Author Interview: Author Interview: Irfan Khan, PhD
Irfan Khan, PhD
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
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Publication:
Author Interview: Irfan Khan, PhD
Association of dialysis facility-level hemoglobin measurement and erythropoiesis-stimulating agent dose adjustment frequencies with dialysis facility-level hemoglobin variation: a retrospective analysis
Irfan Khan Mahesh Krishnan Anupam Kothawala and Akhtar Ashfaq
BMC Nephrology 2011, 12:22doi:10.1186/1471-2369-12-22
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What are the main findings of the study? |
In this retrospective analysis, more frequent hemoglobin (Hb) measurements (once per week compared to once per month) and more frequent erythropoiesis-stimulating agent (ESA) dose adjustments (once per 2 weeks compared to once per 3 months) at the dialysis facility-level were associated with lower facility-level Hb variation and an increase in the number of patients achieving an Hb level closer to the facility-level mean Hb.
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Were any of the findings unexpected? |
Yes. The conclusions are contrary to some previous studies on this topic (Fishbane S et al. Kidney Int. 2005; Fishbane S et al. Nephrol Dial Transplant. 2007), which concluded that ESA dose changes may reinforce Hb variation. Our findings, on the other hand, suggest that facility-level Hb measurement and ESA dose adjustment frequencies higher than commonly observed in current practice could be more optimal.
Results from previous studies were based on unadjusted analyses of patient-level data from single centers, and associations were not assessed within the framework of a systematic multivariate analysis which mitigates the possibility of confounding. Thus, a key limitation of previous studies could be a kind of confounding bias where sicker patients could have both greater intrinsic Hb variation and a greater need to adjust ESA doses.
Our findings are based on analysis frameworks that can mitigate some of the confounding biases of this nature. We adopted a longitudinal mixed-effects modeling approach at the facility-level, which effectively led to the same facility acting as its own control over time. Also, the underlying sample size in our study was quite high with an N of 2,763 facilities, representing 436,442 unique patients. Our results, however, need to be considered in light of study limitations which included lack of important facility-level variables such as iron markers and intravenous iron administration.
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What should clinicians and patients take away from this study? |
Our findings suggest that facility-level protocols for anemia management that encourage frequent Hb monitoring, which may lead to more timely ESA dose adjustments, are associated with lower facility-level Hb variation. There are plausible mechanisms supporting this observation. Frequent Hb monitoring helps the provider distinguish minor Hb variations, which may not require an ESA dose adjustment, from systemic Hb changes that likely do require timely intervention with an appropriate ESA dose adjustment. Frequent Hb monitoring also provides an early indication of significant Hb changes triggered by common intercurrent events that occur in patients on dialysis, such as infection, acute inflammation, bleeding, and hospitalization—all reflecting acute changes in clinical status and marked instability of hemoglobin levels over time.
Due to the relatively long lifespan of red blood cells (approximately 2 months in patients on dialysis; Uehlinger DE et al. Clin Pharmacol Ther. 1992) Hb trajectories have an element of inertia built into them. Thus, the effect of current ESA dosing levels necessarily “carries forward” over time. Maintaining stable ESA doses in light of clinical evidence of a need for change (e.g. due to clinical events such as hospitalizations or patients’ recovery from these events) thus has the potential to actually increase Hb excursions relative to the intended target as the effect of not adjusting ESA dose accumulates over time. |
What recommendations do you have for nephrology health care providers as a result of your study? |
Additional studies, both observational and interventional, are needed to confirm our findings and assess the influence of additional facility-level practice patterns on Hb variation. Dialysis facilities today may have an opportunity to further improve upon their anemia management related quality measures such as ones that form a part of the Quality Incentive Program (QIP) developed by the Centers of Medicare and Medicaid Services (CMS) for bundled payments to dialysis facilities in the United States. To the extent that they can be improved upon in a cost-effective manner via adoption of effective facility-level protocols, studies of this nature will continue to offer value to the dialysis provider community and patients. Addressing broad questions of this nature is becoming especially pertinent in the United States in the context of the current environment of rapid changes to the reimbursement system in dialysis.
