ESRD Networks Research Articles

Practicing health equity in kidney care by establishing improved access to timely disease management and kidney replacement therapy options: from providers to patients.

The aim of this article is to review the current understanding of disparities in healthcare experienced by people living with kidney disease and emerging approaches to address root causes. Health equity for any disease state is an aspirational goal commonly sought out by the medical community, but all too often lacking the understanding and support required to improve the outcomes of people with complex conditions such as chronic kidney disease (CKD). The main themes of the literature covered in this article include a review of the structural drivers of healthcare outcomes, a description of research in the fields of health literacy and patient activation for patients with CKD, and an analysis of the examples of healthcare disparities in CKD patients that include involuntary discharges from dialysis facilities as well as the toll taken from dialysis populations during natural disasters. The National Forum of the ESRD Networks is a coalition of 18 congressionally mandated ESRD network organizations committed to equitable access to home and in-center dialysis modalities and preemptive kidney transplantation. We conclude with the patient-centered story of a patient living with end-stage kidney disease for over 40 years and how her journey has helped shape her view on what she believes should encompass a 'call to action' to provide more equitable healthcare to people living with kidney disease. The overarching implications of this article focus on improving the understanding of present-day healthcare inequality within the community of people living with kidney disease and providing a roadmap of resources and ideas that will help achieve more equitable outcomes. The National Forum of the ESRD Networks is committed to the effective implementation of 'Practicing Health Equity in Kidney Care' and improving access to dialysis modalities including home dialysis as well as kidney transplantation including preemptive transplant options.

Early steps to kidney transplantation among persons with HIV and end-stage renal disease in ESRD network 6.

End-stage renal disease is a significant cause of morbidity and mortality in persons with HIV (PWH). Limited data exist on access to kidney transplantation for this population. A dataset inclusive of incident dialysis patients between 2012 and 2016 with follow-up through December 2017 that identifies PWH and the general dialysis population of Network 6 (Georgia, North Carolina, South Carolina) was created through merging the United States Renal Data System with the southeastern early transplant access registry. Early steps to kidney transplantation and patient and dialysis facility-level characteristics that serve as barriers to transplantation were described. Twenty-three thousand four hundred fourteen patients were identified; 469 were PWH. Compared to non-HIV individuals, PWH were younger (49 vs. 58 years, p<0.001), predominantly Black (87% vs. 56% p<0.001) and male (72% vs. 56% p<0.001). PWH were less likely to be referred to kidney transplant within 1 year of starting dialysis (36% vs. 41% p<0.001) and waitlisted within 1 year of evaluation-start (14% vs. 30%, p=0.05). PWH (vs. non-PWH) waited longer for referral, evaluation-start, and waitlisting and in multivariable analysis; HIV positivity was associated with a lower probability of referral (hazard ratios [HR]: 0.70; 95% confidence intervals [CIs]: 0.62-0.80), evaluation (HR 0.66; 95% CI: 0.55-0.80), and waitlisting (HR 0.29; 95% CI: 0.20-0.41). Targeted interventions are needed to improve access to kidney transplants, particularly in waitlisting, for PWH.

Improving Access to Kidney Transplantation: Perspectives From Dialysis and Transplant Staff in the Southeastern United States

Rationale & ObjectiveThere are many barriers to meeting the goal of increasing kidney transplants in the United States. It is important to understand dialysis and transplant center providers’ existing practices and identified barriers to increasing the number of dialysis patients who are evaluated for and get wait-listed for a transplant.Study DesignCross-sectional survey of dialysis unit and transplant center staff in End Stage Renal Disease Network 6 (Georgia, North Carolina, South Carolina).Setting & ParticipantsNinety-one transplant staff from all 9 transplant centers in the region and 421 dialysis staff from 421 facilities responded to the survey.PredictorsN/AOutcomeProvider perceptions of barriers faced by patients in the kidney transplant evaluation process and suggestions for improving care.Analytical ApproachMixed methods. Descriptive analyses of responses to multiple-choice questions and qualitative analysis of open-ended survey responses.ResultsThe top 5 barriers to kidney transplantation as reported by transplant staff were transportation (63.7%), low health literacy (50.5%), lack of understanding about the transplant process (37.4%), distance to transplant center (29.7%), and low socioeconomic status (28.6%). When asked how dialysis units can help patients complete the evaluation process, the most common responses from transplant center staff were educating patients about transplant (54%), helping patients through steps in the process (35%), and better communication with transplant centers (15%). When dialysis unit staff were asked what could be done to help the facility improve its transplant wait-list rate, the most common responses were educational materials for patients and staff (55%), better communication with transplant centers (12%), and transportation and financial assistance (9%).LimitationsSurvey responses are from 1 end stage renal disease network.ConclusionsDialysis units, transplant centers, and ESRD networks can work together to help patients address key barriers to transplantation to improve the country’s transplantation rate.

