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Kidney failure is an overwhelming, life–shattering event, but patients with ESRD do not see themselves as being at the end stage of their lives. On the contrary, patients opting for kidney dialysis are choosing to live. Ideally, then, public policy would support patients’ choices about how to live—specifically, the choice to continue working. Many patients with ESRD faced with the limitations of their health status and the demands of their treatment understandably choose to leave their jobs, a choice that is facilitated by the availability of public disability and health insurance. However, other patients who have the desire and opportunity to continue working may not get the guidance and support that can actually make their employment possible. Specifically, current disability and health insurance may fail to provide timely treatment and employment counseling to help patients with ESRD remain in their jobs. We, therefore, propose that the Center for Medicare and Medicaid Services support ESRD Networks to initiate more timely employment and treatment counseling in both the ESRD and the late–stage pre–ESRD setting. Although it is too late to require such counseling in the new network scope of work for 2016–2020, active experimentation in the next few years can lay the groundwork for a subsequent contract.

The synthesis of a square-planar cobalt(ii) hydrido complex supported by a pyrrole-based PNP ligand has been reinvestigated and its reactivity with various small molecules examined. Preparation of the complex was accomplished by treatment of the corresponding chloride complex, [CoCl(

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.

Dell pioneered the direct sales model by offering its customers technology solutions through full-system configurability. In 2007, Dell launched several strategic initiatives to drive channel transformation by offering fixed configurations through online channels, retailers, distributors, and other channel partners. Dell's center of excellence (CoE) in analytics developed solutions that apply operations research (OR) to address key challenges across the value chain and enable profitable growth in the new channels. These solutions include (1) a configuration optimizer to reduce product complexity by identifying fixed hardware configurations (FHCs), which Dell builds and stocks, (2) an online conversion rate accelerator to improve the online customer purchase experience, leading to increased revenues and customer satisfaction, and (3) a retail margin maximizer to improve forecasts, mitigate inventory risk, and recommend promotions to increase margins. Since 2007, OR has helped Dell solve complex business problems and has facilitated its growth in the FHC business to $15 billion. Since 2010, these OR solutions have delivered a margin impact of more than $140 million by reducing markdown expenditures, improving online conversion rates, increasing ocean shipments, and enhancing customer satisfaction.

Author(s): Molnar, Miklos Z; Foster, Clarence E; Sim, John J; Remport, Adam; Krishnan, Mahesh; Kovesdy, Csaba P; Kalantar-Zadeh, Kamyar | Abstract: BackgroundPrevious studies have indicated U-shaped associations between blood pressure (BP) and mortality in dialysis patients. We hypothesized that a similar association exists between pre-transplant BP and post-transplant outcomes in dialysis patients who undergo successful kidney transplantation.MethodsData from the Scientific Registry of Transplant Recipients were linked to the five-yr cohort of a large dialysis organization in the United States. We identified all dialysis patients who received a kidney transplant during this period. Unadjusted and multivariate adjusted predictors of transplant outcomes were examined.ResultsA total of 13 881 patients included in our study were 47 ± 14 yr old and included 42% women. There was no association between pre-transplant systolic BP and post-transplant mortality, although a decreased risk trend was observed in those with low post-dialysis systolic BP. Compared to patients with pre-dialysis diastolic BP 70 to l80 mmHg, patients with pre-dialysis diastolic BP l50 mmHg experienced lower risk of post-transplant death (hazard ratios [HR]: 0.74, 95% CI: 0.55-0.99). However, compared to patients with post-dialysis diastolic BP 70 to l80 mmHg, patients with post-dialysis diastolic BP ≥100 mmHg experienced higher risk of death (HR: 3.50, 95% CI: 1.57-7.84). In addition, very low (l50 mmHg for diastolic BP and l110 mmHg for systolic BP) pre-transplant BP was associated with lower risk of graft loss.ConclusionsLow post-dialysis systolic BP and low pre-dialysis diastolic BP are associated with lower post-transplant risk of death, whereas very high post-dialysis diastolic BP is associated with higher mortality in kidney transplant recipients. BP variations in dialysis patients prior to kidney transplantation may have a bearing on post-transplant outcome, which warrants additional studies.

