Is Evidence Based Medicine the Main Barrier to Optimal Dialysis in America?

By Peter Laird, MD

Since the advent of hemodialysis availability in the 1960’s, practitioners have searched for the most optimal way to utilize this life saving technology.  Historical reviews of the pioneering days of hemodialysis reveals experimentation on how frequent and how long we should administer dialysis to patients in need of renal replacement therapy to optimize outcomes.  Surprisingly, the modalities that we now refer to as new and novel were actually described and utilized very early in the course of dialysis experimentation.  Dr. Shaldon was the first nephrologist to prescribe home, nocturnal hemodialysis in 1964 both in London and in Germany followed shortly by Dr. Scribner in Seattle. Dr. Bernard Charra continued overnight hemodialysis in Tassin, France in the 70’s and 80’s with excellent results that were largely overlooked for decades.

The modern era of home, nocturnal hemodialysis reemerged in 1993 in Toronto, Canada by Drs Robert Uldall and Andreas Pierratos. The published observational data from multiple centers utilizing home, nocturnal hemodialysis 3-7 times/week reveals improved anemia control, normalized blood pressure, normalized mineral bone metabolism, normalized functionality and reduced mortality and morbidity compared to conventional incenter dialysis. A recent study with twelve years of follow up showed equal survival with daily, nocturnal hemodialysis as compared to cadaveric transplant. Despite an abundance of observational data and practical experience from Canada, Australia, New Zealand and other nations that have adopted the concept of optimal hemodialysis modalities, America continues to view optimal dialysis modalities with skepticism.

Today, America stands alone as the only developed nation not convinced of the overwhelming evidence that more frequent and longer duration dialysis saves lives.  America also stands alone with an alarming mortality rate among dialysis patients 2.5 times higher than Japan. American healthcare continues to insist on randomized, controlled trials showing the benefits of these alternative dialysis strategies over conventional incenter care even though they readily admit that it is impossible to randomize the 3000 to 5000 patients needed for such a study.  The Frequent Hemodialysis Network is actually unable to recruit even 250 patients for their ongoing nocturnal dialysis study let alone a study with enough statistical power to show a 30% difference in mortality from conventional incenter dialysis. Patients that are knowledgeable of the benefits of extended dialysis are routinely denied access to these life changing home therapies by their insurance companies who allege a lack of evidence of their benefit.

Group Health - Clinical Review Criteria:

Frequent Home Dialysis, Nocturnal or Short Daily
There is insufficient evidence that home nocturnal dialysis improves important health outcomes compared to in-center dialysis. An RCT found improvement in LV mass and phosphate level, intermediate outcomes, and mixed findings in QOL. There is weak evidence from a single cohort study that nocturnal dialysis lowers the rate of dialysis-related or cardiovascular- related hospitalizations. In this cohort study, all-cause hospitalizations did not decrease significantly.  

To date, we have the benefit of only one small RCT on nocturnal hemodialysis which confirmed many of the findings of prior observational studies showing significant benefits of more frequent and longer duration dialysis. America continues to stand alone in it’s call for the highest academic standards of dialysis healthcare, while paradoxically delivering the worst dialysis outcomes anywhere in the civilized world.  America’s search for the holy grail of dialysis evidence based medicine with an optimal randomized  controlled trial that is admittedly impossible to ever complete is nothing but tilting at windmills. 

While America charges ahead with protests of academic purity before accepting the proven benefits of optimal dialysis, patients are needlessly dying at the hands of our own nephrologists who blindly forgo these lifesaving treatments.  While the world embraces optimal dialysis, America instead worships at the altar of optimal randomized controlled dialysis trials which shall never be completed.  It is time to end this quixotic quest, we must stop fighting the windmills of academic purity. Instead let us be inspired by the great pioneers of dialysis in the fight against our true foe, the uremic milieu of too little dialysis and simply ask the dialyzed what frequency and duration of dialysis makes them feel better.

Comments

[Miriam Lippel Blum]

Eloquently stated, Peter. It is really the time for an end to quixotic medicine. But we probably dream the impossible dream when it comes to optimal dialysis in this country as long as profit is the only thing that matters to insurance companies and nephrologists aren't willing to challenge the status quo.

[Dori Schatell]

Bravo, Peter! This is exactly the point I was trying to make to CMS. IMHO, Bleyer's work showing the 50% higher rate of sudden cardiac death on the day after the 2-day no-treatment "weekend" is enough to show that what we are doing now with 3 treatments per week is not only not optimal, but, in fact, LETHAL.

You didn't mention Carl Kjellstrand's work on the "Unphysiology hypothesis" which he summarizes for Home Dialysis Central here: http://www.homedialysis.org/pros/abstracts/20050617/. In essence, he says that treatment that is more like healthy kidneys (such as transplant or longer/more frequent HD) will cause fewer symptoms and extend survival. Sure looks like he was right. Now if CMS would just get on board...

[Peter Laird, MD]

Dear Miriam, it is to dream the impossible dream of optimal dialysis here in America, but since the rest of the world has accepted this basic concept, hopefully America can become less dense and do the same some day. Until then, it gives incentives to DSEN to continue on.

[Peter Laird, MD]

Dear Dori, as always, you steal my thunder of future posts. You did teach me well since it was our conversations nearly two years ago where I first heard of Dr. Kjellstrand's unphysiology and the two day death trap of conventional incenter dialysis on the long weekend without treatment. In fact, there is very little I have gained outside of what you taught me in those emails and phone converstation and I am thankful for that gift you gave to me.

I am in fact just getting revved up on the issue of optimal dialysis in America and it really goes right back to whether the unphysiology theory is correct which I know you are convinced as I am as well. I had already planned a post on both of those issues in the near future. Thank you for all that you do for our community.

[Lydia]

Thanks for such a well written post. I stumbled across your site via Google alerts. Glad that I did.

[Christopher Blagg]

Dear Peter

Perfect! It seems that as with many things everything has to be relearned 40 or 50 years later.

Chris

[Peter Laird, MD]

Dear Chris, thank you for the many years of dedicated study and care to people such as myself. Perhaps the "new and novel" treatments offered today will someday be recognized for the treatments that you and Dr. Scribner and many others already offered and promoted nearly 50 years ago. The only problem is America still hasn't remembered where it came from which blinds its path to the future.

[Linda Gromko, MD]

Peter,

Well stated. I, too, tend to find myself "looking for logic in all the wrong places!" In the quest for good evidence based medicine, I find myself practicing "anecdotal medicine." It's wonderful to be backed up in what you do my a large multi-centered RCT, but in the end, good medicine involves doing the right thing. It requires that most elusive quality: common sense.

[Peter Laird, MD]

Dear Linda, you have summed up well the entire issue of doing the right thing. Perhaps one day, America shall learn to do the right thing as we once did during the pioneering days of dialysis. May it be soon.