A Head-to-Head Comparison of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids Versus Icosapent Ethyl in Adults With Hypertriglyceridemia: The ENHANCE-IT Study.

Background MAT9001 is an omega-3 free fatty acid (FFA) formulation containing mainly eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). Compared with icosapent ethyl (EPA-ethyl esters [EE]), EPA+DPA-FFA previously showed enhanced triglyceride lowering and higher plasma EPA when both were administered once daily with a very-low fat diet. This trial compared pharmacodynamic responses and plasma omega-3 levels following twice daily dosing, with meals, of EPA+DPA-FFA and EPA-EE in hypertriglyceridemic subjects consuming a Therapeutic Lifestyle Changes diet.

Evaluating the cost-effectiveness of a pre-exposure prophylaxis program for HIV prevention for men who have sex with men in Japan.

Men who have sex with men (MSM) have been disproportionally affected by the HIV epidemic in many countries, including Japan. Although pre-exposure prophylaxis (PrEP) is a strong prevention tool, it is not yet approved in Japan. A Markov model was developed to describe HIV infection and disease progression in an MSM cohort (N = 1000) in Japan receiving a PrEP program.

Transparent, Open, and Reproducible Prevention Science.

The field of prevention science aims to understand societal problems, identify effective interventions, and translate scientific evidence into policy and practice. There is growing interest among prevention scientists in the potential for transparency, openness, and reproducibility to facilitate this mission by providing opportunities to align scientific practice with scientific ideals, accelerate scientific discovery, and broaden access to scientific knowledge. The overarching goal of this manuscript is to serve as a primer introducing and providing an overview of open science for prevention researchers.

Modern Meta-Analytic Methods in Prevention Science: Introduction to the Special Issue.

Meta-analyses that statistically synthesize evidence from multiple research studies can play an important role in advancing evidence-informed prevention science. When done in the context of a well-conducted systematic review, meta-analysis is a powerful tool for synthesizing evidence and exploring research questions that are difficult to address in individual studies, such as the association of individual study limitations on intervention effect estimates, replicability of empirical findings, and variation of effect estimates across populations and settings. Alongside the rapid growth in the number of published reviews and meta-analyses, there has been a parallel growth in the development of meta-analytic techniques to handle the increasingly complex types of questions and types of evidence relevant to prevention science.

Relationship between high-risk alcohol consumption and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion: a prospective sero-epidemiological cohort study among American college students.

Aims: To estimate the associations between high-risk alcohol consumption and (1) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion, (2) self-reported new SARS-CoV-2 infection and (3) symptomatic COVID-19.

Design: Prospective cohort study.

Setting: Indiana University Bloomington (IUB), IN, USA.

Designing isolation guidelines for COVID-19 patients utilizing rapid antigen tests: a simulation study using viral dynamics models.

Appropriate isolation guidelines for COVID-19 patients are warranted. Currently, isolating for fixed time is adapted in most countries. However, given the variability in viral dynamics between patients, some patients may no longer be infectious by the end of isolation (thus they are redundantly isolated), whereas others may still be infectious.

Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial.

Objective: Consuming ≥150 g/day carbohydrate is recommended for 3 days before an oral glucose tolerance test (OGTT) for diabetes diagnosis. For evaluation of this recommendation, time courses of glycemic changes following transition from a very-low-carbohydrate (VLC) to high-carbohydrate diet were assessed with continuous glucose monitoring (CGM).

Research Design And Methods: After achieving a weight loss target of 15% (±3%) on the run-in VLC diet, participants (18-50 years old, BMI ≥27 kg/m2) were randomly assigned for 10 weeks to one of three isoenergetic diets: VLC (5% carbohydrate and 77% fat); high carbohydrate, high starch (HC-Starch) (57% carbohydrate and 25% fat, including 20% refined grains); and high carbohydrate, high sugar (HC-Sugar) (57% carbohydrate and 25% fat, including 20% sugar).

Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters.

Background: Cluster randomized controlled trials (cRCTs) are increasingly used but must be analyzed carefully. We conducted a simulation study to evaluate the validity of a parametric bootstrap (PB) approach with respect to the empirical type I error rate for a cRCT with binary outcomes and a small number of clusters.

Methods: We simulated a case study with a binary (0/1) outcome, four clusters, and 100 subjects per cluster.

