Background: In individuals receiving hemodialysis, lower serum magnesium concentrations are associated with a higher risk of death and cardiovascular disease and more discomfort from muscle cramps. Small trials suggest that increasing serum magnesium by using a higher concentration of dialysate magnesium may be beneficial. This protocol outlines a large, randomized trial examining the effects of adopting a high versus low concentration of dialysate magnesium as a hemodialysis center-wide policy on the risk of mortality, major adverse cardiovascular events, and the burden of muscle cramps. Objective: To determine whether implementing a dialysate magnesium concentration of 0.75 mmol/L versus ≤ 0.5 mmol/L as a hemodialysis center-wide policy, for up to 4 years, affects (1) the rate of all-cause mortality or major cardiovascular-related hospitalizations or (2) the level of discomfort individuals experience from muscle cramps. Design: Pragmatic, 2-arm, parallel-group, registry-based, open-label, 2-sided superiority cluster randomized trial. Hemodialysis centers were randomly allocated (1:1) to one of the 2 arms. The assignment was constrained by five center-level prognostic factors and stratified by province. Setting: 137 hemodialysis centers in four Canadian provinces—Ontario, British Columbia, Alberta, and Manitoba. The trial period is from April 4, 2022, to March 31, 2026. Outcomes will be analyzed after March 31, 2026, using provincial health care databases and self-reported questionnaires. Participants: Individuals who received maintenance hemodialysis at participating centers during the trial period. Intervention: Use of a dialysate magnesium concentration of either 0.75 mmol/L or ≤ 0.5 mmol/L as a center-wide policy during the trial period. Measurements: The two primary outcomes are (1) a composite of all-cause mortality or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in large health care databases and (2) self-reported muscle cramps collected from questionnaires. Methods: Using an intent-to-treat approach, the intervention effect on the instantaneous rate of the primary composite outcome will be analyzed using a stratified Cox proportional hazards model accounting for center-level clustering. The observation time will be censored for provincial emigration or the trial end date. Self-reported muscle cramps will be analyzed using a cumulative link (proportional odds) model. All models will be stratified by province and adjusted for the covariates used to constrain randomization. Limitations: The trial start date was delayed in some centers due to post-pandemic supply disruptions (including discontinued dialysate formulations); however, all centers secured dialysate concentrates in alignment with the trial-allocated magnesium level. Conclusions: The results of this pragmatic trial will inform center-wide policy on the optimal dialysate magnesium concentration for patient health. Trial Registration: www.clinicaltrials.gov ; identifier: NCT04079582

Background: Improving interactions between people receiving hemodialysis and health care providers of facility-based hemodialysis care is a top priority for patients, caregivers, and health care providers. Objective: To identify challenges for high-quality clinical interactions in facility-based hemodialysis care as well as potential solutions. Design: Multicentre qualitative study using focus groups and semi-structured interviews to elicit the perspectives of patients, caregivers, and health care providers. Setting: Five Canadian facility-based hemodialysis centers. Participants: English-speaking adults receiving facility-based hemodialysis for longer than 6 months, their caregivers, and hemodialysis health care providers. Methods: Between May 2017 and August 2018, focus groups and interviews with patients and their caregivers subsequently informed semi-structured interviews with providers. Data were analyzed using inductive thematic analysis with application of a grounded theory approach. Results: A total of 8 focus groups and 44 interviews were completed. Participants included 64 people receiving hemodialysis, 18 caregivers, and 31 health care providers. Communication between health care providers and patients was often characterized as intersections of care (unidirectional) rather than interactions (bidirectional). Challenges were grouped into 4 main themes as follows: (1) culture of care provision; (2) mistrust between patients and health care providers; (3) time constraints for clinical interactions, and (4) lack of collaboration and care coordination among health care team. Potential solutions were identified for each challenge. Limitations: Findings were limited to Canadian context, English-speaking adults, and individuals receiving facility-based hemodialysis in urban centers. Conclusions: Interactions between health care providers and people receiving dialysis are often unidirectional, where the patient is a passive recipient of ideas and information from the health care provider. To promote improved bidirectional interactions, team-based care that includes better tools to improve information transfer, better information regarding roles, and identity of health care team members and opportunities for all members of the health care team, including the people receiving dialysis, to provide input on care plans is required. Trial Registration: Not applicable.

Purpose of the Conference: Hemodialysis is a life-sustaining treatment for patients with end-stage kidney disease. However, patients on dialysis continue to face poor quality of life and short life expectancies. Despite this, the nephrology community conducts the fewest randomized controlled trials of any medical discipline, relying instead on expert opinion to guide many aspects of hemodialysis care. There is a need to conduct high-quality pragmatic randomized controlled trials in hemodialysis to drive evidence-based practice. To this end, the Innovative Clinical Trials in Hemodialysis Centers initiative, with the support of the Canadian Institutes of Health Research and its Strategy for Patient-Oriented Research, funded the development of 6 pragmatic trial protocols. Gardener’s Grove 2023 created a space to support the development of these trials and increase awareness and knowledge of past, ongoing, and future innovative, pragmatic, randomized controlled registry trials embedded in routine hemodialysis care. This report summarizes the proceedings of this conference. Sources of information: The conference included 6 panel presentations, each featuring an overview of a new pragmatic trial followed by expert panel feedback from patient partners, nephrologists, researchers, and health care providers. The conference also included 10 educational sessions led by clinicians and researchers with experience in the fields of kidney medicine and clinical trials. Methods: Gardener’s Grove 2023 was a 4-day virtual conference held in March of 2023. Recordings of all the conference presentations were later published on the Gardener’s Grove website and are summarized in the Supplemental Appendix of this report. Key Findings: The conference brought together 118 Canadian and international researchers, patients, and health care providers to collaborate on 6 pragmatic trials intended to test interventions to improve hemodialysis care. The proposed trials included (1) PREventing FracturEs in REnal Disease (PREFERRED), (2) DIALysis with EXpanded solute removal (DIALEX), (3) Sodium fOr diaLysis oUTcome rEduction (SOLUTE), (4) Finding the right blood pressure target for patients on dialysis, (5) DIuretic Use in patients with Residual renal function on hemodialysis (DIURESED), and (6) Lower vs higher dialysate bicarbonate concentration in patients receiving hemodialysis (Dial-Bicarb). All of these interventions were widely supported and received valuable feedback from panelists and conference attendees. The education sessions focused on various design and execution elements of pragmatic, randomized controlled registry trials embedded in routine care. Limitations: The conference could have been improved by streamlining session topics and pacing, allowing additional time for discussions, strengthening online network opportunities, and improving survey response rates. A follow-up conference is planned to take place in a few years, and the coordinators will aim to implement these changes. Implications: Gardener’s Grove 2023 successfully created a space for patients, researchers, and health care providers to support the development of 6 new pragmatic trials in hemodialysis care. Since Gardener’s Grove 2023, several of these trials have secured CIHR funding, obtained ethics approval, and are actively preparing to launch their interventions.

