AAP Policy for Adolescent Bariatric Surgery: Pediatric Obesity 2017

And uh move on with uh Markowski's talk. Uh, Mark is the uh director of the Healthy Weight clinic at uh Nationwide Children's Hospital. He's a professor of surgery and he's also a well-renowned, uh, bariatric or pediatric bariatric surgeon. Uh, Mark has been also involved with the teen lab study. And he's going to talk to us in his position as the liaison to the section on obesity, the AAP section section on obesity. He's the surgical liaison. Hopefully I got that all right, all out correctly, where he's working with the SU and also collaborating with folks in other organizations to come up with some policy statements. So Mark, can you give us an update on where we are? Yeah, thank you. Can everybody hear me? Yeah. Great. Thanks very much for the invitation. And yeah, I mean, I think that obviously in light of what we've just heard from Tom and, and on top of some really great data, I think what's emerged over the last decade or so is the need to also address ways in which we disseminate this important information in order to Um, increase the probability of having a clinical impact for the patients and the patient population that we serve. So really, this talk, which will be relatively brief, is, is, um, as, as Mark Wolkan just said, essentially an update on The AAP policy statement that we're working on, which is a collaboration between Sue and the AAP section on surgery, just to really give everybody a snapshot of these types of advocacy issues with the primary goal of disseminating this ongoing collection of really strong data in support of using this type of Uh, therapeutic intervention to treat the severely obese population that we deal with. So that being said, let's see if I can get this to go. There we go. Um, Obviously, I'm just going to jump through a couple of things here, and I think most people on this call, the panelists and certainly those participating are familiar with a lot of this data, but just for completeness sake, um, You know, the news on the overall prevalence of obesity and in particular severe obesity in the pediatric population continues. To be bad news for all of us. So for anybody who thinks that, you know, we may really have been seeing a leveling off or even a reversal, I'm sorry to say that the opposite is true. Essentially, when we're, when we're looking at severe obesity estimates in the adolescent population range anywhere up to about 2 million. Patients or individuals that have physiologic or anthropomorphic qualifications to broach the subject of bariatric surgery as a consideration. In addition, we know from a number of large cross-sectional studies that extremely obese children and teens do indeed have a very, very high propensity of carrying this obesity on into their adult years. Um, and that's supported or juxtaposed to the very disappointing data that we've seen in the literature looking at non-surgical weight loss paradigms. And again, essentially all of this data continues to support the use of weight loss surgery in this population as an effective treatment overall. Obviously, Tom just really took us through what is the most current. Data and I think the only thing to add to his really excellent presentation is the fact that we've shifted from data being generated about a decade ago, which was mostly consistent of a single institutional relatively small cohort retrospective non-uniform studies. Uh, that were, um, of course, very important and meaningful, but really not up to the level of data collection and reporting that's really required to develop a paradigm shift and and. You know, a widespread clinical application. More recently, obviously with efforts such as Teen Labs, the FAS 5 study, and the AOS study, we're seeing very, very high level prospect of studies using uniform data reporting methodology, and this really is the type of data that we have needed and fortunately we will continue to Uh mine data out of these, uh, these types of studies for years to come, and I think that really, these types of studies really serve as the foundation for making best practice guidelines and widely accepted recommendations on treatment paradigms. Again, I'm not going to spend any substantive time going through this. You've seen This type of data from Tom's presentation, obviously we've seen a significant reduction in percent BMI change over time in all of these studies that that he has highlighted and I've just mentioned. Again, in addition to significant improvement of comorbid states and normalization of risk markers and so on and so forth, and Um, so, hopefully making again the argument that this is important. When we talk about consensus development. You know, that is again an interesting area and really starting in 2004 with Tom's paper in pediatrics, which really was the first consensus-driven effort to make or offer guidelines in terms of who should be considered for a bariatric operation or surgical weight loss in the severely obese population and You know, interestingly of note, that particular paper continues to hold a lot of influence in the insurance industry in terms of access to care and It's probably notable to suggest that from when that paper came