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.

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.

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.

What Matters 2 Adults (WM2Adults): Understanding the Foundations of Aboriginal and Torres Strait Islander Wellbeing.

Aboriginal and Torres Strait Islander people experience a greater range of health and social disadvantages compared to other Australians. Wellbeing is a culturally-bound construct, and to date, a national evidence base around the components of wellbeing for Aboriginal and Torres Strait Islander people is lacking. Understanding and measurement of wellbeing for this population is critical in achieving health equity. This paper aims to identify and describe the foundations of wellbeing for Aboriginal and Torres Strait Islander adults. This national qualitative study was underpinned by an Indigenist research approach which privileges the voices of Aboriginal and Torres Strait Islander people. Aboriginal and Torres Strait Islander adults were purposively recruited from around Australia between September 2017 and September 2018 to participate in Yarning Circles, led by Aboriginal and Torres Strait Islander researchers. Yarning Circles were audio recorded, transcribed and analyzed. A Collaborative Yarning Methodology was used, which incorporated reflexive thematic analysis to identify and describe the foundations of wellbeing reported by participants. A total of 359 Aboriginal and Torres Strait Islander adults participated. Our analysis revealed five foundations of wellbeing: belonging and connection; holistic health; purpose and control; dignity and respect; and basic needs. These foundations were deeply interwoven by three interconnected aspects of Aboriginal and Torres Strait Islander life: family, community and culture. The findings of this study will substantially aid our efforts to develop a new wellbeing measure for Aboriginal and Torres Strait Islander adults. The iterative Indigenist methods used in this study provide a robust research methodology for conducting large-scale, nationally-relevant qualitative research with Aboriginal and Torres Strait Islander people. Policies and practices that are informed by our results have the potential to address outcomes that are meaningful for Aboriginal and Torres Strait Islander people.

From "stuck" to satisfied: Aboriginal people's experience of culturally safe care with interpreters in a Northern Territory hospital.

BACKGROUND: Globally, interpreters are underused by health providers in hospitals, despite 40 years of evidence documenting benefits to both patients and providers. At Royal Darwin Hospital, in Australia's Northern Territory, 60-90% of patients are Aboriginal, and 60% speak an Aboriginal language, but only approximately 17% access an interpreter. Recognising this system failure, the NT Aboriginal Interpreter Service and Royal Darwin Hospital piloted a new model with interpreters embedded in a renal team during medical ward rounds for 4 weeks in 2019. METHODS: This research was embedded in a larger Participatory Action Research study examining cultural safety and communication at Royal Darwin Hospital. Six Aboriginal language speaking patients (five Yolŋu and one Tiwi), three non-Indigenous doctors and five Aboriginal interpreter staff were purposefully sampled. Data sources included participant interviews conducted in either the patient's language or English, researcher field notes from shadowing doctors, doctors' reflective journals, interpreter job logs and patient language lists. Inductive narrative analysis, guided by critical theory and Aboriginal knowledges, was conducted. RESULTS: The hospital experience of Yolŋu and Tiwi participants was transformed through consistent access to interpreters who enabled patients to express their clinical and non-clinical needs. Aboriginal language-speaking patients experienced a transformation to culturally safe care. After initially reporting feeling "stuck" and disempowered when forced to communicate in English, participants reported feeling satisfied with their care and empowered by consistent access to the trusted interpreters, who shared their culture and worldviews. Interpreters also enabled providers to listen to concerns and priorities expressed by patients, which resulted in holistic care to address social determinants of health. This improved patient trajectories and reduced self-discharge rates. CONCLUSIONS: A culturally unsafe system which restricted people's ability to receive equitable healthcare in their first language was overturned by embedding interpreters in a renal medical team. This research is the first to demonstrate the importance of consistent interpreter use for providing culturally safe care for Aboriginal patients in Australia.

Do remote dialysis services really cost more? An economic analysis of hospital and dialysis modality costs associated with dialysis services in urban, rural and remote settings.

