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Aims: To assess the completeness of reporting of group‐based education interventions for the management of type 2 diabetes. Methods: A previous systematic review of group‐based education programmes for adults with type 2 diabetes identified eligible intervention studies. Data were extracted and assessed using the Template for Intervention Description and Replication ('TIDieR') checklist. Missing data were sourced from other published material, or by contacting authors. Results: Fifty‐three publications describing 47 studies were included. No publications sufficiently described all items. Authors of 43 of the 47 included studies (91%) were contacted via e‐mail to obtain missing data in order to complete the TIDieR checklist. Seven (16%) did not respond. Additional data were obtained for 33/47 studies (70%). Most studies (45/47, 96%) described the intervention duration and frequency, detailed the procedures and rationale (40/47, 85%), provided a brief intervention name and explained any individual tailoring (38/47, 81%), defined whether providers received training and adequately described how the programme was delivered (37/47, 79%). However, few described any modifications (28/47, 60%), whether the intervention was delivered as planned (27/47, 57%), where it was delivered (21/47, 45%), whether materials were provided (19/47, 40%), and who delivered the intervention (13/47, 28%). Conclusions: Group‐based education interventions for the management of type 2 diabetes are poorly reported. To translate effective research into practice, practitioners need sufficient detail to implement evidence‐based interventions. Researcher adoption of the TIDieR checklist will assist the translation and replication of published interventions. What's new?: Group‐based education for the management of type 2 diabetes is effective in improving HbA1c, fasting blood glucose, body weight, waist circumference, triglyceride levels and diabetes knowledge.Poorly reported interventions impede intervention replication and research translation.Group‐based education interventions for the management of type 2 diabetes are poorly reported and often incomplete.Authors should use the Template for Intervention Description and Replication ('TIDieR') checklist to plan and report interventions completely to assist the replication and implementation of interventions, and improve group‐based education and outcomes for people with type 2 diabetes in practice. [ABSTRACT FROM AUTHOR]

Background: Dietetics students are a widely researched group. As emerging dietitians, they can provide valuable insights to inform how dietetics education programmes may be enhanced to meet contemporary healthcare needs. This review aimed to systematically synthesise dietetics students' experiences of dietetics workforce preparation. Methods: MEDLINE, CINAHL, Embase, PsycINFO, ERIC, Informit and ProQuest Dissertations and Theses Global were searched to identify research published until June 2017. Studies investigating dietetics students' experiences of dietetics workforce preparation, and employing qualitative data collection and analysis methods were included. Data analysis was guided by thematic synthesis, where themes were constructed through an iterative and inductive process. Study quality was appraised using the RATS Qualitative Research Review Guidelines. Results: From the 3301 records identified, five studies met the inclusion criteria and the views of 120 dietetics students from two countries over a 9‐year period were synthesised. The overarching theme of 'navigating through the ups and downs' was underpinned by four main themes: enduring hurdles; reconciling expectations; transforming self; and making and breaking connections. Quality appraisal results rated selection bias as being inadequate/inappropriate across all studies. Conclusions: Dietetics students undertake a transformational journey through dietetics education. They are inspired by seeing what is possible through meaningful encounters with practitioners in diverse settings. However, they are challenged by competitive environments and perceived ideals that are embedded in the profession. Strategies that focus on exposing dietetics students to inspirational practitioners, increasing and celebrating diversity in academic/placement settings, and incentivising collaboration across dietetics education, could act as catalysts to enhance the experience of future dietetics students and the nutrition‐related health of those they will serve. [ABSTRACT FROM AUTHOR]

