25 results on '"Swift MD"'
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2. Humoral Responses After SARS-CoV-2 mRNA Vaccination and Breakthrough Infection in Cancer Patients
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Saranya Chumsri, MD, Pooja P. Advani, MD, Tanmayi S. Pai, MD, Zhuo Li, MS, Ashita Mummareddy, Marites Acampora, APRN, Gina A. Reynolds, APRN, Natasha Wylie, APRN, Ashton W. Boyle, Yanyan Lou, MD, PhD, Kabir Mody, MD, Alvaro Moreno-Aspitia, MD, Melanie D. Swift, MD, MPH, Abinash Virk, MD, Adil E. Bharucha, MD, Christopher P. Marquez, MD, Tushar C. Patel, MD, Gregory J. Gores, MD, and Keith L. Knutson, PhD
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Medicine (General) ,R5-920 - Abstract
Objective: To evaluate the magnitude of humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients with cancer receiving active therapies. Patients and Methods: Patients 18 years or older in whom SARS-CoV-2 spike antibody (anti-S Ab) levels were measured after 2 doses of SARS-CoV-2 mRNA vaccines were included. Patients with prior coronavirus disease 2019 (COVID-19) infection or receiving other immunosuppressive therapy were excluded. Results: Among 201 patients who met the criteria, 61 were immunocompetent, 91 had a hematologic malignancy, and 49 had a solid malignancy while receiving treatments associated with cytopenia, including chemotherapy or cyclin-dependent kinase 4 and 6 inhibitors. A significantly greater proportion of immunocompetent patients (96.7% [59 of 61]) had anti-S Ab titers of 500 U/mL or greater compared to patients with hematologic (7.7% [7 of 91) and solid (55.1% [27 of 49]) malignancy (P
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- 2022
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3. Ultrasound as an Educational Tool in Facial Aesthetic Injections
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Leonie Schelke, MD, PhD, Nimrod Farber, MD, and Arthur Swift, MD
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Surgery ,RD1-811 - Abstract
Summary:. Injection therapies for cosmetic enhancement, particularly antiaging treatments, are increasingly popular. However, once the needle has penetrated the skin, the injector is “blind” to the depth and exact location of the needle tip. Duplex ultrasound use before and after treatment can allow the injector to visualize in real time the individual anatomy, thereby improving and confirming the accuracy of the injections through visualization of both the target layer and the vital structures to be avoided. Previously injected permanent filler treatments can also be visualized. In this way, ultrasound use becomes an important educational tool in promoting “safer” facial injection therapy. It shifts static anatomy to mobile real-time facial anatomy, thereby establishing itself as an invaluable learning tool through follow-up imaging, with subsequent optimization in techniques and patient outcomes.
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- 2022
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4. Development of 'Core Syllabus' for Facial Anatomy Teaching to Aesthetic Physicians: A Delphi Consensus
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Narendra Kumar, MSc, Arthur Swift, MD, and Eqram Rahman, MBBS, MS, PhD
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Surgery ,RD1-811 - Abstract
Background:. A detailed understanding of facial anatomy, specifically the vascular framework, is crucial for delivering safe nonsurgical aesthetic procedures. To date, there is no core document based on consensus for the teaching of facial anatomy to aesthetic physicians exists. The aim of this study was to ascertain the most critical anatomical structures for avoiding disastrous complications during nonsurgical aesthetic procedures. Methods:. After a detailed literature review, Delphi questionnaire was developed listing 154 anatomical structures of the face and neck for consensus review. Thirty-five international experts in surgical and nonsurgical facial aesthetics were invited to complete an online survey designed to rank the relevance of each anatomical element on a Likert scale from 1 (not at all important) to 4 (very important) or 5 (no opinion). Consensus for items included in the core syllabus was predefined as achieving a Cronbach’s α ≥ 0.90 and an agreement score of ≥ 80%. Results:. Thirty-four international experts (97.14%) completed the iterative online Delphi survey. The consensus among the specialists polled was achieved after 1 round of the survey (Cronbach’s α = 0.94). The expert panel reached an agreement score of ≥ 80% on 137 of the 154 anatomical structures listed. Conclusion:. The outcome of this Delphi study represents an essential first step in systematizing an evidence-based facial anatomy “Core Syllabus” for the teaching of aesthetic physicians and practitioners. This “Core Syllabus” will act as a blueprint for the educators while crafting a program.
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- 2018
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5. Association of COVID-19 Vaccination With Risk of Medically Attended Postacute Sequelae of COVID-19 During the Ancestral, Alpha, Delta, and Omicron Variant Eras.