The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effectiveness of this policy in comparison with other Canadian provinces via a natural experiment evaluation. We will use a cross-sectional controlled interrupted time series quasi-experimental design. Our primary outcome will be consent for deceased donation as confirmed at the time of eligibility (prior registered intent to donate will be noted but not be considered positive unless affirmed at the time of eligibility). Secondary outcomes will include identification and referral of patients who are potential donors, rates of family override of previously registered intent to donate, and donation and transplantation rates per million population. Data will be collected from potential donor audits in Nova Scotia and 3 control provinces (provinces in Canada without deemed consent policies). Study outcomes will be compared in Nova Scotia relative to control provinces in the 3 y before and 3 y after the implementation of legislative reform. These provinces were selected as having systems resembling those of Nova Scotia but without deemed consent.Using controlled interrupted time series methodology compared with other Canadian provinces with otherwise similar systems, we aim to isolate the impact of the deemed consent aspect of legislative reform in Nova Scotia using a robust natural experiment evaluation design as much as possible. Careful selection of outcome measures will allow donation and transplantation stakeholders to properly evaluate if similar reforms should be considered in their jurisdictions.

Purpose of Review: Magnesium is an essential mineral for bone metabolism, but little is known about how magnesium intake alters fracture risk. We conducted a narrative review to better understand how magnesium intake, through supplementation, diet, or altering the concentration of dialysate magnesium, affects mineral bone disease and the risk of fracture in individuals across the spectrum of kidney disease. Sources of Information: Peer-reviewed clinical trials and observational studies. Methods: We searched for relevant articles in MEDLINE and EMBASE databases. The methodologic quality of clinical trials was assessed using a modified version of the Downs and Black criteria checklist. Key Findings: The role of magnesium intake in fracture prevention is unclear in both the general population and in patients receiving maintenance dialysis. In those with normal kidney function, 2 meta-analyses showed higher bone mineral density in those with higher dietary magnesium, whereas 1 systematic review showed no effect on fracture risk. In patients receiving maintenance hemodialysis or peritoneal dialysis, a higher concentration of dialysate magnesium is associated with a lower concentration of parathyroid hormone, but little is known about other bone-related outcomes. In 2 observational studies of patients receiving hemodialysis, a higher concentration of serum magnesium was associated with a lower risk of hip fracture. Limitations: This narrative review included only articles written in English. Observed effects of magnesium intake in the general population may not be applicable to those with chronic kidney disease particularly in those receiving dialysis.

Purpose of the program: This article provides guidance on optimizing the management of pediatric patients with end-stage kidney disease (ESKD) who will be or are being treated with any form of home or in-center dialysis during the COVID-19 pandemic. The goals are to provide the best possible care for pediatric patients with ESKD during the pandemic and ensure the health care team’s safety. Sources of information: The core of these rapid guidelines is derived from the Canadian Society of Nephrology (CSN) consensus recommendations for adult patients recently published in the Canadian Journal of Kidney Health and Disease ( CJKHD ). We also consulted specific documents from other national and international agencies focused on pediatric kidney health. Additional information was obtained by formal review of the published academic literature relevant to pediatric home or in-center hemodialysis. Methods: The Leadership of the Canadian Association of Paediatric Nephrologists (CAPN), which is affiliated with the CSN, solicited a team of clinicians and researchers with expertise in pediatric home and in-center dialysis. The goal was to adapt the guidelines recently adopted for Canadian adult dialysis patients for pediatric-specific settings. These included specific COVID-19-related themes that apply to dialysis in a Canadian environment, as determined by a group of senior renal leaders. Expert clinicians and nurses with deep expertise in pediatric home and in-center dialysis reviewed the revised pediatric guidelines. Key findings: We identified 7 broad areas of home dialysis practice management that may be affected by the COVID-19 pandemic: (1) peritoneal dialysis catheter placement, (2) home dialysis training, (3) home dialysis management, (4) personal protective equipment, (5) product delivery, (6) minimizing direct health care providers and patient contact, and (7) caregivers support in the community. In addition, we identified 8 broad areas of in-center dialysis practice management that may be affected by the COVID-19 pandemic: (1) identification of patients with COVID-19, (2) hemodialysis of patients with confirmed COVID-19, (3) hemodialysis of patients not yet known to have COVID-19, (4) management of visitors to the dialysis unit, (5) handling COVID-19 testing of patients and staff, (6) safe practices during resuscitation procedures in a pandemic, (7) routine hemodialysis care, and (8) hemodialysis care under fixed dialysis resources. We make specific suggestions and recommendations for each of these areas. Limitations: At the time when we started this work, we knew that evidence on the topic of pediatric dialysis and COVID-19 would be severely limited, and our resources were also limited. We did not, therefore, do formal systematic review or meta-analysis. We did not evaluate our specific suggestions in the clinical environment. Thus, this article’s advice and recommendations are primarily expert opinions and subject to the biases associated with this level of evidence. To expedite the publication of this work, we created a parallel review process that may not be as robust as standard arms’ length peer-review processes. Implications: We intend these recommendations to help provide the best care possible for pediatric patients prescribed in-center or home dialysis during the COVID-19 pandemic, a time of altered priorities and reduced resources.

