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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.
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Vacunas contra la COVID-19/inmunología , COVID-19/prevención & control , Ad26COVS1 , Adolescente , Adulto , Anciano , COVID-19/diagnóstico , COVID-19/epidemiología , COVID-19/inmunología , Prueba de Ácido Nucleico para COVID-19 , Vacunas contra la COVID-19/administración & dosificación , Evaluación de Medicamentos , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pandemias , Puntaje de Propensión , Estudios Retrospectivos , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Factores de Tiempo , Estados Unidos/epidemiología , Vacunación/estadística & datos numéricos , Adulto JovenRESUMEN
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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Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , Trombosis de los Senos Intracraneales/epidemiología , Vacunación/efectos adversos , COVID-19/inmunología , COVID-19/virología , Registros Electrónicos de Salud , Humanos , Incidencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Trombosis de los Senos Intracraneales/diagnóstico , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
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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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 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Humanos , Vacunación Masiva , ARN Mensajero , Estudios Retrospectivos , SARS-CoV-2 , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Vacunas contra la COVID-19/uso terapéutico , COVID-19 , Inmunidad Colectiva , COVID-19/epidemiología , COVID-19/prevención & control , COVID-19/terapia , Control de Enfermedades Transmisibles/métodos , Control de Enfermedades Transmisibles/organización & administración , Transmisión de Enfermedad Infecciosa/prevención & control , Diagnóstico Precoz , Humanos , Salud Pública/métodos , SARS-CoV-2/inmunologíaRESUMEN
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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Anticuerpos Antivirales/sangre , Prueba Serológica para COVID-19 , COVID-19 , Transmisión de Enfermedad Infecciosa/estadística & datos numéricos , Personal de Salud/estadística & datos numéricos , SARS-CoV-2 , Centros Médicos Académicos , Adulto , COVID-19/sangre , COVID-19/epidemiología , COVID-19/terapia , Prueba Serológica para COVID-19/métodos , Prueba Serológica para COVID-19/estadística & datos numéricos , Femenino , Humanos , Inmunoglobulina G/sangre , Masculino , Persona de Mediana Edad , Salud Pública/métodos , SARS-CoV-2/inmunología , SARS-CoV-2/aislamiento & purificación , Estudios Seroepidemiológicos , Análisis Espacio-Temporal , Estados Unidos/epidemiologíaRESUMEN
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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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.
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COVID-19/prevención & control , Adolescente , Adulto , Anciano , COVID-19/epidemiología , Niño , Preescolar , Femenino , Vacunas contra Haemophilus/uso terapéutico , Humanos , Inmunización , Lactante , Vacunas contra la Influenza/uso terapéutico , Masculino , Vacuna contra el Sarampión-Parotiditis-Rubéola/uso terapéutico , Persona de Mediana Edad , Vacunas Neumococicas/uso terapéutico , Vacunas contra Poliovirus/uso terapéutico , Factores Protectores , SARS-CoV-2/aislamiento & purificación , Vacunas Conjugadas/uso terapéutico , Vacunas contra Hepatitis Viral/uso terapéutico , Adulto JovenRESUMEN
Longitudinal characterization of SARS-CoV-2 PCR testing from COVID-19 patient's nasopharynx and its juxtaposition with blood-based IgG-seroconversion diagnostic assays is critical to understanding SARS-CoV-2 infection durations. Here, we retrospectively analyze 851 SARS-CoV-2-positive patients with at least two positive PCR tests and find that 99 of these patients remain SARS-CoV-2-positive after 4 weeks from their initial diagnosis date. 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). Our findings from juxtaposing IgG and PCR tests thus reveal that some SARS-CoV-2-positive patients are non-hospitalized and seropositive, yet actively shed viral RNA (14 of 90 patients). This study emphasizes the need for monitoring viral loads and neutralizing antibody titers in long-term non-hospitalized shedders as a means of characterizing the SARS-CoV-2 infection lifecycle.
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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.
