Performance Evaluation of an Automated Peritoneal Dialysis Solution Generation System in Patients Using Automated Peritoneal Dialysis.

Introduction: Most patients on peritoneal dialysis (PD) in the United States are on automated PD (APD) utilizing several liters of PD solution daily for their treatment. The ordering, delivery, and storage of PD solutions can be challenging and is an important factor that can dissuade patients from doing PD. The generation of PD solutions at home is a strategy that could potentially be used to overcome this problem. The APD Solution Generation System (SGS) allowed for PD solution generation using tap water in patients' homes. Methods: In this study, we set out to evaluate the performance of the SGS in prevalent, adult patients with end-stage kidney disease, who are on maintenance PD. We evaluated the primary safety (microbiological testing) and efficacy (chemical composition) of the product water generated by the SGS device. Results: Twenty-two patients from 12 different United States centers were enrolled, of which 14 patients completed the study. The results of the primary safety and efficacy end point analyses of the product water showed that all 64 samples met the International Organization for Standardization (ISO) specifications. Secondary safety analysis found a total of 34 adverse events (AEs) in 12 patients. Of these AEs, 3, namely, culture negative peritonitis, bacterial peritonitis, and atrial fibrillation were deemed serious treatment-emergent AEs. Conclusion: This study demonstrated that the SGS can successfully generate PD solution in patients' homes, while meeting chemical composition and ISO microbiological standards. Lessons learned from this clinical trial will be useful in optimizing product development and future clinical trials.

Early outcomes of peritoneal dialysis in a middle-income country: A retrospective cohort study of a large dialysis network in Colombia.

BACKGROUND: The first year of dialysis is critical given the significant risk for complications following dialysis initiation. We analysed complications during the first year among incident peritoneal dialysis (PD) patients. METHODS: This retrospective cohort study comprised adult kidney failure patients starting PD in Baxter Renal Care Services in Colombia, receiving their first PD catheter between 1 January 2017 and 31 December 2020 and were followed up for up to 1 year. We analysed incidence, causes and factors associated with complications using logistic regression and transfer to haemodialysis (HD) using the Fine-Gray regression model. RESULTS: Among 4743 patients receiving their first PD catheter: 4628 (97.6%) of catheter implantations were successful; 377 (7.9%) patients experienced early complications. The incidence rate of complications during the year was 0.51 events per patient-year (95% CI: 0.48-0.54). Age, obesity and urgent start were associated with higher probability of complications after catheter implantation. The cumulative incidence of transfer to HD within 1 year of PD initiation was 10.1% [95% CI: 9.2-11.1%]. The hazard function for transfer to HD showed an accelerating pattern during the first month followed by progressive decrease during the first year. CONCLUSIONS: In this large population of incident PD patients, there is a high primary catheter placement success rate. Urgent start, age ≥65 years, obesity, centre size ≥150 PD patients and diabetes were risk factors associated with early complications. The follow-up of the cohort from day 1 of PD treatment showed that the risk for transfer to HD was higher during the first month.

Time on Therapy of Automated Peritoneal Dialysis with and without Remote Patient Monitoring: A Cohort Study.

Background: Remote patient monitoring (RPM) of patients undergoing automated peritoneal dialysis (APD-RPM) may potentially enhance time on therapy due to possible improvements in technique and patient survival. Objective: To evaluate the effect of APD-RPM as compared to APD without RPM on time on therapy. Methods: Adult incident APD patients undergo APD for 90 days or more in the Baxter Renal Care Services (BRCS) Colombia network between January 1, 2017, and June 30, 2019, with the study follow-up ending June 30, 2021. The exposure variable was APD-RPM vs. APD-without RPM. The outcomes of time on therapy and mortality rate over two years of follow-up were estimated in the full sample and in a matched population according to the exposure variable. A propensity score matching (PSM) 1:1 without replacement utilizing the nearest neighbor within caliper (0.035) was used and created a pseudopopulation in which the baseline covariates were well balanced. Fine & Gray multivariate analysis was performed to assess the effect of demographic, clinical, and laboratory variables on the risk of death, adjusting for the competing risks of technique failure and kidney transplantation. Results: In the matched sample, the time on APD therapy was significantly longer in the RPM group than in the non-RPM group, 18.95 vs. 15.75 months, p < 0.001. The mortality rate did not differ between the two groups: 0.10 events per patient-year in the RPM group and 0.12 in the non-RPM group, p=0.325. Conclusion: Over two years of follow-up, the use of RPM vs. no RPM in APD patients was associated with a significant increase in time on therapy, by 3.2 months. This result indicates that RPM-supported APD therapy may improve the clinical effectiveness and the overall quality of APD.

