Lag Time Between Evidence and Guidelines: Can Clinical Pathways Bridge the Gap?

Lag Time Between Evidence and Guidelines: Can Clinical Pathw...

JCO Oncology Practice Podcast

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Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the Journal. The best available evidence for cancer treatment seems to change at just a staggering pace. And yet, as physicians, we're expected to keep up with these changes and always give the most evidence-based treatment, which is obviously an incredible ongoing challenge. Guidelines from major organizations can play a role in helping us stay up to date. However, considerable variability exists, even in situations where the best practice seems to be clear. This creates an opportunity where things like care pathways might play a role. Today, we're going to be talking about this topic and about a new paper titled "Lag time between evidence and guidelines-- can clinical pathways bridge the gap?" which will be published in the March 2019 JOP. Joining me today for the podcast is the senior author of the paper Dr. Sushil Beriwal, professor of radiation oncology at the University of Pittsburgh and deputy director of radiation services at UPMC Hillman Cancer Center. Dr. Beriwal, thank you for joining me today. It's my pleasure. Thanks for having me. So why do you think there is so much variability in care, especially around things where a lot of people have broad agreement? So the example in your paper that you use is hypofractionated whole-breast radiation, which has been part of a major guideline since 2011. And yet, it seems as though many people don't use it. So we do see variability in the cancer care. And hypofractionated radiation therapy is one of a good example. What is exactly? It's hard to pinpoint. But I think it's for multiple reasons. Could be a physician is used to practicing a certain why. They don't want to change the practice. They're not aware of the newer data and guidelines. Or it could be the fact that they're concerned about increased side effects and toxicities with this newer approach. They may not have technology or resources to do it. And last, but not the least, sometimes the fee-for-service model may have a detrimental effect in accepting a shorter course of treatment. Oh, I hadn't even thought of that, but that's a good point. So can you take me a little bit through your study? What was the problem that you were trying to solve? As you know, there have been various studies which have come out in the last 5 or 10 years, looking at adoption of hypofractionation for breast cancer care, even though the randomized data suggests that hypofractionation is similar for cancer outcome and possible less side effects, [? with ?] the adoption rate based on the National Cancer Database analysis, or some keyword industries, or some state data, it's somewhere within 10% to 50%. So there is wide variation and acceptance and adoption. And we were trying to figure out a way to make it more uniform so the patient get similar kind of care based on the best available evidence for that patient. Is care pathways or clinical pathways something that you've had experience with working with before? And I guess, maybe just for our listeners, kind of explain to us what a clinical pathway is. Clinical pathways are like additional [? aid ?] tool which basically guides the physician to decide about the care of the patient based on the stage, grade, and other factors associated with that patient. So we at UPMC Hillman Cancer Center started the clinical pathway in a very rudimentary form about 14, 15 years ago. It has come a long way from being a paper trail to an electronic format. The way it works out is anybody who sees a patient in our network of 25 sites has to enter a decision to-- in the care pathway model created by this company called Via Oncology, which was initially part of UPMC, but this year, it was bought by somebody. Well, it was an outside company called [INAUDIBLE]. So say, for example, if I see a patient in my clinic, I go to care pathway website. And automatically, it will ask me for stage, grade, and what needs to be done. And then it gives me the option of what to do. So if the option for that patient is hypofractionated radiation therapy, that's what I have to choose. I see. And how do you decide what goes into these care pathways? Is this determined by an outside group? Is this something that you get to determine within your own institution? When we started, it was within our own institution. But now we have oncologists from all over the country who participate, who are part of the same care pathway module. We have chair and co-chair for each site. And we have committee members for each site. So we meet every six months on a regular conference call. And whatever evidence has come out in the last six months, we try to incorporate that in our discussion and make changes accordingly. So initially, the agenda is discussed. The committee decides and discusses. It goes back and forth. And once the committee agrees, then it's sent out to all the members for voting. And once everybody agrees in the voting, then it is implemented. And that becomes the care pathway for that disease and stage. And so what were the results of your intervention? So we went by a very stepwise manner. So initially, the 10-year data for hypofractionation from the UK group came out in 2013. So when that came out, we as a group decided to mandate hypofractionation for somebody who is 50 and above, like postmenopausal women with early-stage breast cancer. When you're trying to keep breast or just [INAUDIBLE] level to use. And we found when we assessed the outcome that there was a very high acceptance rate of hypofractionation. But one of the concerns we found that the physician had in accepting hypofractionation was how best to do it, because those papers and the data did not define fully the best way to deliver the dose, how best to achieve dose homogeneity, what should be the [INAUDIBLE] and the hard dose. So within our own network, we came up with a very good guideline of how best to achieve dose homogeneity to deliver this dose safely and make it better for the patient. Once we got success with that, then we took the next step of implementing this for younger women. And since we already had the track record, we found that the resistance to the acceptance of hypofractionation was much-- there was much wider acceptance, because people knew