|Sections this intro:|
This is the twenty-second annual report on the end-stage renal disease (esrd) program in the United States, and the eleventh in our atlas series, which provides an in-depth, graphic presentation of data spanning the last quarter century. For the third year we include a volume on chronic kidney disease (CKD), with information on the prevalence of the disease in the general population and on recognized CKD in the Medicare and employer group health plan (EGHP) databases. Data on risk factor awareness, treatment, and control highlight the challenges of providing care to patients with kidney disease. We also examine access to care, demonstrating that, in the years before CKD advances to ESRD, referral to a nephrologist happens far less frequently than previously thought, complicating the planning for preemptive kidney transplantation or placement of a hemodialysis or peritoneal dialysis access.
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, paralleling recent progress in survival following the first year of treatment.
At the end of 2008, the ESRD program was treating 547,982 dialysis and transplant patients a 3.9 percent increase from 2007. There were 112,476 new cases of ESRD reported, 1.3 percent more than in 2007. The population returning to dialysis after a failed kidney transplant increased 1.3 percent, to 5,459. Growth in the incident population should 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 form (ME), which is 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, and compare costs for Medicare and employer group health plan patients during the transition from CKD to ESRD. Total Medicare expenditures for separately billed intravenous medications have been stable since 2004, reflecting changes in payment policies implemented by CMS.
We have reported data related to Healthy People 2010 objectives for several years, tracking progress in basic public health goals for the kidney disease population. Several targets are close to being met, including cardiovascular death rates, fistula use among new dialysis patients, and evaluations of those with diabetes.
This year's chapter on emerging issues focuses on infectious complications in the first year of hemodialysis. In the third month of treatment, rates of hospitalization for vascular access infection are highest among patients age 2044, and have increased almost 400 percent for these patients since 1991. The rise in hospitalizations due to bacteremia/sepsis is also a concern, particularly in light of the slight decline in hospitalizations for vascular access infection. These two observations suggest that there has been a shift in the rates of complications, rather than true progress. The decline in catheter placement rates noted in the HP2010 chapter does not appear to be translating into lower rates of hospitalization for infection, possibly reflecting the use of more cuffed, long-term catheters, which expose patients to persistent risks not associated with an internal access such as a fistula or graft. To provide insight as to how these infectious complications are treated, we conclude the chapter by examining the use of outpatient antibiotics, both oral and intravenous.
Chapter Two reports incident and prevalent counts, highlighting the rising rates of ESRD due to diabetes and hypertension in younger African Americans, and illustrating how growth in the incident population appears to be driven by the large number of patients from the baby boomer generation. We look again at rates of ESRD in major metropolitan areas; data here may help direct public health programs in high-burden areas of the country. Interestingly, the highest incidence of ESRD for both whites and African Americans is reported in Pittsburgh, Pennsylvania, while rates of prevalent ESRD are also high in Pittsburgh for these two populations, and in St. Louis, Missouri, for Hispanics. Later in the chapter we present updated data on patients with ESRD caused by one of the diseases seen infrequently in the ESRD population, such as Fabry's and systemic lupus erythematosus.
In Chapter Three we present information from data fields on the latest revision of the ME form, released in the spring of 2005. Information on vascular access, for example, shows that 82 percent of incident patients use a catheter at their first outpatient dialysis treatment possibly contributing to the high rates of hospitalization for infection in the first months on dialysis, as discussed in Chapters One and Six. Data show that fewer patients are now being treated with erythropoiesis stimulating agents (ESAs) prior to the start of ESRD therapy, and that hemoglobin levels at the initiation of treatment have fallen from a peak of 10.5 g/dl in 2006 to 10.0 g/dl in December, 2008. Safety concerns raised by recent clinical trials may have led providers to withhold therapy until patients reach lower hemoglobin levels. The target hemoglobin based on the FDA package insert, however, is 1012 g/dl, leading to greater efforts to correct hemoglobin levels after the start of dialysis in those with levels lower than 10 g/dl. These findings may have an impact on anemia treatment under the CMS bundled payment system, to be implemented in January, 2011.
The chapter also describes laboratory values at the initiation of therapy, and concludes with data on patients informed at initiation of their options for kidney transplantation. Informed patients are more likely to be placed on the transplant wait list.
Chapter Four illustrates trends in modality use. Peritoneal dialysis is now used by just 6 percent of incident dialysis patients, down from 1114 percent in the mid-1990s. New guidelines on peritoneal dialysis treatment, the emergence of daily home hemodialysis, and the new payment bundle for all modalities may change perceptions about the use of home therapies. Patients treated with these therapies use lower amounts of ESAs and IV medications, thereby costing less under a bundled payment system. The chapter also shows that insurance coverage in the ESRD population appears to be changing, with a larger percentage of patients covered by Medicare Advantage. This may reflect new adjustments to the payment rates, the inclusion of more chronic disease adjusters, and added Part D prescription drug benefits. The percentage of patients with dual Medicare/Medicaid coverage is growing in the prevalent hemodialysis population, possibly reflecting the continued high economic impact of ESRD on patient finances.