Nephrology Social Workers' Caseloads and Hourly Wages in 2014 and 2017: Findings from the National Kidney Foundation Council of Nephrology Social Workers Professional Practice Survey

In 2014 and 2017, the National Kidney Foundation Council of Nephrology Social Workers (NKF-CNSW) conducted online surveys of nephrology social workers employed in outpatient dialysis settings and transplant programs to assess caseload and salary trends at the state, national, and End-Stage Renal Disease Network levels. Between 2014 and 2017, the mean caseloads for outpatient dialysis social workers remained steady at 75 for those employed 20–31 hrs/wk, increased from 113.2 to 126.9 (up 12.1%) for those employed 32–40 hrs/wk, and increased from 116.1 to 129.5 (up 11.5%) for those employed 40 hrs/wk. Median caseloads showed a similar pattern between 2014 and 2017 for those employed 32–40 hrs/wk (110.0 to 120.0; up 9.1%) and for those employed 40 hrs/week (117.0 to 120.0; up 2.6%). Increases in mean hourly wage between 2014 and 2017 were also reported across all three employment status groups: $29.45 to $31.31 per hour (up 6.3%) for those working 20–31 hrs/wk, $28.23 to $30.62 per hour (up 8.5%) for those working 32–40 hrs/wk, and $28.21 to $30.48 per hour (up 8.0%) for dialysis social workers employed 40 hrs/wk.&#x0D; Annual pre-transplant evaluations of potential donors increased between 2014 and 2017 for transplant social workers who were employed full time (32–40 hrs/wk) and those who worked 40 hrs/wk. Specifically, the mean number of potential donor evaluations increased from 22.1 to 33.8 (up 52.9%) for those employed 32–40 hrs/wk and 23.0 to 33.8 (up 46.9%) for those employed 40 hrs/wk. Pre-transplant evaluations of potential recipients decreased for those employed full-time (283.7 to 219.2, down 22.7%) and for those employed 40 hrs/wk (315.6 to 219.2, down 30.5%). Mean hourly wage data showed an increase for transplant social workers employed full time ($30.74 to $31.50, up 2.5%) and for those employed 40 hrs/wk ($28.74 to $31.03, up 7.9%). In general, increases in social work caseloads and increases in hourly wages were found on a national level; however, variability in mean caseloads and mean hourly wages across ESRD Networks and states persists.

Awareness of Racial Disparities in Kidney Transplantation among Health Care Providers in Dialysis Facilities.