how to do it from the previous experience. And the acceptance was much more wider and much more-- the numbers were close to 95% to 100%, which was very reassuring and which was very gratifying to see that patients across our network were getting similar kind of care. No, actually, the numbers are staggering. I mean, in 2015, the number was only 4.2%. But by the second intervention, you said it was 96.5%. So were the doctors actually mandated to use this? Did they have the option of changing it if they wanted to? So the way our system works is the only option we had was to do hypofractionation, but they can change it. But they need to have an evidence-based discussion of why they want to change it. And see, I'm department director for the breast. So anybody who wants to do something different, then he will send an email to me, that he doesn't agree with the pathway recommendation. And these are the reasons why he wants to do it. If the evidence-based discussion is consistent, then we say, go ahead and do the conventional fractionation. Well, it clearly was very effective. I'm curious if you saw pushback from the doctors in making this change? Did people have a problem with being directed towards this particular treatment? Initially, I did. Initially, when we did it for the first time, there was a lot of communication back and forth. And people made different kind of arguments, like we only have 10 years' data. We don't have 20 years' data. And we don't know whether it is safe or not. Or [? they could ?] quote previously have done studies which have shown poor outcome. But they were done with different techniques and different philosophy. So there were a lot of discussions back and forth. And to alleviate some of the concern, I did a [INAUDIBLE] conference in our network, where we mandated all of our physicians to participate and listen to the [INAUDIBLE] conference, where we defined how best to do hypofractionation in terms of dose homogeneity, in terms of heart and lung dose. The most important factor was dose homogeneity. And once physicians understood that the dose homogeneity is the more important component than the fractionation, and they could see the results from the patient's perspective and from physician's perspective, the adoption became like a no-brainer. The other thing that is remarkable to me about the pathways at the University of Pittsburgh and the people who use the Via Oncology Pathways, so my own institution at the Cleveland Clinic, we also come up with our own evidence-based care paths. And we try to educate people about them. But there isn't really a good way to track how well people adhere to them. How important do you think having the web-based monitoring, where people actually have to track what they're doing, is to adherence to these care pathways? Well, it definitely helps us, because there are two ways we monitor it. One is like the [INAUDIBLE] tool. Then anytime you go off pathway, it comes to the pathway director as an email for him to respond to the rationale behind our pathway and whether he or she agrees with it. And if he agrees with it, then it goes into the system as "On Pathway," even though the track was not on pathway. And the second thing is you may say you're doing something, but you may not be doing it. So we have an audit system built in where we have one of our staff members audit the charts randomly across our network and match what has been done to the patient to what has been entered into the clinical pathway, to make sure they match. If other centers wanted to start adopting clinical pathways in order to help improve the quality of their care, what are some of the take-home lessons you learned during this process that you can pass on to them? I think it's important that you have the buy-in from the providers. So in our pathway, it's not like the total is 1% of [INAUDIBLE]. It's a committee, it's a member, and it's an open discussion. If you don't have the buy-in from the people, then it's hard to implement it. You need to explain to the patients it's not taking over their autonomy. The physicians still have the autonomy. It's just helping them guide better to have uniformity of care. And having some-- there are system guidelines. And there are other guidance available. But they try to keep it very lighter in terms of options. The difference between the guidelines of the pathways is there's much more [INAUDIBLE]. Like, for example, we call it the philosophy of efficacy, toxicity, and the cost. All things being equal, the one which is most efficacious gets number one ranking. If it is equally efficacious, then the toxicity gets the high ranking. And if it is equally efficacious and toxic, then the cost gets the high ranking. So the hypofractionation for the breast, it's similarly in approximation to efficacy to [INAUDIBLE] fraction. The toxicity is somewhat better with hypofractionation. And the cost is much better. I think that's a critical point to illustrate, that the first and most important thing is that we make sure that it's just as effective and also at least as tolerable, if not better. We want to make sure people understand that the clinical pathways such as this are not designed just to save money but also to improve actual patient care. And what are the next steps? Where are going from here? So just to take this concept to the next step, like we have recently adopted hypofractionation for prostate cancer. And we have implemented in our data our guidelines how best to do it. So our next step is to look at the adoption of hypofractionation for prostate cancer, which is like nine weeks treatment versus six weeks treatment, with the guidance of how best to do it. And the next thing we'll be executing is whether we are able to successfully do that or not for prostate cancer too. I think this has given us a benchmark and a platform to take it to the next level for other disease sites, and to make sure that we are following the data and evidence to the best of what we can do. Thank you for agreeing to talk to me today. I think this is going to be really of interest to the listeners of the podcast. Thanks for having us. And it was a pleasure talking to you. And I hope that this can send the right message to the audience for them to take these steps in their own practices. I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on December 7, 2018, and will be in the March 2019 JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice, signing off.
