E17 David Urbach On Checklists, Wait Times In The Time Of COVID, And Medical Devices

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Chad Ball  00:15

Welcome to Cold Steel, the Canadian Journal of Surgery podcast with your hosts Ameer Farooq and Chad Ball. The goal of the CJS podcast is threefold. The first is to highlight the best research currently being completed by Canadian surgeons. Second is to offer educational topics for both surgeons and trainees alike. And most importantly, the third goal is to inspire discussion, thoughts, creativity and career development in all Canadian surgeons. We hope you enjoy it.

Ameer Farooq  00:51

In this episode, we had the opportunity to talk to Dr. David Urbach. Dr. Urbach is a MIS in bariatric surgeon and health services researcher at Women’s College Hospital in Toronto, Ontario. We had a really wide ranging discussion with him talking about everything from checklists, to the impact of the word cancer on patient decision-making, to wait times in Canada and how we might address these wait times in the face of COVID as well as medical devices in surgery. Take a look at our show notes for links to the papers. And we hope you enjoy the episode.

Chad Ball  01:24

Well, first, Dr. Urbach, thank you very, very much for joining us in Cold Steel, we really appreciate it. In sort of thinking about you in a more broad context, I think you’re you’re probably Canada’s best example of a true contemporary, maybe triple threat, so to speak, you know, you’re a heavyweight, clearly in research, you’re really busy administrator and of course, really busy clinician. So, again, we know how busy you are, and we can’t thank you enough for coming on. I guess your first question out of the gate is I think most of the country quite frankly knows you quite well, but maybe not personally. So we were curious what your pathway was in terms of moving into medicine, eventually surgery, and then, of course, your subspecialty.

David Urbach  02:06

Well, thanks, Chad for that very, very flattering introduction. You know, it’s really interesting to think about our history and our past and our pathway into medicine. And you really wonder how much of this was what you were thinking at the time given, you know, what I’ve come to learn about this job over the years. But I do know, I grew up in a medical family, like my dad was in was an obstetrician, and, you know, I’d hear him on the phone in the evenings, you know, having these like serious conversations with his residents and asking a couple of questions. And he’d say things like, you know, always Shocky do I need to come in? And, you know, not not really knowing what all that meant. But it did seem very exciting. And, you know, I think that and what I, what I saw on TV, the whole career as a doctor just seemed like a really exciting and interesting way to be involved in helping people. And I was also, you know, I viewed myself as sort of a scientific person, I liked science and in school and biology, and it just seemed like a great way to pull these things together. And in surgery, as well. You know, the young person I thought, like, the greatest thing in the world would be to be up all night, in the hospital wearing scrubs, and, and just doing heroic things to save people. You know, over overtime, I guess, you know, priorities shift a little bit. And, you know, I can say, I, I really love taking call and I and I love the acute side of the work that we do, but you know, I’ve definitely mellowed with age. And I don’t I don’t I don’t live for the all nighters. At this point in my life, I will say.

Ameer Farooq  03:56

It’s funny that you say that you grew up listening to your father talk on the phone. I remember distinctly, as a young kid, hearing my dad at the table, calmly pick up the phone and say, Oh, are they passing gas? What’s the urine output? And as if, as if that was normal dinner conversation. Would you say that it was your dad who was the most influential person and kind of pushing you towards your career or who would you see as the most influential person along the way?

David Urbach  04:25

You know, I, I think when I look back on it, I probably say it with him. And I don’t know that that’s true, but I can’t I can’t imagine because, you know, for him, his career was so was so crucial for him like that’s, that’s what he was. He was a doctor. He actually had a lab he had a he was funded by the MRC doing research in immunology, you know, back in the late 60s, early 70s. So he was like a real clinician scientist. And, you know, it was a career he completely loved and he thought that was the most noble and important thing that a person could do. So I’m sure that was hugely influential on me.

Chad Ball  05:08

Dave, we wanted to dive into a few of your, your your publications, and, you know, I try not to use the word heavyweight, often, but I really did mean that in introducing you. You know, you really are one of our super heavyweights, maybe even in Canada, for sure. It’s impressive. You have multiple New England Journal of Medicine publications, of course. One of the favorite papers that we have around here. And I think, you know, this, having kindly come up to Calgary and give Grand Rounds a couple of years ago was, was your I wouldn’t say retort to response, but your commentary and your work on on surgical checklists and briefings. I was wondering if you could just sort of summarize that publication for maybe those few folks who haven’t read it, and what your take on it was, of course?

David Urbach  05:52

Yeah, so what we did is we wanted to analyze what happened after the introduction of surgical safety checklist in Ontario. And what really prompted this was all this literature that was emerging, that safety checklists were just incredibly like fantastically effective. More effective than any intervention that we’d ever seen in perioperative care at accomplishing things like reducing postoperative complications and reducing operative mortality. And if you actually look at the numbers, they’re phenomenal, like use of a checklist compared with not using a checklist cuts the risk of death and health. So, you know, Carl Sagan used to say, and we use this in one of our commentaries that extraordinary claims, really require extraordinary evidence. And, you know, all the evidence when you went back and looked at it was not what we would expect, for you rigorous, high-quality evidence to support clinical interventions. These were really before and after studies. So there were no clinical trials or well-designed controlled studies. So study designs that we would ordinarily consider highly biased designs and we would normally look very suspiciously at the conclusions from these types of studies really led to an intervention that was actually adopted overnight. If you looked at the timeline, when safety checklist initially were endorsed by the World Health Organization, and the NHS in England, and eventually, throughout the rest of the world. This is something that within months became really much, much a standard of care in hospitals. And we took a step back and said, like, look at once they were introduced, did it achieve what everyone expected it would achieve. So if, if on all these early studies, it reduced the risk of death by 50%, and reduce complications by similar amount, does that happen when you actually introduce it at a population level? And the advantage of doing a population study like we’re able to do in a lot of our jurisdictions in Canada because we have these population-based databases, is you don’t have to worry about selection bias. If you if you look at the entire population before the entire population after, you don’t really have to worry that oh, well, maybe checklists are only being used or used completely in certain populations. And that may make it seem like checklists are really effective. But it might really be some sort of selection bias that’s operating. So what we were able to do was use the entire population data set. And essentially, what we found is that at the population level, nothing much really happened. So all these anticipated benefits that we would have expected based on all these other small before and after studies didn’t happen when you actually studied this at a population level. And that is actually been borne out in some other studies that have been done across large geographic regions, like, you know, entire states in the United States, where it’s been very difficult to show the types of benefits that were demonstrated in, in the early small studies. You know, interestingly, our study was largely criticized or interpreted to show that the reason the checklists weren’t as effective as they should have been, was because they just weren’t done properly in Ontario. Like that was the that was the perspective that, you know, we we didn’t invest in a proper rollout. We didn’t really educate people on how to properly do a checklist. So they were they weren’t doing it full, you know, with their full cause. But, you know, and it never was there sort of this consideration that well, maybe it just isn’t quite as good for these clinical benefits as people think. You know, there was always this assumption that no, no the they must have this effect on operative mortality and complications. You know, I just I do want to say because this comes up quite often, that I’m not a checklist nihilist. Like I, I do believe that they actually have enormous value to us. And I enjoy doing safety checklists with teams that I’m sure a lot of us do. But, you know, I think the benefits are very different from what, what they were purported to be initially, and I really don’t believe that they save lives. But I do believe that they bring teams together that they engage nurses, they force us to know each other’s names and, you know, really engage as people. And and I think they have enormous benefit, you know, for for surgeons, as they, you know, exercise micro-leadership in operating rooms, and are able to really formalize the way that they bring teams together. So, I, I like checklists, I just, I’m very skeptical about some of the claims that have been made about them.

Chad Ball  11:02

Why do you think those those initial publications and obviously, as you pointed out to incredibly such rapid subsequent uptake? We’re like, they were like, why did they show such such massive clinical benefits?

David Urbach  11:18

Right. So I mean, those are two great questions, and I have my own personal answers for both. So the first, I think the reason why they showed such huge clinical benefit is I think the reason why so many of our studies of surgical procedures show really big clinical benefits. And I think the answer for almost every intervention that seems too good to be true, is, you know, why is selection bias causing this effect, and to meet like selection. And non-surgeons and lay people really don’t get the whole concept of how selection profoundly influences the types of patients that we look after and what we do for them, and what happens to them. So and what I mean by how selection bias would have influenced the studies, because at the Toronto General Hospital, we were actually a participant as one of the eight hospitals in the initial World Health Organization, New England Journal and publication that really got the ball rolling, rolling. Yeah, so we Yeah, I comply was one of the surgeons, we completed the yellow form. And the way it worked is that they did this running period where they looked at all the operations over a four-month period, or whatever it was for three months, and looked at the outcomes of all those patients. And then they had a bit of a washout. And then we introduced a checklist. And then we looked at the outcomes of patients who had this checklist procedure done. So in the after period, we had to fill out a little questionnaire about whether the checklist was done or not, and just answer some basic questions. And those patients were then collected and became the after group. And the difference is the before group included everybody. But the after group only included specific patients that we had sort of checked off this sheet and enrolled and said we’d done this safety checklist. So the types of patients who may not have made it in that after a period, and we we’ve never really studied this very well, but I have to assume is that, you know, a lot of emergencies, a lot of reoperations, like middle of the night things and you know, ruptured aneurysms, you know, you name it. So, you know, to me, whenever I look at the results of studies, I always get my first impression is, why is it that I cannot explain this by selection bias. And almost always, you can find how selection bias is likely to play a big role. And, and it’s, it’s a, it’s a very big problem in a lot of our research. So, so the answer to your first question, I believe is I think selection bias was a was a big factor. You know, the, the answer to the next question of like, why was it popularized so quickly? I think there’s a number of factors. But one is, I think we’re primed. We were primed for these types of interventions. And the story was, was a great story. Like, here’s this intervention, it can be applied internationally, it cost nothing. It’s simple. And it’s on the, if you took it at face value, it’s extraordinarily effective. And who’s the proponent, you know, Atul Gawande, one of the most well-known and persuasive and most thoughtful surgeon leaders at the time, who had written some books, who, you know, was very, very well-known for his journalism in the New Yorker, and is an incredibly influential, persuasive and and smart guy. So I think the constellation of all these things, really made it just irresistible and and that’s why what we saw with this uptake, like nothing I’ve ever seen with respect to changing practice overnight.

Ameer Farooq  15:06

I’m curious whether you when you read papers is that the first thing you think is is their selection bias I could explain this. Because what impressed me a lot about this paper is the fact that you would actually think about it and think critically about the paper because it I think for the majority of us, we looked at it and looked at and thought, this is pretty unassailable data. And what motivated you or how did you even come up with the idea to challenge something like this?

David Urbach  15:38

Yeah, so yeah, the answer to your first question is yes, every time every time I look at a paper that’s not say a really good randomized trial, my first thought is just how is this not selection bias? You know, just for example, there was a CMAJ paper recently looking at physician a surgeon age and outcomes, that’s now sort of making the rounds and has a lot of buzz. I’m still going through it myself, so I haven’t had a chance to dissect it. But again, I’d look at the at the conclusion and say, okay, you know, you know, experienced older surgeons may have fewer complications. But then my next question is, like, how, how does not selection bias not come into this? Like, what, what exactly is the practice style of some of these older surgeons that you can’t really dissect out through a lot of the risk adjustment methodologies that they’ve, they’ve applied. And as someone who’s done a lot of this type of health services research, you know, I understand the limits, and I do, you know, I have a, you know, the, the familiar experts understanding that you really can’t do the things that you want to do, which is, pretend you’ve done a really high quality, well-designed randomized trial using just these observational data. So yes, that’s, that’s definitely my, my first thought whenever I read any, any study, and the the idea of trying to use population based research as approaches to get around, selection bias has been, you know, a theme that’s gone throughout my research career whenever, whenever I try and assess the effect of any type of health intervention, without doing randomized trials, which are extraordinarily difficult to do in in surgery, as we all know, my my thinking is always well, how can we study the entire population, and try to use the entire population to figure out what the impact of this intervention might be? So that’s why we looked at that, in particular, for surgical safety checklist.

Ameer Farooq  17:48

Yeah, I think that’s an important lesson for trainees in particular, in that, you know, we spend a lot of times learning what the guidelines save, you know, for that little quiz that we have at the end of residency. But it’s, I think it’s important to still remember that the evidence definitely might not be perfect. And to keep those considerations in mind. I wanted to shift gears a little bit to one of my other favorite papers of yours, which is the paper that you did, I think, last year, which was looking at the impact of the word cancer, on people’s assessments of risk in thyroid nodules. Can you talk about that paper for those people who haven’t read it and what you found?

David Urbach  18:30

Yeah, yeah, and this is actually one of my favorite studies too. And, you know, if there’s a bit of a point and somewhat sad story, which is that I tried to do this the first time about 10 years ago, in a really small study among men with prostate cancer. And we, what we did in that study, is we just gave these hypothetical scenarios to men like, you know, 60-70 year old men, and say, What would you do if, and we gave them a scenario where you have this thing, and it’s, you know, was one centimeter and it was in the prostate gland. And you could do one of two approaches, you could either leave it alone, in which case, you’d be totally fine. Or you could do the surgery, in which case, there’s a 50% chance that you would have impotence or a urinary incontinence, and you would still be fine. So we basically gave the scenario of a localized prostate cancer, and we said, which, which approach would would you most want to take? And when, when we call that prostatopathy, which was the word we use back then for that study, nobody wanted surgery. As you might imagine, because the scenario we gave them suggested that surgery was all harm and no benefit. And if you called it cancer, virtually every man who did this study said they would have surgery, like 90-95% and it was a very small sample size and the confidence interval was wide. And I, we sent this to JAMA as a research letter, and it went through like multiple rounds of peer reviews. And, you know, I thought it was like a done deal. And at the very end, I think they just, they got cold feet. And it’s one of those, like great ideas that just never got published. And I never, never just sort of had the wherewithal to pick it up and, and run with it until I had this resident in ENT and he was really interested in doing a project and we just re-did the same thing with thyroid cancer and, and did the same scenarios. You you do a hypothetical survey among people with this thing of this fibroid thing, and if you call it thyroid cancer, everybody will will want to have it removed. And if you call it a thyroid nodule, then very few people will want to have it removed. And the bottom line is, this tells me and I think should tell all of us that the words we use, and like just basic words, are highly influential in guiding how people make decisions about surgery or other treatments, especially decisions that we think are sometimes not rational or counterintuitive, especially for very low-risk neoplasms, where all the guidelines would suggest conservative therapy. Prostate, prostate is a better example of that, actually, than thyroid because there still isn’t that much support yet for, you know, a watchful waiting approach to low risk, but potentially potentially malignant thyroid nodules. But for prostate cancer for, you know, localized small prostate cancers in men, there’s a lot of evidence that overall, the best approach would be an active surveillance or watchful waiting approach. And what what you see in practice is that men, even with localized prostate cancer, overwhelmingly elect to have surgery. And I have to think it’s because we’re calling it cancer, and people just cannot abide by the fact that they have something in their body called a cancer and not have it removed. It just culturally, it just seems like such a counterintuitive concept, that it’s very difficult to provide guideline concordant care, when it really goes against every emotional impulse that a person has when they’re diagnosed with cancer.

