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1.
BMC Pediatr ; 24(1): 276, 2024 Apr 26.
Artigo em Inglês | MEDLINE | ID: mdl-38671379

RESUMO

BACKGROUND: COVID-19 vaccines are authorized for use in children in the United States; real-world assessment of vaccine effectiveness in children is needed. This study's objective was to estimate the effectiveness of receiving a complete primary series of monovalent BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine in US children. METHODS: This cohort study identified children aged 5-17 years vaccinated with BNT162b2 matched with unvaccinated children. Participants and BNT162b2 vaccinations were identified in Optum and CVS Health insurance administrative claims databases linked with Immunization Information System (IIS) COVID-19 vaccination records from 16 US jurisdictions between December 11, 2020, and May 31, 2022 (end date varied by database and IIS). Vaccinated children were followed from their first BNT162b2 dose and matched to unvaccinated children on calendar date, US county of residence, and demographic and clinical factors. Censoring occurred if vaccinated children failed to receive a timely dose 2 or if unvaccinated children received any dose. Two COVID-19 outcome definitions were evaluated: COVID-19 diagnosis in any medical setting and COVID-19 diagnosis in hospitals/emergency departments (EDs). Propensity score-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated with Cox proportional hazards models, and vaccine effectiveness (VE) was estimated as 1 minus HR. VE was estimated overall, within age subgroups, and within variant-specific eras. Sensitivity, negative control, and quantitative bias analyses evaluated various potential biases. RESULTS: There were 453,655 eligible vaccinated children one-to-one matched to unvaccinated comparators (mean age 12 years; 50% female). COVID-19 hospitalizations/ED visits were rare in children, regardless of vaccination status (Optum, 41.2 per 10,000 person-years; CVS Health, 44.1 per 10,000 person-years). Overall, vaccination was associated with reduced incidence of any medically diagnosed COVID-19 (meta-analyzed VE = 38% [95% CI, 36-40%]) and hospital/ED-diagnosed COVID-19 (meta-analyzed VE = 61% [95% CI, 56-65%]). VE estimates were lowest among children 5-11 years and during the Omicron-variant era. CONCLUSIONS: Receipt of a complete BNT162b2 vaccine primary series was associated with overall reduced medically diagnosed COVID-19 and hospital/ED-diagnosed COVID-19 in children; observed VE estimates differed by age group and variant era. REGISTRATION: The study protocol was publicly posted on the BEST Initiative website ( https://bestinitiative.org/wp-content/uploads/2022/03/C19-VX-Effectiveness-Protocol_2022_508.pdf ).


Assuntos
Vacina BNT162 , COVID-19 , Eficácia de Vacinas , Humanos , Vacina BNT162/administração & dosagem , Criança , Pré-Escolar , Estados Unidos/epidemiologia , Feminino , Masculino , COVID-19/prevenção & controle , COVID-19/epidemiologia , Adolescente , Eficácia de Vacinas/estatística & dados numéricos , Estudos de Coortes , Vacinas contra COVID-19/administração & dosagem , SARS-CoV-2 , Vacinação/estatística & dados numéricos
2.
Breast Cancer Res Treat ; 194(1): 1-11, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35587323

RESUMO

PURPOSE: Human epidermal growth factor receptor 2 (HER2)-targeted therapies improve survival for patients with HER2-positive breast cancer but carry risks of hematologic, cardiopulmonary, gastro-hepatobiliary, and other adverse events (AEs). In this review, we describe published AE incidences for HER2-targeted therapies for metastatic breast cancer (mBC). METHODS: We searched PubMed and Embase to identify studies on HER2-targeted therapies in HER2-positive mBC, reporting on AEs of special interest, and published between January 1, 2009, and February 6, 2020. Treatment regimens were categorized into mutually exclusive therapy-based categories, with primary therapy determined by worldwide approval date. RESULTS: One hundred and fifty-three included articles assessed a combined 29,238 patients treated with the following therapy-based regimens: trastuzumab or biosimilars (78 studies), lapatinib (40), T-DM1 (ado-trastuzumab emtansine) (20), pertuzumab (14), neratinib (8), MM-302 (1), T-DXd (2), tucatinib (3), and pyrotinib (3). While direct comparisons of AE incidence are not warranted owing to study heterogeneity, proportions of patients experiencing any Grade 3 + AE ranged across therapy-based regimens from 39.4% (lapatinib) to 66.3% (neratinib). The most common hematologic AE of special interest, of any grade and regardless of causality, was leukopenia/white blood cells decreased [21.4% (T-DXd)-46.2% (pyrotinib)]. Cardiopulmonary AEs of special interest included interstitial lung disease [2.7% (trastuzumab)-5.2% (T-DXd)], pneumonitis [0.2% (lapatinib)-7.4% (trastuzumab)], and decreased ejection fraction [1% (T-DXd)-13.6% (trastuzumab)]. Gastro-hepatobiliary AEs of special interest included nausea [33.9% (trastuzumab)-78.3% (T-DXd)], vomiting [19.2% (T-DM1)-48.2% (T-DXd)], diarrhea [19.6% (T-DM1)-96.9% (pyrotinib)], and hepatotoxicity [5.9% (lapatinib)-53.6% (T-DM1)]. CONCLUSION: Differing AE profiles for anti-HER2 therapies should be considered when assessing benefit-risk profile for treatment options.


