Crossmodal hierarchical predictive coding for audiovisual sequences in the human brain.

Predictive coding theory suggests the brain anticipates sensory information using prior knowledge. While this theory has been extensively researched within individual sensory modalities, evidence for predictive processing across sensory modalities is limited. Here, we examine how crossmodal knowledge is represented and learned in the brain, by identifying the hierarchical networks underlying crossmodal predictions when information of one sensory modality leads to a prediction in another modality.

Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT).

Introduction: This prospective, longitudinal, community-based study, EpidemiologiCal POpulatioN STudy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Lake CounTy, Illinois (CONTACT), investigated coronavirus disease 2019 (COVID-19) immunity, occupational risks related to SARS-CoV-2 exposure, and long-term immunoglobulin G (IgG) seroconversion kinetics.

Methods: At baseline and follow up (3, 6, and 9 months), non-hospitalized adult participants provided nasal and blood serum specimens for molecular [reverse transcription polymerase chain reaction (RT-PCR)] and serological (IgG) testing (4 November 2020-30 October 2021).

Results: At baseline, 6.

On Reference-based Imputation for Analysis of Incomplete Repeated Binary Endpoints.

Reference-based imputation (RBI) is a popular method for missing data. The methodology is well established for continuous end points but less well developed for repeated binary end points due to the lack of natural multivariate conditional distributions for such end points. In this paper, we propose RBI methods for repeated binary end points based on a multivariate probit model and a logistic model, including jump-to-reference (J2R), copy-reference (CR) and copy-increment-in-reference (CIR).

Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry.

Cluster randomized controlled trials (cluster RCTs), also known as parallel-arm group-randomized trials, are trials in which the randomized units are groups of participants, as opposed to individual participants. These trials have largely been implemented to address broad public health issues, but with the growing interest in use of real-world data in the regulatory setting, this design may be increasingly considered for industry trials. The key difference between cluster RCTs and traditional RCTs is the intraclass correlation coefficient (ICC) that needs to be considered in cluster RCTs.

EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study.

Introduction: EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT) is an observational, epidemiological study with a 9-month longitudinal follow-up of nonhospitalized persons aged 18 years or older currently living or employed in Lake County, IL. We describe the study design and report baseline characteristics of the study participants, including the proportion of participants with acute or previous SARS-CoV-2 infection at enrollment.

Methods: At enrollment and subsequent timepoints, participants recruited through digital and paper-based advertising campaigns reported their occupational and school-based exposure, risk factors, and behaviors, and provided nasal and serum specimens.

Sequential modeling for a class of reference-based imputation methods in clinical trials with quantitative or binary outcomes.

We consider treatment effect estimation in a randomized clinical trial with longitudinally measured quantitative or categorical outcomes. To handle missing data, we usually assume missing at random and then conduct sensitivity analysis for missing not at random. In the literature, several reference-based imputation methods, including "jump to reference" (J2R) and "copy reference" (CR), have been commonly used for conducting sensitivity analysis.

Value of variation of end-tidal carbon dioxide for predicting fluid responsiveness during the passive leg raising test in patients with mechanical ventilation: a systematic review and meta-analysis.

Background: The ability of end-tidal carbon dioxide (ΔEtCO2) for predicting fluid responsiveness has been extensively studied with conflicting results. This meta-analysis aimed to explore the value of ΔEtCO2 for predicting fluid responsiveness during the passive leg raising (PLR) test in patients with mechanical ventilation.

Methods: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched up to November 2021.

Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial.

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The effect of early vasopressin use on patients with septic shock: A systematic review and meta-analysis.

Background: The effect of early vasopressin initiation on clinical outcomes in patients with septic shock is uncertain. A systematic review and meta-analysis was performed to evaluate the impact of early start of vasopressin support within 6 h after the diagnosis on clinical outcomes in septic shock patients.

Methods: We searched the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs) and cohort studies from inception to the 1st of February 2021.

Sample Size Calculation When Planning Clinical Trials with Intercurrent Events.

Background: Missing data are not intercurrent events; missing data are consequences of intercurrent events. When planning clinical trials with potential missing data, a conventional approach is two stage: (1) to calculate a required sample size N without considering missing data; (2) to adjust the sample size using [Formula: see text], where r is the expected missing data rate. However, this approach is not estimand oriented.

Small-molecule mimicry hunting strategy in the imperial cone snail, .

Venomous animals hunt using bioactive peptides, but relatively little is known about venom small molecules and the resulting complex hunting behaviors. Here, we explored the specialized metabolites from the venom of the worm-hunting cone snail, Using the model polychaete worm , we demonstrate that venom contains small molecules that mimic natural polychaete mating pheromones, evoking the mating phenotype in worms. The specialized metabolites from different cone snails are species-specific and structurally diverse, suggesting that the cones may adopt many different prey-hunting strategies enabled by small molecules.