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Swift MD, Breeher LE, Dierkhising R, Hickman J, Johnson MG, Roellinger DL, and Virk A
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Background: Uncertainty exists regarding the effectiveness of COVID-19 vaccine to prevent postacute sequelae of COVID-19 (PASC) following a breakthrough infection. While most studies based on symptom surveys found an association between preinfection vaccination status and PASC symptoms, studies of medically attended PASC are less common and have reported conflicting findings., Methods: In this retrospective cohort of patients with an initial SARS-CoV-2 infection who were continually empaneled for primary care in a large US health system, the electronic health record was queried for preinfection vaccination status, demographics, comorbidity index, and diagnosed conditions. Multivariable logistic regression was used to model the outcome of a medically attended PASC diagnosis within 6 months of SARS-CoV-2 infection. Likelihood ratio tests were used to assess the interaction between vaccination status and prevalent variant at the time of infection and between vaccination status and hospitalization for SARS-CoV-2 infection., Results: During the observation period, 6.9% of patients experienced medically attended and diagnosed PASC. A diagnosis of PASC was associated with older age, female sex, hospitalization for the initial infection, and an increased severity-weighted comorbidity index and was inversely associated with infection during the Omicron period. No difference in the development of diagnosed PASC was observed between unvaccinated patients and those vaccinated with either 2 doses of an mRNA vaccine or >2 doses., Conclusions: We found no association between vaccination status at the time of infection and development of medically diagnosed PASC. Vaccine remains an important measure to prevent SARS-CoV-2 infection and severity. Further research is needed to identify effective measures to prevent and treat PASC., Competing Interests: Potential conflicts of interest. M. D. S. discloses a current unpaid elected position on the American College of Occupational and Environmental Medicine Board of Directors. All other authors report no potential conflicts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2024
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6. Physician Health Series, Part 3: Physician Mental Health.
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Couser GP, Newcomb RD, Swift MD, Hagen PT, and Cowl CT
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- Humans, Physician-Patient Relations, Occupational Stress, Stress, Psychological, Mental Health, Physicians psychology
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This article is the third of 3 articles in a series about managing the care of physicians as patients. In part 1, the authors reviewed unique characteristics of physicians as patients with some general guidance for how to approach their care. Part 2 highlighted role clarity for the treating physician with discussion of the physical and cognitive issues that commonly arise when treating physician-patients along with licensure issues and reporting requirements. This final installment will focus on physician mental health and work-related stress., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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7. Part Two: Managing Physicians as Patients and Their Safe Return to Work.
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Couser GP, Hagen PT, Cowl CT, Newcomb RD, and Swift MD
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- Humans, Physician-Patient Relations, Physician's Role, Physicians psychology, Return to Work
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This second installment in a 3-part series about physicians as patients explores challenges in communication and role definition while managing their care and safe return to work. In the first article of the series, authors reviewed unique characteristics that make physicians different as patients, with some general guidance about how to approach their care. Although most treating physicians receive little occupational training, health issues commonly have an impact on work with imperative to address work issues promptly for best outcome. This paper demystifies the challenge of managing work status and discusses navigating common physical and cognitive issues while maintaining role clarity. The treating clinician reading this paper will learn to avoid common pitfalls and be better equipped to provide initial assessments and interventions to keep physicians working safely, keeping in mind licensure issues and reporting requirements. Part Three of the series will focus on the most common mental health issues seen in physicians., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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8. Physician Health Series Part One: Characteristics of Physicians as Patients.
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Couser GP, Hagen PT, Swift MD, Newcomb RD, and Cowl CT
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- Humans, Physician's Role, Mental Health, Physician-Patient Relations, Physicians psychology
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This is the first article of a 3-part series about physician health. In this installment, we outline the unique characteristics of physicians as patients, challenges and opportunities presented by physician-patients, and recommendations for treating physicians. Future articles will delve into role clarity, occupational considerations, mental health, and interactions with third parties such as the physician's employer or licensing board. Ultimately, this series will help treating clinicians provide the best care to their physician-patients and successfully navigate the unique challenges that may arise, especially when the diagnosis may have an impact on their ability to practice medicine., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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9. Outcomes From a Physician Health Center.
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Swift MD, Couser GP, Hagen PT, Nelson MA, Cowl CT, and Murad MH
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- Humans, Retrospective Studies, Health Facilities, Physicians, Medicine
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This retrospective cohort study describes the population of physicians seeking medical evaluation in a dedicated physician health center and identifies factors associated with needing practice restrictions. Participants had an initial evaluation between January 1, 2016, and December 31, 2022. We report personal and professional demographics and types of medical conditions in this cohort. An ordinal logistic regression analysis was used to identify factors associated with occupational outcomes. Physicians in a wide variety of specialties from 34 different states presented for evaluation of diverse medical problems. More than half of the participants presented with occupational concerns. The presence of a neurologic or psychiatric illness were the only factors associated with temporary or permanent restrictions. Physicians with medical conditions impacting their ability to practice have a professional obligation to obtain a thorough, objective medical evaluation. Such evaluations should support and protect patients, employers, and the physicians themselves., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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10. Who is getting boosted? Disparities in COVID-19 vaccine booster uptake among health care workers.