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.

The American dialysis setting represents one of the most data-dense disease settings in the world ([1][1]). With the hope of better understanding ESRD, its treatment, and its associated costs, data are collected through public databases, registries, and proprietary databases. Although no one data

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.

Hemiprotonated dimers of cytosine derivatives, implicated in the formation of the i-motif of DNA, have been created in solution and the gas phase. The mechanism of dimerization has been analyzed by mass spectrometry and multidimensional NMR spectroscopy.

Author(s): Molnar, Miklos Z; Bunnapradist, Suphamai; Huang, Edmund; Krishnan, Mahesh; Nissenson, Allen R; Kovesdy, Csaba P; Kalantar-Zadeh, Kamyar | Abstract: BackgroundThe role of pre-transplant erythropoiesis-stimulating agent (ESA) responsiveness in affecting post-transplant outcomes is not clear.MethodsLinking 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.ResultsPatients 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.ConclusionsHigher 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.

Author(s): Molnar, Miklos Z; Kovesdy, Csaba P; Rosivall, Laszlo; Bunnapradist, Suphamai; Hoshino, Junichi; Streja, Elani; Krishnan, Mahesh; Kalantar-Zadeh, Kamyar | Abstract: BackgroundDelayed graft function (DGF) complicates kidney allograft outcomes in the immediate post-transplantation period. We hypothesized that in hemodialysis patients more severe anemia, iron deficiency, the requirement for higher doses of erythropoietin-stimulating agents (ESA), or blood transfusions prior to transplantation are associated with higher risk of DGF.MethodsLinking five-yr hemodialysis patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, we identified 11 836 hemodialysis patients. Using logistic regression analyses we examined the association between pre-transplant parameters and post-transplant DGF.ResultsPatients were 49 ± 14 (mean ± SD) yr old and included 38% women, 27% blacks, and 26% diabetics. After adjusting for relevant covariates, pre-transplant blood transfusion was associated with 33% higher DGF risk (odds ratio [OR] = 1.33; 95% confidence interval [CI]: 1.19-1.48); and each 5000 U/wk increase of pre-transplant ESA dose with 5% higher DGF (OR = 1.05; 95% CI: 1.02-1.09). Compared to pre-transplant blood hemoglobin of 12-12.99 g/dL, there was 25% higher risk of DGF with blood hemoglobin 10-10.99 g/dL (OR = 1.25; 95% CI: 1.01-1.55), whereas blood hemoglobin ≥13 g/dL exhibited 15% higher risk of DGF (OR = 1.15; 95% CI: 0.98-1.34).ConclusionsPre-transplant blood transfusion, higher ESA dose, and either high or low blood hemoglobin but not iron markers are associated with higher risk of DGF.

Summary Background and objectives The influence of pretransplant dialysis modality on post-transplant outcomes is not clear. This study examined associations of pretransplant dialysis modality with post-transplant outcomes in a large national cohort of kidney transplant recipients. Design, setting, participants, & measurements Linking the 5-year patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, 12,416 hemodialysis and 2092 peritoneal dialysis patients who underwent first kidney transplantation were identified. Mortality or graft failure and delayed graft function risks were estimated by Cox regression (hazard ratio) and logistic regression (odds ratio), respectively. Results Recipients treated with peritoneal dialysis pretransplantation had lower (21.9/1000 patient-years [95% confidence interval: 18.1–26.5]) crude all-cause mortality rate than those recipients treated with hemodialysis (32.8/1000 patient-years [30.8–35.0]). Pretransplant peritoneal dialysis use was associated with 43% lower adjusted all-cause and 66% lower cardiovascular death. Furthermore, pretransplant peritoneal dialysis use was associated with 17% and 36% lower unadjusted death-censored graft failure and delayed graft function risk, respectively. However, after additional adjustment for relevant covariates, pretransplant peritoneal dialysis modality was not a significant predictor of death-censored graft failure delayed graft function, respectively. Similar trends were noted on analyses using a propensity score matched cohort of 2092 pairs of patients. Conclusions Compared with hemodialysis, patients treated with peritoneal dialysis before transplantation had lower mortality but similar graft loss or delayed graft function. Confounding by residual selection bias cannot be ruled out.