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Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the Journal. The best available evidence for cancer treatment seems to change at just a staggering pace. And yet, as physicians, we're expected to keep up with these changes and always give the most evidence-based treatment, which is obviously an incredible ongoing challenge. Guidelines from major organizations can play a role in helping us stay up to date. However, considerable variability exists, even in situations where the best practice seems to be clear. This creates an opportunity where things like care pathways might play a role. Today, we're going to be talking about this topic and about a new paper titled "Lag time between evidence and guidelines-- can clinical pathways bridge the gap?" which will be published in the March 2019 JOP. Joining me today for the podcast is the senior author of the paper Dr. Sushil Beriwal, professor of radiation oncology at the University of Pittsburgh and deputy director of radiation services at UPMC Hillman Cancer Center. Dr. Beriwal, thank you for joining me today. It's my pleasure. Thanks for having me. So why do you think there is so much variability in care, especially around things where a lot of people have broad agreement? So the example in your paper that you use is hypofractionated whole-breast radiation, which has been part of a major guideline since 2011. And yet, it seems as though many people don't use it. So we do see variability in the cancer care. And hypofractionated radiation therapy is one of a good example. What is exactly? It's hard to pinpoint. But I think it's for multiple reasons. Could be a physician is used to practicing a certain why. They don't want to change the practice. They're not aware of the newer data and guidelines. Or it could be the fact that they're concerned about increased side effects and toxicities with this newer approach. They may not have technology or resources to do it. And last, but not the least, sometimes the fee-for-service model may have a detrimental effect in accepting a shorter course of treatment. Oh, I hadn't even thought of that, but that's a good point. So can you take me a little bit through your study? What was the problem that you were trying to solve? As you know, there have been various studies which have come out in the last 5 or 10 years, looking at adoption of hypofractionation for breast cancer care, even though the randomized data suggests that hypofractionation is similar for cancer outcome and possible less side effects, [? with ?] the adoption rate based on the National Cancer Database analysis, or some keyword industries, or some state data, it's somewhere within 10% to 50%. So there is wide variation and acceptance and adoption. And we were trying to figure out a way to make it more uniform so the patient get similar kind of care based on the best available evidence for that patient. Is care pathways or clinical pathways something that you've had experience with working with before? And I guess, maybe just for our listeners, kind of explain to us what a clinical pathway is. Clinical pathways are like additional [? aid ?] tool which basically guides the physician to decide about the care of the patient based on the stage, grade, and other factors associated with that patient. So we at UPMC Hillman Cancer Center started the clinical pathway in a very rudimentary form about 14, 15 years ago. It has come a long way from being a paper trail to an electronic format. The way it works out is anybody who sees a patient in our network of 25 sites has to enter a decision to-- in the care pathway model created by this company called Via Oncology, which was initially part of UPMC, but this year, it was bought by somebody. Well, it was an outside company called [INAUDIBLE]. So say, for example, if I see a patient in my clinic, I go to care pathway website. And automatically, it will ask me for stage, grade, and what needs to be done. And then it gives me the option of what to do. So if the option for that patient is hypofractionated radiation therapy, that's what I have to choose. I see. And how do you decide what goes into these care pathways? Is this determined by an outside group? Is this something that you get to determine within your own institution? When we started, it was within our own institution. But now we have oncologists from all over the country who participate, who are part of the same care pathway module. We have chair and co-chair for each site. And we have committee members for each site. So we meet every six months on a regular conference call. And whatever evidence has come out in the last six months, we try to incorporate that in our discussion and make changes accordingly. So initially, the agenda is discussed. The committee decides and discusses. It goes back and forth. And once the committee agrees, then it's sent out to all the members for voting. And once everybody agrees in the voting, then it is implemented. And that becomes the care pathway for that disease and stage. And so what were the results of your intervention? So we went by a very stepwise manner. So initially, the 10-year data for hypofractionation from the UK group came out in 2013. So when that came out, we as a group decided to mandate hypofractionation for somebody who is 50 and above, like postmenopausal women with early-stage breast cancer. When you're trying to keep breast or just [INAUDIBLE] level to use. And we found when we assessed the outcome that there was a very high acceptance rate of hypofractionation. But one of the concerns we found that the physician had in accepting hypofractionation was how best to do it, because those papers and the data did not define fully the best way to deliver the dose, how best to achieve dose homogeneity, what should be the [INAUDIBLE] and the hard dose. So within our own network, we came up with a very good guideline of how best to achieve dose homogeneity to deliver this dose safely and make it better for the patient. Once we got success with that, then we took the next step of implementing this for younger women. And since we already had the track record, we found that the resistance to the acceptance of hypofractionation was much-- there was much wider acceptance, because people knew how to do it from the previous experience. And the acceptance was much more wider and much more-- the numbers were