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Rationale & Objective: Missed hemodialysis (HD) treatments not due to hospitalization have been associated with poor clinical outcomes and related in part to treatment nonadherence. Using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) phase 5 (2012-2015), we report findings from an international investigation of missed treatments among patients prescribed thrice-weekly HD., Study Design: Prospective observational study., Setting & Participants: 8,501 patients participating in DOPPS, on HD therapy for more than 120 days, from 20 countries. Longitudinal and cross-sectional analyses were performed based on the 4,493 patients from countries in which 4-month missed treatment risk was > 5%., Predictors: The main predictor of patient outcomes was 1 or more missed treatments in the 4 months before DOPPS phase 5 enrollment; predictors of missed treatments included country, patient characteristics, and clinical factors., Outcomes: Mortality, hospitalization, laboratory measures, patient-reported outcomes, and 4-month missed treatment risk., Analytical Approach: Outcomes were assessed using Cox proportional hazards, logistic, and linear regression, adjusting for case-mix and country., Results: The 4-month missed treatment risk varied more than 50-fold across all 20 DOPPS countries, ranging from < 1% in Italy and Japan to 24% in the United States. Missed treatments were more likely with younger age, less time on dialysis therapy, shorter HD treatment time, lower Kt/V, longer travel time to HD centers, and more symptoms of depression. Missed treatments were positively associated with all-cause mortality (HR, 1.68; 95% CI, 1.37-2.05), cardiovascular mortality, sudden death/cardiac arrest, hospitalization, serum phosphorus level > 5.5mg/dL, parathyroid hormone level > 300pg/mL, hemoglobin level < 10g/dL, higher kidney disease burden, and worse general and mental health., Limitations: Possible residual confounding; temporal ambiguity in the cross-sectional analyses., Conclusions: In the countries with a 4-month missed treatment risk > 5%, HD patients were more likely to die, be hospitalized, and have poorer patient-reported outcomes and laboratory measures when 1 or more missed treatments occurred in a 4-month period. The large variation in missed treatments across 20 nations suggests that their occurrence is potentially modifiable, especially in the United States and other countries in which missed treatment risk is high., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Most patients with end-stage renal disease depend on intermittent hemodialysis to maintain levels of serum potassium and other electrolytes within a normal range. However, one of the challenges has been the safety of using a low-potassium dialysate to achieve that goal, given the concern about the effects that rapid and/or large changes in serum potassium concentrations may have on cardiac electrophysiology and arrhythmia. Additionally, in this patient population, there is a high prevalence of structural cardiac changes and ischemic heart disease, making them even more susceptible to acute arrhythmogenic triggers. This concern is highlighted by the knowledge that about two-thirds of all cardiac deaths in dialysis are due to sudden cardiac death and that sudden cardiac death accounts for 25% of the overall death for end-stage renal disease. Developing new approaches and practice standards for potassium removal during dialysis, as well as understanding other modifiable triggers of sudden cardiac death, such as other electrolyte components of the dialysate (magnesium and calcium), rapid ultrafiltration rates, and safety of a number of medications (ie, drugs that prolong the QT interval or use of digoxin), are critical in order to decrease the unacceptably high cardiac mortality experienced by hemodialysis-dependent patients., (Published by Elsevier Inc.)

