HemoDoc, From Doctor to Patient

CMS and Home Hemodialysis: The Story of 40 Years of Neglect

By Peter Laird, MD

The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering.  The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.

End Stage Renal Disease Program

In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973. 

At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home. 

On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients  were on home dialysis including 59 PD patients at home.

The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program. 

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.

The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.

The politics of health cost containment: end-stage renal disease

R.A. Rettig (pages 132-133)

Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival of home patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers."When we look at patient survival on home dialysis," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .

But the political damage had been done. 

Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.

NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD  - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD  patient was at least $4000.

The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)

Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.

This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere  and at some time one who can make a difference inside our government will.

The "Lucky 13": Survivors from the Early Days of Dialysis

By Peter Laird, MD

Patients undergoing dialysis in America units frequently complain of the misery of their existence with headaches, severe thirst after sessions, cramps, nausea, vomiting, frequent bouts of low blood pressure and the misery of an ever present fatigue that permeates every aspect of their lives. It is no wonder that so many people hate dialysis. These attitudes were not shared by those few lucky to be the first pioneer patients of dialysis in the 1960's in London and Seattle especially, several of whom still are alive today more than forty five years since they were first saved by this therapy (here). The first patients in England are dubbed the "lucky 13."

History of Nephrology: The Record Holders

The Royal Free programme
This photograph of 'The Lucky Thirteen' taken in 1965 shows patients treated at the UK's first centre for long-term dialysis at the Royal Free Hospital, London, with their consultant Dr Stanley Shaldon (centre, front row).  Olga Hepple, left of Dr Shaldon, featured in a Pathe film of very early home haemodialysis in the UK.  Three of them featured in the first episode of the BBC's Tomorrow's World in 1965, which you can see online, a remarkable historical record.

With the median survival for America dialysis patients today of 36-38 months, the thought of surviving for nearly half a century with renal replacement therapy is not the current ideology of most involved with our dialysis industry.  With equipment we consider primitive, the article in the history of nephrology describes what these unique patients have in common:

What do they have in common?
All recognise that they have been lucky.  In the early days, it wasn't easy to get dialysis but the struggle to get onto treatment was just the beginning.  All are grateful for the opportunities that they did not expect to have, and to their families and the medical teams that shared these struggles.  

All of the very long term survivors have spent long periods transplanted, but it is interesting that several of them waited years or decades before their first.  This may have saved them, as the risks of transplantation in the early years were extremely high.  None of the very early transplant recipients are still alive. Most longterm survivors have had long periods of very long-hours dialysis, and this may be important too.  

All of these patients through a combination of extended hours dialysis in the beginning are alive today as a testimony and legacy of Belding Scribner who prescribed longer treatments for any patient who was not rehabilitated. The patient killing metrics of urea kinetics and the terms "adequate dialysis" are foreign to this story.  Dr. Robin Eady waited for twenty five years before he agreed to renal transplantation. He is now nearly fifty years as a renal patient. The will to live and comply with the difficulties of treatments is now his reward for a life well lived, not only as a patient, but as a practicing and successful physician who is highly regarded in his field of dermatology.

Perhaps the element most lacking for patients today is that of hope which has been replaced by despair and complacency by so many patients. The number of patients who could benefit from home hemodialysis is much larger than those that come forward even when offered. The examples of these remarkable patients  serves as a reminder that dialysis truly is the first gift of life in the history of renal replacement therapy. The "lucky 13"and those from several other pioneering programs in the 1960's should remind us that we can do better in America each and every day when we see several still alive today. The legacy of those who went before us and are still alive speaks of how far we have fallen from the precepts of the pioneers of dialysis. The "lucky 13" reminds us that it is not too late to recapture the wonder of life and rehabilitation from a machine.

Perhaps one day, American nephrology will remember the history of dialysis and ask the simple question, where have we gone wrong? Perhaps the answer is the day that this specialty began to pay more attention to biochemical parameters than the patients languishing in their dialysis units. America is not doing well in this "nobel experiment." It is time to learn from history and from those still alive. It is not too late.

The Japanese Dialysis Survival Debate: Ignoring the Evidence

By Peter Laird, MD

The survival differences between Japan and the United States are well documented and extensively researched with the preponderance of the evidence focusing on dialysis practice difference.  I have written on this issue several times in the past three years. (here, here and here) Many have wrongly in my opinion put forth the low incidence of renal transplant in Japan and alleged exclusion criteria coupled with lower co-morbid conditions that have not withstood the light of day as the explanation of these differences. Dr. A.K. Singh entered this debate a few days ago on his Kidney Doctor Blog:

Global Nephrology: Better Cars in Japan Maybe, but also Better Dialysis? The bottom-line?

There are a number of differences in dialysis practice that alone or together could explain the difference in mortality. While the very low transplantation rate in Japan, i.e. selection bias, might be a part of the explanation, it does not explain the two-fold higher mortality rate in the US. In Japan, like the US, there is a highly prevalent diabetic population on dialysis with an average age in the 60s that similarly dialyzes 3 times a week in center. It's either better dialysis or some other factor, but not just differences in transplant rates, nor is it because the Japanese are very selective in who they treat on dialysis.

The underlying untold story line to the great Japanese dialysis survival debate is the allegation that we could never take a group of patients in America and duplicate the Japanese survival outcomes with only a change in dialysis practice due to alleged higher co-morbidities, alleged lower incidence of diabetes, and alleged selection bias. I would urge all to consider that we actually have these answers already starting first of all historically when home dialysis patients and in-center dialysis patients had outcomes as equal or better than the current Japanese survival data. Dr. Lowrie boasted of a mortality rate as low as 7% in 1972:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 receivedcadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Many would state that the dialysis patient of 1972 was younger and diabetics were excluded explaining the historical data by selection bias and exclusion criteria. I won't debate the merits or lack of merit of that type of argument at this point, but let us move on to the real issue; if we changed dialysis practices here in America, could we duplicate the Japanese survival data with a large cohort of American dialysis patients. The answer to that question is yes with 5000 dialysis patients in a CMS demonstration project by Fresenius  which recorded a 9.3% annual mortality rate on thrice weekly in-center dialysis:

The first three years of the demonstration (2006 through 2008) were evaluated and the case-mix adjusted results indicate the following for Fresenius Medical Care (FMC) patients enrolled in the demonstration:

• A significantly larger percentage of patients in the FMC program survived to the one year and two year time points.
  • Patient survival at the one year time point for FMC was 90.7% vs 85.4% for the comparison group. Patient survival at the two year time point for FMC was 80.1% vs 73.9% for the comparison group. This equates to mortality improvement for FMC versus the comparison group of 36.3% at the one year time point (9.3% vs 14.6%) and 23.8% at the two year time point (19.9% vs 26.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “all causes” at one year of 13.6% (51.1% vs 59.1%) and at two years 20.5% (60.5% vs 76.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for cardiovascular disease for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “cardiovascular disease” at one year of 14.1% (50.0% vs 58.2%) and at two years 20.7% (59.7% vs 75.2%).

This project utilizing the Medicare Advantage allocation which has no wall between Part A and Part B in a capitated system allowing Fresenius to eliminate the extra profit centers in fee for service practice at the hospital and other points of care that standard Medicare cannot eliminate. This study has not received broad attention especially given that this was with standard 3.5 hours thrice weekly dialysis in-center. What is also not published nor recognized widely is that Fresenius accomplished similar outcomes in their joint Kaiser/FMC ventures in Southern California which I was able to observe firsthand for two years as a patient. Changing practices by first of all aligning cost incentives to prevent hospitalization and outside medical utilization results in cost containment and improved survival. The principle investigator for Fresenius offered detailed analysis of why they were able to achieve these results in an interview with Medscape:

Battling ESRD With Nutrition and Monitoring: Fresenius Project: the Interview

Mr. Farrell: We really think this is right in the sweet spot of where CMS wants to take health reform. One point about our demonstration program was that this was individual enrollment of patients, so at any given dialysis clinic you might have a handful of patients who choose to enroll in this program. This presents an opportunity when you move to a broader accountable care structure. What we have proposed with CMS is the concept of the integrated care health home, with the nephrologist as the principal care physician for these patients and the dialysis clinic provider and our integrated care program providing the data systems and care program infrastructure of the medical home. We'd like to see CMS give us an opportunity to deploy this kind of a model on a full clinic basis rather than individual patient enrollment. This would give us the opportunity to operationalize this model in a more integrated and efficient manner with our clinics and nephrologists in support of our patients. We're very encouraged by the results we were able to achieve in this demonstration project, even in this individual enrollment environment, but see a huge opportunity for ESRD patients if we are able to deploy this model on a larger scale.

If this model sounds familiar, it is because it is the integrated medical care system that Kaiser pioneered over fifty years ago which allows the provider to capitalize on economies of scale and to capture the health care savings by preventing illness and undo utilization of resources. In addition, I have reported on the benefits of nutritional supplementation in the dialysis unit nearly three years ago on DSEN:

Food Insecurity: The Shameful Secret Affecting Dialysis Patients

In the vacuum left by Medicare, some nephrologists have taken matters into their own hands. One exceptional example is Dr. Phillip Tuso, a nephrologist with Kaiser Permanente who created FIRN in response to the high number of his own patients with food insecurity that were dying at an alarming rate from malnutrition. Dr. Tuso started this non profit organization dedicated to relieving food insecurity within his dialysis population which has succeeded greatly in reducing mortality among his dialysis patients. Hospitalizations are likewise over 50% lower than before he began this intervention in 2004 saving Kaiser Permanente millions of dollars from one dialysis unit alone.

One nephrologist who was motivated by the knowledge of a simple and cost effective intervention with nutritional supplements serves as a outstanding model for how America could once again regain the threshold of humane care of those at risk of food insecurity in our dialysis population. It is time for America to save both lives and money with a simple intervention with oral nutritional supplements. The best medicine is once again the cheapest medicine.

I believe the Japanese survival debate is a false debate clouded by a lack of evaluation of known data and by ignoring extensive studies revealing that the cause of our different outcomes is our different dialysis practices. The American dialysis patient is not the cause of our terrible outcomes as many academic American nephrologists would like all of us to believe. In addition,  Japan also has a different payment system where nephrologists are paid per hour of dialysis not per session of dialysis. I have spoken to many leaders in the dialysis industry in the last three years and many place the blame of our outcomes squarely on our perverse payment system that does not reward dialysis providers for keeping patients out of the hospital and avoiding complications.

I believe it is time to go beyond vacuous debates that fail to examine all of the evidence and instead to move forward with concrete practice changes already demonstrated in Europe, Japan, Australia and even right here in America that I have witnessed firsthand. Practice patterns will change when CMS creates incentives for outcomes instead of processes or biochemical profiles. Practice patterns differences are the reason for the excellent Japanese survival on dialysis and I believe that we can not only duplicate but surpass their survival rates by combining the practice changes that Fresenius utilized in an integrated care system with standard thrice weekly in-center dialysis and nutrition and holistic support and then surpassing that model by incorporating daily dialysis. That is the experiment and the direction that we need to take and stop endless and useless debates long since settled by the preponderance of the evidence.

The Kjellstrand Lecture: The Deadly Delay - Part IV: Survival

By Peter Laird, MD

Since the advent of hemodialysis with the Scribner Shunt in 1960, chronic hemodialysis became the most widely utilized renal replacement therapy which is still true until today. Prior to the ESRD program in 1973, dialysis survival rates were substantially higher than today as noted by Edmund G. Lowrie in a NEJM article on transplant and dialysis survival rates:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 received cadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Survival rates prior to the ESRD program were on the average of around 10% annual mortality in many centers around this nation; the equivalent of the annual Japanese dialysis population today. However, since the NCDS instituted urea kinetics as the standard of care in the early 1980's and shorter and more violent dialysis sessions became the norm in America, annual mortality rates have more than doubled and have hovered around 22% as they are today with no significant improvement in the last twenty years. Many fail to realize that the five year survival for dialysis patients is worse than many of our most dreaded cancers and other ailments.