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care.

Introduction: Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m) or obese range (≥30 kg/m). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months).

Validity and reliability of a short self-efficacy instrument for hypertension treatment adherence among adults with uncontrolled hypertension.

Objective: To establish the reliability and validity of a self-report measure designed to assess self-efficacy for hypertension treatment adherence.

Methods: This investigation was embedded within a six-month randomized clinical trial (RCT), which demonstrated that a tailored, stage-matched intervention was more effective at improving hypertension control than usual care among individuals (n = 533) with repeated uncontrolled hypertension. The instrument used to assess self-efficacy for hypertension treatment adherence (SE-HTA) comprised three subscales that assessed diet self-efficacy (DSE), exercise self-efficacy (ESE), and medication self-efficacy (MSE).

Two basic statistical strategies of conducting causal inference in real-world studies.

Randomized controlled clinical trials are the gold standard in drug development, but their costs, duration, and limited generalizability have motivated some to look for real-world studies as alternatives. On the other hand, real-world studies may be less convincing due to the presence of confounding bias. In the literature of causal inference, a variety of statistical methods have been proposed to adjust for confounding bias.

A method for sample size calculation via E-value in the planning of observational studies.

Confounding adjustment plays a key role in designing observational studies such as cross-sectional studies, case-control studies, and cohort studies. In this article, we propose a simple method for sample size calculation in observational research in the presence of confounding. The method is motivated by the notion of E-value, using some bounding factor to quantify the impact of confounders on the effect size.

Key considerations in the design of real-world studies.

Randomized controlled clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. However, real-world studies may be less convincing due to the lack of randomization and blinding. In this article, we discuss some key considerations in the design of real-world studies, which include experimental studies (e.

A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence.

Randomized controlled clinical trials are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. On the other hand, real-world data may be much less convincing due to the lack of randomization and the presence of confounding bias. In this article, we propose a statistical roadmap to translate real-world data (RWD) to robust real-world evidence (RWE).

Predicting adults likely to develop heart failure using readily available clinical information: An analysis of heart failure incidence using the NHEFS.

Background: Heart failure is a heavy burden on the health care system in the United States. Once heart failure develops, the quality of life and longevity are dramatically affected. As such, its prevention is critical for the well-being of at risk patients.

Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study.

Introduction: Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care.

A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial.

Background: Goals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA's intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC).

The Role of Oral Steroids in the Treatment of Phonotraumatic Vocal Fold Lesions in Women.

Objectives: (1) To determine the short-term effectiveness of oral steroids in women with benign vocal fold lesions and (2) to determine the effectiveness of adjuvant oral steroids in women undergoing voice therapy for benign vocal fold lesions.

Study Design: Randomized, double-blind, placebo-controlled clinical trial.

Setting: Tertiary voice care center.

Joint screening of ultrahigh dimensional variables for family-based genetic studies.

Background: Mixed models are a useful tool for evaluating the association between an outcome variable and genetic variables from a family-based genetic study, taking into account the kinship coefficients. When there are ultrahigh dimensional genetic variables (ie,  ≫ ), it is challenging to fit any mixed effect model.

Methods: We propose a two-stage strategy, screening genetic variables in the first stage and then fitting the mixed effect model in the second stage to those variables that survive the screening.

Human Serum Albumin-Based Drug-Free Macromolecular Therapeutics: Apoptosis Induction by Coiled-Coil-Mediated Cross-Linking of CD20 Antigens on Lymphoma B Cell Surface.

A therapeutic platform-drug-free macromolecular therapeutics (DFMT)-that induces apoptosis in B cells by cross-linking of CD20 receptors, without the need for low molecular weight cytotoxic drug, is developed. In this report, a DFMT system is synthesized and evaluated based on human serum albumin (HSA) and two complementary coiled-coil forming peptides, CCE and CCK. Fab' fragment of anti-CD20 monoclonal antibody rituximab is attached to CCE (Fab'-CCE); multiple grafts of CCK are conjugated to HSA (HSA-(CCK) ).

Value of variation index of inferior vena cava diameter in predicting fluid responsiveness in patients with circulatory shock receiving mechanical ventilation: a systematic review and meta-analysis.

Background: Respiratory variations in the inferior vena cava diameter (ΔIVCD) have been studied extensively with respect to their value in predicting fluid responsiveness, but the results are conflicting. The aim of this meta-analysis was to explore the value of ΔIVCD for predicting fluid responsiveness in patients with circulatory shock receiving mechanical ventilation.

Methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to June 2017.

Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

Background: Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM.