Dialysis Choice or Dollars?
On January 10, 2013, the Patient-Centered Outcomes Research Institute (PCORI) awarded a $1.9 million dollar grant to Arbor Research Collaborative for Health for a study called “Empowering Patients on Choices for Renal Replacement Therapy” (EPOCH-RRT) to study the selection of dialysis modality for kidney failure. Francesca Tentori, MD, a nephrologist and research scientist at Arbor Research, was the lead on the project. The initiative focused on "filling the knowledge gap that currently exists regarding patients’ priorities around dialysis modality" and was intended to gain "meaningful information for patients and caregivers."
There was one problem: the research was proposed to focus solely on in-center hemodialysis and peritoneal dialysis, the two types of dialysis that are the most commonly used—and, coincidentally—the most profitable to use, as well. In the spirit of full disclosure, the study itself did mention other dialysis options, such as hemodialysis done at home (home HD), kidney transplant, and conservative management (no dialysis or transplant), and even provided a very limited list of resources.
However, the new, "Choosing Dialysis" Arbor decision tool based on the EPOCH-RRT study, still only provides for two treatment options: in-center HD and peritoneal dialysis. Home Dialyzors United (HDU), the only dialysis patient group dedicated exclusively to peritoneal dialysis and home hemodialysis, has a mission to inform, inspire, and advocate for the home dialysis community. When we learned that Arbor Research was testing a "decision aid" that excluded home HD, including nocturnal and short daily HD, we vigorously opposed releasing this tool to the public without including ALL available treatments.
HDU reached out to Dr. Tentori in a call on March 19th 2015—National Home Hemodialysis Day—to express our concerns about the omission of home HD in their upcoming study and decision tool and discuss how Arbor could ensure that all patients are told about all modalities of HD (conventional, short daily, nocturnal and in-center) and other options in this study. We approached PCORI, and the Congressional Kidney Caucus, but the standard reply was that there wasn’t enough funding to expand the research.
Having a choice of dialysis options is so vital that Congress mandated in the Social Security Act that the maximum practical number of patients who are medically, socially, and psychologically suitable candidates for home dialysis or transplantation should be so treated. (SSA Section 1881(c)(1)(A)(i)(6) And further, Medicare, in the Conditions for Coverage for Dialysis Facilities (Section 494.70) requires clinics to educate patients about all of their options, and specifically names home hemodialysis and peritoneal dialysis. Clinics must even tell their patients where to get treatment options that they do not offer.
Studies have shown that home HD provides the best option for quality of life, better outcome and, more important, survival. HDU is very concerned that the release of this tool will deny patients information about what may be their best option and violates the Medicare Conditions for Coverage.
HDU feels strongly that patients deserve the right that the Conditions for Coverage grant to: "Be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis,and continuous cycling peritoneal dialysis) and in-facility hemodialysis." And, yet Arbor requested—and PCORI funded—a study that directly contradicts this mandate.
HDU took PCORI to task and asked them to address the fact that they failed to do due diligence by having reviewers who were knowledgeable about dialysis modalities and would have noticed the exclusion of all but two of the most profitable dialysis modalities. While understanding the limited funding available, HDU feels strongly that PCORI (recognizing its error in funding a study that is in direct contradiction to a CMS mandate) should provide Arbor with the additional funding to further this study to include home hemodialysis, transplantation, and other options currently available in the CKD treatment arena.
While HDU was pleased that Dr. Tentori was receptive to our invitation to establish a dialogue and continue discussions with us, it is obvious that her "reaching out to HDU in a collaborative fashion to assist her in developing additional patient tools and provide patient centered resources" was merely lip service, since HDU was not even listed as a resource on the newly released website, nor were any of our recommendations included in the study.
Did Arbor purposely mislead PCORI about what dialysis options exist by omitting home hemodialysis? Per the project description: "Every year, more than 100,000 patients start dialysis to treat kidney failure in the United States. Two types of dialysis are available: hemodialysis (HD) and peritoneal dialysis (PD). HD is done with a machine in a dialysis clinic. PD can be done at home, if the patient or family is willing to perform his or her dialysis treatments."
The inclusion of patients, caregivers, and patient advocacy organizations as research partners in this project allegedly assured that the study addressed those questions of greatest relevance to patients facing the need for dialysis. Based on those findings, practical information was imparted to patients and caregivers, empowering them to play an active role in decision-making at this pivotal transition in their lives. Based on the fact that they only interviewed 180 patients for the study, and actually tested the tool on 140, HDU remains doubtful that the needs of dialyzors were adequately addressed.
In stark contrast to this limited online tool, I recommend reviewing My Life, My Dialysis Choice. This in-depth tool, developed by the Medical Education Institute, is much closer to hitting the mark, in determining which dialysis modality is best suited to the lifestyle goals and quality of life desires of the dialyzor and those who support him or her.
After much anticipation, Arbor Research released its new tool on June 21, 2016, claiming that it is designed to help patients choose a dialysis modality. Nephrology News and Issues gave it a tepid three paragraph announcement, noting that "the new website covers information about in-center hemodialysis and peritoneal dialysis, and offers links to other websites for information on transplant, home hemodialysis, and conservative care." HDU would argue that including links to only 4 (7 total) groups—one of which is in the UK—is certainly not representative of the wealth of resources available to CKD and dialysis patients in the US.
Renalweb, as usual, was a bit more skeptical in its comments regarding the release of the website and "decision making tool", stating that "empowering patients on choices for renal replacement therapy" steers patients into the two most profitable treatment regimens for their existing infrastructure: in-center HD and at-home PD, and went on to query "Was this designed by Fresenius and DaVita?" HDU would tend to agree.
Comments
Dori
Jul 07, 2016 3:12 PM
It also lacked transparency. The PD and in-center HD box moved up and down in response to the sliders, but it was impossible to say how much or why.
And, of course, the omission of home HD was INEXCUSABLE.
Mel Hodge
Jul 06, 2016 11:23 PM
Since in-center HHD and peritoneal differ little in their largely poor outcomes, perhaps the omission of outcome factors doesn't make too much difference. But if they had properfly include the various home hemo options, this omission would be a fatal flaw.
And I would add another criticism. In common with too many 'tools,' there is no provision for weighting the criteria -- all are implicitly assumed to be of equal importance. This kind of tool should require the rater to, say, allocate 100 points among the criteria to reflect their difference in importance.
Sadly, new patients may be delude into thinking they are making a thoughtful choice when they employ this tool. Better it did not exist, and they had to look for guidance elsewhere.
David Rosenbloom
Jul 03, 2016 2:06 AM
For those unaware, 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 the determining what sorts of therapies it will cover.
To add further insult to injury in this sad affair, 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. PCORI receives income from two funding streams: the general fund of the U.S. 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 be subject to the usual financial controls imposed on federal agencies.
Ergo, you and I are paying for this, at best, incomplete, and at worst, biased research, which is not in our best interest. Stated another way, this study is counter to PCORI's stated raison d'etre.