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BACKGROUND: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published. METHODS/DESIGN: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.

Aim: To determine if a Comprehensive Geriatric Assessment (CGA) will allow frail older patients with chronic kidney disease (CKD) to better attain their treatment goals and improve their frailty and quality of life, while being cost-effective. Background(s): There is an increasing number of frail older patients with CKD. Many of them face deteriorating health and functional status, which adversely affects their quality of life. CGA is an effective intervention to improve survival and independence of older people but its effect in people with CKD remains unknown. Method(s): GOAL is a NHMRC-funded cluster randomized controlled trial developed by consumers, clinicians and researchers. It will recruit patients from January 2021 aged >=65 with CKD stage 3-5/5D and a Frailty Index >0.25. The intervention clusters will receive a CGA by a geriatrician to identify medical, social and functional needs, optimize medication prescribing and arrange multidisciplinary referral if required. The primary outcome is attainment of patient determined goals assessed by standardized Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS scores at 6 and 12 months, quality of life (EQ-5D-5L), frailty (Frailty Index - Short Form), transfer to residential aged care facilities, cost effectiveness and safety (causespecific hospitalizations, mortality) at 12 months. Result(s): A two-arm design of 16 clusters with 1:1 allocation (~500 participants) has 90% power to detect a clinically meaningful mean difference in GAS score of 10 units. Conclusion(s): The GOAL trial addresses patient-prioritized outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This is the first study, internationally, to evaluate the clinical and cost effectiveness of CGA in improving patient-important health outcomes in frail older people with CKD.

Background: Hemodialysis treatment prescription varies widely around the world. This study explored patient- and center-level characteristics associated with weekly haemodialysis hours. Method(s): Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry data was analyzed. Characteristics associated with weekly duration were evaluated using mixed-effects linear regression models with patient- and center-level covariates as fixed effects, and dialysis center and state as random effects using the 2017 prevalent in-centre hemodialysis (ICHD) and home hemodialysis (HHD) cohorts. Evaluation of patterns of weekly duration over time analyzed the 2000 to 2017 incident ICHD and HHD cohorts. Result(s): Overall, 12,494 ICHD and 1,493 HHD prevalent patients in 2017 were included. Median weekly treatment duration was 13.5 (interquartile range (IQR) 12-15) hours for ICHD and 16 (IQR 15-20) hours for HHD. Male sex, younger age, higher body mass index, arteriovenous fistula/graft use, Aboriginal and Torres Strait Islander ethnicity and longer dialysis vintage were associated with longer weekly duration for both ICHD and HHD. No center characteristics were associated with weekly duration. Variability in duration across centers was very limited in ICHD compared to HHD, with variation in HHD being associated with state. Duration did not vary significantly over time for ICHD, whereas longer weekly HHD treatments were reported between 2006 and 2012 compared to before and after this period. Conclusion(s): This study in the Australian and New Zealand hemodialysis population showed that weekly treatment duration was primarily associated with patient characteristics. No center effect was demonstrated. Practice patterns seemed to differ across states/countries, with more variability in HHD than in ICHD. (Figure Presented).

Background: This study explored the psychometric properties and dimensionality of the Stress of Conscience Questionnaire (SCQ) in a sample of health professionals from a tertiary-level Australian hospital. The SCQ, a measure of stress of conscience, is a recently developed nine-item instrument for assessing frequently encountered stressful situations in health care, and the degree to which they trouble the conscience of health professionals. This is relevant because stress of conscience has been associated with negative experiences such as job strain and/or burnout. The validity of SCQ has not been explored beyond Scandinavian contexts. Methods: A cross-sectional study of 253 health professionals was undertaken in 2015. The analysis involved estimates of reliability, variability and dimensionality. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to explore dimensionality and theoretical model fit respectively. Results: Cronbach’s alpha of 0.84 showed internal consistency reliability. All individual items of the SCQ (N = 9) met the cut-off criteria for item-total correlations (> 0.3) indicating acceptable homogeneity. Adequate variability was confirmed for most of the items, with some items indicating floor or ceiling effects. EFA retained a single latent factor with adequate factor loadings for a unidimensional structure. When the two‐factor model was compared to the one‐factor model, the latter achieved better goodness of fit supporting a one-factor model for the SCQ. Conclusion: The SCQ, as a unidimensional measure of stress of conscience, achieved adequate reliability and variability in this study. Due to unidimensionality of the tool, summation of a total score can be a meaningful way forward to summarise and communicate results from future studies, enabling international comparisons. However, further exploration of the questionnaire in other cultures and clinical settings is recommended to explore

