Transition Between Different Renal Replacement Modalities: Gaps in Knowledge and Care-The Integrated Research Initiative.

Patients with end-stage kidney disease (ESKD) have different options to replace the function of their failing kidneys. The "integrated care" model considers treatment pathways rather than individual renal replacement therapy (RRT) techniques. In such a paradigm, the optimal strategy to plan and enact transitions between the different modalities is very relevant, but so far, only limited data on transitions have been published. Perspectives of patients, caregivers, and health professionals on the process of transitioning are even less well documented. Available literature suggests that poor coordination causes significant morbidity and mortality.This review briefly provides the background, development, and scope of the INTErnational Group Research Assessing Transition Effects in Dialysis (INTEGRATED) initiative. We summarize the literature on the transition between different RRT modalities. Further, we present an international research plan to quantify the epidemiology and to assess the qualitative aspects of transition between different modalities.

Ethical issues in dialysis therapy.

Treatment for end-stage kidney disease is a major economic challenge and a public health concern worldwide. Renal-replacement therapy poses several practical and ethical dilemmas of global relevance for patients, clinicians, and policy makers. These include how to: promote patients' best interests; increase access to dialysis while maintaining procedural and distributive justice; minimise the influence of financial incentives and competing interests; ensure quality of care in service delivery and access to non-dialytic supportive care when needed; minimise the financial burden on patients and health-care system; and protect the interests of vulnerable groups during crisis situations. These issues have received comparatively little attention, and there is scant ethical analysis and guidance available to decision makers. In this Health Policy, we provide an overview of the major ethical issues related to dialysis provision worldwide, identify priorities for further investigation and management, and present preliminary recommendations to guide practice and policy.

Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration.

The National Kidney Foundation and the U.S. Food and Drug Administration (FDA) convened a symposium in September 2010, bringing together more than 70 experts, including representatives from the FDA, the National Institutes of Health, the Critical Path Institute, nephrologists, patients, and the pharmaceutical industry to discuss the feasibility and process of developing patient-reported outcome (PRO) measures to access how patients feel or function to be used in clinical trials for regulatory review of treatment benefit. Three disease areas were evaluated for development of end point models in which PRO measures may be useful: anemia secondary to chronic kidney disease, autosomal dominant polycystic kidney disease (ADPKD), and nephrotic syndrome. The participants thought it valuable to use observational data to generate hypotheses regarding patient baseline characteristics that are likely to predict clinically important changes in PROs in response to anemia treatment and to design adequately powered blinded randomized controlled trials of anemia treatment using PROs as primary rather than secondary end points. Validated PRO instruments that reflect the patient experience in ADPKD and nephrotic syndrome are essential to incorporate into clinical trials of new therapeutic interventions because glomerular filtration rate decline may occur late in the disease course, at which point therapeutic benefit is less likely. Conference attendees addressed how PRO measures could be used to evaluate, monitor, provide care, and facilitate the introduction of treatments for patients with these challenging conditions.

How to overcome barriers and establish a successful home HD program.

Home hemodialysis (HD) is an underused dialysis modality in the United States, even though it provides an efficient and probably cost-effective way to provide more frequent or longer dialysis. With the advent of newer home HD systems that are easier for patients to learn, use, and maintain, patient and provider interest in home HD is increasing. Although barriers for providers are similar to those for peritoneal dialysis, home HD requires more extensive patient training, nursing education, and infrastructure support in order to maintain a successful program. In addition, because many physicians and patients do not have experience with home HD, reluctance to start home HD programs is widespread. This in-depth review describes barriers to home HD, focusing on patients, individual physicians and practices, and dialysis facilities, and offers suggestions for how to overcome these barriers and establish a successful home HD program.

An integrative approach to advanced kidney disease in the elderly.

