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>>KOPELOW: I'm Murray Kopelow, the President and CEO of the Accreditation Council for Continuing Medical Education.
>>CERVERO: Hello, I'm Ron Cervero, I'm a Professor of Adult Education and Associate Vice President for Instruction at the University of Georgia.
>>KOPELOW: So Ron, you've written a report for the ACCME on 'The Relationship between Commercial Support and Bias in Continuing Medical Education Activities: An updated Literature review.’ Tell us, tell all the providers about how you came to do this study, who you did it with, what were you asking, what did you do?
>>CERVERO: Right, so. Let me back up to the 2008 report. You, ACCME had asked if we could review the literature, there's a lot interest of course out there in whether commercial support creates bias in CME activities; it has been for some time. So, you had commissioned the 2008 report and that one was done with one of my PhD students, Jiang He. We looked at all the literature and basically found there were no studies at that point. And then, fairly recently you asked could we do an update on that, what kind of progress has been made, have there been more studies? So, I brought in a medical librarian, Julie Gaines, to work with me on this, who was incredibly helpful because I needed to make sure that we found everything that was out there. And she worked really hard and found, as we'll talk about, a few studies that indirectly speak to this issue but didn't actually address directly the question of whether CME is biased for the commercial provider.
>>KOPELOW: So looking for the impact of commercial support and bias in accredited CME, no studies?
>>CERVERO: Not one.
>>KOPELOW: That measured it directly?
>>CERVERO: Not one, not one. No.
>>KOPELOW: And why do you think that is?
>>CERVERO: You know I think, first of all you would have to define what bias means, and I think until fairly recently there's been a couple of really good suggestions on this, we haven't really clearly defined what bias means, I think. We've been talking about conflicts of interest but never looking at bias directly. I think it may be a little difficult to measure. I think once you define it operationally though, you can say this is what bias is. Now you have a definition you can go and figure out how to measure it. But first you need a definition of what bias is.
>>KOPELOW: Right, and the people who have worked on this and tried to study it, there's been sort of two camps that have developed. One is people who: ‘We know it when we see it’ camp and they want to just check off: Yes I feel it is. And the others who say that it's checklist-based, that it has a set of criteria, and we should identify what that list is and check off how many of those markers are there, and that would be like, an index of bias. And there hasn't been that much work done. And that's probably the two directions that need to evaluate.
>>CERVERO: Certainly if you're going to change, if it indeed is a problem, if there's some social process going on that creates bias based on the funding of the CME, we absolutely need to know that, this would be a critical issue. And if it is a problem, you need to know how that bias is being manifested and what the mechanisms of action are, because you can't fix it if you don't understand that. So that's why this definition of bias is really critical.
>>KOPELOW: And one of the negative outcomes of bias with the presence of commercial support would be impacts on prescribing patterns. And one study that you reviewed didn't show that?
>>CERVERO: Right.
>>KOPELOW: And so, of the opinion that it might be, no evidence to support?
>>CERVERO: No. Presumably, that's where you would. if you were looking at the negative effects of commercial support, you would expect to see more prescriptions for the pharmaceutical company that was supporting that education. That would be the worst outcome, that the physician was not making an independent clinical judgment about how to treat this patient and was unduly influenced by the CME activity because of how it was funded. I mean that would be, to me that would be the trail of action, and there hasn't been anything that could document that.
>>KOPELOW: And importantly, one of the points that you make is that none under the current regulatory environment. There are a set of standards for commercial support that we have that have been in place since 1991 but strongly updated in 2004. There was evidence in the past, in an unregulated state that industry could influence continuing education but, you looked under the current regulatory environment and found nothing?
>>CERVERO: Right. In fact there were a couple of studies that showed this. They were not that well designed but they did exist. Presumably if they did exist, if there was a problem, that was why the standards for commercial support would have been promulgated to address that. But certainly since that, in this new environment that ACCME created for the CME enterprise, no, there have not been any studies then since 2004.
>>KOPELOW: One of the big factors in play, people's perception, people's beliefs. I mean that's a big part of all these because of the absence of evidence. There was a study that asked docs what they believe to be the impact. Right? And they reported they believe commercial support has an impact, but that's not evidence that there's an impact.
>>CERVERO: No. I mean I think, that's right. The studies and we've reported in the previous 2008 report as well as this one, there are, if you ask physicians, some of them will say that commercial support biases CME. They'll say that, but that's not
>>KOPELOW: That's their belief.
>>CERVERO: That's a belief. And not to take away from their belief, but in an evidence-based environment that we live in, in medicine, it's possible to find out the answer to that question.
>>KOPELOW: Now, there's two different factors in play. One is the commercial support of education leading to bias which these studies talked about and you couldn't find any evidence. The other is conflicts of interest, is that people come with pre-exiting relationships, they create conflicts of interest. And again you looked at a couple or three studies to see. Did you find any evidence in the literature that conflicts of interest caused bias?
