Steve Elias: Welcome everybody once again to the Vein Magazine Podcast, or better known as vein specialists sitting around and talking, having drinks. Today we're at the American Venous Forum annual meeting, and with us is Peter Lawrence from UCLA, Peter Gloviczki from the Mayo Clinic and Mark Meissner, from the entire world because he is the world's best-known vein specialist. Is this true Mark Meissner?

Mark Meissner: I have no response to that Steve because that clearly is not true.

Steve Elias: It takes three vein specialists to do a good job writing new guidelines on the care of varicose veins. And that's why we're here today. We have three people that are on the SVS AVF committee to rewrite the guidelines for the care of patients with varicose veins. Why do we need new guidelines? Don't we already know what we need to do to take care of varicose veins, Peter?

Peter Gloviczki: We have an idea of how to take care of varicose veins, but it's time to write new guidelines. The last guidelines we wrote were published in 2011, so that covered the literature until about the end of 2009. A lot has happened since that time. New evidence emerged, new treatment modalities were introduced and independent of the progress, every clinical practice guideline has to be rewritten every five years.

Steve Elias: What are some of the new things we need to address in the guidelines?

Peter Lawrence: We need to both respond to the MEDCAC report, which was done by CMS and has a big impact on reimbursement. There were several issues there that many of us disagreed with. There were the conclusion, the MEDCAC, one of them being the optimal way of imaging, and the conclusion that duplex ultrasound was not established as the best way to image veins. And you know, all of us, I think, believe that that's the case. So there needs to be, the guidelines need to really address that issue and look at the literature.

The second is since 2011 there's been the introduction of non-thermal as well as thermal techniques to close veins.

The third thing new guidelines need to address is that we see many physicians who are considered vein specialists ablate the perforator vein without any other vein being ablated in the extremity. So the role of certain locations, particularly perforators need to be addressed in the guidelines.

Steve Elias: There is actually a process by which people need to evaluate the literature and the data that's available when you're writing guidelines. I had a little bit of trouble getting my arms around what we need to know when we write guidelines. What are the guidelines for writing guidelines?

Mark Meissner: The guidelines to writing guidelines were part of the Medicare Improvement for Patients and Physicians Act in 2008 that authorize the Institute of Medicine to develop guidelines for writing guidelines. That is a document that's out there. It's a very good document. It's very long, but the executive summary is fairly short, and you can read that and come away with what you need. Peter already mentioned one of them, which is those trustworthy guidelines need to be updated every five years because new information, new data, new evidence comes along, practice patterns change, so they need to be updated.

But there's actually eight elements of it that need to be included in trustworthy guidelines, and essentially that establishes the process and the process is, first of all, coming up with the panel that's going to do the guidelines and there are criteria for that. Any guidelines should include all stakeholders in the guideline, whether you're a vascular surgeon, radiologist, phlebologist in the community. It should include all stakeholders. It should include a methodologist, always, to help you evaluate the data. Optimally it would include patients as well, although that's a bigger hurdle.

Mark Meissner: The second is that every guideline should be based on a systematic review of the literature. It may not be strong enough to do a meta-analysis on, but the literature should be systematically reviewed, and my takeaway from that, which may or may not be true, is that if you can't generate a data table from it showing the outcome and the results, it probably shouldn't be in a guideline. You ought to be able to do that.

The third essential component is grading the evidence, the Society of Vascular Surgery as well as most organizations throughout the year, throughout the world, have chosen the grade approach to do it. So you grade the evidence. The fourth component is writing it and then having an external review of it and I missed the second component which is developing the questions, which is probably the most important thing is developing a reasonable question.

Steve Elias: Did the original guidelines follow the approach that Mark just outlined or this approach came into being after those guidelines are written?

Peter Gloviczki: I think this so-called PICO guideline, or PICO technique to develop a guideline, came after 2010 when we really wrote the guidelines, but the guidelines had a lot of the components of currently anticipated guidelines. Very specifically, we had explicit and transparent questions that we pose and we used the appropriate evaluation when we graded the evidence, the level of evidence and the strength of recommendations.

