Slide 1

Today I have the pleasure to show you some preliminary results of a study that we are doing for the adequacy group.

Slide 2

As what was told to you before in the Adequacy group we worked on a list of indicators that should be implemented in the Registry for benchmarking and we rapidly thought that it would be interesting to see what already exists and what should be done.

Slide 3

That’s why we proposed this study. In fact this study has two parts, the first part had the aim to describe the pattern of methods used to measure Kt/V and other markers of dialysis adequacy in various European dialysis centres and this part is based on a centre questionnaire.

The second part is an observational study on treatment adequacy based on existing Registry data and it’s based on patient’s individual data. I will show you preliminary results.

Slide 4

For the first part we contacted 37 national and regional registries to ask them if they wanted to participate to this study. To date we have received 225 questionnaires from 10 countries, French speaking Belgium, Bosnia Herzegovina, Cantabria, Italy, Finland, 3 regions of France, Macedonia, Norway, Romania and U.K. I’ll take the opportunity to thank all these registries.

Slide 5

As you can see, the 225 teams that responded to the questionnaire are mainly public providers and they do mainly full care dialysis.

Slide 6

In the guidelines it is recommended that the delivered dose of haemodialysis should be checked at least monthly. In the questionnaire we see that 62% of the teams do check at least monthly the haemodialysis dose. But as you can see, there are 7% of the centres that never assess dialysis dose.
The majority of the teams does this measurement in the middle session of the week but there is no recommendation in the appearing guidelines which says you should do it in the middle session or after the long break.

Slide 7

In the guidelines it is recommended that the haemodialysis dose should be expressed in terms of equilibrated Kt/V. As you can see, there is a wide spectrum of answers that we get from the questionnaires. Some teams use only one method, some use 2 methods or 3 or even more. If we look at the centres that use only equilibrated Kt/V, it represents 9.5% but if we look at the centre that uses at least equilibrated Kt/V, it was 14%. It means 29 questionnaires. The majority of the centres uses URR, urea reduction ratio, it represents 57% of the teams. Single pool Kt/V is used by 37% of the teams and online measurement is used by 17% of the teams.

Slide 8

In terms of methods for the urea sampling there is no homogeneity in the way to do this sampling. There’s a large combination between the time, between the number of samples and the technique of slow flow or stop flow. As you can see for the time it goes from 30 minutes before the end of the session to  more than 30 minutes after the end of the session. What can be said is that in the European guidelines there is no standard method that is recognised, it is said that you should use a standard method but no standard method is recommended. The only thing is that if you want to calculate an equilibrated Kt/V, you should sample at 30 minutes after the session.

Slide 9

70% of the centres said that they don’t include the residual renal function in the Kt/V. In the European guidelines there is no recommendation to do this but there are some recommendations how to do this, if you want to do it.

Slide 10

Then we asked them if they changed recently the methodology to measure Kt/V. 75% responded no they didn’t change. If we look at the proportion of patients of teams using equilibrated Kt/V among them who didn’t change we see that it’s 18% of the teams that uses equilibrated Kt/V. In the teams who recently changed their methodology there was 14% who used equilibrated Kt/V, so there’s no difference between these two groups. If we look at the 35 teams that changed their methodology, 73% changed their methodology because of the publication of the European Guidelines but it represents only 24 questionnaires.

Slide 11

This study is based on a voluntary participation. As I told you 10 Registries participated, it represents 26% of the European Registries but within a Registry when they accept a participant the centre response was very high at 72%. It’s a questionnaire, there’s no quality control and maybe the nephrologist could answer what he wants to answer. The main limit is that maybe we cannot exclude a positive selection bias and we can imagine that people who do this measurement will accept more to fill in the questionnaire than centres that don't do this measurement. So maybe it's more than 7% of the centres that never do this measurement.

Slide 12

For the first part I will conclude that 6 years after the publication of the European guidelines only 14% of the teams use the recognised methods. So the question is, are these guidelines applicable?  What should we do? Should we implement these guidelines? Should we change our mind? Just to remind you the KDOQI 2006 recommends single pool method and maybe the future is online measurements because it doesn't need urea samples.

Slide 13

So the second part is based on patient individual data. We also contacted 37 registries and we get to date 24,000 patients’ data on 7 countries, French speaking Belgium, Cantabria, Finland, France (13 regions), Macedonia, Norway and Slovenia.

