KDIGO: NEED AND APPLICABILITY OF GLOBAL GUIDELINES

Garabed Eknoyan, Houston, USA

Chair: Garabed Eknoyan, Houston, USA

Francesco Locatelli, Lecco, Italy

Prof G. Eknoyan Renal Section, Department of Medicine Baylor College of Medicine Houston, TX, USA

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Slide 1

Thank you very much Francesco. I would like to thank the organising committee for the opportunity of making this presentation and also the symposium. I’d also like to thank them for the weather though not the temperature. It’s nice not to be in the rain but we don’t have to trade it off with the heat.

Slide 2

What I will do during my presentation is begin by giving you the background of how we got 2 evidence based guidelines and what are evidence based guidelines, why do we need them in clinical practice and then the need for a global approach to clinical practice guidelines and finally propose an approach that will make them applicable to nephrology.

Slide 3

Now, in terms of how did we get to evidence based guidelines, this is a very quick rough overview of how things evolved and in a way led us to guidelines.

Slide 4

It began like most things with data collection that showed variability, and quality utilisation and costs, which is always a concern of governments and payers and this led to a number of corrective attempts that were initially began again by payers and the government or the regulators, which consisted of peer review, utilisation review, profiling and a number of other terms that one can use and in the process they even developed some guidelines and in a way were instrumental in initiating quality assessment and continuous quality improvement processes. Parallel to that was development in health care research, which principally came up with things like decision analysis and metanalysis that led to some consensus statements by various organisations and also in quotation marks “guidelines”. However, ultimately it was the emergence of evidence based medicine in the 1990s, not that medicine had not been evidence based, it’s just that medicine was changing and this was a response to the change in the practice of medicine which introduced the notion of structured data analysis.

Slide 5

One of the initial organisations was the Federal Organisation in the United States, the AHCPR which was the Agency for Health Care Policy and Research that really put the basis of clinical practice guidelines. This slide just shows in a very quick way the use of the world evidence based medicine in the literature through the ‘90s, the mid ‘90s and you can see the exponential rise where it didn’t even exist in the early 1990s to the dramatic increase that continues to go up with time.

Slide 6

Now the reason the need for evidence based medicine occurred was the information overload and the many effective treatment alternatives that became available and the increased outcome research that was occurring. So that there was need for synthesis and quantification of the data that was there. It was overwhelming particularly for the practitioner but certainly for anybody.

Slide 7

Synthesis of information has two pathways, one is the traditional pathway and one that is still practiced, which you bring experts together and they tell you what you need, they tell you that they know the literature, they tell you what is important, they begin by the conclusion because they know the answers and they’ll make recommendations. What evidence based medicine provided is the systematic synthesis which begins by posing a question, defining strategies, determining the end points that you want to examine, analysing the data that is out there and making recommendations that are data driven.

Slide 8

So the principal products of evidence based medicine when you do systematic data synthesis is in a way the careful narrative reviews but more importantly the metanalysis of the data that is there or the clinical practice guidelines or perhaps the recommendations that can be made on the basis of the systematic data synthesis.

Slide 9

So the term clinical practice guidelines is a relatively new term that AHCPR was sort of instrumental in bringing about.

Slide 10

But the Institute Of Medicine, the IOM on that slide is the one who came with the definition that subsequently was adopted by the American Medical Association and generally accepted that guidelines are systematically developed statements, that’s the systematic analysis component to assess practitioner and patient decisions about the appropriate health care for special conditions.

Slide 11

If you go back to the outline that I showed in my previous slide, clinical practice guidelines are in fact based on metanalysis and narrative reviews.

Slide 12

It’s that type of analysis that leads to clinical practice guidelines, the big difference being that clinical practice guidelines give statements that are simple and direct of how you can take some piece of information and apply it to practice rather than just the data analysis and of course, the systematic data analysis begins by clinical research data that is out there and some basic research, although it’s mostly clinical outcome type of studies or clinical trials that drive clinical practice guidelines.

Slide 13

One other outcome of clinical practice guidelines is that in developing them systematically for the broad topic it allows to identify gaps in clinical data that need to become issues, topics of research that then feedback the research that is going on and this approach is really an article that the Director of the NIH in the United States wrote in an editorial in the New England Journal of Medicine called Translational and Clinical Science: time for a new vision but that’s the mechanism that drives translational research, essentially this gives you the guidelines but also identifies the gap so that research can be made to provide the continuous process that is needed to develop guidelines.

Slide 14

Why do we need then clinical practice guidelines?

Slide 15

I’ve already covered the first four, the next four are really items of measuring performance and making sure that the changes occurring and this is either driven by physicians or by providers.

Slide 16

But key in these reasons to why we need guidelines are the last 2 statements. Patient-physician relationships are changing, they are not what they used to be and there is a higher expectancy from the educated public.

Slide 17

The real educated public knows enough to get the information where you get it, they can go to Pubmed or any of the computers and they come to you with a diagnosis and sometimes knowing more about the subject at least than I do and then I have to check it out.

Slide 18

And if they’re not that sophisticated then industry takes care of that, they have the ads that are on television or in the news and if it’s a psychiatric drug, if they don’t achieve the mood that is expected or the energy from correcting urinemia, they’ll come back and tell you what you are doing wrong.

Slide 19

So we need the guidelines because they provide information to both practitioner and patient. I think that’s important to remember in guideline development and implementation.

