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Introduction: Variable transplant-related knowledge may contribute to inequitable access to living donor kidney transplant (LDKT). We compared transplant-related knowledge between African, Caribbean, and Black (ACB) versus White Canadian patients with kidney failure using the Knowledge Assessment of Renal Transplantation (KART) questionnaire. Methods: This was a cross-sectional cohort study. Data were collected from a cross-sectional convenience sample of adults with kidney failure in Toronto. Participants also answered an exploratory question about their distrust in the kidney allocation system. Clinical characteristics were abstracted from medical records. The potential contribution of distrust to differences in transplant knowledge was assessed in mediation analysis. Results: Among 577 participants (mean [SD] age 57 [14] years, 63% male), 25% were ACB, and 43% were White Canadians. 45% of ACB versus 26% of White participants scored in the lowest tertile of the KART score. The relative risk ratio to be in the lowest tertile for ACB compared to White participants was 2.22 (95% confidence interval [CI]: 1.11, 4.43) after multivariable adjustment. About half of the difference in the knowledge score between ACB versus White patients was mediated by distrust in the kidney allocation system. Conclusion: Participants with kidney failure from ACB communities have less transplant-related knowledge compared to White participants. Distrust is potentially contributing to this difference.

Background: As of 2021, more than 6000 children and youth in Canada were living with end-stage kidney disease (ESKD), for which kidney transplantation is considered the preferred treatment by health professionals. Research shows that living donor kidney transplantation (LDKT) has superior allograft and recipient survival compared to deceased donor kidney transplantation (DDKT). However, in a pediatric setting, the choice of LDKT or DDKT is a summative consideration of factors weighed carefully by the patient’s family, health care team, and patient. Decision-making surrounding transplantation may be more complex for racial and ethnic minorities as culturally specific values and beliefs are interwoven within dominant understandings and concepts of health and accepted models of health care. For example, Chinese Canadians have an increased risk of ESKD, yet reduced access to LDKT compared to White patients, despite being the largest visible minority population in Canada. Objective: The objective of this qualitative study is to deepen our understandings of the decision-making process surrounding DDKT versus LDKT among parents of Chinese Canadian pediatric patients with chronic kidney disease (CKD). Design: Qualitative descriptive study design. Setting: The Nephrology Program at The Hospital for Sick Children in Toronto, Canada. Participants: Caregivers of Chinese Canadian patients with CKD, 18 years of age or older, and who spoke English, Cantonese, or Mandarin. Methods: One-on-one, semistructured interviews were conducted virtually, by a member of the research team and were audio-recorded and transcribed verbatim. Thematic analysis was used to explore participants’ shared experience. Results: Seven interviews were conducted with 6 mothers and 1 father of 6 Chinese Canadian pediatric patients with CKD: 4 patients had undergone a kidney transplant, and 2 were not yet listed for transplant. Analysis of data highlighted that cultural influences affected whether parents shared with others about their child’s illness and experience. The cultural understanding that it is inappropriate to burden others contributed to the creation of an isolating experience for participants. Cultural influences also impacted whether parents asked others to be a living donor as participants articulated this would place a physical burden on the living donor (e.g., potential risk to their health) and an emotional burden on the participant as they would be indebted to a willing donor. Ultimately, parents’ decision to choose DDKT or LDKT for their patient-child was a result of evaluating both options carefully and within an understanding that the ideal treatment choice reflected what was best for all family members. Limitations: Findings reflect experiences of a small sample from a single recruitment site which may limit transferability. Conclusions: Parents in this study felt that they had access to the necessary evidence-based information to make an informed decision about the choice of DDKT versus LDKT for their child. Participant narratives described feeling isolated within cultural communities of family and friends and participants’ suggestion of benefiting from increased support may guide future research directions. Practitioners can offer direct and indirect support to families, with recognition of the importance of cultural values and family-centered care on decision-making within families. Opportunities are needed for accessible, virtual social support platforms to increase parental feelings of culturally mediated peer support from parents who share similar experiences.