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Farah W, Breeher LE, Hainy CM, Tommaso CP, and Swift MD
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COVID-19 vaccination remains one of the most effective tools to reduce the risk of SARS-CoV-2 infection. Unfortunately, vaccine hesitancy has limited primary vaccination and booster uptake among the general population and HCWs. To gain a better understanding of factors associated with booster vaccine uptake, we analyzed COVID-19 vaccine booster rates among HCWs and identified risk factors associated with nonacceptance. Of the 62,387 HCWs included in our analysis, the overall booster uptake rate was 64.8%. Older age, Non-Hispanic White racial group, early initial vaccine uptake and longer duration of employment were associated with higher booster uptake. Significant differences were observed between different job categories. This persistence of vaccine hesitancy and disparities in COVID-19 booster uptake among HCWs, almost 2 years after the rollout of the COVID-19 vaccination, call for further efforts to increase vaccine confidence among HCWs and the general population in light of the continued need for further COVID-19 protection., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)
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- 2023
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11. Integrating Infectious Diseases and Preventive Medicine Specialties Into 1 Division: Experience of an Academic Medical Center.
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Murad MH, Swift MD, Razonable RR, Tande AJ, Wilson JW, Kasten MJ, Sia IG, Matey JN, Vanichkachorn G, Caine NA, Shah V, O'Horo J, Destro Borgen MJ, Cowl CT, and Berbari EF
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- Humans, Academic Medical Centers, Medicine, Communicable Diseases
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- 2023
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12. Durability analysis of the highly effective BNT162b2 vaccine against COVID-19.
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Puranik A, Lenehan PJ, O'Horo JC, Pawlowski C, Niesen MJM, Virk A, Swift MD, Kremers W, Venkatakrishnan AJ, Gordon JE, Geyer HL, Speicher LL, Soundararajan V, and Badley AD
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COVID-19 vaccines are effective, but breakthrough infections have been increasingly reported. We conducted a test-negative case-control study to assess the durability of protection after full vaccination with BNT162b2 against polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection, in a national medical practice from January 2021 through January 2022. We fit conditional logistic regression (CLR) models stratified on residential county and calendar time of testing to assess the association between time elapsed since vaccination and the odds of symptomatic infection or non-COVID-19 hospitalization (negative control), adjusted for several covariates. There were 5,985 symptomatic individuals with a positive test after full vaccination with BNT162b2 (cases) and 32,728 negative tests contributed by 27,753 symptomatic individuals after full vaccination (controls). The adjusted odds of symptomatic infection were higher 250 days after full vaccination versus at the date of full vaccination (Odds Ratio [OR]: 3.62, 95% CI: 2.52 to 5.20). The odds of infection were still lower 285 days after the first BNT162b2 dose as compared to 4 days after the first dose (OR: 0.50, 95% CI: 0.37 to 0.67), when immune protection approximates the unvaccinated status. Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. The odds of non-COVID-19 associated hospitalization (negative control) decreased with time since vaccination, suggesting a possible underestimation of waning protection by this approach due to confounding factors. In summary, BNT162b2 strongly protected against symptomatic SARS-CoV-2 infection for at least 8 months after full vaccination, but the degree of protection waned significantly over this period., (© The Author(s) 2022. Published by Oxford University Press on behalf of the National Academy of Sciences.)
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- 2022
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13. Durability analysis of the highly effective mRNA-1273 vaccine against COVID-19.
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Puranik A, Lenehan PJ, O'Horo JC, Pawlowski C, Virk A, Swift MD, Kremers W, Venkatakrishnan AJ, Challener DW, Breeher L, Gordon JE, Geyer HL, Speicher LL, Soundararajan V, and Badley AD
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COVID-19 vaccines are effective, but breakthrough infections have been increasingly reported. We conducted a test-negative case-control study to assess the durability of protection against symptomatic infection after vaccination with mRNA-1273. We fit conditional logistic regression (CLR) models stratified on residential county and calendar date of SARS-CoV-2 PCR testing to assess the association between the time elapsed since vaccination and the odds of symptomatic infection, adjusted for several covariates. There were 2,364 symptomatic individuals who had a positive SARS-CoV-2 PCR test after full vaccination with mRNA-1273 ("cases") and 12,949 symptomatic individuals who contributed 15,087 negative tests after full vaccination ("controls"). The odds of symptomatic infection were significantly higher 250 days after full vaccination compared to the date of full vaccination (Odds Ratio [OR]: 2.47, 95% confidence interval [CI]: 1.19-5.13). The odds of non-COVID-19 associated hospitalization and non-COVID-19 pneumonia (negative control outcomes) remained relatively stable over the same time interval (Day 250 OR
Non-COVID Hospitalization : 0.68, 95% CI: 0.47-1.0; Day 250 ORNon-COVID Pneumonia : 1.11, 95% CI: 0.24-5.2). The odds of symptomatic infection remained significantly lower almost 300 days after the first mRNA-1273 dose as compared to 4 days after the first dose, when immune protection approximates the unvaccinated state (OR: 0.26, 95% CI: 0.17-0.39). Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. In summary, mRNA-1273 robustly protected against symptomatic SARS-CoV-2 infection at least 8 months after full vaccination, but the degree of protection waned over this time period., (© The Author(s) 2022. Published by Oxford University Press on behalf of the National Academy of Sciences.)- Published
- 2022
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14. Multiple SARS-CoV-2 Reinfections: A Case Series of Thrice-Infected Individuals.
