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Home dialysis modalities (home hemodialysis [HD] and peritoneal dialysis [PD]) are associated with greater patient autonomy and treatment satisfaction compared with in-center modalities, yet the level of home-dialysis use worldwide is low. Reasons for limited utilization are context-dependent, informed by local resources, dialysis costs, access to healthcare, health system policies, provider bias or preferences, cultural beliefs, individual lifestyle concerns, potential care-partner time, and financial burdens. In May 2021, KDIGO (Kidney Disease: Improving Global Outcomes) convened a controversies conference on home dialysis, focusing on how modality choice and distribution are determined and strategies to expand home-dialysis use. Participants recognized that expanding use of home dialysis within a given health system requires alignment of policy, fiscal resources, organizational structure, provider incentives, and accountability. Clinical outcomes across all dialysis modalities are largely similar, but for specific clinical measures, one modality may have advantages over another. Therefore, choice among available modalities is preference-sensitive, with consideration of quality of life, life goals, clinical characteristics, family or care-partner support, and living environment. Ideally, individuals, their care-partners, and their healthcare teams will employ shared decision-making in assessing initial and subsequent kidney failure treatment options. To meet this goal, iterative, high-quality education and support for healthcare professionals, patients, and care-partners are priorities. Everyone who faces dialysis should have access to home therapy. Facilitating universal access to home dialysis and expanding utilization requires alignment of policy considerations and resources at the dialysis-center level, with clear leadership from informed and motivated clinical teams.

Allopurinol should be started at lower doses in patients with chronic kidney disease (CKD) to avoid adverse effects. We examined the risk of severe cutaneous reactions in older adults with CKD who were newly prescribed allopurinol at varied doses.Population-based cohort study using linked health care databases.Patients in Ontario, Canada (2008-2019) aged ≥66 years, with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 mA new prescription for allopurinol100 mg/d versus a dose ≤100 mg/d.The primary outcome was a hospital visit with a severe cutaneous reaction within 180 days of starting allopurinol. Secondary outcomes included all-cause hospitalization and all-cause mortality.The exposure and referent groups were balanced on indicators of baseline health using inverse probability of treatment weighting on the propensity score. Weighted risk ratios (RR) were obtained using modified Poisson regression and weighted risk differences (RD) using binomial regression.Of 47,315 patients (median age, 76 years; median eGFR, 45 mL/min/1.73 mThis study was underpowered to detect risk differences in the association of allopurinol dose with outcomes across eGFR categories (ie, 45-59, 30-44, and 30 mL/min/1.73 mOlder patients with CKD who started allopurinol at100 mg/d versus ≤100 mg/d were twice as likely to visit a hospital with a severe cutaneous reaction in the next 180 days.

Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.MyTEMP was a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomised, superiority trial done at haemodialysis centres in Ontario, Canada. Eligible centres provided maintenance haemodialysis to at least 15 patients a week, and the medical director of each centre had to confirm that their centre would deliver the assigned intervention. Using covariate-constrained randomisation, we allocated 84 centres (1:1) to use either personalised cooler dialysate (nurses set the dialysate temperature 0·5-0·9°C below each patient's measured pre-dialysis body temperature, with a lowest recommended dialysate temperature of 35·5°C), or standard temperature dialysate (36·5°C for all patients and treatments). Patients and health-care providers were not masked to the group assignment; however, the primary outcome was recorded in provincial databases by medical coders who were unaware of the trial or the centres' group assignment. The primary composite outcome was cardiovascular-related death or hospital admission with myocardial infarction, ischaemic stroke, or congestive heart failure during the 4-year trial period. Analysis was by intention to treat. The study is registered at ClinicalTrials.gov, NCT02628366.We assessed all of Ontario's 97 centres for inclusion into the study. Nine centres had less than 15 patients and one director requested that four of their seven centres not participate. 84 centres were recruited and on Feb 1, 2017, these centres were randomly assigned to administer personalised cooler dialysate (42 centres) or standard temperature dialysate (42 centres). The intervention period was from April 3, 2017, to March 31, 2021, and during this time the trial centres provided outpatient maintenance haemodialysis to 15 413 patients (about 4·3 million haemodialysis treatments). The mean dialysate temperature was 35·8°C in the cooler dialysate group and 36·4°C in the standard temperature group. The primary outcome occurred in 1711 (21·4%) of 8000 patients in the cooler dialysate group versus 1658 (22·4%) of 7413 patients in the standard temperature group (adjusted hazard ratio 1·00, 96% CI 0·89 to 1·11; p=0·93). The mean drop in intradialytic systolic blood pressure was 26·6 mm Hg in the cooler dialysate group and 27·1 mm Hg in the standard temperature group (mean difference -0·5 mm Hg, 99% CI -1·4 to 0·4; p=0·14).Centre-wide delivery of personalised cooler dialysate did not significantly reduce the risk of major cardiovascular events compared with standard temperature dialysate. The rising popularity of cooler dialysate is called into question by this study, and the risks and benefits of cooler dialysate in some patient populations should be clarified in future trials.Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ontario Renal Network, Ontario Strategy for Patient-Oriented Research Support Unit, Dialysis Clinic, Inc., ICES (formerly known as the Institute for Clinical Evaluative Sciences), Lawson Health Research Institute, and Western University.