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Betacoronavirus/aislamiento & purificación , Trastornos de la Coagulación Sanguínea/diagnóstico , Pruebas de Coagulación Sanguínea , Coagulación Sanguínea , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Anciano , Betacoronavirus/patogenicidad , Biomarcadores/sangre , Trastornos de la Coagulación Sanguínea/sangre , Trastornos de la Coagulación Sanguínea/virología , COVID-19 , Prueba de COVID-19 , Infecciones por Coronavirus/sangre , Infecciones por Coronavirus/virología , Progresión de la Enfermedad , Femenino , Fibrinógeno/metabolismo , Interacciones Microbiota-Huesped , Humanos , Recuento de Leucocitos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Pandemias , Recuento de Plaquetas , Neumonía Viral/sangre , Neumonía Viral/virología , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios Retrospectivos , SARS-CoV-2 , Factores de TiempoRESUMEN
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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Liderazgo , Orientación Vocacional/normas , Centros Médicos Académicos/organización & administración , Centros Médicos Académicos/tendencias , Adulto , Femenino , Humanos , Persona de Mediana Edad , Investigación Cualitativa , Sexismo , Orientación Vocacional/métodos , Orientación Vocacional/tendencias , Lugar de Trabajo/psicología , Lugar de Trabajo/normasRESUMEN
Understanding temporal dynamics of COVID-19 symptoms could provide fine-grained resolution to guide clinical decision-making. Here, we use deep neural networks over an institution-wide platform for the augmented curation of clinical notes from 77,167 patients subjected to COVID-19 PCR testing. By contrasting Electronic Health Record (EHR)-derived symptoms of COVID-19-positive (COVIDpos; n = 2,317) versus COVID-19-negative (COVIDneg; n = 74,850) patients for the week preceding the PCR testing date, we identify anosmia/dysgeusia (27.1-fold), fever/chills (2.6-fold), respiratory difficulty (2.2-fold), cough (2.2-fold), myalgia/arthralgia (2-fold), and diarrhea (1.4-fold) as significantly amplified in COVIDpos over COVIDneg patients. The combination of cough and fever/chills has 4.2-fold amplification in COVIDpos patients during the week prior to PCR testing, in addition to anosmia/dysgeusia, constitutes the earliest EHR-derived signature of COVID-19. This study introduces an Augmented Intelligence platform for the real-time synthesis of institutional biomedical knowledge. The platform holds tremendous potential for scaling up curation throughput, thus enabling EHR-powered early disease diagnosis.
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Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Adulto , Betacoronavirus/aislamiento & purificación , COVID-19 , Prueba de COVID-19 , Escalofríos/epidemiología , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/virología , Diarrea/virología , Disgeusia/virología , Femenino , Fiebre/virología , Humanos , Masculino , Persona de Mediana Edad , Mialgia/virología , Trastornos del Olfato/virología , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/fisiopatología , Neumonía Viral/virología , Reacción en Cadena de la Polimerasa , SARS-CoV-2RESUMEN
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.
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PURPOSE: To investigate early hemodynamic instability and its implications on adverse outcomes in patients who require continuous renal replacement therapy (CRRT). MATERIALS AND METHODS: A retrospective study of patients admitted to the intensive care unit (ICU) and underwent CRRT at Mayo Clinic, Rochester, Minnesota between December 2006 through November 2015. RESULTS: Multivariate logistic regression was performed to identify predictors of in-hospital mortality and major adverse kidney events (MAKE) at 90â¯days. Hypotension was defined as any of the following criteria occurring during the first hour of CRRT initiation: mean arterial pressureâ¯<â¯60â¯mmHg, systolic blood pressure (SBP) <90â¯mmHg or a decline in SBP >40â¯mmHg from baseline, a positive fluid balance >500â¯mL or increased vasopressor requirement. The analysis included 1743 patients, 1398 with acute kidney injury (AKI). In-hospital mortality occurred in 884 patients (51%). Early hypotension occurred in 1124 patients (64.6%) and remained independently associated with in-hospital mortality (OR 1.56, 95% CI: 1.25-1.9). CONCLUSION: Hypotension occurs frequently in patients receiving CRRT despite having a reputation as the dialysis modality with better hemodynamic tolerance. It is an independent predictor for worse outcomes. Further studies are required to understand this phenomenon.
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Lesión Renal Aguda/terapia , Terapia de Reemplazo Renal Continuo/efectos adversos , Mortalidad Hospitalaria , Hipotensión/etiología , Hipotensión/mortalidad , Diálisis Renal/mortalidad , Lesión Renal Aguda/mortalidad , Adolescente , Adulto , Anciano , Calcio/metabolismo , Femenino , Humanos , Unidades de Cuidados Intensivos , Tiempo de Internación , Persona de Mediana Edad , Minnesota , Pronóstico , Terapia de Reemplazo Renal/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Adulto JovenRESUMEN
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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Amputación Quirúrgica/efectos adversos , Amputación Quirúrgica/mortalidad , Extremidad Inferior/irrigación sanguínea , Readmisión del Paciente , Enfermedad Arterial Periférica/cirugía , Diálisis Renal/efectos adversos , Diálisis Renal/mortalidad , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Bases de Datos Factuales , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/etnología , Enfermedad Arterial Periférica/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND AND OBJECTIVES: Withdrawal from maintenance hemodialysis before death has become more common because of high disease and treatment burden. The study objective was to identify patient factors and examine the terminal course associated with hemodialysis withdrawal, and assess patterns of palliative care involvement before death among patients on maintenance hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We designed an observational cohort study of adult patients on incident hemodialysis in a midwestern United States tertiary center, from January 2001 to November 2013, with death events through to November 2015. Logistic regression models evaluated associations between patient characteristics and withdrawal status and palliative care service utilization. RESULTS: Among 1226 patients, 536 died and 262 (49% of 536) withdrew. A random sample (10%; 52 out of 536) review of Death Notification Forms revealed 73% sensitivity for withdrawal. Risk factors for withdrawal before death included older age, white race, palliative care consultation within 6 months, hospitalization within 30 days, cerebrovascular disease, and no coronary artery disease. Most withdrawal decisions were made by patients (60%) or a family member (33%; surrogates). The majority withdrew either because of acute medical complications (51%) or failure to thrive/frailty (22%). After withdrawal, median time to death was 7 days (interquartile range, 4-11). In-hospital deaths were less common in the withdrawal group (34% versus 46% nonwithdrawal, P=0.003). A third (34%; 90 out of 262) of those that withdrew received palliative care services. Palliative care consultation in the withdrawal group was associated with longer hemodialysis duration (odds ratio, 1.19 per year; 95% confidence interval, 1.10 to 1.3; P<0.001), hospitalization within 30 days of death (odds ratio, 5.78; 95% confidence interval, 2.62 to 12.73; P<0.001), and death in hospital (odds ratio, 1.92; 95% confidence interval, 1.13 to 3.27; P=0.02). CONCLUSIONS: In this single-center study, the rate of hemodialysis withdrawals were twice the frequency previously described. Acute medical complications and frailty appeared to be driving factors. However, palliative care services were used in only a minority of patients.
