Comparison of Acute Health Care Utilization Between Patients Receiving In-Center Hemodialysis and the General Population: A Population-Based Matched Cohort Study From Ontario, Canada.

Background: Patients receiving maintenance hemodialysis have multiple comorbidities and are at high risk of presenting to the hospital. However, the incidence and cost of acute health care utilization in the in-center hemodialysis population and how this compares with other populations is poorly understood. Objective: To determine the rate, pattern, and cost of emergency department visits and hospitalizations in patients receiving in-center hemodialysis compared with a matched general population. Design: Population-based matched cohort study. Setting: We used linked administrative health care databases from Ontario, Canada. Patients: We included 25 379 patients (incident and prevalent) receiving in-center hemodialysis between January 1, 2010, and December 31, 2018. Patients were matched on birth date (±2 years), sex, and cohort entry date using a 1:4 ratio to 101 516 individuals from the general population. Measurements: Our primary outcomes were emergency department visits (allowing for multiple visits per individual) and hospital admissions from the emergency department. We also assessed all-cause hospitalizations, all-cause readmissions within 30 days of discharge from the original hospitalization, length of stay for hospital admissions (including multiple visits per individual), and the financial cost of these admissions. Methods: We presented the rate, percentage, median (25th, 75th percentiles), and incidence rate per 1000 person-years for emergency department visits and hospitalizations. Individual-level health care costs for emergency department visits and all-cause hospitalization were estimated using resource intensity weights multiplied by the cost per weighted case. Results: Patients receiving in-center hemodialysis had substantially more comorbidities (eg, diabetes) than the matched general population. Eighty percent (n = 20 309) of patients receiving in-center hemodialysis had at least 1 emergency department visit compared with 56% (n = 56 452) of individuals in the matched general population, over a median follow-up of 1.8 years (25th, 75th percentiles: 0.7, 3.6) and 5.2 (2.5, 8.4) years, respectively. The incidence rate of emergency department visits, allowing for multiple visits per individual, was 2274 per 1000 person-years (95% confidence interval [CI]: 2263, 2286) for patients receiving in-center hemodialysis, which was almost 5 times as high as the matched general population (471 per 1000 person-years; 95% CI: 469, 473). The rate of hospital admissions from the emergency department and the rate of all-cause hospital admissions in the in-center hemodialysis population was more than 7 times as high as the matched general population (hospital admissions from the emergency department: 786 vs 101 per 1000 person-years; all-cause hospital admissions: 1056 vs 139 per 1000 person-years). The median number of all-cause hospitalization days per patient year was 4.0 (0, 16.5) in the in-center hemodialysis population compared with 0 (0, 0.5) in the matched general population. The cost per patient-year for emergency department visits in the in-center hemodialysis population was approximately 5.5 times as high as the matched general population while the cost of hospitalizations in the in-center hemodialysis population was approximately 11 times as high as the matched general population (emergency department visits: CAN$ 1153 vs CAN$ 209; hospitalizations: CAN$ 21 151 vs CAN$ 1873 [all costs in 2023 CAN$]). Limitations: External generalizability and we could not determine whether emergency department visits and hospitalizations were preventable. Conclusions: Patients receiving in-center hemodialysis have high acute health care utilization. These results improve our understanding of the burden of disease and the associated costs in the in-center hemodialysis population, highlight the need to improve acute outcomes, and can aid health care capacity planning. Additional research is needed to address the risk of hospitalization after controlling for patient comorbidities. Trial registration: This is not applicable as this is a population-based matched cohort study and not a clinical trial.

Contexte: Les patients qui suivent des traitements d'hémodialyse d'entretien présentent de multiples comorbidités et sont hautement susceptibles de se présenter à l'hôpital. On en sait toutefois peu sur l'incidence de l'utilization des soins de santé aigus chez les patients hémodialysés en center, sur les coûts qui y sont associés, ainsi que sur la manière dont cela se compare à d'autres populations. Objectif: Déterminer, dans une population de patients hémodialysés en center, les taux d'hospitalizations et de visites aux urgences, leurs schémas et les coûts qui y sont associés, puis comparer ces résultats à ceux d'une population générale appariée. Type d'étude: Étudede cohorte populationnelle rétrospective. Cadre: Nous avons utilisé les bases de données couplées du système de santé de l'Ontario (Canada). Sujets: Nous avons inclus 25 379 patients (incidents et prévalents) qui recevaient des traitements d'hémodialyse en center entre le 1er janvier 2010 et le 31 décembre 2018. Les patients inclus ont été appariés,en fonction de leur date de naissance (± 2 ans), de leur sexe et de leur date d'entrée dans la cohorte, à 101 516 individus de la population générale dans un rapport de 1:4. Mesures: Nos principaux critères de jugement étaient les visites aux urgences (en permettant plusieurs visites par personne) et les admissions à l'hôpital à partir de l'urgence. Nous avons également évalué les hospitalizations toutes causes confondues, les réadmissions toutes causes confondues dans les 30 jours suivant le congé initial, la durée du séjour (en comptant les visites multiples par personne) et les coûts associés à ces admissions. Méthodologie: Nous avons présenté le nombre, le pourcentage, la médiane (25e et 75e percentile) et le taux d'incidence par 1000 années-personnes pour les visites aux urgences et les hospitalizations. Les coûts de santé par individu associés aux visites à l'urgence et aux hospitalizations toutes causes confondues ont été estimés en multipliant la pondération du volume des ressources par le coût pondéré par cas. Résultats: Les patients hémodialysés en center présentaient beaucoup plus de comorbidités (p. Ex. diabète) que la population générale appariée. Au cours d'un suivi médian respectif de 1,8 an (25e et 75e percentile: 0,7 et 3,6 ans) et de 5,2 ans (2,5 et 8,4 ans), 80 % (n=20 309) des patients hémodialysés en center ont visité l'urgence au moins une fois, contre 56 % (n= 56 452) des patients de la population générale appariée. Le taux d'incidence des visites aux urgences, en permettant plusieurs visites par personne, était de 2274 pour 1000 années-personnes (intervalle de confiance à 95% [IC 95%]: 2 263 à 2 286) chez les patients hémodialysés en center, soit presque cinq fois plus élevé que la population générale appariée (471 pour 1000 années-personnes; IC95 %: 469 à 473). Les taux d'admissions à partir de l'urgence et d'hospitalizations toutes causes confondues dans la population de patients hémodialysés en center étaient plus de sept fois plus élevés que dans la population générale appariée (admissions à partir de l'urgence: 786 contre 101 pour 1000 années-personnes; hospitalizations toutes causes confondues: 1056 contre 139 pour 1000 années-personnes). La durée médiane des hospitalizations toutes causes confondues par année-patient était de 4,0 jours (0 et 16,5 jours) chez les patients hémodialysés en center et de 0 jour (0 et 0,5 jour) dans la population générale appariée. Le coût par année-patient des visites à l'urgence chez les patients hémodialysés en center était environ 5,5 fois plus élevé que dans la population générale appariée, tandis que celui des hospitalizations était environ 11 fois plus élevé (visites à l'urgence: 1153 CAD contre 209 CAD; hospitalizations: 21 151 CAD contre 1873 CAD [coûts en dollars canadiens de 2023]). Limites: Généralisabilité externe; impossiblede déterminer si les visites aux urgences et les hospitalizations étaient évitables. Conclusion: Les patients hémodialysés en center sont de grands utilisateurs des soins de santé aigus. Ces résultats améliorent notre compréhension du fardeau de la maladie et des coûts associés à cette utilization dans cette population. Ces résultats soulignent également la nécessité d'améliorer les résultats des soins aigus et peuvent aider à la planification des capacités en matière de soins de santé. D'autres études sont nécessaires pour examiner le risque d'hospitalization après la gestion des comorbidités des patients.

Infection Control Practices in In-Center Hemodialysis Units During Wave 1 of the COVID-19 Pandemic in Ontario, Canada: Research Letter.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a virus that caused coronavirus disease 2019 (COVID-19), the multisystem disease central to the COVID-19 pandemic. As patients receiving in-center maintenance hemodialysis require treatment 3 times weekly, they were unable to fully isolate. It was important for in-center hemodialysis units to implement robust infection control practices to ensure patient safety and minimize risk of transmitting SARS-CoV-2 among patients and staff. There are 27 renal programs within Ontario, Canada, providing care for about 9000 people across about 100 in-center hemodialysis units. These units are funded by the Ontario Renal Network (ORN), which is part of the provincial agency Ontario Health. Objective: The objective was to track infection control practices that were implemented by in-center hemodialysis units and be able to provide a descriptive narrative of the COVID-19 pandemic response of Ontario's hemodialysis units between March and September 2020. Methods: Between May and September 2020, data were collected from Ontario's 27 renal programs on the implementation of key infection control practices, including symptom screening, use of personal protective equipment, testing, practices specifically related to patients from congregate living settings, other prevention practices, and outbreak management. There were 4 data collection cycles, each approximately 1 month apart. The results were compiled and shared across the province, and infection control practices were also discussed at provincial COVID-19 teleconferences hosted by the ORN. Results: By March 2020, all but one renal program had implemented one or more forms of symptom screening, all renal programs had implemented physical distancing in waiting rooms and restricted visitors, and 74% of renal programs had implemented universal masking for all staff. By April 2020, 89% of renal programs had implemented universal masking for all patients, 52% had implemented enhanced contact and droplet precautions for suspected or positive cases, and 59% of renal programs tested all patients from congregate living settings regularly (with a low symptom threshold for testing). Infection control practices became more homogeneous across renal programs over time, and most practices were in place as of the last data collection. Conclusions: The renal system in Ontario was able to respond quickly within the first 2 months of the pandemic to minimize the spread of COVID-19 within in-center hemodialysis units. Through provincial teleconferences, infection control practices were shared across the province as the pandemic and hemodialysis unit responses evolved. This supported renal programs to advocate locally if their hospital was lagging in practices felt to be of value in other hemodialysis units. Although no direct correlation can be made regarding the implementation of infection control practices within in-center hemodialysis units and the number of COVID-19 cases in this population, the limited number of outbreaks in hemodialysis units may have been influenced by the proactive response of renal programs. Practices described in this article may support management and response to subsequent waves of COVID-19 or future similar infectious diseases.

Province-Wide Prevalence Testing for SARS-CoV-2 of In-Center Hemodialysis Patients and Staff in Ontario, Canada: A Cross-Sectional Study.

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 (<0.07%) were new positive cases, 7 were false positive, and the remaining were recovered positives. Half of the new positive cases had symptoms. Common symptoms reported included fatigue (4%), falls (4%), runny nose (3%), dyspnea (3%), and cough (3%). Staff participation was 49% (2109 of 4325), and less than 5 (<0.24%) were asymptomatic positive. 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.

Growing home dialysis: The Ontario Renal Network Home Dialysis Initiative 2012-2019.

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.

COVID-19 chez les patients ontariens sous dialyse à long terme.

CONTEXTE: Les patients sous dialyse à long terme pourraient avoir un risque accru d'infection par le coronavirus du syndrome respiratoire aigu sévère 2 (SRAS-CoV-2), et de maladie et de mortalité associées. Nous avons voulu décrire l'incidence, les facteurs de risque et les issues de l'infection chez ces patients en Ontario (Canada). MÉTHODES: Nous avons utilisé des ensembles de données reliées pour comparer les caractéristiques de la maladie et la mortalité chez les patients sous dialyse à long terme en Ontario qui ont testé positif pour le SRAS-CoV-2 et ceux qui n'ont pas développé d'infection, entre le 12 mars et le 20 août 2020. Nous avons recueilli des données sur l'infection par le SRAS-CoV-2 de manière prospective. Nous avons évalué les facteurs de risque d'infection et de mortalité par des analyses de régression logistique multivariées. RÉSULTATS: Pendant la période à l'étude, 187 patients dialysés sur 12 501 (1,5 %) ont reçu un diagnostic d'infection par le SRAS-CoV-2. Parmi eux, 117 (62,6 %) ont été hospitalisés, et le taux de mortalité était de 28,3 %. Les facteurs prédictifs significatifs associés à l'infection incluaient l'hémodialyse dans un centre plutôt que la dialyse à domicile (rapport de cotes [RC] 2,54; intervalle de confiance [IC] à 95 % 1,59­4,05), le fait de vivre dans un établissement de soins de longue durée (RC 7,67; IC à 95 % 5,30­11,11), le fait d'habiter la région du Grand Toronto (RC 3,27; IC à 95 % 2,21­4,80), les ethnicités Noire (RC 3,05; IC à 95 % 1,95­4,77), du sous-continent indien (RC 1,70; IC à 95 % 1,02­2,81) et autres non blanches (RC 2,03; IC à 95 % 1,38­2,97) et les quintiles de revenu inférieurs (RC 1,82; IC à 95 % 1,15­2,89). INTERPRÉTATION: Les patients sous dialyse à long terme sont exposés à un risque accru d'infection par le SRAS-CoV-2 et de mortalité due à la maladie à coronavirus 2019. Il faudra travailler à éliminer les facteurs de risque d'infection et vacciner ces patients en priorité.

COVID-19 in patients undergoing long-term dialysis in Ontario.

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.

Health related quality of life utility weights for economic evaluation through different stages of chronic kidney disease: a systematic literature review.

BACKGROUND: A Task Force from the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) provides recommendations on how to systematically identify and appraise health state utility (HSU) weights for cost-effectiveness analyses. We applied these recommendations to conduct a systematic review (SR) to identify HSU weights for different stages of chronic kidney disease (CKD), renal replacement therapy (RRT) and complications. METHODS: MEDLINE® and Embase were searched for interventional and non-interventional studies reporting HSU weights for patients with CKD stages 1-5 or RRT. As per ISPOR Task Force Guidance, study quality criteria, applicability for Health Technology Assessment (HTA) and generalisability to a broad CKD population were used to grade studies as either 1 (recommended), 2 (to be considered if there are no data from grade 1 studies) or 3 (not recommended). RESULTS: A total of 17 grade 1 studies were included in this SR with 51 to 1767 participants, conducted in the UK, USA, Canada, China, Spain, and multiple-countries. Health related quality of life (HRQL) instruments used in the studies included were EQ-5D-3L (10 studies), SF-6D (4 studies), HUI2/HUI3 (1 study), and combinations (2 studies). Although absolute values for HSU weights varied among instruments, HSU weights decreased with CKD severity in a consistent manner across all instruments. CONCLUSIONS: This SR identified HSU weights for a range of CKD states and showed that HRQL decreases with CKD progression. Data were available to inform cost-effectiveness analysis in CKD in a number of geographies using instruments acceptable by HTA agencies.

Home Dialysis Is Associated with Lower Costs and Better Survival than Other Modalities: A Population-Based Study in Ontario, Canada.

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.

Total Kidney Volume as a Biomarker of Disease Progression in Autosomal Dominant Polycystic Kidney Disease.

PURPOSE OF REVIEW: Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disorder characterized by the formation of kidney cysts and kidney enlargement, which progresses to kidney failure by the fifth to seventh decade of life in a majority of patients. Disease progression is evaluated primarily through serum creatinine and estimated glomerular filtration rate (eGFR) measurements; however, it is known that serum creatinine and eGFR values typically do not change until the fourth or fifth decade of life. Until recently, therapy only existed to target complications of ADPKD. As therapeutic agents continue to be investigated for use in ADPKD, a suitable biomarker of disease progression in place of serum creatinine is needed. SOURCES OF INFORMATION: This review summarizes recent research regarding the use of total kidney volume as a biomarker in ADPKD, as presented at the Canadian Society of Nephrology symposium held in April 2015. FINDINGS: Measurement of patients' total kidney volume made using ultrasound (US) or magnetic resonance imaging (MRI) has been shown by the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) study to be directly correlated with both increases in cyst volume and change in glomerular filtration rate (GFR). Additional studies have shown total kidney volume to have an association with complications of ADPKD as well. LIMITATIONS: Areas for further study continue to exist in comparison of methods of measuring total kidney volume. IMPLICATIONS: We believe that the evidence suggests that total kidney volume may be an appropriate surrogate marker for ADPKD disease progression.

MISE EN CONTEXTE ET OBJECTIF DE LA REVUE: La polykystose rénale autosomique dominante (PKD) est une maladie héréditaire caractérisée par la formation de kystes aux reins et par l'hypertrophie des reins. Chez la majorité des patients atteints, la PKD évolue vers l'insuffisance rénale entre l'âge de 50 et de 70 ans. La progression de la maladie est essentiellement évaluée par la mesure de la créatinine sérique et du débit de filtration glomérulaire estimé (DFGe). Toutefois, règle générale, ce n'est que vers l'âge de 40 à 50 ans que l'on observe des changements dans ces paramètres. Jusqu'à tout récemment, les traitements ne ciblaient que les complications de la PKD. Bien que des médicaments fassent l'objet d'études en vue de leur utilisation pour traiter la PKD, on constate l'importance d'identifier un biomarqueur qui remplacerait le dosage de la créatinine sérique et qui faciliterait le suivi de la progression de la maladie. SOURCES: La revue fait la synthèse des recherches menées récemment au sujet de l'utilisation de la mesure du volume total des reins comme biomarqueur de la PKD, comme présenté lors du symposium de la Société canadienne de néphrologie qui s'est tenu en avril 2015. CONSTATATIONS: L'étude CRISP (Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease) a démontré que les mesures du volume rénal total des patients, effectuées par ultrasons (US) ou par imagerie par résonance magnétique (MRI), sont directement corrélées à une augmentation du volume des kystes de même qu'à des variations du débit de filtration glomérulaire (DFG). LIMITES DE L'ÉTUDE: Plusieurs domaines de comparaison entre les différentes méthodes de mesure du volume total des reins sont encore à explorer. CONCLUSION: Nous sommes d'avis que les données probantes suggèrent que la mesure du volume total des reins pourrait s'avérer un marqueur substitut adéquat pour suivre la progression de la PKD.

Clinical safety and performance of VIVIA: a novel home hemodialysis system.

Background: The VIVIA Hemodialysis System (Baxter Healthcare Corporation, Deerfield, IL, USA) was designed for patient use at home to reduce the burden of treatment and improve patient safety. It has unique features including extended use of the dialyzer and blood set through in situ hot-water disinfection between treatments; generation of on-line infusible-quality dialysate for automated priming, rinseback and hemodynamic support during hypotension and a fully integrated access disconnect sensor. Methods: The safety and performance of VIVIA were assessed in two clinical studies. A first-in-man study was a prospective, single-arm study that involved 22 prevalent hemodialysis (HD) patients who were treated for ∼4 h, four times a week, for 10 weeks. A second clinical study was a prospective, single-arm study (6-8 h of dialysis treatment at night three times a week) that involved 17 prevalent patients treated for 6 weeks. Results: There were 1114 treatments from the two studies (first-in-man study, 816; extended duration study, 298). Adverse events (AEs) were similar in the two studies to those expected for prevalent HD patients. No deaths and no device-related serious AEs occurred. Adequacy of dialysis ( Kt / V ) urea in both clinical trials was well above the clinical guidelines. VIVIA performed ultrafiltration accurately as prescribed in the two studies. The majority of patients achieved 10 or more uses of the dialyzer. Endotoxin levels and bacterial dialysate sampling met infusible-quality dialysate standards. Conclusion: These results confirm the safety and expected performance of VIVIA.

Funding and planning: what you need to know for starting or expanding a home hemodialysis program.

Planning and funding a home hemodialysis (HD) program requires a well-organized effort and close collaboration between clinicians and administrators. This resource provides guidance on the processes that are involved, including a thorough situational analysis of the dialysis landscape, emphasizing the opportunity for a home HD program; careful consideration of the clinical and operational characteristics of a proposed home HD program at your institution; the development of a compelling business case, highlighting the clinical and organizational benefits of a home HD program; and careful construction and evaluation of a request for proposal.

Canadian Society of Nephrology commentary on the 2012 KDIGO clinical practice guideline for the management of blood pressure in CKD.