Introduction: An arteriovenous access, including fistula and graft, is preferred to a central venous catheter (CVC) but the majority of patients start haemodialysis with a CVC. The aims of this study were to examine patient- and centre-level factors associated with incident arteriovenous access versus CVC use and the contribution of these factors to centre variation in incident arteriovenous access use. Method(s): Using data from the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, all adult (>=18yo) patients commencing haemodialysis between 1 January 2004 and 31 December 2015 were included. The primary outcome, vascular access type (arteriovenous access versus CVC) at haemodialysis initiation, was analysed using logistic regression models with a random effect for dialysis centre. Patient-level factors examined included sex, age, race, body mass index (BMI), smoking status, primary kidney disease, late referral to nephrology (<3 months), cardiovascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease), diabetes mellitus, chronic lung disease, and previous renal replacement therapy (RRT). Centre-level factors included centre size, transplantation facility status, percentage of home haemodialysis patients, mean weekly haemodialysis hours, and percentage of patients achieving target blood flow rates, phosphate levels, haemoglobin, and weekly Kt/V. Result(s): The study included 27,123 patients from 61 centres. The mean proportion of patients starting haemodialysis with an arteriovenous access varied from 15% to 61% (median 39%). Patient-level factors associated with an increased likelihood of starting haemodialysis with an arteriovenous access were male sex, BMI >25kg/m2and polycystic kidney disease as primary kidney disease. Patient-level factors associated with a decreased likelihood of starting haemodialysis with an arteriovenous access included BMI<18.5kg/m2, late nephrologist referral, diabetes mellitus, ca

Introduction Patients with chronic kidney disease (CKD) are at heightened cardiovascular risk, which has been associated with abnormalities of bone and mineral metabolism. A deeper understanding of these abnormalities should facilitate improved treatment strategies and patient-level outcomes, but at present there are few large, randomised controlled clinical trials to guide management. Positive associations between serum phosphate and fibroblast growth factor 23 (FGF-23) and cardiovascular morbidity and mortality in both the general and CKD populations have resulted in clinical guidelines suggesting that serum phosphate be targeted towards the normal range, although few randomised and placebo-controlled studies have addressed clinical outcomes using interventions to improve phosphate control. Early preventive measures to reduce the development and progression of vascular calcification, left ventricular hypertrophy and arterial stiffness are crucial in patients with CKD. Methods and analysis We outline the rationale and protocol for an international, multicentre, randomised parallel-group trial assessing the impact of the non-calcium-based phosphate binder, lanthanum carbonate, compared with placebo on surrogate markers of cardiovascular disease in a predialysis CKD population - the IM pact of P hosphate R eduction O n V ascular E nd-points (IMPROVE)-CKD study. The primary objective of the IMPROVE-CKD study is to determine if the use of lanthanum carbonate reduces the burden of cardiovascular disease in patients with CKD stages 3b and 4 when compared with placebo. The primary end-point of the study is change in arterial compliance measured by pulse wave velocity over a 96-week period. Secondary outcomes include change in aortic calcification and biochemical parameters of serum phosphate, parathyroid hormone and FGF-23 levels. Ethics and dissemination Ethical approval for the IMPROVE-CKD trial was obtained by each local Institutional Ethics Committee for all 17 partic

We currently live in an era of major global change that has led to the introduction and range expansion of numerous invasive species worldwide. In addition to the ecological and economic consequences associated with most invasive species, invasive arthropods that vector pathogens (IAVPs) to humans and animals pose substantial health risks. Species distribution models that are informed using environmental Earth data are frequently employed to predict the distribution of invasive species, and to advise targeted mitigation strategies. However, there are currently substantial mismatches in the temporal and spatial resolution of these data and the environmental contexts which affect IAVPs. Consequently, targeted actions to control invasive species or to prepare the population for possible disease outbreaks may lack efficacy. Here, we identify and discuss how the currently available environmental Earth data are lacking with respect to their applications in species distribution modeling, particularly when predicting the potential distribution of IAVPs at meaningful space-time scales. For example, we examine the issues related to interpolation of weather station data and the lack of microclimatic data relevant to the environment experienced by IAVPs. In addition, we suggest how these data gaps can be filled, including through the possible development of a dedicated open access database, where data from both remotely- and proximally-sensed sources can be stored, shared, and accessed.

