Medicine and Health Sciences Commons^™

Obesity And Outcomes Of Kawasaki Disease And Covid-19-Related Multisystem Inflammatory Syndrome In Children, Michael Khoury, William B Orr, Et Al.

2020-Current year OA Pubs

IMPORTANCE: Obesity may affect the clinical course of Kawasaki disease (KD) in children and multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19.

OBJECTIVE: To compare the prevalence of obesity and associations with clinical outcomes in patients with KD or MIS-C.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, analysis of International Kawasaki Disease Registry (IKDR) data on contemporaneous patients was conducted between January 1, 2020, and July 31, 2022 (42 sites, 8 countries). Patients with MIS-C (defined by Centers for Disease Control and Prevention criteria) and patients with KD (defined by American Heart Association criteria) were included. Patients with …

Segregated Patterns Of Hospital Care Delivery And Health Outcomes, Sunny C Lin, J. Gmerice Hammond, Michael Esposito, Cassandra Majewski, Randi E Foraker, Karen E Joynt Maddox

2020-Current year OA Pubs

IMPORTANCE: Residential segregation has been shown to be a root cause of racial inequities in health outcomes, yet little is known about current patterns of racial segregation in where patients receive hospital care or whether hospital segregation is associated with health outcomes. Filling this knowledge gap is critical to implementing policies that improve racial equity in health care.

OBJECTIVE: To characterize contemporary patterns of racial segregation in hospital care delivery, identify market-level correlates, and determine the association between hospital segregation and health outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of US hospital referral regions (HRRs) used 2018 Medicare claims, …

Was Covid-19 Associated With Worsening Inequities In Stroke Treatment And Outcomes?, Laurent G Glance, Curtis G Benesch, Karen E Joynt Maddox, Matthew T Bender, Jingjing Shang, Patricia W Stone, Stewart J Lustik, Jacob W Nadler, Christopher Galton, Andrew W Dick

2020-Current year OA Pubs

Background COVID-19 stressed hospitals and may have disproportionately affected the stroke outcomes and treatment of Black and Hispanic individuals. Methods and Results This retrospective study used 100% Medicare Provider Analysis and Review file data from between 2016 and 2020. We used interrupted time series analyses to examine whether the COVID-19 pandemic exacerbated disparities in stroke outcomes and reperfusion therapy. Among 1 142 560 hospitalizations for acute ischemic strokes, 90 912 (8.0%) were Hispanic individuals; 162 752 (14.2%) were non-Hispanic Black individuals; and 888 896 (77.8%) were non-Hispanic White individuals. The adjusted odds of mortality increased by 51% (adjusted odds ratio …

Changes In Cardiovascular Spending, Care Utilization, And Clinical Outcomes Associated With Participation In Bundled Payments For Care Improvement - Advanced, Sukruth A. Shashikumar, Jie Zheng, E. John Orav, Arnold M. Epstein, Karen E. Joynt Maddox

2020-Current year OA Pubs

BACKGROUND: Bundled Payments for Care Improvement - Advanced (BPCI-A) is a Medicare initiative that aims to incentivize reductions in spending for episodes of care that start with a hospitalization and end 90 days after discharge. Cardiovascular disease, an important driver of Medicare spending, is one of the areas of focus BPCI-A. It is unknown whether BPCI-A is associated with spending reductions or quality improvements for the 3 cardiovascular medical events or 5 cardiovascular procedures in the model.

METHODS: In this retrospective cohort study, we conducted difference-in-differences analyses using Medicare claims for patients discharged between January 1, 2017, and September 30, …

Association Between Socioeconomic Factors, Race, And Use Of A Specialty Memory Clinic, Abigail Lewis, Aditi Gupta, Inez Oh, Suzanne E. Schindler, Nupur Ghoshal, Zachary Abrams, Randi Foraker, Barbara Joy Snider, John C. Morris, Joyce Balls-Berry, Mahendra Gupta, Philip R. O. Payne, Albert M. Lai

2020-Current year OA Pubs

BACKGROUND AND OBJECTIVES: The capacity of specialty memory clinics in the United States is very limited. If lower socioeconomic status or minoritized racial group is associated with reduced use of memory clinics, this could exacerbate health care disparities, especially if more effective treatments of Alzheimer disease become available. We aimed to understand how use of a memory clinic is associated with neighborhood-level measures of socioeconomic factors and the intersectionality of race.

