The survival benefit of deceased donor kidney transplantation for Aboriginal and Torres Strait Islander people, 2006-20: a retrospective national cohort study.

OBJECTIVES: To quantify the survival benefit of kidney transplantation for Aboriginal and Torres Strait Islander people waitlisted for deceased donor kidney transplantation in Australia. STUDY DESIGN: Retrospective cohort study; analysis of linked data from the Australia and New Zealand Dialysis and Transplant (ANZDATA) registry, the Australia and New Zealand Organ Donation (ANZOD) registry, and OrganMatch (Australian Red Cross). SETTING, PARTICIPANTS: All adult Aboriginal and Torres Strait Islander people (18 years or older) who commenced dialysis in Australia during 1 July 2006 - 31 December 2020 and were included in the kidney-only deceased donor transplant waiting list. MAIN OUTCOME MEASURES: Survival benefit of deceased donor kidney transplantation relative to remaining on dialysis. RESULTS: Of the 4082 Aboriginal and Torres Strait Islander people who commenced dialysis, 450 were waitlisted for kidney transplants (11%), of whom 323 received deceased donor transplants. Transplantation was associated with a significant survival benefit compared with remaining on dialysis after the first 12 months (adjusted hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.20-0.73). This benefit was similar to that for waitlisted non-Indigenous people who received deceased donor kidney transplants (adjusted HR, 0.47; 95% CI, 0.40-0.57; Indigenous status interaction: P = 0.22). CONCLUSIONS: From twelve months post-transplantation, deceased donor transplantation provides a survival benefit for Aboriginal and Torres Strait Islander people. Our findings provide evidence that supports efforts to promote the waitlisting of Aboriginal and Torres Strait Islander people who are otherwise eligible for transplantation.

Recommendations for culturally safe clinical kidney care for First Nations Australians: a guideline summary.

INTRODUCTION: First Nations Australians display remarkable strength and resilience despite the intergenerational impacts of ongoing colonisation. The continuing disadvantage is evident in the higher incidence, prevalence, morbidity and mortality of chronic kidney disease (CKD) among First Nations Australians. Nationwide community consultation (Kidney Health Australia, Yarning Kidneys, and Lowitja Institute, Catching Some Air) identified priority issues for guideline development. These guidelines uniquely prioritised the knowledge of the community, alongside relevant evidence using an adapted GRADE Evidence to Decision framework to develop specific recommendations for the management of CKD among First Nations Australians. MAIN RECOMMENDATIONS: These guidelines explicitly state that health systems have to measure, monitor and evaluate institutional racism and link it to cultural safety training, as well as increase community and family involvement in clinical care and equitable transport and accommodation. The guidelines recommend earlier CKD screening criteria (age ≥ 18 years) and referral to specialists services with earlier criteria of kidney function (eg, estimated glomerular filtration rate [eGFR], ≤ 45 mL/min/1.73 m2 , and a sustained decrease in eGFR, > 10 mL/min/1.73 m2 per year) compared with the general population. CHANGES IN MANAGEMENT AS RESULT OF THE GUIDELINES: Our recommendations prioritise health care service delivery changes to address institutional racism and ensure meaningful cultural safety training. Earlier detection of CKD and referral to nephrologists for First Nations Australians has been recommended to ensure timely implementation to preserve kidney function given the excess burden of disease. Finally, the importance of community with the recognition of involvement in all aspects and stages of treatment together with increased access to care on Country, particularly in rural and remote locations, including dialysis services.

Development of the Consumer Involvement & Engagement Toolkit: a digital resource to build capacity for undertaking patient-centred clinical trials in Australia.

OBJECTIVE: This manuscript describes the novel approach to developing a toolkit to support meaningful consumer involvement in clinical trials in Australia to help guide others in considering the development of similar resources.The toolkit aims to support greater consumer involvement in shaping how clinical research is prioritised, designed and conducted. Type of program or service: A working group of researchers, research organisations and consumers was established to co-develop the Consumer Involvement and Engagement Toolkit (the 'Toolkit'), a digital resource to guide researchers and organisations regarding consumer involvement in clinical trials. FINDINGS: A literature review and international scan of best practice revealed numerous resources outlining best practice for consumer involvement in clinical research and clear evidence of its impact and value. Through a novel content-sharing process, we were able to utilise these resources to develop a comprehensive Toolkit for researchers and research organisations that provides world-class guidance. LESSONS LEARNT: There is a growing movement to ensure consumer involvement in healthcare, including in clinical research. We discovered its proponents were willing to share their tools and resources to promote international consumer involvement. Although these international tools and resources needed adaptation to suit the Australian research environment, this was achievable with far less effort than developing them from scratch.

