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1.
Rev Bras Med Trab ; 20(2): 222-230, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36127902

RESUMEN

Introduction: Implementation of quality assessment methodologies at healthcare services enables the results achieved to be monitored in terms of established objectives and standards of care delivery. Objectives: To assess the quality of the processes involved in provision of periodic medical examinations at a University Hospital, from the workers' perspective. Methods: This is a cross-sectional study using questionnaires to conduct quality assessment of the periodic medical examination processes, including Net Promoter Score satisfaction questions. Statistical analysis of the results was performed using SPSS version 18. Data on categorical variables are expressed as absolute frequencies and data on continuous variables as means and standard deviations. Chi-square tests and analysis of variance were used to identify associations. A significance level of 0.05 was adopted to determine the statistical relevance of findings. Results: A total of 381 respondents with a mean age of 45.25 years were included, 66% of whom were female. There was a statistically significant (p < 0.001) association between duration of consultations and the number of items assessed in the periodic medical examination. In general, the findings from application of the Net Promoter Score for self-scheduling (45%) and service at reception (42%) indicate a need for process improvement, whereas clinical care (50%) rated as a quality process. Conclusions: This study identified a set of information that can be used to describe, analyze, and improve the care delivered by the institution's occupational health service and to identify opportunities for improvement of periodic medical examination processes.

2.
Int J Health Plann Manage ; 37(1): 189-201, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34505319

RESUMEN

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.


Asunto(s)
Atención a la Salud , Hospitales , Brasil , Costos y Análisis de Costo , Humanos , Factores de Tiempo
4.
Acta Diabetol ; 58(2): 215-220, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33047257

RESUMEN

AIMS: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. METHODS: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30-70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. RESULTS: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. CONCLUSIONS: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. TRIAL REGISTRATION: Clinical trials registration number: NCT00971165.


Asunto(s)
Amilorida/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Clortalidona/administración & dosificación , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipertensión/tratamiento farmacológico , Losartán/administración & dosificación , Adulto , Anciano , Amilorida/efectos adversos , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Brasil , Clortalidona/efectos adversos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/fisiopatología , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/complicaciones , Hipertensión/patología , Losartán/efectos adversos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
5.
Eur J Pediatr ; 179(12): 1859-1865, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32623627

RESUMEN

There is an increasing evidence that strict evaluation of clinical signs is effective in detecting newborns at risk of early-onset sepsis (EOS) that require antibiotic therapy. In a retrospective case control design, we compared EOS antibiotic indication by clinical signs surveillance with multivariate risk analysis (EOSCalc), and estimate their costs. Newborns ≥ 34 weeks who received EOS antibiotics from June 2014 to December 2016 were studied. Were considered symptomatic those with three clinical signs within first 24 h or two signs and one risk factor present. Cost estimative was done using bottom-up hospital's perspective. Eight thousand three hundred twenty-one were born, 384 were included. Two hundred nineteen (57%) would receive antibiotics by EOSCalc and 64 (16.7%) by clinical signs (p < 0.001). All patients with blood cultures were detected and false-negatives were absent. Total cost was US$ 574,121, estimate US$ 415,576 by EOSCalc, and US$ 314,353 by clinical signs (p < 0.001).Conclusions: The use of EOSCalc and clinical signs surveillance seem to be safe and accurate methods in EOS management. Additionally, the two approaches have shown an economic advantage when compared with the hospital's current practice. What is Known: • EOSCalc is a useful method for screening of EOS in late preterm and term infants. • Presence of clinical signs and/or maternal risk factors are present newborns with EOS. What is New: • Rigorous observation of clinical signs is a more accurate method than EOSCalc to screen for EOS in late preterm and term newborns. • Rigorous observation of clinical signs is more economic than EOSCalc in managing EOS in late preterm and term neonates.


