Real-World Evidence in Healthcare Decision Making: Global Trends and Case Studies From Latin America.

BACKGROUND: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown. OBJECTIVES: To identify sources, characteristics, and uses of RWE in Argentina, Brazil, Colombia, and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered. METHODS: A systematic literature review, database mapping, and targeted gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 South American countries. RESULTS: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population, and outcomes captured were reported. Characteristics of national health information systems show efforts to collect interoperable data from service providers, insurers, and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship, and resources. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes. CONCLUSIONS: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.

Internal Consistency of the SF-6D as a Health Status Index in the Brazilian Urban Population.

OBJECTIVES: To investigate the internal consistency of the SF-6D as a health status index in the Brazilian urban population. STUDY DESIGN: Cross-sectional population based study. METHODS: Five thousand individuals, older than the age of 15, were assessed in the five regions of the country. Two different methods of scoring the SF-6D where compared: "weighting the items" of the questionnaire through the Brazilian official weight coefficients, and "unweighting the items" through a parallel non preference scoring rule solely based on patients' answers to SF-6D health classification system (SF-6DHSI). Principal component factor analysis was used for the development of the SF-6DHSI. Pearson's, Spearman's, and intraclass correlation coefficients were used to assess the psychometric properties. RESULTS: The SF-6DHSI scoring formula summarized the pattern of factor loadings and the item-internal consistency (Cronbach's α = 0.858). The scale showed good item-internal consistency, exceeding the 0.70 standard. The association between weighted and unweighted (SF-6DHSI) scores was extremely high (Spearman's ρ = 0.971). The correlations of the SF-6DHSI with the Physical Component of the 12-Item Short-Form Health Survey (SF-12) and the Health Assessment Questionnaire was moderate to strong. The intraclass correlation coefficient obtained (0.917) also suggested that the concordance between the weighted and unweighted score distributions was prominent. CONCLUSIONS: A nonweighted approach to score the SF-6D provides a reliable global measure of health status. The SF-6D health classification system is useful for assessing quality of life in a large and representative sample of the Brazilian population.

Perceptions of the population regarding generic drugs in Brazil: a nationwide survey.

BACKGROUND: Generic drugs (GDs) offer a way to reduce health spending without sacrificing quality. Despite this, there are doubts as to their acceptance by the population. This work aims to assess perceptions of GDs among the Brazilian population. METHODS: We conducted a national household survey face-to-face between April and May 2013, with 5000 individuals aged over 15 years. The questions explored socioeconomic and demographic characteristics, the use of GDs, and perceptions about GDs as compared to brand drugs (BDs). The chi-square test was used to examine the associations between the perceptions and the characteristics of the population. RESULTS: Of the 5000 participants, 51.3% were women, 40.2% were white, 48.6% were between 15 and 34 years of age, and 52.3% had income of less than two minimum wages (US$627.78). In terms of the use of GDs, 44.6% of the participants were taking or had taken GDs in the past three months, with the highest figures among the elderly (61.1%) and female (49.2%) populations. Regarding perceptions, 30.4% of the respondents considered GDs less effective than BDs; provided the same price, 59% would prefer BD, and 45.8% agreed that physicians prefer to prescribe GDs. The most negative perceptions about GDs were observed among lower income, elderly and nonwhite populations. CONCLUSION: The findings provide a better understanding of Brazilians' perceptions regarding GDs. This should be considered when formulating healthcare policies aiming at improving access to effective and quality drugs, and reduction of health costs.

Acompanhamento da capacidade funcional de pacientes com artrite reumatoide por três anos / Monitoring the functional capacity of patients with rheumatoid arthritis for three years