IntroductionExercise training post-transplant has been shown to improve physical function and quality of life in solid organ transplant (SOT) recipients. Online resources in the form of websites and videos are commonly used to provide education and instruction on exercise and physical activity in SOT; however, the content and quality of these online resources has not been evaluated.MethodsThe first 200 websites and videos identified on Google and YouTube using the English search term “exercise and physical activity in solid organ transplantation” were analyzed. Website and video content was evaluated based on 25 key components of exercise and physical activity in SOT as described in established exercise program recommendations. Website and video quality was determined using DISCERN, Global Quality Scale (GQS), and Patient Education Materials and Assessment Tool (PEMAT; threshold for which material is deemed understandable or actionable is >70%). Parametric and non-parametric tests were used to assess website and video characteristics, content, and quality metrics.ResultsForty-nine unique SOT websites (n = 15) and videos (n = 34) were identified, with the two most common categories being foundation/advocacy organizations and scientific resources. The average reading grade level of websites was 13 ± 3. Website and video content scores varied significantly (websites 11.3 ± 6.4; videos 8.4 ± 5.3). DISCERN total score and GQS score were low (median range for DISCERN 2.5–3.0; median for GQS 2.0 for both websites and videos, out of 5). PEMAT understandability and actionability scores were also low across websites and videos (mean range 57%–67% and 47%–65%, respectively). Foundation/advocacy websites had higher content and quality scores compared to scientific organizations and news/media articles.ConclusionsTo our knowledge, this is the first comprehensive assessment of online content and quality of website and video resources on physical activity and exercise in adult SOT recipients. There were a limited number of online English patient-directed resources related to physical activity in SOT, most of which only partly captured items outlined in consensus exercise program recommendations and were of low quality and understandability and actionability. This work provides important insight to the English-speaking transplant community on the current state of online exercise health information and provides future direction for resource development.

Introduction Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis.Methods and analysis This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach.Ethics and dissemination Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings.Protocol version 4 (16 November 2022).Trial registration number NCT05515991.

Abstract Background Although lithium is considered the gold-standard treatment for bipolar disorder (BD), it is associated with a variety of major endocrine and metabolic side effects, including parathyroid hormone (PTH) dependent hypercalcemia. Aside from surgery and medication discontinuation, there are limited treatments for hypercalcemia. This paper will assess data from a randomized controlled trial (RCT). Methods This is a secondary analysis of an RCT that explored the effects of atorvastatin (n = 27) versus placebo (n = 33) on lithium-induced nephrogenic diabetes insipidus (NDI) in patients with BD and major depressive disorder (MDD) using lithium (n = 60), over a 12-week period. This secondary analysis will explore serum calcium levels and thyroid stimulating hormone (TSH) measured at baseline, week 4, and week 12. Results At 12-weeks follow-up while adjusting results for baseline, linear regression analyses found that corrected serum calcium levels were significantly lower in the treatment group (mean (M) = 2.30 mmol/L, standard deviation (SD) = 0.07) compared to the placebo group (M = 2.33 mmol/L, SD = 0.07) (β = − 0.03 (95% C.I.; − 0.0662, − 0.0035), p = 0.03) for lithium users. There were no significant changes in TSH. Conclusion In lithium users with relatively normal calcium levels, receiving atorvastatin was associated with a decrease in serum calcium levels. Although exciting, this is a preliminary finding that needs further investigation with hypercalcemic patients. Future RCTs could examine whether atorvastatin can treat PTH dependent hypercalcemia due to lithium and other causes.

Introduction Living donor (LD) kidney transplant (KT) is the best treatment option for many patients with kidney failure as it improves quality of life and survival compared with dialysis and deceased donor KT. Unfortunately, LDKT is underused, especially among groups marginalised by race and ethnicity. African, Caribbean and Black (ACB) patients are 60%–70% less likely to receive LDKT in Canada compared with white patients. Research from the USA and the UK suggests that mistrust, cultural and generational norms, access, and affordability may contribute to inequities. To date, no Canadian studies have explored the beliefs and behaviours related to LDKT in ACB communities. Research approaches that use a critical, community-based approach can help illuminate broader structural factors that may shape individual beliefs and behaviours. In this qualitative study, we will investigate barriers to accessing LDKT in ACB communities in the Greater Toronto Area, to enhance our understanding of the perspectives and experiences of ACB community members, both with and without lived experience of chronic kidney disease (CKD).Methods and analysis Hospital-based and community-based recruitment strategies will be used to recruit participants for focus groups and individual interviews. Participants will include self-identified ACB individuals with and without experiences of CKD and nephrology professionals. Collaboration with ACB community partners will facilitate a community-based research approach. Data will be analysed using reflexive thematic analysis and critical race theory. Findings will be revised based on feedback from ACB community partners.Ethics and dissemination This study has been approved by the University Health Network Research Ethics Board UHN REB file #15-9775. Study findings will contribute to the codevelopment of culturally safe and responsive educational materials to raise awareness about CKD and its treatments and to improve equitable access to high-quality kidney care, including LDKT, for ACB patients.

