Uptake and Outcomes of Peritoneal Dialysis among Aboriginal and Torres Strait Islander People: Analysis of Registry Data.

Introduction: Peritoneal dialysis (PD) enables people to use kidney replacement therapy (KRT) outside of healthcare-dependent settings, a strong priority of Aboriginal and Torres Strait Islander people. Methods: We undertook an observational study analyzing registry data to describe access to PD and its outcome as the first KRT among Aboriginal and Torres Strait Islander people between January 1, 2004 and December 31 2020. Results: Out of 4604 Aboriginal and Torres Strait Islander people, reflecting 10.4% of all Australians commencing KRT, PD was the first KRT modality among 665 (14.4%). PD utilization was 17.2% in 2004 to 2009 and 12.7% in 2016 to 2020 (P = 0.002); 1105 episodes of peritonitis were observed in 413 individuals, median of 3 (interquartile range [IQR], 2-5) episodes/patient. The crude peritonitis rate was 0.53 (95% confidence interval [CI], 0.50-0.56) episodes/patient-years without any significant changes over time. The median time to first peritonitis was 1.1 years. A decrease in the peritonitis incidence rate ratio (IRR) was observed in 2016 to 2020 (IRR, 0.63 [95% CI, 0.52-0.77], P < 0.001) compared to earlier eras (2010-2015: IRR, 0.90 [95% CI, 0.76-1.07], P = 0.23; Ref: 2004-2009). The cure rates decreased from 80.0% (n = 435) in 2004 to 2009, to 70.8% (n = 131) in 2016 to 2020 (P < 0.001). Conclusion: Aboriginal and Torres Strait Islander people who utilized PD as their first KRT during 2004 to 2020 recorded a higher peritonitis rate than the current benchmark of 0.4 episodes/patient-years. The cure rates have worsened recently, which should be a big concern. There is an exigent need to address these gaps in kidney care for Aboriginal and Torres Strait Islander people.

Association between diabetic status and risk of all-cause and cause-specific mortality on dialysis following first kidney allograft loss.

Background: Diabetes mellitus (DM) is associated with a greater risk of mortality in kidney transplant patients, primarily driven by a greater risk of cardiovascular disease (CVD)-related mortality. However, the associations between diabetes status at time of first allograft loss and mortality on dialysis remain unknown. Methods: All patients with failed first kidney allografts transplanted in Australia and New Zealand between 2000 and 2020 were included. The associations between diabetes status at first allograft loss, all-cause and cause-specific mortality were examined using competing risk analyses, separating patients with diabetes into those with pre-transplant DM or post-transplant diabetes mellitus (PTDM). Results: Of 3782 patients with a median (IQR) follow-up duration of 2.7 (1.1-5.4) years, 539 (14%) and 390 (10%) patients had pre-transplant DM or developed PTDM, respectively. In the follow-up period, 1336 (35%) patients died, with 424 (32%), 264 (20%) and 199 (15%) deaths attributed to CVD, dialysis withdrawal and infection, respectively. Compared to patients without DM, the adjusted subdistribution HRs (95% CI) for pre-transplant DM and PTDM for all-cause mortality on dialysis were 1.47 (1.17-1.84) and 1.47 (1.23-1.76), respectively; for CVD-related mortality were 0.81 (0.51-1.29) and 1.02 (0.70-1.47), respectively; for infection-related mortality were 1.84 (1.02-3.35) and 2.70 (1.73-4.20), respectively; and for dialysis withdrawal-related mortality were 1.71 (1.05-2.77) and 1.51 (1.02-2.22), respectively. Conclusions: Patients with diabetes at the time of kidney allograft loss have a significant survival disadvantage, with the excess mortality risk attributed to infection and dialysis withdrawal.

Postoperative Outcomes After Gastrointestinal Surgery in Patients Receiving Chronic Kidney Replacement Therapy: A Population-based Cohort Study.

