2011 USRDS Annual Data Report
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Introduction

Introduction to Volume Two » ESRD

Sections this chapter: 

This is the twenty-third annual report on the end-stage renal disease (ESRD) program in the United States, and the twelfth in our atlas series, which provides an in-depth, graphic presentation of data spanning the last quarter century.

Chapters

As noted in the introduction to Volume One, this year we use lyrics from American music to illustrate the human impact of kidney disease, with quotations that express some of the many emotions of the human spirit. Across the many perspectives and cultures represented in the United States, music draws on the unique viewpoints of songwriters and their relationships to the society in which they find themselves. So too does kidney disease have a unique and profound impact on different populations, creating daily challenges in adapting to a life-changing disease.

The longing tones of the violin evoke the ways in which our hearts reach out to those living with the challenges of kidney disease. At the same time, seeing the versatility of the people affected by this disease is similar to watching an orchestra of diverse instruments harmonize in a unique arrangement, one that touches us on multiple levels. We hope that the use of music as a framework for this ADR helps us connect further to the varied audiences who read this document and use its information to guide healthcare for a vulnerable population of patients.

Volume Two continues to focus on ESRD, and on the historical surveillance data that were the basis of the first USRDS reports. We summarize the ESRD program in the United States, and examine public health issues such as morbidity and mortality in the first year of therapy — an area in which there has been little progress over the last ten years. This year, however, we show that first-year survival has begun to improve, in parallel to the improved survival after the first year of treatment, something we have observed for a number of years.

At the end of 2009, the ESRD program was treating 571,414 dialysis and transplant patients — a 4.0 percent increase from 2008. There were 116,395 new cases of ESRD reported, 3.5 percent more than in 2008, and the largest increase since 2000. Growth in the incident population should, however, be viewed with caution, as it may take several years to determine if the increase will be sustained. Late reporting of data is always an issue, as complete and stable incident counts sometimes take several years to be finalized.

In this year's Prιcis we again provide an overview of ESRD patients in the U.S., their care, and their expenditures. We examine pre-ESRD care as reported on the ESRD Medical Evidence (ME) form (CMS form 2728), used to register all ESRD patients. We also look at dialysis modality use, the transplant wait list, and indicators of quality of care, and illustrate recent changes in hospitalization rates, mortality rates, and five-year survival in the dialysis population. Prevalent death rates have been falling for a number of years, and death rates in the first year of dialysis have declined since 2004. Figures on ESRD expenditures show per person and total costs in the program. Total Medicare expenditures for separately billed intravenous medications have been stable since 2004, reflecting changes in payment policies implemented by CMS.

Next we provide a full layout of the new Healthy People 2020 goals related to kidney disease. Many of the goals are new to the Healthy People chapter, and, in consultation with the HP2020 group at DHHS and the CDC, we will further develop related data in upcoming reports.

Chapter One consolidates information on incidence, prevalence, patient characteristics, and modalities of therapy. As in prior years, we illustrate trends in incidence and prevalence by age, gender, race, and ethnicity, and present data on modality use and insurance coverage. We examine nephrology referral prior to ESRD, and look at levels of estimated kidney function at initiation, using both the MDRD and CKD-EPI formulas. And we present data on the degree of anemia at initiation, on pre-ESRD treatment with erythropoiesis stimulating agents (ESAs), and, from the most recent version of the Medical Evidence form, on serum albumin, hemoglobin, cholesterol, triglycerides, and hemoglobin A1c levels at initiation.

Chapter Two, on clinical indicators of care, assesses dialysis adequacy, vascular access, anemia treatment, anemia correction in the first months of ESRD, IV iron therapy, and preventive care in the diabetic and general ESRD populations. We look, for instance, at the marked differences in vascular access complication rates associated with the use of fistulas, catheters, and grafts. New this year is information on prescription medication use under the new Medicare Part D benefit, first implemented in January, 2006. We assess data from 2008, the program's second full year, looking at differences in medication use among patients with and without the low income subsidy, in the daily number of medications, and in use of antihypertensive medications, lipid lowering agents, oral vitamin D analogs, phosphate binders, and anti-diabetes agents.

Data on hospitalization and mortality are presented in Chapter Three. In the prevalent hemodialysis population, rates of hospitalization due to infection declined in 2006–2007, rose in 2008, and fell slightly in 2009; they remain, however, 43 percent higher than in 1993. Catheter placement rates have fallen (as shown in the HP2020 chapter), but there is concern that increased use of permanent cuffed catheters may expose patients to a long-term risk of infection. Rates of hospitalization for vascular access infection have also declined, but those due to bacteremia/sepsis have increased, possibly due to a changing classification of these complications. A concurrent decrease in access infections in the peritoneal dialysis population suggests that these trends may be affected by factors outside of the dialysis populations themselves, but may also reflect the use of hemodialysis catheters in peritoneal dialysis patients whose peritoneal dialysis catheter has failed and who are waiting for placement of a new one in order to resume therapy.