Chronic kidney disease (CKD) has increasingly become a "geriatric" disease, with a dramatic rise in incidence in the aging population. Patients aged >75 years have become the fastest growing population initiating dialysis. These patients have increased comorbid diseases and functional limitations which affect mortality and quality of life. This review describes the challenges of dialysis initiation and considerations for management of the elderly subpopulation. There is a need for an integrative approach to care, which addresses management issues, health-related quality of life, and timely discussion of goals of care and end-of-life issues. This comprehensive approach to patient care involves the integration of nephrology, geriatric, and palliative medicine practices.

Treatment and outcome of CPD-associated peritonitis.

CPD-associated peritonitis is a leading cause of morbidity and mortality for ESRD patients maintained on CPD therapy. The percentage of ESRD patients maintained on CPD therapy is declining. The reasons are unclear, but may be due to concerns about CPD-associated peritonitis. The incidence of CPD-associated peritonitis has decreased largely attributed to technical advances and the identification of risk factors including exit-site infection, colonization with Staphylococcus aureus and depression. The typical spectrum of organisms causing peritonitis include gram-positive organisms (67%), gram-negative organisms (28%), fungi (2.5%) or anaerobic organisms (2.5%). Culture-negative episodes do occur: up to 20% of the episodes of peritonitis in some series are culture-negative. The treatment of CPD associated peritonitis is rather standardized with current recommendations by the International Society of Peritoneal Dialysis universally adopted. Approximately 80% of the patients developing peritonitis will respond to antimicrobial therapy and remain on CPD therapy, while 10 to 15% of the patients require catheter removal and transfer to hemodialysis. Approximately 6% of the patients expire as a result of peritonitis. The outcome is different based on organism with gram-negative and fungal episodes having a worse outcome than gram-positive episodes. The development of CPD-associated peritonitis can be linked to traditional risk factors such as exit-site infection and poor technique. Bacterial biofilm has also been suggested as a cause of peritonitis. Our current antimicrobial protocols may not permit adequate dosing to penetrate the biofilm and be a reason for recurrent or repeat episodes of peritonitis. It is important that we improve our understanding of factors responsible for the development and outcome of CPD-associated peritonitis in order for this renal replacement therapy to remain a viable option for patients with ESRD.

The BDI and the SF36: which tool to use to screen for depression?

Recent studies have suggested a relationship between depression--as assessed by the Beck Depression Inventory (BDI)--and mortality in end-stage renal disease (ESRD) patients. A recent study from the Dialysis Outcomes and Practice Patterns Study (DOPPS) indicated an association between mortality in a large cohort of hemodialysis patients and the patients' responses in the preceding 4 weeks to two questions on the Kidney Disease Quality of Life, Short Form (KDQOL-SF36): "Have you felt downhearted and blue?" and "Have you felt so down in the dumps that nothing could cheer you?" A BDI score > or = 11 and a score < or = 3 for the two questions on the SF36 were considered to suggest the presence of depressive symptoms; both scores have been associated with increased mortality in hemodialysis patients. We aimed to examine the relationship of the two SF36 questions with depressive symptoms as assessed by the BDI. All patients on chronic peritoneal dialysis (CPD) therapy and daily hemodialysis therapy in our units between June 2000 and January 2002 were asked to complete a BDI and an SF36. We recorded 135 tests in 80 CPD patients, and 76 tests in 17 daily hemodialysis patients. Correlation coefficients (r2 values) of the responses to the two questions on the SF36 and the BDI scores demonstrated a significant relationship between the scores. The r2 values for the CPD patients' two SF36 responses and the BDI scores were -0.622 and -0.506; the r2 values for the daily hemodialysis patients were -0.363 and -0.317. The sensitivity and specificity for each SF36 response to be < or = 3 when the BDI was > or = 11 were 82.4% and 68.6% for the "downhearted and blue" question and 65% and 67% for the "down in the dumps" question. Whether the two questions on the SF36 that suggest depression can replace the BDI as a screening tool requires further study. Furthermore, it is unclear if the two questions on the SF36 are predictive of mortality because of their association with clinical depression or because of other issues.