Absurd! EPOCH-RRT Study “Decision Aid” Won’t Include Home Hemodialysis
Do you have days when you get an overwhelming feeling of, “why do I bother?” I think we all do, from time to time, and today is one such day.
In the last 24 hours, the faith I have always had that somewhere, somehow, in the immense firmament of dialysis, I might be able to make a small difference, has been hit by not just one, but two uppercuts. Floyd Patterson-like (the first real heavyweight “scalp” of Mohammed Ali, for those of you who don’t recall), I feel that I am sagging on the ropes! Both demand a separate blog post, but which to do first? The Absurd? Or, the Sad?
The absurd cuts to the heart of a life-long belief…that we, as humans, deserve choices, options, and pathways that recognize the diversities of life, that allow us to reach the fullest and best potential each of us can reach—and to be aided to achieve those goals.
The “Sad” extends yet further the publication myths and misinterpretations of what was, to be truthful, a brave but predictably failed attempt to perform a Randomized Control Trial (RCT) on dialysis modalities (in my view, both unrandomizable and uncontrollable). It is sad in two ways: first, the publication of a second round of doubtful science, and second, that it was published under of the authorship of several good, firm, and respected friends; friends who I have a sneaking suspicion are wishing they were elsewhere.
#1: “The Absurd”
In 2003 (or was it 2004?), I was among a small band of Australian and New Zealand invitees to the Observatory Hotel (a very swank joint) in the lee of the Habour Bridge in Sydney, there to be wooed by Fritz Port and his team from Ann Arbour, Michigan. They had come to Australia to persuade us to join the DOPPS study as it extended its international country list from the 3 or 4 that made up DOPPS I, to 12 countries (DOPPS II).
DOPPS II has been a bold, prospective, decade-and-a-half comparison of dialysis practice across the OECD dialysis world, the stated aims of which have been to:
- Identify best practices
- Determine how, where and why some countries were doing better than others
- Assess how we might learn from those doing well (or better than ourselves in any given dialysis endeavor) to lift global dialysis standards.
So, DOPPS was laudable, and badly needed. I (we) had a sneaky suspicion at the time that the DOPPS process had been hatched out of a growing dissatisfaction back home in the US with some of the outcomes (and lags) within US dialysis.
But…the DOPPS study design was to be LIMITED TO centre-based dialysis.
“Hey,” chirped all the Aussies and Kiwis, “the combined bi-national modality mix in ANZ is 15% on home HD, so, if DOPPS only looks at centre-based care, the best 15% of ANZ patients (our data here clearly confirmed our home HD contingent as ‘the best of our best’) would be excluded!”
We argued—forcefully but unsuccessfully—that this might mean that DOPPS would “miss the signal” from two home-friendly contributing nations where home HD was robust and common-place.
“No,” said Fritz and his Ann Arbor team. “We cannot include home HD, as you (meaning ANZ) are an anomaly on the world dialysis stage, and after all, there is little or no home HD in the US (then <0.4%), so what does home matter to us? It would simply ‘dirty’ the data.”
Grudgingly, and it really was grudgingly, we agreed. But…and I would make this point here and now, since that time, all DOPPS-published data on ANZ HD EXCLUDE our best 15%. Even then, I would argue, when any DOPPS paper appears, ANZ performs creditably well from our (arguably less well) lower 85% of patients. That is but the lead-in to “The Absurd.”
Scroll back 5 paragraphs! Read its last sentence again! “… this might mean that DOPPS would ‘miss the signal.’” Miss the signal? How prophetic. Synonyms might be “Ignored,” “Suppressed,” or “Willfully disregarded.”
And so to 2015-2016, and the impending release of the Arbor Research “Decision Aid” (1). This tool, still in production phase, aims to assist patients in their choice of which dialysis to embrace, or, as my introduction states, to learn of the “… choices, options, and pathways that recognize the diversities of life, that allow each of us to reach the fullest and best potential each can reach – and to be aided to achieve those goals.”
