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1.
Cerebrovasc Dis ; : 1-9, 2023 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-37717574

RESUMO

INTRODUCTION: The growing cost of stroke care has created the need for outcome-oriented and cost-saving payment models. Identifying imbalances in the current reimbursement model is an essential step toward designing impactful value-based reimbursement strategies. This study describes the variation in reimbursement fees for ischemic stroke management across the USA. METHODS: This Medicare Fee-For-Service claims study examines USA beneficiaries who suffered an ischemic stroke from 2021Q1 to 2022Q2 identified using the Medicare-Severity Diagnosis-Related Groups (MS-DRGs). Demographic national and regional US data were extracted from the Census Bureau. The MS-DRG codes were grouped into four categories according to treatment modality and clinical complexity. Our primary outcome of interest was payments made across individual USA and US geographic regions, assessed by computing the mean incremental payment in cases of comparable complexity. Differences between states for each MS-DRG were statistically evaluated using a linear regression model of the logarithmic transformed payments. RESULTS: 227,273 ischemic stroke cases were included in our analysis. Significant variations were observed among all DRGs defined by medical complexity, treatment modality, and states (p < 0.001). Differences in mean payment per case with the same MS-DRG vary by as high as 500% among individual states. Although higher payment rates were observed in MS-DRG codes with major comorbidities or complexity (MCC), the variation was more expressive for codes without MCC. It was not possible to identify a standard mean incremental fee at a state level. At a regional level, the Northeast registered the highest fees, followed by the West, Midwest, and South, which correlate with poverty rates and median household income in the regions. CONCLUSIONS: The payment variability observed across USA suggests that the current reimbursement system needs to be aligned with stroke treatment costs. Future studies may go one step further to evaluate accurate stroke management costs to guide policymakers in introducing health policies that promote better care for stroke patients.

2.
BMC Cardiovasc Disord ; 23(1): 250, 2023 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-37173648

RESUMO

This is a reply to the letter titled "Understanding lactate and its clearance during extracorporeal membrane oxygenation for supporting refractory cardiogenic shock patients" by Eva Rully Kurniawati et al. In response to the concerns raised about our paper published in BMC Cardiovascular Disorders, titled "Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support: a multicenter retrospective cohort study," we have addressed the confounding bias on the population included and the use of VA-ECMO and Impella CP. Furthermore, we have provided new data on the correlation of oxygen supply and lactate levels at admission of cardiogenic shock.


Assuntos
Oxigenação por Membrana Extracorpórea , Choque Cardiogênico , Humanos , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/terapia , Ácido Láctico , Oxigenação por Membrana Extracorpórea/efeitos adversos , Estudos Retrospectivos , Mortalidade Hospitalar
3.
BMC Health Serv Res ; 23(1): 198, 2023 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-36829122

RESUMO

BACKGROUND: The COVID-19 pandemic raised awareness of the need to better understand where and how patient-level costs are incurred in health care organizations, as health managers and other decision-makers need to plan and quickly adapt to the increasing demand for health care services to meet patients' care needs. Time-driven activity-based costing offers a better understanding of the drivers of cost throughout the care pathway, providing information that can guide decisions on process improvement and resource optimization. This study aims to estimate COVID-19 patient-level hospital costs and to evaluate cost variability considering the in-hospital care pathways of COVID-19 management and the patient clinical classification. METHODS: This is a prospective cohort study that applied time-driven activity-based costing (TDABC) in a Brazilian reference center for COVID-19. Patients hospitalized during the first wave of the disease were selected for their data to be analyzed to estimate in-hospital costs. The cost information was calculated at the patient level and stratified by hospital care pathway and Ordinal Scale for Clinical Improvement (OSCI) category. Multivariable analyses were applied to identify predictors of cost variability in the care pathways that were evaluated. RESULTS: A total of 208 patients were included in the study. Patients followed five different care pathways, of which Emergency + Ward was the most followed (n = 118, 57%). Pathways which included the intensive care unit presented a statistically significant influence on costs per patient (p <  0.001) when compared to Emergency + Ward. The median cost per patient was I$2879 (IQR 1215; 8140) and mean cost per patient was I$6818 (SD 9043). The most expensive care pathway was the ICU only, registering a median cost per patient of I$13,519 (IQR 5637; 23,373) and mean cost per patient of I$17,709 (SD 16,020). All care pathways that included the ICU unit registered a higher cost per patient. CONCLUSIONS: This is one of the first microcosting study for COVID-19 that applied the TDABC methodology and demonstrated how patient-level costs vary as a function of the care pathways followed by patients. These findings can be used to develop value reimbursement strategies that will inform sustainable health policies in middle-income countries such as Brazil.


