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The aim of this study was to show how the US government could save approximately 47 000 patients with chronic kidney failure each year from suffering on dialysis and premature death by compensating living kidney donors enough to completely end the kidney shortage.Supply and demand analysis was used to estimate the number of donated kidneys needed to end the kidney shortage and the level of compensation required to encourage this number of donations. These results were then input into a detailed cost-benefit analysis to estimate the economic value of kidney transplantation to (1) the average kidney recipient and their caregiver, (2) taxpayers, and (3) society in general.We estimate half of patients diagnosed with kidney failure each year-approximately 62 000 patients-could be saved from suffering on dialysis and premature death if they could receive an average of 1½ kidney transplants. However, currently there are only enough donated kidneys to save approximately 15 000 patients. To encourage sufficient donations to save the other 47 000 patients, the government would have to compensate living kidney donors approximately $77 000 (±50%) per donor. The value of transplantation to an average kidney recipient (and caregiver) would be approximately $1.5 million, and the savings from the recipient not needing expensive dialysis treatments would be approximately $1.2 million.This analysis reveals the huge benefit that compensating living kidney donors would provide to patients with kidney failure and their caregivers and, conversely, the huge cost that is being imposed on these patients and their families by the current legal prohibition against such compensation.

BACKGROUND The goal is to provide a national analysis of organ procurement organization (OPO) costs. METHODS Five years of data, for 51 of the 58 OPOs (2013-2017, a near census) were obtained under a FOIA. OPOs are not-for-profit federal contractors with a geographic monopoly. A generalized 15-factor cost regression model was estimated with adjustments to precision of estimates (P) for repeated observations. Selected measures were validated by comparison to IRS forms. RESULTS Decease donor organ procurement is a $1B/y operation with over 26 000 transplants/y. Over 60% of the cost of an organ is overhead. Profits are $2.3M/OPO/y. Total assets are $45M/OPO and growing at 9%/y. "Tissue" (skin, bones) generates $2-3M profit/OPO/y. A comparison of the highest with the lower costing OPOs showed our model explained 75% of the cost difference. Comparing costs across OPOs showed that highest-cost OPOs are smaller, import 44% more kidneys, face 6% higher labor costs, report 98% higher compensation for support personnel, spend 46% more on professional education, have 44% fewer assets, compensate their Executive Director 36% less, and have a lower procurement performance (SDRR) score. CONCLUSIONS Profits and assets suggest that OPOs are fiscally secure and OPO finances are not a source of the organ shortage. Asset accumulation ($45M/OPO) of incumbents suggests establishing a competitive market with new entrants is unlikely. Kidney-cost allocations support tissue procurements. Professional education spending does not reduce procurement costs. OPO importing of organs from other OPOs is a complex issue possibly increasing cost ($6K/kidney).

A potential solution to the deceased donor organ shortage is to expand donor acceptability criteria. The procurement cost implications of using nonstandard donors is unknown. Using 5 years of US organ procurement organization (OPO) data, we built a cost function model to make cost projections: the total cost was the dependent variable; production outputs, including the number of donors and organs procured, were the independent variables. In the model, procuring one kidney or procuring both kidneys from double/en bloc transplantation from a single-organ donor resulted in a marginal cost of $55 k (95% confidence interval [CI] $28 k, $99 k) per kidney, and procuring only the liver from a single-organ donor results in a marginal cost of $41 k (95% CI $12 k, $69 k) per liver. Procuring two kidneys for two candidates from a donor lowered the marginal cost to $36 k (95% CI $22 k, $66 k) per kidney, and procuring two kidneys and a liver lowers the marginal cost to $24 k (95% CI $17 k, $45 k) per organ. Economies of scale were observed, where high OPO volume was correlated with lower costs. Despite higher cost per organ than for standard donors, kidney transplantation from nonstandard donors remained cost-effective based on contemporary US data.

While recent policy reforms aim to improve access to kidney transplantation for patients with end-stage kidney disease, the cost implications of kidney waiting list expansion are not well understood. The Organ Acquisition Cost Center (OACC) is the mechanism by which Medicare reimburses kidney transplantation programs, at cost, for costs attributable to kidney transplantation evaluation and waiting list management, but these costs have not been well described to date.To describe temporal trends in mean OACC costs per kidney transplantation and to identify factors most associated with cost.This economic evaluation included all kidney transplantation waiting list candidates and recipients in the United States from 2012 to 2017. A population-based study of cost center reports was conducted using data from all Center of MedicareMedicaid-certified transplantation hospitals. Data analysis was conducted from June to August 2021.Year, local price index, transplantation and waiting list volume of transplantation program, and comorbidity burden.Mean OACC costs per kidney transplantation.In 1335 hospital-years from 2012 through 2017, Medicare's share of OACC costs increased from $0.95 billion in 2012 to $1.32 billion in 2017 (3.7% of total Medicare End-Stage Renal Disease program expenditure). Median (IQR) OACC costs per transplantation increased from $81 000 ($66 000 to $103 000) in 2012 to $100 000 ($82 000 to $125 000) in 2017. Kidney organ procurement costs contributed to 36% of mean OACC costs per transplantation throughout the study period. During the study period, transplantation hospitals experienced increases in kidney waiting list volume, kidney waiting list active volume, kidney transplantation volume, and comorbidity burden. For a median-sized transplantation program, mean OACC costs per transplantation decreased with more transplants (-$3500 [95% CI, -$4300 to -$2700] per 10 transplants; P .001) and increased with year ($4400 [95% CI, $3500 to $5300] per year; P .001), local price index ($1900 [95% CI, $200 to $3700] per 10-point increase; P = .03), patients listed active on the waiting list ($3100 [95% CI, $1700 to $4600] per 100 patients; P .001), and patients on the waiting list with high comorbidities ($1500 [9% CI, $600 to $2500] per 1% increase in proportion of waitlisted patients with the highest comorbidity score; P = .002).In this study, OACC costs increased at 4% per year from 2012 to 2017 and were not solely attributable to the cost of organ procurement. Expanding the waiting list will likely contribute to further increases in the mean OACC costs per transplantation and substantially increase Medicare liability.

To predict whether the COVID‐19 pandemic and transplant center responses could have resulted in preventable deaths, we analyzed registry information of the US end‐stage renal disease (ESRD) patient population awaiting kidney transplantation. Data were from the Organ Procurement and Transplantation Network (OPTN), the US Centers for Disease Control and Prevention, and the United States Renal Data System. Based on 2019 OPTN reports, annualized reduction in kidney transplantation of 25%–100% could result in excess deaths of wait‐listed (deceased donor) transplant candidates from 84 to 337 and living donor candidate excess deaths from 35 to 141 (total 119–478 potentially preventable deaths of transplant candidates). Changes in transplant activity due to COVID‐19 varied with some centers shutting down while others simply heeded known or suspected pandemic risks. Understanding potential excess mortality for ESRD transplant candidates when circumstances compel curtailment of transplant activity may inform policy and procedural aspects of organ transplant systems allowing ways to best inform patients and families as to potential risks in shuttering organ transplant activity. Considering that more than 700 000 Americans have ESRD with 100 000 awaiting a kidney transplant, our highest annual estimate of 478 excess total deaths from postponing kidney transplantation seems modest.

