Author Interview: Bruce M. Robinson, MD, MS
Arbor Research Collaborative for Health
340 East Huron St, Ste 300, Ann Arbor, MI 48104
Adjunct Clinical Assistant Professor, Internal Medicine
University of Michigan Health System
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Publication:
The DOPPS Practice Monitor for US Dialysis Care: Trends Through April 2011
Robinson BM, Fuller DS, Bieber BA, Turenne MN, Pisoni RL.
Arbor Research Collaborative for Health, Ann Arbor, MI.
Am J Kidney Dis. 2011 Dec 9
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What are the main findings of the study? |
This is the first overview of the DOPPS Practice Monitor (DPM) findings for AJKD,which covers data through April 2011 for an average of 3,502 hemodialysis patients in 93 facilities per month. Based on a national sample of US hemodialysis patients, the DPM provides the first nationally representative and publicly available data to report trends in dialysis care from before to after implementation of the new end-stage renal disease prospective payment system (PPS) in January 2011.
The PPS is a US Centers for Medicare & Medicaid Services program that is intended to control dialysis costs through bundled payments of dialysis-related medications and services.
DPM findings are publicly available at http://www.dopps.org/DPM/.
Overall dialysis practice – Many clinical practices remained stable from August 2010 through April 2011 with no substantive trends in hospitalization rates, mortality, and other major clinical outcomes. We have seen changes in the management of anemia and mineral bone disorder (MBD). These are, to a large extent, as expected since some anemia and MBD medications are now bundled within the new PPS.
Anemia - Between August 2010 and April 2011, average national hemoglobin levels declined slightly with the steepest drop between November 2010 and February 2011. Of note, the mean prescribed erythropoietin dose decreased by ~3%. However, intravenous iron use increased.
Mineral and bone disorder – Nationally, mean serum parathyroid hormone (PTH) levels increased by nearly 30% between August 2010 and April 2011. Reasons for this spike are not yet apparent, as large changes in intravenous vitamin D or oral mineral and bone disorder medications are not yet evident.
As suggested by the 2010 Government Accountability Office report, the DPM also tracks trends in dialysis care by patient group (African Americans, dual-coverage Medicare and Medicaid recipients, younger patients). Among these groups, findings by race were noteworthy. African Americans saw a greater shift to lower hemoglobin levels than others. PTH levels increased at approximately the same rate for African Americans as for others. However, because African American dialysis patients have higher PTH levels, the percentage with very high PTH increased more among African American patients.
An advantage of the DPM is that we can compare to trends in care internationally. Data so far indicate that the changes described in this DPM update did not occur during the same period in the other 11 DOPPS countries.
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Were any of the findings unexpected? |
The increase in average PTH levels is greater than we’d expected.
We’re still looking into reasons for this, but it may partly reflect a delayed response to the 2009 Kidney Disease Improving Global Outcomes (KDIGO) MBD Clinical Practice Guidelines, which liberalized the PTH target range.
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What should clinicians and patients take away from this study? |
Hemoglobin levels have decreased, especially for African Americans on average, and PTH levels have increased substantially.
That said, despite the landmark changes to the US dialysis payment system in January 2011, most dialysis practices remained relatively steady during the immediate transition period (through April 2011). |
What recommendations do you have for future studies as a result of your study? |
Future monitoring of the trends we’ve seen will need to be confirmed with national data when it eventually becomes available. I’d also like to emphasize that we do not know the effect of these trends, if any, on clinical outcomes for patients. This will be an important focus of future study.
Lastly, we’ll update the DPM website in early January 2012. This update will include dialysis data through August 2011, which will be especially interesting given the modified FDA dosing recommendations for Erythropoiesis-Stimulating Agents released in June 2011.
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Emerging trends in hemodialysis care through August 2011, based on a sample of US dialysis facilities, are included in the latest update to the DOPPS Practice Monitor (DPM, at http://www.dopps.org/DPM), run by the Dialysis Outcomes and Practice Patterns Study (DOPPS) at Arbor Research Collaborative for Health.
Ongoing Changes in the US Dialysis Environment – Recent changes in dialysis payment and regulatory guidance are expected to affect hemodialysis practice. In January 2011, the Centers for Medicare & Medicaid Services (CMS) launched a new Prospective Payment System (PPS) with the intent to control dialysis costs through bundled payments. In June 2011, the FDA approved revised prescribing information for erythropoiesis-stimulating agents (ESAs), used to treat anemia in most dialysis patients. Previously, the label recommended a hemoglobin target range of 10-12 g/dL. The June 2011 update removed the target range, advising instead to start ESA therapy for dialysis patients at hemoglobin less than 10 g/dL, and to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL.
