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Objective: To examine the prognostic values of systemic immune-inflammation indices of hemodialysis (HD) vascular access failure and develop a prediction model for vascular access failure based on the most pertinent systemic immune-inflammation index., Study Design: A prospective cohort study., Setting & Participants: Patients undergoing autogenous HD vascular access surgeries or arteriovenous graft as a permanent hemodialysis access in a tertiary center in southwest China from January 2020 to June 2022., Predictors: Systemic immune-inflammation indices, including NLR, dNLR, AAPR, SIRI, SII, PNI, PLR, and LIPI, and clinical variables., Outcomes: The outcome was defined as survival of the hemodialysis access, with both occluded and stenotic access being considered as instances of access failure., Analytical Approach: Cox proportional hazard regression model., Results: 2690 patients were included in the study population, of whom 658 experienced access failure during the follow-up period. The median duration of survival for HD vascular access was 18 months. The increased systemic immune-inflammation indices, including dNLR, NLR, SII, PNI, SIRI, PLR, and LIPI, are predictive of HD access failure, with SII demonstrating the strongest prognostic value. A simple SII-based prediction model for HD access failure was developed, achieving C-indexes of 0.6314 (95% CI: 0.6249 - 0.6589) and 0.6441 (95% CI: 0.6212 - 0.6670) for predicting 6- and 12-month access survival, respectively., Conclusions: Systemic immune-inflammation indices are significantly and negatively associated with HD vascular access survival. A simple SII-based prediction model was developed and anticipates further improvement through larger study cohort and validation from diverse centers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ren, Xv, Wang, Xiao, Yu, Tang, Yang, Meng, Zhang, Zhang, He, Li, Gallagher and Feng.)

Background/aims: To examine how measuring adherence at 3 weeks by self-report and pill counts compares to measurements at 7 weeks in a pre-randomization run-in period., Methods: Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks., Results: 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p < 0.001)., Conclusions: Three and seven-week run-in periods and both self-reported and pill count assessments performed similarly., Trial Registration: ClinicalTrials.gov Identifier: NCT03020303., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aim: Extended hours haemodialysis is associated with superior survival to standard hours. However, residual confounding limits the interpretation of this observation. We aimed to determine the effect of a period of extended hours dialysis on long-term survival among participants in the ACTIVE Dialysis trial., Methods: Two-hundred maintenance haemodialysis recipients were randomized to extended hours dialysis (median 24 h/wk) or standard hours dialysis (median 12 h/wk) for 12 months. Further pre-specified observational follow up occurred at 24, 36 and 60 months. Vital status and modality of renal replacement therapy were ascertained., Results: Over the 5 years, 38 participants died, 30 received a renal transplant, and 6 were lost to follow up. Total weekly dialysis hours did not differ between standard and extended groups during the follow-up period (14.1 hours [95%CI 13.4-14.8] vs 14.8 hours [95%CI 14.1-15.6]; P = .16). There was no difference in all-cause mortality (hazard ratio for extended hours 0.91 [95%CI 0.48-1.72]; P = .77). Similar results were obtained after censoring participants at transplantation, and after adjusting for potential confounding variables. Subgroup analysis did not reveal differences in treatment effect by region, dialysis setting or vintage (P-interaction .51, .54, .12, respectively)., Conclusion: Twelve months of extended hours dialysis did not improve long-term survival nor affect dialysis hours after the intervention period. An urgent need remains to further define the optimal dialysis intensity across the broad range of dialysis recipients., (© 2020 Asian Pacific Society of Nephrology.)

Background: The influence of health insurance systems on the treatment of end-stage kidney disease (ESKD) patients ispoorly understood., Aim: We investigated how supplemental private health insurance (PHI) coverage impacted ESKD treatment modalitiesand patient outcomes. The influence of health insurance systems on the treatment of end-stage kidney disease (ESKD) patients is poorly understood. We investigated how supplemental private health insurance (PHI) coverage impacted ESKD treatment modalities and patient outcomes., Methods: All adult patients commencing ESKD treatment in New South Wales, Australia from 2000 to 2010 were identified using the Australia and New Zealand Dialysis and Transplant Registry. Data were linked to the state hospitalisation dataset to obtain insurance status, allowing the comparisons of mortality, ESKD treatment modality and health service utilisation between privately insured and public patients., Results: The cohort of 5737 patients included 38% (n = 2152) with PHI. At 1 year after ESKD treatment initiation, PHI patients had lower mortality (hazard ratio 0.84, 95% confidence interval (CI) 0.74-0.95, P = 0.01), were more likely to be receiving home haemodialysis (HD) (odds ratio (OR) 1.38, 95% CI 1.01-1.89, P = 0.04), to have been transplanted (OR 1.75, 95% CI 1.25-2.46, P = 0.001) and used fewer hospital days (incidence rate ratio 0.85, 95% CI 0.74-0.96, P = 0.01). After adjustment, PHI patients were more likely to initiate ESKD treatment with facility-based HD (OR 1.22, 95% CI 1.01-1.46, P = 0.03) but were less likely to be started on peritoneal dialysis (OR 0.81, 95% CI 0.67-0.98, P = 0.03)., Conclusion: Our findings suggest that supplemental PHI in Australia is associated with lower-risk ESKD treatment attributes and improved health outcomes. A greater understanding of the treatment pathways that deliver these outcomes may inform treatment for the broader ESKD treatment population., (© 2019 Royal Australasian College of Physicians.)

Background and Objectives: Little is known about the effect of changes in dialysis hours on patient-reported outcome measures. We report the effect of doubling dialysis hours on a range of patient-reported outcome measures in a randomized trial, overall and separately for important subgroups., Design, Setting, Participants, & Measurements: The A Clinical Trial of IntensiVE Dialysis trial randomized 200 participants to extended or standard weekly hours hemodialysis for 12 months. Patient-reported outcome measures included two health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score). Outcomes were assessed as the mean difference from baseline using linear mixed effects models adjusted for time point and baseline score, with interaction terms added for subgroup analyses. Prespecified subgroups were dialysis location (home- versus institution-based), dialysis vintage (≤6 months versus >6 months), region (China versus Australia, New Zealand, Canada), and baseline score (lowest, middle, highest tertile). Multiplicity-adjusted P values (Holm-Bonferroni) were calculated for the main analyses., Results: Extended dialysis hours was associated with improvement in Short Form-6 Dimension (mean difference, 0.027; 95% confidence interval [95% CI], 0.00 to 0.05; P =0.03) which was not significant after adjustment for multiple comparisons ( P adjusted =0.05). There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P =0.2; P adjusted =0.2) or in quality-adjusted life years. There were small positive differences in generic and disease-specific quality of life: Physical Component Summary (mean difference, 2.3; 95% CI, 0.6 to 4.1; P =0.01; P adjusted =0.04), Mental Component Summary (mean difference, 2.5; 95% CI, 0.5 to 4.6; P =0.02; P adjusted =0.05) and Kidney Disease Component Score (mean difference, 3.5; 95% CI, 1.5 to 5.5; P =0.001; P adjusted =0.005). The results did not differ among predefined subgroups or by baseline score., Conclusions: The effect of extended hours hemodialysis on patient-reported outcome measures reached statistical significance in some but not all measures. Within each measure the effect was consistent across predefined subgroups. The clinical importance of these differences is unclear., (Copyright © 2019 by the American Society of Nephrology.)