METHODS: We conducted an observational cross-sectional study using electronic health record data to compare the neighborhood advantage of patients seen at the Washington University Memory Diagnostic Center with the …

Diagnostic Criteria For Identifying Individuals At High Risk Of Progression From Mild Or Moderate To Severe Alcohol Use Disorder, Alex P Miller, Emma C Johnson, Rebecca Tillman, Vivia V Mccutcheon, Kathleen K Bucholz, Arpana Agrawal, Et Al.

2020-Current year OA Pubs

IMPORTANCE: Current Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) diagnoses of substance use disorders rely on criterion count-based approaches, disregarding severity grading indexed by individual criteria.

OBJECTIVE: To examine correlates of alcohol use disorder (AUD) across count-based severity groups (ie, mild, moderate, mild-to-moderate, severe), identify specific diagnostic criteria indicative of greater severity, and evaluate whether specific criteria within mild-to-moderate AUD differentiate across relevant correlates and manifest in greater hazards of severe AUD development.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study involved 2 cohorts from the family-based Collaborative Study on the Genetics of Alcoholism (COGA) with 7 sites …

Introduction To A Compendium Of Strategies To Prevent Healthcare-Associated Infections In Acute-Care Hospitals: 2022 Updates, Deborah S Yokoe, Hilary M Babcock, Erik R Dubberke, Jonas Marschall, Et Al.

2020-Current year OA Pubs

Since the initial publication of

Adding Pharmacist-Led Home Blood Pressure Telemonitoring To Usual Care For Blood Pressure Control: A Systematic Review And Meta-Analysis, Nischit Baral, Annabelle Santos Volgman, Amith Seri, Vijaya Chelikani, Sakiru Isa, Sri L P Javvadi, Timir K Paul, Joshua D Mitchell

2020-Current year OA Pubs

Health systems have been quickly adopting telemedicine throughout the United States, especially since the onset of the COVID-19 pandemic. However, there are limited data on whether adding pharmacist-led home blood pressure (BP) telemonitoring to office-based usual care improves BP. We searched PubMed/MEDLINE and Embase for randomized controlled trials from January 2000 until April 2022, comparing studies on pharmacist-led home BP telemonitoring with usual care. Six randomized controlled trials, including 1,550 participants, satisfied the inclusion criteria. There were 774 participants in the pharmacist-led telemonitoring group and 776 in the usual care group. The addition of pharmacist-led telemonitoring to usual care was …

State Public Assistance Spending And Survival Among Adults With Cancer, Justin M Barnes, Kenton J Johnston, Kimberly J Johnson, Fumiko Chino, Nosayaba Osazuwa-Peters

2020-Current year OA Pubs

IMPORTANCE: Social determinants of health contribute to disparities in cancer outcomes. State public assistance spending, including Medicaid and cash assistance programs for socioeconomically disadvantaged individuals, may improve access to care; address barriers, such as food and housing insecurity; and lead to improved cancer outcomes for marginalized populations.

OBJECTIVE: To determine whether state-level public assistance spending is associated with overall survival (OS) among individuals with cancer, overall and by race and ethnicity.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included US adults aged at least 18 years with a new cancer diagnosis from 2007 to 2013, with follow-up through 2019. Data …

Postacute Sequelae Of Covid-19 At 2 Years, Benjamin Bowe, Yan Xie, Ziyad Al-Aly

2020-Current year OA Pubs

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can lead to postacute sequelae in multiple organ systems, but evidence is mostly limited to the first year postinfection. We built a cohort of 138,818 individuals with SARS-CoV-2 infection and 5,985,227 noninfected control group from the US Department of Veterans Affairs and followed them for 2 years to estimate the risks of death and 80 prespecified postacute sequelae of COVID-19 (PASC) according to care setting during the acute phase of infection. The increased risk of death was not significant beyond 6 months after infection among nonhospitalized but remained significantly elevated through the …

Perspectives On Long-Acting Formulations Of Pre-Exposure Prophylaxis (Prep) Among Men Who Have Sex With Men Who Are Non-Adherent To Daily Oral Prep In The United States, Brooke G Rogers, R R Patel, K Curoe, J Villalobos, A Underwood, Et Al.