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Swift MD, Hainy CM, Sampathkumar P, and Breeher LE
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- Humans, Reinfection, Research, COVID-19, SARS-CoV-2
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- 2022
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15. Surveillance of Safety of 3 Doses of COVID-19 mRNA Vaccination Using Electronic Health Records.
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Niesen MJM, Pawlowski C, O'Horo JC, Challener DW, Silvert E, Donadio G, Lenehan PJ, Virk A, Swift MD, Speicher LL, Gordon JE, Geyer HL, Halamka JD, Venkatakrishnan AJ, Soundararajan V, and Badley AD
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- Aged, BNT162 Vaccine, Cohort Studies, Electronic Health Records, Female, Humans, Male, RNA, Messenger, SARS-CoV-2, Vaccination adverse effects, Vaccines, Synthetic, mRNA Vaccines, COVID-19 prevention & control, COVID-19 Vaccines adverse effects
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Importance: Recent reports on waning of COVID-19 vaccine-induced immunity have led to the approval and rollout of additional doses and booster vaccinations. Individuals at increased risk of SARS-CoV-2 infection are receiving additional vaccine doses in addition to the regimen that was tested in clinical trials. Risks and adverse event profiles associated with additional vaccine doses are currently not well understood., Objective: To evaluate the safety of third-dose vaccination with US Food and Drug Administration (FDA)-approved COVID-19 mRNA vaccines., Design, Setting, and Participants: This cohort study was conducted using electronic health record (EHR) data from December 2020 to October 2021 from the multistate Mayo Clinic Enterprise. Participants included all 47 999 individuals receiving 3-dose COVID-19 mRNA vaccines within the study setting who met study inclusion criteria. Participants were divided into 2 cohorts by vaccine brand administered and served as their own control groups, with no comparison made between cohorts. Data were analyzed from September through November 2021., Exposures: Three doses of an FDA-authorized COVID-19 mRNA vaccine, BNT162b2 or mRNA-1273., Main Outcomes and Measures: Vaccine-associated adverse events were assessed via EHR report. Adverse event risk was quantified using the percentage of study participants who reported the adverse event within 14 days after each vaccine dose and during a 14-day control period, immediately preceding the first vaccine dose., Results: Among 47 999 individuals who received 3-dose COVID-19 mRNA vaccines, 38 094 individuals (21 835 [57.3%] women; median [IQR] age, 67.4 [52.5-76.5] years) received BNT162b2 (79.4%) and 9905 individuals (5099 [51.5%] women; median [IQR] age, 67.7 [59.5-73.9] years) received mRNA-1273 (20.6%). Reporting of severe adverse events remained low after the third vaccine dose, with rates of pericarditis (0.01%; 95% CI, 0%-0.02%), anaphylaxis (0%; 95% CI, 0%-0.01%), myocarditis (0%; 95% CI, 0%-0.01%), and cerebral venous sinus thrombosis (no individuals) consistent with results from earlier studies. Significantly more individuals reported low-severity adverse events after the third dose compared with after the second dose, including fatigue (2360 individuals [4.92%] vs 1665 individuals [3.47%]; P < .001), lymphadenopathy (1387 individuals [2.89%] vs 995 individuals [2.07%]; P < .001), nausea (1259 individuals [2.62%] vs 979 individuals [2.04%]; P < .001), headache (1185 individuals [2.47%] vs 992 individuals [2.07%]; P < .001), arthralgia (1019 individuals [2.12%] vs 816 individuals [1.70%]; P < .001), myalgia (956 individuals [1.99%] vs 784 individuals [1.63%]; P < .001), diarrhea (817 individuals [1.70%] vs 595 individuals [1.24%]; P < .001), fever (533 individuals [1.11%] vs 391 individuals [0.81%]; P < .001), vomiting (528 individuals [1.10%] vs 385 individuals [0.80%]; P < .001), and chills (224 individuals [0.47%] vs 175 individuals [0.36%]; P = .01)., Conclusions and Relevance: This study found that although third-dose vaccination against SARS-CoV-2 infection was associated with increased reporting of low-severity adverse events, risk of severe adverse events remained comparable with risk associated with the standard 2-dose regime. These findings suggest the safety of third vaccination doses in individuals who were eligible for booster vaccination at the time of this study.
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- 2022
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16. Comparative effectiveness of mRNA-1273 and BNT162b2 against symptomatic SARS-CoV-2 infection.
