RESUMO
OBJECTIVE: To assess the association of COVID-19 vaccines and non-COVID-19 vaccines with cerebral venous sinus thrombosis (CVST). MATERIALS AND METHOD: We retrospectively analyzed a cohort of 771,805 vaccination events across 266,094 patients in the Mayo Clinic Health System between 01/01/2017 and 03/15/2021. The primary outcome was a positive diagnosis of CVST, identified either by the presence of a corresponding ICD code or by an NLP algorithm which detected positive diagnosis of CVST within free-text clinical notes. For each vaccine we calculated the relative risk by dividing the incidence of CVST in the 30 days following vaccination to that in the 30 days preceding vaccination. RESULTS: We identified vaccination events for all FDA-approved COVID-19 vaccines including Pfizer-BioNTech (n = 94,818 doses), Moderna (n = 36,350 doses) and Johnson & Johnson - J&J (n = 1,745 doses). We also identified vaccinations events for 10 common FDA-approved non-COVID-19 vaccines (n = 771,805 doses). There was no statistically significant difference in the incidence rate of CVST in 30-days before and after vaccination for any vaccine in this population. We further found the baseline CVST incidence in the study population between 2017 and 2021 to be 45 to 98 per million patient years. CONCLUSIONS: This real-world evidence-based study finds that CVST is rare and is not significantly associated with COVID-19 vaccination in our patient cohort. Limitations include the rarity of CVST in our dataset, a relatively small number of J&J COVID-19 vaccination events, and the use of a population drawn from recipients of a SARS-CoV-2 PCR test in a single health system.
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Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Trombose dos Seios Intracranianos/epidemiologia , Vacinação/efeitos adversos , COVID-19/imunologia , COVID-19/virologia , Registros Eletrônicos de Saúde , Humanos , Incidência , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose dos Seios Intracranianos/diagnóstico , Fatores de Tempo , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: Patients receiving dialysis are at increased risk for lower extremity amputations (LEAs) and postoperative morbidity. Limited studies have examined differences in 30-day outcomes of mortality and health care use after amputation or the preoperative factors that relate to worsened outcomes in dialysis patients. Our objective was to examine dialysis dependency and other preoperative factors associated with readmission or death after LEA. METHODS: A retrospective cohort study was conducted of dialysis-dependent and nondialysis patients undergoing major LEA in the 2012 to 2013 American College of Surgeons National Surgical Quality Improvement Program. Primary outcomes included death and hospital readmission within 30 days of amputation. RESULTS: Of 6468 patients, 1166 (18%) were dialysis dependent. The dialysis cohort had more blacks (39% vs 23%), diabetes (76% vs 58%), below-knee amputations (62% vs 55%), and in-hospital deaths (8% vs 3%; all P < .001). The 30-day postoperative death rates (15% vs 7%) and readmission rates (35% vs 20% per 30 person-days; both P < .001) were higher in dialysis patients. Among the live discharges, the rate of any readmission or death within 30 days from amputation was highest in those aged ≥50 years (40% per 30 person-days). Multivariable analyses in the dialysis cohort revealed increased age, above-knee amputation, decreased physical status, heart failure, high preoperative white blood cell count, and low platelet count to be associated with death (P < .05; C statistic, 0.75). The only preoperative factor associated with readmission in dialysis patients was race (P = .04; C statistic, 0.58). CONCLUSIONS: Readmission or death after amputation is increased among dialysis patients. Predicting which dialysis patients are at highest risk for death is feasible, whereas predicting which will require readmission is less so. Risk factor identification may improve risk stratification, inform reimbursement policies, and allow targeted interventions to improve outcomes.
