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BACKGROUND: For hypertensive patients without a history of stroke or myocardial infarction (MI), the China Stroke Primary Prevention Trial (CSPPT) demonstrated that treatment with enalapril-folic acid reduced the risk of primary stroke compared with enalapril alone. Whether folic acid therapy is an affordable and beneficial treatment strategy for the primary prevention of stroke in hypertensive patients from the Chinese healthcare sector perspective has not been thoroughly explored. METHODS: We performed a cost-effectiveness analysis alongside the CSPPT, which randomized 20,702 hypertensive patients. A patient-level microsimulation model based on the 4.5-year period of in-trial data was used to estimate costs, life years, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) for enalapril-folic acid vs. enalapril over a lifetime horizon from the payer perspective. RESULTS: During the in-trial follow-up period, patients receiving enalapril-folic acid gained an average of 0.016 QALYs related primarily to reductions in stroke, and the incremental cost was $706.03 (4553.92 RMB). Over a lifetime horizon, enalapril-folic acid treatment was projected to increase quality-adjusted life years by 0.06 QALYs or 0.03 life-year relative to enalapril alone at an incremental cost of $1633.84 (10,538.27 RMB), resulting in an ICER for enalapril-folic acid compared with enalapril alone of $26,066.13 (168,126.54 RMB) per QALY gained and $61,770.73 (398,421.21 RMB) per life-year gained, respectively. A probabilistic sensitivity analysis demonstrated that enalapril-folic acid compared with enalapril would be economically attractive in 74.5% of simulations at a threshold of $37,663 (242,9281 RMB) per QALY (3x current Chinese per capita GDP). Several high-risk subgroups had highly favorable ICERs < $12,554 (80,976 RMB) per QALY (1x GDP). CONCLUSIONS: For both in-trial and over a lifetime, it appears that enalapril-folic acid is a clinically and economically attractive medication compared with enalapril alone. Adding folic acid to enalapril may be a cost-effective strategy for the prevention of primary stroke in hypertensive patients from the Chinese health system perspective.
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Hipertensión , Accidente Cerebrovascular , Humanos , Análisis Costo-Beneficio , Enalapril/uso terapéutico , Ácido Fólico/uso terapéutico , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Prevención Primaria , Años de Vida Ajustados por Calidad de Vida , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/tratamiento farmacológicoRESUMEN
BACKGROUND: Epidemiological evidence suggests potential associations of road traffic noise exposure with cardiovascular disease (CVD) and mortality, but uncertainty remains. OBJECTIVES: We examined the association of road traffic noise with the risk of CVD and mortality in a large longitudinal cohort study and meta-analysis. METHODS: We analyzed 342, 566 participants from the UK Biobank who were free of CVD at baseline and had complete covariate data. We also performed a meta-analysis of road traffic noise effects on CVD and mortality by including qualified cohort studies published before April 2021. RESULTS: After adjustment for potential confounders, the odds for the risk of stroke, CVD, and all-cause mortality increased by 1.07 (95%CI: 1.01-1.13, P = 0.019), 1.13 (95%CI: 1.04-1.22, P = 0.003) and 1.08 (95%CI: 1.04-1.12, P < 0.001) times per 10 dB increases in road traffic noise, respectively. Among men, high road traffic noise exposure was significantly associated with an increased risk in stroke (HR = 1.08 per 10 dB increase, 95%CI: 1.00-1.16, P = 0.043), CVD (HR = 1.12 per 10 dB increase, 95%CI: 1.02-1.23, P = 0.020) and all-cause mortality (HR = 1.12 per 10 dB increase, 95%CI: 1.07-1.17 P < 0.001), whereas we did not find a significant association in women. The meta-analysis showed that road traffic noise exposure was significantly associated with a high risk of stroke (risk ratio [RR]: 1.06, 95% CI: 1.02-1.11), CVD mortality (RR: 1.03, 95% CI: 1.00-1.05), all-cause mortality (RR: 1.05, 95% CI: 1.02-1.07). CONCLUSIONS: This study provides more evidence of increased risk of stroke, CVD, and all-cause mortality in association with exposure to road traffic noise pollution, especially in men.