Using 5 years of US organ procurement organization (OPO) data, we determined the cost of recovering a viable (ie, transplanted) kidney for each of 51 OPOs. We also examined the effects on OPO costs of the recovery of nonviable (ie, discarded) kidneys and other OPO metrics. Annual cost reports from 51 independent OPOs were used to determine the cost per recovered kidney for each OPO. A quadratic regression model was employed to estimate the relationship between the cost of kidneys and the number of viable kidneys recovered, as well as other OPO performance indicators. The cost of transplanted kidneys at individual OPOs ranged widely from $24 000 to $56 000, and the average was $36 000. The cost of a viable kidney tended to decline with the number of kidneys procured up to 549 kidneys per year and then increase. Of the total 81 401 kidneys recovered, 66 454 were viable and 14 947 (18.4%) were nonviable. The costs of kidneys varied widely over the OPOs studied, and costs were a function of the recovered number of viable and nonviable organs, local cost levels, donation after cardiac death, year, and Standardized Donor Rate Ratio. Cost increases were 3% per year.

Government compensation of kidney donors would likely increase the supply of kidneys and prevent the premature deaths of tens of thousands of patients with kidney failure each year. The major argument against it is that it would exploit the poor who would be more likely to accept the offers of compensation. This overlooks the fact that many poor patients desperately need a kidney transplant and would greatly benefit from an increased supply of kidneys. The objective of this study is to empirically test the hypothesis that government compensation of kidney donors would exploit the poor. Exploitation is defined by economists and several noted ethicists as paying donors less than the fair market value of their kidney. Exploitation is expressed in monetary terms and compared with the economic benefit recipients receive from a transplant. Data are from the Scientific Registry of Transplant Recipients and the United States Renal Data System annual data reports. Educational attainment is used as a proxy for income. We estimate that if the government rewards living donors with a package of non-cash benefits worth $75,000 per kidney, donors would not be exploited. Much more important, this compensation would likely end the kidney shortage, enabling many more patients with kidney failure to obtain transplants and live longer and healthier lives. The value of kidney transplantation to a U.S. recipient is about $1,330,000, which is an order of magnitude greater than any purported exploitation of a living donor (zero to $75,000). Consequently, the aggregate net benefit to the poor alone from kidney transplantation would increase to about $12 billion per year from $1 billion per year currently. Most of the benefit would accrue to poor kidney recipients. But poor donors would receive the fair market value of their kidney, and hence would not be exploited. If the government wanted to ensure that donors also received a net benefit, it could easily do so by increasing the compensation above $75,000 per donor.

Approximately 40% of the kidneys for transplant worldwide come from living donors. Despite advantages of living donor transplants, rates have stagnated in recent years. One possible barrier may be costs related to the transplant process that potential willing donors may incur for travel, parking, accommodation, and lost productivity.To better understand and quantify the financial costs incurred by living kidney donors, we conducted a prospective cohort study, recruiting 912 living kidney donors from 12 transplant centers across Canada between 2009 and 2014; 821 of them completed all or a portion of the costing survey. We report microcosted total, out-of-pocket, and lost productivity costs (in 2016 Canadian dollars) for living kidney donors from donor evaluation start to 3 months after donation. We examined costs according to (Living kidney donors incurred a median (75th percentile) of $1254 ($2589) in out-of-pocket costs and $0 ($1908) in lost productivity costs. On average, total costs were $2226 higher in spousal compared with emotionally related nonspousal donors (Our results can be used to inform strategies to minimize the financial burden of living donation, which may help improve the donation experience and increase the number of living donor kidney transplants.

From 5000 to 10 000 kidney patients die prematurely in the United States each year, and about 100 000 more suffer the debilitating effects of dialysis, because of a shortage of transplant kidneys. To reduce this shortage, many advocate having the government compensate kidney donors. This paper presents a comprehensive cost‐benefit analysis of such a change. It considers not only the substantial savings to society because kidney recipients would no longer need expensive dialysis treatments—$1.45 million per kidney recipient—but also estimates the monetary value of the longer and healthier lives that kidney recipients enjoy—about $1.3 million per recipient. These numbers dwarf the proposed $45 000‐per‐kidney compensation that might be needed to end the kidney shortage and eliminate the kidney transplant waiting list. From the viewpoint of society, the net benefit from saving thousands of lives each year and reducing the suffering of 100 000 more receiving dialysis would be about $46 billion per year, with the benefits exceeding the costs by a factor of 3. In addition, it would save taxpayers about $12 billion each year., This analysis of a government program to compensate kidney donors indicates the monetary value of saving thousands of lives each year and reducing the suffering of a hundred thousand more on dialysis would be about $46 billion per year, and would save taxpayers about $12 billion a year.

Background: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. Methods: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. Results: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. Conclusion: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

HLA typing and the time a patient has spent on the waiting list are the primary criteria used to allocate cadaveric kidneys for transplantation in the United States. Candidates with no HLA-A, B, and DR mismatches are given top priority, followed by candidates with the fewest mismatches at the HLA-B and DR loci; this policy contributes to a higher transplantation rate among whites than nonwhites. We hypothesized that changing this allocation policy would affect graft survival and the racial balance among transplant recipients.We estimated the relative rates of kidney transplantation according to race resulting from the current allocation policy and racial differences in HLA antigen profiles, using a Cox model for the time from placement on the waiting list to transplantation. Another model, also adjusted for HLA-B and DR antigen profiles, estimated the relative rates of kidney transplantation that would result if the distribution of these antigen profiles were identical among the racial and ethnic groups. We also investigated the effect of HLA matching on the risk of graft failure, using a Cox model for the time from the first transplantation to graft failure. The results of the two analyses were used to estimate the change in the racial balance of transplantation and graft-failure rates that would result from the elimination of HLA-B matching or HLA-B and DR matching as a means of assigning priority.Eliminating the HLA-B matching as a priority while maintaining HLA-DR matching as a priority would decrease the number of transplantations among whites by 4.0 percent (166 fewer transplantations over a one-year period), whereas it would increase the number among nonwhites by 6.3 percent and increase the rate of graft loss by 2.0 percent.Removing HLA-B matching as a priority for the allocation of cadaveric kidneys could reduce the existing racial imbalance by increasing the number of transplantations among nonwhites, with only a small increase in the rate of graft loss.

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin

Background. Mortality and hospitalization rates are reported for nationally representative random samples of haemodialysis patients treated at randomly selected dialysis facilities in five European countries participating in the Dialysis Outcomes and Practice Pattern Study (DOPPS) (France, Germany, Italy, Spain and the UK). Results. In the UK, 28.1% of haemodialysis patients received prior peritoneal dialysis treatment compared with 4.2–8.3% in other countries. Kidney transplantation rates ranged from 3.3 (per 100 patient years) in Italy to 11.6 in Spain. The relative risk (RR) of mortality, adjusted for age, sex and diabetes status was significantly higher in the UK (RR ¼ 1.39, P ¼ 0.02) compared with Italy (reference) and increased in association with age (RR ¼ 1.60 for every 10 years older, P

The success of renal transplantation may be counterbalanced by serious adverse medical events. The effect of immunosuppression on the incidence of de novo neoplasms among kidney recipients should be monitored continuously. Using data from the Scientific Registry of Transplant Recipients, we studied the association of induction therapy by immunosuppression with antilymphocyte antibodies, with the development of de novo neoplasms. The study population included more than 41 000 recipients who received a cadaveric first kidney transplant after December 31, 1995, and were followed through February 28, 2002. Using Cox regression models, we estimated time to development of two types of malignancy: de novo solid tumors and post-transplant lymphoproliferative disorder (PTLD). We made adjustments for several patient demographic factors and comorbidities. Induction therapy was significantly associated with a higher relative risk (RR) of PTLD (RR = 1.78, p < 0.001), but not with a greater likelihood of de novo tumors (RR = 1.07, p = 0.42). Treatment with maintenance tacrolimus vs. cyclosporine showed a significantly different RR of developing de novo tumors for recipients with induction than for those not receiving induction (p = 0.024). These new estimates of the magnitude of malignancy risk associated with induction therapy may be useful for clinical practice.