ESAs should be administered according to the full current FDA-approved prescribing information for each product.
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| Abstract: |
Background
A key goal of anemia management in dialysis patients is to maintain patients' hemoglobin (Hb) levels consistently within a target range. Our aim in this study was to assess the association of facility-level practice patterns representing Hb measurement and erythropoiesis-stimulating agent (ESA) dose adjustment frequencies with facility-level Hb variation.
Methods
This was a retrospective observational database analysis of patients in dialysis facilities affiliated with large dialysis organizations as of July 01, 2006, covering a follow-up period from July 01, 2006 to June 30, 2009. A total of 2,763 facilities representing 436,442 unique patients were included. The predictors evaluated were facility-level Hb measurement and ESA dose adjustment frequencies, and the outcome measured was facility-level Hb variation.
Results
First to 99th percentile ranges for facility-level Hb measurement and ESA dose adjustment frequencies were approximately once per month to once per week and approximately once per 3 months to once per 3 weeks, respectively. Facility-level Hb measurement and ESA dose adjustment frequencies were inversely associated with Hb variation. Modeling results suggested that more frequent Hb measurement (once per week rather than once per month) was associated with approximately 7% to 9% and 6% to 8% gains in the proportion of patients with Hb levels within a +/-1 and +/-2 g/dL range around the mean, respectively. Similarly, more frequent ESA dose adjustment (once per 2 weeks rather than once per 3 months) was associated with approximately 6% to 9% and 5% to 7% gains in the proportion of patients in these respective Hb ranges.
Conclusions
Frequent Hb measurements and timely ESA dose adjustments in dialysis patients are associated with lower facility-level Hb variation and an increase in proportion of patients within +/-1 and +/-2 g/dL ranges around the facility-level Hb mean.
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Home Dialysis Summit Recommends Policy Changes to Increase Home Dialysis Usage
WASHINGTON, April 25, 2012 /PRNewswire -- On the heels of the first National Summit on Home Dialysis Policy, Summit organizers released a report reflecting the views of the delegates -- leaders in the kidney disease patient, clinician, facility and industry communities -- on federal policy steps to improve utilization of home dialysis for patients who can benefit from this often advantageous form of treatment. Many of the organizers also announced they have formed a new alliance, called the Alliance for Home Dialysis, to advance the recommendations identified at the Summit.
The Summit's "Report of the Delegates" highlights key findings from a March 29th meeting in Washington, DC where experts probed why, despite widely accepted and well-documented benefits of home dialysis -- improved outcomes, enhanced patient satisfaction, improved quality of life, and lower costs-- fewer than ten percent of the more than 390,000 current U.S. dialysis patients receive treatment at home. Current rates of home dialysis utilization reflect a steep decline from the 1970s, when almost 40% of U.S. dialysis patients were treated in-home.
Specifically, delegates found that policymakers should work with stakeholders in the dialysis community to confront three areas:
Accessibility: Patients and clinicians face array of hurdles in education, training, and infrastructure that hinder equalized access to home dialysis.
Accountability: Utilization of home dialysis can be improved through measures within government programs that are designed to recognize and support excellence in the delivery of home dialysis services.
Aligning Incentives: Reimbursement policies, regulation of new technologies and other policy incentives can be realigned to better support federal policy goals of expanding access to home dialysis.
The Report includes 15 recommendations to serve these goals, including that federal policymakers should:
Maintain parity for home and in-center dialysis in Medicare reimbursement;
Support home dialysis mentoring programs, particularly those that use existing patients as mentors; and
Align federal and state regulatory requirements for home therapies, such as revising the Centers for Medicare and Medicaid Services Conditions for Coverage requirements, to reflect differences in home and in-center dialysis.
Summit supporters will begin work through the new Alliance to dialogue with federal policymakers and advance policy improvements in the three consensus areas that emerged at the Summit.
SOURCE National Summit on Home Dialysis Policy
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National Kidney Foundation's Top 10 Things Every Dialysis Patient Should Know.