Aspirin for the prevention of pre-eclampsia in women with pre-existing diabetes: Systematic review.

BACKGROUND: There is a lack of evidence for pre-eclampsia prophylaxis with aspirin in women with pre-existing diabetes mellitus (DM). AIMS: To examine the evidence for aspirin in pre-eclampsia prophylaxis in women with pre-existing DM. MATERIAL AND METHODS: An electronic search using Ovid MEDLINE, Embase, CinicalTrials.gov and the Cochrane CENTRAL register of controlled trials through to February 2021 was performed. Reference lists of identified studies, previous review articles, clinical practice guidelines and government reports were manually searched. Randomised controlled trials (RCTs) of aspirin vs placebo for pre-eclampsia prophylaxis were included. Articles were manually reviewed to determine if cohorts included women with DM. The systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data from included trials were extracted independently by two authors who also independently assessed risk of bias as per the Cochrane Handbook criteria version 5.1.0. Data were analysed using Rev-Man 5.4. RESULTS: Forty RCTs were identified, of which 11 included a confirmed subset of women with DM; however, data were insufficient for meta-analysis. Meta-analysis of 930 women with DM, from individual patient data included in a systematic review and unpublished data from one of the 11 RCTs, showed a non-significant difference in the outcome of pre-eclampsia in participants treated with aspirin compared to placebo (odds ratio 0.58; 95% CI 0.20-1.71; P = 0.33). CONCLUSIONS: Pre-eclampsia risk reduction with aspirin prophylaxis in women with pre-existing DM may be similar to women without pre-existing DM. However, randomised data within this meta-analysis were insufficient, warranting the need for further studies within this high-risk group of women.

Gastrointestinal symptom burden and dietary intake in patients with chronic kidney disease.

BACKGROUND: Gastrointestinal (GI) symptoms can present a significant burden to patients with chronic kidney disease (CKD) but the reported prevalence is inconsistent. OBJECTIVE: To examine the GI burden and dietary intake in patients with CKD with or without dialysis. METHODS: This was a cross-sectional study of 216 adults, recruited from outpatient and dialysis clinics, with CKD stage 4 or 5 not receiving dialysis (CKD-ND), or receiving haemodialysis (HD) or peritoneal dialysis (PD). Three questionnaires were administered: the Bristol Stool Form Scale (BSFS); a modified Gastrointestinal Symptom Rating Scale and a short Food Frequency Questionnaire. Outcomes were stool frequency and consistency, GI symptoms and dietary intake. RESULTS: Data were collected from 216 patients (mean age, 63 years [95% CI: 61, 65]; 63% males; CKD-ND: n = 134; HD: n = 67; PD: n = 15). Mean stool frequency for all groups was one bowel action per day (p = .45) and consistency was normal (BSFS type 4, p = .95). Overall GI symptom burden was low but several symptoms occurred at least "most of the time" including "tiredness/lethargy" (54% of participants), "reduced appetite" (29%), "early satiety" (25%) and "change in taste" (15%). Low intakes of fresh fruit, vegetables, whole-grains and legumes were found. No associations were observed between diet and GI symptoms. CONCLUSION: The overall GI symptom burden was low, but >15% of participants reported several symptoms as occurring most to all of the time. Low intakes of fresh fruit, vegetables, whole-grains and legumes were observed in all CKD patients.

"Can I go to Glasgow?" Learnings from patient involvement at the 17th Congress of the International Society for Peritoneal Dialysis (ISPD).

