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1.
Gynecol Oncol ; 186: 1-8, 2024 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-38554624

RESUMO

OBJECTIVE: Despite similar incidence, non-Hispanic Black women are twice as likely to die of endometrial cancer as non-Hispanic White women. The social determinants of health may contribute to this disparity. We studied barriers to care and social needs of endometrial cancer patients. METHODS: In a cohort of patients with endometrial cancer from the All of Us study, participants self-reported demographics and completed validated surveys (access to medical care, transportation, caregiving, finances, medication, general care, specialty care, housing insecurity). Univariate and multivariate logistic regression models evaluated demographic and access factors associated with any need. RESULTS: Of 568 participants, 77.7% identified as non-Hispanic White, 7.5% Black, and 8.8% Hispanic. 59% were > 65 years and 95.8% insured. Contributors to delays in care were paying out of pocket (9.9%), provider anxiety (7.6%), transportation (6.3%), cost of copay (6.2%), and insufficient leave from work (5.6%). To mitigate healthcare costs, 16.2% of participants inquired about lower-cost medications, 11.1% reported delaying filling prescriptions, 7.6% taking fewer prescribed medications, and 6.5% skipped doses. Regarding multivariate analysis, participants earning <$25,000 had a 7.3 (95% CI 1.7-31.7) higher adjusted odds of transportation needs and 3.6 (95% CI 1.4-9.7) higher difficulty accessing specialists. No racial/ethnic disparities were identified. CONCLUSIONS: Social needs and barriers to care are most pronounced among endometrial cancer survivors earning <$25,000. Unexpectedly, and possibly related to sample size or survey tool, race/ethnicity were not zassociated with barriers to care. Further studies on health-related social needs, optimal screening tools, and effective interventions are needed in order to achieve equity in cancer outcomes for endometrial cancer patients.

3.
Spat Spatiotemporal Epidemiol ; 47: 100607, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-38042530

RESUMO

Rapidly emerging research on the mental health consequences of the COVID-19 pandemic shows increasing patterns of psychological distress, including anxiety and depression, and self-harming behaviors, particularly during the early months of the pandemic. Yet, few studies have investigated the spatial and temporal changes in depressive disorders and suicidal behavior during the pandemic. The objective of this retrospective analysis was to evaluate geographic patterns of emergency department admissions for depression and suicidal behavior in North Carolina before (March 2017-February 2020) and during the COVID-19 pandemic (March 2020 - December 2021). Univariate cluster detection examined each outcome separately and multivariate cluster detection was used to examine the co-occurrence of depression and suicide-related outcomes in SatScan; the Rand index evaluated cluster overlap. Cluster analyses were adjusted for age, race, and sex. Findings suggest that the mental health burden of depression and suicide-related outcomes remained high in many communities throughout the pandemic. Rural communities exhibited a larger increase in the co-occurrence of depression and suicide-related ED visits during the pandemic period. Results showed the exacerbation of depression and suicide-related outcomes in select communities and emphasize the need for targeted and sustained mental health interventions throughout the many phases of the COVID-19 pandemic.


Assuntos
COVID-19 , Suicídio , Humanos , COVID-19/epidemiologia , Pandemias , Depressão/epidemiologia , Estudos Retrospectivos
4.
Can Commun Dis Rep ; 49(2-3): 76-80, 2023 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38090723