- You have treatment choices. Options exist for how, where and when you dialyze. Dialysis can be done in a hospital, in a dialysis unit that is not part of a hospital, or at home. You and your doctor will decide which place is best, based on your medical condition and your wishes. There are different types of dialysis - peritoneal and hemodialysis. Work with your health care team to determine a treatment plan that makes you feel comfortable. Recent studies show that the majority of patients beginning in-center hemodialysis (HD) know very little, if anything, about the option to dialyze at home. Once informed, 40% or more of patients are interested in this treatment option, and yet less than 10% actually begin home dialysis. If you're dissatisfied with the type of dialysis treatment that you're receiving, ask your healthcare team if another type of dialysis treatment would be better.
- You can compare in-center dialysis facilities online. Information on over 5,600 US-based dialysis centers is available online through the Medicare website. To help you make choices about your care, you can compare different facilities side-by-side and evaluate each facility based upon clinic characteristics and quality measures. You can search for dialysis facilities by name or geographic proximity. After completing an initial facility comparison to determine which facilities best meet your needs - such as the number of hemodialysis stations at a particular location and whether there are evening shifts available - visit the facilities that you're most interested in. Talk to the staff and other patients, as well as your doctor to ensure that this dialysis facility is a good fit for you.
- There are ways to prepare ahead for an emergency. Ask your dialysis facility about their emergency plan in case of a snow storm, fire, power outage or other natural disaster. As back up, make sure you have the names, locations and phone numbers of other dialysis units and hospitals in your area. Since regular community transportation services may not be working in an emergency, be prepared to make other arrangements for getting to dialysis. You may need to contact the police and Emergency Medical Services (EMS) for assistance. If you dialyze at home, make sure you have at least two weeks' worth of unexpired supplies on hand. If you have to miss a dialysis treatment, begin your emergency meal plan.
- There is an easy way to transfer patient records between clinics. There is an easy, secure way for your health care team to transfer your treatment records online. In 2009, the Centers for Medicare and Medicaid Services (CMS) created a centralized web-based data collection system called CROWNWeb to help reduce and eliminate patient treatment interruptions. This central system helps to streamline patient care regardless of the reason for changing dialysis centers. For example, if you've been admitted to the hospital, or if you needed to relocate during an emergency evacuation, your doctors and health care team can access up-to-date information about your dialysis so that you continue to receive appropriate care no matter where you are.
- You can travel while on dialysis.
Dialysis centers are located in every part of the United States and in many foreign countries. The treatment is standardized, but you need to plan ahead by making an appointment for dialysis at another center before you go. The staff at your center may help you make these appointments.
- You can be your own best advocate. Know what key questions to ask your doctor or other healthcare professionals. Take notes so that you can refer back to them later. Partner with your doctor and decide on a treatment plan together. Advocate for yourself and share how you're feeling.
- You have many rights. You as a patient have a great deal of control over your treatments. Patients have a bill of rights which includes receiving quality care, counseling about your medical information, and an expectation of privacy.
You also have responsibilities. Once you decide on a course of treatment, it's important to follow the recommendations of your health care team. If you decide to receive in-center dialysis, arrive at dialysis on time so that you can receive the full treatment without delays.
- You can receive insurance coverage. If you have end stage renal failure, you are likely eligible for Medicare insurance coverage. Speak with your health care team and social worker for help filling out insurance paperwork.
- You may need to follow a special diet. When your kidneys are not working properly, you may not be able to eat everything you like, and you may need to limit how much you drink. Your diet may vary according to the type of dialysis you receive. It is important to speak with a renal dietitian so that you are able to understand what you can and cannot eat based on your full health history.
- Dialysis patients can work. Many dialysis patients can go back to work or school after they have gotten used to dialysis. After establishing a dialysis routine, many patients have more energy and find that they are able to time to work around this new schedule. Some patients even find creative ways to work remotely from dialysis with the use of a laptop or cell phone, depending on their field of expertise.
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