Assuntos
Medicamentos Biossimilares , Neoplasias da Mama , Maitansina , Segunda Neoplasia Primária , Ado-Trastuzumab Emtansina/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Neoplasias da Mama/patologia , Feminino , Humanos , Incidência , Lapatinib/efeitos adversos , Segunda Neoplasia Primária/etiologia , Receptor ErbB-2/metabolismo , Trastuzumab
3.
BMC Geriatr ; 22(1): 784, 2022 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-36203129

RESUMO

BACKGROUND: Little is known about the incidence of clinical events and treatment patterns among older adults with dementia-related psychosis. Given that dementia-related psychosis comprises various dementia types, this study describes the incidence of clinical events and treatment patterns by dementia type after patients with dementia are diagnosed with psychosis. METHODS: Adults aged ≥ 65 years with dementia and newly diagnosed with psychosis were identified in US Medicare claims during 2013-2018. Baseline characteristics were evaluated at the time of the psychosis diagnosis. After the initial psychosis diagnosis, incidence rates (IRs) of clinical events (e.g., falls/fractures, infections, healthcare utilization), mortality, and patterns of antipsychotic treatment were described for each dementia type (Alzheimer's disease [AD], Parkinson's disease dementia [PDD], dementia with Lewy bodies [DLB], frontotemporal dementia [FTD], vascular dementia [VD], and unspecified dementia). Daily mean cumulative counts were estimated to describe the incidence of recurrent events over time. Mortality was described using Kaplan-Meier survival curves. RESULTS: We identified 484,520 patients with dementia-related psychosis: mean age, 84 years (standard deviation, 7.8); female, 66%. At the time of psychosis diagnosis, the most prevalent type of dementia was unspecified dementia (56%), followed by AD (31%), VD (12%), PDD (10%), DLB (3%), and FTD (< 1%), and most patients had scores indicating severe illness on the Charlson Comorbidity Index (71%) and frailty index (62%). Across all dementia types, IRs (per 100 person-years) were high for emergency department visits, oral anti-infective use, and urinary tract infections after the initial psychosis diagnosis. Patients with DLB had the highest incidence of most clinical outcomes. After 1 year of follow-up, the cumulative probability of death was about 30% for all dementia types, and after 5 years, was about 80% among patients with DLB, VD, AD, or PDD and about 60%-65% among patients with FTD or unspecified dementia. CONCLUSIONS: Patients with dementia-related psychosis had a high burden of comorbidities, frailty, emergency department visits, infections, and death. Specifically, after DRP diagnosis, patients with DLB and VD had the highest burden of clinical events of interest.


Assuntos
Doença de Alzheimer , Antipsicóticos , Fragilidade , Demência Frontotemporal , Doença por Corpos de Lewy , Doença de Parkinson , Transtornos Psicóticos , Idoso , Idoso de 80 Anos ou mais , Doença de Alzheimer/diagnóstico , Antipsicóticos/uso terapêutico , Feminino , Humanos , Doença por Corpos de Lewy/diagnóstico , Masculino , Medicare , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/epidemiologia , Transtornos Psicóticos/terapia , Estados Unidos/epidemiologia
4.
Am J Kidney Dis ; 75(1): 72-83, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31378646

RESUMO

RATIONALE & OBJECTIVE: Studies of patients on maintenance dialysis therapy suggest that standard-dose influenza vaccine (SDV) may not prevent influenza-related outcomes. Little is known about the comparative effectiveness of SDV versus high-dose influenza vaccine (HDV) in this population. STUDY DESIGN: Cohort study using data from the US Renal Data System. SETTING & PARTICIPANTS: 507,552 adults undergoing in-center maintenance hemodialysis between the 2010 to 2011 and 2014 to 2015 influenza seasons. EXPOSURES: SDV and HDV. OUTCOMES: All-cause mortality, hospitalization due to influenza or pneumonia, and influenza-like illness during the influenza season. ANALYTIC APPROACH: Patients were eligible for inclusion in multiple yearly cohorts; thus, our unit of analysis was the influenza patient-season. To examine the relationship between vaccine dose and effectiveness outcomes, we estimated risk differences and risk ratios using propensity score weighting of Kaplan-Meier functions, accounting for a wide range of patient- and facility-level characteristics. For nonmortality outcomes, we used competing-risk methods to account for the high mortality rate in the dialysis population. RESULTS: Within 225,215 influenza patient-seasons among adults 65 years and older, 97.4% received SDV and 2.6% received HDV. We observed similar risk estimates for HDV and SDV recipients for mortality (risk difference, -0.08%; 95% CI, -0.85% to 0.80%), hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI, -0.69% to 0.93%), and influenza-like illness (risk difference, 0.00%; 95% CI, -1.50% to 1.08%). Our findings were similar among adults younger than 65 years, as well as within other subgroups defined by influenza season, age group, dialysis vintage, month of influenza vaccination, and vaccine valence. LIMITATIONS: Residual confounding and outcome misclassification. CONCLUSIONS: The HDV does not appear to provide additional protection beyond the SDV against all-cause mortality or influenza-related outcomes for adults undergoing hemodialysis. The additional cost and side effects associated with HDV should be considered when offering this vaccine. Future studies of HDV and other influenza vaccine strategies are warranted.