Sadly, the American nephrology community as a whole has ignored the pioneering work of Scribner and his colleagues for nearly three decades as preventable deaths soared. Many fail to remember that Dr. Lowrie recorded annual mortality as low as 7% in 1972 as the gold standard renal replacement therapy, even better than renal transplant at that time. Beginning in the 1990's with the investigation of daily, nocturnal home hemodialysis by Uldall and Pierratos, short daily and nocturnal dialysis modalities have shown significant survival benefit in line with the original survival in the 1960's and early 1970's.

Today, we have several well done observation studies following patients on daily dialysis for several years. These results are not center specific and have been duplicated in the United States, Australia and Canada. Dr. Carl Kjellstrand has supported daily dialysis for nearly forty years while instead, his colleagues adopted shorter and shorter dialysis sessions supported by the measurement of urea kinetics.

After all, the randomized and controlled trial, the NCDS had "proven" that the length of a dialysis session as measured in "TIME" had no statistically significant correlation with outcomes. Amazingly, the NCDS is still quoted widely by dialysis experts debating the outcomes of these observational studies yet fail to question why the dialysis outcomes forty years ago with inferior equipment, inferior knowledge of secondary morbidity associated with dialysis and inferior pharmaceutical support had paradoxically far superior outcomes.

Just as in 1973, without the benefit of randomized and controlled trials, the standard of comparison for the effectiveness of the renal replacement therapies was a direct comparison between the modalities.  Just as in 1973, dialysis and renal transplant which by the way has NEVER had a single randomized and controlled trial compared to dialysis outcomes is one measure of renal replacement therapy that does give comparative meaningful values.  Dr. Kjellstrand compared his own short daily dialysis studies with over twenty years of data to the USRDS in-center PD and HD patients as well as the renal transplant revealing equal survival with the daily dialysis options.

In 2009, Pauly, et al likewise utilized the measuring stick of transplant survival and compared their results directly to the average survival of living donor transplant and cadaveric transplants. Despite the number of earlier studies showing equal results as well as the original outcomes all the way back to the time of Dr. Lowrie's 1973 article with 7% annual mortality, many continue to question the validity of Dr. Pauly's results since they are observational in nature and not from a randomized and controlled trial.

After fifty years of data collection, the American nephrology community remains in a catatonic state paralyzed by indecision on what is the basic and standard dialysis dosage. Urea kinetics has brainwashed the American nephrologist into an altered state of consciousness in blissful ignorance of the damage done to millions of patients by poorly conducted and openly accepted randomized and controlled trials including the HEMO study which simply asked the wrong question: is a higher Kt/V the answer for survival. They likewise never question the lack of RCT studies proving thrice weekly, 3-4 hour treatments against the standard of thrice weekly 6-8 hour treatments.

The American nephrologist is religiously vested in the irrational belief that urea removal has clinical importance when we know that higher blood flows, higher ultrafiltration rates, high flux kidneys and other factors which completely ignore the underlying "unphysiology" of dialysis can all be manipulated to "improve" urea kinetics while at the same time our average annual survival is double the rate prior to the introduction of urea kinetics in the 1970's and early 1980's especially after the NCDS.

The early pioneers utlized very simple clinical monitors of how "adequate" the dialysis was for an individual patient, that of survival and rehabilitation. If the patient didn't feel well enough to return to work and a have viable life, the pioneers of dialysis simply increased their dosage in time on dialysis. That is how they derived the minimum standard dosage of thrice weekly 6-8 hour sessions most of which were done at home ovenight.

Now, a year and a half after the publication of the FHN short daily dialysis study, all that the American nephrologist can offer as advice is that we need larger and clearer endpoints in another randomized and controlled trial looking at mortality. Certainly ASN and the RPA have not in any manner stated that the standard of care for all dialysis patients should be daily dialysis with the best results from NHHD. Some illogically utilize the known results of the "killer" weekend to suggest we have equipoise, the genuine uncertainty over whether a treatment will be beneficial, to justify such a study. It appears that they are the only group that believes we have clinical uncertainty in daily dialysis. They have certainly forgotten that the NEJM and Dr. Lowrie used dialysis outcomes as the gold standard to compare mortality to renal transplant with dialysis outcomes better in those days, double the survival of transplant in its early years. We now have double the survival with transplant, but only if we don't compare it directly to optimal dialysis strategies that return us to the historical mortality rate noted by Lowrie in 1972.  A short memory of the history of dialysis is in many ways our worst enemy of the truth.

In 2001, those that supported the FHN promised it would be the arbiter of these questions. Although the short daily dialysis study did offer up a positive result, many American nephrologists reject its conclusions based on the coprimary outcomes that do not differentiate the contributions of death and LVMI separately for individual analysis, thus rendering its positive outcomes wasted. Likewise, the failed recruitment and changes to the exclusion criteria of the nocturnal study leave us without any direct conclusions from the FHN nocturnal arm. After ten years of a deadly delay, the FHN has not lived up to its promise and the American nephrology community remains unconvinced. At this point, I am not sure that CMS or the American academic nephrology community will ever be convinced. Instead, it will be the market place and patient demand that turn the tide on the economics of daily dialysis that will lead to a rebound of optimal therapy.

Hopefully, the American nephrologist will return to the patient and ask the simple questions that Dr. Scribner and his colleagues asked? How do you feel? Can you work? Have we restored your life? Until those simple questions once again become the measure of adequacy, the mental masturbation of making the nephrologist feel good about the patient's Kt/V while the patients life paradoxically slips away may one day come to an end. We can only hope that we avoid any further deadly delays.