The KDIGO (Kidney Disease: Improving Global Outcomes) 2012 clinical practice guideline for the management of blood pressure (BP) in chronic kidney disease (CKD) provides the structural and evidence base for the Canadian Society of Nephrology (CSN) commentary on this guideline's relevancy and application to the Canadian health care system. While in general agreement, we provide commentary on 13 of the 21 KDIGO guideline statements. Specifically, we agreed that nonpharmacological interventions should play a significant role in the management of hypertension in patients with CKD. We also agreed that the approach to the management of hypertension in elderly patients with CKD should be individualized and take into account comorbid conditions to avoid adverse outcomes from excessive BP lowering. In contrast to KDIGO, the CSN Work Group believes there is insufficient evidence to target a lower BP for nondiabetic CKD patients based on the presence and severity of albuminuria. The CSN Work Group concurs with the Canadian Hypertension Education Program (CHEP) recommendation of a target BP for all non-dialysis-dependent CKD patients without diabetes of ≤140 mm Hg systolic and ≤90 mm Hg diastolic. Similarly, it is our position that in diabetic patients with CKD and normal urinary albumin excretion, raising the threshold for treatment from <130 mm Hg systolic BP to <140 mm Hg systolic BP could increase stroke risk and the risk of worsening kidney disease. The CSN Work Group concurs with the CHEP and the Canadian Diabetic Association recommendation for diabetic patients with CKD with or without albuminuria to continue to be treated to a BP target similar to that of the overall diabetes population, aiming for BP levels < 130/80 mm Hg. Consistent with this, the CSN Work Group endorses a BP target of <130/80 mm Hg for diabetic patients with a kidney transplant. Finally, in the absence of evidence for a lower BP target, the CSN Work Group concurs with the CHEP recommendation to target BP<140/90 mm Hg for nondiabetic patients with a kidney transplant.

The Canadian Society of Nephrology methods in developing and adapting clinical practice guidelines: a review.

INTRODUCTION: The Canadian Society of Nephrology (CSN) was established to promote the highest quality of care for patients with renal diseases and to encourage research related to the kidney and its disorders. The CSN Clinical Practice Guideline (CPG) Committee develops guidelines with clear recommendations to influence physicians' practice and improve the health of patients with kidney disease in Canada. REVIEW: In this review we describe the CSN process in prioritizing CPGs topics. We document the CSN experience using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We then detail the CSN process in developing de novo CPGs and in adapting existing CPGs and developing accompanying commentaries. We also discuss challenges faced during this process and suggest solutions. Furthermore, we summarize the CSN effort in disseminating and implementing their guidelines. Additionally, we describe recent development and partnerships that allow evaluation of the effect of the CSN guidelines and commentaries. CONCLUSION: The CSN follows a comprehensive process in identifying priority areas to be addressed in CPGs. In 2010, the CSN adopted GRADE, which enhanced the rigor and transparency of guideline development. This process focuses on systematically identifying best available evidence and carefully assessing its quality, balancing benefits and harms, considering patients' and societies' values and preferences, and when possible considering resource implications. Recent partnership allows wider dissemination and implementation among end users and evaluation of the effects of CPG and commentaries on the health of Canadians.

INTRODUCTION: La mission de la Société canadienne de néphrologie (SCN) est de promouvoir des soins de grande qualité aux patients atteints de maladies rénales et d'encourager la recherche en néphrologie. Le comité des guides de pratique clinique (GPC) de la SCN a pour objectif le développement de lignes directrices comportant des recommandations claires de façon à influencer la pratique médicale et d'améliorer le bien-être des patients atteints de maladies rénales au Canada. REVUE: Dans cette publication, nous décrivons l'approche utilisée par la SCN dans la priorisation des différents sujets abordés dans les GPC. Nous abordons l'expérience de la SCN avec l'utilisation de l'approche GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Nous détaillons également le processus utilisé par la SCN dans le développement de nouveaux GPC et dans la modification des GPC existants. Nous discutons des difficultés rencontrées lors de ce processus tout en suggérant des solutions. Nous résumons les efforts encourus par la SCN pour la diffusion et l'application des lignes directrices. Finalement, nous décrivons les récentes collaborations de la SCN permettant l'évaluation de l'impact des lignes directrices de la SCN. CONCLUSION: La SCN suit un processus rigoureux dans l'identification des priorités à aborder dans les GPC. Depuis 2010, la SCN a décidé d'adopter l'approche GRADE pour faire preuve de plus de rigueur et de transparence dans l'élaboration de lignes directrices. Cette approche consiste à identifier toutes les évidences en étudiant leur qualité, en mesurant les risques et les bénéfices, en considérant les valeurs et les préférences pour les patients ainsi que la société et en tenant compte des ressources disponibles. Le partenariat permet une plus grande diffusion des guides de pratique et une évaluation des effets des GPC sur la santé des canadiens.

Canadian Society of Nephrology commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD.