BACKGROUND: Arteriovenous fistulas (AVF) for haemodialysis often experience early thrombosis and maturation failure requiring intervention and/or central venous catheter (CVC) placement. This secondary and exploratory analysis of the FAVOURED study determined whether omega-3 fatty acids (fish oils) or aspirin affected AVF usability, intervention rates and CVC requirements. METHODS: In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation. RESULTS: Final analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation. CONCLUSION: Although fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.

Aim: As part of the FAVOURED Study, we examined the effect of fish oil and aspirin on arteriovenous fistula (AVF) interventions and central venous catheter (CVC) use. Background(s): Successful creation of an AVF is limited by early thrombosis and maturation failure requiring interventions and/or placement of CVC. These complications may be reduced by pleotropic effects of fish oil upon vascular biology and inflammation, and platelet inhibition by aspirin. Method(s): In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting 1 day pre-surgery and continued for 12 weeks. Pre-specified secondary outcomes included rates of rescue interventions for AVF thrombosis, non-rescue interventions, and the frequency and duration of CVC requirements within 12 months of access creation. Result(s): The mean age was 55 years, 64% were male and 47% diabetic. Fish oil supplementation significantly reduced the overall rate of access interventions compared to placebo (0.82 vs 1.14 interventions/1000 patient-days, incident rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97, p=0.03), driven by a reduction in rescue interventions (0.09 vs 0.17 interventions/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Similarly, low-dose aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78) but not overall intervention rates (IRR 0.84, 95% CI 0.59-1.19). Half of the participants required a CVC and neither fish oil nor aspirin reduced the frequency or duration of CVC requirements compared to placebo. Conclusion(s): Fish oil and aspirin given for 3 months both independently reduced intervention rates in newly created AVF but they had no significant effects on CVC requirements. Reduction in access interventions benefits patients, reduces costs and warrants further study.

Introduction and Aims: Successful creation of a native arteriovenous fistula (AVF) for patients in need of haemodialysis is limited by early thrombosis and maturation failure requiring interventions and/or placement of central venous catheters (CVC). These complications maybe reduced by pleotropic effects of omega-3 polyunsaturated fatty acids (fish oils) upon vascular biology and inflammation and platelet inhibition by aspirin. As part of the Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study, we examined the effect offish oil supplementation and aspirin use on the rate of AVF interventions and need for CVC. Method(s): 567 adults with chronic kidney disease currently receiving or expecting to receive haemodialysis within 12 months were randomly allocated to fish oil (4g/d) or placebo. A subset of 406 participants was randomised to aspirin (100mg/d) or placebo. Treatment commenced 1 day prior to surgery and continued for 12 weeks. This study examined secondary and exploratory outcomes including AVF interventions for acute thrombosis, interventions to assist AVF maturation and the need for CVC placement within 12 months of access creation. Relative risks [RR] for binary outcomes and incidence rate ratios [IRR] for count outcomes are reported. Result(s): The mean age was 55 years, 64% were male and 47% diabetic. Fish oil supplementation significantly reduced the overall rate of access interventions compared to placebo (0.82 vs 1.14 interventions/1000 patient-days, IRR 0.72,95% confidence interval [CI] 0.54-0.97, p=0.03), driven by a reduction in rescue interventions (0.09 vs 0.17 interventions/1000 patient-days, IRR 0.53,95% CI 0.34-0.84); Table 1A. Similarly, low-dose aspirin significantly reduced rescue intervention rates (IRR 0.45,95% CI 0.27-0.78) but not overall intervention rates (IRR 0.84,95% CI 0.59-1.19); Table 1B. Half of the participants required a CVC and neither fish oil nor aspirin reduced the freque

