries (e.g., the USA) and low- and middle-income countries. As a result, a scholarly debate on cultural adaptation has evolved over the years. Specifically, some scholars have argued that in diverse cultural contexts, existing evidence-based parenting interventions should be delivered with strict fidelity to ensure effectiveness. Others have emphasized the need for cultural adaptations of interventions when disseminated among diverse populations. In this paper, we propose that discussions on cultural adaptation should be conceptualized as a "both-and," rather than an "either-or" process. To justify this stance, we describe three distinct parenting intervention projects to illustrate how cultural adaptation and efficacy of evidence-based interventions can be achieved using contrasting approaches and frameworks, depending on cultural preferences and available resources of local contexts. Further, we suggest the need to develop guidelines for consistent reporting of cultural adaptation procedures as a critical component of future investigations. This discussion is relevant for the broader public health field and prevention science.

Tele-Nephrology: A Feasible Way to Improve Access to Care for Patients with Kidney Disease Who Reside in Underserved Areas.

BACKGROUND: The Miami VA Healthcare System serves veterans in three South Florida counties: Miami-Dade, Broward, and Monroe, with an estimated veteran population of 175,000. To overcome geographical barriers and facilitate the access to nephrology clinics, we implemented provider-patient tele-nephrology using secured videoconferencing. METHODS: A retrospective and descriptive study design was used to evaluate the effect of the tele-nephrology clinic intervention. Multiple clinical indicators were included in the analysis: blood pressure (BP) control, stabilization of the renal function, and electrolyte/metabolic control. One hundred one patients who were evaluated in the clinic between 2013 and 2015 were included in the analysis, and the indicators were collected retrospectively. RESULTS: One hundred one patients were included in the analysis, with 95% of patients being male (n = 96) and 5% female (n = 5). The mean age was 65.5 years. Fifty patients had chronic kidney disease (CKD) stage III (49.5%), 14 patients had CKD stage IV (13%), and 8 patients had CKD stage II (7.9%). A one-way analysis of variance between subjects was conducted and showed that the effect of the tele-nephrology clinic intervention on reducing BP was statistically significant (systolic BP less than 140 p value <0.0001). Renal function stabilized but the creatinine changes over time were not statistically significant (p value: 0.50). Potassium showed a significant improvement in this sample (p value: 0.0076). Phosphorous and bicarbonate did not show a statistically significant improvement (p value 0.79 and 0.91, respectively). CONCLUSION: With the tele-nephrology clinic intervention, we were able to effectively improve BP and stabilize renal function in patients with kidney disease who reside in underserved areas.

Transcutaneous Temperature Controlled Radiofrequency (TTCRF) for the Treatment of Menopausal Vaginal/Genitourinary Symptoms.

OBJECTIVE: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment. MATERIALS AND METHODS: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test. Vaginal health was evaluated with the Vaginal Health Index (VHI) score and visual analogue score (VAS) for dyspareunia and dryness. Punch biopsies were obtained at the urethra-vesical junction in the anterior compartment, before and at the end of the treatment protocol. Basic and histochemical staining methods were used. RESULTS: In subjects suffering SUI, TTCRF treatment was associated with a significant (p<0.01) improvement of ICIQ-SF and UDI-6 scores. Seven of 10 patients (70%) had a negative cough stress test after the treatment protocol. Improvements were maintained up to the 12th week of follow-up. The results were supported by the positive histologic changes seen vaginally in women suffering from postmenopausal vaginal atrophy. TTCRF was well tolerated with no complications reported in study patients. CONCLUSION: TTCRF treatment in postmenopausal women suffering from SUI showed significant improvement in both objective and subjective symptoms. Vaginal health scores also improved as did VAS for dryness and dyspareunia. We feel these improvements were related to histological changes related to improvement in vaginal atrophy that were not observed in placebo patients.