Asunto(s)
Recien Nacido Prematuro , Sepsis , Antibacterianos/uso terapéutico , Humanos , Lactante , Recién Nacido , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Sepsis/diagnóstico , Sepsis/tratamiento farmacológico
6.
Eur J Health Econ ; 20(8): 1133-1145, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31286291

RESUMEN

Micro-costing studies still deserving for methods orientation that contribute to achieve a patient-specific resource use level of analysis. Time-driven activity-based costing (TDABC) is often employed by health organizations in micro-costing studies with that objective. However, the literature shows many deviations in the implementation of TDABC, which might compromise the accuracy of the results obtained. One reason for that can be attributed to the non-existence of a step-by-step orientation to conduct cost analytics with the TDABC specific for micro-costing studies in healthcare. This article aimed at exploring the literature and practical cases to propose an eight-step framework to apply TDABC in micro-costing studies for health care organizations. The 8-step TDABC framework is presented and detailed exploring online spreadsheets already coded to demonstrate data structure and math formula building. A list of analyses that can be performed is suggested, including an explanation about the information that each analysis can provide to increase the organization capability to orient decision making. The case study developed show that actual micro-costing of health care processes can be achieved with the 8-step TDABC framework and its use in future researches can contribute to increase the number of studies that achieve high-quality level in cost information, and consequently, in health resource evaluation.


Asunto(s)
Análisis Costo-Beneficio/métodos , Costos de la Atención en Salud , Recursos en Salud/economía , Brasil , Economía Hospitalaria , Humanos , Estudios de Casos Organizacionales , Factores de Tiempo
7.
J. bras. econ. saúde (Impr.) ; 11(1): 87-95, Abril/2019.
Artículo en Portugués | ECOS, LILACS | ID: biblio-1005738

RESUMEN

Objetivo: No cenário da avaliação de tecnologias em saúde (ATS), as estimativas de custos são um fator crítico no desenvolvimento das avaliações econômicas completas, especialmente pelo uso de diferentes metodologias de custeio. A fim de contribuir com a acurácia dos dados de custos usados nessas análises, este artigo sugere recomendações para apuração de custos em saúde no Brasil. Métodos: Reuniram-se pesquisadores de ATS de diferentes expertises e centros de pesquisa do Brasil, e ao longo de dois anos foram conduzidas revisões da literatura nacional e internacional e discussões sobre as formas de abordar a temática. Três simpósios foram realizados reunindo os pesquisadores com o propósito de alcançar o consenso entre os autores sobre as melhores recomendações para a realização de estudos de Microcusteio. Resultados: Consolidou-se em forma de uma recomendação este artigo que representa uma versão compacta da diretriz completa a ser publicada pela Rede Brasileira de Avaliação de Tecnologias em Saúde. A metodologia de Microcusteio é considerada como padrão-ouro para a identificação dos custos em saúde. Os métodos de definição do estudo, coleta e análise de dados apresentados são descritos de modo a permitir uma valoração dos custos validada e homogênea, principalmente para o uso dessa informação em avaliações econômicas de saúde. Conclusão: Essa recomendação tem o propósito de aumentar a acurácia das estimativas dos custos de saúde no nosso meio e homogeneizar a comunicação entre estudos conduzidos por diferentes grupos de pesquisa. Por fim, é esperado que a utilização dessas recomendações contribua para que as decisões baseadas em dados econômicos sejam mais acuradas e equânimes quando da incorporação de tecnologias no país.


Objective: In the context of health technology assessment (HTA), cost estimates are a critical factor in the development of economic evaluations, especially through the use of different costing methodologies. In order to contribute to the accuracy of the cost data used in these analyzes, this article suggests recommendations to develop health cost analysis in Brazil. Methods: HTA researchers with heterogeneous background and from different Brazilian research centers were engaged on the development of this health cost analysis recommendation over two years. Reviews of national and international literature and discussions on how to approach the theme were conducted. Three symposia were held bringing together the researchers with the purpose of reaching consensus among the authors on the best recommendations for micro-accounting studies. Results: This article was consolidated as a recommendation, which represents a compact version of the complete guideline that will be published by the Brazilian Health Technology Assessment Network (REBRATS). The Microcosting methodology is considered as a gold standard for the analysis of health costs. Methods to define the study, to perform data collection and analysis are described in order to allow a validated and homogeneous cost evaluation, mainly for the use of this information in economic health assessments. Conclusion: This recommendation is intended to increase the health cost estimated accuracy in our country and to homogenize the communication between studies conducted by different research groups. Finally, it is expected that the use of these recommendations will contribute to make decisions based on economic data more accurate and equitable when incorporating health technologies in the country.


