Chemotherapy-Surgery Interval Effects on Tumor Necrosis and Outcome in Children and Young Adults With Osteosarcoma.

Background/objective: Osteosarcoma treatment incorporates chemotherapy and surgery. Resection of the primary tumor usually occurs after induction chemotherapy. Occasionally, scheduling challenges and medical complications result in delay.

Neurodevelopment in preschool children exposed and unexposed to Zika virus in utero in Nicaragua: a prospective cohort study.

Background: Data on long-term neurodevelopmental outcomes of normocephalic children (born with normal head circumference) exposed to Zika virus in utero are scarce. We aimed to compare neurodevelopmental outcomes in normocephalic children up to age 48 months with and without Zika virus exposure in utero.

Methods: In this prospective cohort study, we included infants from two cohorts of normocephalic children born in León and Managua, Nicaragua during the 2016 Zika epidemic.

Assessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials.

Understanding whether and how treatment effects vary across subgroups is crucial to inform clinical practice and recommendations. Accordingly, the assessment of heterogeneous treatment effects based on pre-specified potential effect modifiers has become a common goal in modern randomized trials. However, when one or more potential effect modifiers are missing, complete-case analysis may lead to bias and under-coverage.

Acceptability of a Randomized Trial of Anti-depressant Medication or Interpersonal Therapy for Treatment of Perinatal Depression in Women with HIV.

Postpartum depression (PPD) affects nearly 20% of postpartum women in Sub-Saharan Africa (SSA), where HIV prevalence is high. Depression is associated with worse HIV outcomes in non-pregnant adults and mental health disorders may worsen HIV outcomes for postpartum women and their infants. PPD is effectively treated with psychosocial or pharmacologic interventions; however, few studies have evaluated the acceptability of treatment modalities in SSA.

Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial.

Background: Recent work has shown that cluster-randomised trials can estimate two distinct estimands: the participant-average and cluster-average treatment effects. These can differ when participant outcomes or the treatment effect depends on the cluster size (termed informative cluster size). In this case, estimators that target one estimand (such as the analysis of unweighted cluster-level summaries, which targets the cluster-average effect) may be biased for the other.

Causal Bayesian machine learning to assess treatment effect heterogeneity by dexamethasone dose for patients with COVID-19 and severe hypoxemia.

The currently recommended dose of dexamethasone for patients with severe or critical COVID-19 is 6 mg per day (mg/d) regardless of patient features and variation. However, patients with severe or critical COVID-19 are heterogenous in many ways (e.g.

Structured Mobilization for Critically Ill Patients: A Pragmatic Cluster-randomized Trial.

Small trials and professional recommendations support mobilization interventions to improve recovery among critically ill patients, but their real-world effectiveness is unknown. To evaluate a low-cost, multifaceted mobilization intervention. We conducted a stepped-wedge cluster-randomized trial across 12 ICUs with diverse case mixes.

A Bayesian Interpretation of a Pediatric Cardiac Arrest Trial (THAPCA-OH).

BACKGROUND: Pediatric out-of-hospital cardiac arrest results in high morbidity and mortality. Currently, there are no recommended therapies beyond supportive care. The THAPCA-OH (Therapeutic Hypothermia after Pediatric Cardiac Arrest Out-of-Hospital) trial compared hypothermia (33.

Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial.

Introduction: Postpartum depression (PPD) is a prevalent and debilitating disease that may affect medication adherence and thus maternal health and vertical transmission among women with HIV. We assessed the feasibility of a trial of interpersonal psychotherapy (IPT) versus antidepressant medication (ADM) to treat PPD and/or anxiety among postpartum women with HIV in Lusaka, Zambia.

Methods: Between 29 October 2019 and 8 September 2020, we pre-screened women 6-8 weeks after delivery with the Edinburgh Postnatal Depression Scale (EPDS) and diagnosed PPD or anxiety with the Mini International Neuropsychiatric Interview.

Clinical and Epidemiological Features of Acute Zika Virus Infections in León, Nicaragua.