Patient navigators enable adult patients to circumnavigate complex health systems, improving access to health care and outcomes. Here, we aimed to evaluate the effects of a patient navigation program in children with chronic kidney disease (CKD). In this multi-center, randomized controlled trial, we randomly assigned children (aged 0-16 years) with CKD stages 1-5 (including children on dialysis or with kidney transplants), from low socioeconomic status backgrounds, and/or residing in remote areas, to receive patient navigation at randomization (immediate) or at six months (waitlist). The primary outcome was self-rated health (SRH) of participating children at six months, using intention to treat analysis. Secondary outcomes included caregivers' SRH and satisfaction with health care, children's quality of life, hospitalizations, and missed school days. Repeated measures of the primary outcome from baseline to six months were analyzed using cumulative logit mixed effects models. Semi-structured interviews were thematically evaluated. Of 398 screened children, 162 were randomized (80 immediate and 82 waitlist); mean age (standard deviation) of 8.8 (4.8) years with 64.8% male. SRH was not significantly different between the immediate and wait-listed groups at six months. There were also no differences across all secondary outcomes between the two groups. Caregivers' perspectives were reflected in seven themes: easing mental strain, facilitating care coordination, strengthening capacity to provide care, reinforcing care collaborations, alleviating family tensions, inability to build rapport and unnecessary support. Thus, in children with CKD, self-rated health may not improve in response to a navigator program, but caregivers gained skills related to providing and accessing care., (Copyright © 2024 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Frailty is an important concept in the care of older adults. Over the past two decades, significant advances have been made in measuring frailty. While it is now well-recognised that frailty status is an important determinant of outcomes from medical illnesses or surgical interventions, frailty measurement is not currently routinely integrated into clinical practice. In the community setting, it is uncommon for general practitioners to deliver frailty-optimised care. In hospitals, there is substantial variability in how people living with frailty are managed. This variability is notable between and even within disciplines. Furthermore, gains from understanding frailty mechanisms and risk factors are not yet applied/implemented at scale to delay the progression of frailty in community-dwellers. The Australian Frailty Network (AFN) is a national collaborative group of researchers, clinicians, non-government organisations, consumers and policymakers, in which the engagement and active involvement of consumers has been embedded from the outset. The AFN aims to generate new knowledge to improve health outcomes, to ensure evidence-based management is translated into clinical practice and to build capacity in multidisciplinary and translational frailty research. Here, we describe the development of the AFN, highlighting important milestones: (i) securing funding for the network and flagship elements; (ii) an inaugural summit to establish the strategic vision, values and scope with end-users; (iii) sabbatical visits to learn from international examples; and (iv) developing the governance structure and an actionable plan encompassing consumer engagement, research, education and policy and practice to maximise impact., (© 2024 AJA Inc.)

Introduction: Inequitable access to health care based on demographic factors such as ethnicity, socioeconomic status and geographical location has been consistently found in children with chronic kidney disease (CKD). However, little is known about the perspectives of caregivers on accessing health care. We described caregivers' perspectives on accessing health care for children with CKD from socioeconomically disadvantaged backgrounds and/or rural or remote areas., Methods: Caregivers of Australian children aged 0 to 16 years, across all CKD stages, from low socioeconomic status backgrounds, and/or residing in rural or remote areas, purposively sampled from 5 centers, participated in semi structured interviews on accessing health care. Transcripts were analyzed thematically., Results: From 32 interviews, we identified 6 themes: lack of agency undermining ability to seek care (obscurity of symptoms, uncertain and confused about care processes, and vulnerable and unable to advocate), losing trust in clinicians (confused by inconsistencies and ambiguities in advice, and distressed by lack of collaborative care), exasperated by organizational rigidity (frustrated by bureaucratic roadblocks, lack of access to specialist care in rural and remote settings, and inadequacies of support programs), compounding burden of caregiving (unsustainable financial pressure, debilitating exhaustion, and asymmetry of responsibility), intensifying strain on family (uprooting to relocate, sibling stress and neglect, and depending on family support), building resilience and stability (empowerment through education and confidence in technical and medical support)., Conclusions: Caregivers of children with CKD from disadvantaged backgrounds feel disempowered and vulnerable when accessing care for their child. Strategies are needed to improve access to health care for families who are socioeconomically or geographically disadvantaged., (© 2024 International Society of Nephrology. Published by Elsevier Inc.)