BackgroundLiving donor kidney transplantation (LDKT) is the best treatment option for patients with kidney failure and offers significant medical and economic advantages for both patients and health systems. Despite this, rates of LDKT in Canada have stagnated and vary significantly across Canadian provinces, the reasons for which are not well understood. Our prior work has suggested that system-level factors may be contributing to these differences. Identifying these factors can help inform system-level interventions to increase LDKT. ObjectiveOur objective is to generate a systemic interpretation of LDKT delivery across provincial health systems with variable performance. We aim to identify the attributes and processes that facilitate the delivery of LDKT to patients, and those that create barriers and compare these across systems with variable performance. These objectives are contextualized within our broader goal of increasing rates of LDKT in Canada, particularly in lower-performing provinces. MethodsThis research takes the form of a qualitative comparative case study analysis of 3 provincial health systems in Canada that have high, moderate, and low rates of LDKT performance (the percentage of LDKT to all kidney transplantations performed). Our approach is underpinned by an understanding of health systems as complex adaptive systems that are multilevel and interconnected, and involve nonlinear interactions between people and organizations, operating within a loosely bounded network. Data collection will comprise semistructured interviews, document reviews, and focus groups. Individual case studies will be conducted and analyzed using inductive thematic analysis. Following this, our comparative analysis will operationalize resource-based theory to compare case study data and generate explanations for our research question. ResultsThis project was funded from 2020 to 2023. Individual case studies were carried out between November 2020 and August 2022. The comparative case analysis will begin in December 2022 and is expected to conclude in April 2023. Submission of the publication is projected for June 2023. ConclusionsBy investigating health systems as complex adaptive systems and making comparisons across provinces, this study will identify how health systems can improve the delivery of LDKT to patients with kidney failure. Our resource-based theory framework will provide a granular analysis of the attributes and processes that facilitate or create barriers to LDKT delivery across multiple organizations and levels of practice. Our findings will have practice and policy implications and help inform transferrable competencies and system-level interventions conducive to increasing LDKT. International Registered Report Identifier (IRRID)DERR1-10.2196/44172

Abstract Kidney transplantation with grafts procured after donation-after-cardiac death (DCD) has led to an increase in incidence of delayed graft function (DGF). It is thought that the warm ischemic (WI) insult encountered during DCD procurement is the cause of this finding, although few studies have been designed to definitely demonstrate this causation in a transplantation setting. Here, we use a large animal renal transplantation model to study the effects of prolonged WI during procurement on post-transplantation renal function. Kidneys from 30 kg-Yorkshire pigs were procured following increasing WI times of 0 min (Heart-Beating Donor), 30 min, 60 min, 90 min, and 120 min (n = 3–6 per group) to mimic DCD. Following 8 h of static cold storage and autotransplantation, animals were followed for 7-days. Significant renal dysfunction (SRD), resembling clinical DGF, was defined as the development of oliguria 6.0 mmol/L. Increasing WI times resulted in incremental elevation of post-operative serum creatinine that peaked later. DCD120min grafts had the highest and latest elevation of serum creatinine compared to all groups (POD5: 19.0 ± 1.1 mg/dL, p 500 mL and POD7 serum potassium