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Amputação Cirúrgica/efeitos adversos , Amputação Cirúrgica/mortalidade , Extremidade Inferior/irrigação sanguínea , Readmissão do Paciente , Doença Arterial Periférica/cirurgia , Diálise Renal/efeitos adversos , Diálise Renal/mortalidade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/etnologia , Doença Arterial Periférica/mortalidade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
AIMS: This paper reports on rounding interventions employed at high performing hospitals, and provides three case studies on how proactive nurse rounding was successfully implemented to improve patient-centredness. BACKGROUND: Proactive nurse rounding is a popular form of rounding that has shown promise for improving patient outcomes, yet, little evidence exists on how to implement it successfully. METHODS: We identified high-performing hospitals in the domains of staff responsiveness and nurse communications in the Hospital Consumer Assessment of Health Providers and Systems survey nationally, and conducted case studies at three of these hospitals exploring their implementation of proactive nurse rounding. We partnered with leaders from these hospitals to describe the associated challenges and lessons learned. RESULTS: Twenty-six high performing hospitals in the domains of staff responsiveness and/or nurse communication were identified. The majority of nursing units reported proactive nurse rounding as their main rounding intervention (96%). CONCLUSIONS: Proactive rounding interventions are a feasible approach to help surface and address hospitalized patients' needs in a timely manner. IMPLICATIONS FOR NURSING MANAGEMENT: The information and tools provided in this paper build upon the learning from high performing hospitals' experiences and are useful to nurse leaders in their efforts to improve the patient-centeredness in the hospital.
Assuntos
Pacientes Internados/estatística & dados numéricos , Avaliação das Necessidades/normas , Enfermeiras e Enfermeiros/normas , Competência Clínica/normas , Hospitalização/estatística & dados numéricos , Humanos , Enfermeiras e Enfermeiros/psicologia , Cultura Organizacional , Assistência Centrada no Paciente/normasRESUMO
Recent literature suggests an increase in the incidence of acute kidney injury (AKI). We evaluated population-based trends of AKI over the course of nine years, using a validated electronic health record tool to detect AKI. All adult residents (18 years of age and older) of Olmsted County, Minnesota (MN), admitted to the Mayo Clinic Hospital between 2006 and 2014 were included. The incidence rate of AKI was calculated and temporal trends in the annual AKI incident rates assessed. During the nine-year study period, 10,283, and 41,847 patients were admitted to the intensive care unit or general ward, with 1,740 and 2,811 developing AKI, respectively. The unadjusted incidence rates were 186 and 287 per 100,000 person years in 2006 and reached 179 and 317 per 100,000 person years in 2014. Following adjustment for age and sex, there was no significant change in the annual AKI incidence rate during the study period with a Relative Risk of 0.99 per year (95% confidence interval 0.97-1.01) for intensive care unit patients and 0.993 per year (0.98-1.01) for the general ward patients. Similar results were obtained when the ICD-9 codes or administrative data for dialysis-requiring AKI was utilized to determine incident cases. Thus, despite the current literature that suggests an epidemic of AKI, we found that after adjusting for age and sex the incidence of AKI in the general population remained relatively stable over the last decade.
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Injúria Renal Aguda/epidemiologia , Monitoramento Epidemiológico , Unidades de Terapia Intensiva/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Hospitalização/tendências , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Minnesota/epidemiologia , Diálise Renal , Fatores de RiscoRESUMO
AIMS: End-stage renal disease (ESRD) is associated with high morbidity and mortality. A prior study showed that many Canadian patients regretted their decision to start dialysis. We sought to determine if US patients also regretted dialysis. MATERIALS AND METHODS: We surveyed hemodialysis patients within 55 miles of Rochester, MN, with a 25-question survey about their perceptions of their health, preparedness for dialysis, advance care planning, and regrets about starting dialysis. Surveys were administered in person at the patients' usual dialysis session from July 1 through December 1, 2014; responses were captured electronically. RESULTS: Of the 198 eligible patients, 128 participated (70% men); 80% received dialysis for more than 1 year; 38% reported their health and 58% described their quality of life as "good" or "very good"; 51% had started dialysis in the hospital; and 68% agreed they were prepared for what to expect. Only 35% of patients reported being offered supportive care without dialysis. Most patients (82%) recalled a discussion about prognosis. Only 43% completed an advance directive, but 72% thought it was at least "very important" to plan for the end of life. Nine (7%) reported regretting the decision to start dialysis. CONCLUSIONS: Most of our patients were optimistic about their health and prognosis. Few regretted the decision to start dialysis.â©.