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Enfermedades Cardiovasculares , Ruido del Transporte , Accidente Cerebrovascular , Bancos de Muestras Biológicas , Exposición a Riesgos Ambientales/efectos adversos , Femenino , Humanos , Estudios Longitudinales , Masculino , Ruido del Transporte/efectos adversos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: Increased life expectancy and improved medical technology allow increasing numbers of elderly patients to undergo cardiac surgery. Elderly patients may be at greater risk of postoperative morbidity and mortality. Complications can lead to worsened quality of life, shortened life expectancy and higher healthcare costs. Reducing perioperative complications, especially severe adverse events, is key to improving outcomes in patients undergoing cardiac surgery. The objective of this study is to determine whether perioperative lipid-lowering medication use is associated with a reduced risk of complications and mortality after coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). METHODS: After IRB approval, we reviewed charts of 9,518 patients who underwent cardiac surgery with CPB at three medical centers between July 2001 and June 2015. The relationship between perioperative lipid-lowering treatment and postoperative outcome was investigated. 3,988 patients who underwent CABG met inclusion criteria and were analyzed. Patients were divided into lipid-lowering or non-lipid-lowering treatment groups. RESULTS: A total of 3,988 patients were included in the final analysis. Compared to the patients without lipid-lowering medications, the patients with lipid-lowering medications had lower postoperative neurologic complications and overall mortality (P < 0.05). Propensity weighted risk-adjustment showed that lipid-lowering medication reduced in-hospital total complications (odds ratio (OR) = 0.856; 95% CI 0.781-0.938; P < 0.001); all neurologic complications (OR = 0.572; 95% CI 0.441-0.739; P < 0.001) including stroke (OR = 0.481; 95% CI 0.349-0.654; P < 0.001); in-hospital mortality (OR = 0.616; 95% CI 0.432-0.869; P = 0.006; P < 0.001); and overall mortality (OR = 0.723; 95% CI 0.634-0.824; P < 0.001). In addition, the results indicated postoperative lipid-lowering medication use was associated with improved long-term survival in this patient population. CONCLUSIONS: Perioperative lipid-lowering medication use was associated with significantly reduced postoperative adverse events and improved overall outcome in elderly patients undergoing CABG surgery with CPB.
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Puente de Arteria Coronaria , Calidad de Vida , Anciano , Puente Cardiopulmonar/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Humanos , Lípidos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Estudios RetrospectivosRESUMEN
BACKGROUND: Dexmedetomidine sedation has been associated with favourable outcomes after surgery. We aimed to assess whether perioperative dexmedetomidine use is associated with improved survival after cardiac surgery. METHODS: This retrospective cohort study included 2068 patients undergoing on-pump coronary artery bypass grafting and/or valve surgery. Among them, 1029 patients received dexmedetomidine, and 1039 patients did not. Intravenous dexmedetomidine infusion of 0.007 µg kg-1 min-1 was initiated before or immediately after cardiopulmonary bypass and lasted for < 24 h. The primary outcome was 5-year survival after cardiac surgery. The propensity scores matching (PSM), inverse probability of treatment weighting (IPTW), and overlap weighting approaches were used to minimise bias. Survival analyses were performed with Cox proportional-hazard models. RESULTS: The median age was 63 yr old and the male to female ratio was 71:29 in both groups. Baseline covariates were balanced between groups after adjustment using PSM, IPTW, or overlap weighting. Patients receiving dexmedetomidine in cardiac surgical procedures had higher survival during postoperative 5 yr in unadjusted analysis (hazard ratio [HR]=0.63; 95% confidence interval [CI], 0.51-0.78; P<0.001), and after adjustment with PSM (HR=0.63; 95% CI, 0.45-0.89; P=0.009), IPTW (HR=0.70; 95% CI, 0.51-0.95; P=0.023), or overlap weighting (HR=0.67; 95% CI, 0.51-0.89; P=0.006). The 5-yr mortality rate after cardiac surgery was 13% and 20% in the dexmedetomidine and non-dexmedetomidine groups, respectively (PSM adjusted odds ratio=0.61; 95% CI, 0.42-0.89; P=0.010). CONCLUSION: Perioperative dexmedetomidine infusion was associated with improved 5-yr survival in patients undergoing cardiac surgery.