BACKGROUND: Rates of end-stage kidney disease in Australia are highest in the Northern Territory (NT), with the burden of disease heaviest in remote areas. However, the high cost of delivering dialysis services in remote areas has resulted in centralisation, requiring many people to relocate for treatment. Patients argue that treatment closer to home improves health outcomes and reduces downstream healthcare use. Existing dialysis cost studies have not compared total health care costs associated with treatment in different locations. OBJECTIVE: To estimate and compare, from a payer perspective, the observed health service costs (all cause hospital admissions, emergency department presentations and maintenance dialysis) associated with different dialysis models in urban, rural and remote locations. METHODS: Using cost weights attributed to diagnostic codes in the NT Department of Health's hospital admission data set (2008-2014), we calculated the mean (SD) total annual health service costs by dialysis model for 995 dialysis patients. Generalized linear modeling with bootstrapping tested the marginal cost differences between different explanatory variables to estimate 'best casemix'/'worst casemix' cost scenarios. RESULTS: The mean annual patient hospital expenditure was highest for urban models at $97 928 (SD $21 261) and $43 440 (SD $5 048) and lowest for remote at $19 584 (SD $4 394). When combined with the observed maintenance dialysis costs, expenditure was the highest for urban models at $148 510 (SD $19 774). The incremental cost increase of dialysing in an urban area, compared with a rural area, for a relocated person from a remote area, was $5 648 more and increased further for those from remote and very remote areas to $10 785 and $15 118 respectively. CONCLUSIONS: This study demonstrates that dialysis treatment in urban areas for relocated people has health and cost implications that maybe greater than the cost of remote service delivery. The study emphasises the importance of considering all health service costs and cost consequences of service delivery models. KEY POINTS FOR DECISION MAKERS: Relocation for dialysis treatment has serious health and economic consequences. Relocated people have low dialysis attendance and high hospital costs in urban areas. While remote dialysis service models are more expensive than urban models, the comparative cost differences are significantly reduced when all health service costs are included. The delivery of equitable and accessible dialysis service models requires a holistic approach that incorporates the needs of the patient; hence dialysis cost studies must consider the full range of cost impacts beyond the dialysis treatments alone.

Most people requiring ongoing treatment for end-stage kidney disease in the Northern Territory (NT) identify as Aboriginal with the majority residing in areas classified as remote or very remote. Unlike other jurisdictions in Australia, haemodialysis in a satellite unit is the most common form of treatment. However, there is a geographic mismatch between demand and service provision, with services centralised in urban areas. Patients and communities have long advocated for services at or closer to home, maintaining that the consequences of relocation and dislocation have far reaching health, psychosocial and economic ramifications. We analysed retrospective hospital data for 995 maintenance dialysis patients, stratified by the model of care they received in urban, rural and remote locations. Using cost weights attributed to diagnosis codes, we costed hospital admissions, emergency department presentations and maintenance dialysis attendances, to provide a mean total health service cost/patient/year for each model of care. We found that urban services were associated with low observed maintenance dialysis and high hospital costs, but the inverse was true for remote and very remote models. Remote models had high maintenance dialysis costs (due to expense of remote service delivery and good dialysis attendance) but low hospital usage and costs. When adjusted for other variables such as age, dialysis vintage and comorbidities, lower total hospital costs were associated with rural and remote service provision. In an environment of escalating demand and constrained budgets, this study underlines the need for policy decisions to consider the full cost consequences of different dialysis service models.

Quantitative evaluation of an outreach case management model of care for urban Aboriginal and Torres Strait Islander adults living with complex chronic disease: a longitudinal study.

BACKGROUND: Chronic diseases are the leading contributor to the excess morbidity and mortality burden experienced by Aboriginal and Torres Strait Islander (hereafter, respectfully, Indigenous) people, compared to their non-Indigenous counterparts. The Home-based Outreach case Management of chronic disease Exploratory (HOME) Study provided person-centred, multidisciplinary care for Indigenous people with chronic disease. This model of care, aligned to Indigenous peoples' conceptions of health and wellbeing, was integrated within an urban Indigenous primary health care service. We aimed to determine the impact of this model of care on participants' health and wellbeing at 12 months. METHODS: HOME Study participants were Indigenous, regular patients of the primary health care service, with a diagnosis of at least one chronic disease, and complex health and social care needs. Data were collected directly from participants and from their medical records at baseline, and 3, 6 and 12 months thereafter. Variables included self-rated health status, depression, utilisation of health services, and key clinical outcomes. Participants' baseline characteristics were described using frequencies and percentages. Generalized estimating equation (GEE) models were employed to evaluate participant attrition and changes in outcome measures over time. RESULTS: 60 participants were enrolled into the study and 37 (62%) completed the 12-month assessment. After receiving outreach case management for 12 months, 73% of participants had good, very good or excellent self-rated health status compared with 33% at baseline (p < 0.001) and 19% of participants had depression compared with 44% at baseline (p = 0.03). Significant increases in appointments with allied health professionals (p < 0.001) and medical specialists other than general practitioners (p = 0.001) were observed at 12-months compared with baseline rates. Mean systolic blood pressure decreased over time (p = 0.02), but there were no significant changes in mean HbA1c, body mass index, or diastolic blood pressure. CONCLUSIONS: The HOME Study model of care was predicated on a holistic conception of health and aimed to address participants' health and social care needs. The positive changes in self-rated health and rates of depression evinced that this aim was met, and that participants received the necessary care to support and improve their health and wellbeing.