Assuntos
Hospitalização/estatística & dados numéricos , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Falência Renal Crônica/terapia , Mortalidade , Pneumonia/epidemiologia , Diálise Renal , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade
5.
Med Care ; 57(1): 73-78, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30422840

RESUMO

BACKGROUND: Estimating influenza vaccine effectiveness using an unvaccinated comparison group may result in biased effect estimates. OBJECTIVES: To explore the reduction of confounding bias in an active comparison of high-dose versus standard-dose influenza vaccines, as compared with vaccinated versus unvaccinated comparisons. METHODS: Using Medicare data from the United States end-stage renal disease program (2009-2013), we compared the risk of all-cause mortality among recipients of high-dose vaccine (HDV) versus standard-dose vaccine (SDV), HDV versus no vaccine, and SDV versus no vaccine. To quantify confounding bias, analyses were restricted to the preinfluenza season, when the protective effect of vaccination should not yet be observed. We estimated the standardized mortality ratio-weighted cumulative incidence functions using Kaplan-Meier methods and calculated risk ratios (RRs) and risk differences between groups. RESULTS: Among 350,921 eligible patients contributing 825,642 unique patient preinfluenza seasons, 0.8% received HDV, 70.5% received SDV, and 28.7% remained unvaccinated. Comparisons with unvaccinated patients yielded spurious decreases in mortality risk during the preinfluenza period, for HDV versus none [RR, 0.60; 95% confidence interval (CI), 0.51-0.70)] and SDV versus none (RR, 0.72; 95% CI, 0.70-0.75). The effect estimate was attenuated in the HDV versus SDV comparison (RR, 0.89; 95% CI, 0.77-1.03). Estimates on the absolute scale followed a similar pattern. CONCLUSIONS: The HDV versus SDV comparison yielded less-biased estimates of the all-cause mortality before influenza season compared to those with nonuser comparison groups. Vaccine effectiveness and safety researchers should consider the active comparator design to reduce bias due to differences in underlying health status between vaccinated and unvaccinated individuals.


Assuntos
Viés , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Vacinação/métodos , Idoso , Feminino , Humanos , Revisão da Utilização de Seguros , Falência Renal Crônica , Masculino , Medicare , Pessoa de Meia-Idade , Estações do Ano , Estados Unidos
6.
Am J Kidney Dis ; 72(3): 337-348, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29653770

RESUMO

BACKGROUND: Carvedilol and metoprolol are the ß-blockers most commonly prescribed to US hemodialysis patients, accounting for ∼80% of ß-blocker prescriptions. Despite well-established pharmacologic and pharmacokinetic differences between the 2 medications, little is known about their relative safety and efficacy in the hemodialysis population. STUDY DESIGN: A retrospective cohort study using a new-user design. SETTING & PARTICIPANTS: Medicare-enrolled hemodialysis patients treated at a large US dialysis organization who initiated carvedilol or metoprolol therapy from January 1, 2007, through December 30, 2012. PREDICTOR: Carvedilol versus metoprolol initiation. OUTCOMES: All-cause mortality, cardiovascular mortality, and intradialytic hypotension (systolic blood pressure decrease ≥ 20mmHg during hemodialysis plus intradialytic saline solution administration) during a 1-year follow-up period. MEASUREMENTS: Survival models were used to estimate HRs and 95% CIs in mortality analyses. Poisson regression was used to estimate incidence rate ratios (IRRs) and 95% CIs in intradialytic hypotension analyses. Inverse probability of treatment weighting was used to adjust for several demographic, clinical, laboratory, and dialysis treatment covariates in all analyses. RESULTS: 27,064 individuals receiving maintenance hemodialysis were included: 9,558 (35.3%) carvedilol initiators and 17,506 (64.7%) metoprolol initiators. Carvedilol (vs metoprolol) initiation was associated with greater all-cause (adjusted HR, 1.08; 95% CI, 1.02-1.16) and cardiovascular mortality (adjusted HR, 1.18; 95% CI, 1.08-1.29). In subgroup analyses, similar associations were observed among patients with hypertension, atrial fibrillation, heart failure, and a recent myocardial infarction, the main cardiovascular indications for ß-blocker therapy. During follow-up, carvedilol (vs metoprolol) initiators had a higher rate of intradialytic hypotension (adjusted IRR, 1.10; 95% CI, 1.09-1.11). LIMITATIONS: Residual confounding may exist. CONCLUSIONS: Relative to metoprolol initiation, carvedilol initiation was associated with higher 1-year all-cause and cardiovascular mortality. One potential mechanism for these findings may be the increased occurrence of intradialytic hypotension after carvedilol (vs metoprolol) initiation.


Assuntos
Antagonistas de Receptores Adrenérgicos beta 1/uso terapêutico , Carvedilol/uso terapêutico , Metoprolol/uso terapêutico , Diálise Renal/mortalidade , Insuficiência Renal Crônica/mortalidade , Antagonistas de Receptores Adrenérgicos beta 1/efeitos adversos , Idoso , Carvedilol/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Masculino , Metoprolol/efeitos adversos , Pessoa de Meia-Idade , Mortalidade/tendências , Diálise Renal/efeitos adversos , Diálise Renal/tendências , Insuficiência Renal Crônica/terapia , Estudos Retrospectivos , Fatores de Tempo
7.
Clin Endocrinol (Oxf) ; 88(5): 719-727, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29446829