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Emoções , Falência Renal Crônica/terapia , Satisfação do Paciente , Qualidade de Vida , Diálise Renal/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Inquéritos Epidemiológicos , Humanos , Falência Renal Crônica/psicologia , Masculino , Pessoa de Meia-Idade , PrognósticoRESUMO
BACKGROUND: Efficient and safe delivery of care to dialysis patients is essential. Concerns have been raised regarding the ability of accountable care organizations to adequately serve this high-risk population. Little is known about primary care involvement in the care of dialysis patients. This study sought to describe the extent of primary care provider (PCP) involvement in the care of hemodialysis patients and the outcomes associated with that involvement. METHODS: In a retrospective cohort study, patients accessing a Midwestern dialysis network from 2001 to 2010 linked to United States Renal Database System and with >90 days follow up were identified (n = 2985). Outpatient visits were identified using Current Procedural Terminology (CPT)-4 codes, provider specialty, and grouped into quartiles-based on proportion of PCP visits per person-year (ppy). Top and bottom quartiles represented patients with high primary care (HPC) or low primary care (LPC), respectively. Patient characteristics and health care utilization were measured and compared across patient groups. RESULTS: Dialysis patients had an overall average of 4.5 PCP visits ppy, ranging from 0.6 in the LPC group to 6.9 in the HPC group. HPC patients were more likely female (43.4% vs. 35.3%), older (64.0 yrs. vs. 60.0 yrs), and with more comorbidities (Charlson 7.0 vs 6.0). HPC patients had higher utilization (hospitalizations 2.2 vs. 1.8 ppy; emergency department visits 1.6 vs 1.2 ppy) and worse survival (3.9 vs 4.3 yrs) and transplant rates (16.3 vs. 31.5). CONCLUSIONS: PCPs are significantly involved in the care of hemodialysis patients. Patients with HPC are older, sicker, and utilize more resources than those managed primarily by nephrologists. After adjusting for confounders, there is no difference in outcomes between the groups. Further studies are needed to better understand whether there is causal impact of primary care involvement on patient survival.
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Recursos em Saúde/estatística & dados numéricos , Falência Renal Crônica/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Assistência ao Paciente/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Diálise Renal/estatística & dados numéricos , Adolescente , Adulto , Idoso , Estudos de Coortes , Feminino , Recursos em Saúde/tendências , Humanos , Falência Renal Crônica/epidemiologia , Masculino , Pessoa de Meia-Idade , Meio-Oeste dos Estados Unidos/epidemiologia , Assistência ao Paciente/tendências , Atenção Primária à Saúde/tendências , Diálise Renal/tendências , Estudos Retrospectivos , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Though cardiovascular disease is an important cause of mortality in patients with end-stage renal disease, epidemiology of ST-elevation myocardial infarction (STEMI) is less well described in this population. METHODS: This study included STEMI hospitalizations in patients aged ≥20 using Nationwide Inpatient Sample Database from 2006 to 2010. Primary outcomes were incidence and trends of STEMI hospitalizations based on renal function status. We also looked at utilization of revascularization procedures, all-cause-hospital mortality and predictors of mortality. RESULTS: Of the estimated 882,447 STEMI hospitalizations, 11,383 were on maintenance dialysis and 1,076 had renal transplants. The incidence of STEMI was over 7 times in patients on maintenance dialysis and 1.73 times in renal transplant recipients compared to the general population. This incidence has however declined in those on maintenance dialysis (p for trend <0.001) to a greater extent than the general population and patients with renal transplant. Utilization of revascularization procedures was lowest in patients on maintenance dialysis (51.6 vs. 73.3% in renal transplant recipients and 77.0% in general population; p < 0.001) and mortality was highest (21.6 vs. 10.9 vs. 6.8%; p < 0.001). Being on maintenance dialysis or having a renal transplant were both independent predictors of mortality in patients hospitalized with STEMI. There was a differential effect of cardiac catheterization on odds of mortality with lesser impact in patients on maintenance dialysis. CONCLUSIONS: STEMI hospitalizations are more common in patients on maintenance dialysis and with renal transplants. The utilization of revascularizations procedures remains low and mortality high in these patients.
