Medicine and Health Sciences Commons^™

Vaccine Effectiveness Against Influenza A(H3n2)-Associated Hospitalized Illness: United States, 2022, Mark W Tenforde, Jennie H Kwon, Et Al.

2020-Current year OA Pubs

BACKGROUND: The COVID-19 pandemic was associated with historically low influenza circulation during the 2020-2021 season, followed by an increase in influenza circulation during the 2021-2022 US season. The 2a.2 subgroup of the influenza A(H3N2) 3C.2a1b subclade that predominated was antigenically different from the vaccine strain.

METHODS: To understand the effectiveness of the 2021-2022 vaccine against hospitalized influenza illness, a multistate sentinel surveillance network enrolled adults aged ≥18 years hospitalized with acute respiratory illness and tested for influenza by a molecular assay. Using the test-negative design, vaccine effectiveness (VE) was measured by comparing the odds of current-season influenza vaccination in influenza-positive …

Molnupiravir And Risk Of Hospital Admission Or Death In Adults With Covid-19: Emulation Of A Randomized Target Trial Using Electronic Health Records, Yan Xie, Benjamin Bowe, Ziyad Al-Aly

2020-Current year OA Pubs

OBJECTIVE: To emulate a randomized target trial to estimate the association between the antiviral drug molnupiravir and hospital admission or death in adults with SARS-CoV-2 infection in the community during the omicron predominant era who were at high risk of progression to severe covid-19.

DESIGN: Emulation of a randomized target trial using electronic health records.

SETTING: US Department of Veterans Affairs.

PARTICIPANTS: 85 998 adults with SARS-CoV-2 infection between 5 January and 30 September 2022 and at least one risk factor for progression to severe covid-19: 7818 participants were eligible for and treated with molnupiravir and 78 180 received no …

Long-Term Gastrointestinal Outcomes Of Covid-19, Evan Xu, Yan Xie, Ziyad Al-Aly

2020-Current year OA Pubs

A comprehensive evaluation of the risks and 1-year burdens of gastrointestinal disorders in the post-acute phase of COVID-19 is needed but is not yet available. Here we use the US Department of Veterans Affairs national health care databases to build a cohort of 154,068 people with COVID-19, 5,638,795 contemporary controls, and 5,859,621 historical controls to estimate the risks and 1-year burdens of a set of pre-specified incident gastrointestinal outcomes. We show that beyond the first 30 days of infection, people with COVID-19 exhibited increased risks and 1-year burdens of incident gastrointestinal disorders spanning several disease categories including motility disorders, acid …

Social Determinants, Cardiovascular Disease, And Health Care Cost: A Nationwide Study In The United States Using Machine Learning, Feinuo Sun, Jie Yao, Shichao Du, Feng Qian, Allison A Appleton, Cui Tao, Hua Xu, Lei Liu, Qi Dai, Brian T Joyce, Drew R Nannini, Lifang Hou, Kai Zhang

2020-Current year OA Pubs

Background Existing studies on cardiovascular diseases (CVDs) often focus on individual-level behavioral risk factors, but research examining social determinants is limited. This study applies a novel machine learning approach to identify the key predictors of county-level care costs and prevalence of CVDs (including atrial fibrillation, acute myocardial infarction, congestive heart failure, and ischemic heart disease). Methods and Results We applied the extreme gradient boosting machine learning approach to a total of 3137 counties. Data are from the

Care Of Bullet-Related Injuries: A Cross-Sectional Study Of Instructions And Prescriptions Provided On Discharge From The Emergency Department, Jane M. Hayes, L J. Punch, Kristen L. Mueller

2020-Current year OA Pubs

INTRODUCTION: There are more than 80,000 emergency department (ED) visits for non-fatal bullet-related injuries (BRI) per year in the United States. Approximately half of these patients are discharged home from the ED. Our objective in this study was to characterize the discharge instructions, prescriptions, and follow-up plans provided to patients discharged from the ED after BRI.

METHODS: This was a single-center, cross-sectional study of the first 100 consecutive patients who presented to an urban, academic, Level I trauma center ED with an acute BRI beginning on January 1, 2020. We queried the electronic health record for patient demographics, insurance status, …

Incidence, Attributable Mortality, And Healthcare And Out-Of-Pocket Costs Of Clostridioides Difficile Infection In Us Medicare Advantage Enrollees, Holly Yu, Tamuno Alfred, Jennifer L Nguyen, Jingying Zhou, Margaret A Olsen

2020-Current year OA Pubs

BACKGROUND: US attributable Clostridioides difficile infection (CDI) mortality and cost data are primarily from Medicare fee-for-service populations, and little is known about Medicare Advantage Enrollees (MAEs). This study evaluated CDI incidence among MAEs from 2012 to 2019 and determined attributable mortality and costs by comparing MAEs with and without CDI occurring in 2018.

