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.     

A systematic review of the cost-effectiveness of renal replacement therapies,and consequences for decision-making in the end-stage renal disease treatment pathway

Objectives

Comparative economic assessments of renal replacement therapies (RRT) are common and often used to inform national policy in the management of end-stage renal disease (ESRD). This study aimed to assess existing cost-effectiveness analyses of dialysis modalities and consider whether the methods applied and results obtained reflect the complexities of the real-world treatment pathway experienced by ESRD patients.

Methods

A systematic literature review (SLR) was conducted to identify cost-effectiveness studies of dialysis modalities from 2005 onward by searching Embase, MEDLINE, EBM reviews, and EconLit. Economic evaluations were included if they compared distinct dialysis modalities (e.g. in-centre haemodialysis [ICHD], home haemodialysis [HHD] and peritoneal dialysis [PD]).

Results

In total, 19 cost-effectiveness studies were identified. There was considerable heterogeneity in perspectives, time horizon, discounting, utility values, sources of clinical and economic data, and extent of clinical and economic elements included. The vast majority of studies included an incident dialysis patient population. All studies concluded that home dialysis treatment options were cost-effective interventions.

Conclusions

Despite similar findings across studies, there are a number of uncertainties about which dialysis modalities represent the most cost-effective options for patients at different points in the care pathway. Most studies included an incident patient cohort; however, in clinical practice, patients may switch between different treatment modalities over time according to their clinical need and personal circumstances.

Promoting health policies through financial incentives in renal care should reflect the cost-effectiveness of a comprehensive approach that considers different RRTs along the patient pathway; however, no such evidence is currently available.

     

International Study of Health Care Organization and Financing for end-stage renal disease in France

The major features of ESRD management in France include the predominance of hemodialysis and the resulting competition for dialysis stations. In 2003, the prevalence of ESRD in France was 0.087%. Of the 52,000 ESRD patients, 30,882 were receiving dialysis and 21,233 had functioning renal transplants. The annual expenditure per ESRD patient in 2003 was estimated at €40,975. Autodialysis, at €49,133 per patient per year, was much less expensive than dialyzing in-center at either a public or private facility (€111,006 and €75,125, respectively). Transplant activity in France has rapidly increased in recent years, reaching 22 donors per million population in 2005.      

Illustrating the impact of including future costs in economic evaluations: an application to end-stage renal disease care

There are strong theoretical arguments for including future costs for related and unrelated medical care and non-medical expenditures within economic evaluations. Nevertheless, there is limited data on how inclusion of such costs affects the cost effectiveness of medical interventions in practice. For a low-cost intervention that improves survival in end-stage renal disease (ESRD) patients, we sought to determine how the inclusion of future costs for related medical care (i.e. dialysis and transplantation) and for unrelated medical care and non-medical expenditure would affect the magnitude of the cost per QALY ratio. We performed a cost-utility analysis comparing hemodialysis using a synthetic dialyser (the current treatment of choice in Canada) with the historical gold-standard treatment (use of a cellulose dialyser). We contrasted the results of the analysis including and excluding various measures of future costs. While the inclusion of future costs for unrelated medical care and non-medical expenditures had a significant impact on the cost per QALY ratio, the size of the cost per QALY ratio was most sensitive to inclusion of future costs for related medical care. Our analysis shows that even relatively inexpensive interventions that extend survival of dialysis patients may not be cost-effective since, by extending survival, the extra outpatient dialysis costs that are incurred are large. Inclusion of such costs (which, in and of itself, is methodologically correct) in economic evaluations in this area may mitigate against the acceptance of interventions that are relatively inexpensive themselves but which improve patient survival.     

A Bayesian approach to assess heart disease mortality among persons with diabetes in the presence of missing data

Some states’ death certificate form includes a diabetes yes/no check box that enables policy makers to investigate the change in heart disease mortality rates by diabetes status. Because the check boxes are sometimes unmarked, a method accounting for missing data is needed when estimating heart disease mortality rates by diabetes status. Using North Dakota’s data (1992–2003), we generate the posterior distribution of diabetes status to estimate diabetes status among those with heart disease and an unmarked check box using Monte Carlo methods. Combining this estimate with the number of death certificates with known diabetes status provides a numerator for heart disease mortality rates. Denominators for rates were estimated from the North Dakota Behavioral Risk Factor Surveillance System. Accounting for missing data, age-adjusted heart disease mortality rates (per 1,000) among women with diabetes were 8.6 during 1992–1998 and 6.7 during 1999–2003. Among men with diabetes, rates were 13.0 during 1992–1998 and 10.0 during 1999–2003. The Bayesian approach accounted for the uncertainty due to missing diabetes status as well as the uncertainty in estimating the populations with diabetes. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of CDC.     

