Similar survival on home haemodialysis and automated peritoneal dialysis: an inception cohort study.

BACKGROUND: Several studies have shown superior survival of patients on home haemodialysis (HD) compared with peritoneal dialysis (PD), but patients on automated PD (APD) and continuous ambulatory PD (CAPD) have not been considered separately. As APD allows larger fluid volumes and may be more efficient than CAPD, we primarily compared patient survival between APD and home HD. METHODS: All adult patients who started kidney replacement therapy (KRT) between 2004 and 2017 in the district of Helsinki-Uusimaa in Finland and who were on one of the home dialysis modalities at 90 days from starting KRT were included. We used intention-to-treat analysis. Survival of home HD, APD and CAPD patients was studied using Kaplan-Meier curves and Cox regression with adjustment for propensity scores that were based on extensive data on possible confounding factors. RESULTS: The probability of surviving 5 years was 90% for home HD, 88% for APD and 56% for CAPD patients. After adjustment for propensity scores, the hazard ratio of death was 1.1 [95% confidence interval (CI) 0.52-2.4] for APD and 1.6 (95% CI 0.74-3.6) for CAPD compared with home HD. Censoring at the time of kidney transplantation (KTx) or at transfer to in-centre HD did not change the results. Characteristics of home HD and APD patients at the start of dialysis were similar, whereas patients on CAPD had higher median age and more comorbidities and received KTx less frequently. CONCLUSIONS: Home HD and APD patients had comparable characteristics and their survival appeared similar.

Rotigotine in Hemodialysis-Associated Restless Legs Syndrome: A Randomized Controlled Trial.

BACKGROUND: Restless legs syndrome (RLS) has been associated with insomnia, decreased quality of life, and increased morbidity and mortality in end-stage renal disease. This randomized controlled trial investigated effects of rotigotine in patients with RLS and end-stage renal disease. STUDY DESIGN: Double-blind placebo-controlled study. SETTING & PARTICIPANTS: Adults with moderate to severe RLS (International RLS Study Group Rating Scale [IRLS] ≥ 15) and Periodic Limb Movement Index (PLMI) ≥ 15 who were receiving thrice-weekly hemodialysis enrolled from sites in the United States and Europe. INTERVENTION: Following randomization and titration (≤21 + 3 days) to optimal-dose rotigotine (1-3mg/24 h) or placebo, patients entered a 2-week maintenance period. Polysomnography was performed at baseline and the end of maintenance. OUTCOMES & MEASUREMENTS: Primary efficacy outcome: reduction in PLMI, assessed by ratio of PLMI at end of maintenance to baseline. Secondary/other outcomes (P values exploratory) included mean changes from baseline in PLMI, IRLS, and Clinical Global Impression item 1 (CGI-1 [severity of illness]) score. RESULTS: 30 patients were randomly assigned (rotigotine, 20; placebo, 10); 25 (15; 10) completed the study with evaluable data. Mean (SD) PLMI ratio (end of maintenance to baseline) was 0.7±0.4 for rotigotine and 1.3±0.7 for placebo (analysis of covariance treatment ratio, 0.44; 95% CI, 0.22 to 0.88; P=0.02). Numerical improvements were observed with rotigotine versus placebo in IRLS and CGI-1 (least squares mean treatment differences of -6.08 [95% CI, -12.18 to 0.02; P=0.05] and -0.81 [95% CI, -1.94 to 0.33; P=0.2]). 10 of 15 rotigotine and 2 of 10 placebo patients were CGI-1 responders (≥50% improvement). Hemodialysis did not affect unconjugated rotigotine concentrations. The most common adverse events (≥2 patients) were nausea (rotigotine, 4 [20%]; placebo, 0); vomiting (3 [15%]; 0); diarrhea (1 [5%]; 2 [20%]); headache (2 [10%]; 0); dyspnea (2 [10%]; 0); and hypertension (2 [10%]; 0). LIMITATIONS: Small sample size and short duration. CONCLUSIONS: Rotigotine improved periodic limb movements and RLS symptoms in the short term among ESRD patients requiring hemodialysis in a small-scale study. No dose adjustments are necessary for hemodialysis patients.

An international feasibility study of home haemodialysis in older patients.

BACKGROUND: Home haemodialysis (HHD) is undergoing a significant revival. There is a global demographic shift with a rising mean age of dialysis patients. We postulated that intensive HHD may also benefit the older dialysis population. However, there is a lack of literature on the feasibility of HHD in older patients with end-stage renal disease (ESRD). The purpose of this study was to ascertain the feasibility of delivering HHD to older patients. METHODS: We conducted a multi-centre multinational retrospective cohort study of HHD patients ≥65 years of age at the time of HHD initiation; 79 patients were included. Baseline demographic data included age at start of dialysis, race and sex. Dialysis characteristics including total weekly treatment hours, need for assistance, training time, dialysis access, modality and dialysis vintage were captured, as well as cause of ESRD and medical co-morbidities. The primary outcome was time to technique failure or death. Rates of hospitalization, cardiovascular events, non-infectious vascular access events and infections were collected. RESULTS: Median age at start was 68 (interquartile range 66-71) years. An arteriovenous fistula was the predominant access, and most patients were receiving <16 h of total weekly dialysis treatment. Family or nurse assistance for dialysis was required in 54% of patients. There were 17 (22%) deaths and 20 (26%) technique failures. The cumulative time at risk was 188 years. Event-free survival at 1, 2 and 5 years was 85, 77 and 24%, respectively, and technique survival was 92, 83 and 56%, respectively. Advancing age (categorized into quartiles) was an unadjusted risk factor for death and technique failure. CONCLUSIONS: This analysis confirms feasibility of HHD in patients 65 years or older at the start of this modality and should foster further research on the potential benefits of (intensive) HHD in older ESRD patients.

Designing for Improved Patient Experiences in Home Dialysis: Usability and User Experience Findings From User-Based Evaluation Study With Patients With Chronic Conditions.

BACKGROUND: Chronic kidney disease affects 10% of the population worldwide, and the number of patients receiving treatment for end-stage kidney disease is forecasted to increase. Therefore, there is a pressing need for innovative digital solutions that increase the efficiency of care and improve patients' quality of life. The aim of the eHealth in Home Dialysis project is to create a novel eHealth solution, called eC4Me, to facilitate predialysis and home dialysis care for patients with chronic kidney disease. OBJECTIVE: Our study aimed to evaluate the usability, user experience (UX), and patient experience (PX) of the first version of the eC4Me solution. METHODS: We used a user-based evaluation approach involving usability testing, questionnaire, and interview methods. The test sessions were conducted remotely with 10 patients with chronic kidney disease, 5 of whom had used the solution in their home environment before the tests, while the rest were using it for the first time. Thematic analysis was used to analyze user test and questionnaire data, and descriptive statistics were calculated for the UMUX (Usability Metric for User Experience) scores. RESULTS: Most usability problems were related to navigation, the use of terminology, and the presentation of health-related data. Despite usability challenges, UMUX ratings of the solution were positive overall. The results showed noteworthy variation in the expected benefits and perceived effort of using the solution. From a PX perspective, it is important that the solution supports patients' own health-related goals and fits with the needs of their everyday lives with the disease. CONCLUSIONS: A user-based evaluation is a useful and necessary part of the eHealth solution development process. Our study findings can be used to improve the usability and UX of the evaluated eC4Me solution. Patients should be actively involved in the solution development process when specifying what information is relevant for them. Traditional usability tests complemented with questionnaire and interview methods can serve as a meaningful methodological approach for gaining insight not only into usability but also into UX- and PX-related aspects of digital health solutions.

Developing eHealth for Home Dialysis: Clinicians' Needs for a Digital Patient Engagement Platform.

eHealth solutions such as digital patient engagement platforms (DPEPs) aim at enhancing communication and collaboration between patients and clinicians. From the clinicians' viewpoint, concerns exist about new information systems (IS) leading to increased workload and interoperability problems. This article aims to support the development and implementation of DPEPs from the end-users' perspective. We studied clinicians' needs for a new DPEP developed to support home dialysis (HD) care. Eight clinicians participated in remote semi-structured interviews. Clinicians had positive expectations for the new DPEP as it could provide an overall picture of patients' status, support patients' self-care, and save time during patient visits. However, they had concerns about successful implementation, changes to workflows, and integration issues. To conclude, it is important to design and agree on changes in work practices, patient care, and complex IS environments when implementing new DPEP solutions in clinics.

