Clinically Speaking

CEP presents Clinically Speaking, a podcast series that unpacks the past, present and future of evidence-based medicine in primary care, hosted by Dr. Jamie Meuser and Christine Papoushek, PharmD. In each episode, we speak with academics, clinical experts and practitioners who are just as passionate as we are about how evidence could and should be used to guide optimal care.

This podcast is available on iTunes. 



Changing how we practice evidence-based medicine in the 21st century

Episode 6
Dr. Onil Bhattacharyya, Associate Professor, Evaluation Lead for the Institute for Health Service Solutions and Virtual Care and Frigon Blau Chair in Family Medicine Research, both at Women's College Hospital in Toronto, draws on his personal experience as a guideline development panelist, family physician and information scientist, to offer his ideas on how we can leverage technology and individual patient experiences to bring EBM into the 21st century.

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Dr. Jamie Meuser:  You're listening to "Clinically Speaking," a podcast that explores the past, present and future of evidence based medicine in primary care. Brought to you by the Centre for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

Dr. Meuser:  As we've established, evidence based medicine has been seen as the root through which conscientious practitioners could achieve optimal practice through the application of the best available evidence to their clinical decision making. The idea of best has been seen to include notions of quality of evidence, comprehensiveness, absence of bias and clarity around to whom and in what circumstances the evidence applied.

Christine:  Best hasn't been that simple. As we've touched on in previous episodes, there are a number of critiques, limitations and qualifications when it comes to practicing EBM.

Dr. Meuser:  Today we speak with Dr. Onil Bhattacharyya, the Frigon Blau Chair in Family Medicine Research at Women's College Hospital in Toronto. Onil's an associate professor in the Department of Family and Community Medicine at the University of Toronto. He's also the evaluation lead for the Institute for Health Service Solutions and Virtual Care at Women's College.

Christine:  He advocates for some radical solutions to make evidence more meaningful to practice, including less rigid reliance on published studies and more attention to the values, preferences, and experiences of individual patients.

Dr. Meuser:  Is Onil's approach a harbinger of EBM 2.0? Only time will tell, but it's certainly an exciting option.

Onil, as you know, as we discussed, the general theme for this is around use of evidence in clinical decision making in medicine. This is an area that you're well versed in and well familiar with. We'll probably get into some very specific aspects of that in a bit.

I wonder if we could spend a little bit, at the beginning, talking about where you think we are with evidence based medicine. Maybe starting with what forces you think have driven us towards clinical practice guidelines as they currently exist.

Dr. Onil Bhattacharyya:  Going back to the early days of evidence based medicine, I think it was originally framed as a clinical skill. Critical appraisal is a clinical skill. If you remember there was a JAMA series on how to critically appraise articles. That was taught, when I was a medical student we learned about critical appraisal.

But I think at some point in the process of training people to do critical appraisal we realized it's extraordinarily time consuming and extremely difficult. There's a ton of nuance that is hard to capture. When is a clinician going to review enough clinical articles to answer every question they might have?

I think that was a first transition is to say, some learned group needs to summarize all that is known on a specific topic and then lay it out in a format.

I think that really motivated some of the clinical practice guidelines as a concept. The idea that somebody is going to filter the information, condense it, and put it into a usable format.

The quality chasm kind of report, the Institute of Medicine, and this focus on qualities, measured against what, right? What is quality? This gap is really between what is known to be effective and what is routinely done. How do you codify that? That has to be summarized in a document or somewhere. I think that gave another use for clinical practice guidelines.

The other piece is around, how do we use this in a clinical context? This body of information has to be presented in a way that's usable. You're summarizing all the published evidence in a series of steps versus answering questions that clinicians might have.

Guidelines are currently structured to summarize what's known. Many questions that people will have are not covered by guidelines because they're too specific, they relate to patients that have well studied, etc. You have decision support tools like UptoDate and DynaMed that serve that purpose but they're distinct from guidelines.

I would say that's some of the broad forces.

Dr. Meuser:  I think what you've described is two pieces of the guideline construction and dissemination puzzle. One is what content goes into these evidence packages that we hope that people will use for making decisions about what is the next right thing to do with their patients. Then there's the content, what's in it, and then there's the package.

Can you talk a little bit about how packaging affects usefulness and what opportunities exist in that context for making guidelines more useful?

Dr. Bhattacharyya:  Sure. Making guidelines that accurately represent the evidence generally results in paragraphs of text that read like a legal document, tons of hedging, deliberate ambiguity, because they're trying to be faithful to the evidence.

To go from being evidence based to information that is actionable requires a departure from the evidence, to some extent, extrapolation around two different groups or simplification to make it easier to communicate. That's the basic thing, is that information if it's actionable, is more likely to be acted upon, but actionable information is often less evidence based. So, there's one compromise.

The other thing is, use of visual information. Communicating a risk, understanding risk benefit, is challenging for doctors, but even more challenging for patients. If we think back to the many original definitions about evidence based medicine, it was about information that is incorporated with patient preferences to informed decisions.

If incorporating patient preference is an important part in evidence based decision making, that evidence has to be transparent, or easily understood by the patient. I think using visual communication tools is something that we're seeing more of, but there's an important part of guidelines.

The other piece is algorithmic decision making. Many guidelines will have decision trees, but having worked on somebody's decision trees, they get really complicated.

Just think of the 2013 diabetes guideline, and the more recent one, on the pharmacotherapy. Now, you can input data with a very simple decision support system, that orders and organizes the information. You'll see the most relevant to your patient. You've got actionable language, you've got visual communication that is clear, and then you have ways that embed algorithmic thinking in an interface that's easier to engage with.

Dr. Meuser:  I guess that each of those stages, there's a potential third doing much better, but there's also a potential for doing very wrong if you stray too far from the science then, the guideline is less of a conveyor for truth, however, if you do it right, you're going to take it in a direction that allows for more people to use them more of the time.

Can you give some examples? I'm intrigued by the engagement of patients in the decision process, and especially, developing a guideline that reflects values and preferences of individual patients. Can you give some examples of how that could be done within the context of a guideline?

Dr. Bhattacharyya:  Sure. I did a whole literature on decision aids, and decision aids, I think, put a lot of energy into making things clear in eliciting preference, and all that, but they're like focused on one decision often.

A guideline could have a bunch of decision aids embedded in it, which I haven't seen, actually. I often feel that decision aids are built for one thing, and that's it. The system addict incorporation disintegrates into guidelines would be a great progress, but at least that's an established thing.

The other option is something called an option grid, and that is like a table with a bunch of questions, and key information on questions. Should I screen for PSA? Should I take stance for prevention of cardiovascular disease? And so the risks and benefits, the number needed to treat, the number needed to harm, all these things are presented in a graph that frames the conversation between a physician and a patient.

As a provider, when I use those tools, I'm often learning at the moment, especially if it's a condition that I don't do very often. Who remembers all the numbers to treat for every condition?

It's an opportunity to structure conversation, it creates transparency, and also allows the physician to learn it at the same moment. I think we over estimate how much physicians can retain and process in a clinical encounter. Building tools that are for patients will also create tools that are useful for doctors.

Dr. Meuser:  It sounds like this is also tailor made for an application for EMR's capacities, if only we have an EMR that capacity, of course, but is that the kind of thing you're talking about, that you could share the patient record with the patient, and the clinical practice guideline that applied to their particular condition, and then learn together what the options are, and what the basics of an informed choice would look like?

Dr. Bhattacharyya:  Absolutely. A simple application would be, you have the Framingham risk score, that's automatically generated in the electronic medical record, so that stratifies your risk, and then you present a series of options, right?

Dr. Meuser:  Yes. So, that's certainly one way that it's easy to imagine, would make guidelines more useful for the primary care audience. Can you think of any other ways that guidelines could be formatted or constructed differently to allow for them to be more useful to people in making patient care decisions in primary care?

Dr. Bhattacharyya:  We've just talked about present stratifying patients, but embedding decision support in an EMR would be another obvious application which hasn't been that well developed.

Aside from a couple of alerts, like you've got an interaction or this patient needs a Pap test because they haven't had one for three years, that's not a very robust function in most EMRs.

There'd be a lot of work to be done there. Just as a caution, the back end algorithm, in order to program the algorithm, you're moving away from the evidence. You're making a lot of assumptions in decisions.

Dr. Meuser:  The assumptions would have to be as transparent as they could be. How many assumptions would apply to all patients? Would the assumptions have to be different depending on the patient?

Can you think of any other ways in which technology could be harnessed to serve the interests that we're talking about?

Dr. Bhattacharyya:  Yeah. There are many applications. First of all, we've talked about decision support for clinicians but also decision support for patients. Guidelines could be made accessible to patients for basic decisions around trilogies.

Is this important? You can imagine a simple model that already exists as an action plan for asthma, for COPD. It's based on a guideline. It's individualized to a patient in a support decision making during an episode of acute illness.

The other application, which I think is just not part of guidelines is...We've got the application of population averages generated through trials that we apply to an individual.

For an individual in primary care, we are applying sequential treatments to people over time to try and manage their condition. Many of the drugs that we prescribe in family medicine have very small effects. We're talking about 10 percent reductions in some parameter that we actually have difficulty capturing.

An obvious application of technology would be to be measuring, if you've got migraines, your headache frequency, intensity, duration, what medication you used. This would allow us to know if you tried a particular approach to migraines prophylaxis. Is it working? Do we need to try something else? The evidence as applied to the individual is not something that we do that well.

Dr. Meuser:  If I understand you correctly, then it would allow the patient to be the generator of his or her own evidence for his or her own treatment.

Dr. Bhattacharyya:  Yeah.