Trajectories of alcohol use and problems during the COVID-19 pandemic: The role of social stressors and drinking motives for men and women.

Introduction: Increased alcohol use coinciding with onset of the COVID-19 pandemic, particularly among women, has been documented among U.S. adults.

Association of Plasma Tau With Mortality and Long-term Neurocognitive Impairment in Survivors of Pediatric Cerebral Malaria and Severe Malarial Anemia.

Importance: Cerebral malaria (CM) and severe malarial anemia (SMA) are associated with persistent neurocognitive impairment (NCI) among children in Africa. Identifying blood biomarkers of acute brain injury that are associated with future NCI could allow early interventions to prevent or reduce NCI in survivors of severe malaria.

Objective: To investigate whether acutely elevated tau levels are associated with future NCI in children after CM or SMA.

Difficulty Regulating Social Media Content of Age-Restricted Products: Comparing JUUL's Official Twitter Timeline and Social Media Content About JUUL.

Background: In 2018, JUUL Labs Inc, a popular e-cigarette manufacturer, announced it would substantially limit its social media presence in compliance with the Food and Drug Administration's (FDA) call to curb underage e-cigarette use. However, shortly after the announcement, a series of JUUL-related hashtags emerged on various social media platforms, calling the effectiveness of the FDA's regulations into question.

Objective: The purpose of this study is to determine whether hashtags remain a common venue to market age-restricted products on social media.

Peer review reduces spin in PCORI research reports.

Background: The Patient-Centered Outcomes Research Institute (PCORI) is obligated to peer review and to post publicly "Final Research Reports" of all funded projects. PCORI peer review emphasizes adherence to PCORI's Methodology Standards and principles of ethical scientific communication. During the peer review process, reviewers and editors seek to ensure that results are presented objectively and interpreted appropriately, e.

Concurrent use of e-cigarettes and cannabis and associated COVID-19 symptoms, testing, and diagnosis among student e-cigarette users at four U.S. Universities.

Introduction: This investigation assessed whether current (past 30-day) electronic cigarette (e-cigarette) and cannabis use was associated with coronavirus disease 2019 (COVID-19) symptomatology, testing, and diagnosis among college student e-cigarette users.

Methods: Participants were 18-26-year-old college student e-cigarette users attending four geographically diverse, large U.S.

"It Was Scary, But Then It Was Kind of Exciting": Young Women's Experiences with Choking During Sex.

Choking/strangulation during sex is prevalent among young adults, with one study finding that 58% of women college students had ever been choked during sex. However, no qualitative study has examined women's experiences with choking/strangulation during sex outside of intimate partner violence. The purpose of our qualitative interview study was to investigate women's experiences with choking and/or being choked during partnered sex.

Toward more rigorous and informative nutritional epidemiology: The rational space between dismissal and defense of the status quo.

To date, nutritional epidemiology has relied heavily on relatively weak methods including simple observational designs and substandard measurements. Despite low internal validity and other sources of bias, claims of causality are made commonly in this literature. Nutritional epidemiology investigations can be improved through greater scientific rigor and adherence to scientific reporting commensurate with research methods used.

The Strategic Council for Research Excellence, Integrity, and Trust.

We announce the creation of a new body within the National Academies of Sciences, Engineering, and Medicine called the Strategic Council for Research Excellence, Integrity, and Trust, charged with advancing the overall health, quality, and effectiveness of the research enterprise across all domains that fund, execute, disseminate, and apply scientific work in the public interest. By promoting the alignment of incentives and policies, adoption of standard tools, and implementation of proven methods, the Strategic Council seeks to optimize the excellence and trustworthiness of research for the benefit of society.

Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI.

Background: The aim of obesity treatment is to promote loss of fat relative to lean mass. However, body composition changes with calorie restriction differ among individuals.

Objectives: The goal of this study was to test the hypothesis that insulin secretion predicts body composition changes among young and middle-age adults with high BMI (in kg/m2) following major weight loss.

Factors associated with adherence to guideline-recommended cardiovascular disease prevention among HIV clinicians.

Integrating cardiovascular disease (CVD) prevention in routine HIV care remains a challenge. This study aimed to identify factors associated with adherence to guideline-recommended CVD preventive practices among HIV clinicians. Clinicians from eight HIV clinics in Atlanta were invited to complete an online survey.

The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies.

Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example.

Background: Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.