RESUMO

Background: Tecovirimat (TCV, TPOXX®) is an orthopox-specific antiviral drug indicated for the treatment of smallpox. There is also a mechanistic basis for its use in mpox infection. However, its approval was based on animal studies, and its efficacy and side-effect profile in human patients with disease is unknown. Methods: During the 2022 international mpox epidemic, clinicians in Canada accessed TCV from the Public Health Agency of Canada's National Emergency Strategic Stockpile for severe cases of mpox disease. We describe the use of TCV in nine adults with severe mpox virus infection in Montréal, Canada. Results: Five patients were treated for severe and potentially life-threatening head and neck symptoms, while four were treated for genitourinary or anorectal disease. Two-thirds of patients were also treated for suspected bacterial superinfection. All patients recovered (median time to resolution of severe symptoms: nine days) without relapse or hospital readmission. No patients reported adverse events attributable to TCV and no patients stopped their treatment early. Conclusion: Our experience suggests that TCV is well tolerated and may accelerate recovery in severe cases. These preliminary, observational data may also be explained by concomitant treatment for superinfection and are limited by the absence of a control group. Controlled, clinical trials should be conducted to clarify the attributable benefit of TCV in severe mpox infection.

5.
Obstet Gynecol ; 142(3): 688-697, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37535956

RESUMO

OBJECTIVE: To use a spatial modeling approach to capture potential disparities of gynecologic oncologist accessibility in the United States at the county level between 2001 and 2020. METHODS: Physician registries identified the 2001-2020 gynecologic oncology workforce and were aggregated to each county. The at-risk cohort (women aged 18 years or older) was stratified by race and ethnicity and rurality demographics. We computed the distance from at-risk women to physicians. Relative access scores were computed by a spatial model for each contiguous county. Access scores were compared across urban or rural status and racial and ethnic groups. RESULTS: Between 2001 and 2020, the gynecologic oncologist workforce increased. By 2020, there were 1,178 active physicians and 98.3% practiced in urban areas (37.3% of all counties). Geographic disparities were identified, with 1.09 physicians per 100,000 women in urban areas compared with 0.1 physicians per 100,000 women in rural areas. In total, 2,862 counties (57.4 million at-risk women) lacked an active physician. Additionally, there was no increase in rural physicians, with only 1.7% practicing in rural areas in 2016-2020 relative to 2.2% in 2001-2005 ( P =.35). Women in racial and ethnic minority populations, such as American Indian or Alaska Native and Hispanic women, exhibited the lowest level of access to physicians across all time periods. For example, 23.7% of American Indian or Alaska Native women did not have access to a physician within 100 miles between 2016 and 2020, which did not improve over time. Non-Hispanic Black women experienced an increase in relative accessibility, with a 26.2% increase by 2016-2020. However, Asian or Pacific Islander women exhibited significantly better access than non-Hispanic White, non-Hispanic Black, Hispanic, and American Indian or Alaska Native women across all time periods. CONCLUSION: Although the U.S. gynecologic oncologist workforce increased steadily over 20 years, this has not translated into evidence of improved access for many women from rural and underrepresented areas. However, health care utilization and cancer outcomes may not be influenced only by distance and availability. Policies and pipeline programs are needed to address these inequities in gynecologic cancer care.


Assuntos
Ginecologia , Acesso aos Serviços de Saúde , Disparidades em Assistência à Saúde , Oncologia Cirúrgica , Feminino , Humanos , Asiático , Etnicidade , Acesso aos Serviços de Saúde/estatística & dados numéricos , Hispânico ou Latino , Grupos Minoritários , Oncologistas , Estados Unidos/epidemiologia , Ginecologia/estatística & dados numéricos , Oncologia Cirúrgica/estatística & dados numéricos , Disparidades em Assistência à Saúde/etnologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Adolescente , Adulto Jovem , Adulto , Brancos , Negro ou Afro-Americano , Havaiano Nativo ou Outro Ilhéu do Pacífico , Indígena Americano ou Nativo do Alasca
7.
Vaccine ; 41(38): 5486-5489, 2023 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-37524629

RESUMO

In the province of Quebec, Canada, a 2 + 1 dose pneumococcal conjugate vaccine (PCV) program for children was implemented in 2004. PCV7 was replaced by PCV10 in 2009, by PCV13 in 2011 and by PCV10 in 2018, without catch-up in all instances. The objective was to estimate PCV13 effectiveness to prevent serotype 3 invasive pneumococcal disease in children aged less than 5 years, using 2010-2018 mandatory notification and laboratory surveillance data, an indirect cohort design and multivariate logistic regression models. A total of 29 cases of serotype 3 and 290 non-vaccine serotype cases as controls were analysed. Overall vaccine effectiveness (≥1 dose) was estimated at 59% [-39% to 88%]. During the first year after the last dose effectivness was 88% [47% to 97%] whereas no protection was observed thereafter. There was no trend towards increased effectiveness with the number of doses. PCV13 protection against serotype 3 IPD seems to be short-lived.