Dr. Meuser:  In fact, you wouldn't have to use population norms to decide what the next right thing to do would be, but use the actual experience of that patient with whatever combination of treatments and results of treatments that will apply to that patient.

Dr. Bhattacharyya:  That's right.

Dr. Meuser:  Fascinating. You know of any place where this is actually happening?

Dr. Bhattacharyya:  I don't know of groups that are systematically applying it. To do this in a reliable way, you would need...You have five time points to establish a baseline for some symptom, then you apply a new treatment and you look for a change in the slope of that symptom in the next five time points.

For blood pressure, that would be relatively easy to do, but I'm not aware of people doing it systematically.

Dr. Meuser:  This is something that an app on somebody's phone could be easily applied to. In fact, it wouldn't even necessarily have to be specific to a condition. You specify the treatments that you're using, you specify the symptoms that you're tracking, and then the report spits itself out essentially from visit to visit. Very interesting.

This is end of one stuff that we're talking about. End of one tracking and planning based on the result. In a slightly different direction, we've spent a fair bit of time in our survey of clinical practice guidelines and how they're useful and not useful in 2018.

Looking at the degree to which clinical practice guidelines these days are aimed at specific audiences and especially a family physicians and other care providers in family medicine. Can you talk a little bit about your experience on these panels?

There must be something about that process that is able to produce a result. But also seems to produce a result that many family docs, at least, wouldn't recognize reflects their world very often.

Dr. Bhattacharyya:  In having worked on the previous diabetes guideline, there's 20 people in the steering committee. There was three family doctors, but two of them only saw people with diabetes. I was the only family doctor with a general practice on the committee.

They had methodologists, they had other folks, but the vast majority were cardiologists, endocrinologists, there were dietitians. People whose whole world for the most part is vascular health or diabetes. They value outcomes in their area above other outcomes.

They have a huge amount of knowledge of every trial, and every subgroup, and every P value. To some extent, it takes them away from the big picture. As one of 20 people who would say, "I'm not sure how this would fit with the competing demands of the average patient in my practice."

I think that was listened to but it didn't drive the conversation. [inaudible 15:01] make a big issue about conflict of interest. At that panel, there was definitely a fair amount but it was declared. In recent panels, this is addressed more.

If you think about it, if you had a guideline on surgical CABG, appropriate management of cardiovascular disease surgically, and most of the panel were surgeons, you would get a certain [laughs] result.

There are conflicts that are just so deeply embedded that it can't be overcome. If I think in contrast in Holland, where the vast majority of people constructing a guideline for a common primary care condition would be primary care providers, the result will be very different.

Dr. Meuser:  Is it? To your knowledge to those guidelines that are produced by family doctors presumably fewer of whom would have over conflicts, at least, monetary conflicts. We all bring our conflicts based on the nature of the practice that we have. Do you think the outcome is that much different?

Dr. Bhattacharyya:  That I'm not sure. I haven't seen a head to head comparison. I would say the [inaudible 15:58] these guideline and some independent review of the quality of the evidence and transparency has scored quite well. It's like you said, you're in the room. You're going to make a decision. There are tons of compromises made.

The direction of the compromise, sometimes there's an explicit process, sometimes it's just the way the conversation is going and who's driving it and what's the mood of the room. My sense is that it would be different.

Dr. Meuser:  It's hard to believe that any guideline that's constructed by family doctors would come out of 160 recommendations.

Dr. Bhattacharyya:  [laughs]

Dr. Meuser:  We'd get tired of it long before that [laughs] and would have caused the question of usefulness of any document that tells us there's 160 things we need to do differently. That's it.

Dr. Bhattacharyya:  Keep in mind, if you had to read that document and retain it, it's impossible. If you have in the course of a year 2,000 questions, you might want 160 points of information that you may want to refer to.

Dr. Meuser:  Comprehensiveness on the one hand and usability on the other. Tell us what else you're working on here at Women's College that might be useful to the practice of evidence based medicine.

Dr. Bhattacharyya:  I'm at the Institute for Health System Solutions and Virtual Care. We are evaluating a wide range of virtual tools. I think of them as the building blocks of modern ambulatory care. If you think in family medicine primary care, as we say, it's the cornerstone of health services, but as a service, it's somewhat under powered.

There's a wide range of things that are available but not used. If you think of building modern building blocks, this could include virtual visits or digital on demand services, remote monitoring, care coordination platforms, specialist decisions support for primary care, and point of care diagnostics.

These are all tools that we are trailing in a range of settings, and every one of our studies has a vendor, a clinical site, a payer, and we are the third party evaluator.

I think there are a wide range of things that could transform primary care, but for which there's not a ton of appetite at the front lines.

Dr. Meuser:  Interesting.

Dr. Bhattacharyya:  It's just the value propositions don't align, so often the patients love them. Increased convenience for patients, increased workload for provider, increased liability for institutions and increased costs in the short term for someone who doesn't have a line item that's called patient facing digital tool.

There is enormous potential, but under the current system with the current incentives, it's a bit of a slog to sort it out.

Dr. Meuser:  Taking us back to the evidence, so there's a usefulness presumed with this. Where does evidence fit in the assessment of what tools you would trial, at least? Is there a phase of evaluating whether the assumptions behind it are evidence based, for instance?

Dr. Bhattacharyya:  Yes. Our approach is in the early stages, something we call value proposition design. What is the target user, the clinical model, the technology and the outcome that you're proposing? Is that feasible? Is that appropriate? Then we have a series of different payer, provider, patient, caregiver, institution, and how do we get those interests to align?

We often do very rapid implementations where we iterate on the target user, on the clinical features, on the technology or features of the technology to find a use case where there's a fit between a problem and a solution and then we trial it.

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Dr. Meuser:  Cool.

Christine:  Thank you for listening to this episode of Clinically Speaking. It was produced and edited by Pippy Scott Meuser at the Centre for Effective Practice.

Dr. Meuser:  Special thanks to our guest this episode, Onil Bhattacharyya, for taking time out of his busy schedule to talk with us.

If you like what you heard today, we encourage you to share with your friends and colleagues. Your support goes a long way.

Christine:  Don't forget to subscribe on iTunes, our website, or wherever else you get your podcasts.

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The argument for reevaluating the evidence that informs clinical decision making

Episode 5
If we have doubts about the scientific studies that are at the core of clinical practice guidelines, how can we rely on them to support our clinical decision making? Dr. Nav Persaud has, since residency, consistently questioned the value of some evidence presented in clinical practice guidelines. He proposes ideas for how we could rationalize the process for determining the use, and place, of new treatments in the work that we do.

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Dr. Jamie Meuser:  You're listening to "Clinically Speaking." A podcast that explores the past, present and future of evidence based medicine in primary care. Brought to you by the Center for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

If we have doubts about the basic quality and credibility of the scientific studies that are the core elements of clinical practice guidelines, then how can we rely on them to support our clinical decision making?

Dr. Meuser:  In our last episode, we heard a strong critique of the quality of some of the core evidence used in psychiatry. Not surprisingly, doubts about our ability to rely on published studies, let alone clinical practice guidelines are certainly not confined to any particular branch of medicine.

Christine:  Today's guest, Dr. Nav Persaud, is a respected clinician scientist who has, since residency, consistently and cogently questioned the value of the evidence underpinning many common, accepted clinical practices.

Dr. Meuser:  His criticism takes us down some unusual directions that may surprise you. We also think they also provide some ideas about possible future directions for EBM.

We are sitting down today with Dr. Nav Persaud. Nav is a family doctor at the St. Michael's Family Health Team in Toronto and a scientist and researcher at the Li Ka Shing Research Centre associated with St. Michael's Hospital in Toronto.

Nav, thank you and welcome. As we've discussed, this podcast series that we're doing is broadly scoped around the use of the place of the future of evidence in clinical decision making in medicine.

We'll get into, in a little bit, your particular interest in, and role in that enterprise. I would like to start, though, by asking you your take on the current state of evidence based medicine.

Dr. Nav Persaud:  Most research done today is of low value. The purpose of health research is ultimately to promote the health of people. When you look at most of the individual research studies being done today, they would have little or no benefit to people.

I'm thinking largely of trials where one medication is trialed against another, one antidepressant is tested against another. Most of that time those trials find little or no important differences between two treatments, so why are all of these studies being done?

There was recently a meta analysis of head to head trials of antidepressants. It included more than 500 trials where antidepressants had been trialed against each other. The main conclusion was that there didn't seem to be a really big difference between them.

In fact, what I thought was the most striking finding, is that a medication appeared to be better when it was new. The very same medication appeared to more effective and have fewer side effects when it was introduced as the new product and it was trialed against other ones that were older, but then when that very same medicine became an old product, it looked worse.

That shows there is a huge problem with the validity of studies being done. The answer is definitely not, in my view, to do another 500 head to head trials of antidepressants, but if you look at what's being done, it probably won't actually be that long before there are another 500.

Dr. Meuser:  If I take your point correctly, a major threat, then, to the usefulness of evidence in the early 21st century to clinical decision making in medicine is simply that what goes into the crafting of it is suspect sometimes. It's not done with the intent of helping clinical decision making.

Dr. Persaud:  Exactly. Those sorts of trials seem to be done mostly because a company wants to sell a different antidepressant. It may not be any worse than the other antidepressants. It may not be problematic, but it also isn't advancing the care of people with anxiety or depression.

Dr. Meuser:  In your view, what would constitute high quality evidence?

Dr. Persaud:  Testing interventions, could actually have an important difference from existing interventions that we have. Testing medications that really are new, not just me too drugs that are in the same class, do the same thing as existing treatments. Where there's at least a chance that there would be a real benefit, I would consider that to be higher value research.