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Falência Renal Crônica/complicações , Transplante de Rim , Revascularização Miocárdica/estatística & dados numéricos , Complicações Pós-Operatórias/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Adulto , Idoso , Feminino , Hospitalização/tendências , Humanos , Incidência , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Diálise Renal , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Recent policy clarifications by the Centers for Medicare & Medicaid Services have changed access to outpatient dialysis care at end-stage renal disease (ESRD) facilities for individuals with acute kidney injury in the United States. Tools to predict "ESRD" and "acute" status in terms of kidney function recovery among patients who previously initiated dialysis therapy in the hospital could help inform patient management decisions. STUDY DESIGN: Historical cohort study. SETTING & PARTICIPANTS: Incident hemodialysis patients in the Mayo Clinic Health System who initiated in-hospital renal replacement therapy (RRT) and continued outpatient dialysis following hospital dismissal (2006 through 2009). PREDICTOR: Baseline estimated glomerular filtration rate (eGFR), acute tubular necrosis from sepsis or surgery, heart failure, intensive care unit, and dialysis access. OUTCOMES: Kidney function recovery defined as sufficient kidney function for outpatient hemodialysis therapy discontinuation. RESULTS: Cohort consisted of 281 patients with a mean age of 64 years, 63% men, 45% with heart failure, and baseline eGFR≥30mL/min/1.73m(2) in 46%. During a median of 8 months, 52 (19%) recovered, most (94%) within 6 months. Higher baseline eGFR (HR per 10-mL/min/1.73m(2) increase eGFR, 1.27; 95% CI, 1.16-1.39; P<0.001), acute tubular necrosis from sepsis or surgery (HR, 3.34; 95% CI, 1.83-6.24; P<0.001), and heart failure (HR, 0.40; 95% CI, 0.19-0.78, P=0.007) were independent predictors of recovery within 6 months, whereas first RRT in the intensive care unit and catheter dialysis access were not. There was a positive interaction between absence of heart failure and eGFR≥30mL/min/1.73m(2) for predicting kidney function recovery (P<0.001). LIMITATIONS: Sample size. CONCLUSIONS: Kidney function recovery in the outpatient hemodialysis unit following in-hospital RRT initiation is not rare. As expected, higher baseline eGFR is an important determinant of recovery. However, patients with heart failure are less likely to recover even with a higher baseline eGFR. Consideration of these factors at hospital discharge informs decisions on ESRD status designation and long-term hemodialysis care.
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Pacientes Internados , Falência Renal Crônica/terapia , Rim/fisiologia , Pacientes Ambulatoriais , Recuperação de Função Fisiológica/fisiologia , Diálise Renal , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Taxa de Filtração Glomerular/fisiologia , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Unidades de Terapia Intensiva/estatística & dados numéricos , Falência Renal Crônica/fisiopatologia , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos RetrospectivosRESUMO
AIMS: The number of elderly persons with end-stage renal disease is increasing with many requiring hospitalizations. This study examines the causes and predictors of hospitalization in older haemodialysis patients. METHODS: We reviewed hospitalizations of older (≥65 years) incident chronic haemodialysis patients initiating therapy between 1 January 2007 and 31 December 2009 under the care of a single Midwestern United States dialysis provider. RESULTS: Of 125 patients, the mean age was 76 ± 7 years and 72% were male. At first dialysis, 68% used a central venous catheter (CVC) and 51% were in the hospital. Mean follow-up was 1.8 ± 1.0 years. At least one hospitalization occurred in 89 (71%) patients and half of all patients were hospitalized once within the first 223 days. Total hospital admission rate was 1.48 per patient year with hospital days totalling 8.54 days per patient year. The three most common reasons for first admission were cardiac (33%), infection (18%) and gastrointestinal (12%). Predictors of future hospitalization included the first dialysis occurring in hospital (hazard ratios (HR) 2.1, 95% CI 1.4-3.3, P = 0.0005) and the use of a CVC at first haemodialysis (HR 2.6, CI 1.6-4.4, P < 0.0001). CONCLUSION: Hospitalizations are common in older incident haemodialysis patients. Access preparation and overall burden of illness leading to the initial hospitalization appear to play a role. Identification of additional factors associated with hospitalization will allow for focused interventions to reduce hospitalization rates and increase the value of care.
