Development of PD in lower-income countries: a rational solution for the management of AKI and ESKD.

It is estimated that >50% of patients with end-stage kidney disease (ESKD) in low-resource countries are unable to access dialysis. When hemodialysis is available, it often has high out-of-pocket expenditure and is seldom delivered to the standard recommended by international guidelines. Hemodialysis is a high-cost intervention with significant negative effects on environmental sustainability, especially in resource-poor countries (the ones most likely to be affected by resultant climate change). This review discusses the rationale for peritoneal dialysis (PD) as a more resource and environmentally efficient treatment with the potential to improve dialysis access, especially to vulnerable populations, including women and children, in lower-resource countries. Successful initiatives such as the Saving Young Lives program have demonstrated the benefit of PD for acute kidney injury. This can then serve as a foundation for later development of PD services for end-stage kidney disease programs in these countries. Expansion of PD programs in resource-poor countries has proven to be challenging for various reasons. It is hoped that if some of these issues can be addressed, PD will be able to permit an expansion of end-stage kidney disease care in these countries.

Computerized adaptive technology for the assessment of HRQOL of PD and CKD patients.

This study was designed as a pilot study to see whether electronic patient-reported outcome measures using computer adaptive technology (CAT) could be successfully implemented in clinics caring for chronic kidney disease (CKD) and peritoneal dialysis (PD) patients. The results demonstrate the feasibility of using CAT on an iPad to assess the symptom burden and health-related quality of life of both PD and CKD patients.

Challenges of access to kidney care for children in low-resource settings.

Kidney disease is a global public health concern across the age spectrum, including in children. However, our understanding of the true burden of kidney disease in low-resource areas is often hampered by a lack of disease awareness and access to diagnosis. Chronic kidney disease (CKD) in low-resource settings poses multiple challenges, including late diagnosis, the need for ongoing access to care and the frequent unavailability of costly therapies such as dialysis and transplantation. Moreover, children in such settings are at particular risk of acute kidney injury (AKI) owing to preventable and/or reversible causes - many children likely die from potentially reversible kidney disease because they lack access to appropriate care. Acute peritoneal dialysis (PD) is an important low-cost treatment option. Initiatives, such as the Saving Young Lives programme, to train local medical staff from low-resource areas to provide care for AKI, including acute PD, have already saved hundreds of children. Future priorities include capacity building for both educational purposes and to provide further resources for AKI management. As local knowledge and confidence increase, CKD management strategies should also develop. Increased awareness and advocacy at both the local government and international levels will be required to continue to improve the diagnosis and treatment of AKI and CKD in children worldwide.

Increasing access to integrated ESKD care as part of universal health coverage.

The global nephrology community recognizes the need for a cohesive strategy to address the growing problem of end-stage kidney disease (ESKD). In March 2018, the International Society of Nephrology hosted a summit on integrated ESKD care, including 92 individuals from around the globe with diverse expertise and professional backgrounds. The attendees were from 41 countries, including 16 participants from 11 low- and lower-middle-income countries. The purpose was to develop a strategic plan to improve worldwide access to integrated ESKD care, by identifying and prioritizing key activities across 8 themes: (i) estimates of ESKD burden and treatment coverage, (ii) advocacy, (iii) education and training/workforce, (iv) financing/funding models, (v) ethics, (vi) dialysis, (vii) transplantation, and (viii) conservative care. Action plans with prioritized lists of goals, activities, and key deliverables, and an overarching performance framework were developed for each theme. Examples of these key deliverables include improved data availability, integration of core registry measures and analysis to inform development of health care policy; a framework for advocacy; improved and continued stakeholder engagement; improved workforce training; equitable, efficient, and cost-effective funding models; greater understanding and greater application of ethical principles in practice and policy; definition and application of standards for safe and sustainable dialysis treatment and a set of measurable quality parameters; and integration of dialysis, transplantation, and comprehensive conservative care as ESKD treatment options within the context of overall health priorities. Intended users of the action plans include clinicians, patients and their families, scientists, industry partners, government decision makers, and advocacy organizations. Implementation of this integrated and comprehensive plan is intended to improve quality and access to care and thereby reduce serious health-related suffering of adults and children affected by ESKD worldwide.