Other things, like looking at how medications work in the context of other medications. It is one thing to demonstrate that an antidepressant is effective, another thing to demonstrate that it's effective in the people who are typically using it, people with other chronic diseases.

Looking for those sorts of interactions in real world effects of medicines, I think, is more useful than these efficacy studies of medications that are very similar to each other.

Sometime they are, if fact, the same molecule being trialed against itself. These enantiomers of one proton pump inhibitor versus another enantiomer where it's almost impossible to imagine how there could be any important difference between them.

Dr. Meuser:  You're saying save the effort for things that are truly different from each other, or that they have some innate difference from each other that...?

Dr. Persaud:  I'm sure that people are arguing that there's some reason that there's an enantiomer of [inaudible 5:05] is going to be better than that enantiomer, but if there really was a big difference we would have to rewrite the laws of physics and chemistry.

It's unlikely we're going to discover something like that in a clinical trial. Given that we have limited resources, given that there are always going to be risks and downsides to the patients participating in these studies, it probably makes more sense to only do studies when there could be a value.

Actually if you go back to the fundamentals of the ethical principles for doing clinical research, there has to be some prospect that care is going to be improved before a study could be ethical regardless of how else it is conducted. I would argue that many of the clinical trials being done today are not ethical.

Dr. Meuser:  You've [inaudible 6:38] a position. That's a pretty strong one. Can you describe some of the projects you're working on these days, that if realized will allow clinicians to have a higher level of confidence than the evidence that is put in front of them for clinical decision making?

Dr. Persaud:  One focus now is on essential medicine's list. The idea is we should be able to write down on one piece of paper the most important medicines that a family doctor should know about and should have available to them. Also, that patients should have access to. That may sound to some people as a pretty lofty goal.

Consider the alternative, what if after decades of doing clinical research, after tens of thousands of clinical trials we couldn't do that. Someone would say, "Well, what are you doing then in healthcare if you haven't been able to figure out which are the most important treatments? What is all that research you're doing for?"

I see creating an Essential Medicines List first as a way to improve clinical practice because the reality is healthcare providers, physicians, family physicians, in particular, cannot possibly keep track of thousands of medicines, can't know the indications for them, the adverse effects all of their interaction.

It's just impossible. We know that doctors aren't going to take 15 minutes to look that up each time they want to prescribe a medication. It is possible that a individual clinician can learn about a hundred or two hundred medicines that they commonly use. Most already do that, but they may or may not be the best ones to prescribe.

We know that doctors can be influenced, not just by the evidence but by other actors who are eager to influence doctors. That is really the way to focus clinical practice. It also sets us up to do high value research. We have the current state, the medications, and interventions that are currently being used.

Then if a medication is to be added, if there's a question about whether it should be added obviously that needs to be based on research. If there really is an antidepressant that's better than the ones that are on our Essential Medicines List, then it should be added, but we'd have to do research to find that out. We don't necessarily need to do research on a dozen different antidepressants.

Dr. Meuser:  Can you tie the idea of having a finite list of essential medicines back to the point you made earlier about the evidence just not being that good for many of the choices that we currently have?

Dr. Persaud:  First of all, I think one main issue is there are just too many studies of too many medicines going on. Having an Essential Medicines List where we had a handful of antidepressants on that list, two or three. Then we would focus the question.

The question is if someone is saying there's this new antidepressant that we should be prescribing. The question is obviously, "Is it better than the ones that we currently have?" You limit the number of studies that you need to do. Then hopefully you can pool resources to do those studies properly, and importantly you can try to replicate findings.

If a pharmaceutical company does a clinical trial and finds that a medication is more effective than another, before we added to the list because there aren't that many decisions we have to make, someone else can try and replicate that finding. If it is replicated then absolutely the medication should be added.

That's not what we're doing now. Now what happens is a study is done, medication gets approved, it gets marketed, there's a promotion because it's new and expensive, so there's an incentive to get doctors to prescribe it. Then there's all of this excitement. I'm just thinking about the prescribing of antipsychotics that I see.

I can hardly keep up with the new antipsychotics being prescribed. Then when I sit down and try to understand first of all what they are, because usually they're being referred to by their brand names. You don't even know what the medication is.

When you find out what the medication is actually called and you look at the evidence, it doesn't seem to be any better than the older antipsychotics. That shows how quickly this low value research gets translated into changes in clinical practice, that don't    as far as I can see benefit patients.

Dr. Meuser:  You've been tied to some efforts in the re review of past evidence has been used to include particular drugs. In many cases are particular interventions as the standard of care.

Do you want to talk a little bit about where that effort came from? I said it's very parallel to what you've already discussed but some of the things you found out along the way?

Dr. Persaud:  Yeah. It came from a mistake. I used to prescribe Diclectin, Doxylamine, and Pyridoxine for nausea and vomiting during pregnancy. I prescribed it routinely, just like many other clinicians in Canada have prescribed it and still prescribe it today.

Thankfully, I had a patient come in and question the prescription. She said, "Are you sure that I should take this?" I said, "Yeah, of course, I'm sure. It's recommended as the first line treatment. I prescribe it all of the time."

She had some misgivings and after she left, I went back to the guidelines and I looked at what it was based on. I wasn't sure that everything I said was in fact true.

The guideline was ridiculous. Instead of referring back to a systematic review or even a clinical trial, it referred back to the product monograph. A document made by the drug company that sells the medicine. Not the basis for a first line recommendation.

Over the years, I have been trying to understand why this medication is so strongly recommended. The answer is not to be found in the published literature. When I started this, there were no studies in the published literature that would demonstrate that this medication was effective. Not even that it was better than a placebo.

Certainly not that it was better than other treatments for nausea and vomiting that can be used during pregnancy.

Over time I have tried to obtain both from the company and from Health Canada all of the information about the clinical effects of this medication. I was shocked to find out that that sort of information is considered confidential    was not disclosed by the company that makes it. It's called Duchesnay, based in Quebec. It was also initially not disclosed by Health Canada.

In response to my freedom of information request, they sent me a whole bunch of redacted pages and marked them as confidential. This is not    to be clear detailed information about where this product is manufactured, this was information about the effectiveness and safety of the medication.

Over time, after a change in the law    this is now more than five years down the line    eventually we got access to this detailed clinical study report. An hour interpretation of the findings is that they're consistent with the medication not being effective at all.

Dr. Meuser:  Have you been able to come to any conclusions along the way then based on this? This has certainly been influential work you've done, not just for that product and that clinical condition but has triggered a lot of similar efforts along the way.

It raises for me the question of how good evidence has to be to be useful, to be applicable for people like us whose job it is to make decisions every day?

Dr. Persaud:  First of all, I don't know that it has been that influential. It seems like doctors are pretty happy to keep prescribing this medication despite the information that's been uncovered recently.

That is partially an answer to your question. In actuality, prescribing is not necessarily based on the quality of this trial. It's based on a lot of other factors. One of them that I think is at play to a large extent here is habit and familiarity.

Doctors and other healthcare providers like midwives and nurse practicians have been prescribing this medication for a long time. They know the starting dose. They know the maximum dose and the instructions you're supposed to give. They haven't encountered problems. They haven't had many women come back with concerns.

I have had senior doctors say to me, "You're telling me that this medication I've been prescribing for the last 20 years doesn't work. I've been prescribing since before you were practicing medicine. Before you went to medical school. Maybe you weren't born, I've been prescribing this medication and now you're telling me..."

Dr. Meuser:  Sunny boy.

[laughter]

Dr. Persaud:  They don't have detailed questions about whether there was allocation concealment in the trial. That's really not the conversation that we're having.

There's a pretty big disconnect between details of the quality of clinical trials and what medications people are prescribed by their doctor.

I don't actually think that the main issue is that we need to improve the technical quality of clinical trials. Obviously, we need to have trials that are technically sound and better designed properly, but that's not the major problem with evidence based medicine today.

Dr. Meuser:  Your word has brought into question    for some people in fact whether a particular drug which was seen as a standard of practice actually should be and have them potentially reconsider a decision about what they are going to recommend the patients they see.

I wonder if this will bring into question, for them or others, the whole notion of clinical practice guidelines for being away of packaging information. Whether there are consequences to lowering confidence in clinical practice guidelines in general.

Do you think we should have less confidence than we do in guidelines?

Dr. Persaud:  I don't know that the confidence is high right now but it probably is too high. I think that many of the clinical practice guidelines that exist today don't address the major issues, the major uncertainties that doctors have and that would have implications for care.

I could give a few examples. Let's start with the one we've already been talking about, the nausea and vomiting during pregnancy.

If there were no clinical practice guidelines in Canada, what would've happened is we likely would have treated nausea and vomiting during pregnancy the way we would treat allergies during pregnancy. We would take treatments that are effective for allergies outside of pregnancy and we would use them during pregnancy, provided that the safety of those medications during pregnancy had been assessed.

We could inform women about the risks during pregnancy. In fact, we tend to prescribe the same medications for women who have allergy symptoms during pregnancy as outside of pregnancy.

Those medications overlap with the medications we could prescribe for nausea and vomiting. If you look at what is prescribed in other countries, that's what they do. They prescribe medications like Metoclopramide that work for nausea and vomiting outside of pregnancy during pregnancy.

It's not a big surprise that that medication could be effective during pregnancy because pregnant women are still human beings, when they have nausea and vomiting, medications that work for other human beings help too.

We could've had a more rational approach but what has happened and is happening today is people say, "Well, this is the nausea and vomiting during pregnancy pill. When a woman comes in with nausea and vomiting during pregnancy, this is what I have to prescribe."

There's that herd mentality, "I feel safe because all my colleagues prescribed it. If someone were to criticize me...if a woman did have a child with a malformation and she came back and tried to say it was this medicine, I would just say I was prescribing what everyone else prescribed. That would be safe."