Assuntos
Hospitalização/estatística & dados numéricos , Diálise Renal/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: Although an arteriovenous fistula (AVF) is the hemodialysis access of choice, its prevalence continues to be lower than recommended in the United States. We assessed the association between past peripherally inserted central catheters (PICCs) and lack of functioning AVFs. STUDY DESIGN: Case-control study. PARTICIPANTS & SETTING: Prevalent hemodialysis population in 7 Mayo Clinic outpatient hemodialysis units. Cases were without functioning AVFs and controls were with functioning AVFs on January 31, 2011. PREDICTORS: History of PICCs. OUTCOMES: Lack of functioning AVFs. RESULTS: On January 31, 2011, a total of 425 patients were receiving maintenance hemodialysis, of whom 282 were included in this study. Of these, 120 (42.5%; cases) were dialyzing through a tunneled dialysis catheter or synthetic arteriovenous graft and 162 (57.5%; controls) had a functioning AVF. PICC use was evaluated in both groups and identified in 30% of hemodialysis patients, with 54% of these placed after dialysis therapy initiation. Cases were more likely to be women (52.5% vs 33.3% in the control group; P = 0.001), with smaller mean vein (4.9 vs 5.8 mm; P < 0.001) and artery diameters (4.6 vs 4.9 mm; P = 0.01) than controls. A PICC was identified in 53 (44.2%) cases, but only 32 (19.7%) controls (P < 0.001). We found a strong and independent association between PICC use and lack of a functioning AVF (OR, 3.2; 95% CI, 1.9-5.5; P < 0.001). This association persisted after adjustment for confounders, including upper-extremity vein and artery diameters, sex, and history of central venous catheter (OR, 2.8; 95% CI, 1.5-5.5; P = 0.002). LIMITATIONS: Retrospective study, participants mostly white. CONCLUSION: PICCs are commonly placed in patients with end-stage renal disease and are a strong independent risk factor for lack of functioning AVFs.
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Derivação Arteriovenosa Cirúrgica , Cateterismo Venoso Central , Falência Renal Crônica/terapia , Adulto , Idoso , Estudos de Casos e Controles , Cateterismo Venoso Central/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Diálise Renal , Estudos RetrospectivosRESUMO
Clinical studies are ongoing to assess whether existing vaccines may afford protection against SARS-CoV-2 infection through trained immunity. In this exploratory study, we analyze immunization records from 137,037 individuals who received SARS-CoV-2 PCR tests. We find that polio, Haemophilus influenzae type-B (HIB), measles-mumps-rubella (MMR), Varicella, pneumococcal conjugate (PCV13), Geriatric Flu, and hepatitis A/hepatitis B (HepA-HepB) vaccines administered in the past 1, 2, and 5 years are associated with decreased SARS-CoV-2 infection rates, even after adjusting for geographic SARS-CoV-2 incidence and testing rates, demographics, comorbidities, and number of other vaccinations. Furthermore, age, race/ethnicity, and blood group stratified analyses reveal significantly lower SARS-CoV-2 rate among black individuals who have taken the PCV13 vaccine, with relative risk of 0.45 at the 5 year time horizon (n: 653, 95% CI (0.32, 0.64), p-value: 6.9e-05). Overall, this study identifies existing approved vaccines which can be promising candidates for pre-clinical research and Randomized Clinical Trials towards combating COVID-19.