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the “clusters”). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the “registry”). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521 ). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Background: Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring. Objective: To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change). Design: A mixed-methods process evaluation informed by new practice implementation and theories of behavior change. Setting: Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021. Participants: Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario’s 27 CKD programs. Methods: We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change. Limitations: The long trial period may result in poor participant recall. Conclusion: This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Context Patients treated with maintenance hemodialysis experience significant symptom burden resulting in impaired quality of life. However, the association of patient reported symptom burden and the risk of healthcare use for patients with end stage kidney disease on hemodialysis has not been fully explored. Objectives To investigate if higher symptom burden, assessed by the Edmonton Symptom Assessment System-revised (ESASr), is associated with increased healthcare use in patients with end stage kidney disease on hemodialysis. Methods Prospective, single-center, study of adult patients on HD. Participants completed the ESASr questionnaire at enrollment. Baseline demographic, clinical information as well as healthcare use events during the 12-month following enrollment were extracted from medical records. The association between symptom burden and healthcare use was examined with a multivariable adjusted negative binomial model. Results Mean (SD) age of the 80 participants was 71 (13) years, 56% diabetic, and 70% male. The median (IQR) dialysis vintage was 2 (1–4) years. In multivariable adjusted models, higher global [incident rate ratio (IRR) 1.02, 95% confidence interval (CI) 1.00–1.04, p = .025] and physical symptom burden score [IRR 1.03, CI 1.00–1.05, p = .034], but not emotional symptom burden score [IRR 1.05, CI 1.00–1.10, p = .052] predicted higher subsequent healthcare use. Conclusions Our preliminary evidence suggests that higher symptom burden, assessed by ESASr may predict higher risk of healthcare use amongst patients with end stage kidney disease on hemodialysis. Future studies need to confirm the findings of this preliminary study and to assess the utility of ESASr for systematic symptom screening.

Background: Depression and anxiety affect approximately 50% of patients with kidney failure receiving hemodialysis and are associated with decreased quality of life and increased risk of hospitalization and mortality. A Brief Mindfulness Intervention (BMI) may be promising in treating depressive and anxiety symptoms in this population, but the long-term sustainability of the intervention’s effects is unknown. Objective: We previously conducted a randomized controlled trial (RCT; n = 55) comparing an 8-week BMI with an active control (Health Enhancement Program [HEP]) for patients receiving dialysis, with depression and/or anxiety. Here, we examine the 6-month follow-up data to determine the long-term sustainability of BMI versus HEP in reducing (1) depressive symptoms, (2) anxiety symptoms, and (3) the efficacy of BMI versus HEP in reducing the likelihood of hospitalization. Design: In this study, we analyzed 6-month follow-up data from an 8-week assessor-blinded parallel RCT, which evaluated the efficacy of a BMI against an active control, HEP, in patients receiving hemodialysis with symptoms of depression and/or anxiety. Setting: The study took place at hemodialysis centers in 4 tertiary-care hospitals in Montreal, Canada. Participants: Participants included adults aged ≥18 years who were receiving in-center hemodialysis 3 times per week and had symptoms of depression and/or anxiety as indicated by a score ≥6 on the Patient Health Questionnaire–9 (PHQ-9) and/or the General Anxiety Disorder–7 (GAD-7). Methods: Participants were randomized to the treatment arm (BMI) or the active control arm (HEP) and completed assessments at baseline, 8 weeks, and 6-month follow-up. Depression was assessed using the PHQ-9, and anxiety was assessed by the GAD-7. Hospitalization rates were assessed using medical chart information. Results: We observed significant decrease in depression scores over 6 months in both BMI and HEP groups, with no significant difference between groups. Anxiety scores significantly decreased over 6 months, but only in the BMI group. Brief Mindfulness Intervention and Health Enhancement Program were comparable in terms of hospitalization rates. Limitations: The limitations of our study include the modest sample size and lack of a third arm such as a waitlist control. Conclusions: Our results suggest that the beneficial effects of BMI and HEP for improving mood disorder symptoms in patients receiving dialysis persist at 6-month follow-up. Both interventions showed sustained effects for depressive symptoms, but BMI may be more useful in this population given its efficacy in reducing anxiety symptoms as well. Trial registration: Prior to recruitment, the trial had been registered (ClinicalTrials.gov Identifier: NCT03406845).