OBJECTIVE: This study evaluated the postoperative mortality and morbidity outcomes following the different subtypes of gastrointestinal (GI) surgery over a 15-year period. BACKGROUND: Patients receiving chronic kidney replacement therapy (KRT) experience higher rates of general surgery compared with other surgery types. Contemporary data on the types of surgeries and their outcomes are lacking. KRT was defined as patients requiring chronic dialysis (hemodialysis or peritoneal dilaysis) or having a functioning kidney transplant long-term. METHODS: All incident and prevalent patients aged greater than 18 years identified in the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry as receiving chronic KRT were linked with jurisdictional hospital admission datasets between January 1, 2000 until December 31, 2015. Patients were categorized by their KRT modality [hemodialysis (HD), peritoneal dialysis (PD), home hemodialysis (HHD), and kidney transplant (KT)]. GI surgeries were categorized as upper gastrointestinal (UGI), bowel (small and large bowel), anorectal, hernia surgery, cholecystectomy, and appendicectomy. The primary outcome was the rates of the different surgeries, estimated using Poisson models. Secondary outcomes were risks of 30-day/in-hospital postoperative mortality risk and nonfatal outcomes and were estimated using logistic regression. Independent predictors of 30-day mortality were examined using comorbidity-adjusted Cox models. RESULTS: Overall, 46,779 patients on chronic KRT were linked to jurisdictional hospital datasets, and 9,116 patients were identified as having undergone 14,540 GI surgeries with a combined follow-up of 76,593 years. Patients on PD had the highest rates of GI surgery (8 per 100 patient years), with hernia surgery being the most frequent. Patients on PD also had the highest risk of 30-day postoperative mortality following the different types of GI surgery, with the risk being more than 2-fold higher after emergency surgery compared with elective procedures. Infective postoperative complications were more common than cardiac complications. This study also observed a U-shaped association between body mass index (BMI) and mortality, with a nadir in the 30 to 35 kg/m 2 group. CONCLUSIONS: Patients on chronic KRT have high rates of GI surgery and morbidity, particularly in those who receive PD, are older, or are either underweight or moderately obese.

Associations of neutral pH, low-GDP peritoneal dialysis solutions with patient survival, transfer to haemodialysis and peritonitis.

BACKGROUND: Peritoneal dialysis (PD) solutions containing low levels of glucose degradation products (GDPs) are associated with attenuation of peritoneal membrane injury and vascular complications. However, clinical benefits associated with neutral-pH, low-GDP (N-pH/L-GDP) solutions remain unclear. METHODS: Using data from the Australia and New Zealand Dialysis and Transplant Registry, we examined the associations between N-pH/L-GDP solutions and all-cause mortality, cause-specific mortality, transfer to haemodialysis (HD) for ≥30 days and PD peritonitis in adult incident PD patients in Australia and New Zealand between 1 January 2005 and 31 December 2020 using adjusted Cox regression analyses. RESULTS: Of 12 814 incident PD patients, 2282 (18%) were on N-pH/L-GDP solutions. The proportion of patients on N-pH/L-GDP solutions each year increased from 11% in 2005 to 33% in 2017. During the study period, 5330 (42%) patients died, 4977 (39%) experienced transfer to HD and 5502 (43%) experienced PD peritonitis. Compared with the use of conventional solutions only, the use of any form of N-pH/L-GDP solution was associated with reduced risks of all-cause mortality {adjusted hazard ratio [aHR] 0.67 [95% confidence interval (CI) 0.61-0.74]}, cardiovascular mortality [aHR 0.65 (95% CI 0.56-0.77)], infection-related mortality [aHR 0.62 (95% CI 0.47-0.83)] and transfer to HD [aHR 0.79 (95% CI 0.72-0.86)] but an increased risk of PD peritonitis [aHR 1.16 (95% CI 1.07-1.26)]. CONCLUSIONS: Patients who received N-pH/L-GDP solutions had decreased risks of all-cause and cause-specific mortality despite an increased risk of PD peritonitis. Studies assessing the causal relationships are warranted to determine the clinical benefits of N-pH/L-GDP solutions.

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.

BACKGROUND: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. METHODS: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.

Multicentre registry analysis of incremental peritoneal dialysis incidence and associations with patient outcomes.

BACKGROUND: Incremental peritoneal dialysis (PD) is increasingly advocated to reduce treatment burden and costs, with potential to better preserve residual kidney function. Global prevalence of incremental PD use is unknown and use in Australia and New Zealand has not been reported. METHODS: Binational registry analysis including incident adult PD patients in Australia and New Zealand (2007-2017), examining incidence of and outcomes associated with incremental PD (first recorded PD exchange volume <42 L/week (incremental) vs. ≥42 L/week (standard)). RESULTS: Incremental PD use significantly increased from 2.7% of all incident PD in 2007 to 11.1% in 2017 (mean increase 0.84%/year). Duration of incremental PD use was 1 year or less in 67% of cases. Male sex, Aboriginal and Torres Strait Islander (ATSI) or Maori ethnicities, age 45-59 years, medical comorbidities or treatment at a centre with low use of automated PD or icodextrin was associated with lower incidence of incremental PD use. Low body mass index and higher estimated glomerular filtration rate was associated with higher incidence. After accounting for patient and centre variables, commencing PD with an incremental prescription was associated with reduced peritonitis risk (adjusted hazard ratio 0.73, 95% confidence interval (CI) 0.61-0.86).When kidney transplantation and death were considered as competing risks, the association between incremental PD and peritonitis was not significant (sub-hazard ratio [SHR] 0.91, 95%CI 0.71-1.17, p = 0.5), however cumulative incidence of 30-day transfer to haemodialysis was lower in those receiving incremental PD (SHR 0.73, 95%CI 0.56-0.94, p = 0.01). There was no association between incremental PD and death. CONCLUSIONS: Incremental PD use is increasing in Australia and New Zealand and is not associated with patient harm.

Participant Perceptions in a Long-term Clinical Trial of Autosomal Dominant Polycystic Kidney Disease.

Rationale & Objective: The development of new therapies for autosomal dominant polycystic kidney disease requires clinical trials to be conducted efficiently. In this study, the factors affecting the recruitment and retention of participants enrolled in a 3-year randomized controlled trial in autosomal dominant polycystic kidney disease were investigated. Study Design: Qualitative study. Setting & Participants: All participants (N=187) were invited to complete a 16-item questionnaire at the final study visit of the primary trial. Participants were recruited to complete a semistructured interview using purposeful sampling according to age, self-reported gender, and randomization group. Analytical Approach: Descriptive statistics were used for demographic data and questionnaires. The interview transcripts underwent inductive thematic coding. Results: One hundred and forty-six of the 187 randomized participants (79%) completed the post-trial questionnaire, and 31 of the 187 participants (21%) completed the interview. Most participants (94%) rated their global satisfaction with the trial as high (a score of 8 or more out of 10). Altruism, knowledge gain, and access to new treatments were the main motivators for recruitment. The main reasons for considering leaving the study were concerns about the risk of intervention and family or work issues. Strategies that favored retention included flexibility in attending different study sites, schedule flexibility, staff interactions, and practical support with parking and reminders. The main burden was time away from work with lost wages, and burden associated with magnetic resonance imaging scans and 24-hour urine output collections. Limitations: The study population was restricted to participants in a single nondrug clinical trial, and the results could be influenced by selection and possible social desirability bias. Conclusions: Participants reported high levels of satisfaction that occurred as a function of the trial meeting participants' expectations. Furthermore, retention was a balance between the perceived benefits and burden of participation. Consideration of these perspectives in the design of future clinical trials will improve their efficiency and conduct. Plain-Language Summary: Advances in the clinical practice of autosomal dominant polycystic kidney disease (ADPKD) require affected individuals to voluntarily participate in long-term multicenter randomized controlled trials (RCTs). In this qualitative post hoc study of a 3-year RCT of increased water intake in ADPKD, altruism, knowledge gain, and access to a nondrug treatment positively influenced the decision to volunteer. Ongoing participation was enabled by building flexibility into the study protocol and staff prioritizing a participant's needs during study visits. Although participants completed the required tests, most were considered burdensome. This study highlights the importance of incorporating protocol flexibility into trial design; the preference for interventions with a low risk of adverse effects; and the urgent requirement for robust surrogate noninvasive biomarkers to enable shorter RCTs in ADPKD.

Validation of a Phosphorus Food Frequency Questionnaire in Patients with Kidney Failure Undertaking Dialysis.

Nutritional guidelines recommended limiting dietary phosphorus as part of phosphorus management in patients with kidney failure. Currently, there is no validated phosphorus food frequency questionnaire (P-FFQ) to easily capture this nutrient intake. An FFQ of this type would facilitate efficient screening of dietary sources of phosphorus and assist in developing a patient-centered treatment plan. The objectives of this study were to develop and validate a P-FFQ by comparing it with the 24 hr multi-pass recall. Fifty participants (66% male, age 70 ± 13.3 years) with kidney failure undertaking dialysis were recruited from hospital nephrology outpatient departments. All participants completed the P-FFQ and 24 hr multi-pass recalls with assistance from a renal dietitian and then analysed using nutrient analysis software. Bland-Altman analyses were used to determine the agreement between P-FFQ and mean phosphorus intake from three 24 hr multi-pass recalls. Mean phosphorous intake was 1262 ± 400 mg as determined by the 24 hr multi pass recalls and 1220 ± 348 mg as determined by the P-FFQ. There was a moderate correlation between the P-FFQ and 24 hr multi pass recall (r = 0.62, p = 0.37) with a mean difference of 42 mg (95% limits of agreement: 685 mg; -601 mg, p = 0.373) between the two methods. The precision of the P-FFQ was 3.33%, indicating suitability as an alternative to the 24 hr multi pass recall technique. These findings indicate that the P-FFQ is a valid, accurate, and precise tool for assessing sources of dietary phosphorus in people with kidney failure undertaking dialysis and could be used as a tool to help identify potentially problematic areas of dietary intake in those who may have a high serum phosphate.

Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis.

BACKGROUND: Hypoxia-inducible factor prolyl hydroxylase inhibitors such as vadadustat may provide an oral alternative to injectable erythropoiesis-stimulating agents for treating anemia in patients receiving peritoneal dialysis. In two randomized (1:1), global, phase 3, open-label, sponsor-blind, parallel-group, active-controlled noninferiority trials in patients with dialysis-dependent chronic kidney disease (INNO2VATE), vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety and hematological efficacy. Vadadustat's effects in patients receiving only peritoneal dialysis is unclear. METHODS: We conducted a post hoc analysis of patients in the INNO2VATE trials receiving peritoneal dialysis at baseline. The prespecified primary safety endpoint was time to first major cardiovascular event (MACE; defined as all-cause mortality or nonfatal myocardial infarction or stroke). The primary efficacy endpoint was mean change in hemoglobin from baseline to the primary evaluation period (Weeks 24-36). RESULTS: Of the 3923 patients randomized in the two INNO2VATE trials, 309 were receiving peritoneal dialysis (vadadustat, n = 152; darbepoetin alfa, n = 157) at baseline. Time to first MACE was similar in the vadadustat and darbepoetin alfa groups [hazard ratio 1.10; 95% confidence interval (CI) 0.62, 1.93]. In patients receiving peritoneal dialysis, the difference in mean change in hemoglobin concentrations was -0.10 g/dL (95% CI -0.33, 0.12) in the primary evaluation period. The incidence of treatment-emergent adverse events (TEAEs) was 88.2% versus 95.5%, and serious TEAEs was 52.6% versus 73.2% in the vadadustat and darbepoetin alfa groups, respectively. CONCLUSIONS: In the subgroup of patients receiving peritoneal dialysis in the phase 3 INNO2VATE trials, safety and efficacy of vadadustat were similar to darbepoetin alfa.

The living kidney donor profile index fails to discriminate allograft survival: implications for its use in kidney paired donation programs.

The inclusion of blood group- and human leukocyte antigen-compatible donor and recipient pairs (CPs) in kidney paired donation (KPD) programs is a novel strategy to increase living donor (LD) transplantation. Transplantation from a donor with a better Living Donor Kidney Profile Index (LKDPI) may encourage CP participation in KPD programs. We undertook parallel analyses using data from the Scientific Registry of Transplant Recipients and the Australia and New Zealand Dialysis and Transplant Registry to determine whether the LKDPI discriminates death-censored graft survival (DCGS) between LDs. Discrimination was assessed by the following: (1) the change in the Harrell C statistic with the sequential addition of variables in the LKDPI equation to reference models that included only recipient factors and (2) whether the LKDPI discriminated DCGS among pairs of prognosis-matched LD recipients. The addition of the LKDPI to reference models based on recipient variables increased the C statistic by only 0.02. Among prognosis-matched pairs, the C statistic in Cox models to determine the association of the LKDPI with DCGS was no better than chance alone (0.51 in the Scientific Registry of Transplant Recipient and 0.54 in the Australia and New Zealand Dialysis and Transplant Registry cohorts). We conclude that the LKDPI does not discriminate DCGS and should not be used to promote CP participation in KPD programs.

A different PET test: The relationship between pet ownership and peritonitis risk in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Pet ownership is common around the world, with pet ownership increasing in many countries. Current guidelines are not supportive of pet ownership for peritoneal dialysis (PD) patients. We examined the association between ownership of cats and dogs and the incidence of peritonitis among PD patients participating in the prospective, observational Peritoneal Dialysis Outcomes and Practice Patterns Study. A total of 3655 PD patients from eight different countries was included, with a median follow-up of 14 months and a total exposure time of 55,475 patient-months. There were 1347 peritonitis episodes with an overall peritonitis rate of 0.29 episodes per patient year. There was no significant increased risk of peritonitis with any type of pet ownership, adjusted hazard ratio (HR) of 1.09 (95% confidence interval (95% CI): 0.96-1.25). However, patients who owned both cats and dogs had an increased risk of peritonitis compared to patients without pets, HR = 1.45 (95% CI: 1.14-1.86). These results suggest that there is no increased risk of peritonitis with pet ownership except for those with both cats and dogs. This information should not prevent PD patients from owning pets but may be helpful for PD patients and their care team to direct training to minimise the risk of peritonitis.

Haemodialysis vascular catheter-related blood stream infection: Organism types and clinical outcomes.

Catheter-related bloodstream infection (CRBI) is an important complication of catheter use for haemodialysis, but it remains unclear whether clinical outcomes following CRBI are influenced by organism type. This study aims to compare clinical outcomes following CRBI from Gram-positive and non-Gram-positive organisms. This was a retrospective cohort study of patients with kidney failure receiving haemodialysis (HD) via vascular catheters who had a documented episode of CRBI in Western Australia between 2005 and 2018. The associations between organism type, likelihood of hospitalization, catheter removal and death from CRBI were examined using adjusted logistic regression models. There were 111 episodes of CRBI in 99 patients (6.1 episodes per 1000-catheter-days at risk). Of the study cohort, 53 (48%) were male and 38 (34%) identified as Aboriginal or Torres Strait Islander. Gram-positive organisms were identified in 73 (66%) CRBI episodes, most commonly Staphylococcus aureus. Of those with non-Gram-positive CRBI, 9 (24%) were attributed to Pseudomonas aeruginosa. One-hundred and two (92%) episodes of CRBI required hospitalization and 15 (13%) patients died from CRBI. Compared with non-Gram-positive CRBI, Gram-positive CRBI was associated with an increased risk of hospitalization and catheter removal, with adjusted odds ratio of 9.34 (95% CI 1.28-68.03) and 3.47 (95% CI 1.25-9.67), respectively. There was no association between organism type and death from CRBI. Staphylococcus aureus remains the most common organism causing CRBI in HD patients. CRBI is associated with substantial morbidity, particularly CRBI attributed to Gram-positive organisms.

Evaluating data quality in the Australian and New Zealand dialysis and transplant registry using administrative hospital admission datasets and data-linkage.

Background: Clinical quality registries provide rich and useful data for clinical quality monitoring and research purposes but are susceptible to data quality issues that can impact their usage. Objective: This study assessed the concordance between comorbidities recorded in the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry and those in state-based hospital admission datasets. Method: All patients in New South Wales, South Australia, Tasmania, Victoria and Western Australia recorded in ANZDATA as requiring chronic kidney replacement therapy (KRT) between 01/07/2000 and 31/12/2015 were linked with state-based hospital admission datasets. Coronary artery disease, diabetes mellitus, cerebrovascular disease, chronic lung disease and peripheral vascular disease recorded in ANZDATA at each annual census date were compared overall, over time and between different KRT modalities to comorbidities recorded in hospital admission datasets, as defined by the International Classification of Diseases (ICD-10-AM), using both the kappa statistic and logistic regression analysis. Results: 29, 334 patients with 207,369 hospital admissions were identified. Comparison was made at census date for every patient comparison. Overall agreement was "very good" for diabetes mellitus (92%, k = 0.84) and "poor" to "fair" (21-61%, k = 0.02-0.22) for others. Diabetes mellitus recording had the highest accuracy (sensitivity 93% (±SE 0.2) and specificity 93% (±SE 0.2)), and cerebrovascular disease had the lowest (sensitivity 54% (±SE 0.2) and specificity 21% (±SE 0.3)). The false positive rates for cerebrovascular disease, peripheral vascular disease and chronic airway disease ranged between 18 and 33%. The probability of a false positive was lowest for kidney transplant patients for all comorbidities and highest for patients on haemodialysis. Conclusions and Implications: Agreement between the clinical quality registry and hospital admission datasets was variable, with the prevalence of comorbidities being higher in ANZDATA.

Sex Disparity in Cause-Specific and All-Cause Mortality Among Incident Dialysis Patients.

RATIONALE & OBJECTIVE: Early mortality rates of female patients receiving dialysis have been, at times, observed to be higher than rates among male patients. The differences in cause-specific mortality between male and female incident dialysis patients with kidney failure are not well understood and were the focus of this study. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Incident patients who had initiated dialysis in Australia and New Zealand in 1998-2018. EXPOSURE: Sex. OUTCOMES: Cause-specific and all-cause mortality while receiving dialysis, censored for kidney transplant. ANALYTICAL APPROACH: Adjusted cause-specific proportional hazards models, focusing on the first 5 years following initiation of dialysis. RESULTS: Among 53,414 patients (20,876 [39%] female) followed for a median period of 2.8 (IQR, 1.3-5.2) years, 27,137 (51%) died, with the predominant cause of death attributed to cardiovascular disease (18%), followed by dialysis withdrawal (16%). Compared with male patients, female patients were more likely to die in the first 5 years after dialysis initiation (adjusted hazard ratio [AHR], 1.08 [95% CI, 1.05-1.11]). Even though female patients experienced a lower risk of cardiovascular disease-related mortality (AHR, 0.93 [95% CI, 0.89-0.98]) than male patients, they experienced a greater risk of infection-related (AHR, 1.20 [95% CI, 1.10-1.32]) and dialysis withdrawal-related (AHR, 1.19 [95% CI, 1.13-1.26]) mortality. LIMITATIONS: Possibility of residual and unmeasured confounders. CONCLUSIONS: Compared with male patients, female patients had a higher risk of all-cause mortality in the first 5 years after dialysis initiation, a difference driven by higher rates of mortality from infections and dialysis withdrawals. These findings may inform the study of sex differences in mortality in other geographic settings.

Peritoneal Dialysis-Associated Peritonitis Trends Using Medicare Claims Data, 2013-2017.

RATIONALE & OBJECTIVE: The occurrence and consequences of peritoneal dialysis (PD)-associated peritonitis limit its use in populations with kidney failure. Studies of large clinical populations may enhance our understanding of peritonitis. To facilitate these studies we developed an approach to measuring peritonitis rates using Medicare claims data to characterize peritonitis trends and identify its clinical risk factors. STUDY DESIGN: Retrospective cohort study of PD-associated peritonitis. SETTING & PARTICIPANTS: US Renal Data System standard analysis files were used for claims, eligibility, modality, and demographic information. The sample consisted of patients receiving PD treated at some time between 2013 and 2017 who were covered by Medicare fee-for-service (FFS) insurance with paid claims for dialysis or hospital services. EXPOSURES/PREDICTORS: Peritonitis risk was characterized by year, age, sex, race, ethnicity, vintage of kidney replacement therapy, cause of kidney failure, and prior peritonitis episodes. OUTCOME: The major outcome was peritonitis, identified using ICD-9 and ICD-10 diagnosis codes. Closely spaced peritonitis claims (30 days) were aggregated into 1 peritonitis episode. ANALYTICAL APPROACH: Patient-level risk factors for peritonitis were modeled using Poisson regression. RESULTS: We identified 70,271 peritonitis episodes from 396,289 peritonitis claims. Although various codes were used to record an episode of peritonitis, none was used predominantly. Peritonitis episodes were often identified by multiple aggregated claims, with the mean and median claims per episode being 5.6 and 2, respectively. We found 40% of episodes were exclusively outpatient, 9% exclusively inpatient, and 16% were exclusively based on codes that do not clearly distinguish peritonitis from catheter infections/inflammation ("catheter codes"). The overall peritonitis rate was 0.54 episodes per patient-year (EPPY). The rate was 0.45 EPPY after excluding catheter codes and 0.35 EPPY when limited to episodes that only included claims from nephrologists or dialysis providers. The peritonitis rate declined by 5%/year and varied by patient factors including age (lower rates at higher ages), race (Black > White>Asian), and prior peritonitis episodes (higher rate with each prior episode). LIMITATIONS: Coding heterogeneity indicates a lack of standardization. Episodes based exclusively on catheter codes could represent false positives. Peritonitis episodes were not validated against symptoms or microbiologic data. CONCLUSIONS: PD-associated peritonitis rates decline over time and were lower among older patients. A claims-based approach offers a promising framework for the study of PD-associated peritonitis.

Can Telehealth Improve Access to Dietary Management in Patients Receiving Dialysis? Insights from Consumers.

Timely, effective, and individualised dietary interventions are essential for patients undergoing dialysis. However, delivery of dietary advice is challenging due to limited access to renal dietitians, as well as logistic and scheduling difficulties for patients receiving dialysis. The objectives of this study were to explore consumer perspectives regarding dietary advice utilising telehealth technology. Twenty-two participants (seventeen patients receiving dialysis, five caregivers) were purposively recruited from a local dialysis centre and participated in one of three focus groups. Each focus group was recorded, transcribed, and analysed using inductive thematic analysis. One overarching theme: "a desire to learn" was apparent. The four themes that facilitated this process are herein described: Meaningful communication-a need for improved and individualised communication about diet using positively framed messages with consistency among clinicians. Conducive information-a preference for tailored, current, and clear dietary information (plain language was preferred, with practical advice on making dietary changes). Appropriate timing-health advice at the right time (consumers felt overwhelmed, not supported enough with timely advice, and experienced difficulty attending appointments in addition to dialysis treatments). Contemporary modalities-delivering information using different technologies (consumers preferred a combination of delivery methods for dietetic advice including text/SMS/App messages as an adjunct to face-to-face care). The results showed that consumers believe that telehealth options are an acceptable adjunct to receive dietary advice in a timely manner, and feedback from patients and caregivers has informed the design of a clinical trial to incorporate the use of telehealth to improve the management of serum phosphate.

Association of Peritonitis With Cardiovascular Mortality Over Time in the Peritoneal Dialysis Population: An Australia and New Zealand Dialysis and Transplant Registry Study.

Introduction: Though peritonitis is associated with increased mortality in patients receiving peritoneal dialysis (PD), its association with cardiovascular mortality remains uncertain. Methods: The study participants included adult patients (≥18 years old) commencing PD in Australia (from October 2003 to December 2019) using the Australia and New Zealand Dialysis and Transplant (ANZDATA) registry. Association between peritonitis and cardiovascular mortality was evaluated using Cox proportional hazards analysis and competing risks analysis. Associations between peritonitis rates between different eras and cardiovascular mortality were also compared using Jointpoint regression model to determine the time point when a significant change in peritonitis trend occurred to define the era for cardiovascular mortality. Subgroup analysis dividing the groups into 0, 1 and ≥2 episodes of peritonitis and sensitivity analysis censoring at 90 days post-transfer to hemodialysis (HD) were performed. Results: The study included 9699 incident PD patients. The overall peritonitis rate was 0.37 episodes per patient-year and declined by 4.7% (95% confidence interval [CI] 3.6-5.8%) during the study period. Peritonitis was associated with increased cardiovascular mortality risk (subdistribution hazard ratio [SHR] 1.53, 95% CI 1.39-1.69, P < 0.001) with increasing peritonitis episodes associated with higher risk (1 episode of peritonitis SHR 1.41, 95%CI 1.24-1.61; ≥2 episodes of peritonitis SHR 1.69, 95% CI 1.47-1.93, P < 0.001). Patients who commenced PD between 2012 and 2019 had a lower risk of cardiovascular mortality (SHR 0.60, 95% CI 0.50-0.72, P < 0.001), compared to patients who commenced between 2003 and 2011. Results were consistent in the sensitivity analysis. Conclusion: Peritonitis is independently associated with an increased risk of cardiovascular mortality, and the association is episode-dependent. Prevention and adequate treatment of PD peritonitis may improve cardiovascular outcomes among patients receiving PD.

The Living Kidney Donor Safety Study: Protocol of a Prospective Cohort Study.

Background: Living kidney donation is considered generally safe in healthy individuals; however, there is a need to better understand the long-term effects of donation on blood pressure and kidney function. Objectives: To determine the risk of hypertension in healthy, normotensive adults who donate a kidney compared with healthy, normotensive non-donors with similar indicators of baseline health. We will also compare the 2 groups on the rate of decline in kidney function, the risk of albuminuria, and changes in health-related quality of life. Design Participants and Setting: Prospective cohort study of 1042 living kidney donors recruited before surgery from 17 transplant centers (12 in Canada and 5 in Australia) between 2004 and 2014. Non-donor participants (n = 396) included relatives or friends of the donor, or donor candidates who were ineligible to donate due to blood group or cross-match incompatibility. Follow-up will continue until 2021, and the main analysis will be performed in 2022. The anticipated median (25th, 75th percentile, maximum) follow-up time after donation is 7 years (6, 8, 15). Measurements: Donors and non-donors completed the same schedule of measurements at baseline and follow-up (non-donors were assigned a simulated nephrectomy date). Annual measurements were obtained for blood pressure, estimated glomerular filtration rate (eGFR), albuminuria, patient-reported health-related quality of life, and general health. Outcomes: Incident hypertension (a systolic/diastolic blood pressure ≥ 140/90 mm Hg or receipt of anti-hypertensive medication) will be adjudicated by a physician blinded to the participant's donation status. We will assess the rate of change in eGFR starting from 12 months after the nephrectomy date and the proportion who develop an albumin-to-creatinine ratio ≥3 mg/mmol (≥30 mg/g) in follow-up. Health-related quality of life will be assessed using the 36-item RAND health survey and the Beck Anxiety and Depression inventories. Limitations: Donation-attributable hypertension may not manifest until decades after donation. Conclusion: This prospective cohort study will estimate the attributable risk of hypertension and other health outcomes after living kidney donation.

Contexte: Chez les personnes en bonne santé, faire don d'un rein est généralement considéré comme sûr. Il convient toutefois de mieux comprendre les effets à long terme de ce don sur la pression artérielle et la fonction rénale. Objectifs: Déterminer le risque d'hypertension chez les adultes sains et normotendus qui donnent un rein par rapport à des non-donneurs sains et normotendus ayant des indicateurs de santé de base similaires. Nous comparerons également le taux de réduction de la fonction rénale, le risque d'albuminurie et les changements dans la qualité de vie liée à la santé entre les deux groupes. Cadre type d'étude et participants: Étude de cohorte rétrospective menée sur 1 042 donneurs de rein vivants, recrutés avant la chirurgie dans 17 centres de transplantation (12 au Canada et 5 en Australie) entre 2004 et 2014. Le groupe des non-donneurs (n=396) était constitué de parents ou amis du donneur, ou de candidats donneurs non admissibles à faire un don en raison d'une incompatibilité de groupe sanguin ou lors du test de compatibilité croisée. Le suivi s'est poursuivi jusqu'en 2021 et l'analyse principale sera effectuée en 2022. Le temps de suivi médian prévu (25e percentile, 75e percentile, maximum) après le don est de 7 ans (6, 8, 15 ans). Mesures: Les donneurs et les non-donneurs ont complété le même calendrier de mesures à l'inclusion et pendant le suivi (une date simulée de néphrectomie a été attribuée aux non-donneurs). Des mesures annuelles de pression artérielle, de débit de filtration glomérulaire estimé (DFGe), d'albuminurie, de qualité de vie liée à la santé autodéclarée et de santé générale ont été obtenues. Issues principales: L'hypertension incidente (pression artérielle systolique/diastolique ≥ 140/90 mm Hg ou prise d'un médicament antihypertenseur) sera jugée par un médecin aveugle au statut de don du participant. Nous évaluerons le taux de variation du DFGe à partir de 12 mois après la date de la néphrectomie et la proportion de participants qui développeront un rapport albumine/créatinine ≥ 3 mg/mmol (≥ 30 mg/g) pendant le suivi. La qualité de vie liée à la santé sera évaluée à l'aide du questionnaire de santé RAND de 36 questions et de l'Inventaire d'anxiété et de dépression de Beck. Limites: L'hypertension attribuable au don pourrait ne pas se manifester avant des décennies après le don. Conclusion: Cette étude de cohorte prospective permettra d'estimer le risque d'hypertension attribuable au don et d'autres effets sur la santé du donneur après un don de rein.

Trends in Rates of Surgery and Postoperative Mortality Among Patients Receiving Chronic Kidney Replacement Therapy: A Population-based Cohort Study.

OBJECTIVE: To estimate the incidence and postoperative mortality rates of surgery, and variations by age, diabetes, kidney replacement therapy (KRT) modality, and time over a 15-year period. BACKGROUND: Patients with kidney failure receiving chronic KRT (dialysis or kidney transplantation) have increased risks of postoperative mortality and morbidity. Contemporary data on the incidence and types of surgery these patients undergo are lacking. METHODS: This binational population cohort study evaluated all incident and prevalent patients receiving chronic KRT using linked data between Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry and jurisdictional hospital admission datasets between 2000 and 2015. Patients were categorized by their KRT modality (hemodialysis, peritoneal dialysis, home hemodialysis, and kidney transplant) for each calendar year. Incidence rates for overall surgery and subtypes were estimated using Poisson models. Logistic regression was used to estimate 30-day/in-hospital mortality risk. RESULTS: Overall, 46,497 patients over a median (interquartile range) follow-up of 6.3 years (3.5-10.2 years) underwent 81,332 surgeries. The median incidence rate of surgery remained stable over this period with a median of 14.9 surgeries per 100 patient-years. Annual incidence rate was higher in older people and those with diabetes mellitus. Patients receiving hemodialysis had a higher incidence rate of surgery compared with kidney transplant recipients (15.8 vs 10.0 surgeries per 100 patient-years, respectively). Overall adjusted postoperative mortality rates decreased by >70% over the study period, and were lowest in kidney transplant recipients (1.7%, 95% confidence interval, 1.4-2.0). Postoperative mortality following emergency surgery was >3-fold higher than elective surgery (8.4% vs 2.3%, respectively). CONCLUSIONS: Patients receiving chronic KRT have high rates of surgery and morbidity. Further research into strategies to mitigate perioperative risk remain a priority.