Care would actually be more rational and it would've been better in the case of nausea and vomiting during pregnancy if we just had zero clinical practice guidelines.

There is an open question about the relationship between the manufacturer of this medication, Duchesnay, and the two organizations that both issued clinical practice guidelines with this medication at the front line.

Those are the Society of Obstetricians and Gynecologists and the Motherisk Program at The Hospital for Sick Children, both of which over the years have received funding from Duchesnay.

Chronic non cancer pain is another example. If you look at the earlier guidelines, they recommended maximum or watchful doses of 200 milligrams of morphine or equivalent per day. In retrospect, that was based on very little.

Looks like nothing really and it was seen as an advance because the prior position that had been disseminated in various ways throughout the profession was that opioids had no ceiling dose.

Even in the case of non cancer pain, non palliative pain, you could go as high as you like. That's a pretty astounding view, actually, for any medication    the suggestion that the dose didn't matter, you could go as high as you like. Especially for a medication that's fatal in overdose, seems like dangerous and hazardous prescribing.

That was an example where a guideline recommendation, it was very important and had important implications for people's health. In fact, important implications for the death rate, related to opioids in Canada, and maybe even for the life expectancy for Canadians we're seeing now. That sort of recommendation was based on very little.

Now, there are current attempts to try and walk back from that but it's also very difficult just based on the way that clinicians operate. The particulars of this medication, where once a patient is on a high dose, it becomes very difficult to lower the dose.

You look at other examples, like the guidelines for diabetes. They tend to list every medication that's out there and make vague statements about how to select them. Some of the national guidelines for diabetes care just list the medications in alphabetical order because they couldn't think of any way to prioritize them.

Even though insulin has a different history and standing than these newer treatments do, they're listed in alphabetical order.

In many ways the actual decisions that a clinician has to make when a patient is in the room aren't helpfully informed by recommendations from clinical practice guidelines. They're not critical and reliable sources of information.

Dr. Meuser:  This takes us back to the point you started with around the Essential Medicines List. Which is    as I understand it is if we can't count on clinical practice guidelines and the packaging of evidence the CPGs would represent, if in fact what they offer to clinicians is scant help in making important decisions about what they're going to do next with their patient.

Then maybe what we should do is stick with medicines for which there is solid evidence and let everything else that comes along compare itself to the solidness of solid evidence.

Dr. Persaud:  Exactly. What gets lost in these clinical practice guidelines is we do have very effective medications. We have life changing medications for HIV Aids, for infectious diseases, for high blood pressure, for diabetes. That gets lost when there are these long list of medications.

The other thing that gets lost is that there are conditions where there aren't effective treatments. There are clinical practice guidelines for the treatment of overactive bladder. They will also mention a number of medications that you can use and they'll compare the side effects of them and the effectiveness.

When you look at the evidence, it doesn't look like any of these medications have a clinically important benefit. A benefit that a patient would actually notice and would want to accept the risks that are present with any medication.

Dr. Meuser:  It's pretend guidance.

Dr. Persaud:  Yeah. It would really be a sham guideline there where there in fact is not an effective medical treatment.

Dr. Meuser:  The Essential Medicine List feels to me to be something not many people are talking about yet in this world. At least not in the context of evidence based clinical decision making.

Dr. Persaud:  It's really striking to me that there is a disconnect between essential medicines and evidence based medicine. Those two worlds really haven't spoken to each other at all.

That's something I've been thinking through and wondering if there's a contribution to be made there because Essential Medicine List would be a way to apply all of the great methodological work that has been done in evidence based medicine.

On the other hand, looking at it the other way, I think evidence based medicine is mostly spinning its wheels today. The details of how to conduct a clinical trial today are being applied to low value or wasteful studies. Testing two similar antidepressants against each other. That is a useless thing to do.

On top of that, doing those trials and people are synthesizing all of that useless information and creating guidelines based on useless information. This big and really efficient and well thought out machine of evidence based medicine is being miss applied to answering useless questions. It could be put to much better use to answer the important question of which are the medicines that people should be using.

Dr. Meuser:  Besides the Essential Medicine List, any other opportunities that have emerged from the things that you've been looking at and thinking about for improving access to and use of evidence for clinical practice?

Dr. Persaud:  One is going to the source and determining whether the trials being done today are ethical. That is actually what has worked the literature and worked...

Dr. Meuser:  What do you mean by ethical?

Dr. Persaud:  I mean, "Are they answering an important question or not?"

This mountain of clinical trials being done answering unimportant questions is created. People feel they need to synthesize it and they need to make recommendations because nobody can sort through which of them is better. We could stop synthesizing that and we could stop the clinical practice guidelines. That would be a useful thing to do.

Even better, just to stop those trials being done. Let's take those fundamental ethical principles seriously and ask ourselves whether or not these clinical trials are ethical.

Dr. Meuser:  A couple of points that have come up in talking to others about evidence based medicine and clinical practice guidelines. Any thoughts about the role of patients? Your Diclectin example started with a patient question.

I wonder if there is anything that you've been thinking about or you have come across that speaks to an important role for patients in either creation of new evidence that we can use and apply to other people like them or an assessment of the compilation of evidence. Should patients be involved for instance, at any point in the clinical practice guidelines process?

Dr. Persaud:  I completely agree that it's patients and members of the public who are going to save us here. The first place it should be involved is in prioritization. Determining what are the most important research questions we should be asking and answering.

In my research, we are working to also involve members of the public and patients in designing studies so that we are measuring the right outcomes, measuring outcomes that are important to people.

Not just ones that can convince a clinician to prescribe a medication, but that would make a patient actually want to take the medication. I also think that there is an important role for patients in synthesizing evidence, in creating clinical practice guidelines.

It's both in terms of crafting the recommendations properly but again making sure that the recommendations are on issues that are important to patients.

[background music]

Christine:  Thank you for listening to this episode of Clinically Speaking. It was produced and edited by Pippi Scott Meuser at the Center for Effective Practice.

Dr. Meuser:  Special thanks to our guest this episode, Nav Persaud, for taking time out of his busy schedule to talk with us. We'd love to hear from you. If there's a specific topic you'd like us to cover, please feel free to send us an email at info@CEP.heath or come and find us on Twitter @CEPHealth.

Christine:  Don't forget to subscribe on iTunes, our website, or wherever else you get your podcasts.

Who influences the evidence in evidence-based medicine?

Episode 4
We rely on evidence to help us make the best clinical decisions. What happens when the evidence we rely on isn’t so reliable? Dr. Elia Abi-Jaoude, a psychiatrist at SickKids Hospital in Toronto is one of a group of international clinicians and researchers that have taken on the task to re-review the accepted evidence that has gone into assumptions made in psychiatry. He shares examples of how evidence is used and sometimes misused in health care.

 [background music]

Dr. Jamie Meuser:  You're listening to "Clinically Speaking." A podcast that explores the past, present and future of evidence Based Medicine in primary care. Brought to you by the Center for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

We rely on clinical practice guidelines and systematic reviews to package and deliver us the evidence we need to help us make the most informed and best decisions for our patients. What happens when that so called evidence we rely on isn't reliable at all?

Dr. Meuser:  Psychiatry and mental healthcare in general have long suffered from nebulous, malleable and ever changing evidence. This is also the place where some of the earliest and most seminal work has been done to re examine and, where necessary, to correct tainted evidence that has long informed diagnosis and treatment of patients.

Christine:  Today we speak with Dr. Elia Abi Jaude, a psychiatrist at SickKids in Toronto with an academic reputation for critiquing how evidence is used, and sometimes misused, in psychiatry.

He is one in a group of clinicians and researchers from around the world who have taken on the task of re reviewing the accepted evidence that has gone into the assumptions made about how diagnosis and treatment happens in psychiatry.

Dr. Meuser:  He has plenty to say and he certainly doesn't hold back, so stick around.

We're talking today with Elia Abi Jaude. Elia is a psychiatrist at the Hospital for Sick Children in Toronto. Practice, Elia, is primarily child and adolescent these days?

Dr. Elia Abi Jaoude:  These days, yes. I see across the lifespan.

Dr. Meuser:  The other side of your practice is primarily focused on individuals with tics?

Dr. Abi Jaoude:  Yeah, tic disorders and related disorder.

Dr. Meuser:  Then a particular academic interest, as I understand it, in looking deeply at how the degree to which we can rely on the evidence that's used for clinical decision making in psychiatry. What's your reputation amongst your colleagues?

Dr. Abi Jaoude:  Depends who you ask.

[laughter]

Dr. Meuser:  Are you seen as a cynic, a skeptic, a rabble rouser?

Dr. Abi Jaoude:  I would say all of those, I think by people who don't like the establishment being shaken up too much, may be seen as a threat, too much of a radical. The other extreme is people who see me as an advocate and someone who is a progressive and wanting change.

This is an area that I've gotten into in spite of me. This is not an area that I ever planned to get into. In my training, even starting in medical school, especially so in residency, I was asking a lot of fundamental questions that I expected some reassuring answers, but the answers were not addressing some of the very fundamental important questions.

I continued to question things, and as you know, the more you question, the less you can rely on blind faith in terms of what you're learning and what you're being taught.

I gradually got into this field, initially, after my residency training, I was asked to give the odd teaching session and the odd presentation. Then it just grew. I've started even doing academic research along these lines.

Most notably in the last couple years, I was involved in the reanalysis of Study 329. For those who are not familiar with it, this was a drug company funded study, looking at the antidepressant paroxetine in adolescents for depression.

The company concluded that the drug was safe and effective, but there were questions about the study. I and a group of international researchers, we were able to access the raw data, reanalyze the study entirely, we come to the exact opposite conclusion of drug being ineffective and unsafe. Then, as you might imagine, got a lot of attention.