Assuntos
COVID-19 , Procedimentos Clínicos , Humanos , Brasil , Estudos Prospectivos , Pandemias , Fatores de Tempo , Custos Hospitalares , Hospitais , Hospitalização , Custos de Cuidados de Saúde
4.
Telemed J E Health ; 29(7): 1043-1050, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36445772

RESUMO

Introduction: Data addressing the economic aspects of telehealth initiatives are incipient. This study aimed to evaluate the labor costs for running a COVID-19 telehealth system and its potential incremental access to health care service. Methods: From July 2020 to July 2021, data from a Brazilian teleconsultation service were analyzed. Labor costs were estimated by time-driven activity-based costing. A Generalized Reduced Gradient solving method was coded to maximize the mean incremental access rate and two scenarios were considered to compare the teleconsultation with the in-person consultation: (1) only the length of time that patients spent with a clinician in an in-person consultation was accounted and (2) in addition to the medical consultation, nursing screening was accounted. The mean incremental access rate of the teleconsultation service was defined as a maximization objective in the model. Results: Mean labor costs per medical and nursing teleconsultations are Int$ 24 and Int$ 10, based on data analyses from 25,258 patients. Telemonitoring a patient with a daily call for 7 days costs, on average, Int$ 14. COVID-19 teleconsultation service represents, on average, an incremental access to medical consultation rate of 35% to 52% (min 23% max 63%) for the scenarios (1) and (2), respectively, and considering the current consumed budget for this service. Discussion: A COVID-19 telehealth service contributes to increasing access to the health care system without increasing costs. These services can be included in the bundle of care strategies offered in a national public health care system that looks for more sustainable strategies to provide care.


Assuntos
COVID-19 , Consulta Remota , Telemedicina , Humanos , COVID-19/epidemiologia , Atenção à Saúde , Telemedicina/métodos , Brasil/epidemiologia
5.
Int J Health Plann Manage ; 37(1): 189-201, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34505319

RESUMO

Monitoring the costs is one of the key components underlying value-based health care. This study aimed to evaluate the cost-saving opportunities of interventional coronary procedures (ICPs). Data from 90 patients submitted to elective ICP were evaluated in five Brazilian hospitals. Time-driven activity-based costing, that guides the cost estimates using the time consumed and the capacity cost rates per resource as the data input, was used to assess costs and the time spent over the care pathway. Descriptive cost analyses were followed by a labour cost-saving estimate potentially achieved by the redesign of the ICP pathway. The mean cost per patient varied from $807 to $2639. The length of the procedure phase per patient was similar among the hospitals, while the post-procedure phase presented the highest variation in length. The highest direct cost saving opportunities are concentrated in the procedure phase. By comparing the benchmark service with the most expensive one, it was estimated that redesigning physician practices could decrease 51% of the procedure cost. This application is pioneered in Brazil and demonstrates how detailed cost information can contribute to driving health care management to value by identifying cost-saving opportunities.


Assuntos
Atenção à Saúde , Hospitais , Brasil , Custos e Análise de Custo , Humanos , Fatores de Tempo
6.
Int J Technol Assess Health Care ; 37(1): e60, 2021 Apr 26.
Artigo em Inglês | MEDLINE | ID: mdl-33896428