METHODS: This retrospective cohort study assessed CDI incidence and associated mortality and costs for eligible MAEs ≥65 years of age using the de-identified Optum Clinformatics Data Mart database (Optum; Eden Prairie, Minnesota, USA). Outcomes included mortality, healthcare utilization, and costs, which were assessed via a propensity score-matched …

Protection Of Messenger Rna Vaccines Against Hospitalized Coronavirus Disease 2019 In Adults Over The First Year Following Authorization In The United States, Mark W Tenforde, Hilary M Babcock, Jennie H Kwon, Et Al.

2020-Current year OA Pubs

BACKGROUND: Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines were authorized in the United States in December 2020. Although vaccine effectiveness (VE) against mild infection declines markedly after several months, limited understanding exists on the long-term durability of protection against COVID-19-associated hospitalization.

METHODS: Case-control analysis of adults (≥18 years) hospitalized at 21 hospitals in 18 states 11 March-15 December 2021, including COVID-19 case patients and reverse transcriptase-polymerase chain reaction-negative controls. We included adults who were unvaccinated or vaccinated with 2 doses of a mRNA vaccine before the date of illness onset. VE over time was assessed using logistic regression comparing …

Fifty Years Of Global Cardiovascular Research In Africa: A Scientometric Analysis, 1971 To 2021, Jean Jacques Noubiap, Dominic Millenaar, Dike Ojji, Q Eileen Wafford, Christian Ukena, Michael Böhm, Karen Sliwa, Mark D Huffman, Felix Mahfoud

2020-Current year OA Pubs

Background To analyze the quantity and impact of cardiovascular research done in Africa or coauthored by researchers based in Africa, their determinants, and the patterns of research collaboration. Methods and Results We retrieved data from Web of Science and additional sources. We analyzed temporal trends from 1971 to 2021 and geographical distribution, research impact using country-level h-index, international research cooperation, and associations of research quantity and quality using linear regression. The annual volume of cardiovascular research from Africa has increased from 4 publications in 1971 to 3867 in 2020 and currently represents ~3% of the global cardiovascular research output. Authors …

Identification Of Bradycardia Following Remdesivir Administration Through The Us Food And Drug Administration American College Of Medical Toxicology Covid-19 Toxic Pharmacovigilance Project, Jason M Devgun, Rongmei Zhang, Jeffrey Brent, Paul Wax, Keith Burkhart, Alison Meyn, Sharan Campleman, Stephanie Abston, Kim Aldy, Toxicology Investigators Consortium Fact Study Group

2020-Current year OA Pubs

IMPORTANCE: The rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion-associated AE listed in the US Food and Drug Administration-approved prescribing information.

OBJECTIVE: To evaluate the magnitude and duration of bradycardic events following remdesivir administration.

DESIGN, SETTING, AND PARTICIPANTS: A multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 …

Alcohol Consumption And Epigenetic Age Acceleration In Young Adults, Drew R Nannini, Lei Liu, Et Al.

2020-Current year OA Pubs

Alcohol is a widely consumed substance in the United States, however its effect on aging remains understudied. In this study of young adults, we examined whether cumulative alcohol consumption, i.e., alcohol years of beer, liquor, wine, and total alcohol, and recent binge drinking, were associated with four measures of age-related epigenetic changes via blood DNA methylation. A random subset of study participants in the Coronary Artery Risk Development in Young Adults Study underwent DNA methylation profiling using the Illumina MethylationEPIC Beadchip. Participants with alcohol consumption and methylation data at examination years 15 (

Large Variations In The Prices Of Urologic Procedures At Academic Medical Centers 1 Year After Implementation Of The Price Transparency Final Rule, Zeynep G Gul, Danielle R Sharbaugh, Cailey J Guercio, Daniel L Pelzman, Cameron A Jones, Emily C Hacker, Vivian I Anyaeche, Levi Bowers, Ashti M Shah, Michael G Stencel, Jonathan G Yabes, Bruce L Jacobs, Benjamin J Davies

2020-Current year OA Pubs

IMPORTANCE: Patients with urologic diseases often experience financial toxicity, defined as high levels of financial burden and concern, after receiving care. The Price Transparency Final Rule, which requires hospitals to disclose both the commercial and cash prices for at least 300 services, was implemented to facilitate price shopping, decrease price dispersion, and lower health care costs.