New insights into the epidemiology of ANCA-associated vasculitides in Germany: results from a claims data study.

OBJECTIVE: ANCA-associated vasculitides (AAV) are rare, potentially life-threatening autoimmune diseases characterized by systemic inflammation and organ damage. AAV prevalence rates reported in Europe vary considerably and robust data sources are often lacking. This study aimed to examine the feasibility of claims data analysis as a complementary method to registry-based studies to assess the epidemiology of AAV. METHODS: In this retrospective observational study, anonymized longitudinal claims data from years 2013-2016 from German statutory health insurance companies (data source: InGef, Institute for Applied Health Research) have been analysed on an age- and gender-stratified cohort of ∼3 million persons representative of the German population. In this cohort, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) patients were identified. RESULTS: The study cohort revealed a prevalence for GPA and MPA of 210 and 46 cases per million people, respectively. The annual incidence comprised 34 GPA cases and 13 MPA cases per million people per year. Hence, 17 500 AAV patients (GPA and MPA) are estimated to live in Germany, with an annual increase of 3200 patients. According to their demographic and disease-specific characteristics, AAV patients identified in this claims data approach are representative. CONCLUSION: This is the first study using claims data to assess the epidemiology of AAV. In Germany, AAV was diagnosed more frequently than it was estimated by previous self-reporting registry-based studies. The findings indicate that epidemiological data of AAV may have been underestimated but may also reflect improved diagnostic methods and disease recognition.

Composite Outcome Improves Feasibility of Clinical Trials in Peritoneal Dialysis.

Background:Peritoneal dialysis (PD) is complicated by a high rate of adverse events that might be attributed to cytotoxicity of currently used PD fluids. However, clinical development of novel PD fluids is virtually non-existent, in part due to difficulties in recruiting sufficiently large populations for adequately powered trials. The aim of this study is to understand the potential impact of introducing composite outcomes on clinical trial feasibility in PD.Methods:A composite outcome "major adverse peritoneal events (MAPE)" was designed to combine clinically relevant complications of PD, such as (1) technical failure (cause-specific for peritonitis and/or insufficient dialysis), (2) peritonitis, and (3) peritoneal membrane deterioration. Incidence rates of individual endpoints were obtained from the literature and expert panel estimations, and population sizes were computed based on Chi-square test for adequately powered confirmatory randomized controlled clinical trials with 2 parallel arms.Results:Incidence rates for technical failure, peritonitis, and peritoneal membrane deterioration were estimated at 15%, 50%, and 23%, respectively, at 2 years follow-up, with adequate agreement between the literature and expert opinion. Assuming that a given intervention reduces adverse outcomes by 30%, an adequately powered clinical trial needs to recruit up to 1,720 patients when studying individual outcomes. Combining endpoints increases power in simulated trials despite considerable overlap, and the composite outcome MAPE reduces the required population to 202 patients aiming for 80% power.Conclusion:Introduction of the composite outcome MAPE, covering relevant major adverse peritoneal events, may improve the feasibility of clinical trials to adequately test novel PD fluids.

Biomarker research to improve clinical outcomes of peritoneal dialysis: consensus of the European Training and Research in Peritoneal Dialysis (EuTRiPD) network.

Peritoneal dialysis (PD) therapy substantially requires biomarkers as tools to identify patients who are at the highest risk for PD-related complications and to guide personalized interventions that may improve clinical outcome in the individual patient. In this consensus article, members of the European Training and Research in Peritoneal Dialysis Network (EuTRiPD) review the current status of biomarker research in PD and suggest a selection of biomarkers that can be relevant to the care of PD patients and that are directly accessible in PD effluents. Currently used biomarkers such as interleukin-6, interleukin-8, ex vivo-stimulated interleukin-6 release, cancer antigen-125, and advanced oxidation protein products that were collected through a Delphi procedure were first triaged for inclusion as surrogate endpoints in a clinical trial. Next, novel biomarkers were selected as promising candidates for proof-of-concept studies and were differentiated into inflammation signatures (including interleukin-17, M1/M2 macrophages, and regulatory T cell/T helper 17), mesothelial-to-mesenchymal transition signatures (including microRNA-21 and microRNA-31), and signatures for senescence and inadequate cellular stress responses. Finally, the need for defining pathogen-specific immune fingerprints and phenotype-associated molecular signatures utilizing effluents from the clinical cohorts of PD patients and "omics" technologies and bioinformatics-biostatistics in future joint-research efforts was expressed. Biomarker research in PD offers the potential to develop valuable tools for improving patient management. However, for all biomarkers discussed in this consensus article, the association of biological rationales with relevant clinical outcomes remains to be rigorously validated in adequately powered, prospective, independent clinical studies.

Dialysis access, infections, and hospitalisations in unplanned dialysis start patients: results from the OPTiONS study.

INTRODUCTION: Unplanned dialysis start (UPS) associates with worse clinical outcomes, higher utilisation of healthcare resources, lower chances to select dialysis modality and UPS patients typically commenced in-centre haemodialysis (HD) with central venous catheter (CVC). We evaluated patient outcomes and healthcare utilisation depending on initial dialysis access (CVC or PD catheter) and subsequent pathway of UPS patients. METHODS: In this study patient demographics, access procedures, hospitalisations, and major infectious complications were analysed over 12 months in 270 UPS patients. PD technique survival and impact of switching from HD to PD was examined along with logistic regression to investigate factors predicting AV fistula formation. RESULTS: 72 UPS patients started with PD catheter and 198 with CVC. PD patients were older and more comorbid but had a significantly lower number of access procedures while there was no difference in hospitalisation or major infections. 13/72 initial PD patients switched to HD and 1-year technique survival was 79%. 158/198 patients remained on HD and 73/158 reported permanent access formation. Older age, OR = 0.34 (CI,0.17-0.68) and cardiac failure, OR = 0.31(CI,0.13-0.78), were significant negative predictors of receiving fistula. Younger patients, OR = 0.29 (CI, 0.11-0.79) and those who received AVF, OR = 0.11 (CI,0.03-0.38), had significantly lower odds of death. DISCUSSION: UPS with initial PD was possible in many patients and was associated with lower requirement for access procedures. AVF formation in UPS patients starting on HD was associated with better 1-year survival. Modality switching in UPS patients requires careful clinical management, including clinical practice patterns promoting permanent HD access formation.

Offering Patients Therapy Options in Unplanned Start (OPTiONS): Implementation of an educational program is feasible and effective.

BACKGROUND: Patients with unplanned dialysis start (UPS) have worse clinical outcomes than non-UPS patients, and receive peritoneal dialysis (PD) less frequently. In the OPTiONS study of UPS patients, an educational programme (UPS-EP) aiming at improving care of UPS patients by facilitating care pathways and enabling informed choice of dialysis modality was implemented. We here report on impact of UPS-EP on modality choice and clinical outcomes in UPS patients. METHODS: This non-interventional, prospective, multi-center, observational study included 270 UPS patients from 26 centers in 6 European countries (Austria, Germany, Denmark, France, United Kingdom and Sweden) who prior to inclusion presented acutely, or were being followed by nephrologists but required urgent dialysis commencement by an acutely placed CVC or PD catheter. Effects of UPS-EP on choice and final decision of dialysis therapy and outcomes within 12 months of follow up were analysed. RESULTS: Among 270 UPS patients who had an unplanned start to dialysis, 214 were able to receive and 203 complete UPS-EP while 56 patients - who were older (p = 0.01) and had higher Charlson comorbidity index (CCI; p < 0.01) - did not receive UPS-EP. Among 177 patients who chose dialysis modality after UPS-EP, 103 (58%) chose PD (but only 86% of them received PD) and 74 (42%) chose HD (95% received HD). Logistic regression analysis showed that diabetes 1.88 (1.05 - 3.37) and receiving UPS-EP, OR = 4.74 (CI, 2.05 - 10.98) predicted receipt of PD. Patients choosing PD had higher CCI (p = 0.01), higher prevalence of congestive heart failure (p < 0.01) and myocardial infarction (p = 0.02), and were more likely in-patients (p = 0.02) or referred from primary care (p = 0.02). One year survival did not differ significantly between PD and HD patients. Peritonitis and bacteraemia rates were better than international guideline standards. CONCLUSIONS: UPS-EP predicted patient use of PD but 14% of those choosing PD after UPS-EP still did not receive the modality they preferred. Patient survival in patients choosing and/or receiving PD was similar to HD despite age and comorbidity disadvantages of the PD groups.