The KDIGO (Kidney Disease: Improving Global Outcomes) 2012 clinical practice guideline for anemia management in patients with chronic kidney disease provides the structural and evidence base for the Canadian Society of Nephrology commentary on this guideline's relevancy and application to the Canadian health care system. While in general agreement, we provide commentary on 11 of the 61 KDIGO guideline statements. Specifically, we agreed that a therapeutic trial of iron is appropriate in cases in which a reduction in erythropoiesis-stimulating agent (ESA) dosage or avoidance of ESA and transfusion is desired, transferrin saturations are >30%, and ferritin concentrations are >500 µg/L. However, we concluded that there is insufficient evidence to support an upper target or threshold for ferritin and transferrin saturation levels. We agree with the initiation of ESA treatment when hemoglobin (Hb) level is 90-100 g/L; however, we specifically state that an acceptable range for Hb level is 95-115 g/L, with a target of 100-110 g/L, and add caution to individualization above this range due to concerns regarding the safety of ESAs. We agree that ESAs should be used with considerable caution in patients with active malignancy, history of stroke, or history of malignancy, and we suggest initiating ESA therapy at Hb level of 90 g/L and to aim for a Hb level in the range of 90-105 g/L. The reader is encouraged to note the level of evidence and review the entire KDIGO anemia guideline to interpret the guideline statements and commentary appropriately.

Prevalence estimates of chronic kidney disease in Canada: results of a nationally representative survey.

BACKGROUND: Chronic kidney disease is an important risk factor for death and cardiovascular-related morbidity, but estimates to date of its prevalence in Canada have generally been extrapolated from the prevalence of end-stage renal disease. We used direct measures of kidney function collected from a nationally representative survey population to estimate the prevalence of chronic kidney disease among Canadian adults. METHODS: We examined data for 3689 adult participants of cycle 1 of the Canadian Health Measures Survey (2007-2009) for the presence of chronic kidney disease. We also calculated the age-standardized prevalence of cardiovascular risk factors by chronic kidney disease group. We cross-tabulated the estimated glomerular filtration rate (eGFR) with albuminuria status. RESULTS: The prevalence of chronic kidney disease during the period 2007-2009 was 12.5%, representing about 3 million Canadian adults. The estimated prevalence of stage 3-5 disease was 3.1% (0.73 million adults) and albuminuria 10.3% (2.4 million adults). The prevalence of diabetes, hypertension and hypertriglyceridemia were all significantly higher among adults with chronic kidney disease than among those without it. The prevalence of albuminuria was high, even among those whose eGFR was 90 mL/min per 1.73 m(2) or greater (10.1%) and those without diabetes or hypertension (9.3%). Awareness of kidney dysfunction among adults with stage 3-5 chronic kidney disease was low (12.0%). INTERPRETATION: The prevalence of kidney dysfunction was substantial in the survey population, including individuals without hypertension or diabetes, conditions most likely to prompt screening for kidney dysfunction. These findings highlight the potential for missed opportunities for early intervention and secondary prevention of chronic kidney disease.

The STARRT trial: a cost comparison of optimal vs sub-optimal initiation of dialysis in Canada.

BACKGROUND: Sub-optimal transitioning of patients from chronic kidney disease (CKD) to end stage renal disease (ESRD) may result in poor clinical outcomes and increased healthcare costs. The objectives of this study were to estimate the average total cost per patient who requires initiation of renal replacement therapy (RRT) stratified by status at initiation; optimal (RRT initiation as an outpatient with an arterio-venous [AV] Fistula, Graft or Peritoneal Dialysis [PD] catheter), and sub-optimal (RRT initiation as an inpatient and/or via central venous catheter [CVC]). METHODS: Data from the Study To Assess Renal Replacement Therapy (STARRT), a Canadian, multi-centre, 6 month retrolective study (n = 339), were used for this analysis. Unit costs for resources were obtained from participating hospitals, the literature, and/or standard costing sources. The analysis was performed from the perspective of healthcare payors and reported in 2011 Canadian Dollars (CAD). A propensity score technique was applied to control for potential confounders between the two groups. RESULTS: Two hundred of the eligible patients for analysis (61.9%) were sub-optimally and 123 (38.1%) were optimally prepared. For this analysis, 106 "matched" pairs were used. The average total cost per patient was estimated to be $63,225 (with a 95% CI ranging from $58,663-$67,958) for the sub-optimally initiated patients, and $39,260 (with a 95% CI ranging from $35,683-$43,007) for the optimally initiated patients (p < 0.001). LIMITATIONS: Costs were calculated utilizing a conservative approach, using the cheapest available prices for medications and other resources. Assumptions had to be made for the costing of dialyses. CONCLUSION: The results of this study indicate, after adjusting for potential confounders, that optimally initiated patients for RRT have significantly lower healthcare-associated costs compared to sub-optimally initiated patients.

