Hyperkalaemia prevalence, recurrence and management in chronic haemodialysis: a prospective multicentre French regional registry 2-year survey.

BACKGROUND: Observational studies have reported increased mortality rates in hyperkalaemic or hypokalaemic chronic haemodialysis patients. This study assessed the prevalence and recurrence of hyperkalaemia (HK) along with the concomitant prescription of low-potassium (K) dialysis baths and of K-binding agents in a registry within a French regional disease management programme. METHODS: This was a prospective multicentre (14 chronic haemodialysis centres, Lorraine Region) study encompassing 527 chronic haemodialysis patients followed from 2 January 2014 to 31 December 2015. Predialysis serum K (14 734) measurements, dialysis bath K concentrations and concomitant K binder prescriptions were collected with an electronic health record system. RESULTS: At baseline, 26.4%, 13.8% and 4.9% of patients were hyperkalaemic (i.e. K >5.1, 5.5 or 6 mmol/L, respectively) and 12.5%, 1.9% and 0.4% were hypokalaemic (i.e. K<4, 3.5 or 3 mmol/L, respectively). A total of 61% of patients were prescribed a K-binding resin [essentially sodium polystyrene sulfonate (SPS)], while 2 mmol/L and 3 mmol/L K concentration baths were used relatively equally. Over time, the proportion of patients being prescribed any K-binding agent increased up to 78%. The percentage of patients experiencing HK at any time was 73.8% (HK >5.1 mmol/L), 57.9% (HK >5.5 mmol/L) and 34.5% (HK >6 mmol/L). Only 6.3% of patients became normokalaemic within 3 months after an HK >5.5 mmol/L despite dynamic management of K baths and K binders (i.e. increased prescription of 2 mmol/L K baths and increased SPS doses). CONCLUSIONS: HK was found to be highly prevalent and recurrent in this regional registry despite the widespread and dynamic prescription of low-K dialysis baths and K binders. More effective potassium mitigating strategies are eagerly warranted.

Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

BACKGROUND: Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. METHODS: eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. DISCUSSION: The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. TRIAL REGISTRATION: This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014).

[Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique]. / Recommandations d'utilisation des biosimilaires de l'érythropoïétine (EPO). Propositions de la Société de néphrologie, de la Société francophone de dialyse et de la Société de néphrologie pédiatrique.

The European patents for epoetin alpha recently expired. Biosimilars (i.e. "a medicine which is similar to a biological medicine that has already been authorized" [EMEA 2007]) of epoetins have thus been released on the market in Europe. Because of the complexity of the processes that are required to produce medicinal products containing biotechnology-derived proteins as active substances and to characterize the physicochemical properties of these compounds, the guidelines that have been developed for generic drugs cannot be used for approval of biosimilar products. The EMEA guidelines do not answer all questions that have been raised for the development of biosimilars, and in some cases, decisions will have to be taken at a national level. This is why the Society of Nephrology (Société de néphrologie), the French-speaking Society of Dialysis (Société francophone de dialyse) and the Pediatric Society of Nephrology (Société de néphrologie pédiatrique) established guidelines for the usage of biosimilar epoetins concerning approval, identification, substitution of an innovator drug, post-marketing surveillance, extension of indication and pharmacovigilance plan.

Clinical evaluation of an expert system for arteriovenous fistula assessment.

The monitoring of ionic dialysance in hemodialysis allows early detection of arterio-venous fistula stenosis. One limitation to the practical use of ionic dialysance is that the analysis is very time consuming on a majority of normal cases.The purpose of the study is to evaluate the utility of an expert system reproducing a human analysis and allowing continuous monitoring of the ionic dialysance by helping the physician to focus his or her expertise on the abnormal cases.The method is based on a Bayesian model that analyzes the blood flow rate, the ionic dialysance, and the venous and arterial pressures measured on the extra corporeal circuit.The clinical evaluation was performed on 90 dialysis patients at the hospital dialysis center of Saint Brieux in France with a history of at least four consecutive months of validated recording. The retrospective automated analysis was evaluated in comparison to vascular access problems identified from invasive investigation or treatment. The sensitivity of the automated analysis is 92% with a specificity of 75%.As a conclusion we suggest that this expert system could be used in a continuous vascular access monitoring procedure consisting in a weekly review of the patient population at the dialysis center. The patients with the highest risk score need a further investigation of their historical data and their medical history in order to decide whether or not to perform an invasive intervention.

Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study.

INTRODUCTION: There is scant real-world information on switching treatment for anemia associated with chronic kidney disease (CKD) from methoxy polyethylene glycol-epoetin beta (PEG-Epo) to darbepoetin alfa (DA). TRANSFORM was a multi-center, observational study designed to describe the time course of hemoglobin (Hb) concentration (primary outcome measure) and other parameters of clinical management of anemia in European hemodialysis patients in clinical practice before and after a switch from PEG-Epo to DA. METHODS: Eligible subjects were adult patients with CKD dialyzed at European dialysis centers for ≥26 weeks and treated with PEG-Epo for ≥14 weeks immediately prior to being switched to DA and no earlier than January 2011. Erythropoiesis-stimulating agent doses and Hb values were recorded for the 14-week pre-switch and 26-week post-switch periods. RESULTS: Of the 1,027 eligible patients enrolled at 42 hemodialysis centers in 7 European countries, 785 were included in analyses. Mean (95% confidence interval [CI]) Hb was generally stable: 11.19 (11.11, 11.26), 11.48 (11.40, 11.57), and 11.29 (11.20, 11.37) g/dL at month -1 pre-switch and months 3 and 6 post-switch, respectively. The geometric mean (95% CI) PEG-Epo dose at month -1 was 27.4 (26.0, 28.8) µg/week; DA dose was 29.4 (27.9, 30.9), 23.3 (21.9, 24.9), and 25.6 (24.1, 27.1) µg/week at months 1, 4, and 6, respectively. The geometric mean (95% CI) dose ratio at switching was 1.06 (1.01, 1.11). When stratifying by dose-ratio categories <0.8, 0.8-1.2, and >1.2 at switching, mean DA dose and Hb converged within narrow ranges by month 6 post-switch: 23.9-27.0 µg/week and 11.1-11.5 g/dL, respectively. Hb excursions <10 g/dL were less frequent post-switch versus pre-switch. CONCLUSION: Mean Hb values remained within a narrow range following switching from PEG-Epo to DA in this population of hemodialysis patients. Time trends of mean Hb and DA dose indicate that physicians titrated DA doses post-switch, to attain Hb concentrations comparable to those attained pre-switch with PEG-Epo.

[Peritoneal dialysis for ESRD patients: financial aspects]. / La dialyse péritonéale dans le parcours de soins de l'insuffisant rénal: aspects financiers.

Peritoneal dialysis (PD) is as least as good as hemodialysis (HD) for the treatment of end stage kidney disease, considering morbidity and mortality, and better for quality of life. The best result is obtained when the patient can benefit of the sequential treatment, PD first and then HD if necessary. Furthermore, the cost of a patient treated by PD is less than the cost of the same patient treated by HD, at least in developed countries. But, all around the word, the rate of usage of PD don't grow, or decline. One can expect that, as no medical reason can explain this, the cause is economic. Multiple economics aspects and expenses posts for DP are analyzed, as the results of some financial decisions taken in one country or the other, keeping in mind the French system or reimbursement. We conclude that economic incitations may help for the development of PD, if they don't penalize one of the partners (insurance, clinics, doctors of patients), and if in the same time there is an improvement of the formation and information of doctors and patient.

Changes in health-related quality of life in patients of self-care vs. in-center dialysis during the first year.

OBJECTIVE: In the Lorraine area (France), dialysis centers propose an educational program to improve patient's ability to perform dialysis by themselves. The objective was to assess changes in health-related quality of life (HRQoL) during the first year of dialysis, comparing independent patients with patients on in-center dialysis. METHOD: All patients aged between 18 and 70 and having started their first dialysis between June 1997 and June 1999 in the Lorraine area were included. Socio-demographic, medical data and HRQoL (KDQoL) were assessed for each patient at enrollment, at 6 and 12 months. RESULTS: At 12 months, 195 patients were in dialysis, 147 were non-autonomous, and 48 were autonomous. Independent patients were younger, were more often in occupational activity, had a lower body mass index and had fewer comorbidities. Several dimensions of the HRQoL were significantly higher in autonomous patients at baseline: physical functioning (60.4 vs. 50.7) and work status (30.9 vs. 18.4); and at 12 months: less burden of kidney disease (51.7 vs. 37.3), fewer effects of kidney disease (65.9 vs. 54.0), cognitive function (72.0 vs. 62.7) and role-emotional (53.0 vs. 34.5). CONCLUSION: These results show improved HRQoL among independent patients. Our regional care network may be a particularly useful model for undertaking actions motivating the healthcare teams and for enhancing the human resources devoted to patient education.

Telehomecare for vulnerable populations: The evaluation of new models of care.

The use of telehomecare has the potential to facilitate access to healthcare services for vulnerable populations. However, evidence on the implications of telehomecare on various aspects related to patients, healthcare professionals, organizations, and healthcare systems is still limited. Assessing the various effects of telehomecare for these different groups of stakeholders is thus an essential step to ensure future integration of this technology into mainstream healthcare services. A synthesis of lessons learned from the evaluation of three telehomecare experimentations targeting specific vulnerable groups is proposed. This paper presents the various models that were implemented to assess telehomecare services for vulnerable populations, explores issues related to conducing telehomecare evaluations, and provides a reflection on key factors that might influence the success of telehomecare projects. Lessons learned from these three experimentations provide valuable insights to orient the development of telehomecare services for various vulnerable groups in the population.