out to more recent updated recommendations, there was a bit of a shift in terms of the general level of qualification based on BMI. So during that initial paper, BMI recommendations for eligibility were a little bit higher than what we currently have today. Here with Jamie Pratt and again backed up a couple of years later from ASNBS, which are more reflective, not identical, but more reflective of the type of BMI eligibility guidelines that were that are used in the adult population and were a byproduct of the 1991 NIH consensus conference. In addition, there has been, there have been a number of publications. Reporting out not just clinical eligibility guidelines, but guidelines and recommendations for the development of multidisciplinary centers designed specifically to treat severely obese adolescents under consideration for surgery. And again, just making the point which I'm sure for most people on this call would seem obvious that Although the adult experience, both in terms of clinical eligibility as well as programmatic logistics are important and used as a template, they are not identical and really need to be done in the context of the special considerations that go on in the adolescent population. This particular paper in pediatrics was as a result of the Children's Hospital Association efforts specifically focus on a fitter future, which developed a consensus panel which met over approximately about an 18 month time period. So I think really helpful again in terms of eligibility criteria, just to review for everybody, this is, this continues to be the most contemporary. Eligibility criteria we generally talk about and Tom alluded to the fact that we generally target around 40 kg per meter square or higher, although you can see here that in certain individual cases getting below. Below 40 is is considered reasonable for consideration and then obviously other eligibility criteria that you can see here and again this has all been published a number of times and in fact is in the process of being updated right now again through ASNDS to the pediatric Committee under the leadership of Jamie Pratt and the Committee itself. So we probably will be seeing updated guidelines from ASMBS sometime within, I would estimate the next 12 to 18 months. In addition to all of this, and I think equally as important is national accreditation. You know, Up until relatively recently, what's been going on in the pediatric and adolescent world has been somewhat cloistered and separated from what goes on in the adult world, and I think in the current atmosphere of quality initiatives and accreditation and outcome tracking, I think it's very appropriate that Pediatric surgery, pediatric bariatric surgery fall in line with what's happening on the adult side. So just briefly, prior to 2014, ASMBS and the American College of Surgeons developed separately and administered separately national accreditation guidelines for adult bariatric surgery. There really was Although the American College of Surgeons did have a pediatric component, it was rather a sparse set of recommendations and folded into more of the adult construct. ASMBS had really no specific. Pediatric standards set in their centers of excellence designation. Around 2012, both of these organizations decided to get together and form a combined national accreditation architecture which is called MBSAQIP. which stands for Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, and for the first time ever this included a separate designation for centers that were equipped to offer bariatric surgery to individuals under the age of 18. The first set of standards were rolled out in 2014 and more recently on the right side of the screen here you can see they were updated just recently in 2016 and the important thing to understand here is again I think that this particular tool is the culmination of Much of the literature that has been published with regards to best practice guidelines and the importance of multidisciplinary clinical evaluation standards for adolescent bariatric surgery, ensuring that Patients, adolescents, patients that present for bariatric surgery are expected to receive care that is optimized and tweaked specifically for the pediatric population rather than facing a situation where they're dumped into an adult program that has Um, perhaps little to no experience, uh, treating with or dealing with the nuances of the adolescent population. So we're very happy about that and, um, um, I'm, I'm happy certainly to answer more specific questions about that afterwards if anybody has them. When we look at challenges to care and again back to the initial premise of this talk, which was to discuss, you know, how we Spread and disseminate the favorable outcomes that we see in order to increase the ability for patients to access this type of therapeutic intervention. You know, a number of things come up and several years. Ago in 2014, we published a review of really insurance data that was associated with the teen lab centers, the five teen lab centers, and found a couple of interesting facts. Our objective was to determine factors that influenced insurance authorization, and again this was a retrospective review of consecutive cases among the five centers. So this was going on during the enrollment period of Teen labs. And outcomes that we looked at included number and timing of authorizations, denials, and results of appeals. And interestingly, we looked specifically at about 57 adolescents, 74% female with a mean age of about 16. You can see the range here. And what we found that of this cohort 47% were able to accomplish initial authorization at the original request for surgery. And while that may sound good overall, it's strikingly different than the adult experience, which is about an 85% initial authorization at the. request. So quite a disparity. 