BACKGROUND The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study based on data collected from nationally representative samples of haemodialysis facilities. The burden of anaemia in haemodialysis patients is substantial, leading to considerable morbidity, mortality and reduced quality of life. This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS: France, Germany, Italy, Spain and the UK. METHODS Baseline data on demographics, co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998-2000. Using multivariate Cox survival analyses to adjust for patient characteristics, relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated. RESULTS For a year 2000 sample of prevalent patients on haemodialysis >180 days, mean haemoglobin concentration was 11.0 g/dl; 53% had a haemoglobin concentration > or = 11 g/dl [1998-1999 = 44% (P < 0.05)]. In 2000, 84% of prevalent patients were prescribed recombinant human erythropoietin (rHuEpo). Higher haemoglobin concentrations were associated with decreased relative risk (RR) for mortality (RR = 0.95 for every 1 g/dl higher haemoglobin, P = 0.03) and hospitalization (RR = 0.96, P = 0.02). Patients with haemoglobin

Background. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study designed to evaluate practice patterns in random samples of haemodialysis facilities and patients across three continents. Participating countries include France, Germany, Italy, Spain and the UK (Euro-DOPPS), Japan and the USA. DOPPS data collection has used the same questionnaires and protocols across all participating countries to assess components of dialysis therapy and outcomes. This study focuses on dialysis prescription, adherence and nutrition among the Euro-DOPPS countries. Methods. In each Euro-DOPPS country, patients were selected randomly from 20–21 representative facilities. Simple means and frequencies were calculated to compare relevant data elements to gain insights into differences in therapeutic aspects among nationally representative patients. Participants entering the study within 90 days of beginning dialysis therapy were excluded from these analyses. Results. Among the five countries, mean delivered dose as measured by normalized urea clearance (Kt/V) varied from 1.28 to 1.50 and was accompanied by differences in dialysis prescription components, including blood flow rates, treatment times, and dialyser membrane and flux characteristics. By country, a nearly 2-fold difference was observed in indicators of patient adherence and management (skipping and shortening dialysis, hyperkalaemia, hyperphosphataemia and high interdialytic weight gain). Indicators of malnutrition varied substantially. Conclusions. This study demonstrates differences in the management of haemodialysis patients across Euro-DOPPS and offers opportunities for improving dialysis dose, adherence and nutrition. Correlation of differences in practice patterns at the dialysis unit level with patient outcomes will offer new insights into improving dialysis therapy.

Mortality rates among hemodialysis patients vary greatly across regions. Representative databases containing extensive profiles of patient characteristics and outcomes are lacking. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States (US) that captures extensive data relating to patient characteristics, prescriptions, laboratory values, practice patterns, and outcomes. This report describes the case-mix features and mortality among 16,720 patients followed up to 5 yr. The crude 1-yr mortality rates were 6.6% in Japan, 15.6% in Europe, and 21.7% in the US. After adjusting for age, gender, race, and 25 comorbid conditions, the relative risk (RR) of mortality was 2.84 (P < 0.0001) for Europe compared with Japan (reference group) and was 3.78 (P < 0.0001) for the US compared with Japan. The adjusted RR of mortality for the US versus Europe was 1.33 (P < 0.0001). For most comorbid diseases, prevalence was highest in the US, where the mean age (60.5 +/- 15.5 yr) was also highest. Older age and comorbidities were associated with increased risk of death (except for hypertension, which carried a multivariate RR of mortality of 0.74 [P < 0.0001]). Variability in demographic and comorbid conditions (as identified by dialysis facilities) explains only part of the differences in mortality between dialysis centers, both for comparisons made across continents and within the US. Adjustments for the observed variability will allow study of association between practice patterns and outcomes.

Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS).BackgroundWe investigated whether indicators of health-related quality of life (HRQOL) may predict the risk of death and hospitalization among hemodialysis patients treated in seven countries, taking into account serum albumin concentration and several other risk factors for death and hospitalization. We also compared HRQOL measures with serum albumin regarding their power to predict outcomes.MethodsWe analyzed data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), an international, prospective, observational study of randomly selected hemodialysis patients in the United States (148 facilities), five European countries (101 facilities), and Japan (65 facilities). The total sample size was composed of 17,236 patients. Using the Kidney Disease Quality of Life Short Form (KDQOL-SFTM), we determined scores for three components of HRQOL: (1) physical component summary (PCS), (2) mental component summary (MCS), and (3) kidney disease component summary (KDCS). Complete responses on HRQOL measures were obtained from 10,030 patients. Cox models were used to assess associations between HRQOL and the risk of death and hospitalization, adjusted for multiple sociodemographic variables, comorbidities, and laboratory factors.ResultsFor patients in the lowest quintile of PCS, the adjusted risk (RR) of death was 93% higher (RR = 1.93, P < 0.001) and the risk of hospitalization was 56% higher (RR = 1.56, P < 0.001) than it was for patients in the highest quintile level. The adjusted relative risk values of mortality per 10-point lower HRQOL score were 1.13 for MCS, 1.25 for PCS, and 1.11 for KDCS. The corresponding adjusted values for RR for first hospitalization were 1.06 for MCS, 1.15 for PCS, and 1.07 for KDCS. Each RR differed significantly from 1 (P < 0.001). For 1g/dL lower serum albumin concentration, the RR of death adjusted for PCS, MCS, and KDCS and the other covariates was 1.17 (P < 0.01). Albumin was not significantly associated with hospitalization (RR = 1.03, P> 0.5).ConclusionLower scores for the three major components of HRQOL were strongly associated with higher risk of death and hospitalization in hemodialysis patients, independent of a series of demographic and comorbid factors. A 10-point lower PCS score was associated with higher elevation in the adjusted mortality risk, as was a 1g/dL lower serum albumin level. More research is needed to assess whether interventions to improve quality of life lower these risks among hemodialysis patients.

Liver allocation policy recently was modified to use the Model for End-Stage Liver Disease (MELD) for patients with chronic liver disease to stratify potential recipients according to risk for waitlist death. In this study, a retrospective cohort of 760 adult patients with chronic liver disease placed on the liver transplant waitlist between January 1995 and March 2001 and followed up for up to 74 months was studied to assess the ability of the MELD to predict mortality among waitlisted candidates and evaluate the prognostic importance of changes in MELD score over time. Serial MELD scores predicted waitlist mortality significantly better than baseline MELD scores or medical urgency status. Each unit of the 40-point MELD score was associated with a 22% increased risk for waitlist death (P.001), whereas medical urgency status was not a significant independent predictor. For any given MELD score, the magnitude and direction of change in MELD score during the previous 30 days (DeltaMELD) was a significant independent mortality predictor. Patients with MELD score increases greater than 5 points over 30 days had a threefold greater waitlist mortality risk than those for whom MELD scores increased more gradually (P.0001). We conclude that mortality risk on the liver transplant waitlist is predicted more accurately by serial MELD score determinations than by medical urgency status or single MELD measurements. DeltaMELD score over time reflects progression of liver disease and conveys important additional prognostic information that should be considered in the further evolution of national liver allocation policy.