Background: Clinical trial evidence underpins evidence-based medicine and the improvement of healthcare worldwide. In Australasia, a significant proportion of clinical trials are conducted by geographically dispersed and multidisciplinary clinical researchers under the auspices of Clinical Trials Networks (CTNs). These groups play an important role in contributing to evidence-based medicine, primarily by conducting investigator-initiated clinical trials. Despite their clear benefits in terms of return on investment, CTNs suffer significant challenges., Methods: We conducted surveys and focus groups with Australian and New Zealand CTNs to identifying the activities and attributes that enable CTNs to operate successfully. Based on our findings, we then conducted further surveys of Australian and New Zealand CTNs to identify the prevalence of these success factors in existing CTNs., Results: Our focus groups identified three key themes associated with success and growth of a CTN: engaged membership, established infrastructure, and sustainability; and thirteen critical success factors: shared vision and motivation; strong leaders, governance and succession planning; an executive officer; sustainable funding for operations; effective communication; diverse representation and consumer input; transparent processes; a strong pipeline of trials; a reputable and recognised CTN brand; innovation and adaption; an effective group of network sites with a skilled workforce; embedded trials and prioritisation of research. These key themes and the relevant key areas were presented to 30 CTNs. Two factors were almost universally present in CTNs, reflecting the importance of these attributes: the presence of an executive officer, and a strong pipeline of trials. Three factors had a particularly low prevalence: sustainable funding for operations, effective communication, and embedded trials., Conclusions: By supporting both emerging and established CTNs to achieve critical success factors, we can improve the efficiency of CTNs to continue to contribute and expand their clinical trial activities. Particular focus needs to be on finding sustainable funding for CTNs, and raising awareness of the critical role undertaken by CTNs to improve healthcare and health outcomes., (© 2023. The Author(s).)

Background: Delayed graft function (DGF) is a major adverse complication of deceased donor kidney transplantation. Intravenous fluids are routinely given to patients receiving a transplant to maintain intravascular volume and optimise graft function. Saline (0·9% sodium chloride) is widely used but might increase the risk of DGF due to its high chloride content. We aimed to test our hypothesis that using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce the incidence of DGF., Methods: BEST-Fluids was a pragmatic, registry-embedded, multicentre, double-blind, randomised, controlled trial at 16 hospitals in Australia and New Zealand. Adults and children of any age receiving a deceased donor kidney transplant were eligible; those receiving a multi-organ transplant or weighing less than 20 kg were excluded. Participants were randomly assigned (1:1) using an adaptive minimisation algorithm to intravenous balanced crystalloid solution (Plasma-Lyte 148) or saline during surgery and up until 48 h after transplantation. Trial fluids were supplied in identical bags and clinicians determined the fluid volume, rate, and time of discontinuation. The primary outcome was DGF, defined as receiving dialysis within 7 days after transplantation. All participants who consented and received a transplant were included in the intention-to-treat analysis of the primary outcome. Safety was analysed in all randomly assigned eligible participants who commenced surgery and received trial fluids, whether or not they received a transplant. This study is registered with Australian New Zealand Clinical Trials Registry, (ACTRN12617000358347), and ClinicalTrials.gov (NCT03829488)., Findings: Between Jan 26, 2018, and Aug 10, 2020, 808 participants were randomly assigned to balanced crystalloid (n=404) or saline (n=404) and received a transplant (512 [63%] were male and 296 [37%] were female). One participant in the saline group withdrew before 7 days and was excluded, leaving 404 participants in the balanced crystalloid group and 403 in the saline group that were included in the primary analysis. DGF occurred in 121 (30%) of 404 participants in the balanced crystalloid group versus 160 (40%) of 403 in the saline group (adjusted relative risk 0·74 [95% CI 0·66 to 0·84; p<0·0001]; adjusted risk difference 10·1% [95% CI 3·5 to 16·6]). In the safety analysis, numbers of investigator-reported serious adverse events were similar in both groups, being reported in three (<1%) of 406 participants in the balanced crystalloid group versus five (1%) of 409 participants in the saline group (adjusted risk difference -0·5%, 95% CI -1·8 to 0·9; p=0·48)., Interpretation: Among patients receiving a deceased donor kidney transplant, intravenous fluid therapy with balanced crystalloid solution reduced the incidence of DGF compared with saline. Balanced crystalloid solution