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Utilización de Instalaciones y Servicios/estadística & datos numéricos , Cuidados Paliativos/estadística & datos numéricos , Diálisis Renal/estadística & datos numéricos , Cuidado Terminal/estadística & datos numéricos , Privación de Tratamiento , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Cuidados Paliativos/métodos , Cuidado Terminal/métodosRESUMEN
Routine preventive cancer screening is not recommended for patients with end-stage renal disease (ESRD) due to their limited life expectancy. The current extent of cancer screening in this population is unknown. Primary care (PC) reminder systems or performance incentives may encourage indiscriminate cancer screening. We compared rates of cancer screening in patients with ESRD, with and without PC visits. This is a retrospective cohort study using United States Renal Data System (USRDS) billing data and electronic medical record data. Patients aged ≥18â¯years starting dialysis from 2001 to 2008, Midwest regional dialysis network were categorized with or without a PC visit (defined as an office visit in family practice, internal medicine, pediatrics, geriatrics or preventive medicine during the first two years of dialysis). Cancer screening was based on Current Procedural Terminology codes in USRDS. We identified 2512 incident dialysis patients (60% men, median age 65y). Cancer screening rates were more frequent among those seen in PC: 38% vs 19% (Pâ¯=â¯0.0002), for breast; 18% vs 10% (Pâ¯=â¯0.047) for cervical; 13% versus 8% (Pâ¯=â¯0.024) for prostate; and 18% vs 9% (Pâ¯=â¯0.0002) for colon cancer. Multivariable analyses found that those with PC were more likely to be screened after adjusting for age, sex, and comorbidities. In our practice, cancer screening rates among chronic dialysis patients are lower than those previously reported for our general population (64% for breast cancer). However, a sizeable proportion of our ESRD population does receive cancer screening, especially those still seen in primary care.
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BACKGROUND/AIMS: Over one-third of hospital discharges among dialysis patients are followed by 30-day readmission. The first year after dialysis start is a high-risk time frame. We examined the rate, causes, timing, and predictors of 30-day readmissions among adult, incident dialysis patients. METHODS: Hospital readmissions were assessed from the 91st day to the 15th month after the initiation of dialysis using a Mayo Clinic registry linkage to United States Renal Data System claims during the period January 2001-December 2010. RESULTS: Among 1,727 patients with ≥1 hospitalization, 532 (31%) had ≥1, and 261 (15%) had ≥2 readmissions. Readmission rate was 1.1% per person-day post-discharge, and the highest rates (2.5% per person-day) occurred ≤5 days after index admission. The overall cumulative readmission rate was 33.8% at day 30. Common readmission diagnoses included cardiac issues (22%), vascular disorders (19%), and infection (13%). Similar-cause readmissions to index hospitalization were more common during days 0-14 post-discharge than days 15-30 (37.5 vs. 22.9%; p = 0.004). Younger age at dialysis initiation, inability to transfer/ambulate, serum creatinine ≤5.3 mg/dL, higher number of previous hospitalizations, and longer duration on dialysis were associated with higher readmission rates in multivariable analyses. Patients aged 18-39 were few (8.3%) but comprised 17.7% of "high-readmission" users such that a 30-year-old patient had an 87% chance of being readmitted within 30 days of any hospital discharge, whereas an 80-year-old patient had a 25% chance. CONCLUSIONS: Overall, 30-day readmissions are common within the first year of dialysis start. The first 10-day period after discharge, young patients, and those with poor functional status represent key areas for targeted interventions to reduce readmissions.