The American Zika virus (ZIKV) epidemic has highlighted the need to gain a better understanding of this emerging virus. The goal of this study was to describe the clinical symptoms, laboratory findings, and risk factors for symptomatic ZIKV infection in an area with ongoing transmission of other arboviral infections. We recruited patients at least 2 years of age seeking care at public health centers in León, Nicaragua, between January 2016 and August 2017, for fever, maculopapular rash, and/or nonsuppurative conjunctivitis with a duration of less than 1 week.

Neurodevelopmental Outcomes of Children Following In Utero Exposure to Zika in Nicaragua.

Background: Neurodevelopmental outcomes of asymptomatic children exposed to Zika virus (ZIKV) in utero are not well characterized.

Methods: We prospectively followed 129 newborns without evidence of congenital Zika syndrome (CZS) up to 24 months of age. Participants were classified as ZIKV exposed or ZIKV unexposed.

Risk Factors and Clinical Profile of Sapovirus-associated Acute Gastroenteritis in Early Childhood: A Nicaraguan Birth Cohort Study.

Background: Sapovirus is increasingly recognized as an important cause of acute gastroenteritis (AGE) in children. We identified risk factors and characterized the clinical profile of sapovirus AGE in a birth cohort in León, Nicaragua.

Methods: We conducted a case-control study nested within a birth cohort (n = 444).

Serologic surveillance of maternal Zika infection in a prospective cohort in Leon, Nicaragua during the peak of the Zika epidemic.

Background: Zika virus caused thousands of congenital anomalies during a recent epidemic. Because Zika emerged in areas endemic for dengue and these related flaviviruses elicit cross-reactive antibodies, it is challenging to serologically monitor pregnant women for Zika infection.

Methods: A prospective cohort of 253 pregnant women was established in León, Nicaragua.

Post-randomization Biomarker Effect Modification Analysis in an HIV Vaccine Clinical Trial.

While the HVTN 505 trial showed no overall efficacy of the tested vaccine to prevent HIV infection over placebo, markers measuring immune response to vaccination were strongly correlated with infection. This finding generated the hypothesis that some marker-defined vaccinated subgroups were partially protected whereas others had their risk increased. This hypothesis can be assessed using the principal stratification framework (Frangakis and Rubin, 2002) for studying treatment effect modification by an intermediate response variable, using methods in the sub-field of principal surrogate (PS) analysis that studies multiple principal strata.

Antibody Fc effector functions and IgG3 associate with decreased HIV-1 risk.

HVTN 505 is a preventative vaccine efficacy trial testing DNA followed by recombinant adenovirus serotype 5 (rAd5) in circumcised, Ad5-seronegative men and transgendered persons who have sex with men in the United States. Identified immune correlates of lower HIV-1 risk and a virus sieve analysis revealed that, despite lacking overall efficacy, vaccine-elicited responses exerted pressure on infecting HIV-1 viruses. To interrogate the mechanism of the antibody correlate of HIV-1 risk, we examined antigen-specific antibody recruitment of Fcγ receptors (FcγRs), antibody-dependent cellular phagocytosis (ADCP), and the role of anti-envelope (anti-Env) IgG3.

High School Physical Activity and Nutrition Policy: Summarizing Changes Over Time Using Latent Class Analysis.

Introduction: High school physical activity and nutrition policies can substantially affect student behavior and outcomes. Although public health officials and legislators have advocated for policy improvements, the extent to which policies have changed at local levels is not well understood. This study identifies latent classes of physical activity and nutrition policy environments and explores changes in prevalence of these classes from 2000 to 2016.

Changes in the incidence of pneumonia, bacterial meningitis, and infant mortality 5 years following introduction of the 13-valent pneumococcal conjugate vaccine in a "3+0" schedule.

Background: Streptococcus pneumoniae causes about 826,000 deaths of children in the world each year and many health facility visits. To reduce the burden of pneumococcal disease, many nations have added pneumococcal conjugate vaccines to their national immunization schedules. Nicaragua was the first country eligible for GAVI Alliance funding to introduce the 13-valent pneumococcal conjugate vaccine (PCV13) in 2010, provided to infants at 2, 4, and 6 months of age.