Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.

Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.

Using Z Codes to Document Social Risk Factors in the Electronic Health Record: A Scoping Review.

Introduction: Individual-level social risk factors have a significant impact on health. Social risks can be documented in the electronic health record using ICD-10 diagnosis codes (the "Z codes"). This study aims to summarize the literature on using Z codes to document social risks.

Using Patient Experience Surveys to Identify Potential Diagnostic Safety Breakdowns: A Mixed Methods Study.

Objectives: One in 20 outpatients in the United States experiences a diagnostic error each year, but there are no validated methods for collecting feedback from patients on diagnostic safety. We examined patient experience surveys to determine whether patients' free text comments indicated diagnostic breakdowns. Our objective was to evaluate associations between patient-perceived diagnostic breakdowns reported in free text comments and patients' responses to structured survey questions.

"What Else Could It Be?" A Scoping Review of Questions for Patients to Ask Throughout the Diagnostic Process.

Background: Diagnostic errors are a global patient safety challenge. Over 75% of diagnostic errors in ambulatory care result from breakdowns in patient-clinician communication. Encouraging patients to speak up and ask questions has been recommended as one strategy to mitigate these failures.

Ebola virus-induced eye sequelae: a murine model for evaluating glycoprotein-targeting therapeutics.

Background: Ebola virus disease (EVD) survivors experience ocular sequelae including retinal lesions, cataracts, and vision loss. While monoclonal antibodies targeting the Ebola virus glycoprotein (EBOV-GP) have shown promise in improving prognosis, their effectiveness in mitigating ocular sequelae remains uncertain.

Methods: We developed and characterized a BSL-2-compatible immunocompetent mouse model to evaluate therapeutics targeting EBOV-GP by inoculating neonatal mice with vesicular stomatitis virus expressing EBOV-GP (VSV-EBOV).

Racial/ethnic differences in medication for addiction treatment for opioid use disorders among pregnant women in treatment facilities supported by state funds.

Introduction: Medication for addiction treatment (MAT) for opioid use disorder (OUD) in pregnant women is known to improve neonatal health outcomes. Despite the benefits of this evidence-based treatment for OUD, MAT has been underutilized during pregnancy among certain racial/ethnic groups of women in the United States. The purpose of this study was to examine racial/ethnic differences and factors that affect MAT administration among pregnant women with OUD seeking treatment at publicly funded facilities.

The current diabetes education experience: Findings of a cross-sectional survey of adults with type 2 diabetes.

Objective: To survey persons with type 2 diabetes (PWD) on their experiences with diabetes education to better understand what it means when a PWD says they have "had diabetes education."

Methods: We conducted a cross-sectional descriptive study among a convenience sample of adult PWD receiving primary care and/or diabetes self-management education and support in a mid-Atlantic regional US healthcare system. Descriptive, bivariate, and regression analyses were used to describe and explore the diabetes education experience.

Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients.

Unintended immunogenicity can affect the safety and efficacy of therapeutic proteins and peptides, so accurate assessments of immunogenicity risk can aid in the selection, development, and regulation of biologics. Product- and process- related impurities can act as adjuvants that activate the local or systemic innate immune response increasing the likelihood of product immunogenicity. Thus, assessing whether products have innate immune response modulating impurities (IIRMI) is a key component of immunogenicity risk assessments.

BSL2-compliant lethal mouse model of SARS-CoV-2 and variants of concern to evaluate therapeutics targeting the Spike protein.

Since first reported in 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rapidly acquiring mutations, particularly in the spike protein, that can modulate pathogenicity, transmission and antibody evasion leading to successive waves of COVID19 infections despite an unprecedented mass vaccination necessitating continuous adaptation of therapeutics. Small animal models can facilitate understanding host-pathogen interactions, target selection for therapeutic drugs, and vaccine development, but availability and cost of studies in BSL3 facilities hinder progress. To generate a BSL2-compatible system that specifically recapitulates spike protein mediated disease we used replication competent, GFP tagged, recombinant Vesicular Stomatitis Virus where the VSV glycoprotein was replaced by the SARS-CoV-2 spike protein (rVSV-SARS2-S).

Passenger Presence and the Relative Risk of Teen Driver Death.

Purpose: This study examines the relative risk of death among crash-involved teenage drivers in relation to the number and ages of passengers present.

Methods: We performed cross-sectional analysis of police-reported crashes in the United States in years 2016-2019 to estimate rate ratios for death among drivers aged 16-17 years by passenger composition (no passengers, one teen, ≥two teens, teens and adults aged 20-34 years, adults aged 20-34 years only, ≥one adult aged 35-64 years). Models were adjusted for confounding and effect modification related to driver, crash, and environmental factors.

Prevalence of alcohol among drivers, riders and pedestrians injured in road traffic crashes in Cameroon: a cross-sectional study.

The use of alcohol among road users injured in road traffic crashes and admitted to three major hospitals in Cameroon was studied. Alcohol use was measured using breathalyzers, and data on age, gender, education level, religion, type of road user, time of the crash, crash characteristics, and injury severity were recorded using a questionnaire. Of the 350 participants, 30.

Characterization of the therapeutic effect of antibodies targeting the Ebola glycoprotein using a novel BSL2-compliant rVSVΔG-EBOV-GP infection model.

Ebola virus (EBOV) infections cause haemorrhagic fever, multi-organ failure and death, and survivors can experience neurological sequelae. Licensing of monoclonal antibodies targeting EBOV glycoprotein (EBOV-GP) improved its prognosis, however, this treatment is primarily effective during early stages of disease and its effectiveness in reducing neurological sequela remains unknown. Currently, the need for BSL4 containment hinders research and therapeutic development; development of an accessible BSL-2 mouse model would facilitate preclinical studies to screen and select therapeutics.