Background: Patterns of early outcomes in peritoneal dialysis (PD) are not well studied and dialysis providers need to establish a baseline of key outcomes for continuous quality improvement initiatives., Study Design: Retrospective cohort study., Setting & Participants: Incident PD patients from Fresenius Medical Care, North America from January 1 through December 31, 2009., Factors: Case-mix, comorbid illness, and baseline laboratory values., Outcomes: Death, hospitalization, peritonitis, and switch to hemodialysis (HD) within the first year on PD therapy., Measurements: Event rates and outcome predictors., Results: Of 1,677 incident PD patients, 1,313 started on PD therapy and 367 switched from HD therapy within the first 90 days. Normalized first-year event rates for mortality, switch to HD therapy, peritonitis, and hospitalization were 10, 27, 42, and 128 per 100 patient-years, respectively. 336 of 463 (72.6%) first peritonitis episodes and 637 of 939 (67.8%) first hospitalizations occurred within the first 6 months of PD treatment. Black race, higher body mass index, non-Hispanic ethnicity, peripheral vascular disease, and low weekly Kt/V associated with peritonitis risk. Dialysis vintage, female sex, diabetes, congestive heart failure, peripheral vascular disease, and history of limb amputation along with lower laboratory values for albumin, hemoglobin, and phosphorus and weekly Kt/V associated with hospitalization. Switchers to HD therapy (n=350) used central venous catheters 81.4% of the time as initial access (still 78.3% at 90 days later) because of lack of permanent access., Limitations: Residual confounding from unmeasured variables and exclusion of patients with a training day but who never started home PD therapy., Conclusions: Despite low first-year mortality, incident PD patients had high morbidity, particularly within the first 3-6 months. Increased focus to identify patients at greatest risk for peritonitis and hospitalization, as well as evaluation of care processes and implementation of preventive strategies, is required. Access planning for transition to HD therapy needs more attention, even during the first PD year., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Hemodialysis (HD) access is considered a critical and actionable determinant of morbidity, with a growing literature suggesting that initial HD access type is an important marker of long-term outcomes. Accordingly, we examined HD access during the incident dialysis period, focusing on infection risk and successful fistula creation during the first dialysis year., Study Design: Longitudinal cohort., Setting & Participants: All US adults admitted to Fresenius Medical Care North America facilities within 15 days of first maintenance dialysis session between January 1 and December 31, 2007., Predictor: Vascular access type at HD therapy initiation., Outcomes: Vascular access type at 90 days and at the end of the first year on HD therapy, bloodstream infection within the first year by access type, and catheter complication rate., Results: Of 25,003 incident dialysis patients studied, 19,622 (78.5%) initiated dialysis with a catheter; 4,151 (16.6%), with a fistula; and 1,230 (4.9%), with a graft. At 90 days, 14,105 (69.7%) had a catheter, 4,432 (21.9%) had a fistula, and 1,705 (8.4%) had a graft. Functioning fistulas and grafts at dialysis therapy initiation had first-year failure rates of 10% and 15%, respectively. Grafts were seldom replaced by fistulas (3%), whereas 7,064 (47.6%) of all patients who initiated with a catheter alone still had only a catheter at 1 year. Overall, 3,327 (13.3%) patients had at least one positive blood culture during follow-up, with the risk being similar between the fistula and graft groups, but approximately 3-fold higher in patients with a catheter (P<0.001 for either comparison). Nearly 1 in 3 catheters (32.5%) will require tissue plasminogen activator use by a median of 41 days, with 59% requiring more than one tissue plasminogen activator administration., Limitations: Potential underestimation of bacteremia because follow-up blood culture results did not include samples sent to local laboratories., Conclusions: In a large and representative population of incident US dialysis patients, catheter use remains very high during the first year of HD care and is associated with high mechanical complication and bloodstream infection rates., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Insufficient clinical data exist to determine whether provision of oral nutritional