Background: The creation and maintenance of dialysis vascular access is associated with significant morbidity. Structured management pathways can reduce this morbidity, yet practice patterns in Australia and New Zealand are not known. We aimed to describe the arteriovenous access practices in dialysis units in Australia and New Zealand., Methods: An online survey comprising 51 questions was completed by representatives from dialysis units from both countries. In addition to descriptive analysis, responses were compared between units inside and outside of major cities., Results: Of 64 contacted units, 48 (75%) responded (Australia 43, New Zealand 5), representing 38% of dialysis units in Australia and New Zealand. While 94% of units provided pre-dialysis education, only 60% reported a structured pre-dialysis pathway and 69% had a dedicated vascular access nurse. Most units routinely monitored fistula/graft function using flow rate measurement (73%) or recirculation studies (63%). A minority used routine ultrasound (35%). Thrombectomy, fistuloplasty and peritoneal dialysis catheter insertion were rarely performed by nephrologists (4%, 4% and 17% of units, respectively). Units outside of a major city were less likely to have access to a local vascular access surgeon (6/13 (46%) vs 35/35 (100%), P < 0.001). There were no other significant differences between units on the basis of location., Conclusion: Much variation exists in unit management of arteriovenous access. Structured pre-dialysis pathways and dedicated vascular access nurses may be underutilised in Australia and New Zealand. The use of regular access blood flow measurement and ultrasound is common in both countries despite a lack of data supporting its effectiveness. There is room for both practice improvement and a need for further evidence to ensure optimal arteriovenous access care.

Background: Mortality in intensive care unit (ICU) patients with acute kidney injury (AKI) remains high. Previous studies have explored the role of HMG-CoA reductase inhibitors (statins) with variable findings., Methods: The Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Study recruited 1508 participants requiring dialysis in ICU between 2006 and 2009. Statin use was recorded at study baseline. Multivariate Cox modelling was used to assess associations of such statin use and all-cause mortality. Propensity score analysis was performed for sensitivity analysis. The primary outcome was all-cause mortality at 90 days., Results: Of the 1462 participants with the available data on statin usage, 187 (12.8%) received statin therapy at baseline. Participants who receiving statins were older (P < 0.001), less likely to have sepsis or require mechanical ventilation (P < 0.001). Multivariable analysis showed statin use did not have significant associations with mortality at both day 28 (hazard ratio (HR) = 1.053, 95% confidence interval (CI) = 0.784-1.415, P = 0.730) and day 90 (HR = 1.091, 95% CI = 0.836-1.424, P = 0.520). Propensity score analysis confirmed the lack of association between statin use and mortality at day 90 (HR = 1.042, 95% CI = 0.734-1.479, P = 0.819). However, in septic patients, multivariable analysis suggested statin therapy was associated with a trend to higher mortality at day 90 (HR = 1.688, 95% CI = 1.132-2.519, P = 0.010) and continuation of statins was associated with higher mortality (HR = 2.160, 95% CI = 1.296-3.599, P = 0.003), compared with statin withdrawal., Conclusion: In the RENAL study cohort, baseline statin use was not associated with mortality. Our findings do not support a protective role of statins in ICU patients with severe AKI. Clinical Trials registration number for the RENAL study: NCT00221013, the date of registration: September 14, 2005., (© 2019 Asian Pacific Society of Nephrology.)

Aim: Dialysis catheter-associated infections (CAI) are a serious and costly burden on patients and the health-care system. Many approaches to minimizing catheter use and infection prophylaxis are available and the practice patterns in Australia and New Zealand are not known. We aimed to describe dialysis catheter management practices in dialysis units in Australia and New Zealand., Methods: Online survey comprising 52 questions, completed by representatives from dialysis units from both countries., Results: Of 64 contacted units, 48 (75%) responded (Australia 43, New Zealand 5), representing 79% of the dialysis population in both countries. Nephrologists (including trainees) inserted non-tunnelled catheters at 60% and tunnelled catheters at 31% of units. Prophylactic antibiotics were given with catheter insertion at 21% of units. Heparin was the most common locking solution for both non-tunnelled (77%) and tunnelled catheters (69%), with antimicrobial locks being predominant only in New Zealand (80%). Eight different combinations of exit site dressing were in use, with an antibiotic patch being most common (35%). All units in New Zealand and 84% of those in Australia undertook CAI surveillance. However, only 51% of those units were able to provide a figure for their most recent rate of catheter-associated bacteraemia per 1000 catheter days., Conclusion: There is wide variation in current dialysis catheter management practice and CAI surveillance is suboptimal. Increased attention to the scope and quality of CAI surveillance is warranted and further evidence to guide infection prevention is required., (© 2018 Asian Pacific Society of Nephrology.)

Aim: Contemporary data on clinical and economic outcomes and quality of care amongst dialysis patients in India are not available. This pilot prospective study aimed to evaluate the feasibility of data collection and follow up within routine dialysis practice to inform setting up a dialysis registry., Methods: An electronic instrument was developed to collect information on clinical and socio-demographic characteristics, outcome and out-of-pocket expenditure on incident patients commencing haemodialysis (HD) at two centres. Dialysis unit staff were trained in collecting and entering information on an electronic case record form. Patients were followed up at 1, 3, 6, 9 and 12 months to ascertain outcomes and treatment related costs., Results: A total of 119 patients (37 females, age 47.5 ± 17.2 years) were enrolled. After 1 year, 38 (32%) patients were continuing on HD; 35 (29%) had died, 30 (25%) underwent a kidney transplant, and 16 (13%) had stopped dialysis. We noted a high prevalence of catastrophic health expenditure. Data collection was facilitated by appointing a designated staff member who received an incentive. Collection of financial information, clinical course for patients transferring out of the primary unit and the cause of death, when it occurred out of hospital was challenging., Conclusion: Prospective data collection of incident dialysis patients was feasible but is resource-intensive. High out-of-pocket costs force some patients to stop dialysis and can generate a sense of despair. Poor patient experiences and suspicion over the use of such data adversely affects collection of important clinical and health economic data., (© 2018 Asian Pacific Society of Nephrology.)

