Association Between the Dialysate Bicarbonate and the Pre-dialysis Serum Bicarbonate Concentration in Maintenance Hemodialysis: A Retrospective Cohort Study.

Background: It is unclear whether the use of higher dialysate bicarbonate concentrations is associated with clinically relevant changes in the pre-dialysis serum bicarbonate concentration. Objective: The objective is to examine the association between the dialysate bicarbonate prescription and the pre-dialysis serum bicarbonate concentration. Design: This is a retrospective cohort study. Setting: The study was performed using linked administrative health care databases in Ontario, Canada. Patients: Prevalent adults receiving maintenance in-center hemodialysis as of April 1, 2020 (n = 5414) were included. Measurements: Patients were grouped into the following dialysate bicarbonate categories at the dialysis center-level: individualized (adjustment based on pre-dialysis serum bicarbonate concentration) or standardized (>90% of patients received the same dialysate bicarbonate concentration). The standardized category was stratified by concentration: 35, 36 to 37, and ≥38 mmol/L. The primary outcome was the mean outpatient pre-dialysis serum bicarbonate concentration at the patient level. Methods: We examined the association between dialysate bicarbonate category and pre-dialysis serum bicarbonate using an adjusted linear mixed model. Results: All dialysate bicarbonate categories had a mean pre-dialysis serum bicarbonate concentration within the normal range. In the individualized category, 91% achieved a pre-dialysis serum bicarbonate ≥22 mmol/L, compared to 87% in the standardized category. Patients in the standardized category tended to have a serum bicarbonate that was 0.25 (95% confidence interval [CI] = -0.93, 0.43) mmol/L lower than patients in the individualized category. Relative to patients in the 35 mmol/L category, patients in the 36 to 37 and ≥38 mmol/L categories tended to have a serum bicarbonate that was 0.70 (95% CI = -0.30, 1.70) mmol/L and 0.87 (95% CI = 0.14, 1.60) mmol/L higher, respectively. There was no effect modification by age, sex, or history of chronic lung disease. Limitations: We could not directly confirm that all laboratory measurements were pre-dialysis. Data on prescribed dialysate bicarbonate concentrations for individual dialysis sessions were not available, which may have led to some misclassification, and adherence to a practice of individualization could not be measured. Residual confounding is possible. Conclusions: We found no significant difference in the pre-dialysis serum bicarbonate concentration irrespective of whether an individualized or standardized dialysate bicarbonate was used. Dialysate bicarbonate concentrations ≥38 mmol/L (vs 35 mmol/L) may increase the pre-dialysis serum bicarbonate concentration by 0.9 mmol/L.

Contexte: On ignore si des concentrations plus élevées de bicarbonate dans le dialysat sont associées à des changements cliniquement significatifs dans le taux de bicarbonate sérique prédialyse. Objectif: Examiner l'association entre la prescription de bicarbonate du dialysat et le taux de bicarbonate sérique prédialyse. Conception: Étude de cohorte rétrospective. Cadre: Étude réalisée en Ontario (Canada) à partir des données administratives de santé. Sujets: Ont été inclus les adultes prévalents qui recevaient une hémodialyse chronique en centre le 1er avril 2020 (n=5 414). Mesures: Les sujets ont été regroupés dans les catégories suivantes de concentration en bicarbonate dans le dialysat utilisée dans leur unité de dialyse: individualisée (ajustée selon le taux de bicarbonate sérique prédialyse) ou normalisée (même concentration pour >90% des sujets). La catégorie « standardisée ¼ a été stratifiée selon la concentration: 35 mmol/L, 36 à 37 mmol/L et ≥38 mmol/L. Le principal critère d'évaluation était le taux moyen de bicarbonate sérique prédialyse en ambulatoire au niveau du patient. Méthodologie: Nous avons examiné l'association entre la catégorie de concentration en bicarbonate du dialysat et le taux de bicarbonate sérique prédialyse à l'aide d'un modèle linéaire mixte corrigé. Résultats: Pour toutes les catégories de concentration en bicarbonate du dialysat, le taux moyen de bicarbonate sérique prédialyse était dans la plage normale. Dans la catégorie « individualisée ¼, 91% des sujets avaient un taux de bicarbonate sérique prédialyse de ≥22 mmol/L, comparativement à 87% dans la catégorie « standardisée ¼. Les patients de la catégorie « standardisée ¼ tendaient à avoir un taux de bicarbonate sérique de 0,25 mmol/L (IC 95%: -0,93 à 0,43) inférieur à celui des patients de la catégorie « individualisée ¼. Comparé aux patients de la catégorie 35 mmol/L, les patients des catégories 36 à 37 mmol/L et ≥38 mmol/L tendaient respectivement à avoir un taux de bicarbonate sérique de 0,70 mmol/L (IC 95%: -0,30 à 1,70) et de 0,87 mmol/L (IC 95%: 0,14 à 1,60) plus élevé. L'âge, le sexe ou les antécédents de maladie pulmonaire chronique n'ont pas semblé modifier l'effet. Limites: Il n'a pas été possible de confirmer directement que toutes les mesures de laboratoire avaient été effectuées avant la dialyse. Les données sur les concentrations de bicarbonate prescrites pour les séances de dialyse individuelles n'étaient pas disponibles, ce qui peut avoir conduit à une classification erronée. De plus, l'observance d'une pratique d'individualisation n'a pas pu être mesurée. Une confusion résiduelle est possible. Conclusion: Nous n'avons observé aucune différence significative dans les taux de bicarbonate sériques prédialyse, qu'on ait utilisé une concentration individualisée ou standardisée de bicarbonate dans le dialysat. L'utilisation d'un dialysat à ≥38 mmol/L (c. 35 mmol/L) de bicarbonate peut entraîner une hausse de 0,9 mmol/L du taux de bicarbonate sérique prédialyse.

Exercise perceptions and practices of people receiving peritoneal dialysis: An international cross-sectional survey.

BACKGROUND: Low physical activity and functional impairment are prevalent and unaddressed in people receiving peritoneal dialysis (PD). Exercise has been shown to improve physical function and mental health for people with kidney disease. METHODS: Cross-sectional descriptive survey aimed at identifying the exercise and physical activity perceptions and practice patterns of people receiving PD. The survey was developed and pretested with persons living with kidney disease, PD clinicians and exercise specialists. RESULTS: There were 108 respondents (people receiving PD) with the majority from Canada (68%) and the United Kingdom (25%). Seventy-one per cent were engaged in physical activity two or more times per week. Most (91.8%) believed that physical activity is beneficial, and 61.7% reported healthcare provider discussion about physical activity. Perceptions regarding weightlifting restrictions varied: 76% were told not to lift weight with a maximum amount ranging from 2 kg to 45 kg. Few (28%) were instructed to drain PD fluid prior to physical activity. Mixed advice regarding swimming ability was common (44% were told they could swim and 44% were told they should not). CONCLUSIONS: Knowledge gaps suggest that education for both healthcare providers and patients is needed regarding the practice of exercise for people living with PD. Common areas of confusion include the maximum weight a person should lift, whether exercise was safe with or without intrabdominal PD fluid in situ and whether swimming is allowed. Further research is needed to provide patients with evidence-based recommendations rather than defaulting to restricting activity.

Randomized Controlled Trial of the Effect of an Exercise Rehabilitation Program on Symptom Burden in Maintenance Hemodialysis: A Clinical Research Protocol.

Background: People receiving hemodialysis experience high symptom burden that contributes to low functional status and poor health-related quality of life. Management of symptoms is a priority for individuals receiving hemodialysis but limited effective treatments exist. There is emerging evidence that exercise programming can improve several common dialysis-related symptoms. Objective: The primary aim of this study is to evaluate the effect of an exercise rehabilitation program on symptom burden in individuals receiving maintenance hemodialysis. Design: Multicenter, randomized controlled, 1:1 parallel, open label, prospective blinded end point trial. Setting: Three facility-based hemodialysis units in Winnipeg, Manitoba, Canada. Participants: Adults aged 18 years or older with end-stage kidney disease receiving facility-based maintenance hemodialysis for more than 3 months, with at least 1 dialysis-related symptom as indicated by the Dialysis Symptom Index (DSI) severity score >0 (n = 150). Intervention: Supervised 26-week exercise rehabilitation program and 60 minutes of cycling during hemodialysis thrice weekly. Exercise intensity and duration were supervised and individualized by the kinesiologist as per participant baseline physical function with gradual progression over the course of the intervention. Control: Usual hemodialysis care (no exercise program). Measurements: Our primary outcome is change in symptom burden at 12 weeks as measured by the DSI severity score. Secondary outcomes include change in modified DSI severity score (includes 10 symptoms most plausible to improve with exercise), change in DSI severity score at 26 and 52 weeks; time to recover post-hemodialysis; health-related quality of life measured using EuroQol (EQ)-5D-5L; physical activity behavior measured by self-report (Godin-Shepherd questionnaire) and triaxial accelerometry; exercise capacity (shuttle walk test); frailty (Fried); self-efficacy for exercise; and 1-year hospitalization and mortality. Methods: Change in primary outcome will be compared between groups by independent 2-tailed t test or Mann-Whitney U test depending on data distribution and using generalized linear mixed models, with study time point as a random effect and adjusted for baseline DSI score. Similarly, change in secondary outcomes will be compared between groups over time using appropriate parametric and nonparametric statistical tests depending on data type and distribution. Limitations: The COVID-19 pandemic restrictions on clinical research at our institution delayed completion of target recruitment and prevented collection of accelerometry and physical function outcome data for 15 months until restrictions were lifted. Conclusions: The application of an exercise rehabilitation program to improve symptom burden in individuals on hemodialysis may ameliorate common symptoms observed in individuals on hemodialysis and result in improved quality of life and reduced disability and morbidity over the long term. Importantly, this pragmatic study, with a standardized exercise intervention that is adaptable to baseline physical function, addresses an important gap in both clinical care of hemodialysis patients and our current knowledge.

Contexte: Les personnes sous hémodialyse éprouvent un grand nombre de symptômes qui contribuent à un faible état fonctionnel et à une mauvaise qualité de vie liée à la santé. La prise en charge des symptômes est une priorité pour les personnes sous hémodialyse, mais les traitements efficaces sont limités. De nouvelles preuves montrent que l'adoption d'un programme d'exercice permettrait d'améliorer plusieurs symptômes courants liés à la dialyse. Objectifs: Le principal objectif de cette étude est d'évaluer l'effet d'un programme de rééducation par l'exercice sur le fardeau des symptômes chez les personnes recevant une hémodialyse d'entretien. Conception: Essai clinique prospectif randomisé-contrôlé, en aveugle, en parallèle 1:1 et ouvert, multicentrique. Cadre: Trois unités d'hémodialyse de Winnipeg, au Manitoba (Canada). Sujets: Des adultes atteints d'insuffisance rénale terminale qui reçoivent des traitements d'hémodialyse d'entretien en centre depuis plus de trois mois et qui présentent au moins un symptôme lié à la dialyse, tel qu'indiqué par un score de gravité de l'indice des symptômes de la dialyse (Dialysis Symptom Index) supérieur à zéro (n = 150). Intervention: Programme supervisé de rééducation par l'exercice d'une durée de 26 semaines et 60 minutes de vélo trois fois par semaine pendant l'hémodialyse. L'intensité et la durée de l'exercice ont été supervisées par un kinésiologue qui les a ensuite personnalisées en fonction de la forme physique initiale du participant en prévoyant une progression graduelle tout au long de l'intervention. Groupe témoin: Soins habituels d'hémodialyse (sans programme d'exercice). Mesures: Notre principal critère de jugement est un changement dans le fardeau lié aux symptômes après 12 semaines, tel que mesuré par le score de gravité de l'indice des symptômes de dialyse (ISD). Les critères d'évaluation secondaires comprennent un changement du score modifié de gravité de l'ISD (portant sur 10 symptômes les plus plausibles de s'améliorer avec l'exercice), la modification du score de gravité de l'ISD après 26 et 52 semaines, le temps de récupération après l'hémodialyse, la qualité de vie liée à la santé mesurée par le questionnaire EQ5D-5L, le comportement lié à l'activité physique mesuré par autoévaluation (questionnaire Godin-Shepherd) et par accéléromètre triaxial, la capacité d'effort (test de marche navette), la fragilité (Fried), le sentiment d'efficacité autodéclaré face à l'exercice, ainsi que les hospitalisations et la mortalité à un an. Méthodologie: Les changements pour le principal critère de jugement seront comparés entre les groupes par un test t bilatéral indépendant ou un test U de Mann-Whitney en fonction de la distribution des données, ainsi qu'à l'aide de modèles linéaires mixtes généralisés avec un point temporel de l'étude comme effet aléatoire et corrigé en fonction du score ISD initial. Les changements dans les résultats secondaires seront comparés entre les groupes au fil du temps à l'aide des tests statistiques paramétriques et non paramétriques appropriés selon le type de données et la distribution. Limites: Les restrictions liées à la pandémie de COVID-19 dans notre établissement ont retardé le recrutement des cibles et empêché pendant 15 mois la collecte de données sur les résultats mesurés par l'accéléromètre et les mesures de la fonction physique, soit jusqu'à ce que les restrictions soient levées. Conclusion: L'adoption d'un programme de rééducation par l'exercice visant à réduire le fardeau lié aux symptômes chez les personnes sous hémodialyse peut améliorer les symptômes courants observés dans cette population et se traduire par une amélioration de la qualité de vie et une réduction de l'invalidité et de la morbidité à long terme. Il convient de noter que cet essai pragmatique, avec son intervention d'exercice standardisée adaptable à la condition physique initiale de la personne, comble une lacune importante dans les soins cliniques des patients sous hémodialyse et dans nos connaissances actuelles.

Impact of a Medical Fitness Model on Incident Major Adverse Cardiovascular Events: A Prospective Cohort Study of 11 000 Members.

BACKGROUND: Cardiovascular disease remains the leading cause of disease burden and death in the world. The medical fitness model may be an alternative public health strategy to address cardiovascular risk factors with medical integrated programming. METHODS AND RESULTS: We performed a retrospective cohort study between January 1, 2005, and December 31, 2015. Adults (aged ≥18 years) who did not have a prior major adverse cardiovascular event were included. Controls were assigned a pseudo-index date at random on the basis of the frequency distribution of start dates in the medical fitness facility group. Multivariate Cox proportional hazards regression models were adjusted for age, sex, socioeconomic status, comorbidities, and year of index date. We stratified the medical fitness facility group into low-frequency attenders (≤1 weekly visit) and regular-frequency attenders (>1 weekly visit). Our primary outcome was a hospitalization for nonfatal myocardial infarction and stroke, heart failure, or cardiovascular death. We included 11 319 medical fitness facility members and 507 400 controls in our study. Compared with controls, members had a lower hazard risk of a major adverse cardiovascular event-plus (hazard ratio [HR], 0.88 [95% CI, 0.81-0.96]). Higher weekly attendance was associated with a lower hazard risk of a major adverse cardiovascular event-plus compared with controls, but the effect was not significant for lower weekly attendance (low-frequency attenders: HR, 0.94 [95% CI, 0.85-1.04]; regular-frequency attenders: HR, 0.77 [95% CI, 0.67-0.89]). CONCLUSIONS: Medical fitness facility membership and attendance at least once per week may lower the risk of a major adverse cardiovascular event-plus. The medical fitness model should be considered as a public health intervention, especially for individuals at risk for cardiovascular disease.

Measurement properties of performance-based measures to assess physical function in chronic kidney disease: recommendations from a COSMIN systematic review.

Background: There is wide heterogeneity in physical function tests available for clinical and research use, hindering our ability to synthesize evidence. The aim of this review was to identify and evaluate physical function measures that could be recommended for standardized use in chronic kidney disease (CKD). Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL, Scopus and Web of Science were searched from inception to March 2022, identifying studies that evaluated a clinimetric property (validity, reliability, measurement error and/or responsiveness) of an objectively measured performance-based physical function outcomes using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) based recommendations. Studies with individuals of all ages and of any stage of CKD were included. Results: In total, 50 studies with 21 315 participants were included. Clinimetric properties were reported for 22 different physical function tests. The short physical performance battery (SPPB), Timed-up-and-go (TUG) test and Sit-to-stand tests (STS-5 and STS-60) had favorable properties to support their use in CKD and should be integrated into routine use. However, the majority of studies were conducted in the hemodialysis population, and very few provided information regarding validity or reliability. Conclusion: The SPPB demonstrated the highest quality of evidence for reliability, measurement error and construct validity amongst transplant, CKD and dialysis patients. This review is an important step towards standardizing a core outcome set of tools to measure physical function in research and clinical settings for the CKD population.

Use of Wearable and Wireless Technology in Real-World Clinical Settings to Improve Patient Outcomes in Chronic Kidney Disease: A Mixed Methods Pilot Prospective Trial.

Background: During the 30-day period prior to initiating dialysis, there is a 10-fold rise in emergency department visits and hospitalizations related to kidney failure. Objective: The Virtual Ward Incorporating Electronic Wearables (VIEWER) trial implemented a home telemonitoring system to track changes in patients' vitals and assess their adherence and the acceptability of telemonitoring in a chronic kidney disease (CKD) population. Design: A pilot prospective clinical trial using a mixed methods approach was performed. Setting: The research was conducted in Winnipeg, Manitoba. Participants: There were 2 phases: Phase 1 was a 2-week-long pilot trial consisting of 10 participants. Phase 2 was a 3-month-long trial with a total of 26 participants. Patients with an estimated glomerular filtration rate <15 and a >40% risk of beginning dialysis in the next 2 years according to the kidney failure risk equation were eligible to participate in the study. Methods: The primary quantitative outcome was adherence, defined as the proportion of daily self-assessments completed using VIEWER over the follow-up period. The usability and acceptability of VIEWER was assessed qualitatively at the end of the trial through structured questionnaires and focus groups. Results: Phase 1 participants (n = 10) had a median adherence of 77.17% for the 2-week observation period. Phase 2 participants (n = 26) showed a lower median adherence of 36% for the 3-month period. Focus group participants (n = 11) identified many positive aspects of VIEWER, including increased awareness and empowerment over health, simplicity of the data platform, and the ability to show clinical staff their health trends. Some challenges identified with VIEWER were connectivity issues with the Bluetooth, perceived inconvenience, and negative thoughts toward their health. Limitations: Limitations of the study include a small sample size, which limited our ability to measure quantitative outcomes. In addition, patients agreeing to participate in any trial are generally more highly motivated and engaged in their care than those declining participation. Therefore, our results may not be generalizable to individuals who are not interested in self-management of their health. Conclusion: Our results suggest that home telemonitoring in patients with advanced CKD is feasible using a CKD-specific platform like VIEWER. We anticipate that improved functionality with incorporation of feedback from this study will result in greater long-term adherence. A future randomized clinical trial is planned.

Contexte: Les visites aux urgences et les hospitalisations en lien avec l'insuffisance rénale augmentent d'environ dix fois dans les 30 jours qui précèdent le début de la dialyse. Objectif: L'essai VIEWER a mis en œuvre un système de télésurveillance à domicile qui permet de suivre les changements dans les paramètres vitaux des patients atteints d'insuffisance rénale chronique (IRC). L'essai permet également d'évaluer l'observance et l'acceptabilité de la télésurveillance dans cette population. Conception: Un essai clinique pilote prospectif utilisant une approche par méthodes mixtes. Cadre: Les recherches ont été menées à Winnipeg, au Manitoba. Sujets: L'essai s'est déroulé en deux phases: un essai pilote de deux semaines avec 10 participants (phase 1) et un essai de trois mois avec un total de 26 participants (phase 2). Étaient admissibles à participer: les patients présentant un DFGe inférieur à 15 ml/kg/1,73 m2 et une probabilité d'au moins 40 % d'amorcer des traitements de dialyse dans les deux ans, selon l'équation KFRE (kidney failure risk equation). Méthodologie: Le principal critère d'évaluation quantitatif était l'observance, définie par la proportion d'auto-évaluations réalisées quotidiennement à l'aide VIEWER au cours de la période de suivi. La facilité d'utilisation et l'acceptabilité de VIEWER ont été évaluées qualitativement à la fin de l'essai au moyen de questionnaires structurés et de groupes de discussion. Résultats: Les participants à la phase 1 (n=10) ont montré une observance médiane de 77,17 % pendant les deux semaines d'observation. Les participants à la phase 2 (n=26) ont montré une observance médiane inférieure, soit de 36 %, pendant les trois mois du suivi. Les participants au groupe de discussion (n=11) ont identifié plusieurs aspects positifs de VIEWER, notamment: une sensibilisation et une responsabilisation accrues à l'égard de la santé, la simplicité de la plateforme de données, et le fait de pouvoir montrer leurs tendances de santé au personnel clinique. Parmi les défis identifiés figurent des problèmes de connectivité avec Bluetooth, des désagréments perçus à son utilisation et des pensées négatives à l'égard de la santé. Limites: La faible taille des échantillons a limité notre capacité à mesurer les résultats quantitatifs. En outre, les patients qui acceptent de participer à un essai clinique sont généralement plus motivés et impliqués dans leurs soins que ceux qui refusent de participer. Par conséquent, nos résultats pourraient ne pas être généralisables aux personnes qui ne sont pas intéressées par l'autogestion de leur santé. Conclusion: Nos résultats suggèrent que la télésurveillance des patients atteints d'IRC avancée est réalisable par le biais d'une plateforme spécifique à l'IRC comme VIEWER. Nous pensons que l'amélioration de sa fonctionnalité, découlant des résultats de cette étude, se traduira par une plus grande observance à long terme. Un futur essai clinique randomisé est prévu.

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease.

Despite over 30 years of evidence for improvements in physical function, physical fitness, and health-related quality of life with exercise training in individuals with chronic kidney disease, access to dedicated exercise training programs remains outside the realm of standard of care for most kidney care programs. In this review, we explore possible reasons for this by comparing approaches in other chronic diseases where exercise rehabilitation has become the standard of care, identifying enablers and factors that need to be addressed for continued growth in this area, and discussing knowledge gaps for future research. For exercise rehabilitation to be relevant to all stakeholders and become a sustainable component of kidney care, a focus on the effect of exercise on clinically relevant outcomes that are prioritized by individuals living with kidney disease, use of evidence-based implementation strategies for diverse settings and populations, and approaching exercise as a medical therapy are required.

Exercise Rehabilitation for People With End-Stage Kidney Disease: Who Will Fill the Gaps?

Exercise rehabilitation is a well established therapy for reducing morbidity and mortality and improving quality of life and function across chronic conditions. People with dialysis-dependent kidney failure have a high burden of comorbidity and symptoms, commonly characterised as fatigue, dyspnoea, and the inability to complete daily activities. Despite more than 30 years of exercise research in people with kidney disease and its established benefit in other chronic diseases, exercise programs are rare in kidney care and are not incorporated into routine management at any stage. In this review, we describe the mechanisms contributing to exercise intolerance in those with end-stage kidney disease and outline the role of exercise rehabilitation in addressing the major challenges to kidney care: cardiovascular disease, symptom burden, and physical frailty. We also draw on existing models of exercise rehabilitation from other chronic conditions to inform the way forward and challenge the status quo of exercise rehabilitation in both practice and research.

An International Survey of Peritoneal Dialysis Exercise Practices and Perceptions.

Introduction: Low activity levels and poor physical function are associated with technique failure and mortality in people receiving peritoneal dialysis (PD). Adequate levels of physical function are required to maintain independence for people choosing this predominantly home-based therapy. The objective of this study was to identify the exercise-related perceptions and practices of PD clinicians globally. Methods: We conducted a cross-sectional survey of PD clinicians from English-, Thai-, Spanish-, and Portuguese-speaking PD-prevalent countries exploring clinicians' perceptions and practices of swimming, activity following PD catheter insertion, lifting, and falls prevention. This study was convened by the International Society of Peritoneal Dialysis and Global Renal Exercise Network between July and December 2021. Results: Of 100 of the highest PD-prevalent countries, 85 responded and were represented in the findings. A total of 1125 PD clinicians (448 nephrologists, 558 nephrology nurses, 59 dietitians, and 56 others) responded from 61% high-income, 32% upper middle-income and 7% lower middle-income countries. The majority (n = 1054, 94%) agreed that structured exercise programs would be beneficial for people receiving PD. Most respondents believed people on PD could perform more exercise (n = 907, 81%) and that abdominal strengthening exercises could be safely performed (n = 661, 59%). Compared to clinicians in high-income countries, clinicians from lower middle-income status (odds ratio [OR], 5.57; 1.64 to 18.9) are more likely to promote participation in physical activity. Conclusion: Clinicians know the importance of physical activity in people receiving PD. Exercise counseling and structured exercise plans could be included in the standard care of people receiving PD to maintain independence.

A Randomized Trial Examining the Impact of Timing of Intradialytic Cycling on Intradialytic Hypotension.

Introduction: Intradialytic cycling is often performed during the first half of hemodialysis because of concerns regarding increased frequency of intradialytic hypotension (IDH) late in hemodialysis. This increases exercise program resource needs and limits utility of intradialytic cycling to treat dialysis-related symptoms. Methods: This multicenter, randomized, crossover trial compared IDH rate when cycling during the first half versus the second half of hemodialysis in 98 adults on maintenance hemodialysis. Group A cycled during the first half of hemodialysis for 2 weeks and subsequently during the second half for 2 weeks. In group B, the cycling schedule was reversed. Blood pressure (BP) was measured every 15 minutes throughout hemodialysis. Primary outcome was IDH rate (systolic BP [SBP] decrease of >20 mm Hg or SBP <90 mm Hg). Secondary outcomes included symptomatic IDH rate and time to recover post hemodialysis. Data were analyzed using negative binomial and gamma distribution mixed regression. Results: Mean age 64.7 (SD 12.0) and 64.7 (SD 14.2) years in group A (n = 52) and group B (n = 46), respectively. Proportions of females were 33% in group A and 43% in group B. Median time on hemodialysis was 4.1 (interquartile range [IQR] 2.5, 6.1]) years in group A and 3.9 years (IQR 2.5, 6.7) in group B. IDH rate per 100 hemodialysis hours (95% confidence interval [CI]) was 34.2 (26.4, 42.0) and 36.0 (28.9, 43.1) during early and late intradialytic cycling, respectively (P = 0.53). Timing of intradialytic cycling was not associated with symptomatic IDH (relative risk [RR]: 1.07 [0.75-1.53]) or time to recover post hemodialysis (odds ratio: 0.99 [0.79-1.23]). Conclusion: We found no association between the rate of overall or symptomatic IDH and the timing of intradialytic cycling in patients enrolled in an intradialytic cycling program. Increased use of cycling late in hemodialysis may optimize intradialytic cycling program resource use and should be studied as a possible treatment for symptoms common in late hemodialysis.

Magnitude of the Potential Screening Gap for Fabry Disease in Manitoba: A Population-Based Retrospective Cohort Study.

Background: Fabry disease is a rare disorder caused by the deficient activity of α-galactosidase A (GLA) that often leads to organ damage. Fabry disease can be treated with enzyme replacement or pharmacological therapy, but due to its rarity and nonspecific manifestations, it often goes undiagnosed. Mass screening for Fabry disease is impractical; however, a targeted screening program for high-risk individuals may uncover previously unknown cases. Objective: Our objective was to use population-level administrative health databases to identify patients at high risk of Fabry disease. Design: Retrospective cohort study. Setting: Population-level health administrative databases housed at the Manitoba Centre for Health Policy. Patients: All residents of Manitoba, Canada, between 1998 and 2018. Measurements: We ascertained the evidence of GLA testing in a cohort of patients at high risk of Fabry disease. Methods: Individuals without a hospitalization or prescription indicative of Fabry disease were included if they had evidence of 1 of 4 high-risk conditions for Fabry disease: (1) ischemic stroke <45 years of age, (2) idiopathic hypertrophic cardiomyopathy, (3) proteinuric chronic kidney disease or kidney failure of unknown cause, or (4) peripheral neuropathy. Patients were excluded if they had known contributing factors to these high-risk conditions. Those who remained and had no prior GLA testing were assigned a 0% to 4.2% probability of having Fabry disease depending on their high-risk condition and sex. Results: After applying exclusion criteria, 1386 individuals were identified as having at least 1 high-risk clinical condition for Fabry disease in Manitoba. There were 416 GLA tests conducted during the study period, and of those, 22 were conducted in individuals with at least 1 high-risk condition. This leaves a screening gap of 1364 individuals with a high-risk clinical condition for Fabry disease in Manitoba who have not been tested. At the end of the study period, 932 of those individuals were still alive and residing in Manitoba, and if screened today, we expect between 3 and 18 would test positive for Fabry disease. Limitations: The algorithms we used to identify our patients have not been validated elsewhere. Diagnoses of Fabry disease, idiopathic hypertrophic cardiomyopathy, and peripheral neuropathy were only available via hospitalizations and not physician claims. We were only able to capture GLA testing processed through public laboratories. Patients identified to be at high risk of Fabry disease by the algorithm did not undergo GLA testing due to a clinical rationale that we were unable to capture. Conclusions: Administrative health databases may be a useful tool to identify patients at higher risk of Fabry disease or other rare conditions. Further directions include designing a program to screen high-risk individuals for Fabry disease as identified by our administrative data algorithms.

