Monday at the Annual Dialysis Conference - the debate

By Bill Peckham

I attended a great session this afternoon at the Annual Dialysis Conference:

Challenges to and Defenses of Dr. Kjellstrand’s Keynote Address at the 2009 ADC: Clinical Observations vs. Randomized Controlled Trials (RCTs) in Dialysis Research
Richard Amerling, MD, Presiding

• RCT Is Redundant if Observational Studies Consistently Show that Daily HD Is Superior- Zbylut Twardowski, MD
• Observational Studies Are Not Always Reliable Due to Lack of Randomization and Biases - Marcelo Tonelli, MD
• There Is Not Enough Observational Evidence to Support Funding and Widespread Application of Daily HD - James Sloand, MD
• The Waste of Life, Time, and Money Waiting for the Results of RCT in Daily HD - Carl Kjellstrand, MD

I really enjoyed the exchange; I'm looking forward to writing about it but not tonight.

Maybe I'll be able to write something  while I'm traveling to Baltimore tomorrow for the TEP (the full roster of all six TEPs is posted). Once the meeting starts DSEN may go quiet for a few days.

Comments

[Linda Gromko, MD]

As a physician, I am always intrigued by the balance between "evidence based medicine" and what I call "anecdotal medicine." As a Home Dialysis Care Partner, we keep coming back to the observation that if you ask any MD or RN what they'd prefer if they had ESRD, it's frequent Home Dialysis! Sometimes anecdotal medicine MUST move to the forefront when time is of the essence -- and when you've got skin in the game!
Linda Gromko, MD
www.LindaGromkoMD.com

[Peter Laird, MD]

The biggest issue is the barriers to completing randomized controlled trials of sufficient size to answer the questions of morbidity and mortality in a quotidian dialysis setting. The current FHN nocturnal study has only been able to recruit a little over a 3rd of the 250 patients originally planned for this study. At the ADC they mentioned some of the characteristics of this branch and I was quite surprised by the excessive number of cigarette smokers and high catheter use in this group. Both of these factors will blunt the effectiveness of quotidian dialysis lending the results less impressive than could be hoped for when published. Obviously, if these were exclusion factors, the study size would have been cut nearly in half jeopardizing its completion even with such a low number of participants.

Many patients will not accept randomization to the possibility of remaining in-center which is one of the biggest barriers to completing a RCT in home nocturnal dialysis studies. The use of surrogate markers of morbidity and mortality are reasonable targets, yet it adds another layer of variability that could skew results.

There are many times that RCTs cannot be completed for ethical issues in other areas of medicine that has not kept them from adopting the results of observation studies into current practice patterns. Smoking cessation and renal transplant are two such interventions widely accepted that neither have been subjected to RCTs. Yet, for dialysis, the only acceptable study to many looking at these issues is to do an RCT. This is a catch 22 since payment for optimal dialysis strategies cannot be proven by a large enough RCT. Observation trials when done well do offer meaningful directions.

Dr. Kjellstrand makes a convincing and impassioned plea to proceed to optimal dialysis strategies. It is time, it is past time to implement optimal dialysis.