BACKGROUND: Recognition of the discrepancy between the research priorities of patients and health professionals has prompted efforts to involve patients as active contributors in research activities, including scientific conferences. However, there is limited evidence about the experience, challenges, and impacts of patient involvement to inform best practice. This study aims to describe patient and health professional perspectives on patient involvement at the Congress of the International Society for Peritoneal Dialysis (ISPD). METHODS: Semi-structured interviews were conducted with 14 patients/caregivers and 15 health professionals from six countries who attended ISPD. Interviews were recorded and transcribed verbatim, and transcripts were analyzed thematically. RESULTS: We identified four themes: protecting and enhancing scientific learning (grounding science in stories, sharing and inspiring new perspectives, distilling the key messages of research presentations, striking a balance between accommodating patients and presenting the science); democratizing access to research (redistributing power, challenging the traditional ownership of knowledge, cultivating self-management through demystifying research); inadequate support for patient/caregiver delegates (lacking purposeful inclusion, challenges in interpreting research findings, soliciting medical advice, difficulty negotiating venue and program, limited financial assistance in attending); and amplifying impact beyond the room (sparking innovation in practice, giving patients and families hope for the future). CONCLUSIONS: Patient involvement at the ISPD Congress clarified the applicability of research to patient care and self-management, democratized science, and strengthened the potential impact of research. More structured support for patients to help them purposefully articulate their experience in relation to session objectives may enhance their contribution and their own learning experience.

Cannulation practices at haemodialysis initiation via an arteriovenous fistula or arteriovenous graft.

INTRODUCTION: A functioning long-term vascular access is required for haemodialysis therapy; however, establishing this can be challenging in the setting of advanced age and vessels damaged by diabetes. Complications include the inability to insert two needles for the treatment resulting in miscannulation trauma and in some cases insertion of a temporary central venous access device. The broad objective of this review is to define the evidence base regarding cannulation practices in the initiation of haemodialysis via an arteriovenous fistula or an arteriovenous graft. METHODS: This review uses the framework recommended by the Joanna Briggs Institute and the process by which papers were included or excluded followed the standard Preferred Reporting Items for Systematic Reviews and Meta-Analyses group approach. A total of 20 primary research studies met the inclusion criteria. RESULTS: Cannulation in the 10- to 15-week period rather than delaying past this time frame is associated with the best outcomes. New vascular access given time to mature through single-needle haemodialysis treatments may improve long-term patency. Duplex ultrasound mapping prior to initiation of cannulation supports the clinical decision-making process on timing of and selection of cannulation sites. CONCLUSION: Cannulation trauma at the initiation of haemodialysis could potentially be reduced with a strategy of incremental haemodialysis using single-needle treatment supported with duplex ultrasonography assessment to 'map' the vascular access as a guide for clinicians prior to cannulation initiation.

An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis.

Shared decision-making about clinical care options in end-stage kidney disease is limited by inconsistencies in the reporting of outcomes and the omission of patient-important outcomes in trials. Here we generated a consensus-based prioritized list of outcomes to be reported during trials in peritoneal dialysis (PD). In an international, online, three-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale (with 7-9 indicating critical importance) and provided comments. Using a Best-Worst Scale (BWS), the relative importance of outcomes was estimated. Comments were analyzed thematically. In total, 873 participants (207 patients/caregivers and 666 health professionals) from 68 countries completed round one, 629 completed round two and 530 completed round three. The top outcomes were PD-related infection, membrane function, peritoneal dialysis failure, cardiovascular disease, death, catheter complications, and the ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to six outcomes: blood pressure (mean difference, 0.4), fatigue (0.3), membrane function (0.3), impact on family/friends (0.1), peritoneal thickening (0.1) and usual activities (0.1). Four themes were identified that underpinned the reasons for ratings: contributing to treatment longevity, preserving quality of life, escalating morbidity, and irrelevant and futile information and treatment. Patients/caregivers and health professionals gave highest priority to clinical outcomes. In contrast to health professionals, patients/caregivers gave higher priority to lifestyle-related outcomes including the impact on family/friends and usual activities. Thus, prioritization will inform a core outcome set to improve the consistency and relevance of outcomes for trials in PD.

NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. There is growing evidence of socioeconomic disparities in health outcomes among children with CKD. Patient navigators are trained non-medical personnel who assist patients with chronic conditions journey through the continuum of care and transit across different care settings. They help vulnerable and underserved populations to better understand their diagnosis, treatment options, and available resources, guide them through complex medical systems, and help them to overcome barriers to health care access. Given the complexity and chronicity of the disease process and concerns that current models of care may not adequately support the provision of high-level care in children with CKD from socioeconomically disadvantaged backgrounds, a patient navigator program may improve the provision of care and overall health of children with CKD. METHODS: The NAV-KIDS2 trial is a multi-centre, staggered entry, waitlisted randomised controlled trial assessing the health benefits and costs of a patient navigator program in children with CKD (stages 3-5, on dialysis, and with kidney transplants), who are of low socioeconomic backgrounds. Across 5 sites, 210 patients aged from 3 to 17 years will be randomised to immediate receipt of a patient navigator intervention for 24 weeks or waitlisting with standard care until receipt of a patient navigator at 24 weeks. The primary outcome is child self-rated health (SRH) 6-months after completion of the intervention. Other outcomes include utility-based quality of life, caregiver SRH, satisfaction with healthcare, progression of kidney dysfunction, other biomarkers, missed school days, hospitalisations and mortality. The trial also includes an economic evaluation and process evaluation, which will assess the cost-effectiveness, fidelity and barriers and enablers of implementing a patient navigator program in this setting. DISCUSSION: This study will provide clear evidence on the effectiveness and cost-effectiveness of a new intervention aiming to improve overall health and well-being for children with CKD from socioeconomically disadvantaged backgrounds, through a high quality, well-powered clinical trial. TRIAL REGISTRATION: Prospectively registered (12/07/2018) on the Australian New Zealand Clinical Trials Registry ( ACTRN12618001152213 ).