Nonadherence in hemodialysis: Associations with mortality, hospitalization, and practice patterns in the DOPPS. Background Nonadherence among hemodialysis patients compromises dialysis delivery, which could influence patient morbidity and mortality. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to review this problem and its determinants on a global level. Methods Nonadherence was studied using data from the DOPPS, an international, observational, prospective hemodialysis study. Patients were considered nonadherent if they skipped one or more sessions per month, shortened one or more sessions by more than 10 minutes per month, had a serum potassium level openface>6.0mEq/L, a serum phosphate level openface>7.5mg/dL (>2.4mmol/L), or interdialytic weight gain (IDWG)>5.7% of body weight. Predictors of nonadherence were identified using logistic regression. Survival analysis used the Cox proportional hazards model adjusting for case-mix. Results Skipping treatment was associated with increased mortality [relative risk (RR) = 1.30, P = 0.01], as were excessive IDWG (RR = 1.12, P = 0.047) and high phosphate levels (RR = 1.17, P = 0.001). Skipping also was associated with increased hospitalization (RR = 1.13, P = 0.04), as were high phosphate levels (RR = 1.07, P = 0.05). Larger facility size (per 10 patients) was associated with higher odds ratios (OR) of skipping (OR = 1.03, P = 0.06), shortening (OR = 1.03, P = 0.05), and IDWG (OR = 1.02, P = 0.07). An increased percentage of highly trained staff hours was associated with lower OR of skipping (OR = 0.84 per 10%, P = 0.02); presence of a dietitian was associated with lower OR of excessive IDWG (OR = 0.75, P = 0.08). Conclusion Nonadherence was associated with increased mortality risk (skipping treatment, excessive IDWG, and high phosphate) and with hospitalization risk (skipping, high phosphate). Certain patient/facility characteristics also were associated with nonadherence.

Dialyzer reuse is practiced in more than 75% of the patients and dialysis units in the United States. However, reuse is not practiced in a small fraction of patients treated in reuse units (RUUs). This study evaluates both patient and facility characteristics associated with nonreuse in RUUs. The data source is from the Dialysis Mortality and Morbidity Study, Waves 1, 3, and 4, of the US Renal Data System. Only facilities that practiced dialyzer reuse were included in the analysis. A total of 12,094 patients from 1,095 reuse facilities were studied. Patients undergoing hemodialysis as of December 31, 1993, were selected. Of all patients treated in RUUs, 8% did not reuse dialyzers. Nonreuse was significantly (P0.02) more common, based on adjusted odds ratios (ORs), among patients who were younger (OR = 1.16 per 10 years younger), had primary glomerulonephritis (OR = 1.26 versus diabetes), had lower serum albumin level (OR = 1.72 per 1 g/dL lower), had more years on dialysis, and had higher level of education. Nonreuse patients were more likely to be treated with low-flux dialyzers (OR = 7.35; P0. 0001) and have a lower dialysis dose. No reuse was more likely in larger units and in not-for-profit and hospital-based units. Patient refusal accounted for one fourth of nonreuse in RUUs and was associated with the same factors, as well as with fewer comorbid conditions and non-Hispanic ethnicity. Significant geographic variations (up to eightfold) were documented. Nonreuse patients are treated with smaller, low-flux dialyzers and, on average, receive a lower Kt/V than reuse patients in the same units.

This national study compares waitlisting and transplantation rates by gender, race, and diabetes and evaluates physiologic factors (panel-reactive antibodies [PRA], blood type, HLA matchability) and related practices (early and multiple waitlisting) as explanatory factors. This longitudinal study of the time to transplant waitlisting among 228,552 incident end-stage renal disease (ESRD) dialysis patients and to cadaveric transplantation among 46,164 waitlist dialysis patients (n = 23,275 first cadaveric transplants) used US data for 1991 to 1997. Relative rates of waitlisting (RRWL) after ESRD onset and of cadaveric transplantation (RRTx) after waitlist (Cox proportional hazards models) were adjusted for age, race, sex, ESRD cause, region, and incidence/waitlist year. We found that women have an RRWL = 0.84 (P < 0.0001) and RRTx = 0.86 (P < 0. 0001). PRA levels can explain the difference in the transplantation rate, because accounting for PRA gives an adjusted RRTx = 0.98 (NS) for women. For blacks versus whites, the RRWL = 0.59 (P < 0.0001) and RRTx = 0.55 (P < 0.0001). However, the transplantation rate can only partly be explained by ABO types, rare HLA types, and early and multiple waitlisting (adjusted RRTx = 0.67 [P < 0.0001]). For diabetes versus glomerulonephritis, the RRWL = 0.52 (P < 0.0001) and RRTx = 0.98 (NS). Older patients (40 to 59 years of age) are less likely to be waitlisted and to receive a transplant after waitlisting (RRWL = 0.57 [P < 0.0001], RRTx = 0.88 [P < 0.0001]) versus younger patients (ages 18 to 39 years). These results indicate substantial differences by age, sex, race, and diabetes in rates of waitlisting for transplantation and by age and race for transplantation after waitlisting. These differences by race were not explained by referral practices or the physiologic factors studied here.

Clinical and biochemical correlates of starting “daily” hemodialysis.BackgroundDaily hemodialysis has been proposed to improve outcomes for patients with end-stage renal disease. There has been increasing evidence that daily hemodialysis might have potential advantages over intermittent dialysis. However, despite these potential advantages, daily hemodialysis is infrequently used in the United States, and published accounts on the technique are few.MethodsWe describe patient outcomes after increasing their hemodialysis frequency from three to six times per week in a cohort of 72 patients treated at nine centers during 1972 to 1996. Analyses of predialysis blood pressure and laboratory parameters from 6months before until 12months after starting frequent hemodialysis used a repeated-measures statistical technique.ResultsPredialysis systolic and diastolic blood pressures fell by 7 and 4mm Hg, respectively, after starting frequent hemodialysis (P = 0.02). Reductions were greatest among patients being treated with antihypertensive medications, despite a reduction in their dosage of medications. Postdialysis weight fell by 1.0% within one month of starting frequent hemodialysis and improved control of hypertension. After the initial drop, postdialysis weight increased at a rate of 0.85kg per six months. Serum albumin rose by 0.29g/dl (P < 0.001) between months 1 to 12 of treatment with daily hemodialysis. Hematocrit rose by 3.0 percentage points (P = 0.02) among patients (N = 56) not treated with erythropoietin during this period. Two years after the start of daily hemodialysis, Kaplan–Meier analyses showed a patient survival of 93%, a technique survival of 77%, and an arteriovenous fistula patency of 92%. Vascular access patency was excellent despite more frequent use of the access.ConclusionsThese results suggest that in certain patients, daily hemodialysis might have advantages over three times per week hemodialysis.