Assuntos
Infecções Pneumocócicas , Streptococcus pneumoniae , Humanos , Criança , Lactente , Quebeque/epidemiologia , Vacinas Conjugadas , Sorogrupo , Vacina Pneumocócica Conjugada Heptavalente , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas , Canadá
8.
J Viral Hepat ; 30(10): 810-818, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37382024

RESUMO

We evaluated geographic heterogeneity in hepatitis C virus (HCV) treatment penetration among people who inject drug (PWID) across Baltimore, MD since the advent of direct-acting antivirals (DAAs) using space-time clusters of HCV viraemia. Using data from a community-based cohort of PWID, the AIDS Linked to the IntraVenous Experience (ALIVE) study, we identified space-time clusters with higher-than-expected rates of HCV viraemia between 2015 and 2019 using scan statistics. We used Poisson regression to identify covariates associated with HCV viraemia and used the regression-fitted values to detect adjusted space-time clusters of HCV viraemia in Baltimore city. Overall, in the cohort, HCV viraemia fell from 77% in 2015 to 64%, 49%, 39% and 36% from 2016 to 2019. In Baltimore city, the percentage of census tracts where prevalence of HCV viraemia was ≥85% dropped from 57% to 34%, 25%, 22% and 10% from 2015 to 2019. We identified two clusters of higher-than-expected HCV viraemia in the unadjusted analysis that lasted from 2015 to 2017 in East and West Baltimore and one adjusted cluster of HCV viraemia in West Baltimore from 2015 to 2016. Neither differences in age, sex, race, HIV status, nor neighbourhood deprivation were able to explain the significant space-time clusters. However, residing in a cluster with higher-than-expected viraemia was associated with age, sex, educational attainment and higher levels of neighbourhood deprivation. Nearly 4 years after DAAs became available, HCV treatment has penetrated all PWID communities across Baltimore city. While nearly all census tracts experienced improvements, change was more gradual in areas with higher levels of poverty.


Assuntos
Usuários de Drogas , Hepatite C Crônica , Hepatite C , Abuso de Substâncias por Via Intravenosa , Humanos , Hepacivirus , Abuso de Substâncias por Via Intravenosa/complicações , Abuso de Substâncias por Via Intravenosa/epidemiologia , Abuso de Substâncias por Via Intravenosa/tratamento farmacológico , Antivirais/uso terapêutico , Baltimore/epidemiologia , Viremia/epidemiologia , Viremia/tratamento farmacológico , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/complicações , Hepatite C/tratamento farmacológico , Hepatite C/epidemiologia , Hepatite C/complicações
9.
JMIR Mhealth Uhealth ; 11: e43990, 2023 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-37327031