There are additional components that we will be very careful to include in the new guidelines, and very specifically that transparent representation of the data that we collect and that's what Mark was referring to, the data tables. And that really just makes it transparent to everyone who reads the guidelines, what the literature offers in regard to the evaluation or the treatment that we recommend.

Steve Elias: Is the audience MEDCAC that we're playing to, or are we playing to the practicing physician to give them real guidelines and then MEDCAC can come in secondarily, but there are people out there want to know, "Oh hey, I got this patient, has this problem. What do the guidelines tell me I should consider doing?" What audience are we playing too?

Peter Lawrence: Both, but most importantly to the patient. I think Mark's talked today about being patient-focused. That's always the best approach to use, and what is in the best interest of patients. But guidelines require or are followed or used by well-intentioned physicians who want to do the right thing and the reason that the MEDCAC comes in is because they also have a huge impact on reimbursement because many people follow the CMS guidelines, and they're based on MEDCAC, so if they come to conclusions which are felt to be by most people practicing inappropriate, then I think that you can be misled or they can be misled.

The challenge of MEDCAC is that having sat on that for six years, and particularly on the venous MEDCAC, is that the group that does the research is given some limits and they were told, as I understand it, because I got all the data that they provided to the MEDCAC committee, was that they only would consider prospective studies less than 10 years with more than 500 patients. And as we all know, things like duplex ultrasound was developed and established the standard of care well before that. So there are a lot of changes that could be done, that are needed in the MEDCAC decision in summary, which happened as you probably know, because you are involved in it, over a period of six hours. In six hours made decisions that probably should have been done over a year with several meetings.

Steve Elias: What are some of the questions we should ask so that we can help the practicing physician? As Peter said, do the MEDCAC people understand what it takes to manage patients with varicose vein disease? What are some of those?

Mark Meissner: Part of the thing for trustworthy guidelines, which I'm surprised MEDCAC didn't realize, is having all stakeholders involved in the systematic review. And that was part of the problem with the MEDCAC systematic review, it was done by people with no knowledge of venous disease, with no clinical input whatsoever. And not that as clinicians we can do the methodology of it, but we can guide it and do not have clinical input in a systematic review is just not appropriate.

The SVS and the AVF have used the Mayo Group to do their statistical part of it, but they have always offered, if there was an interested panel member, which I participated in it for the thrombolytic guidelines, to be part of the systematic review and actually review the evidence with them, which I think is very valuable. And I think the Mayo Group recognizes that some clinical input is required. So I think that's part of the problem with the MEDCAC process.

To answer your question directly, I think we need to look at what's been developed since 2011 when the last guidelines came along. Probably the biggest thing in superficial venous disease is the non-thermal technologies. Those need to be addressed. Unfortunately a lot of the data is not real strong to support them, but I think if you follow the guideline process on what raises or lowers the degrees of confidence in the estimate of the effect for those guidelines, we can confidently recommend non-thermal technologies in an evidence-based fashion that will influence, I think, both patients, physicians as well as payers and really that's our role, is to interpret the data in light of... Lend some clinical credibility to what evidence is out there.

So I think that's a big one in 2019, is what is the role of non-tumescent technologies?. I think there are other things; a big question is what is the role of compression after endovenous ablation? And I think there's been some evidence that's come along since 2011. I think the management of complications, particularly thrombus extension at the saphenofemoral junction, not a lot of data, but that can be addressed. And those are some of the, three of the important questions, as well as I, think Peter's question is important too, is duplex ultrasound, the evidence-based standard of care for the evaluation of venous disease?

Steve Elias: I mean this to me, with the duplex ultrasound, it kind of blows my mind. I mean it's kind of like, we already know duplex ultrasound is the gold standard but how are we going to answer this question? Is there not data that duplex ultrasound is the gold standard.

Peter Lawrence: There's a lot of data, but if you're restricted in doing the systematic review to the last 10 years and much of the data was developed 15 to 30 years ago, then you're going to miss it in the 10-year review. So it all has to do with the budget and how much, if they had been able to go back 20 or 30 years, I think they would have come to the conclusion that duplex ultrasound was the best diagnostic technique and was appropriate today. So in all of it has to do with the restrictions of the limitation in doing the systematic review.