Asunto(s)
Humanos , Evaluación en Salud , Costos y Análisis de Costo , Uso de la Información Científica en la Toma de Decisiones en Salud
8.
J Hypertens ; 36(4): 933-938, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29227377

RESUMEN

BACKGROUND: To determine the effectiveness of low-dose diuretic therapy to achieve an optimal level of blood pressure (BP) in adults with prehypertension. METHODS: The PREVER-prevention trial was a randomized, parallel, double-blinded, placebo-controlled trial, with 18 months of follow-up, conducted at 21 academic medical centers in Brazil. Of 1772 individuals evaluated for eligibility, 730 volunteers with prehypertension who were aged 30-70 years, and who did not reach optimal blood pressure after 3 months of lifestyle intervention, were randomized to a fixed association of chlorthalidone 12.5 mg and amiloride 2.5 mg or placebo once a day. The main outcomes were the percentage of participants who achieved an optimal level of BP. RESULTS: A total of 372 participants were randomly allocated to diuretics and 358 to placebo. After 18 months of treatment, optimal BP was noted in 25.6% of the diuretic group and 19.3% in the placebo group (P < 0.05). The mean net reduction in SBP and DBP for the diuretic group compared with placebo was 2.8 mmHg (95% CI 1.1 to 4.5) and 1.1 mmHg (95% CI -0.09 to 2.4), respectively. Most participants in the active treatment group (74.5%) and in the placebo group (80.7%) continued to have BP in the prehypertension range or progressed to hypertension. CONCLUSION: Low-dose diuretic therapy increased the probability of individuals with prehypertension to achieve optimal BP but most of those treated continued to have a BP in the prehypertension range or progressed to having overt hypertension.


Asunto(s)
Amilorida/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Clortalidona/administración & dosificación , Diuréticos/administración & dosificación , Prehipertensión/tratamiento farmacológico , Adulto , Amilorida/uso terapéutico , Antihipertensivos/uso terapéutico , Clortalidona/uso terapéutico , Diástole , Progresión de la Enfermedad , Diuréticos/uso terapéutico , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sístole
9.
BMC Cardiovasc Disord ; 17(1): 180, 2017 07 04.
Artículo en Inglés | MEDLINE | ID: mdl-28676042

RESUMEN

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.


Asunto(s)
Atención Ambulatoria/economía , Costos de Hospital , Hospitales de Enseñanza/economía , Isquemia Miocárdica/economía , Isquemia Miocárdica/terapia , Evaluación de Procesos, Atención de Salud/economía , Anciano , Brasil/epidemiología , Fármacos Cardiovasculares/economía , Fármacos Cardiovasculares/uso terapéutico , Comorbilidad , Costos de los Medicamentos , Femenino , Humanos , Modelos Lineales , Modelos Logísticos , Masculino , Persona de Mediana Edad , Modelos Económicos , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
10.
J Am Heart Assoc ; 5(12)2016 12 13.
Artículo en Inglés | MEDLINE | ID: mdl-27965209

RESUMEN

BACKGROUND: Prehypertension is associated with higher cardiovascular risk, target organ damage, and incidence of hypertension. The Prevention of Hypertension in Patients with PreHypertension (PREVER-Prevention) trial aimed to evaluate the efficacy and safety of a low-dose diuretic for the prevention of hypertension and end-organ damage. METHODS AND RESULTS: This randomized, parallel, double-blind, placebo-controlled trial was conducted in 21 Brazilian academic medical centers. Participants with prehypertension who were aged 30 to 70 years and who did not reach optimal blood pressure after 3 months of lifestyle intervention were randomized to a chlorthalidone/amiloride combination pill or placebo and were evaluated every 3 months during 18 months of treatment. The primary outcome was incidence of hypertension. Development or worsening of microalbuminuria, new-onset diabetes mellitus, and reduction of left ventricular mass were secondary outcomes. Participant characteristics were evenly distributed by trial arms. The incidence of hypertension was significantly lower in 372 study participants allocated to diuretics compared with 358 allocated to placebo (hazard ratio 0.56, 95% CI 0.38-0.82), resulting in a cumulative incidence of 11.7% in the diuretic arm versus 19.5% in the placebo arm (P=0.004). Adverse events; levels of blood glucose, glycosylated hemoglobin, creatinine, and microalbuminuria; and incidence of diabetes mellitus were no different between the 2 arms. Left ventricular mass assessed through Sokolow-Lyon voltage and voltage-duration product decreased to a greater extent in participants allocated to diuretic therapy compared with placebo (P=0.02). CONCLUSIONS: A combination of low-dose chlorthalidone and amiloride effectively reduces the risk of incident hypertension and beneficially affects left ventricular mass in patients with prehypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov, www.ensaiosclinicos.gov. Unique identifiers: NCT00970931, RBR-74rr6s.