2020-Current year OA Pubs

INTRODUCTION: Pre-exposure prophylaxis (PrEP) persistence among men who have sex with men (MSM) in real world clinical settings for HIV prevention is suboptimal. New longer-acting formulations of PrEP are becoming available, including injectables, subdermal implants, and other oral medications. These longer-acting formulations have the potential to improve retention among those who have challenges remaining adherent to daily oral PrEP.

METHODS: We interviewed 49 MSM who had initiated but discontinued oral PrEP at three diverse clinics across the United States. We examined participants' perspectives about long-acting PrEP formulations and how long-acting options could affect PrEP use using thematic analysis.

RESULTS: Participants …

The Covid-19 Pandemic And Associated Inequities In Acute Myocardial Infarction Treatment And Outcomes, Laurent G Glance, Karen E Joynt Maddox, Jingjing Shang, Patricia W Stone, Stewart J Lustik, Peter W Knight, Andrew W Dick

2020-Current year OA Pubs

IMPORTANCE: The COVID-19 pandemic disrupted usual care for emergent conditions, such as acute myocardial infarction (AMI). Understanding whether Black and Hispanic individuals experiencing AMI had greater increases in poor outcomes compared with White individuals during the pandemic has important equity implications.

OBJECTIVE: To investigate whether the COVID-19 pandemic was associated with increased disparities in treatment and outcomes among Medicare patients hospitalized with AMI.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used Medicare data for patients hospitalized with AMI between January 2016 and November 2020. Patients were categorized as Hispanic, non-Hispanic Black, and non-Hispanic White. The association between race and ethnicity …

Alcohol Consumption Among Adults With A Cancer Diagnosis In The All Of Us Research Program, Mengyao Shi, Chongliang Luo, Oluseye K Oduyale, Xiaoyu Zong, Noelle K Loconte, Yin Cao

2020-Current year OA Pubs

IMPORTANCE: Alcohol consumption is associated with adverse oncologic and treatment outcomes among individuals with a diagnosis of cancer. As a key modifiable behavioral factor, alcohol consumption patterns among cancer survivors, especially during treatment, remain underexplored in the United States.

OBJECTIVE: To comprehensively characterize alcohol consumption patterns among US cancer survivors.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from May 6, 2018, to January 1, 2022, from the National Institutes of Health All of Us Research Program, a diverse US cohort with electronic health record (EHR) linkage, and included 15 199 participants who reported a cancer diagnosis and 1839 …

Proportion Of Physicians Who Treat Patients With Greater Social And Clinical Risk And Physician Inclusion In Medicare Advantage Networks, Jung Ho Gong, Kenton J Johnston, David J Meyers

2020-Current year OA Pubs

IMPORTANCE: Medicare Advantage (MA) plans are expanding rapidly, now serving 50% of all Medicare enrollees. Little is known about how inclusion rates of physicians in MA plan networks vary by the social and clinical risks of their patients.

OBJECTIVE: To examine the association of physicians caring for patients with higher levels of social and clinical risk in traditional Medicare (TM) with the likelihood of inclusion in MA plan networks.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study evaluated the number of patients of physicians participating in TM Part B in 2019. The data analysis was conducted between June 2022 and March …

Economic Impact Of Recurrent Clostridioides Difficile Infection In The Usa: A Systematic Literature Review And Cost Synthesis, Kelly R Reveles, Min Yang, Viviana Garcia-Horton, Marie Louise Edwards, Amy Guo, Thomas Lodise, Markian Bochan, Glenn Tillotson, Erik R Dubberke

2020-Current year OA Pubs

INTRODUCTION: Up to 35% of patients with a first episode of Clostridioides difficile infection (CDI) develop recurrent CDI (rCDI), and of those, up to 65% experience multiple recurrences. A systematic literature review (SLR) was conducted to review and summarize the economic impact of rCDI in the United States of America.