BACKGROUND AND OBJECTIVES: Patients receiving hemodialysis are at high risk from coronavirus disease 2019 (COVID-19) and demonstrate impaired immune responses to vaccines. There have been several descriptions of their immunologic responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, but few studies have described the clinical efficacy of vaccination in patients on hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a multicenter observational study of the London hemodialysis population undergoing surveillance PCR testing during the period of vaccine rollout with BNT162b2 and AZD1222, all of those positive for SARS-CoV-2 were identified. Clinical outcomes were analyzed according to predictor variables, including vaccination status, using a mixed effects logistic regression model. Risk of infection was analyzed in a subgroup of the base population using a Cox proportional hazards model with vaccination status as a time-varying covariate. RESULTS: SARS-CoV-2 infection was identified in 1323 patients of different ethnicities (Asian/other, 30%; Black, 38%; and White, 32%), including 1047 (79%) unvaccinated, 86 (7%) after first-dose vaccination, and 190 (14%) after second-dose vaccination. The majority of patients had a mild course; however, 515 (39%) were hospitalized, and 172 (13%) died. Older age, diabetes, and immune suppression were associated with greater illness severity. In regression models adjusted for age, comorbidity, and time period, prior two-dose vaccination was associated with a 75% (95% confidence interval, 56 to 86) lower risk of admission and 88% (95% confidence interval, 70 to 95) fewer deaths compared with unvaccinated patients. No loss of protection was seen in patients over 65 years or with increasing time since vaccination, and no difference was seen between vaccine types. CONCLUSIONS: These data demonstrate a substantially lower risk of severe COVID-19 after vaccination in patients on dialysis who become infected with SARS-CoV-2.

The Ontario Renal Network (ORN), a provincial government agency in Ontario, Canada, launched an initiative in 2012 to increase home dialysis use province-wide. The initiative included a new modality-based funding formula, a standard mandatory informatics system, targets for prevalent home dialysis rates, the development of a ‘network’ of renal programmes with commitment to home dialysis and a culture of accountability with frequent meetings between ORN and each renal programme leadership to review their results. It also included funding of home dialysis coordinators, encouragement and funding of assisted peritoneal dialysis (PD), and support for catheter insertion and urgent start PD. Between 2012 and 2017, home dialysis use rose from 21.9% to 26.5% and then between 2017 and 2019 stabilised at 26% to 26.5%. Over 7 years, the absolute number of people on home dialysis increased 40% from 2222 to 3105, while the number on facility haemodialysis grew 11% from 7935 to 8767. PD prevalence rose from 16.6% to 20.9%, a relative increase of 25%. The initiative showed that a sustained multifaceted approach can increase home dialysis utilisation.

CONTEXTE: Les patients sous dialyse a long terme pourraient avoir un risque accru d’infection par le coronavirus du syndrome respiratoire aigu severe 2 (SRAS-CoV-2), et de maladie et de mortalite associees. Nous avons voulu decrire l’incidence, les facteurs de risque et les issues de l’infection chez ces patients en Ontario (Canada). METHODES: Nous avons utilise des ensembles de donnees reliees pour comparer les caracteristiques de la maladie et la mortalite chez les patients sous dialyse a long terme en Ontario qui ont teste positif pour le SRAS-CoV-2 et ceux qui n’ont pas developpe d’infection, entre le 12 mars et le 20 aout 2020. Nous avons recueilli des donnees sur l’infection par le SRAS-CoV-2 de maniere prospective. Nous avons evalue les facteurs de risque d’infection et de mortalite par des analyses de regression logistique multivariees. RESULTATS: Pendant la periode a l’etude, 187 patients dialyses sur 12 501 (1,5 %) ont recu un diagnostic d’infection par le SRAS-CoV-2. Parmi eux, 117 (62,6 %) ont ete hospitalises, et le taux de mortalite etait de 28,3 %. Les facteurs predictifs significatifs associes a l’infection incluaient l’hemodialyse dans un centre plutot que la dialyse a domicile (rapport de cotes [RC] 2,54; intervalle de confiance [IC] a 95 % 1,59–4,05), le fait de vivre dans un etablissement de soins de longue duree (RC 7,67; IC a 95 % 5,30–11,11), le fait d’habiter la region du Grand Toronto (RC 3,27; IC a 95 % 2,21–4,80), les ethnicites Noire (RC 3,05; IC a 95 % 1,95–4,77), du sous-continent indien (RC 1,70; IC a 95 % 1,02–2,81) et autres non blanches (RC 2,03; IC a 95 % 1,38–2,97) et les quintiles de revenu inferieurs (RC 1,82; IC a 95 % 1,15–2,89). INTERPRETATION: Les patients sous dialyse a long terme sont exposes a un risque accru d’infection par le SRAS-CoV-2 et de mortalite due a la maladie a coronavirus 2019. Il faudra travailler a eliminer les facteurs de risque d’infection et vacciner ces patients en priorite.