supplements during dialysis can improve survival in hypoalbuminemic maintenance hemodialysis patients., Study Design: Retrospective matched-cohort study., Setting & Participants: All oral nutritional supplement program-eligible in-center maintenance hemodialysis patients with albumin level ≤3.5 g/dL in quarter 4 of 2009 without oral nutritional supplements in the prior 90 days at Fresenius Medical Care, North America facilities., Quality Improvement Plan: Monitored intradialytic oral nutritional supplements were provided to eligible maintenance hemodialysis patients upon physician order, to continue for a year or until serum albumin level was ≥4.0 g/dL., Outcome: Mortality (including deaths and withdrawals), followed up until December 31, 2010., Measurements: Both an intention-to-treat (ITT) and an as-treated analysis was performed using a 1:1 geographic region and propensity score-matched study population (using case-mix, laboratory test, access type, 30-day prior hospitalization, and incident patient status) comparing patients treated with intradialytic oral nutritional supplements with usual-care patients. Cox models were constructed, unadjusted and adjusted for facility standardized mortality ratio and case-mix and laboratory variables., Results: The ITT and as-treated analyses both showed lower mortality in the oral nutritional supplement group. The conservative ITT models with 5,227 matched pairs had 40% of controls subsequently receiving oral nutritional supplements after January 1, 2010 (because many physicians delayed participation), with comparative death rates of 30.1% versus 30.4%. The corresponding as-treated (excluding crossovers) death rates for 4,289 matched pairs were 30.9% versus 37.3%. The unadjusted ITT mortality HR for oral nutritional supplement use was 0.95 (95% CI, 0.88-1.01), and the adjusted HR was 0.91 (95% CI, 0.85-0.98); the corresponding as-treated HRs were 0.71 (95% CI, 0.66-0.76) and 0.66 (95% CI, 0.61-0.71) before and after adjustment, respectively., Limitations: Limited capture of oral nutritional supplement intake outside the facility and potential residual confounding from unmeasured variables, such as dietary intake., Conclusions: Maintenance hemodialysis patients with albumin levels ≤3.5 g/dL who received monitored intradialytic oral nutritional supplements showed survival significantly better than similar matched patient controls, with the as-treated analysis highlighting the potentially large effect of this strategy in clinical practice., (Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Patients' education about transplant, hemodialysis (HD), peritoneal dialysis (PD), and conservative care often is provided by nephrologists as needed and occurs as time allows., Study Design: Quality improvement report., Setting & Participants: Attendees of a national treatment options program (TOPs) who initiated long-term dialysis therapy (median, 3.4 months) at Fresenius Medical Care, North America facilities throughout 2008 were compared with period-prevalent incident patients receiving usual care., Quality Improvement Plan: Standardized predialysis treatment options education., Outcomes: Rates of opting for PD modality, arteriovenous HD access at initiation, and early (90-day) mortality risk., Measurements: Logistic regression (for choice of PD and HD access type) and Cox models (for early mortality) were constructed, including a 1:1 matched cohort. A post hoc sensitivity analysis also compared a propensity score-matched cohort., Results: 3,165 TOPs attendees (10.5% of 30,217 incident patients admitted between January 1 and December 31, 2008), were younger, more likely to be white, and had slightly larger body surface area. The unadjusted OR for TOPs attendees for selecting PD therapy was 8.45 (95% CI, 7.63-9.37) with a case-mix plus laboratory-adjusted OR of 5.13 (95% CI, 3.58-7.35). For patients who opted for in-center HD therapy, the OR was 2.14 (95% CI, 1.96-2.33) and adjusted OR was 2.06 (95% CI, 1.88-2.26) for starting with a fistula or graft. The unadjusted early mortality HR was 0.51 (95% CI, 0.43-0.60) and case-mix plus laboratory-adjusted adjusted HR was 0.61 (95% CI, 0.50-0.74) for TOPs attendees (all outcomes, P < 0.001). These results were consistent in the 1:1 matched analysis and propensity score-matched analysis., Limitations: It is possible that physicians who referred to these programs were more likely to prescribe PD therapy or place arteriovenous accesses. Motivated, treatment-adherent patients (who would have better outcomes) may have