Introduction and Aims: Technique failure is a major complication of peritoneal dialysis (PD) treatment and is associated with significant risk to patients and health services. The first year has been recognised as a particularly vulnerable period, with studies estimating that just under one-half of patients who develop technique failure do so within this time. This study aimed to identify the key risk factors and risk periods for early transfer to haemodialysis or death in incident PD patients. Method(s): Using data from the ANZDATA Registry, this study included all adult patients who commenced PD in Australia and New Zealand between 2000 and 2014. Competing risk regression models were used to analyse the primary outcome, which was technique failure within the first year (kidney transplantation was the competing risk), as well as the secondary outcomes, which examined each cause of technique failure (kidney transplantation and other causes of technique failure were the competing risks). Patients were censored at the time of kidney transplantation, recovery of renal function, loss to follow up, or at 365.25 days after commencement of PD. Result(s): Of 16,748 patients who commenced PD during the study period, 4,389 patients reached the primary outcome. Factors associated with increased risk included age >70 years, diabetes or vascular disease, prior renal replacement therapy, late referral to a nephrology service, or management in a smaller centre. Asian or other race and use of continuous ambulatory PD were associated with reduced risk, as was commencement of PD between 2010 and 2014. Although the risk of technique failure due to death or infection was constant over the first year, mechanical and other causes accounted for a greater number of cases within the initial 9 months of treatment. [Figure Presented] Conclusion(s): Several modifiable and non-modifiable factors are associated with early technique failure. Variation in the principal cause of early technique fai

Background: Pentoxifylline has been shown to increase haemoglobin levels in patients with chronic kidney disease (CKD) and erythropoietin-stimulating agent (ESA)-hyporesponsive anaemia in the Handling Erythropoietin Resistance with Oxpentifylline multicentre double-blind, randomized controlled trial. The present sub-study evaluated the effects of pentoxifylline on the iron-regulatory hormone hepcidin in patients with ESA-hyporesponsive CKD. Methods: This sub-study included 13 patients in the pentoxifylline arm (400 mg daily) and 13 in the matched placebo arm. Hepcidin-25 was measured by ultra performance liquid chromatography/quadrupole time-of-flight mass spectrometry following isolation from patient serum. Serum hepcidin-25, serum iron biomarkers, haemoglobin and ESA dosage were compared within and between the two groups. Results: Hepcidin-25 concentration at 4 months adjusted for baseline did not differ significantly in pentoxifylline versus placebo treated patients (adjusted mean difference (MD) -7.9 nmol, P = 0.114), although the difference between the groups mean translated into a > 25% reduction of circulating hepcidin-25 due to pentoxifylline compared with the placebo baseline. In paired analysis, serum hepcidin-25 levels were significantly decreased at 4 months compared with baseline in the pentoxifylline group (-5.47 ± 2.27 nmol/l, P < 0.05) but not in the placebo group (2.82 ± 4.29 nmol/l, P = 0.24). Pentoxifylline did not significantly alter serum ferritin (MD 55.4 mcg/l), transferrin saturation (MD 4.04%), the dosage of ESA (MD -9.93 U/kg per week) or haemoglobin concentration (MD 5.75 g/l). Conclusion: The reduction of circulating hepcidin-25 due to pentoxifylline did not reach statistical significance; however, the magnitude of the difference suggests that pentoxifylline may be a clinically and biologically meaningful modulator of hepcidin-25 in dialysis of patients with ESA-hyporesponsive anaemia. © 2016 Asian Pacific Society of Nephrology.