Differences in Knowledge, Stress, Sensation Seeking, and Locus of Control Linked to Dietary Adherence in Hemodialysis Patients.

Patients with chronic kidney disease (CKD) often require regular hemodialysis (HD) to prolong life. However, between HD sessions, patients have to restrict their diets carefully to avoid excess accumulation of potassium, phosphate, sodium, and fluid, which their diseased kidneys can no longer regulate. Failure to adhere to their renal dietary regimes can be fatal; nevertheless, non-adherence is common, and yet little is known about the psychological variables that might predict this dietary behavior. Thus, this study aimed to assess whether dietary adherence might be affected by a variety of psychological factors including stress, personality, and health locus of control, as well as dietary knowledge, in chronic HD patients. Fifty-one patients (30 men; age range 25-85) who had undergone HD for at least 3 months and had been asked to restrict at least one of potassium, phosphate or fluid, were recruited from a hospital renal unit. Measures of adherence to each of potassium, phosphate, and fluid were derived from standard criteria for these physiological indices in renal patients. Knowledge of food/drink sources of these dietary factors, and their medical implications in relation to HD and CKD were assessed by a bespoke questionnaire. Psychological factors including stress, personality and health locus of control beliefs were measured by standardized questionnaires. Having to restrict a particular nutrient was associated with better knowledge of both food sources and medical complications for that nutrient; however, greater dietary knowledge was not linked to adherence, and knowledge of medical complications tended to be associated with poorer adherence to potassium and phosphate levels. Adherence to these two nutrient requirements was also associated with lower reported stress in the past week. Adherence was associated with differences in locus of control: these differences varied across indices although there was a tendency to believe in external loci. For potassium, phosphate, and fluid restriction, adherers were less likely to be sensation seekers but did not differ from non-adherers on impulsivity, anxiety sensitivity, or hopelessness. In conclusion, the links between dietary adherence and stress, locus of control and personality suggests that screening for such psychological factors may assist in managing adherence in HD patients.

Factors influencing access to education, decision making, and receipt of preferred dialysis modality in unplanned dialysis start patients.

OBJECTIVES: Unplanned dialysis start (UPS) leads to worse clinical outcomes than planned start, and only a minority of patients ever receive education on this topic and are able to make a modality choice, particularly for home dialysis. This study aimed to determine the predictive factors for patients receiving education, making a decision, and receiving their preferred modality choice in UPS patients following a UPS educational program (UPS-EP). METHODS: The Offering Patients Therapy Options in Unplanned Start (OPTiONS) study examined the impact of the implementation of a specific UPS-EP, including decision support tools and pathway improvement on dialysis modality choice. Linear regression models were used to examine the factors predicting three key steps: referral and receipt of UPS-EP, modality decision making, and actual delivery of preferred modality choice. A simple economic assessment was performed to examine the potential benefit of implementing UPS-EP in terms of dialysis costs. RESULTS: The majority of UPS patients could receive UPS-EP (214/270 patients) and were able to make a decision (177/214), although not all patients received their preferred choice (159/177). Regression analysis demonstrated that the initial dialysis modality was a predictive factor for referral and receipt of UPS-EP and modality decision making. In contrast, age was a predictor for referral and receipt of UPS-EP only, and comorbidity was not a predictor for any step, except for myocardial infarction, which was a weak predictor for lower likelihood of receiving preferred modality. Country practices predicted UPS-EP receipt and decision making. Economic analysis demonstrated the potential benefit of UPS-EP implementation because dialysis modality costs were associated with modality distribution driven by patient preference. CONCLUSION: Education and decision support can allow UPS patients to understand their options and choose dialysis modality, and attention needs to be focused on ensuring equity of access to educational programs, especially for the elderly. Physician practice and culture across units/countries is an important predictor of UPS patient management and modality choice independent of patient-related factors. Additional work is required to understand and improve patient pathways to ensure that modality preference is enacted. There appears to be a cost benefit of delivering education, supporting choice, and ensuring that the choice is enacted in UPS patients.