Chad Ball  22:31

That’s such an important study, David. You know, it speaks even I think more broadly to just how we talk to patients in general. You know, as an HPB, surgeon, of course, you know, even how you talk to them about dying, is so heterogeneous from from partner to partner, and some do it, you know, beautifully and some do less less well. And the words you write the selection of the words we use is so, so very important and really frames not only to how the patient, you know, views their their scenario, but how they view that future as well. Whether it’s upfront, like you’re describing and in prostate and thyroid lesions, or whether it’s at the back end, you know, dying of a pancreas cancer, metastatic like this important idea.

David Urbach  23:16

I think a word that we should think a lot more about that we use all the time is the word leak. When people talk to patients about complication, they’ll often use, you know, surgeons will will talk about a leak, right, and the word leak, like, for the average person, like a leak sounds almost cute. Like it doesn’t like what a leak means to you and me, the garden hose. Yeah, like, and the consequences and, you know, reoperations, and stomas and drains and prolonged course, but it’s like, each, the word leak just does not do justice to to the nature of that complication. So, and that’s just an example of words, and how influential they can be. So I think we, we really have to be aware, in all the work that we do about the words that we that we use, and and like you say, how we talk to patients, because there’s a lot of variation. And there’s, there’s really good techniques that we can pick up to, to communicate better.

Chad Ball  24:18

I mean, you know, in particular, and you know, from that from the view of a trainee, you you’re going through your residency and you’re trying to understand didactically, and then technically, all this, all this information. But I think we all run across, you know, once a year, twice a year, maybe more if we’re very lucky, but a particular faculty surgeon in clinic that you see connects with patients over and over and over again, in a way that that is awe inspiring, maybe too strong, but really, really impressive. And I think all of us should probably, you know, as we move through that process, sort of stop and try and reflect on it for exactly the reasons you’re saying because some people do do it so well. Although it’s a bit tangential. Maybe Dave, there’s so many challenges in performing high quality research in surgery, and you’ve, you’ve touched on them in the first half hour here a little bit. But, you know, from at least from our point of view, if we look around, you know, in Calgary, some of us that try and grind along in doing do research, you know, there’s, there’s obviously, less funding mechanisms, it’s harder to get that money to support your study. There seems to be new, new barriers, really every month, whether it comes from the university side of things on the on the ethics side, or now, you know, requiring trial insurance or whether it’s really are proven. And I don’t say this in a negative way, necessarily, but our provincial governments really focused on clinical care, as opposed to the academic side of things. Maybe less of a drive in the trainees to participate in research for a whole host of different reasons. It just seems like there’s more and more challenges all the time. So I was curious, on your view of what are those challenges in general? And then and then maybe some advice in terms of how we can overcome them? Or what do you think of all that?

David Urbach  26:02

Yeah, I, I have to agree it, it’s, it’s so hard to do research and to practice as an academic in surgery. And, you know, just when you think it can’t get harder to it gets even harder. And, you know, I have a I have a huge admiration for for those of us who still actually have active labs, like do real wet lab scientific research and get CIHR funding and, and keep keep that going when it’s, it’s so expensive, and competitive and time consuming, that it’s, you know, I have so much admiration for the people who are still able to do it. So, you know, I think one of the biggest barriers to developing, you know, academic faculty in Canada has still is, is the way that we work in our, in our universities. And we we don’t work the same way, as a lot of American universities, for example, that can develop academic faculty who they basically hire, do people who are well trained, pay them a salary, tell them, okay, you’ve got these clinical responsibilities, but but this is your research job. And these are your research days, and this is what we’re paying you for. And you’re going to do this for three years, and we’ll review you every year, and then eventually, your, your promotion and your tenure will be based on how you perform in all these different dimensions. And in Canada, it’s, it’s very difficult, because of the way clinical revenues come in, and because of the way hospitals are funded, and because of the way our academic departments work, it’s very hard for us to do that. We can, we can try and put some plans together to protect young academic faculty and try and get them to sit and think and write and collaborate. But it’s very hard to keep the drive to do clinical work at bay, and to really put the rewards from clinical work into some, you know, prioritization so that you’re not you so pressured to do clinical work to maintain your income and to contribute to whatever, you know, group arrangement you have in, in your hospital or university, which, which varies a lot, obviously, from province to province, and university to university. So I think the, the opportunity, the ability to support people to be disciplined, is, is very difficult for us in Canada, and I think that’s a huge problem. And then, and then the rest of them, you could you could make the list, it’s, it’s so competitive. You know, CIHR, funding rates are, you know, between 10 and 15%. So, yeah, you have to, you have to get rejected a lot of times, at CIHR before you ever get, get a grant funded. And to do high quality research, takes time takes money, and takes training and collaboration and, you know, put into all the other, you know, competing things that people need to do, it’s just so hard. I know I keep saying that over and over. But I really sympathize with our young faculty now trying to, you know, starting out on their careers and and trying to develop their own nation research. And, you know, I, I do what I can to support them, but I have so much sympathy for what they’re dealing with because I recognize how difficult it is for them as well.