Slide 20

It takes two parties, this is not a Doctor business only this is a doctor-patient relationship that has to be addressed and the outcome then can be just like Janus a good guideline or a bad guideline. Part of it begins by bad guidelines are just like you stabbing yourself. On the other hand good guidelines are like good wine but even good wine can be made better, it depends on who you drink it with and what you drink it with.

Slide 21

So for a good clinical practice guideline part of the goodness begins up here of how the systematic development of the guideline but unless that guideline is implemented, it improves performance, you can document that performance is improving and finally, demonstrate that you can improve outcome then that’s not really a good guideline from which you’re getting the full benefit.

Slide 22

That’s why the statement has been made that the implementation of rigorously developed practice guidelines can lead to even greater improvements in patient care than the introduction of some new technologies.

Slide 23

Indeed many people believe that and hence the proliferation in guidelines that occurs and this is just a number of the guidelines that somebody in the general practice needs to be informed about and as you can see, the editorial in BMJ calls it the tower of Babel. I’ll come back to that.

Slide 24

That’s why the need for global approach to clinical practice guidelines.

Slide 25

There are several organisations that are developing guidelines, principally the big organisations are the European Best Practice Guidelines, the Canadian Clinical Practice Guidelines, the Renal Association Standards, the CARI Guidelines, and the KDOQI Clinical Practice Guidelines.

Slide 26

Now that’s a multiplicity of guidelines that have often looked at the same topic and it is the people working in this entity that realised that there is an increasing prevalence of kidney disease, which needs to be attended to and the problems encountered by patients are universal and while resources vary of how you can apply, them the science of evidence based care of patients is independent of geography or borders and that there is room for cooperation which led to the establishment about 3 years ago of the entity called KDIGO or kidney disease improving global outcomes.

Slide 27

Those of you who would like to have additional information there is a booth, it’s booth 32 in the exhibit hall, which has much more information on some of the activities that it does.

Slide 28

The official authority of KDIGO after it became incorporated as a foundation is vested in the board of directors that consists of some 44 members and the way these individuals were selected is because of their expertise, their clinical expertise and familiarity with guidelines. Nobody was selected because they belong to an organisation and no organisation appointed them as directors, they were just voluntarily agreed to get together and form this organisation.

Slide 29

There’s a third from the Americas, North and South, a third from Europe and a third from Africa, Asia and Australia.

Slide 30

The mission statement of KDIGO is to improve the care and outcomes of kidney disease patients worldwide through promoting coordination, collaboration and integration of initiatives to develop and implement clinical practice guidelines.

Slide 31

It has a methodology and a process of following mainly the scientific rigour of the evidence based, the multidisciplinary and international composition of the workgroups that develop the guidelines, the guideline development workgroups and then the independence of these workgroups which have the final responsibility.

Slide 32

Then an open reviewed process before the guidelines are published. KDIGO has embarked on the development of 3 guidelines currently. One is on hepatitis C that will ready for review some time early next year. The second on mineral and bone disease, the so-called old renal osteodistrophy and the third is on transplant recipients.

Slide 33

Now are these guidelines applicable, if they are developed under the KDIGO?

Slide 34

The mission statement that I mentioned of KDIGO emphasises promoting coordination, collaboration and integration of initiatives to develop and implement guidelines.

Slide 35

And to this end KDIGO convened a meeting about three months ago in London where representatives from the 5 major guideline development groups met and arrived at certain agreements that are still in the process of being spelt out and defined.

Slide 36

One was the notion to globalise the evidence. The evidence is universal. It is the decision of how you’re going to apply the evidence that is local and that in developing guidelines, new guidelines like the 3 I mentioned would be global guidelines and which would be allowed to be adopted for local implantation and that for existing clinical practice guidelines there will be a coordinated and cooperative process between all 5 groups as these existing guidelines are updated and that we would work all together in doing that.

Slide 37

This is not a new notion, this is what the WHO has already recommended and has tried to initiate worldwide and in a way hopefully we’re in setting the tone to how this thing can be done. WHO or the World Health Organisation has guidelines on how to do guidelines in which they have a 3 stage process. Stage 1 which is developing the evidence which is developed only from the perspective of the patient and what is best for the patient and if resources were unlimited, essentially you could do the best thing that can be done for a patient. However, as scientific as that may be the reality is there are variations in available resources and so the stage 2 examines at the model in trade off between very limited and unlimited resources. In essence it identifies core things that everybody should have and are affordable. In stage 3 becomes the local adoption where the evidence based that led to the guideline development is adopted by local guideline development group in grading the recommendations using the scientific approach that was developed in the previous guidelines but now in the context of the local consideration.

Slide 38

So all we have to do is really follow what the WHO recommends and in fact, we have begun talking to WHO on how we can work in this area together and hence the last part of the mission statement that ultimately a guideline is for special conditions that are unique geographically.

Slide 39

The existing guideline review process which begins with the internal review, organisation review and open review that KDIGO had already adopted has to be modified whereby people involved in guideline development begin to get involved earlier in the process. As I said this is a process that we’re working on, I can’t give any more specifics other than the fact that several groups have agreed to follow this process.

Slide 40

So in conclusion...

Slide 41

there is a tower of Babel of existing guidelines.

Slide 42

However I think I can report that at least within nephrology, we have began to develop a common language that the tower will be built and it’s not going to be something that falls to pieces because of divergence in language and by doing that hopefully we will facilitate the whole process.

Slide 43

And in closing Mr Chairman I’d like to thank you and everyone for your attention and this opportunity to speak at the 43rd congress. Thank you very much.