Objetivo Quantificar a modificação da capacidade funcional em um período de três anos em um grupo de pacientes com artrite reumatoide (AR), utilizando os inventários HAQ e EPM-ROM. Métodos Quarenta pacientes com AR em tratamento com metotrexato (MTX) como fármaco antirreumático modificador da doença (DMARD) foram acompanhados por até três anos. O estado funcional foi avaliado no início e no final do período por HAQ e EPM-ROM. Resultados Trinta e dois pacientes foram recuperados, com escore HAQ inicial de 1,14 ± 0,49 (média ± DP) e EPM-ROM de 5,8 ± 2,75. Após um período médio de três anos, o HAQ foi de 1,13 ± 0,49 e EPM-ROM em 6,81 ± 3,66. No subgrupo de sete pacientes submetidos a cirurgia ortopédica, o HAQ diminuiu de 0,84 ± 0,72 para 1,64 ± 0,56; e o EPM-ROM, de 5,8 ± 1,80 para 8,3 ± 0,74. No subgrupo de pacientes não operados, o HAQ variou de 1,2 ± 0,45 para 1,07 ± 0,70; e o EPM-ROM, de 5,7 ± 3,06 para 6,4 ± 3,90. Conclusão Em um grupo de pacientes com AR medicados apenas com MTX como DMARD, houve pouca mudança nas pontuações HAQ e EPM-ROM durante o período médio de três anos. Observou-se agravamento da capacidade funcional no grupo de pacientes operados, em comparação com os não operados. Este fato nos alerta para a necessidade do uso de esquemas terapêuticos mais abrangentes e de maior disponibilidade de cirurgias musculoesqueléticas, em tempo hábil, em pacientes com AR. .

Objective To quantify modification of functional capacity in a three-year period in a group of patients with rheumatoid arthritis (RA) using HAQ and EPM-ROM inventories. Methods Forty patients with RA on methotrexate (MTX) as disease-modifying antirheumatic drug (DMARD) were followed for up to three years. The functional status was assessed at the beginning and end of the period by HAQ and EPM-ROM. Results Thirty-two patients were retrieved, with initial HAQ score of 1.14 ± 0.49 (mean ± SD) and EPM-ROM score of 5.8 ± 2.75. After an average period of three years, the HAQ score was 1.13 ± 0.49 and EPM-ROM score, 6.81 ± 3.66. In the subgroup of seven patients submitted to orthopedic surgery, HAQ score decreased from 0.84 ± 0.72 to 1.64 ± 0.56 and the EPM-ROM score, from 5.8 ± 1.80 to 8.3 ± 0.74. In the subgroup of non-operated patients, HAQ score varied from 1.2 ± 0.45 to 1.07 ± 0.70 and EPM-ROM score, from 5.7 ± 3.06 to 6.4 ± 3.90. Conclusion In a group of RA patients in use of only MTX as DMARD, there was little change on HAQ score and EPM-ROM scores over the average period of three years. Worsening functional capacity was observed in the group of operated patients in comparison to the not operated ones. This fact alerts us to the need for use of broader therapeutic regimens availability of musculoskeletal surgeries in a timely manner in patients with RA. .

[Monitoring the functional capacity of patients with rheumatoid arthritis for three years]. / Acompanhamento da capacidade funcional de pacientes com artrite reumatoide por três anos.

OBJECTIVE: To quantify modification of functional capacity in a three year period in a group of patients with rheumatoid arthritis (RA) using HAQ and EPM-ROM inventories. METHODS: Forty patients with RA on methotrexate (MTX) as disease-modifying anti rheumatic drug (DMARD) were followed for up to three years. The functional status was assessed at the beginning and end of the period by HAQ and EPM-ROM. RESULTS: Thirty two patients were retrieved, with initial HAQ score of 1.14±0.49 (mean±SD) and EPM-ROM score of 5.8±2.75. After an average period of three years, the HAQ score was 1.13±0.49 and EPM-ROM score, 6.81±3.66. In the subgroup of seven patients submitted to orthopedic surgery, HAQ score decreased from 0.84±0.72 to 1.64±0.56 and the EPM-ROM score, from 5.8±1.80 to 8.3±0.74. In the subgroup of non-operated patients, HAQ score varied from of 1.2±0.45 to 1.07±0.70 and EPM-ROM score, from 5.7±3.06 to 6.4±3.90. CONCLUSION: In a group of RA patients in use of only MTX as DMARD, there was little change on HAQ score and EPM-ROM scores over the average period of three years. Worsening functional capacity was observed in the group of operated patients in comparison to the not operated ones. This fact alerts us to the need for use of broader therapeutic regimens availability of musculoskeletal surgeries in a timely manner in patients with RA.

Quality-adjusted life-years gain and health status in patients with OSAS after one year of continuous positive airway pressure use.