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Procedimientos Quirúrgicos Cardíacos/métodos , Dexmedetomidina/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Atención Perioperativa/métodos , Complicaciones Posoperatorias/prevención & control , Anciano , Estudios de Cohortes , Puente de Arteria Coronaria , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: In the Systolic Blood Pressure Intervention Trial (SPRINT), adults at high risk for cardiovascular disease who received intensive systolic blood-pressure control (target, <120 mm Hg) had significantly lower rates of death and cardiovascular disease events than did those who received standard control (target, <140 mm Hg). On the basis of these data, we wanted to determine the lifetime health benefits and health care costs associated with intensive control versus standard control. METHODS: We used a microsimulation model to apply SPRINT treatment effects and health care costs from national sources to a hypothetical cohort of SPRINT-eligible adults. The model projected lifetime costs of treatment and monitoring in patients with hypertension, cardiovascular disease events and subsequent treatment costs, treatment-related risks of serious adverse events and subsequent costs, and quality-adjusted life-years (QALYs) for intensive control versus standard control of systolic blood pressure. RESULTS: We determined that the mean number of QALYs would be 0.27 higher among patients who received intensive control than among those who received standard control and would cost approximately $47,000 more per QALY gained if there were a reduction in adherence and treatment effects after 5 years; the cost would be approximately $28,000 more per QALY gained if the treatment effects persisted for the remaining lifetime of the patient. Most simulation results indicated that intensive treatment would be cost-effective (51 to 79% below the willingness-to-pay threshold of $50,000 per QALY and 76 to 93% below the threshold of $100,000 per QALY), regardless of whether treatment effects were reduced after 5 years or persisted for the remaining lifetime. CONCLUSIONS: In this simulation study, intensive systolic blood-pressure control prevented cardiovascular disease events and prolonged life and did so at levels below common willingness-to-pay thresholds per QALY, regardless of whether benefits were reduced after 5 years or persisted for the patient's remaining lifetime. (Funded by the National Heart, Lung, and Blood Institute and others; SPRINT ClinicalTrials.gov number, NCT01206062 .).
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Antihipertensivos/economía , Enfermedades Cardiovasculares/prevención & control , Costos de la Atención en Salud , Hipertensión/tratamiento farmacológico , Años de Vida Ajustados por Calidad de Vida , Adulto , Antihipertensivos/administración & dosificación , Enfermedades Cardiovasculares/economía , Enfermedades Cardiovasculares/mortalidad , Costo de Enfermedad , Análisis Costo-Beneficio , Humanos , Hipertensión/economía , Modelos EconómicosRESUMEN
OBJECTIVES: To compare the number of intermittent hypoxia events before and after packed red blood cell (pRBC) and non-pRBC transfusions in very low birth weight infants, and to compare the time spent with saturations of ≤85% before and after transfusions in the same population. STUDY DESIGN: This prospective observational study was conducted from April 2014 to August 2017. It included 92 transfusions (81 pRBC, 11 non-pRBC) from 41 very low birth weight infants between 230/7 and 286/7 weeks of gestation. The primary outcome was number of intermittent hypoxia events. Secondary outcomes included the percent time of Peripheral capillary oxygen saturation (SpO2)of ≤85%, ≤80%, and ≤75%. A mixed ANOVA model was used to examine the relationship between event rate and covariates. RESULTS: The mean number of intermittent hypoxia events per hour decreased from 5.27 ± 5.02 events per hour before pRBC transfusion to 3.61 ± 3.17 per hour after pRBC transfusions (P < .01) and intermittent hypoxia did not change after non-RBC transfusions (before, 4.45 ± 3.19 vs after, 4.47 ± 2.78; P = NS). The percent time with saturations of ≤80% and ≤75% significantly decreased after pRBC transfusions (P = .01). The time with saturations of ≤85% did not significantly change after non-pRBC transfusion. CONCLUSIONS: In very low birth weight infants with a hematocrit of 20%-42%, pRBC transfusions are associated with decreased frequency of intermittent hypoxia. No such diminution of intermittent hypoxia events was observed in infants who had received a non-pRBC transfusion. This finding suggests that the observed beneficial effects of RBC transfusions on apnea and its clinical manifestations of intermittent hypoxia are mediated through an enhanced oxygen carrying capacity.
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Transfusión de Eritrocitos , Hipoxia/prevención & control , Femenino , Humanos , Recién Nacido , Recién Nacido de muy Bajo Peso , Masculino , Estudios ProspectivosRESUMEN
INTRODUCTION: Hospitalization and post-discharge provide an opportune time for tobacco cessation. This study tested the feasibility, uptake, and cessation outcomes of a hospital-based tobacco cessation program, delivered by volunteers to the bedside with post-discharge referral to Quitline services. Patient characteristics associated with Quitline uptake and cessation were assessed. METHODS: Between February and November 2016, trained hospital volunteers approached inpatient tobacco users on six pilot units. Volunteers shared a cessation brochure and used the ASK-ADVISE-CONNECT model to connect ready to quit patients to the Delaware Quitline via fax-referral. Volunteers administered a follow-up survey to all admitted tobacco users via telephone or email at 3-months post-discharge. RESULTS: Of the 743 admitted tobacco users, 531 (72%) were visited by a volunteer, and 97% (531/547) of those approached, accepted the visit. Over one-third (201/531; 38%) were ready to quit and fax-referred to the Quitline, and 36% of those referred accepted Quitline services. At 3 months post-discharge, 37% (135/368) reported not using tobacco in the last 30 days; intent-to-treat cessation rate was 18% (135/743). In a multivariable regression model of Quitline fax-referral completion, receiving nicotine replacement therapy (NRT) during hospitalization was the strongest predictor (odds ratios [OR] = 1.97; 95% confidence interval [CI] = 1.34 to 2.90). In a model of 3-month cessation, receiving Quitline services (OR = 3.21, 95% CI = 1.35 to 7.68) and having coronary artery disease (OR = 2.28; 95% CI = 1.11 to 4.68) were associated with tobacco cessation, but a volunteer visit was not. CONCLUSIONS: An "opt-out" tobacco cessation service using trained volunteers is feasible for connecting patients to Quitline services. IMPLICATIONS: This study demonstrates the feasibility of a systems-based approach to link inpatients to evidence-based treatment for tobacco use. This model used trained bedside volunteers to connect inpatients to a state-funded Quitline after discharge that offers free cessation treatment of telephone coaching and cessation medications. Receiving NRT during hospitalization positively impacted Quitline referral, and engagement with Quitline resources was critical to tobacco abstinence post-discharge. Future work is needed to evaluate the cost-effectiveness and sustainability of this volunteer model.