Despite the important role that health care providers at dialysis facilities have in reducing racial disparities in access to kidney transplantation in the United States, little is known about provider awareness of these disparities. We aimed to evaluate health care providers' awareness of racial disparities in kidney transplant waitlisting and identify factors associated with awareness. We conducted a cross-sectional analysis of a survey of providers from low-waitlisting dialysis facilities (n=655) across all 18 ESRD networks administered in 2016 in the United States merged with 2014 US Renal Data System and 2014 US Census data. Awareness of national racial disparity in waitlisting was defined as responding "yes" to the question: "Nationally, do you think that African Americans currently have lower waitlisting rates than white patients on average?" The secondary outcome was providers' perceptions of racial difference in waitlisting at their own facilities. Among 655 providers surveyed, 19% were aware of the national racial disparity in waitlisting: 50% (57 of 113) of medical directors, 11% (35 of 327) of nurse managers, and 16% (35 of 215) of other providers. In analyses adjusted for provider and facility characteristics, nurse managers (versus medical directors; odds ratio, 7.33; 95% confidence interval, 3.35 to 16.0) and white providers (versus black providers; odds ratio, 2.64; 95% confidence interval, 1.39 to 5.02) were more likely to be unaware of a national racial disparity in waitlisting. Facilities in the South (versus the Northeast; odds ratio, 3.05; 95% confidence interval, 1.04 to 8.94) and facilities with a low percentage of blacks (versus a high percentage of blacks; odds ratio, 1.86; 95% confidence interval, 1.02 to 3.39) were more likely to be unaware. One quarter of facilities had >5% racial difference in waitlisting within their own facilities, but only 5% were aware of the disparity. Among a limited sample of dialysis facilities with low waitlisting, provider awareness of racial disparities in kidney transplant waitlisting was low, particularly among staff who may have more routine contact with patients.

Using Patient-Reported Measures in Dialysis Clinics.

Patient-reported outcome measures (PROMs), including patient-reported outcomes (PROs), are one of two primary sources of data about patients on dialysis ([1][1]); the other is biologically based patient data. The Food and Drug Administration definition of a PRO is “any report coming from patients

Kidney transplant referral practices in southeastern dialysis units.

The Southeastern Kidney Transplant Coalition was created in 2010 to improve kidney transplant (KTx) rates in Georgia, North Carolina, and South Carolina. To identify dialysis staff-reported barriers to transplant, the Coalition developed a survey of dialysis providers in the region. All dialysis units in the ESRD Network (n = 586) were sent a survey to be completed by the professional responsible for helping patients get transplants. One staff member at almost all (n = 546) of the dialysis units in Network 6 completed the survey (93% response rate). Almost all respondents reported being very comfortable (51.47%) or comfortable (46.89%) discussing the KTx process with patients. Just over half (56%) of facilities reported discussing KTx as a treatment option with patients on an annual basis. Fewer than one quarter of respondents (19%) perceived that more than 50% of their patients were interested in kidney transplant, and most of the staff surveyed (68%) reported that <25% of their dialysis patients completed the evaluation process and been wait-listed for a kidney transplant. The survey results provide insight into KTx referral practices in southeastern dialysis units that may be contributing to low KTx rates in this region.

A Matter of Choice: Opportunities and Obstacles Facing People with ESRD.

Kidney failure is an overwhelming, life-shattering event, but patients with ESRD do not see themselves as being at the end stage of their lives. On the contrary, patients opting for kidney dialysis are choosing to live. Ideally, then, public policy would support patients' choices about how to live-specifically, the choice to continue working. Many patients with ESRD faced with the limitations of their health status and the demands of their treatment understandably choose to leave their jobs, a choice that is facilitated by the availability of public disability and health insurance. However, other patients who have the desire and opportunity to continue working may not get the guidance and support that can actually make their employment possible. Specifically, current disability and health insurance may fail to provide timely treatment and employment counseling to help patients with ESRD remain in their jobs. We, therefore, propose that the Center for Medicare and Medicaid Services support ESRD Networks to initiate more timely employment and treatment counseling in both the ESRD and the late-stage pre-ESRD setting. Although it is too late to require such counseling in the new network scope of work for 2016-2020, active experimentation in the next few years can lay the groundwork for a subsequent contract.

Managing Disruptive Behavior by Patients and Physicians: A Responsibility of the Dialysis Facility Medical Director.

The Centers for Medicare & Medicaid Services' Conditions for Coverage make the medical director of an ESRD facility responsible for all aspects of care, including high-quality health care delivery (e.g., safe, effective, timely, efficient, and patient centered). Because of the high-pressure environment of the dialysis facility, conflicts are common. Conflict frequently occurs when aberrant behaviors disrupt the dialysis facility. Patients, family members, friends, and, less commonly appreciated, nephrology clinicians (i.e., nephrologists and advanced care practitioners) may manifest disruptive behavior. Disruptive behavior in the dialysis facility impairs the ability to deliver high-quality care. Furthermore, disruptive behavior is the leading cause for involuntary discharge (IVD) or involuntary transfer (IVT) of a patient from a facility. IVD usually results in loss of continuity of care, increased emergency department visits, and increased unscheduled, acute dialysis treatments. A sufficient number of IVDs and IVTs also trigger an extensive review of the facility by the regional ESRD Networks, exposing the facility to possible Medicare-imposed sanctions. Medical directors must be equipped to recognize and correct disruptive behavior. Nephrology-based literature and tools exist to help dialysis facility medical directors successfully address and resolve disruptive behavior before medical directors must involuntarily discharge a patient or terminate an attending clinician.