80% of the denials were approved after appeals, but took as many as 5 appeals. So again, if you can think of the effort, both just logistically as well as the emotional toll that it takes on a family to have to appeal a A denial for authorization as many as 5 times. You can imagine that this is quite discouraging to many families, and most families that are denied, certainly a proportion of them or a significant proportion of them, will never get to the 5th appeal that may or may not result in a positive outcome. 11% ultimately were unable to obtain authorization. And interestingly enough, the most cited reason for denial was age less than 18 years of age, so very interesting. In addition to that being an obvious Um, challenge or obstacle to access to care. Obviously attitudes towards adolescent weight loss surgery amongst our colleagues, our surgical colleagues, our medical colleagues is also quite important. Susan Woolford. Attempted to look at this several years ago by assessing primary care physician opinions regarding the potential for referrals to adolescent bariatric surgery, and she did this by surveying about 375 pediatricians and an equally large. cohort of family physicians and asked specifically whether or not they would consider referring an adolescent patient for weight loss surgery, what the minimal age is, and prerequisites towards weight loss surgery itself. Interestingly, almost half of the respondents declared that they would never refer a patient for an adolescent operation. Again, about half endorsed a minimal age of 18, which is interestingly similar to our colleagues in the insurance industry. Um, and, um, ultimately 99% endorsed participation in a monitored weight management program prior to referral for weight loss surgery, which, um, certainly, uh, seems, um, seems reasonable. And then I think when you take these two issues together and juxtapose it with juxtapose it to You know what our best data is so far at the procedural prevalence for adolescent bariatric surgery, this really makes the argument for a need to do to do better. I will say admittedly that I don't really think we have a great handle on the number of individual teams undergoing bariatric surgery in the US for a number of reasons, obviously. This is a study by Kelleher from 2012 looking at data over about a decade designed to determine national, the national rate of adolescent bariatric surgery. And it was a retrospective, retrospective analysis from the kids inpatient database, which interestingly enough, showed early on at the earlier part of the 2000s a significant increase in procedural prevalence from 2000 to 2003, but really from about 2003 to 2009. You can see that there's essentially been no substantive change, at least not statistically significant, suggesting that there's been a plateau of procedures being used despite the fact, or in contrast to the fact that we continue to have this output of good and markedly improved. Level of data suggesting that adolescent bariatric surgery is favorable and should be highly considered. And again, admittedly these results may underestimate the number of adolescent cases being done on an annual basis and hopefully through efforts including the ongoing Pokori Pornet study of bariatric surgery in kids, we will get to continue, we will continue to look at data on prevalence. You know, finally, I think it's worth mentioning as I'm wrapping up here that, you know, we're not seeing strong evidence of acceptance of this type of data in the pediatric world, which is again something that we need to work on. This, this survey that I have up here from 2013, again out of the Children's Hospital Association. showed a survey with results from about 188 hospitals with a 54% response rate and looking at the stage of or level of obesity treatment care, stage 4 being centers that offer, in addition to multidisciplinary analysis or rather multidisciplinary care, offer therapeutic intervention including pharmacologic as well as surgical intervention. So 49 of the 188 centers that responded declared that they had either drug therapy protocols in place and or bariatric surgery, about 88% of those 49 centers stated that they had some access to bariatric surgery, and the details of which are in that report, which are quite interesting and online if anybody is interested at the Children's Hospital Association website. But you know, interestingly and again to sort of drill the point home a little bit further, this is the most recent report from AHRQ that was developed by Kaiser suggesting an overall review of current and contemporary management