Background: Clinical trials are most informative for evidence-based decision making when they consistently measure and report outcomes of relevance to stakeholders. We aimed to assess the scope and consistency of outcomes reported in trials for hemodialysis., Study Design: Systematic review., Setting & Population: Adults requiring maintenance hemodialysis enrolled in clinical trials., Selection Criteria: All Cochrane systematic reviews of interventions published by August 29, 2016, and the trials published and registered in ClinicalTrials.gov since January 2011., Interventions: Any hemodialysis-related interventions., Outcomes: Frequency and characteristics of the reported outcome domains and measures., Results: From the 362 trials, we extracted and classified 10,713 outcome measures (a median of 21 [IQR, 10-39] per trial) into 81 different outcome domains, of which 42 (52%) were surrogate; 25 (31%), clinical; and 14 (17%), patient reported. The number of outcome measures reported significantly changed over time. The 5 most commonly reported domains were all surrogates: phosphate (125 [35%] trials), dialysis adequacy (120 [33%]), anemia (115 [32%]), inflammatory markers (114 [31%]), and calcium (109 [30%]). Mortality, cardiovascular diseases, and quality of life were reported very infrequently (73 [20%], 44 [12%], and 32 [9%], respectively)., Limitations: For feasibility, we included a sampling frame that included only trials identified in Cochrane systematic reviews or ClinicalTrials.gov., Conclusions: Outcomes reported in clinical trials involving adults receiving hemodialysis are focused on surrogate outcomes, rather than clinical and patient-centered outcomes. There is also extreme multiplicity and heterogeneity at every level: domain, measure, metric, and time point. Estimates of the comparative effectiveness of available interventions are unreliable and improvements over time have been inconsistent., (Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: There is no consensus whether higher intensity dose renal replacement therapy (RRT) compared with standard intensity RRT has survival benefit and achieves better renal recovery in acute kidney injury (AKI)., Methods: In an individual patient data meta-analysis, we merged individual patient data from randomized controlled trials (RCTs) comparing high with standard intensity RRT in intensive care unit patients with severe AKI. The primary outcome was all-cause mortality. The secondary outcome was renal recovery assessed as the proportion of patients who were RRT dependent at key trial endpoints and by time to the end of RRT dependence., Results: Of the eight prospective RCTs assessing different RRT intensities, seven contributed individual patient data (n = 3682) to the analysis. Mortality was similar between the two groups at 28 days [769/1884 (40.8%) and 744/1798 (41.4%), respectively; P = 0.40] after randomization. However, more participants assigned to higher intensity therapy remained RRT dependent at the most common key study point of 28 days [e.g. 292/983 (29.7%) versus 235/943 (24.9%); relative risk 1.15 (95% confidence interval 1.00-1.33); P = 0.05]. Time to cessation of RRT through 28 days was longer in patients receiving higher intensity RRT (log-rank test P = 0.02) and when continuous renal replacement therapy was used as the initial modality of RRT (log-rank test P = 0.03)., Conclusions: In severe AKI patients, higher intensity RRT does not affect mortality but appears to delay renal recovery., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) identifier ACTRN12615000394549 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000394549).

Background: Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis., Study Design: In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated., Setting & Participants: 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3., Outcomes & Measurements: Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10., Results: Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively)., Limitations: The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection., Conclusions: Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions., (Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

The relationship between increased hemodialysis hours and patient outcomes remains unclear. We randomized (1:1) 200 adult recipients of standard maintenance hemodialysis from in-center and home-based hemodialysis programs to extended weekly (≥24 hours) or standard (target 12-15 hours, maximum 18 hours) hemodialysis hours for 12 months. The primary outcome was change in quality of life from baseline assessed by the EuroQol 5 dimension instrument (3 level) (EQ-5D). Secondary outcomes included medication usage, clinical laboratory values, vascular access events, and change in left ventricular mass index. At 12 months, median weekly hemodialysis hours were 24.0 (interquartile range, 23.6-24.0) and 12.0 (interquartile range, 12.0-16.0) in the extended and standard groups, respectively. Change in EQ-5D score at study end did not differ between groups (mean difference, 0.04 [95% confidence interval, -0.03 to 0.11]; P =0.29). Extended hours were associated with lower phosphate and potassium levels and higher hemoglobin levels. Blood pressure (BP) did not differ between groups at study end. Extended hours were associated with fewer BP-lowering agents and phosphate-binding medications, but were not associated with erythropoietin dosing. In a substudy with 95 patients, we detected no difference between groups in left ventricular mass index (mean difference, -6.0 [95% confidence interval, -14.8 to 2.7] g/m 2 ; P =0.18). Five deaths occurred in the extended group and two in the standard group ( P =0.44); two participants in each group withdrew consent. Similar numbers of patients experienced vascular access events in the two groups. Thus, extending weekly hemodialysis hours did not alter overall EQ-5D quality of life score, but was associated with improvement in some laboratory parameters and reductions in medication burden. (Clinicaltrials.gov identifier: NCT00649298)., (Copyright © 2017 by the American Society of Nephrology.)

Aim: The aim is to explore (i) the relationship between quality of life and physical parameters (muscle strength and mobility) among people undergoing maintenance haemodialysis; (ii) changes in strength and mobility over time and predictors of changes; and (iii) whether strength and mobility were associated with falls., Methods: We recruited 51 maintenance haemodialysis patients to a prospective longitudinal study. Baseline quality of life was assessed using the SF-36 physical component summary and mental component summary scores. Muscle strength (ankle dorsiflexion strength measured with a hand-held dynamometer), mobility (short physical performance battery) and falls history were assessed at baseline, 12 and 36 months. Associations between variables at baseline were assessed with linear regression models. Changes in physical parameters were evaluated with paired t-tests and prediction of falls assessed by negative binominal regression., Results: Fifty and 34 patients completed 12 and 36 month follow-ups, respectively. Baseline mobility but not muscle strength correlated with physical component summary (P = 0.01 and P = 0.23, respectively). Neither baseline mobility nor muscle strength correlated with mental component summary. At 12 months, muscle strength and mobility had significantly deteriorated (mean ankle dorsiflexion strength 11.0 lb (SD 1.5) from 14.0 lb (SD 2.2), P < 0.01; short physical performance battery 8.5 (SD 2.8) from 9.3 (SD 2.6), P < 0.01). Falls at 12 and 36 months were predicted by baseline mobility (P = 0.06 and P = 0.02, respectively) but not muscle strength., Conclusion: Physical parameters appear to be associated with meaningful patient outcomes and showed measurable deterioration over relatively short time frames. Interventions, with the potential to slow physical decline in people receiving maintenance dialysis, such as exercise programmes, warrant further investigation., (© 2016 Asian Pacific Society of Nephrology.)