Slides courtesy of Dr. Carl Kjellstrand.

The Kjellstrand Lecture: The Deadly Delay - Part I: Introduction

By Peter Laird, MD

Dr. Carl Kjellstrand is one of the most published and respected investigational researchers in the dialysis field of nephrology. For those that strive to overcome the hegemony of optimal dialysis in America, Dr Kjellstrand is a champion of daily dialysis and with good reason with hundreds of journal publications in a long career spanning several decades.

I  recently asked Dr.Kjellstrand if I could have a copy of his lecture from the 2009 Annual Dialysis Conference questioning the need for further randomized and controlled trials on more frequent dialysis. Dr. Kjellstrand has been gracious enough to not only share these slides with me, but to also allow this issue to be revisited one more time from the perspective he had prior to the completion of the FHN in 2010. As Dr. Kjellstrand summarized to me, he thinks it is "even more appropriate now."

The FHN is one of the most controversial trials in the field of nephrology among those that have a vested interest in dialysis outcomes, i.e. the patients themselves. CMS is one of the principle advocates that promoted this study citing the need to know that more frequent dialysis is the best dialysis modality before authorizing payment for more than the standard thrice weekly 3-4 hour conventional in-center dosage. It is truly a shame that CMS did not demand the same level of proof when CMS implemented the business friendly shortened dialysis schedule from what was the standard thrice weekly 6-8 hour nocturnal at home therapy in the 1970's.  

If they had demanded the same level of proof that they demand to return to the original optimal rehabilitative dose worked out by Dr. Scribner and his colleagues, we wouldn't have wasted nearly forty years debating this topic; needless to say of the hundreds of thousands of patients who have suffered and died during those years. Consider that there would not have been the recruitment issues that hampered the FHN because in the 1970's, the patients wanted the option of short dialysis treatments provided outside of their homes. Today, patients understand that the business of dialysis as practiced today is not good for their survival on dialysis and refuse to forego home dialysis options and have a 50% chance of staying in the confines of conventional in-center hemodialysis to participate in these studies. The one definitive finding of the FHN nocturnal study is that patients don't want to stay in-center when they have the ability to do dialysis at home. For patients, there is no "equipoise."

Dr. Kjellstrand entered this debate in 1975 with the Unphysiology Theory of  conventional in-center dialysis:

Dialysis Unphysiology and Sodium Balance

Dialysis unphysiology was first discussed by Carl Kjellstrand in 1975 for the possible negative effects of the unphysiology of intermittent dialysis treatment. Current hemodialysis practices are still unphysiologic because they cannot keep blood chemistries within normal limits, both before and after dialysis. In addition, the discontinuous nature of hemodialysis causes saw-tooth volume fluctuations, and the extracellular fluid volume expansion during the interdialytic period may lead to hypertension and adverse cardiovascular consequences.

While the academic world of dialysis continues to debate this issue for over forty years, many of whom with strong ties to the dialysis industry with conflicts of interest that were not reported in the early days of dialysis studies, thousands of patients needlessly die every month.

The most popular topic for dialysis advocacy posts on essentially every dialysis related blog is whether more frequent dialysis will improve outcomes. Now, more than one year after the publication of the short daily dialysis arm of the FHN, we still have no changes in the dialysis practices that Dr. Kjellstrand reveals as a preventable cause of 100 deaths  a day. Even with the positive results of the Culleton trial and the short daily FHN arm, the nocturnal portion of the FHN has produced further disunity on how to proceed. Instead of providing the guidance needed, the FHN instead is  a source of more confusion and debate on these issues.

As Dr. Kjellstrand stated about his 2009 lecture, it is "even more appropriate now." I invite all to review the evidence presented by Dr. Kjellstrand from his viewpoint  in 2009 prior to the completion of the FHN. In my opinion, the entire debate on the frequency and duration of dialysis sessions has for decades ignored the simple unphysiology of dialysis described in detail in 1975. I know of no other specialty in medicine that has so ignored basic science principles than nephrology for the one procedure most identified by this specialty.

Yes, it is even more appropriate now to revisit this issue one more time. Perhaps before the 40th anniversary of Dr. Kjellstrand's 1975 paper, his colleagues who have declared his views "controversial" for years will finally recognize his contributions and design optimal dialysis modalities around this unifying theme. History shall recognize that he was right all along. Yet the pride of those that irrationally oppose his theories can never justify the deadly death toll that mounts daily from their intransigent rejection of his views. It is time to revisit what we knew before the FHN was published and move forward with optimal dialysis. The time for study has passed. It is time to put this ten year deadly delay to rest once and for all.

(I wish to thank Dr. Kjellstrand for making this lecture and his actual slides available to the dialysis patients of America, most of whom will not have the opportunity to hear him speak in person.)

The Kt/V Kinetics Deception

By Peter Laird, MD

The NCDS introduced urea kinetics to the dialysis world as the most important measurable factor in the prescription of dialysis even though there was no financial disclosure by the authors including the fact that Edmund G. Lowrie was then the Vice President of National Medical Care Inc., the largest for-profit dialysis corporation in America at that time. Since the publication of the secondary analysis in 1985 introducing the Kt/V concept by Gotch and Sargent, dialysis outcomes in America have plummeted to the lowest survival of any in the industrialized world. As Gary Peterson noted in today's lead story on RenalWeb, the discussion and controversy continues unabated as seen in a recent editorial in MedScape by Joel D. Glickman, a respected nephrologist who has served as a consultant for both Davita and NxStage.

Nephrologists Unite: Time to Put the 't' back in Kt/V.