should be the standard-of-care intravenous fluid used in deceased donor kidney transplantation., Funding: Medical Research Future Fund and National Health and Medical Research Council (Australia), Health Research Council (New Zealand), Royal Australasian College of Physicians, and Baxter., Competing Interests: Declaration of interests MGC has received research support from Baxter Healthcare, the manufacturer of Plasma-Lyte 148, via a Baxter Investigator-Initiated Research grant that provided fluids for the BEST-Fluids trial (commercial value of US$36 270). DWJ has received consultancy fees, research grants, speaker's honoraria, and travel sponsorships from Baxter Healthcare and Fresenius Medical Care; consultancy fees from AstraZeneca and AWAK; speaker's honoraria and travel sponsorships from ONO; and travel sponsorships from Amgen. DR, LEH, LAV, EMP, CK, and JV are employees of the sponsor, The University of Queensland. KBD's salary was funded by a Better Evidence and Translation in Chronic Kidney Disease (BEAT-CKD) grant' and she is an employee of the ANZDATA Registry. PAC is the Deputy Executive Officer of the ANZDATA Registry. CMH has received fees for research committee activities from Janssen and GlaxoSmithKline paid to her institution; personal fees from Otsuka; research grants from Fresenius, Shire, and PKD Australia outside the submitted work; and research grants from Baxter and the National Health and Medical Research Council of Australia related to the current project. LW works in the Department of Anaesthesia at Austin Health, which has received funding from Baxter Healthcare for investigator-initiated clinical research. PFM has received honoraria for presentations on behalf of AstraZeneca and consultancy fees from Vifor. LW has received honoraria from Baxter Healthcare for consulting activities. All LW's fluid-related research, including study design, execution, data collection, analysis, and reporting, has been conducted independently of Baxter Healthcare and other commercial entities. ZHE has received consultancy fees and travel sponsorships from AstraZeneca. WHL has received honoraria from Alexion and education or research grants from Astellas. SJC has received research support, travel support, speaker fees, or honoraria from AstraZeneca, Bayer, CSL-Behring, Novartis, and Takeda. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: An increasing number of older people are living with chronic kidney disease (CKD). Many have complex healthcare needs and are at risk of deteriorating health and functional status, which can adversely affect their quality of life. Comprehensive geriatric assessment (CGA) is an effective intervention to improve survival and independence of older people, but its clinical utility and cost-effectiveness in frail older people living with CKD is unknown., Methods: The GOAL Trial is a pragmatic, multi-centre, open-label, superiority, cluster randomised controlled trial developed by consumers, clinicians, and researchers. It has a two-arm design, CGA compared with standard care, with 1:1 allocation of a total of 16 clusters. Within each cluster, study participants ≥ 65 years of age (or ≥ 55 years if Aboriginal or Torres Strait Islander (First Nations Australians)) with CKD stage 3-5/5D who are frail, measured by a Frailty Index (FI) of > 0.25, are recruited. Participants in intervention clusters receive a CGA by a geriatrician to identify medical, social, and functional needs, optimise medication prescribing, and arrange multidisciplinary referral if required. Those in standard care clusters receive usual care. The primary outcome is attainment of self-identified goals assessed by standardised Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS at 6 and 12 months, quality of life (EQ-5D-5L), frailty (Frailty Index - Short Form), transfer to residential aged care facilities, cost-effectiveness, and safety (cause-specific hospitalisations, mortality). A process evaluation will be conducted in parallel with the trial including whether the intervention was delivered as intended, any issue or local barriers to intervention delivery, and perceptions of the intervention by participants. The trial has 90% power to detect a clinically meaningful mean difference in GAS of 10 units., Discussion: This trial addresses patient-prioritised outcomes. It will be conducted, disseminated and implemented by clinicians and researchers in partnership with consumers. If CGA is found to have clinical and cost-effectiveness for frail older people with CKD, the intervention framework could be embedded into routine clinical practice. The implementation of the trial's findings will be supported by presentations at conferences and forums with clinicians and consumers at specifically convened workshops, to enable rapid adoption into practice and policy for both nephrology and geriatric disciplines. It has potential to materially advance patient-centred care and improve clinical and patient-reported outcomes (including quality of life) for frail older people living with CKD., Trial Registration: ClinicalTrials.gov NCT04538157. Registered on 3 September 2020., (© 2023. The Author(s).)