Peritoneal dialysis use within the context of the population and healthcare systems of Europe - differences, trends and future challenges.

INTRODUCTION: Peritoneal dialysis (PD) and haemodialysis (HD) are complementary therapies in end-stage renal disease (ESRD). Despite survival benefit, PD remains an underused therapy with variable utilisation and a common descriptive framework for this variation is not established. We reviewed the renal literature, general population and healthcare data to examine factors leading to variable PD use in Europe and possible changes in the future. METHODS: ERA-EDTA data were used to examine PD distribution in Europe. Statistics and descriptive data about population structure and living conditions published by Eurostat, the World Health Organization (WHO) and the European Observatory were examined. Published literature (Pubmed), health system data (formal internet search approach) and professional body data (internet and personal communication) were examined to describe the factors that may explain PD variation. RESULTS: PD usage varies across Europe and analysis of contributing factors enabled the development of a descriptive framework. PD variation cannot be entirely explained by the reimbursement system. It appears that factors specific to countries and centres as well as personalised ones involving patient-physician interaction are the most influential. The current and projected European population demographics and living conditions will lead to more elderly patients who live alone being on dialysis. DISCUSSION: Factors relating to the patient-physician interaction are prime determinants around the utilization of PD. Population demographic change will lead to additional challenges to renal services. The descriptive framework postulated should be considered in strategic dialysis service planning and future product design to meet the needs of future dialysis patients and deliver patient choice.

European Training and Research in Peritoneal Dialysis--A Network to Deliver Scientific Peritoneal Dialysis Training to a New Generation of Researchers.

Peritoneal dialysis (PD) utilization varies across countries, and of the factors that explain the variation, the scientific and clinical knowledge of health care professionals is potentially important. In this paper, we describe a European collaboration--between 8 academic PD research programs, a small-to-medium-sized enterprise, and a large PD product manufacturer--that received significant research funding from the EU commission to establish a training network. European Training and Research in Peritoneal Dialysis (EuTRiPD) is providing training to 12 PhD students who have moved within the European Union and are completing research training. The underlying structure and processes within EuTRiPD (http://www.eutripd. eu) are described, and the benefits of the collaborative approach are discussed. This model could be useful to other research groups and will assist in maintaining and growing scientific expertise in PD research.

Offering Patients Therapy Options in Unplanned Start: Development and Implementation of an Education Program for Unplanned-Start Patients.

Unplanned start of dialysis is still a common and important problem for dialysis units in Europe and across the world: 30%-50% of patients can commence therapy in that way. Such patients are known to experience increased morbidity and mortality, to make greater demands on health care resources, and to be less likely to receive their dialysis modality choice. We therefore aimed to meet the specific needs of unplanned-start patients by developing and implementing an Unplanned Start Educational Programme in dialysis units. The new program--which is intended to effectively influence the clinical pathway for patients and to equip health care professionals with the tools necessary to support and optimize the process of unplanned dialysis start--was created with the support of 5 dialysis units and academic experts in patient education. It involves process mapping of patient flows so as to recognize the key steps in the management of unplanned dialysis. Following its successful development, the Unplanned Start Educational Programme was delivered to patients. To evaluate the effectiveness of the program, an observational study, Offering Patients Therapy Options in Unplanned Start, had the primary outcome of measuring the impact of the education program on dialysis modality choice (peritoneal dialysis or hemodialysis).