RESUMO

CONTEXT: Exogenous testosterone administration may affect blood clotting, polycythaemia, and may increase atherosclerosis, though any association with cardiovascular events is unclear. While the literature is inconclusive, some studies have suggested testosterone use may increase short-term risk of cardiovascular events and stroke, and injection testosterone may convey higher risks than other dosage forms. OBJECTIVE: We sought to evaluate the short-term cardiovascular risk of receiving injection testosterone. DESIGN: We conducted a case-crossover analysis comparing injection testosterone exposure in the 7 days prior to an outcome event to referent windows in the past to estimate the acute association of cardiovascular outcomes with the receipt of testosterone injections. PATIENTS: We identified adult male testosterone users hospitalized with myocardial infarction (MI), stroke or a composite of MI, stroke or unstable angina in US commercial claims (2000-2013) or Medicare (2007-2010) databases. MEASUREMENTS: We identified testosterone use for the patients from pharmacy dispensing claims or in-office procedure codes in the insurance billing data. RESULTS: We identified 2898 commercially insured men with events and recent testosterone use, and 339 from Medicare. Injected testosterone was associated with an increased risk of adverse events (composite outcome of myocardial infarction, stroke or unstable angina) in the immediate postinjection period for the older, Medicare population only: commercial insurance, odds ratios (OR) = 0.98 (95% confidence intervals [CI]: 0.86-1.12); Medicare, OR = 1.45 (1.07, 1.98). This association was either greatly attenuated or not present when evaluating receipt of any testosterone dosage forms (injection, gel, patch, implant): commercial insurance, OR = 1.01 (0.92, 1.11); Medicare, OR = 1.26 (95% CI: 0.98-1.63). CONCLUSIONS: Testosterone injections were uniquely associated with short-term risk of acute cardio- and cerebrovascular events in older adult men following injection receipt.


Assuntos
Sistema Cardiovascular/efeitos dos fármacos , Testosterona/efeitos adversos , Idoso , Estudos Cross-Over , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Acidente Vascular Cerebral/etiologia
8.
Paediatr Perinat Epidemiol ; 32(5): 448-457, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30048564

RESUMO

BACKGROUND: The aim of this study was to evaluate the short-term risk of adverse events associated with rotavirus vaccine (RV) in infants, overall and by vaccine formulation (three-dose pentavalent, RV5; two-dose monovalent, RV1). METHODS: We identified US newborns with commercial insurance during 2006-2014 receiving a diphtheria-tetanus-pertussis vaccine (DTaP) dose and assessed if RV was administered concurrently. We followed infants for 30 days after each dose for diagnoses of intussusception, other gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, all-cause emergency department visits, and all-cause hospitalisations. We estimated adjusted hazard ratios (HR) and 95% confidence intervals (CI) with multivariable Cox proportional hazards models comparing: (a) those receiving DTaP+RV vs those receiving DTaP alone; and (b) RV5 vs RV1. Analyses were performed separately within DTaP doses and then meta-analysed across doses. RESULTS: We identified 1 031 431 first DTaP doses, 821 833 second doses, and 615 293 third doses; 79.2% had a concurrent RV, 94.1% of which were RV5. Absolute risks of serious outcomes were very low. Compared to infants who received DTaP alone, infants who received RV+DTaP did not experience consistently increased risk of intussusception (hazard ratio [HR] 1.13, 95% confidence interval [CI] 0.68, 1.88) or any other outcome except for otitis media after dose 2: HR 1.11, 95% CI 1.08, 1.15. This increased otitis media risk was not as pronounced in RV5 when comparing RV5 to RV1; HR 0.92, 95% CI 0.89, 0.95. CONCLUSIONS: These data were not consistent with an increased risk of intussusception or other adverse events following vaccination with RV, except potentially for a small increased risk of otitis media, particularly in RV1.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Vacinas contra Rotavirus/efeitos adversos , Vacinas contra Rotavirus/imunologia , Vacinação/estatística & dados numéricos , Estudos de Coortes , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Intussuscepção/epidemiologia , Intussuscepção/etiologia , Masculino , Otite Média/epidemiologia , Otite Média/etiologia , Vacinas contra Rotavirus/administração & dosagem , Estados Unidos/epidemiologia
9.
J Card Fail ; 23(11): 802-808, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28893677

RESUMO

OBJECTIVE: The aim of this work was to estimate agreement of self-reported heart failure (HF) with physician-diagnosed HF and compare the prevalence of HF according to method of ascertainment. METHODS AND RESULTS: ARIC cohort members (60-83 years of age) were asked annually whether a physician indicated that they have HF. For those self-reporting HF, physicians were asked to confirm their patients' HF status. Physician-diagnosed HF included surveillance of hospitalized HF and hospitalized and outpatient HF identified in administrative claims databases. We estimated sensitivity, specificity, positive predicted value, kappa, prevalence and bias-adjusted kappa (PABAK), and prevalence. Compared with physician-diagnosed HF, sensitivity of self-report was low (28%-38%) and specificity was high (96%-97%). Agreement was poor (kappa 0.32-0.39) and increased when adjusted for prevalence and bias (PABAK 0.73-0.83). Prevalence of HF measured by self-report (9.0%), ARIC-classified hospitalizations (11.2%), and administrative hospitalization claims (12.7%) were similar. When outpatient HF claims were included, prevalence of HF increased to 18.6%. CONCLUSIONS: For accurate estimates HF burden, self-reports of HF are best confirmed by means of appropriate diagnostic tests or medical records. Our results highlight the need for improved awareness and understanding of HF by patients, because accurate patient awareness of the diagnosis may enhance management of this common condition.