OBJECTIVE: To evaluate compliance with the Price Transparency Final Rule and to quantify variations in the price of urologic procedures among academic hospitals and by insurance class.

DESIGN, SETTING, AND PARTICIPANTS: This was a cross-sectional study that determined the prices of 5 common urologic …

Use Of Learner-Driven, Formative, Ad-Hoc, Prospective Assessment Of Competence In Physical Therapist Clinical Education In The United States: A Prospective Cohort Study, Carey Holleran, Jeffrey Konrad, Barbara Norton, Tamara Burlis, Steven Ambler

2020-Current year OA Pubs

PURPOSE: The purpose of this project was to implement a process for learner-driven, formative, prospective, ad-hoc, entrustment assessment in Doctor of Physical Therapy clinical education. Our goals were to develop an innovative entrustment assessment tool, and then explore whether the tool detected (1) differences between learners at different stages of development and (2) differences within learners across the course of a clinical education experience. We also investigated whether there was a relationship between the number of assessments and change in performance.

METHODS: A prospective, observational, cohort of clinical instructors (CIs) was recruited to perform learner-driven, formative, ad-hoc, prospective, entrustment assessments. …

Biologic Targets Of Prescription Medications And Risk Of Neurodegenerative Disease In United States Medicare Beneficiaries, Yizhe Song, Brad A. Racette, Alejandra Camacho-Soto, Susan Searles Nielsen

2020-Current year OA Pubs

OBJECTIVE: To identify prescription medications associated with a lower risk of three neurodegenerative diseases: Parkinson disease, Alzheimer disease, and amyotrophic lateral sclerosis.

METHODS: We conducted a population-based, case-control study of U.S. Medicare beneficiaries in 2009 (42,885 incident neurodegenerative disease cases, 334,387 randomly selected controls). Using medication data from 2006-2007, we categorized all filled medications according to their biological targets and mechanisms of action on those targets. We used multinomial logistic regression models, while accounting for demographics, indicators of smoking, and health care utilization, to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for 141 target-action pairs and each neurodegenerative …

Association Of Hospital Centrality In Inter-Hospital Patient-Sharing Networks With Patient Mortality And Length Of Stay, Regan W. Bergmark, Ginger Jin, Robert S. Semco, Marc Santolini, Margaret A. Olsen, Amar Dhand

2020-Current year OA Pubs

OBJECTIVE: The interdependence of hospitals is underappreciated in patient outcomes studies. We used a network science approach to foreground this interdependence. Specifically, within two large state-based interhospital networks, we examined the relationship of a hospital's network position with in-hospital mortality and length of stay.

METHODS: We constructed interhospital network graphs using data from the Healthcare Cost and Utilization Project and the American Hospital Association Annual Survey for Florida (2014) and California (2011). The exposure of interest was hospital centrality, defined as weighted degree (sum of all ties to a given hospital from other hospitals). The outcomes were in-hospital mortality and …

Characterization Of Combined Endoscopies And Aerodigestive Care: An Analysis Of Utilization And Financial Feasibility, Jennifer Brinkmeier, Noor Al-Hammadi, Sumana Shashidhar, Leslie Hinyard, Dhiren Patel

2020-Current year OA Pubs

BACKGROUND: Aerodigestive care is one model of multi-disciplinary care, which is a valuable tool for both providers and patients. Aerodigestive care models are associated with improved outcomes, reduced anesthesia exposure, reduction in hospital admissions, and fewer days of missed work or school. This is the first study to explore national usage and cost trends in combined endoscopy utilization to identify gaps in care and the potential for financial resource optimization.

METHODS: Data from the Healthcare Cost and Utilization Project (HCUP) Kid's Inpatient Sample (KID) was used from 2016 and 2019. Diagnoses and procedures were identified using ICD-10 codes, for patients …

Utilization Of Cardiovascular Magnetic Resonance (Cmr) Imaging For Resumption Of Athletic Activities Following Covid-19 Infection: An Expert Consensus Document On Behalf Of The American Heart Association Council On Cardiovascular Radiology And Intervention (Cvri) Leadership And Endorsed By The Society For Cardiovascular Magnetic Resonance (Scmr), Frederick L. Ruberg, Aaron L. Baggish, Allison G. Hays, Michael Jerosch-Herold, Jiwon Kim, Karen G. Ordovas, Gautham Reddy, Chetan Shenoy, Jonathan W. Weinsaft, Pamela K. Woodard