Measurement properties of the Short Form-36 (SF-36) and the Functional Assessment of Cancer Therapy - Anemia (FACT-An) in patients with anemia associated with chronic kidney disease.

BACKGROUND: Anemia is a common and debilitating manifestation of chronic kidney disease (CKD). Data from two clinical trials in patients with anemia of CKD were used to assess the measurement properties of the Medical Outcomes Survey Short Form-36 version 2 (hereafter SF-36) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An). The Vitality and Physical functioning domains of the SF-36 and the FACT-An Total, Fatigue and Anemia subscales were identified as domains relevant to CKD-associated anemia. METHODS: A total of 204 patients aged 18-80 years were included in the analyses that included internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficients [ICCs]), convergent and known-groups validity, responsiveness, and estimates of important change. RESULTS: Both the SF-36 and the FACT-An had strong psychometric properties with high internal consistency (Cronbach's alpha: 0.69-0.93 and 0.79-0.95), and test-retest reliability (ICCs: 0.64-0.83 and 0.72-0.88). Convergent validity, measured by correlation coefficients between similar concepts in SF-36 and FACT-An, ranged from 0.52 to 0.77. Correlations with hemoglobin (Hb) levels were modest at baseline; by Week 9, the correlations with Hb were somewhat higher, r = 0.23 (p < 0.05) for SF-36 Vitality, r = 0.22 (p < 0.05) for FACT-An Total, r = 0.26 (p < 0.001) for FACT-Fatigue and r = 0.22 (p < 0.01) for Anemia. Correlations with Hb at Week 13/17 were r = 0.28 (p < 0.001) for SF-36 Vitality and r = 0.25 (p < 0.05) for Role Physical; FACT-An Total correlation was r = 0.33 (p < 0.0001), Anemia was r = 0.28 (p < 0.001), and Fatigue was r = 0.30 (p < 0.001). The SF-36 domains and Component Summary scores (p < 0.05-p < 0.0001) demonstrated ability to detect change. For the FACT-An, significant differences (p < 0.05-p < 0.0001) were observed between responder and non-responder change scores: important change score estimates ranged from 2 to 4 for Vitality and 2-3 for Physical functioning. Important change scores were also estimated for the FACT-An Total score (6-9), the Anemia (3-5), and Fatigue subscale (2-4). CONCLUSIONS: Both the SF-36 Vitality and Physical function scales and the FACT-An Total, Fatigue and Anemia scales, are reliable and valid measures for assessing health-related quality of life in anemia associated with CKD.

Acute Kidney Injury in Low-Resource Settings: Barriers to Diagnosis, Awareness, and Treatment and Strategies to Overcome These Barriers.

Acute kidney injury (AKI) is increasingly recognized as a major health problem worldwide, responsible for an estimated 1.4 million deaths per year. The occurrence of and approach to AKI in low-resource settings (LRS) present special challenges due to often limited health care resources, including insufficient numbers of trained personnel, diagnostic tools, and treatment options. Although the International Society of Nephrology set a goal of eliminating preventable deaths from AKI by 2025, implementation of this program in LRS presents major challenges not only because of the lack of resources, but also because of the lack of awareness of the impact of AKI on patient outcomes, factors that are complicated by the challenge of cognitively dissociating the care of patients with AKI from the care of patients with chronic kidney failure. To better understand how to increase the awareness of AKI and develop strategies to improve the identification and treatment of patients with AKI in LRS, we administered an 18-item web-based questionnaire to physicians actively engaged in providing nephrology care in LRS. A checklist was then developed of meaningful and targeted approaches for implementation, with focus on engaging local and regional stakeholders, developing education programs and appropriate guidelines, enhancing training of health care workers, expanding health care resources, linking with other regional health care projects, and broadening research opportunities.

Impact of baseline health-related quality of life scores on survival of incident patients on peritoneal dialysis: a cohort study.