self-selected to attend education sessions., Conclusion: Attending an options class predialysis was associated with more frequent selection of home dialysis, fewer tunneled HD catheters, and lower mortality risk during the first 90 days of dialysis therapy., (Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Incremental achievement of quality indicator goals has been associated with progressive improvement in mortality and hospitalization risk in hemodialysis (HD) patients., Study Design: Descriptive cross-sectional study., Setting & Participants: All 33,879 HD patients treated at Fresenius Medical Care North America facilities for >90 days with scorable 36-Item Short Form Health Survey responses from January 1, 2006, to December 31, 2006., Predictor: We hypothesized that achieving up to 5 HD goals before the survey (albumin >or= 4.0 g/dL, hemoglobin of 11-12 g/dL, equilibrated Kt/V >or= 1.2, phosphorus of 3.5-5.5 mg/L, and absence of HD catheter) results in better self-reported quality of life (QoL)., Outcomes & Measurements: Distributions of Physical and Mental Component Summary (PCS/MCS) scores within and across quality indicator categories determined during the prior 90 days from survey date (compared using analysis of covariance and linear regression models, with adjustment for case-mix and each of the quality indicators)., Results: Incremental achievement of up to 5 goals was associated with progressively higher PCS and MCS scores (both P for trend < 0.001). Compared with patients meeting all 5 goals (n = 4,208; reference group), case-mix-adjusted PCS score was lower by 1.8 point with only 4 goals met (n = 11,785), 3.4 points for 3 goals (n = 10,906), 4.9 points for 2 goals (n = 5,119), 5.9 points for 1 goal (n = 1,592), and 7.8 points in the 269 patients who failed to meet any goal (each P < 0.001 vs the reference group). The corresponding decreases in case-mix-adjusted MCS scores were 1.0 point for 4 goals met, 1.7 point for 3 goals, 2.3 points for 2 goals, 3.0 points for 1 goal, and 4.7 points with no goal met, with each P < 0.001 compared with the MCS score from patients who achieved all 5 goals., Limitations: Potential residual confounding from unmeasured covariates., Conclusion: Patients progressively meeting more quality goals report incrementally better QoL. Further studies are needed to determine whether prospective achievement of quality goals will result in improved QoL for HD patients.

Background: We hypothesized that a change from central venous catheters to a fistula or graft would improve short-term mortality risk in maintenance hemodialysis patients., Design: Prospective observational study., Setting & Participants: All maintenance in-center hemodialysis patients treated in Fresenius Medical Care, North America legacy facilities alive on January 1, 2007 with baseline laboratory data from December 2006., Predictor: Access type (fistula, catheter, or graft), determined on December 31, 2006, and monthly thereafter. Conversion from a catheter to a fistula or graft during the 4-month period from January 1 to April 30, 2007., Outcome: Mortality was tracked from May 1, 2007, to December 31, 2007. Standard and time-dependent Cox models were used to determine hazard risks (HRs) of death with and without adjustment for case-mix and laboratory values., Results: At baseline, 79,545 patients had 43% fistulas, 29% catheters, and 27% grafts. Mean age was 62 +/- 15 years, 54% were men, 51% were white, and 53% had diabetes. Compared with fistulas, unadjusted HRs of death were higher for grafts (1.22) and catheters (1.76; P < 0.001). In adjusted models, overall risk for grafts was decreased to 1.05 (95% limits, 1.003-1.100; P < 0.05) and approached that for fistulas consistently across multiple strata. Compared with patients who continued using a catheter, those who converted to either a graft or fistula had an HR of 0.69, whereas those who converted from a graft or fistula to a catheter had increased HRs to 2.12 (both P < 0.001). Similar trends were observed in the subset of incident patients (vintage < 90 days at study onset)., Limitations: Observational design with residual confounding from unmeasured patient, facility, and treatment-related factors., Conclusions: Catheters have the worst associated mortality risk. Changing from a catheter to a fistula or graft is associated with significantly improved survival. The risk for grafts approached that of fistulas, providing an alternative to prolonged catheter exposure and potentially less hazardous "bridge" toward a fistula.