It all started with the NCDS published in the New England Journal of Medicine in 1981.^[1] This study randomly assigned just 151 hemodialysis patients into 4 treatment groups to measure the effect of 2 variables on survival: time on dialysis (short or long) and time average urea concentration (high or low). The authors of the study concluded that morbidity was worse in the group with high blood urea nitrogen, but time on dialysis was not a significant determinant of outcomes. Patients who received longer dialysis treatments had a trend to less time to first hospitalization, but the P value was .06.

Commenting on the article, Chertow and colleagues said, "It is difficult to conclude from the NCDS that session length is not meaningful; the authors presciently stated that the study conclusions should be interpreted cautiously, given the design and limited powers of NCDS. In retrospect, one might argue that the NCDS' session length P = .06 was the most significant (important) "nonsignificant'" (statistically) effect in the history of dialysis research."^[2]  Regardless of the interpretation of the study results, we must recognize that the long treatment time was 4:30 + 3 minutes and the short treatment time was 3:15 + 3 minutes. The effects of shorter treatment times, such as the 3 hours K.R. was prescribed, were not studied.

Where could we have gone wrong when these results which were both significant and randomized in a controlled study? Simply put, Kt/V and urea kinetics from the NCDS not only ignores the influence of TIME in dialysis outcomes in what I believe was a flawed analysis, it completely ignores the founding principles of optimal dialysis: the Middle Molecule Hypothesis by Dr. AL Babb, et al (here) and Dr. Carl Kjellstrand's Unphysiology Hypothesis (here), both known at that time. Urea is a small molecule easily cleared by dialysis that many argue has no clinical impact in the physiology of the uremic condition. It is a marker but probably not a direct player in the damage done by uremia. Better dialysis markers are problematic to measure such as B-2 microglobulin which has complicated kinetics that are TIME dependent. Fortunately, many researchers are revisiting the middle molecule theory identifying several of the toxic molecules of uremia:

The middle-molecule hypothesis 30 year after: lost and rediscovered in the universe of uremic toxicity?

Clinical dialysis studies should from now on be focused on more efficient, convective removal strategies, first searching for the most adequate applications and then evaluating their clinical impact. The next step then should be to develop more specific removal strategies (e.g., adsorption) aimed at the compounds which are classified as the most important ones. This might emanate in less costly removaloptions than the empiric strategies applied as of today, and such systems might also be regenerated, hence enabling an earlier start of removal than currently applied. 

The measurement of urea and the subsequent mathematical mental masturbation we call the Kt/V that makes researchers, clinicians and patients feel good about the "adequate" dialysis they deliver fails to have an underlying theoretical physiologic basis other than the transfer of urea. High Kt/V's can be manufactured in dialysis units by manipulating ultra-filtration rates, blood flow rates and other factors that foreshorten dialysis treatments especially in patients with a small total surface area and total body volume such as many petite female patients who often receive the shortest dialysis sessions of any patients, yet have the highest Kt/V's paradoxically. Kt/V measures the clearance of a clinically unimportant molecule masquerading as the arbiter of dialysis outcomes. 

Dr. Kjellstrand's Unphysiology theory should instead also be one of the guiding factors in improving dialysis outcomes through more frequent and longer duration dialysis thus eliminating the unphysiology of dialysis from infrequent, rapid and short dialysis sessions common in American dialysis units today. The NCDS neglected this theory as did the HEMO study two decades later bringing death by randomized and controlled study from adherence to the failed concepts of Kt/V. Each month, dialysis patients anxiously await the results of blood tests. Each month, the renal staff and physicians pronounce their dialysis adequate by a magical wand without dimensions called the Kt/V. Yet, each month, these same patients die at a rate 2.5 times that of patients undergoing chronic hemodialysis in Japan. This is the cost of ignoring Dr. Kjellstrand and Dr. Babb for over 35 years:

The Rationale for More Frequent Hemodialysis – ‘Unphysiology’ 

In the early 1970s, Kjellstrand et al. [12, 13] investigated factors related the untoward effects of dialysis. They showed that large fluctuations in body weight, electrolytes, osmolality, and urea concentration were more important with respect to morbidity than concentrations of small uremic toxins or middle molecules. This led them to formulate the ‘unphysiology’ hypothesis which suggested that wide swings of solutes and fluids in the body were significant causes of morbidity in dialysis patients. Daily or continuous dialysis would more closely mimic the function of the native kidney by reducing the magnitude of solute and fluid oscillations and so would be expected to be superior to the usual intermittent dialysis regimens.

The deception of "adequate" hemodialysis is at the center of our horrific American dialysis mortality rates now debated for the last four decades, yet so little is done to correct this situation. As much as I appreciate the commentary by Dr. Joel Glickman to focus on longer dialysis treatments, I believe that the error of his opinion is to continue to utilize the current urea kinetics model as the basic standard of care. Putting the 't' back in Kt/V will only impede implementation of physiologic based dialysis treatments. Nephrology is perhaps the most highly dependent specialty based on physiology. Ironically, dialysis, the most recognized nephrology procedure ignores the unphysiology of dialysis for the majority patients nor does it correct the middle molecule millieu of uremia.

I would hope nephrology will one day unite and recognize that Scribner, Kjellstrand and their colleagues were right all along. I suspect that pride shall prevent that epiphany for many years to come at the cost of hundreds of thousands of lives unless the patients themselves one day learn enough to refuse the substandard conventional American dialysis protocols. The popularity of medical blogs coupled with market pressures from new and innovative dialysis machines is more likely to become the instrument of change than decades of reason and logic. What a sad commentary from a discipline that pays frightful attention to the most minute changes of urine physiology thereby diagnosing complex renal disease from human waste, while at the same time ignoring the basic physiology of their most important medical procedure rendering their patients lives wasted and disposable to the system. Perhaps, instead it will be the patients who one day unite and overcome the enslavement of the large dialysis organizations that use our pain and suffering to their advantage. Perhaps one day.

A Fresh Perspective or More of the Same?