BACKGROUND:Patients with kidney failure are exposed to a surfeit of new information about their disease and treatment, often resulting in ineffective communication between patients and providers. Improving the amount, timing, and individualization of information received has been identified as a priority in in-center hemodialysis care.OBJECTIVE:To describe and explicate patient, caregiver, and health care provider perspectives regarding challenges and solutions to information transfer in clinical hemodialysis care.DESIGN:In this multicenter qualitative study, we gathered perspectives of patients, their caregivers, and health care providers conducted through focus groups and interviews.SETTING:Five Canadian hemodialysis centers: Calgary, Edmonton, Winnipeg, Ottawa, and Halifax.PARTICIPANTS:English-speaking adults receiving in-center hemodialysis for longer than 6 months, their caregivers, and hemodialysis health care providers.METHODS:Between May 24, 2017, and August 16, 2018, data collected through focus groups and interviews with hemodialysis patients and their caregivers subsequently informed semi-structured interviews with health care providers. For this secondary analysis, data were analyzed through an inductive thematic analysis using grounded theory, to examine the data more deeply for overarching themes.RESULTS:Among 82 patients/caregivers and 31 healthcare providers, 6 main themes emerged. Themes identified from patients/caregivers were (1) overwhelmed at initiation of hemodialysis care, (2) need for peer support, and (3) improving comprehension of hemodialysis processes. Themes identified from providers were (1) time constraints with patients, (2) relevance of information provided, and (3) technological innovations to improve patient engagement.LIMITATIONS:Findings were limited to Canadian context, English speakers, and individuals receiving hemodialysis in urban centers.CONCLUSIONS:Participants identified challenges and potential solutions to improve the amount, timing, and individualization of information provided regarding in-center hemodialysis care, which included peer support, technological innovations, and improved knowledge translation activities. Findings may inform the development of interventions and strategies aimed at improving information delivery to facilitate patient-centered hemodialysis care.

Purpose: The Canadian Nephrology Trials Network (CNTN) was formed in 2014 to support Canadian researchers in developing, designing, and conducting prospective studies in nephrology. In response to the changing landscape and needs within the Canadian nephrology research community, an interest in further growth and development of the network was identified. In the following report, we describe the process undertaken to re-envision the network through the creation of 3 new committees and how the committees are facilitating change and growth within the CNTN for future sustainability. Sources of information: To understand areas for improvement and capacity building, the organization charged with overseeing the CNTN, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), began by conducting an environmental scan. As well, 2 informal surveys were sent to nephrology professionals (who were members of the CNTN and the Canadian Society of Nephrology) and patient partners (from Can-SOLVE CKD). Methods: In September 2018, 44 CNTN members and other stakeholders from across Canada (including patient partners and representatives from research funding agencies) convened for a 2-day visioning workshop in Mississauga, Ontario. The agenda for this workshop was largely based on the results from the informal surveys. CNTN leadership participated and chose other workshop participants through informal stakeholder mapping and purposeful recruitment. Patient partners were recruited to participate in the workshop through advertisement within the Can-SOLVE-CKD patient council. The survey results and discussion questions were presented to participants at the workshop who, in turn, discussed in large- and small-group session ways in which the CNTN might be expanded. Results: Surveys of patient partners indicated that they would like to see greater involvement of patients in the research process. Surveys of researchers indicated that they wanted more support and resources for coordinating prospective trials. The themes which emerged from the workshop discussions were peer review, engagement, and training. These themes were broadened and formally re-named to Scientific Operations, Communications and Engagement, and Capacity Building. A working committee, each co-led by a nephrologist with research experience and a patient partner, was created to advance each of these identified themes. An executive committee was created to provide overall strategic leadership and governance to the network. The Scientific Operations Committee conducts peer reviews; provides letters of endorsement after peer review; and holds semi-annual in-person meetings where researchers can present their proposals and obtain feedback from multiple stakeholders, including patients. The Communications and Engagement Committee publishes a quarterly newsletter, engages the community on Twitter, and reaches out to community sites and new nephrologists to engage them in research. The Capacity Building Committee conducts webinars to encourage patient partners to develop their own research questions and is developing a hub-and-spoke model to improve research collaboration. Limitations: We did not conduct formal stakeholder mapping. Only attendees of the visioning workshop provided input, and not everyone’s comment or opinion was included in the workshop report. Perspectives were limited to the sample of people who attended the workshop or were surveyed and may not reflect perspectives of all stakeholders in nephrology research in Canada. We did not use formal qualitative methodology to summarize the workshops. Implications: Renewed areas of focus and related committees within the CNTN could lead to an increased capacity for nephrology research, increased engagement and collaboration with researchers, a higher likelihood of funding with rigorous peer review, and more clinical trials and multicenter collaborative prospective research being conducted in Canada.