2020-Current year OA Pubs

The global pandemic of coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory suyndrome coronavirus 2 (SARS-CoV-2) is now entering its 4th year with little evidence of abatement. As of December 2022, the World Health Organization Coronavirus (COVID-19) Dashboard reported 643 million cumulative confirmed cases of COVID-19 worldwide and 98 million in the United States alone as the country with the highest number of cases. While pneumonia with lung injury has been the manifestation of COVID-19 principally responsible for morbidity and mortality, myocardial inflammation and systolic dysfunction though uncommon are well-recognized features that also associate with adverse prognosis. …

Utilization Of Cardiovascular Magnetic Resonance (Cmr) Imaging For Resumption Of Athletic Activities Following Covid-19 Infection: An Expert Consensus Document On Behalf Of The American Heart Association Council On Cardiovascular Radiology And Intervention (Cvri) Leadership And Endorsed By The Society For Cardiovascular Magnetic Resonance (Scmr), Frederick L Ruberg, Aaron L Baggish, Allison G Hays, Michael Jerosch-Herold, Jiwon Kim, Karen G Ordovas, Gautham Reddy, Chetan Shenoy, Jonathan W Weinsaft, Pamela K Woodard

2020-Current year OA Pubs

The global pandemic of coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory suyndrome coronavirus 2 (SARS-CoV-2) is now entering its 4th year with little evidence of abatement. As of December 2022, the World Health Organization Coronavirus (COVID-19) Dashboard reported 643 million cumulative confirmed cases of COVID-19 worldwide and 98 million in the United States alone as the country with the highest number of cases. While pneumonia with lung injury has been the manifestation of COVID-19 principally responsible for morbidity and mortality, myocardial inflammation and systolic dysfunction though uncommon are well-recognized features that also associate with adverse prognosis. …

Topics And Sentiment Surrounding Vaping On Twitter And Reddit During The 2019 E-Cigarette And Vaping Use-Associated Lung Injury Outbreak: Comparative Study, Dezhi Wu, Erin Kasson, Avineet Kumar Singh, Yang Ren, Nina Kaiser, Ming Huang, Patricia A Cavazos-Rehg

2020-Current year OA Pubs

BACKGROUND: Vaping or e-cigarette use has become dramatically more popular in the United States in recent years. e-Cigarette and vaping use-associated lung injury (EVALI) cases caused an increase in hospitalizations and deaths in 2019, and many instances were later linked to unregulated products. Previous literature has leveraged social media data for surveillance of health topics. Individuals are willing to share mental health experiences and other personal stories on social media platforms where they feel a sense of community, reduced stigma, and empowerment.

OBJECTIVE: This study aimed to compare vaping-related content on 2 popular social media platforms (ie, Twitter and Reddit) …

Racial And Ethnic Disparities In Access To Minimally Invasive Mitral Valve Surgery, Laurent G Glance, Karen E Joynt Maddox, Michael Mazzefi, Peter W Knight, Michael P Eaton, Changyong Feng, Miklos D Kertai, James Albernathy, Isaac Y Wu, Julie A Wyrobek, Marisa Cevasco, Nimesh Desai, Andrew W Dick

2020-Current year OA Pubs

IMPORTANCE: Whether people from racial and ethnic minority groups experience disparities in access to minimally invasive mitral valve surgery (MIMVS) is not known.

OBJECTIVE: To investigate racial and ethnic disparities in the utilization of MIMVS.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from the Society of Thoracic Surgeons Database for patients who underwent mitral valve surgery between 2014 and 2019. Statistical analysis was performed from January 24 to August 11, 2022.

EXPOSURES: Patients were categorized as non-Hispanic White, non-Hispanic Black, and Hispanic individuals.

MAIN OUTCOMES AND MEASURES: The association between MIMVS (vs full sternotomy) and race and ethnicity …

Wellness And Coping Of Physicians Who Worked In Icus During The Pandemic: A Multicenter Cross-Sectional North American Survey, Karen E. A. Burns, Rachel K. Mcdonald, Et Al.

2020-Current year OA Pubs

OBJECTIVES: Few surveys have focused on physician moral distress, burnout, and professional fulfilment. We assessed physician wellness and coping during the COVID-19 pandemic.

DESIGN: Cross-sectional survey using four validated instruments.

SETTING: Sixty-two sites in Canada and the United States.