New this year is a section on rehospitalization after a prior discharge. Twenty-two percent of hemodialysis patients are rehospitalized within 14 days of discharge, and 36 percent are readmitted within 30 days — a number substantially higher than the 20 percent reported for the general Medicare population (Jencks et al.).

We next look at further at hospitalizations due to infection, adding data by organ system to give a more complete picture of this area of morbidity. We then conclude the chapter by looking at hospitalizations in matched dialysis populations. Comparisons of hemodialysis and peritoneal dialysis patients are challenging, since there is substantial selection bias in those treated with peritoneal dialysis. This year we compare hemodialysis patients, peritoneal dialysis patients, and hemodialysis patients matched to those on peritoneal dialysis, looking at hospital admissions in the first and second years after the initiation of ESRD therapy.

In Chapter Four we examine cardiovascular disease in patients with ESRD, beginning with data on cardiovascular mortality, then looking at prescription drug therapy used by patients with various cardiovascular diagnoses and by those undergoing cardiovascular procedures such as revascularization.

We begin Chapter Five, on mortality, by highlighting trends in the first and subsequent years on ESRD therapy, with data now showing similar reductions in mortality rates among patients of all vintages. Figures then detail mortality during the first year of hemodialysis, illustrating a sharp increase in all-cause rates in month two of treatment, following by a steady decline during the rest of the year. Five-year survival has been improving slowly, but survival in the first six months of treatment has changed little since 1996. The issue of early survival clearly merits increased attention, and the role of infectious complications — particularly those related to dialysis catheters — needs to be addressed. Perhaps the changing incentives in the new bundled payment system, directed at lowering costs and complications, may translate to reductions in the use of dialysis catheters and to a focus on preventive care.

New this year is a chapter focused on use of the Medicare Part D prescription drug benefit in the ESRD population. In Chapter Six we show, for example, that CKD, dialysis, and transplant patients are quite different from those in the general Medicare population in their use of the low income subsidy (LIS). Heavy use of LIS among ESRD patients is also reflected in the proportion of patients who reach the coverage gap. The chapter includes data on Medicare costs for the Part D benefit, on out-of-pocket expenditures for enrollees, and on the most frequently used and most expensive drugs.

As we illustrate in Chapter Seven, the number of transplants from deceased donors has slightly declined from its peak of 10,906 in 2006 to 10,679 in 2009, while the number from living donors has rebounded to 5,981, a level just below the 6,028 reported for 2006. Waiting times continue to grow, due to the continued shortage of donated kidneys. And death with a functioning graft continues to be a concern, with cardiovascular disease accounting for 30 percent of deaths with a known cause. The rate of influenza vaccinations among transplant patients is still far lower than that in the dialysis population, with very little progress since 1991.

In Chapter Eight, on the pediatric ESRD population, we lead with data on incidence and prevalence since 1980, and present data on the full breadth of diseases that have accounted for new ESRD cases in pediatric patients over the last decade. Rates of influenza vaccinations in this population continue to be low, with fewer than one in three children receiving this treatment, despite their high rates of pneumonia and other respiratory infections. In contrast to adults, for whom hospitalization rates are high in the first months of dialysis and decline within the first year, children have progressively higher rates over the first 15 months after the initiation of ESRD therapy. Death rates in children are highest in the first six months of treatment, particularly for those younger than five. And as noted last year, five-year survival among children with ESRD has not changed in more than a decade.

In Chapter Nine, the Special Studies Centers of the USRDS — Nutrition, Rehabilitation/Quality of Life, and Cardiovascular — outline details of ACTIVE/ADIPOSE: A Cohort Study to Investigate the Value of Exercise in ESRD/Analyses Designed to Investigate the Paradox of Obesity and Survival in ESRD. A prospective, multi-center study of prevalent hemodialysis patients, the study will be conducted in collaboration with the NIH/NIDDK Division of Kidney, Urologic, and Hematologic Diseases and the USRDS Coordinating Center.

The landscape of dialysis providers continued to evolve in 2009, with growth in some of the smaller dialysis organizations (SDOs). Large dialysis organizations (LDOs) now treat 63 percent of dialysis patients in the United States; SDOs account for 11.6 percent, hospital-based units 10 percent, and independently owned units 15 percent. In Chapter Ten we provide data on the duration of unit ownership among both the consolidated and remaining providers. We also address iron dosing practices and transfusion use, and costs for intervention and preventive care. Comparisons of standardized hospitalization and mortality ratios show that hospital-based units have substantially narrowed the gap in outcomes over the past five years, with ratios now only 7 percent higher than the national average, compared to 20 percent in the past.