RESUMO

OBJECTIVE: To estimate the cost of metastatic prostate cancer (mPC) treatment using the time-driven activity-based costing (TDABC) method from the perspective of a philanthropic hospital in the Brazilian public health system (PHS) and to identify determinants of costs. METHODS: We used data from patients who received docetaxel chemotherapy in the Brazilian PHS from September 2012 to May 2017. Direct medical costs were estimated with the TDABC microcosting method, taking into account the multiple departments and services the patients interacted with during their oncological treatment. RESULTS: The median overall survival of the forty-three patient sample was 1.8 years (95% CI 1.45-2.30), and the total cost of the sample was BRL 917.005 (USD 250,878). The median monthly cost per patient was BRL 20.201 (USD 5,526). The end-of-life cost per patient using the TDABC method was BRL 5.151 (USD 1,409). Patients who had received previous treatment at the center registered the lowest cost for hospitalizations and exams, suggesting an opportunity to better manage healthcare resources. CONCLUSIONS: This is the first study on the economic burden of mPC in the Brazilian PHS using the TDABC costing evaluation method. Accurate cost information obtained with the TDABC can be helpful in guiding disease management to guarantee better use of ever-scarcer resources.


Assuntos
Hospitais , Neoplasias da Próstata , Brasil , Humanos , Masculino , Neoplasias da Próstata/tratamento farmacológico , Fatores de Tempo
7.
J Healthc Manag ; 66(5): 340-365, 2021 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-34192716

RESUMO

EXECUTIVE SUMMARY: Value-based initiatives are growing in importance as strategic models of healthcare management, prompting the need for an in-depth exploration of their outcome measures. This systematic review aimed to identify measures that are being used in the application of the value agenda. Multiple electronic databases (PubMed/MEDLINE, Embase, Scopus, Cochrane Central Register of Controlled Trials) were searched. Eligible studies reported various implementations of value-based healthcare initiatives. A qualitative approach was used to analyze their outcome measurements. Outcomes were classified according to a tier-level hierarchy. In a radar chart, we compared literature to cases from Harvard Business Publishing. The value agenda effect reported was described in terms of its impact on each domain of the value equation. A total of 7,195 records were retrieved; 47 studies were included. Forty studies used electronic health record systems for data origin. Only 16 used patient-reported outcome surveys to cover outcome tiers that are important to patients, and 3 reported outcomes to all 6 levels of our outcome measures hierarchy. A considerable proportion of the studies (36%) reported results that contributed to value-based financial outcomes focused on cost savings. However, a gap remains in measuring outcomes that matter to patients. A more complete application of the value agenda by health organizations requires advances in technology and culture change management.


Assuntos
Atenção à Saúde , Instalações de Saúde , Redução de Custos , Humanos
8.
Value Health ; 23(6): 812-823, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32540239

RESUMO

OBJECTIVES: Implementation of value-based initiatives depends on cost-assessment methods that can provide high-quality cost information. Time-driven activity-based costing (TDABC) is increasingly being used to solve the cost-information gap. This study aimed to review the use of the TDABC methodology in real-world settings and to estimate its impact on the value-based healthcare concept for inpatient management. METHODS: This systematic review was conducted by screening PubMed/MEDLINE and Scopus databases following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, including all studies up to August 2019. The use of TDABC for inpatient management was the main eligibility criterion. A qualitative approach was used to analyze the different methodological aspects of TDABC and its effective contribution to the implementation of value-based initiatives. RESULTS: A total of 1066 studies were retrieved, and 26 full-text articles were selected for review. Only studies focused on surgical inpatient conditions were identified. Most of the studies reported the types of activities on a macrolevel. Professional and structural cost variables were usually assessed. Eighteen studies reported that TDABC contributed to value-based initiatives, especially cost-saving findings. TDABC was satisfactorily applied to achieve value-based contributions in all the studies that used the method for this purpose. CONCLUSIONS: TDABC could be a strategy for increasing cost accuracy in real-world settings, and the method could help in the transition from fee-for-service to value-based systems. The results could provide a clearer idea of the costs, help with resource allocation and waste reduction, and might support clinicians and managers in increasing value in a more accurate and transparent way.