Aim: To compare comorbidity recording and predictive power of comorbidities for mortality between a clinical renal registry and a state-based hospitalisation dataset., Methods: All patients that started renal replacement therapy (dialysis or transplant - RRT) in New South Wales between 1/07/2001 and 31/7/2010 were identified using the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) and linked to the State Admitted Patient Data Collection (APDC) and the Death Registry. Comorbidities (diabetes mellitus, coronary artery disease (CAD), chronic lung disease, peripheral vascular disease and cerebrovascular disease) were identified at the start of RRT in both datasets and compared using kappa statistics (κ). Survival was calculated using cox proportional hazards models from the start of RRT to death date or end of study (31/07/2011). Four multivariable models were adjusted for age, gender and comorbidities to estimate the predictive power of the comorbidities as recorded in ANZDATA, APDC, either or both datasets RESULTS: We identified 6285 people (23,845 person-years follow-up). Diabetes recording had excellent agreement (94.5%, κ = 0.88), CAD had fair to good agreement (80. 6, κ = 0.56), with poor agreement between the two datasets for the other comorbidities. Deaths totalled 2594 (41.3%). Median follow up time was 3.3 years (IQR 1.7 to 5.4). All five comorbidities were powerful predictors of poor survival in all four models. All models had a similar predictive ability (Harrell's c = 0.71-0.72)., Conclusion: Variable agreement exists in comorbidity recording between the ANZDATA and APDC. The comorbidities have a similar predictive ability, irrespective of dataset of origin in an End Stage Kidney Disease (ESKD) population., (© 2015 Asian Pacific Society of Nephrology.)

Background: People with end-stage kidney disease (ESKD) have high rates of cardiovascular events. Randomised controlled trials (RCTs) of homocysteine-lowering therapies have not shown reductions in cardiovascular event rates in the general population. However, people with kidney disease have higher levels of homocysteine and may have different mechanisms of cardiovascular disease. We performed a systematic review of the effect of homocysteine-lowering therapies in people with ESKD., Objectives: To evaluate the benefits and harms of established homocysteine lowering therapy (folic acid, vitamin B6, vitamin B12) on all-cause mortality and cardiovascular event rates in patients with ESKD., Search Methods: We searched Cochrane Kidney and Transplant's Specialised Register to 25 January 2016 through contact with the Information Specialist using search terms relevant to this review., Selection Criteria: Studies conducted in people with ESKD that reported at least 100 patient-years of follow-up and assessed the effect of therapies that are known to have homocysteine-lowering properties were included., Data Collection and Analysis: Two authors independently extracted data using a standardised form. The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, incident cardiovascular disease (fatal and nonfatal myocardial infarction and coronary revascularisation), cerebrovascular disease (stroke and cerebrovascular revascularisation), peripheral vascular disease (lower limb amputation), venous thromboembolic disease (deep vein thrombosis and pulmonary embolism), thrombosis of dialysis access, and adverse events. The effects of homocysteine-lowering therapies on outcomes were assessed with meta-analyses using random-effects models. Prespecified subgroup and sensitivity analyses were conducted., Main Results: We included six studies that reported data on 2452 participants with ESKD. Interventions investigated were folic acid with or without other vitamins (vitamin B6, vitamin B12). Participants' mean age was 48 to 65 years, and proportions of male participants ranged from 50% to 98%.Homocysteine-lowering therapy probably leads to little or no effect on cardiovascular mortality (4 studies, 1186 participants: RR 0.93, 95% CI 0.70 to 1.22). There was no evidence of heterogeneity among the included studies (I² = 0%). Homocysteine-lowering therapy had little or no effect on all-cause mortality or any other of this review's secondary outcomes. All prespecified subgroup and sensitivity analyses demonstrated little or no difference. Reported adverse events were mild and there was no increase in the incidence of adverse events from homocysteine-lowering therapies (3 studies, 1248 participants: RR 1.12, 95% CI 0.51 to 2.47; I(2) = 0%). Overall, studies were assessed as being at low risk of bias and there was no evidence of publication bias., Authors' Conclusions: Homocysteine-lowering therapies were not found to reduce mortality (cardiovascular and all-cause) or cardiovascular events among people with ESKD.

Background: Catheter malfunction, including thrombosis, is associated with reduced dialysis adequacy, as well as an increased risk of catheter-related bacteraemia and mortality. The role of anticoagulants in the prevention of catheter malfunction remains uncertain., Objectives: This review aimed to compare the prophylactic effect of different anticoagulant agents, preparations, doses and administration on the incidence of central venous haemodialysis catheter-related malfunction and sepsis in patients with end-stage kidney disease (ESKD)., Search Methods: We searched the Cochrane Renal Group's Specialised Register to 7 January 2016 through contact with the Trials' Search Co-ordinator using search terms relevant to this review., Selection Criteria: We included all randomised controlled trials (RCT) assessing anticoagulants compared with conventional care for the prevention of catheter malfunction in adult patients receiving haemodialysis for ESKD., Data Collection and Analysis: The primary outcome was catheter malfunction defined as a catheter blood flow of 200 mL/min or less, or as defined by study authors. Secondary outcomes were catheter-related bacteraemia, all-cause mortality and bleeding events. Relative risks (RR) with 95% confidence intervals (CI) for individual studies were pooled using random effects models within treatment classes. Analyses were conducted by class, with subgroup analyses performed of individual agents within classes., Main Results: We included 27 studies (3003 participants) that were followed up for a median of six months. Study interventions included alternative anticoagulant locking solutions (19 studies, 2216 patients), systemic agents (6 studies, 664 patients) and low or no dose heparin (2 studies, 123 patients). The most common comparison treatment was a locking solution of heparin 5000 IU/mL, used in 17 studies. No significant effect on catheter malfunction was observed for alternative anticoagulant locking solutions (RR 0.96, 95% CI 0.74 to 1.26), systemic agents (RR 0.59, 95% CI 0.28 to 1.23), or low or no dose heparin (RR 0.90, 95% CI 0.10 to 8.31). A significant reduction on incidence of catheter-related bacteraemia was observed for alternative anticoagulant locking solutions (RR 0.46, 95% CI 0.32 to 0.66) but not systemic agents (RR 2.41, 95% CI 0.89 to 6.55), and could not be assessed in reports of low or no dose heparin studies. No significant effect on all-cause mortality was observed for alternative anticoagulant locking solutions (RR 0.88, 95% CI 0.54 to 1.43) or systemic agents (RR 0.78, 95% CI 0.37 to 1.65), and was not reported in studies of low or no dose heparin. Bleeding events were only reported in eight studies, including only 2/5 studies of systemic warfarin, with no clear effect demonstrated (RR 1.43, 95% CI 0.86 to 2.39). For individual agents, recombinant tissue plasminogen (rt-PA) was the only locking solution shown to reduce catheter malfunction (RR 0.58, 95% CI 0.37 to 0.91) based on the results of a single study. No significant on catheter malfunction was observed for other individual classes of alternative anticoagulant locking solutions (citrate: RR 1.14, 95% CI 0.76 to 1.69; antibiotic: RR 1.48, 95% CI 0.79 to 2.77; ethanol: RR 0.88, 95% CI 0.21 to 3.67). On the other hand, all individual classes of alternative anticoagulant locking solutions, except ethanol, reduced catheter-related bacteraemia (citrate: RR 0.49, 95% CI 0.36 to 0.68; antibiotic: RR 0.27, 95% CI 0.11 to 0.70; rt-PA: RR 0.35, 95% CI 0.13 to 0.93; ethanol: RR 0.33, 95% CI 0.03 to 4.05). No significant effect on all-cause mortality was observed for any individual agent within the class of alternative locking solutions. Studies were mainly of low quality and underpowered with an average participant number of 75 and study duration of six months. The interpretation of the study evidence was further limited by the variation in tested interventions and outcome reporting., Authors' Conclusions: The relative net benefit of anticoagulant therapies for prevention of catheter malfunction remains uncertain. Multiple agents appear to reduce catheter-related bacteraemia although the lack of clear assessment of harms and the limitations of study quality mean these results should be interpreted with caution. Methodological approaches can be used to avoid methods of reporting unduly affecting on the results of meta-analyses incorporating studies employed mixed reporting methods. Further high quality randomised studies, including safety outcomes, are needed.