Background: Citrasate®, citric acid dialysate (CD), contains 2.4 mEq of citric acid (citrate), instead of acetic acid (acetate) as in standard bicarbonate dialysate. Previous studies suggest CD may improve dialysis adequacy and decrease heparin requirements, presumably due to nonsystemic anticoagulant effects in the dialyzer. Methods: We prospectively evaluated 277 hemodialysis patients in eight outpatient facilities to determine if CD with reduced heparin N (HN) would maintain dialyzer clearance. Subjects progressed through four study periods [baseline (B): bicarbonate dialysate + 100% HN; period 1 (P1): CD + 100% HN; period 2 (P2): CD + 80% HN; period 3 (P3): CD + 66.7% HN]. The predefined primary endpoint was noninferiority (margin –8%) of the percent change in mean dialyzer conductivity clearance between baseline and P2. Results: Subjects were 57.4% male, 41.7% white, 54.3% black, and 44.4% diabetic; mean age was 59 ± 14.4 years; mean time on dialysis was 1,498 ± 1,165 days; 65.7% had arteriovenous fistula, 19.9% arteriovenous graft, 14.4% catheters, and 27.8% used antiplatelet agents. Mean dialyzer clearance increased 0.9% (P1), 1.0% (P2), and 0.9% (P3) with CD despite heparin reduction. SpKt/V remained stable (B: 1.54 ± 0.29; P1: 1.54 ± 0.28; P2: 1.55 ± 0.27; P3: 1.54 ± 0.26). There was no significant difference in dialyzer/dialysis line thrombosis, post-HD time to hemostasis, percent of subjects with adverse events (AEs), or study-related AEs. Conclusions: CD was safe, effective, and met all study endpoints. Dialyzer clearance increased approximately 1% with CD despite 20–33% heparin reduction. Over 92% of P3 subjects demonstrated noninferiority of dialyzer clearance with CD and 33% HN reduction. There was no significant difference in dialyzer clotting, bleeding, or adverse events.

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 /lL) have a higher mortality rate and that this association may be related to malnutritioninflammation 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 6 78 · 10 3 /lL. 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 /lL (reference), the allcause (and cardiovascular) mortality rate with platelet counts between 300 and ,350, between 350 and ,400, and 400 ·10 3 /l Lw ere 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. Am J Clin Nutr 2011;94:945‐54.

In the development of wet granulated drug products, two primary sources of variance (disturbance) include the operational scale of the high shear wet granulation (HSWG) process and active pharmaceutical ingredient (API) lot-to-lot variability, particularly for formulations containing a high drug load. This paper presents a novel Process Analytical Technology strategy using latent variable modeling with near-infrared spectroscopy (NIRS) to reduce risk in scale-up operations of the HSWG process while simultaneously accounting for API lot-to-lot variability, even with limited manufacturing history. The process involves building a partial least square (PLS) model among the API material properties, the HSWG process parameters, and the NIRS end points of the HSWG process based on small-scale design of experiment batches. The PLS model is then used in an optimization framework to find suitable small-scale mechanical process parameters (impeller/chopper speed) that approximate a previous large-scale operation so as to keep the NIRS end point of large-scale operation constant. Prior to making additional large-scale batches with a new lot of API, NIRS end points of large-scale HSWG with the new API lot are predicted based on the PLS model developed from the small-scale operation. If the predicted NIRS end point for the HSWG using the new API lot is not within the target region, the risks associated with the scale-up operation can then be significantly reduced by modifying other HSWG process parameters such as the total amount of water added or total granulation time to achieve the target region. A case study is presented that demonstrates the effectiveness of this methodology during development and scale-up of a drug product manufactured using a HSWG process.