RESUMO

BACKGROUND: Interest in quitting smoking is common among young adults who smoke, but it can prove challenging. Although evidence-based smoking cessation interventions exist and are effective, a lack of access to these interventions specifically designed for young adults remains a major barrier for this population to successfully quit smoking. Therefore, researchers have begun to develop modern, smartphone-based interventions to deliver smoking cessation messages at the appropriate place and time for an individual. A promising approach is the delivery of interventions using geofences-spatial buffers around high-risk locations for smoking that trigger intervention messages when an individual's phone enters the perimeter. Despite growth in personalized and ubiquitous smoking cessation interventions, few studies have incorporated spatial methods to optimize intervention delivery using place and time information. OBJECTIVE: This study demonstrates an exploratory method of generating person-specific geofences around high-risk areas for smoking by presenting 4 case studies using a combination of self-reported smartphone-based surveys and passively tracked location data. The study also examines which geofence construction method could inform a subsequent study design that will automate the process of deploying coping messages when young adults enter geofence boundaries. METHODS: Data came from an ecological momentary assessment study with young adult smokers conducted from 2016 to 2017 in the San Francisco Bay area. Participants reported smoking and nonsmoking events through a smartphone app for 30 days, and GPS data was recorded by the app. We sampled 4 cases along ecological momentary assessment compliance quartiles and constructed person-specific geofences around locations with self-reported smoking events for each 3-hour time interval using zones with normalized mean kernel density estimates exceeding 0.7. We assessed the percentage of smoking events captured within geofences constructed for 3 types of zones (census blocks, 500 ft2 fishnet grids, and 1000 ft2 fishnet grids). Descriptive comparisons were made across the 4 cases to better understand the strengths and limitations of each geofence construction method. RESULTS: The number of reported past 30-day smoking events ranged from 12 to 177 for the 4 cases. Each 3-hour geofence for 3 of the 4 cases captured over 50% of smoking events. The 1000 ft2 fishnet grid captured the highest percentage of smoking events compared to census blocks across the 4 cases. Across 3-hour periods except for 3:00 AM-5:59 AM for 1 case, geofences contained an average of 36.4%-100% of smoking events. Findings showed that fishnet grid geofences may capture more smoking events compared to census blocks. CONCLUSIONS: Our findings suggest that this geofence construction method can identify high-risk smoking situations by time and place and has potential for generating individually tailored geofences for smoking cessation intervention delivery. In a subsequent smartphone-based smoking cessation intervention study, we plan to use fishnet grid geofences to inform the delivery of intervention messages.


Assuntos
Aplicativos Móveis , Abandono do Hábito de Fumar , Adulto Jovem , Humanos , Smartphone , Abandono do Hábito de Fumar/métodos , Fumantes , Autorrelato
10.
Blood ; 142(2): 202-209, 2023 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-37172200

RESUMO

Frequent plateletpheresis is associated with severe lymphopenia of uncertain clinical significance. We assessed the functional impact of frequent platelet donations and associated lymphopenia on the response to neoantigens. We conducted a prospective study of 102 platelet donors (HIV uninfected) who were naive to meningococcal vaccination recruited at Brigham and Women's Hospital. One dose of quadrivalent meningococcal conjugate vaccine was administered. Seroresponse was defined as a fourfold increase of serum bactericidal antibody titers and seroprotection was defined as postvaccination titers of ≥1:8, for each of the 4 vaccine antigens (A, C, W, and Y). Mean age of participants was 61 years, 69% were male, and medial number of platelet donations in prior year was 14 (interquartile range, 4-20). Frequent platelet donors had a low CD4 count (14% with ≤200/µL and 34% with ≤350/µL). Seroresponse rates varied from 68% for serogroup Y to 86% for serogroup A and were higher for participants with baseline titers of <1:8. Postvaccination seroprotection rates varied from 76% for serogroup Y to 96% for serogroup A. After adjustments for age, sex, and frequent donations, lower total lymphocyte or lower CD4 counts were not associated with lower responses. These data suggest no impairment by plateletpheresis-associated lymphopenia on response to these neoantigens. This trial was registered at www.clinicaltrials.gov as #NCT04224311.