Approaches to the reversal of malnutrition,inflammation, and atherosclerosis in end-stage renal disease

Uremic malnutrition and chronic inflammation are important comorbid conditions that predict poor clinical outcome in end-stage renal disease (ESRD) patients. These conditions are also closely associated with cardiovascular disease, the major cause of death in ESRD patients. A pathophysiologic link between malnutrition, inflammation, and atherosclerosis has been proposed in this patient population. Indeed, multiple lines of evidence suggest that chronic inflammation can predispose ESRD patients to a catabolic and atherogenic state. Malnutrition can also result from chronic inflammation and can accelerate the progression of cardiovascular disease. Whereas a single common etiology has not been identified in this complex process, nutritional and anti-inflammatory interventions provide potential treatment options to counter the high mortality and morbidity in ESRD patients.     

The quality of maintenance therapy for end-stage renal disease. A review of social adjustment and rehabilitation

Prior to 1972, ESRD patients selected for maintenance dialysis or renal transplantation were generally young, emotionally and socially well-adjusted, and physically healthy except for their renal disease. Following the enactment of Public Law 92-603 (1972), which extended Medicare coverage to virtually all ESRD patients, the criteria for the selection of patients were substantially liberalized. During the past decade, maintenance therapy has increasingly been provided for severely debilitated ESRD patients whose reported levels of rehabilitation have been less than desired. While the majority of the current ESRD patient population have not been restored to their premorbid levels of individual and social functioning, recent studies suggest this may be the result of initiating rehabilitation efforts too late in the disease process. For optimal social functioning to be achieved by ESRD patients, it is concluded that psychosocial intervention and support must be initiated at the time ESRD is diagnosed and be focused on the maintenance, rather than rehabilitation, of the patient's functioning.     

Iniquities in the access to renal transplant for patients with end-stage chronic renal disease in Brazil

The objective of this present study is to analyze individual and contextual factors associated with access to renal transplant in Brazil. An observational, prospective and non-concurrent study was carried out, based on data from the National Database on renal replacement therapies in Brazil. Patients undergoing dialysis between 01/Jan/2000 and 31/Dec/2000 were included and monitored up to the point of transplant, death or until the end of the study period. Variables that were analyzed included: individual variables (age, sex, region of residence, primary renal disease, hospitalizations); and context variables concerning both the dialysis unit (level of complexity, juridical nature, hemodialysis machines and location) and the city (geographic region, location and HDI). Proportional hazard models were adjusted with hierarchical entry to identify factors associated with the risk of transplant. The results point to differentials in access according to socio-demographic, clinical, geographic and social factors, indicating that the organ allocation system has not eliminated avoidable disparities for those who compete for an organ in the nationwide waiting list.     

Incidence of end-stage renal disease attributed to diabetes among persons with diagnosed diabetes --- United States and Puerto Rico, 1996-2007

During 2007, approximately 110,000 persons in the United States and Puerto Rico began treatment for end-stage renal disease (ESRD) (i.e., kidney failure requiring dialysis or transplantation). Diabetes is the leading cause of ESRD in the United States, accounting for 44% of new cases in 2007. Although the number of persons initiating treatment for kidney failure each year who have diabetes listed as a primary cause (ESRD-D) has increased since 1996, ESRD-D incidence among persons with diagnosed diabetes has declined since 1996. To determine whether this decline occurred in every U.S. region and in every state, CDC analyzed 1996-2007 data from the U.S. Renal Data System (USRDS) and the Behavioral Risk Factor Surveillance System (BRFSS). During the period, the age-adjusted rate of ESRD-D among persons with diagnosed diabetes declined 35% overall, from 304.5 to 199.1 per 100,000 persons with diagnosed diabetes, and declined in all U.S. regions and in most states. No state showed a significant increase in the age-adjusted ESRD-D rate. Continued awareness of risk factors for kidney failure and interventions to improve diabetes care are needed to sustain and improve these trends.     