Ameer Farooq  29:47

Dr. Ball had talked about, not only you’re doing this really tough work with research, but you’re also involved in administration and particularly you’ve looked a lot at trying to improve the whole Canadian healthcare system, it’s particularly with wait times. Do you what do you think are the big things that we should be working on as a country? I know it’s a bit hard right now with, with COVID sort of looming on our minds, but if we back ourselves up two months and kind of think globally about the Canadian health care system, and the issues that we’re facing, what are your thoughts about how we can improve access to care and overall our system?

David Urbach  30:32

Right, so if I, if I was to back up a couple of months, I would say, what’s the biggest threat to Canadian Medicare, like what’s if there’s one thing that’s gonna topple the system and create the, you know, have the Supreme Court of Canada just say, this is no longer consistent with our charter rights, it would have been access and wait times, for sure. Of all the concerns that people have, that’s the one that hits a nerve and gets a lot of attention. And, and it’s something I’ve been thinking about for a while. In international surveys, Canada performs, you know, not great on the on health system performance. So, you know, the Commonwealth does the survey every couple of years, and it was a real wake up call, where the, the think the 2017, one showed that Canada was, you know, close to the bottom in international rankings. And, and the reason the biggest reason that we perform poorly is access and wait times. And these are things like, wait times for elective surgery, you know, ability to get a primary care appointment within a day, like, like, waiting for a specialist for more than a few months. And these, these are huge challenges. You know, one thing I will say, because people sometimes lose sight of this fact, is that no, nobody loves their health system in any country. Like, if, if you look at that Commonwealth survey about how people rank their health system, internationally, like the country that did the best in the 2017 survey was Germany. And then they ask questions, like, you know, are you mostly satisfied? Or are there major problems? Or do you have to destroy the whole health system and rebuild it from scratch? And in Germany, which was the best 60% of people thought it was largely Okay. That it didn’t have to be knocked down and rebuilt or did not require sort of major major changes. So 40% of people in the best country, like in the country, where people thought the health system was the best by international comparisons, 40% still had major problems with it. So I think the notion that there’s a solution to the problems of providing health care in a way that’s satisfying to populations in western countries like that, that’s not, that’s never going to be something that we’re able to achieve, just because of the way that health care is now that it’s, it’s very expensive. And people’s expectations of care is very high, and they want access to it. And it’s like the classic line in business is good, cheap, fast, pick two. It, it’s exactly the same in health care, like, you know, you can have in Canada like to think we have, you know, good and maybe cheap, but but not fast. And you can have, you know, fast and good if you can argue that maybe the United States health care is very good health care, and very accessible health care, but it’s not cheap. So, you know, something has to give just because people expect a very high standard of care. And, and that has become extraordinarily expensive. So, you know, per capita health expenditures in Canada are around, you know, they vary province-to-province, but you know, like, say $6,000 per year per capita. You know, nobody really wants to spend that much money. If you look at median household incomes and what that represents, you know, whether people pay for care out of pocket or insurance premiums or taxation, nope, nobody wants to shell out those dollars and think that that’s going for their healthcare. So you have this basically unsolvable conundrum. So that’s just my my little sideways, diatribe on, on the fact that well health care systems can’t be fixed, they just have to be managed. So Canada, the, the biggest crisis point to me has been the issue of wait times and access, especially in surgery. I think that’s, that’s our challenge. And the the approach that I’ve become most interested in recently, has been looking at innovative ways to manage referrals to surgeons, and innovative ways of health surgeons work together to provide care. And the the best model that I can find in the literature and one that we’re studying now in Ontario using administrative data is what are called single-entry models. So single-entry models, everyone’s familiar with, you know, if you go to most Tim Hortons or banks or whatever, you just joined a single line in the beginning, and then at the very end, you just get assigned to the next available person who can, who can, you know, provide you a service. And there’s a lot of literature on single-entry models in health care. So, essentially, patients wouldn’t, your family doctor wouldn’t have to figure out who, which surgeon to send you to who might have the shortest wait time who they think is the best to, you know, whatever, whatever goes into the minds of referring physicians, when they try to find a surgeon to look after a patient, but that you would have a common queue, and then the patients would just be assigned to the next available provider. So if you know in, you know, in Ontario, well demonstrate, I know, there’s that there’s a great hernia surgeon in Toronto, who has a waitlist, or, you know, this is, before this whole COVID thing started somewhere like, you know, 12 months or 18 months to see him for an inguinal hernia. And you know, other hernia, other hernia surgeons had a waitlist of just a couple of weeks. And, you know, primary care doctors have have no idea about who’s you know, who’s got the shortest list. Like we don’t really publicize all this information. But if there was a common list for hernia surgery, and, you know, patients who just entered this common list and just get partitioned out to the next available provider, all of a sudden, what you’ve done is you’ve sort of harmonized that waitlist and, and gotten it down to kind of the lowest median wait that you could have. Because you’re, you’re pooling all the resources together and just using a common queue. So the concept of a single-entry model, and people sometimes call this central intake or centralized triage models, but the notion of having a common queue, and then assigning patients to the next available provider, can go a really long way, in harmonizing wait times and shortening wait times for most people. The other, the other approach that I think helps quite a bit as well is establishing team-based models of care. So right now, a lot of surgeons for most of what we do still work as essentially, solo providers, and we kind of run our own practices, and we get referrals to patients, and we evaluate them and decide whether or not they should have surgery. And then generally we do the surgery ourselves. You know, sometimes there’s a bit of group input through tumor boards, for example, and, you know, for some cancer sites, but by and large surgeons manage patients on their own. The alternative is to have team-based or group models of care, where care of patients is shared between surgeons in a program. So say at a hospital, you have three or four surgeons who work together to co-manage patients. The way that can also help wait times is once a patient enters into your program, they also just get assigned to the next available surgeon. So if you happen to see a patient in your in your common program, but you don’t have a ward time for like two months and one of your partners has a ward time in two weeks, then that patient could actually go and have surgeon primarily have surgery primarily by your partner instead of by you and still get the quickest next available appointment. So that that model is a little bit different from the way that most surgeons work. And there’s, you know, a lot of reluctance to embrace different types of models. But, you know, I think you could do a lot to improve the system dynamics and improve access to care, and probably also improve the work lives of surgeons by embracing some of these innovative models of care a little bit more than we have in the past.

