The effect of ambient temperatures on hospital admissions for kidney diseases in Central Australia.

This study aimed to quantify risk of hospitalisations for kidney diseases related to ambient temperature in Central Australia, Northern Territory (NT). Daily hospitalisation data were extracted for Alice Springs Hospital, Central Australia, 2010-2021. The association between daily mean temperature and daily hospital admissions for total kidney and specific kidney conditions was assessed using a quasi-Poisson Generalized Linear Model combined with a distributed lag non-linear model. A total of 52,057 hospitalisations associated with kidney diseases were recorded. In general, risk of specific kidney related hospitalisations was immediate due to hot temperatures and prolonged due to cold temperatures. Relative to the minimum-risk temperature (5.1 °C), at 31 °C, cumulative relative risk (RR) of hospitalisations for total kidney disease (TKD) was 1.297 [95% CI 1.164,1.446] over lag0-1 days, for chronic kidney disease (CKD) cumulative RR was 1.269 [95% CI 1.115,1.444] and for kidney failure (KF) cumulative RR was 1.252 [95% CI 1.107,1.416] at lag 0, and for urinary tract infection (UTI) cumulative RR was 1.522 [95% CI 1.072,2.162] over lag0-7 days. At 16 °C and over lag0-7 days, cumulative RR of hospitalisations for TKD was 1.320 [95% CI 1.135,1.535], for CKD was 1.232 [95% CI 1.025,1.482], for RF was 1.233 [95% CI 1.035,1.470] and for UTI was 1.597 [95% CI 1.143, 2.231]. Both cold and hot temperatures were also associated with increased risks of kidney related total hospitalisations among First Nations Australians and women. Overall, temperature attributable to 13.7% (i.e. 7138 cases) of kidney related hospitalisations with higher attributable hospitalisations from cold temperature. Given the significant burden of kidney disease and projected increases in extreme temperatures associated with climate change in NT including Central Australia there is a need to implement public health and environmental health risk reduction strategies and awareness programs to mitigate potential adverse health effects of extreme temperatures.

Avoiding misclassification of acute kidney injury: Timing is everything.

Accurate detection of acute kidney injury (AKI) in clinical trials is important. Using a 'baseline' creatinine from trial enrolment may not be ideal for understanding a participant's true baseline kidney function. We aimed to determine if a 'pre-trial baseline creatinine' resulted in comparable creatinine concentrations to a 'trial baseline creatinine', and how the timing of baseline creatinine affected the incidence of AKI in the Combination Antibiotic therapy for MEthicillin Resistant Staphylococcus aureus (CAMERA2) randomised trial. Study sites retrospectively collected a pre-trial baseline creatinine from up to 1 year before CAMERA2 trial enrolment ideally when the patient was medically stable. Baseline creatinine from CAMERA2 (the 'trial baseline creatinine'), was the highest creatinine measurement in the 24 h preceding trial randomisation. We used Wilcoxon sign rank test to compare pre-trial and trial baseline creatinine concentrations. We included 217 patients. The median pre-trial baseline creatinine was significantly lower than the median trial baseline creatinine (82 µmol/L [IQR 65-104 µmol/L] versus 86 µmol/L [IQR 66-152 µmol/L] p = <0.001). Using pre-trial baseline creatinine, 48 of 217 patients (22%) met criteria for an AKI at CAMERA2 enrolment and only 5 of these patients met criteria for an AKI using the CAMERA2 study protocol (using baseline creatinine from trial entry). Using a baseline creatinine from the time of trial enrolment failed to detect many patients with AKI. Trial protocols should consider the optimal timing of baseline creatinine and the limitations of using a baseline creatinine during an acute illness.

Costs and healthcare use of patients with chronic kidney disease in the Northern Territory, Australia.