Assuntos
Custos e Análise de Custo/métodos , Atenção à Saúde/economia , Custos de Cuidados de Saúde , Redução de Custos , Planos de Pagamento por Serviço Prestado/economia , Humanos , Pacientes Internados , Alocação de Recursos/economia , Fatores de Tempo
9.
BMC Cardiovasc Disord ; 20(1): 496, 2020 11 24.
Artigo em Inglês | MEDLINE | ID: mdl-33234107

RESUMO

BACKGROUND: To evaluate the prognostic value of peak serum lactate and lactate clearance at several time points in cardiogenic shock treated with temporary mechanical circulatory support (MCS) using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP®. METHODS: Serum lactate and clearance were measured before MCS and at 1 h, 6 h, 12 h, and 24 h post-MCS in 43 patients at four tertiary-care centers in Southern Brazil. Prognostic value was assessed by univariable and multivariable analysis and receiver operating characteristic (ROC) curves for 30-day mortality. RESULTS: VA-ECMO was the most common MCS modality (58%). Serum lactate levels at all time points and lactate clearance after 6 h were associated with mortality on unadjusted and adjusted analyses. Lactate levels were higher in non-survivors at 6 h, 12 h, and 24 h after MCS. Serum lactate > 1.55 mmol/L at 24 h was the best single prognostic marker of 30-day mortality [area under the ROC curve = 0.81 (0.67-0.94); positive predictive value = 86%). Failure to improve serum lactate after 24 h was associated with 100% mortality. CONCLUSIONS: Serum lactate was an important prognostic biomarker in cardiogenic shock treated with temporary MCS. Serum lactate and lactate clearance at 24 h were the strongest independent predictors of short-term survival.


Assuntos
Oxigenação por Membrana Extracorpórea , Ácido Láctico/sangue , Implantação de Prótese , Choque Cardiogênico/terapia , Adulto , Biomarcadores/sangue , Brasil , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/instrumentação , Oxigenação por Membrana Extracorpórea/mortalidade , Feminino , Coração Auxiliar , Humanos , Masculino , Pessoa de Meia-Idade , Oxigenadores de Membrana , Valor Preditivo dos Testes , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Implantação de Prótese/mortalidade , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/sangue , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/mortalidade , Fatores de Tempo , Resultado do Tratamento
10.
BMC Health Serv Res ; 20(1): 1107, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33256733

RESUMO

BACKGROUND: This Consensus Statement introduces a standardized framework, in a checklist format, to support future development and reporting of TDABC studies in healthcare, and to encourage their reproducibility. Additionally, it establishes the first formal networking of TDABC researchers through the creation of the TDABC in Healthcare Consortium. METHODS: A consensus group of researchers reviewed the most relevant TDABC studies available in Medline and Scopus databases to identify the initial elements of the checklist. Using a Focus Group process, each element received a recommendation regarding where in the scientific article section it should be placed and whether the element was required or suggested. A questionnaire was circulated with expert researchers in the field to provide additional recommendations regarding the content of the checklist and the strength of recommendation for each included element. RESULTS: The TDABC standardized framework includes 32 elements, provides recommendations where in the scientific article to include each element, and comments on the strength of each recommendation. All 32 elements were validated, with 21 elements classified as mandatory and 11 as suggested but not mandatory. CONCLUSIONS: This is the first standardized framework to support the development and reporting of TDABC research in healthcare and to stablish a community of experts in TDABC methodology. We expect that it can contribute to scale strategies that would result in cost-savings outcomes and in value-oriented strategies that can be adopted in healthcare systems and institutions.


Assuntos
Atenção à Saúde , Consenso , Redução de Custos , Humanos , Reprodutibilidade dos Testes , Fatores de Tempo
12.
BMC Public Health ; 19(1): 657, 2019 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-31142294

RESUMO

BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals. METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention. DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices. TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.