Assuntos
COVID-19/prevenção & controle , Adolescente , Adulto , Idoso , COVID-19/epidemiologia , Criança , Pré-Escolar , Feminino , Vacinas Anti-Haemophilus/uso terapêutico , Humanos , Imunização , Lactente , Vacinas contra Influenza/uso terapêutico , Masculino , Vacina contra Sarampo-Caxumba-Rubéola/uso terapêutico , Pessoa de Meia-Idade , Vacinas Pneumocócicas/uso terapêutico , Vacinas contra Poliovirus/uso terapêutico , Fatores de Proteção , SARS-CoV-2/isolamento & purificação , Vacinas Conjugadas/uso terapêutico , Vacinas contra Hepatite Viral/uso terapêutico , Adulto JovemRESUMO
OBJECTIVE: To assess demographic characteristics and perceptions of female physicians in attendance at a medical conference for women with content focused on growth, resilience, inspiration, and tenacity to better understand major barriers women in medicine face and to find solutions to these barriers. PATIENTS AND METHODS: A Likert survey was administered to female physicians attending the conference (September 20 to 22, 2018). The survey consisted of demographic data and 4 dimensions that are conducive to women's success in academic medicine: equal access, work-life balance, freedom from gender biases, and supportive leadership. RESULTS: All of the 228 female physicians surveyed during the conference completed the surveys. There were 70 participants (31.5%) who were in practice for less than 10 years (early career), 111 (50%) who were in practice for 11 to 20 years (midcareer), and 41 (18.5%) who had more than 20 years of practice (late career). Whereas participants reported positive support from their supervisors (mean, 0.4 [SD 0.9]; P<.001), they did not report support in the dimensions of work-life balance (mean, -0.2 [SD 0.8]; P<.001) and freedom from gender bias (mean, -0.3 [SD 0.9]; P<.001). CONCLUSION: Female physicians were less likely to feel support for work-life balance and did not report freedom from gender bias in comparison to other dimensions of support. Whereas there was no statistically significant difference between career stage, trends noting that late-career physicians felt less support in all dimensions were observed. Future research should explore a more diverse sample population of women physicians.
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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 88â¯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 88â¯898 unvaccinated patients (44â¯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 88â¯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.
Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Ad26COVS1 , Adolescente , Adulto , Idoso , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/imunologia , Teste de Ácido Nucleico para COVID-19 , Vacinas contra COVID-19/administração & dosagem , Avaliação de Medicamentos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Pandemias , Pontuação de Propensão , Estudos Retrospectivos , SARS-CoV-2 , Índice de Gravidade de Doença , Fatores de Tempo , Estados Unidos/epidemiologia , Vacinação/estatística & dados numéricos , Adulto JovemRESUMO
Intensive care unit (ICU) admissions and mortality in severe COVID-19 patients are driven by "cytokine storms" and acute respiratory distress syndrome (ARDS). Interim clinical trial results suggest that the corticosteroid dexamethasone displays better 28-day survival in severe COVID-19 patients requiring ventilation or oxygen. In this study, 10 out of 16 patients (62.5%) that had an average plasma IL-6 value over 10 pg/mL post administration of corticosteroids also had worse outcomes (i.e., ICU stay >15 days or death), compared to 8 out of 41 patients (19.5%) who did not receive corticosteroids (p-value = 0.0024). Given this potential association between post-corticosteroid IL-6 levels and COVID-19 severity, we hypothesized that the glucocorticoid receptor (GR or NR3C1) may be coupled to IL-6 expression in specific cell types that govern cytokine release syndrome (CRS). Examining single-cell RNA-seq data from BALF of severe COVID-19 patients and nearly 2 million cells from a pan-tissue scan shows that alveolar macrophages, smooth muscle cells, and endothelial cells co-express NR3C1 and IL-6, motivating future studies on the links between the regulation of NR3C1 function and IL-6 levels.
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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.
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COVID-19 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Vacinação em Massa , RNA Mensageiro , Estudos Retrospectivos , SARS-CoV-2 , Estados Unidos , United States Food and Drug AdministrationRESUMO
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.