Background: Current health systems do not effectively address all aspects of chronic care. For better self-management of disease, kidney patients have identified the need for improved health care information, interaction with health care providers, and individualization of care. Objective: The Triple I study examined challenges to exchange of information, interaction between patients and health care providers and individualization of care in in-center hemodialysis with the aim of identifying the top 10 challenges that individuals on in-center hemodialysis face in these 3 areas. Design: We employed a sequential mixed methods approach with 3 phases: 1. A qualitative study with focus groups and interviews (Apr 2017 to Aug 2018); 2. A cross-sectional national ranking survey (Jan 2019 to May 2019); 3. A prioritization workshop using a modified James Lind Alliance process (June 2019) Setting: In-center hemodialysis units in 7 academic centers across Canada: Vancouver, Calgary, Edmonton, Winnipeg, Ottawa, Montreal, and Halifax. Participants: Individuals receiving in-center hemodialysis, their caregivers, and health care providers working in in-center hemodialysis participated in each of the 3 phases. Methods: In Phase 1, we collected qualitative data through (1) focus groups and interviews with hemodialysis patients and their caregivers and (2) individual interviews with health care providers and decision makers. Participants identified challenges to in-center hemodialysis care and potential solutions to these challenges. In Phase 2, we administered a pan-Canadian cross-sectional ranking survey. The survey asked respondents to prioritize the challenges to in-center hemodialysis care identified in Phase 1 by ranking their top 5 topics/challenges in each of the 3 “I” categories. In Phase 3, we undertook a face-to-face priority setting workshop which followed a modified version of the James Lind Alliance priority setting workshop process. The workshop employed an iterative process incorporating small and large group sessions during which participants identified, ranked, and voted on the top challenges and innovations to hemodialysis care. Four patient partners contributed to study design, implementation, analysis, and interpretation. Results: Across the 5 participating centers, we conducted 8 focus groups and 44 interviews, in which 113 participants identified 45 distinct challenges to in-center hemodialysis care. Subsequently, completion of a national ranking survey (n = 323) of these challenges resulted in a short-list of the top 30 challenges. Finally, using small and large group sessions to develop consensus during the prioritizing workshop, 38 stakeholders used this short-list to identify the top 10 challenges to in-center hemodialysis care. These included individualization of dialysis-related education; improved information in specific topic areas (transplant status, dialysis modalities, dialysis-related complications, and other health risks); more flexibility in hemodialysis scheduling; better communication and continuity of care within the health care team; and increased availability of transportation, financial, and social support programs. Limitations: Participants were from urban centers and were predominately English-speaking. Survey response rate of 31.5% in Phase 2 may have led to selection bias. We collected limited information on social determinants of health, which could confound our results. Conclusion: Overall, the challenges we identified demonstrate that individualized care and information that improves interaction with health care providers is important to patients receiving in-center hemodialysis. In future stages of this project, we will aim to address these challenges by trialing innovative patient-centered solutions. Trial Registration: Not applicable.

PURPOSE OF REVIEW:Strategies to mitigate muscle cramps are a top research priority for patients receiving hemodialysis. As hypomagnesemia is a possible risk factor for cramping, we reviewed the literature to better understand the physiology of cramping as well as the epidemiology of hypomagnesemia and muscle cramps. We also sought to review the evidence from interventional studies on the effect of oral and dialysate magnesium-based therapies on muscle cramps.SOURCES OF INFORMATION:Peer-reviewed articles.METHODS:We searched for relevant articles in major bibliographic databases including MEDLINE and EMBASE. The methodological quality of interventional studies was assessed using a modified version of the Downs and Blacks criteria checklist.KEY FINDINGS:The etiology of muscle cramps in patients receiving hemodialysis is poorly understood and there are no clear evidence-based prevention or treatment strategies. Several factors may play a role including a low concentration of serum magnesium. The prevalence of hypomagnesemia (concentration of <0.7 mmol/L) in patients receiving hemodialysis ranges from 10% to 20%. Causes of hypomagnesemia include a low dietary intake of magnesium, use of medications that inhibit magnesium absorption (eg, proton pump inhibitors), increased magnesium excretion (eg, high-dose loop diuretics), and a low concentration of dialysate magnesium. Dialysate magnesium concentrations of ≤0.5 mmol/L may be associated with a decrease in serum magnesium concentration over time. Preliminary evidence from observational and interventional studies suggests a higher dialysate magnesium concentration will raise serum magnesium concentrations and may reduce the frequency and severity of muscle cramps. However, the quality of evidence supporting this benefit is limited, and larger, multicenter clinical trials are needed to further determine if magnesium-based therapy can reduce muscle cramps in patients receiving hemodialysis. In studies conducted to date, increasing the concentration of dialysate magnesium appears to be well-tolerated and is associated with a low risk of symptomatic hypermagnesemia.LIMITATIONS:Few interventional studies have examined the effect of magnesium-based therapy on muscle cramps in patients receiving hemodialysis and most were nonrandomized, pre-post study designs.

Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, and regulators. However, no harmonized international consensus definitions of kidney failure and key surrogates of progression to kidney failure exist specifically for clinical trials. The International Society of Nephrology convened an international multi-stakeholder meeting to develop consensus on this topic. A core group, experienced in design, conduct, and outcome adjudication of clinical trials, developed a database of 64 randomized trials and the 163 included definitions relevant to kidney failure. Using an iterative process, a set of proposed consensus definitions were developed and subsequently vetted by the larger multi-stakeholder group of 83 participants representing 18 different countries. The consensus of the meeting participants was that clinical trial kidney failure outcomes should be comprised of a composite that includes receipt of a kidney transplant, initiation of maintenance dialysis, and death from kidney failure; it may also include outcomes based solely on laboratory measurements of glomerular filtration rate: a sustained low glomerular filtration rate and a sustained percent decline in glomerular filtration rate. Discussion included important considerations, such as (i) recognition of existing nomenclature for kidney failure; (ii) applicability across resource settings; (iii) ease of understanding for all stakeholders; and (iv) avoidance of inappropriate complexity so that the definitions can be used across ranges of populations and trial methodologies. The final definitions reflect the consensus for use in clinical trials.