Assuntos
Promoção da Saúde/métodos , Hipertensão/prevenção & controle , Estilo de Vida , Idoso , Protocolos Clínicos , Humanos , Pessoa de Meia-Idade
13.
Int J Qual Health Care ; 31(9): 676-681, 2019 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-30576452

RESUMO

OBJECTIVE: The fractional flow reserve (FFR) versus angiography for multivessel evaluation (FAME) study has demonstrated that FFR substantially reduces major adverse cardiac events and resource utilization in coronary artery disease (CAD) patients. We aimed to assess the cost utility of FFR in percutaneous coronary interventions (PCI) from the perspective of the Brazilian Public Health System (SUS). DESIGN: Patient-level cost-utility analysis along the FAME study. PARTICIPANTS: Multivessel coronary artery disease patients. INTERVENTION: PCI, either guided by FFR or by angiography alone. SETTING: The procedure costs were based on the mean amount of unitary resource utilization multiplied by the costs from SUS reimbursement list. The utilities were derived using Brazilian weights for time trade-off European Quality of Life-5 Dimensions. The World Health Organization recommendation based on gross domestic product per capita (international dollars [I$] 35 876/quality-adjusted life year [QALY]) was used as willingness-to-pay threshold. MAIN OUTCOME MEASURE: We determined the incremental cost-utility ratio (ICUR) in I$ per QALY gained during the 1-year time horizon. RESULTS: One-year costs were I$ 8931 for the angiography-guided PCI and I$ 8968 for the FFR-guided PCI, resulting in an incremental cost of I$ 37. Effectiveness during 1 year was 0.798 QALYs for angiography-guided PCI and 0.811 for FFR-guided PCI, resulting in an incremental effectiveness of 0.013 QALYs. The base-case ICUR of FFR versus angiography-guided PCI was 2780 I$/QALY. Cost-saving results are achieved with a FFR price reduction of at least 2.2%. CONCLUSIONS: Developing countries should give attention to strategies proven to be cost-effective in other health systems. In our analysis, FFR-guided PCI is very cost-effective in the Brazilian SUS and with a minimal price reduction of the device, FFR could be cost saving.


Assuntos
Doença da Artéria Coronariana/cirurgia , Análise Custo-Benefício , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea/métodos , Idoso , Brasil , Angiografia Coronária/economia , Doença da Artéria Coronariana/economia , Humanos , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/economia , Anos de Vida Ajustados por Qualidade de Vida , Resultado do Tratamento
14.
Int J Technol Assess Health Care ; 35(3): 195-203, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31023393

RESUMO

BACKGROUND: Healthcare organizations have invested efforts on hospital-based health technology assessment (HB-HTA) and enterprise risk management (ERM) processes for novel systems to obtain more accurate data on which to base strategic decisions. This study proposes to analyze how HB-HTA and ERM processes can share personal resources and skills to achieve principles with value-oriented results. METHODS: Literature on ERM and HB-HTA and data from interviews with healthcare managers compose the research data sources, which were submitted to a qualitative data analysis. It was oriented to identify the association between ERM and HB-HTA application in hospitals and the common principles between both processes, in addition to proposing the capability to share personal resources between both teams in a matrix. RESULTS: The common principles and personal background suggested for HB-HTA and ERM teams allowed the build of a matrix identifying how both teams can work in an integrated manner being more effective and value-oriented. The shared resource matrix reports how each professional (with a specific background) may interact with each activity associated to HB-HTA or ERM implementation guidelines. CONCLUSIONS: The identification of common principles and capabilities between ERM and HB-HTA suggested advances with the literature from both research areas. The opportunity to share personal resources also contributes to the implementation of those processes in hospitals with less financial resources, approaching its own management to be more efficient with the care chain.


Assuntos
Tomada de Decisões Gerenciais , Administração Hospitalar , Gestão de Riscos/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração , Comportamento Cooperativo , Humanos , Capacitação em Serviço , Gestão de Riscos/normas , Avaliação da Tecnologia Biomédica/normas
15.
Am Heart J ; 198: 129-134, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29653634

RESUMO

BACKGROUND: Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. OBJECTIVES: The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. DESIGN: The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. SUMMARY: The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Atorvastatina/uso terapêutico , Intervenção Coronária Percutânea/métodos , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Idoso , Anticolesterolemiantes/uso terapêutico , Brasil , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Revascularização Miocárdica/mortalidade , Intervenção Coronária Percutânea/mortalidade , Cuidados Pós-Operatórios/métodos , Cuidados Pré-Operatórios/métodos , Prognóstico , Modelos de Riscos Proporcionais , Medição de Risco , Taxa de Sobrevida , Resultado do Tratamento
16.
JAMA ; 319(13): 1331-1340, 2018 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-29525821