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Anticorpos Antivirais/sangue , Teste Sorológico para COVID-19 , COVID-19 , Transmissão de Doença Infecciosa/estatística & dados numéricos , Pessoal de Saúde/estatística & dados numéricos , SARS-CoV-2 , Centros Médicos Acadêmicos , Adulto , COVID-19/sangue , COVID-19/epidemiologia , COVID-19/terapia , Teste Sorológico para COVID-19/métodos , Teste Sorológico para COVID-19/estatística & dados numéricos , Feminino , Humanos , Imunoglobulina G/sangue , Masculino , Pessoa de Meia-Idade , Saúde Pública/métodos , SARS-CoV-2/imunologia , SARS-CoV-2/isolamento & purificação , Estudos Soroepidemiológicos , Análise Espaço-Temporal , Estados Unidos/epidemiologiaRESUMO
Importance: Women in academic medicine continue to face systemic obstacles on their paths to leadership. In addition to improving recruitment and advancement opportunities, academic medical centers must facilitate a cultural shift that ensures sustained leadership pathways for women. Objective: To better understand, from the perspective of women leaders, the workplace and cultural changes that need to take place in academic medicine to increase inclusivity and gender equity. Design, Setting, and Participants: This qualitative study of 40 women physicians and administrators with senior leadership roles at Mayo Clinic, a nonprofit academic medical center and research institution with campuses in Arizona, Florida, and Minnesota, examined participants' responses to a question regarding their paths to leadership. Replies were submitted between November and December 2018. Main Outcomes and Measures: Women were asked to describe career advice (positive or negative) they had received that was the hardest to accept but, in retrospect, turned out to be valuable. Results: Of 40 participants, 25 (63%) were physicians and 15 (37%) were administrators at Mayo Clinic; 27 (68%) had achieved the role of chair or the administrative equivalent. Career experience ranged from 6 to 40 years. Of the 40 women leaders queried, 38 (95%) provided written responses, which were separated into the 4 following categories: leadership styles are perceived as having gendered qualities, attaining leadership skills involves a strategic learning process, collisions between personal life and the workplace should not deter individuals from pursuing leadership roles, and leadership pathways for women involved hurdles. These categories represented a roadmap illuminating perceptions about the academic medical workplace. Conclusions and Relevance: These findings link generalizable principles to help to drive new strategies for gender parity. Shifting the culture of academic medicine begins with fully understanding impediments to women's advancement. The advice women leaders recounted offered a roadmap as well as a glimpse of the extra effort required for women to succeed amid some of the system's limitations and obstacles. A more complete understanding of gender biases may help to shape future programs to expand inclusivity and establish sustained leadership paths for women.
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Liderança , Orientação Vocacional/normas , Centros Médicos Acadêmicos/organização & administração , Centros Médicos Acadêmicos/tendências , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Pesquisa Qualitativa , Sexismo , Orientação Vocacional/métodos , Orientação Vocacional/tendências , Local de Trabalho/psicologia , Local de Trabalho/normasRESUMO
Analysis of 851 COVID-19 patients with a SARS-CoV-2-positive PCR at follow-up shows 99 patients remained SARS-CoV-2-positive after four weeks from initial diagnosis. Surprisingly, a majority of these long-term viral RNA shedders were not hospitalized (61 of 99), with variable PCR Crossing point values over the month post diagnosis. For the 851-patient cohort, the mean lower bound of viral RNA shedding was 17.3 days (SD: 7.8), and the mean upper bound of viral RNA shedding from 668 patients transitioning to confirmed PCR-negative status was 22.7 days (SD: 11.8). Among 104 patients with an IgG test result, 90 patients were seropositive to date, with mean upper bound of time to seropositivity from initial diagnosis being 37.8 days (95%CI: 34.3-41.3). Juxtaposing IgG/PCR tests revealed that 14 of 90 patients are non-hospitalized and seropositive yet shed viral RNA. This study emphasizes the need for monitoring viral loads and neutralizing antibody titers in long-term shedders.
RESUMO
Temporal inference from laboratory testing results and triangulation with clinical outcomes extracted from unstructured electronic health record (EHR) provider notes is integral to advancing precision medicine. Here, we studied 246 SARS-CoV-2 PCR-positive (COVIDpos) patients and propensity-matched 2460 SARS-CoV-2 PCR-negative (COVIDneg) patients subjected to around 700,000 lab tests cumulatively across 194 assays. Compared to COVIDneg patients at the time of diagnostic testing, COVIDpos patients tended to have higher plasma fibrinogen levels and lower platelet counts. However, as the infection evolves, COVIDpos patients distinctively show declining fibrinogen, increasing platelet counts, and lower white blood cell counts. Augmented curation of EHRs suggests that only a minority of COVIDpos patients develop thromboembolism, and rarely, disseminated intravascular coagulopathy (DIC), with patients generally not displaying platelet reductions typical of consumptive coagulopathies. These temporal trends provide fine-grained resolution into COVID-19 associated coagulopathy (CAC) and set the stage for personalizing thromboprophylaxis.