Aim: Elderly people comprise a large and growing proportion of the global dialysis population. Regional differences in rates of dialysis in the elderly suggest multiple factors influence treatment decision-making including beliefs about the relative benefits and harms of dialysis and supportive (non-dialysis) care. We therefore systematically reviewed the literature reporting survival of elderly patients treated with either treatment pathway., Methods: Systematic review and meta-analysis of cohort studies or randomized controlled trials identified in MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials published before July 2014. Survival by treatment modality was calculated. Subgroup analyses by study design, study size, patient age and cohort era were conducted., Results: Eighty-nine studies published between 1976 and 2014 reported on 294 921 elderly end-stage kidney disease (ESKD) patients. There was a paucity of data for supportive care (724 patients or 0.2% of the total patients) and supportive care studies were susceptible to lead-time bias. One-year survival for elderly patients treated with undifferentiated dialysis was 73.0% (95% confidence interval (CI) 66.3-79.7%), 78.4% (95% CI 75.2-81.6) for haemodialysis and 77.9% (95% CI 73.8-81.9) for peritoneal dialysis. Supportive care patients had a 1-year survival of 70.6% (95% CI 63.3-78.0%). Residual heterogeneity remained within individual treatment modalities despite subgroup analyses., Conclusions: While the available literature demonstrates a broadly similar 1-year survival in elderly ESKD patients, it does not allow a confident estimate of the relative survival benefits of dialysis or supportive care. This uncertainty needs urgent attendance by further prospective data, which avoid bias and allow comparisons of quality of life and survival., (© 2015 Asian Pacific Society of Nephrology.)

Background: Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis., Methods/design: SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials., Discussion: Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public.

Aim: Long-term prospective studies of health outcomes for dialysis patients are common in many parts of the world but have been rare in India. As renal replacement therapy becomes more widespread and more affordable, the measurement of patient outcomes and comparison with national and international benchmarks will be a valuable tool in planning health services and demonstrating effective use of resources. To this end, we describe a pilot study of dialysis outcomes in India which could form the basis of a comprehensive national programme of data collection., Methods: One hundred incident patients commencing chronic haemodialysis in two north Indian nephrology centres will be followed prospectively for 12 months. Clinical outcome data will be collected comparable with that used by established dialysis registries in other countries. The economic impact of dialysis upon patients is central to the use of this treatment, so data will be collected on the direct and indirect costs of the treatment and the economic impact of dialysis on the patient and their family., Value of Project: This prospective cohort study of dialysis outcomes in northern India is a pilot for the collection of similar comparative data in dialysis centres in different states across the country with a view to the development of a national dialysis registry. The information on the economic impact of dialysis on patients and their families will provide one of the first detailed insights into this critical aspect of dialysis services., (© 2015 Asian Pacific Society of Nephrology.)

Aims: Observational reports suggest extended dialysis hours are associated with improved outcomes. These findings are confounded by better prognostic characteristics among people practising extended hours. The aim of this article is to provide an overview of the methods and baseline characteristics for ACTIVE Dialysis Study participants., Methods: This multicentre, randomized, open-label, blinded endpoint-assessment trial randomized participants receiving maintenance haemodialysis therapy to either extended (≥24 h) or standard (12-18 h) weekly haemodialysis for 12 months. A web-based randomization system used minimization to ensure balanced allocation across regions, dialysis setting and dialysis vintage. The primary outcome is the change in quality of life over 12 months of study treatment assessed by EQ-5D. Secondary outcomes include change in left ventricular mass index assessed by magnetic resonance imaging and safety outcomes including dialysis access events., Results: A total of 200 participants were recruited between 2009 and 2013 from Australia (29.0%), China (62.0%), Canada (5.5%) and New Zealand (3.5%). Participants had a mean age of 52 (± 12) years and 11.5% were dialysing at home, with a mean duration of 13.9 h per week over a median of three sessions. At baseline, 32.5% had a history of cardiovascular disease and 36.5% had diabetes., Conclusion: The ACTIVE Dialysis Study has met its planned recruitment target. The participant population are drawn from a range of health service settings in a global context. The study will contribute important evidence on the benefits and harms of extending weekly dialysis hours. The trial is registered at clinicaltrials.gov (NCT00649298)., (© 2014 Asian Pacific Society of Nephrology.)