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Puranik A, Lenehan PJ, Silvert E, Niesen MJM, Corchado-Garcia J, O'Horo JC, Virk A, Swift MD, Gordon JE, Speicher LL, Geyer HL, Kremers W, Halamka J, Badley AD, Venkatakrishnan AJ, and Soundararajan V
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- 2019-nCoV Vaccine mRNA-1273, BNT162 Vaccine, COVID-19 Vaccines therapeutic use, Humans, Retrospective Studies, SARS-CoV-2 genetics, COVID-19 prevention & control
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Background: mRNA coronavirus disease 2019 (COVID-19) vaccines are safe and effective, but increasing reports of breakthrough infections highlight the need to vigilantly monitor and compare the effectiveness of these vaccines., Methods: We retrospectively compared protection against symptomatic infection conferred by mRNA-1273 and BNT162b2 at Mayo Clinic sites from December 2020 to September 2021. We used a test-negative case-control design to estimate vaccine effectiveness (VE) and to compare the odds of symptomatic infection after full vaccination with mRNA-1273 versus BNT162b2, while adjusting for age, sex, race, ethnicity, geography, comorbidities, and calendar time of vaccination and testing., Findings: Both vaccines were highly effective over the study duration (VE
mRNA-1273 : 84.1%, 95% confidence interval [CI]: 81.6%-86.2%; VEBNT162b2 : 75.6%, 95% CI: 72.2%-78.7%), but their effectiveness was reduced during July-September (VEmRNA-1273 : 75.6%, 95% CI: 70.1%-80%; VEBNT162b2 : 63.5%, 95% CI: 55.8%-69.9%) as compared to December-May (VEmRNA-1273 : 93.7%, 95% CI: 90.4%-95.9%; VEBNT162b2 : 85.7%, 95% CI: 81.4%-88.9%). Adjusted for demographic characteristics, clinical comorbidities, time of vaccination, and time of testing, the odds of experiencing a symptomatic breakthrough infection were lower after full vaccination with mRNA-1273 than with BNT162b2 (odds ratio: 0.60; 95% CI: 0.55-0.67)., Conclusions: Both mRNA-1273 and BNT162b2 strongly protect against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. It is imperative to continue monitoring and comparing available vaccines over time and with respect to emerging variants to inform public and global health decisions., Funding: This study was funded by nference., Competing Interests: A.P., P.J.L., E.S., M.J.M.N., J.C.O., A.J.V., and V.S. are employees of nference and have financial interests in the company. nference is collaborating or has collaborated with Moderna, Pfizer, Janssen, and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. J.C.O. receives personal fees from Elsevier and Bates College and receives small grants from nference, Inc., outside the submitted work. A.D.B. is supported by grants from NIAID (grants AI110173 and AI120698), Amfar (no. 109593), and Mayo Clinic (HH Shieck Khalifa Bib Zayed Al-Nahyan Named Professorship of Infectious Diseases). A.D.B. is a paid consultant for Abbvie, Gilead, Freedom Tunnel, Pinetree Therapeutics, Primmune, Immunome, and Flambeau Diagnostics; is a paid member of the DSMB for Corvus Pharmaceuticals, Equilium, and Excision Biotherapeutics; has received fees for speaking for Reach MD and Medscape; owns equity for scientific advisory work in Zentalis and nference; and is founder and President of Splissen Therapeutics. M.D.S. received grant funding from Pfizer via Duke University for a vaccine side effect registry. J.C.O., A.V., M.D.S., J.E.G., L.L.S., H.L.G., W.K., J.H., and A.D.B. are employees of the Mayo Clinic. The Mayo Clinic may stand to gain financially from the successful outcome of the research. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies., (© 2021 The Authors.)- Published
- 2022
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17. Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19.
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Corchado-Garcia J, Zemmour D, Hughes T, Bandi H, Cristea-Platon T, Lenehan P, Pawlowski C, Bade S, O'Horo JC, Gores GJ, Williams AW, Badley AD, Halamka J, Virk A, Swift MD, Wagner T, and Soundararajan V
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- Ad26COVS1, Adolescent, Adult, Aged, COVID-19 diagnosis, COVID-19 epidemiology, COVID-19 immunology, COVID-19 Nucleic Acid Testing, COVID-19 Vaccines administration & dosage, Drug Evaluation, Female, Humans, Incidence, Male, Middle Aged, Pandemics, Propensity Score, Retrospective Studies, SARS-CoV-2, Severity of Illness Index, Time Factors, United States epidemiology, Vaccination statistics & numerical data, Young Adult, COVID-19 prevention & control, COVID-19 Vaccines immunology
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Importance: Continuous assessment of the effectiveness and safety of the US Food and Drug Administration-authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes., Objective: To evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection., Design, Setting, and Participants: This comparative effectiveness research study used large-scale longitudinal curation of electronic health records from the multistate Mayo Clinic Health System (Minnesota, Arizona, Florida, Wisconsin, and Iowa) to identify vaccinated and unvaccinated adults between February 27 and July 22, 2021. The unvaccinated cohort was matched on a propensity score derived from age, sex, zip code, race, ethnicity, and previous number of SARS-CoV-2 polymerase chain reaction tests. The final study cohort consisted of 8889 patients in the vaccinated group and 88 898 unvaccinated matched patients., Exposure: Single dose of the Ad26.COV2.S vaccine., Main Outcomes and Measures: The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing., Results: The study was composed of 8889 vaccinated patients (4491 men [50.5%]; mean [SD] age, 52.4 [16.9] years) and 88 898 unvaccinated patients (44 748 men [50.3%]; mean [SD] age, 51.7 [16.7] years). The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts was 0.26 (95% CI, 0.20-0.34) (60 of 8889 vaccinated patients vs 2236 of 88 898 unvaccinated individuals), which corresponds to an effectiveness of 73.6% (95% CI, 65.9%-79.9%) and a 3.73-fold reduction in SARS-CoV-2 infections., Conclusions and Relevance: This study's findings are consistent with the clinical trial-reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.