METHODS: English-language publications reporting real-world healthcare resource utilization (HRU) and/or direct medical costs associated with rCDI in the USA were searched in MEDLINE, MEDLINE In-Process, Embase, and the Cochrane Library databases over the past 10 years (2012-2022), as well as in selected scientific conferences that publish research on rCDI and …

Inequities In Treatments And Outcomes Among Patients Hospitalized With Hypertrophic Cardiomyopathy In The United States, Daniel Y Johnson, R J Waken, Daniel K Fox, Gmerice Hammond, Karen E Joynt Maddox, Sharon Cresci

2020-Current year OA Pubs

Background Hypertrophic cardiomyopathy (HCM) is the most common heritable cardiac disease. In small studies, sociodemographic factors have been associated with disparities in septal reduction therapy, but little is known about the association of sociodemographic factors with HCM treatments and outcomes more broadly. Methods and Results Using the National Inpatient Survey from 2012 to 2018, HCM diagnoses and procedures were identified by

American Academy Of Orthopaedic Surgeons Clinical Practice Guideline Summary: Management Of Anterior Cruciate Ligament Injuries, Robert H. Brophy, Kent Jason Lowry

2020-Current year OA Pubs

Management of Anterior Cruciate Ligament Injuries : Evidence-based Clinical Practice Guideline is based on a systematic review of published studies for the treatment of anterior cruciate ligament injurie in both skeletally mature and immature patients. This guideline contains eight recommendations and seven options to assist orthopaedic surgeons and all qualified physicians managing patients with ACL injuries based on the best current available evidence. It is also intended to serve as an information resource for professional healthcare practitioners and developers of practice guidelines and recommendations. In addition to providing pragmatic practice recommendations, this guideline also highlights gaps in the literature and …

Integrating Tobacco Treatment Into Oncology Care: Reach And Effectiveness Of Evidence-Based Tobacco Treatment Across National Cancer Institute-Designated Cancer Centers, Sarah D Hohl, Alex T Ramsey, Li-Shiun Chen, Et Al.

2020-Current year OA Pubs

PURPOSE: Quitting smoking improves patients' clinical outcomes, yet smoking is not commonly addressed as part of cancer care. The Cancer Center Cessation Initiative (C3I) supports National Cancer Institute-designated cancer centers to integrate tobacco treatment programs (TTPs) into routine cancer care. C3I centers vary in size, implementation strategies used, and treatment approaches. We examined associations of these contextual factors with treatment reach and smoking cessation effectiveness.

METHODS: This cross-sectional study used survey data from 28 C3I centers that reported tobacco treatment data during the first 6 months of 2021. Primary outcomes of interest were treatment reach (reach)-the proportion of patients identified …

The Evolution Of Primary Care Telehealth Disparities During Covid-19: Retrospective Cohort Study, Rachel D'Amico, Patrick M Schnell, Randi Foraker, J Nwando Olayiwola, Daniel E Jonas, Seuli Bose Brill

2020-Current year OA Pubs

BACKGROUND: Telehealth has become widely used as a novel way to provide outpatient care during the COVID-19 pandemic, but data about telehealth use in primary care remain limited. Studies in other specialties raise concerns that telehealth may be widening existing health care disparities, requiring further scrutiny of trends in telehealth use.

OBJECTIVE: Our study aims to further characterize sociodemographic differences in primary care via telehealth compared to in-person office visits before and during the COVID-19 pandemic and determine if these disparities changed throughout 2020.