Chapter Five, 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. Catheter use in prevalent patients fell below 20 percent in 2008, though it will take several years to determine if this decline will be sustained. 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 2007, the program's first full year, looking at rates of enrollment and use of the benefit among ESRD patients.
Data on hospitalization and mortality are presented in Chapter Six. Infectious hospitalization rates among prevalent hemodialysis patients appeared to decline in 20062007, but are still 46 percent higher than a decade ago. Although catheter placement rates have fallen, there is concern, as noted above, that use of more permanent cuffed catheters may expose patients to a long-term risk of infection. While rates of hospitalization for vascular access infection have declined, those due to bacteremia/sepsis have increased, possibly reflecting a changing classification of these infectious complications, one which merits careful consideration. Survival of the prevalent population continues to improve, with lower death rates across all vintages, and the rate of first-year mortality continues to fall, reaching 240 deaths per 1,000 patient years for 2007 incident hemodialysis patients. New this year is a comparison of hospitalization and survival by modality, in which we match hemodialysis and peritoneal dialysis populations so as to reduce selection bias; differences in the costs incurred by these matched populations are assessed in Chapter Eleven.
As we illustrate in Chapter Seven, the number of transplants from deceased donors remains stable, while the number from living donors has continued to fall from its peak in 2004 a decline seen primarily among those younger than 45. 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 those deaths with a known cause. The chapter ends with new data on blood transfusions and panel reactive antibodies.
In Chapter Eight, on the pediatric ESRD population, we lead with data on incidence and prevalence in the last 28 years. Rates of influenza vaccinations continue to be low, with fewer than one in three children receiving this treatment, despite 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 treatment. Death rates in children are highest in the first six months of treatment, a pattern similar to that seen in their adult counterparts.
In Chapter Nine, the USRDS Cardiovascular Special Studies Center (SSC) presents data on the use of defibrillators in the ESRD population, examines the use of prescription drugs and their associated outcomes, and looks at obesity, heart failure, and the use of bariatric surgery. The Rehabilitation/Quality of Life SSC presents data from new questions on the ME form examining whether patients are informed of their transplant options at the initiation of ESRD therapy. And the Nutrition SSC examines the treatment of malnutrition in the dialysis population, looking at enteral, parenteral, and anabolic therapies.
The landscape of dialysis providers has altered dramatically, with the consolidation of smaller providers into large chains. In 2005 and 2006 it changed even further, with the acquisition of Renal Care Group by Fresenius Medical Care, and the purchase of Gambro Healthcare by DaVita. In Chapter Ten this year 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, costs for intervention and preventive care, hospitalization for vascular access infection, fluid overload, and heart failure, and regional comparisons of dialysis organizations.
Chapter Eleven, on expenditures related to ESRD, begins with data on spending for injectables. We again present information on costs during the transition from CKD to ESRD, and illustrate expenditures for clinical services, injectables, preventive care, and vascular access. New this year, we highlight differences by race in expenditures for laboratory tests, injectables, and hospitalizations. We also use the new 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, and present a new spread on the incidence of ESRD in Asian populations in the U.S., Taiwan, and Japan and among indigenous populations in the U.S., Australia, New Zealand, and Canada. 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 2010 ADR contains data through December 31, 2008; data on patient characteristics, obtained from the Medical Evidence form, are complete through June, 2009. Only the 2007 Medicare Part D data were available for the 2010 ADR; 20082009 data will be available for the 2011 edition.
Current estimated incident and prevalent counts can be found on the USRDS website.
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.
The USRDS dataset is a living record of patient care in the U.S., 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 ME form, claims for hospital and physician services, and updates of the Medicare Enrollment Database received after the ADR has gone to press.
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 (Table i.d) 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.
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 on page 208, 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 gray 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.
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.
|Co-Project Officer, USRDS
Lawrence Y.C. Agodoa, MD
2 Democracy, Room 653
6707 Democracy Blvd
Bethesda, MD 20892-5454
|Co-Project Officer, USRDS
Paul W. Eggers, PhD
2 Democracy, Room 615
6707 Democracy Blvd
Bethesda, MD 20892-5454
914 South 8th Street
Minneapolis, MN 55404
Allan J. Collins, MD, FACP
|CC Deputy Director
Robert N. Foley, MB, MSc
|CC data requests
612.347.7776 or 1.888.99USRDS
|CC data files
Shu-Cheng Chen, MS, MPH
Eric Frazier, BS
Stephan Dunning, MGIS
Special Studies Center (SSC)
Charles Herzog, MD
|Director, Nutrition SSC
Kirsten Johansen, MD
|Director, Rehabilitation &
Quality of Life SSC
Nancy Kutner, PhD