SUBJECTS: Attending physicians (adult, pediatric; intensivist, nonintensivist) who worked in North American ICUs.

INTERVENTION: None.

MEASUREMENTS AND MAIN RESULTS: We analysed 431 questionnaires (43.3% response rate) from 25 states and eight provinces. Respondents were predominantly male (229 [55.6%]) and in practice for 11.8 ± 9.8 years. Compared with prepandemic, respondents reported significant intrapandemic increases in days worked/mo, ICU bed occupancy, and …

Changes In Racial Equity Associated With Participation In The Bundled Payments For Care Improvement Advanced Program, Gmerice Hammond, E John Orav, Jie Zheng, Arnold M Epstein, Karen E Joynt Maddox

2020-Current year OA Pubs

IMPORTANCE: The Medicare alternative payment models are designed to incentivize cost reduction and quality improvement, but there are no requirements established for evaluating the outcomes of the Medicare populations.

OBJECTIVE: To examine whether participation in the Medicare Bundled Payments for Care Improvement Advanced (BPCI-A) program was associated with narrowing or widening of Black and White racial inequities in outcomes and access.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort alternative payment models on equity and quality for disadvantaged populations were studied between April 6, 2021, and August 28, 2022, in US hospitals. Black and White Medicare beneficiaries admitted for any of the …

Gantenerumab: An Anti-Amyloid Monoclonal Antibody With Potential Disease-Modifying Effects In Early Alzheimer's Disease, Randall J Bateman, Jeffrey Cummings, Scott Schobel, Stephen Salloway, Bruno Vellas, Mercè Boada, Sandra E Black, Kaj Blennow, Paulo Fontoura, Gregory Klein, Sheila Seleri Assunção, Janice Smith, Rachelle S Doody

2020-Current year OA Pubs

BACKGROUND: This review describes the research and development process of gantenerumab, a fully human anti-amyloid monoclonal antibody in development to treat early symptomatic and asymptomatic Alzheimer's disease (AD). Anti-amyloid monoclonal antibodies can substantially reverse amyloid plaque pathology and may modify the course of the disease by slowing or stopping its clinical progression. Several molecules targeting amyloid have failed in clinical development due to drug-related factors (e.g., treatment-limiting adverse events, low potency, poor brain penetration), study design/methodological issues (e.g., disease stage, lack of AD pathology confirmation), and other factors. The US Food and Drug Administration's approval of aducanumab, an anti-amyloid monoclonal …

Return Of Non-Acmg Recommended Incidental Genetic Findings To Pediatric Patients: Considerations And Opportunities From Experiences In Genomic Sequencing, Kevin M Bowling, Michelle L Thompson, Melissa A Kelly, Sarah Scollon, Anne M Slavotinek, Bradford C Powell, Brian M Kirmse, Laura G Hendon, Kyle B Brothers, Bruce R Korf, Gregory M Cooper, John M Greally, Anna C E Hurst

2020-Current year OA Pubs

BACKGROUND: The uptake of exome/genome sequencing has introduced unexpected testing results (incidental findings) that have become a major challenge for both testing laboratories and providers. While the American College of Medical Genetics and Genomics has outlined guidelines for laboratory management of clinically actionable secondary findings, debate remains as to whether incidental findings should be returned to patients, especially those representing pediatric populations.

METHODS: The Sequencing Analysis and Diagnostic Yield working group in the Clinical Sequencing Evidence-Generating Research Consortium has collected a cohort of pediatric patients found to harbor a genomic sequencing-identified non-ACMG-recommended incidental finding. The incidental variants were not thought …

Real-World Utilization And Outcomes Of Systemic Therapy Among Patients With Advanced Or Recurrent Endometrial Cancer In The United States, Jinan Liu, Bruno Emond, Eric M Maiese, Marie-Hélène Lafeuille, Patrick Lefebvre, Isabelle Ghelerter, Caterina Wu, Jean A Hurteau, Premal H Thaker

2020-Current year OA Pubs

OBJECTIVE: Evaluate systemic therapy utilization patterns and outcomes by line of therapy among patients with advanced/recurrent endometrial cancer (EC) treated in the United States.