Health-related quality of life among patients with comorbid diabetes and kidney disease attending a codesigned integrated model of care: a longitudinal study.

OBJECTIVE: To evaluate the impact of an integrated diabetes and kidney disease model of care on health-related quality of life (HRQOL) of patients with comorbid diabetes and chronic kidney disease (CKD). RESEARCH DESIGN AND METHODS: A longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (stage 3a or worse) who attended a new diabetes kidney disease service was conducted at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Kidney Disease Quality of Life (KDQOL-36) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12-month scores. A subgroup analysis examined the effects by patient gender. Multiple regression analysis examined the factors associated with changes in scores. RESULTS: 179 patients, 36% of whom were female, with baseline mean±SD age of 65.9±11.3 years, were studied. Across all subscales, HRQOL did not significantly change over time (p value for all mean differences >0.05). However, on subgroup analysis, symptom problem list and physical composite summary scores increased among women (MD=9.0, 95% CI 1.25 to 16.67; p=0.02 and MD=4.5, 95% CI 0.57 to 8.42; p=0.03 respectively) and physical composite scores decreased among men (MD=-3.35, 95% CI -6.26 to -0.44; p=0.03). CONCLUSION: The HRQOL of patients with comorbid diabetes and CKD attending a new codesigned, integrated diabetes and kidney disease model of care was maintained over 12 months. Given that HRQOL is known to deteriorate over time in this high-risk population, the impact of these findings on clinical outcomes warrants further investigation.

Aboriginal and Torres Strait Islander people's domains of wellbeing: A comprehensive literature review.

There are significant health and social disparities between the world's Indigenous and non-Indigenous people on factors likely to influence quality of life (QOL) and wellbeing. However, these disparities in wellbeing are not captured in conventional QOL instruments, as they often do not include dimensions that are likely to be relevant to Indigenous people. The objective of this comprehensive literature review was to identify these wellbeing domains for Aboriginal and Torres Strait Islander people in Australia (hereafter, respectfully referred to collectively as Indigenous Australians). We searched PsycINFO, MEDLINE, Econlit, CINAHL, and Embase (from inception to June 2017, and updated in March 2019), and grey literature sources using keywords relating to adult Indigenous Australians' QOL and wellbeing. From 278 full-text articles assessed for eligibility, 95 were included in a thematic analysis. This synthesis revealed nine broad interconnected wellbeing dimensions: autonomy, empowerment and recognition; family and community; culture, spirituality and identity; Country; basic needs; work, roles and responsibilities; education; physical health; and mental health. The findings suggest domains of wellbeing relevant to and valued by Indigenous Australians that may not be included in existing QOL and wellbeing instruments, domains that may be shared with Indigenous populations globally. This indicates the need for a tailored wellbeing instrument that includes factors relevant to Indigenous Australians. Developing such an instrument will ensure meaningful, culturally-relevant measurement of Indigenous Australians' wellbeing.

Fish oil and aspirin effects on arteriovenous fistula function: Secondary outcomes of the randomised omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial.

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.

Models of care for co-morbid diabetes and chronic kidney disease.

Diabetes and chronic kidney disease (CKD) are two of the most prevalent co-morbid chronic diseases in Australia. The increasing complexity of multi-morbidity, and current gaps in health-care delivery for people with co-morbid diabetes and CKD, emphasize the need for better models of care for this population. Previously, proposed published models of care for co-morbid diabetes and CKD have not been co-designed with stake-holders or formally evaluated. Particular components of health-care shown to be effective in this population are interventions that: are structured, intensive and multifaceted (treating diabetes and multiple cardiovascular risk factors); involve multiple medical disciplines; improve self-management by the patient; and upskill primary health-care. Here we present an integrated patient-centred model of health-care delivery incorporating these components and co-designed with key stake-holders including specialist health professionals, general practitioners and Diabetes and Kidney Health Australia. The development of the model of care was informed by focus groups of patients and health-professionals; and semi-structured interviews of care-givers and health professionals. Other distinctives of this model of care are routine screening for psychological morbidity; patient-support through a phone advice line; and focused primary health-care support in the management of diabetes and CKD. Additionally, the model of care integrates with the patient-centred health-care home currently being rolled out by the Australian Department of Health. This model of care will be evaluated after implementation across two tertiary health services and their primary care catchment areas.

Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial.

Importance: Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure. Objective: To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure. Design, Setting, and Participants: The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation. Interventions: Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks. Main Outcomes and Measures: The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome. Results: Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68). Conclusions and Relevance: Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery. Trial Registration: anzctr.org.au Identifier: CTRN12607000569404.

Investigating the feasibility, acceptability and appropriateness of outreach case management in an urban Aboriginal and Torres Strait Islander primary health care service: a mixed methods exploratory study.

BACKGROUND: The disparities in health and life expectancy of Aboriginal and Torres Strait Islander peoples compared to non-Indigenous Australians are well documented. Chronic diseases are a leading contributor to these disparities. We aimed to determine the feasibility, acceptability and appropriateness of a case management approach to chronic disease care integrated within an urban Aboriginal and Torres Strait Islander primary health care service. METHODS: The Home-based, Outreach case Management of chronic disease Exploratory (HOME) Study provided holistic, patient centred multidisciplinary care for Aboriginal and Torres Strait Islander people with chronic disease. A developmental evaluation approach supported the implementation and ongoing adaptations in the delivery of the model of care, and ensured its alignment with Aboriginal and Torres Strait Islander peoples' understandings of, and approaches to, health and wellbeing. In-depth, semi-structured interviews were conducted with nine patient participants (one interview also included a participant's spouse) and 15 health service staff and key themes were identified through an iterative reflective process. Quantitative data were collected directly from patient participants and from their medical records at baseline, 3 and 6 months. Patient participants' baseline characteristics were described using frequencies and percentages. Attrition and patterns of missing values over time were evaluated using binomial generalized estimating equation (GEE) models and mean differences in key clinical outcomes were determined using normal GEE models. RESULTS: Forty-one patients were recruited and nine withdrew over the 6 month period. There was no evidence of differential attrition. All participants (patients and health service staff) were very positive about the model of care. Patient participants became more involved in their health care, depression rates significantly decreased (p = 0.03), and significant improvements in systolic blood pressure (p < 0.001) and diabetes control (p = 0.05) were achieved. CONCLUSIONS: The exploratory nature of our study preclude any definitive statements about the effectiveness of our model of care. However, staff and patients' high levels of satisfaction and improvements in the health and wellbeing of patients are promising and suggest its feasibility, acceptability and appropriateness. Further research is required to determine its efficacy, effectiveness and cost-effectiveness in improving the quality of life and quality of care for Aboriginal and Torres Strait Islander peoples living with chronic disease.

Effectiveness, cost effectiveness, acceptability and implementation barriers/enablers of chronic kidney disease management programs for Indigenous people in Australia, New Zealand and Canada: a systematic review of mixed evidence.

BACKGROUND: Indigenous peoples in Australia, New Zealand and Canada carry a greater burden of chronic kidney disease (CKD) than the general populations in each country, and this burden is predicted to increase. Given the human and economic cost of dialysis, understanding how to better manage CKD at earlier stages of disease progression is an important priority for practitioners and policy-makers. A systematic review of mixed evidence was undertaken to examine the evidence relating to the effectivness, cost-effectiveness and acceptability of chronic kidney disease management programs designed for Indigenous people, as well as barriers and enablers of implementation of such programs. METHODS: Published and unpublished studies reporting quantitative and qualitative data on health sector-led management programs and models of care explicitly designed to manage, slow progression or otherwise improve the lives of Indigenous people with CKD published between 2000 and 2014 were considered for inclusion. Data on clinical effectiveness, ability to self-manage, quality of life, acceptability, cost and cost-benefit, barriers and enablers of implementation were of interest. Quantitative data was summarized in narrative and tabular form and qualitative data was synthesized using the Joanna Briggs Institute meta-aggregation approach. RESULTS: Ten studies were included. Six studies provided evidence of clinical effectiveness of CKD programs designed for Indigenous people, two provided evidence of cost and cost-effectiveness of a CKD program, and two provided qualitative evidence of barriers and enablers of implementation of effective and/or acceptable CKD management programs. Common features of effective and acceptable programs were integration within existing services, nurse-led care, intensive follow-up, provision of culturally-appropriate education, governance structures supporting community ownership, robust clinical systems supporting communication and a central role for Indigenous Health Workers. CONCLUSIONS: Given the human cost of dialysis and the growing population of people living with CKD, there is an urgent need to draw lessons from the available evidence from this and other sources, including studies in the broader population, to better serve this population with programs that address the barriers to receiving high-quality care and improve quality of life.

Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

AIM: The Fish oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial investigated whether 3 months of omega-3 polyunsaturated fatty acids, either alone or in combination with aspirin, will effectively reduce primary access failure of de novo arteriovenous fistulae. This report presents the baseline characteristics of all study participants, examines whether study protocol amendments successfully increased recruitment of a broader and more representative haemodialysis cohort, including patients already receiving aspirin, and contrasts Malaysian participants with those from Australia, New Zealand and the United Kingdom (UK). METHOD: This international, randomized, double-blind, placebo-controlled trial included patients older than 19 years with stage 4 or 5 chronic kidney disease currently receiving, or planned within 12 months to receive haemodialysis. RESULTS: Participants (n = 568) were overweight (28.6 ± 7.3 kg/m(2) ), relatively young (54.8 ± 14.3 years), and predominantly male (63%) with a high prevalence of diabetes mellitus (46%) but low rate of ischaemic heart disease (8%). Sixty one percent were planned for lower arm arteriovenous fistula creation. Malaysian participants (n = 156) were younger (51.8 ± 13.6 years vs 57.1 ± 14.2 years, P < 0.001) with a higher prevalence of diabetes mellitus (65% vs 43%, P < 0.001), but less ischaemic heart disease (5% vs 14%, P < 0.01) compared with the combined Australian, New Zealand and UK cohort (n = 228). Protocol modifications allowing for inclusion of patients receiving aspirin increased the prevalence of co-morbidities compared with the original cohort. CONCLUSIONS: The FAVOURED study participants, while mostly similar to patients in contemporary national registry reports and comparable recent clinical trials, were on average younger and had less ischaemic heart disease. These differences were reduced as a consequence of including patients already receiving aspirin.

The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications.

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 a more representative cohort of haemodialysis patients, who are significantly older with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of the study. TRIAL REGISTRATION: Australia & New Zealand Clinical Trial Register (ACTRN12607000569404).

Interventions for lowering plasma homocysteine levels in kidney transplant recipients.

BACKGROUND: Elevated homocysteine levels have been shown to be an independent risk factor for cardiovascular disease. However studies of homocysteine lowering in general and end-stage kidney disease (ESKD) populations have not demonstrated a reduction in cardiovascular event rates. Kidney transplant recipients have high homocysteine levels, high cardiovascular event rates and, unlike the ESKD population, may achieve normalisation of homocysteine levels with homocysteine lowering therapies. Thus may benefit from homocysteine lowering therapy. OBJECTIVES: To evaluate the effects of established homocysteine lowering therapy on cardiovascular mortality in patients with functioning kidney transplants. SEARCH METHODS: We searched the Cochrane Renal Group's Specialised Register to 16 March 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: Randomised controlled trials of any therapy that has been shown to significantly lower homocysteine levels conducted in people with functioning kidney transplants. Studies were to be included if they compared homocysteine lowering therapy with placebo or usual care, or compare higher versus lower doses of homocysteine lowering therapy. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. Results were to be expressed as the risk ratio (RR) for dichotomous outcomes or mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). Data was to be pooled using the random effects model. MAIN RESULTS: The literature search yielded 359 reports of which only one study was identified that met our inclusion criteria and reported relevant clinical endpoints. This study randomised 4110 adult participants with a functioning kidney transplant and elevated homocysteine levels to folic acid plus high dose B multivitamins or low dose multivitamins who were followed for a mean 4.0 years. Despite effectively lowering homocysteine levels) in homocysteine levels at follow-up (MD -4.40 µmol/L, 95% CI -5.98 to -2.82) there was no evidence the intervention impacted on any of the outcomes reported including cardiovascular mortality (RR 0.91, 95% CI 0.69 to 1.20), all-cause mortality (RR 1.04, 95% CI 0.88 to 1.22), myocardial infarction (RR 1.02, 95% CI 0.77 to 1.35), stroke (RR 1.08, 95% CI 0.69 to 1.71), commencement of renal replacement therapy (RR 1.12, 95% CI 0.91 to 1.37) or all reported adverse events (RR 1.02, 95% CI 0.87 to 1.20). There was no evidence the intervention impacted on the primary endpoint of the study, a cardiovascular event composite (RR 0.99, 95% CI 0.85 to 1.15). The study was of high quality. AUTHORS' CONCLUSIONS: There is no current evidence to support the use of homocysteine lowering therapy for cardiovascular disease prevention in kidney transplant recipients.