To examine whether a higher body mass index (BMI) in kidney recipients is associated with delayed graft function (DGF), we analyzed data from 11,836 hemodialysis patients in the Scientific Registry of Transplant Recipients who underwent kidney transplantation. The patient cohort included women, blacks, and diabetics; the average age was 49 years; and the mean BMI was 26.8 kg/m(2). After adjusting for relevant covariates, multivariate logistic regression analyses found that one standard deviation increase in pretransplant BMI was associated with a higher risk of DGF (odds ratio (OR) 1.35). Compared with patients with a pretransplant BMI of 22-24.99 kg/m(2), overweight patients (BMI 25-29.99 kg/m(2)), mild obesity patients (BMI 30-34.99 kg/m(2)), and moderate-to-severe obesity patients (BMI 35 kg/m(2) and over) had a significantly higher risk of DGF, with ORs of 1.30, 1.42, and 2.18, respectively. Similar associations were found in all subgroups of patients. Hence, pretransplant overweight or obesity is associated with an incrementally higher risk of DGF.

Summary 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.

A higher proportion of patients initiate hemodialysis (HD) with an arteriovenous fistula (AVF) in countries with universal health care systems compared with the United States. Because federally sponsored national health care organizations in the United States, such as the Department of Veterans Affairs (DVA) and the Department of Defense (DoD), are similar to a universal health care model, we studied AVF use within these organizations. We used the US Renal Data System database to perform a cross-sectional analysis of patients who initiated HD between 2005 and 2006. Patients who received predialysis nephrology care had 10-fold greater odds of initiating dialysis with an AVF (adjusted odds ratio [aOR] 10.3; 95% confidence interval [CI] 9.6 to 11.1). DVA/DoD insurance also independently associated with initiating HD with an AVF (aOR 1.4; 95% CI 1.2 to 1.5). Fewer patients initiated HD at a DoD facility, but these patients were also approximately twice as likely to use an AVF (aOR 2.3; 95% CI 1.2 to 4.6). In conclusion, patients in DVA/DoD systems are significantly more likely to use an AVF at initiation of HD than patients with other insurance types, including Medicare. Further study of these federal systems may identify practices that could improve processes of care across health care systems to increase the number of patients who initiate HD with an AVF.

This study develops and empirically tests a model for determining the determinants and effects of brand equity for the Indian passenger car market. Towards the same, the Brand Equity Creation Model developed by Yoo, Donthu and Lee (2000) was expanded and combined with the Brand Choice Model developed by Erdem, et al (1999). The dimensions of brand equity were thought to affect Overall Brand Equity, which in turn affected the final brand choice made by the consumers. The effect that ten selected marketing activities had on the dimensions of brand equity was examined. The passenger car market was differentiated on the basis of the price of car as premium, volume, and economy type and shopping centre intercept survey was conducted to collect respondent data across ten centres throughout the country. Multiple time passenger car buyers were considered as the respondent base for the study. A total of 1,932 consumers were contacted and 302 valid responses were received. Structural Equation Model was used as the tool for analysis. The results showed that: Of the ten marketing mix elements considered, some had a very strong impact on brand equity because they positively impacted both the dimensions considered for the study. However, contrary to what many previous studies reported, country of origin and price promotion did not impact the brand equity for such consumers. Advertising frequency is not a builder of brand equity; word-of-mouth is a better determinant of brand equity for repeat passenger car buyers. The different results obtained in this study vis- à- vis those from earlier studies suggest that the cultural differences between consumers of two countries mediates the effect of the marketing efforts on brand equity creation. Again since each of the dimensions of brand equity under this study was found to positively impact brand choice, it has been posited that the probability of the consumers choosing the final brand is increased with an increase in the equity of the brand. Geographical limitation of the sample and absence of interaction of marketing mix elements amongst themselves were identified as some of the key limitations of the study.