It's something that I've gotten sucked into. It's just you cannot be a practicing clinician, and turn a blind eye to this. It's as important as Evidence Based Medicine is, basically. If we accept that we should make decisions based on evidence, then it behooves us to make sure that the evidence on which we are basing our decisions is sound and independent.

Christine:  Is there anything different about the context of decision making for clinicians dealing with mental health that has influenced EBM practice in this clinical area?

Dr. Abi Jaoude:  I would say yes and no. I always want to point out very quickly this is not a psychiatry issue. Psychiatry has a reputation of, we have our nebulous, diagnostic boundaries, that intersects with culture so much, even law and philosophy. It's complex to make a diagnosis and say, "OK, what is an illness and what's not?"

This applies across medicine. Just because there's a number on a blood pressure reading or a blood sugar level or bone densitometry scan or lipid level doesn't all of a sudden make it objective. There are all sort of complexities that go into determining where the thresholds are.

This is not unique to psychiatry, I cannot over emphasize that. However, I think I see psychiatry as the canary in the mine when it comes to these issues. We have to acknowledge it has been particularly susceptible to these issues. It's not new, it's not recent.

The concerns that are often raised, and again this is not specific to psychiatry, but particular to psychiatry is the medicalization of life. Pathologizing of the human experience.

I need to rush to say often colleagues become uncomfortable when they hear me talking along these lines. They start to bring up the issue of antipsychiatry and whatnot. I'm a practicing psychiatrist. I love my field. There's a lot to be done to help people who come in with psychiatric challenges.

I don't think we should be afraid of the antipsychiatry movement. It's because we don't self critique enough. We've allowed the antipsychiatry movement to do the critiquing themselves. In our field, there's a lot of diagnoses that I think are problematic in terms of the thresholds and how we determine them to them.

Maybe I'll touch on one that's probably going to surprise people and it's very hard to question. Andre Picard did a very good job questioning it in a recent article. That was at "The National Post" or "The Globe" [inaudible 6:19]?

Dr. Meuser:  "Globe and Mail."

Dr. Abi Jaoude:  Globe and Mail. Anyhow, in particular what I'm talking about is depression.

What we call depression today is very different than what was depression a half a century ago. Half a century ago you would see the person you could tell there's something wrong. It was no question about it. This was a severe serious mental illness.

With every iteration of the DSM that threshold has gone lower and lower for what determine as depression. First of all, there was a conflation between what's referred to sometimes as the melancholic depression and people who are struggling because of what's going on in their lives.

Today the numbers that are given...I think we're conflating depression with suffering, but when we follow the current DSM 5 criteria which have become ridiculous, to be honest. Especially now that they've removed the grief exclusion criteria.

Meaning if you meet these criteria for two weeks because you lost your loved one, you can still become someone with a mental illness. Unfortunately, this triggers a very formulaic algorithmic approach to helping the person in front of you. That's overly narrow. It doesn't address what's really going on in their lives.

It floods the system with people who are suffering, but I don't know that these people need to access care in the tertiary care centers and such, and then makes access more difficult to people who have very serious mental illnesses. This is an example of where psychiatry had become particularly problematic.

Dr. Meuser:  It sounds like you're not overly impressed by the use of evidence and formulation of the DSM.

Dr. Abi Jaoude:  No, I think there was the Wild West before Evidence Based Medicine. The Wild West was a combination of culture, tradition, confounding biases that were blind to overreliance on observation the expert opinion and such. I don't know that Evidence Based Medicine has been able to address these things fully.

On top of that in the last three decades or so, the power of the biopharmaceutical industry in generating this so called evidence and in disseminating this so called evidence. The evidence is not just for treatment but even for what we call it a condition.

Let's look at the last hundred years. If we focus on psychiatry what it's been defined by? It's been defined by insulin coma therapy, it's been defined by lobotomies, it's been defined by the psychoanalysis. It was religion. Each of these things becomes, you don't dare to question.

Young children who have been unwell for a few weeks were getting lobotomies. That's how it was. Again it was very hard to question these things. Comes to psychoanalysis we had concepts like refrigerator mothers. It's schizophrenogenic mothers. Think of the damage we've caused with that.

Then move in the last few decades to the rise of the biomedical industry, and it's like the volume housewife [inaudible 9:07]. Everyone's getting volume. Then the rise of the serotonin theory that was based more on pseudoscience than science. What it was is the rise of Prozac. Then move another decade or so and it's the rise of the atypical antipsychotics.

If you look at the evidence for what really defines an atypical from a typical really there's nothing that stands firmly, that neatly separates the two other than that they were on patent when they first came on. All of a sudden there's this volume housewife was went on Prozac, next thing she's on Zyprexa.

If you follow pharmaceutical marketing when you look at the internal industry documents and where they wanted things to go. Then you'll see how the field is actually moving along, it's fascinating. That's where the evidence is today. It's very hard to trust any published papers. The degree of bias, the extent is huge.

I can give you some specific examples just to give you an idea of what I'm talking about. Eric Turner, a psychiatrist in the US, used the Freedom of Information Act to access all studies submitted to the FDA to get approval for 12 antidepressants that were on the market at the time.

What he wanted to see is what the FDA decision was on these studies, in terms of them being positive, negative or whatnot, and what then it looked like when these studies were published in the literature. Comparing what the FDA has around these pivotal trials, and how it looks like in the literature.

They found that there were, I think about 74 pivotal trials for these 12 antidepressants. About half, the FDA considered positive. About half, they considered negative. Actually, negative or possibly failed trials on their [inaudible 10:59], but let's put them together. Half positive and half negative.

Then, they went through what the literature was in these same studies. Who you'd expect if there's publication bias. You'd expect that some of these negative studies would be published as positive studies, and some of them would not be published at all. In the published literature for these trials, there were 48 positive studies and three negative studies published.

It is very striking. What's published in the literature is what guides us as clinicians. It's what guides clinical practice guidelines, and all such. The reality is, basically, what the FDA had. Another example I'll give you. The atypical antipsychotics at the time, the so called atypical, I should say.

The three that dominated the market in the mid 2000s were olanzapine, quetiapine and risperidone. They looked at all head to head trials between these three drugs that dominated the market. They found that whoever was funding the study, 90 percent of the time, their drug came out on top. You cannot rely on published papers. It's as simple as that, unfortunately.

You mentioned Gordon Guyatt before we started. When I started teaching on this topic, I didn't want to end with a nihilistic note. I wanted something to give my audience, something practical that they can take with them, so I started emailing a whole bunch of people.

I emailed Dave Sackett. I emailed Gordon Guyatt. I emailed a lot of people, saying, "You know, you guys are among the pioneers of EBM." Asking them, "Given the state that you acknowledge"    because these people acknowledge, it's pretty problematic "what suggestions do you have?" They didn't have very many practical suggestions for me, to be honest.

In fact, one of the responses I got was from John Abramson. He's with the Department of Family Medicine at the Harvard, in Boston. His response was just very nihilistic. He said, "We have to acknowledge that our evidence is completely screwed up. This is a bitter pill to swallow, but we have no choice but to recognize that."

I still don't stop there. I think that we have to make decisions as clinicians. There's ways to make decisions, but we have to acknowledge this very uncomfortable position that we're in today, that there's a huge schism between the actual evidence and the practice. The evidence itself, it's not easy to sort through, because the degree of bias in it is still huge.

Dr. Meuser:  What's your fondest hope?

Dr. Abi Jaoude:  My fondest hope is that we can do something that is very difficult to do as clinicians. It sounds obvious, but we acknowledge this, first of all, to ourselves. Not become nihilistic as a result of it, but be able to tolerate uncertainty and ambiguity. Again, it's not just psychiatry, but it's across the board.

We are increasingly recognizing that this is an important skill. The content is changing all the time, but there's some basics that I think are important. There was an article not long ago, in "The New England Journal." The title was, "Tolerating Uncertainty," where they're saying, "This is something we need to emphasize more in medical training."

As Stephen Hawking said, "The enemy of knowledge is not ignorance, it's the illusion of knowledge." Because if you're aware of the limitations of your knowledge, at least you're open to the possibilities. When you're able to tolerate doubts, you're able to be on your toes and think in different ways, and be open to alternatives. That as a first step.

Then, I think we need to go back to the roots, in terms of how we work with patients. The most effective thing that we have with patients, in general, is the therapeutic relationship. It's having a connection with the person, especially when it comes to primary care. Having an ongoing longitudinal relationship.

Everything we do, the degree of its success, regardless of the intervention, is very much dependent on the strength of that relationship. Then, when it comes to actual intervention, I think we have to be very mindful. Not rushed to what's ever in vogue these days, and following guidelines like technicians. Sometimes it involves going against the grain.

That's also an uncomfortable position to be in. I practice that way, and I'm very mindful that if something goes wrong I may be questioned. I'm going to be scrutinized. I might be [inaudible 14:56] off the college. I need to be ready to rationalize and defend it, and explain why I thought that what I was doing was truly in the best interest of my patient.

To think of a bigger context, a bigger picture, when you're talking about diagnosis. Then, when it comes to intervention, to practice conservative prescribing. There's a beautiful article written now, I think 2011. The first author is Gordon Schiff. He's an internist in Boston. The title is "Principles of Conservative Prescribing." It's really rational prescribing.

As you read through it, it includes things that are obvious, such as, "Beyond drugs. Don't jump into drugs right away." "Strategic prescribing. You don't just give the person multiple drugs like that." It also includes things that we may not think about as much, like being skeptical of the new stuff.