A number of studies have suggested that type of dialysis membrane is associated with differences in long-term outcome of patients undergoing hemodialysis, both in terms of morbidity and mortality. The purpose of this study was to determine the relationship of membrane type and specific causes of death. Data from the United States Renal Data System Case Mix Adequacy Study, a national random sample of hemodialysis patients who were alive on December 31, 1990, were used. Our study was limited to patients in this data set who were undergoing dialysis for at least 1 year (n = 4,055). For the main analytic models, membrane type was classified into two categories: unmodified cellulose or MC/SYN (which combines modified cellulose [MC] and synthetic membranes [SYN]). The relationships of membrane type and major causes of mortality were analyzed using Cox proportional hazards models, which adjusted for multiple (21) covariates, including demographics, comorbidity, Kt/V, and other parameters. Patients were censored at transplantation or 60 days after a switch to peritoneal dialysis. Compared with patients dialyzed with unmodified cellulose membranes, the adjusted relative mortality risk (RR) from infection was 31% lower (RR = 0.69; P = 0.03) and from coronary artery disease was 26% lower (RR = 0.74; P = 0.07) for patients dialyzed with MC/SYN membranes. No statistically significant difference (all P > 0.1) was found in mortality risk from cerebrovascular disease (RR = 1.08), other cardiac causes (RR = 0.86), malignancy (RR = 0.90), or other known causes (RR = 0.82) between patients dialyzed with MC/SYN compared with unmodified cellulose membranes. These results offer support to reported experimental and observational clinical studies that have found that unmodified cellulose membranes may increase the risk for both infection and atherogenesis. Further studies are necessary to evaluate the possibility of confounding factors, compare more specific membrane types, and determine the pathophysiology linking membrane type to cause-specific mortality.

Noncompliance with hemodialysis (HD), depending on the definition, occurs in 2% to more than 50% of patients. To better understand predictors and outcomes of noncompliance, we evaluated patient characteristics associated with noncompliance and the impact of noncompliance on survival. Using data from two USRDS special studies, we identified 6,251 patients who were on dialysis for more than 1 year for inclusion in this study. Noncompliance was defined in four ways: skipping one or more HD sessions in a month, shortening by 10 or more minutes one or more HD sessions in a month, an interdialytic weight gain (IWG) of more than 5.7% of dry weight, or a serum phosphate (PO4) of greater than 7.5 mg/dL. Sociodemographic predictors of noncompliance were identified using logistic regression. Survival analysis was done using Cox proportional hazards models with adjustments for sociodemographics, comorbid conditions, and dose of HD. Overall, 8.5% of patients skipped HD, 20% shortened HD (7% three or more times), 10% had more than a 5.7% IWG, and 22% had a PO4 greater than 7.5. There was a significant correlation among the measures of noncompliance. Blacks (adjusted odds ratio [AOR] = 2.10), patients aged 20 to 39 years (AOR = 1.62), and smokers (AOR = 1.34) were significantly more likely to skip HD than whites, patients aged 40 to 59 years, and nonsmokers, respectively (P0.01 for each). Similar results were seen for the other measures of noncompliance, except for PO4, in which blacks were significantly less likely to be noncompliant (NC) (AOR = 0.85, P0.05). Compared with compliant patients, those who skipped one or more HD sessions in a month had a 25% higher risk of death (P0.01). Those who had greater than a 5.7% IWG had a 35% higher risk of death (P0.001), whereas those with a PO47.5 had a 13% higher risk of death (P0.05). Overall, patients who shortened HD sessions did not have a higher risk of death, but those who shortened three or more in 1 month had a 20% higher risk of death (P0.05). Compliance with a medical regimen is a complex issue. Noncompliance in HD often, but not always, is associated with a higher risk of an adverse outcome. This is a US government work. There are no restrictions on its use.

A strong association exists between nutritional status and morbidity and mortality in patients with end-stage renal disease who are treated with hemodialysis. Described here is the predictive value for mortality over 5 years of follow-up of a number of risk factors, recorded at baseline, in a national sample of 3,607 hemodialysis patients. Among the variables studied were case-mix covariates, caregiver classifications of nutritional status, serum albumin concentration, and body mass index (BMI). The Case Mix Adequacy special study of the United States Renal Data System (USRDS) provided these measurements as of December 31, 1990. The USRDS patient standard analysis file provided follow-up data on mortality for all patients through December 31, 1995, by which time 64.7% of the patients had died. BMI is a simple anthropometric measurement that has received little attention in dialysis practice. Caregiver classification refers to documentation in a patient's dialysis facility medical records that stated an individual to be "undernourished/cachectic," "obese/overweight," or "well- nourished." The mean serum albumin was 3.7 +/- 0.45 (SD) g/dL, and the mean BMI was 24.4 +/- 5.3 (SD) kg/m2. By caregiver classification, 20.1% of patients were undernourished, and 24.9% obese. In hazard regression models, including but not limited to the Cox proportional hazards model, low BMI, low serum albumin, and the caregiver classification "undernourished" were independently and significantly predictive of increased mortality. In analyses allowing for time- varying relative mortality risks (ie, nonproportional hazards), the greatest predictive value of all three variables occurred early during follow-up, but the independent predictive value of baseline serum albumin and BMI measurements on mortality risk persisted even 5 years later. No evidence of increasing mortality risk was found for higher values of BMI. Serum albumin was confirmed to be a useful predictor of mortality risk in hemodialysis patients; BMI was established as an independently important predictor of mortality; both serum albumin and BMI, measured at baseline, continue to possess predictive value 5 years later; the subjective caregiver classification of nutritional status "undernourished" has independent value in predicting mortality risk beyond the information gained from two other markers of nutritional status–BMI and serum albumin. (Am J Kidney Dis 1998 Jun;31(6):997-1006)

Vascular access failure causes substantial morbidity to hemodialysis patients. We sought to identify factors determining survival of the permanent vascular access in use at the start of end-stage renal disease during 1990 in a national sample of 784 incident hemodialysis patients insured by Medicare. Medicare claims records were used to identify access failures or revisions among patients with an arteriovenous (AV) fistula (n = 245) and an AV vascular graft (n = 539). A proportional hazards analysis of time to first failure or revision, controlled by stratification for sex, race, and cause of end-stage renal disease, was used to determine the effect of age, access type, and peripheral vascular disease on vascular access survival. Patients with an AV fistula and who were older than 65 years had a risk of access failure that was 24% lower than similar patients with an AV graft (P < 0.02). The relative risk of access failure for an AV fistula, but not an AV graft, varied significantly with age for patients younger than 65 years (P < 0.01). The relative risk of access failure for a patient with an AV fistula, compared with a patient of the same age with an AV graft, was 67% lower at the age of 40 years, 54% lower at the age of 50 years, and 24% lower at the age of 65 years. A history of peripheral vascular disease was associated with a 24% higher risk of AV graft or fistula failure (P = 0.05). Measures to decrease vascular access-related morbidity among hemodialysis patients should include reversing the current trend toward increasing use of AV grafts, particularly in patients younger than 65 years.