Background: Clinical settings often make it challenging for patients with kidney failure to receive individualized hemodialysis (HD) care. Individualization refers to care that reflects an individual’s specific circumstances, values, and preferences. Objective: This study aimed to describe patient, caregiver, and health care professional perspectives regarding challenges and solutions to individualization of care in people receiving in-center HD. Design: In this multicentre qualitative study, we conducted focus groups with individuals receiving in-center HD and their caregivers and semi-structured interviews with health care providers from May 2017 to August 2018. Setting: Hemodialysis programs in 5 cities: Calgary, Edmonton, Winnipeg, Ottawa, and Halifax. Participants: Individuals receiving in-center HD for more than 6 months, aged 18 years or older, and able to communicate in English were eligible to participate, as well as their caregivers. Health care providers with HD experience were recruited using a purposive approach and snowball sampling. Methods: Two sequential methods of qualitative data collection were undertaken: (1) focus groups and interviews with HD patients and caregivers, which informed (2) individual interviews with health care providers. A qualitative descriptive methodology guided focus groups and interviews. Data from all focus groups and interviews were analyzed using conventional content analysis. Results: Among 82 patients/caregivers and 31 health care providers, we identified 4 main themes: session set-up, transportation and parking, socioeconomic and emotional well-being, and HD treatment location and scheduling. Particular challenges faced were as follows: (1) session set-up: lack of preferred supplies, machine and HD access set-up, call buttons, bed/chair discomfort, needling options, privacy in the unit, and self-care; (2) transportation and parking: lack of reliable/punctual service, and high costs; (3) socioeconomic and emotional well-being: employment aid, finances, nutrition, lack of support programs, and individualization of treatment goals; and (4) HD treatment location and scheduling: patient displacement from their usual spot, short notice of changes to dialysis time and location, lack of flexibility, and shortages of HD spots. Limitations: Uncertain applicability to non-English speaking individuals, those receiving HD outside large urban centers, and those residing outside of Canada. Conclusions: Participants identified challenges to individualization of in-center HD care, primarily regarding patient comfort and safety during HD sessions, affordable and reliable transportation to and from HD sessions, increased financial burden as a result of changes in functional and employment status with HD, individualization of treatment goals, and flexibility in treatment schedule and self-care. These findings will inform future studies aimed at improving patient-centered HD care.

Purpose of program: This article will provide guidance on how to best manage patients with glomerulonephritis (GN) during the COVID-19 pandemic. Sources of information: We reviewed relevant published literature, program-specific documents, and guidance documents from international societies. An informal survey of Canadian nephrologists was conducted to identify practice patterns and expert opinions. We hosted a national webinar with invited input and feedback after webinar. Methods: The Canadian Society of Nephrology (CSN) Board of Directors invited physicians with expertise in GN to contribute. Specific COVID-19-related themes in GN were identified, and consensus-based recommendations were made by this group of nephrologists. The recommendations received further peer input and review by Canadian nephrologists via a CSN-sponsored webinar. This was attended by 150 kidney health care professionals. The final consensus recommendations also incorporated review by Editors of the Canadian Journal of Kidney Health and Disease. Key findings: We identified 9 areas of GN management that may be affected by the COVID-19 pandemic: (1) clinic visit scheduling, (2) clinic visit type, (3) provision of multidisciplinary care, (4) blood and urine testing, (5) homebased monitoring essentials, (6) immunosuppression, (7) other medications, (8) patient education and support, and ( 9) employment. Limitations: These recommendations are expert opinion, and are subject to the biases associated with this level of evidence. To expedite the publication of this work, a parallel review process was created that may not be as robust as standard arm's length peer review processes. Implications: These recommendations are intended to provide optimal care during the COVID-19 pandemic. Our recommendations may change based on the evolving evidence.

One-year patient and allograft survival have improved dramatically since the first successful kidney transplant in 1954. At many programs, 1-year allograft survival now exceeds 95%. Short-term survival metrics, such as 1-year patient and/or graft survival, are commonly used as a gauge to determine the “quality” of a transplant program. Although most patients and clinicians have some understanding of what quality means, it is not easily defined in the health care setting. In a landmark report, the Institute of Medicine characterized high-quality health care as being safe, effective, patient-centered, timely, efficient, and equitable (Table 1).1Institute of Medicine (US)Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press, Washington, DC2001Google Scholar When quality is viewed from this wider lens, it becomes evident that the use of one or two survival metrics can in no way fully capture whether high-quality transplant care has been delivered. In fact, using survival measures in isolation, without balancing metrics, can lead to reduced quality by denying access to higher-risk candidates and the under-utilization of increased risk donor organs, leading to fewer transplants.2Schold J.D. Patzer R.E. Pruett T.L. Mohan S. Quality metrics in kidney transplantation: current landscape, trials and tribulations, lessons learned, and a call for reform.Am J Kidney Dis. 2019; 74: 382-389Abstract Full Text Full Text PDF PubMed Scopus (20) Google ScholarTable 1Domains of health care quality as defined by the Institute of Medicine1Institute of Medicine (US)Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press, Washington, DC2001Google ScholarDomain of qualityDefinitionSafeAvoiding injuries to patients from the care that is intended to help themEffectiveProviding services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefitPatient-centeredProviding care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisionsTimelyReducing waits and sometimes harmful delays for both those who receive and those who give careEfficientAvoiding waste, including waste of equipment, supplies, ideas, and energyEquitableProviding care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status Open table in a new tab A systematic review of quality indicators in transplantation has shown a considerable gap between the ideal measurement of quality, as defined by the Institute of Medicine, and what is currently being measured in kidney transplantation.3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar Although over 300 transplantation quality indicators have been reported in the literature, most have focused on safety and effectiveness, with very few addressing other domains of quality such as equity and patient centeredness. In addition, virtually no patient involvement has been seen in the development or selection of kidney transplantation quality indicators. In a recent qualitative interview study, patients and clinicians had a more holistic view of transplantation quality.