I reproduce here the opening sentences of Arbor’s “Patient-Centered” Outcomes Research Institute (PCORI) Project Summary titled: Selection of Peritoneal Dialysis or Hemodialysis for Kidney Failure: Gaining Meaningful Information for Patients and Caregivers(1) … a “decision aid” project with, mind you, a cool US $1.8 million in funding.
“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. …based on specific clinical parameters and a patient’s needs, one of the two dialysis types is usually going to be a better fit for a given patient.”
Really?! Just two options? HD in a centre, or PD at home? …and, that’s all there are?
There are times when I despair that the message will ever hit home; if it will ever be possible to “turn on the lights.” That there are just two dialysis options— centre-based HD or PD—is patently absurd.
It insults, brushes aside, ignores, and “willfully disregards” the users of dialysis, the patients, and is especially dismissive of the many home HD patients who enjoy the freedoms and benefits of HD in the home.
More, it rolls back US dialysis, yet again, into the dark places in which it has lurked these 5 decades past.
Emotionally exhausted, I will hang up my thoughts till next week…my Mohammed Ali “uppercut #2.”
Reference.
- Patient-Centered Outcomes Research Institute (P-Cori) Project: “Selection of Peritoneal Dialysis or Hemodialysis for Kidney Failure: Gaining Meaningful Information for Patients and Caregivers. To be found at: http://www.pcori.org/research-results/2012/selection-peritoneal-dialysis-or-hemodialysis-kidney-failure-gaining
Comments
Bill Peckham
Apr 20, 2015 8:03 PM
Leaving HHD out of the EPOCH-RRT Study “Decision Aid” is a symptom of a larger pathology, the underlying cause being the power of the conventional incenter dialysis business model. Across the entire globe, including in ANZ, the continuing use of conventional incenter dialysis is excused because of the availability of HD - both PD and HHD. In the US the excuse is weaker but none the less, an excuse. Just as boxing the sport has been corrupted by boxing the business, so to has dialysis the medical procedure been corrupted by dialysis the business.
John Agar
Apr 22, 2015 2:55 AM
Of course you are right. The centre-based business model is the global behemoth that drives and nourishes the myth that centre-based HD care is ‘the only HD care’. However, I think the drivers for this juggernaut are a little different, jurisdiction to jurisdiction. In the US, it seems that the prime driver is a for-profit ethic that has grown up around a privately owned or company-owned business model. In ANZ, where the vast majority of centre-based dialysis – indeed all dialysis – is federal and/or state government funded, the primary drivers are more like custom, convenience, control and cost management. Whatever the drivers, though, the end result has been centre-based care. But, the glimmer of choice has remained alive and well in ANZ where home-based care models have historically remained as well-resourced and supported as centre-based care.
More recently, as cost management has morphed into cost containment, Federal and State governments alike have recognised that…
(1) as home therapy survival data show that, especially for home HD, the adjusted outcomes are better than for centre-based care (adjusted for as many of the biases that may predilect for better outcomes at home), and …
(2) as home therapy costs (be those the costs of home HD or home PD) are about 2/3rds the cost of centre-based care
… then encouraging home-based care (or either ilk) is a no-brainer.
While to be sure, no system has got it right, at least governments here are financially incentivizing home HD and PD programs, with several state governments having already set 5 year home therapy targets (eg: Queensland and New South Wales = 50% or greater, and Victoria = 35% or greater), the mix of home HD and PD being a matter for patient preference and choice + unit expertise and capability. The lower target in Victoria (my own state) recognises that some services have, until recently, had only small home programs and need an achievable target rather than one that is beyond their reasonable reach. Other units (like our own unit) that are already well above the 35% level, are being encouraged to build their home therapies (both PD and HD) even further, and as far as practical and possible.
All this is a little away from the theme of this blog which is to decry what appears to be the total absence of home HD from the modality mix of the DOPPS decision aid. DOPPS, with its international/global reach, might of all US bodies be expected to ‘known better’ … but, perhaps the roots of this untenable omission by the DOPPS group harkens back to the attitudes expressed in that meeting in Sydney more than a decade ago when only centre-based care was ‘of interest’ to this US-based group and home HD was considered an ANZ aberration.