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- 2021
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18. FDA-authorized mRNA COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system.
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Pawlowski C, Lenehan P, Puranik A, Agarwal V, Venkatakrishnan AJ, Niesen MJM, O'Horo JC, Virk A, Swift MD, Badley AD, Halamka J, and Soundararajan V
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- 2019-nCoV Vaccine mRNA-1273, BNT162 Vaccine, Clinical Trials, Phase III as Topic, Humans, Retrospective Studies, SARS-CoV-2 genetics, United States epidemiology, United States Food and Drug Administration, COVID-19 epidemiology, COVID-19 prevention & control, COVID-19 Vaccines
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Background: Two US Food and Drug Administration (FDA)-authorized coronavirus disease 2019 (COVID-19) mRNA vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna), have demonstrated high efficacy in large phase 3 randomized clinical trials. It is important to assess their effectiveness in a real-world setting., Methods: This is a retrospective analysis of 136,532 individuals in the Mayo Clinic health system (Arizona, Florida, Iowa, Minnesota, and Wisconsin) with PCR testing data between December 1, 2020 and April 20, 2021. We compared clinical outcomes for a vaccinated cohort of 68,266 individuals who received at least one dose of either vaccine (n
BNT162b2 = 51,795; nmRNA-1273 = 16,471) and an unvaccinated control cohort of 68,266 individuals propensity matched based on relevant demographic, clinical, and geographic features. We estimated real-world vaccine effectiveness by comparing incidence rates of positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR testing and COVID-19-associated hospitalization and intensive care unit (ICU) admission starting 7 days after the second vaccine dose., Findings: The real-world vaccine effectiveness of preventing SARS-CoV-2 infection was 86.1% (95% confidence interval [CI]: 82.4%-89.1%) for BNT162b2 and 93.3% (95% CI: 85.7%-97.4%) for mRNA-1273. BNT162b2 and mRNA-1273 were 88.8% (95% CI: 75.5%-95.7%) and 86.0% (95% CI: 71.6%-93.9%) effective in preventing COVID-19-associated hospitalization. Both vaccines were 100% effective (95% CIBNT162b2 : 51.4%-100%; 95% CImRNA-1273 : 43.3%-100%) in preventing COVID-19-associated ICU admission., Conclusions: BNT162b2 and mRNA-1273 are effective in a real-world setting and are associated with reduced rates of SARS-CoV-2 infection and decreased burden of COVID-19 on the healthcare system., Funding: This study was funded by nference., Competing Interests: C.P., P.L., A.P., V.A., A.V., M.J.M.N., and V.S. are employees of nference and have financial interests in the company and in the successful application of this research. J.C.O. receives personal fees from Elsevier and Bates College and small grants from nference, Inc., outside of the submitted work. A.D.B. is a consultant for Abbvie, is on scientific advisory boards for nference and Zentalis, and is founder and President of Splissen Therapeutics. J.H., J.C.O., M.D.S., A.V., and A.D.B. are employees of the Mayo Clinic. The Mayo Clinic may stand to gain financially from the successful outcome of the research. nference collaborates with Janssen and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies., (© 2021 Elsevier Inc.)- Published
- 2021
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19. Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines.