>>CERVERO: No. The studies that were done were looking at, did the physicians report potential conflicts of interest and they did. Some of this, a couple of studies found some slippage between whether they did receive commercial support and whether they listed that on the paper they presented. But to me that's more of a process issue, it doesn't show that in fact the, it didn't actually ask the question, was the CME biased that they delivered, it just says that they did not report in all cases the potential conflict of interest.
>>KOPELOW Yeah, and I think it's important, you use the potential conflict of interest. When I read those studies there often is missing information in the study that's important to some of these issues. They often don't talk about whether the CME is accredited or not accredited. So what are the regulatory environment? And in this context, it's quite often that we find that people equate and feel are identical, a relationship and a conflict of interest. So that it is a plausible statement to say that this slippage, this failure to report, was that we require at the ACCME and the system that the state medical society and ACCME accredit that relevant financial relationships be used to mitigate conflict of interest and to be disclosed. So if someone could have a financial relationship that is not a conflict of interest, because the relationship isn't relevant, not be disclosed and that could also produce the findings in the papers that you talked about. So it is important for us to deal with the slippage because we know in our accreditation requirements there is a 10%, 15%, 20%, in some organizations where complete disclosure doesn't occur. So it corroborates that, but it also, we always need to make sure, and the editors of journals need to make sure, that in this complex world precision in language is very important and they need to add that to the information that they talk about.
>>CERVERO: Just one
>>KOPELOW: Go ahead, go ahead.
>>CERVERO: One point on that was one or maybe two of the studies looked at the type of financial relationships and found that if the financial relationship with the pharmaceutical company or device manufacture was related to the topic of the presentation, those are the ones that are reported most frequently. So that is consistent with this issue of relevance. Like if I did research on this, on what I'm presenting to you about and that research was funded by the agency, those were in most cases, the vast majority of cases those are reported, as opposed to just having a relationship with the pharmaceutical company unrelated to the presentation.
>>KOPELOW: Right, right. So the, in your report you summarize what the evidence shows, what you could learn from it. Of interest, your first thing is that commercially supported continuing medical education can be effective in improving what people know or do. That it is, I was going to say it's just as likely, I don't know if it's just as likely but it doesn't, it's not precluded, The presence of commercial support doesn't preclude effectiveness. True?
>>CERVERO: No. Well yeah, so there was the one study in women's health, and what they concluded was they looked at the content of programs and whether it was clinically accurate, and I believe this was a CDC report. Was the content clinically accurate, and actually found that there was a slightly higher rate for those programs that had commercial support than if they didn't. I think it was seven out of eight where they were, they had, programs had commercial support and maybe only three quarters of those that didn't have commercial support.
>>KOPELOW: And I
>>CERVERO: So whether it was clinically accurate.
>>KOPELOW: And accuracy judged by concurrence with guidelines. It wasn't just somebody subjective looking at the literature?
>>CERVERO: No, no, no it was looking at, this was a CDC, I believe a CDC, so it was looking at what should have been taught.
>>KOPELOW: Which was established a priority by teaching to guidelines, so that the variable was whether it was said or not.
>>CERVERO: So the point is that it can, just because of some commercial support doesn't mean it's biased. It can be very well-attuned to the evidence out there.
>>KOPELOW: And that also, right. That speaks to the value of having the content pre-determined and validated before you move forward. The other that you found is that in 3%-5% of participants in educational activities will observe bias regardless of all circumstances. It's not dependent on commercial support being present or not. It's sort of background noise.
>>CERVERO: Yeah, there's going to be certain background noise there. I think that the studies that you're referencing were that they surveyed the physicians on whether the program was biased by commercial support. So, about the same 3%-5% report that it was, whether the program actually was supported by commercial entity or whether it was not. So there is definitely some background noise. There's some belief, face validity, whatever you want to call it, that if there is commercial support by definition, there will be bias. That's what I would take away from that.
>>KOPELOW: It's a firmly held belief.
>>CERVERO: It is definitely a firmly held belief, independent of whether there was commercial support or not.
>>KOPELOW: And because there is no evidence. It isn't that the evidence says there's no bias. It's not that the evidence says there is bias. There is just no evidence to support the opinion that commercially supported education is biased.
>>CERVERO: Right.
>>KOPELOW: Now that's important. Because in your report you go on, at our request, to look at the national reports about bias and the viewpoint articles that have been published because they have a great, they have a large voice in the community. And it would seem that from what I've read, there's quite some seriously damning statements of continuing medical education that have been written that are not evidence-based. And they are alluded to, and I'm going to read some of them. In the Macy report from 2008, they talk about a ‘long-standing concern that continuing medical education is often a marketing activity.’ That in the 2009 IOM they say,‘Funding may influence CME in other ways that are not conducive to optimal patient care. CME has become too reliant on funding. Funding tends to promote a narrow focus that neglect the provision of a broader education. Industry funding creates a substantial risk of bias. Such efforts may not be sufficient to keep activities free of bias.’ They talk about our standards of commercial support: ‘The availability of funding has the potential to influence types of programs offered.’ There's no evidence for these statements, is there?