Successful pregnancy in a recipient of an ABO-incompatible renal allograft.

Kidney transplantation restores fertility in patients with end-stage renal disease, with many successful pregnancies after kidney transplantation being reported. However, there are little data regarding pregnancy in women transplanted under modern-era desensitisation protocols that utilise rituximab, plasma exchange and intravenous immunoglobulin, including ABO-incompatible transplants. Pregnancies in ABO-incompatible recipients can pose new challenges from an immunological perspective. Here, we report a case of successful pregnancy using in vitro fertilisation, in a renal transplant recipient who underwent desensitisation two years prior, that included use of rituximab and plasma exchange to receive an ABO-incompatible transplant from her husband and subsequent father of the baby. We believe this was the first case of successful pregnancy after ABO-incompatible kidney transplantation in Australia and New Zealand. This case also highlights the difficulties faced in conception following transplantation and demonstrates that in vitro fertilisation utilising ovulation induction can be successfully utilised for conception in this cohort. This recipient also had gestational diabetes, worsening renal function and preterm delivery which are important complications often seen in pregnancies of solid organ transplant recipients.

Microalbuminuria as an early predictor of preeclampsia in the pre-gestational diabetic population: A prospective cohort study.

OBJECTIVES: To determine if microalbuminuria can be used as a predictive marker of preeclampsia and adverse pregnancy and neonatal outcomes in women with pre-existing diabetes and to compare the prognostic utility of urinary albumin to creatinine ratio (uACR) and urinary protein to creatinine ratio (uPCR). STUDY DESIGN: Multicentre prospective cohort study. Antenatal Diabetes in Pregnancy clinics at three tertiary referral hospitals in Western Sydney, Australia. 158 women with pre-existing diabetes requiring insulin in pregnancy. A spot uPCR and uACR was performed in each trimester. Pregnancy and fetal outcomes were investigated using linear models and receiver-operating characteristic (ROC) curves. MAIN OUTCOME MEASURES: The primary outcome was preeclampsia (PE). Secondary outcomes investigated were other adverse pregnancy and neonatal outcomes. RESULTS: Increased levels of both uPCR and uACR in trimester 3 were associated with the occurrence of PE (p = 0.007, 0.010 respectively). In the 113 patients with normal pregnancy uPCR (<30 mg/mmol) in trimester 1, microalbuminuria was found to be predictive of PE (p = 0.01) and need for operative delivery (p = 0.03). CONCLUSIONS: In women with pre-existing diabetes, uPCR and uACR appear to have similar ability to diagnose PE, but microalbuminuria demonstrates prognostic ability at a much earlier gestation, prior to the onset of other signs or symptoms of PE. We therefore suggest that assessing microalbuminuria rather than overt proteinuria in trimester 1 provides prognostic information in women with pre-existing diabetes requiring insulin and should be used routinely to evaluate risk of PE in this high-risk cohort of women.

Gastrointestinal symptoms in patients receiving dialysis: A systematic review.

