How a Bottom-Up Multi-Stakeholder Initiative Helped Transform the Renal Replacement Therapy Landscape in Spain.

Healthcare reforms aim to change certain parts of the health system to improve quality of care, access, or financial sustainability. Traditionally, healthcare reform is understood as an action undertaken by a government at a national or local level. However, bottom-up changes can also lead to improvements in the health system. This paper describes the efforts of a coordinated multi-stakeholder advocacy group in Spain to promote a more cost-effective and patient-centred treatment for people receiving renal replacement therapy and assesses the outcomes of their advocacy for health system financing and patient satisfaction. It concludes that bottom-up initiatives do indeed have the power to change health policy and that policy makers should pay attention to their arguments.

Biocompatible Dialysis Solutions Preserve Peritoneal Mesothelial Cell and Vessel Wall Integrity. A Case-Control Study on Human Biopsies.

UNLABELLED: ♦ INTRODUCTION: Chronic exposure to conventional peritoneal dialysis (PD) solutions has been related to peritoneal function alterations in PD patients, and associated with mesothelial cell loss, submesothelial fibrosis, vasculopathy, and angiogenesis. In vitro and ex vivo analyses, as well as studies with animal models, have demonstrated that biocompatible PD solutions attenuate these morphological alterations. Our aim was to confirm the morphological benefits of biocompatible solutions in PD patients. ♦ METHODS: We analyzed biopsies from 23 patients treated with biocompatible solutions (study group, SG), and compared them with a control group (n = 23) treated with conventional solutions (CG), matched for time on PD. ♦ RESULTS: A total of 56.5% of SG patients showed total or partial preservation of mesothelial cells monolayer, in contrast with 26.1% of patients in CG (p = 0.036). Peritoneal fibrosis was not significantly less frequent in SG patients (47.8% SG vs 69.6% CG; p = 0.13). In patients without previous peritonitis, a significantly lower prevalence of fibrosis was present in SG patients (41.7% SG vs 77.8% CG; p = 0.04). Hyalinizing vasculopathy (HV) was significantly lower in SG (4.3% SG vs 30.4% CG; p = 0.02). Cytokeratin-positive fibroblast-like cells were detected in 10 patients (22%), but the prevalence was not significantly lower in SG. In the univariate regression analysis, the use of biocompatible solutions was associated with mesothelial monolayer integrity (p = 0.04) and an absence of vasculopathy (p = 0.04). ♦ CONCLUSION: The present study demonstrates in vivo in human biopsies that biocompatible solutions are better tolerated by the peritoneum in the medium and long term than conventional solutions.

Trends in dialysis modality choice and related patient survival in the ERA-EDTA Registry over a 20-year period.

BACKGROUND: Although previous studies suggest similar patient survival for peritoneal dialysis (PD) and haemodialysis (HD), PD use has decreased worldwide. We aimed to study trends in the choice of first dialysis modality and relate these to variation in patient and technique survival and kidney transplant rates in Europe over the last 20 years. METHODS: We used data from 196 076 patients within the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry who started renal replacement therapy (RRT) between 1993 and 2012. Trends in the incidence rate and prevalence on Day 91 after commencing RRT were quantified with Joinpoint regression. Crude and adjusted hazard ratios (HRs) for 5-year dialysis patient and technique survival were calculated using Cox regression. Analyses were repeated using propensity score matching to control for confounding by indication. RESULTS: PD prevalence dropped since 2007 and HD prevalence stabilized since 2009. Incidence rates of PD and HD decreased from 2000 and 2009, respectively, while the incidence of kidney transplantation increased from 1993 onwards. Similar 5-year patient survival for PD versus HD patients was found in 1993-97 [adjusted HR: 1.02, 95% confidence interval (95% CI): 0.98-1.06], while survival was higher for PD patients in 2003-07 (HR: 0.91, 95% CI: 0.88-0.95). Both PD (HR: 0.95, 95% CI: 0.91-1.00) and HD technique survival (HR: 0.93, 95% CI: 0.87-0.99) improved in 2003-07 compared with 1993-97. CONCLUSIONS: Although initiating RRT on PD was associated with favourable patient survival when compared with starting on HD treatment, PD was often not selected as initial dialysis modality. Over time, we observed a significant decline in PD use and a stabilization in HD use. These observations were explained by the lower incidence rate of PD and HD and the increase in pre-emptive transplantation.

The Concordance between Patients' Renal Replacement Therapy Choice and Definitive Modality: Is It a Utopia?

INTRODUCTION: It is desirable for patients to play active roles in the choice of renal replacement therapy (RRT). Patient decision aid tools (PDAs) have been developed to allow the patients to choose the option best suited to their individual needs. MATERIAL AND METHODS: An observational, prospective registry was conducted in 26 Spanish hospitals between September 2010 and May 2012. The results of the patients' choice and the definitive RRT modality were registered through the progressive implementation of an Education Process (EP) with PDAs designed to help Chronic Kidney Disease (CKD) patients choose RRT. RESULTS: Patients included in this study: 1044. Of these, 569 patients used PDAs and had made a definitive choice by the end of registration. A total of 88.4% of patients chose dialysis [43% hemodialysis (HD) and 45% peritoneal dialysis (PD)] 3.2% preemptive living-donor transplant (TX), and 8.4% conservative treatment (CT). A total of 399 patients began RRT during this period. The distribution was 93.4% dialysis (53.6% HD; 40% PD), 1.3% preemptive TX and 5.3% CT. The patients who followed the EP changed their mind significantly less often [kappa value of 0.91 (95% CI, 0.86-0.95)] than those who did not follow it, despite starting unplanned treatment [kappa value of 0.85 (95% CI, 0.75-0.95]. A higher agreement between the final choice and a definitive treatment was achieved by the EP and planned patients [kappa value of 0.93 (95% CI, 0.89-0.98)]. Those who did not go through the EP had a much lower index of choosing PD and changed their decision more frequently when starting definitive treatment [kappa value of 0.73 (95% CI, 0.55-0.91)]. CONCLUSIONS: Free choice, assisted by PDAs, leads to a 50/50 distribution of PD and HD choice and an increase in TX choice. The use of PDAs, even with an unplanned start, achieved a high level of concordance between the chosen and definitive modality.