Assuntos
Aterosclerose/diagnóstico , Aterosclerose/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Características de Residência , Autorrelato/normas , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco
10.
Crit Care ; 21(1): 326, 2017 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-29282093

RESUMO

BACKGROUND: The optimal time to initiate renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unclear. We examined the impact of early RRT on long-term mortality, risk of chronic kidney disease (CKD), and end-stage renal disease (ESRD). METHODS: This cohort study included all adult patients treated with continuous RRT in the ICU at Aarhus University Hospital, Skejby, Denmark (2005-2015). Data were obtained from a clinical information system and population-based registries. Early treatment was defined as RRT initiation at AKI stage 2 or below, and late treatment was defined as RRT initiation at AKI stage 3. Inverse probability of treatment (IPT) weights were computed from propensity scores. The IPT-weighted cumulative risk of CKD (estimated glomerular filtration rate < 60 ml/minute/1.73 m2), ESRD, and mortality was estimated and compared using IPT-weighted Cox regression. RESULTS: The mortality, CKD, and ESRD analyses included 1213, 303, and 617 patients, respectively. The 90-day mortality in the early RRT group was 53.6% compared with 46.0% in the late RRT group (HR 1.24, 95% CI 1.03-1.48). The 90-day to 5-year mortality was 37.7% and 41.5% in the early and late RRT groups, respectively (HR 0.95, 95% CI 0.70-1.29). The 5-year risk of CKD was 35.9% in the early RRT group and 44.9% in the late RRT group (HR 0.74, 95% CI 0.46-1.18). The 5-year risk of ESRD was 13.3% in the early RRT group and 16.7% in the late RRT group (HR 0.79, 95% CI 0.47-1.32). CONCLUSIONS: Early initiation was associated with increased 90-day mortality. In patients surviving to day 90, early initiation was not associated with a major impact on long-term mortality or risk of CKD and ESRD. Despite potential residual confounding due to the observational design, our findings do not support that early RRT initiation is superior to late initiation.


Assuntos
Injúria Renal Aguda/complicações , Insuficiência Renal Crônica/etiologia , Terapia de Substituição Renal/métodos , Fatores de Tempo , Injúria Renal Aguda/mortalidade , Idoso , Estudos de Coortes , Dinamarca , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/mortalidade , Terapia de Substituição Renal/normas , Fatores de Risco
11.
JAMA ; 317(11): 1159-1166, 2017 03 21.
Artigo em Inglês | MEDLINE | ID: mdl-28324090

RESUMO

Importance: Testosterone initiation increased substantially in the United States from 2000 to 2013, especially among men without clear indications. Direct-to-consumer advertising (DTCA) also increased during this time. Objective: To investigate associations between televised DTCA and testosterone testing and initiation in the United States. Design, Setting, and Population: Ecologic study conducted in designated market areas (DMAs) in the United States. Monthly testosterone advertising ratings were linked to DMA-level testosterone use data from 2009-2013 derived from commercial insurance claims. Associations between DTCA and testosterone testing, initiation, and initiation without recent baseline tests were estimated using Poisson generalized estimating equations. Exposures: Monthly Nielsen ratings for testosterone DTCA in the 75 largest DMAs. Main Outcomes and Measures: (1) Rates of new serum testosterone testing; (2) rates of testosterone initiation (in-office injection, surgical implant, or pharmacy dispensing) for all testosterone products combined and for specific brands; and (3) rates of testosterone initiation without recent serum testosterone testing. Results: Of 17 228 599 commercially insured men in the 75 DMAs, 1 007 990 (mean age, 49.6 [SD, 11.5] years) had new serum testosterone tests and 283 317 (mean age, 51.8 [SD, 11.3] years) initiated testosterone treatment. Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household. Nonbranded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing (rate ratio [RR], 1.006; 95% CI, 1.004-1.008), initiation (RR, 1.007; 95% CI, 1.004-1.010), and initiation without a recent test (RR, 1.008; 95% CI, 1.002-1.013). Mean absolute rate increases were 0.14 tests (95% CI, 0.09-0.19), 0.05 new initiations (95% CI, 0.03-0.08), and 0.02 initiations without a recent test (95% CI, 0.01-0.03) per 10 000 men for each monthly ad exposure over the entire period. Conclusions and Relevance: Among US men residing in the 75 designated market areas, regional exposure to televised direct-to-consumer advertising was associated with greater testosterone testing, new initiation, and initiation without recent testing.


Assuntos
Androgênios/administração & dosagem , Publicidade Direta ao Consumidor/estatística & dados numéricos , Cobertura do Seguro/estatística & dados numéricos , Testosterona/administração & dosagem , Testosterona/sangue , Adulto , Distribuição por Idade , Idoso , Publicidade Direta ao Consumidor/tendências , Terapia de Reposição Hormonal/estatística & dados numéricos , Terapia de Reposição Hormonal/tendências , Humanos , Cobertura do Seguro/tendências , Masculino , Pessoa de Meia-Idade , Televisão/estatística & dados numéricos , Fatores de Tempo , Estados Unidos
13.
Osteoporos Int ; 26(5): 1515-24, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25600474