Aim: To describe and compare arteriovenous fistula failure between Australia and New Zealand (ANZ) and Malaysia. Background(s): Arteriovenous fistulae (AVF) are the preferred haemodialysis access but limited by early failure in 20-50%. Failure rates in ANZ and Malaysia are unknown. Method(s): We assessed 353 participants from ANZ and Malaysia included in the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) randomized-controlled trial. AVF failure was defined as a composite of AVF thrombosis and/or abandonment and/or cannulation failure. The composite and each component were compared between participants from ANZ (n = 209) and Malaysia (n= 144) using log binomial regression with adjustment for predictors of AVF failure. Result(s): The mean age was 55 years, 64%weremale and 52% diabetic. At twelvemonths after AVF creation, 47%ofAVF had failed. AVF failure was significantly lower in participants in Malaysia compared to participants in ANZ (54/144 [38%] versus 113/209 [54%], p<0.01). This remained significant after adjustment (risk ratio [RR] 0.71, 95% confidence interval [CI] 0.53-0.96, p = 0.02). This difference in AVF failure was driven by a lower risk of cannulation failure (42/144 [29%] versus 98/209 [47%], adjusted RR 0.63, 95% CI 0.44-0.91, p<0.01), while the proportions of AVF thrombosis (25/144 [17%] versus 42/209 [20%], p = 0.91) and abandonment (36/144 [25%] versus 49/209 [23%], p = 0.91) were not different. Conclusion(s): This analysis confirms the high proportion of AVF failure. However, the risk of AVF failure was significantly lower in Malaysia compared to ANZ and was driven by a lower risk of cannulation failure. Differences in practice patterns, including patient selection, surgical and/or cannulation techniques, likely contributed to the observed differences in outcomes and warrant further investigation.

Background: The aim of the present study was to evaluate the predictors of transfer to home hemodialysis (HHD) after peritoneal dialysis (PD) completion. Methods: All Australian and New Zealand patients treated with PD on day 90 after initiation of renal replacement therapy between 2000 and 2012 were included. Completion of PD was defined by death, transplantation, or hemodialysis (HD) for 180 days or more. Patients were categorized as "transferred to HHD" if they initiated HHD fewer than 180 days after PD had ended. Multivariable logistic regression was used to evaluate predictors of transfer to HHD in a restricted cohort experiencing PD technique failure; a competing-risks analysis was used in the unrestricted cohort. Results: Of 10 710 incident PD patients, 3752 died, 1549 underwent transplantation, and 2915 transferred to HD, among whom 156 (5.4%) started HHD. The positive predictors of transfer to HHD in the restricted cohort were male sex [odds ratio (OR): 2.81], obesity (OR: 2.20), and PD therapy duration (OR: 1.10 per year). Negative predictors included age (OR: 0.95 per year), infectious cause of technique failure (OR: 0.48), underweight (OR: 0.50), kidney disease resulting from hypertension (OR: 0.38) or diabetes (OR: 0.32), race being Maori (OR: 0.65) or Aboriginal and Torres Strait Islander (OR: 0.30). Comparable results were obtained with a competing-risks model. Conclusion(s): Transfer to HHD after completion of PD is rare and predicted by patient characteristics at baseline and at the time of PD end. Transition to HHD should be considered more often in patients using PD, especially when they fulfill the identified characteristics.Copyright © 2016 International Society for Peritoneal Dialysis.

Aim: To determine whether fish oil or aspirin is effective in reducing arteriovenous fistula (AVF) failure. Background(s): Increasing the use of AVF to improve haemodialysis access outcomes is limited by early thrombosis and maturation failure. Omega-3 polyunsaturated fatty acids (fish oils) have pleiotropic effects upon vascular biology and inflammation, and aspirin impairs platelet aggregation, which may reduce access failure. Method(s): In this double-blind, placebo-controlled trial, 567 participants from Australia, Malaysia, New Zealand and the United Kingdom planning to undergo AVF surgery were randomized to fish oil (4 g/day) or placebo for 12weeks. Of these, 406 participants were also randomized to aspirin (100mg/day) or placebo for 12weeks. The primary outcome was AVF failure at 12months, a composite of AVF thrombosis and/or abandonment and/or cannulation failure. Result(s): The proportion of AVF failure in the fish oil and placebo arms was similar (47% versus 47%, relative risk [RR] adjusted for aspirin use 1.03, 95% confidence interval [CI] 0.86-1.23, p = 0.78). Fish oil did not reduce the risk of AVF thrombosis (22% versus 23%, RR 0.98, 95% CI 0.72-1.34, p = 0.90), abandonment (19% versus 22%, RR 0.87, 95% CI 0.62-1.22, p = 0.43) or cannulation failure (40% versus 39%, RR 1.03, 95% CI 0.83-1.26, p = 0.81). There were no significant differences in adverse drug events (9% versus 13%, p = 0.15) including bleeding complications (6% versus 4%, p = 0.26) between the fish oil and placebo arms. The risk of AVF failure did not differ between the aspirin and placebo arms (45% versus 43%, RR 1.05, 95% CI 0.84-1.31, p = 0.68), and adverse events including bleeding were comparable between participants assigned to aspirin or placebo. Conclusion(s): Neither fish oil nor aspirin was effective in preventing AVF failure.