AIM: The aim of the present study was to describe the prevalence of all gastrointestinal (GI) symptoms reported by dialysis patients, as well as the tools being used for diagnosis. GI symptoms are commonly reported in patients having haemodialysis (HD) and peritoneal dialysis (PD), but there are multiple definitions and assessment tools reported in the literature. METHODS: A comprehensive systematic review was undertaken using five databases (Embase, Medline, CINAHL, Psycinfo and Web of Science) between 1996 and 2017. Articles were critically appraised using the Newcastle Ottawa Scale (NOS). Data collected were analyzed in a Microsoft Excel spreadsheet. RESULTS: Thirty studies (24 cross-sectional, six cohort) met the inclusion criteria. In total 5161 patients were studied (3804 HD and 1507 PD). Fifteen studies included HD, five included PD and 10 included both dialysis modalities. GI symptoms were heterogeneous, with the reported prevalence highly dependent on the definitions used, inclusion/exclusion criteria, assessment tools and methods used. The most prevalent symptoms were constipation, indigestion, abdominal pain and reflux. Medication use and dietary data were poorly reported. The most common tools used were Gastrointestinal Symptom Rating Scale (GSRS), Rome II and Rome III. Constipation was more common in HD patients than PD patients. Indigestion, abdominal pain and reflux were commonly reported in both dialysis modalities. CONCLUSIONS: Gastrointestinal symptoms are highly prevalent in people on dialysis; however, the evidence base is limited and further investigation of preventable causes and potential interventions such as medications and diet are required in future research.

Bowel health in chronic kidney disease: Patient perceptions differ from clinical definitions.

BACKGROUND: The bowel health of those with chronic kidney disease (CKD) can be affected by medications, fluid/dietary allowances, reduced activity and pre-existing medical conditions. Patient perceptions of their bowel health can differ from those of health care professionals and the burden of gastrointestinal symptoms could be inaccurately reported. METHODS: Adults with CKD, including those undergoing haemodialysis, peritoneal dialysis and kidney transplant from four South Australian hospitals enrolled in the study. Participants completed a five-item questionnaire, to investigate their perception of bowel health compared with clinical criteria for 'normal and abnormal' bowel health using the Bristol Stool Form Scale, bowel frequency and reported symptoms. RESULTS: A total of 324 individuals completed the questionnaire. Of those with clinically defined 'abnormal' bowel health (n = 180), 50.6% perceived their bowels as 'normal' or 'more normal than abnormal'. Only 6% of this clinically 'abnormal' group perceived their bowel health as abnormal. Of those with clinically defined 'normal' bowel health (n = 144), 16% perceived their bowel health as 'abnormal', 'more abnormal than normal' or 'variable'. Fifty-seven percent of patients with clinically defined 'abnormal' bowel health were not taking any treatments. Peritoneal dialysis recipients were the highest users of treatments to improve bowel function, with 62% using 1 or more treatment. CONCLUSIONS: It is common for patients with CKD to experience signs and symptoms of abnormal bowel health. There is a disconnect between patient perceptions and clinical definitions of normal or abnormal bowel health. Clinical care team members must carefully obtain and clarify patient-reported symptoms related to bowel function in order to help ensure recommendations and use of appropriate treatments.

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals.

BACKGROUND: Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. METHODS: In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. RESULTS: One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. CONCLUSIONS: Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.

Perspectives on pregnancy in women with chronic kidney disease: systematic review of qualitative studies.

BACKGROUND: Achieving parenthood in women with chronic kidney disease (CKD) is challenging due to reduced fertility and the risk of adverse outcomes. We aimed to describe women's perspectives of pregnancy in CKD. METHODS: Electronic databases were searched to April 2014. Studies were synthesized thematically. RESULTS: From 15 studies (n = 257) we identified seven themes. 'Pursuing motherhood' was fulfilling an innate or social desire to have a child. 'Failure to fulfill social norms' of being unable to conceive diminished their self-worth. 'Fear of birth defects' was attributed to the potential side effects of immunosuppression. 'Decisional insecurity and conflict' encompassed uncertainties of prioritizing pregnancy as sacrifices had to be made in family life and work to minimize their risk of complications. Transplant recipients were concerned about the increased likelihood of graft loss. The possibility of genetic transmission of kidney disease influenced decisions about childbearing. 'Withholding emotional investment' was a way of protecting against the devastation of inability to conceive, miscarriage or stillbirth. 'Control and determination' reflected their capacity to choose to accept the risks of pregnancy. Some felt traumatized when their physician unduly warned against pregnancy. 'Exacerbating disease' due to pregnancy was also of concern to women. CONCLUSIONS: For women with CKD, pregnancy decisions can be emotionally complicated by health risks, family burden and the perceived risk of fetal malformation. Proactive counseling, shared decision-making about family planning and managing pregnancy in CKD that addresses patient preferences, and multidisciplinary care involving nephrologists, reproductive and obstetrics specialists, and psychological support may improve management of pregnancy issues in CKD.