Prospective randomized trial to assess caloric and protein needs of critically Ill, anuric, ventilated patients requiring continuous renal replacement therapy

OBJECTIVES: We measured the energy and protein needs in 50 sequential, critically ill, ventilated patients requiring continuous renal replacement therapy (CRRT) for renal failure by using indirect calorimetry and three sequential isocaloric protein-feeding regimes of 1.5, 2.0, and 2.5 g. kg(-1). d(-1). We also assessed the compliance of actual feeding with target feeding and correlated the predictive energy requirements of the formulae with the actual energy expenditure (EE) measured by indirect calorimetry. We also determined whether these feeding regimes affected patient outcome. METHODS: The energy and protein needs of 50 consecutive, critically ill patients (31 male; age 53.3 +/- 17.4 y; Acute Physiology and Chronic Health Evaluation (APACHE II) score: 26.0 +/- 8.0; Acute Physiology and Chronic Health Evaluation score predicted risk of death: 50.0 +/- 25.0%) were assessed by using indirect calorimetry and ultrafiltrate nitrogen loss. Entry into this study was on commencement of CRRT. To eliminate any beneficial effect from the passage of time on nitrogen balance, 10 of the 50 patients were randomized to receive 2.0 g. kg(-1). d(-1) throughout the study, and the others received an escalating isocaloric feeding regime (1.5, 2.0, and 2.5 g. kg(-1). d(-1)) at 48-h intervals. Enteral feeding was preferred, but if this was not tolerated or unable to meet target, it was supplemented or replaced by a continuous infusion of total parenteral nutrition. Energy was given to meet caloric requirements as predicted by the Schofield equation corrected by stress factors or based on the metabolic cart readings of EE and was kept constant for all patients throughout the trial. Patients were stabilized on each feeding regime for at least 24 h before samples of dialysate were taken for nitrogen analysis at 8-h intervals on the second day. CRRT was performed by using a blood pump with a blood flow of 100 to 175 mL/min. Dialysate was pumped in and out counter-currently to the blood flow at 2 L/h. A biocompatible polyacrylonitrile hemofilter was used in all cases. RESULTS: EE was 2153 +/- 380 cal/d and increased by 56 +/- 24 cal/d (P < 0.0001) throughout the 6-d study period to 2431 +/- 498 cal/d. At study entry, the mean predicted (Schofield) caloric requirement was 2101 +/- 410. Patients received 99% of the predicted energy requirements. However, the mean EE was 11% higher at 2336 +/- 482 calories. This difference was not uniform. If the predicted caloric requirement was less than 2500, the EE exceeded the predicted by an average of 19%. If the predicted caloric requirement was greater than 2500, the EE on average was 6% less than predicted. This relation was significant (P = 0.025) and has not been described previously. Nitrogen balance was inversely related to EE (P = 0.05), positively related to protein intake (P = 0.0075), and more likely to be attained with protein intakes larger than 2 g. kg(-1). d(-1) (P = 0.0001). Nitrogen balance became positive in trial patients over time but were negative in control patients over time (P = 0.0001). Nitrogen balance was directly associated with hospital outcome (P = 0.03) and intensive care unit outcome (P = 0.02). For every 1-g/d increase in nitrogen balance, the probability of survival increased by 21% (P = 0.03; odds ratio, 1.211; 95% confidence limits, 1.017,1.443). Further, although enterally and parenterally fed patients had lower mortalities than predicted, the presence of enteral feeding, even after adjusting for predicted risk of death, had a statistically significant benefit to patient outcome (P = 0.04). CONCLUSIONS: This study found that a metabolic cart can improve the accuracy of energy provision and that a protein intake of 2.5 g. kg(-1). d(-1) in these patients increases the likelihood of achieving a positive nitrogen balance and improving survival. Enteral feeding is preferable, but if this is not possible or does not achieve the target, then it should be supplemented by parenteral feeding.     

An estimate of lifelong costs and QALYs in renal replacement therapy based on patients' life expectancy

OBJECTIVES: To estimate lifelong costs and quality adjusted life years (QALYs) of hemodialysis (HD), peritoneal dialysis (PD) and renal transplantation (Tx) in Greece, based on individual patient life expectancy. METHODS: A nationally representative patient sample on each modality, HD: N=642, PD: N=65 and Tx: N=167, was self-administered the SF-36 Health Survey, from which the preference-based SF-6D utility index was derived. Lifelong QALYs were estimated from literature-based expected remaining life years according to age, gender and modality. Cost analyses were performed from the perspective of the health system. Costs and QALYs were discounted at 5% and sensitivity analyses were performed. RESULTS: Estimated lifelong QALYs were 4.37 (HD), 3.94 (PD) and 16.11 (Tx) (P<0.001). Annual HD and PD costs per patient were estimated at euro36,247 and euro30,719 respectively. For Tx, average 1st year, 3-year and lifelong (undiscounted) costs were euro31,714, euro43,275 and euro151,274 respectively. Cost per QALY was higher in HD (euro60,353) compared to PD (euro54,504) and 1st year Tx (euro45,523). CONCLUSIONS: HD is used by 75% of the Greek ESRD patients, hence cost-saving efforts must be intensified. Reconsidering supply and reimbursement policies for dialyzers and drugs, establishing satellite dialysis units and adopting telemedicine in remote areas could be explored. Wider use of PD is also in the direction of increasing cost-effectiveness. Finally, efforts are required for disseminating the idea of organ donation.     