RESUMO

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Atorvastatina/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/terapia , Idoso , Atorvastatina/efeitos adversos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Método Duplo-Cego , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia
17.
BMC Cardiovasc Disord ; 17(1): 180, 2017 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-28676042

RESUMO

BACKGROUND: Coronary artery disease is the most prevalent cardiovascular disease. In the United States, 7% of adults over 20 years of age are estimated to have coronary artery disease. In Brazil, a prevalence of 5 to 8% has been estimated in adults over 40 years of age, with an increased number of hospitalizations associated with both stable and acute clinical manifestations; and health care costs have quadrupled in the last decade. To estimate the direct costs of managing ischemic heart disease patient care in a teaching hospital in Brazil from the perspective of the service payer, the Brazilian Unified Health System. METHODS: This study was a retrospective cohort study for the identification and valuation of resources used at both the outpatient and in-hospital levels in a sample of 330 patients selected from the hospital's ischemic heart disease clinic. Data were collected from computerized hospital records and patients' hospital bills from January 2000 to October 2015. A bivariate analysis and binary logistic regression were performed with p < 0.05 considered statistically significant. RESULTS: The study population consisted of 330 patients with a mean age 61 ± 10 years and a follow-up period of 107 ± 2.6 months; of the patients, 55% were male, 89% had hypertension, 48% had diabetes, and 65% had acute myocardial infarction. The mean annual cost of outpatient management was US $1,521 per patient. The mean cost per hospitalization was US $1,976, and the expenses were higher in the first and last years of follow-up. Unstable angina, revascularization procedures, diabetes, hypertension and obesity were predictors of higher hospitalization costs (p <0.05). CONCLUSION: The cost estimates in this study indicate a high proportion of drug treatment costs in the treatment of ischemic heart disease. Treatment costs are higher in the first year and at the end of treatment, and some clinical factors are associated with greater hospital care costs. These results may serve as a basis for the evaluation of existing public policies and inputs for cost-effectiveness studies in coronary artery disease. TRIAL REGISTRATION: CEP HCPA 11-0460 . Ethics Committee of Hospital de Clínicas de Porto Alegre.


Assuntos
Assistência Ambulatorial/economia , Custos Hospitalares , Hospitais de Ensino/economia , Isquemia Miocárdica/economia , Isquemia Miocárdica/terapia , Avaliação de Processos em Cuidados de Saúde/economia , Idoso , Brasil/epidemiologia , Fármacos Cardiovasculares/economia , Fármacos Cardiovasculares/uso terapêutico , Comorbidade , Custos de Medicamentos , Feminino , Humanos , Modelos Lineares , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
18.
BMC Health Serv Res ; 16: 227, 2016 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-27387752

RESUMO

BACKGROUND: Many Brazilian patients with complex diseases who are treated in tertiary referral clinics have been stable for long periods. The main needs of these patients involve monitoring of risk factors and review of drug prescriptions, which could be satisfactorily done in primary care facilities. The goal of this protocol is to evaluate the safety and effectiveness of telemedicine services to support the transition of patients with stable chronic coronary artery disease from the tertiary to the primary level of care. METHODS/DESIGN: We designed a randomized non-inferiority protocol that will include 280 patients with stable coronary artery disease (for at least 12 months). Patients will be selected from the Ischemic Heart Disease Clinic in a tertiary care hospital in southern Brazil. Enrolled participants will be randomized into one of two groups: 12 months of follow-up at the same clinic; or 12 months of follow-up at a primary care facility with clinical support from a telemedicine platform including a toll-free line for physicians (intervention group). In the intervention group, decisions to refer patients to tertiary care during follow-up will be made jointly by primary physicians and medical teleconsultants. The groups will be compared in terms of the primary outcome-maintenance of baseline functional class 1 or 2 after 12 months. Secondary outcomes include control of risk factors and instability of the disease. DISCUSSION: We intend to determine the effectiveness of using telemedicine to qualify the transition of patients with chronic coronary disease from the tertiary to the primary level of care. This should facilitate the access of patients to the healthcare system, since care will be provided closer to their homes, and provide more opportunities for treatment of severe cases at tertiary care hospitals that are often overcrowded. TRIAL REGISTRATION: ClinicalTrials.gov # NCT02489565 - trial registration date May 13, 2015.