Relationship of dose of hemodialysis and cause-specific mortality. A number of studies have found a relationship of lower all-cause mortality risk for ESRD patients treated with increasing dose of dialysis. The objective of this study was to determine the relationship of delivered dose of dialysis with cause-specific mortality. Data from the USRDS Case Mix Adequacy Study, which includes a national random sample of hemodialysis patients, were utilized. To minimize the contribution of unmeasured residual renal function, the sample used in this analysis (N = 2479) included only patients on dialysis for one year or more. Cox proportional hazards models, stratified for diabetes, were used to analyze the effect of delivered dose of dialysis (measured and reported by both Kt/V and URR) on major causes of death and withdrawal from dialysis, adjusting for other covariates including demographics, comorbid diseases present at start of study, functional status, laboratory values and other dialysis parameters. Patient follow-up for mortality was censored at the earliest of time of transplantation, 60 days after a switch to peritoneal dialysis or at the time of data abstraction. For each 0.1 higher Kt/V, the adjusted relative risk of death due to coronary artery disease was 9% lower (RR = 0.91, P < 0.05), due to other cardiac causes was 12% lower (RR = 0.88, P < 0.01), due to cerebrovascular disease (CVD) was 14% lower (RR = 0.86, P < 0.05), due to infection was 9% lower (RR = 0.91, P = 0.05), and due to other known causes was 6% lower (RR = 0.94, P < 0.05). There was no statistically significant relationship of Kt/V and risk of death among patients who died of malignancy (RR = 0.84, P = 0.10) or among patients whose death cause was missing (RR = 0.95, P = 0.41). The risk of withdrawal from dialysis prior to death due to any cause was 9% lower (RR = 0.91, P < 0.05) for each 0.1 higher Kt/V. The relationships of delivered dose of dialysis, as measured by URR, and cause-specific mortality were essentially similar in relative magnitude and statistical significance as the relationships observed using Kt/V as the measurement of dialysis dose, with the exception that the relationship was less significant for cerebrovascular disease and withdrawal from dialysis. The relationship of dialysis dose with risk of death due to each cause of death category except other cardiac causes and “other” causes appeared to be of greater magnitude and of greater statistical significance among diabetics than non-diabetics. These results indicate that low dose of dialysis is not associated with mortality due to just one isolated cause of death, but rather is due to a number of the major causes of death in this population. This study is consistent with hypotheses that low doses of dialysis may promote atherogenesis, infection, malnutrition and failure to thrive through a variety of pathophysiologic mechanisms. Further study is necessary to confirm these results and to test hypotheses that are developed.

Treated end-stage renal disease continues to increase at an alarming rate in the US. There has been an exponential growth in the incidence rate between 1982 and 1991 at the rate of 8.76% per year. Approximately 218,042 patients received treatment for ESRD in 1991, of which 49,909 were new patients. Although the increase in the incidence rate is seen for all the major disease categories responsible for ESRD, diabetes mellitus, probably type 2, and hypertension are responsible for the bulk of the increase. African Americans and Native Americans have shown the most dramatic increase; diabetes being the major reason for both races, but for African Americans, hypertension is the leading cause of ESRD. A bulk of the increase in the ESRD patient population has been in the older age (greater than 65 years of age) group. The mortality rate for the ESRD patient population, and, specifically, for the dialysis population remains relatively high, with 1-year survival probabilities of approximately 78%. Some of the contributing factors cited for the high death rate, especially in the dialysis patient population include inadequate dialysis dose, low flux of the dialysis membranes, shortened dialysis times, an increase in the age of the ESRD population, and bioincompatible dialysis membranes. The effect of the widely practiced dialyzer reuse on dialysis patient morbidity and mortality remains unclear.

The benefits of HLA-A, B, and DR matching of cadaveric kidney grafts and recipients remain controversial when viewed from the perspective of social equity and graft survival.We estimated graft survival using proportional-hazards techniques, adjusting for patient and donor characteristics, for a series of 30,564 Medicare patients receiving a first cadaveric kidney transplant between 1984 and 1990. The effects of minimal achievable HLA mismatches and maximal matching on graft survival were estimated by simulated allocation of a sample of organs to a sample of 20,000 candidates for transplantation.The adjusted one-year graft survival was 84.3 percent for grafts with no mismatches and 77.0 percent for grafts with four mismatches. National rationing of donor organs to achieve minimal mismatching and maximal matching could potentially decrease the average number of HLA mismatches from 3.6 to 1.2, with a corresponding increase in the number of matches. As a consequence, projected five-year graft survival could potentially increase from 58.5 percent to 62.9 percent. This would be associated with a decrease in the proportion of kidneys allocated to black recipients from 22.2 to 15.0 percent.Under ideal circumstances, a policy of maximal matching of cadaveric renal transplants would increase five-year graft survival by a comparatively small 4.4 percentage points, but the actual benefit is likely to be smaller.

Hemodialysis vascular access morbidity in the United States. Extensive morbidity related to hemodialysis vascular access exists among endstage renal disease (ESRD) patients, but the risk factors for this morbidity have not been extensively studied. Medicare ESRD patient data were obtained from 1984, 1985, and 1986. Hospitalization for vascular access morbidity (ICD-996.1, 996.6, or 996.7) was analyzed among prevalent patients and, using survival analysis, among incident patients to assess sex, age, race, and underlying cause of renal failure as risk factors. We found that 15 to 16% of hospital stays among prevalent ESRD patients were associated with vascular access-related morbidity. Black race, older age, female sex, and diabetes mellitus as a cause of kidney failure were all independent risk factors for access-related morbidity. The rate ratio comparing Blacks to Whites was 1.12 (95% C.I., 1.09, 1.16); > 64 years to 20 to 44 years, 1.53 (1.46, 1.59); men to women, 0.81 (0.79, 0.84); and diabetes to glomerulonephritis, 1.29 (1.24, 1.35). We conclude that hemodialysis vascular access malfunction causes much hospitalization among ESRD patients. Women, Blacks, the elderly, and diabetics appear to be at particularly high risk, and additional studies are needed to understand these patterns.

Outcomes among dialysis patients vary considerably internationally and across regions within the United States. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a large, prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. The DOPPS collects a wealth of data regarding the patients' demographic characteristics, medical histories, laboratory values, prescriptions, dialysis unit practices, and outcomes. The study seeks to clarify which dialysis practices contribute to improved mortality rates, hospitalization rates, health related quality of life, and vascular access outcomes, after adjusting for the effects of comorbid disease and demographic variables. Over 18,000 patients have been enrolled to date. This paper describes the initial findings and outlines the plans to expand the trial.

Using USRDS generated mortality tables to compare local ESRD mortality rates to national rates. Mortality tables of the U.S. Renal Data System allow description of national mortality rates among prevalent dialysis patients in five-year age groups and four major categories of causes of ESRD for Black and White patients. Based on these tables derived from over 50,000 deaths in dialysis patients during 1987 to 1989a methodology is described that allows comparison of local or regional mortality rates to national rates with determination of a standardized mortality ratio and statistical significance. Since this methodology adjusts for patient age, race and cause of ESRD, it can serve as a useful tool for dialysis research and local quality assurance.

Blood type O recipients of cadaveric renal transplants have longer pretransplant waiting periods than blood type A, B, and AB recipients. To evaluate reasons for and consequences of this discrepancy, we studied both the frequency of various donor and recipient blood type combinations and their outcomes. Among 37,659 cadaveric renal transplants performed during 1983 through 1989, there were 2,625 transplants (7%) received by patients of compatible but nonidentical blood types. Of 18,575 type O donor organs, 16,784 were received by type O patients for a recipient to donor ratio of 0.9. The corresponding ratios were greater than 1.0 for all other blood types (1.02 for blood type A, 1.14 for type B, and 2.18 for type AB). This causes blood type O patients to have a lower access to transplantation and to have significantly longer waiting times than patients of all other blood types. This inequality of access diminished significantly (P less than 0.001) over the years, but did not resolve by 1989. Analysis of relative risk for first graft loss by multiple regression (Cox) showed that transplantation across compatible blood types had a 9.1% higher risk (P less than 0.1) than that of transplantation among identical blood types. Cadaveric renal transplantation within identical blood types optimizes access to transplantation and avoids further aggravating past disadvantages for blood type O recipients.