Increased risk of fatal infections in women starting peritoneal dialysis.

BACKGROUND AND OBJECTIVES: Although cardiovascular disease (CVD) is an important cause of morbidity and mortality in patients with end-stage renal disease, non-CVD causes account for more than 50% of total deaths. We previously showed that, compared with men, women starting dialysis-- both hemodialysis and peritoneal dialysis (PD)--have higher non-CVD mortality rates. Here, we evaluate sex-specific outcomes in a large cohort of incident PD patients. METHODS: Incident de novo PD patients from the Andalusian SICATA Registry for 1999 - 2010, with follow-up until 31 December 2010 or up to 5 years, were investigated for fatal outcomes. Causes of death were extracted from medical records. The analysis used traditional and competing-risk Cox models for all-cause and cause-specific mortality in men and women, correcting in the competing-risk models for the events of kidney transplantation and transfer to hemodialysis. RESULTS: A total of 1458 patients (57% men; mean overall age: 55.3 ± 17.0 years) initiated PD in Andalusia during the study period. During follow-up, 350 deaths, 355 renal transplantation procedures, and 331 transfers to hemodialysis were recorded. Vascular disease and diabetic nephropathy were the most frequent causes of kidney failure in men; other causes were more common in women. In the traditional Cox model, both sexes showed a similar all-cause mortality risk [crude hazard ratio (HR): 0.90; 95% confidence interval (CI): 0.72 to 1.12]. However, with respect to specific causes of death, women showed a borderline lower risk of both CVD (crude HR: 0.71; 95% CI: 0.50 to 0.99) and non-CVD mortality from other than infection (crude HR: 0.81; 95% CI: 0.57 to 1.15). In contrast, the risk of death from infection was almost doubled in women compared with men (crude HR: 1.92; 95% CI: 1.15 to 3.20), a finding that held true after multivariate adjustment for age, primary renal disease, period of inclusion, and initial PD modality (adjusted HR: 1.76; 95% CI: 1.03 to 3.01). This result was confirmed even taking into consideration the competing events of kidney transplantation and transfer to hemodialysis. CONCLUSIONS: Compared with men starting PD, women starting PD are at higher risk of mortality from infection. More stringent screening measures and corrective efforts in women might be indicated.

'Reality and desire' in the care of advanced chronic kidney disease.

There is a long distance between the actual worldwide reality in advanced chronic kidney disease care and the desire of how these patients should be managed to decrease cardiovascular and general morbidity and mortality. Implementation of adequate infrastructures may improve clinical outcomes and increase the use of home renal replacement therapies (RRT). Current pitfalls should be addressed to optimise care: inadequate medical training for nephrological referral and RRT selection, late referral to nephrologists, inadequate patient education for choice of RRT modality, lack of multidisciplinary advanced kidney disease clinics and lack of programmed RRT initiation. These deficiencies generate unintended consequences, such as inequality of care and limitations in patient education and selection-choice for RRT technique with limited use of peritoneal dialysis. Multidisciplinary advanced kidney disease clinics may have a direct impact on patient survival, morbidity and quality of life. There is a common need to reduce health care costs and scenarios increasing PD incidence show better efficiency. The following proposals may help to improve the current situation: defining the scope of the problem, disseminating guidelines with specific targets and quality indicators, optimising medical speciality training, providing adequate patient education, specially through the use of general decision making tools that will allow patients to choose the best possible RRT in accordance with their values, preferences and medical advice, increasing planned dialysis starts and involving all stakeholders in the process.

Icodextrin does not impact infectious and culture-negative peritonitis rates in peritoneal dialysis patients: a 2-year multicentre, comparative, prospective cohort study.

BACKGROUND: Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. The different biocompatibility profile of icodextrin-containing peritoneal dialysis (PD) solutions may have a positive influence on peritoneal host defence. Furthermore, cases of sterile peritonitis potentially associated with icodextrin have been reported. METHODS: The primary objective of this multicentre, longitudinal, observational, non-interventional, prospective cohort study, which included 722 PD patients, was to evaluate the incidence of overall peritonitis in patients treated with icodextrin-containing PD solutions (Extraneal) used during one long-dwell exchange/day compared with those treated with non-icodextrin-containing PD solutions. The secondary objective was to determine if culture-negative peritonitis rates differed between patients treated with icodextrin from two independent manufacturers. All peritonitis episodes were assessed by a Steering Committee in a blind manner. RESULTS: There was no significant difference between icodextrin-treated and control patients in the adjusted overall, culture-positive or culture-negative peritonitis rates. When stratified by the icodextrin supplier, there was no significant difference in the adjusted rate of culture-negative peritonitis episodes between groups. CONCLUSION: Subjects receiving icodextrin as part of their PD regimen experienced neither a higher rate of culture-negative peritonitis nor a lower rate of infectious peritonitis compared with non-icodextrin users. There was no significant influence of the icodextrin raw material supplier on peritonitis rates.