Contexte: La maladie de Fabry est un trouble rare causé par une activité déficiente de α-galactosidase A (GLA) qui conduit fréquemment à des dommages aux organes. La maladie de Fabry peut être traitée par remplacement enzymatique ou par traitement pharmacologique, mais elle passe souvent inaperçue en raison de sa rareté et de ses manifestations non spécifiques. Le dépistage de masse de la maladie de Fabry est irréalisable, mais un programme de dépistage ciblé pour les personnes présentant un risque élevé pourrait révéler des cas auparavant inconnus. Objectif: Notre objectif était d'utiliser les bases de données administratives sur la santé des populations pour recenser les patients présentant un risque élevé de maladie de Fabry. Conception: Étude de cohorte rétrospective. Cadre: Les bases de données administratives sur la santé des populations hébergées au Manitoba Centre for Health Policy. Sujets: Tous les résidents du Manitoba (Canada) entre 1998 et 2018. Mesures: Nous avons examiné les preuves d'un dosage de la GLA dans une cohorte de patients présentant un risque élevé de maladie de Fabry. Méthodologie: Les individus sans hospitalisation ou ordonnance indicative de la maladie de Fabry ont été inclus s'ils présentaient une des quatre affections suivantes, jugées à haut risque pour la maladie de Fabry: 1) accident vasculaire cérébral ischémique avant 45 ans; 2) cardiomyopathie hypertrophique idiopathique; 3) insuffisance rénale chronique protéinurique ou insuffisance rénale de cause inconnue; 4) neuropathie périphérique. Les patients ont été exclus s'ils présentaient des facteurs de contribution connus à ces maladies à haut risque. Les personnes restantes qui n'avaient pas de preuves d'un dosage antérieur de la GLA ont reçu une probabilité de 0 à 4,2 % d'avoir la maladie de Fabry, selon leur maladie à risque élevé et leur sexe. Résultats: Après l'application des critères d'exclusion, 1 386 personnes ont été identifiées au Manitoba comme ayant au moins une affection clinique présentant un risque élevé pour la maladie de Fabry. Pendant la période de l'étude, 416 dosages de GLA ont été effectués, dont 22 chez des individus présentant au moins une affection à risque élevé; soit un déficit de dépistage pour 1 364 Manitobains présentant un risque élevé de maladie de Fabry à qui aucun dosage n'avait été fait. À la fin de la période de l'étude, 932 de ces personnes étaient encore vivantes et résidaient toujours au Manitoba. Si ces individus étaient dépistés aujourd'hui, on pourrait s'attendre à obtenir entre 3 et 18 dosages positifs pour la maladie de Fabry. Limites: Les algorithmes que nous avons utilisés pour identifier nos sujets n'avaient pas été validés ailleurs. Les diagnostics de maladie de Fabry, de cardiomyopathie hypertrophique idiopathique et de neuropathie périphérique n'étaient disponibles que par une hospitalisation et non par demande d'un médecin. Seuls les dosages de la GLA effectués par des laboratoires publics ont pu être saisis. Les patients répertoriés par l'algorithme comme présentant un risque élevé de maladie de Fabry n'avaient pas subi de dosage de la GLA en raison d'une justification clinique qu'il nous a été impossible de saisir. Conclusion: Les bases de données administratives sur la santé peuvent s'avérer un bon outil pour recenser les patients présentant un risque plus élevé de développer la maladie de Fabry ou d'autres maladies rares. Les orientations futures comprennent la conception d'un programme de dépistage des individus présentant un risque élevé pour la maladie de Fabry, tels que recensés par nos algorithmes de données administratives.

Magnesium and Fracture Risk in the General Population and Patients Receiving Dialysis: A Narrative Review.

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.

Justification: Le magnésium est un minéral essentiel pour le métabolisme osseux, mais on en sait peu sur la façon dont un apport en magnésium modifie le risque de fracture. Nous avons procédé à un examen narratif afin de mieux comprendre comment les maladies liées à la densité minérale osseuse et le risque de fracture sont affectés par un apport en magnésium (supplémentation, régime alimentaire ou modification de la concentration de dialysat de magnésium) chez les personnes atteintes d'insuffisance rénale. Sources: Essais cliniques et études observationnelles examinés par des pairs. Méthodologie: Nous avons répertorié les articles pertinents dans les bases de données MEDLINE et EMBASE. Une version modifiée des critères de contrôle de la qualité des études de Downs et Black a servi à évaluer la qualité méthodologique des essais cliniques retenus. Principaux résultats: Le rôle d'un apport en magnésium dans la prévention des fractures n'est pas clair, tant dans la population générale que chez les patients sous dialyse d'entretien. Chez les personnes ayant une fonction rénale normale, deux méta-analyses ont montré que les personnes dont le régime alimentaire est riche en magnésium présentent une densité minérale osseuse plus élevée; alors qu'une revue systématique n'a montré aucun effet sur le risque de fracture. Chez les patients sous hémodialyse d'entretien ou dialyse péritonéale, une concentration plus élevée de dialysat de magnésium est associée à une plus faible concentration d'hormone parathyroïdienne, mais on en sait peu sur les autres effets liés aux os. Dans deux études observationnelles portant sur des patients sous hémodialyse, une concentration plus élevée de magnésium sérique a été associée à un risque plus faible de fracture de la hanche. Limites: Cet examen narratif ne comprend que des articles rédigés en anglais. Il est possible que les effets d'un apport en magnésium observés dans la population générale ne puissent s'appliquer aux personnes atteintes d'une néphropathie chronique, en particulier aux personnes sous dialyse.