Background. The increased usage of marginal grafts has triggered interest in perfused kidney preservation to minimize graft injury. We used a donation after circulatory death (DCD) porcine kidney autotransplantation model to compare 3 of the most frequently used ex vivo kidney perfusion techniques: nonoxygenated hypothermic machine perfusion (non-oxHMP), oxygenated hypothermic machine perfusion (oxHMP), and normothermic ex vivo kidney perfusion (NEVKP). Methods. Following 30 min of warm ischemia, grafts were retrieved and preserved with either 16 h of non-oxHMP, oxHMP, or NEVKP (n = 5 per group). After contralateral nephrectomy, grafts were autotransplanted and animals were followed for 8 d. Kidney function and injury markers were compared between groups. Results. NEVKP demonstrated a significant reduction in preservation injury compared with either cold preservation method. Grafts preserved by NEVKP showed superior function with lower peak serum creatinine (NEVKP versus non-oxHMP versus oxHMP: 3.66 ± 1.33 mg/dL, 8.82 ± 3.17 mg/dL, and 9.02 ± 5.5 mg/dL) and more rapid recovery. The NEVKP group demonstrated significantly increased creatinine clearance on postoperative day 3 compared with the cold perfused groups. Tubular injury scores on postoperative day 8 were similar in all groups. Conclusions. Addition of oxygen during HMP did not reduce preservation injury of DCD kidney grafts. Grafts preserved with prolonged NEVKP demonstrated superior initial graft function compared with grafts preserved with non-oxHMP or oxHMP in a model of pig DCD kidney transplantation.

Background. Normothermic ex vivo kidney perfusion (NEVKP) has demonstrated superior outcomes for donation-after-cardiovascular death grafts compared with static cold storage (SCS). To determine the mechanisms responsible for this, we performed an unbiased genome-wide microarray analysis. Methods. Kidneys from 30-kg Yorkshire pigs were subjected to 30 min of warm ischemia followed by 8 h of NEVKP or SCS, or no storage, before autotransplantation. mRNA expression was analyzed on renal biopsies on postoperative day 3. Gene set enrichment analysis was performed using hallmark gene sets, Gene Ontology, and pathway analysis. Results. The gene expression profile of NEVKP-stored grafts closely resembled no storage kidneys. Gene set enrichment analysis demonstrated enrichment of fatty acid metabolism and oxidative phosphorylation following NEVKP, whereas SCS-enriched gene sets were related to mitosis, cell cycle checkpoint, and reactive oxygen species (q

An application of telemedicine of growing interest and relevance is the use of personal computers and mobile devices to collect patient-reported outcomes (PROs). PROs are self-reports of patients’ health status without interpretation by anyone else. The tools developed to assess PROs are known as patient-reported outcomes measures (PROMs). The technological innovations that have led to an increased ownership of electronic devices have also facilitated the development of electronic PROMs (ePROMs). ePROMs are a conduit for telemedicine in the care of patients with chronic diseases. Various studies have demonstrated that the use of ePROMs in routine clinical practice is both acceptable and feasible with patients increasingly expressing a preference for an electronic mode of administration. There is increasing evidence that the use of electronic patient-reported outcome (ePROMs) could have significant impacts on outcomes valued by patients, healthcare providers and researchers. Whilst the development and implementation of these systems may be initially costly and resource-intensive, patient preferences and existing evidence to support their implementation suggests the need for continued research prioritisation in this area. This narrative review summarises and discusses evidence of the impact of ePROMs on clinical parameters and outcomes relevant to chronic diseases. We also explore recently published literature regarding issues that may influence the robust implementation of ePROMs for routine clinical practice.

Background: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. Objective: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. Design: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial—the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Setting: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. Participants: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. Intervention: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Primary Outcome: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. Planned Primary Analysis: Study data will be obtained from Ontario’s linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. Limitations: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. Conclusions: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Background: Kidney transplantation (KT), a treatment option for end-stage kidney disease (ESKD), is associated with longer survival and improved quality of life compared with dialysis. Inequities in access to KT, and specifically, living donor kidney transplantation (LDKT), have been documented in Canada along various demographic dimensions. In this article, we review existing evidence about inequitable access and barriers to KT and LDKT for patients from Indigenous communities in Canada. Objective: To characterize the current state of literature on access to KT and LDKT among Indigenous communities in Canada and to answer the research question, “what factors may influence inequitable access to KT among Indigenous communities in Canada.” Eligibility criteria: Databases and gray literature were searched in June and November 2020 for full-text original research articles or gray literature resources addressing KT access or barriers in Indigenous communities in Canada. A total of 26 articles were analyzed thematically. Sources of evidence: Gray literature and CINAHL, OVID Medline, OVID Embase, and Cochrane databases. Charting methods: Literature characteristics were recorded and findings which described rates of and factors that influence access to KT were summarized in a narrative account. Key themes were subsequently identified and synthesized thematically in the review. Results: Indigenous communities in Canada experience various barriers in accessing culturally safe medical information and care, resulting in inequitable access to KT. Barriers include insufficient incorporation of Indigenous ways of knowing and being in information dissemination and care for ESKD and KT, spiritual concerns, health beliefs, logistical hurdles to accessing care, and systemic mistrust resulting from colonialism and systemic racism. Limitations: This review included studies that used various methodologies and did not assess study quality. Data on Indigenous status were not reported or defined in a standardized manner. Indigenous communities are not homogeneous and views on organ donation and KT vary by individual. Conclusions: Our scoping review has identified potential barriers that Indigenous communities may face in accessing KT and LDKT. Further research is urgently needed to better understand barriers and support needs and to develop strategies to improve equitable access to KT and LDKT for Indigenous populations in Canada.