Severe infections in peritoneal dialysis and home hemodialysis patients: An inception cohort study.

OBJECTIVES: Infections are the most common non-cardiovascular cause of death among dialysis patients. Earlier studies have shown similar or higher risk of infectious complications in peritoneal dialysis (PD) compared to hemodialysis (HD) patients, but comparisons to home HD patients have been rare. We investigated the risk of severe infections after start of continuous ambulatory PD (CAPD) and automated PD (APD) as compared to home HD. METHODS: All adult patients (n = 536), who were on home dialysis at day 90 from starting kidney replacement therapy (KRT) between 2004 and 2017 in Helsinki healthcare district, were included. We defined severe infection as an infection with C-reactive protein of 100 mg/l or higher. Cumulative incidence of first severe infection was assessed considering death as a competing risk. Hazard ratios were estimated using Cox regression with propensity score adjustment. RESULTS: The risk of getting a severe infection during the first year of dialysis was 35% for CAPD, 25% for APD and 11% for home HD patients. During five years of follow-up, the hazard ratio of severe infection was 2.8 [95% CI 1.6-4.8] for CAPD and 2.2 [95% CI 1.4-3.5] for APD in comparison to home HD. Incidence rate of severe infections per 1000 patient-years was 537 for CAPD, 371 for APD, and 197 for home HD patients. When excluding peritonitis, the incidence rate was not higher among PD than home HD patients. CONCLUSIONS: CAPD and APD patients had higher risk of severe infections than home HD patients. This was explained by PD-associated peritonitis.

IL5RA and TNFRSF6B gene variants are associated with sporadic IgA nephropathy.

Familial clustering and genome-wide linkage scans strongly support a genetic susceptibility to familial IgA nephropathy (IgAN), but genetic factors that predispose to sporadic IgAN are unknown. A high-throughput single nucleotide polymorphism (SNP) association study was conducted using a customized Illumina BeadChip in 732 white patients with biopsy-proven IgAN and 503 control subjects from Canada, France, and Finland. Approximately 93% of 1536 SNPs on the array were tag SNPs from Phase I+II of the HapMap with a minor allele frequency > or =5%, designed to capture the common variants of genes within the critical interval of IGAN1 on chromosome 6q22 and 69 biologic candidate genes for IgAN. SNPs of suggestive or significant association were identified by using logistic regression to adjust for age, gender, study site, and population stratification. Despite using a dense marker set that covered an average interval of 6.5 kb between SNPs, there was no strong and consistent association signal within the IGAN1 critical interval. Among the biologic candidate genes examined, two significant association signals were found at IL5RA and TNFRSF6B, the latter being particularly interesting because this gene encodes a decoy receptor for a TNF family ligand that causes IgAN in mice when overexpressed. Pending replication, these data suggest that variants of IL5RA and TNFRSF6B may predispose to sporadic IgAN.

What happened in Finland to increase home hemodialysis?

Finland is geographically a rather large country with a relatively sparse population (5.3 million). Home hemodialysis (HHD) was started in Helsinki 40 years ago and in the early years it was only used in selected patients. However, by the late 1980s HHD almost disappeared owing to the advent of CAPD and new HD centers. Towards the end of the 1990s, it became evident that PD had limitations and new ways had to be found to individualize HD, improve the outcome, increase capacity, and limit the growth of costs of HD. After careful planning, HHD was reinstituted at the Helsinki University Hospital in 1998 and since then the program has grown steadily. By December 31, 2007, altogether 163 patients had started at home. This has required changes in the predialysis program where the "home first" policy was adopted. Other important features include close cooperation with other nephrological centers as well as centralized HHD training that also supports more remote hospitals. Since then this therapy has been started in several other academic and in some smaller hospitals, and at the end of last year about 4% of all Finnish dialysis patients (n=1.600) were on HHD (prevalence 11.8/million). In the Helsinki metropolitan area this treatment is the most economical modality (estimated annual global costs euro37.000), comparable to self-care satellite HD and CAPD. A successful HHD program requires a well-organized predialysis program, a highly motivated multidisciplinary team, and well-developed training networks.

Lower urinary-interleukin-1 receptor-antagonist excretion in IgA nephropathy than in Henoch-Schönlein nephritis.