Background: Nephrologists often face difficult decisions when recommending dialysis or non-dialysis (supportive) care for elderly patients, given the uncertainty around survival and the burden of dialysis. Discrete choice experiments (DCEs) mimic real-world decisions through simultaneous consideration of multiple variables. We aimed to determine the relative influence of patient characteristics on dialysis recommendations., Methods: We conducted a DCE among Australasian nephrologists consisting of 12 scenarios of two patients (described in terms of age, gender, cognition, comorbidity, life expectancy, current quality of life (QOL), expected QOL with dialysis, social support, patient and family inclination). Nephrologists indicated which patient they preferred recommending dialysis for, or whether they preferred 'neither'. Mixed logit models determined the odds of recommending dialysis over no dialysis. Trade-offs between QOL and survival were calculated., Results: A total of 159 nephrologists participated (34% aged 40-49 years, 62% male and 69% Caucasian). All patient characteristics except gender significantly affected the likelihood of dialysis recommendation. Nephrologists were more likely to recommend dialysis for patients with preserved cognition (odds ratio [OR]: 68.3; 95% confidence interval [CI]: 33.4-140.0), lower comorbidity (OR: 2.1; 95% CI: 1.1-4.1), increased life expectancy (OR: 2.8; 95% CI: 2.1-3.7), high current QOL (OR: 2.8; 95% CI: 2.0-3.8) and positive patient and family dialysis inclination (OR: 27.5; 95% CI: 16.2-46.8 and OR: 2.0; 95% CI: 1.3-3.3, respectively). Nephrologists aged >65 were more likely (OR: 11.7; 95% CI: 1.8-77.2) to recommend dialysis. Nephrologists were willing to forgo 12 months of patient survival to avoid substantial QOL decrease with dialysis., Conclusion: Nephrologists avoided dialysis recommendation if it was expected to considerably reduce QOL. To inform elderly patients' dialysis decisions, systematic and longitudinal cognition and QOL evaluations are needed as well as better research into understanding patient preferences., (© The Author 2014. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

Background: Whether convective modalities of dialysis, including hemofiltration (HF) and hemodiafiltration (HDF), improve cardiovascular outcomes and mortality is unclear., Study Design: Systematic review and meta-analysis., Setting & Population: Patients receiving HDF, HF, or standard hemodialysis (HD)., Selection Criteria for Studies: Randomized controlled trials., Intervention: Convective modalities of dialysis (HDF and HF) versus standard HD., Outcomes: The primary outcome was clinical cardiovascular outcomes. Secondary outcomes were all-cause mortality, episodes of symptomatic hypotension, dialysis adequacy, and β2-microglobulin level. Relative risks (RRs) or weighted mean differences with 95% CIs for individual trials were pooled using random-effects models., Results: The search yielded 16 trials including 3,220 patients. Therapies assessed were convective modalities (HDF or HF) compared with standard HD. Compared with HD, convective modalities did not significantly reduce the risk of cardiovascular events (RR, 0.85; 95% CI, 0.66-1.10) or all-cause mortality (RR, 0.83; 95% CI, 0.65-1.05). Convective modalities reduced symptomatic hypotension (RR, 0.49; 95% CI, 0.30-0.81) and improved serum β2-microglobulin levels (-5.95 mg/L; 95% CI, -10.27 to -1.64), but had no impact on small-molecule clearance (weighted mean difference in Kt/V, 0.04; 95% CI, -0.04 to 0.12). There was a nonsignificant trend to a greater likelihood of receiving a kidney transplant for participants allocated to filtration therapies (RR, 1.19; 95% CI, 0.99-1.42)., Limitations: The trials were predominantly of suboptimal quality and underpowered, with imbalance in some prognostic variables at baseline. Intention-to-treat analysis was not used in some trials. Our analysis was limited to published outcomes., Conclusions: The potential benefits of convective modalities over standard HD for cardiovascular outcomes and mortality remain unproved. Further high-quality randomized trials are needed to define the impact of these modalities on clinically important outcomes., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI., Methods and Findings: We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0-48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96-1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63-2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration., Conclusions: Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis., Trial Registration: www.ClinicalTrials.govNCT00221013.

Background: Catheter malfunction (CM), including thrombosis, is associated with reduced dialysis adequacy, as well as an increased risk of catheter-related bacteraemia (CRB) and mortality. The role of alternative anticoagulant regimens for CM prevention remains uncertain., Methods: A systematic review and meta-analysis were performed examining all randomized controlled trials (RCTs) assessing interventions acting via an anticoagulant mechanism compared with conventional care for the prevention of CM in adult patients receiving haemodialysis for end-stage kidney disease. Medline, EMBASE and the Cochrane Register were searched to November 2012. The primary outcome was CM. Secondary outcomes were CRB, all-cause mortality and bleeding events (all bleeding events reported or as defined by authors). Relative risks with 95% confidence intervals (CIs) for individual trials were pooled using random effects models for treatment classes., Results: The search yielded 28 trials including 3081 patients. Therapies assessed were alternative anticoagulant locking solutions (ALSs), systemic warfarin and low/no dose heparin locking solutions (normal saline locks). No significant effect on CM (18 trials, 1579 participants) was observed for alternative ALSs (9 trials, 887 participants, RR 0.85, 95% CI 0.68-1.07), or low/no dose heparin (4 trials, 231 participants, RR 0.99, CI 0.60-1.62), compared with heparin locking solutions (5000 units). Similarly, no significant effect was observed for warfarin (5 trials, 479 participants, RR 0.59, 95% CI 0.28-1.22) compared with placebo. No significant effect on CRB was observed (15 trials, 2367 participants) for alternative ALSs (11 trials, 2010 participants, RR 0.57, 95% CI 0.30-1.10), warfarin (1 trial, 174 participants, RR 2.40, 95% CI 0.88-6.52) or low/no dose heparin (3 trials, 183 participants, RR 0.76, 95% CI 0.35-1.64). All-cause mortality was not affected by alternative ALSs (9 trials, 1719 participants, RR 0.83, 95% CI 0.56-1.24) or warfarin (3 trials, 403 participants, RR 0.78, 95% CI 0.37-1.65). Bleeding events were only reported in seven trials, including only two trials of warfarin, with no clear effect demonstrated. Within the alternative ALSs group, the only agent with a reduction in CM was recombinant tissue plasminogen activator (rt-PA)-locking solution (RR 0.52, 95% CI 0.32-0.86) based on the results of a single trial. Trials were mainly of high risk of bias., Conclusions: There is uncertainty on the benefits and harms of anticoagulant therapies over conventional care for prevention of CM. Further high-quality randomized trials, including safety outcomes, are needed.