RESUMO

UNLABELLED: Anti-osteoporosis medication (AOM) use in patients exposed to glucocorticoids is thought to reduce fractures. We found post-menopausal women using glucocorticoids for at least 90 days who also used an AOM within 90 days had 48 % fewer fractures by 1 year and 32 % fewer fractures by 3 years compared to non-AOM users. INTRODUCTION: The purpose of this study is to explore the effectiveness of adherence to quality measures by estimating the effect of anti-osteoporosis medication (AOM) initiation within 90 days after chronic (≥90 days) glucocorticoid (GC) therapy on osteoporotic fracture. METHODS: A new-user cohort was assembled using the MarketScan databases between 2000 and 2012. Included patients were female, age ≥50 at GC initiation, had a first GC fill daily dose ≥10 mg and persisted for at least 90 days. During a 365-day baseline period, patients were excluded for prior GC or AOM (bisphosphonate, denosumab, teriparatide) use, fracture, or cancer diagnosis. Initiators of an AOM in the 14 days pre- or 90 days post-GC fill were characterized as AOM users; those without, AOM non-users. Follow-up began 91 days after GC fill with patients followed until fracture, loss of continuous enrollment, initiation of AOM by AOM non-users, or end of study period. A propensity score was estimated for AOM receipt using all measured covariates and converted to a stabilized inverse probability of treatment weights (IPTW). Weighted hazard ratios (HR) and associated 95% confidence intervals (95% CI) were estimated using weighted Cox proportional hazard models. RESULTS: Of the 7885 women eligible for the study, 12.1% were AOM users. AOM use was associated with lower fracture incidence: weighted HR of 0.52 (95% CI 0.29, 0.94) at 1 year and weighted HR of 0.68 (95% CI 0.47, 0.99) at 3 years. CONCLUSIONS: AOM initiation within 90 days of chronic GC use was associated with a fracture reduction of 48% at 1 year and 32% at 3 years.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Glucocorticoides/efeitos adversos , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Feminino , Seguimentos , Glucocorticoides/administração & dosagem , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/induzido quimicamente , Osteoporose Pós-Menopausa/complicações , Fraturas por Osteoporose/etiologia , Estudos Retrospectivos
14.
J Cardiothorac Vasc Anesth ; 29(3): 617-25, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25575408

RESUMO

OBJECTIVE: To examine the impact of postoperative acute kidney injury (AKI) on the long-term risk of myocardial infarction, heart failure, stroke, and all-cause mortality after elective cardiac surgery. The authors investigated whether time of onset of AKI altered the association between AKI and the adverse events. DESIGN: Population-based cohort study in 2006-2011. SETTING: Two university hospitals. PARTICIPANTS: Adult elective cardiac surgical patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: AKI was defined as an increase in baseline creatinine according to the Kidney Disease Improving Global Outcomes criteria. AKI was defined within 30 days of surgery, and also analyzed as early- or late-onset AKI. The authors followed patients from postoperative day 30 until hospitalization with myocardial infarction, heart failure, stroke, or death. Adjustment for confounding factors was done using propensity scores and standardized-mortality-ratio weights. A total of 1,457 (30.7%) of 4,742 patients developed AKI within 30 days of surgery and 470 (9.9%) patients experienced a composite cardiovascular endpoint. Comparing patients with and without postoperative AKI, weighted hazard ratio (HR) and 95% confidence intervals (CI) of 5-year risk of the composite cardiovascular endpoint was 1.41 (95% CI: 1.11-1.80). For each endpoint separately the weighted HR was similarly increased. Ninety-one days to 5-year weighted HR of all-cause mortality was 1.37 (95% CI: 1.05-1.80). The effect of AKI was similar for early- and late-onset AKI. CONCLUSIONS: Early- and late-onset AKI within 30 days of elective cardiac surgery was associated with a similarly increased 5-year risk of myocardial infarction, heart failure, stroke, and increased all-cause mortality.


Assuntos
Injúria Renal Aguda/epidemiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Doenças Cardiovasculares/epidemiologia , Vigilância da População , Complicações Pós-Operatórias/epidemiologia , Injúria Renal Aguda/diagnóstico , Adulto , Idoso , Procedimentos Cirúrgicos Cardíacos/tendências , Doenças Cardiovasculares/diagnóstico , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância da População/métodos , Complicações Pós-Operatórias/diagnóstico , Sistema de Registros , Fatores de Risco , Fatores de Tempo
15.
Clin Gastroenterol Hepatol ; 12(9): 1514-21.e3, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24486407

RESUMO

BACKGROUND & AIMS: Oral sodium phosphate (OSP) is a common bowel purgative administered before colonoscopy; the Food and Drug Administration has warned against its use because of concerns about acute kidney injury (AKI) from the absorbed phosphate and dystrophic calcification. However, it is not clear if OSP is associated with AKI in the general population or in high-risk subgroups undergoing colonoscopy. We estimated the risk of AKI among patients undergoing a screening colonoscopy using OSP vs polyethylene glycol (PEG) for bowel cleansing in a large, US-based claims database. METHODS: We used an insurance database to identify a cohort of patients ages 50 to 75 years who underwent screening colonoscopies as outpatients from January 2000 through November 2008 (before the Food and Drug Administration warning), receiving OSP (n = 121,266) or PEG (n = 429,430) within 30 days beforehand, without prior use of either drug. We collected data from patients for 6 months afterward to identify those who developed AKI or renal failure, or received dialysis. Adjusted and propensity score-matched hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox proportional hazards models. We investigated the effects in subgroups with higher AKI risk (patients with chronic kidney disease, kidney stones, hypertension, or diabetes, or using antihypertensive or nonsteroidal anti-inflammatory drugs). RESULTS: AKI occurred in 0.2% of OSP users and in 0.3% of PEG users (adjusted HR, 0.86; 95% CI, 0.75-0.99). OSP users matched well with PEG users, producing similar estimates (HR, 0.85; 95% CI, 0.72-1.01). We did not observe a consistent increase in the risk of AKI or other outcomes in any subgroups analyzed. CONCLUSIONS: In a large database analysis, we did not associate administration of OSP before colonoscopy with increased risk of postprocedure AKI, even in high-risk clinical subgroups.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Catárticos/efeitos adversos , Colonoscopia/métodos , Fosfatos/efeitos adversos , Polietilenoglicóis/efeitos adversos , Cuidados Pré-Operatórios/efeitos adversos , Idoso , Catárticos/administração & dosagem , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fosfatos/administração & dosagem , Polietilenoglicóis/administração & dosagem , Cuidados Pré-Operatórios/métodos , Medição de Risco , Estados Unidos
16.
Acta Psychol (Amst) ; 244: 104179, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38364634