Roadside surveys of drinking and driving in Cameroon.

Objective: This study aimed to assess the prevalence of drinking and driving on roadways in urban areas and highways in Cameroon, and to determine the associations between drinking and driving and socio-demographic factors.

Methods: A cross-sectional study of motor vehicle drivers was performed on Fridays, Saturdays, and Sundays between May and September 2020 with three driver groups: (1) random motor vehicle drivers (including riders) on major highways, (2) drivers recruited at car stations in Yaoundé, and (3) at fuel stations in Douala. Alcohol was measured using breathalyzers, and a questionnaire collected socio-demographic data.

Potentially Inappropriate Medication Use and Hard Braking Events in Older Drivers.

Potentially inappropriate medications (PIMs) identified by the American Geriatrics Society should generally be avoided by older adults because of ineffectiveness or excess risk of adverse effects. Few studies have examined the effects of PIMs on driving safety measured by prospectively and objectively collected driving data. Data for this study came from the Longitudinal Research on Aging Drivers study, a multisite naturalistic driving study of older adults.

Cannabis and crash risk among older drivers.

The purpose of this research was to reanalyze data collected from the National Highway Traffic Safety Administration's Drug and Alcohol Crash Risk Study to investigate whether driving under the influence of cannabis (THC-positive) was associated with elevated crash risk for younger and older drivers. The data came from a case-control relative risk study collected from Virginia Beach, VA, over a 20-month period. Data collectors gathered driver information from the scene of vehicle crashes and, in some cases, from hospitals.

Diabetes to Go-Inpatient: Pragmatic Lessons Learned from Implementation of Technology-Enabled Diabetes Survival Skills Education Within Nursing Unit Workflow in an Urban, Tertiary Care Hospital.

Background: Diabetes survival skills education (DSSE) focuses on core knowledge and skills necessary for safe, effective, short-term diabetes self-care. Inpatient DSSE delivery approaches are needed. Diabetes to Go (D2Go) is an evidence-based DSSE program originally designed for outpatients.

Long-term persistence of infectious Zika virus: Inflammation and behavioral sequela in mice.

The neurodevelopmental defects associated with ZIKV infections early in pregnancy are well documented, however the potential defects and long-term consequences associated with milder infections in late pregnancy and perinatal period are less well understood. To model these, we challenged 1 day old (P1) immunocompetent C57BL/6 mice with ZIKV. The animals developed a transient neurological syndrome including unsteady gait, kinetic tremors, severe ataxia and seizures 10-15 days post-infection (dpi) but symptoms subsided after a week, and most animals survived.

Medication use and driving patterns in older drivers: preliminary findings from the LongROAD study.

Background: The potential for impaired driving due to medication use can occur at any age, though older adults are more likely to take multiple prescribed medications and experience side effects that may affect driving ability. The purpose of this study was to characterize the relationship between medications and driving safety behaviors.

Methods: Data for this study came from the five-site Longitudinal Research on Aging Drivers (LongROAD) project.

To drive or not to drive? A study of travel behavior for a recent drinking occasion.

Despite decades of education and enforcement campaigns, alcohol-impaired driving persists as a social problem in the U.S. Are there other factors influencing decisions to drive after alcohol consumption that may be amenable to change? We conducted a roadside survey in California in 2012 to assess whether residential accessibility, travel attitudes (indicated by ratings of convenience and safety for travel options), and perceptions of arrest risk affect travel choices made subsequent to alcohol consumption.

Understanding the impact of road design characteristic on teen driver's fatality.

There is little research simultaneously examining both teen drivers' characteristics and the driving environment. This study aimed to investigate how traffic engineering factors (road designs, traffic operations, and surface conditions) contribute to risks of teen driver's fatality. Understanding the role of traffic engineering factors can further improve efforts to reduce teen diving-related fatal crashes.

The Relationship between in-Vehicle Technologies and Self-Regulation among Older Drivers.

The study sought to understand the relationship between in-vehicle technologies (IVTs) and self-regulatory behaviors among older drivers. In a large multi-site study of 2990 older drivers, self-reported data on the presence of IVTs and avoidance of various driving behaviors (talking on a mobile phone while driving, driving at night, driving in bad weather, and making left turns when there is no left turn arrow) were recorded. Self-reports were used to identify whether avoidance was due to self-regulation.

Measuring Drug Use Among Drivers: How Accurate Is Self-Reported Use?

Objective: There has been considerable work validating self-reported drug use with bioassays, but these studies have not been conducted with respondents on the roadway. The objective of this study was to assess the validity of drivers' self-reported drug use.

Method: This study analyzed 2007 and 2013-2014 data from nationally representative roadside surveys of U.

Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes.

Objective: Type 2 diabetes care management (DCM) is challenging. Few studies report meaningful improvements in clinical care settings, warranting DCM redesign. We developed a Boot Camp to provide timely, patient-centered, technology-enabled DCM.

Social Support Moderates the Negative Association Between Reduced Driving and Life Satisfaction in Older Adults.

When older adults reduce their driving, there can be subsequent decreases in life satisfaction. In this cross-sectional study, we used baseline data from the multi-site Longitudinal Research on Aging Drivers (LongROAD) study to examine whether social support moderates the negative association between reduced driving and life satisfaction. The outcome variable was life satisfaction, and the main predictor variable was past-year reduced driving (yes/no).