STUDY OBJECTIVES: To estimate the health utility score and quality-adjusted life-years (QALY) index of obstructive sleep apnea syndrome (OSAS) in patients over 1 y of continuous positive airway pressure (CPAP) treatment. DESIGN: Longitudinal interventional study. SETTING: The study was carried out in Sao Paulo Sleep Institute, Brazil. PATIENTS AND PARTICIPANTS: Ninety-five patients with OSAS and with apnea-hypopnea index (AHI) > 20 of either sex, body mass index < 40 kg/m(2), and no previous contact with CPAP were included. INTERVENTIONS: The participants underwent baseline and titration polysomnographies, clinical evaluation, and ambulatory blood pressure (BP) measurement, completed Short-Form 6 Dimension Health Survey (SF-6D) and Epworth Sleepiness Scale (ESS) questionnaires, and implementation of CPAP. The patients were followed for 1 y. MEASUREMENTS AND RESULTS: The mean AHI and age were 57.6 ± 29.2 events/h and 53.3 ± 9.3 y, respectively. One year of CPAP treatment increased the health utility score from 0.611 ± 0.112 to 0.710 ± 0.121 (P < 0.01). Therefore, CPAP resulted in a mean gain of 0.092 QALY/patient. The improvements in utility scores were associated with decreases in the ESS after 1 mo, in systolic BP after 1 y, and in diastolic BP at 6 mo. BP normalization group (≤ 130/85 mmHg) showed higher QALY than that of the non-normalization group (0.10 ± 0.09 versus 0.05 ± 0.10; P = 0.03). One-year ESS score (P = 0.03), diastolic BP reduction P = 0.01) and baseline utility scores (P < 0.01) were significantly associated with QALY gain. CONCLUSION: This study showed a significant QALY/patient gain after 1 y of regular CPAP use. In addition, BP normalization was associated with higher QALY gain. Thus, utility studies can provide more complete analyses of the total benefits of CPAP treatment in patients with OSAS and should be encouraged.

Willingness to pay as patient preference to bariatric surgery.

BACKGROUND: An obesity epidemic is spreading worldwide. In addition to comorbidities, social and emotional problems contribute to reduce the quality of life (QoL) of obese people. Considering the heterogeneity of outcomes from clinical and surgical approaches, it is recommended that severely obese patients participate in their treatment decisions. This study evaluated preferences of severely obese patients for obesity surgical treatment using the willingness to pay (WTP) and to assess the impact of the presence of some clinical disorders, socioeconomic conditions and QoL on their decisions. METHODS: The selected patients were invited to answer the WTP questionnaire using two formats of contingent valuation questions: dichotomous choice (yes/no) and a bidding game. The answers were correlated with clinical features, QoL assessed by the SF-36 and the Moorehead-Ardelt Quality of Life Questionnaire II, Brazilian socioeconomic classification, and family and personal incomes. RESULTS: The group of patients who accepted the first bid was older and had higher frequency of sleep apnoea when compared to those who rejected the offer. A significant correlation between the bidding game value and family income was found (r = 0.28; P < 0.02). In the logistic regression model, socioeconomic classification and sleep apnoea were shown to be independently associated with acceptance the bid. CONCLUSIONS: Sleep apnoea was the comorbidity that most influenced the acceptance in dichotomous choice for bariatric surgery, probably due to the deleterious effects on daily activities induced by sleep disturbances. Our findings also suggest that the frequency of surgical procedures is below the preference of the obese population in Brazil.

A cost evaluation of peritoneal dialysis and hemodialysis in the treatment of end-stage renal disease in Sao Paulo, Brazil.

OBJECTIVE: Conventional hemodialysis (HD) predominates over peritoneal dialysis (PD) around the world. Prospective and comparative studies comparing the costs of these modalities are scarce. In the present prospective assessment, we describe the resources used and total patient costs for both HD and PD. ♢ METHODOLOGY: We assessed 249 patients on HD and 228 on PD. All patients were 18 years of age or older and on stable dialysis. The information was collected at three points over 1 year, using standard questionnaires. The sources for costs were the Brazilian public and private health care systems. Societal perspective was considered. ♢ STATISTICAL ANALYSIS: Core trends and dispersions were measured. Regression models assessed the impact of modality on the average total cost per patient per year. ♢ RESULTS: Of the 249 HD patients and 228 PD dialysis patients, 189 (74%) and 160 (70%) respectively completed follow-up. The mean age for women was 55.8 years; for men, it was 59.8 years (p = 0.001). The average total cost per patient-year was US$28 570 for HD and US$27 158 for PD. By category, the costs consisted of direct medical-hospital costs (82.3% for HD, 86.5% for PD), direct nonmedical costs (5.3% for HD, 3.7% for PD), and indirect costs (12.4% for HD, 9.8% for PD). Overall costs were less for PD patients than for their HD counterparts (p = 0.025). ♢ CONCLUSIONS: Maintenance dialysis represented the most important source of costs for both modalities; loss of productivity incurred significant costs. Future studies should contemplate the social consequences arising from each modality.