By Peter Laird, MD

In 2006, as my own renal function declined and dialysis became a certainty, I researched the best treatment options for my own situation and settled on daily home hemodialysis with consideration of my relative contraindications for renal transplant. However, I did not become a dialysis advocate until 2008 when Dori Schattell of MEI and Home Dialysis Central taught me the historical context of optimal dialysis where the patients dialyzed 8-9 hours thrice weekly for 24-27 hours a week of dialysis and despite obsolete technology, enjoyed better outcomes.  After the advent of the 1973 ESRD program, for-profit dialysis became the driving force behind "ultra-short" dialysis studies that many allege were profit motivated. Yet today, few recognize that the gold standard of care for dialysis was 8-12 hours thrice weekly when Congress enacted the ESRD program:

Long, 3x8hr/week, hemodialysis : A three-decade summary

Long hemodialysis (HD) 3x8 to 12 hours per week, using 1 m2 flat plate cuprophan dialysers, was, in the 70’s, the most common form of empirical dialysis, the “gold standard”1. Technical advances, changing scientific views on uremia pathophysiology, as well as social and economic pressure (to make better use of the scarce dialysis stations) have led HD to apparition and the to development of shorter dialysis sessions.

In the late 1970's, treatment times dropped dramatically without the benefit of any randomized and controlled trials comparing outcomes between the "gold standard" of 8-12 hour dialysis sessions and the new standard of 3-4 hours.  Urea kinetics became enshrined by the NCDS which in reality compared four suboptimal modalities and then sold the American public and congress that this was the best we could offer patients. Many stood in opposition to these changes, but their voices were ignored. The debate over treatment times continues today over thirty years later. Despite the fact that the current standard of care never underwent an RCT to prove its efficacy, any changes to this business based model continue to be delayed by calls for more and more studies. The latest evaluation of this from the for-profit industry continues to ignore the original gold standard which was established by clinical parameters, not biochemical profiles. 

Hemodialysis Treatment Time: A Fresh Perspective

Moving Forward

. . . In the interim, inadequate short dialysis treatments likely lead to complications, increased hospitalization, and decreased survival and may have a negative effect on the total cost of therapy. We suggest that in the setting of three-times-per-week HD, a new minimum adequacy prescription target can be established by physicians to include specifications for TT ≥4 hours, with anything less becoming the exception rather than the rule.

The authors of this influential article in a widely read nephrology journal essentially dismiss in-center nocturnal hemodialysis and home hemodialysis options maintaining that "moving forward" will only be within the context of in-center models of care. Certainly, eliminating dialysis sessions less than 4 hours will be a giant step forward, yet it continues to fall short of the gold standard of the 1970's where people on dialysis continued to work and participate in all aspects of life.  They likewise dismissed every other day dialysis options which would eliminate the long interdialytic period every weekend which in itself would significantly improve survival. As much as I long to hear a "fresh perspective" from the dialysis industry, in the final analysis, this article does not contain anything but more of the same.

 

For the Love of Money: The DaVita Investigations

By Peter Laird, MD

Davita continues to encounter more allegations of improper business dealings in civil, state and Federal investigations. (here, here and here)  The allegations are augmented by whistle-blower civil lawsuits recently filed against the dialysis giant. The main thrust of the alleged illegal business arrangements focusses on the issue of improving Davita's bottom line at all costs but doing nothing to improve patient outcomes:

Whistleblowers file suit against dialysis provider DaVita Inc.

"The complaint makes clear that for years, DaVita has used different sets of rules to game the Medicare system and illegally inflate their government reimbursements at taxpayer and patient expense," said L. Lin Wood, attorney for the whistleblowers. "Taxpayers and patients should feel a sense of outrage when they read the complaint and learn how DaVita has become a multi-billion dollar business due in large part to corporate strategies and protocols focused on extracting every dollar possible from the government rather than on improving the care of chronically ill patients."  

The allegations against the dialysis industry as a whole of placing greed and profits above patient outcomes is not new. Belding Scribner, the inspiration behind chronic hemodialysis spoke out against the for-profit dialysis practices that have resulted in the developed world's worst patient outcomes . Dr Scribner spent his last remaining years critizing the emphasis on profits instead of saving lives with this unique technology. Dr. Scribner ironically gave up the riches of his shunt invention and instead focussed on simply saving lives when he gave his shunt freely to the world lending his criticism more relevance:

Belding Scribner: The Inventor of Shunt Dialysis

A less known aspect of Scribner's world-view was his abhorrence for the contaminating effects of the profit motive on medical care. He felt strongly that a physician's commitment to a patient should not be tainted by profits. “He was disturbed that what had been a ‘noble experiment’ was degenerating into a rush for profits,” says Dr Christopher Blagg, professor emeritus of medicine at the University of Washington. “In 1960 it wasn't usual for academic physicians to patent inventions. They sort of gave them away. He joked that if he'd patented the shunt he could have bought an island,” said Dr Blagg. “He was upset that academia was becoming more and more involved with commercial entities.”

Today, many aspects of the American dialysis experience of rapid patient turnover, short treatment times compared to other nations and overly aggressive ultrafiltration are directly attributable to the for-profit dialysis industry which has worse outcomes than the non-profit dialysis providers as noted in a recent study.

Dialysis Center Choice Makes Difference in Death Risk

Newswise — If you need dialysis for advanced kidney disease, where you get it could make a big difference. A large study found that patients in certain large chain facilities are significantly more likely to die than those treated elsewhere. Mortality was also higher in for-profit than non-profit dialysis centers.

“The differences were not minor,” said Yi Zhang, Ph.D., lead study author. “We need to find out what caused them.”

Whatever the outcomes of all of the DaVita investigations is, America is already under an indictment of the love of money more than the love of man in many aspects of health care. In my opinion, the love of money is most noted especially in the American dialysis industry that continues to reap the benefits of huge profits while delivering the highest mortality and worst outcomes of all the developed nations. It is time to place saving lives as the highest goal of dialysis treatment. Americans are not getting their money's worth out of delivering huge profits to these large dialysis organizations that dominate the provision of dialysis today. Many note that where there is smoke there is fire. If so, DaVita certainly may be on fire today.