Review of predialysis education programs: a need for standardization.

To make an informed decision on renal replacement therapy, patients should receive education about dialysis options in a structured program covering all modalities. Many patients do not receive such education, and there is disparity in the information they receive. This review aims to compile evidence on effective components of predialysis education programs as related to modality choice and outcomes. PubMed MEDLINE, Cochrane Library, and Ovid searches (from January 1, 1995 to December 31, 2013) with the main search terms of "predialysis", "peritoneal dialysis", "home dialysis", "education", "information", and "decision" were performed. Of the 1,005 articles returned from the initial search, 110 were given full text reviews as they potentially met inclusion criteria (for example, they included adults or predialysis patients, or the details of an education program were reported). Only 29 out of the 110 studies met inclusion criteria. Ten out of 13 studies using a comparative design, showed an increase in home dialysis choice after predialysis education. Descriptions of the educational process varied and included individual and group education, multidisciplinary intervention, and varying duration and frequency of sessions. Problem-solving group sessions seem to be an effective component for enhancing the proportion of home dialysis choice. Evidence is lacking for many components, such as timing and staff competencies. There is a need for a standardized approach to evaluate the effect of predialysis educational interventions.

The role of noise in clinical environments with particular reference to mental health care: A narrative review.

BACKGROUND: There is a large literature suggesting that noise can be detrimental to health and numerous policy documents have promoted noise abatement in clinical settings. OBJECTIVES: This paper documents the role of noise in clinical environments and its deleterious effects with a particular focus on mental health care. Our intention however, is to go beyond the notion that noise is simply undesirable and examine the extent to which researchers have explored the meaning of sound in hospital settings and identify new opportunities for research and practice. DATA SOURCES AND REVIEW METHODS: This is a narrative review which has grouped the literature and issues in the field into themes concerning the general issues of noise in health care; sleep noise and hospital environments; noise in intensive care units; implications for service users and staff; and suggestions for new ways of conceptualising and researching clinical soundscapes. Data sources comprised relevant UK policy documents and the results of a literature search of Pubmed, Scopus and Web of Knowledge using terms such as noise, health, hospital, soundscape and relevant additional terms derived from the papers retrieved. In addition the references of retrieved articles were scanned for additional relevant material and historical items significant in shaping the field. RESULTS: Excess unwanted noise can clearly be detrimental to health and impede recovery, and this is clearly recognised by policymakers especially in the UK context. We use the literature surveyed to argue that it is important also to see the noise in clinical environments in terms of the meaning it conveys and rather than merely containing unwanted sound, clinical environments have a 'soundscape'. This comprises noises which convey meaning, for example about the activities of other people, the rhythms of the day and the nature of the auditory community of the hospital. Unwanted sound may have unwanted effects, especially on those who are most vulnerable, yet this does not necessarily mean that silence is the better option. Therefore it is our contention that it is important to begin thinking about the social functions of sound in the mental health environment. CONCLUSIONS: Whilst it can be stressful, sound can also be soothing, reassuring and a rich source of information about the environment as well. It may be used to secure a degree of privacy for oneself, to exclude others or as a source of solidarity among friends and colleagues. The challenge then is to understand the work that sound does in its ecological context in health care settings.

A global overview of renal registries: a systematic review.

BACKGROUND: Patient registries have great potential for providing data that describe disease burden, treatments, and outcomes; which can be used to improve patient care. Many renal registries exist, but a central repository of their scope, quality, and accessibility is lacking. The objective of this study was to identify and assess worldwide renal registries reporting on renal replacement therapy and compile a list of those most suitable for use by a broad range of researchers. METHODS: Renal registries were identified through a systematic literature review and internet research. Inclusion criteria included information on dialysis use (yes/no), patient counts ≥300, and evidence of activity between June 2007 and June 2012. Public availability of information on dialysis modality, outcomes, and patient characteristics as well as accessibility of patient-level data for external research were evaluated. RESULTS: Of 144 identified renal registries, 48 met inclusion criteria, 23 of which were from Europe. Public accessibility to annual reports, publications, or basic data was good for 17 registries and moderate for 22. Patient-level data were available to external researchers either directly or through application and review (which may include usage fees) for 13 of the 48 registries, and were inaccessible or accessibility was unknown for 25. CONCLUSIONS: The lack of available data, particularly in emerging economies, leaves information gaps about health care and outcomes for patients with renal disease. Effective multistakeholder collaborations could help to develop renal registries where they are absent, or enhance data collection and dissemination for currently existing registries to improve patient care.