Mark Meissner: And not only that, that that question was not asked appropriately because that question should have been asked is in patients with symptomatic venous disease, acute deep venous thrombosis, anything else, is duplex ultrasound more accurate than X comparator in the diagnosis and what's the X comparator? Is it venography? Is it CT venography? And there's virtually no data to suggest that anything is better than duplex ultrasound. So it's not only a problem that they didn't look far enough back, but the questions weren't formatted appropriately.

Peter Lawrence: I’ll add that the people sitting on the MEDCAC committee who voted, there were two clinicians who took care of patients and one was Tony Comarado who was invited as a guest. So his votes were counted separately from the rest. I was the only person who took care of venous disease. These were well-intentioned people, but none of them had taken care of patients with venous disease. And so it's not surprising that their decisions were not particularly appropriate or relevant because they had no background in venous disease management.

Steve Elias: For the physicians who are taking care of patients they look to this, not just for guidance in a particular patient, but they look to it for, to cover themselves when they're treating the patient and they're concerned that people are going to say, "I'm doing the wrong thing." And they look to the guidelines and say, "No, the guidelines tell me this." So how does a practicing physician utilize the guidelines that we're going to be writing? In other words, how would you say to them, "Here are the guidelines, here's what you can do with these guidelines."

Peter Gloviczki: You bring up an excellent point. What is the goal of a guideline? Is the goal of a guideline to decide on reimbursement? Is the goal of the guidelines to protect the physician? No, I think the guideline should have one major goal in mind: deliver the best care to our patients. That is our primary goal, and any guideline should be part of the decision making of what is the type of tests that we order and what is the treatment that we offer to our patients. So a guideline should be used by the physician and by the patient, but a guideline should be a major tool to determine the best care, together with the physician's clinical experience and judgment, together with the patient's values and preferences, together with the most cost effective and affordable treatment and all this is going to ultimately decide the best treatment for the patient.

Steve Elias: Does industry have any role in giving us any information when we're writing the guidelines?

Peter Lawrence: Industry shouldn’t have direct input but there are industry studies or supported studies which are good studies. So in reviewing the systematic review, not all, but there are industry-sponsored studies that are very well conducted and industry obviously has a lot more money than societies or individuals. So they have the potential to do excellent studies.

I think that the key is so that industry is both not in the room influencing or writing the studies, number one, and that the people who are writing the studies aren't influenced by industry, that they fully disclose their connections to industry. There's no reason to exclude people who have a relationship with industry. It just has to be disclosed and balanced with people who don't have a connection. We shouldn’t be in an antagonistic relationship with industry, because it's critical to us having good devices and developing good care, and as was pointed out in Mark's lecture today, right now they're very involved in training physicians in the use of devices. So until we have another system, they're a very important role in clinical care, just not sitting in the room while the guidelines are being written.

Steve Elias: Logistically what happens? All of you got us all together, the people who are writing this; now what are the steps. Who gets what roles? Who's addressing one issue, another issue. I want readers to understand that guidelines are not a willy-nilly couple of, as Mark says, BOGSAT—a bunch of old guys sitting around and talking. It actually is a real process. It takes a lot of work.

Peter Gloviczki, you bring up a very good point. Putting together an expert committee is the most important to me. A panel of experts, who are experts in the topic of the guidelines. The second step is really, discuss and agree on explicit and transparent questions. Once we have the questions then we actually decide and divide the guidelines to a different group of people who are going to work out the guidelines based on topics and grade them. And then I think we all kind of have regular phone conferences where we debate the grading and answer questions or answer comments, and like this, the entire committee is involved in the final decision making. How long do you think it's going to take in general, the process?

Peter Gloviczki: It's going to take about a year to a year and a half to write the varicose vein guidelines, because we have to have, first, the appropriate questions for the systematic reviews. To have a good set of guidelines, we need systematic reviews or data tables for each of the questions that we ask. That takes time and I would say it's about a year, year and a half. What do you think?