Health-related quality of life of patients recieving hemodialysis and peritoneal dialysis in São Paulo, Brazil: a longitudinal study.

OBJECTIVES: The aim of this study was to evaluate quality of life in patients undergoing hemodialysis (HD) or peritoneal dialysis (PD) in São Paulo, Brazil. METHODS: Inclusion criteria for this is a 1-year prospective study included being 18 years of age or older and clinically stable receiving chronic dialysis. Quality of life was measured using the SF-12 and the Kidney Disease Quality of Life questionnaires at baseline, 6 months, and 12 months. Patients who completed the surveys for all three periods were evaluated. Differences in quality of life scores were measured using univariate and multivariate regression analyses. RESULTS: One hundred eighty-nine of 249 (76%) HD patients and 161 of 228 (71%) PD patients completed all three surveys. The PD group was older and a larger number had diabetes. PD patients consistently had higher scores than HD patients at all three measurement periods for patient satisfaction (P = 0.002, P = 0.005, and P = 0.005, respectively), encouragement/support from staff (P = 0.003, P = 0.017, and P = 0.029, respectively), and burden of kidney disease (P = 0.003, P = 0.017, and P = 0.057, respectively). The HD group had a greater percent of patients who clinically improved from baseline to 12 months compared to PD patients for sleep quality, social support, encouragement/support from staff, and overall health. Scores for other dimensions of the Kidney Disease Quality of Life and SF-12 questionnaires were not significantly different between the PD and HD groups. CONCLUSIONS: The results provide evidence that PD and HD patients have equivalent health-related quality of life in several domains, although the former performed better in some quality of life domains despite being older and having more comorbidities.

The burden of osteoporosis in Brazil: regional data from fractures in adult men and women--the Brazilian Osteoporosis Study (BRAZOS).

OBJECTIVES: The BRAZOS (The Brazilian Osteoporosis Study) study is the first epidemiological and population-based study carried out in a representative sample of Brazilian men and women, 40 years or older, with the objective of identifying the prevalence and main clinical risk factors (CRF) associated with low-impact fractures. This report shows the main results according to each region of the country. PATIENTS AND METHODS: A total of 2,420 subjects (70% women) from 150 different cities in five geographic regions in Brazil, and from all different socio-economical classes were included in this study. Anthropometrical data, as well life style, previous fractures, nutritional status, physical activity, falls, and quality of life were evaluated by a quantitative individual survey. Low-impact fracture was defined as that resulting from a fall no greater than standing height of an individual. A P < 0.05 was considered significant. RESULTS: Statistically significant differences in the prevalence of fractures among the five Brazilian regions according to gender or social class were not observed. However, in women, a higher incidence of fractures was observed in metropolitan areas than in rural areas, and a tendency for a higher frequency of fractures was observed in men from Northeastern states. Statistically significant differences among men from metropolitan areas or rural areas were not observed. CONCLUSIONS: Significant differences in the prevalence of low-impact fractures among the five different regions of Brazil were not observed, as well as its frequency or relevance of risk factors.

O impacto da osteoporose no Brasil: dados regionais das fraturas em homens e mulheres adultos: The Brazilian Osteoporosis Study (BRAZOS) / The burden of osteoporosis in Brazil: regional data from fractures in adult men and women: The Brazilian Osteoporosis Study (BRAZOS)