RESUMO

The COVID-19 pandemic had a significant impact on the mental health of individuals, particularly in the area of anxiety-related disorders. Anxiety regarding COVID-19 has been associated with health anxiety, panic disorder, and obsessive-compulsive disorder symptoms. Additionally, COVID-19 anxiety has been associated with anxiety sensitivity, disgust, maladaptive metacognitions, and intolerance of uncertainty. While researchers have established that anxiety disorders and anxiety-related mechanisms were associated with COVID-19 anxiety, which specific anxiety-related symptoms and mechanisms are primarily associated with COVID-19 anxiety needs to be more extensively explored. The current study sought to further this area by examining which particular anxiety-related disorder symptoms and mechanisms were uniquely associated with COVID-19 anxiety. A non-clinical sample of 593 Canadian undergraduate participants (Mage = 21.13 years; 67.7 % female) completed this cross-sectional study between September 2020 and February 2021. Participants completed online questionaries assessing anxiety-related disorder symptoms and mechanisms in addition to multiple scales of COVID-19 anxiety. When examining symptoms, health anxiety (prs = 0.17-0.29) and obsessive-compulsive disorder (prs = 0.16-0.35) symptoms had the strongest unique associations with COVID-19 anxiety. Among the anxiety-related mechanisms, disgust sensitivity (prs = 0.14-0.16) and health anxiety-specific intolerance of uncertainty (prs = 0.12-0.30) had the strongest unique associations with COVID-19 anxiety. Individuals experiencing these disorders and anxiety-related mechanisms may be at a heightened vulnerability to experiencing heightened anxiety during future pandemics. Mental health professionals should discuss COVID-19 anxiety with individuals experiencing health anxiety or obsessive-compulsive disorder symptoms. Lastly, the study highlights the significance of considering a variety of specific anxiety-related disorder symptoms and mechanisms when working to understand pandemic anxiety.


Assuntos
COVID-19 , Feminino , Humanos , Masculino , Pandemias , Estudos Transversais , Canadá/epidemiologia , Transtornos de Ansiedade/psicologia , Ansiedade/psicologia
17.
Kidney Int Rep ; 9(2): 257-265, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38344741

RESUMO

Introduction: Influenza infections contribute to excess healthcare utilization, morbidity, and mortality in individuals with glomerular disease (GD); however, influenza vaccination may not yield protective immune responses in this high-risk patient population. The objective of the present study was to describe influenza vaccine administration from 2010 to 2019 and explore the effectiveness of influenza vaccination in patients with GD. Methods: We conducted an observational cohort study using healthcare claims for seasonal influenza vaccination (exposure) as well as influenza and influenza-like illness (outcomes) from commercially insured children and adults <65 years of age with primary GD in the Merative MarketScan Research Databases. Propensity score-weighted cox proportional hazards models and ratio-of-hazard ratios (RHR) analyses were used to compare influenza infection risk in years where seasonal influenza vaccines matched or mismatched circulating viral strains. Results: The mean proportion of individuals vaccinated per season was 23% (range 19%-24%). In pooled analyses comparing matched to mismatched seasons, vaccination was minimally protective for both influenza (RHR 0.86, 95% confidence interval [CI]: 0.52-1.41) and influenza-like illness (RHR 0.86, 95% CI 0.59-1.24), though estimates were limited by sample size. Conclusion: Rates of influenza vaccination are suboptimal among patients with GD. Protection from influenza after vaccination may be poor, leading to excess infection-related morbidity in this vulnerable population.

18.
Vaccine X ; 16: 100447, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38318230

RESUMO

Background: Monovalent booster/additional doses of COVID-19 vaccines were first authorized in August 2021 in the United States. We evaluated the real-world effectiveness of receipt of a monovalent booster/additional dose of COVID-19 vaccine compared with receiving a primary vaccine series without a booster/additional dose. Methods: Cohorts of individuals receiving a COVID-19 booster/additional dose after receipt of a complete primary vaccine series were identified in 2 administrative insurance claims databases (Optum, CVS Health) supplemented with state immunization information system data between August 2021 and March 2022. Individuals with a complete primary series but without a booster/additional dose were one-to-one matched to boosted individuals on calendar date, geography, and clinical factors. COVID-19 diagnoses were identified in any medical setting, or specifically in hospitals/emergency departments (EDs). Propensity score-weighted hazards ratios (HRs) and 95% confidence intervals (CI) were estimated with Cox proportional hazards models; vaccine effectiveness (VE) was estimated as 1 minus the HR by vaccine brand overall and within subgroups of variant-specific eras, immunocompromised status, and homologous/heterologous booster status. Results: Across both data sources, we identified 752,165 matched pairs for BNT162b2, 410,501 for mRNA-1273, and 11,398 for JNJ-7836735. For any medically diagnosed COVID-19, meta-analyzed VE estimates for BNT162b2, mRNA-1273, and JNJ-7836735, respectively, were: BNT162b2, 54% (95% CI, 53%-56%); mRNA-1273, 58% (95% CI, 56%-59%); JNJ-7836735, 34% (95% CI, 23%-44%). For hospital/ED-diagnosed COVID-19, VE estimates ranged from 70% to 76%. VE was generally lower during the Omicron era than the Delta era and for immunocompromised individuals. There was little difference observed by homologous or heterologous booster status. Conclusion: The original, monovalent booster/additional doses were reasonably effective in real-world use among the populations for which they were indicated during the study period. Additional studies may be informative in the future as new variants emerge and new vaccines become available.Registration: The study protocol was publicly posted on the BEST Initiative website (https://bestinitiative.org/wp-content/uploads/2022/03/C19-VX-Effectiveness-Protocol_2022_508.pdf).