Background: Kidney transplantation (KT), a treatment option for end-stage kidney disease (ESKD), is associated with longer survival and improved quality of life compared with dialysis. Inequities in access to KT, and specifically, living donor kidney transplantation (LDKT), have been documented in Canada, along various demographic dimensions. In this article, we review existing evidence about inequitable access to KT and LDKT for patients from communities marginalized by race and ethnicity in Canada. Objective: To characterize the currently published data on rates of KT and LDKT among East Asian, South Asian, and African, Caribbean, and Black (ACB) Canadian communities and to answer the research question, “what factors may influence inequitable access to KT among East Asian, South Asian, and ACB Canadian communities?.” Eligibility criteria: Databases and gray literature were searched in June and November 2020 for full-text original research articles or gray literature resources addressing KT access or barriers in East Asian, South Asian, and ACB Canadian communities. A total of 25 articles were analyzed thematically. Sources of evidence: Gray literature and CINAHL, OVID Medline, OVID Embase, and Cochrane databases. Charting methods: Literature characteristics were recorded and findings which described rates of and factors that influence access to KT were summarized in a narrative account. Key themes were subsequently identified and synthesized thematically in the review. Results: East Asian, South Asian, and ACB communities in Canada face barriers in accessing culturally appropriate medical knowledge and care and experience inequitable access to KT. Potential barriers include gaps in knowledge about ESKD and KT, religious and spiritual concerns, stigma of ESKD and KT, health beliefs, social determinants of health, and experiences of systemic racism in health care. Limitations: This review included literature that used various methodologies and did not assess study quality. Data on ethnicity and race were not reported or defined in a standardized manner. The communities examined in this review are not homogeneous and views on organ donation and KT vary by individual. Conclusions: Our review has identified potential barriers for communities marginalized by race and ethnicity in accessing KT and LDKT. Further research is urgently needed to better understand the barriers and support needs of these communities, and to develop strategies to improve equitable access to LDKT for the growingly diverse population in Canada.

Background. Normothermic ex vivo kidney perfusion (NEVKP) is an emerging technique for renal graft preservation. We investigated whether NEVKP could improve early function of severely injured grafts and reduce the incidence of significant renal dysfunction (SRD) similar to delayed graft function in a model of donation after circulatory death. Methods. Kidneys from 30-kg Yorkshire pigs were removed following 120 minutes of warm ischemia (WI). These grafts were then preserved in static cold storage (SCS, n = 6) or subjected to NEVKP (n = 5) for 8 hours before heterotopic autotransplantation. SRD was defined as postoperative day (POD) 4 oliguria 6.0 mmol/L. Results. All 4 surviving animals with 120 minutes WI grafts stored with SCS developed SRD, compared with 1/5 in the NEVKP group (P = 0.02). The NEVKP group, when compared with SCS, also demonstrated significantly decreased serum creatinine peak values (1118.51 ± 206.90 µmol/L versus 1675.56 ± 98.15 µmol/L; P = 0.002) and higher creatinine clearance (POD4: 9.05 ± 6.97 mL/min versus 0.89 ± 0.56 mL/min; P = 0.05). By POD7, serum creatinine was not significantly different than baseline in the NEVKP (431.49 ± 492.50 µmol/L versus 90.19 ± 14.15 µmol/L, respectively; P = 0.20) but remained elevated following SCS (1189.25 ± 309.47 µmol/L versus 97.26 ± 29.18 µmol/L, respectively; P < 0.01). Histology demonstrated significantly decreased tubular injury scores compared with SCS grafts (P = 0.03). Conclusions. Kidney grafts subjected to 120 minutes WI before retrieval showed significant improvement in function, prevention of SRD, and decreased injury following 8 hours of NEVKP.