Development and Validation of Patient Education Tools for Deprescribing in Patients on Hemodialysis.

Background: Deprescribing is a patient-centered solution to reducing polypharmacy in patients on hemodialysis (HD). In a deprescribing pilot study, patients were hesitant to participate due to limited understanding of their own medications and their unfamiliarity with the concept of deprescribing. Therefore, patient education materials designed to address these knowledge gaps can overcome barriers to shared decision-making and reduce hesitancy regarding deprescribing. Objective: To develop and validate a medication-specific, patient education toolkit (bulletin and video) that will supplement an upcoming nationwide deprescribing program for patients on HD. Methods: Patient education tools were developed based on the content of previously validated deprescribing algorithms and literature searches for patients' preferences in education. A preliminary round of validation was completed by 5 clinicians to provide feedback on the accuracy and clarity of the education tools. Then, 3 validation rounds were completed by patients on HD across 3 sites in Vancouver, Winnipeg, and Toronto. Content and face validity were evaluated on a 4-point and 5-point Likert scale, respectively. The content validity index (CVI) score was calculated after each round, and revisions were made based on patient feedback. Results: A total of 105 patients participated in the validation. All 10 education tools achieved content and face validity after 3 rounds. The CVI score was 1.0 for most of the tools, with 0.95 being the lowest value. Face validity ranged from 72% to 100%, with majority scoring above 90%. Conclusion: Ten patient education tools on deprescribing were developed and validated by patients on HD. These validated, medication-specific education tools are the first of its kind for patients on HD and will be used in a nationwide implementation study alongside the validated deprescribing algorithms developed by our research group.

Contexte: La déprescription est une solution axée sur le patient pour réduire la polypharmacie chez les patients sous hémodialyse (HD). Dans une étude pilote sur la déprescription, les patients ont hésité à participer en raison de leur compréhension limitée de leurs propres médicaments et de leur manque de connaissance du concept de déprescription. Par conséquent, du matériel éducatif conçu pour combler ces lacunes dans les connaissances des patients pourrait surmonter les obstacles à la prise de décision partagée et réduire les hésitations à l'égard de la déprescription. Objectifs: Développer et valider une trousse d'information (bulletin et vidéo) pour les patients portant sur les médicaments. Cette trousse viendra compléter un futur programme national de déprescription pour les patients sous HD. Méthodologie: Des outils d'éducation pour les patients ont été développés à partir du contenu d'algorithmes de déprescription validés précédemment et de recherches documentaires sur les préférences des patients en matière d'éducation. Une ronde préliminaire de validation a été complétée par cinq cliniciens afin d'obtenir des commentaires sur l'exactitude et la clarté des outils d'éducation. Trois cycles de validation ont ensuite été réalisés par des patients sous HD dans trois sites: Vancouver, Winnipeg et Toronto. La validité du contenu et la validité apparente ont été évaluées à l'aide d'échelles de Likert à 4 et 5 points, respectivement. L'indice de validité du contenu (IVC) a été calculé après chaque ronde et des révisions ont été effectuées en fonction des commentaires des patients. Résultats: En tout, 105 patients ont participé à la validation. La validité du contenu et la validité apparente ont été atteintes pour les dix outils d'éducation après trois rondes auprès des patients. L'IVC s'établissait à 1,0 pour la plupart des outils évalués; 0,95 était la valeur d'indice la plus faible. La validité apparente variait entre 72% et 100%, la majorité des outils ayant obtenu un score supérieur à 90%. Conclusion: Dix outils d'éducation pour les patients portant sur la déprescription ont été développés et validés par des patients sous HD. Ces outils d'éducation validés portant spécifiquement sur les médicaments sont les premiers du genre conçus pour les patients sous HD. Ils seront utilisés dans le cadre d'une étude nationale de mise en œuvre, parallèlement aux algorithmes validés de déprescription qui ont été développés par notre groupe de recherche.

Transportation Burden Associated With Hemodialysis in Canada: A Qualitative Study of Stakeholders.

Rationale & Objective: For patients requiring in-center hemodialysis, suboptimal transportation arrangements are commonly cited as a source of ongoing stress and anxiety and have been associated with a reduced quality of life and increased mortality risk. Transportation-related problems are especially pronounced in Canada given its size, low population density, and long, often snowy winters. We aimed to identify and better understand transportation options for hemodialysis patients in Canada and to describe stakeholder experiences. Study Design: We used a qualitative descriptive research design to explore stakeholder experiences and perspectives of transportation to and from dialysis facilities. Setting & Participants: We recruited participants from a large urban hemodialysis program in Western Canada and included 11 participants from a project group, 45 participants from an open forum, and a survey of 8 social workers. Data collection occurred at a series of project group meetings and an open forum (n=45). In addition, we asked 8 renal social workers based in major cities across Canada to comment on the provision of transport for patients in their area via email or telephone consult. Analytical Approach: We used conventional content analysis to explore stakeholder experiences. Results: Traveling to and from dialysis facilities remains a source of stress and anxiety for many patients and their families. Patients described several factors contributing to these feelings including: the challenges of physically getting to the treatment center, particularly in adverse weather conditions; being a burden on family and friends; difficulties accessing the treatment facility; issues with public transport; and financial worries related to high costs. Limitations: Findings may not be relevant in low- and middle-income countries and those with a warmer climate. Conclusions: Without a concerted and collaborative approach to address the barriers identified here, it is likely that travel to and from in-center hemodialysis will continue to adversely affect patients' quality of life.

