Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial.

Importance: There is a need for improved immunogenicity of hepatitis B virus (HBV) vaccines among young adults with risk of infection.

Objectives: To demonstrate manufacturing equivalence of a 3-antigen (3A) HBV vaccine, evaluate noninferiority of seroprotection rate (SPR) of 3A-HBV vs single-antigen (1A) HBV after 2 and 3 vaccine doses, and compare safety and reactogenicity between 3A-HBV and 1A-HBV vaccines.

Design, Setting, And Participants: This phase 3, double-blinded, randomized clinical trial included healthy adults aged 18 to 45 years randomized to 1 of three 3A-HBV groups or 1 control group receiving 1A-HBV.

Effect of Remote Cardiac Monitoring System Design on Response Time to Critical Arrhythmias.

Introduction: In many hospitals across the country, electrocardiograms of multiple at-risk patients are monitored remotely by telemetry monitor watchers in a central location. However, there is limited evidence regarding best practices for designing these cardiac monitoring systems to ensure prompt detection and response to life-threatening events. To identify factors that may affect monitoring efficiency, we simulated critical arrhythmias in inpatient units with different monitoring systems and compared their efficiency in communicating the arrhythmias to a first responder.

Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial.

Background: The seroprotection rate (SPR) of hepatitis B vaccination in adults is suboptimal. The aim of this study was to compare the SPR of a tri-antigenic hepatitis B vaccine (TAV), with a mono-antigenic vaccine (MAV) in adults of all ages.

Methods: This was a multicentre, double-blind, phase 3, randomised controlled trial (PROTECT) comparing the immunogenicity and safety of TAV with MAV in 28 community and hospital sites in the USA, Finland, Canada, and Belgium.

Organizing Audible Alarm Sounds in the Hospital: A Card-Sorting Study.

In hospitals, clinicians are presented with varied and disorganized alarm sounds from disparate devices. While there has been attention to reducing inactionable alarms to address alarm overload, little effort has focused on organizing, simplifying, or improving the informativeness of alarms. We sought to elicit nurses' tacit interpretation of alarm events to create an organizational structure to inform the design of advanced alarm sounds or integrated alert systems.

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.

Background: Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.

Methods: This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States.

Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial.

Background: Group B streptococcus (GBS) is a major cause of invasive disease in young infants. Infants born to women with sufficient pre-existing anti-GBS capsular IgG antibodies are at reduced risk of GBS disease, making maternal immunisation a potential strategy for prevention. We aimed to assess the safety and immunogenicity of a novel hexavalent (serotypes Ia, Ib, II, III, IV, and V) GBS conjugate vaccine (GBS6).

Iterative heuristic design of temporal graphic displays with clinical domain experts.

Conventional electronic health record information displays are not optimized for efficient information processing. Graphical displays that integrate patient information can improve information processing, especially in data-rich environments such as critical care. We propose an adaptable and reusable approach to patient information display with modular graphical components (widgets).

Impact of integrated graphical display on expert and novice diagnostic performance in critical care.

Objective: To determine the impact of a graphical information display on diagnosing circulatory shock.

Materials And Methods: This was an experimental study comparing integrated and conventional information displays. Participants were intensivists or critical care fellows (experts) and first-year medical residents (novices).

Development and usability testing of an audit and feedback tool for anesthesiologists.

Background: We describe the creation and evaluation of a personal audit and feedback (A&F) tool for anesthesiologists.

Methods: A survey aimed at capturing barriers for personal improvement efforts and feedback preferences was administered to attending anesthesiologists. The results informed the design and implementation of 4 dashboards that display information on individual practice characteristics as well as comparative performance on several quality metrics.

The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial.

Background: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.

Methods: In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group.

Critical care information display approaches and design frameworks: A systematic review and meta-analysis.

Objective: To systematically review original user evaluations of patient information displays relevant to critical care and understand the impact of design frameworks and information presentation approaches on decision-making, efficiency, workload, and preferences of clinicians.

Methods: We included studies that evaluated information displays designed to support real-time care decisions in critical care or anesthesiology using simulated tasks. We searched PubMed and IEEExplore from 1/1/1990 to 6/30/2018.

Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis.

Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three large, 2-week seasonal allergic rhinitis studies. To evaluate long-term (52 weeks) safety and efficacy of GSP301 in patients with perennial allergic rhinitis (PAR). In this randomized, double-blind, parallel-group study, 601 patients (ages ≥ 12 years) with PAR were randomized 4:1:1 to twice-daily GSP301 (olopatadine 665 μg and mometasone 25 μg [pH 3.

Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.

Background: This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily to record changes over seven days. A more sensitive application of this instrument should allow for a better understanding of short-term tolerability of adjuvanted vaccines.

Motion of active tracer in a lattice gas with cross-shaped particles.

We analyze the dynamics of an active tracer particle embedded in a thermal lattice gas. All particles are subject to exclusion up to third nearest neighbors on the square lattice, which leads to slow dynamics at high densities. For the case with no rotational diffusion of the tracer, we derive an analytical expression for the resulting drift velocity v of the tracer in terms of non-equilibrium density correlations involving the tracer particle and its neighbors, which we verify using numerical simulations.

Novel displays of patient information in critical care settings: a systematic review.

Objective: Clinician information overload is prevalent in critical care settings. Improved visualization of patient information may help clinicians cope with information overload, increase efficiency, and improve quality. We compared the effect of information display interventions with usual care on patient care outcomes.

Critical care information display approaches and design frameworks: A systematic review and meta-analysis.

Objective: To systematically review original user evaluations of patient information displays relevant to critical care and understand the impact of design frameworks and information presentation approaches on decision-making, efficiency, workload, and preferences of clinicians.

Methods: We included studies that evaluated information displays designed to support real-time care decisions in critical care or anesthesiology using simulated tasks. We searched PubMed and IEEExplore from 1/1/1990 to 6/30/2018.

Patient information organization in the intensive care setting: expert knowledge elicitation with card sorting methods.

Introduction: Many electronic health records fail to support information uptake because they impose low-level information organization tasks on users. Clinical concept-oriented views have shown information processing improvements, but the specifics of this organization for critical care are unclear.

Objective: To determine high-level cognitive processes and patient information organization schema in critical care.

Triangulating Methodologies from Software, Medicine and Human Factors Industries to Measure Usability and Clinical Efficacy of Medication Data Visualization in an Electronic Health Record System.

Within the last decade, use of Electronic Health Record (EHR) systems has become intimately integrated into healthcare practice in the United States. However, large gaps remain in the study of clinical usability and require rigorous and innovative approaches for testing usability principles. In this study, validated tools from the core functions that EHRs serve-software, medicine and human factors-were combined to holistically understand and objectively measure usability of medication data displays.

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

Background: H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality.

Methods: In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.

Toward Designing Information Display to Support Critical Care. A Qualitative Contextual Evaluation and Visioning Effort.

Objectives: Electronic health information overload makes it difficult for providers to quickly find and interpret information to support care decisions. The purpose of this study was to better understand how clinicians use information in critical care to support the design of improved presentation of electronic health information.

Methods: We conducted a contextual analysis and visioning project.

Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults.

Background:  Almost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development.

Methods:  We evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18-64 years.