>>CERVERO: No, I mean this is a serious issue, and I think we would all agree this is a serious issue. The level of evidence is not consistent with the seriousness of this issue, so that if it is that important, we need to find out what bias means and how it impacts CME and whether there's a negative impact. Because if there is, I think everyone would feel like that's something that needs to be addressed. So, but to this date, there haven't been any studies to look at that.
>>KOPELOW: And we've observed sort of a meta phenomenon that is, I think, serious and disturbing, is that now people are quoting the unsupported statements. Like Tabas and Baron in 2012 say that ‘Several prominent organizations including the Association of American Medical Colleges, the Institute of Medicine, and the Macy Foundation have called for limits on the amount and scope.’ The unsubstantiated reports and observations have become themselves referenced. And that's a phenomenon I've never witnessed before where, and opening lines of articles say ‘It's well known that commercially supported CME is biased,’ and they quote these observations. And you and I agree that a really good article, a thoughtful article, came out from Bernie Lo, from Lo and Ott in 2013. They say, they define bias as ‘Presenting information, drawing conclusions, or making recommendations that are not scientifically valid or not supported by the weight of rigorous evidence.’ That describes to me these observational studies and reports. Do you think that's a fair statement to be made?
>>CERVERO: Yeah, I think that's a great, if I had to select a definition of bias, I would certainly start with that one. I think it's exactly right that the CME activity is providing information that is not evidence-based, that is not the best information out there to help physicians to integrate into their clinical decision making. I mean that's what we're trying to give them in CME. If it's not that, then that's a problem. And so that's why I think that definition begins to point us to how we can move into research in this area.
>>KOPELOW: And that's what your conclusion is, that each of these proposes policy solutions, like these many reports. You make the observation, they propose policy solutions based on the assumption that commercial support biases Accredited CME. Although the evidence base reviewed in the first section of your paper shows that no study has been published that supports or refutes this hypothesis.
>>CERVERO: And I think, to be fair, those national reports also come to the same conclusion. I mean, when they talk about the evidence, they say there really isn't a lot of evidence, or weak evidence at best. So,
>>KOPELOW: But we believe this anyway.
>>CERVERO: But this, we, there's some face validity to this proposition that if there is funding of research or funding of the CME, that that is necessarily providing physicians with less than the best information in the CME activity.
>>KOPELOW: Alright.
>>CERVERO: So, I mean, that's a proposition that needs to be tested.
>>KOPELOW: Right. So, it's not that, this is an important distinction. It's not that the evidence is weak about bias, or commercially support causes bias, or the presence of, it's not that the evidence is weak and it hasn't reached the statistical significance, there's just no evidence. There's an absence of it.
Now you end, which I think is the right way and an optimistic way of looking at the future, based on what Lo and Ott talk about, about many of the things that we could do going forward. You talked about asking questions, ‘Does it produce bias? What are the mechanism which bias is produced?’ Talk a little bit for us as we draw to an end here about what you think the accreditor providers, the CME community, the academics, what should we be doing about trying to answer some of these questions?
>>CERVERO: Well, certainly as a community, if we're serious about this, I think that these questions need to be addressed. I mean, they can be researched for sure. Until we can get to the point of getting evidence-based solutions, some of the things that Lo and Ott talk about, I mean, you could simply do now. If you were going to have a session on CME, even if you have someone that reports a conflict of interest, have someone up on the stage with that individual that doesn't have a conflict of interest in relation to this topic. So, I think there are things that we can do as providers to ensure that the physician is receiving unbiased information, independent of whether, until we can get to the point of doing the research.
>>KOPELOW: Yeah, and the research described maybe by these five questions, right: Does commercial support produce bias? What are the mechanisms by which bias is produced? That's the path of physiology of the bad outcome.
>>CERVERO: Yeah. Yeah. Right.
>>KOPELOW: Are accreditation guidelines or other strategies effective in preventing bias? Because we say that our standards are. And in what ways does commercial support of CME contribute to physicians' adoption of the sponsor's product in the context of the other influences on their clinical decision making?
>>CERVERO: Right.
>>KOPELOW: That's a complex question, but it gets to the core of the issue like the last one does. As a result of commercial supported CME, does physicians' adoption of the sponsor's product lead to better patient care?
>>CERVERO: Yeah.
>>KOPELOW: I mean, the Food and Drug Administration has demanded that the companies that produce long-acting and sustained released opioids, commercially support accredited medical education, nursing education, pharmacy education, on how to use these produces successfully. If that education has the outcome that the executive branch of the FDA want, that's a piece of data in support of the question that a good outcome can follow with truthfulness and absence of bias in an evidence-based way. Fair to say that? Ron, thanks very much.
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This is a transcript of Discussion of ACCME 2014 Report on the Relationship between Commercial Support and Bias in CME Activities - http://www.accme.org/education-and-support/video/interview/accme-2014-report-relationship-between-commercial-support-and
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