Background: Children with chronic kidney disease (CKD) require multidisciplinary care to meet their complex healthcare needs. Patient navigators are trained non-medical personnel who assist patients and caregivers to overcome barriers to accessing health services through care coordination. This trial aims to determine the effectiveness of a patient navigator program in children with CKD., Methods: The NAVKIDS 2 trial is a multi-center, waitlisted, randomized controlled trial of patient navigators in children with CKD conducted at five sites across Australia. Children (0-16 years) with CKD from low socioeconomic status rural or remote areas were randomized to an intervention group or a waitlisted control group (to receive intervention after 6 months). The study primary and secondary endpoints include the self-rated health (SRH) (primary), and utility-based quality of life, progression of kidney dysfunction of the child, SRH, and satisfaction with healthcare of the caregiver at 6 months post-randomization., Results: The trial completed recruitment in October 2021 with expected completion of follow-up by October 2022. There were 162 patients enrolled with 80 and 82 patients randomized to the immediate intervention and waitlisted groups, respectively. Fifty-eight (36%) participants were from regional/remote areas, with a median (IQR) age of 9.5 (5.0, 13.0) years, 46% were of European Australian ethnicity, and 65% were male. A total of 109 children (67%) had CKD stages 1-5, 42 (26%) were transplant recipients, and 11 (7%) were receiving dialysis., Conclusion: The NAVKIDS 2 trial is designed to evaluate the effectiveness of patient navigation in children with CKD from families experiencing socioeconomic disadvantage. A higher resolution version of the Graphical abstract is available as Supplementary information., (© 2022. The Author(s), under exclusive licence to International Pediatric Nephrology Association.)

Introduction: Most patients with kidney failure commence and continue hemodialysis (HD) thrice weekly. Incremental initiation (defined as HD less than thrice weekly) is increasingly considered to be safe and less burdensome, but little is known about patients' perspectives. We aimed to describe patients' priorities and concerns regarding incremental HD., Methods: Patients currently, previously, or soon to be receiving HD in Australia participated in two 90-minute online workshops to discuss views about HD focusing on incremental start and priorities for trial outcomes. Transcripts were analyzed using thematic analysis. Outcomes were ranked on the basis of the sum of participants' priority scores (i.e., single allocation of 3 points for most important, 2 for second, and 1 for third most important outcome)., Results: All 26 participants (1 caregiver and 25 patients) preferred an incremental HD approach. The top prioritized outcomes were quality of life (QOL) (56 points), residual kidney function (RKF) (27 points), and mortality (16 points). The following 4 themes underpinning outcome priorities, experience, and safety concerns were identified: (i) unpreparedness and pressure to adapt, (ii) disruption to daily living, (iii) threats to safety, and (iv) hope and future planning., Conclusion: Patients with kidney failure preferred an incremental start to HD to minimize disruption to daily living and reduce the negative impacts on their education, ability to work, and family life. QOL was the most critically important outcome, followed by RKF and survival., (© 2022 Published by Elsevier Inc. on behalf of the International Society of Nephrology.)