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar Although measures of safety and effectiveness were still discussed and considered important, other domains such as access to care, timeliness of services, patient satisfaction, communication, and quality of life were critical to study participants.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar The International Consortium for Health Outcomes Measurement (ICHOM) recently published a report on patient-centred outcomes for chronic kidney disease.5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar Within these recommendations were treatment-specific outcomes important to kidney transplant patients such as allograft function, allograft survival, acute rejection, and malignancy. Patients involved with the ICHOM process, however, ranked health-related quality of life as the most relevant outcome with approximately 95% ranking it as an essential outcome to track.5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar The National Surgical Quality Program has recently developed a kidney transplant–specific platform (“National Surgical Quality Program Transplant”) to establish benchmarks for surgical outcomes beyond patient and allograft survival.6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar They have developed standard definitions and have already shown important variations in practice that can serve as a starting point for quality improvement measures at the site level.6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar The highlighted work indicates how the field of kidney transplantation is evolving from a “survival-focused” quality paradigm to a multidimensional approach that includes patient experience, clinical outcomes beyond survival, and outcomes that are important to patients, such as quality of life, physical functioning, and daily activity.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar, 5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar To better define which of the many proposed quality indicators are important and should be measured, we held a Canadian consensus workshop involving key stakeholders in kidney transplantation. The stakeholder groups, which would be similar in other jurisdictions around the globe, included patient partners and patient organizations; nephrologists and surgeons involved in living kidney donation and kidney transplantation; government agencies involved in health care delivery and data collection; health quality and safety organizations; and representatives from organ donation organizations, professional societies, and health care charities (details of meeting process and participants can be found in the Supplementary Appendix). A comprehensive set of potential quality indicators was compiled from the findings of our systematic review,3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar qualitative interviews,4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar and an environmental scan. Participants were preassigned into groups of diverse stakeholders to capture a range of opinions. Each table reviewed the potential quality indicators according to prespecified selection criteria as to whether the metric was important and/or relevant, measurable, actionable, evidence-based, feasible, interpretable, and based on sound data quality (Table 2).7How indicators are selected to measure Ontario’s health system performanceHealth Quality Ontario.https://www.hqontario.ca/System-Performance/Measuring-System-Performance/How-Indicators-are-SelectedDate accessed: April 30, 2020Google Scholar Groups rated each selection criterion (e.g., strongly agree, agree, disagree, strongly disagree) and based on these ratings provided a final recommendation of either essential, optional, or exclude. In situations in which groups did not reach consensus on an indicator, the workshop steering committee reviewed the relevant worksheets and key discussion points to determine the final recommendation for the indicator. Implementation issues and recommendations were developed by the groups focusing on the systems required for quality indicator collection and how to use quality measurement to effect system change. To put this process in context, currently in Canada there is limited reporting of quality indicators in kidney transplantation even at the center level. Canada does have a national registry (Canadian Organ Replacement Register), but because of its voluntary nature, the data are incomplete and insufficient in scope to inform practice. Some reporting to provincial agencies occurs in the provinces of Ontario and British Columbia, but little elsewhere. As such, the development of these indicators was a first and necessary step toward the development of a Canadian performance measurement system.Table 2Criteria to select a quality indicator7How indicators are selected to measure Ontario’s health system performanceHealth Quality Ontario.https://www.hqontario.ca/System-Performance/Measuring-System-Performance/How-Indicators-are-SelectedDate accessed: April 30, 2020Google ScholarCriteriaDefinitionImportant and/or relevantThe indicator reflects an issue that is important to the general population and to relevant stakeholders in the health system.MeasurableData sources can be used to measure the indicator.ActionableThe indicator is likely to inform and influence public policy or funding, alter behavior of health care providers, and/or increase general understanding by the public to improve quality of care and population health.Evidence-basedGood evidence supports the process, or evidence of the importance of the outcome of measuring and reporting on the indicator.FeasibleThe indicator is calculable; data are timely.InterpretableThe indicator is clear and can be easily interpreted by a range of audiences; the results of the indicator are comparable and easy to understand, including what constitutes improved performance, such as clear directionality (i.e., a lower number is better).Data qualityThe indicator includes data quality such as technical definition, calculation methodology, validity and reliability of measurement, and timeliness of data. Open table in a new tab The quality indicators deemed essential for kidney transplantation are listed in Table 3. Effectiveness measures, such as patient and graft survival, remained important and were the most frequently represented domain of quality. In contrast to the findings of the systematic review,3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar several quality indicators in the domains of equity, timeliness, and patient-centeredness were deemed essential. Novel patient-reported outcome and experience measures were considered important and included in the essential list of quality indicators, particularly relating to patient satisfaction with the process. Many of the proposed quality indicators focused on access to transplantation, which has previously been identified as a crucial aspect of care by patients.8Husain S.A. Brennan C. Michelson A. et al.Patients prioritize waitlist over post-transplant outcomes when evaluating kidney transplant centers.Am J Transplant. 