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Hospitalización , Alta del Paciente/estadística & datos numéricos , Teléfono/estadística & datos numéricos , Cese del Uso de Tabaco/métodos , Voluntarios , Femenino , Humanos , Masculino , Persona de Mediana Edad , Derivación y Consulta , Cese del Uso de Tabaco/psicologíaRESUMEN
The national rate of lung cancer screening, approximately 3-5%, is too low and strategies which include shared decision-making and increase screening are needed. A feasibility study in one large primary care practice of telephone-based delivery of decision support via an online tool, the Decision Counseling Program© (DCP) was administered to patients eligible for lung cancer screening according to USPSTF screening guidelines. We collected data on demographics, decisional conflict, and conducted chart audits to ascertain screening. From electronic medical record data, we identified 829 age-eligible current or former smokers. Of the 297 individuals reached, 54 were eligible and 28 were recruited to the study and 20 underwent the DCP© intervention. Participants in the intervention were more likely to complete low-dose CT scans at 90 days. Current smokers were less likely to complete the DCP. Women were less likely to complete LDCT. This non-persuasive, high-quality shared decision-making intervention significantly increased lung cancer screening and was feasible in real-world clinical care. This intervention offers a promising model whereby patients can be supported in a decision, based on their values and beliefs while also supporting gains in lung cancer screening.
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Toma de Decisiones Clínicas , Toma de Decisiones Conjunta , Detección Precoz del Cáncer/psicología , Neoplasias Pulmonares/diagnóstico , Atención Primaria de Salud/estadística & datos numéricos , Fumadores/estadística & datos numéricos , Teléfono/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Detección Precoz del Cáncer/métodos , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/psicología , Masculino , Persona de Mediana Edad , Relaciones Médico-Paciente , Tomografía Computarizada por Rayos X/métodosRESUMEN
BACKGROUND: Although the prevalence of hypertension (HTN) continues to increase in developing countries, including China, recent data are lacking. A nationwide survey was conducted from October 2012 to December 2015 to assess the prevalence of HTN in China. METHODS: A stratified multistage random sampling method was used to obtain a nationally representative sample of 451 755 residents ≥18 years of age from 31 provinces in mainland China from October 2012 to December 2015. Blood pressure (BP) was measured after resting for 5 minutes by trained staff using a validated oscillometric BP monitor. HTN was defined as systolic BP (SBP) ≥140 mm Hg/or diastolic BP (DBP) ≥90 mm Hg or use of antihypertensive medication within 2 weeks. Pre-HTN was defined as SBP 120 to 139 mm Hg and DBP 80 to 89 mm Hg without antihypertensive medication. HTN control was defined as SBP <140 mm Hg and DBP<90 mm Hg. In addition, the prevalence of HTN (SBP ≥130 or DBP ≥80 mm Hg) and control rate (SBP <130 and DBP <80 mm Hg) of HTN were also estimated according to the 2017 American College of Cardiology/American Heart Association High Blood Pressure Guideline. RESULTS: Overall, 23.2% (≈244.5 million) of the Chinese adult population ≥18 years of age had HTN, and another 41.3% (≈435.3 million) had pre-HTN according to the Chinese guideline. There were no significant differences of HTN prevalence between urban and rural residents (23.4% versus 23.1%, P=0.819). Among individuals with HTN, 46.9% were aware of their condition, 40.7% were taking prescribed antihypertensive medications, and 15.3% had controlled HTN. Calcium channel blockers were the most commonly used antihypertensive medication (46.5%) as monotherapy, and 31.7% of treated hypertensive patients used ≥2 medications. The prevalence of HTN based on the 2017 American College of Cardiology/American Heart Association guideline was twice as high as that based on 2010 Chinese guideline (46.4%), whereas the control rate fell to 3.0%. CONCLUSIONS: In China, there is a high prevalence of HTN and pre-HTN, and awareness, treatment, and control of HTN were low. Management of medical therapy for HTN needs to improve.