METHODS: We conducted a retrospective cohort study in a large US academic center with 46 primary …

Dynamic Frailty Risk Assessment Among Older Adults With Multiple Myeloma: A Population-Based Cohort Study, Hira Mian, Tanya M Wildes, Ravi Vij, Matthew J Pianko, Ajay Major, Mark A Fiala

2020-Current year OA Pubs

Multiple myeloma (MM) is a cancer of older adults and those who are more frail are at high risk of poor outcomes. Current tools for identifying and categorizing frail patients are often static and measured only at the time of diagnosis. The concept of dynamic frailty (i.e. frailty changing over time) is largely unexplored in MM. In our study, adults with newly-diagnosed MM who received novel drugs between the years 2007-2014 were identified in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked databases. Using a previously published cumulative deficit approach, a frailty index score was calculated at diagnosis and each …

State-Level Macro-Economic Factors Moderate The Association Of Low Income With Brain Structure And Mental Health In U.S. Children, David G Weissman, Mark L Hatzenbuehler, Mina Cikara, Deanna M Barch, Katie A Mclaughlin

2020-Current year OA Pubs

Macrostructural characteristics, such as cost of living and state-level anti-poverty programs relate to the magnitude of socioeconomic disparities in brain development and mental health. In this study we leveraged data from the Adolescent Brain and Cognitive Development (ABCD) study from 10,633 9-11 year old youth (5115 female) across 17 states. Lower income was associated with smaller hippocampal volume and higher internalizing psychopathology. These associations were stronger in states with higher cost of living. However, in high cost of living states that provide more generous cash benefits for low-income families, socioeconomic disparities in hippocampal volume were reduced by 34%, such that …

Molnupiravir And Risk Of Post-Acute Sequelae Of Covid-19: Cohort Study, Yan Xie, Taeyoung Choi, Ziyad Al-Aly

2020-Current year OA Pubs

OBJECTIVE: To examine whether treatment with the antiviral agent molnupiravir during the first five days of SARS-CoV-2 infection is associated with reduced risk of post-acute adverse health outcomes.

DESIGN: Cohort study.

SETTING: US Department of Veterans Affairs.

PARTICIPANTS: 229 286 participants who tested positive for SARS-CoV-2 between 5 January 2022 and 15 January 2023, had at least one risk factor for progression to severe covid-19, and survived the first 30 days after testing positive were enrolled. 11 472 participants received a prescription for molnupiravir within five days of the positive test result and 217 814 received no covid-19 antiviral or …

Changing Trends In Demographics, Risk Factors, And Clinical Features Of Patients With Infective Endocarditis-Related Stroke, 2005-2015, Mohamed Ridha, Opeolu Adeoye, Et Al.

2020-Current year OA Pubs

BACKGROUND AND OBJECTIVES: There is a rising incidence of infective endocarditis-related stroke (IERS) in the United States attributed to the opioid epidemic. A contemporary epidemiologic description is necessary to understand the impact of the opioid epidemic on clinical characteristics of IERS. We describe and analyze trends in the demographics, risk factors, and clinical features of IERS.

METHODS: This is a retrospective cohort study within a biracial population of 1.3 million in the Greater Cincinnati/Northern Kentucky region. All hospitalized patients with hemorrhagic or ischemic stroke were identified and physician verified from the 2005, 2010, and 2015 calendar years using ICD-9 and …

Air Pollution And Acute Kidney Injury In The U.S. Medicare Population: A Longitudinal Cohort Study, Whanhee Lee, Ziyad Al-Aly, Et Al.

2020-Current year OA Pubs

BACKGROUND: Recent studies have reported the association between air pollution exposure and reduced kidney function. However, it is unclear whether air pollution is associated with an increased risk of acute kidney injury (AKI).

OBJECTIVES: To address this gap in knowledge, we investigated the effect estimates of long-term exposures to fine particulate matter [PM

METHODS: This nationwide population-based longitudinal cohort study included 61,300,754 beneficiaries enrolled in Medicare Part A fee-for-service (FFS) who were

RESULTS: Exposure to

DISCUSSION: This study found an association between exposures to air pollution and the risk of the first hospital admission with AKI, and this association persisted …

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 …

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 …

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 …

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, …

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 …