When a medical intervention is found to be cost effective, what level of insurance coverage should apply to it? The optimal level of coverage may be less than or greater than full coverage of medical care costs; a finding of cost effectiveness for a service does not necessarily imply v full coverage or coverage at the same rate as other services. If there is some imperfection in the ability to translate higher insurance benefits into higher insurer revenues, the optimal level of coverage will be greater the higher the degree of moral hazard applying to the service.

Many hemodialysis patients in Japan have symptoms of depression, but whether those patients are treated appropriately is unknown. As part of the Dialysis Outcomes and Practice Patterns Study, data on symptoms of depression, physician-diagnosed depression, prescribed medications, and death were collected prospectively in cohorts in Japan ( n =1603) and 11 other countries ( n =5872). Symptoms of depression were as prevalent in Japan as elsewhere, but in Japan a much smaller percentage of patients had physician-diagnosed depression: only 2% in Japan vs 17% elsewhere. Antidepressants were much less commonly prescribed in Japan: only 1% in Japan vs 17% elsewhere for patients with many and frequent symptoms of depression, and 16% in Japan vs 34% elsewhere for patients with physician-diagnosed depression. In Japan, symptoms of depression were associated with prescription of benzodiazepines (without antidepressants), and patients with physician-diagnosed depression were twice as likely to be given benzodiazepines: 32% in Japan vs 16% elsewhere. Benzodiazepine monotherapy was associated with death (relative risk 1.56, 95% confidence interval (CI), 1.25–1.94), even after adjustments for 13 likely confounders (relative risk 1.27, 95% CI, 1.01–1.59). Hemodialysis patients in Japan with symptoms of depression are given not antidepressants but benzodiazepines, a practice associated with higher mortality.

To identify modifiable factors associated with health-related quality of life (HRQOL) among chronic hemodialysis patients.Analysis of baseline data of 9,526 hemodialysis patients from seven countries enrolled in phase I of the Dialysis Outcomes and Practice Patterns Study (DOPPS). Using the Kidney Disease Quality of Life Short Form (KDQOL-SF(TM)), we determined scores for 8 generic scale summaries derived from these scales, i.e., the physical component summary [PCS] and mental component summary [MCS], and 11 kidney disease- targeted scales. Regression models were used to adjust for differences in comorbidities and sociodemographic and treatment factors. The Benjamini-Hochberg procedure was used to correct P-values for multiple comparisons.Unemployment and psychiatric disease were independently and significantly associated with lower scores for all generic and several kidney disease-targeted HRQOL measures. Several other comorbidities, lower educational level, lower income, and hypoalbuminemia were also independently and significantly associated with lower scores of PCS and/or MCS and several generic and kidney disease-targeted scales. Hemodialysis by catheter was associated with significantly lower PCS scores, partially explained by the correlation with covariates.Associations of poorer HRQOL with preventable or controllable factors support a greater focus on psychosocial and medical interventions to improve the well-being of hemodialysis patients.

Anemia is common in hemodialysis (HD) patients.Data collected from nationally representative samples of HD patients (n = 11,041) in 2002 to 2003 were used to describe current anemia management for long-term HD patients at 309 dialysis units in 12 countries. Analyses of associations and outcomes were adjusted for demographics, 15 comorbid classes, laboratory values, country, and facility clustering.For patients on dialysis therapy for longer than 180 days, 23% to 77% had a hemoglobin (Hgb) concentration less than 11 g/dL (110 g/L), depending on country; 83% to 94% were administered erythropoietin (EPO). Mean Hgb levels were 12 g/dL (120 g/L) in Sweden; 11.6 to 11.7 g/dL (116 to 117 g/L) in the United States, Spain, Belgium, and Canada; 11.1 to 11.5 g/dL (111 to 115 g/L) in Australia/New Zealand, Germany, Italy, the United Kingdom, and France; and 10.1 g/dL (101 g/L) in Japan. Hgb levels were substantially lower for new patients with end-stage renal disease, and EPO use before ESRD ranged from 27% (United States) to 65% (Sweden). By patient, EPO use significantly declined with greater Hgb concentration (adjusted odds ratio, 0.61 per 1-g/dL [10-g/L] greater Hgb level; P0.0001), as did EPO dosage. Case-mix-adjusted mortality and hospitalization risk declined by 5% and 6% per 1-g/dL greater patient baseline Hgb level (Por = 0.003 each), respectively. Furthermore, patient mortality and hospitalization risks were 10% to 12% lower for every 1-g/dL greater facility mean Hgb level. Patients were significantly more likely to have Hgb levels of 11 g/dL or greater (or =110 g/L) if they were older; were men; had polycystic kidney disease; had greater albumin, transferrin saturation, or calcium levels; were not dialyzing with a catheter; or had lower ferritin levels. Facilities with greater intravenous iron use showed significantly greater facility mean Hgb concentrations. Mean EPO dose varied from 5,297 (Japan) to 17,360 U/wk (United States). Greater country mean EPO doses were significantly associated with greater country mean Hgb concentrations. Several patient characteristics were associated with greater EPO doses. Even in some countries with high intravenous iron use, 35% to 40% of patients had a transferrin saturation less than 20% (below guidelines).These findings indicate large international variations in anemia management, with significant improvements during the last 5 years, although many patients remain below current anemia guidelines, suggesting large and specific opportunities for improvement.

Several observational studies reported lower mortality risk among hemodialysis patients treated with doses greater than the standard dose. The present study evaluates, with observational data, the secondary randomized Hemodialysis (HEMO) Study finding that greater dialysis dose may benefit women, but not men.Data from 74,120 US hemodialysis patients starting end-stage renal disease therapy were analyzed. Patients were classified into 1 of 5 categories of hemodialysis dose according to their average urea reduction ratio (URR), and their relative risk (RR) for mortality was evaluated by using Cox proportional hazards models. Similar analyses using equilibrated Kt/V were completed for 10,816 hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 7 countries.For both men and women, RR was substantially lower in the URR 70%-to-75% category compared with the URR 65%-to-70% category. Among women, RR in the URR greater-than-75% category was significantly lower compared with the URR 70%-to-75% group (P0.0001); however, no further association with mortality risk was observed for the greater-than-75% category among men (P = 0.22). RR associated with doses greater than the Kidney Disease Outcomes Quality Initiative guidelines (URRor = 65%) was significantly different for men compared with women (P0.01). Similar differences by sex were observed in DOPPS analyses.The agreement of these observational studies with the HEMO Study supports the existence of a survival benefit from greater dialysis doses for women, but not for men. Responses to greater dialysis dose by sex deserve additional study to explain these differences.