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Hipertensión/diagnóstico , Adolescente , Adulto , Anciano , Antihipertensivos/uso terapéutico , Presión Sanguínea , Índice de Masa Corporal , China/epidemiología , Escolaridad , Femenino , Encuestas Epidemiológicas , Humanos , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Masculino , Persona de Mediana Edad , Prehipertensión/diagnóstico , Prehipertensión/epidemiología , Prevalencia , Medición de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Hospital-based palliative care consultation is consistently associated with reduced hospitalization costs and more importantly with improved patient quality of life. As healthcare systems move toward value-based purchasing rather than fee-for-service models, understanding how palliative care consultation is associated with value-based purchasing metrics can provide evidence for expanded health system support for a greater palliative care presence. AIM: To understand how a palliative care consultation impacts rates of patient readmission and hospital-acquired infections associated with value-based purchasing metrics. DESIGN: Retrospective propensity-matched case-control study evaluating the impact of palliative care consultation on hospital charges, hospital and intensive care unit length of stay, readmission rates, and rates of hospital-acquired conditions. SETTING/PARTICIPANTS: All adult patients admitted to a two hospital healthcare system over a 2-year period from 1 April 2015 to 31 March 2017. The palliative care team involved three physicians, five advanced practice providers, a social worker, and a chaplain during the study period. RESULTS: A total of 3415 patients receiving a palliative consult were propensity matched to 25,028 controls. Compared to controls, cases had decreased charges per day and decreased rates of 7-, 30-, and 90-day readmissions. CONCLUSION: Through value-based purchasing, hospitals have 3% of their Medicare reimbursements at risk based on readmission rates. By clarifying prognosis and patient goals, palliative care consultation reduces readmission rates. Hospital systems may want to invest in larger palliative care programs as part of their efforts to reduce hospital readmissions.
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Hospitalización , Cuidados Paliativos/economía , Puntaje de Propensión , Derivación y Consulta , Anciano , Anciano de 80 o más Años , Femenino , Precios de Hospital/tendencias , Humanos , Masculino , Persona de Mediana Edad , Readmisión del Paciente/tendencias , Calidad de la Atención de Salud , Estudios Retrospectivos , Compra Basada en CalidadRESUMEN
Purpose To compare the clinical performance of synthesized two-dimensional (s2D) mammography combined with digital breast tomosynthesis (DBT) with that of full-field digital mammography (FFDM) alone and FFDM combined with DBT in a large community-based screening population by analyzing recall rate, positive predictive value, and cancer detection rate. Materials and Methods This was a retrospective study approved by the institutional review board and was HIPAA compliant with waiver of informed consent. A total of 78 810 screening mammograms from October 11, 2011, to June 30, 2016, were retrospectively collected. Of these, 32 076 were FFDM, 30 561 were DBT-FFDM, and 16 173 were DBT-s2D mammograms. Diagnostic performance of FFDM, DBT-FFDM, and DBT-s2D mammography was compared. Statistical significance was determined by using the Pearson χ2 test and was expressed as odds ratios and related confidence intervals determined by means of logistic regression analysis with pairwise comparisons. Results Recall rates were significantly lower with DBT-s2D mammography (4.3%, 687 of 16 173) when compared with DBT-FFDM (5.8%, 1785 of 30 561; odds ratio, 0.72; 95% confidence interval: 0.65, 0.78; P < .0001) and when compared with FFDM alone (8.7%, 2799 of 32 076; odds ratio, 0.46; 95% confidence interval: 0.43, 0.51). The cancer detection rate was similar among FFDM alone (5.3 of 1000 screening examinations), DBT-FFDM (6.4 of 1000 screening examinations), and DBT-s2D mammography (6.1 of 1000 screening examinations) with no significant difference (FFDM vs DBT-FFDM, P = .08; FFDM vs DBT-s2D, P = .27). The percentage of invasive cancers detected was significantly higher with DBT-s2D mammography (76.5%) than with DBT-FFDM (61.3%, P = .01), and positive predictive values with DBT-s2D mammography (40.8%) were significantly higher than those with DBT-FFDM (28.5%, P < .0001). Conclusion Screening with DBT-s2D mammography in a large community-based practice improved recall rate and positive predictive values without loss of cancer detection rate when compared with DBT-FFDM and FFDM alone. © RSNA, 2017.