BACKGROUND: The burden of chronic kidney disease (CKD) is high in the Northern Territory (NT), Australia. This study aims to describe the healthcare use and associated costs of people at risk of CKD (e.g. acute kidney injury, diabetes, hypertension, and cardiovascular disease) or living with CKD in the NT, from a healthcare funder perspective. METHODS: We included a retrospective cohort of patients at risk of, or living with CKD, on 1 January 2017. Patients on kidney replacement therapy were excluded from the study. Data from the Territory Kidney Care database, encompassing patients from public hospitals and primary health care services across the NT was used to conduct costing. Annual healthcare costs, including hospital, primary health care, medication, and investigation costs were described over a one-year follow-up period. Factors associated with high total annual healthcare costs were identified with a cost prediction model. RESULTS: Among 37,398 patients included in this study, 23,419 had a risk factor for CKD while 13,979 had CKD (stages 1 to 5, not on kidney replacement therapy). The overall mean (± SD) age was 45 years (± 17), and a large proportion of the study cohort were First Nations people (68%). Common comorbidities in the overall cohort included diabetes (36%), hypertension (32%), and coronary artery disease (11%). Annual healthcare cost was lowest in those at risk of CKD (AUD$7,958 per person) and highest in those with CKD stage 5 (AUD$67,117 per person). Inpatient care contributed to the majority (76%) of all healthcare costs. Predictors of increased total annual healthcare cost included more advanced stages of CKD, and the presence of comorbidities. In CKD stage 5, the additional cost per person per year was + $53,634 (95%CI 32,769 to 89,482, p < 0.001) compared to people in the at risk group without CKD. CONCLUSION: The total healthcare costs in advanced stages of CKD is high, even when patients are not on dialysis. There remains a need for effective primary prevention and early intervention strategies targeting CKD and related chronic conditions.

Developing an integrated clinical decision support system for the early identification and management of kidney disease-building cross-sectoral partnerships.

BACKGROUND: The burden of chronic conditions is growing in Australia with people in remote areas experiencing high rates of disease, especially kidney disease. Health care in remote areas of the Northern Territory (NT) is complicated by a mobile population, high staff turnover, poor communication between health services and complex comorbid health conditions requiring multidisciplinary care. AIM: This paper aims to describe the collaborative process between research, government and non-government health services to develop an integrated clinical decision support system to improve patient care. METHODS: Building on established partnerships in the government and Aboriginal Community-Controlled Health Service (ACCHS) sectors, we developed a novel digital clinical decision support system for people at risk of developing kidney disease (due to hypertension, diabetes, cardiovascular disease) or with kidney disease. A cross-organisational and multidisciplinary Steering Committee has overseen the design, development and implementation stages. Further, the system's design and functionality were strongly informed by experts (Clinical Reference Group and Technical Working Group), health service providers, and end-user feedback through a formative evaluation. RESULTS: We established data sharing agreements with 11 ACCHS to link patient level data with 56 government primary health services and six hospitals. Electronic Health Record (EHR) data, based on agreed criteria, is automatically and securely transferred from 15 existing EHR platforms. Through clinician-determined algorithms, the system assists clinicians to diagnose, monitor and provide guideline-based care for individuals, as well as service-level risk stratification and alerts for clinically significant events. CONCLUSION: Disconnected health services and separate EHRs result in information gaps and a health and safety risk, particularly for patients who access multiple health services. However, barriers to clinical data sharing between health services still exist. In this first phase, we report how robust partnerships and effective governance processes can overcome these barriers to support clinical decision making and contribute to holistic care.

Effects of Allopurinol on the Progression of Chronic Kidney Disease.

BACKGROUND: Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known. METHODS: In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m2 of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation. RESULTS: Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m2; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m2 per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m2 per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m2 per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group. CONCLUSIONS: In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).

Retrospective case-control study exploring pretransplant predictors for loss of kidney transplant function or death among indigenous kidney transplant recipients.

BACKGROUND: The factors affecting the outcomes among Indigenous kidney transplant recipients is not fully understood. We conducted a retrospective case control study to identify risk factors beyond those explained by the ANZDATA registry. AIM: To identify the risk factors for loss of kidney transplant function or death among Indigenous kidney transplant recipients. METHODS: Cases were defined as all Indigenous Australian kidney transplant recipients from 1 January 2005 to 31 December 2015 from the major hospitals in the Northern Territory (NT) and South Australia (SA) who experienced graft loss (including patient death) up to 2-years post-transplant. Controls (matched 4:1) were defined as all indigenous kidney transplant recipients during the same period with functioning transplants at 2-years post-transplant operation. Matching was done on gender and diabetes status. Regression analysis adjusted for age was used for comparing cases and controls. RESULTS: There were 17 cases and 68 matched controls. Among cases, the odds ratio for more than one hospital admission episode (compared with ≤1 episode) in the 2-year pretransplant period was 6.2 (95% confidence interval, 1.2-32.5). However, there were no significant differences in the frequency of comorbidities at renal replacement therapy start, cardiovascular intervention pretransplant, pretransplant infection screening, age and gender of the donors, frequency of admission episodes where an infection was documented, the total length of inpatient stay or admission to intensive care unit during pretransplant hospital admission between cases and controls. CONCLUSION: Early graft loss was associated with a higher frequency of hospital admissions in the 2-years pretransplant period. In contrast, other measured factors in the pretransplant period did not predict these adverse outcomes.

Comparing survival in patients with chronic kidney disease across three countries - Results from the study of heart and renal protection-extended review.