2018; 18: 2781-2790Crossref PubMed Scopus (30) Google Scholar It is important to point out the need for including balancing metrics. Implementing an indicator for the percentage of dialysis patients referred for transplantation may incentivize a dialysis unit to increase referral rates. However, if many referrals are inappropriate, that particular unit would be a poor-performing outlier for the indicator measuring the percentage accepted for transplantation from that dialysis program. The quality indicators deemed essential for living kidney donation are listed in Table 4 and are well balanced across the 6 domains of quality.Table 3Kidney transplantation quality indicators and definitions by domain of qualityKidney transplantation quality indicatorDefinitionEQUITABLE Percentage of CKD and/or dialysis patients who have a documented discussion about their consideration for transplantationDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who have a documented discussion about their consideration for transplantationPoints to consider for implementation: consideration for transplantation can denote whether patient would be a candidate for transplantation Percentage of CKD and/or dialysis patients who have a documented discussion about the option or possibility of receiving a living donor transplant.Denominator: total number of CKD and/or dialysis patients who have a documented discussion about their consideration for transplantationNumerator: number of people in the denominator who have a documented discussion about the option or possibility of receiving a living donor transplant Percentage of CKD and/or dialysis patients who are referred for transplant evaluationDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who are referred for transplant evaluation (i.e., to determine transplantation suitability)Points to consider for implementation: (i) CKD program and dialysis unit will be calculated separately; (ii) consider measuring by sociodemographic or disease subgroups Percentage of CKD and/or dialysis patients referred for evaluation who are accepted for transplantationDenominator: total number of CKD and/or dialysis patients who are referred for transplant evaluationNumerator: number of people in the denominator who are accepted for transplantationPoints to consider for implementation: (i) separate measure can be calculated for transplant program, CKD program, and dialysis unit; (ii) consider measuring by sociodemographic or disease subgroups Percentage of deceased donor kidney offers that are accepted by the transplant programDenominator: total number of deceased donor kidney offersNumerator: number of offers in the denominator that are accepted by the transplant programPoints to consider for implementation: (i) consider measuring percentage of refused deceased donor kidney offers that are transplanted at another transplant program; (ii) separate measure can be calculated for individual physicians as well as entire transplant program Number of kidney transplants performedCalculation: can be measured as mean, or median of the number of transplants (living and deceased donor) performed annually over a certain period (e.g., 5 yr).Points to consider for implementation: stratify by demographic and risk factor categories (e.g., number of females undergoing transplantation, number patients >65 yr receiving transplants, etc.) Percentage of CKD and/or dialysis patients who receive a kidney transplantDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who receive a kidney transplantPoints to consider for implementation: (i) separate measure can be calculated for CKD program and dialysis unit; (ii) need to include pre-emptive transplants in numerator and denominatorTIMELY Number of days from when patient starts dialysis to when the transplant referral is madeCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patient starts dialysis to when they are referred for transplant evaluation Number of days from when the referral is made to when the patient is seen for transplant evaluationCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patients are referred for transplant evaluation to when they are seen by the transplant program Number of days from when patient starts evaluation to when suitability for kidney transplantation is determinedCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patient starts the transplant evaluation to when patient suitability for kidney transplantation is determinedEFFECTIVE Percentage of CKD and/or dialysis patients on the wait list who die before receiving a kidney transplantDenominator: total number of CKD and/or dialysis patients on the kidney transplant wait listNumerator: number of people in the denominator who die before receiving a kidney transplantPoints to consider for implementation: include patients who die while active on the wait list as well as those who die within 12 months after removal from the wait list Percentage of CKD patients who receive a living donor kidney transplant before starting dialysisDenominator: total number of CKD patients who have not started dialysisNumerator: number of people in the denominator who receive a living donor kidney transplant Percentage of transplant recipients who receive a living donor kidney transplant before starting dialysisDenominator: total number of transplant recipientsNumerator: number of people in the denominator who receive a living donor transplant before starting dialysis Percentage of patients who receive dialysis in the first week after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who receive dialysis in the first week after kidney transplantationPoints to consider for implementation: stratification by donor (ECD or high KDPI, DCD, living) Percentage of patients who have a complication during the first 30 days after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a complication during the first 30 days after kidney transplantationNote: a complication can be an infection (pneumonia, urinary tract infection, bacteremia, surgical site infection); cardiovascular (myocardial infarction, cardiac arrest, DVT, PE, stroke); blood transfusion; or need for an unplanned operationPoints to consider for implementation: (i) overall measure of 30-day complication rate as well as separate measures for infection, cardiovascular, transfusion, and unplanned operation; (ii) consider incorporating NSQIP Transplant Percentage of patients with an unplanned readmission to any hospital within 30 days of discharge after kidney transplantationDenominator: total number of kidney transplant recipients discharged from hospitalNumerator: number of people in the denominator who have an unplanned readmission to any hospital within 30 days of discharge after kidney transplantation Percentage of patients who have a complication from day 31 to day 365 after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a complication from day 31 to day 365 after kidney transplantationNote: a complication can be an infection (cytomegalovirus, BK, pneumonia, urinary tract infection, bacteremia, surgical site infection), or cardiovascular (myocardial infarction, cardiac arrest, DVT, PE, stroke)Points to consider for implementation: overall measure of 30-day complication rate as well as separate measures for infection and cardiovascular Percentage of patients with an unplanned readmission to any hospital within 31 to 365 days of discharge after kidney transplantationDenominator: total number of kidney transplant recipients discharged from hospitalNumerator: number of people in the denominator who have an unplanned readmission to any hospital within 31 to 365 days of discharge after kidney transplantation Percentage of patients who have a rejection after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who have a rejection of their kidney transplantPoints to consider for implementation: (i) overall measure as well cellular and antibody-mediated rejection rate are options; (ii) time period will need to be determined—i.e., percentage rejection at 6 months, 12 months, or some other time point post-transplantation Percentage of patients diagnosed with cancer after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who are newly diagnosed with cancerNote: cancers of interest would be those most associated with transplantation, such as PTLD, nonmelanoma skin cancer, lip cancer, melanoma, kidney cancer, and ano-genital cancersPoints to consider for implementation: time period will need to be