Inflammation is common among hemodialysis patients, and evidence is accumulating to suggest that inflammation is a major contributor to morbidity and mortality. Several factors have been suggested as potential causes of inflammation, including infections and the atherosclerosis process, as well as etiologies directly related to kidney disease such as reduced renal function and dialysis. Among several inflammatory biomarkers investigated, serum C-reactive protein (CRP) is the most widely used. In hemodialysis patients, raised CRP levels have been shown to be predictive of cardiovascular events, hospitalization, and all-cause and cardiovascular mortality. Elevated CRP levels may correlate with comorbidities and intercurrent events, all of which may impact the response to erythropoiesis-stimulating agents (ESAs) and lead to higher ESA doses. Most dialysis facilities do not routinely measure CRP, despite recommendations by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. Regular measurement of CRP levels may help providers to understand change in ESA dosing and identify patients at risk for cardiovascular events. This review explores the inter-relationships between inflammation, CRP levels, and anemia management in patients receiving hemodialysis.

Background Inflammation in an ESRD patient may impact responsiveness to erythropoiesis-stimulating agent (ESA) therapy. We sought to investigate the association between C-reactive protein (CRP) levels and average per-administration epoetin alfa (EPO) dose over 3 months following a CRP measurement. Methods The study is a retrospective cohort study of hemodialysis patients >or=18 years of age receiving care at a Fresenius Medical Care-North America facility between 1 July 2000 and 30 June 2002 who had no history of peritoneal dialysis. All patients had >or=1 CRP measurement and >or=3 months of recorded information before the CRP measurement (entry period). We evaluated the association between CRP levels and average hemoglobin (Hb) and per-administration EPO dose over the 3 months following the CRP measurement. Results We identified 1754 patients with a CRP measurement; mean age was 62.6 years (SD 14.1), 51.5% were male, 56.2% were white and the median CRP value was 2.04 mg/dL (20.4 mg/L). Patients in the upper CRP quartiles were more likely to be older, recently hospitalized; have a catheter vascular access; have lower albumin, Hb and transferrin saturation levels and greater EPO doses. In the subsequent 3 months, EPO doses but not Hb levels were significantly higher for patients in the highest CRP quartile [3.21 mg/dL (32.1 mg/L)] (P = 0.01). Conclusions Inflammation as measured by an elevated CRP level appears to be an independent predictor of greater ESA dose requirements. Patients with the highest CRP levels required significantly higher ESA doses to achieve comparable Hb levels even after controlling for potential confounding variables.

Objective To investigate whether treatment with abetimus delays renal flare in patients with lupus nephritis. Secondary objectives included evaluation of the effect of abetimus on C3 levels, anti–double-stranded DNA (anti-dsDNA) antibody levels, use of high-dose corticosteroids and/or cyclophosphamide, and major systemic lupus erythematosus (SLE) flare. Methods We conducted a randomized, placebo-controlled study of treatment with abetimus at 100 mg/week for up to 22 months in SLE patients. Three hundred seventeen patients with a history of renal flare and anti-dsDNA levels >15 IU/ml were randomized to a treatment group (158 abetimus, 159 placebo); 298 (94%) were enrolled in the intent-to-treat (ITT) population (145 abetimus, 153 placebo), based on the presence of high-affinity antibodies for the oligonucleotide epitope of abetimus at baseline screening. Results Abetimus did not significantly prolong time to renal flare, time to initiation of high-dose corticosteroid and/or cyclophosphamide treatment, or time to major SLE flare. However, there were 25% fewer renal flares in the abetimus group compared with the placebo group (17 of 145 abetimus-treated patients [12%] versus 24 of 153 placebo-treated patients [16%]). Abetimus treatment decreased anti-dsDNA antibody levels (P < 0.0001), and reductions in anti-dsDNA levels were associated with increases in C3 levels (P < 0.0001). More patients in the abetimus group experienced ≥50% reductions in proteinuria at 1 year, compared with the placebo group (nominal P = 0.047). Trends toward reduced rates of renal flare and major SLE flare were noted in patients treated with abetimus who had impaired renal function at baseline. Treatment with abetimus for up to 22 months was well tolerated. Conclusion Abetimus at 100 mg/week significantly reduced anti-dsDNA antibody levels but did not significantly prolong time to renal flare when compared with placebo. Multiple positive trends in renal end points were observed in the abetimus treatment group.