Asunto(s)
Amilorida/administración & dosificación , Antihipertensivos/administración & dosificación , Clortalidona/administración & dosificación , Diuréticos/administración & dosificación , Hipertensión/prevención & control , Adulto , Anciano , Presión Sanguínea/efectos de los fármacos , Método Doble Ciego , Combinación de Medicamentos , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/fisiopatología , Hipertrofia Ventricular Izquierda/fisiopatología , Hipertrofia Ventricular Izquierda/prevención & control , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
11.
Genet Mol Biol ; 39(2): 203-9, 2016 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-27275664

RESUMEN

Germline mutations in the TP53 gene are associated with Li-Fraumeni and Li-Fraumeni-Like Syndromes, characterized by increased predisposition to early-onset cancers. In Brazil, the prevalence of the TP53-p.R337H germline mutation is exceedingly high in the general population and in cancer-affected patients, probably as result of a founder effect. Several genotyping methods are used for the molecular diagnosis of LFS/LFL, however Sanger sequencing is still considered the gold standard. We compared performance, cost and turnaround time of Sanger sequencing, PCR-RFLP, TaqMan-PCR and HRM in the p.R337H genotyping. The performance was determined by analysis of 95 genomic DNA samples and results were 100% concordant for all methods. Sequencing was the most expensive method followed by TaqMan-PCR, PCR-RFLP and HRM. The overall cost of HRM increased with the prevalence of positive samples, since confirmatory sequencing must be performed when a sample shows an abnormal melting profile, but remained lower than all other methods when the mutation prevalence was less than 2.5%. Sequencing had the highest throughput and the longest turnaround time, while TaqMan-PCR showed the lowest turnaround and hands-on times. All methodologies studied are suitable for the detection of p.R337H and the choice will depend on the application and clinical scenario.

12.
J Hypertens ; 34(4): 798-806, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26938814

RESUMEN

OBJECTIVES: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of stage I hypertension. METHODS: In a randomized, double-blind, controlled trial, 655 participants were followed for 18 months in 21 Brazilian academic centers. Trial participants were adult volunteers aged 30-70 years with stage I hypertension (BP 140-159 or 90-99 mmHg) following 3 months of a lifestyle intervention. Participants were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 333) or 50 mg of losartan (N = 322). If BP remained uncontrolled after 3 months, study medication dose was doubled, and if uncontrolled after 6 months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg twice daily) were added as open-label drugs in a progressive fashion. At the end of follow-up, 609 (93%) participants were evaluated. RESULTS: The difference in SBP during 18 months of follow-up was 2.3 (95% confidence interval: 1.2 to 3.3) mmHg favoring chlorthalidone/amiloride. Compared with those randomized to diuretic, more participants allocated to losartan had their initial dose doubled and more of them used add-on antihypertensive medication. Levels of blood glucose, glycosilated hemoglobin, and incidence of diabetes were no different between the two treatment groups. Serum potassium was lower and serum cholesterol was higher in the diuretic arm. Microalbuminuria tended to be higher in patients with diabetes allocated to losartan (28.5 ±â€Š40.4 versus 16.2 ±â€Š26.7 mg, P = 0.09). CONCLUSION: Treatment with a combination of chlorthalidone and amiloride compared with losartan yielded a greater reduction in BP. CLINICAL TRIALS REGISTRATION NUMBER: NCT00971165.


Asunto(s)
Amilorida/uso terapéutico , Antihipertensivos/uso terapéutico , Clortalidona/uso terapéutico , Hipertensión/tratamiento farmacológico , Losartán/uso terapéutico , Adulto , Anciano , Amilorida/farmacología , Antihipertensivos/farmacología , Presión Sanguínea/efectos de los fármacos , Clortalidona/farmacología , Humanos , Losartán/farmacología , Persona de Mediana Edad
13.
Genet Mol Biol ; 38(3): 332-7, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26500437

RESUMEN

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.

16.
Trials ; 12: 65, 2011 Mar 05.
Artículo en Inglés | MEDLINE | ID: mdl-21375762

RESUMEN

BACKGROUND: Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. DISCUSSION: The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil. TRIAL REGISTRATION: Clinical Trials NCT00970931.