Five different people have recommended five to seven years before a drug is on the market, before starting to use it, because whenever a drug is new it seems promising. It's the best thing ever. That's like what William Osler said about new drugs. He said something like, "When a new drug comes out, you should use it as much as you can and as fast as you can before it stops working."

Waiting for a certain amount of time. Not jumping to new drugs freely. There are rarely true advances, when you come to think about it. Different groups have evaluated this in different ways, where they look at new drugs on the market in any given year. You look at what proportion was actually a true advance.

When we're talking true advance, it's a very small proportion, because it's hard. It's much easier and safer to develop a "#MeToo" drug. Practicing these principals of conservative prescribing, thinking of the big picture, these would be my hope, and being skeptical, overall.

Christine:  Given the substantial uncertainty and doubt about the quality of evidence clinicians are facing, not only in prescribing and practicing psychiatric care, but in medicine in general. Can you comment on what tools you might suggest for clinicians to utilize, to help advise their decision and the choice that they make?

Dr. Meuser:  Yeah, absolutely. First of all, when people hear about the literature, it feels overwhelming right away. I would say there's no need to be overwhelmed. There's no need to keep on top of the literature. Most of it is crap, anyway. There's the primary literature, but there's secondary literature.

I acknowledge I don't read the primary literature regularly. Then, if you decide that it's worth your while, you have to invest a lot of time and effort into it. You can't just take it at face value. You certainly can't just read the abstract. That's the most mindless part of the paper, in fact. You want to be very skeptical when you're reading it.

There's the typical classic Cochrane style of critical appraise. You want to do that, but even that's not enough. You want to be thinking broadly. You want to be thinking, first of all, who's funding the study. You want to look at clinical trials registries to see if the outcome measures have changed, from what was registered to what is published in the paper, because, invariably, they have been.

Just the narrative. Get a feel. "First of all, is this even a valuable question? Who's going to benefit from this? Did I get a feel that someone is trying to sell me something?" It does take a lot of energy to read through a paper. It's very doable, but I think you need to do it in a way that you're not just taking at face value what you're reading.

If you decide to read primary literature, that's ideal. If you don't, and most of the time you're not reading primary literature regularly, you're relying more on secondary literature, which I do.

Then the question becomes, "What secondary literature?" Because I would say most of these commercial entities are highly biased, partly because sometimes the free ones, which I can name a few, are highly biased. These are either entirely or in part related to what I refer to as max MECC, which stands for Medical Education and Communications Companies.

These companies have very interesting Web pages. I've been collecting these over time, where one side talks about improving healthcare, including the well being of physicians, and whatnot. The other side is marketing themselves to drug companies, talking about leveraging, influencing prescribers, etc. These are the free ones.

Some of them are very well known, and occasionally will have an interesting article. Even the non free ones, I would say it's hit and miss to what extent I would consider their work truly independent. Now, there are some that I would say are truly independent, and these are the ones that I follow.

Maybe I'll start with a Canadian one. There's a Canadian one that's free. It's called "Therapeutics Initiative." It's based out of the University of British Columbia. They're an excellent group. Unfortunately, they're not a very large group. Their funding has been repeatedly cut with pressure from pharma.

Some people criticize them as being overly critical and overly conservative. On the other hand, I think it's worth remembering that it is thanks to Therapeutics Initiative that [inaudible 19:34] never made it to the formulary NBC. That's their approach, and I trust what they have.

The others that I subscribe to, one is called "Prescrire International." Prescrire is a group based in France. They have a French publication, but they have one called Prescrire International, which is in English. They're very independent. They don't manage conflicts of interest, they just don't accept any conflicts of interest. They do things like...it's not just reviewing the literature.

They do very much the big picture stuff, which is, they go the gray literature, to the drug regulatory agencies. They go to the FDA. They get all the submissions to the FDA, but also in Europe, to the EMA, and across the world. They collect surveillance data from across the world, and all of that.

Then, the third one is called "Worst Pills, Best Pills." This is by Public Citizen in the United States. It's also subscription based. That one is very cheap, I should say. It's like $15 a year. The target is patients, but they give you the same kind of high quality analysis that Prescrire and TI does, for that matter.

Interestingly, all three of them pretty much align in their recommendations. In terms of the things that I've seen, they tend to align.

Dr. Meuser:  You've spent a lot of your energy and time looking at the difficulties with the application of evidence to clinical decision making in psychiatry. We can extend lots of what you say to other branches of medicine.

I'm sure you've had occasion to try to look for some light at the end of that tunnel. I wonder if you can talk about any opportunities you see for improving access and use of evidence for guiding clinical care in the future.

Dr. Abi Jaoude:  There's some light at the end of the tunnel, I just don't know how long this tunnel is. I don't know how stable it will be. I would say the major development is in the form of the recognition. That everything I'm saying today, if I were to say it 10, 15 years ago, certainly, I think I would have been considered a complete nutcase.

Today, people are saying these things, and they're not considered nutcases. That was why clinical trials registries were developed, for example, as a way to try to address that. Unfortunately, the clinical trials registries have failed in terms of their primary purpose because, first of all, the International Committee of Medical Journal Editors still published unregistered trials.

Second of all, there are journals that are not part of this group and will easily publish an unregistered trial. Third of all, that study is negative and it's not published, so who cares that it was registered? Fourth, most commonly is you change the outcomes and you publish it. No one is checking the outcomes. There are not enough people that are checking the outcomes.

It's failed in this respect. It's still useful if you access it regularly, and I...but this was an example of recognition. Another example of recognition is the whole discourse on transparency and conflicts of interest. We talk about this a lot now. We have to fill out yearly forms. When you're submitting a paper, there's a whole thing about these disclosures.

Again, this has failed in terms of its purpose, because who cares? The other thing is, declaration on its own is not enough. In fact, there's some behavioral psychology evidence that's interesting, suggesting it makes things worse, because the person making the disclosure feels they have a moral license now, so they can exaggerate even more.

On the receiver end, if they've heard the disclosure, they also let their guard down a little bit because they feel like, "OK, the person is transparently disclosing." The other thing is we need full access to the data. Not that we're all going to go through thousands and thousands of pages of data of every trial.

We need that data to be available for independent researchers to be able to interrogate it whenever they want. There's been a number of movements along these lines, around the world, that are promising. First of all, the FDA. I wouldn't say there's been particularly progressive moves in this regard, and nor would I expect anything very radical of the FDA under the current administration in the US.

Quite the contrary, unfortunately. However, having said that, they do make very thorough reviews available on their website for all trials. That's something that's a very underused resource.

In Europe, the European Medicines Agency, they've moved to making clinical study reports accessible publicly, as well. That's taken years because they've had challenges from drug companies that have challenged them legally. At this point, as we speak, CSRs are available through the EMA, and that's very valuable.

Then, Health Canada. Health Canada, we have some promising initiatives in Canada. You guys have heard of Vanessa's Law. I forget what bill number it is. This was brought forward by Terence Young when he was with the Conservative Federal MP. It's named after his daughter, who died after taking Prepulsid. She had sudden cardiac death from QT prolongation.

The company had interfered or had influence, I should say, with Health Canada. Vanessa's Law includes a number of things, one of which is access to data. It also gives Health Canada and the Minister of Health more power in terms of being able to remove a drug from the market or issue warnings and such.

Vanessa's Law has the potential to allow Canada to be the most progressive in terms of access to data in the world, but it all depends. The devil is in the details. From a systemic point of view, I see this as very promising, but also very cautiously so, because, as you know, companies with vested interests are watching these things very carefully and trying to influence things.

That's in terms of the what's happening systemically. On an individual practitioner level, I do find it promising that there's more awareness about this, and in particular, trainees. I see our trainees today as very bright. They tend to be progressive.

Again, it's one thing to interact with them on one on one, or as a group in a teaching session. To what extent they will be influenced by the establishment as they go through their training, or to what extent they'll be able to change things, remains to be seen.

[background music]

Dr. Meuser:  Thanks for listening to this episode of Clinically Speaking. It was produced and edited by Pippy Scott Meuser at the Center for Effective Practice.

Christine:  Special thanks to our guest this episode, Elia Abi Jaude, for taking the time out of his busy schedule to talk with us.

Dr. Meuser:  We're always looking for interested and engaged primary care providers to contribute to our development process. Interested in becoming a clinical lead or a working group member? Please visit our website at cep.health/participate to sign up.

Christine:  Don't forget to subscribe on iTunes, our website, or wherever else you get your podcasts.

What it takes to produce a good clinical practice guideline

Episode 3

Keeping up with the evidence can be a daily struggle. We often turn to, and depend on, clinical practice guidelines to help make evidence-informed decisions. Dr. Jan Hux, President and CEO of Diabetes Canada, provides her insights on tackling one of the most difficult and complex areas of practice: diabetes.

[background music]

Jamie Meuser:  You're listening to "Clinically Speaking," a podcast that explores the past, present, and future of evidence based medicine and primary care, brought to you by the Center for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

Jamie:  As described by Gordeyev in our first episode, evidence based medicine or EBM for short was originally conceived and taught as an individual practitioner's pursuit to find and appraise evidence to inform their everyday clinical decision making. It became abundantly clear, however, early in the EBM movement, just how impractical that was.

Christine:  Stay on top of new publications and studies relevant to your practice while it's also assessing the quality of said evidence became its own full time job.

In response, we've turned to a more collective approach to EBM through the creation and dissemination of clinical practice guidelines or CPGs. CPGs have become one of the most important tools clinicians use to guide their clinical care decisions.

Jamie:  The prevalence of diabetes in the work of all primary care practitioners makes the Diabetes Canada guidelines a particularly important patient care information tool.

Today, we speak with Dr. Jan Hux, president and CEO of Diabetes Canada, to get a better sense of the CPG development process, who is involved and how they work to make their guidelines useful for a broad audience of practitioners.