Chad Ball  39:01

It’s interesting, David, I think you’re dead on as usual with that we just recently had the Edmonton group come down to Calgary and give Grand Rounds about their program up there. They call it an Access Program. But effectively, that’s exactly what you’ve described as what they’ve done. And it was interesting to hear, you know, in terms of adoption, and sort of negative view of it amongst some surgeons up front and how that you know, it was the minority but that that relatively vocal group up front had all come on to the program at the at the back end because they thought the so successful, not only for patients, but also for the surgeons themselves. They talked about reducing a lot of the administrative stresses that that they individually as well as their offices had to deal with and it was a remarkable presentation, which we’re trying to pursue in Calgary here. But as you say there’s a lot of skeptics in particular, maybe surgeons that have been around for a long time and have deep relationships with referring physicians. You know, probably there, there’ll be the late adopters, but the data was was very clear, it was significantly beneficial to northern Alberta and patients and relief surgeons at the end of day too.

David Urbach  40:11

Yeah, well, you know, changes is hard and, and painful. And, you know, but I will say, I think you’re, you’re dead on that once once people implement these types of programs, they never go back. And wherever they’re like, there’s, there’s so little back. And, you know, a great example. And I’ll go back to my dad, the the obstetrician, who, you know, is obviously retired. But he spent his whole career until the very end of his career, looking after his own patients. And he’d, like at three in the morning, he would be on a Thursday, you know, he not on call, but he’d have to, you know, if one of his patients was in labor, he’d drive down to like the Wellesley Hospital in downtown Toronto and go and, you know, deal with a woman who was laboring and deliver her baby or section or whatever. And you know, that people now would look at that as craziness. Like any no obstetrician. And, and here, you know, women, because people often say that, Oh, no, a patient won’t tolerate this. Like, once you have that relationship formed with a surgeon or a provider, then that’s inviolate. And that there’s no way that patient will ever allow anyone else or have confidence in any other provider. But, you know, just look at obstetrics. And there’s so many other examples. But, you know, here you have, you know, pregnant women who see their obstetrician, you know, periodically, you know, every week towards the end of their pregnancy, you know, developing strong relationships, I’m sure with their obstetricians. And then when push comes to shove, and you’re in labor, you know, it’s, let’s meet Dr. Smith. And, you know, whether you have a section or you know, forceps or whatever the obstetric decision-making is, you basically trust the person who’s there. And it’s not the person you had a relationship with before, but it’s the best person who’s skilled and inspires confidence, and they can look after you in the moment. So, you know, to me, there’s, there’s, there’s no reason why it’s not possible. And, you know, I think surgeons often will do things and value them, particularly when it when it helps them as well. And I think as surgeons realize how much improve their worklives as surgeons. And, you know, you mentioned, just the stress of managing a practice and patients and wait time, like, our lives are almost all workarounds for for a system. Right? Exactly. That, and it’s, it’s, it’s one workaround after another. And it’s all just done to preserve this notion that we own the patient, it’s our patient, and we have to figure out with the resources that are given to me, like, how am I going to get this, like, how am I gonna get this person done? I’ve got these four other people. But if you if you shift to a system perspective, and say, you know, the patient doesn’t necessarily belong to you, it’s a patient of the system, and how can you construct a system to provide patient-centered care? You know, then, you know, you open a whole new universe of creative ideas.