Background: We evaluated whether incremental achievement of up to 8 facility quality goals was associated with improvement in facility-specific mortality and hospitalization rates., Study Design: Prospective observational study., Setting & Participants: 1,085 Fresenius Medical Care, North America facilities providing hemodialysis (HD) for 25 or more patients during January 2006., Measurements: The facility average for the period up to December 31, 2006, was used to determine achievement of each goal for equilibrated Kt/V, missed HD treatments, hemoglobin level, bicarbonate level, albumin level, phosphorus level, fistulae, and HD catheters. Linear regression models were used to relate facility-wide achievement of goals with facility-specific hospital days and standardized mortality ratios., Results: Most facilities (64%) achieved 2 to 4 of 8 goals, with only 8% meeting more than 5 quality goals. Achieving more than 5 goals averaged 3.5 fewer hospital days/patient-year and 20% lower standardized mortality ratios (all P < 0.001). The incremental number of goals met also was associated with improvement in facility mortality (P < 0.001) and hospital days (P < 0.001). Catheter and albumin level goals were achieved least (6% and 9% of facilities, respectively), but they had the best outcomes. Facilities achieving more than 5 goals had older patients (64.0 versus 61.5 years; P < 0.001), fewer African American patients (16% versus 38%; P < 0.001), and fewer women (44% versus 46%; P = 0.003) compared with the average., Limitations: Observational design with residual confounding from unmeasured patient-, facility-, and treatment-related factors., Conclusions: Achieving more facility quality goals was significantly associated with better facility-based measurements of patient outcomes. Although these results do not establish a causal relationship, findings agree with the present practice of monitoring facility performance for continuous quality improvement.

Background: To determine the most significant potentially actionable clinical variables associated with mortality and hospitalization risk in hemodialysis (HD) patients., Study Design: Cohort study., Setting & Participants: Adult maintenance HD patients in the Fresenius Medical Care, North America database as of January 1, 2004, with baseline information from October 1, 2003, to December 31, 2003, comprising approximately 26% of the US HD population., Predictors: Case-mix (age, sex, race, diabetes, vintage, and body surface area), vascular access, and laboratory (albumin, equilibrated Kt/V, hemoglobin, calcium, phosphorus, creatinine, bicarbonate, biointact parathyroid hormone, transferrin saturation, and white blood cell count) variables., Outcomes: 1-year mortality and hospitalization risk from January 1 to December 31, 2004., Measurements: Cox proportional hazards models for death and hospitalization., Results: The cohort (N = 78,420) had a mean age of 61.4 +/- 15.0 years, 47% were women, 49% were white, 41% were black race (10% defined as "other"), and 52% had diabetes. The top 5 actionable variables were the same for mortality and hospitalization. Final case-mix plus laboratory-adjusted hazard ratios for these top 5 actionable variables indicate 177% increased risk of death and 67% increased risk of hospitalization per 1-g/dL decrease in albumin level, 39% and 45% greater risk with catheters compared with fistulas, 18% and 9% greater risk per 1-mg/dL greater phosphorus level, 11% and 9% lower risk per 1-g/dL greater hemoglobin level, and 5% and 2% greater risk per 0.1-unit decrease in equilibrated Kt/V, respectively (all P < 0.0001)., Limitations: Observational cross-sectional study with limited comorbidity adjustment (for diabetes)., Conclusion: The same variables are associated with both mortality and hospitalization in HD patients. The top 5 potentially actionable variables are readily identifiable, with albumin level and catheter use the most prominent, and all 5 are appropriate targets for improvement.