Assuntos
Linfopenia , Infecções Meningocócicas , Vacinas Meningocócicas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anticorpos Antibacterianos , Infecções Meningocócicas/prevenção & controle , Estudos Prospectivos , Vacinas Conjugadas
11.
Clin Biochem ; 117: 60-68, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36878344

RESUMO

BACKGROUND: Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response. METHODS: We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluated 291 negative controls (NEG CTRL), 91 PCR positive (PCR POS) patients (179 samples), 126 convalescent plasma donors (CPD), 27 healthy vaccinated donors (VD), and 20 allogeneic hematopoietic stem cell transplant (HSCT) recipients (45 samples). RESULTS: We observed good agreement with the method performance claims for specificity (93-100%) in NEG CTRL but only 85% for EU IgA. The sensitivity claims in the first 2 weeks of symptom onset was lower (26-61%) than performance claims based on > 2 weeks since PCR positivity. We observed high sensitivities (94-100%) in CPD except for AB IgM (77%), EP IgM (0%). Significantly higher RS TOT was observed for Moderna vaccine recipients then Pfizer (p-values < 0.0001). A sustained RS TOT response was observed for the five months following vaccination. HSCT recipients demonstrated significantly lower RS TOT than healthy VD (p < 0.0001) at dose 2 and 4 weeks after. CONCLUSIONS: Our data suggests against the use of anti-SARS-CoV-2 assays to aid in acute diagnosis. RN TOT and RS TOT can readily identify past-resolved infection and vaccine response in the absence of native infection. We provide an estimate of expected antibody response in healthy VD over the time course of vaccination for which to compare antibody responses in immunosuppressed patients.


Assuntos
COVID-19 , Humanos , COVID-19/diagnóstico , SARS-CoV-2 , Sensibilidade e Especificidade , Anticorpos Antivirais , Imunoglobulina G , Soroterapia para COVID-19 , Imunoglobulina M , Imunoglobulina A , Teste para COVID-19
12.
Health Place ; 80: 102994, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36791507

RESUMO

All aspects of public health research require longitudinal analyses to fully capture the dynamics of outcomes and risk factors such as ageing, human mobility, non-communicable diseases (NCDs), climate change, and endemic, emerging, and re-emerging infectious diseases. Studies in geospatial health are often limited to spatial and temporal cross sections. This generates uncertainty in the exposures and behavior of study populations. We discuss a research agenda, including key challenges and opportunities of working with longitudinal geospatial health data. Examples include accounting for residential and human mobility, recruiting new birth cohorts, geoimputation, international and interdisciplinary collaborations, spatial lifecourse studies, and qualitative and mixed-methods approaches.


Assuntos
Envelhecimento , Saúde Pública , Humanos , Fatores de Risco
13.
J Adolesc Health ; 72(1): 27-35, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35985915

RESUMO

PURPOSE: Suicide is an ongoing public health crisis among youth and adolescents, and few studies have investigated the spatial patterning in the United States among this subpopulation. Potential precursors to suicide in this vulnerable group are also on the rise, including nonfatal self-injury. METHODS: This study uses emergency department data, death certificates, and violent death reporting system data for North Carolina from 2009 to 2018 to investigate spatial clusters of self-injury and suicide. RESULTS: Findings show that the demographic characteristics of individuals committing fatal and nonfatal self-injury are quite different. Self-injury and completed suicides exhibited different geographical patterns. Area-level measures like micropolitan status and measures of racial and income segregation predicted the presence of high-risk suicide clusters. Suicides among Native Americans and veteran status/military personnel also were associated with higher risk suicide clusters. DISCUSSION: Future interventions should target these specific high-risk locations for immediate reductions in adolescent and youth suicides.


Assuntos
Suicídio , Adolescente , Adulto Jovem , Humanos , Estados Unidos , Homicídio , North Carolina/epidemiologia , Causas de Morte , Vigilância da População
14.
Can Commun Dis Rep ; 49(10): 433-438, 2023 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-38481651