Aim: To evaluate the efficacy of a team-led anaemia management protocol based on current guidelines., Methods: The effect of a treatment protocol in implementing an anaemia guideline was evaluated in a large teaching hospital, encompassing three (two in-hospital and one satellite) dialysis facilities. Quarterly data were collected, over a 6-year period, on all patients dialysing in these facilities, before and after implementation of an anaemia management treatment protocol. This protocol was developed by a physician-led team and implemented by an anaemia coordinator assisted by the unit staff. The primary outcome measure was the proportion of patients receiving erythropoietin with ferritin levels within the national guidelines target range calculated using data on haemoglobin (Hb), iron studies, dry weight and erythropoietin dose., Results: Data was collected on >150 patients every quarter between 2005 and 2010 (inclusive). The proportion of patients within the primary outcome target range increased from a nadir of 17% to 51% with evidence of true systematic change. The proportion of patients with Hb values within the unit target range also increased from 46% to 56% (P = 0.25) between the first and last years of the project. These changes were also associated with reduced erythropoietin drug use down to 0.44 μg/kg per week., Conclusion: Implementation of a treatment protocol for anaemia management in haemodialysis patients was associated with greater consistency with guideline evidence and lower drug use. Achieving such guideline recommendations for ferritin targets in more than 50% of patients appears feasible., (© 2013 The Authors. Nephrology © 2013 Asian Pacific Society of Nephrology.)

Establishing and maintaining hemodialysis access are major challenges in dialysis patient care. The impact of implementing guideline recommendations around vascular access surveillance, which lacks strong evidence, is poorly understood. We report the results of a vascular access surveillance and early intervention program upon hemodialysis thrombosis rates for all patients hemodialyzing in a single center between January 2005 and March 2011. Data were derived from hospital records and the Australian and New Zealand Dialysis and Transplant Registry (ANZDATA). Data were collected of 227 prevalent patients over the 6-year period. Crude ultrasound and angiography intervention rates increased from 23 and 57 per 100 prevalent patients per quarter (/100 pts/qtr) to 31 and 83/100 pts/qtr, respectively, during the study. Crude thrombosis rates fell from 21 to 2/100 pts/qtr during the study. After adjustment for comorbidities, mean ultrasound use increased by 4.6% per quarter (95% CI: 2.4-6.9, p<0.001), mean interventional angiography increased by 2.6% per quarter (95% CI: 1.1-4.2, p=0.001), and the predicted mean of the number of thromboses decreased by 8.4% per quarter (95% CI: 5.6-11.1, p<0.001). Implementation of a vascular access surveillance increases service utilization and is associated with a reduction in vascular access thrombosis., (© 2012 Wiley Periodicals, Inc.)

Background: Increasing numbers of elderly patients face decisions about the management of end-stage kidney disease. Improved understanding of contemporary patient and practice factors influencing prognosis may assist decision making for individual patients and their care providers., Methods: This is a prospective registry study using multivariable proportional hazards models. A total of 1781 patients aged ≥ 75 years at dialysis initiation recorded in ANZDATA, the Australia and New Zealand renal replacement registry, between January 2002 and December 2005. The patient characteristics were demographic and comorbid conditions. The practice characteristics were late referral, access at dialysis initiation and intended dialysis modality (modality established by 90 days). The study outcome was mortality censored at 31 December 2007 or at recovery of renal function (of at least 30 days), transplantation or loss to follow-up., Results: Median follow-up was 2.3 years (interquartile range 1.1-3.3 years) during which time, 65% of the patients died. Baseline factors independently associated with mortality were older age [hazard ratio (HR) 1.24 for 5-year increase, 95% confidence interval (CI) 1.13-1.36], body mass index <18.5 (HR 1.78, 95% CI 1.33-2.38), number of comorbidities (one comorbidity HR 1.38, 95% CI 1.13-1.69; two comorbidities HR 1.55, 95% CI 1.27-1.89; three or more comorbidities HR 1.89, 95% CI 1.55-2.31), late referral (HR 1.19, 95% CI 1.02-1.39), peritoneal dialysis as intended modality (HR 1.26, 95% CI 1.08-1.47) and unprepared access (HR 1.43, 95% CI 1.23-1.67). The limitations of the study were the observational nature of the analysis, potential selection bias introduced through analysis of a group who actually commenced dialysis and the potential confounding from unmeasured factors or dichotomous reporting of comorbidities., Conclusions: Within the elderly cohort, other patient characteristics have a greater association with mortality than 5-year age increments. Even after consideration of patient characteristics, practice factors have a striking impact on the survival of elderly patients commencing dialysis. In the absence of randomized studies, efforts to enhance the identification and preparation of elderly patients for dialysis may improve outcomes within current settings.

Background and Objectives: Measurement of C-reactive protein (CRP) levels remains uncommon in North America, although it is now routine in many countries. Using Dialysis Outcomes and Practice Patterns Study data, our primary aim was to evaluate the value of CRP for predicting mortality when measured along with other common inflammatory biomarkers., Design, Setting, Participants, & Measurements: We studied 5061 prevalent hemodialysis patients from 2005 to 2008 in 140 facilities routinely measuring CRP in 10 countries. The association of CRP with mortality was evaluated using Cox regression. Prediction of 1-year mortality was assessed in logistic regression models with differing adjustment variables., Results: Median baseline CRP was lower in Japan (1.0 mg/L) than other countries (6.0 mg/L). CRP was positively, monotonically associated with mortality. No threshold below which mortality rate leveled off was identified. In prediction models, CRP performance was comparable with albumin and exceeded ferritin and white blood cell (WBC) count based on measures of model discrimination (c-statistics, net reclassification improvement [NRI]) and global model fit (generalized R(2)). The primary analysis included age, gender, diabetes, catheter use, and the four inflammatory markers (omitting one at a time). Specifying NRI ≥5% as appropriate reclassification of predicted mortality risk, NRI for CRP was 12.8% compared with 10.3% for albumin, 0.8% for ferritin, and <0.1% for WBC., Conclusions: These findings demonstrate the value of measuring CRP in addition to standard inflammatory biomarkers to improve mortality prediction in hemodialysis patients. Future studies are indicated to identify interventions that lower CRP and to identify whether they improve clinical outcomes.

