The Symptom Monitoring with Feedback Trial (SWIFT):protocol for a registry‑based cluster randomised controlled trial in haemodialysis

BACKGROUND: Kidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend life with kidney failure. People receiving haemodialysis commonly experience fatigue, pain, nausea, cramping, itching, sleeping difficulties, anxiety and depression. This symptom burden contributes to poor health-related quality of life (QOL) and is a major reason for treatment withdrawal and death. The Symptom monitoring WIth Feedback Trial (SWIFT) will test the hypothesis that regular symptom monitoring with feedback to people receiving haemodialysis and their treating clinical team can improve QOL. METHODS: We are conducting an Australia and New Zealand Dialysis and Transplant (ANZDATA) registry-based cluster randomised controlled trial to determine the clinical- and cost-effectiveness at 12 months, of 3-monthly symptom monitoring using the Integrated Palliative Outcome Scale-Renal (IPOS-Renal) survey with clinician feedback, compared with usual care among adults treated with haemodialysis. Participants complete symptom scoring using a tablet, which are provided to participants and to clinicians. The trial aims to recruit 143 satellite haemodialysis centres, (up to 2400 participants). The primary outcome is change in health-related QOL, as measured by EuroQol 5-Dimension, 5-Level (EQ-5D-5L) instrument. Secondary outcomes include overall survival, symptom severity (including haemodialysis-associated fatigue), healthcare utilisation and cost-effectiveness. DISCUSSION: SWIFT is the first registry-based trial in the Australian haemodialysis population to investigate whether regular symptom monitoring with feedback to participants and clinicians improves QOL. SWIFT is embedded in the ANZDATA Registry facilitating pragmatic recruitment from public and private dialysis clinics, throughout Australia. SWIFT will inform future collection, storage and reporting of patient-reported outcome measures (PROMs) within a clinical quality registry. As the first trial to rigorously estimate the efficacy and cost-effectiveness of routine PROMs collection and reporting in haemodialysis units, SWIFT will provide invaluable information to health services, clinicians and researchers working to improve the lives of those with kidney failure. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001061921. Registered on 16 October 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06355-0

Denosumab-Induced Severe Hypocalcaemia in Chronic Kidney Disease

Background. Hypocalcaemia is increasingly recognized as a complication of denosumab use in Chronic Kidney Disease (CKD) patients with osteoporosis. Despite Therapeutic Goods Administration (TGA) notifications in 2013, we have subsequently encountered several cases of denosumab-induced hypocalcaemia, raising concern about lack of widespread awareness among prescribing practitioners. Aims. We reviewed the morbidity and healthcare intervention needs of CKD patients with hypocalcaemia attributed to denosumab. Methods. A retrospective case series of CKD patients with clinically significant hypocalcaemia after exposure to denosumab, encountered at the tertiary care referral hospital from December 2013 to February 2017, was undertaken. Results. Eight patients (52-85 years of age) with stage 4-5 CKD developed clinically significant hypocalcaemia (corrected calcium 1.45±0.21mmol/L) following denosumab therapy for osteoporosis. Seven of the eight patients required inpatient management with three patients requiring intravenous calcium replacement and cardiac monitoring in a high dependency unit. Our study also identified additional factors that could potentially contribute to hypocalcaemia such as lack of calcium supplementation, use of noncalcium based phosphate binders, absence of or use of lower doses of calcitriol supplementation, low vitamin D levels, concomitant treatment with loop diuretics, history of parathyroidectomy, or presence of acute medical illness. Conclusion. Multiple cases of severe hypocalcaemia in CKD patients following denosumab exposure were encountered after TGA warnings, resulting in considerable morbidity and intensive healthcare interventions in CKD patients. We advocate greater awareness amongst the medical profession, careful consideration before using denosumab in CKD patients, and close follow-up after administration to prevent morbidity

Pregnancy outcomes according to dialysis commencing before or after conception in women with ESRD