RESUMO

Evidence on the protective effect of influenza vaccines to prevent cardiovascular disease (CVD) is mounting. We identified 28 systematic reviews/meta-analyses on the effect of influenza vaccines on CVD using different research questions, data sources, selection criteria and outcomes. Most results leaned towards a protective effect. Results of recently published experimental and observational studies not included in these reviews were going in the same direction. The evidence is very robust for cardiovascular deaths and nonfatal myocardial infarction in high-risk individuals, but lower for heart failure, arrhythmia, and stroke and also for all outcomes in low-risk adults. There is also limited evidence for pneumococcal polysaccharide vaccines and evidence has to be collected from ongoing trials on respiratory syncytial virus vaccines. Up to now, this effect has not been considered in economic evaluations of influenza vaccines and its inclusion may change CVD results markedly. This effect is not mentioned in the Canadian Immunization Guide and not known by a majority of vaccinators. The objective of this short commentary is to alert the Canadian public health community and to provide information that could be used at the field level to promote the usefulness of influenza vaccines.

16.
Rev Soc Bras Med Trop ; 55: e0607, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35946634

RESUMO

BACKGROUND: The number of deaths and people infected with coronavirus disease 2019 (COVID-19) in Brazil has steadily increased in the first few months of the pandemic. Despite the underreporting of coronavirus cases by government agencies across the country, São Paulo has the highest rate among all Brazilian states. METHODS: To identify the highest-risk municipalities during the initial outbreak, we utilized daily confirmed case data from official reports between February 25 and May 5, 2020, which were aggregated to the municipality level. A prospective space-time scan statistic was conducted to detect active clusters in three different time periods. RESULTS: Our findings suggest that approximately 4.6 times more municipalities belong to a significant space-time cluster with a relative risk (RR) > 1 on May 5, 2020. CONCLUSIONS: Our study demonstrated the applicability of the space-time scan statistic for the detection of emerging clusters of COVID-19. In particular, we identified the clusters and RR of municipalities in the initial months of the pandemic, explaining the spatiotemporal patterns of COVID-19 transmission in the state of São Paulo. These results can be used to improve disease monitoring and facilitate targeted interventions.


Assuntos
COVID-19 , Brasil/epidemiologia , Cidades , Surtos de Doenças , Humanos , Pandemias
17.
Open Forum Infect Dis ; 9(8): ofac417, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36043177

RESUMO

Background: Patients with lymphoid malignancies are at risk for poor coronavirus disease 2019 (COVID-19)-related outcomes and have reduced vaccine-induced immune responses. Currently, a 3-dose primary regimen of mRNA vaccines is recommended in the United States for immunocompromised hosts. Methods: A prospective cohort study of healthy adults (n = 27) and patients with lymphoid malignancies (n = 94) was conducted, with longitudinal follow-up through completion of a 2- or 3-dose primary mRNA COVID vaccine series, respectively. Humoral responses were assessed in all participants, and cellular immunity was assessed in a subset of participants. Results: The rate of seroconversion (68.1% vs 100%) and the magnitude of peak anti-S immunoglobulin G (IgG) titer (median anti-S IgG = 32.4, IQR = 0.48-75.0 vs median anti-S IgG = 72.6, IQR 51.1-100.1; P = .0202) were both significantly lower in patients with lymphoid malignancies compared to the healthy cohort. However, peak titers of patients with lymphoid malignancies who responded to vaccination were similar to healthy cohort titers (median anti-S IgG = 64.3; IQR, 23.7-161.5; P = .7424). The third dose seroconverted 7 of 41 (17.1%) patients who were seronegative after the first 2 doses. Although most patients with lymphoid malignancies produced vaccine-induced T-cell responses in the subset studied, B-cell frequencies were low with minimal memory cell formation. Conclusions: A 3-dose primary mRNA series enhanced anti-S IgG responses to titers equivalent to healthy adults in patients with lymphoid malignancies who were seropositive after the first 2 doses and seroconverted 17.1% who were seronegative after the first 2 doses. T-cell responses were present, raising the possibility that the vaccines may confer some cell-based protection even if not measurable by anti-S IgG.