Abstract Background Lithium is the gold-standard treatment for bipolar disorder, is highly effective in treating major depressive disorder, and has anti-suicidal properties. However, clinicians are increasingly avoiding lithium largely due to fears of renal toxicity. Nephrogenic Diabetes Insipidus (NDI) occurs in 15–20% of lithium users and predicts a 2–3 times increased risk of chronic kidney disease (CKD). We recently found that use of statins is associated with lower NDI risk in a cross-sectional study. In this current paper, we describe the methodology of a randomized controlled trial (RCT) to treat lithium-induced NDI using atorvastatin. Methods We will conduct a 12-week, double-blind placebo-controlled RCT of atorvastatin for lithium-induced NDI at McGill University, Montreal, Canada. We will recruit 60 current lithium users, aged 18–85, who have indicators of NDI, which we defined as urine osmolality (UOsm)

Abstract Background Collecting patient reported outcome measures (PROMs) via computer-based electronic data capture system may improve feasibility and facilitate implementation in clinical care. We report our initial experience about the acceptability of touch-screen tablet computer-based, self-administered questionnaires among patients with chronic kidney disease (CKD), including stage 5 CKD treated with renal replacement therapies (RRT) (either dialysis or transplant). Methods We enrolled a convenience sample of patients with stage 4 and 5 CKD (including patients on dialysis or after kidney transplant) in a single-centre, cross-sectional pilot study. Participants completed validated questionnaires programmed on an electronic data capture system (DADOS, Techna Inc., Toronto) on tablet computers. The primary objective was to evaluate the acceptability and feasibility of using tablet-based electronic data capture in patients with CKD. Descriptive statistics, Fischer’s exact test and multivariable logistic regression models were used for data analysis. Results One hundred and twenty one patients (55% male, mean age (± SD) of 58 (±14) years, 49% Caucasian) participated in the study. Ninety-two percent of the respondents indicated that the computer tablet was acceptable and 79% of the participants required no or minimal help for completing the questionnaires. Acceptance of tablets was lower among patients 70 years or older (75% vs. 95%; p = 0.011) and with little previous computer experience (81% vs. 96%; p = 0.05). Furthermore, a greater level of assistance was more frequently required by patients who were older (45% vs. 15%; p = 0.009), had lower level of education (33% vs. 14%; p = 0.027), low health literacy (79% vs. 12%; p = 0.027), and little previous experience with computers (52% vs. 10%; p = 0.027). Conclusions Tablet computer-based electronic data capture to administer PROMs was acceptable and feasible for most respondents and could therefore be used to systematically assess PROMs among patients with CKD. Special consideration should focus on elderly patients with little previous computer experience, since they may require more assistance with completion.

(1) Objective: to determine if a brief mindfulness intervention (BMI) and a health education program (HEP) could improve measures of insomnia in patients undergoing hemodialysis. (2) Methods: this was a planned secondary analysis of a randomized controlled trial of BMI vs. HEP for hemodialysis patients with depression and/or anxiety symptoms. The primary outcome for the analysis was the Athens Insomnia Scale (AIS). The secondary outcome was consolidation of daily inactivity (ConDI), an actigraphy measure that describes sleep continuity and is based on a sleep detection algorithm validated by polysomnography. We also explored whether changes in AIS and ConDI were associated with changes in depression, anxiety, and quality of life scores over 8-week follow-up. (3) Results: BMI and HEP groups did not differ significantly from one another. Exposure to BMI or HEP improved sleep quality (baseline AIS 9.9 (±5.0) vs. 8-week follow-up 6.4 (±3.9), (V = 155.5, p = 0.015)), but not ConDI. Improvements in AIS were associated with lower depression scores (Rho = 0.57, p = 0.01) and higher quality-of-life scores (Rho = 0.46, p = 0.04). (4) Conclusions: mindfulness and HEP may be helpful interventions to improve self-reported sleep quality in patients undergoing hemodialysis. Decreases in insomnia scores were associated with decreased depression symptoms and increased quality of life scores.