I'm pleased to welcome Jan Hux whose president of Diabetes Canada. We're going to talk today about the construction project that is the Diabetes Canada Clinical Practice Guideline. Can you give us a bit of an idea of the process of pulling a massive endeavor like that guideline together?

Dr. Jan Hux:  Sure. We actually start with the consumer. Do a needs assessment and really get a sense of what are the needs? What are the questions? Where are the gaps in knowledge? Where do healthcare providers feel they need support in their decision making and in the care they deliver?

I guess the next step would be to generate our team of volunteers, endocrinologists, primary care practitioners, both physicians and nurse practitioners, pharmacists, dietitians, nurse educators as well as patients. Then from that, generate the questions that are going to be relevant to drive the content of the guidelines.

Those questions are then given to a literature searching service that's run through McMaster University. They do the literature search for us which is a non insubstantial task. When we did the 2018 guidelines, there were over 200,000 articles that could be potentially relevant for practice of diabetes care that were identified.

Then the job becomes separating the wheat from the chaff, identifying what the messages were from the good articles, and then resolving the apparent contradictions. Even LA audiences is familiar with the notion that one week, coffee causes cancer and the next week, it cures heart disease.

We see that, of course, in the diabetes literature, so resolving contradictions, then distilling that down to recommendations, publishing the book, peer reviewing it, and then disseminating.

Jamie:  You talked about pulling together a team of people to help construct this guideline. What kind of expertise is necessary to do a high quality guideline in 2018?

Dr. Hux:  I think a range of expertise. Since we have, I believe, 38 chapters in this guideline, each chapter having its own team. We may not have the bench strength in some of the technical areas, methodology, and statistics.

We actually have a two phase process. For each chapter, the people with that content expertise review the literature and bring forth recommendations.

Then it goes under separate evidence review where the people with more clinical epidemiology expertise, statistical ability will go through and make sure that every one of the recommendations is actually supported at the level of strength that its reported at.

The skills that would be needed would be the direct clinical care, the application of evidence. That's why we feel it's important to have patients involved in our panels and then both a primary care and specialist care perspective so that we want guidelines that are durable across the setting in which they're used.

Jamie:  You talked about the massive number of studies. How do you select the evidence that you choose to use and not to use?

Dr. Hux:  That's a great question. You end up with over 200,000 because you want to keep your filters very wide at the beginning. You find that a bunch of them are most studies, or studies that aren't likely to be relevant in practice, or studies that are in a very specialized setting that we're not confident is generalizable.

Beyond that, we want to look for, "Are they actually providing the light on the question we were asking?" Then as I said looking at the quality of the study so we can get the wheat from the chaff and trying to resolve the conflicts.

Both studies may be completely accurate, but the population in which they're studied or the duration of the intervention or the intensity of the intervention may have led to a different outcome in the study.

Jamie:  It's certainly one of the trends in primary care in the hospital that allows the involvement of patients to a much greater degree in participating in and often directing their own care. You've talked about involving patients in the construction of this past guideline. I think that began a few guidelines ago.

What have you found out about what's the right part of the process to involve patients? How do you do that effectively?

Dr. Hux:  I'm becoming convinced there's no wrong spot for the patients to be, that we need to create a welcoming space. We need to empower them to bring their unique perspective. They can bring value anywhere. The challenge is to create a space that welcomes them.

Sometimes, that involves some training and education ahead of time so that they have the background they need. Then it's chairing the panels well so that their voice is recognized and called on.

Jamie:  You alluded to this, but I wonder if you can be explicit about who the audience or audiences are for the guideline that you're producing.

Dr. Hux:  The answer to that question is our audience is evolving. In the past, we had been fairly content to preach to the choir that the people who came together to produce the guidelines were people whose primary practice was diabetes.

Even though some of them, for instance, might be a general internist or geriatrician or a family doc, they had oriented their practice toward diabetes. It was worth it to them to invest a fair amount of time in informing themselves of the latest evidence.

We've realized that if we only focus on people whose primary practice is diabetes, many of them will be relatively up to date on this literature anyway.

The unmet need is in the generalist audience, the people who have a much broader demand on their attention, who need to know everything from immunization schedules for infants through to screening for dementia in the elderly and have a narrow capacity to take up diabetes information.

Curating the information and packaging it to be useful in primary care has become a real emphasis in the 2018 iteration of the guidelines.

Jamie:  We've talked about creating guidelines. I guess the end point of that will be recommendations for how care should be organized or prioritized. Any thoughts around formatting how that content gets presented to the various audiences and distributed to them?

Dr. Hux:  Yeah, I think that it became clear to me in my med school class of 252 people at UT that one size does not fit all. There were clearly students who sat in the front row and meticulously wrote down everything the professor said.

There were others who never attended a lecture. There were people who bought and read all of "Harrison's Principles of Internal Medicine." There were those who bought the skinniest internal medicine textbook in the bookstore. I think...

Jamie:  They're all called doctor. [laughs]

Dr. Hux:  They are all called doctor. To think that one tool is going to meet the need of all providers is naive. We need to have a range of things. There will be some people who will take great comfort in the 218 page tome, and other books we'll only find it useful as a doorstop.

We need to not be shirty about the fact that people have different preferences. Electronic tools, paper based tools, book based tools, web based tools. We need a range of tools. We also need a range of depth. There are some personalities that need the story behind the story before they're confident in making the decision.

There are others who just, "Give me the bottom line. Tell me what to do." Trying to have a smorgasbord for people to eat where they want and what they want is going to be the best approach.

Jamie:  What kind of strategies have you used or have you contemplated for simplification?

Dr. Hux:  The most important thing is have the end users on the panels. After the guidelines are produced, they go into the hands of our dissemination and implementation group. This time, we have two co chairs, one of whom is a family doc. We felt that was extremely important to have a range of primary care providers around the table who are actively informing.

Again, if they choose to give a ton of volunteer time to have diabetes guideline, they still may not be representative of the general population, but at least they are pushing us in that direction.

If we can get a guideline that only contains 40 percent, or 30 percent of the content of the main guideline but is 80 percent applicable rather than 100 percent of the guideline is 2 percent applicable, we're further ahead.

Jamie:  Have you considered doing that? Have you considered putting out a version of the guideline with emphases that are appropriate to the audience?

Dr. Hux:  Yeah. We're talking about a variety of schemes, none of which are set on yet but would include picking only the chapters that are likely to be relevant to most providers, i.e., primary care, and updating them annually, and focusing much more on practical actionable recommendations even in areas where there's not a ton of evidence.

Often, those are the areas where providers need even more help. It's the expert, "Here's what I would do in my practice. There's no evidence, but it seems to work," because they've seen a thousand patients like that, and you're on your second or third one.

Jamie:  Save the easiest question for the end. Guidelines, clearly, are very intense and complex endeavors, requiring our suspect substantial resources to pull that off. Where should the resources come from?

Dr. Hux:  That's a great question. For many organizations and for us in the past, the obvious answer has been the pharmaceutical industry because they have a vested interest in seeing particularly new products that are bringing to market pushed out and education around their appropriate use being provided.

There's equally, if one wants to be evidence based, good evidence that shows that guidelines where industry has been involved in the development at an uncontrolled level due to the biased guidelines and would promote inappropriate overutilization.

We've taken the step to not use any corporate funding for the development of our guidelines this time and even prior to that, really worked very hard to build that Chinese wall so that our funders had no access to the guidelines until they were printed.

Then that leaves the question, "Who should?" Governments aren't keen to fund this kind of work. They would be seen to have a conflict of interest as well.

At Diabetes Canada, we're in the luxury space of being the only health charity that is both the professional section who would rightly lead a guideline process and health charity that might have the resources to fund that. We use general donations because the guidelines are critical to our mission to fund that.

[background music]

Christine:  Thank you for listening to this episode of Clinically Speaking. It was produced and edited by Pippy Scott Meuser at the Center for Effective Practice.

Jamie:  Special thanks to our guest this episode, Jan Hux, for taking time out of her busy schedule to talk with us.

Christine:  We'd love to hear from you. If there's a specific topic you'd like us to cover, please feel free to send us an email at info@cep.health, or come and find us on Twitter @CEPhealth.

Jamie:  Don't forget to subscribe on iTunes, our website, or however else you get your podcasts.

[music]

Making clinical practice guidelines more useful for everyday practice

Episode 2

Dr. Mike Allan, a family physician and academic from Alberta, heads an initiative that takes a very different approach to producing clinical guidance for decision making, specifically by targeting primary care practitioners at all stages of the process.

[background music]

Dr. Jamie Meuser:  You're listening to "Clinically Speaking," a podcast that explores the past, present, and future of evidence based medicine in primary care, brought to you by the Center for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  And I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

Dr. Meuser:  By far, the most read and referred to article in "Canadian Family Physician," the official journal of the College of Family Physicians of Canada, is the simplified lipid guidelines. Published in 2015, volume 61, issue 10 for those who haven't read it, by Dr. Mike Allan and his team at the Alberta College of Family Physicians and the University of Alberta.

The simplified lipid guidelines strayed from the traditional CPD development process in an attempt to achieve a more useful, more practical and a more relevant guideline for its users.

Christine:  Ironically, very few clinical practice guidelines are developed with much or significant input from primary care providers, the chief users of them. The simplified lipid guideline flipped this on its head. They stacked the development group to ensure that the resulting guideline was focused, relevant, and easy to implement for their target audience, primary care providers.

Dr. Meuser:  By focusing the output to a more narrow audience and by explicitly addressing questions relevant to them, this guideline has the potential to be more useful as a tool for supporting clinical decision making, and will hopefully set a precedent for the development of future guidelines.