Background: Current clinical practice guidelines recommend a native arteriovenous fistula (AVF) as the vascular access of first choice. Despite this, most patients in western countries start hemodialysis therapy using a catheter. Little is known regarding specific physician and system characteristics that may be responsible for delays in permanent access creation., Study Design: Multicenter cohort study using mixed methods; qualitative and quantitative analysis., Setting & Participants: 9 nephrology centers in Australia and New Zealand, including 319 adult incident hemodialysis patients., Predictor: Identification of barriers and enablers to AVF placement., Outcomes: Type of vascular access used at the start of hemodialysis therapy., Measurements: Prospective data collection included data concerning predialysis education, interviews of center staff, referral times, and estimated glomerular filtration rate (eGFR) at AVF creation and dialysis therapy start., Results: 319 patients started hemodialysis therapy during the 6-month period, 39% with an AVF and 59% with a catheter. Perceived barriers to access creation included lack of formal policies for patient referral, long wait times for surgical review and access placement, and lack of a patient database for management purposes. eGFR thresholds at referral for and creation of vascular accesses were considerably lower than appreciated (in both cases, median eGFR of 7 mL/min/1.73 m(2)), with median wait times for access creation of only 3.7 weeks. First assessment by a nephrologist less than 12 months before dialysis therapy start was an independent predictor of catheter use (OR, 8.71; P < 0.001). Characteristics of the best performing centers included the presence of a formalized predialysis pathway with a centralized patient database and low nephrologist and surgeon to patient ratios., Limitations: A limited number of patient-based barriers was assessed. Cross-sectional data only., Conclusions: A formalized predialysis pathway including patient education and eGFR thresholds for access placement is associated with improved permanent vascular access placement., (Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Kidney disease-related loss is clinically significant in patients with ESRD and is related to depression and quality of life. The Kidney Disease Loss Scale (KDLS) was recently developed for long-term dialysis patients as a means of studying loss and applying it to clinical practice; however, its validity and usability in the other developmental stages of ESRD-predialysis and early dialysis-remain unknown. This study examined the validity and reliability of the KDLS in the long-term dialysis, early dialysis, and predialysis populations., Design, Setting, Participants, & Measurements: Four groups of participants were recruited from four large university teaching hospitals in the Sydney metropolitan area. Participants were long-term dialysis (n=151), early dialysis (n=163), and predialysis (n=111) patients. An additional independent group of dialysis (n=50) patients were recruited to measure the test-retest reliability. Multisample confirmatory factor analysis and correlational analysis were used., Results: Results demonstrated good internal consistency and test-retest reliability for KDLS. Multisample confirmatory factor analysis indicated that the factor structure of KDLS was invariant across samples and thus supported its construct validity. The convergent and discriminant validities of KDLS were supported by its correlations with scales that measure health-related quality of life, depression, and positive affect in the expected directions and magnitudes. The KDLS was sensitive to the developmental stages of ESRD., Conclusions: These findings demonstrated that the concept of loss exists in dialysis patients. The KDLS is a reliable measure of loss in ESRD and valid in the developmental stages of ESRD.

Variability in implementing research evidence into clinical practice is widespread, including in the management of patients with kidney disease. There are numerous well-known barriers and facilitators to evidence implementation identified in other clinical settings and a few chronic kidney disease studies. The necessary changes to health systems that support evidence implementation take time to design, apply and to have a measurable effect. Measurement against an agreed standard is fundamental to this process. We use the example of renal anaemia management across a dialysis unit to illustrate an approach to these issues.

Background: Patients undergoing dialysis have a substantially increased risk of cardiovascular mortality and morbidity. Although several trials have shown the cardiovascular benefits of lowering blood pressure in the general population, there is uncertainty about the efficacy and tolerability of reducing blood pressure in patients on dialysis. We did a systematic review and meta-analysis to assess the effect of blood pressure lowering in patients on dialysis., Methods: We systematically searched Medline, Embase, and the Cochrane Library database for trials reported between 1950 and November, 2008, without language restriction. We extracted a standardised dataset from randomised controlled trials of blood pressure lowering in patients on dialysis that reported cardiovascular outcomes. Meta-analysis was done with a random effects model., Findings: We identified eight relevant trials, which provided data for 1679 patients and 495 cardiovascular events. Weighted mean systolic blood pressure was 4.5 mm Hg lower and diastolic blood pressure 2.3 mm Hg lower in actively treated patients than in controls. Blood pressure lowering treatment was associated with lower risks of cardiovascular events (RR 0.71, 95% CI 0.55-0.92; p=0.009), all-cause mortality (RR 0.80, 0.66-0.96; p=0.014), and cardiovascular mortality (RR 0.71, 0.50-0.99; p=0.044) than control regimens. The effects seem to be consistent across a range of patient groups included in the studies., Interpretation: Treatment with agents that lower blood pressure should routinely be considered for individuals undergoing dialysis to reduce the very high cardiovascular morbidity and mortality rate in this population.

Background: Patients who are dependant on a percutaneous central venous catheter for dialysis have an excess morbidity and mortality compared with patients with an autologous arteriovenous fistula., Methods: In an effort to improve outcomes related to episodes of permanent access insufficiency, defined as a patient requiring a venous catheter for haemodialysis, a 12-month prospective audit of surgery carried out to establish and maintain dialysis access was carried out at our institution., Results: Effective measures that reduced the period of time that patients required a venous catheter for dialysis included regular communication between dialysis staff, the surgical service and patients attending for treatment in the dialysis unit, liberal use of duplex ultrasound imaging, pursuing autologous access in the majority of patients, early intervention to correct failing vascular access before conduit thrombosis, using both traditional open surgical and endovascular solutions in establishing and maintaining vascular access, using peritoneal dialysis as a long-term or temporary alternative to haemodialysis and, in cases of arteriovenous polytetrafluoroethylene graft occlusion, early thrombectomy and mandatory revision to provide a conduit immediately available for effective dialysis., Conclusion: Conducting an audit of surgical practice contributed to an improvement in outcomes for dialysis-dependant patients. Establishing an arteriovenous fistula in a greater proportion of cases before initiating renal replacement therapy may further address the problem of dialysis access insufficiency.

Objective: To evaluate the outcomes of and barriers to implementing standard guidelines (Caring for Australasians with renal impairment [CARI]), using iron management in patients having dialysis as an example., Design and Setting: On-site review of iron management processes at six Australian dialysis units varying in size and locality. Patients' iron indices and haemoglobin levels were obtained from the Australian and New Zealand Dialysis and Transplant Registry., Participants: Patients with chronic kidney disease who were dependent on dialysis., Main Outcome Measures: Processes for assessing indices of iron stores and iron supplementation; comparison with target indices in the CARI guidelines., Results: There was considerable variability among the units in achievement of haemoglobin and iron targets, with 25%-32% of patients achieving haemoglobin targets of 110-120 g/L, 30%-68% achieving ferritin targets of 300-800 microg/L, and 65%-73% achieving transferrin saturation targets of 20%-50%. Implementation barriers included lack of knowledge, lack of awareness of or trust in the CARI guideline, inability to implement the guideline, and inability to agree on a uniform unit protocol. Factors associated with achieving the CARI guideline targets included nurse-driven iron management protocols, use of an iron management decision aid, fewer nephrologists per dialysis unit, and a "proactive" (actively keeping iron levels within target range) rather than "reactive" (only reacting if iron levels are out of the range) protocol., Conclusions: Variability in achievement of iron targets, despite the availability of a clinical practice guideline, may be explained by variability in processes of care for achieving and maintaining adequate iron parameters.

Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.