BACKGROUND: Patients undergoing long-term dialysis may be at higher risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and of associated disease and mortality. We aimed to describe the incidence, risk factors and outcomes for infection in these patients in Ontario, Canada. METHODS: We used linked data sets to compare disease characteristics and mortality between patients receiving long-term dialysis in Ontario who were diagnosed SARS-CoV-2 positive and those who did not acquire SARS-CoV-2 infection, between Mar. 12 and Aug. 20, 2020. We collected data on SARS-CoV-2 infection prospectively. We evaluated risk factors for infection and death using multivariable logistic regression analyses. RESULTS: During the study period, 187 (1.5%) of 12 501 patients undergoing dialysis were diagnosed with SARS-CoV-2 infection. Of those with SARS-CoV-2 infection, 117 (62.6%) were admitted to hospital and the case fatality rate was 28.3%. Significant predictors of infection included in-centre hemodialysis versus home dialysis (odds ratio [OR] 2.54, 95% confidence interval [CI] 1.59–4.05), living in a long-term care residence (OR 7.67, 95% CI 5.30–11.11), living in the Greater Toronto Area (OR 3.27, 95% CI 2.21–4.80), Black ethnicity (OR 3.05, 95% CI 1.95–4.77), Indian subcontinent ethnicity (OR 1.70, 95% CI 1.02–2.81), other non-White ethnicities (OR 2.03, 95% CI 1.38–2.97) and lower income quintiles (OR 1.82, 95% CI 1.15–2.89). INTERPRETATION: Patients undergoing long-term dialysis are at increased risk of SARS-CoV-2 infection and death from coronavirus disease 2019. Special attention should be paid to addressing risk factors for infection, and these patients should be prioritized for vaccination.

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.To prespecify the statistical analysis plan for the EnAKT LKD trial.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").Twenty-six CKD programs in Ontario, Canada.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.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.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.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.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.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).Version 1.0 August 26, 2022.EnAKT LKD est une intervention d’amélioration de la qualité visant à améliorer l’accès à la transplantation rénale et au don vivant de rein. Nous avons mené un essai clinique randomisé par grappes afin d’évaluer l’effet de l’intervention, par rapport aux soins habituels, sur le taux d’étapes clés réalisées dans le processus de réception d’une greffe de rein.Exposer les grandes lignes du plan d’analyse statistique de l’essai EAKT LKD.EAKT LKD est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. La randomisation a été réalisée au niveau des programmes d’insuffisance rénale chronique (IRC) (les « grappes »).26 programmes d’IRC en Ontario (Canada).Plus de 10 000 patients atteints d’IRC de stade avancé (des patients approchant le besoin de dialyse ou recevant une hémodialyse d’entretien) sans contre-indication documentée à la greffe rénale.Les données de l’essai (y compris les caractéristiques et les résultats des patients) seront obtenues à partir de bases de données administratives en santé (le « registre »). La randomisation stratifiée avec contraintes de covariables a servi à répartir les 26 programmes d’IRC (1:1) selon qu’ils allaient fournir l’intervention ou les soins habituels entre le 1er novembre 2017 et le 31 décembre 2021 (4,17 ans). Les programmes d’IRC du bras d’intervention ont eu droit au soutien suivant: (1) des équipes locales d’amélioration de la qualité et du soutien administratif; (2) de l’information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien de la part de receveurs et de donneurs vivants; et (4) des rapports sur le rendement au niveau du programme et une surveillance assurée par les chefs de programme.Le principal critère d’évaluation est le taux d’étapes clés accomplies vers la réception d’une greffe de rein, où jusqu’à quatre étapes uniques par patient seront comptabilisées: (1) le patient est aiguillé vers un centre de transplantation pour évaluation; (2) un possible donneur vivant de rein contacte un centre de transplantation pour un receveur en particulier et amorce son évaluation; (3) le patient est ajouté à la liste d’attente pour une transplantation d’un donneur décédé, et (4) le patient reçoit une greffe de rein d’un donneur vivant ou décédé.Selon une approche fondée sur l’intention de traiter, le critère d’évaluation principal sera analysé au niveau du patient en utilisant un modèle multiétats contraint, corrigé dans les programmes d’IRC en fonction du regroupement.L’essai EnAKT LKD s’est tenu du 1er novembre 2017 au 31 décembre 2021. Nous analyserons les résultats et en rendrons compte dès que les données seront disponibles dans les bases de données administratives couplées du système de santé.

Canada is a federation of ten provinces and three territories, and health care is primarily a provincial responsibility. The provinces, therefore, have substantial autonomy in health care delivery but are required to follow the basic tenets of the 1967 Canada Health Act as a condition for receiving essential health care transfer payments from the federal government. These conditions include the key requirement that all essential medical services have a single public payer, and therefore, no private insurance systems are allowed to fund such services. Therefore, neither dialysis providers nor physicians can directly charge patients for dialysis care, and conversely, patients cannot pay extra to see a particular nephrologist or attend a particular dialysis unit. This is uniquely restrictive compared with other countries (1). Health care funds come from provincial tax revenues and from federal transfer payments. Exclusively public funding does not exclude private provision of health care, and indeed, most Canadian physicians are self-employed and reimbursed “fee for service” by provincial governments. Hospital care is delivered by “not for profit” hospitals that are nominally independent, but they are funded by the provincial ministries of health (1). The delivery of maintenance dialysis services described here will be primarily on the basis of the model used in Ontario, the most populous province with 40% of the entire population. Key points of difference from other provinces will be noted however. Maintenance dialysis is almost entirely provided by Renal Programs based in “not for profit” government-funded hospitals. These range from large academic centers associated with medical schools to modest-sized community hospitals. These Renal Programs typically provide in-center hemodialysis (HD), home peritoneal dialysis (PD), and often, home hemodialysis (HHD) as well as outpatient and inpatient nephrology. Most academic Renal Programs have an associated kidney transplant unit. Many of the Renal Programs operate in …