18.
Ann Intern Med ; 175(9): 1258-1265, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35785530

RESUMO

BACKGROUND: Immunoassays for determining past SARS-CoV-2 infection have not been systematically evaluated in vaccinated persons in comparison with unvaccinated persons. OBJECTIVE: To evaluate antinucleocapsid antibody (anti-N Ab) seropositivity in mRNA-1273 (Moderna) vaccinees with breakthrough SARS-CoV-2 infection. DESIGN: Nested substudy of a phase 3 randomized, double-blind, placebo-controlled vaccine efficacy trial. (ClinicalTrials.gov: NCT04470427). SETTING: 99 sites in the United States, July 2020 through March 2021. PARTICIPANTS: Participants were aged 18 years or older, had no known history of SARS-CoV-2 infection, and were at risk for SARS-CoV-2 infection or severe COVID-19. Substudy participants were diagnosed with SARS-CoV-2 infection during the trial's blinded phase. INTERVENTION: 2 mRNA-1273 or placebo injections 28 days apart. MEASUREMENTS: Nasopharyngeal swabs from days 1 and 29 (vaccination days) and from symptom-prompted illness visits were tested for SARS-CoV-2 via polymerase chain reaction (PCR). Serum samples from days 1, 29, and 57 and the participant decision visit (PDV, when participants were informed of treatment assignment; median day 149) were tested for anti-N Abs by the Elecsys immunoassay. RESULTS: Among 812 participants with PCR-confirmed COVID-19 illness during the blinded phase of the trial (through March 2021), seroconversion to anti-N Abs (median of 53 days after diagnosis) occurred in 21 of 52 mRNA-1273 vaccinees (40% [95% CI, 27% to 54%]) versus 605 of 648 placebo recipients (93% [CI, 92% to 95%]). Each 1-log increase in SARS-CoV-2 viral copies at diagnosis was associated with 90% higher odds of anti-N Ab seroconversion (odds ratio, 1.90 [CI, 1.59 to 2.28]). LIMITATION: The scope was restricted to mRNA-1273 vaccinees and the Elecsys assay, the sample size was small, data on Delta and Omicron infections were lacking, and the analysis did not address a prespecified objective of the trial. CONCLUSION: Vaccination status should be considered when interpreting seroprevalence and seropositivity data based solely on anti-N Ab testing. PRIMARY FUNDING SOURCE: National Institute of Allergy and Infectious Diseases of the National Institutes of Health.


Assuntos
COVID-19 , Vacina de mRNA-1273 contra 2019-nCoV , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Método Duplo-Cego , Humanos , SARS-CoV-2 , Estudos Soroepidemiológicos , Estados Unidos , Eficácia de Vacinas
19.
PLoS One ; 17(3): e0264281, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35271615

RESUMO

BACKGROUND: An increased risk of acute kidney injury (AKI) with the widely prescribed piperacillin-tazobactam(PTZ)-vancomycin combination in hospitalized patients has recently been reported, but evidence in ICU patients remain uncertain. This study evaluates the association between the exposure of various broad-spectrum antibiotic regimens with Pseudomonas and/or methicillin-resistance Staphylococcus aureus (MRSA) coverage and the risk of AKI in critically ill patients. METHODS AND FINDINGS: A retrospective cohort study based on the publicly available MIMIC-III database reporting hospitalization data from ICU patients from a large academic medical center between 2001 and 2012. Adult patients receiving an anti-pseudomonal or an anti-MRSA agent in the ICU for more than 24-hours were included. Non-PTZ anti-pseudomonal agents were compared to PTZ; non-vancomycin agents covering MRSA were compared to vancomycin; and their combinations were compared to the PTZ-vancomycin combination. The primary outcome was defined as new or worsening AKI within 7 days of the antibiotic exposure using an adjusted binomial generalized estimating equation. Overall, 18 510 admissions from 15 673 individual patients, cumulating 169 966 days of antibiotherapy were included. When compared to PTZ, exposure to another anti-pseudomonal agent was associated with lower AKI risk (OR, 0.85; 95% CI, 0.80-0.91; p < .001). When compared to vancomycin, exposure to another anti-MRSA was also associated with lower AKI risk (OR, 0.71; 95% CI, 0.64-0.80; p < .001). Finally, when compared to the PTZ-vancomycin combination, exposure to another regimen with a similar coverage was associated with an even lower risk (OR, 0.63; 95% CI; 0.54-0.73; p < .001). A sensitivity analysis of patients with high illness severity showed similar results. CONCLUSIONS: These results suggest that the risk of AKI in ICU patients requiring antibiotherapy may be partially mitigated by the choice of antibiotics administered. Further clinical trials are required to confirm these findings.