Medical Director Responsibilities to the ESRD Network.

The 18 regional ESRD Networks are established in legislation and contract with the Centers for Medicare and Medicaid Services to improve the quality and safety of dialysis, maximize patient rehabilitation, encourage collaboration among and between providers toward common quality goals, and improve the reliability and the use of data in pursuit of quality improvement. The Networks are funded by a $0.50 per treatment fee deducted from the reimbursement to dialysis providers, and their deliverables are determined by a statement of work, which is updated in a new contract every 3 years. The Conditions for Coverage require dialysis providers to participate in Network activities, and failure to do so can be the basis for sanctions against the provider. However, the Networks attempt to foster a collegial relationship with dialysis facilities by offering tools, educational activities, and other resources to assist the facilities in meeting the evolving requirements by the Centers for Medicare and Medicaid Services on the basis of national aims and domains for quality improvement in health care that transcend the ESRD program. Because of his/her responsibility for implementing the quality assessment and performance improvement activities in the facility, the medical director has much to gain by actively participating in Network activities, especially those focused on quality, safety, patient grievance, patient engagement, and coordination of care. Membership on Network committees can also foster the professional growth of the medical director through participation in quality improvement activity development and implementation, authorship of articles in peer-reviewed journals, creation of educational tools and presentations, and application of Network-sponsored materials to improve patient outcomes, engagement, and satisfaction in the medical director's facility. The improvement of care of patients on dialysis will be beneficial to the facility in achieving its goals of quality, safety, and financial viability.

The Association of Dialysis Facilitiesʼ Protocols and Staffʼs Perceptions and On Standardized Transplant Ratio.

Dialysis facilities in ESRD Network 6 have the lowest kidney standardized transplant ratios (STR), defined as the ratio of observed to expected transplants in a facility, in the United States. We investigated whether facility protocols, practices, and staff perceptions about kidney transplant (KTx) were associated with low STR. All dialysis facilities in the Network (n=586) were invited to participate in a 25 question environmental scan, with a 93.2% completion rate. The survey was completed primarily by nurse managers (51.0%) and social workers (21.8%). Surveys were linked to the 2012 Dialysis Facility Report for STR and facility demographic data. The majority (83.7%) of facilities said they had a patient-education protocol and 82.2% had dedicated staff to discuss the transplantation process. Most facilities (74.3%) perceived that < 50% of their patients were eligible for a kidney transplant and only 12.4% of facilities say they referred 75% or more of their patients. The facilities that report referring the most patients have the highest STR (mean=0.89, 95% CI 0.74, 1.03) compared to STR=0.62 (95% CI 0.53, 0.71) among facilities that report referring less than 25% of their patient population (p<0.001). Compared to non-profit facilities, for profit facilities had a higher proportion of facilities with patient-education protocols in place and significantly higher proportion of facilities with staff dedicated to transplant (p= 0.03). Improved staff perception of patient interest in KTx was positively associated (β=0.08 SE=0.02 p=0.002) with an increase in STR after adjusting for number of staff, percent African American, and percent of patients with comorbidities.Figure: No Caption available.Dialysis facilities' perceptions of their patients and the transplant process may influence access to transplantation. Future programs should focus on the improvement of staff's perceptions by developing programs to better enable staff to champion transplant as a viable treatment option.

Training Dialysis Providers to Educate About Transplant: In-Person vs. E-Learning Delivery Approaches.