Peter Lawrence: We're told that it will take for the systematic review about four months, and then after that, we'll do the work of the committee, and then it has to go out to the public or to review by professionals who get a chance to have input. So I think a year, to a year and a half. One of the things, just to add to what Peter said, is that one of the things, and I, this is not my own personal learning experience, but the doc committee, which Peter chaired and now Tom Ford chairs.

Steve Elias: Now, Mark, are you good with that? Three or four critical questions, or five questions, that the practicing physician, when he sees a patient with varicose veins needs to answer. He said, "Okay, I got someone with varicose veins. How am I going to treat him? Okay. And here are the five questions I need to ask myself and go to the guidelines to say the guidelines tell me this, this and this." In other words, you know, in general, I think of a simplistic, practical approach rather than a bombastic scholastic approach that, as Peter said, you got to read through a hundred pages to find out what the hell to do with the patient. Is our goal, should I go also be to make it as simple as possible for the overall practicing physician?

Mark Meissner: Well, I think the goal should always be to make it as simple as possible, but I think we all realize, as practicing physicians, that we go to multiple sources for our information, and I think it's important to discern, there's a difference between expert opinions, sort of best practices, standard of care, which is important. One of the recommendations which I often cite as an example, in the original varicose based guidelines, is every patient should have a CEAP designation, which is certainly very true, but that belongs in an expert opinion sort of piece. And I think if you're looking for that comprehensive of expert opinion, you go to the Handbook of Venous Disorders, which does a very nice job putting it all in one place.

But then the practice guidelines need to be things that are really based on evidence and data, and not an expert opinion. And I don't think there are a lot of questions that can be answered with data. And so I do think that everything, every question we ask ought to be answered with the data. And then we should look to other important sources, like the Handbook and things to answer those questions about what well-meaning physicians consider the standard of care, but isn't necessarily supported by data.

Steve Elias: All right, so in conclusion, I want to ask the three of you, I mean all three of you have treated veins for a long time. Why do we need to go through all this? Can't the three you just come up with, "Here's what you do."? Don't you guys know enough? Why do we need to go to the literature? Why do we need literature, Peter Gloviczki? You guys, if I asked you, Peter, I have a 42-year-old patient, has varicose veins and the woman is like, she stands all day, she works as a waitress. She has saphenous vein incompetence. Couldn't you tell me what to do? Do you need the literature? Do I need guidelines?

Peter Gloviczki: I think we absolutely need guidelines. We need evidence, we need evidence to support our expert opinion. And I think that is a combination of clinical experience and evidence-based clinical practice guidelines that will deliver the best care to our patients. So I think the best thing we can do is put together our evidence-based guidelines and have that available to our physicians who will then make the final decision based on their experience and the patient's values and preferences.

Peter Lawrence: We need guidelines, not necessarily for the person who's been doing it for 30 or 40 years, but for the well-intentioned clinician who wants some advice and is looking to do the right thing for patients. So those of us who are very experienced might occasionally be surprised by something in the practice guidelines, but unlikely. But the person who's inexperienced is going to be the person who benefits most greatly from the practice guidelines.

Steve Elias: There's a significant amount of work that goes into writing guidelines. They're not taken lightly and that's why they are so important. And that's why MEDCAC looks at these guidelines. Practitioners look at these guidelines, and societies look at these guidelines, and it's not an easy process, and it's a very rigorous process and those are things that people could hang their hats on.

Peter Lawrence: Practice guidelines, although the intent is not to establish standards when people vary so much from what is in practice guidelines, there can be a benchmarking and I think it does a have a threat to those who are doing very inappropriate care. They're out of the practice guidelines. So an institution, a hospital, a society, if someone varies so much repeatedly from practice guidelines, it can become a way to either stop that practice or at least give them feedback about how inappropriate.

Steve Elias: Yes, and we're definitely dealing with that issue of overuse and abuse in the varicose vein world.

Peter Gloviczki: I would finish emphasizing how important the guidelines are, but I would finish with a quote of Mayo, who said that the best interest of the patient is the only interest that should be considered.