AIM: This study examined whether survival and causes of death differed between participants enrolled from Australia (AUS), Malaysia (MYL), and New Zealand (NZ) in extended follow-up of the Study of Heart and Renal Protection (SHARP), a randomized controlled trial (RCT) of participants with moderate to severe chronic kidney disease comparing placebo to combination therapy with Simvastatin and Ezetimibe. METHODS: All participants alive at final SHARP study visit in participating centres were eligible for inclusion. Consenting participants were re-enrolled following final SHARP Study visit and followed for 5 years. Data collection included: significant medical events, hospital admissions and requirement for kidney replacement therapy. Data linkage was performed to national kidney and mortality registries. The primary outcome was all-cause mortality compared across the three countries. RESULTS: The SHARP trial randomized 2029 participants from AUS (1043/2029, 51%), MYL (701/2029, 35%), and NZ (285/2029, 14%), with 1136 participants alive and eligible for extended follow-up at the end of SHARP. In multivariable analysis, risk of death was increased for participants in MYL (HR 1.37, 95% CI 1.17-1.61, p < .001) and NZ (HR 1.28, 95% CI 1.04-1.57, p = .02) when compared to AUS participants. Adjustment for kidney transplantation as a competing risk did not explain the variation seen between countries. CONCLUSION: This study allows a better understanding of the differences in long-term mortality risk across participants from AUS, MYL, and NZ in extended follow-up of the SHARP study and demonstrates the feasibility and value of extended follow-up of participants enrolled in RCTs.

A codesigned integrated kidney and diabetes model of care improves patient activation among patients from culturally and linguistically diverse backgrounds.

BACKGROUND: Little is known about the relationship between patients' cultural and linguistic backgrounds and patient activation, especially in people with diabetes and chronic kidney disease (CKD). We examined the association between culturally and linguistically diverse (CALD) background and patient activation and evaluated the impact of a codesigned integrated kidney and diabetes model of care on patient activation by CALD status in people with diabetes and CKD. METHODS: This longitudinal study recruited adults with diabetes and CKD (Stage 3a or worse) who attended a new diabetes and kidney disease service at a tertiary hospital. All completed the patient activation measure at baseline and after 12 months and had demographic and clinical data collected. Patients from CALD backgrounds included individuals who spoke a language other than English at home, while those from non-CALD backgrounds spoke English only as their primary language. Paired t-tests compared baseline and 12-month patient activation scores by CALD status. RESULTS: Patients from CALD backgrounds had lower activation scores (52.1 ± 17.6) compared to those from non-CALD backgrounds (58.5 ± 14.6) at baseline. Within-group comparisons showed that patient activation scores for patients from CALD backgrounds significantly improved by 7 points from baseline to 12 months follow-up (52.1 ± 17.6-59.4 ± 14.7), and no significant change was observed for those from non-CALD backgrounds (58.5 ± 14.6-58.8 ± 13.6). CONCLUSIONS: Among patients with diabetes and CKD, those from CALD backgrounds report worse activation scores. Interventions that support people from CALD backgrounds with comorbid diabetes and CKD, such as the integrated kidney and diabetes model of care, may address racial and ethnic disparities that exist in patient activation and thus improve clinical outcomes. PATIENT OR PUBLIC CONTRIBUTION: Patients, caregivers and national consumer advocacy organisations (Diabetes Australia and Kidney Health Australia) codesigned a new model of care in partnership with healthcare professionals and researchers. The development of the model of care was informed by focus groups of patients and healthcare professionals and semi-structured interviews of caregivers and healthcare professionals. Patients and caregivers also provided a rigorous evaluation of the new model of care, highlighting its strengths and weaknesses.

Comparison of two ferritin assay platforms to assess their level of agreement in measuring serum and plasma ferritin levels in patients with chronic kidney disease.

BACKGROUND: Ferritin levels are used to make decisions on therapy of iron deficiency in patients with chronic kidney disease (CKD). Hyperferritinaemia, common among patients with CKD from the Northern Territory (NT) of Australia, makes use of ferritin levels as per clinical guidelines challenging. No gold standard assay exists for measuring ferritin levels. Significant variability between results from different assays creates challenges for clinical decision-making regarding iron therapy. In the NT, different laboratories use different methods. In 2018, Territory Pathology changed the assay from Abbott ARCHITECT i1000 (AA) to Ortho-Clinical Diagnostics Vitros 7600 (OCD). This was during the planning of the INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis (INFERR) clinical trial. The trial design was based on AA assay ferritin levels. We compared the two assays' level of agreement in measuring ferritin levels in CKD patients. METHODS: Samples from INFERR clinical trial participants were analysed. Other samples from patients whose testing were completed the same day on OCD analyzers and run within 24 h on AA analyzers were added to ensure wide range of ferritin levels, adding statistical strength to the comparison. Ferritin levels from both assays were compared using Pearson's correlation, Bland-Altman, Deming and Passing-Bablok regression analyses. Differences between sample types, plasma and serum were assessed. RESULTS: Sixty-eight and 111 (179) samples from different patients from Central Australia and Top End of Australia, respectively, were analyzed separately and in combination. The ferritin levels ranged from 3.1 µg/L to 3354 µg/L and 3 µg/L to 2170 µg/L for AA and OCD assays respectively. Using Bland-Altman, Deming and Passing-Bablok regression methods for comparison, ferritin results were consistently 36% to 44% higher with AA than OCD assays. The bias was up to 49%. AA ferritin results were the same in serum and plasma. However, OCD ferritin results were 5% higher in serum than plasma. CONCLUSIONS: When making clinical decisions, using ferritin results from the same assay in patients with CKD is critical. If the assay is changed, it is essential to assess agreement between results from the new and old assays. Further studies to harmonize ferritin assays are required.

An evaluation of the quality of ear health services for Aboriginal children living in remote Australia: a cascade of care analysis.

BACKGROUND: In the Northern Territory (NT) the prevalence of otitis media (OM) in young Aboriginal children living in remote communities has persisted at around 90% over the last few decades. OM-associated hearing loss can cause developmental delay and adversely impact life course trajectories. This study examined the 5-year trends in OM prevalence and quality of ear health services in remote NT communities. METHODS: A retrospective analysis was performed on de-identified clinical data for 50 remote clinics managed by the NT Government. We report a 6-monthly cascade analysis of the proportions of children 0-16 years of age receiving local guideline recommendations for surveillance, OM treatment and follow-up at selected milestones between 2014 and 2018. RESULTS: Between 6,326 and 6,557 individual children were included in the 6-monthly analyses. On average, 57% (95%CI: 56-59%) of eligible children had received one or more ear examination in each 6-monthly period. Of those examined, 36% (95%CI: 33-40%) were diagnosed with some type of OM, of whom 90% had OM requiring either immediate treatment or scheduled follow-up according to local guidelines. Outcomes of treatment and follow-up were recorded in 24% and 23% of cases, respectively. Significant decreasing temporal trends were found in the proportion diagnosed with any OM across each age group. Overall, this proportion decreased by 40% over the five years (from 43 to 26%). CONCLUSIONS: This cascade of care analysis found that ear health surveillance and compliance with otitis media guidelines for treatment and follow-up were both low. Further research is required to identify effective strategies that improve ear health services in remote settings.

A co-designed integrated kidney and diabetes model of care improves mortality, glycaemic control and self-care.

BACKGROUND: Current healthcare models are ill-equipped for managing people with diabetes and chronic kidney disease (CKD). We evaluated the impact of a new diabetes and kidney disease service (DKS) on hospitalization, mortality, clinical and patient-relevant outcomes. METHODS: Longitudinal analyses of adult patients with diabetes and CKD (Stages 3a-5) were performed using outpatient and hospitalization data from January 2015 to October 2018. Data were handled according to whether patients received the DKS intervention (n = 196) or standard care (n = 7511). The DKS provided patient-centred, coordinated multidisciplinary assessment and management of patients. Primary analyses examined hospitalization and mortality rates between the two groups. Secondary analyses evaluated the impact of the DKS on clinical target attainment, changes in estimated glomerular filtration rate (eGFR), glycated haemoglobin A1c (HbA1c), self-care and patient activation at 12 months. RESULTS: Patients who received the intervention had a higher hospitalization rate {incidence rate ratio [IRR] 1.20 [95% confidence interval (CI) 1.13-1.30]; P < 0.0001}, shorter median length of stay {2 days [interquartile range (IQR) 1-6] versus 4 days [IQR 1-9]; P < 0.0001} and lower all-cause mortality rate [IRR 0.4 (95% CI 0.29-0.64); P < 0.0001] than those who received standard care. Improvements in overall self-care [mean difference 2.26 (95% CI 0.83-3.69); P < 0.001] and in statin use and eye and feet examinations were observed. The mean eGFR did not change significantly after 12 months [mean difference 1.30 mL/min/1.73 m2 (95% CI -4.17-1.67); P = 0.40]. HbA1c levels significantly decreased by 0.40, 0.35, 0.34 and 0.23% at 3, 6, 9 and 12 months of follow-up, respectively. CONCLUSIONS: A co-designed, person-centred integrated model of care improved all-cause mortality, kidney function, glycaemic control and self-care for patients with diabetes and CKD.