BACKGROUND: Vaccination studies in the hemodialysis population have demonstrated decreased antibody response compared with healthy controls, but vaccine effectiveness for preventing SARS-CoV-2 infection and severe disease is undetermined. METHODS: We conducted a retrospective cohort study in the province of Ontario, Canada, between December 21, 2020, and June 30, 2021. Receipt of vaccine, SARS-CoV-2 infection, and related severe outcomes (hospitalization or death) were determined from provincial health administrative data. Receipt of one and two doses of vaccine were modeled in a time-varying cause-specific Cox proportional hazards model, adjusting for baseline characteristics, background community infection rates, and censoring for non-COVID death, recovered kidney function, transfer out of province, solid organ transplant, and withdrawal from dialysis. RESULTS: Among 13,759 individuals receiving maintenance dialysis, 2403 (17%) were unvaccinated and 11,356 (83%) had received at least one dose by June 30, 2021. Vaccine types were BNT162b2 (n=8455, 74%) and mRNA-1273 (n=2901, 26%); median time between the first and second dose was 36 days (IQR 28–51). The adjusted hazard ratio (HR) for SARS-CoV-2 infection and severe outcomes for one dose compared with unvaccinated was 0.59 (95% CI, 0.46 to 0.76) and 0.54 (95% CI, 0.37 to 0.77), respectively, and for two doses compared with unvaccinated was 0.31 (95% CI, 0.22 to 0.42) and 0.17 (95% CI, 0.1 to 0.3), respectively. There were no significant differences in vaccine effectiveness among age groups, dialysis modality, or vaccine type. CONCLUSIONS: COVID-19 vaccination is effective in the dialysis population to prevent SARS-CoV-2 infection and severe outcomes, despite concerns about suboptimal antibody responses.

At least 23 case reports link the muscle relaxant baclofen to encephalopathy in patients receiving dialysis. To explore this issue, we conducted a study to quantify the risk of encephalopathy from baclofen in patients receiving dialysis. Linked healthcare databases were used to conduct a population-based cohort study of older adults receiving maintenance dialysis in Ontario, Canada (1997-2018) to compare new users of baclofen to non-users. The primary outcome was the 30-day risk of hospitalization with encephalopathy, defined as a main diagnosis of delirium, disorientation, transient alteration of awareness, or transient cerebral ischemic attack. Inverse probability of treatment weighting on the propensity score was used to balance comparison groups on indicators of baseline health. Weighted risk ratios (RR) were obtained using modified Poisson regression and weighted risk differences (RD) using binomial regression. We studied 360 new baclofen users and 6109 non-users (2638 [41%] women; median age 75). The median baclofen dose was 20 mg/day. Hospitalization with encephalopathy occurred in 26 of 360 baclofen users (7.2%) and in under six of 6109 non-users (under 0.1%); weighted risk ratios, 78.3 (95% confidence interval 27.9 to 219.2); weighted risk differences, 7.1% (4.5% to 9.8%). The median time from baclofen dispensing to hospitalization with encephalopathy was three days. Among patients receiving dialysis, approximately one in 14 were hospitalized with encephalopathy shortly after starting baclofen. Thus, baclofen should be avoided in older adults receiving dialysis, and other muscle relaxants considered in its place. Hence, if baclofen must be used, a low dose should be prescribed, and older adults should be carefully monitored for signs of encephalopathy.

Background and objectives The Edmonton Symptom Assessment System Revised: Renal is a patient-reported outcome measure used to assess physical and psychosocial symptom burden in patients treated with maintenance dialysis. Studies of patient-reported outcome measures suggest the need for deeper understanding of how to optimize their implementation and use. This study examines patient and provider perspectives of the implementation process and the influence of the Edmonton Symptom Assessment System Revised: Renal on symptom management, patient-provider communication, and interdisciplinary communication. Design, setting, participants, & measurements Eight in-facility hemodialysis programs in Ontario, Canada, assessed patients using the Edmonton Symptom Assessment System Revised: Renal every 4–6 weeks for 1 year. Screening and completion rates were tracked, and pre- and postimplementation surveys and midimplementation interviews were conducted with patients and providers. A chart audit was conducted 12 months postimplementation. Results In total, 1459 patients completed the Edmonton Symptom Assessment System Revised: Renal; 58% of eligible patients completed the preimplementation survey (n=718), and 56% of patients who completed the Edmonton Symptom Assessment System Revised: Renal at least once completed the postimplementation survey (n=569). Provider survey response rates were 71% (n=514) and 54% (n=319), respectively. Nine patients/caregivers from three sites and 48 providers from all sites participated in interviews. A total of 1207 charts were audited. Seven of eight sites had mean screening rates over 80%, suggesting that routine use of the Edmonton Symptom Assessment System Revised: Renal in clinical practice is feasible. However, the multiple data sources painted an inconsistent picture of the value and effect of the Edmonton Symptom Assessment System Revised: Renal. The Edmonton Symptom Assessment System Revised: Renal standardized symptom screening processes across providers and sites; improved patient and provider symptom awareness, particularly for psychosocial symptoms; and empowered patients to raise issues with providers. Yet, there was little, if any, statistically significant improvement in the metrics used to assess symptom management, patient-provider communication, and interdisciplinary communication. Conclusions The Edmonton Symptom Assessment System Revised: Renal patient-reported outcome measure may be useful to standardize symptom screening, enhance awareness of psychosocial symptoms among patients and providers, and empower patients rather than to reduce symptom burden.

Prevention and early detection of kidney diseases in adults and children should be a priority for any government health department. This is particularly pertinent in the low-middle-income countries, mostly in Asia, Africa, Latin America, and the Caribbean, where up to 7 million people die because of lack of end-stage kidney disease treatment. The nephrology workforce (nurses, technicians, and doctors) is limited in these countries and expanding the size and expertise of the workforce is essential to permit expansion of treatment for both chronic kidney disease and end-stage kidney disease. To achieve this will require sustained action and commitment from governments, academic medical centers, local nephrology societies, and the international nephrology community.