Tripterygium preparations for the treatment of CKD: a systematic review and meta-analysis.

BACKGROUND: Preparations of the herb Tripterygium wilfordii Hook F are used widely for the treatment of chronic kidney disease in China. The efficacy and safety of Tripterygium preparations still have not been fully identified. STUDY DESIGN: Systematic review and meta-analysis. SETTING & POPULATION: Patients with chronic kidney disease. SELECTION CRITERIA FOR STUDIES: Randomized controlled trials. INTERVENTION: Tripterygium preparations (Tripterygium glycoside tablets, Tripterygium hypoglaucum Hutch tablets, and Tripterygium granules or extracts) versus placebo, standard care, or other immunosuppressive treatment. OUTCOMES: Weighted mean difference and summary estimates of relative risk (RR) reductions with 95% CIs were calculated with a random-effects model. Outcomes analyzed included change in proteinuria, serum creatinine level, and creatinine clearance rate, as well as remission and relapse rate and drug-related adverse events. RESULTS: We identified 75 trials that included 4,386 participants. Overall, Tripterygium therapy reduced proteinuria by protein excretion of 628 (95% CI, -736 to -521) mg/d and reduced serum creatinine level by 0.12 (95% CI, -0.17 to -0.06) mg/dL compared with controls (both P < 0.001) in a range of kidney conditions. Tripterygium preparations also increased the rate of complete remission by 56% (95% CI, 32%-85%; P < 0.001) and of complete or partial remission by 24% (95% CI, 17%-31%; P < 0.001) while reducing relapse by 58% (95% CI, 42%-69%; P < 0.001). Tripterygium preparations increased the rate of liver function test result abnormalities (RR, 4.03; 95% CI, 2.24-7.25; P < 0.001) and altered menstruation (RR, 5.29; 95% CI, 2.09-13.38; P < 0.001). LIMITATIONS: Suboptimal study quality, significant heterogeneity in the primary outcome. CONCLUSIONS: Tripterygium preparations may have nephroprotective effects, but high-quality trials are required to reliably determine the balance of benefits and harms.

The effect of folic acid based homocysteine lowering on cardiovascular events in people with kidney disease: systematic review and meta-analysis.

OBJECTIVE: To systematically review the effect of folic acid based homocysteine lowering on cardiovascular outcomes in people with kidney disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, the Cochrane Library, and ClinicalTrials.gov to June 2011. STUDY SELECTION: Randomised trials in people with non-dialysis dependent chronic kidney disease or end stage kidney disease or with a functioning kidney transplant reporting at least 100 patient years of follow-up and assessing the effect of folic acid based homocysteine lowering therapy. No language restrictions were applied. DATA EXTRACTION: Two reviewers independently extracted data on study setting, design, and outcomes using a standardised form. The primary endpoint was cardiovascular events (myocardial infarction, stroke, and cardiovascular mortality, or as defined by study author). Secondary endpoints included the individual composite components, all cause mortality, access thrombosis, requirement for renal replacement therapy, and reported adverse events, including haematological and neurological events. The effect of folic acid based homocysteine lowering on outcomes was assessed with meta-analysis using random effects models. RESULTS: 11 trials were identified that reported on 4389 people with chronic kidney disease, 2452 with end stage kidney disease, and 4110 with functioning kidney transplants (10,951 participants in total). Folic acid based homocysteine therapy did not prevent cardiovascular events (relative risk 0.97, 95% confidence interval 0.92 to 1.03, P = 0.326) or any of the secondary outcomes. There was no evidence of heterogeneity in subgroup analyses, including those of kidney disease category, background fortification, rates of pre-existing disease, or baseline homocysteine level. The definitions of chronic kidney disease varied widely between the studies. Non-cardiovascular events could not be analysed as few studies reported these outcomes. CONCLUSIONS: Folic acid based homocysteine lowering does not reduce cardiovascular events in people with kidney disease. Folic acid based regimens should not be used for the prevention of cardiovascular events in people with kidney disease.