Risk factors for incident kidney disease in older adults: an Australian prospective population-based study.

BACKGROUND AND AIM: To determine risk factors for incident chronic kidney disease (CKD) in a large population-based cohort. METHODS: This prospective opt-in population-based cohort study is based on the 45 and Up Study, where New South Wales residents aged ≥45 years were randomly sampled from the Services Australia database and agreed to complete the 45 and Up Study baseline questionnaire and have their responses linked to their health data in routinely collected databases. The primary outcome was the development of incident CKD, defined as eGFR < 60 mL/min/1.73 m2 . CKD incidence was calculated using Poisson regression. Risk factors for incident CKD were assessed using Cox regression in multivariable models. RESULTS: In 39 574 participants who did not have CKD at enrolment, independent factors associated with developing CKD included: older age, regional residence (HR 1.38 (1.27-1.50) for outer regional vs major city), smoking (1.13 (1.00-1.27) for current smoker vs non-smoker), obesity (1.25 (1.16-1.35) for obese vs normal body mass index), diabetes mellitus (1.41 (1.33-1.50)), hypertension (1.53 (1.44-1.62)), coronary heart disease (1.13 (1.07-1.20)), depression/anxiety (1.16 (1.09-1.24)) and cancer (1.29 (1.20-1.39)). Migrants were less likely to develop CKD compared with people born in Australia (0.88 (0.83-0.94)). Gender, partner status and socioeconomic factors were not independently associated with developing CKD. CONCLUSIONS: This large population-based study found multiple modifiable and non-modifiable factors were independently associated with developing CKD. In the Australian setting, the risk of CKD was higher with regional residence. Differences according to socioeconomic status were predominantly explained by age, comorbidities and harmful health-related behaviours.

The stay strong app as a self-management tool for first nations people with chronic kidney disease: a qualitative study.

BACKGROUND: The high burden of chronic kidney disease in First Nations peoples requires urgent attention. Empowering people to self-manage their own condition is key, along with promotion of traditional knowledge and empowerment of First Nations communities. This study explores the potential of a culturally responsive tool, already found to have high acceptability and feasibility among First Nations people, to support self-management for First Nations people with kidney failure. The Stay Strong app is a holistic wellbeing intervention. This study explores the suitability of the Stay Strong app to support self-management as shown by the readiness of participants to engage in goal setting. Data were collected during a clinical trial which followed adaption of research tools and procedures through collaboration between content and language experts, and community members with lived experience of kidney failure. METHODS: First Nations (i.e., Aboriginal and Torres Strait Islander) participants receiving haemodialysis in the Northern Territory (n = 156) entered a three-arm, waitlist, single-blind randomised controlled trial which provided collaborative goal setting using the Stay Strong app at baseline or at 3 months. Qualitative data gathered during delivery of the intervention were examined using both content and thematic analysis. RESULTS: Almost all participants (147, 94%) received a Stay Strong session: of these, 135 (92%) attended at least two sessions, and 83 (56%) set more than one wellbeing goal. Using a deductive approach to manifest content, 13 categories of goals were identified. The three most common were to: 'connect with family or other people', 'go bush/be outdoors' and 'go home/be on country'. Analysis of latent content identified three themes throughout the goals: 'social and emotional wellbeing', 'physical health' and 'cultural connection'. CONCLUSION: This study provides evidence of the suitability of the Stay Strong app for use as a chronic condition self-management tool. Participants set goals that addressed physical as well as social and emotional wellbeing needs, prioritising family, country, and cultural identity. The intervention aligns directly with self-management approaches that are holistic and prioritise individual empowerment. Implementation of self-management strategies into routine care remains a key challenge and further research is needed to establish drivers of success.

Development and validation of algorithms to identify patients with chronic kidney disease and related chronic diseases across the Northern Territory, Australia.