Metabolic acidosis is undertreated and underdiagnosed: a retrospective cohort study.

BACKGROUND: Guidelines recommend treatment of metabolic acidosis (MA) in patients with chronic kidney disease (CKD), but the diagnosis and treatment rates in real-world settings are unknown. We investigated the frequency of MA treatment and diagnosis in patients with CKD. METHODS: In this retrospective cohort study, we examined administrative health data from two US databases [Optum's de-identified Integrated Claims + Clinical Electronic Health Record Database (US EMR cohort; 1 January 2007 to 30 June 2019) and Symphony Health Solutions IDV® (US claims cohort; 1 May 2016 to 30 April 2019)] and population-level databases from Manitoba, Canada (1 April 2006 to 31 March 2018). Patients who met laboratory criteria indicative of CKD and chronic MA were included: two consecutive estimated glomerular filtration results <60 mL/min/1.73 m2 and two serum bicarbonate results 12 to <22 mEq/L over 28-365 days. Outcomes included treatment of MA (defined as a prescription for oral sodium bicarbonate) and a diagnosis of MA (defined using administrative records). Outcomes were assessed over a 3-year period (1 year pre-index, 2 years post-index). RESULTS: A total of 96 184 patients were included: US EMR, 6179; Manitoba, 3223; US Claims, 86 782. Sodium bicarbonate treatment was prescribed for 17.6%, 8.7% and 15.3% of patients, and a diagnosis was found for 44.7%, 20.9% and 20.9% of patients, for the US EMR, Manitoba and US Claims cohorts, respectively. CONCLUSIONS: This analysis of 96 184 patients with laboratory-confirmed MA from three independent cohorts of patients with CKD and MA highlights an important diagnosis and treatment gap for this disease-modifying complication.

Metabolic Acidosis is Associated With Acute Kidney Injury in Patients With CKD.

Introduction: Metabolic acidosis in patients with chronic kidney disease (CKD) results from a loss of kidney function. It has been associated with CKD progression, all-cause mortality, and other adverse outcomes. We aimed to determine whether metabolic acidosis is associated with a higher risk of acute kidney injury (AKI). Methods: This was a retrospective cohort study. Using electronic health records and administrative data, we enrolled 2 North American cohorts of patients with CKD Stages G3-G5 as follows: (i) 136,067 patients in the US electronic medical record (EMR) based cohort; and (ii) 34,957 patients in the Manitoba claims-based cohort. The primary exposure was metabolic acidosis (serum bicarbonate between 12 mEq/l and <22 mEq/l). The primary outcome was the development of AKI (defined using ICD-9 and 10 codes at hospital admission or a laboratory-based definition based on Kidney Disease: Improving Global Outcomes guidelines). We applied Cox proportional hazards regression models adjusting for relevant demographic and clinical characteristics. Results: In both cohorts, metabolic acidosis was associated with AKI: hazard ratio (HR) 1.57 (95% confidence interval [CI] 1.52-1.61) in the US EMR cohort, and HR 1.65 (95% CI 1.58-1.73) in the Manitoba claims cohort. The association was consistent when serum bicarbonate was treated as a continuous variable, and in multiple subgroups, and sensitivity analyses including those adjusting for albuminuria. Conclusion: Metabolic acidosis is associated with a higher risk of AKI in patients with CKD. AKI should be considered as an outcome in studies of treatments for patients with metabolic acidosis.

Patient Navigators for CKD and Kidney Failure: A Systematic Review.

Rationale & Objective: To what degree and how patient navigators improve clinical outcomes for patients with chronic kidney disease (CKD) and kidney failure is uncertain. We performed a systematic review to summarize patient navigator program design, evidence, and implementation in kidney disease. Study Design: A search strategy was developed for randomized controlled trials and observational studies that evaluated the impact of navigators on outcomes in the setting of CKD and kidney failure. Articles were identified from various databases. Two reviewers independently screened the articles and identified those meeting the inclusion criteria. Setting & Participants: Patients with CKD or kidney failure (in-center hemodialysis, peritoneal dialysis, home hemodialysis, or kidney transplantation). Selection Criteria for Studies: Studies that compared patient navigators with a control, without limits on size, duration, setting, or language. Studies focusing solely on patient education were excluded. Data Extraction: Data were abstracted from full texts and risk of bias was assessed. Analytical Approach: No meta-analysis was performed. Results: Of 3,371 citations, 17 articles met the inclusion criteria including 14 original studies. Navigators came from various healthcare backgrounds including nursing (n=6), social worker (n=2), medical interpreter (n=1), research (n=1), and also included kidney transplant recipients (n=2) and non-medical individuals (n=2). Navigators focused mostly on education (n=9) and support (n = 6). Navigators were used for patients with CKD (n=5), peritoneal dialysis (n=2), in-center hemodialysis (n=4), kidney transplantation (n=2), but not home hemodialysis. Navigators improved transplant workup and listing, peritoneal dialysis utilization, and patient knowledge. Limitations: Many studies did not show benefits across other outcomes, were at a high risk of bias, and none reported cost-effectiveness or patient-reported experience measures. Conclusions: Navigators improve some health outcomes for CKD but there was heterogeneity in their structure and function. High-quality randomized controlled trials are needed to evaluate navigator program efficacy and cost-effectiveness.