In 1996, CMS launched the end stage renal disease (ESRD) managed care demonstration to study the experience of offering managed care to ESRD patients. This article analyzes the financial impact of the demonstration, which sought to assess its economic impact on the Federal Government, the sites, and the ESRD Medicare beneficiaries. Medicare's costs for demonstration enrollees were greater than they would have been if these enrollees had remained in the fee-for-service (FFS) system. This loss was driven by the lower than average predicted Medicare spending given the demonstration patients' conditions. The sites experienced losses or only modest gains, primarily because they provided a larger benefit package than traditional Medicare coverage, including no patient obligations and other benefits, especially prescription drugs. Patient financial benefits were approximately $9,000 annually.

The Centers for Medicare & Medicaid Service's (CMS') end stage renal disease (ESRD) managed care demonstration offered an opportunity to assess patient selection among a chronically ill and inherently costly population. Patient selection refers to the phenomenon whereby those Medicare beneficiaries who choose to enroll or stay in health maintenance organizations (HMOs) are, on average, younger, healthier, and less costly to treat than beneficiaries who remain in the traditional Medicare fee-for-service (FFS) sector. The results presented in this article show that enrollees into the demonstration were generally younger and healthier than a representative group of comparison patients from the same geographic areas.

Health-related quality of life among dialysis patients on three continents: The Dialysis Outcomes and Practice Patterns Study. Background Assessing health-related quality of life (HRQOL) can provide information on the types and degrees of burdens that afflict patients with chronic medical conditions, including end-stage renal disease (ESRD). Several studies have shown important international differences among ESRD patients treated with hemodialysis, but no studies have compared these patients' HRQOL. Our goal was to document international differences in HRQOL among dialysis patients and to identify possible explanations of those differences. Methods We examined data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, observational, international study of hemodialysis patients. We performed a cross-sectional analysis of DOPPS data from the United States, five countries in Europe (France, Germany, Italy, Spain, and the United Kingdom), and Japan. Linear mixed models were used to analyze differences in HRQOL, using the KDQOL-SF TM . Norm-based scores were used to minimize cultural response bias. Linear regression analysis was used to adjust for confounding factors. Other variables included demographic variables, comorbidities, primary cause of ESRD, complications of ESRD and treatment, and socioeconomic status. Results In all generic HRQOL subscales, patients on all three continents had much lower scores than their respective population norm values. Patients in the United States had the highest scores on the mental health subscale and the highest mental component summary scores. Japanese patients reported better physical functioning than did patients in the United States or Europe, but they also reported the greatest burden of kidney disease. Overall, these differences remained even after adjusting for possible confounders. Conclusion On all three continents, ESRD and hemodialysis profoundly affect HRQOL. In the United States, the effects on mental health are smaller than in other countries. Japanese hemodialysis patients perceived that their kidney disease imposes a greater burden, but their physical functioning was significantly higher. Different distributions of socioeconomic factors and major comorbid conditions could explain little of this difference in physical functioning. Other possible factors, such as quality of dialysis and related health care, deserve careful study.

Despite declining in-hospital deaths, deceased donor organ donation increased in all demographic segments of the US population from 1990 to 1999. Although the rate of growth in older donors was more dramatic, there was substantial growth in the most physiologically suitable donor age groups, which contribute most to the donor pool. Nationwide, the average annual growth in donation rate for in-hospital deaths ages 1-70 was 5.0%, with wide regional variation. While the national trend is patently inadequate to meet the need for organ transplantation, the wide range of programs aimed at improving organ donation at all levels of society point to an encouraging pattern that may have resulted, in part, from these initiatives.

Transplantation of nonrenal organs is often complicated by chronic renal disease with multifactorial causes. We conducted a population-based cohort analysis to evaluate the incidence of chronic renal failure, risk factors for it, and the associated hazard of death in recipients of nonrenal transplants.Pretransplantation and post-transplantation clinical variables and data from a registry of patients with end-stage renal disease (ESRD) were linked in order to estimate the cumulative incidence of chronic renal failure (defined as a glomerular filtration rate of 29 ml per minute per 1.73 m2 of body-surface area or less or the development of ESRD) and the associated risk of death among 69,321 persons who received nonrenal transplants in the United States between 1990 and 2000.During a median follow-up of 36 months, chronic renal failure developed in 11,426 patients (16.5 percent). Of these patients, 3297 (28.9 percent) required maintenance dialysis or renal transplantation. The five-year risk of chronic renal failure varied according to the type of organ transplanted - from 6.9 percent among recipients of heart-lung transplants to 21.3 percent among recipients of intestine transplants. Multivariate analysis indicated that an increased risk of chronic renal failure was associated with increasing age (relative risk per 10-year increment, 1.36; P0.001), female sex (relative risk among male patients as compared with female patients, 0.74; P0.001), pretransplantation hepatitis C infection (relative risk, 1.15; P0.001), hypertension (relative risk, 1.18; P0.001), diabetes mellitus (relative risk, 1.42; P0.001), and postoperative acute renal failure (relative risk, 2.13; P0.001). The occurrence of chronic renal failure significantly increased the risk of death (relative risk, 4.55; P0.001). Treatment of ESRD with kidney transplantation was associated with a five-year risk of death that was significantly lower than that associated with dialysis (relative risk, 0.56; P=0.02).The five-year risk of chronic renal failure after transplantation of a nonrenal organ ranges from 7 to 21 percent, depending on the type of organ transplanted. The occurrence of chronic renal failure among patients with a nonrenal transplant is associated with an increase by a factor of more than four in the risk of death.

presented to The Society for Organ Sharing 2nd International Congress. Vancouver, BC, July 4–6, 1993. Nathan et al. 40 American Journal of Transplantation 2003; 3 (Suppl. 4): 29–40

Background: In the United States, an association between mortality risk and ethnicity has been observed among hemodialysis patients. This study was developed to assess whether health-related quality of life (HRQOL) scores also vary among patients of different ethnic backgrounds. Associations between HRQOL and adverse dialysis outcomes (ie, death and hospitalization) also were assessed for all patients and by ethnicity. Methods: Data are from the Dialysis Outcomes and Practice Patterns Study for 6,151 hemodialysis patients treated in 148 US dialysis facilities who filled out the Kidney Disease Quality of Life Short Form. We determined scores for three components of HRQOL: Physical Component Summary (PCS), Mental Component Summary (MCS), and Kidney Disease Component Summary (KDCS). Patients were classified by ethnicity as Hispanic and five non-Hispanic categories: white, African American, Asian, Native American, and other. Multiple linear regression models were used to estimate differences in HRQOL scores among ethnic groups, using whites as the referent category. Cox regression models were used for associations between HRQOL and outcomes. Regression models were adjusted for sociodemographic variables, delivered dialysis dose (equilibrated Kt/V), body mass index, years on dialysis therapy, and several laboratory/comorbidity variables. Results: Compared with whites, African Americans showed higher HRQOL scores for all three components (MCS, PCS, and KDCS). Asians had higher adjusted PCS scores than whites, but did not differ for MCS or KDCS scores. Compared with whites, Hispanic patients had significantly higher PCS scores and lower MCS and KDCS scores. Native Americans showed significantly lower adjusted MCS scores than whites. The three major components of HRQOL were significantly associated with death and hospitalization for the entire pooled population, independent of ethnicity. Conclusion: The data indicate important differences in HRQOL among patients of different ethnic groups in the United States. Furthermore, HRQOL scores predict death and hospitalization among these patients. Am J Kidney Dis 41:605-615. © 2003 by the National Kidney Foundation, Inc.