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March 07, 2010

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M3Riddler

Unfortunately, I have to agree that "American Surgeons are Still Last" as posted above. There are some exceptions to this. I am finding this out for myself. I have been to 3 different surgeons regarding my fistula for revision or creation of new fistula. All three surgeons have very different ideas on how to revise. Two out of the three wanted to just throw a graft in. After researching myself and asking questions it appears there are now "other" options than suddenly are now available than a graft. Why coudln't they suggest this without educating myself on the topic. As I have always stated, the more you know, the more the docs are willing to openly tell you.
There needs to be more research on the topic of Fistulas in the United States. They have been using fistulas for many years and there is little advancement in my opinion...

Miriam Lippel Blum

Peter,

Thanks for your report and perspectives on the the conference proceedings. While there is so far for the US to go in regard to dialysis, it is good to have hope. I hope that we'll be able to meet when the conference is in Phoenix since I am so close I will just have to make the trip.

Best wishes always,
Miriam

somerville

I love the 1984ish 'doublethink' in the phrase, 'NxStage Freedom.' Where is the freedom in having your home invaded by the Sisyphean duty to undergo an elaborate medical process six days out of seven forever just to stay alive? Every unreasonable tyranny always seeks to disguise what it is doing by adopting the exact opposite name for its institutions from what they actually deserve, such as the French Revolution's 'Committee of Public Safety' which executed thousands for no gain in public security.

Peter Laird, MD

The NxStage System One study is quite appropriately named in that I have FREEDOM from nurses who refuse to follow basic hand washing standards, it gives me FREEDOM to set my own schedule, it gives me FREEDOM to choose what chair to sit in, it gives me FREEDOM to set my own ambient temperature, it gives me FREEDOM to eat and drink whatever I want on dialysis, it gives me FREEDOM to exercise my right to health care related privacy, it gives me FREEDOM to choose my own health care treatments, it gives me FREEDOM to exercise patient related health autonomy. I would say it has an appropriate name indeed.

John Daugirdas

Dear Peter,

I always enjoy reading your thoughtful comments, but here you were a bit off-base in 2 areas:

1) You wrote:
"The FREEDOM study may be one of the first to dramatically validate Dr. Scribner's hemodialysis product (pdf link) which gives much more weight to frequency than to duration of dialysis."

Actually, the hemodialysis product (HDP) is not that different from the standard Kt/V as recommended by KDOQI 2006. For an example, see:

http://ureakinetics.org/files/hdp_vs_stdktv.pdf

where I modeled the same treatments as in the Scribner/Oreopoulos paper (D&T 2002) and calculated the approximate standard Kt/V values and then plotted the hemodialysis product (HDP) against std_Kt/V. As you can see from the plot, the relative values of HDP and standard Kt/V with the various more frequent and extended session length schedules are quite similar.

2) You also wrote:
"In addition, in juxtaposition to the FHN closed mouth investigators, the FREEDOM study has already published several aspects of their interim results and has two more announcements tomorrow in the Monday morning sessions of the ADC. Have we lost the love of research that money talks more than disseminating preliminary results in meetings such as this as in times past?"

None of the results of the FHN trial are in yet. Patients are still running on the trial, with an expected end date in Spring of 2010 (very soon now!). In a double-blind trial, interim analyses are never released to the study investigators until the trial is completely finished to avoid the risk of biasing the investigators. In contrast, in an observational or unblinded randomized trial, preliminary results often are made available.

So your statement about "money talks" as a reason for not disseminating results of FHN is not relevant. Hopefully the primary analyses of the FHN studies will be ready for presentation at ASN in 2010, assuming that we can finish up the data analysis in time for the abstract deadline.

With best regards,

John Daugirdas, MD

John Daugirdas

Ok, I misspoke :-). The FHN is not, of course, a blinded study. But the principle is the same. If preliminary trends in data are released to the investigators while they have still not finished collecting the data on all patients, there is a risk of biasing the data not yet collected.

JTD

Peter Laird, MD

Dear John,

Thank you for your thoughtful explanations on both the dialysis product and the release of preliminary information. First of all, I have modified my post and deleted some of my commentary on the issue of preliminary results that you found offensive. Forgive me for expressing my disappointment of the lack of data that I had looked forward to seeing during the ADC which I had mistakingly thought was the purpose of the update. Your explanation is quite reasonable and I have edited my post to hopefully reflect more accurately my own response at the session in question without undue reflection against anyone involved in the study.

Perhaps it was mentioned during their presentation on why no interim results were released and I missed it, but if not, that may be a good starting point for such a lecture in the future explaining why interim results might actually interfere with ongoing data collection to those of us not involved in the research world.

Secondly, thank you for the graph that you put together which really does validate the hemodialysis product as a secondary method of calculating the adequacy of dialysis. The correlation between the two methods is quite astounding really. It may be useful to use that graph in future posts should the issue come up again in another post if you will grant your permission to do so with appropriate credits.

Thank you once again for your thoughtful correction of those points in my post.

Most sincerely,

Peter Laird, MD

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