Introduction: Intuitive eating interventions aim to improve individual health and promote sustainable changes to one's relationship with food. However, there is no evidence-based consensus on the impact of intuitive eating interventions on diet quality. This systematic review aimed to investigate intuitive eating interventions and their impact on diet quality., Method: PubMed, Embase, CINAHL, PsycInfo, and Cochrane databases were systematically searched to October 2021 for studies reporting interventions that encompassed the principles of intuitive eating and measured diet quality. Other health outcomes were used for secondary analysis. Findings were synthesized narratively., Results: Seventeen papers reporting 14 intervention studies (n = 3,960) were included in the review. All studies found a positive or neutral effect on diet quality following an intuitive eating intervention. A favorable change in eating behavior following these interventions was also observed., Discussion: Intuitive eating promotes an attunement to the body, which aids in improving diet quality because of increased awareness of physiological cues. The reduction of emotional and binge eating may also increase diet quality., Implications for Research and Practice: Findings from the current review suggest that intuitive eating interventions are most effective face-to-face, in a group setting, and sustained for at least 3 months., (Copyright © 2022 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Background: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative., Methods: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors., Discussion: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care., Trial Registration: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019., (© 2022. Crown.)

Delayed graft function (DGF) is a major complication of deceased donor kidney transplantation. Saline (0.9% sodium chloride) is a commonly used intravenous fluid in transplantation but may increase the risk of DGF because of its high chloride content. Better Evidence for Selecting Transplant Fluids (BEST-Fluids), a pragmatic, registry-based, double-blind, randomized trial, sought to determine whether using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce DGF. We sought to evaluate the generalizability of the trial cohort by reporting the baseline characteristics and representativeness of the trial participants in detail., Methods: We compared the characteristics of BEST-Fluids participants with those of a contemporary cohort of deceased donor kidney transplant recipients in Australia and New Zealand using data from the Australia and New Zealand Dialysis and Transplant Registry. To explore potential international differences, we compared trial participants with a cohort of transplant recipients in the United States using data from the Scientific Registry of Transplant Recipients., Results: During the trial recruitment period, 2373 deceased donor kidney transplants were performed in Australia and New Zealand; 2178 were eligible' and 808 were enrolled in BEST-Fluids. Overall, trial participants and nonparticipants were similar at baseline. Trial participants had more coronary artery disease (standardized difference [d] = 0.09; P = 0.03), longer dialysis duration (d = 0.18, P < 0.001), and fewer hypertensive (d = -0.11, P = 0.03) and circulatory death (d = -0.14, P < 0.01) donors than nonparticipants. Most key characteristics were similar between trial participants and US recipients, with moderate differences (|d| ≥ 0.2; all P < 0.001) in kidney failure cause, diabetes, dialysis duration, ischemic time, and several donor risk predictors, likely reflecting underlying population differences., Conclusions: BEST-Fluids participants had more comorbidities and received slightly fewer high-risk deceased donor kidneys but were otherwise representative of Australian and New Zealand transplant recipients and were generally similar to US recipients. The trial results should be broadly applicable to deceased donor kidney transplantation practice worldwide., Competing Interests: M.G.C. has received research support from Baxter Healthcare Pty Ltd, the manufacturer of Plasma-Lyte 148, through a Baxter Investigator-Initiated Research grant that provided fluids for the BEST-Fluids trial (commercial value of US $36 270). D.W.J. has received consultancy fees, research grants, speaker’s honoraria, and travel sponsorships from Baxter Healthcare and Fresenius Medical Care; consultancy fees from AstraZeneca and AWAK; speaker’s honoraria and travel sponsorships from ONO; and travel sponsorships from Amgen. D.R., L.E.H. L.A.V., E.M.P., C.K., and J.V. are employees of the