Background and objectives: Among hemodialysis patients, achieved hemoglobin is associated with Epoetin alfa dose and erythropoietin responsiveness. A prospective erythropoietin responsiveness measure was developed and its association with mortality evaluated. Design, setting, participants, & measurements: Data from 321 participants were used and randomized to the hematocrit normalization arm of the Normal Hematocrit Cardiac Trial. Subjects were to receive a 50% Epoetin alfa dose increase at randomization. The prospective erythropoietin responsiveness measure was defined as the ratio of weekly hematocrit change (over the 3 wk after randomization) per Epoetin alfa dose increase (1000 IU/wk) corresponding to the mandated 50% dose increase at randomization. The distribution of responsiveness was divided into quartiles. Over a 1-yr follow-up, Cox proportional hazard modeling evaluated associations between this responsiveness measure and mortality. Results: Erythropoietin responsiveness values ranged from −2.1% to 2.4% per week per 1000 IU. Although subjects were similar across response quartiles, mortality ranged between 14% and 34% among subjects in the highest and lowest response quartiles (P = 0.0004), respectively. After adjusting for baseline prognostic indicators, highest versus lowest responsiveness was associated with a hazard ratio of 0.41 (95% confidence interval, 0.20 to 0.87). Conclusion: Lower erythropoietin responsiveness is a strong, independent predictor of mortality risk and should be considered when evaluating associations between clinical outcomes and potential prognostic indicators, such as Epoetin alfa dose and achieved hemoglobin values.

This study assessed the hypothesis that the clinic site of service socioeconomic status (SES) represents an unmeasured confounder for clinical outcome comparisons between dialysis clinics and provider types, using data from the federal pay-for-performance program for end-stage renal disease. A total of 6506 dialysis facilities were categorized by clinic SES status (rurality and poverty status). Clinics were then grouped by provider type (chain size and tax status). Lastly, performance penalties were determined by each of these classifications. Findings were that 7.4% of dialysis clinics could be classified as being in rural locations, and 20.6% could be classified as being in high-poverty locations. Large dialysis organizations served more rural (65%) and high-poverty areas (metropolitan, 69%; micropolitan, 75%; rural, 75%) compared to other providers (medium, small, hospital/university). For-profit providers accounted for a majority of dialysis clinics in rural areas (78%) and high poverty areas (metropolitan, 84%; micropolitan, 85%; rural, 90%). This study found that dialysis clinic performance penalties did vary by SES, with poorer outcomes observed for clinic locations with lower SES. This finding, along with the nonrandom distribution of provider types by SES status, suggests that clinic and provider location SES may need to be considered when comparing providers.

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.

It is unknown to what degree physicians adjust erythropoietin doses to achieve hemoglobin levels (11.0 to 12.0 g/dL [110 to 120 g/L]) recommended by the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) for patients with end-stage renal disease receiving hemodialysis. Our objective is to examine epoetin alfa prescribing patterns for achieving the target hemoglobin level range in this population.Monthly hemoglobin levels and epoetin alfa doses from 2 large databases were retrospectively analyzed. One data set comprised 31,267 patients from the Fresenius Medical Care-North America (FMC-NA) database, and the other comprised 128,761 patients based on claims for Medicare services.Longitudinal evaluation of the FMC-NA data set showed that hemoglobin levels in patients administered epoetin alfa cycled in and out of the NKF-K/DOQI hemoglobin target range, and doses were decreased in 98.8% of patients with persistent hemoglobin levels greater than 12.0 g/dL (120 g/L). Hemoglobin levels in patients from the Medicare data set that initially were outside the target range migrated into the range with epoetin alfa dose titration. FMC-NA patients with a 3-month average hemoglobin level less than 11.0 g/dL (110 g/L) were administered significantly greater epoetin alfa doses than those with average hemoglobin levels greater than 12.0 g/dL (120 g/L; 21,838 versus 13,503 U/wk; P0.0001). Less than 0.4% of patients administered epoetin alfa were persistently anemic (hemoglobin11.0 g/dL [110 g/L]) and were administered persistently high doses (30,000 U/wk), but failed to respond with a 0.5-g/dL or greater (or = 5-g/L) increase in hemoglobin levels.In these analyses, few hemodialysis patients experienced persistent anemia while being administered high epoetin alfa doses. Physicians appeared to appropriately adjust doses to achieve hemoglobin levels recommended by the NKF-K/DOQI guidelines.