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Neoplasias de la Mama/diagnóstico por imagen , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/normas , Mamografía/métodos , Mamografía/normas , Tamizaje Masivo/normas , Adulto , Anciano , Anciano de 80 o más Años , Detección Precoz del Cáncer/estadística & datos numéricos , Femenino , Humanos , Mamografía/estadística & datos numéricos , Tamizaje Masivo/métodos , Tamizaje Masivo/estadística & datos numéricos , Persona de Mediana Edad , Reproducibilidad de los Resultados , Estudios RetrospectivosRESUMEN
BACKGROUND: Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS: We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS: Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS: In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.).
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Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad Coronaria/terapia , Anciano , Investigación sobre la Eficacia Comparativa , Factores de Confusión Epidemiológicos , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/cirugía , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Humanos , Masculino , Observación , Modelos de Riesgos Proporcionales , Análisis de Supervivencia , Estados UnidosRESUMEN
BACKGROUND: The efficacy of sotagliflozin in patients with diabetes and recent worsening of heart failure was shown in the SOLOIST-WHF trial. However, the cost-effectiveness of sotagliflozin in these patients has not been previously investigated. OBJECTIVES: The authors sought to determine the cost-effectiveness of sotagliflozin in patients with diabetes and recent worsening of heart failure. METHODS: Based on SOLOIST-WHF trial data (N = 1,222), we constructed a Markov model to estimate the lifetime impact of sotagliflozin from a U.S. health care sector perspective. Cost data were sourced from the National Inpatient Sample. Life expectancy was modeled from census data and modified by the mortality rate in SOLOIST-WHF. Fatal and nonfatal event rates were carried forward from the trial data. Utility was assessed from the published reports. RESULTS: Lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in the sotagliflozin and placebo groups, respectively, and lifetime costs were $220,113 and $188,198 in the sotagliflozin and placebo groups, respectively. The point estimate incremental cost-effectiveness ratio was $81,823 per QALY gained. The probability of being cost-effective was 3.6%, 67.5%, and 89.4% at willingness-to-pay thresholds of $50,000, $100,000, and $150,000, respectively, per QALY gained. CONCLUSIONS: In patients with diabetes and recent worsening of heart failure, sotagliflozin is cost-effective in the U.S. using commonly accepted willingness-to-pay thresholds. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934).
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The AVERT PRETERM trial (NCT03151330) evaluated whether screening clinically low-risk pregnancies with a validated maternal blood biomarker test for spontaneous preterm birth (sPTB) risk, followed by preventive treatments for those screening positive, would improve neonatal outcomes compared to a clinically low-risk historical population that had received the usual care. Prospective arm participants with singleton non-anomalous pregnancies and no PTB history were tested for sPTB risk at 191/7-206/7 weeks' gestation and followed up with after neonatal discharge. Screen-positive individuals (≥16% sPTB risk) were offered vaginal progesterone (200 mg) and aspirin (81 mg) daily, with twice-weekly nurse phone calls. Co-primary outcomes were neonatal morbidity and mortality, measured using a validated composite index (NMI), and neonatal hospital length of stay (NNLOS). Endpoints were assessed using survival analysis and logistic regression in a modified intent-to-treat population comprising screen-negative individuals and screen-positive individuals accepting treatment. Of 1460 eligible participants, 34.7% screened positive; of these, 56.4% accepted interventions and 43.6% declined. Compared to historical controls, prospective arm neonates comprising mothers accepting treatment had lower NMI scores (odds ratio 0.81, 95% CI, 0.67-0.98, p = 0.03) and an 18% reduction in severe morbidity. NNLOS was shorter (hazard ratio 0.73, 95% CI, 0.58-0.92, p = 0.01), with a 21% mean stay decrease among neonates having the longest stays. Sensitivity analyses in the entire intent-to-treat population supported these findings. These results suggest that biomarker sPTB risk stratification and preventive interventions can ameliorate PTB complications in singleton, often nulliparous, pregnancies historically deemed low risk.