close to 95% to 100%, which was very reassuring and which was very gratifying to see that patients across our network were getting similar kind of care. No, actually, the numbers are staggering. I mean, in 2015, the number was only 4.2%. But by the second intervention, you said it was 96.5%. So were the doctors actually mandated to use this? Did they have the option of changing it if they wanted to? So the way our system works is the only option we had was to do hypofractionation, but they can change it. But they need to have an evidence-based discussion of why they want to change it. And see, I'm department director for the breast. So anybody who wants to do something different, then he will send an email to me, that he doesn't agree with the pathway recommendation. And these are the reasons why he wants to do it. If the evidence-based discussion is consistent, then we say, go ahead and do the conventional fractionation. Well, it clearly was very effective. I'm curious if you saw pushback from the doctors in making this change? Did people have a problem with being directed towards this particular treatment? Initially, I did. Initially, when we did it for the first time, there was a lot of communication back and forth. And people made different kind of arguments, like we only have 10 years' data. We don't have 20 years' data. And we don't know whether it is safe or not. Or [? they could ?] quote previously have done studies which have shown poor outcome. But they were done with different techniques and different philosophy. So there were a lot of discussions back and forth. And to alleviate some of the concern, I did a [INAUDIBLE] conference in our network, where we mandated all of our physicians to participate and listen to the [INAUDIBLE] conference, where we defined how best to do hypofractionation in terms of dose homogeneity, in terms of heart and lung dose. The most important factor was dose homogeneity. And once physicians understood that the dose homogeneity is the more important component than the fractionation, and they could see the results from the patient's perspective and from physician's perspective, the adoption became like a no-brainer. The other thing that is remarkable to me about the pathways at the University of Pittsburgh and the people who use the Via Oncology Pathways, so my own institution at the Cleveland Clinic, we also come up with our own evidence-based care paths. And we try to educate people about them. But there isn't really a good way to track how well people adhere to them. How important do you think having the web-based monitoring, where people actually have to track what they're doing, is to adherence to these care pathways? Well, it definitely helps us, because there are two ways we monitor it. One is like the [INAUDIBLE] tool. Then anytime you go off pathway, it comes to the pathway director as an email for him to respond to the rationale behind our pathway and whether he or she agrees with it. And if he agrees with it, then it goes into the system as "On Pathway," even though the track was not on pathway. And the second thing is you may say you're doing something, but you may not be doing it. So we have an audit system built in where we have one of our staff members audit the charts randomly across our network and match what has been done to the patient to what has been entered into the clinical pathway, to make sure they match. If other centers wanted to start adopting clinical pathways in order to help improve the quality of their care, what are some of the take-home lessons you learned during this process that you can pass on to them? I think it's important that you have the buy-in from the providers. So in our pathway, it's not like the total is 1% of [INAUDIBLE]. It's a committee, it's a member, and it's an open discussion. If you don't have the buy-in from the people, then it's hard to implement it. You need to explain to the patients it's not taking over their autonomy. The physicians still have the autonomy. It's just helping them guide better to have uniformity of care. And having some-- there are system guidelines. And there are other guidance available. But they try to keep it very lighter in terms of options. The difference between the guidelines of the pathways is there's much more [INAUDIBLE]. Like, for example, we call it the philosophy of efficacy, toxicity, and the cost. All things being equal, the one which is most efficacious gets number one ranking. If it is equally efficacious, then the toxicity gets the high ranking. And if it is equally efficacious and toxic, then the cost gets the high ranking. So the hypofractionation for the breast, it's similarly in approximation to efficacy to [INAUDIBLE] fraction. The toxicity is somewhat better with hypofractionation. And the cost is much better. I think that's a critical point to illustrate, that the first and most important thing is that we make sure that it's just as effective and also at least as tolerable, if not better. We want to make sure people understand that the clinical pathways such as this are not designed just to save money but also to improve actual patient care. And what are the next steps? Where are going from here? So just to take this concept to the next step, like we have recently adopted hypofractionation for prostate cancer. And we have implemented in our data our guidelines how best to do it. So our next step is to look at the adoption of hypofractionation for prostate cancer, which is like nine weeks treatment versus six weeks treatment, with the guidance of how best to do it. And the next thing we'll be executing is whether we are able to successfully do that or not for prostate cancer too. I think this has given us a benchmark and a platform to take it to the next level for other disease sites, and to make sure that we are following the data and evidence to the best of what we can do. Thank you for agreeing to talk to me today. I think this is going to be really of interest to the listeners of the podcast. Thanks for having us. And it was a pleasure talking to you. And I hope that this can send the right message to the audience for them to take these steps in their own practices. I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on December 7, 2018, and will be in the March 2019 JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice, signing off.
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