Assuntos
Injúria Renal Aguda , Staphylococcus aureus Resistente à Meticilina , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/tratamento farmacológico , Injúria Renal Aguda/epidemiologia , Adulto , Antibacterianos/efeitos adversos , Estado Terminal , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pseudomonas , Estudos Retrospectivos , Vancomicina/efeitos adversos
20.
Microbiol Spectr ; 10(2): e0021122, 2022 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-35311584

RESUMO

The use of anti-spike (S) serologic assays as surrogate measurements of SARS-CoV-2 vaccine induced immunity will be an important clinical and epidemiological tool. The characteristics of a commercially available anti-S antibody assay (Roche Elecsys anti-SARS-CoV-2 S) were evaluated in a cohort of vaccine recipients. Levels were correlated with pseudotype neutralizing antibodies (NAb) across SARS-CoV-2 variants. We recruited adults receiving a two-dose series of mRNA-1273 or BNT162b2 and collected serum at scheduled intervals up to 8 months post-first vaccination. Anti-S and NAb levels were measured, and correlation was evaluated by (i) vaccine type and (ii) SARS-CoV-2 variant (wild-type, Alpha, Beta, Gamma, and three constructs Day 146*, Day 152*, and RBM-2). Forty-six mRNA vaccine recipients were enrolled. mRNA-1273 vaccine recipients had higher peak anti-S and NAb levels compared with BNT162b2 (P < 0.001 for anti-S levels; P < 0.05 for NAb levels). When anti-S and NAb levels were compared, there was good correlation (all r values ≥ 0.85) in both BNT162b2 and mRNA-1273 vaccine recipients across all evaluated variants; however, these correlations were nonlinear in nature. Lower correlation was identified between anti-S and NAb for the Beta variant (r = 0.88) compared with the wild-type (WT) strain (r = 0.94). Finally, the degree of neutralizing activity at any given anti-S level was lower for each variant compared with that of the WT strain, (P < 0.001). Although the Roche anti-S assay correlates well with NAb levels, this association is affected by vaccine type and SARS-CoV-2 variant. These variables must be considered when interpreting anti-S levels. IMPORTANCE We evaluated anti-spike antibody concentrations in healthy mRNA vaccinated individuals and compared these concentrations to values obtained from pseudotype neutralization assays targeting SARS-CoV-2 variants of concern to determine how well anti-spike antibodies correlate with neutralizing titers, which have been used as a marker of immunity from COVID-19 infection. We found high peak anti-spike concentrations in these individuals, with significantly higher levels seen in mRNA-1273 vaccine recipients. When we compared anti-spike and pseudotype neuralization titers, we identified good correlation; however, this correlation was affected by both vaccine type and variant, illustrating the difficulty of applying a "one size fits all" approach to anti-spike result interpretation. Our results support CDC recommendations to discourage anti-spike antibody testing to assess for immunity after vaccination and cautions providers in their interpretations of these results as a surrogate of protection in COVID-vaccinated individuals.


Assuntos
COVID-19 , SARS-CoV-2 , Vacina de mRNA-1273 contra 2019-nCoV , Adulto , Anticorpos Neutralizantes , Anticorpos Antivirais , Vacina BNT162 , COVID-19/diagnóstico , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Humanos , SARS-CoV-2/genética , Vacinas Sintéticas , Vacinas de mRNA
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