A key component of treatment for all people with advanced kidney disease is supportive care, which aims to improve quality of life and can be provided alongside therapies intended to prolong life, such as dialysis. This article addresses the key considerations of supportive care as part of integrated end-stage kidney disease care, with particular attention paid to programs in low- and middle-income countries. Supportive care should be an integrated component of care for patients with advanced chronic kidney disease, patients receiving kidney replacement therapy (KRT), and patients receiving non-KRT conservative care. Five themes are identified: improving information on prognosis and support, developing context-specific evidence, establishing appropriate metrics for monitoring care, clearly communicating the role of supportive care, and integrating supportive care into existing health care infrastructures. This report explores some general aspects of these 5 domains, before exploring their consequences in 4 health care situations/settings: in people approaching end-stage kidney disease in high-income countries and in low- and middle-income countries, and in people discontinuing KRT in high-income countries and in low- and middle-income countries.

Person-centered care has become a dominant paradigm in modern health care. It needs to be applied to people with end-stage kidney disease considering the initiation of dialysis and to peritoneal dialysis (PD) prescription and care delivery. It is relevant to their decisions about goals of care, transplantation, palliative care, and discontinuation of dialysis. It is also relevant to decisions about how PD is delivered, including options such as incremental PD. Shared decision-making is the essence of this process and needs to become a standard principle of care. It requires engagement, education, and empowerment of patients. Patient-reported outcomes and patient-reported experience are also central to person-centered care in PD.

The terrible effect of coronavirus disease 2019 (COVID-19) on people on maintenance dialysis is now well recognized. The case fatality rate of 20%–30% combined with the exposure risk, particularly for those on hemodialysis (HD), has led to a high overall death rate ([1][1],[2][2]). In Ontario

In-center hemodialysis (HD) patients face greater communicable disease risks, including drug-resistant bacterial colonization and viral hepatitis, compared with home dialysis patients, who limit these risks, avoiding three-times weekly travel to dialysis clinics for treatments ([1][1],[2][2]).

Background Severely ill people with COVID-19 are at risk of acute kidney injury treated with renal replacement therapy (AKI-RRT). Understanding of risk factors and outcomes for AKI-RRT is incomplete. Methods We prospectively collected data on the incidence, demographics, area of residence, time course, outcomes, and associated risk factors for all COVID-19 AKI-RRT cases during the first 2 waves of the pandemic in Ontario, Canada Results There were 271 people with AKI-RRT, representing 0.1% of all diagnosed SARS-CoV-2 cases. These included 10% of SARS-CoV-2 admissions to intensive care units (ICU). Median age was 65 years, with 11% under 50, 76% were male, 47% non-white, and 48% had diabetes. Overall, 59% resided in the quintile of Ontario neighborhoods with the greatest ethnocultural composition and 51% in the 2 lowest income quintile neighborhoods. Mortality was 58% at 30 days after RRT initiation, and 64% at 90 days. By 90 days, 20% of survivors remained RRT-dependent and 31% were still hospitalized. On multivariable analysis, people aged over 70 had higher mortality (odds ratio (OR) 2.4, 95% CI: 1.3, 4.6). Cases from the second versus the first COVID-19 wave were older, had more baseline co-morbidity, and were more likely to initiate RRT over 2 weeks after SARS-CoV-2 diagnosis (34% vs 14%, p, Graphical Abstract Graphical Abstract

Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster").The objective is to outline the statistical analysis plan for the MyTEMP trial.MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial.A total of 84 dialysis centers in Ontario, Canada.Approximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers during the trial period (April 3, 2017, to March 1, 2021, with a maximum follow-up to March 31, 2021).Patient identification, baseline characteristics, and study outcomes will be obtained primarily through Ontario administrative health care databases held at ICES. Covariate-constrained randomization was used to allocate the 84 dialysis centers (1:1) to the intervention group or the control group. Centers in the intervention group used a personalized, temperature-reduced dialysate protocol, and centers in the control group used a fixed dialysate temperature of 36.5°C.The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization (defined as a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in administrative health care databases. The key secondary outcome is the mean drop in intradialytic systolic blood pressure, defined as the patients' predialysis systolic blood pressure minus their nadir systolic blood pressure during the dialysis treatment. Anonymized data on patients' predialysis and intradialytic systolic blood pressure were collected at monthly intervals from each dialysis center.The primary analysis will follow an intent-to-treat approach. The primary outcome will be analyzed at the patient level as the hazard ratio of time-to-first event, estimated from a subdistribution hazards model. Within-center correlation will be accounted for using a robust sandwich estimator. In the primary analysis, patients' observation time will end if they experience the primary outcome, emigrate from Ontario, or die of a noncardiovascular cause (which will be treated as a competing risk event). The between-group difference in the mean drop in intradialytic systolic blood pressure obtained during the dialysis sessions throughout the trial period will be analyzed at the center level using an unadjusted random-effects linear mixed model.The MyTEMP trial period is April 3, 2017, to March 31, 2021. We expect to analyze and report results by 2023 once the updated data are available at ICES.MyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366).Version 1.1 June 15, 2021.L’essai MyTEMP (Exposer les grandes lignes du plan d’analyse statistique de l’essai MyTEMP.MyTEMP est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes.L’essai est mené dans 84 centres de dialyse en Ontario (Canada).On estime qu’environ 13 500 patients auront reçu des soins d’hémodialyse dans les 84 centres de dialyse participants au cours de la période de l’essai (3 avril 2017 au 1er mars 2021; suivi maximal jusqu’au 31 mars 2021).Les résultats et les données concernant l’identification des patients et leurs caractéristiques initiales seront principalement tirés des bases de données administratives du système de santé ontarien tenues par l’ICES. Une répartition aléatoire restreinte par les covariables a été employée pour classer les 84 centres de dialyse (1:1) dans le groupe d’intervention ou le groupe témoin. Le groupe d’intervention a utilisé un protocole personnalisé de dialysat à température réduite et le groupe témoin un dialysat à température fixe (36,5 °C).Le principal critère d’évaluation est la combinaison d’un décès d’origine cardiovasculaire ou d’une hospitalisation majeure liée à la santé cardiovasculaire (définie comme une hospitalisation pour un infarctus du myocarde, une insuffisance cardiaque congestive ou un AVC ischémique) enregistrée dans les bases de données administratives du système de santé. Le principal critère d’évaluation secondaire est la baisse moyenne de la tension artérielle systolique intradialytique, laquelle est définie comme la tension artérielle systolique du patient avant la dialyse moins la tension artérielle systolique minimale pendant la dialyse. Les données anonymisées sur la tension artérielle systolique initiale et la tension artérielle systolique intradialytique des patients ont été colligées à intervalles mensuels dans chaque centre de dialyse.L’analyse primaire adoptera une approche fondée sur l’intention de traiter. Le principal critère d’évaluation sera analysé au niveau du patient comme le risque relatif de survenue d’un premier événement, estimé à partir d’un modèle de risques de sous-distribution. La corrélation intracentre sera prise en compte à l’aide d’un robuste estimateur sandwich. Dans l’analyse primaire, le temps d’observation des patients prendra fin s’ils présentent le principal critère d’évaluation, s’ils déménagent hors de l’Ontario ou s’ils décèdent d’une cause non cardiovasculaire (qui sera traitée comme un événement à risque concurrentiel). La différence entre les groupes quant à la baisse moyenne de la tension artérielle systolique intradialytique, obtenue pendant les séances de dialyse tout au long de l’essai, sera analysée au niveau du centre avec un modèle linéaire mixte à effets aléatoires non corrigé.L’essai MyTEMP couvre la période du 3 avril 2017 au 31 mars 2021. Nous comptons analyser et rendre compte des résultats d’ici 2023, dès que les données mises à jour seront disponibles à l’ICES.MyTEMP est enregistré auprès du National Institute of Health des États-Unis sur clincaltrials.gov (NCT02628366).

Background How and where to initiate dialysis are policy challenges with enormous economic and health consequences. Initiating with home hemodialysis (HD) or peritoneal dialysis (PD) may reduce costs and improve outcomes but evidence is conflicting. Methods We conducted a population-based study in patients aged ≥ 18 years who initiated chronic dialysis in the province of Ontario, Canada from 2006 to 2014 ( N = 12,691) using linked administrative data. Patients were grouped by initial modality: facility HD, facility short daily or slow nocturnal (SD/SN) HD, PD, home HD. We estimated publicly-paid healthcare costs (2015 Canadian dollars; 1 = 0.947 US dollar) and survival, from dialysis initiation to March 2015. Results By 5 years after dialysis initiation, mean 30-day costs (as-treated) for patients receiving PD and home HD were 50% and 64% lower, respectively, than for facility HD patients ($11,011). Approximately 50% of costs were unrelated to dialysis, reflecting high comorbidity in these patients. With covariate adjustment, mean 5-year cumulative costs were similar for initiators of home HD and PD ($304,178 and $349,338) and higher for facility HD initiators ($410,981). The highest 5-year unadjusted survival was for home HD patients (80%), followed by PD (52%), SD/SN HD (50%), and facility HD (42%). Conclusions This study in a large cohort over 9 years provides new population-based evidence suggesting that initiating dialysis at home is cost-effective, with lower costs and better survival, than starting with facility HD. Survival differences persisted after adjustment for baseline characteristics but we could not adjust for functional status or severity of comorbidities.

Rationale & Objective Clinical practice guidelines discourage the use of central venous catheters (CVCs) for vascular access in dialysis. However, some patients have inadequate vessels for arteriovenous fistula creation or choose to use a dialysis catheter. The risks associated with CVC use and their relationship to patient age are poorly characterized. Study Design Observational retrospective cohort study. Setting & Participants Cohort of 1,041 patients older than 18 years from 5 Canadian dialysis programs who initiated outpatient maintenance hemodialysis therapy with a tunneled CVC between 2004 and 2012 and who had no creation of an arteriovenous fistula or arteriovenous graft. Exposures Age, sex, body size, initiating dialysis therapy in the hospital, and comorbid conditions. Outcomes CVC-related procedures, hospitalization, and death. Analytical Approach Complications were reported as a cumulative risk at 1 and 2 years. Cox proportional hazards regression for recurrent events was used to evaluate risk factors for study outcomes. Results At 1 year, risks for CVC-related bacteremia, malfunction, and central stenosis were 9%, 15%, and 2%, respectively. Risks for any CVC-related complication at 1 and 2 years were 30% and 38%, respectively. Death related to CVC complications occurred in 6 of 1,041 (0.5%) patients. Compared with patients younger than 60 years, patients aged 70 to 79 and those 80 years or older experienced lower rates of CVC complications: HRs of 0.67 (95% CI, 0.52-0.85; P = 0.001) and 0.69 (95% CI, 0.52-0.92; P = 0.01), respectively. Limitations This Canadian dialysis population may not be representative of populations in other countries. CVC use was not compared with other types of hemodialysis vascular access. Conclusions Approximately one-third of hemodialysis patients who used tunneled CVCs during 1 to 2 years experienced complications. Bacteremia occurred in ∼9% of patients at 1 year and were the most common cause of CVC-related hospitalizations. CVC-related death was infrequent. This information could be used to communicate the risk for CVC complications to patients treated with this type of hemodialysis vascular access.