METHODS: This retrospective observational study used the Optum Clinformatics Extended Data Mart Date of Death database (1 January 2004-31 December 2019) and included de-identified data from adult patients with advanced/recurrent EC who were treated with first-line (1L) platinum-based chemotherapy and initiated second-line (2L) anti-neoplastic therapy. The index date was the date of 1L therapy initiation. The number and sequence of treatments received and the proportion of patients who received each type of treatment for each line …

Accounting For The Growth Of Observation Stays In The Assessment Of Medicare's Hospital Readmissions Reduction Program, Amber K Sabbatini, Karen E Joynt-Maddox, Joshua M Liao, Anirban Basu, Canada Parrish, William Kreuter, Brad Wright

2020-Current year OA Pubs

IMPORTANCE: Decreases in 30-day readmissions following the implementation of the Medicare Hospital Readmissions Reduction Program (HRRP) have occurred against the backdrop of increasing hospital observation stay use, yet observation stays are not captured in readmission measures.

OBJECTIVE: To examine whether the HRRP was associated with decreases in 30-day readmissions after accounting for observation stays.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included a 20% sample of inpatient admissions and observation stays among Medicare fee-for-service beneficiaries from January 1, 2009, to December 31, 2015. Data analysis was performed from November 2021 to June 2022. A differences-in-differences analysis assessed changes in …

Real-World Evidence Supporting Tandem Control-Iq Hybrid Closed-Loop Success In The Medicare And Medicaid Type 1 And Type 2 Diabetes Populations, Gregory P Forlenza, Anders L Carlson, Rodolfo J Galindo, Davida F Kruger, Carol J Levy, Janet B Mcgill, Guillermo Umpierrez, Grazia Aleppo

2020-Current year OA Pubs

No abstract provided.

Association Between The Affordable Care Act Medicaid Expansion And Receipt Of Cardiac Resynchronization Therapy By Race And Ethnicity, Hunter Mwansa, Ibrahim Barry, Shannon M Knapp, Sula Mazimba, Elizabeth Calhoun, Nancy K Sweitzer, Khadijah Breathett

2020-Current year OA Pubs

Background Black and Hispanic patients are less likely to receive cardiac resynchronization therapy (CRT) than White patients. Medicaid expansion has been associated with increased access to cardiovascular care among racial and ethnic groups with higher prevalence of underinsurance. It is unknown whether the Medicaid expansion was associated with increased receipt of CRT by race and ethnicity. Methods and Results Using Healthcare Cost and Utilization Project Data State Inpatient Databases from 19 states and Washington, DC, we analyzed 1061 patients from early-adopter states (Medicaid expansion by January 2014) and 745 patients from nonadopter states (no implementation 2013-2014). Estimates of change in …

Effectiveness Of The Ad26.Cov2.S (Johnson & Johnson) Coronavirus Disease 2019 (Covid-19) Vaccine For Preventing Covid-19 Hospitalizations And Progression To High Disease Severity In The United States, Nathaniel M Lewis, Hilary M Babcock, Jennie H Kwon, Et Al.

2020-Current year OA Pubs

Background . Adults in the United States (US) began receiving the adenovirus vector coronavirus disease 2019 (COVID-19) vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. Methods . In a multicenter case-control analysis of US adults (≥18 years) hospitalized 11 March to 15 December 2021, we estimated VE against susceptibility to COVID-19 hospitalization (VEs), comparing odds of prior vaccination with a single dose Ad26.COV2.S vaccine between hospitalized cases with COVID-19 and controls without COVID-19. Among hospitalized patients with COVID-19, …

Incisionless Targeted Adeno-Associated Viral Vector Delivery To The Brain By Focused Ultrasound-Mediated Intranasal Administration, Dezhuang Ye, Jinyun Yuan, Yaoheng Yang, Yimei Yue, Zhongtao Hu, Siaka Fadera, Hong Chen

2020-Current year OA Pubs

BACKGROUND: Adeno-associated viral (AAV) vectors are currently the leading platform for gene therapy with the potential to treat a variety of central nervous system (CNS) diseases. There are numerous methods for delivering AAVs to the CNS, such as direct intracranial injection (DI), intranasal delivery (IN), and intravenous injection with focused ultrasound-induced blood-brain barrier disruption (FUS-BBBD). However, non-invasive and efficient delivery of AAVs to the brain with minimal systemic toxicity remain the major challenge. This study aims to investigate the potential of focused ultrasound-mediated intranasal delivery (FUSIN) in AAV delivery to brain.

METHODS: Mice were intranasally administered with AAV5 encoding enhanced …

Evaluation Challenges For The Application Of Extended Reality Devices In Medicine, Ryan Beams, Jennifer Silva, Et Al.

2020-Current year OA Pubs

Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices' safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration's public workshop, "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine" and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight …