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Physicians across the care continuum are increasingly aligned around the belief that coordinated care can improve patient outcomes. As the principal caregivers for one of the most medically fragile patient groups in healthcare, nephrologists are especially attuned to the potential value of integrated care. Medicare Advantage (MA) offers one way to test this hypothesis. By law, end-stage renal disease patients currently cannot enroll into an MA plan, but if they develop ESRD while in such a plan, they may continue to be enrolled. The contrast between these patients and their counterparts who carry Medicare fee for service (MFFS) thereby represents a natural experiment that affords an opportunity to examine whether enrollment in a coordinated care system may improve outcomes. In order to promote (unbiased) comparison of patients in a non-randomized context, we propensity score-matched incident dialysis patients enrolled in MA versus those in MFFS. The data demonstrate that patients who were enrolled in an MA plan upon initiation of dialysis had a 9% lower mortality rate than their MFFS counterparts. This beneficial association of MA enrollment was found to be sustained over the first two years of dialysis treatment.

Uncorrected serum calcium concentration is the first mineral metabolism metric planned for use as a quality measure in the United States ESRD population. Few studies in patients undergoing either peritoneal dialysis (PD) or hemodialysis (HD) have assessed the association of uncorrected serum calcium concentration with clinical outcomes. We obtained data from 129,076 patients on dialysis (PD, 10,066; HD, 119,010) treated in DaVita, Inc. facilities between July 1, 2001, and June 30, 2006. After adjustment for potential confounders, uncorrected serum calcium <8.5 and ≥10.2 mg/dl were associated with excess mortality in patients on PD or HD (comparison group uncorrected calcium 9.0 to <9.5 mg/dl). Additional adjustment for serum albumin concentration substantially attenuated the all-cause mortality hazard ratios (HRs) associated with uncorrected calcium <8.5 mg/dl (HR, 1.29; 95% confidence interval [95% CI], 1.16 to 1.44 for PD; HR, 1.17; 95% CI, 1.13 to 1.20 for HD) and amplified the HRs associated with calcium ≥10.2 mg/dl (HR, 1.65; 95% CI, 1.42 to 1.91 for PD; HR, 1.59; 95% CI, 1.53 to 1.65 for HD). Albumin-corrected calcium ≥10.2 mg/dl and serum phosphorus ≥6.4 mg/dl were also associated with increased risk for death, irrespective of dialysis modality. In summary, in a large nationally representative cohort of patients on dialysis, abnormalities in markers of mineral metabolism, particularly high concentrations of serum calcium and phosphorus, were associated with increased mortality risk. Additional studies are needed to investigate whether control of hypercalcemia and hyperphosphatemia in patients undergoing dialysis results in improved clinical outcomes., (Copyright © 2015 by the American Society of Nephrology.)

The medical director has been a part of the fabric of Medicare's ESRD program since entitlement was extended under Section 299I of Public Law 92-603, passed on October 30, 1972, and implemented with the Conditions for Coverage that set out rules for administration and oversight of the care provided in the dialysis facility. The role of the medical director has progressively increased over time to effectively extend to the physicians serving in this role both the responsibility and accountability for the performance and reliability related to the care provided in the dialysis facility. This commentary provides context to the nature and expected competencies and behaviors of these medical director roles that remain central to the delivery of high-quality, safe, and efficient delivery of RRT, which has become much more intensive as the dialysis industry has matured., (Copyright © 2015 by the American Society of Nephrology.)

Since the completion of the Centers for Medicare and Medicaid Services' end-stage renal disease (ESRD) demonstration projects, passage of the Affordable Care Act, and announcement of ESRD Seamless Care Organizations (ESCOs) by CMS' Innovation Center, it seems that ESRD-centered accountable care organizations will be the future model for kidney care of Medicare beneficiaries. Regardless of what you call it--managed care organization, special needs plan, ESCO--balancing quality of health care with costs of health care will continue to be the primary directive for physicians and institutions using integrated care management (ICM) strategies to manage their ESRD patients' health. The renal community has had previous success with ICM, and these experiences could help to guide our way.

Background: Patient outcomes have been compared on the basis of the profit status of the dialysis provider (for-profit [FP] and not-for-profit [NFP]). In its annual report, United States Renal Data System (USRDS) provides dialysis provider level death and hospitalization rates adjusted by age, race, sex, and dialysis vintage; however, recent analyses have suggested that other variables impact these outcomes. Our current analysis of hospitalization and mortality rates of hemodialysis patients included adjustments for those used by the USRDS plus other potential confounders: facility geography (end-stage renal disease network), length of facility ownership, vascular access at first dialysis session, and pre-dialysis nephrology care., Methods: We performed a provider level, retrospective analysis of 2010 hospitalization and mortality rates among US hemodialysis patients exclusively using USRDS sources. Crude and adjusted incidence rate ratios (IRRs) were calculated using the 4 standard USRDS patient factors plus the 4 potential confounders noted above., Results: The analysis included 366,011 and 34,029 patients treated at FP and NFP facilities, respectively. There were statistical differences between the cohorts in geography, facility length of ownership, vascular access, and pre-dialysis nephrology care (p < 0.001), as well as age (p < 0.01), race (p < 0.001), and vintage (p < 0.001), but not sex (p = 0.12). When using standard USRDS adjustments, hospitalization and mortality rates for FP and NFP facilities were most disparate, favoring the NFP facilities. Rates were most similar between providers when adjustments were made for each of the 8 factors. With the FP IRR as the referent (1.0), the hospitalization IRR for NFP facilities was 1.00 (95% confidence interval [CI] 0.97-1.02; p = 0.69), while the NFP mortality IRR was 1.01 (95% CI 0.97-1.05; p = 0.64)., Conclusions: These data suggest there is no difference in mortality and hospitalization rates between FP and NFP dialysis clinics when appropriate statistical adjustments are made.

The Centers for Medicare and Medicaid Services oversees the ESRD Quality Incentive Program to ensure that the highest quality of health care is provided by outpatient dialysis facilities that treat patients with ESRD. To that end, Centers for Medicare and Medicaid Services uses clinical performance measures to evaluate quality of care under a pay-for-performance or value-based purchasing model. Now more than ever, the ESRD therapeutic area serves as the vanguard of health care delivery. By translating medical evidence into clinical performance measures, the ESRD Prospective Payment System became the first disease-specific sector using the pay-for-performance model. A major challenge for the creation and implementation of clinical performance measures is the adjustments that are necessary to transition from taking care of individual patients to managing the care of patient populations. The National Quality Forum and others have developed effective and appropriate population-based clinical performance measures quality metrics that can be aggregated at the physician, hospital, dialysis facility, nursing home, or surgery center level. Clinical performance measures considered for endorsement by the National Quality Forum are evaluated using five key criteria: evidence, performance gap, and priority (impact); reliability; validity; feasibility; and usability and use. We have developed a checklist of special considerations for clinical performance measure development according to these National Quality Forum criteria. Although the checklist is focused on ESRD, it could also have broad application to chronic disease states, where health care delivery organizations seek to enhance quality, safety, and efficiency of their services. Clinical performance measures are likely to become the norm for tracking performance for health care insurers. Thus, it is critical that the methodologies used to develop such metrics serve the payer and the provider and most importantly, reflect what represents the best care to improve patient outcomes., (Copyright © 2014 by the American Society of Nephrology.)

Background: In contrast to the general population, higher body mass index (BMI) is associated with greater survival in patients receiving hemodialysis (HD; "obesity paradox"). We hypothesized that this paradoxical association between BMI and death may be modified by age and dialysis vintage., Study Design: Retrospective observational study using a large HD patient cohort., Setting & Participants: 123,383 maintenance HD patients treated in DaVita dialysis clinics between July 1, 2001, and June 30, 2006, with follow-up through September 30, 2009., Predictors: Age, dialysis vintage, and time-averaged BMI. Time-averaged BMI was divided into 6 subgroups; <18.5, 18.5-<23.0, 23.0-<25.0, 25.0-<30.0, 30.0-<35.0, and ≥35.0kg/m(2). BMI category of 23-<25kg/m(2) was used as the reference category., Outcomes: All-cause, cardiovascular, and infection-related mortality., Results: Mean BMI of study participants was 27±7kg/m(2). Time-averaged BMI was <18.5 and ≥35kg/m(2) in 5% and 11% of patients, respectively. With progressively higher time-averaged BMI, there was progressively lower all-cause, cardiovascular, and infection-related mortality in patients younger than 65 years. In those 65 years or older, even though overweight/obese patients had lower mortality compared with underweight/normal-weight patients, sequential increases in time-averaged BMI > 25kg/m(2) added no additional benefit. Based on dialysis vintage, incident HD patients had greater all-cause and cardiovascular survival benefit with a higher time-averaged BMI compared with the longer term HD patients., Limitations: Causality cannot be determined, and residual confounding cannot be excluded given the observational study design., Conclusions: Higher BMI is associated with lower death risk across all age and dialysis vintage groups. This benefit is more pronounced in incident HD patients and those younger than 65 years. Given the robustness of the survival advantage of higher BMI, examining interventions to maintain or even increase dry weight in HD patients irrespective of age and vintage are warranted., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

The availability of life-saving dialysis therapy has been one of the great successes of medicine in the past four decades. Over this time period, despite treatment of hundreds of thousands of patients, the overall quality of life for patients with ESRD has not substantially improved. A narrow focus by clinicians and regulators on basic indicators of care, like dialysis adequacy and anemia, has consumed time and resources but not resulted in significantly improved survival; also, frequent hospitalizations and dissatisfaction with the care experience continue to be seen. A new quality paradigm is needed to help guide clinicians, providers, and regulators to ensure that patients' lives are improved by the technically complex and costly therapy that they are receiving. This paradigm can be envisioned as a quality pyramid: the foundation is the basic indicators (outstanding performance on these indicators is necessary but not sufficient to drive the primary outcomes). Overall, these basics are being well managed currently, but there remains an excessive focus on them, largely because of publically reported data and regulatory requirements. With a strong foundation, it is now time to focus on the more complex intermediate clinical outcomes-fluid management, infection control, diabetes management, medication management, and end-of-life care among others. Successfully addressing these intermediate outcomes will drive improvements in the primary outcomes, better survival, fewer hospitalizations, better patient experience with the treatment, and ultimately, improved quality of life. By articulating this view of quality in the ESRD program (pushing up the quality pyramid), the discussion about quality is reframed, and also, clinicians can better target their facilities in the direction of regulatory oversight and requirements about quality. Clinicians owe it to their patients, as the ESRD program celebrates its 40th anniversary, to rekindle the aspirations of the creators of the program, whose primary goal was to improve the lives of the patients afflicted with this devastating condition.

Purpose: Low serum albumin concentration and low dietary protein intake are associated with protein-energy wasting (PEW) and higher mortality in maintenance hemodialysis patients. The role of these nutritional markers is less clear in clinical outcomes of the first several months of dialysis therapy, where mortality is exceptionally high., Methods: In a cohort of 17,445 incident hemodialysis patients, we examined variation in serum albumin and the normalized protein catabolic rate (nPCR), a surrogate of dietary intake, and quarterly mortality in the first 2 years of dialysis therapy. Cox proportional hazard models were fitted to estimate the association between mortality and combined albumin/nPCR categories for eight quarters. We investigated the associations between mortality and baseline and subsequent serum albumin levels per cohort quarter as well as changes in albumin and nPCR over time., Results: Patients were 64 ± 15 years old (mean ± SD) and included 45 % women, 24 % African Americans and 58 % diabetics. Correlations between quarterly serum albumin and nPCR varied from 0.18 to 0.25. Serum albumin <3.5 g/dL was consistently associated with high mortality as was nPCR <1 g/kg/day (except for qtr1). Low serum albumin and nPCR greater than 0.2 g/dLg/dL or g/kg/day, respectively, were associated with increased risk of death. Quarterly rise in nPCR (>+0.2 g/kg/day) showed reverse effect on mortality from the 2nd to the last quarter., Conclusions: Low serum albumin and nPCR are associated with mortality. A rapid rise in nPCR by the end of the second year may indicate pre-existing PEW.

Background: Observational studies have consistently demonstrated the survival benefits of a greater dialysis dose in maintenance hemodialysis (MHD) patients, whereas randomized controlled trials have shown conflicting results. The possible causal impact of dialysis dose on mortality needs to be investigated using rich cohort data analyzed with novel statistical methods such as marginal structural models (MSMs) that account for time-varying confounding and exposure., Methods: We quantified the effect of delivered dose of hemodialysis (HD) [single-pool Kt/V (spKt/V)] on mortality risk in a contemporary cohort of 68,110 patients undergoing HD 3 times weekly (7/2001- 9/2005). We compared conventional Cox proportional hazard and MSM survival analyses, accounting for time-varying confounding by applying longitudinally modeled inverse-probability-of-dialysis-dose weights to each observation., Results: In conventional Cox models, baseline spKt/V showed a weak negative association with mortality, while higher time-averaged spKt/V was strongly associated with lower mortality risk. In MSM analyses, compared to a spKt/V range of 1.2 - <1.4, a spKt/V range of <1.2 was associated with a higher risk of mortality [HR (95% CI) 1.67 (1.54 - 1.80)], whereas mortality risks were significantly lower with higher spKt/V [HRs (95% CI): 0.74 (0.70-0.78), 0.63 (0.59-0.66), 0.56 (0.52-0.60), and 0.56 (0.52-0.61) for spKt/V ranges of 1.4 - <1.6, 1.6-<1.8, 1.8 - <2.0, and ≥2.0, respectively]. Thus, MSM analyses showed that the greatest survival advantage of a higher dialysis dose was observed for a spKt/V range of 1.8-<2.0, and the dialysis dose-mortality relationship was robust in almost all subgroups of patients., Conclusions: Higher HD doses were robustly associated with greater survival in MSM analyses that more fully and appropriately accounted for time-varying confounding.

Background: Prior studies show that African-American and Hispanic dialysis patients have lower mortality risk than whites. Recent age-stratified analyses suggest this survival advantage may be limited to younger age groups, but did not concurrently compare Hispanic, African-American, and white patients, nor account for differences in nutritional and inflammatory status as potential confounders. Minorities experience inequities in kidney transplantation access, but it is unknown whether these racial/ethnic disparities differ across age groups., Methods: The associations between race/ethnicity with all-cause mortality and kidney transplantation were separately examined among 130,909 adult dialysis patients from a large national dialysis organization (entry period 2001-2006, follow-up through 2009) within 7 age categories using Cox proportional hazard models adjusted for case-mix and malnutrition and inflammatory surrogates., Results: African-Americans had similar mortality versus whites in younger age groups (18-40 years), but decreased mortality in older age groups (>40 years). In contrast, Hispanics had lower mortality versus whites across all ages. In sensitivity analyses using competing risk regression to account for differential kidney transplantation rates across racial/ethnic groups, the African-American survival advantage was limited to >60-years age categories. African-Americans and Hispanics were less likely to undergo kidney transplantation from all donor types versus whites across all ages, and these disparities were even more pronounced for living donor kidney transplantation (LDKT)., Conclusions: Hispanic dialysis patients have greater survival versus whites across all ages; in African-Americans, this survival advantage is limited to patients >40 years of age. Minorities are less likely to undergo kidney transplantation, particularly LDKT, across all ages.

Elevated serum phosphorus is associated with higher death risk in hemodialysis patients. Previous studies have suggested that both higher serum parathyroid hormone (PTH) level and higher dietary protein intake may contribute to higher serum phosphorus levels. However, it is not well known how these two factors simultaneously contribute to the combined risk of hyperphosphatemia in real patient-care scenarios. We hypothesized that the likelihood of hyperphosphatemia increases across higher serum PTH and higher normalized protein catabolic rate (nPCR) levels, a surrogate of protein intake. Over an 8-year period (July 2001-June 2009), we identified 69,355 maintenance hemodialysis patients with PTH, nPCR, and phosphorus data in a large dialysis provider. Logistic regression models were examined to assess the association between likelihood of hyperphosphatemia (serum phosphorus >5.5 mg/dl) and serum PTH and nPCR increments. Patients were 61±15 years old and included 46% women, 33% blacks, and 57% diabetics. Both higher serum PTH level and higher protein intake were associated with higher risk of hyperphosphatemia in dialysis patients. Compared with patients with PTH level 150-<300 pg/ml and nPCR level 1.0-<1.2 g/kg/day, patients with iPTH>600 pg/ml and nPCR>1.2 g/kg/day had a threefold higher risk of hyperphosphatemia (OR: 3.17, 95% CI: 2.69-3.75). Hyperphosphatemia is associated with both higher dietary protein intake and higher serum PTH level in maintenance hemodialysis patients. Worsening or resistant hyperphosphatemia may be an under-appreciated consequence of secondary hyperparathyroidism independent of dietary phosphorus load. Management of hyperphosphatemia should include diligent correction of hyper-parathyroidism while maintaining adequate intake of high protein foods with low phosphorus content.

Objective: Hypo- and hyperphosphatemia have each been associated with increased mortality in maintenance hemodialysis (MHD) patients. There has not been previous evaluation of a differential relationship between serum phosphorus level and death risk across varying age groups in MHD patients., Design and Settings: In a 6-year cohort of 107,817 MHD patients treated in a large dialysis organization, we examined the association between serum phosphorus levels with all-cause and cardiovascular mortality within 5 age categories (15 to <45, 45 to <65, 65 to <70, 70 to <75, and ≥75 years old) using Cox proportional hazards models adjusted for case-mix covariates and malnutrition inflammation complex syndrome (MICS) surrogates., Main Outcome Measure: All-cause and cardiovascular mortality., Results: The overall mean age of the cohort was 60 ± 16 years, among whom there were 45% women, 35% Blacks, and 58% diabetics. The time-averaged serum phosphorus level (mean ± SD) within each age category was 6.26 ± 1.4, 5.65 ± 1.2, 5.26 ± 1.1, 5.11 ± 1.0, and 4.88 ± 1.0 mg/dL, respectively (P for trend <.001). Hyperphosphatemia (>5.5 mg/dL) was consistently associated with increased all-cause and cardiovascular mortality risks across all age categories, including after adjustment for case-mix and MICS-related covariates. In fully adjusted models, a low serum phosphorus level (<3.5 mg/dL) was associated with increased all-cause mortality only in elderly MHD patients ≥65 years old (hazard ratio [95% confidence interval]: 1.21 [1.07-1.37], 1.13 [1.02-1.25], and 1.28 [1.2-1.37] for patients 65 to <70, 70 to <75, and ≥75 years old, respectively), but not in younger patients (<65 years old). A similar differential cardiovascular mortality risk for low serum phosphorus levels between old and young age groups was observed., Conclusions: The association between hyperphosphatemia and mortality is similar across all age groups of MHD patients, whereas hypophosphatemia is associated with increased mortality only in elderly MHD patients. Preventing very low serum phosphorus levels in elderly dialysis patients may be associated with better outcomes, which needs to be examined in future studies., (Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: In hemodialysis patients, higher serum creatinine (Cr) concentration represents larger muscle mass and predicts greater survival. However, this association remains uncertain in peritoneal dialysis (PD) patients., Methods: In a cohort of 10 896 PD patients enrolled from 1 July 2001 to 30 June 2006, the association of baseline serum Cr level and change during the first 3 months after enrollment with all-cause mortality was examined., Results: The cohort mean ± SD age was 55 ± 15 years old and included 52% women, 24% African-Americans and 48% diabetics. Compared with patients with serum Cr levels of 8.0-9.9 mg/dL, patients with serum Cr levels of <4.0 mg/dL and 4.0-5.9 mg/dL had higher risks of death {HR 1.36 [95% confidence interval (95% CI) 1.19-1.55] and 1.19 (1.08-1.31), respectively} whereas patients with serum Cr levels of 10.0-11.9 mg/dL, 12.0-13.9 mg/dL and ≥14.0 mg/dL had lower risks of death (HR 0.88 [95% CI 0.79-0.97], 0.71 [0.62-0.81] and 0.64 [0.55-0.75], respectively) in the fully adjusted model. Decrease in serum Cr level over 1.0 mg/dL during the 3 months predicted an increased risk of death additionally. The serum Cr-mortality association was robust in patients with PD treatment duration of ≥12 months, but was not observed in those with PD duration of <3 months., Conclusions: Muscle mass reflected in serum Cr level may be associated with survival even in PD patients. However, the serum Cr-mortality association is attenuated in the early period of PD treatment, suggesting competing effect of muscle mass versus residual renal function on mortality.

Objective: To determine whether the association of body size and muscle mass with survival among patients undergoing long-term hemodialysis (HD) is consistent across race, especially in East Asian vs white and African American patients., Patients and Methods: Using data from 20,818 patients from South Korea who underwent HD from February 1, 2001, to June 30, 2009, and 20,000 matched patients from the United States (10,000 whites and 10,000 African Americans) who underwent HD from July 1, 2001, to June 30, 2006, we compared mortality associations of baseline body mass index (BMI) and serum creatinine level as likely surrogates of obesity and muscle mass across the 3 races., Results: In Korean HD patients, higher BMI together with higher serum creatinine levels were associated with greater survival, as previously reported from US and European studies. In the matched cohort (10,000 patients from each of the 3 races), mortality risks were lower across higher BMI and serum creatinine levels, and these associations were similar in all 3 races (reference groups: patients with BMI >25.0 kg/m(2) or serum creatinine >12 mg/dL in each race). White, African American, and Korean patients with BMI levels of 18.5 kg/m(2) or less (underweight) had 78%, 79%, and 57% higher mortality risk, respectively, and white, African American, and Korean patients with serum creatinine levels of 6.0 mg/dL or less had 108%, 87%, and 78% higher mortality, respectively., Conclusion: This study shows that race does not modify the association of higher body size and muscle mass with greater survival in HD patients. Given the consistency of the obesity paradox, which may be related to a mitigated effect of protein-energy wasting on mortality irrespective of racial disparities, nutritional support to improve survival should be tested in HD patients of all races., (Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Under the Patient Protection and Affordable Care Act of 2010, accountable care organizations (ACOs) will be the primary mechanism for achieving the dual goals of high-quality patient care at managed per capita costs. To achieve these goals in the newly emerging health care environment, the nephrology community must plan for and direct integrated delivery and coordination of renal care, focusing on population management. Even though the ESRD patient population is a complex group with comorbid conditions that may confound integration of care, the nephrology community has unique experience providing integrated care through ACO-like programs. Specifically, the recent ESRD Management Demonstration Project sponsored by the Centers for Medicare & Medicaid Services and the current ESRD Prospective Payment System with it Quality Incentive Program have demonstrated that integrated delivery of renal care can be accomplished in a manner that provides improved clinical outcomes with some financial margin of savings. Moving forward, integrated renal care will probably be linked to provider performance and quality outcomes measures, and clinical integration initiatives will share several common elements, namely performance-based payment models, coordination of communication via health care information technology, and development of best practices for care coordination and resource utilization. Integration initiatives must be designed to be measured and evaluated, and, consistent with principles of continuous quality improvement, each initiative will provide for iterative improvements of the initiative.

Background and Objectives: There are conflicting research results about the survival differences between hemodialysis and peritoneal dialysis, especially during the first 2 years of dialysis treatment. Given the challenges of conducting randomized trials, differential rates of modality switch and transplantation, and time-varying confounding in cohort data during the first years of dialysis treatment, use of novel analytical techniques in observational cohorts can help examine the peritoneal dialysis versus hemodialysis survival discrepancy., Design, Setting, Participants, & Measurements: This study examined a cohort of incident dialysis patients who initiated dialysis in DaVita dialysis facilities between July of 2001 and June of 2004 and were followed for 24 months. This study used the causal modeling technique of marginal structural models to examine the survival differences between peritoneal dialysis and hemodialysis over the first 24 months, accounting for modality change, differential transplantation rates, and detailed time-varying laboratory measurements., Results: On dialysis treatment day 90, there were 23,718 incident dialysis-22,360 hemodialysis and 1,358 peritoneal dialysis-patients. Incident peritoneal dialysis patients were younger, had fewer comorbidities, and were nine and three times more likely to switch dialysis modality and receive kidney transplantation over the 2-year period, respectively, compared with hemodialysis patients. In marginal structural models analyses, peritoneal dialysis was associated with persistently greater survival independent of the known confounders, including dialysis modality switch and transplant censorship (i.e., death hazard ratio of 0.52 [95% confidence limit 0.34-0.80])., Conclusions: Peritoneal dialysis seems to be associated with 48% lower mortality than hemodialysis over the first 2 years of dialysis therapy independent of modality switches or differential transplantation rates.

Morbidity, hospitalizations, and costs for the treatment of individuals with end-stage renal disease are simply not improving at a rate that is acceptable to many physicians and dialysis providers in the United States. Various conferences and papers have suggested what processes need to become part of the dialysis prescription to accelerate change. Controlling cardiovascular disease is a part of that change, and controlling extra-cellular volume (ECV) is necessary to accomplish this. Three dialysis providers joined in a quality initiative to objectively assess the ultrafiltration process and measure "normalized" ECV, with the outcome objective to decrease ECV-related hospitalizations. The results show a decrease in ECV-related hospitalizations by 50%. The model of dialysis prescription needs to now change to Kt/V + objective ECV control.

Background: Cognitive impairment is common in patients with end-stage renal disease receiving hemodialysis 3 times per week., Study Design: Randomized clinical trial., Setting & Participants: 218 individuals participating in the Frequent Hemodialysis Network (FHN) Daily Trial and 81 participating in the FHN Nocturnal Trial., Intervention: The Daily Trial tested in-center hemodialysis 6 times per week versus 3 times per week. The Nocturnal Trial tested home nocturnal hemodialysis 6 times per week versus home or in-center hemodialysis 3 times per week., Outcomes: Cognitive function was measured at baseline, month 4, and month 12. The primary outcome was performance on the Trail-Making Test, Form B, a measure of executive function, and a secondary outcome was performance on the Modified Mini-Mental State Examination, a measure of global cognition. The domains of attention, psychomotor speed, memory, and verbal fluency were assessed in 59 participants in the Daily Trial and 19 participants in the Nocturnal Trial., Results: We found no benefit of frequent hemodialysis in either trial for the primary cognitive outcome (Daily Trial: OR for improvement, 0.99; 95% CI, 0.59-1.66; Nocturnal Trial: OR, 1.19; 95% CI, 0.48-2.96). Similarly, there was no benefit of frequent hemodialysis in either trial on global cognition, the secondary cognitive outcome. Exploratory analyses in the Daily Trial suggested possible benefits of frequent hemodialysis for memory and verbal fluency, but not for attention and psychomotor speed. Exploratory analyses in the Nocturnal Trial suggested no benefit of frequent hemodialysis on attention, psychomotor speed, memory, or verbal fluency., Limitations: Unblinded intervention, small sample., Conclusions: Frequent hemodialysis did not improve executive function or global cognition., (Published by Elsevier Inc.)

Background: Sparse data are available about the natural history of hemoglobin (Hb) level trends in contemporary patients with anemia, chronic kidney disease (CKD), and type 2 diabetes mellitus. We intended to describe Hb level trends over time with no or minimal administration of erythropoiesis-stimulating agents., Study Design: Prospective clinical trial cohort., Setting & Participants: 2,019 individuals with type 2 diabetes, moderate anemia, and CKD from the placebo arm of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) followed up for 2.3 years with an average of 32 monthly Hb level determinations per patient. Darbepoetin alfa was administered only if Hb level decreased to <9 g/dL., Outcomes & Measurements: Number of protocol-directed doses of darbepoetin alfa received due to an Hb level decrease to <9 g/dL., Results: 1,106 (55%) placebo patients consistently maintained an Hb level ≥9 g/dL and received no protocol-directed darbepoetin alfa. The other patients received 1 (16%), 2-4 (16%), or 5 or more (13%) doses of darbepoetin alfa. Those who received no darbepoetin alfa doses had higher baseline Hb levels, higher estimated glomerular filtration rates (eGFRs), less proteinuria, and lower ferritin and transferrin saturation values. On average, Hb levels were stable or increased in all groups. Compared with individuals who received no darbepoetin alfa, those who received 5 or more doses were more likely to receive intravenous iron therapy and blood transfusions and progress to renal replacement therapy, but were not at higher risk of death. The strongest predictors of requiring 5 or more doses of darbepoetin alfa were lower baseline Hb level, lower eGFR, and higher proteinuria level., Limitations: Post hoc analysis of a clinical trial of a specific population with diabetes, anemia, and non-dialysis-dependent CKD., Conclusions: In the TREAT placebo arm, Hb levels were stable with no or minimal protocol-directed darbepoetin alfa during 2.3 years of follow-up. Most patients with moderate anemia, non-dialysis-dependent CKD, and type 2 diabetes are able to maintain a stable Hb level without implementing long-term erythropoiesis-stimulating agent therapy., (Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Hemodialysis patients using central venous catheters (CVCs) for vascular access are at greater risk of infection and death vs. arterial venous fistula (AVF). In 2008, DaVita initiated the CathAway quality improvement initiative, a multidisciplinary program to reduce CVC use in favor of AVF. Our retrospective analysis examined CVC use for incident (≤90 days) and prevalent (>90 days) patients receiving hemodialysis in the years 2006 to 2010. Outcomes included annual mean percentage of patients with CVCs, new CVC placements per 100 patient years, CVC survival, and percentage patient days with CVC. Over 152,000 patient records were reviewed. Between 76.2% and 79.7% of incident patients used a CVC annually, but for prevalent patients, the proportion decreased from 41.1% in 2006 to 33.5% in 2010. The number of new CVC placements per 100 patient years increased slightly for incident patients but fell annually from 64.8 in 2006 to 55.2 in 2010 for prevalent patients. The percentage of treatment days with CVCs was stable among incident patients (70.4%-74.3%) but fell among prevalent patients from 26.1% in 2006 to 16.5% in 2010. The mean duration of CVC use in incident patients was between 53.0 days (SD, 27.8) in 2006 and 54.1 days (SD, 28.1) in 2009, and for prevalent patients between 158.9 days (SD, 123.0) in 2006 and 128.1 days (SD, 112.0) in 2010. CathAway significantly decreased CVC use in prevalent hemodialysis patients. Decreasing incident patient use will require improvements in predialysis care., (© 2012 The Authors. Hemodialysis International © 2012 International Society for Hemodialysis.)

Purpose: The Charlson comorbidity index (CCI) is a commonly used scale for assessing morbidity, but its role in assessing mortality in hemodialysis patients is not clear. Age, a component of CCI, is a strong risk factor for morbidity and mortality in chronic diseases and correlates with comorbidities. We hypothesized that the Charlson comorbidity index without age is a strong predictor of mortality in hemodialysis patients., Methods: A 6-year cohort of 893 hemodialysis patients was examined for an association between a modified CCI (without age and kidney disease) (mCCI) and mortality., Results: Patients were 53±15 years old (mean±SD), had a median mCCI score of 2, and included 47% women, 31% African Americans and 55% diabetics. After adjusting for case-mix and nutritional and inflammatory markers including C-reactive protein and interleukin-6, 2nd (mCCI: 1-2), 3rd (mCCI=3), and 4th (mCCI: 4-9) quartiles compared to 1st (mCCI=0) quartiles showed death hazard ratios (95% confidence intervals) of 1.43 (0.92-2.23), 1.70 (1.06-2.72), and 2.33 (1.43-3.78), respectively. The mCCI-death association was robust in non-African Americans. The CCI-death association linearity was verified in cubic splines. Each 1 unit higher mCCI score was associated with a death hazard ratio of 1.16 (1.07-1.27)., Conclusions: CCI independent of age is a robust and linear predictor of mortality in hemodialysis patients, in particular in non-African Americans.

Background: Patients beginning dialysis therapy are at risk of death and illness. The IMPACT (Incident Management of Patients, Actions Centered on Treatment) quality improvement program was developed to improve incident hemodialysis patient outcomes through standardized care., Study Design: Quality improvement report., Setting & Participants: Patients who started hemodialysis therapy between September 2007 and December 2008 at DaVita facilities using the IMPACT program (n = 1,212) constituted the intervention group. Propensity score-matched patients who initiated hemodialysis therapy in the same interval at DaVita facilities not using the IMPACT program (n = 2,424) made up the control group., Quality Improvement Plan: IMPACT intervention included a structured intake process and monitoring reports; patient enrollment in a 90-day patient education program and 90-day patient management pathway., Outcomes: Mean dialysis adequacy (Kt/V), hemoglobin and albumin levels, percentage of patients using preferred vascular access (arteriovenous fistula or graft), and mortality at each quarter., Results: Compared with the non-IMPACT group, the IMPACT group was associated with a higher proportion of patients dialyzing with a preferred access at 90 days (0.50 [95% CI, 0.47-0.53] vs 0.47 [95% CI, 0.45-0.49]; P = 0.1) and 360 days (0.63 [95% CI, 0.61-0.66] vs 0.48 [95% CI, 0.46-0.50]; P < 0.001) and a lower mortality rate at 90 days (24.8 [95% CI, 19.0-30.7] vs 31.9 [95% CI, 27.1-36.6] deaths/100 patient-years; P = 0.08) and 360 days (17.8 [95% CI, 15.2-20.4] vs 25.1 [95% CI, 20.7-25.2] deaths/100 patient-years; P = 0.01)., Limitations: The study does not determine the care processes responsible for the improved outcomes., Conclusions: Intense management of incident dialysis patients with the IMPACT quality improvement program was associated with significantly decreased first-year mortality. Focused attention to the care of incident patients is an important part of a dialysis program., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The role of pre-transplant erythropoiesis-stimulating agent (ESA) responsiveness in affecting post-transplant outcomes is not clear., Methods: Linking the 5-year patient data of a large dialysis organization to the 'Scientific Registry of Transplant Recipients', we identified 8795 hemodialyzed patients who underwent first kidney transplantation. Mortality or graft failure, delayed graft function (DGF) and acute rejection risks were estimated by Cox regression [hazard ratio (HR)] and logistic regression, respectively., Results: Patients were 48 ± 14 years old and included 38% women and 36% diabetics. Compared to renal allograft recipients who were in the first quartile of pre-transplant ESA responsiveness index (ERI), i.e. ESA dose divided by hemoglobin and weight, recipients in second, third and fourth quartiles had higher adjusted graft-censored death HR (and 95% confidence intervals) of 1.7 (1.0-2.7), 1.8 (1.1-2.9) and 2.3 (1.4-3.9) and higher death-censored graft failure HR of 1.6 (1.0-2.5), 2.0 (1.2-3.1) and 1.6 (0.9-2.6), respectively. No significant association between pre-transplant ERI and post-transplant DGF or acute rejection was detected., Conclusions: Higher pre-transplant ERI during the hemodialysis treatment period was associated with worse post-transplant long-term outcomes including increased all-cause death and higher risk of graft failure.

Accountable care organizations (ACOs) are a newly proposed vehicle for improving or maintaining high-quality patient care while controlling costs. They are meant to achieve the goals of the Medicare Shared Savings Program mandated by the Patient Protection and Affordable Care Act (PPACA) of 2010. ACOs are voluntary groups of hospitals, physicians, and health care teams that provide care for a defined group of Medicare beneficiaries and assume responsibility for providing high-quality care through defined quality measures at a cost below what would have been expected. If an ACO succeeds in achieving both the quality measures and reduced costs, the ACO will share in Medicare's cost savings. Health care for patients with end-stage renal disease is complex due to multiple patient comorbid conditions, expensive, and often poorly coordinated. Due to the unique needs of patients with end-stage renal disease receiving dialysis, ACOs may be unable to provide the highly specialized quality care these patients require. We discuss the benefits and risks of a renal-focused ACO for dialysis patients, as well as the kidney community's prior experience with an ACO-like demonstration project., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Relatively little is known about the effects of hemodialysis frequency on the disability of patients with ESRD., Design, Setting, Participants, & Measurements: This study examined changes in physical performance and self-reported physical health and functioning among subjects randomized to frequent (six times per week) compared with conventional (three times per week) hemodialysis in both the Frequent Hemodialysis Network daily (n=245) and nocturnal (n=87) trials. The main outcome measures were adjusted change in scores over 12 months on the short physical performance battery (SPPB), RAND 36-item health survey physical health composite (PHC), and physical functioning subscale (PF) based on the intention to treat principle., Results: Overall scores for SPPB, PHC, and PF were poor relative to population norms and in line with other studies in ESRD. In the Daily Trial, subjects randomized to frequent compared with conventional in-center hemodialysis experienced no significant change in SPPB (adjusted mean change of -0.20±0.19 versus -0.41±0.21, P=0.45) but experienced significant improvement in PHC (3.4±0.8 versus 0.4±0.8, P=0.009) and a relatively large change in PF that did not reach statistical significance. In the Nocturnal Trial, there were no significant differences among subjects randomized to frequent compared with conventional hemodialysis in SPPB (adjusted mean change of -0.92±0.44 versus -0.41±0.43, P=0.41), PHC (2.7±1.4 versus 2.1±1.5, P=0.75), or PF (-3.1±3.5 versus 1.1±3.6, P=0.40)., Conclusions: Frequent in-center hemodialysis compared with conventional in-center hemodialysis improved self-reported physical health and functioning but had no significant effect on objective physical performance. There were no significant effects of frequent nocturnal hemodialysis on the same physical metrics.

As with other disease states, mineral and bone disorder (MBD) management is challenging and may benefit from more systematic management. To evaluate the effectiveness of a focused campaign to improve MBD outcomes, we compared the percentage of patients meeting 2003 Kidney Dialysis Outcomes Quality Initiative (KDOQI)-recommended MBD targets between baseline and 18 months after programme initiation. The four components of the clinical campaign were: (1) a set of grids allowing simultaneous evaluation of MBD test results, (2) a weighted, facility-level cumulative scoring system representing percent of patients within KDOQI-recommended MBD targets, (3) team involvement and (4) patient education. Eighteen months after programme initiation, the percent of patients simultaneously meeting all 2003 KDOQI targets increased 7% and the percent meeting calcium and phosphorus targets increased 24% and 8%, respectively. These findings suggest that a coordinated clinical campaign with effective tools, outcome tracking and sharing and team involvement is an effective strategy to improve MBD outcomes., (© 2011 European Dialysis and Transplant Nurses Association/European Renal Care Association.)

Background: Incident hemodialysis patients have the highest mortality in the first several months after starting dialysis treatments. We hypothesized that the patterns and risk factors associated with this early mortality differ from those in later dialysis therapy periods., Methods: We examined mortality patterns and predictors during the first several months of hemodialysis treatment in 18,707 incident patients since the first week of hemodialysis therapy and estimated the population attributable fractions for selected time periods in the first 24 months., Results: The 18,707 incident hemodialysis patients were 45% women and 54% diabetics. The standardized mortality ratios (95% confidence interval) in the 1st to 3rd month of hemodialysis therapy were 1.81 (1.74-1.88), 1.79 (1.72-1.86), and 1.34 (1.27-1.40), respectively. The standardized mortality ratio reached prevalent mortality only by the 7th month. No survival advantage for African Americans existed in the first 6 months. Patients with low albumin <3.5 g/dl had the highest proportion of infection-related deaths while patients with higher albumin levels had higher cardiovascular deaths including 76% of deaths during the first 3 months. Use of catheter as vascular access and hypoalbuminemia <3.5 g/dl explained 34% (17-54%) and 33% (19-45%) of all deaths in the first 90 days, respectively., Conclusions: Incident hemodialysis patients have the highest mortality during the first 6 months including 80% higher death risk in the first 2 months. The presence of a central venous catheter and hypoalbuminemia <3.5 g/dl each explain one third of all deaths in the first 90 days., (Copyright © 2012 S. Karger AG, Basel.)

Background and Objectives: Conventional lipid profiles usually cannot predict cardiovascular outcomes in chronic disease states. We hypothesized that novel lipoprotein subfraction concentrations and LDL particle size measurements better predict mortality in maintenance hemodialysis (MHD) patients., Design, Setting, Participants, & Measurements: Mortality-predictability of LDL particle diameter and lipoprotein subfraction concentrations, measured by novel ion mobility, was examined in a cohort of 235 hemodialysis patients who were followed for up to 6 years using Cox models with adjustment for important covariables., Results: Patients were 54 ± 14 years old (mean ± SD) and included 45% women with total, LDL and HDL cholesterol levels of 143 ± 42, 76 ± 29, and 37 ± 12 mg/dl, respectively. Over 6 years, 71 patients (31%) died. Conventional lipid profile was not associated with mortality. The death hazard ratio (HR, 95% confidence interval) of the highest versus lowest quartiles of very small and large LDL particle concentrations were 2.43 (1.03 to 5.72) and 0.38 (0.15 to 0.96), respectively. Across increasing quartiles of LDL particle diameter, death HRs were 1.00, 0.93 (0.46 to 1.87), 0.43 (0.21 to 0.89), and 0.45 (0.31 to 1.00), respectively., Conclusions: Whereas conventional lipid profile cannot predict mortality in MHD patients, larger novel LDL particle diameter or higher large LDL particle concentrations appear predictive of greater survival, whereas higher very small LDL particle concentration is associated with higher death risk. Examining lipoprotein subfraction modulation in chronic diseases is indicated.

Objective: Observational studies have yielded inconsistent findings regarding the association of hemoglobin A(1c) (HbA(1c)) with survival in diabetic patients on dialysis. The association between pretransplant glycemic control and short- and long-term posttransplant outcomes in kidney transplant recipients is not clear., Research Design and Methods: Linking the 5-year patient data of a large dialysis organization (DaVita) to the Scientific Registry of Transplant Recipients, we identified 2,872 diabetic dialysis patients who underwent first kidney transplantation. Mortality or graft failure and delayed graft function (DGF) risks were estimated by Cox regression (hazard ratio [HR]) and logistic regression (odds ratio), respectively., Results: Patients were 53 ± 11 years old and included 36% women and 24% African Americans. In our fully adjusted model, allograft failure-censored, all-cause death HR and 95% CI for time-averaged pretransplant HbA(1c) categories of 7 to <8%, 8 to <9%, 9 to 10%, and ≥10%, compared with 6 to <7% (reference), were 0.89 (0.59-1.36), 2.06 (1.31-3.24), 1.41 (0.73-2.74), and 3.43 (1.56-7.56), respectively; and graft failure-censored cardiovascular death HR was 0.38 (0.13-1.05), 1.78 (0.69-4.55), 1.59 (0.44-5.76), and 4.28 (0.85-21.64), respectively. We did not find any difference in risk of death-censored graft failure or DGF with different pretransplant HbA(1c) levels., Conclusions: Poor pretransplant glycemic control appears associated with decreased posttransplant survival in kidney transplant recipients, whereas allograft outcomes may not be affected.

As with other disease states, mineral and bone disorder (MBD) management is challenging and may benefit from more systematic management. To evaluate the effectiveness of a focused campaign to improve MBD outcomes, we compared the percentage of patients meeting 2003 Kidney Dialysis Outcomes Quality Initiative (KDOQI)-recommended MBD targets between baseline and 18 months after programme initiation. The four components of the clinical campaign were: (1) a set of grids allowing simultaneous evaluation of MBD test results, (2) a weighted, facility-level cumulative scoring system representing percent of patients within KDOQI-recommended MBD targets, (3) team involvement and (4) patient education. Eighteen months after programme initiation, the percent of patients simultaneously meeting all 2003 KDOQI targets increased 7% and the percent meeting calcium and phosphorus targets increased 24% and 8%, respectively. These findings suggest that a coordinated clinical campaign with effective tools, outcome tracking and sharing and team involvement is an effective strategy to improve MBD outcomes., (© 2011 European Dialysis and Transplant Nurses Association/European Renal Care Association.)

Background and Objectives: Serum phosphorus levels are associated with mortality, cardiovascular disease, and renal function loss in individuals with and without chronic kidney disease. The association of pretransplant serum phosphorus levels with transplant outcomes is not clear., Design, Setting, Participants, & Measurements: Data of the Scientific Registry of Transplant Recipients (SRTR) up to June 2007 were linked to the database (2001 through 2006) of one of the U.S.-based large dialysis organizations (DaVita). The selected 9384 primary kidney recipients were divided into five groups according to pretransplant serum phosphorus levels (mg/dl): <3.5, 3.5 to <5.5 (reference group), 5.5 to <7.5, 7.5 to <9.5, and ≥9.5. Unadjusted and multivariate adjusted risks for transplant outcomes were compared., Results: Patients were 48 ± 14 years old and included 37% women and 27% African Americans. After multivariate adjustment, all-cause and cardiovascular death hazard ratios were 2.44 (95% confidence interval: 1.28 to 4.65) and 3.63 (1.13 to 11.64), respectively, in recipients in the ≥9.5 group; allograft loss hazard ratios were 1.42 (1.04 to 1.95) and 2.36 (1.33 to 4.17) in recipients with 7.5 to >9.5 and ≥9.5, respectively. No significant association with delayed graft function was found., Conclusions: Pretransplant phosphorus levels 7.5 to <9.5 mg/dl and ≥9.5 mg/dl were associated with increased risk of functional graft failure and increased risk of all-cause and cardiovascular deaths, respectively, when compared with 3.5 to <5.5 mg/dl. Additional studies are needed to examine whether more aggressive control of pretransplant serum phosphorus may improve posttransplant outcomes.

Background: In maintenance hemodialysis (HD) patients, overweight and obesity are associated with survival advantages. Given the greater survival of maintenance HD patients who are minorities, we hypothesized that increased body mass index (BMI) is associated more strongly with lower mortality in blacks and Hispanics relative to non-Hispanic whites., Study Design: Retrospective cohort study., Setting & Participants: We examined a 6-year (2001-2007) cohort of 109,605 maintenance HD patients including 39,090 blacks, 17,417 Hispanics, and 53,098 non-Hispanic white maintenance HD outpatients from DaVita dialysis clinics. Cox proportional hazards models examined the association between BMI and survival., Predictors: Race and BMI., Outcomes: All-cause mortality., Results: Patients had a mean age of 62 ± 15 (standard deviation) years and included 45% women and 45% patients with diabetes. Across 10 a priori-selected BMI categories (<18-≥40 kg/m(2)), higher BMI was associated with greater survival in all 3 racial/ethnic groups. However, Hispanic and black patients experienced higher survival gains compared with non-Hispanic whites across higher BMI categories. Hispanics and blacks in the ≥40-kg/m(2) category had the largest adjusted decrease in death HR with increasing BMI (0.57 [95% CI, 0.49-0.68] and 0.63 [95% CI, 0.58-0.70], respectively) compared with non-Hispanic whites in the 23- to 25-kg/m(2) group (reference category). In linear models, although the inverse BMI-mortality association was observed for all subgroups, overall black maintenance HD patients showed the largest consistent decrease in death HR with increasing BMI., Limitations: Race and ethnicity categories were based on self-identified data., Conclusions: Whereas the survival advantage of high BMI is consistent across all racial/ethnic groups, black maintenance HD patients had the strongest and most consistent association of higher BMI with improved survival., (Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: It is not clear why cardiac or renal cachexia in chronic diseases is associated with poor cardiovascular outcomes. Platelet reactivity predisposes to thromboembolic events in the setting of atherosclerotic cardiovascular disease, which is often present in patients with end-stage renal disease (ESRD)., Objectives: We hypothesized that ESRD patients with relative thrombocytosis (platelet count >300 × 10(3)/μL) have a higher mortality rate and that this association may be related to malnutrition-inflammation cachexia syndrome (MICS)., Design: We examined the associations of 3-mo-averaged platelet counts with markers of MICS and 6-y all-cause and cardiovascular mortality (2001-2007) in a cohort of 40,797 patients who were receiving maintenance hemodialysis., Results: The patients comprised 46% women and 34% African Americans, and 46% of the patients had diabetes. The 3-mo-averaged platelet count was 229 ± 78 × 10(3)/μL. In unadjusted and case-mix adjusted models, lower values of albumin, creatinine, protein intake, hemoglobin, and dialysis dose and a higher erythropoietin dose were associated with a higher platelet count. Compared with patients with a platelet count of between 150 and 200 × 10(3)/μL (reference), the all-cause (and cardiovascular) mortality rate with platelet counts between 300 and <350, between 350 and <400, and ≥400 ×10(3)/μL were 6% (and 7%), 17% (and 15%), and 24% (and 25%) higher (P < 0.05), respectively. The associations persisted after control for case-mix adjustment, but adjustment for MICS abolished them., Conclusions: Relative thrombocytosis is associated with a worse MICS profile, a lower dialysis dose, and higher all-cause and cardiovascular disease death risk in hemodialysis patients; and its all-cause and cardiovascular mortality predictability is accounted for by MICS. The role of platelet activation in cachexia-associated mortality warrants additional studies.

Purpose: This study aimed to evaluate the relevance and importance of two SF-36 subscales, Vitality (VT) and Physical Function (PF), to assess concepts of energy and physical function in patients with type 2 diabetes mellitus (DM) and non-dialysis CKD-related anemia., Methods: Patients with clinical history of DM and non-dialysis CKD-related anemia (n = 68) were identified as follows: 40 participated in concept elicitation (CE) interviews; 20 in cognitive interviews (CI), and 8 in pilot interviews. Relevance and importance ratings for SF-36 VT and PF items were obtained. Interviews were recorded, transcribed, and patient expressions of concepts coded. Inter-rater agreement was used to evaluate coding consistency. Concepts elicited were mapped to SF-36 VT and PF items., Results: Patients (n = 64) were 65.6% women, 42.2% Caucasian, with mean age of 66.1 ± 11.6 years. Of 830 coded concepts, 388 (47%) were "Energy" expressions and 287 (35%) were "PF limitations" expressions. Low energy was reported by 85% patients and rated as an important limitation by 88%. Limitations in PF were reported by 56-82% patients and rated important by 44-96%. CE and CI quotes correspond well to SF-36 VT and PF items., Conclusion: SF-36 VT and PF contents were suitable for assessing energy and physical function limitations, respectively, in this patient population.

Background and Objectives: Numerous studies have shown the overall benefits of dialysis filter reuse, including superior biocompatibility and decreased nonbiodegradable medical waste generation, without increased risk of mortality. A recent study reported that dialyzer reprocessing was associated with decreased patient survival; however, it did not control for sources of potential confounding. We sought to determine the effect of dialyzer reprocessing with peracetic acid on patient mortality using contemporary outcomes data and rigorous analytical techniques., Design, Setting, Participants, & Measurements: We conducted a series of analyses of hemodialysis patients examining the effects of reuse on mortality using three techniques to control for potential confounding: instrumental variables, propensity-score matching, and time-dependent survival analysis., Results: In the instrumental variables analysis, patients at high reuse centers had 16.2 versus 15.9 deaths/100 patient-years in nonreuse centers. In the propensity-score matched analysis, patients with reuse had a lower death rate per 100 patient-years than those without reuse (15.2 versus 15.5). The risk ratios for the time-dependent survival analyses were 0.993 (per percent of sessions with reuse) and 0.995 (per unit of last reuse), respectively. Over the study period, 13.8 million dialyzers were saved, representing 10,000 metric tons of medical waste., Conclusions: Despite the large sample size, powered to detect miniscule effects, neither the instrumental variables nor propensity-matched analyses were statistically significant. The time-dependent survival analysis showed a protective effect of reuse. These data are consistent with the preponderance of evidence showing reuse limits medical waste generation without negatively affecting clinical outcomes.

Background: Observational studies indicate greater survival in African American and Hispanic maintenance hemodialysis patients compared with their non-Hispanic white counterparts, although African Americans have shorter life expectancy than whites in the general population. We hypothesized that this apparent survival advantage is due to a more favorable nutritional/inflammatory profile in minority hemodialysis patients., Study Design: We examined the association between race/ethnicity and 5-year survival before and after adjustment for case-mix and surrogates of the malnutrition-inflammation complex syndrome (MICS) using Cox regression with or without matched sampling in a large cohort of adult hemodialysis patients., Setting & Participants: 124,029 adult hemodialysis patients, including 16% Hispanics, 49% non-Hispanic whites, and 35% African Americans., Predictors: Race/ethnicity before and after adjustment for MICS, including values for body mass index, serum albumin, total iron-binding capacity, ferritin, creatinine, phosphorus, calcium, bicarbonate, white blood cell count, lymphocyte percentage, hemoglobin, and protein intake., Outcomes: 5-year (July 2001 to June 2006) survival., Results: In dialysis patients, blacks and Hispanics had lower mortality overall than non-Hispanic whites after traditional case-mix adjustment. However, after additional control for MICS, Hispanics had mortality similar to non-Hispanic whites, and African Americans had even higher mortality. Unadjusted, case-mix-, and MICS-adjusted HRs for African Americans versus whites were 0.68 (95% CI, 0.66-0.69), 0.89 (95% CI, 0.86-0.91), and 1.06 (95% CI, 1.03-1.09) in the unmatched cohort and, 0.95 (95% CI, 0.90-0.99), 0.89 (95% CI, 0.84-0.94), and 1.16 (95% CI, 1.07-1.26) in the matched cohort, and for Hispanics versus whites, 0.66 (95% CI, 0.64-0.69), 0.84 (95% CI, 0.81-0.87), and 0.97 (95% CI, 0.94-1.00) in the unmatched cohort and 0.89 (95% CI, 0.84-0.95), 0.88 (95% CI, 0.83-0.95), and 0.98 (95% CI, 0.91-1.06) in the matched cohort, respectively., Limitations: Adjustment cannot be made for unmeasured confounders., Conclusions: Survival advantages of African American and Hispanic hemodialysis patients may be related to differences in nutritional and inflammatory status. Further studies are required to explore these differences., (Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: The association between pretransplant body composition and posttransplant outcomes in renal transplant recipients is unclear. It was hypothesized that in hemodialysis patients higher muscle mass (represented by higher pretransplant serum creatinine level) and larger body size (represented by higher pretransplant body mass index [BMI]) are associated with better posttransplant outcomes., Design, Setting, Participants, & Measurements: Linking 5-year patient data of a large dialysis organization (DaVita) to the Scientific Registry of Transplant Recipients, 10,090 hemodialysis patients were identified who underwent kidney transplantation from July 2001 to June 2007. Cox regression hazard ratios and 95% confidence intervals of death and/or graft failure were estimated., Results: Patients were 49 ± 13 years old and included 49% women, 45% diabetics, and 27% African Americans. In Cox models adjusted for case-mix, nutrition-inflammation complex, and transplant-related covariates, the 3-month-averaged postdialysis weight-based pretransplant BMI of 20 to <22 and < 20 kg/m(2), compared with 22 to <25 kg/m(2), showed a nonsignificant trend toward higher combined posttransplant mortality or graft failure, and even weaker associations existed for BMI ≥ 25 kg/m(2). Compared with pretransplant 3-month- averaged serum creatinine of 8 to <10 mg/dl, there was 2.2-fold higher risk of combined death or graft failure with serum creatinine <4 mg/dl, whereas creatinine ≥14 mg/dl exhibited 22% better graft and patient survival., Conclusions: Pretransplant obesity does not appear to be associated with poor posttransplant outcomes. Larger pretransplant muscle mass, reflected by higher pretransplant serum creatinine level, is associated with greater posttransplant graft and patient survival.

Background and Objectives: The optimal target for glycemic control has not been established for diabetic peritoneal dialysis (PD) patients., Design, Setting, Participants, & Measurements: We examined mortality-predictability of hemoglobin A1c random serum glucose in a contemporary cohort of diabetic PD patients treated in DaVita dialysis clinics July 2001 through June 2006 with follow-up through June 2007., Results: We identified 2798 diabetic PD patients with A1c data. Serum glucose correlated with A1C (r=0.51). Adjusted all-cause death hazard ratio and 95% confidence interval for baseline A1c increments of 7.0 to 7.9%, 8.0 to 8.9%, 9.0 to 9.9%, and ≥10%, compared with 6.0 to 6.9% (reference), were 1.13 (0.97 to 1.32), 1.05 (0.88 to 1.27), 1.06 (0.84 to 1.34), and 1.48 (1.18 to 1.86); and for time-averaged A1c values were 1.10 (0.96 to 1.27), 1.28 (1.07 to 1.53), 1.34 (1.05 to 1.70), and 1.81 (1.33 to 2.46), respectively. The A1c-mortality association was modified by hemoglobin level such that higher all-cause mortality was evident only in nonanemic patients. Similar but non-significant trends in cardiovascular death risk was found across A1c increments. Adjusted all-cause death HR for time-averaged blood glucose 150 to 199, 200 to 249, 250 to 299, and ≥300 mg/dl, compared with 60 to 99 mg/dl (reference), were 1.02 (0.70 to 1.47), 1.12 (0.77 to 1.63), 1.45 (0.97 to 2.18), and 2.10 (1.37 to 3.20), respectively., Conclusions: Poor glycemic control appears associated incrementally with higher mortality in PD patients. Moderate to severe hyperglycemia is associated with higher death risk especially in certain subgroups., (Copyright © 2011 by the American Society of Nephrology)