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McMurry R, Lenehan P, Awasthi S, Silvert E, Puranik A, Pawlowski C, Venkatakrishnan AJ, Anand P, Agarwal V, O'Horo JC, Gores GJ, Williams AW, Badley AD, Halamka J, Virk A, Swift MD, Carlson K, Doddahonnaiah D, Metzger A, Kayal N, Berner G, Ramudu E, Carpenter C, Wagner T, Rajasekharan A, and Soundararajan V
- Subjects
- BNT162 Vaccine, COVID-19 Vaccines adverse effects, Humans, Mass Vaccination, RNA, Messenger, Retrospective Studies, SARS-CoV-2, United States, United States Food and Drug Administration, COVID-19 prevention & control, Drug-Related Side Effects and Adverse Reactions
- Abstract
Background: As the coronavirus disease 2019 (COVID-19) vaccination campaign unfolds, it is important to continuously assess the real-world safety of Food and Drug Administration (FDA)-authorized vaccines. Curation of large-scale electronic health records (EHRs) enables near-real-time safety evaluations that were not previously possible., Methods: In this retrospective study, we deployed deep neural networks over a large EHR system to automatically curate the adverse effects mentioned by physicians in over 1.2 million clinical notes between December 1, 2020 and April 20, 2021. We compared notes from 68,266 individuals who received at least one dose of BNT162b2 (n = 51,795) or mRNA-1273 (n = 16,471) to notes from 68,266 unvaccinated individuals who were matched by demographic, geographic, and clinical features., Findings: Individuals vaccinated with BNT162b2 or mRNA-1273 had a higher rate of return to the clinic, but not the emergency department, after both doses compared to unvaccinated controls. The most frequently documented adverse effects within 7 days of each vaccine dose included myalgia, headache, and fatigue, but the rates of EHR documentation for each side effect were remarkably low compared to those derived from active solicitation during clinical trials. Severe events, including anaphylaxis, facial paralysis, and cerebral venous sinus thrombosis, were rare and occurred at similar frequencies in vaccinated and unvaccinated individuals., Conclusions: This analysis of vaccine-related adverse effects from over 1.2 million EHR notes of more than 130,000 individuals reaffirms the safety and tolerability of the FDA-authorized mRNA COVID-19 vaccines in practice., Funding: This study was funded by nference., Competing Interests: R.M., P.L., E.S., A.P., S.A., C.P., V.A., A.J.V., P.A., A.R., C.C., K.C., D.D., N.K., E.R., G.B., A.M., T.W., and V.S. are employees of nference and have financial interests in the company and in the successful application of this research. R.M. is a student at Boston University School of Medicine. P.L. is a student at Harvard Medical School. J.C.O. receives personal fees from Elsevier and Bates College and small grants from nference outside the submitted work. A.D.B. is a consultant for AbbVie, is on scientific advisory boards for nference and Zentalis, and is founder and president of Splissen Therapeutics. J.H., J.C.O., G.J.G., A.W.W., A.V., M.D.S., and A.D.B. are employees of the Mayo Clinic. The Mayo Clinic may stand to gain financially from the successful outcome of the research. nference collaborates with Janssen and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic conflict-of-interest policies., (© 2021 Elsevier Inc.)
- Published
- 2021
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20. Prevalence of SARS-CoV-2 Antibodies in a Multistate Academic Medical Center.
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Carter RE, Theel ES, Breeher LE, Swift MD, Van Brunt NA, Smith WR, Blanchfield LL, Daugherty EA, Chapital AB, Matson KM, Bews KA, Johnson PW, Domnick RA, Joyce DE, Geyer HL, Granger D, Hilgart HR, Turgeon CT, Sanders KA, Matern D, Nassar A, Sampathkumar P, Hainy CM, Orford RR, Vachon CM, Didehban R, Morice WG, Ting HH, Williams AW, Gray RJ, Thielen KR, and Farrugia G
- Subjects
- Academic Medical Centers, Adult, Female, Humans, Immunoglobulin G blood, Male, Middle Aged, Public Health methods, Seroepidemiologic Studies, Spatio-Temporal Analysis, United States epidemiology, Antibodies, Viral blood, COVID-19 blood, COVID-19 epidemiology, COVID-19 therapy, COVID-19 Serological Testing methods, COVID-19 Serological Testing statistics & numerical data, Disease Transmission, Infectious statistics & numerical data, Health Personnel statistics & numerical data, SARS-CoV-2 immunology, SARS-CoV-2 isolation & purification
- Abstract
Objective: To estimate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in health care personnel., Methods: The Mayo Clinic Serology Screening Program was created to provide a voluntary, two-stage testing program for SARS-CoV-2 antibodies to health care personnel. The first stage used a dried blood spot screening test initiated on June 15, 2020. Those participants identified as reactive were advised to have confirmatory testing via a venipuncture. Venipuncture results through August 8, 2020, were considered. Consent and authorization for testing was required to participate in the screening program. This report, which was conducted under an institutional review board-approved protocol, only includes employees who have further authorized their records for use in research., Results: A total of 81,113 health care personnel were eligible for the program, and of these 29,606 participated in the screening program. A total of 4284 (14.5%) of the dried blood spot test results were "reactive" and warranted confirmatory testing. Confirmatory testing was completed on 4094 (95.6%) of the screen reactive with an overall seroprevalence rate of 0.60% (95% CI, 0.52% to 0.69%). Significant variation in seroprevalence was observed by region of the country and age group., Conclusion: The seroprevalence for SARS-CoV-2 antibodies through August 8, 2020, was found to be lower than previously reported in other health care organizations. There was an observation that seroprevalence may be associated with community disease burden., (Copyright © 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2021
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21. Evidence-Based Strategies for Clinical Organizations to Address COVID-19 Vaccine Hesitancy.