Gabapentinoids are opioid substitutes whose elimination by the kidneys is reduced as kidney function declines. To inform their safe prescribing in older adults with chronic kidney disease (CKD), we examined the 30-day risk of serious adverse events according to the prescribed starting dose.Population-based cohort study.74,084 older adults (64% women; median age, 79 [interquartile range, 73-85] years) with CKD (defined for this study as an estimated glomerular filtration rate 60 mL/min/1.73 mHigher-dose gabapentinoids (gabapentin300 mg/d or pregabalin75 mg/d) versus lower-dose gabapentinoids (gabapentin ≤300 mg/d or pregabalin ≤75 mg/d).The primary composite outcome was the 30-day risk of a hospital visit with encephalopathy, a fall, or a fracture or a hospitalization with respiratory depression.Comparison groups were balanced on indicators of baseline health using inverse probability of treatment weighting using propensity score analysis that generated a pseudosample for the reference group with a distribution of measured covariates similar to the exposed group. Weighted risk ratios were estimated using modified Poisson regression, and weighted risk differences were estimated using binomial regression. Prespecified subgroup analyses were conducted by estimated glomerular filtration rate category and type of gabapentinoid.Among 74,084 patients identified with CKD and a new prescription for gabapentin or pregabalin, 41% started at300 or75 mg/d, respectively. From this set of patients, a weighted study population with a size of 61,367 was generated. Patients who started at a higher dose had a higher 30-day risk of the primary outcome than patients who started at lower dose. Within the weighted population, the numbers of events for higher versus lower dose were 585 of 30,660 (1.9%) versus 462 of 30,707 (1.5%), respectively. The weighted risk ratio was 1.27 (95% CI, 1.13-1.42), and the weighted risk difference was 0.40% (95% CI, 0.21%-0.60%). In subgroup analyses, neither multiplicative nor additive interactions were statistically significant.Residual confounding.In this population-based study, starting a gabapentinoid at a higher versus a lower dose was associated with a slightly higher risk of a hospital visit with encephalopathy, a fall, or a fracture or hospitalization with respiratory depression. If verified, these risks should be balanced against the benefits of using a higher-dose gabapentinoid.

Introduction: Patients with advanced Chronic Kidney Disease (CKD) have complex health needs, and thus require care that is coordinated across professionals and organizations. This study aimed to describe the extent of coordinated care delivery for patients with advanced CKD from the perspectives of both patients and healthcare professionals. Methods: The Coordination Scale of the Patient Assessment of Chronic Illness Care (PACIC-26) survey was administered to a random sample of 14,257 patients on maintenance dialysis or receiving care in end-stage kidney disease preparation clinics in Ontario, Canada. A five-item survey was administered to 596 multidisciplinary nephrology professionals. Results: Among the 1,925 patient respondents, 67% reported they had been referred to an allied health professional; 19% had been encouraged to attend programs in the community; and 34% had been told how their visits with other types of doctors helped their treatment (% reporting “always” or “most of the time”). Patient responses were significantly different by treatment modality/setting, but not by gender or geographic location of treatment facility. Among the 276 professional respondents, 37% reported their patients’ care was well-coordinated across settings; 56% reported participating in interdisciplinary care planning discussions; and 53% reported they are aware of appropriate home and community services to support their patients (% reporting “always” or “most of the time”). Conclusion: The results suggest that care for patients with advanced CKD in Ontario is not consistently coordinated. Healthcare professionals may enhance patient perceptions of coordinated care through explicit communication with patients about how the professionals they see and treatments or services they receive influence their overall health and well-being. At a systems level, there is a need to improve professional awareness of and linkages to home- and community-based services.

Background: People receiving in-center hemodialysis face a high risk for contracting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experience poor outcomes. During the first wave of the coronavirus disease 2019 (COVID-19) pandemic in Ontario (between March and June 2020), it was unclear whether asymptomatic or presymptomatic cases were common and whether widespread testing of all dialysis patients and staff would identify cases earlier and prevent transmission. Ontario has a population of about 14.5 million. Approximately 8900 people receive dialysis across 102 in-center dialysis units. Objective: The objective of this study was to determine participation rates for patients and staff in point prevalence testing in dialysis units across the province and to determine the prevalence of asymptomatic or presymptomatic infection. Design: Cross-sectional study design. Setting: In-center hemodialysis units at 27 renal programs across Ontario. Participants: Patients and staff in in-center dialysis units in Ontario. Measurements: Participation rates, demographic data, SARS-CoV-2 positivity rates, and COVID-19-related symptom data. Methods: From June 8 to 30, 2020, all in-center dialysis patients and staff in the Province of Ontario were requested to undergo a symptom screening assessment and nasopharyngeal swab. Testing was done using polymerase chain reaction to detect SARS-CoV-2. A standardized questionnaire of atypical and typical COVID-19-related symptoms was administered to patients, to assess for new or worsening COVID-19-related symptoms. Results: Patient participation was 83% (7155 of 8612) of which 15 tests were positive: less than 5 (Limitations: As point prevalence testing was voluntary, not all patients and staff participated. Lower participation rate may be due to decreasing new cases in Ontario, and testing or pandemic fatigue, among other factors. This study did not use serology to identify prior infections because it was not widely available in Ontario. With respect to the standardized symptom questionnaire, it was only available in English and French and could not be tested due to the urgency of the initiative. Conclusions: Participation among patients in point prevalence testing was good, but participation among staff was relatively low. Asymptomatic positivity in the dialysis patient and staff population was rare during the first wave of the COVID-19 pandemic in Ontario.