Theodôr
Apr 17, 2015 6:08 AM
We over here in the Netherlands are also convinced for at least 10% of our patients, HHD would be choice nr 1 to enjoy the best outcome possible and achieve things in life which persons would not be able to perform because of lesser physical and psychological/emotional balance!!
Fully agree John that this is a narrow minded study.
Throughout history bad choices and in this era "scientific studies" influence them. Let's hope doctors see through them as they are tought to. Decison makers have their own responsibility to search for a broader view on life than just RRT's , especially those excluding options.
Some things in life are so obvious the need to study and understand it seems a bit far fetched like this article supports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/
But more tot the point however the outcomes in a clinical practical perspective do show; HHD deserves its place in the renal field and to be included in RRT's!
John Agar
Apr 22, 2015 3:34 AM
You are right in all but one aspect … this is NOT a study … it is a decision aid. It is a decision aid that, presumably, will be put out there for patients to use as a guide to their best dialysis potential. In that respect, it is far more than a study – it is a
Last time I looked there were far more than the two options this decision aid ‘promotes’ – i.e. HD in a centre and PD at home. Last time I looked there was:
1. Centre-based ‘conventional’ HD – but this option alone is a minefield as the word conventional means very different things to different populations
• In the US, ‘conventional’ centre-based HD tends to indicate a mean dialysis duration of about 215 minutes (that’s 3 ½ hrs) 3 times a week = about 645 minutes of dialysis a week.
• In ANZ, ‘conventional’ centre-based HD means in at 275 minutes x 3 times a week = 825 minutes a week
• In Japan, sessional duration can be even longer
• I, for one, think this matters
• So … the word ‘conventional’ is, of itself, a helpful word at all.
2. Home based PD
• There are two prime choices here, not just one
i. CAPD (manual exchange PD)
ii. APD (automated machine-assisted PD)
3. Home HD
• ‘Conventional’ (there is that meaningless word again – for what does it really mean or specify) HD at home … but at home, there are choices around not only sessional duration but sessional frequency, with the chance to abolish Carl Kjellstrand’s ‘killer weekend’
• High dose home dialysis – this includes variants of time, frequency, and time of day (or night)
i. Alternate day (or longer overnight) home HD
ii. More frequent (4, 5 or 6) days (or nights) home HD
iii. Here, options include short daily at home x 5-6 per week = not a model we espouse here in ANZ, or extended hour and high frequency ‘intensive’ home HD (= the ANZ model)
Then there are ‘the other’ centre-based options – perhaps these may be addressed in the DOPPS decision aid, though the lead-in doesn’t suggest so …
4. Centre-based short daily HD – an option that is used differently by different populations – where some, like in ANZ, tend to use c-b SDHD more as ‘rescue therapy’ for sick, narrow-volume-window patients, and less as a ‘better dialysis’ option, believing that home HD is the better way to go to achieve the ‘better dialysis’ goal.
5. Centre-based nocturnal HD – an increasingly popular option in some jurisdictions (though not in ANZ).
6. The Auckland patient-run, self-care, shared community house model = a very successful alternative to home care where home care is desired but where the home is not suitable for machine or equipment installation
Theodor … I could go on – but I won’t. You should be getting my drift! The point is that dialysis should be and must be patient-oriented and patient-centric. It should offer multi-modelled care. Any decision aid worth its salt should reflect this. I fear this P-CORI one does not.
That is what is regrettable, indeed, what is absurd.
lana
Apr 16, 2015 11:47 PM
I also think its crazy/bizarre how difficult it is for the renal professionals to let patients know of all their options???
I don't think they have trouble letting cancer patients know their options...
its really unbelievable the trouble nxstage has with getting the word out to patients about their machine!
Marcia
May 12, 2015 9:07 PM