America's Dialysis RCT's: Clinical Trials or Economic Assessments?

By Peter Laird, MD

The debate over dialysis  treatment frequency and duration and its associated outcomes started with the original inception of chronic dialysis by Belding Scribner in the 1960's. Thrice weekly dialysis came about essential from limited resources and the need to treat as many patients as possible with the few available machines and supplies. The researchers initially started with once weekly dialysis, then twice weekly sessions sometimes lasting as long as 24 hours. Three times a week dialysis for 8-9 hours was the minimum dosage that allowed patients to return to a rehabilitated life. In the 1960's, that was the most important the measure of dialysis adequacy.  Dr. Shaldon relayed his success with nocturnal treatments in England which soon became the standard treatment in Seattle and throughout the United States.

Shortly after the Federal government funded the ESRD program in 1973, Congress became increasingly interested in studies to show the best utilization of their funding coupled with outcomes. The first randomized and controlled dialysis trial was  the NCDS published in 1981 which compared high flux vs low flux and short (3-3.5 hours) vs longer times (4.5 - 5 hours). Mortality and hospitalization were the two main outcomes of this study which concluded that treatment times were not as important as maximzing urea clearances.  

Effect of the Hemodialysis Prescription on Patient Morbidity - Report from the National Cooperative Dialysis Study

This report summarizes morbidity in 151 patients in a cooperative trial designed to evaluate the clinical effects of different dialysis prescriptions. Four treatment groups were divided along two dimensions: dialysis treatment time (long or short), and blood urea nitrogen (BUN) concentration averaged with respect to time (TAC_urea) (high or low). Dietary protein was not restricted. There was no difference in mortality between the groups. Withdrawal of patients from the high-BUN groups for medical reasons was significantly greater than withdrawal from the lowBUN groups. Hospitalization was also greater in the high-BUN groups, but dialysis treatment time had no significant effects.

The data indicate that the occurrence of morbid events is affected by the dialysis prescription. Increased morbidity appears to accompany prescriptions associated with a relatively high BUN. Conversely, morbidity may be decreased by prescriptions associated with more efficient removal of urea if the dietary intake of protein and other nutrients is adequate. (N Engl J Med. 1981; 305:1176–81.)

Gotch and Sargent followed this report with a post hoc analysis of the data in 1985 introducing Kt/V as a measure of urea clearance setting minimal adequacy measures as the standard of care.  The NCDS and the post hoc analysis never rendered a true test of Kjellstrand's Unphysiology theory and with the element of dialysis time reduced to a brief comment in the report and summarily dismissed, the nightmare of short, violent dialysis sessions in America became the standard of care.

The second dialysis RCT in America was the HEMO trial published in the NEJM in 2002. The HEMO trial tested whether more intensive urea removal would improve outcomes compared to lower Kt/V targets.  The Europeans took a critical look at the HEMO trial and concluded that time and frequency of dialysis was not adequately tested as one of the independent factors as noted in one analysis of the study:

Dose of dialysis, convection and haemodialysis pateints outcome - what the HEMO study doesn't tell us: the European viewpoint

The HEMO results demonstrate that an increase of the dialysis dose above the currently recommended minimum dose (spKt/V of 1.3) or the use of high‐flux membranes do not improve patient outcomes. However, each of these high dose and high‐flux dialysis were associated with a trend towards a decrease in mortality. While this did not reach statistical significance, the trend could be relevant in clinical practice. The lack of a statistically significant difference does not imply equivalence; rather, there was not enough evidence to conclude for high‐dose and/or high‐flux superiority. Therefore, we should try to avoid making the same mistake we made in interpreting the NCDS results: as time of dialysis was not significantly associated with an improved outcome, its importance was neglected and time on dialysis was shortened, without considering the associated risks (difficulties in reaching ‘dry body weight’ and blood pressure control with related potential increase in cardiovascular morbidity and mortality). Therefore, the HEMO study results should not be used to justify reducing dose of dialysis; after our experience in interpreting the NCDS study results we should avoid P‐values being used to kill more patients!

The latest RCT is the Frequent Hemodialysis Network Trial Group (FHN) which had siginificant difficulties recruiting enough participants especially in the nocturnal portion of the trial. Due to the limited study parameters and combined end points, a true evaluation of the middle molecule theory and Kjellstrand's Unphysiology theory has never been adequately tested. In many ways, the lack of acceptance of a cohesive theory to test may be in part at fault with the American dialysis RCT's outcomes. The NCDS and the HEMO studies conducted their evaluations within the confines of the standard of care set forth by business decisions in the For Profit dialysis corporations in conjuction with the Federal governments cost containment ventures. The FHN attempted to evaluate alternative schedules but failed to recruit an adequate number of participants especially for the nocturnal study.

The short daily arm of the trial also confounded interpretation of the results by using composite outcomes of mortality or change in LVH as well as mortality change in RAND 36-item health survey. Many nephrologists dismiss the results due to this combined outcome that does not allow a separate analysis of each endpoint individually. The short time frame of this study also renders many of the questions unanswered that may have been answered by simply extending the time frame as the trends were already beginning to separate but did not reach statistical significance of each individual parameter.

To date, despite the heated debate on these issues of dialysis frequency and duration for over four decades, no large RCT has ever successfully evaluated Dr. Kjellstrand's Unphysiology theory specifically and methodically. If there is a better theory of adverse dialysis outcomes that is better fitted to testing, then that clinical theory and hypothesis should be the foundation of any further attempts to answer these longstanding questions. Submitting patients to scientific study in the guise of clinical questions that in reality are better suited to answering the business aspects of dialysis practice does not do justice to those willing to submit to these trials.  