Asunto(s)
Amilorida/uso terapéutico , Antihipertensivos/uso terapéutico , Clortalidona/uso terapéutico , Diuréticos/uso terapéutico , Hipertensión/terapia , Prehipertensión/tratamiento farmacológico , Proyectos de Investigación , Adulto , Anciano , Presión Sanguínea/efectos de los fármacos , Brasil , Método Doble Ciego , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/etiología , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Efecto Placebo , Prehipertensión/complicaciones , Prehipertensión/fisiopatología , Resultado del Tratamiento
17.
Trials ; 12: 53, 2011 Feb 24.
Artículo en Inglés | MEDLINE | ID: mdl-21349192

RESUMEN

BACKGROUND: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted. METHODS/DESIGN: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution. DISCUSSION: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov: NCT00971165.


Asunto(s)
Amilorida/uso terapéutico , Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Clortalidona/uso terapéutico , Diuréticos/uso terapéutico , Hipertensión/tratamiento farmacológico , Losartán/uso terapéutico , Proyectos de Investigación , Adulto , Anciano , Amilorida/efectos adversos , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Antihipertensivos/efectos adversos , Brasil , Clortalidona/efectos adversos , Diuréticos/efectos adversos , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/fisiopatología , Losartán/efectos adversos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
18.
Artículo en Portugués | LILACS | ID: biblio-834334

RESUMEN

Este artigo apresenta a justificativa e o processo de elaboração do marco normativo do Hospital de Clínicas de Porto Alegre (HCPA) para o armazenamento e utilização de materiais biológicos humanos e suas informações associadas em atividades de pesquisa. Um grupo de trabalho multiprofissional se reuniu e discutiu todos os aspectos referentes a esta questão que envolve as atividades de biobanco e de biorrepositórios. Como produto deste trabalho é apresentada a Normativa Institucional.


This article presents the rationale and framework for developing the Hospital de Clinicas de Porto Alegre (HCPA) normative for storage and use of human biological material and their associated information on research activities. A multidisciplinary task force was established and all issues related to biobanks and biorepositories activities in periodic meetings were discussed; the final result is presented as an Institutional Normative.


Asunto(s)
Humanos , Bancos de Muestras Biológicas/normas , Bancos de Muestras Biológicas/organización & administración , Manejo de Especímenes/métodos , Manejo de Especímenes/normas , Investigación Biomédica/métodos
19.
Artículo en Portugués | LILACS | ID: lil-691445

RESUMEN

O Centro de Terapia Gênica é um laboratório compartilhado, implantado em 2002, que atuana área de genética e localiza-se no Centro de Pesquisas do Hospital de Clínicas de Porto Alegre.Tem como característica principal ser um prestador de serviços de biologia molecular e celular para os projetos de pesquisa que se desenvolvem no hospital. Os resultados financeiros negativos ao final de cada período motivaram este estudo, que teve como objetivo desenvolver e aplicar o sistema de gestão balanced scorecard. Realizou-se a revisão da literatura, o levantamento de dados do laboratório e o desenvolvimento do planejamento estratégico. O trabalho foi implementado em novembro de 2004. Os resultados foram a construção do mapa estratégico, definição de metas para o período 2005-2008, crescimento da receita de faturamento em 21%, redução dos custos operacionais em 43%, estabelecimento dos custos de 39% das técnicas básicas do laboratório e aumento da captação de projetos em 47%. Este estudo mostra que a gestão das atividades de pesquisa, vista sob uma perspectiva estratégica, poderá agregar valor tanto científico como econômico à instituição, expresso sob a forma dos novos conhecimentos gerados,publicações realizadas, captação de recursos para a pesquisa e redução dos custos operacionais.


The Centro de Terapia Gênica (Gene Therapy Center), which was established in 2002, is a shared laboratory specialized in genetics. It is located at Research Center, Hospital de Clínicasde Porto Alegre. Its main characteristic is to provide services of molecular and cellular biologyfor research projects that are being developed at the hospital. This study was motivated by thenegative financial results at the end of each year. Therefore, it aims to develop and apply thebalanced scorecard, a strategic management system. We performed a literature review, laboratory data collection, and development of the strategic planning. This study was implemented on November 2004. Results were: elaboration of a strategic map, definition of goals for 2005-2008, increase in revenue by 21%, reduction in operational costs by 43%, establishment of the costs concerning 39% of basic laboratory techniques, and increase in submission of projects by 47%.This study shows that the strategic administration of research activities may add scientific and economic value to the institution. This value is expressed as increased knowledge, publications, generation of resources for research, and reduction in operational costs.


Asunto(s)
Terapia Genética , Laboratorios , Salud Pública
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