人乳头瘤病毒治疗性疫苗综合疗法的研究现状与临床潜力

近年来,人乳头瘤病毒(HPV)治疗性疫苗的研究一直处于非常热门的地位,不少研究已经进入临床试验。HPV是宫颈癌的主要诱因,除了肿瘤细胞逃逸免疫机制外,HPV本身也有其特殊的逃逸机制,因此单一有效的治疗性疫苗研发有其一定的难度。从研究趋势上看,HPV治疗性疫苗联合其他治疗方式的综合性治疗或许成为有效的最新的研究热点而被认...     

Lifetime medical costs for women: cardiovascular disease, diabetes, and stress urinary incontinence

PURPOSE: To estimate the absolute and relative lifetime medical costs of treating women with cardiovascular disease (CVD), diabetes, or stress urinary incontinence (SUI). METHODS: Women under 65 years, treated for CVD, diabetes, or SUI, were identified using administrative medical claims data from a large employer (n >100,000). A case-control methodology was used to estimate the annual medical costs of these women. Based on these estimates and published government statistics, annual costs for women 65 years and older were calculated. An incidence-based methodology with steady-state assumptions was used to project to lifetime medical costs. Cost estimates are incremental, measured as the difference between costs of patients and their demographically similar controls without the condition. They therefore represent the additional costs of treating patients with the condition, beyond the average, baseline costs incurred by controls without the condition. FINDINGS: The incremental lifetime medical cost of treating a woman (in 2002 dollars) with CVD is $423,000, with diabetes is $233,000, and with SUI is $58,000 US dollars. Including the baseline medical costs of the control, the total lifetime medical costs (i.e., sum of incremental and baseline lifetime medical costs) of treating a woman with CVD are 3.4 times greater than the costs of a woman without CVD. Similarly, a woman with diabetes has total costs on average, 2.5 times greater than the costs of her control, whereas a woman with SUI has total lifetime medical costs 1.8 times greater than the costs of a similar woman without SUI. CONCLUSIONS: These substantial cost estimates suggest the need for further gender-specific research and policies addressing the long-term implications of health care financing, treatment, and preventive care.     

A rational approach to the use of hormonal replacement therapy in postmenopausal and older women

This report reviews the use of hormonal therapy in postmenopausal women and gives specific attention to its benefits in the older patients. Concomitant use of progestin is recommended for all but the very old who are being treated for urogenital problems. Strategies for minimizing withdrawal bleeding and the adverse impacts of progestins on lipoprotein subfractions are discussed.     

Patients' decisions for treatment of end-stage renal disease and their implications for access to transplantation

Gaining access to kidney transplantation is a complex process that involves treatment decisions made by patients. Despite several advantages of kidney transplantation, some patients choose to remain on hemodialysis for treatment of end-stage renal disease. The present study was undertaken to describe the sociocultural factors influencing patients' decisions to remain on dialysis compared to those who sought a transplant. The study also examined whether African Americans made decisions different from European Americans which would offer insights into one of many factors resulting in them receiving disproportionately fewer kidney transplants. Using a qualitative approach supplemented by a quantitative approach, interviews employing open-ended questions and a card sort technique were conducted with 79 hemodialysis patients. Patients who preferred to remain on dialysis were significantly older and more likely to be unmarried and Protestant. The relationship between treatment decisions and ethnicity was inconclusive due to multiple, interrelated covariates. The three most common reasons patients reported for remaining on dialysis included: doing well on dialysis, fear of being "cut on" from a transplant, and knowing other patients whose kidney transplant failed. This study identified sociocultural and ethnomedical beliefs and values about the body and transplantation that inform patients' treatment decisions. This study also generated data that illuminate the complexity of patients' decisions and how these affect patients' preferences regarding transplantation. The results emphasize the need for policy makers to recognize patients' decisions when accounting for alleged difficulties in gaining access to transplantation.