Most Recent Trends in Care – Over the August 2010 to August 2011 time period, many hemodialysis practices have remained stable; examples include nutrition measures and hemodialysis treatment time and dose. There have been notable trends in the following practice areas:
- Anemia: Hemoglobin levels have decreased since the June 2011 ESA label update. While the mean hemoglobin level declined by 0.12 g/dL over 12 months from August 2010 to July 2011, it declined in August 2011 by another 0.10 g/dL to 11.26 g/dL. The percentage of patients with hemoglobin levels greater than 12 g/dL declined sharply (from 28% to 23%) in July/August 2011, while the percentage with hemoglobin levels less than 10 g/dL increased slightly from 8.5% to 10% and the percentage with hemoglobin levels less than 9 g/dL remained under 3%.
Mean prescribed epoetin dose (among patients receiving epoetin) decreased by 15%, from 21,100 units/wk to 17,900 units/wk, from August 2010 to August 2011, with the greatest decline in June-August 2011. Epoetin doses at the higher end of the dose range have decreased most notably. IV iron use increased from August 2010 to August 2011 though has recently stabilized. In keeping with greater IV iron use, serum ferritin levels (indicative of iron stores) continue to rise. Serum ferritin concentration exceeded 500 ng/mL in 65% of patients, 800 ng/mL in 34% of patients, and 1,200 ng/mL in 11% of patients in August 2011.
- Mineral & Bone Disorder: In our last report, we noted a 29% increase in serum parathyroid hormone (PTH) levels through April 2011, and differences by race were described. Since then, PTH levels have remained stable or declined slightly in both black and non-black patients. In August 2011, 22% of black patients and 12% of non-black patients had very high PTH values (defined here as PTH >600 pg/mL). The percentage of hemodialysis patients for whom PTH is measured has declined slightly since August 2010. There have been no clear changes in serum calcium or serum phosphorus levels.
- Clinical Outcomes: Preliminary data indicate that the 30-day hospitalization rate has increased somewhat from August 2010 to August 2011. The DPM does not report yet on trends in red blood cell transfusions, as dialysis units are often unaware of transfusions occurring in the inpatient setting. Additional efforts to comprehensively monitor trends in transfusions are warranted. To date mortality rate has not changed appreciably, though further follow-up time is necessary as we continue to track this outcome.
Future monitoring of these trends, confirmation with national data when eventually available, and understanding their effect on clinical outcomes, if any, is required.
DPM data are aggregated across dialysis organizations and facilities. Aggregated trends may not reflect trends in individual dialysis organizations or facilities, and are not intended to provide oversight of performance in individual dialysis organizations or facilities.
Read the rest of the DOPPS Practice Monitor: Update on Trends in US Hemodialysis Care Following Launch of Bundled Payment System and Revisions to ESA Labels Press Release |
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Hemodialysis Research Interview of the Week |
Dr. Miklos Z Molnar MD, PhD and Dr. Kam Kalantar-Zadeh MD, MPH, PhD
Harold Simmons Center at Harbor-UCLA. |
Mortality Associated with Dose Response of Erythropoiesis-Stimulating Agents in Hemodialysis versus Peritoneal Dialysis Patients
Duong U, Kalantar-Zadeh K, Molnar MZ, Zaritsky JJ,
Teitelbaum I, Kovesdy CP, Mehrotra R:
Am J Nephrol 2012;35:198-208 (DOI: 10.1159/000335685)
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What are the main findings of the study? |
The analysis of the data was from a large and contemporary cohort of 10,527 peritoneal dialysis and 139,103 hemodialysis patients in a single dialysis provider with relatively uniform anemia management practice patterns between 7/2001 and 6/2006, i.e., during the era with the highest ESA dose administration in the United
States.
We found that peritoneal dialysis patients with the same achieved hemoglobin levels received substantially lower dose of ESA than hemodialysis patients, and the
differential was even wider among African Americans.
We also found that in peritoneal dialysis patients an ESA dose below 10,000 U/week was not associated with higher mortality, but a 28% higher death risk in those receiving significantly higher dose (>15,000 U/week).
In contrast, higher ESA dose was linearly and incrementally associated with higher all-cause and cardiovascular mortality in hemodialysis.
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Were any of the findings unexpected?
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While the administered ESA dose was linearly and incrementally associated with higher mortality in hemodialysis patients, the dose was used in everyday clinical practice in PD patients was not associated with mortality.
Only large doses (>15,000 U/week) were associated with higher mortality risk in PD
population.
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What should clinicians and patients take away from this study?
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PD patients require substantially lower ESA dose than hemodialysis to achieve same hemoglobin levels.
In both PD and hemodialysis patients Lower ESA dose (< 15,000 U/week) are safer than higher doses.
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