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Introduction: Risk of complications due to gestational diabetes mellitus is increasing in the U.S., particularly among individuals from racial minorities. Research has focused largely on clinical interventions to prevent complications, rarely on individuals' residential environments. This retrospective cohort study aims to examine the association between individuals' neighborhoods and complications of gestational diabetes mellitus. Methods: Demographic and clinical data were extracted from electronic health records and linked to American Community Survey data from the U.S. Census Bureau for 2,047 individuals who had 2,164 deliveries in 2014-2018. Data were analyzed in 2021-2022 using Wilcoxon rank sum test and chi-square test for bivariate analyses and logistic regression for analysis of independent effects. All census tract-based variables used in the model were dichotomized at the median. Results: Bivariate analysis showed that the average percentage of adults earning <$35,000 was higher in neighborhoods where individuals with complications were living than in neighborhoods where individuals without complications were living (30.40%±12.05 vs 28.94%±11.71, p=0.0145). Individuals who lived in areas with ≥8.9% of residents aged >25 years with less than high school diploma had a higher likelihood of complications than those who lived in areas with <8.9% of such residents (33.43% vs 29.02%, p=0.0272). Individuals who lived in neighborhoods that had ≥1.8% of households receiving public assistance were more likely to have complications than those who lived in areas where <1.8% of households received public assistance (33.33% vs 28.97%, p=0.0287). Logistic regression revealed that the odds of deliveries with complications were 44% higher for individuals with obesity (OR=1.44; 95% CI=1.17, 1.77), 35% greater for individuals residing in neighborhoods with higher percentages of households living below the poverty level (OR=1.35; 95% CI=1.09, 1.66), and 28% lower for individuals from neighborhoods where a higher percentage of households had no vehicles available for transportation to work (OR=0.72; 95% CI=0.59, 0.89). Conclusions: Clinical interventions in concert with environmental changes could contribute to preventing maternal and neonatal complications of gestational diabetes mellitus.
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BACKGROUND: Cardiovascular disease (CVD) is among the costliest conditions in the United States, and cost-effectiveness analyses can be used to assess economic impact and prioritize CVD treatments. We aimed to develop standardized, nationally representative CVD events and selected possible CVD treatment-related complication hospitalization costs for use in cost-effectiveness analyses. METHODS: Nationally representative costs were derived using publicly available inpatient hospital discharge data from the 2012-2018 National Inpatient Sample. Events were identified using the principal International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision codes. Facility charges were converted to costs using charge-to-cost ratios, and total costs were estimated by applying a published professional fee ratio. All costs are reported in 2021 US dollars. Mean costs were estimated for events overall and stratified by age, sex, and survival status at discharge. Annual costs to the US health care system were estimated by multiplying the mean annual number of events by the mean total cost per discharge. RESULTS: The annual mean number of hospital discharges among CVD events was the highest for heart failure (1â 087â 000 per year) and cerebrovascular disease (800â 600 per year). The mean cost per hospital discharge was the highest for peripheral vascular disease ($33â 700 [95% CI, $33â 300-$34â 000]) and ventricular tachycardia/ventricular fibrillation ($32â 500 [95% CI, $32â 100-$32â 900]). Hospitalizations contributing the most to annual US health care costs were heart failure ($19â 500 [95% CI, $19â 300-$19â 800] million) and acute myocardial infarction ($18â 300, [95% CI, $18â 200-$18â 500] million). Acute kidney injury was the most frequent possible treatment complication (515â 000 per year), and bradycardia had the highest mean hospitalization costs ($17â 400 [95% CI, $17â 200-$17â 500]). CONCLUSIONS: The hospitalization cost estimates and statistical code reported in the current study have the potential to increase transparency and comparability of cost-effectiveness analyses for CVD in the United States.
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Enfermedades Cardiovasculares , Insuficiencia Cardíaca , Humanos , Estados Unidos/epidemiología , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/terapia , Hospitalización , Costos de la Atención en Salud , Alta del Paciente , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapiaRESUMEN
BACKGROUND: South Africa has the highest rate of fetal alcohol spectrum disorders (FASD) globally. As with alcohol use during pregnancy, alcohol consumption while breastfeeding adversely impacts infant development. We pilot tested an incentive-based text-messaging intervention to reduce alcohol use during pregnancy and lactation in South Africa. METHODS: A single-arm pilot trial was conducted over 3 months in healthcare facilities in Cape Town, South Africa. Pregnant and breastfeeding participants tested positive for recent alcohol use by urinalysis. The three-month intervention had two components, contingency management of alcohol abstinence confirmed by urinalysis twice weekly and weekly health-related text messaging from an evidence-based brief intervention. We collected twice weekly urine samples for measurement of ethyl glucuronide (EtG), an alcohol biomarker, and measures of self-reported alcohol and drug use, violence exposure, and mental health at six weeks and three months post-enrollment. RESULTS: Sixty participants were enrolled, of whom 31 were pregnant and 29 lactating. The number of days with four or more drinks in the past month decreased from 9 days at baseline, on average, to 1-3 days (p-value range: 0.144-0.010) at follow-up timepoints. There were statistically significant increases in the proportions of participants with alcohol-negative urine tests (p < 0.001). The percentages of participants breastfeeding while using alcohol decreased from baseline to the end of 3 months in the overall sample and among those enrolled postpartum, though these were not significant (p-value range: 0.255-0.147). Maternal depression scores also decreased among participants enrolled postpartum (p = 0.054). Emotional abuse by the main partner, but neither physical nor sexual abuse, significantly decreased at both follow-ups in the overall sample (p = 0.032) and among participants enrolled while pregnant (p = 0.015). CONCLUSIONS: This study is among the first to pilot test an incentive-based text-messaging intervention for maternal alcohol use and other outcomes such as depression and violence exposure. Further testing is warranted in a well-powered, randomized controlled trial.