19.
BMC Med Res Methodol ; 13: 142, 2013 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-24245772

RESUMO

BACKGROUND: The High-Dimensional Propensity Score (hd-PS) algorithm can select and adjust for baseline confounders of treatment-outcome associations in pharmacoepidemiologic studies that use healthcare claims data. How hd-PS performance is affected by aggregating medications or medical diagnoses has not been assessed. METHODS: We evaluated the effects of aggregating medications or diagnoses on hd-PS performance in an empirical example using resampled cohorts with small sample size, rare outcome incidence, or low exposure prevalence. In a cohort study comparing the risk of upper gastrointestinal complications in celecoxib or traditional NSAIDs (diclofenac, ibuprofen) initiators with rheumatoid arthritis and osteoarthritis, we (1) aggregated medications and International Classification of Diseases-9 (ICD-9) diagnoses into hierarchies of the Anatomical Therapeutic Chemical classification (ATC) and the Clinical Classification Software (CCS), respectively, and (2) sampled the full cohort using techniques validated by simulations to create 9,600 samples to compare 16 aggregation scenarios across 50% and 20% samples with varying outcome incidence and exposure prevalence. We applied hd-PS to estimate relative risks (RR) using 5 dimensions, predefined confounders, ≤ 500 hd-PS covariates, and propensity score deciles. For each scenario, we calculated: (1) the geometric mean RR; (2) the difference between the scenario mean ln(RR) and the ln(RR) from published randomized controlled trials (RCT); and (3) the proportional difference in the degree of estimated confounding between that scenario and the base scenario (no aggregation). RESULTS: Compared with the base scenario, aggregations of medications into ATC level 4 alone or in combination with aggregation of diagnoses into CCS level 1 improved the hd-PS confounding adjustment in most scenarios, reducing residual confounding compared with the RCT findings by up to 19%. CONCLUSIONS: Aggregation of codes using hierarchical coding systems may improve the performance of the hd-PS to control for confounders. The balance of advantages and disadvantages of aggregation is likely to vary across research settings.


Assuntos
Pontuação de Propensão , Adolescente , Adulto , Idoso , Algoritmos , Artrite/tratamento farmacológico , Celecoxib , Fatores de Confusão Epidemiológicos , Inibidores de Ciclo-Oxigenase 2/efeitos adversos , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , Diclofenaco/efeitos adversos , Diclofenaco/uso terapêutico , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/epidemiologia , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Ibuprofeno/efeitos adversos , Ibuprofeno/uso terapêutico , Incidência , Pessoa de Meia-Idade , Modelos Estatísticos , Prevalência , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Sulfonamidas/efeitos adversos , Sulfonamidas/uso terapêutico , Resultado do Tratamento , Adulto Jovem
20.
Crit Care ; 17(6): R292, 2013 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-24330762

RESUMO

INTRODUCTION: The prognostic impact of acute kidney injury (AKI) on long-term clinical outcomes remains controversial. We examined the five-year risk of death, myocardial infarction, and stroke after elective cardiac surgery complicated by AKI. METHODS: We conducted a cohort study among adult elective cardiac surgical patients without severe chronic kidney disease and/or previous heart or renal transplant surgery using data from population-based registries. AKI was defined by the Acute Kidney Injury Network (AKIN) criteria as a 50% increase in serum creatinine from baseline level, acute creatinine rise of ≥26.5 µmol/L (0.3 mg/dL) within 48 hours, and/or initiation of renal replacement therapy within five days after surgery. We followed patients from the fifth post-operative day until myocardial infarction, stroke or death within five years. Five-year risk was computed by the cumulative incidence method and compared with hazards ratios (HR) from a Cox proportional hazards regression model adjusting for propensity score. RESULTS: A total of 287 (27.9%) of 1,030 patients developed AKI. Five-year risk of death was 26.5% (95% CI: 21.2 to 32.0) among patients with AKI and 12.1% (95% CI: 10.0 to 14.7) among patients without AKI. The corresponding adjusted HR of death was 1.6 (95% CI: 1.1 to 2.2). Five-year risk of myocardial infarction was 5.0% (95% CI: 2.9 to 8.1) among patients with AKI and 3.3% (95% CI: 2.1 to 4.8) among patients without AKI. Five-year risk of stroke was 5.0% (95% CI: 2.8 to 7.9) among patients with AKI and 4.2% (95% CI: 2.9 to 5.8) among patients without AKI. Adjusted HRs were 1.5 (95% CI: 0.7 to 3.2) of myocardial infarction and 0.9 (95% CI: 0.5 to 1.8) of stroke. CONCLUSIONS: AKI, within five days after elective cardiac surgery, was associated with increased five-year mortality and a statistically insignificant increased risk of myocardial infarction. No association was seen with the risk of stroke.


Assuntos
Injúria Renal Aguda/etiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Causas de Morte , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Infarto do Miocárdio/etiologia , Acidente Vascular Cerebral/etiologia , Injúria Renal Aguda/diagnóstico , Idoso , Estudos de Coortes , Feminino , Taxa de Filtração Glomerular , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Prognóstico , Fatores de Risco , Fatores de Tempo
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