INTRODUÇÃO/OBJETIVOS: O BRAZOS (The Brazilian Osteoporosis Study) é um estudo epidemiológico, de base populacional, realizado em amostra representativa de mulheres e homens brasileiros, de idade superior a 40 anos, com o objetivo de identificar os principais fatores clínicos de risco associados com fratura por baixo impacto. Nesse artigo são apresentados os principais resultados do estudo, de acordo com cada região do país. PACIENTES E MÉTODOS: Um total de 2.420 indivíduos, provenientes das cinco regiões do país e de todas as classes socioeconômicas foram incluídos no estudo. Foram avaliados dados antropométricos, bem como aspectos relacionados aos hábitos de vida, fraturas, ingestão alimentar, atividade física, quedas e qualidade de vida por meio de entrevista individual e quantitativa. Fratura por baixo impacto foi definida como aquela decorrente de queda da própria altura ou menos. Valor de P < 0,05 foi considerado como estatisticamente significante. RESULTADOS: Não houve diferença estatisticamente significativa da prevalência de fratura nas cinco regiões do Brasil, de acordo com o sexo ou classe social. No entanto, nas mulheres, houve maior ocorrência de fraturas na região metropolitana do que nos municípios do interior dos estados e tendência a maior frequência de fraturas em homens da região nordeste. Não foi verificada diferença estatisticamente significativa de fraturas se os homens eram provenientes das capitais ou do interior dos estados. CONCLUSÕES: De acordo com os nossos resultados, não foi observada diferença significativa da prevalência de fraturas por baixo impacto nem da frequência ou relevância de fatores de risco entre as cinco regiões do Brasil.

OBJECTIVES: The BRAZOS (The Brazilian Osteoporosis Study) study is the first epidemiological and population-based study carried out in a representative sample of Brazilian men and women, 40 years or older, with the objective of identifying the prevalence and main clinical risk factors (CRF) associated with low-impact fractures. This report shows the main results according to each region of the country. PATIENTS AND METHODS: A total of 2,420 subjects (70 percent women) from 150 different cities in five geographic regions in Brazil, and from all different socio-economical classes were included in this study. Anthropometrical data, as well life style, previous fractures, nutritional status, physical activity, falls, and quality of life were evaluated by a quantitative individual survey. Low-impact fracture was defined as that resulting from a fall no greater than standing height of an individual. A P < 0.05 was considered significant. RESULTS: Statistically significant differences in the prevalence of fractures among the five Brazilian regions according to gender or social class were not observed. However, in women, a higher incidence of fractures was observed in metropolitan areas than in rural areas, and a tendency for a higher frequency of fractures was observed in men from Northeastern states. Statistically significant differences among men from metropolitan areas or rural areas were not observed. CONCLUSIONS: Significant differences in the prevalence of low-impact fractures among the five different regions of Brazil were not observed, as well as its frequency or relevance of risk factors.

Estimated annual cost of arterial hypertension treatment in Brazil.

OBJECTIVES: To estimate the direct annual cost of systemic arterial hypertension (SAH) treatment in Brazil's public and private health care systems, assess its economic impact on the total health care budget, and determine its proportion of the 2005 gross domestic product (GDP). METHODS: A decision tree model was used to determine direct costs based on estimated use of various resources in SAH diagnosis and care, including treatment (medication and non-medication), complementary exams, doctor visits, nutritional assessments, and emergency room visits. RESULTS: Estimated direct annual cost of SAH treatment was approximately US$ 398.9 million for the public health care system and US$ 272.7 million for the private system, representing 0.08% of the 2005 GDP (ranging from 0.05% to 0.16%). With total health care expenses comprising about 7.6% of Brazil's GDP, this cost represented 1.11% of overall health care costs (0.62% to 2.06%)-1.43% of total expenses for the Unified Healthcare System (Sistema Unico de Saúde, SUS) (0.79% to 2.75%) and 0.83% of expenses for the private health care system (0.47% to 1.48%). Conclusion. To guarantee public or private health care based on the principles of universality and equality, with limited available resources, efforts must be focused on educating the population on prevention and treatment compliance in diseases such as SAH that require significant health resources.

Estimated annual cost of arterial hypertension treatment in Brazil / Costo estimado anual del tratamiento de la hipertensión arterial en Brasil