Assuntos
Doença da Artéria Coronariana/terapia , Atenção Primária à Saúde , Telemedicina , Centros de Atenção Terciária , Brasil , Doença Crônica , Feminino , Humanos , Masculino , Encaminhamento e Consulta , Projetos de Pesquisa , Fatores de Risco , Telemedicina/métodos , Cuidado Transicional
19.
BMC Health Serv Res ; 16: 456, 2016 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-27581760

RESUMO

BACKGROUND: Hypertension is a public health problem and a major risk factor for cardiovascular disease. The purpose of this study is to compare the effectiveness of a multidisciplinary program based on group and individual care versus group-only care, to promote blood pressure control in hypertensive patients in primary health care. METHODS: Randomized controlled clinical trial. The study was conducted within the primary health care, in two units of the Family Health Strategy, covering 11,000 individuals, in Porto Alegre, Brazil. Two hundred and 56 patients, older than 40 years old and with uncontrolled hypertension, systolic blood pressure (BP) ≥140 mmHg and/or diastolic BP ≥90 mmHg or ≥130 mmHg and/or diastolic BP ≥80 mmHg for individuals with diabetes. Eligible patients were randomly assigned to a health care program aiming for blood pressure control, with the multidisciplinary program group or with the multidisciplinary program plus personalized care group. Primary outcome measures were reduction in systolic BP from baseline to 6 months. Secondary measures included proportion of patients with systolic or diastolic BP controlled. Student t test, Pearson's chi-squared test, Fisher's exact test, Mann-Whitney U test, Wilcoxon signed-ranks test and generalized estimating equation (GEE) model were used in the analysis. RESULTS: The baseline characteristics of participants were similar between groups. After 6 months of follow-up, systolic BP decreased markedly in both groups (Δ - 11.8 mmHg [SD, 20.2] in the multidisciplinary program group and Δ - 12.9 mmHg [SD, 19.2] in the personalized care group; p < 0.001). Similarly, we noted a significant change in diastolic BP over time in both groups (Δ - 8.1 mmHg [SD, 10.8] in the multidisciplinary program group and Δ - 7.0 mmHg [SD, 11.5] in the personalized care group; p < 0.001). CONCLUSIONS: The study demonstrates similar effectiveness of a group intervention in comparison to a personalized education program in hypertension patients to achieve BP control. These findings indicate that the intervention can be for all hypertensive patients assisted in primary health care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01696318 (May 2013).


Assuntos
Hipertensão/terapia , Educação de Pacientes como Assunto , Medicina de Precisão , Atenção Primária à Saúde/métodos , Adulto , Idoso , Pressão Sanguínea , Brasil , Feminino , Pessoal de Saúde/educação , Humanos , Masculino , Pessoa de Meia-Idade , Equipe de Assistência ao Paciente , Atenção Primária à Saúde/organização & administração , Fatores de Risco
20.
Genet Mol Biol ; 38(3): 332-7, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26500437

RESUMO

This study identifies and describes the operating costs associated with the molecular diagnosis of diseases, such as hereditary cancer. To approximate the costs associated with these tests, data informed by Standard Operating Procedures for various techniques was collected from hospital software and a survey of market prices. Costs were established for four scenarios of capacity utilization to represent the possibility of suboptimal use in research laboratories. Cost description was based on a single site. The results show that only one technique was not impacted by rising costs due to underutilized capacity. Several common techniques were considerably more expensive at 30% capacity, including polymerase chain reaction (180%), microsatellite instability analysis (181%), gene rearrangement analysis by multiplex ligation probe amplification (412%), non-labeled sequencing (173%), and quantitation of nucleic acids (169%). These findings should be relevant for the definition of public policies and suggest that investment of public funds in the establishment of centralized diagnostic research centers would reduce costs to the Public Health System.

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