Trends in Chronic Kidney Disease Care in the US by Race and Ethnicity, 2012-2019.

Importance: Significant racial and ethnic disparities in chronic kidney disease (CKD) progression and outcomes are well documented, as is low use of guideline-recommended CKD care. Objective: To examine guideline-recommended CKD care delivery by race and ethnicity in a large, diverse population. Design, Setting, and Participants: In this serial cross-sectional study, adult patients with CKD that did not require dialysis, defined as a persistent estimated glomerular filtration rate less than 60 mL/min/1.73 m2 or a urine albumin-creatinine ratio of 30 mg/g or higher for at least 90 days, were identified in 2-year cross-sections from January 1, 2012, to December 31, 2019. Data from the OptumLabs Data Warehouse, a national data set of administrative and electronic health record data for commercially insured and Medicare Advantage patients, were used. Exposures: The independent variables were race and ethnicity, as reported in linked electronic health records. Main Outcomes and Measures: On the basis of guideline-recommended CKD care, the study examined care delivery process measures (angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker prescription for albuminuria, statin prescription, albuminuria testing, nephrology care for CKD stage 4 or higher, and avoidance of chronic nonsteroidal anti-inflammatory drug prescription) and care delivery outcome measures (blood pressure and diabetes control). Results: A total of 452 238 patients met the inclusion criteria (mean [SD] age, 74.0 [10.2] years; 262 089 [58.0%] female; a total of 7573 [1.7%] Asian, 49 970 [11.0%] Black, 15 540 [3.4%] Hispanic, and 379 155 [83.8%] White). Performance on process measures was higher among Asian, Black, and Hispanic patients compared with White patients for angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker use (79.8% for Asian patients, 76.7% for Black patients, and 79.9% for Hispanic patients compared with 72.3% for White patients in 2018-2019), statin use (72.6% for Asian patients, 69.1% for Black patients, and 74.1% for Hispanic patients compared with 61.5% for White patients), nephrology care (64.8% for Asian patients, 72.9% for Black patients, and 69.4% for Hispanic patients compared with 58.3% for White patients), and albuminuria testing (53.9% for Asian patients, 41.0% for Black patients, and 52.6% for Hispanic patients compared with 30.7% for White patients). Achievement of blood pressure control to less than 140/90 mm Hg was similar or lower among Asian (71.8%), Black (63.3%), and Hispanic (69.8%) patients compared with White patients (72.9%). Achievement of diabetes control with hemoglobin A1c less than 7.0% was 50.1% in Asian patients, 49.3% in Black patients, and 46.0% in Hispanic patients compared with 50.3% for White patients. Conclusions and Relevance: Higher performance on CKD care process measures among Asian, Black, and Hispanic patients suggests that differences in medication prescription and diagnostic testing are unlikely to fully explain known disparities in CKD progression and kidney failure. Improving care delivery processes alone may be inadequate for reducing these disparities.

Cost Structures of US Organ Procurement Organizations.

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).

The organ procurement costs of expanding deceased donor organ acceptance criteria: Evidence from a cost function model.

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.

Obstetric Deliveries in US Women With ESKD: 2002-2015.

RATIONALE & OBJECTIVE: Women with end-stage kidney disease (ESKD) have decreased fertility and are at increased risk for pregnancy complications. This study examined secular trends and outcomes of obstetric deliveries in a US cohort of women with ESKD. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Women aged 18 to 44 years with ESKD and registered in the US Renal Data System from 2002 to 2015. EXPOSURE: ESKD modality (hemodialysis [HD], peritoneal dialysis, transplantation). OUTCOMES: Infant delivery, preterm delivery, cesarean delivery. ANALYTICAL APPROACH: Unadjusted delivery rates were expressed as number of delivering women per 1,000 patient-years among women aged 18 to 44 years within each year during the study period, stratified by ESKD modality. Logistic regression models were used to evaluate associations of delivery, preterm delivery, and cesarean delivery with patient characteristics. RESULTS: The delivery rate in women undergoing HD and women with a kidney transplant increased from 2.1 to 3.6 and 3.1 to 4.6 per 1,000 patient-years, respectively (P<0.001 for each). The delivery rate in patients undergoing peritoneal dialysis was lower and did not increase significantly (P=0.9). Women with a transplant were less likely to deliver preterm compared with women undergoing HD (OR, 0.92; 95% CI, 0.84-1.00), though more likely have a cesarean delivery (OR, 1.18; 95% CI, 1.06-1.31). For deliveries occurring in the 2012 to 2015 period, 75% of women treated with HD were prescribed 4 or fewer outpatient HD treatments per week and 25% were prescribed 5-plus treatments per week in the 30 days before delivery. LIMITATIONS: Ascertainment of outcomes and comorbid conditions using administrative claims data. CONCLUSIONS: The delivery rate in women of reproductive age with ESKD increased from 2002 to 2015 among those treated with transplantation or HD. Women with a functioning transplant were less likely to deliver preterm, but more likely to have a cesarean delivery. Prescriptions for outpatient intensified HD for pregnant women with ESKD were infrequent in 2012 to 2015.

The cost of procuring deceased donor kidneys: Evidence from OPO cost reports 2013-2017.

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.

Changes in anemia management and hemoglobin levels following revision of a bundling policy to incorporate recombinant human erythropoietin.

In April 2006, Japan's health insurance system instituted a bundling policy that included recombinant human erythropoietin (rHuEPO) in outpatient hemodialysis therapy. To evaluate outcomes of this, we analyzed a prospective cohort of hemodialysis patients in the Japan Dialysis Outcomes and Practice Patterns Study, in 53 facilities using prevalent cross-sections of 1584 patients before and 1622 patients after the rHuEPO reimbursement change. Patient data included hemoglobin levels, iron management profiles, and anemia treatment with rHuEPO and intravenous iron. No significant differences were found in pre- or post-policy cross-sections for hemoglobin distributions or the percentage of patients prescribed rHuEPO. Among patients receiving rHuEPO, the mean dose significantly decreased by 11.8 percent. The percentage of patients prescribed intravenous iron over 4 months significantly increased; however, the mean dose of iron did not significantly change. Thus, this bundling policy was associated with reduced rHuEPO doses, increased intravenous iron use, and stable hemoglobin levels in Japanese patients receiving hemodialysis.

Optimizing hemodialysis practices in Canada could improve patient survival.

Data from the Canadian Organ Replacement Registry (CORR) and the Dialysis Outcomes and Practice Patterns Study (DOPPS) were used to determine whether practice patterns have changed in Canada since the introduction of the Canadian Society of Nephrology (CSN) Guidelines in 1999. DOPPS data were then used to calculate the impact of not meeting the proposed guideline targets and to estimate the potential life years gained if all Canadian hemodialysis patients achieved guideline targets. For dialysis dose and hemoglobin targets, Canadian facility performance has significantly improved over time. The vascular access use patterns show trends toward a worse pattern with increased catheter use. A calculation of the percentage of attributable risk suggests that 49% of deaths could possibly be averted if all patients currently outside the guidelines achieved them over the next five years. This corresponds to a decrease in the annual death rate from 18 to 10.1 per hundred patient years. These data support the need for improved adherence to guidelines. If Canadian caregivers were to optimize practice patterns, patient outcomes could be improved.

Effect of changing the priority for HLA matching on the rates and outcomes of kidney transplantation in minority groups.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

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.

Quality of life and patient satisfaction: ESRD managed care demonstration.

To study the effects of managed care on dialysis patients, we compared the quality of life and patient satisfaction of patients in a managed care demonstration with three comparison samples: fee-for-service (FFS) patients, managed care patients outside the demonstration, and patients in a separate national study. Managed care patients were less satisfied than FFS patients about access to health care providers, but more satisfied with the financial benefits (copayment coverage, prescription drugs, and nutritional supplements) provided under the demonstration managed care plan (MCP). After 1 year in the demonstration, patients exhibited statistically and clinically significant increases in quality of life scores.

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-SFTM. 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.

Health-related quality of life and associated outcomes among hemodialysis patients of different ethnicities in the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

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.