sponsor, The University of Queensland. K.B.D.’s salary was funded by a BEAT-CKD grant‚ and she is an employee of the ANZDATA Registry. P.A.C. is the deputy executive officer of the ANZDATA Registry. C.M.H. has received fees for research committee activities from Janssen and GlaxoSmithKline paid to her institution; personal fees from Otsuka; research grants from Fresenius, Shire, and PKD Australia outside the submitted work; and research grants from Baxter and NHMRC related to the current project. L.W. works in the Department of Anaesthesia at Austin Health, which has received funding from Baxter Healthcare for investigator-initiated clinical research. L.W. has received honoraria from Baxter Healthcare for consulting activities. All L.W.’s fluid-related research, including study design, execution, data collection, analysis, and reporting, has been conducted independently of Baxter Healthcare and other commercial entities. Z.H.E. has received consultancy fees and travel sponsorships from AstraZeneca. W.H.L. has received honoraria from Alexion and education/research grants from Astellas. S.J.C. has received research support, travel support, speaker fees, or honoraria from AstraZeneca, Bayer, CSL-Behring, Novartis, and Takeda. The other authors declare no conflicts of interest., (Copyright © 2022 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)

Aims: People who live in rural areas have reduced access to appropriate and timely healthcare, leading to poorer health outcomes than their metropolitan-based counterparts. The aims of the workshops were to ascertain participants' perspectives on barriers to access to dialysis and transplantation, to identify and prioritize the roles of a rural patient navigator, to discuss the acceptability and feasibility of implementing this role and identify possible outcomes that could be used to measure the success of the programme in a clinical trial., Methods: Rural patients (n = 19), their caregivers (n = 5) and health professionals (n = 18) from Australia participated in three workshops. We analysed the data using thematic analysis., Results: We identified four themes related to access to dialysis and transplantation: overwhelmed by separate and disconnected health systems, unprepared for emotional toll and isolation, lack of practical support and inability to develop trust and rapport. Four themes related to the role of the patient navigator programme: valuing lived experience, offering cultural expertise, requiring a conduit, and flexibility of the job description. The key roles prioritized by participants were psychological support and networking, provision/consolidation of education, and provision of practical support., Conclusion: Rural patients, caregivers and health professionals believed that programmes that include navigators with lived experience of dialysis and kidney transplantation and cultural expertise, especially for Aboriginal Australians, may have the potential to improve patient experiences in accessing healthcare., (© 2022 The Authors. Nephrology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Nephrology.)

Background: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS 2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published., Methods/design: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018., (© 2022. The Author(s).)

Background: Anti-neutrophil cytoplasm antibody-associated vasculitis is a multisystem, autoimmune disease that causes organ failure and death. Physical removal of pathogenic autoantibodies by plasma exchange is recommended for severe presentations, along with high-dose glucocorticoids, but glucocorticoid toxicity contributes to morbidity and mortality. The lack of a robust evidence base to guide the use of plasma exchange and glucocorticoid dosing contributes to variation in practice and suboptimal outcomes., Objectives: We aimed to determine the clinical efficacy of plasma exchange in addition to immunosuppressive therapy and glucocorticoids with respect to death and end-stage renal disease in patients with severe anti-neutrophil cytoplasm antibody-associated vasculitis. We also aimed to determine whether or not a reduced-dose glucocorticoid regimen was non-inferior to a standard-dose regimen with respect to death and end-stage renal disease., Design: This was an international, multicentre, open-label, randomised controlled trial. Patients were randomised in a two-by-two factorial design to receive either adjunctive plasma exchange or no plasma exchange, and either a reduced or a standard glucocorticoid dosing regimen. All patients received immunosuppressive induction therapy with cyclophosphamide or rituximab., Setting: Ninety-five