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BACKGROUND: In 3146 REDUCE-IT USA (Reduction of Cardiovascular Events With Icosapent Ethyl Intervention Trial USA) participants, icosapent ethyl (IPE) reduced first and total cardiovascular events by 31% and 36%, respectively, over 4.9 years of follow-up. METHODS AND RESULTS: We used participant-level data from REDUCE-IT USA, 2021 US costs, and IPE costs ranging from $4.59 to $11.48 per day, allowing us to examine a range of possible medication costs. The in-trial analysis was participant-level, whereas the lifetime analysis used a Markov model. Both analyses considered value from a US health sector perspective. The incremental cost-effectiveness ratio (incremental costs divided by incremental quality-adjusted life-years) of IPE compared with standard care (SC) was the primary outcome measure. There was incremental gain in quality-adjusted life-years with IPE compared with SC using in-trial (3.28 versus 3.13) and lifetime (10.36 versus 9.83) horizons. Using an IPE cost of $4.59 per day, health care costs were lower with IPE compared with SC for both in-trial ($29 420 versus $30 947) and lifetime ($216 243 versus $219 212) analyses. IPE versus SC was a dominant strategy in trial and over the lifetime, with 99.7% lifetime probability of an incremental cost-effectiveness ratio <$50 000 per quality-adjusted life-year gained. At a medication cost of $11.48 per day, the cost per quality-adjusted life-year gained was $36 208 in trial and $9582 over the lifetime. CONCLUSIONS: In this analysis, at $4.59 per day, IPE offers better outcomes than SC at lower costs in trial and over a lifetime and is cost-effective at $11.48 per day for conventional willingness-to-pay thresholds. Treatment with IPE should be strongly considered in US patients like those enrolled in REDUCE-IT USA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.
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Enfermedades Cardiovasculares , Costos de la Atención en Salud , Humanos , Estados Unidos/epidemiología , Análisis Costo-Beneficio , Ácido Eicosapentaenoico/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & controlRESUMEN
Introduction: The rapid implementation of telemedicine during the COVID-19 pandemic may have exacerbated the existing health disparities. This study investigated the association between the area deprivation index (ADI), which serves as a measure of socioeconomic deprivation within a geographic area, and the utilization of telemedicine in primary care. Methods: The study data source was electronic health records. The study population consisted of patients with at least one primary care visit between March 2020 and December 2021. The primary outcome of interest was the visit modality (office, phone, and video). The exposure of interest was the ADI score grouped into quartiles (one to four, with one being the least deprived). The confounders included patient sociodemographic characteristics (e.g., age, gender, race, ethnicity, insurance coverage, marital status). We utilized generalized estimating equations to compare the utilization of telemedicine visits with office visits, as well as phone visits with video visits. Results: The study population included 41,583 patients with 127,165 office visits, 39,484 phone visits, and 20,268 video visits. Compared to patients in less disadvantaged neighborhoods (ADI quartile = one), patients in more disadvantaged neighborhoods (ADI = two, three, or four) had higher odds of using phone visits vs office visits, lower odds of using video visits vs office visits, and higher odds of using phone visits vs video visits. Conclusions: Patients who resided in socioeconomically disadvantaged neighborhoods mainly relied on phone consultations for telemedicine visits with their primary care provider. Patient-level interventions are essential for achieving equitable access to digital healthcare, particularly for low-income individuals.
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Objectives: To conduct a secondary data analysis of how changes in smoking and drinking during pregnancy impact status of any breastfeeding and breastfeeding duration in a national cohort. Materials and Methods: A cross-sectional study was conducted using Pregnancy Risk Assessment Monitoring System (PRAMS) data between 2009 and 2017 (n = 334,203). Univariate and multivariate analyses were conducted on the status of any breastfeeding and breastfeeding duration. Results: A dose-dependent inverse relationship was found in which women who smoked the same or more or resumed smoking during pregnancy showed the lowest likelihood and shortest duration of breastfeeding, followed by reduced smokers, quitters, and nonsmokers. Women with a history of alcohol use were significantly more likely to breastfeed compared with women without a history of alcohol use. Conclusions: The profile of smoking change during pregnancy impacts the likelihood and duration of breastfeeding in a dose-dependent and inverse manner. No such relationship was found with drinking change during pregnancy. Public Health Implications: Significant public health efforts should focus on implementing and sustaining evidence-based interventions for prenatal smoking cessation and educating providers and maternal populations on the adverse effect of postpartum alcohol exposure.