Purpose: Many dialysis providers have insufficient kidney transplant (KTX) knowledge and education materials to help their patients learn about KTX. In-person (live) Explore Transplant (ET) trainings were shown to improve providers' KTX knowledge and education practices, but many providers cannot attend a live training due to location or patient care loads. We created a second training delivery approach, E-learning training, and assessed its equivalence (non-inferiority) to live trainings in improving providers' KTX knowledge, motivation to educate patients about KTX, and actual education practices 6 months later. Methods: From 2011-2013, dialysis providers in 14 ESRD Networks participated in either ET live and E-learning trainings. The E-learning program offered identical content to the live trainings, but was administered in four, one-hour online sessions. Providers were surveyed directly before and after the trainings, then 6 months later, to assess improvement in their KTX knowledge, plans to educate their patients, and their KTX education practices. Pairs of providers, one from each delivery type, were matched by ESRD Network and job title. Equivalence across educational delivery approaches was defined as ≤ 15% worse outcomes (i.e., 1.8 pts difference in knowledge change on 12 pt knowledge scale or rate ratio lower bound of 0.85). Results: 280 matched pairs (27% social workers, 34% nurses, 39% others) were created from providers participating in the live (n=1485) or E-learning trainings (n=308). E-learning was equivalent to live trainings at increasing providers' KTX knowledge and motivation to educate 1 patient but not at motivating providers to commit to educating 5 patients and doing this 6 months later (Table).Table: No Caption available.Discussion: While a cost-effective, widely disseminable ET E-learning training was shown to be equivalent to live trainings in increasing dialysis providers' KTX knowledge and motivation to start educating about KTX, follow-up by email or phone may be necessary to reinforce E-learning attendees to actively engage in new KTX education.

Geographic Variation in Access to Kidney Transplantation in the United States By Race.

Background: Racial disparities exist in access to kidney transplantation in the United States (US), and kidney transplant rates are lowest in the Southeastern US compared to other regions. However, it is unknown whether racial disparities vary across geographic regions in the US. Methods: Among a cohort of 681,521 adult ESRD patients in the United States Renal Data System from 2005 through 2011, we examined black vs. white racial disparity in waitlisting and transplantation across geographic regions. We used Cox proportional hazards models to estimate crude hazard ratios (HRs) of waitlisting and transplantation by ESRD Network region. Results: On average, there are minor black vs. white racial disparities in access to waitlisting in the US (HR=0.98; 95% CI: 0.97-0.99). However, regional differences exist in racial disparities in access to waitlisting (interaction p<0.0001), with the Southeastern US having the worst racial disparity in access to waitlisting (HR=0.81; 95% CI: 0.77-0.84).Figure: No Caption available.Racial disparities exist in access to both deceased and living donor kidney transplantation in the US, where blacks have half the rate of transplantation vs. whites (HR=0.49; 95% CI: 0.48-0.50). Regional differences exist in racial disparities in access to kidney transplantation (interaction p <0.0002), and similar to waitlisting access, the Southeastern US has the worst racial disparity in access to kidney transplantation (HR=0.38; 95% CI: 0.35-0.40).Figure: No Caption available.Conclusion: We observed a large difference in racial disparity between access to waitlisting and transplantation, such that racial disparities were more pronounced after waitlisting. Further, disparities differed dramatically by US region, suggesting that it is essential to consider geographical differences when examining racial disparities in access to kidney transplantation.

Nephrologists’ Professional Ethics in Dialysis Practices

Although the number of incidents is unknown, professional quality-oriented renal organizations have become aware of an increased number of complaints regarding nephrologists who approach patients with the purpose of influencing patients to change nephrologists or dialysis facilities (hereinafter referred to as patient solicitation). This development prompted the Forum of ESRD Networks and the Renal Physicians Association to publish a policy statement on professionalism and ethics in medical practice as these concepts relate to patient solicitation. Also common but not new is the practice of nephrologists trying to recruit their own patients to a new dialysis unit in which they have a financial interest. This paper presents two illustrative cases and provides an ethical framework for analyzing patient solicitation and physician conflict of interest. This work concludes that, in the absence of objective data that medical treatment is better elsewhere, nephrologists who attempt to influence patients to change nephrologists or dialysis facilities fall short of accepted ethical standards pertaining to professional conduct, particularly with regard to the physician-patient relationship, informed consent, continuity of care, and conflict of interest.