BACKGROUND: Electronic health records can be used for population-wide identification and monitoring of disease. The Territory Kidney Care project developed algorithms to identify individuals with chronic kidney disease (CKD) and several commonly comorbid chronic diseases. This study aims to describe the development and validation of our algorithms for CKD, diabetes, hypertension, and cardiovascular disease. A secondary aim of the study was to describe data completeness of the Territory Kidney Care database. METHODS: The Territory Kidney Care database consolidates electronic health records from multiple health services including public hospitals (n = 6) and primary care health services (> 60) across the Northern Territory, Australia. Using the database (n = 48,569) we selected a stratified random sample of patients (n = 288), which included individuals with mild to end-stage CKD. Diagnostic accuracy of the algorithms was tested against blinded manual chart reviews. Data completeness of the database was also described. RESULTS: For CKD defined as CKD stage 1 or higher (eGFR of any level with albuminuria or persistent eGFR < 60 ml/min/1.732, including renal replacement therapy) overall algorithm sensitivity was 93% (95%CI 89 to 96%) and specificity was 73% (95%CI 64 to 82%). For CKD defined as CKD stage 3a or higher (eGFR < 60 ml/min/1.732) algorithm sensitivity and specificity were 93% and 97% respectively. Among the CKD 1 to 5 staging algorithms, the CKD stage 5 algorithm was most accurate with > 99% sensitivity and specificity. For related comorbidities - algorithm sensitivity and specificity results were 75% and 97% for diabetes; 85% and 88% for hypertension; and 79% and 96% for cardiovascular disease. CONCLUSIONS: We developed and validated algorithms to identify CKD and related chronic diseases within electronic health records. Validation results showed that CKD algorithms have a high degree of diagnostic accuracy compared to traditional administrative codes. Our highly accurate algorithms present new opportunities in early kidney disease detection, monitoring, and epidemiological research.

Dialysis attendance patterns and health care utilisation of Aboriginal patients attending dialysis services in urban, rural and remote locations.

BACKGROUND: Aboriginal people in the Northern Territory (NT) suffer the heaviest burden of kidney failure in Australia with most living in remote areas at time of dialysis commencement. As there are few dialysis services in remote areas, many Aboriginal people are required to relocate often permanently, to access treatment. Missing dialysis treatments is not uncommon amongst Aboriginal patients but the relationship between location of dialysis service and dialysis attendance (and subsequent hospital use) has not been explored to date. AIM: To examine the relationships between location of dialysis service, dialysis attendance patterns and downstream health service use (overnight hospital admissions, emergency department presentations) among Aboriginal patients in the NT. METHODS: Using linked hospital and dialysis registry datasets we analysed health service activity for 896 Aboriginal maintenance dialysis patients in the NT between 2008 and 2014. Multivariate linear regression and negative binomial regression analyses explored the associations between dialysis location, dialysis attendance and health service use. RESULTS: We found missing two or more dialysis treatments per month was more likely for Aboriginal people attending urban services and this was associated with a two-fold increase in the rate of hospital admissions and more than three-fold increase in ED presentations. However, we found higher dialysis attendance and lower health service utilisation for those receiving care in rural and remote settings. When adjusted for age, time on dialysis, region, comorbidities and residence pre-treatment, among Aboriginal people from remote areas, those dialysing in remote areas had lower rates of hospitalisations (IRR 0.56; P < 0.001) when compared to those who relocated and dialysed in urban areas. CONCLUSION: There is a clear relationship between the provision and uptake of dialysis services in urban, rural and remote areas in the NT and subsequent broader health service utilisation. Our study suggests that the low dialysis attendance associated with relocation and care in urban models for Aboriginal people can potentially be ameliorated by access to rural and remote models and this warrants a rethinking of service delivery policy. If providers are to deliver effective and equitable services, the full range of intended and unintended consequences of a dialysis location should be incorporated into planning decisions.

Dietary habits in Australian, New Zealand and Malaysian patients with end stage kidney failure: A pre-specified cross-sectional study of the FAVOURED trial participants.

BACKGROUND: Dietary management plays an important role in patients with kidney failure. Current dietary habits of Australians and New Zealanders (ANZ) and Malaysians with chronic kidney disease (CKD Stage 4-5) have not been adequately investigated. We report the dietary habits of people with advanced CKD and their adherence to country-specific dietary guidelines. METHODS: Participants with CKD Stage 4-5, enrolled in the Omega-3 Fatty Acids (Fish oils) and Aspirin in Vascular access Outcomes in Renal Disease (FAVOURED) trial, completed a lifestyle questionnaire at baseline on their dietary intake. RESULTS: Of 567 participants, 538 (ANZ, n = 386; Malaysian, n = 152; mean ± SD age 54.8 ± 14.3 years, 64% male) completed the questionnaire. Dietary fruit and vegetable intakes were higher in ANZ participants; 49% (n = 189) consumed ≥2 serves day-1 of fruit and 61% (n = 235) ate ≥2 serves day-1 of vegetables compared to 24% (n = 36) and 34% (n = 52) of Malaysians, respectively (p < 0.0001). Only 4% (n = 15) of ANZ participants met Australian Dietary recommendations of two fruit and five vegetable serves day-1 . Fish consumption was higher in Malaysians with 83% (n = 126) consuming ≥2 serves week-1 compared to 21% (n = 81) of ANZ participants (p < 0.001). Red meat intake was higher in ANZ participants; however, chicken consumption was similar; 48% (n = 185) consumed >2 chicken serves week-1 and 65% (n = 251) ate >2 serves week-1 of red meat compared to 43% (n = 65) and 15% (n = 23) of Malaysians, respectively. CONCLUSIONS: Significant regional variation in dietary intake for fruit, vegetables and animal protein is described that likely reflects cultural and economic differences. Barriers to meeting recommended dietary intakes require further investigation.

Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial.

Importance: The effect of glucocorticoids on major kidney outcomes and adverse events in IgA nephropathy has been uncertain. Objective: To evaluate the efficacy and adverse effects of methylprednisolone in patients with IgA nephropathy at high risk of kidney function decline. Design, Setting, and Participants: An international, multicenter, double-blind, randomized clinical trial that enrolled 503 participants with IgA nephropathy, proteinuria greater than or equal to 1 g per day, and estimated glomerular filtration rate (eGFR) of 20 to 120 mL/min/1.73 m2 after at least 3 months of optimized background care from 67 centers in Australia, Canada, China, India, and Malaysia between May 2012 and November 2019, with follow-up until June 2021. Interventions: Participants were randomized in a 1:1 ratio to receive oral methylprednisolone (initially 0.6-0.8 mg/kg/d, maximum 48 mg/d, weaning by 8 mg/d/mo; n = 136) or placebo (n = 126). After 262 participants were randomized, an excess of serious infections was identified, leading to dose reduction (0.4 mg/kg/d, maximum 32 mg/d, weaning by 4 mg/d/mo) and addition of antibiotic prophylaxis for pneumocystis pneumonia for subsequent participants (121 in the oral methylprednisolone group and 120 in the placebo group). Main Outcomes And Measures: The primary end point was a composite of 40% decline in eGFR, kidney failure (dialysis, transplant), or death due to kidney disease. There were 11 secondary outcomes, including kidney failure. Results: Among 503 randomized patients (mean age, 38 years; 198 [39%] women; mean eGFR, 61.5 mL/min/1.73 m2; mean proteinuria, 2.46 g/d), 493 (98%) completed the trial. Over a mean of 4.2 years of follow-up, the primary outcome occurred in 74 participants (28.8%) in the methylprednisolone group compared with 106 (43.1%) in the placebo group (hazard ratio [HR], 0.53 [95% CI, 0.39-0.72]; P < .001; absolute annual event rate difference, -4.8% per year [95% CI, -8.0% to -1.6%]). The effect on the primary outcome was seen across each dose compared with the relevant participants in the placebo group recruited to each regimen (P for heterogeneity = .11): full-dose HR, 0.58 (95% CI, 0.41-0.81); reduced-dose HR, 0.27 (95% CI, 0.11-0.65). Of the 11 prespecified secondary end points, 9 showed significant differences in favor of the intervention, including kidney failure (50 [19.5%] vs 67 [27.2%]; HR, 0.59 [95% CI, 0.40-0.87]; P = .008; annual event rate difference, -2.9% per year [95% CI, -5.4% to -0.3%]). Serious adverse events were more frequent with methylprednisolone vs placebo (28 [10.9%] vs 7 [2.8%] patients with serious adverse events), primarily with full-dose therapy compared with its matching placebo (22 [16.2%] vs 4 [3.2%]). Conclusions and Relevance: Among patients with IgA nephropathy at high risk of progression, treatment with oral methylprednisolone for 6 to 9 months, compared with placebo, significantly reduced the risk of the composite outcome of kidney function decline, kidney failure, or death due to kidney disease. However, the incidence of serious adverse events was increased with oral methylprednisolone, mainly with high-dose therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT01560052.

Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.

BACKGROUND: Intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury and associated adverse outcomes after angiography without definitive evidence of their efficacy. METHODS: Using a 2-by-2 factorial design, we randomly assigned 5177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo; of these patients, 4993 were included in the modified intention-to-treat analysis. The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days. Contrast-associated acute kidney injury was a secondary end point. RESULTS: The sponsor stopped the trial after a prespecified interim analysis. There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P=0.33). The primary end point occurred in 110 of 2511 patients (4.4%) in the sodium bicarbonate group as compared with 116 of 2482 (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P=0.62) and in 114 of 2495 patients (4.6%) in the acetylcysteine group as compared with 112 of 2498 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P=0.88). There were no significant between-group differences in the rates of contrast-associated acute kidney injury. CONCLUSIONS: Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury. (Funded by the U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466 .).