BACKGROUND: IgA nephropathy (IgAN) and Henoch-Schönlein nephritis (HSN) share many clinical, histological and immunological features. It has been postulated that these two conditions have a common pathogenesis and that HSN might be a systemic form of IgAN. Activity of interleukin-1beta (IL-1beta) in urine has been found to be higher in IgAN and HSN patients than in healthy controls. Interaction between IL-1beta and interleukin-1 receptor antagonist (IL-1ra) plays a significant role in the regulation of inflammatory responses. We studied levels of urinary excretion of IL-1beta and IL-1ra in patients with IgAN and HSN. METHODS: Amounts of IL-1beta and IL-1ra excreted in 24-h urine samples collected from 241 IgAN, 26 HSN patients and from 33 healthy controls were determined. Results were expressed as cytokine/creatinine (ng/mmol) ratios. RESULTS: Urinary IL-1beta excretion by the IgAN and HSN patients was no greater than urinary IL-1beta excretion by healthy controls. Urinary IL-1ra excretion by the IgAN patients was lower than urinary IL-1ra excretion by healthy controls (P < 0.05) and by the HSN patients (P < 0.01). In both patients and controls women had significantly higher IL-1ra, IL-1beta excretion levels and IL-1ra/IL-1beta ratios. The differences in urinary excretions of IL-1ra by the healthy controls and by the IgAN and HSN patients were significant in both sexes. Excretion of IL-1beta or IL-1ra did not correlate with excretion of urinary protein, duration of the disease or any histopathological variable. However, histopathological changes in renal biopsy specimens from patients with IL-1ra/IL-1beta ratios above normal were significantly milder than in renal biopsy specimens from patients with low or normal IL-1ra/IL-1beta ratios. CONCLUSION: Urinary IL-1ra levels in IgAN patients were lower than urinary IL-1ra levels in healthy controls or HSN patients, a finding which may indicate that the two diseases have a different pathogenesis. Whether the male predominance in IgAN and HSN and the worse outcomes in males that have been reported previously in IgAN and HSN are connected with the lower excretion of IL-1ra and consequently lower IL-1ra/IL-1beta ratios in male patients than in female patients needs more thorough investigation.

A tricontinental view of IgA nephropathy.

BACKGROUND: The purpose of this retrospective study was to analyse patients from four centres in three continents to determine if differences in long-term outcome of IgA nephropathy (IgAN) are explained by clinical and laboratory features at presentation. METHODS: The study included 711 adults with biopsy-proven IgAN from Glasgow, UK (n = 112), Helsinki, Finland (n = 204), Sydney, Australia (n = 121) and Toronto, Canada (n = 274). Data collected from time of presentation to a nephrologist were age, gender, 24-h urine protein excretion (UP(0)), mean arterial pressure (MAP(0)) and creatinine clearance (CrCl(0)). Outcomes were slope of creatinine clearance (CrCl) and renal survival. RESULTS: At presentation there was significant vari-ability in baseline clinical features with patients from Helsinki having the lowest median UP(0), lowest MAP(0) and highest CrCl(0), all suggesting milder disease. There was significant variability in renal survival between centres with 10-year actuarial survival of 95.7, 87.0, 63.9 and 61.6% in Helsinki, Sydney, Glasgow and Toronto, respectively (P < 0.0001; log rank). Cox proportional hazards model revealed lower age(0) and lower CrCl(0) were significant independent predictors of reduced renal survival. In addition, patients from Helsinki and Sydney but not Glasgow had significantly longer renal survival than patients from Toronto. Median slope of CrCl varied by region from -1.24 ml/min/year in Helsinki, to -3.99 ml/min/year in Toronto (Kruskal-Wallis H test P < 0.0001). By multivariate analysis older age(0), higher CrCl(0) and lower UP(0) were independently associated with slower progression. Subjects from Helsinki had a significantly slower deterioration independent of the other clinical parameters at presentation. When the 269 patients presenting with CrCl(0) <75 ml/min were analysed separately there was no independent centre effect. CONCLUSIONS: The findings are consistent with the hypothesis that geographical variability in long-term outcome of IgAN is explained by lead-time bias and inclusion of milder cases in centres with apparent good outcome, but do not exclude the possibility that some of the variability is due to other factors such as genetics, diet or treatment.