ESRD Networks

Established by Federal law in 1978, the ESRD Networks are regional nonprofit organizations that contract with the Centers for Medicare and Medicaid Services to provide quality oversight services to chronic dialysis facilities. The governing bodies and medical review boards of each network are populated by volunteer professionals and patients. The medical review boards drive the quality agenda for each network, addressing specific local barriers to improvement. The network contract deliverables are defined by the Centers for Medicare and Medicaid Services in a scope of work document (SOW) that is generally revised with each 3-year contracting cycle. The current SOW has not been revised since the implementation of the new Conditions for Coverage for dialysis facilities in 2008 or the implementation of a bundled payment system and quality incentive program for dialysis providers in 2011. The future success of the ESRD Network Program will depend upon adequate funding, data accessibility to drive rapid-cycle quality improvement efforts, and partnerships with other stakeholder groups to address the continuum of care of patients with CKD. The Forum of ESRD Networks has developed a strategic plan that aligns the priorities of the networks with the National Quality Strategy. The integration of these objectives into the next SOW will augment the relevance of the network program to the ESRD stakeholder community as the networks move from a task-oriented approach to a system-improvement approach to quality oversight.

Fistula First Breakthrough Initiative: Targeting Catheter Last in Fistula First

An arteriovenous fistula (AVF) is the optimal vascular access for hemodialysis (HD), because it is associated with prolonged survival, fewer infections, lower hospitalization rates, and reduced costs. The AVF First breakthrough initiative (FFBI) has made dramatic progress, effectively promoting the increase in the national AVF prevalence since the program's inception from 32% in May 2003 to nearly 60% in 2011. Central venous catheter (CVC) use has stabilized and recently decreased slightly for prevalent patients (treated more than 90 days), while CVC usage in the first 90 days remains unacceptably high at nearly 80%. This high prevalence of CVC utilization suggests important specific improvement goals for FFBI. In addition to the current 66% AVF goal, the initiative should include specific CVC usage target(s), based on the KDOQI goal of less than 10% in patients undergoing HD for more than 90 days, and a substantially improved initial target from the current CVC proportion. These specific CVC targets would be disseminated through the ESRD networks to individual dialysis facilities, further emphasizing CVC avoidance in the transition from advanced CKD to chronic kidney failure, while continuing to decrease CVC by prompt conversion of CVC-based hemodialysis patients to permanent vascular access, utilizing an AVF whenever feasible.

Processes of Care and Reduced Mortality among Hemodialysis Patients in the United States

A major accomplishment of clinical nephrology during the past 15 years has been the substantial improvement in the quality of ESRD care. The proportion of underdialyzed patients in the United States was reduced from >60 to <10% of hemodialysis (HD) patients (1) (www.cms.gov/CPMProject/). Additional improvements have been observed during the past decade in the use of arteriovenous fistulas (AVFs) (2). In turn, better HD care has been associated with decreasing mortality among both prevalent and incident patients with ESRD (3). The association between temporal trends in mortality and better care persists after accounting for changes in other case-mix factors, and Wolfe et al. (4) showed that each 10% increase in the proportion of patients who received adequate HD was associated with a 2.2% decrease in case mix–adjusted mortality rates. These observations about improved quality of care and reduced mortality reflect information provided by a comprehensive, population-based ESRD surveillance system and national registry, composed of 18 regional Networks and the US Renal Data System (5). This surveillance system routinely collects, analyzes, and disseminates information about the occurrence, treatment, and outcomes of ESRD in the US population. The information is used to plan, implement, and evaluate interventions to reduce the occurrence and improve outcomes of individuals with ESRD. Examples of quality improvement interventions are those conducted by the ESRD Networks. The Networks use continuous quality improvement (CQI) to foster transfer and adoption of evidence-based HD practices (6) by ESRD treatment facilities (7). These CQI interventions have been shown to contribute independently to improved care (8,9). This system of data-driven, patient-oriented quality improvement predates …

Geographic Concentration of Poverty and Arteriovenous Fistula Use among ESRD Patients