Background: Between 20–50% of patients undergoing maintenance dialysis for end-stage kidney disease experience symptoms of depression and/or anxiety, associated with increased mortality, greater health care utilization, and decreased quality of life. It is unknown whether mindfulness-based interventions can improve depression and anxiety symptoms in patients receiving this treatment. Methods: We conducted an 8-week multicenter randomized controlled trial comparing a brief mindfulness intervention (BMI) vs. an active control (Health Enhancement Program [HEP]) in 55 patients receiving dialysis with symptoms of depression and/or anxiety. The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) depression scores, with a primary analysis in participants with baseline PHQ-9 ≥ 10, and a secondary analysis including all participants. The secondary outcome was change in Generalized Anxiety Disorder-7 (GAD-7) anxiety scores with corresponding primary and secondary analyses. Results: Both BMI and HEP reduced depressive symptoms, with no difference between trial arms (PHQ-9 change = −7.0 vs. −6.1, p = 0.62). BMI was more effective than HEP in reducing anxiety (GAD-7 change = −8.7 vs. −1.4, p = 0.01). Secondary analyses revealed no differences between arms. Conclusions: For patients undergoing dialysis, both BMI and HEP may be helpful interventions for depression symptoms, and BMI may be superior to HEP for anxiety symptoms. Mindfulness-based and other psychosocial interventions may be further evaluated in those undergoing dialysis as treatment options for symptoms of depression and anxiety.

Purpose: In this article, we describe a province-wide collaborative project in which we adapted the Explore Transplant (ET) education program for use in Ontario, Canada, to develop Explore Transplant Ontario (ETO). Kidney transplantation (KT), especially living donor kidney transplantation (LDKT), is the best treatment for many patients with end-stage kidney disease (ESKD), with the best patient survival and quality of life and also reduced health care costs. Yet KT and LDKT are underutilized both internationally and in Canada. Research has demonstrated that patients with ESKD who receive personalized transplant education are more likely to complete the transplant evaluation process and to receive LDKT compared with patients who do not receive this education. Sources of information: Research expertise of the lead authors and Medline search of studies assessing the impact of education interventions on access to KT and LDKT. Methods: The ET program, developed by Dr Amy Waterman, has been used in thousands of patients with ESKD in the United States to enhance KT and LDKT knowledge. To adapt this program for use in Ontario, we convened a working group, including patient representatives, nephrologists, transplant coordinators, dialysis nurses, and patient educators from all Ontario KT centers and selected dialysis units. In an iterative process concluding in a consensus workshop, the working group reviewed and edited the text of the original ET program and suggested changes to the videos. Key findings: The adapted program reflects the Ontario health care environment and responds to the specific needs of patients with chronic kidney disease (CKD) in the province. The videos feature Ontario transplant nephrologists, transplant coordinators, and patients, representative of the ethnic diversity in Ontario, sharing their transplant experience and expertise. Despite the changes, ETO is consistent with the quality and style of the original ET program. At the end of this article, we summarize subsequent steps to test and utilize ETO. Those projects, specifically the ETO pilot study and a multicomponent quality improvement initiative to increase utilization of KT and LDKT across Ontario, will be described in full in future papers. Limitations: This article describes a provincial initiative; therefore, our findings may not be fully generalizable without further considerations. The adapted education program has not yet been tested in large trial for effectiveness. Implications: As a program grounded in the theoretical model of behavior change, ETO places patients with ESKD at the center of a complex process of navigating renal replacement therapy modalities and acknowledges a broad range of patient values, priorities, and states of readiness to pursue KT.

Chronic kidney disease (CKD) is a complex medical condition that is associated with several comorbidities and requires comprehensive medical management. Given the chronic nature of the condition, its frequent association with psychosocial distress, and its very significant symptom burden, the subjective patient experience is key toward understanding the true impact of CKD on the patients’ life. Patient-reported outcome measures are important tools that can be used to support patient-centered care and patient engagement during the complex management of patients with CKD. The routine collection and use of patient-reported outcomes (PROs) in clinical practice may improve quality of care and outcomes, and may provide useful data to understand the disease from both an individual and a population perspective. Many tools used to measure PROs focus on assessing health-related quality of life, which is significantly impaired among patients with CKD. Health-related quality of life, in addition to being an important outcome itself, is associated with clinical outcomes such as health care use and mortality. In Part 1 of this review, we provide an overview of PROs and implications of their use in the context of CKD. In Part 2, we will review the selection of appropriate measures and the relevant domains of interest for patients with CKD.