Introduction and Aims: Long-term peritoneal dialysis (PD) is often limited by technique failure and a significant proportion of PD patients are eventually transferred to hemodialysis. In countries promoting home dialysis, home hemodialysis (HHD) has been identified as an attractive alternative for patients experiencing PD technique failure. Nonetheless, there is still a paucity of data regarding predictors of transfer to HHD after PD completion, which is the main objective of this study. Method(s): This registry study included all Australian and New Zealand patients treated with PD in the first 90 days after renal replacement therapy initiation, between 2000 and 2012. Definitive PD completion was defined by hemodialysis treatment for 180 days or more. Patients with definitive PD completion were further categorized as 'transferred to HHD' if they initiated HHD less than 180 days after PD ending (first day of hemodialysis). Predictors of transfer to HHD (versus chronic transfer to facility hemodialysis) were evaluated through a multivariable logistic regression. Result(s): The total cohort included 10 710 incident PD patients. Definitive PD completion was identified in 2915 patients, among which 156 (5.4%) were transferred to HHD while the other patients remained treated by facility hemodialysis. In the multivariable logistic regression model, male gender, obesity and longer duration of PD therapy were identified as positive predictors of transfer to HHD while increasing age, infectious cause of PD completion, underweight, hypertension and diabetes as cause of kidney disease and Indigenous races were found to be negative predictors. (Table 1) The predictive capacity of the model was overall good (area under receiving operator characteristics [ROC] 0.81). Conclusion(s): Only 5% of patients with definitive PD completion were transferred to HHD in less than 180 days after PD ending. Based registry data from Australia and New Zealand, predictors of transfer to HHD include

Introduction and Aims: The 'Integrated home dialysis' model involving initiation of peritoneal dialysis (PD) first followed by home hemodialysis (HHD) has previously been proposed as an optimal form of dialysis that maximises the advantages of both modalities. While this model has great potential, its clinical outcomes, especially compared to direct HHD initiation, remain uncertain. Hence, the aim of this study was to evaluate survival in patients treated with PD and subsequently HHD, compared to treatment with a single home dialysis modality. Method(s): This study included all incident home dialysis patients, defined as PD or HHD in the first 90 days after renal replacement therapy initiation, in Australia and New Zealand between 2000 and 2012. Propensity score matching was performed to evaluate patients initially treated with PD followed by HHD ('PD + HHD' group), PD without subsequent transition to HHD ('PD only' group) and HHD without subsequent transition to PD ('HHD only' group). The composite primary outcome was death and home dialysis technique failure (defined as transfer to facility hemodialysis for at least 90 days). The secondary outcome included death on home dialysis (censored for technique failure). For all time-to-event analyses, time zero was defined as the time when HHD was initiated for patients in the 'PD+HHD' group and matching time for the other groups. Groups were compared using Cox proportional hazards models. Result(s): The 2:1 matched cohort included 84 patients in the 'PD+HHD' group, 168 patients in the 'HHD only' group and 168 patients in the 'PD only' group. Baseline characteristics were similar across the three matched groups. Compared to the 'PD +HHD' group, death and home dialysis technique failure was similar for patients treated with 'HHD only' (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.52-1.62; p=0.77) and higher for those treated with 'PD only' (HR 3.22, 95% CI 1.97-5.25; p<0.001). Similar results were observed for mo

Background: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design. Methods/design: The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome 'early thrombosis' at 3 months following AVF creation was broadened to a more clinically relevant outcome of 'AVF access failure'; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure. Discussion(s): This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enro

BACKGROUND: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design. METHODS/DESIGN: The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome 'early thrombosis' at 3 months following AVF creation was broadened to a more clinically relevant outcome of 'AVF access failure'; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure. DISCUSSION: This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enroll