The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) Study: Trial Design and Baseline Characteristics.

INTRODUCTION: Despite optimal current care, up to 30% of individuals suffering from immunoglobulin A nephropathy (IgAN) will develop kidney failure requiring dialysis or kidney transplantation. The Therapeutic Evaluation of STeroids in IgA Nephropathy Global (TESTING) study was designed to assess the benefits and risks of steroids in people with IgAN. We report the trial design as well as the baseline characteristics of study participants. METHODS: It is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized trial of individuals with kidney biopsy-confirmed IgAN, proteinuria ≥1 g/day, and an estimated GFR of 20-120 mL/min/1.73 m2, following at least 3 months of standard of care including maximum labelled (or tolerated) dose of renin-angiotensin system blockade. The original study design randomized participants 1:1 to oral methylprednisolone (0.6-0.8 mg/kg/day, maximum 48 mg/day) for 2 months, with subsequent weaning by 8 mg/day/month over 6-8 months, or matching placebo. The intervention was modified in 2016 (due to an excess of serious infection) to low-dose methylprednisolone (0.4 mg/kg/day, maximum 32 mg/day) for 2 months, followed by weaning by 4 mg/day/month over 6-9 months, or matching placebo. Participants recruited after 2016 also received prophylaxis against Pneumocystis jirovecii pneumonia during the first 12 weeks of treatment. RESULTS: The study recruitment period extended from May 2012 to November 2019. By the time the excess of serious infections was observed, 262 participants had been randomized to the original full-dose treatment algorithm, and an interim analysis was reported in 2016. Subsequently, 241 additional participants were randomized to a revised low-dose protocol, for a total of 503 participants from China (373), India (78), Canada (24), Australia (18), and Malaysia (10). The mean age of randomized participants was 38, 39% were female, mean eGFR at randomization was 62.7 mL/min/1.73 m2, and mean 24-h urine protein 2.54 g. The primary endpoint is a composite of 40% eGFR decline from baseline or kidney failure (dialysis, transplantation, or death due to kidney disease), and participants will be followed until the primary outcome has been observed in at least 160 randomized participants. Analyses will also be made across predefined subgroups. Effects on eGFR slope and albuminuria will also be assessed overall, as well as by the steroid dosing regimen. CONCLUSIONS: The TESTING study (combined full and low dose) will define the benefits of corticosteroid use on major kidney outcomes, as well as the risks of therapy, and provide data on the relative effects of different doses, in individuals with high-risk IgAN.

Using web conferencing to engage Aboriginal and Torres Strait Islander young people in research: a feasibility study.

BACKGROUND: While web conferencing technologies are being widely used in communication and collaboration, their uptake in conducting research field work has been relatively slow. The benefits that these technologies offer researchers for engaging with hard-to-reach populations are beginning to be recognised, however, the acceptability and feasibility of using web conferencing technology to engage Aboriginal and Torres Strait Islander young people in research is unknown. OBJECTIVE: This study aims to evaluate whether the use of web conferencing to engage Aboriginal and Torres Strait Islander young people in research is an acceptable and feasible alternative to conventional face-to-face methods. METHODS: Aboriginal and Torres Strait Islander young people aged between 18 and 24 years were recruited via emails, flyers and snowballing to participate in an Online Yarning Circle (OYC) about wellbeing conducted via web conferencing. Five young Aboriginal and Torres Strait Islander Australians were trained as peer facilitators and each conducted one or more OYCs with support from an experienced Aboriginal and Torres Strait Islander researcher. The OYCs were recorded and the researchers conducted post-OYC interviews with the facilitators. OYC recordings, facilitator interviews and researchers' reflections about the method were analysed to assess acceptability and feasibility for use with this population. RESULTS: 11 OYCs were conducted with 21 participants. The evaluation focused on (a) acceptability of the method for participants and facilitators and (b) feasibility of data collection method and procedures for use in research. Our evaluation revealed good acceptability and feasibility of the method, with only minor challenges experienced, which were predominantly logistical in nature and related to scheduling, obtaining documentation of consent, and technical issues. These challenges were offset by the greater control over the level of engagement that was comfortable for individual participants and the greater ease with which they felt they could withdraw from participating. This shift in the traditional researcher-participant power dynamic was recognised by both participants and peer facilitators and was regarded as a support for Aboriginal and Torres Strait Islander young people's participation in research. CONCLUSIONS: The use of web conferencing to engage Aboriginal and Torres Strait Islander young people in research offers an acceptable and feasible alternative to face-to-face research methods. The benefits conferred by these technologies associated with yielding greater control and power to the research participant has broad relevance to research with marginalised populations.