Objectives: To estimate the direct annual cost of systemic arterial hypertension (SAH) treatment in Brazil's public and private health care systems, assess its economic impact on the total health care budget, and determine its proportion of the 2005 gross domestic product (GDP). Methods: A decision tree model was used to determine direct costs based on estimated use of various resources in SAH diagnosis and care, including treatment (medication and non-medication), complementary exams, doctor visits, nutritional assessments, and emergency room visits. Results: Estimated direct annual cost of SAH treatment was approximately US$ 398.9 million for the public health care system and US$ 272.7 million for the private system, representing 0.08 percent of the 2005 GDP (ranging from 0.05 percent to 0.16 percent). With total health care expenses comprising about 7.6 percent of Brazil's GDP, this cost represented 1.11 percent of overall health care costs (0.62 percent to 2.06 percent)-1.43 percent of total expenses for the Unified Healthcare System (Sistema Único de Saúde, SUS) (0.79 percent to 2.75 percent) and 0.83 percent of expenses for the private health care system (0.47 percent to 1.48 percent). Conclusion. To guarantee public or private health care based on the principles of universality and equality, with limited available resources, efforts must be focused on educating the population on prevention and treatment compliance in diseases such as SAH that require significant health resources.

Objetivos: Estimar el costo directo anual del tratamiento de la hipertensión arterial sistémica (HAS) en los sistemas sanitarios público y privado de Brasil, evaluar su impacto económico en el presupuesto total de salud y determinar la proporción del producto interno bruto (PIB) que ocupó en 2005. Métodos: Se empleó un modelo de árbol de decisión para determinar los costos directos según el uso estimado de varios recursos en el diagnóstico y la atención de la HAS, incluidos el tratamiento (con medicamentos y sin ellos), los exámenes complementarios, las visitas del médico, las evaluaciones nutricionales y las visitas a servicios de emergencia. Resultados: El costo anual directo estimado del tratamiento de la HAS fue de aproximadamente US$ 398,9 millones en el sistema público y US$ 272,7 millones en el privado, lo que representó 0,08 por ciento del PIB en 2005 (mínimo: 0,05 por ciento; máximo: 0,16 por ciento). Con un gasto total en salud de cerca de 7,6 por ciento del PIB de Brasil, este costo representó 1,11 por ciento del costo total en salud (de 0,62 por ciento a 2,06 por ciento): 1,43 por ciento de los gastos totales del Sistema Único de Salud (de 0,79 por ciento a 2,75 por ciento) y 0,83 por ciento de los gastos del sistema privado (de 0,47 por ciento a 1,48 por ciento). Conclusiones: Para garantizar servicios públicos o privados de salud basados en los principios de universalidad y equidad, con recursos limitados, los esfuerzos se deben enfocar en educar a la población en el cumplimiento de las medidas de prevención y el tratamiento de enfermedades, que como la HAS, requieren considerables recursos sanitarios.

Cost-effectiveness of home visits in the outpatient treatment of patients with alcohol dependence.

The purpose of this study was to compare the cost-effectiveness of conventional outpatient treatment for alcoholic patients (CT) with this same conventional treatment plus home visits (HV), a new proposal for intervention within the Brazilian outpatient treatment system. A cost-effectiveness evaluation alongside a 12-week randomized clinical trial was performed. We identified the resources utilized by each intervention, as well as the cost according to National Health System (SUS), Brazilian Medical Association (AMB) tables of fees, and others based on 2005 data. The incremental cost-effectiveness ratio (ICER) was estimated as the main outcome measure - abstinent cases at the end of treatment. There were 51.8% abstinent cases for HV and 43.1% for CT, a clinically relevant finding. Other outcome measures, such as quality of life, also showed significant improvements that favored HV. The baseline scenario presented an ICER of USD 1,852. Sensitivity analysis showed an ICER of USD 689 (scenario favoring HV) and USD 2,334 (scenario favoring CT). The HV treatment was found to be cost-effective according to the WHO Commission on Macroeconomics and Health.

Nutrient intakes related to osteoporotic fractures in men and women--the Brazilian Osteoporosis Study (BRAZOS).