Background: Medicare data indicate that black hemodialysis patients receive greater doses of erythropoietin (EPO) than white patients when achieving similar hemoglobin levels. We confirmed and evaluated this observed association between race and EPO dose., Study Design: Cross-sectional cohort study., Setting & Participants: Primary Medicare-insured white (57%) and black (43%) adult long-term hemodialysis patients treated by Fresenius Medical Care who received EPO from January 1 to 31, 2004 (N = 44,721)., Predictor: White/black race., Outcomes: Average weekly EPO dose., Measurements: Associations between race and baseline demographic and laboratory variables were evaluated by using logistic and linear regression models. Correlates of log-transformed weekly EPO dose were determined using linear regression models., Results: Black patients received 12.6% more EPO than white patients (95% limits, 10.9% to 14.3%; P < 0.001). This racial difference in EPO dose was observed across similar hemoglobin levels despite fewer catheters (P < 0.001) and fewer prior hospitalization events in black patients (P = 0.002). Black patients were younger and had larger body size and greater albumin and biointact parathyroid hormone levels, but lower equilibrated Kt/V and white blood cell counts (all P < 0.001). In the 95th percentile of EPO dose (those receiving > 60,000 U/wk), there was a greater proportion of black patients (6% of total black population compared with only 4% in all white patients; P < 0.001). The difference in EPO dose between black and white patients was modified by age and was significant at ages younger than 45 and 65 years or older., Limitations: Observational study limited to white and black adult Medicare patients only, correlating with EPO doses from a single month, without adjustment for comorbid conditions., Conclusions: Black patients were administered approximately 12% greater EPO doses than white patients while achieving similar hemoglobin levels. We identified variables that differed across race that may explain this difference, but they were either not actionable or presented limited opportunity for intervention. Additional studies are needed to define a physiological (or pathological) basis for these observations.

The success of Fistula First nationwide has been accompanied by an unplanned increase in hemodialysis catheters. Complications related to prolonged hemodialysis catheter use include increased morbidity, mortality, and cost. We hypothesize that the national focus on increasing fistulas may have inadvertently diverted attention away from initiatives to decrease dependence on hemodialysis catheters. Based on a synthesis of guidelines, reviews, published evidence, and the authors' opinions, we propose that the national vascular access initiative be revised to have a dual goal of Fistula First and "Catheters Last." These goals are not mutually exclusive, but rather complementary. We recommend a systematic refocus on interventions that not only increase fistulas, but help avoid extended catheter use. Clearly, the ideal practice for hemodialysis vascular access remains early placement of fistulas with enough maturation time such that they can be used for initiating long-term hemodialysis therapy when the need arises. To effect this change, a reimbursement policy covering the costs associated with permanent access placement before the need for dialysis is essential. Individualized patient management strategies may consider such innovative approaches as initiating patients on peritoneal dialysis therapy or using nonautogenous grafts as bridge accesses in lieu of catheters. For patients who are dialyzing using catheters, immediate active planning for permanent access placement and removal of the catheter is necessary. In the same vein as Fistula First, the renal community should once again be galvanized in working together toward controlling the catheter epidemic in our dialysis population.

Background: Protein-calorie malnutrition is highly prevalent in patients with chronic renal failure and on chronic dialysis therapy. Longitudinal studies evaluating nutritional outcomes after the initiation of chronic dialysis therapy in incident dialysis patients are limited., Methods: This prospective cohort study evaluated time-dependent changes in several well-defined markers of nutritional status before and after initiation of chronic hemodialysis therapy. Fifty incident hemodialysis (HD) patients (60% men, 38% white, 32% with insulin-dependent diabetes mellitus) were studied. Multiple nutritional markers, including biochemical parameters and analysis of body composition, were assessed before the initial outpatient CHD treatment and every 3 months thereafter for 12 months., Results: At baseline, nutritional markers correlated well with each other. After the initiation of HD therapy, there were marked improvements in most nutritional parameters, including serum albumin, serum prealbumin, normalized protein catabolic rate, fat mass, reactance, and phase angle (P < 0.05 for all). Improvements in nutritional parameters were influenced by baseline nutritional status; ie, baseline nutritional parameters were predictors of their end-of-study value., Conclusion: Initiation of CHD therapy is associated with improvements in most nutritional markers. Nutritional benefits of increased solute clearance provided by the initiation of chronic dialysis therapy prevail over its potential catabolic effects. However, the extent of improvement was dependent on nutritional status at the time of initiation of dialysis therapy, which remained an important determinant of subsequent nutritional improvements during the first year of treatment., (Copyright 2002 by the National Kidney Foundation, Inc.)