Legislative standards of care questions

I don’t know if you have had a chance to check out our wish-list so far for a Colorado state bill: http://forums.homedialysis.org/showthread.php/3179-Standards-of-Care-in-Colorado

We haven’t heard a “STOP YOU LUNATICS!” yet, so I guess we will keep going.

Anyway, I know you hate answering about Kt/V, but I did have a couple of more questions. I was looking at the formula for standardized Kt/V and it looks like it takes into account that person is producing urea while receiving dialysis? Is that correct?

And for one of the purposes of our bill - increasing time - using standardized Kt/V would be a better number than Kt/V?

John Leypoldt has written (in a paper in HDI in 2004) that …

“Urea standard Kt/V urea (stdKt/Vurea) has been proposed as a dose measure to assess the adequacy of dialysis treatments of arbitrary length and frequency. It is based on two fundamental assumptions: 1) that clinical outcomes for hemodialysis and peritoneal dialysis patients are equivalent and 2) that the equivalency of such clinical outcomes is achieved when the mean predialysis blood urea nitrogen or urea concentration is identical for both therapies”

and further that …

“it is proposed that urea stdKt/Vurea is a dose measure for both water-soluble and protein-bound toxin clearances; therefore, this parameter may be a practical dose measure for assessing the adequacy of dialysis during treatments of arbitrary length and frequency.”

In a commentary on this paper, Todd Ing has written that …

“Dr. Leypoldt asserts in the present communication that the standard Kt/Vurea concept is based on the hypothesis that equal peak or predialysis concentrations of a water-soluble uremic toxin in blood, such as urea, predict equivalent overall patient outcomes. Indeed, this standard Kt/V value … may serve as a universal dose gauge for hemodialysis therapies of arbitrary length and frequency. Formulas and nomograms depicting the relationship between the single-pool Kt/V per treatment and the weekly standard Kt/V for various treatment durations and different treatment frequencies have been reported. In the instance of 6 times per week, short daily hemodialysis therapy, the minimum per-session, single-pool Kt/V corresponding to a weekly standard Kt/V of approximately 2.0 (for patients with a residual renal function of less than 2 mL/min/1.73 square meters surface area) has been suggested by Kidney Disease Outcomes Quality Initiative (KDOQI) to be 0.5. [It is noteworthy that a weekly standard Kt/V value of 2.1 is closely equivalent to that dialysis dose provided by 3 conventional, thrice weekly (e.g., 3.5 hours per session) hemodialysis treatments with a singlepool Kt/V level of 1.2 each]. Future studies are required to determine if this novel standard Kt/V concept is the dialysis adequacy measure of choice.”

In response to your two questions, I would say that the (likely) answer … if you must use Kt/V (a measure and concept with which I disagree as a measure of good dialysis: see many previous discussions!) … then the answers are (likely) yes and (certainly) yes.

I am not sure there is much more I can add.

Thanks! I will carefully read over what you posted and try to figure out what the heck you are talking about. (think I understand the “(likely) yes and (certainly) yes” part)

So I assume (always dangerous) asking for a weekly std. Kt/V of 2.2 or greater is doable? Any particular number you like to see?

By the way, I did give your Good Dialysis Index to a young wanna-be neph I know.

Sorry: I have been away …

So, first, let me apologise for the tardy response.

Yes … I have looked at your submission re the standards of care in Colorado.

I don’t feel competent (with your US health policies and practices) to comment on points (4) and (5) of the ‘Standards of care’ document prepared by DialysisEthics.org except to say that we do prefer (but do not limit) blood transfusions - relatively uncommon though they be - to our incentre units, though my comment on point (2) – see below – may have some bearing on this.

I cannot comment on (5) as, in Australia, dialysis is funded by government and is non-competitive by design. As such, point (5) is irrelevant to us here. I am unable to comment on the need for such a concept – as we have none – and to me, the dialysis-for-profit ethic that seems to dominate in the US is arguably the major and overarching problem that your system has created - to the detriment of the patients - and one that you must, somehow, solve. Remember … these are my personal views.

As for passing comment in your points (1), (2) and (3) … again, while I have strong personal views about the inadequacies of some of the assessment and delivery concepts extant in the US, I need to caution that any comments I make are made from the ‘outside looking in’ and are from a nephrologist who works - may the gods be thanked - in a very different (and dare I say it, more equitable) system compared with that within which most function in the US.

Re (1) … I would agree with the premise as written in your question to me - it is, after all one I believe in and espouse - and I also concur with the reasons that underpin your argument.

While I personally do not believe that dialysis should be delivered to a Kt/V of any ilk and format (Kt/V, spKt/V, stdKt/V, dpKt/V, eKt/V etc) or to any number for any of these various Kt/V variants used as the lone determinant and yardstick of what is ‘adequate’ … as, sadly, seems to have been (and arguably still is) the dominant proposition in the US … I do accept that you are stuck with Kt/V in some guise for the medium term.