Slide 14

So, these patients were patients on dialysis at the end of December 2005. Their median age is 67, 60% of males, BMI at 24, a quarter are diabetics and they have been treated for 3 years. The majority has a native fistula, they are in full care centres for 3 or 4 of them and they are on conventional haemodialysis for the majority.

Slide 15

Now, the guidelines recognise that a minimum time of 12 hours a week is desirable. As you can see 83% of the patients received at least 12 hours a week. If we look more precisely at the number of the sessions, we see that 5% of the patients received less than 3 sessions a week. 1% of the patients received 5 or more sessions a week, so-called daily haemodialysis. If we look at the middle end of the session, 1% of the patients received long haemodialysis more than 8 hours. 6% received short haemodialysis less than 3 hours.

Slide 16

Now, if we focus on the patients that received less than 3 sessions a week, it represents 5% of the whole population. As you can see, 96% of this group received less than 12 hours a week. They are older 74 years, a little bit less male, the same frequency of diabetes and they have been treated for a shorter time but they are not beginners, We thought maybe it could be the way to begin dialysis slowly increasing the dose. The median time is 1.5 years. In the guidelines it is said that twice weekly schedules are not recommended and it is said that treatment time and frequency should be increased especially in aged patients and what we see is the opposite.

Slide 17

If we focus on the patient on daily haemodialysis, it represents 0.6% of the patients. They all have more than 12 hours a week except one. They are a little bit younger, 55 years, more males, the same BMI, the same frequency of diabetes but they have been a longer time on dialysis, 5 years.

Slide 18

Now if we look at the Kt/V, the Kt/V is the value given by the nephrologist in the Registry. So we don’t have an idea of what method was used to calculate this Kt/V but if we pull it all together we see that 87% of the patients have a Kt/V equal or more than 1.2 and 61% have a Kt/V equal or more than 1.4.

Slide 19

If we look at the patients who have a Kt/V less than 1.2, it represents 13% of the patients. As you can see 28% of these patients have less than 12 hours a week, 13 have short haemodialysis and 8% have less than 3 sessions a week. The median age is not different from the whole group. There are more males, they are bigger, a little more diabetics. I remind you the guidelines, the equilibrated Kt/V should be over 1.2 which corresponds to a single pool Kt/V of 1.4.

Slide 20

As the first part this study is a voluntary participation study, so there is only 18% of the registry that participated but within the registry who participated we can assume that we have all the patients. The problem is that because of the weight of France it represents 71% of the whole group and we cannot assume that the way patients are treated in France is representative of the rest of Europe.
The most interesting thing is that Kt/V was not available in 2 registries among 7 and in the registry where it was available we had 65% of missing data. We also have 14% of missing data for frequency and duration of the haemodialysis session.
Because of the voluntary participation, because of the high rate of missing data we cannot exclude a positive selection bias. Maybe the nephrologist who doesn’t have a good Kt/V doesn’t give this value in the Registry. The second limit is that we didn’t link the results at an individual level to the results in the questionnaires; we will try to do it because it was not always the same country and not the same identification code so we have to work on it.

Slide 21

So the conclusion of the second part is that 83% of the patients have at least 12 hours a week as recommended and when available the Kt/V is over 1.2 in 87%. The discussion is that although considered as a standard in the all the recommendations, in all the publications, Kt/V is not a priority among the registries.

Slide 22

So, a little bit provocative I would say that today adequacy guidelines are not well implemented and although registries are I think the best tool for this, registries today are not well organised to be the evaluation tool of these guidelines. So I ask why?

Slide 23

I will thank all the participating registries, all the nephrologists who gave the data and filled in the questionnaires, I will also thank the ERA-EDTA registry coordination who makes this possible, the adequacy group members and all the future registries because I know some of them will participate.

Slide 24

Chairman: This is open for discussion.

Question: Cecile congratulations, this is very important, this is probably the single most important determinant of the outcome of dialysis patients and what you’ve demonstrated is that there’s no consensus on how to measure the quality of dialysis across Europe. But I would say that we should now go back to the guidelines group and say that you haven't specified clearly enough what should be measured and how it should be measured because until the EBPG say how a post dialysis sample should be taken and achieve a consensus on that and until they say how an equilibrated Kt/V should be calculated the registries cannot and you’ve already demonstrated this, they cannot collect data, their data would be meaningless because we would not be comparing the same data items, if they’re collected in different ways. So I think the report should go back to the EBPG saying get your act together.

Dr Couchoud: I fully agree.