There is substantial geographic variability in both incident and prevalent arteriovenous fistula (AVF) use among patients with ESRD. This study examined the degree to which these variations associate with poverty in the county of a patient's treatment center. We performed a cross-sectional study including 28,135 patients treated by 1127 hemodialysis centers in five ESRD networks (16 states) between June 1, 2005 and May 31, 2006. We used the 2000 U.S. Census to categorize county-level poverty and ascertained incident AVF use from the Medicare CMS 2728 form. We calculated the 30-month slope of change in AVF prevalence from monthly facility reports collected between 2003 and 2005. More than 33% of treatment centers were located in high-poverty counties. County poverty inversely associated with incident AVF use (P for trend = 0.001). In contrast, substantial increases in prevalent AVF rates from 30.9 to 38.6% (P < 0.001) among treatment centers did not associate with county poverty (P = 0.9519). In conclusion, the concentration of poverty in the county where a treatment is located associates with incident AVF use by patients with ESRD but not with subsequent improvement in AVF use among prevalent patients. These results suggest that the Medicare ESRD program may mitigate poverty effects on AVF use.

Message to the FDA on ESAs

Since March 24, 2010, the Food and Drug Administration (FDA) has been requiring a “Risk Evaluation and Mitigation Strategy” (REMS) for all patients who are treated with erythropoiesis-stimulating agents (ESAs) (1). Although regulatory authorities elsewhere in the world have not as yet taken this approach, experience suggests that these agencies often take their cues from the FDA. Most nephrologists are unaware that the FDA now requires distribution to both dialysis and nondialysis patients of a medication guide that explains the risks and benefits of ESAs. The FDA is also mandating that oncologists—but not nephrologists, at least thus far—register and participate in a program called Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs (APPRISE) (2); however, APPRISE for ESAs in cancer could herald a similar program for ESAs in the anemia of kidney disease. What is REMS? Should nephrologists be required to register in an APPRISE-like program? Should the FDA be doing more to address safety concerns with ESAs? REMS was announced in February for all patients who receive ESAs, and notices have been sent to ESRD networks asking that medication guides be distributed to patients (3). In addition, for the ESA cancer indication, oncologists need to undergo training on the risks and benefits of ESAs to continue prescribing them. This involves discussion about ESAs with patients who have cancer before beginning a course of treatment. Oncologists have to document that this discussion took place. A health care provider enrollment form that was developed by Amgen and Centocor Ortho Biotech and approved by the FDA must be completed for oncologists to prescribe ESAs (4). The FDA gained authority to require REMS under the Food and Drug Administration Amendments Act (FDAAA) of 2007 (5). The goal of REMS is to manage a known or potentially …

Racial and Gender Differences in Arteriovenous Fistula Use among Incident Hemodialysis Patients

Background: Arteriovenous fistula (AVF) use is reported to differ among racial and gender groups. We sought to identify risk factors associated with incident AVF and whether racial and gender differences in AVF use persist after controlling for these factors. Methods: We evaluated 28,712 incident adult hemodialysis patients (age ≧18) from five ESRD networks starting dialysis between June 1, 2005 and May 31, 2006. Data were obtained from the Center for Medicaid and Medicare Services 2728 form. Results: Incident AVF use was reported for 11% of black and 12% of white patients [OR = 0.89 (95% CI: 0.83, 0.96)], and for 9% of females and 13% of males [OR = 0.66 (0.62–0.71)]. After adjusting for facility clustering, blacks were as likely as whites to use an AVF [OR = 1.00 (0.92–1.09)], while gender differences persisted [OR = 0.64 (0.59–0.69)]. Compared to patients with no renal care prior to dialysis initiation, incident AVF use was 16-fold greater among those with ≧12 months of nephrology care [OR = 15.99 (13.25–19.29)], 9-fold greater among those with 6–12 months of care [OR = 9.00 (7.45–10.88)] and 7-fold greater among those with at least 6 months of care [OR = 7.13 (5.73–8.88)]. Conclusion: Racial, but not gender, differences in incident AVF use were eliminated after accounting for clustering within facilities.