Ameer Farooq  43:22

Well, if COVID has done one good thing, it’s shown us that we have to probably get a bit more innovative and and maybe have to embrace change, you know, people are doing telemedicine consults, for example. And that’s not something we thought was ever going to take off in the way that it has. But talking about wait times, how are we going to address this backlog of cases, after we have elective surgery turned back on? Once you know what, you know, whether COVID is going to go away or not is it remains to be seen. But once the elective surgeries sort of start taking off again, what are we going to do about this massive backlog? And what are your thoughts about how to best address this?

David Urbach  44:06

Yeah, well, I mean, it probably won’t surprise you that, I think, you know, team-based care and single-entry models are a big part of how we’re going to address this problem. You know, my personal feeling and you know, none of us know what’s going to happen. But I don’t see this as a as a problem that we’re going to get beyond in a couple months time and then say, Okay, how are we gonna dig ourselves out of this backlog? Let’s Well, you know, let’s operate Saturday on Sunday and every night till 10 pm just to get through all this backlog of elective surgery that’s accumulated now that we’re over the hump. You know, I think probably we’re going to be managing or you know, coping in some way with COVID for for many months and possibly a year or more. So I don’t see us as getting, you know, back up to 100% of capacity let alone, you know 150%. So I think we’re going to be stuck with a, what’s probably an ethical problem for the foreseeable future, which is how do you provide care to people with limited resources? Including sort of care that kind of falls between the cracks like, we might be able to construct a system that gets all the patients with breast cancer and colon cancer and hepatic biliary cancers. But, you know, it does is no way going to have a knee replacement for the next year and a half or a hernia repair or cholecystectomy. You know, we have to figure out a way to do this fairly, ethically and equitably to patients and, and also to surgeons. You know, if you’re, you know, benign general, a general surgeon who does benign surgery like hernias and gall bladders, you know, there’s a scenario where you might not operate for months. You know, what does it mean to be a surgeon who doesn’t do an operation for six months or nine months. So I think we need a way to treat patients ethically in patient-centered manner. And I think we need a way to keep surgeons working. Number one, because it’s, it has to be fair to surgeons. And number two is, you know, the catastrophe if you if you force surgeons to to basically stop working for a long period of time, you may not get them back. Yeah, you know, I’m not sure what happens to people skills after prolonged period of time. It’s, it’s not ideal for anybody. So what I view as a very effective and ethical and fair system is to say, you know, look at what’s, what do we need to do, and what are the resources we have, and what’s the most fair and ethical way to do it. So, again, you’re not going to be surprised. But I think, working together in teams and sharing resources equally. So instead of just who’s got the most patients on a list, let’s just let let everyone get equal access to resources. So all the surgeons have a chance to keep their skills up and get access to resources for patient care, because I think that’s important for surgeons. And then, for patients, I think we need to work off common lists within our groups. Like if you’re in a hospital with a few partners, I think we all need to put our patient list together and say, Okay, let’s prioritize them based on urgency and try and get the urgent ones first, through the list, but also make lists for everything so that we don’t ignore some of the benign conditions that still cause a lot of suffering and chronic problems for people. So, you know, I think that the same types of strategies that would be good for Canadian health care in normal times, are even more important in in these crazy crisis times.

Chad Ball  47:58

So Dave, one of the passions you and I share for short in length, lots of share across the country, to be honest, and, and I just wanted to touch on it before we close this, especially, you know, our concerns around implantable medical devices. And that’s a broad description or broad term. But, you know, obviously, in the general surgery world, for example, we would talk about some of the many types of mesh that have been say recalled for incisional hernia repairs, as you know, there’s, in fact, the largest class action lawsuit in America right now surrounds a dual layer mesh in Canada, it’s it’s ramping up, we tend to, at least from, from my point of view, dropped these implantable devices into patients in what seems like a very rapid and sometimes unsafe manner, based on data and opinions from industry. And I don’t guess its the fault of the surgeon necessarily, but it certainly is a concern. What do you think about that?