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.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.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.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.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.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.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.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.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.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.Clinicaltrials.gov; identifier: NCT03329521.Plusieurs patients atteints d’insuffisance rénale vivront plus longtemps et en meilleure santé s’ils reçoivent une greffe de rein plutôt que des traitements de dialyze. De nombreux obstacles empêchent cependant les patients d’accéder à la transplantation.Déterminer si une intervention visant l’amélioration de la qualité menée dans les programs d’insuffisance rénale chronique (IRC) permettrait à davantage de patients sans contre-indications à une greffe d’aller plus loin (comparativement aux soins habituels) dans le processus menant à la transplantation.Ce protocole décrit un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, à répartition aléatoire en grappes et fondé sur un registre — l’essaiLes 26 programs d’IRC de l’Ontario (Canada). L’essai a débuté le 1er novembre 2017 et devait initialement se terminer le 31 mars 2021 (3,4 ans); cette date a été reportée au 31 décembre 2021 (4,1 ans) en raison de la pandémie de COVID-19.Au cours de l’essai, on estime que les 26 programs d’IRC prendront en charge plus de 10 000 adultes atteints d’IRC (y compris des patients approchant le besoin de dialyze et des patients dialysés) sans contre-indications à une greffe.Les programs ont été répartis aléatoirement pour intégrer une intervention d’amélioration de la qualité ou pour prodiguer les soins habituels. L’intervention consiste en quatre composantes principales: (1) des équipes locales d’amélioration de la qualité et de soutien administratif; (2) de l’information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien pour les receveurs et les donneurs vivants; et (4) des rapports sur le rendement au niveau du program et une surveillance assurée par les chefs de program.Le principal critère d’évaluation est le nombre d’étapes clés complétées en vue de la réception d’une greffe de rein tel qu’analysé au niveau de la grappe (program d’IRC). Pour chaque patient, quatre étapes spécifiques seront comptabilisées: (I) le patient est aiguillé vers un center de transplantation pour évaluation; (II) au moins un donneur vivant de rein contacte un center de transplantation pour un receveur en particulier et amorce son évaluation en remplissant un questionnaire sur ses antécédents médicaux; (III) le patient est ajouté à la liste d’attente pour une transplantation d’un donneur décédé, et (IV) le patient reçoit une greffe de rein d’un donneur vivant ou décédé.Les données sont tirées des bases de données administratives du système de santé ontarien. Une analyze en intention de traiter sera effectuée en comparant le principal critère d’évaluation entre les groupes répartis aléatoirement à l’aide d’une approche en deux étapes. Première étape: obtention de valeurs résiduelles en adaptant un modèle de régression aux variables de niveau individuel et en ignorant les effets de l’intervention et du regroupement. Deuxième étape: les valeurs résiduelles de la première étape agrégées au niveau du groupe constitueront le résultat.Il pourrait ne pas être possible d’isoler les effets indépendants de chaque composante de l’intervention. L’équipe prodiguant les soins habituels pourrait adopter des composantes de l’intervention menant à un biais de contamination. Le nombre relativement faible de groupes pourrait signifier que les deux bras ne sont pas équilibrés sur tous les facteurs pronostiques de base.L’essai EnAKT LKD fournira des données de haute qualité sur la question de savoir si une intervention à composantes multiples visant l’amélioration de la qualité aide effectivement les patients à franchir davantage d’étapes vers une transplantation rénale.

Background Despite increasing interest in joint research priority-setting, few studies engage end-user groups in setting research priorities at the intersection of the healthcare and management disciplines. With health systems increasingly establishing performance management programmes to account for and incentivize performance, it is important to conduct research that is actionable by the end-users involved with or impacted by these programmes. The aim of this study was to co-design a research agenda on healthcare performance management with and for end-users in a specific jurisdictional and policy context. Methods We undertook a rapid review of the literature on healthcare performance management (n = 115) and conducted end-user interviews (n = 156) that included a quantitative ranking exercise to prioritize five directions for future research. The quantitative rankings were analysed using four methods: mean, median, frequency ranked first or second, and frequency ranked fifth. The interview transcripts were coded inductively and analysed thematically to identify common patterns across participant responses. Results Seventy-three individual and group interviews were conducted with 156 end-users representing diverse end-user groups, including administrators, clinicians and patients, among others. End-user groups prioritized different research directions based on their experiences and information needs. Despite this variation, the research direction on motivating performance improvement had the highest overall mean ranking and was most often ranked first or second and least often ranked fifth. The research direction was modified based on end-user feedback to include an explicit behaviour change lens and stronger consideration for the influence of context. Conclusions Joint research priority-setting resulted in a practice-driven research agenda capable of generating results to inform policy and management practice in healthcare as well as contribute to the literature. The results suggest that end-users are keen to open the “black box” of performance management to explore more nuanced questions beyond “does performance management work?” End-users want to know how, when and why performance management contributes to behaviour change (or fails to) among front-line care providers.