My own view is that while Kt/V represents (in some measure) urea clearance … and it should be remembered that even that and the assumptions that surround Kt/V can be challenged … urea clearance does NOT represent the be-all and end-all of what dialysis should set out to achieve for patients with ESKD (call it CKD5d, if you like).

I believe that dialysis and the goals it must attempt to achieve for each patient are far wider than urea clearance alone. That belief underpins my slightly heart-in-mouth attack on the bastion of ‘dialysis adequacy’ … as I realize I am treading on an icon when I bypass Kt/V to a more holistic measure of what good dialysis should be: the Good Dialysis Index (GDI).

The GDI (as I have suggested) is essentially a ‘concept measure’ to show that far more than Kt/V is important in achieving good care, good dialysis-dependent health and good outcomes. The GDI seeks to restore the patient, as a living, suffering, but hopeful human being into the assessment of what is good dialysis. While Kt/V lives on in the GDI as only 1 of 20 measures, it lives a far less prominent existence!

Remember though: the GDI remains to be validated … and indeed, it may never be as it would require an extensive, multi-site effort to do so … but like the HDP (also never validated), it seeks – if nothing else - to implore of colleagues a pause for thought.

Remember, also, that the GDI is but a figment of my imagination as I thought - broadly - around the topic of ‘what might constitute good dialysis’. As I did so, I recognized that any guide to better dialysis would need to incorporate patient issues, their symptoms and their desired outcomes, health care professional issues and desired outcomes (potentially and in actuality different from those of patients, yet equally as valid), laboratory measures, medication endpoints (especially around blood pressure and anaemia), and process-generated data.

While the GDI drags all these into its mix, at the end of that day they are just the 20 things-that-matter that I , as an individual, came up with … there was no ‘group’ consensus exercised here!

Are they the right questions? Are they balanced? Well, broadly, I think so – but others might think not, or suggest modifications. And, frankly, I wish they would!

As for a desired ‘number’ for Kt/V … this differs, paper to paper, reference to reference, guideline to guideline - and from Kt/V ‘version’ to Kt/V version.

The KDIGO working group, when referring to the KDOQI guideline …

Minimally adequate (dialysis) dose: the minimally adequate dose of HD given 3 times per week to patients with Kr less than 2 mL/min/1.73 m2 should be a spKt/V (excluding RKF) of 1.2 per dialysis. For treatment times less than 5 hours, an alternative minimum dose is a URR of 65%.

… says … that the recently published European guidelines recommends substantially higher minimal doses of HD based on an eKt/V measure, (corresponding to spKt/V minimum targets of about 1.4 to 1.5) then those recommended by the NKF KDOQI guidelines

I agree. I (and others) believe that the US guidelines actually direct subsistence and not good dialysis. The European Renal Best Practice guidelines are set to a much higher standard than are the US guidelines … as, mind you, are the European water quality standards and a raft of their other dialysis-defining measures.

Our own Australian CARI guidelines = Caring for Australians with Renal Impairment … which I also like better than KDOQI (obviously I would, as I was involved in writing some of them) … includes the following summation as regards the minimum weekly Kt/V(s) for PD and for HD:

… typical weekly CAPD clearance is 2.0. Since the blood urea does not change, total weekly URR is also 2.0, or 200%. A typical weekly haemodialysis clearance is 3.6 (1.2 x 3). The URR per dialysis is about 65%, for a total weekly URR of 195%. This is very close to the URR achieved by CAPD and the outcome is similar in both cases. URR is easier to measure than Kt/V. It may also be a more fundamental measure of what we are trying to achieve in dialysis.

We ignore Kt/V here … no-one measures it!

Our CARI guideline (3) states: “the (per treatment) target Kt/V should be 1.2 (or URR of 65%)”.

In our own unit, we do not accept less than a URR of 70% (though I prefer to call this measure the PRU = the percentage reduction urea)

So, to answer your question, while I detest Kt/V – or, rather, the confinement it implies - most regard that the minimum per-treatment Kt/V should be 1.2 (I think 1.3) and thus the minimum weekly Kt/V should be 3.6. My preference is the URR (per treatment = 70% and weekly = 210%).

As for the other 2 points in your Colorado document (2) and (3) …

Point (2) … registered nurses (most with dialysis or renal qualifications) and not dialysis ‘technicians’ (whatever is meant by that term) provide dialysis in Australia.

The general nurse-to-patient ratio that applies in most dialysis services across the country = 3.5 patients/nurse though in-centre patient:nurse ratios are often somewhat less and some partial self-care community-based satellites are out at 4:1 or beyond. While there are also some state v state differences to this broad principle, these generally include only minor variations.

Point (3) … Australia legislated to abolish the reuse of dialysis consumables including dialysers in around 1992 or 1993. It is illegal to reuse a dialyser here – and has been for 20 years and I strongly support that approach!