BACKGROUND AND OBJECTIVES: Pregnancy in ESRD is rare and poses substantial risk for mother and baby. This study describes a large series of pregnancies in women undergoing long-term dialysis treatment and reviews maternal and fetal outcomes. Specifically, women who had conceived before and after starting long-term dialysis are compared. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT: All pregnancies reported to the Australian and New Zealand Dialysis and Transplantation Registry from 2001 to 2011 (n=77), following the introduction of specific parenthood data collection, were analyzed. RESULTS: Between 2001 and 2011, there were 77 pregnancies among 73 women. Of these, 53 pregnancies were in women who conceived after long-term dialysis was established and 24 pregnancies occurred before dialysis began. The overall live birth rate (after exclusion of elective terminations) was 73%. In pregnancies reaching 20 weeks gestation, the live birth rate was 82%. Women who conceived before dialysis commenced had significantly higher live birth rates (91% versus 63%; P=0.03), but infants had similar birthweight and gestational age. This difference in live birth rate was primarily due to higher rates of early pregnancy loss before 20 weeks in women who conceived after dialysis was established. In pregnancies that reached 20 weeks or more, the live birth rate was higher in women with conception before dialysis commenced (91% versus 76%; P=0.28). Overall, the median gestational age was 33.8 weeks (interquartile range, 30.6-37.6 weeks) and median birthweight was 1750 g (interquartile range, 1130-2417 g). More than 40% of pregnancies reached >34 weeks' gestation; prematurity at <28 weeks was 11.4% and 28-day neonatal survival rate was 98%. CONCLUSIONS: Women with kidney disease who start long-term dialysis after conception have superior live birth rates compared with those already established on dialysis at the time of conception, although these pregnancies remain high risk.Shilpanjali Jesudason, Blair S. Grace, Stephen P. McDonal

The Burden of Travel-Time and Distance Traveled for Hemodialysis Patients in Australian Major City Areas

Research LetterThe number of Australians receiving long-term dialysis for kidney failure is steadily increasing. Of the 13,051 patients undergoing dialysis at the end of 2017 in Australia, over 70% were receiving “facility” hemodialysis, at a hospital or satellite dialysis unit.1 In Australia, the type of dialysis facility is dependent on many complex factors, including patient clinical status and medical indications as well as dialysis capacity constraints and dialysis service structures. Typically, patients receive thrice weekly dialysis for 4 to 5 hours per treatment. In addition to time actually receiving hemodialysis, traveling to and from the treatment location is another physical, social, and financial burden for patients and their families, incurred at a high frequency typically for several years. Travel time and associated costs are a barrier to treatment adherence and access.2,3 Among those receiving hemodialysis, greater travel times have been associated with shortened and missed dialysis treatments, poorer quality of life, and increased mortality risk.3 Despite this, there are no published data on actual travel time or distance for patients receiving hemodialysis services in Australia and little elsewhere. For adults receiving facility-based hemodialysis treatment in a Major City in Australia (Supplementary Figure S1), we estimated travel distance and time from the population centroid of their residential postcode (postal area) to the treatment center (Supplementary Figure S2).Stephen P. McDonald, Shahid Ullah, Kathryn Dansie, Emily Duncanson, Aarti Gulyani, Christopher E. Davies and Shilpanjali Jesudaso

Interventions for improving adherence to dietary salt and fluid restrictions in people with chronic kidney disease (stage 4 and 5)

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. This review aims to look at the benefits and harms of non-pharmacological interventions to improve adherence to dietary salt and fluid restriction in people with CKD (stages 4 and 5)

Maximizing Oral Health Outcomes of Aboriginal and Torres Strait Islander People With End-stage Kidney Disease Through Culturally Secure Partnerships: Protocol for a Mixed Methods Study

BackgroundDialysis for end-stage kidney disease (ESKD) is the leading cause of hospitalization among Aboriginal and Torres Strait Islander individuals in Australia. Poor oral health is commonly the only obstacle preventing Aboriginal and Torres Strait Islander people with ESKD in Australia from receiving kidney transplant. ObjectiveThis study aims to improve access, provision, and delivery of culturally secure dental care for Aboriginal and Torres Strait Islander individuals with ESKD in South Australia through the following objectives: investigate the facilitators of and barriers to providing oral health care to Aboriginal and Torres Strait Islander patients with ESKD in South Australia; investigate the facilitators of and barriers to maintaining oral health among Aboriginal and Torres Strait Islander people with ESKD in South Australia; facilitate access to and completion of culturally secure dental care for Aboriginal and Torres Strait Islander individuals with ESKD and their families; provide oral health promotion training for Aboriginal health workers (AHWs) at each of the participating Aboriginal Community Controlled Health Services, with a specific emphasis on oral health needs of patients with ESKD; generate co-designed strategies to better facilitate access to and provision of culturally secure dental services for Aboriginal and Torres Strait Islander people living with ESKD; and evaluate participant progress and AHW oral health training program. MethodsThis collaborative study is divided into 3 phases: exploratory phase (baseline), intervention phase (baseline), and evaluation phase (after 6 months). The exploratory phase will involve collaboration with stakeholders in different sectors to identify barriers to providing oral health care; the intervention phase will involve patient yarns, patient oral health journey mapping, clinical examinations, culturally secure dental care provision, and strategy implementation workshops; and the evaluation phase will involve 6-month follow-up clinical examinations, participant evaluations of dental care provision, and AHW evaluation of oral health training. ResultsStakeholder interviews were initiated in November 2021, and participant recruitment commenced in February 2022. The first results are expected to be submitted for publication in December 2022. ConclusionsExpected outcomes will identify the burden of oral disease experienced by Aboriginal and Torres Strait Islander people with ESKD in South Australia. Qualitative outcomes are expected to develop a deeper appreciation of the unique challenges regarding oral health for individuals with ESKD. Through stakeholder engagement, responsive strategies and policies will be co-designed to address participant-identified and stakeholder-identified challenges to ensure accessibility to culturally secure dental services for Aboriginal and Torres Strait Islander individuals with ESKD. International Registered Report Identifier (IRRID)PRR1-10.2196/3968