determined (i.e., total number of patients transplanted over 1 yr, 5 yr, etc.) for correct calculation of incidence Percentage of patients who are alive after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who are alivePoints to consider for implementation: time period will need to be determined—i.e., percentage alive at 1 yr, 5 yr, or some other time post-transplant Percentage of patients who have a functioning kidney transplantDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who have a functioning kidney transplantPoints to consider for implementation: time period will need to be determined—i.e., percentage with functioning transplant at 1 yr, 5 yr, or some other time point post-transplant Percentage of nondiabetic patients screened for diabetes after kidney transplantationDenominator: total number of nondiabetic kidney transplant recipientsNumerator: number of people in the denominator who are screened for diabetesPoints to consider for implementation: (i) KDIGO transplant recipient guideline recommends screening for diabetes weekly × 4, then every 3 months for the first year and then annually thereafter; (ii) successful screening will need to be determined—do you need to be screened 8 times in the first year or is once acceptable? Percentage of patients who are diagnosed with new-onset diabetes after kidney transplantationDenominator: total number of nondiabetic kidney transplant recipientsNumerator: number of people in the denominator who are diagnosed with new-onset diabetesPoints to consider for implementation: (i) time period will need to be determined—i.e., percentage with new-onset diabetes at 1 yr, 3 yr, or some other time post-transplant; (ii) consider alternate denominator of number of nondiabetic kidney transplant recipients screened for diabetes Percentage of diabetic kidney transplant recipients who meet current treatment targets for glycemic controlDenominator: total number of kidney transplant recipients with diabetesNumerator: number of people in the denominator who meet current treatment targets for glycemic control Percentage of kidney transplant recipients who had their blood lipid profile measured at least once in the past yearDenominator: total number of patients who are at least 1-yr post-transplantNumerator: number of people in the denominator who had a blood lipid profile measuredPoints to consider for implementation: KDIGO transplant recipient guideline recommends screening for dyslipidemia at 3 months post-transplant and then annually thereafter Percentage of kidney transplant recipients who meet current guidelines for lipid managementDenominator: total number of patients who are at least 1 yr post-transplantNumerator: number of people in the denominator who meet current guidelines for lipid managementPoints to consider for implementation: guidelines evolving but may indicate a specific treatment target (e.g., low-density lipoprotein < 2.0 mmol/l) or that a treatment is given (e.g., patient on a statin) Percentage of kidney transplant recipients who meet current guidelines for BP managementDenominator: total number of patients who are at least 6 months post-transplantNumerator: number of people in the denominator who meet current guidelines for BP managementPoints to consider for implementation: (i) assumes BP is measured at each clinic visit; (ii) BP guidelines evolving so exact BP target not indicated for this metric; (iii) will need to decide which BP value to use (i.e., last recorded BP, average of last 3 visits, etc.)EFFICIENT Number of days from admission to discharge after kidney transplantation (length of stay)Calculation: can be measured as mean, median, or distribution of length of stay (in days) from time patient admitted until discharged after kidney transplantationSAFE Percentage of patients who die during the initial hospitalization for kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who die during the initial hospitalization for kidney transplantation Percentage of patients who experience a serious safety event during the initial hospitalization for kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a serious safety event during the initial hospitalization for kidney transplantationNote: a serious safety event can be an erroneous and/or incompatible blood transfusion, major medication error, retained foreign body, pressure ulcer, fracture, fallPATIENT-CENTERED Percentage of patients evaluated for kidney transplantation who report a high level of satisfaction with the educational resources providedDenominator: total number of patients being evaluated for kidney transplantationNumerator: number of people in the denominator who report a high level of satisfaction with the educational resources providedNote: educational resources (e.g., information sessions, videos, handouts) may be provided by CKD program, dialysis unit, or transplant programPoints to consider for implementation: (i) separate measure can be calculated for transplant program, CKD program, and dialysis unit; (ii) questionnaire will need to be developed Percentage of patients undergoing evaluation who consider themselves to have a good understanding of the kidney transplant processDenominator: total number of patients evaluated for kidney transplantationNumerator: number of people in the denominator who consider themselves to have a good understanding of the kidney transplant processNote: this is a self-assessment done by the patientPoints to consider for implementation: (i) measure soon after evaluation process completed; (ii) questionnaire will need to be developed Percentage of kidney transplant patients who thought they were well informed about the procedureDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who thought they were well informed about the procedureNote: this is a self-assessment done by the patientPoints to consider for implementation: (i) measure near the day of discharge from hospital; (ii) questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received during the pretransplant evaluation processDenominator: total number of patients being evaluated for transplantationNumerator: number of people in the denominator who report a high level of satisfaction with the care receivedPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received during the transplant hospitalizationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who report a high level of satisfaction with the care received during the hospitalizationPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received in the post-transplant clinicDenominator: total number of kidney transplant patients discharged from hospitalNumerator: number of people in the denominator who report a high level of satisfaction with the care received in post-transplant clinicPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report excellent HR

Background. This is the first time deemed consent, where the entire population of a jurisdiction is considered to have consented for donation unless they have registered otherwise, will be implemented in North America. While relatively common in other regions of the world—notably Western Europe—it is uncertain how this practice will influence deceased donation practices and attitudes in Canada. Methods. We describe a Health Canada funded program of research that will evaluate the implementation process and full impact of the deceased organ donation legislation and the health system transformation in Nova Scotia that includes opt-out consent. Results. There is a need to evaluate the impact of these changes to inform not only Nova Scotia and Atlantic Canada, but also other provincial, national, and international stakeholders. Conclusions. We establish a rigorous academic framework that we will use to evaluate this significant health system transformation.