Background: The influence of intravenous drug abuse (IVDA) on hemodialysis access placement practices and access survival in HIV-infected patients is unknown. Methods: We conducted a retrospective study of 60, HIV seropositive, maintenance hemodialysis patients. Type of access and assisted access survival (measured from date of placement) were compared in those with (77%) and without (23%) a history of IVDA. Results: Mean age was 37.8 years, mean baseline serum albumin was 2.9 g/dl and median CD4 count was 222 cells/mm3. Fifteen patients, all IVDA, were dialyzed using only tunneled catheters (median number of catheters per person (range): 2.5 (1–11)). There were longer delays in creation of a permanent access (p = 0.08), but no difference in the type of permanent access placed in IVDA versus the non-IVDA group. Over 1,051 cumulative months of access follow-up, 134 tunneled catheters, 28 grafts and 19 fistulae were placed, with observed failure rates of 1 per 4.7 access-months, 1 per 19.7 access-months, 1 per 38.2 access-months, respectively. The adjusted relative hazard of access failure for grafts versus catheters was 0.41 (95% CI: 0.23, 0.72; p = 0.002) and for fistulae versus catheters was 0.21 (95% CI: 0.08, 0.52; p = 0.001). Thirty-two percent of accesses were removed due to infection, an infection removal rate for catheters of 1 per 7.8 access-months and for grafts of 1 per 62.5 access-months; all graft infections occurred in the IVDA group. No fistula was removed due to infection. Conclusion: Fistulae are the first line of choice for hemodialysis access in HIV-seropositive patients regardless of IVDA history; if not feasible, graft placement in non-IVDA or abstinent IVDA patients is recommended. In those with active IVDA, the optimal method of renal replacement therapy and type of hemodialysis access remain uncertain.

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Acid anhydrides are considered as important reagents in organic and peptide synthesis and in recent years for the formation of prodrugs and biomaterials for controlled release of drugs. This article highlights the analysis of mixed anhydrides and polyanhydrides synthesized by various methods. Analytical methods including HPLC, GLC, 1 H NMR and IR spectroscopy are described for the determination of anhydride hydrolysis and amidation.

Background The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. Study Design Observational cohort study using US Renal Data System data. Setting & Participants Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. Index Tests 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. Reference Test None. Results Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. Limitations Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. Conclusions Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data.

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

The development of pleural effusions in ESRD patients is a relatively common occurrence. Uremia, currently a rare cause of effusion, can lead to the development of hemorrhagic pleural fluid collections in patients who are underdialyzed. Uremic pleural effusions should be considered when common etiologies of effusions such as volume overload, congestive heart failure (CHF), infection, and malignancy have been excluded. Uremia-associated serosal injury allows transudation of fluid into the pleural space, and defective platelet function contributes to the hemorrhagic nature of the effusion. Although uremic effusions may occur less frequently in peritoneal dialysis patients, we present a patient who developed this complication due to a peritoneal dialysis regimen that was inadequate by current Dialysis Outcomes Quality Initiative guidelines. The pleural effusion resolved with an intensified dialysis regimen in the absence of a change in the underlying volume status.