It is time to rally behind a single theory and test it specifically and methodically finding the best clincial solution without forethought of what business model it currently fits into. If that theory fails to produce improved results, it should be abandoned and another explored. Once a clear clinical hypothesis surpasses the current standard in-center practice, the business models to fit that clnical parameter can then be developed to maximize utilization of limited resources. Focussing on the business aspects firsts in my opinion has clouded the clinical picture for decades here in America.

The Long Dialysis Weekend Might Kill You, But We Won't Change

By Peter Laird, MD

The NEJM of medicine recently published an article on evidence of the long dialysis weekend associated with an increased risk of cardiac death. This is not new information, in fact, Dr. Carl Kjellstrand noted the "unphysiology" of thrice weekly, short dialysis back in 1975 (here).  In his treatise nearly 40 years ago, Dr. Kjellstrand showed convincing data that the then newly adopted thrice weekly short dialysis schedule popularized by large dialysis organizations is harmful to patients. In a historical review by Dr. Blagg, Dr. Ing, Dr. Berry and Dr. Kjellstrand, the rational basis of more frequent hemodialysis is described in part due to the discoveries of unphysiology by Dr. Kjellstrand in the early 1970's:

The Rationale for More Frequent Hemodialysis – ‘Unphysiology’ 

In the early 1970s, Kjellstrand et al. [12, 13] investigated factors related the untoward effects of dialysis. They showed that large fluctuations in body weight, electrolytes, osmolality, and urea concentration were more important with respect to morbidity than concentrations of small uremic toxins or middle molecules. This led them to formulate the ‘unphysiology’ hypothesis which suggested that wide swings of solutes and fluids in the body were significant causes of morbidity in dialysis patients. Daily or continuous dialysis would more closely mimic the function of the native kidney by reducing the magnitude of solute and fluid oscillations and so would be expected to be superior to the usual intermittent dialysis regimens.

The debate over the long dialysis weekend is not a new argument at all. It is a forty year debate based not on clinical evidence in the end ananlysis but instead on the business of dialysis.  The thrice weekly dialysis schedule came about through the need to spread limited resources to keep as many people alive as possible. There has never been a single randomized and controlled trial setting this "standard" schedule, it was a business and financial decision that holds dialysis patients in America today prisoners of these fatal long weekends. Yet, instead of discussing how we can change this situation, many bloggers and influential nephrologists are calling for more studies before we change anything.

Interdialysis interval and mortality - dangers of a long weekend?

The data provides a compelling reason to do an adequately powered randomised controlled trial examing the impact of dialysis frequency and duration on clinical outcomes - though the logistical and funding issues around such a trial would be challenging to say the least.

How bad is the long break for dialysis patients?

What's next?: Further research is NEEDED before wide-spread practice alteration is warranted particularly given the profound policy implications, but our patients deserve this now. Specifically, we must determine:

o Optimal dialysis scheduling

o Patient preferences regarding frequency and duration (i.e.... will they come??)

o Cost-effectivness analyses (will more frequent HD reduce morbidity and thus cost?)

Mortlity Increases After 2-Day Interdialytic Intervals

Despite the study's limitations, the authors conclude the results provide sufficient clinical rationale for conducting a controlled trial assessing how dialysis services are provided.

It is time for action instead of further studies. The issue of more frequent and longer duration hemodialysis is a settled body of literature dating back to the 1960's and includes the recent FHN randomized and controlled trial which is largely ignored. Daily dialyis is a better solution and when applied in the setting of the home, it becomes the most cost effective and clinically beneficial dialysis modality.  

I am grateful for one more well done study, but I see no need for any delay in implementing more frequent hemodialysis. In the study in question from the NEJM, the most important statistic to consider is that 41% of the patients in this study died over a two year period of time. With more frequent hemodialysis and of longer duration, that number could have been reduced by more than 60% according to several observation studies. It is time to place wasted lives at a higher importance than maximizing profit margins for Fresenius, Davita and the other giants of the dialysis industry.

How quickly we forget that the Frequent Hemodialysis Network Trial came about by observational data suggesting higher mortality with thrice weekly hemodialysis back in the 1990's. Here we are nearly 20 years later and all that the dialysis pundits can state after a compelling study showing further evidence that the long dialysis weekend kills the patients that dialysis is meant to keep alive is a call to more studies.  When will we wake up to the circle of death surrounding all of these studies that continue to propagate more government grants for further study yet never apply the findings to saving lives.

The definititive randomized and controlled trial of adequate power is an impossible request since it would involve over 5000 patients, a number equal to the number of home hemodialysis patients in America today. 

High-Frequency Hemodialysis: Rationale for Randomized Clinical Trials

Given these uncertainties, we do not have sufficient data on the effects of daily and nocturnal hemodialysis to advocate for its widespread use and underwrite its cost. In 2001, Chertow (19) argued that a RCT of frequent hemodialysis was necessary to answer the fundamental questions of whether these treatments improve outcomes and, if so, by how much. He urged that the primary outcome of such a trial should be mortality alone or mortality combined with a major morbid event. . .

When these investigators considered study design, it became increasingly clear that a study that is powered to detect a mortality effect was not feasible at this time. We estimate that currently 55 centers in the United States and Canada are performing frequent hemodialysis five times per week or more. These centers are dialyzing a total of approximately 600 patients with high-frequency hemodialysis at home or in-center. Power analysis showed us that with 1 yr of follow-up, we would need to enroll >3500 patients in the daily study and >5000 in the nocturnal study to achieve 90% power to detect a relatively substantial 30% reduction in mortality. 

Ten years after the calls for the FHN randomized and controlled trial, forty years after Dr. Kjellstrand's unphysiology reports and over firty years since Dr. Scribner urged America to save lives, we can progress no further than to call for more study. History will not look kindly on this part of our American history that gave us the highest mortality rate for dialysis patients in the developed world. It is time indeed to apply what we have already learned and stop the catch 22 debates on more frequent hemodialysis that only propagate further study and little or no corrective action.