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Finney Rutten LJ, Zhu X, Leppin AL, Ridgeway JL, Swift MD, Griffin JM, St Sauver JL, Virk A, and Jacobson RM
- Subjects
- COVID-19 epidemiology, Humans, Pandemics, COVID-19 prevention & control, COVID-19 Vaccines pharmacology, Health Knowledge, Attitudes, Practice, Patient Acceptance of Health Care, SARS-CoV-2 immunology, Social Media, Vaccination statistics & numerical data
- Abstract
The success of vaccination programs is contingent upon irrefutable scientific safety data combined with high rates of public acceptance and population coverage. Vaccine hesitancy, characterized by lack of confidence in vaccination and/or complacency about vaccination that may lead to delay or refusal of vaccination despite the availability of services, threatens to undermine the success of coronavirus disease 2019 (COVID-19) vaccination programs. The rapid pace of vaccine development, misinformation in popular and social media, the polarized sociopolitical environment, and the inherent complexities of large-scale vaccination efforts may undermine vaccination confidence and increase complacency about COVID-19 vaccination. Although the experience of recent lethal surges of COVID-19 infections has underscored the value of COVID-19 vaccines, ensuring population uptake of COVID-19 vaccination will require application of multilevel, evidence-based strategies to influence behavior change and address vaccine hesitancy. Recent survey research evaluating public attitudes in the United States toward the COVID-19 vaccine reveals substantial vaccine hesitancy. Building upon efforts at the policy and community level to ensure population access to COVID-19 vaccination, a strong health care system response is critical to address vaccine hesitancy. Drawing on the evidence base in social, behavioral, communication, and implementation science, we review, summarize, and encourage use of interpersonal, individual-level, and organizational interventions within clinical organizations to address this critical gap and improve population adoption of COVID-19 vaccination., (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2021
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22. Revisiting the Safety of Health Care Workers.
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Breeher LE, Sampathkumar P, Beam E, Hainy CM, Austin MD, and Swift MD
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- COVID-19 epidemiology, COVID-19 prevention & control, COVID-19 therapy, Humans, Occupational Exposure prevention & control, Quarantine, Respiration, Artificial adverse effects, Respiration, Artificial instrumentation, Health Personnel, Infectious Disease Transmission, Patient-to-Professional prevention & control, Occupational Health
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- 2020
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23. Vaccines for Health Care Personnel.
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Swift MD and Behrman AJ
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- Humans, Occupational Diseases microbiology, Health Personnel, Occupational Diseases prevention & control, Occupational Health, Vaccination, Vaccines
- Abstract
Medical Center Occupational Health (MCOH) programs must protect health care personnel (HCP) against the occupational risk of vaccine-preventable diseases. This thematic review outlines the rationale for the use of recommended vaccines in HCP; summarizes the available evidence regarding vaccine effectiveness, administration, and assessment of immunity; and provides guidance for MCOH programs navigating challenging situations., (Copyright © 2019 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2019
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24. Emergency Preparedness in the Workplace: The Flulapalooza Model for Mass Vaccination.
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Swift MD, Aliyu MH, Byrne DW, Qian K, McGown P, Kinman PO, Hanson KL, Culpepper D, Cooley TJ, and Yarbrough MI
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- Humans, Models, Organizational, Tennessee, Civil Defense organization & administration, Disaster Planning organization & administration, Influenza, Human prevention & control, Mass Vaccination organization & administration, Workplace organization & administration
- Abstract
Objectives: To explore whether an emergency preparedness structure is a feasible, efficient, and sustainable way for health care organizations to manage mass vaccination events., Methods: We used the Hospital Incident Command System to conduct a 1-day annual mass influenza vaccination event at Vanderbilt University Medical Center over 5 successive years (2011-2015). Using continuous quality improvement principles, we assessed whether changes in layout, supply management, staffing, and documentation systems improved efficiency., Results: A total of 66 591 influenza vaccines were administered at 5 annual Flulapalooza events; 13 318 vaccines per event on average. Changes to the physical layout, staffing mix, and documentation processes improved vaccination efficiency 74%, from approximately 38 to 67 vaccines per hour per vaccinator, while reducing overall staffing needs by 38%. An unexpected finding was the role of social media in facilitating active engagement., Conclusions: Health care organizations can use a closed point-of-dispensing model and Hospital Incident Command System to conduct mass vaccination events, and can adopt the "Flulapalooza method" as a best practice model to enhance efficiency.
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- 2017
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25. The Need for Mandatory Random Drug Testing in Anesthesia Providers.
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Rice MJ, Grek SB, Swift MD, Nance JJ, and Shaw AD
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- Anesthesiology standards, Humans, Anesthesiologists standards, Mandatory Testing methods, Substance Abuse Detection methods, Substance-Related Disorders diagnosis, Substance-Related Disorders prevention & control
- Published
- 2017
- Full Text
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