David Urbach  49:02

Yeah, I mean, this is such a fascinating area. And I’ve done a lot of work with device regulation in in Canada, and also, you know, read a lot about how this works internationally. And, you know, I think it was fascinating to me, because I knew so little about it before, and I can guarantee you that most surgeons really don’t understand the process by which these implantable devices are evaluated, regulated and approved. And here’s what I mean by that. In Canada, it’s Health Canada, that’s the agency that regulates and provides licenses for health products. In the United States is the FDA, the Food and Drug Administration, and, you know, every country has its own process. And the legislation used by Health Canada, as well, by the FDA, basically says that they approve health products, if they’re safe and effective. So those those are the criteria. Now, if if what they’re evaluating is a new drug to determine that that new drug is safe and effective, they’ve decided based on this, you know, evolving consensus that that requires large clinical trials. You know, and for most drugs, it’s, you know, there are 1000s of patients and placebo-controlled studies, they’re obviously funded by pharma, because there’s, at the end of this is a company that stands to get a lot of return on investment. But because of that, you can actually get fairly well-designed clinical trials, that actually can tell you that a drug is effective, and largely safe, although, even with these, you know, big expensive clinical trials that that the pharmaceutical industry does, people still criticize them, because well, you know, follow up with only one year, like, we don’t know what happened after two years, or three years or something. But, but at least they have these big clinical trials. So the amazing thing is, for implantable devices, there’s really no requirement for clinical trial. And at first, you may think about that, well, that’s crazy, like, how can you approve new implantable devices without doing, you know, randomized trials or controlled trials in people that are large enough and well-designed enough and long enough, with follow up to figure out if they’re safe and effective. And as it turns out, when you dig deeper into it, it’s, it’s extraordinarily difficult to do that. And I would say impossible, mostly because of how expensive it is to do these types of studies. And the fact that the manufacturers of devices could never ever recover the the cost of development if they had to actually pay to do clinical trials. So to put this in perspective, you know, drug studies to get these things approved by the FDA, are, you know, hundreds of millions of dollars, by and large, and people argue whether it actually cost that much and where the money goes to. But it’s it, it costs at least 10s of millions of dollars, probably hundreds of millions of dollars per product, to get it on the market with clinical trials. And so, you can do that with drugs, because, you know, you get, you know, market exclusivity and patents, and you get 18 years or 21 years, or whatever it is to, to sell a drug at a high price with essentially a monopoly market. Yeah, but you don’t have that with devices, because they’re, they’re not patented molecules, and different manufacturers can provide similar products. The intellectual property doesn’t stick in the same way that it does, for drugs, and, and the products don’t stay in the marketplace that long. So you can’t actually, you know, develop a, say, a piece of mesh, patent it, you know, prevent any of your competitors for creating a similar type of mesh, and then market it at retail prices for 20 years. You know, the meshes change every few years. So the whole business model just makes it unaffordable to do clinical trials. And the other problem is that the sheer number of devices, so, you know, people may not realize this, but new drugs is, every year, there’s like a handful of new drugs that are approved by Health Canada or the FDA, it’s like maybe a couple dozen. But you know, less than 50 for sure, every year. Whereas for, you know, medical devices and implantable health products, it’s 1000s. Like, there’s this probably many 10s of 1000s, or 100s of 1000s of medical devices that have licenses that are being marketed. And it would just be an overwhelming, you know, task to, to do the same type of regulation that people do with drugs. So the problem with devices is we have exactly the same language from the regulators that we we had that they use for drugs, with devices. So they’ll say that, yes, this mesh is approved, because we’ve determined it’s safe and effective. But, but if determining something is safe, and effective, actually means doing clinical trials, with long-term follow up. They actually haven’t done that, like all they’ve done is they’ve gone through with largely an engineering process, or they’ve done enough due diligence to show that it’s not too different from other types of meshes. And that’s really the evidence that gets the mesh on the market. And, and I think surgeons don’t understand this, that the process by which these implantable medical products get to market don’t necessarily rule out the fact that there may be problems, there may be long term problems, or maybe short term problems. And, and you can’t foresee all these problems. And, you know, I don’t blame the manufacturers. Because, you know, I do see this as a very, you know, it’s a very complicated problem. But one thing we need to do is, is change our mindset about how we think about all of these products and implantable devices and sort of think of them a little bit more as experimental things rather than approved known quantities. And I think if we, if we thought a little bit more of them as always somewhat experimental, I think we’d be much less likely to use the latest thing. Like I think we’d be much more likely to use the mesh that we use 10 years ago, and 15 years ago, that seemed to be pretty good. And, but, but once you start to change your mindset, and and you try to try and reduce your susceptibility to the latest and greatest, which is such an normal human emotion, I think it would all make us all better off.

Ameer Farooq  55:54

You’ve been listening to Cold steel, the official podcast of the Canadian Journal of Surgery. If you’ve liked what you’ve been listening to, please leave us a review on iTunes. We’d love to hear your comments and feedback. So feel free to email us at podcast.cjs@gmail.com or connect with us on Twitter @CanJSurg. Thanks again.