BACKGROUND: Adequate nutrition plays an important role in bone mass accrual and maintenance and has been demonstrated as a significant tool for the prevention of fractures in individuals with osteoporosis. OBJECTIVE: The aim of the present study was to evaluate bone health-related nutrients intake and its association with osteoporotic fractures in a representative sample of 2344 individuals aged 40 years or older in Brazil. METHODS: In a transversal population-based study, a total of 2420 individuals over 40 years old were evaluated from March to April 2006. Participants were men and women from all socio-economic classes and education levels living around the Brazilian territory Individuals responded a questionnaire including self reported fractures as well a 24-hour food recall. Nutrient intakes were evaluated by Nutrition Data System for Research software (NDSR, University of Minnesota, 2007). Low trauma fracture was defined as that resulting of a fall from standing height or less. Nutrient intakes adequacies were performed by using the DRI's proposed values. Statistical analysis comprises Oneway ANCOVA adjusted by age and use of nutritional supplements and multiple logistic regression. SAS software was used for statistical analysis. RESULTS: Fractures was reported by 13% of men and 15% of women. Women with fractures presented significantly higher calcium, phosphorus and magnesium intakes. However, in all regions and socio-economical levels mean intakes of bone related nutrients were below the recommended levels. It was demonstrated that for every 100 mg/phosphorus increase the risk of fractures by 9% (OR 1.09; IC95% 1.05-1.13, p < 0.001). CONCLUSION: The results demonstrated inadequacies in bone related nutrients in our population as well that an increase in phosphorus intake is related to bone fractures.

Dialysis care, cardiovascular disease, and costs in end-stage renal disease in Brazil.

OBJECTIVES: This study evaluates the cost of dialysis care in Brazil, including costs of ambulatory care and hospital admissions due to all causes and cardiovascular events. METHODS: Data were analyzed for 200 patients with end-stage renal disease (ESRD) on chronic hemodialysis in Brazil between 2001 and 2004. Main end points were all-cause mortality, all-cause hospital admissions, and cardiovascular events. Direct costs of dialysis treatment and complications were computed from the perspective of two payers, the Ministry of Health (MoH) and private health insurance (PHI). RESULTS: Mean number of days of hospitalization was 12 per patient-year. There were 105 cardiovascular events; the most frequent events were coronary disease (n = 59, 56 percent) and congestive heart failure (n = 26, 25 percent). The rate of cardiovascular events was 193 per 1,000 patient-years. There were 43 deaths, and the death rate was 79 per 1,000 patient-years. Median cost per hospital admission was US$ 675 and US$ 932 from the perspective of the MoH and PHI. For admissions due to cardiovascular causes, the corresponding costs were US$ 1,639 and US$ 4,499, respectively. Mean global cost per patient-year for chronic hemodialysis therapy was US$ 7,980 and US$ 13,428 from the perspective of the MoH and PHI, respectively. CONCLUSIONS: Patients on chronic hemodialysis care incur significant healthcare resources due to the costs of dialysis and complications, notably cardiovascular disease. New disease management programs aimed at reducing cardiovascular morbidity and efficient use of resources are critical to ensuring the sustainability of treatments for ESRD in Brazil.

Conceitos introdutórios de economia da saúde e o impacto social do abuso de álcool / Introductory concepts of health economics and the social impact of the alcohol misuse

A sociedade brasileira arca, atualmente, com um elevado custo econômico frente aos problemas decorrentes do uso abusivo de álcool. No Brasil, estudos econômicos relacionados ao abuso e/ou dependência química são escassos ou inexistentes, embora exista uma grande limitação de recursos e enormes problemas de saúde decorrentes. Este artigo tem como objetivo introduzir aos profissionais da saúde conceitos fundamentais da Economia da Saúde, tais como: avaliação econômica completa e incompleta, custo da doença, comparação de custos, tipos de avaliação (custo-minimização, custo-efetividade, custo-utility e custo-benefício), pontos de vista da análise (do paciente, da Instituição de Saúde, do Ministério da Saúde ou da sociedade), tipos de custos (diretos, indiretos e intangíveis) e outros. Além disso, serão descritos alguns dados de pesquisas sobre o impacto do consumo de álcool na sociedade brasileira. Não pretendemos esgotar os assuntos tratados, mas sim, enfatizar a necessidade de pesquisas nacionais que aliem a avaliação econômica à dependência alcoólica, tendo por finalidade propiciar o maior ganho de saúde possível, com a menor utilização dos escassos recursos destinados ao sistema saúde, na busca de maior eficiência.

Brazilian society bears high economic costs in view of the problems resulting from the alcohol consumption. There is a lack of economic studies into alcohol misuse or dependence in Brazil due to the limited financial resources, despite the huge health problems the country has been facing. This paper aims to introduce basic concepts of Heath Economics to health care practitioners, such as: Complete and Incomplete Economic Evaluation, Disease Costs, Cost Comparison, Types of Evaluation (cost-minimisation, cost-effectiveness, cost-utility, and cost-benefice), Point of View Analysis (from patient, health institution, Ministry of Health, or society), Types of Costs (direct, indirect and intangible), and other ones. In addition, research data on the impact of the alcohol consumption on the Brazilian society is described. We do not intend to exhaust the subjects addressed in this paper, but emphasise the need for more national researches that link the economic evaluation to the alcohol addiction issue in order to seek maximum efficiency by maximising the health care and minimising the scarce health system resources.