INTRODUCTION: In an attempt to decrease mortality in patients with end-stage renal disease, an increase in the lifetime of these patients without much focus on health-related quality of life (HRQOL) was pursued for a long period of time. However, lately, an improvement in the quality of this extended lifetime has focused on both the physical as well as the social and emotional aspects, as these parameters may be associated with clinical outcomes in end-stage renal disease patients. AIM: To evaluate the impact of self-determined HRQOL at admission on survival of incident peritoneal dialysis (PD) patients. PATIENTS AND METHODS: A total of 1,624 incident Brazilian PD patients participating in a multicenter prospective cohort study (BRAZPD) were evaluated. HRQOL was assessed using the SF-36, divided into mental and physical components. Cox proportional regression analysis was used to determine the influence of HRQOL (mental and physical components) on mortality. Multivariate Cox proportional hazards analyses were used to adjust gradually for more potential explanatory variables: first for demographic variables, followed by additional adjustment for socioeconomic, clinical and laboratory variables. The significance level in all analyses was set at p < 0.05. All analyses were carried out with SPSS 17.0. RESULTS: Incident PD patients presented with low HRQOL scores on admission to therapy. Even after correction for sociodemographic variables, comorbidities, PD modality and laboratory parameters, HRQOL (both the mental and the physical components) remained a predictor [HR: 0.97 (CI: 0.95-0.98); HR: 0.97 (CI: 0.96-0.99), respectively] of survival. CONCLUSION: On admission to therapy, patients presenting with low HRQOL scores for both the mental and the physical components were associated with a higher mortality. These results suggest that early and timely intervention measures to improve the QOL of these patients are important.

Longitudinal changes in health-related quality of life scores in Brazilian incident peritoneal dialysis patients (BRAZPD): socio-economic status not a barrier.

BACKGROUND AND OBJECTIVES: A large proportion of the patients on peritoneal dialysis (PD) in Brazil have low levels of education and family income. The present study assessed whether education level and family income are associated with baseline and longitudinal changes in health-related quality of life (HRQOL) scores during the first year of PD therapy. METHODS: We evaluated 1624 incident patients from the Brazilian Peritoneal Dialysis Multicenter Study (BRAZPD) at baseline, and 486 of them after 12 months. The SF-36 was used to determine HRQOL and the Karnofsky index (KI), physical performance. RESULTS: At baseline, patients received high KI scores compared with scores on the SF-36. The means of the mental and physical components at baseline and after 12 months were 39.9 ± 10.5 compared with 38.7 ± 11.7 and 41.8 ± 9.6 compared with 40.7 ± 9.8 respectively, which were not statistically different. A multivariate regression analysis showed that age, sex, diabetes, and cardiovascular disease were predictors of the mental component (respectively, ß = 0.12, p < 0.001; ß = 0.11, p < 0.001; ß = -0.08, ß = 0.007; and ß = -0.07, p = 0.007) and that age, sex, diabetes, cardiovascular disease, hemoglobin, glucose, and creatinine were predictors of the physical component (respectively, ß = -0.28, p < 0.001; ß = 0.06, p = 0.009; ß = -0.09, p = 0.002; ß = -0.09, p = 0.001; ß = 0.07, p = 0.004; ß = -0.05, p = 0.040; and ß = 0.05, p = 0.040). Education level and family income were not significantly associated with HRQOL (mental and physical components) in the multivariate regression. CONCLUSIONS: The results indicate that, as predictors, family income and education level have no impact on HRQOL, supporting the idea that socio-economic status should not be a barrier to the selection of PD as a treatment modality in Brazil.

Kidney failure: aims for the next 10 years and barriers to success.

Although in some parts of the world acute and chronic kidney diseases are preventable or treatable disorders, in many other regions these diseases are left without any care. The nephrology community needs to commit itself to reduction of this divide between high-income and low-income regions. Moreover, new and exciting developments in fields such as pharmacology, genetic, or bioengineering, can give a boost, in the next decade, to a new era of diagnosis and treatment of kidney diseases, which should be made available to more patients.

Systematic barriers to the effective delivery of home dialysis in the United States: a report from the Public Policy/Advocacy Committee of the North American Chapter of the International Society for Peritoneal Dialysis.

Home dialysis, currently underused in the United States compared with other industrialized countries, likely will benefit from the newly implemented US prospective payment system. Not only is home dialysis less expensive from the standpoint of pure dialysis costs, but overall health system costs may be decreased by more subtle benefits, such as reduced transportation. However, many systematic barriers exist to the successful delivery of home dialysis. We organized these barriers into the categories of educational barriers (patient and providers), governmental/regulatory barriers (state and federal), and barriers specifically related to the philosophies and business practices of dialysis providers (eg, staffing, pharmacies, supplies, space, continuous quality improvement practices, and independence). All stakeholders share the goal of delivering home dialysis therapies in the most cost- and clinically effective and least problematic manner. Identification and recognition of such barriers is the first step. In addition, we have suggested action plans to stimulate the kidney community to find even better solutions so that collectively we may overcome these barriers.

Design and rationale of health-related quality of life and patient-reported outcomes assessment in the Frequent Hemodialysis Network trials.

BACKGROUND: End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important. AIMS: The aim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials. METHODS: In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients' self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden. CONCLUSIONS: Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.

Content validation of two SF-36 subscales for use in type 2 diabetes and non-dialysis chronic kidney disease-related anemia.

PURPOSE: This study aimed to evaluate the relevance and importance of two SF-36 subscales, Vitality (VT) and Physical Function (PF), to assess concepts of energy and physical function in patients with type 2 diabetes mellitus (DM) and non-dialysis CKD-related anemia. METHODS: Patients with clinical history of DM and non-dialysis CKD-related anemia (n = 68) were identified as follows: 40 participated in concept elicitation (CE) interviews; 20 in cognitive interviews (CI), and 8 in pilot interviews. Relevance and importance ratings for SF-36 VT and PF items were obtained. Interviews were recorded, transcribed, and patient expressions of concepts coded. Inter-rater agreement was used to evaluate coding consistency. Concepts elicited were mapped to SF-36 VT and PF items. RESULTS: Patients (n = 64) were 65.6% women, 42.2% Caucasian, with mean age of 66.1 ± 11.6 years. Of 830 coded concepts, 388 (47%) were "Energy" expressions and 287 (35%) were "PF limitations" expressions. Low energy was reported by 85% patients and rated as an important limitation by 88%. Limitations in PF were reported by 56-82% patients and rated important by 44-96%. CE and CI quotes correspond well to SF-36 VT and PF items. CONCLUSION: SF-36 VT and PF contents were suitable for assessing energy and physical function limitations, respectively, in this patient population.

Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study.

BACKGROUND: Clinical depression and postdialysis fatigue are important concerns for patients with kidney failure and can have a negative impact on quality of life and survival. STUDY DESIGN: The FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study is an ongoing prospective cohort study investigating the clinical and economic benefits of daily (6 times per week) hemodialysis (HD). In this interim report, as part of an a priori planned analysis, we examine the long-term impact of daily HD on depressive symptoms, measured using the Beck Depression Inventory (BDI) survey, and postdialysis recovery time, measured using a previously validated questionnaire. SETTING & PARTICIPANTS: Adult patients initiating daily HD with a planned 12-month follow-up. OUTCOMES & MEASUREMENTS: The BDI survey and postdialysis recovery time question were administered at baseline, and changes were assessed at months 4 and 12. RESULTS: 239 participants were enrolled (intention-to-treat cohort) and 128 completed the study (per-protocol cohort). Mean age was 52 years, 64% were men, 55% had an arteriovenous fistula, and 90% transitioned from in-center HD therapy. In the per-protocol cohort, there was a significant decrease in mean BDI score over 12 months (11.2 [95% CI, 9.6-12.9] vs 7.8 [95% CI, 6.5-9.1]; P<0.001). For robustness, the intention-to-treat analysis was performed, yielding similar results. The percentage of patients with depressive symptoms (BDI score>10) significantly decreased during 12 months (41% vs 27%; P=0.03). Similarly, in the per-protocol cohort, there was a significant decrease in postdialysis recovery time over 12 months (476 [95% CI, 359-594] vs 63 minutes [95% CI, 32-95]; P<0.001). The intention-to-treat analysis yielded similar results. The percentage of patients experiencing prolonged postdialysis recovery time (>or=60 minutes) also significantly decreased (81% vs 35%; P=0.001). LIMITATIONS: Observational study with lack of control arm. CONCLUSIONS: Daily HD is associated with long-term improvement in depressive symptoms and postdialysis recovery time.