Patient and partner perspectives of pregnancy-related counseling and information needs in women with kidney disease : an Australian national survey

Introduction: The experiences and information needs for reproductive health counseling in women with chronic kidney disease (CKD) are poorly defined, despite the known importance of pregnancy planning in this higher-risk cohort. Methods: Australian adult women with CKD and their partners or family members completed a consumer codesigned survey about experiences of and preferences for pregnancy-related counseling, support, and education. Data were analyzed descriptively and with qualitative content analysis of free-text responses. Results: Responses were received from 102 women (CKD, n = 60; dialysis, n = 11; transplant, n = 26; unsure, n = 5 ) and 17 partners/family members. Pregnancy-related discussions were initiated mostly by women themselves (60.0%) compared to nephrologists (26.7%), and only after conception in 14.7%. Women found pregnancy-related discussions satisfactory (68.0%) and useful (50.7%) but also stressful (66.7%), with only 54.7% feeling in control of decision-making. Information deficits and quality, preformed decisions, clinician-patient disconnect, and burden of decision-making contributed to usefulness and outcomes of pregnancy-related counseling. Women received insufficient information about contraception (not provided in 35.2% of cases), medication safety (40.9%), fetal complications (33.8%) and emotional and psychological impact of pregnancy (73.2%). Women preferred counseling from nephrologists (86.4%), face-to-face settings (79.6%), websites (72.7%), handouts (61.4%), and online support groups (46.6%). High-quality, multiformat information by content experts, peer support, and psychological support were also strongly desired. Conclusion: This study highlights that preconception counseling and information needs of women with CKD are currently not being met. Frameworks and tools to assist patients and clinicians, particularly nephrologists, to initiate and conduct sensitive, useful, and informed shared decision-making (SDM) about pregnancy are urgently needed. © 202

Comparison of catheters or new arteriovenous fistulas for commencement of haemodialysis in pregnant women with chronic kidney disease: an international observational study.

BACKGROUND Evidence surrounding vascular access options for commencing dialysis in pregnancy complicated by chronic kidney disease (CKD) is limited. Creation of new arteriovenous fistulas (AVFs) in pregnant women is rare. METHODS Retrospective cohort study of approaches to vascular access in pregnancy in centres in Australia, the United Kingdom (UK) and Canada (2002-2018). RESULTS Twenty-three women with advanced CKD commenced dialysis in pregnancy (n = 20) or planned to commence (n = 3). Access at dialysis start was a tunnelled catheter (n = 13), temporary catheter (n = 1), AVF created pre-conception but used in pregnancy (n = 3) and AVF created during pregnancy (n = 3). No women commencing dialysis with an AVF required a catheter. No differences in perinatal outcomes were observed comparing AVFs and catheters at dialysis commencement. No AVFs were created in pregnancy in Canadian women. From Australia and the UK, 10 women had a new AVF created in pregnancy, at median gestation 14.5 weeks (IQR 12.5, 20.75). Four women still needed a catheter for dialysis initiation and 3 eventually used the new AVF. Six AVFs were successfully used in pregnancy at median gestation 24 weeks (IQR 22.5, 28.5), 2 were successfully created but not used and 2 had primary failure. No catheter-associated complications were identified except one episode of catheter-related sepsis. CONCLUSIONS Catheter-related complications were minimal. In selected women, with sufficient pre-planning, an AVF can be created and successfully used during pregnancy to minimise catheter use if preferred. Pre-conception counselling in advanced CKD should include discussing vascular access options reflecting local expertise and patient preferences