This year, PCORI, the Patient-Centered Outcomes Research Institute, awarded a $6.7 million, five-year grant to two professors from the University of Michigan School of Public Health to do a study entitled “Enhancing the Cardiovascular Safety of Hemodialysis Care: A Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions.” It deals primarily with educating dialysis patients and training providers on how to ensure ‘patient stability’ during the in-center dialysis treatment by properly removing excess fluid and avoiding cardiac damage in the process. 1
This study is misguided and duplicates many prior studies on the subject, and the money could be put to more effective use looking into related but more critical areas of dialysis treatment.
We do not question the need for new and in-depth research on preventing sudden cardiac death. It is the single, largest cause of death in dialysis patients annually, accounting for more than 25% of mortalities. 2 What we question is the intent of this study to only cover old ground, which will result in no new important findings. We also question PCORI’s motivation behind the award.
In awarding such a large grant, PCORI didn’t thoroughly do its homework. A review of research literature on fluid removal shows this is one of the most studied subjects in dialysis over the last 50 years. 3 Standard medical practices for adequate and safe fluid removal have been established and enforced for years by CMS though its ESRD (End Stage Renal Disease) Quality Improvement Program. 4
PCORI is a U.S. based, non-governmental institute created in 2010 when the Social Security Act was modified by the Patient Protection and Affordable Care Act. It is a government-sponsored organization charged with investigating the relative effectiveness of various medical treatments. Medicare may consider the Institute’s research in determining what sorts of therapies it will cover. 5
PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCORTF), which was authorized by Congress as part of the Patient Protection and Affordable Care Act of 2010, and receives income from two funding streams: the general fund of the Treasury and a small fee assessed on Medicare, private health insurance and self-insured plans. The act mandates a $2 fee, adjusted by inflation, for each person covered on a group plan. As a result of this tax, PCORI will collect an estimated $3.5-4.5 billion through 2019. It does not have to get annual appropriations from Congress and is not subject to the usual financial controls imposed on federal agencies. 6
The researchers say this study is unique, in that it is a clinical trial comparing the effectiveness of two educational approaches, peer mentoring and provider education. “National and international organizations have called for patient involvement in safety enhancement efforts in health care,” says Tiffany Veinot, associate professor and co-leader of the study at the Univ. of Michigan. “Yet, efforts to promote patient involvement in safety activities have had mixed success in changing behavior.” 7
Patients in the study will attend six peer-mentoring sessions that aim to support behavior change. The sessions, provided through a partnership with the National Kidney Foundation, will encourage patients to eat a healthy, low-salt diet; drink appropriate amounts of fluid; stay at the dialysis clinic for the full length of sessions; if necessary, stay longer to allow staff to take fluid out at the right rate; work with doctors and nurses to make decisions about care; and notice and quickly report the dizziness and cramping that could signal session instability. Medical professionals in the study will receive online education, team training and checklists aimed at helping them: regularly checking patients’ fluid status; revisiting patients’ fluid removal targets and treatment times more frequently; involving patients in making decisions; making sure the rate of fluid removal stays at a safe level; and responding quickly to session instability. 8
While her motives are laudatory, Prof. Veinot is probably unaware that patient educators like the authors of this critique are certified peer mentors and have been mentoring fellow patients for many years, both in the U.S. and in Denmark. Recently a new peer-mentoring pilot program was launched by the ESRD National Coordinating Center in six of the 18 ESRD U.S. regions to provide face-to-face patient education and answer questions about dialysis treatment options. Patient peer mentors like ourselves have unparalleled credibility with fellow patients, having personally experienced different types of dialysis, including in-center and home modalities and transplantation.
If PCORI is serious about ‘patient stability’ during the in-center dialysis treatment, it needs look no further than at the massive international, peer-reviewed literature on the subjects of dialysis frequency and duration, as well as home hemodialysis vs. in-center dialysis. 9
We know that the underlying problem is the way dialysis is typically delivered in the U.S. (3x weekly), because fluid build-up is inevitable and most dangerous following the time where the patient has two days off from dialysis, normally on the Monday after a weekend. A number of reviews show the highest rate of sudden cardiac death for dialysis patients at this critical juncture. 10
Educating patients is in and of itself a worthy cause, as PCORI has shown in its recent $5.6 million, five-year grant to Duke University entitled “Putting Patients at the Center of Kidney Care Transitions.” This study aims to educate patients as they transition through early stages of ESRD toward kidney failure, and prepare them for the type of dialysis, which they choose, to fit their lifestyles and quality of life desired. This is true patient-centered research.
But misguided education is in many ways worse than no education, and in that light, the $6.7M given to University of Michigan is taxpayer money that can be better spent. Unless patients are taught the simple facts regarding the importance of frequency, duration and modality of hemodialysis as well as how the 2-day weekend is the most likely culprit in morbidity and mortality, the information gained from the study will be of little use.”
If PCORI is serious about funding research that offers patients and caregivers important health care information in dialysis, we respectfully submit, that the $6.7 million grant is better spent exploring the following:
- What are the (financial, attitudinal or other) barriers to providing home dialysis, either hemodialysis (HHD) or peritoneal (PD) in the United States. The prevalence in the United States is around 2% for HHD and 7% peritoneal dialysis (PD) while more than 90% of nephrologists would prefer a home modality for themselves. 11
- Fluid management in HHD vs. in-center hemodialysis (CHD). Circumstantial evidence suggests that HHD patients experience much better fluid management than CHD patients. A study comparing similar groups of patients might shed some light on the reasons for this.
3. Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced cardiac injury: Determinants and associated outcomes. CJASN. 2009; 4:914–920.
Chaigiion M, Chen WT, Tarazi RC, Bravo EL, Nakamoto S. Effect of hemodialysis on blood volume distribution and cardiac output. Hypertension. 1981; 3:327–332
Flythe JE, Kimmel SE, Brunelli SM. Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality. Kidney Int. 2011; 79:250–257.
McIntyre CW, Burton JO, Selby S. Haemodialysis induced cardiac dysfunction is associated with an acute reduction in global and segmental myocardial blood flow. CJASN. 2008; 3:19–26.
5. Enabling legislation, U.S. Congress
6. How We’re Funded, Patient-Centered Outcomes Research Institute
9. Mcfarlane, Bayoumi, Pierratos & Redelmeier (2003) The quality of life and cost utility of home nocturnal and conventional in-center hemodialysis. Kidney International (2003) 64, 1004–1011
The FHN Trial Group (2010) In-Center Hemodialysis Six Times per Week versus Three Times per Week. N Engl J Med. 2010 363(24): 2287–2300.
Weinhandl et al (2012) Survival in Daily Home Hemodialysis and Matched Thrice-Weekly In-Center Hemodialysis Patients. JASN 2012 23, 5895-904
10. Bleyer, Hartman, Brannon, Reeves-Daniel, Satko & Russel (2006) Characteristics of sudden death in hemodialysis patients. Kidney International, 2006; 69, 2268–2273
12. Schiller, Neitzer & Doss (2010) Perceptions about renal replacement therapy amongst Nephrology professionals, NN&I, September 2010