Burden of illness for patients with non-dialysis chronic kidney disease and anemia in the United States: review of the literature.

OBJECTIVE: To assess the health-related quality of life (HRQL) and economic burden of chronic kidney disease (CKD) related anemia in non-dialysis patients in the United States (US) via literature review. METHODS: MEDLINE, EMBASE, PROQOLID, and Cochrane Library/Renal Group Resources were searched. Studies were appraised for patient populations, disease-specific versus generic HRQL assessments, and type and magnitude of health-related costs. RESULTS: The treatment costs for CKD patients with anemia compared to those without anemia were significantly higher and were blunted but persistent after controlling for comorbidities and confounders. Intervention with erythropoiesis stimulating agents (ESA) decreased anemia and avoided hospital admissions. Costs were higher when anemia was poorly controlled or untreated. HRQL burden was mainly due to physical limitations and difficulty in ability to perform activities of daily living. Significant positive correlations between increases in hemoglobin levels and HRQL measures were reported. CONCLUSIONS: Although evidence is limited, the economic and HRQL burden of non-dialysis CKD-related anemia is substantial. Under-treatment of anemia may contribute to higher resource consumption and higher costs; however, patient co-morbidities, use of erythropoietin-stimulating agents, and overall management introduce potential confounds. The contribution of anemia to humanistic disease burden is due to a constellation of factors, including physical activity and functional status.

Health related quality of life and the CKD patient: challenges for the nephrology community.

The compromised health-related quality of life (HRQOL) of patients with chronic kidney disease is now well documented. The recent mandate by the Center for Medicare Services in the United States that all dialysis units monitor HRQOL as a condition of coverage has focused attention on the importance of these measures. The challenge for the nephrology care team is understanding how to interpret and utilize the information obtained from these HRQOL measurements. Can HRQOL of these patients be improved? The present review addresses this issue by commenting on strategies that have been used to improve the HRQOL of chronic kidney disease patients. A systematic approach is suggested for nephrology care providers to attempt to evaluate and improve the HRQOL of CKD patients.

Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study.

BACKGROUND: Conventional thrice-weekly hemodialysis (HD) has limited the ability to generate further improvements in patient quality of life, morbidity, and mortality. Daily HD (DHD) offers the promise of providing clinical and economic benefits. The objectives of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study are to evaluate outcomes of DHD (6 times/wk) with the NxStage System One (NxStage Medical Inc, Lawrence, MA) device. DESIGN: Cohort study with matched control group. SETTING & PARTICIPANTS: The DHD group will include up to 500 participants at 70 clinical sites, enrolling for 3 years with a minimum of 1-year follow-up. Study candidates include adult patients (age >or= 18 years) with end-stage renal disease who are considered suitable candidates for DHD with the NxStage System One device by the treating physician and who have Medicare as their primary insurance payer. The control group will consist of a matched thrice-weekly in-center HD cohort derived from the US Renal Data System database using a 10:1 ratio, totaling 5,000 patients. PREDICTOR: Treatment with DHD and "standard of care" thrice-weekly HD. OUTCOMES & MEASUREMENTS: The primary intent-to-treat analysis compares hospitalization days/patient-year between the DHD and thrice-weekly HD groups. Other outcomes recorded in both groups include non-treatment-related medical expenditures. In addition, in the DHD cohort, changes in quality-of-life measures (baseline, 4 and 12 months, and every 6 months thereafter); urea kinetics; parameters related to anemia, bone and mineral metabolism, and nutrition; vascular access interventions; and use of medications will be examined. CONCLUSIONS: This study has the potential to elucidate the health and economic benefits of DHD and complement results of current clinical trials.

Psychosocial assessment of the patient on chronic peritoneal dialysis: an overview.

The psychosocial assessment of the patient with end-stage renal disease is critically important because (1) there is growing evidence that the psychosocial status of the patient impacts medical outcomes and (2) the objective of therapy is to maximize a patient's sense of well-being and quality of life. This is particularly true for patients receiving a home-based therapy such as chronic peritoneal dialysis. The present review outlines a possible structure and format for performing psychosocial evaluations for patients maintained on chronic peritoneal dialysis. But, each facility must design its own format, making sure that the critical domains discussed in this review are addressed.