Economic considerations in frequent home hemodialysis.

Hemodialysis (HD) is often used as an example of the most expensive chronic medical intervention that society will pay for on an ongoing basis. More intensive forms of HD have been associated with improved clinical outcomes, but concerns have been raised regarding the possibility of increased costs. We review recent Canadian studies examining the costs and cost utility of intensive HD, with a focus on comparisons with conventional in-center hemodialysis (IHD). The costs of starting a new home nocturnal hemodialysis (HNHD) program in British Columbia was estimated to be about $510,000 for the first year of the program, including the training of the first 53 patients, or about $18,830 per patient. A study by Lee et al. found the costs of home HD to be substantially less than IHD ($93,976 vs. $54,936, p < 0.001). A study by Kroeker et al. found that the lowest costs were seen with home short daily HD ($82,522), compared with $89,154 for IHD, and $91,218 for HNHD. Two studies by McFarlane et al. found that total costs were lower for those receiving HNHD (IHD $87,172 vs. HNHD $71,313), and that HNHD was associated with a superior cost-utility ratio (CAN$ 2011, HNHD $84,430/quality-adjusted life year [QALY] vs. IHD $148,722/QALY, incremental cost-effectiveness ratio: -$54,281, p < 0.05). While consistent findings of lower staffing and overhead costs for home HD, and higher consumable costs for frequent dialysis are probably reliable, findings of lower medication and hospital admission costs seen with intensive HD will need confirmation in randomized studies. Modifications to conventional dialysis funding are needed to accommodate for the additional costs of supplies and technology needed to support intensive modalities.

Conditionally funded field evaluations--a solution to the economic barriers limiting evidence generation in dialysis?

Evaluation of new therapies after licensing is usually a binary decision by payers; to fund or not to fund. In the real world, many therapies fall into a gray zone of incomplete evaluation. Many clinical and economic issues in nephrology have combined to create a long list of such promising but incompletely evaluated therapies. This article focuses on the economic challenges that limit evidence generation in nephrology. Conditionally funded field evaluations such as coverage with evidence development can allow both earlier access to new treatments and rigorous evaluation. The authors propose that field evaluations will stimulate an environment that promotes pivotal renal care advances. Certainly, the evidence challenge faced by nephrology requires urgent discussions on creating conditions that catalyze and accelerate innovation, and improve patient outcomes.

Use of the BioHole™ device for the creation of tunnel tracks for buttonhole cannulation of fistula for hemodialysis.

Buttonhole cannulation is a method of cannulation of native arteriovenous fistulae traditionally practiced by self-cannulators. At St Michael's Hospital, this method has been modified to allow its use in problematic fistulae by multiple cannulators. In a busy dialysis unit, the need for a few specific cannulators to establish the tunnel tracks in combination with the variable dialysis schedules creates logistical challenges. A new method of creating tunnel tracks with the use of the BioHole™ device was evaluated. Buttonhole tracks were created in 12 patients using a peg of polycarbonated material with a holder (BioHole™ kit). The peg was inserted into the path left by the hemodialysis sharp needle following the index cannulation. Four of the 12 patients had an alternate access. Buttonhole tracks were successfully created in all the patients, albeit in 2 patients, the initial attempt to establish buttonhole tracks was aborted due to complications and the procedure was rescheduled. Compared with the modified buttonhole technique, pain on cannulation following track creation was significantly less in the BioHole™ group (P < 0.001). Ease of cannulation was significantly improved in the BioHole™ group (P<0.05) when compared with that in thrice-weekly patients using the modified buttonhole technique. Hemostasis postdialysis did not differ between the study groups. The use of the BioHole™ device is effective in the creation of tunnel tracks for buttonhole cannulation, is associated with less pain, and simplifies the logistics of arranging patient and nurses' schedules.