for children that are obese and severely obese and really only a scant. Reference to bariatric surgery is made, including citation of the DDK website, as well as the ASMBS best practice guidelines from 2012. For the most part, this particular document more or less ignores bariatric surgery as a as a consideration for this population, so. Back to the main purpose of this particular Talk to update everybody on the development of a policy statement from the AAP and just as a quick review, you know, there are several levels of statements that come from the AAP including policy statements, technical reports, and clinical reports. These are reviewed on a regular basis and or retired or rewritten as as required through ongoing review. Um, and again, in 2016, the section on obesity as well as the section on surgery executive committees agreed in principle to sponsor joint policy statements and assigned authors. That include myself, Chris Bowling, Sarah Armstrong, and Kurt Reichert, and we've been working on this for the last, I guess, 6 or 8 months and moving forward in terms of where we are and, you know, what the development of a policy statement. And if Chris is still here with us, you know, when I asked Chris to help me understand the difference between all of these types of statements and output that come from the AAP, he referred to the policy statement as the big kahuna. Um, and I think it's hopefully the equivalent to a bullhorn from the AAP which, um, you know, really will get some attention in terms of helping to disseminate the information that we have here. in an effort to create a shift in recommendations for this particular subpopulation of the the whole pediatric population that is affected by obesity and specifically severe obesity. So Where we've been and where we're going, the intent phase of the development of this policy, as I mentioned, happened in the latter half of 2016. Currently, after receiving endorsement from both the SU and the section on surgery and ultimately obtaining authorization to proceed from AAP leadership. We are currently have the draft in committee and are working on our first draft, which will presumably go to peer review sometime here in the first quarter of 2017 with a a proposed publication hopefully by the end of this year or early next year at the latest, and we feel very enthusiastic about this and I'm hopeful that we'll, that this will help to address. The need to come up with effective methodology to disseminate the type of information that we have accrued so far and will continue to accrue as time goes on. In addition, you know, this statement will come out in and around the same time as the revised best practice guidelines from ASMBS. So we're really hoping for a 12 punch here in terms of spreading the good word. So to just wrap things up again, we have continued to develop and report high quality data supporting the use of weight loss surgery in the pediatric population. Consensus-driven best practice guidelines and accreditation standards have been established and continue to be updated appropriately. Procedural prevalence, as I've shown, remains stable despite these favorable outcomes and standardization of care. Access to care is limited by several variables which I've shown you, and again, efforts should be undertaken to try and increase both public and professional awareness related to weight loss surgery in this particular population, and I'm happy to answer any questions in the rapid fire. Thank you. Uh Thank you, Mark. Uh, that was, uh, really great, and uh we really all of us appreciate all the efforts that, uh, you and Chris and the rest of the super executive Committee are putting into this, and I think that this policy statement's gonna be really important for us to have as we move forward. So I. Oh, Mark, I was just gonna address to really quickly, um, Mark's comments about where we are with things right now, um, in the draft and committee piece, um, it's currently being held up by yours truly as soon as I get my pieces all put together, it goes off to AAP. We actually have our, um, uh, just to kind of give complete knowledge on where we are with it. Our, our section manager is out on maternity leave right now, but as soon as she's back, it's the first thing on her desk. Um, and like Mark said, we're really, when we're looking at it, the AEP has these different sort of statements. They have technical reports and clinical reports, and, and Sarah and I, and, and, and when we talked with Mark and Kirk about it and talked with our other executive committee members, we're all just like, you know, the data is there. We really need to be very clear about it and not go for something like you might think. We have clear indications on when this is appropriate, and it's, it's time to get that out there and, and the timing is, we, we all feel it's really, really important with, with the Amos results and the teen labs results and the FAS 5 results. It's, it's time to get it out there. So that's why I refer to that as the big kahuna. We want something that has as much teeth as we can possibly give it going forward. Right. No, thanks. Uh, I, I, I agree, I agree, and thank you, Chris, for all your advocacy and support as well.