[Introductory concepts of health economics and the social impact of alcohol abuse]. / Conceitos introdutórios de economia da saúde e o impacto social do abuso de álcool.

Brazilian society bears high economic costs in view of the problems resulting from the alcohol consumption. There is a lack of economic studies into alcohol misuse or dependence in Brazil due to the limited financial resources, despite the huge health problems the country has been facing. This paper aims to introduce basic concepts of Heath Economics to health care practitioners, such as: Complete and Incomplete Economic Evaluation, Disease Costs, Cost Comparison, Types of Evaluation (cost-minimisation, cost-effectiveness, cost-utility, and cost-benefice), Point of View Analysis (from patient, health institution, Ministry of Health, or society), Types of Costs (direct, indirect and intangible), and other ones. In addition, research data on the impact of the alcohol consumption on the Brazilian society is described. We do not intend to exhaust the subjects addressed in this paper, but emphasise the need for more national researches that link the economic evaluation to the alcohol addiction issue in order to seek maximum efficiency by maximising the health care and minimising the scarce health system resources.

[Critical appraisal of sevelamer for the treatment of hyperphosphatemia in patients with chronic renal failure]. / Avaliação crítica do sevelamer no tratamento da hiperfosfatemia em pacientes com insuficiência renal crônica.

OBJECTIVE: To evaluate in patients with chronic renal failure (CRF) the effectiveness and the costs of sevelamer, a cationic polymer calcium- and aluminum-free, that is a new gastrointestinal phosphate binder. METHODS: Literature review and critical appraisal of six clinical trials about the effectiveness and two economic studies of sevelamer in CRF patients. RESULTS: Sevelamer is an effective phosphate binder (used in a mean daily dose of 3.5 g three times per day with meals) and with similar effect as that obtained with calcium salts, without the adverse manifestations of the latter (elevation of calcium x phosphorus product, hypercalcemia, vascular and cardiac calcifications, etc.). Moreover, sevelamer reduced serum LDL cholesterol in around 30%. Despite the greater direct costs of sevelamer compared with calcium salts, the total costs may be lower due to the reduction of costs with clinical complications and hospitalizations. CONCLUSIONS: Sevelamer has important therapeutic value in CRF patients with hyperphosphatemia. Economic analyses should be performed in our setting to define the cost-effectiveness relationship of sevelamer.

Avaliaçäo crítica do sevelamer no tratamento da hiperfosfatemia em pacientes com insuficiência renal crônica / Critical appraisal of sevelamer for the treatment of hyperphosphatemia in patients with chronic renal failure

OBJETIVO: Avaliar em pacientes com insuficiência renal crônica (IRC), a efetividade e os custos do sevelamer, um polímero catiônico livre de alumínio e cálcio, que é um novo quelante de fósforo no trato gastrointestinal. MÉTODOS: Revisäo da literatura e avaliaçäo crítica de seis ensaios clínicos publicados sobre efetividade e duas avaliações econômicas do sevelamer em pacientes com IRC. RESULTADOS: O sevelamer é um quelante de fosfato efetivo (utilizado na dose média de 3,5g/dia dividido em 3 doses às refeições) e com efeito similar ao obtido com sais de cálcio, além de näo apresentar os efeitos colaterais destes últimos (elevaçäo do produto cálcio x fósforo, hipercalcemia, calcificaçäo vascular, musculo-esquelética e cardíaca, etc.). Além disso, o sevelamer promove reduçäo em cerca de 30 por cento nos níveis de LDL colesterol. Custos diretos do sevelamer säo maiores que os dos sais de cálcio, embora os custos totais possam ser menores devido a menor taxa de complicações clínicas e hospitalizações. CONCLUSÕES: Sevelamer agrega valor terapêutico importante em pacientes com IRC e hiperfosfatemia. Estudos fármaco-econômicos devem ser realizados em nosso meio para se avaliar a relaçäo custo-efetividade do uso do sevelamer