hospitals in Europe, North America, Australia/New Zealand and Japan participated., Participants: Participants were aged ≥ 16 years with a diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, and either proteinase 3 anti-neutrophil cytoplasm antibody or myeloperoxidase anti-neutrophil cytoplasm antibody positivity, and a glomerular filtration rate of < 50 ml/minute/1.73 m 2 or diffuse alveolar haemorrhage attributable to active anti-neutrophil cytoplasm antibody-associated vasculitis., Interventions: Participants received seven sessions of plasma exchange within 14 days or no plasma exchange. Oral glucocorticoids commenced with prednisolone 1 mg/kg/day and were reduced over different lengths of time to 5 mg/kg/day, such that cumulative oral glucocorticoid exposure in the first 6 months was 50% lower in patients allocated to the reduced-dose regimen than in those allocated to the standard-dose regimen. All patients received the same glucocorticoid dosing from 6 to 12 months. Subsequent dosing was at the discretion of the treating physician., Primary Outcome: The primary outcome was a composite of all-cause mortality and end-stage renal disease at a common close-out when the last patient had completed 10 months in the trial., Results: The study recruited 704 patients from June 2010 to September 2016. Ninety-nine patients died and 138 developed end-stage renal disease, with the primary end point occurring in 209 out of 704 (29.7%) patients: 100 out of 352 (28%) in the plasma exchange group and 109 out of 352 (31%) in the no plasma exchange group (adjusted hazard ratio 0.86, 95% confidence interval 0.65 to 1.13; p  = 0.3). In the per-protocol analysis for the non-inferiority glucocorticoid comparison, the primary end point occurred in 92 out of 330 (28%) patients in the reduced-dose group and 83 out of 325 (26%) patients in the standard-dose group (partial-adjusted risk difference 0.023, 95% confidence interval 0.034 to 0.08; p  = 0.5), thus meeting our non-inferiority hypothesis. Serious infections in the first year occurred in 96 out of 353 (27%) patients in the reduced-dose group and in 116 out of 351 (33%) patients in the standard-dose group. The rate of serious infections at 1 year was lower in the reduced-dose group than in the standard-dose group (incidence rate ratio 0.69, 95% confidence interval 0.52 to 0.93; p  = 0.016)., Conclusions: Plasma exchange did not prolong the time to death and/or end-stage renal disease in patients with anti-neutrophil cytoplasm antibody-associated vasculitis with severe renal or pulmonary involvement. A reduced-dose glucocorticoid regimen was non-inferior to a standard-dose regimen and was associated with fewer serious infections., Future Work: A meta-analysis examining the effects of plasma exchange on kidney outcomes in anti-neutrophil cytoplasm antibody-associated vasculitis is planned. A health-economic analysis of data collected in this study to examine the impact of both plasma exchange and reduced glucocorticoid dosing is planned to address the utility of plasma exchange for reducing early end-stage renal disease rates. Blood and tissue samples collected in the study will be examined to identify predictors of response to plasma exchange in anti-neutrophil cytoplasm in antibody-associated vasculitis. The benefits associated with reduced glucocorticoid dosing will inform future studies of newer therapies to permit further reduction in glucocorticoid exposure. Data from this study will contribute to updated management recommendations for anti-neutrophil cytoplasm antibody-associated vasculitis., Limitations: This study had an open-label design which may have permitted observer bias; however, the nature of the end points, end-stage renal disease and death, would have minimised this risk. Despite being, to our knowledge, the largest ever trial in anti-neutrophil cytoplasm antibody-associated vasculitis, there was an insufficient sample size to assess clinically useful benefits on the separate components of the primary end-point: end-stage renal disease and death. Use of a fixed-dose plasma exchange regimen determined by consensus rather than data-driven dose ranging meant that some patients may have been underdosed, thus reducing the therapeutic impact. In particular, no biomarkers have been identified to help determine dosing in a particular patient, although this is one of the goals of the biomarker plan of this study., Trial Registration: This trial is registered as ISRCTN07757494, EudraCT 2009-013220-24 and Clinicaltrials.gov NCT00987389., Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 26, No. 38. See the NIHR Journals Library website for further project information.