Aim: This paper is a report of the comparison of perceptions of family-centred care by hospital staff (nurses, doctors and allied health staff) and parents of hospitalised children in 2 Australian tertiary paediatric hospitals.Background: Family-centred care is an accepted approach to caring for children and their families in hospital. Previous publications have been inconsistent, ranging from promoting its benefits and integration into practice, reporting operational difficulties and proposing that family-centred care may not be working at all. An evaluation of the model of care is long overdue.Method: A quantitative comparative cross-sectional survey was used to collect data in 2010 from a convenience sample of 309 parents of hospitalised children and 519 staff. Participants rated 20 items grouped into 3 subscales of respect, collaboration and support.Findings: Both parents and staff responses were positive and parents had significantly higher subscale scores for respect, collaboration and support (all p<0.0001). Parents’ responses for 19 of the 20 items were significantly higher than for staff. The item on which parents and staff did not differ was concerned with being able to question recommendations about the child’s treatment.Conclusion: Both parents and staff had positive perceptions of their family-centred care experiences. Parents’ perception of their experience was more positive than staff perceptions of their delivery of family-centred care in hospital. Whilst the positive experience by both consumers and healthcare providers is an important finding, reasons for differences, in particular in supporting parents, require further examination.

Background. It is uncertain whether particular clones causing invasive community-onset methicillin-resistant and methicillin-sensitive Staphylococcus aureus (cMRSA/cMSSA) infection differ in virulence. Methods. Invasive cMRSA and cMSSA cases were prospectively identified. Principal component analysis was used to derive an illness severity score (ISS) from clinical data, including 30-day mortality, requirement for intensive hospital support, the presence of bloodstream infection, and hospital length of stay. The mean ISS for each S. aureus clone (based on MLST) was compared with its DNA microarray-based genotype. Results. Fifty-seven cMRSA and 50 cMSSA infections were analyzed. Ten clones caused 82 (77%) of these infections and had an ISS calculated. The enterotoxin gene cluster (egc) and the collagen adhesin (cna) gene were found in 4 of the 5 highest-ranked clones (ST47-MSSA, ST30-MRSA-IV[2B], ST45-MSSA, and ST22-MRSA-IV[2B]) compared with none and 1 of the lowest 5 ranked clones, respectively. cMSSA clones caused more severe infection than cMRSA clones. The lukF/lukS Panton–Valentine leukocidin (PVL) genes did not directly correlate with the ISS, being present in the second, fourth, and 10th most virulent clones. Conclusions. The clinical severity of invasive cMRSA and cMSSA infection is likely to be attributable to the isolates’ entire genotype rather than a single putative virulence determinant such as PVL.

Background: This is an update of the Cochrane systematic review of family-centred care published in 2007 (Shields 2007). Family-centred care (FCC) is a widely used model in paediatrics, is thought to be the best way to provide care to children in hospital and is ubiquitous as a way of delivering care. When a child is admitted, the whole family is affected. In giving care, nurses, doctors and others must consider the impact of the child’s admission on all family members. However, the effectiveness of family-centred care as a model of care has not been measured systematically. Objectives: To assess the effects of family-centred models of care for hospitalised children aged from birth (unlike the previous version of the review, this update excludes premature neonates) to 12 years, when compared to standard models of care, on child, family and health service outcomes. Search methods: In the original review, we searched up until 2004. For this update, we searched: the Cochrane Central Register of Controlled Trials (CENTRAL,The Cochrane Library, Issue 12 2011); MEDLINE (Ovid SP); EMBASE (Ovid SP); PsycINFO (Ovid SP); CINAHL(EBSCO Host); and Sociological Abstracts (CSA). We did not search three that were included in the original review: Social Work Abstracts, the Australian Medical Index and ERIC. We searched EMBASE in this update only and searched from 2004 onwards. There was no limitation by language. We performed literature searches in May and June 2009 and updated them again in December 2011.Selection criteria: We searched for randomised controlled trials (RCTs) including cluster randomised trials in which family-centred care models are compared with standard models of care for hospitalised children (0 to 12 years, but excluding premature neonates). Studies had to meet criteria for family-centredness. In order to assess the degree of family-centredness, we used a modified rating scale based on a validated instrument, (same instrument used in the initial review), howeve