The Benefit of a Glucose-Sparing PD Therapy on Glycemic Control Measured by Serum Fructosamine in Diabetic Patients in a Randomized, Controlled Trial (IMPENDIA).

BACKGROUND/AIMS: Poor glycemic control can lead to increased morbidity and mortality in peritoneal dialysis (PD) patients. Serum fructosamine may be a more reliable marker of glycemic control than HbA1c in dialysis patients. METHODS: We evaluated the effects of a glucose-sparing PD regimen on serum fructosamine. In the multicenter, controlled IMPENDIA trial, eligible diabetic PD patients were randomized (1:1) to a 24-hour combination of a glucose sparing regimen (n = 89) or a glucose-based therapy (n = 91). Serum fructosamine and HbA1c were measured at baseline, 3 months and 6 months; fructosamine measurements were corrected for serum albumin (AlbF). RESULTS: Serum fructosamine decreased from 297 to 253 µmol/l in the glucose-sparing group (95% confidence interval [CI] for the difference, -26 to -68, p < 0.001), and increased from 311 to 314 µmol/l in the glucose-only group (95% CI for the difference, -23 to +19, p = 0.87). The mean difference in change of fructosamine levels between groups at 6 months was 64 µmol/l (95% CI 29-99, p < 0.001). HbA1c decreased versus baseline in both groups (treatment difference 0.3%, p = 0.07). The correlation between AlbF and baseline fasting serum glucose was stronger than that seen between HbA1c and baseline fasting serum glucose (r = 0.47, p < 0.0001 and r = 0.31, p < 0.0001, respectively). CONCLUSION: A glucose-sparing regimen (P-E-N) improved glycemic control as measured by serum fructosamine. Further studies are needed to establish fructosamine targets that will reduce the morbidity risk related to hyperglycemia in PD patients.

Predialysis education in practice: a questionnaire survey of centres with established programmes.

BACKGROUND: There is growing evidence that renal replacement therapy option education (RRTOE) can result in enhanced quality of life, improved clinical outcomes, and reduced health care costs. However, there is still no detailed guidance on the optimal way to run such programmes. To help address this knowledge gap, an expert meeting was held in March 2013 to formulate a position statement on optimal ways to run RRTOE. Experts were selected from units that had extensive experience in RRTOE or were performing research in this field. Before the meeting, experts completed a pilot questionnaire on RRTOE in their own units. They also prepared feedback on how to modify this questionnaire for a large-scale study. METHODS: A pilot, web-based questionnaire was used to obtain information on: the renal unit and patients, the education team, RRTOE processes and content, how quality is assessed, and funding. RESULTS: Four nurses, 5 nephrologists and 1 clinical psychologist (9 renal units; 6 EU countries) participated. Nurses were almost always responsible for organising RRTOE. Nephrologists spent 7.5% (median) of their time on RRTOE. Education for the patient and family began several months before dialysis or according to disease progression. Key topics such as the 'impact of the disease' were covered by every unit, but only a few units described all dialysis modalities. Visits to the unit were almost always arranged. Materials came in a wide variety of forms and from a wide range of sources. Group education sessions were used in 3/9 centres. Expectations on the timing of patients' decisions on modality and permanent access differed substantially between centres. Common quality assurance measures were: patient satisfaction, course attendance, updated materials. Only 1 unit had a dedicated budget. CONCLUSIONS: There were substantial variations in how RRTOE is run between the units. A modified version of this questionnaire will be used to assess RRTOE at a European level.