Chapter Eleven, on expenditures related to ESRD, begins with data on total spending by type of insurer. After a large increase in 2008, the change in expenditures between 2008 and 2009 was the lowest since 1998. The chapter includes data on expenditure patterns for injectable medications and laboratory testing, and we use the matched hemodialysis and peritoneal dialysis populations to better compare expenditures across modalities; such comparisons may influence modality use under the new CMS bundled payment system. We conclude with new data on costs associated with the Part D prescription drug benefit.

In Chapter Twelve we summarize data from the international community. We are again grateful to the registries providing this information, allowing us to see the U.S. ESRD community through a wider lens.

Most of the 2011 ADR contains data through December 31, 2009; data on patient characteristics, obtained from the Medical Evidence form, are complete through June, 2010. Only Medicare Part D data through 2008 were available for this ADR; more recent data should be available for the 2012 edition.

Current estimated incident and prevalent counts can be found on the USRDS website.

Render and the Researcher's Guide Top

Our real-time online query system allows users to build data tables and maps. The Renal Data Extraction and Referencing System (RenDER) can be accessed on our website.

To assist users of USRDS data, the Coordinating Center (CC) annually updates the Researcher's Guide, which provides information on all analytical methods used by the CC, along with a detailed index of files and variables in the USRDS researcher datasets. It is available on our website in PDF format.

USRDS Database Top

The USRDS dataset is a living record of patient care in the United States, continually updated with new data. Delays in data reporting are unavoidable, and we add late information as soon as it becomes available. This includes data from the Medical Evidence form, claims for hospital and physician services, and updates of the Medicare Enrollment Database received after the ADR has gone to press.

Administrative Oversight Top

Project Officers (POs) Lawrence Agodoa, MD, and Paul Eggers, PhD, provide direct oversight of the CC and Special Studies Centers (SSCs), and members of CMS, the ESRD networks, and the renal community provide crucial input and feedback through their committee participation.

The Steering Committee, the governing body of the USRDS, is responsible for the operations of the CC and SSCs. It works under the direction of the POs, and includes representatives from CMS, the National Institutes of Health, the CC, and the SSCs. Its responsibilities include coordination among the centers, study design, project tracking, data management and validation, assurance of data availability for researchers and government officials, and oversight of ADR production.

The USRDS External Advisory Committee plays a major role in advising POs on special studies, data studies, and analyses. It is also responsible for reviewing manuscripts and ADRs.

The Special Studies Review and Implementation Committee, the operations committee for SSC proposals and CC project support, is a collaboration of CMS, the ESRD networks, and the providers. The Data Request Review Committee reviews data requests requiring more than two hours of staff time to fulfill, and makes recommendations to the POs based on the datasets requested and the ways in which the CC can improve data availability.

Reading the Maps Top

Many maps in the ADR are by Health Service Area (HSA), a group of counties described by authors of the CDC Atlas of United States Mortality as "an area that is relatively self-contained with respect to hospital care."

Maps here present data divided into quintiles, with each range in a legend containing approximately one-fifth of the data points. In the sample map, for example, one-fifth of all data points have a value of 10.8 or above. Ranges include the number at the lower end of the range, and exclude that at the upper end (i.e, the second range in the sample map is 8.2–<9.2). To facilitate comparisons of maps with data for different periods, we commonly apply a single legend to each map in a series. Because such a legend applies to multiple maps, the data in each individual map are not evenly distributed in quintiles, and a map for a single year may not contain all listed colors or ranges.

Numbers in the first and last boxes indicate the mean values of data points in the highest and lowest quintiles; these can be used to calculate the percent variation between quintiles. For maps with shared legends we have provided these values by repeating the legends and inserting the unique quintile values. Mean numbers within the quintiles can be calculated as a simple half-way point.

On the Excel page for each map (found on the website and CD-ROM) we include several numbers to help you interpret the maps and their relation to other data in the ADR. The map-specific mean is calculated using only the population whose data are included in the map itself. This mean will usually not match data presented in tables elsewhere in the ADR, and should be quoted with caution. The overall mean includes all patients for whom data are available, whether or not their residency is known. We also include the number of patients excluded in the map-specific mean, and the total number of patients used for the overall calculation.

Acknowledgements Top

The ADR could not be produced without the extraordinary work of members of the ESRD community — including the staff of CMS and the ESRD networks — and the dedicated efforts of the USRDS staff and investigators. The efforts of the providers themselves are crucial in the collection of data used by the USRDS, and their dedication to this task is greatly appreciated.

We welcome feedback on all elements of USRDS work. All comments are reviewed by the Director, Deputy Director, and staff of the USRDS in order to improve future materials and to ensure a strong working relationship between the USRDS and the clinicians, researchers, patients, and others involved in the care of ESRD patients across the United States and throughout the world.