Christine:  We had the pleasure to speak with Mike about the work that he's been doing, what's to come, and how we can work towards making EBM more meaningful for primary care providers.

Dr. Meuser:  Today, we're welcoming Dr. Mike Allan. Mike's a family physician in Edmonton, founder and leader of the evidence based medicine group at University of Alberta. Mike's been active in CPD in Alberta, BC and well beyond, and in particular has been a primary contributor to the Tools for Practice evidence based medicine group at University of Alberta.

Mike is also a contributor and co host for the "BS Medicine Podcasts." You might want to take a listen to that. These are superb podcasts and lots of them. How many now?

Dr. Mike Allan:  300 and something? I believe so. [laughs]

Dr. Meuser:  Really? Holy mackerel!

[laughter]

Dr. Meuser:  Wow!

Dr. Allan:  It's robust. [laughs]

Dr. Meuser:  Lots of background there and really a focus on particular clinical topics similar to the Tools for Practice or write ups that you've gotten, brief reviews of evidence on particular clinical topics.

Probably more recently and more germanely to our discussion today, Mike is the principal author of what they've called, "Simplified Guidelines," the two that have so far been on lipids and on cannabis. You have been invited, first and foremost, because of the interests that we share with you and commitments that we have to evidence as a cornerstone for the practice of primary care.

Why don't we start by having you describe the various roles you've got currently around clinical practice guideline creation dissemination?

Dr. Allan:  Well, right now, I'm at the University of Alberta. I'm a professor there in the Department of Family Medicine. The section that we're in within the department is called Evidence Based Medicine.

We call ourselves the peer group, and that comes from the very foundation of evidence based medicine. Patients is the "P", Experience is the first "E", Evidence is the second "E". Then Research because of what we do. Also, we didn't want to call ourselves the "PEE" group.

[laughter]

Dr. Allan:  There was a problem with that.

Dr. Meuser:  Thank God for research, eh?

Dr. Allan:  Thank God research came along. Tina and I and Mike Culver, we co lead that group. Scott's a part of our group, Scott Garrison, and then all sorts of other people.

Then I also am the incoming director of programs and practice support at the College of Family Physicians of Canada and hoping to continue all of this kind of work there. That's the intention. Then, of course, I have a clinical practice, like many of us. Those are the hats I wear.

Within CPD and guidelines, I noticed early that CPD wasn't being delivered for primary care, by primary care. I did a research study with Doug Klein that showed that. Then a bunch of us did research study asking that of guidelines.

We realized we were 17 percent of the total contributors to our own guidelines. That made me motivated to get more involved in guidelines. On top of the Tools for Practice and best science medicine, I became quite passionate about trying to develop guidelines with a more primary care focus.

Dr. Meuser:  You talked about being a researcher and creates some of the knowledge that goes into the package into guidelines, developer guidelines, so part of the packaging process and then a consumer, a user?

Dr. Allan:  Yes, that's right.

Dr. Meuser:  From those various points of view, how important do you think practice guidelines are to clinical decision making for Canadian family physicians, for Canadian patients?

Dr. Allan:  Because their very name is guidelines, they're guides, they're not strict rules to be enforced. That needs to be stressed for everyone because we all have patients that are exceptions or that don't fit into the constraints of a guideline.

Accepting that, and being comfortable with that, I think guidelines still have a role. They fill a series of voids. One is sometimes we don't have research. Sometimes we don't really know what direction.

Having a guidance document to help direct care, give suggestions in care can be very helpful. We know family doctors couldn't possibly keep up with reading to stay up to date. The best estimate is that would take pretty close to 20 hours a day.

What are we going to do instead? Well, guidelines have a potential role to fill there in summarizing the evidence in key areas of practice. They fill a bunch of potential roles for us, and they can be very helpful in practice.

We just have to make sure that they don't dominate our decision making or restrict us in any way to take care of people. We have to make sure that they're done the right way and by the right people.

Dr. Meuser:  We've got a guideline for just about everything these days.

Dr. Allan:  Hopefully, just one for everything, but we don't. We have way more than that.

Dr. Meuser:  No shortage of guidance, I would say. All those guidelines came from somewhere. Someone thought they were a good idea. Someone, in fact, put resources into making that good idea come true.

Based on what you've experienced through your career, talk about what forces have driven the current model of clinical practice guideline creation and dissemination.

Dr. Allan:  There're a lot of forces. Some of them are good, neutral, and some of them are less than good. [laughs] A good one is just what we talked about. There's a need out there and a lot of clinicians appreciate having a guideline to turn to to help them in managing their patients. My only fear there is how rigid they are in that recommendation.

There's other reasons that guidelines have come to be and become such a big part of what we do, and that is some people feel ownership of certain conditions. We, in primary care, we see all the conditions. We don't really care about diabetes unless our patient has diabetes.

There's different viewpoints where they only care about that patient because they have the condition they care about. It's kind of a reverse thinking. When you have control of a condition, you want to write the rules for that condition.

That's one of the motivators that goes behind guidelines is there's a sense of wanting to control it. Within a field, if I was an endocrinologist, for example, getting a seat at the table of the Canadian Diabetes Association and being an author of part of that guideline would be considered a bit of a feather in the cap.

I would want to be at that table if I could. There's a motivation from that perspective. I would consider that more of a neutral thing. Then there's certainly is influence within industry and that kind of thing to direct guideline base care to enhance a certain bottom line.

Dr. Meuser:  Can you give us any thoughts about the kinds of differences in the process that you would see as contributing to usefulness?

Dr. Allan:  There's a group called the Institute of Medicine. They wrote a document called Guidelines We Can Trust. It's supposed to be a guidance document itself for the writing of guidelines.

It follows some very basic principles. One is the lack of conflict of interest, so to avoid any conflict of interest, if at all possible. One of the pieces that falls out from that that we often forget about is something called predisposition bias. That's where you already have a belief system in place.

I would say that you also need to tread quite carefully there. If I'm a researcher and all I've done in my entire career is research apolipoprotein B, you put me on a guideline I am going to advocate heavily for testing for apolipoprotein B. If I was in the diabetes and I studied glucagon, I'd want that in the guideline somehow.

Many people will focus on what's happening with industry funding. Also, as important, I would say is this. It's been shown in a study by Oxman and Guyatt, that the more specialized you become in an area, the less likely you are to be objective about new research that comes along.

The next thing is being evidence based as much as possible. Where they're not, I think we need more flexibility and less rigidity.

Then the last thing, I think, or not the last thing. The second last thing is if we accept that primary care is providing the majority of care, and I think that's inarguable. Then we need more primary care on these guidelines. The best estimate is just for all of care in Canada, all of healthcare in Canada, we're delivering 65, 67 percent of all of the care.

For guidelines targeting primary care, we need to be at that table. We need to be the majority of that table, not to exclude our colleagues and pharmacology, or pharmacy, or nurse practitioners, or nurses, or our specialist colleagues. We need to be the leads and the leaders of that guideline, not the other way around.

The last piece is simple. Primary care is very, very busy. The research shows, again and again, that we're swamped with all that we're supposed to do. If we were to take care of chronic disease and preventive medicine alone, it would take around 18 hours every day.

Because we've ended up in a situation where specialty societies continually parse off their niche and don't worry about what is the broader picture of what's affecting our population and our patients, we end up with a burdensome amount of things that are recommended for us in primary care. I think the better approach for us is to simplify that.

Why don't we spend more time doing the actual shared decision making with our patients? Listening to their stories, listening to their concerns and addressing those. Rather than, I've got to get through this huge checklist of preventative care maneuvers and this periodic health exam today.

I've got to squeeze it into your complaint about your ankle today so I'd like to skim along and talk about the PSA which is going to take 10 minutes.

Instead of doing that, I'd like to see us simplify things a lot more where we can. I'm not saying where things are complex, we just abandon that complexity, but where they are simpler, where they could be simple, why don't we gravitate in that direction? Rather than always looking to make things more complex and difficult.

Dr. Meuser:  Can you give us any thoughts about how you would organize or prioritize the care recommendations that come out of a guideline? In some ways, some would say that two dozen recommendations without prioritization attached to them is almost useless. It doesn't help me in my decision making very much if I got to focus on two dozen things, because I never will.

Dr. Allan:  Exactly. Within the actual framework of recommendations, the goal is to keep it to 10. You can't always because there's too many, but some will obviously bubble up to the top. Those are the ones with better evidence. Those are the ones the committee would feel are essential to practice.

Then that would be something we would obviously focus on and bring more front and center into the guideline write up.

Dr. Meuser:  Any thoughts about how format can influence uptake in successful guideline?

Dr. Allan:  Absolutely. If you look at our guidelines, there's three pieces to the guideline.

The first is the evidence review. That's a massive document, generally. I don't think anyone is going to read that, or I certainly hope they don't. Unless they're super keen on finding out what we did and have maybe distrust for what we did or maybe are just really keen on pursuing a certain area of research.

The next step is the guideline itself. That is something between a 5 and a 10 page document, at most. That might be read by more than a few people, but it certainly won't be read by everybody. They're going to want to read a summarized version. Because some people still like all of the key recommendations on a single page, we provide that as well.

Then we have something we call a one pager. We create that as an algorithm so that it's as simple as possible for docs to use in primary care.

Dr. Meuser:  If this, then that.

Dr. Allan:  We try and make it as straightforward as possible. If you looked at the cannabinoid guideline, the evidence section was very, very big. Then we got it down, in the end, to an algorithm that's less than half a page in size.

The goal of the one pager is not only to provide the algorithm but to provide the tools that allow a clinician to do everything that's needed, key from the guideline.

If you look at our lipid one, we have an algorithm for deciding on who should have a discussion about treatment and the relative strengths of that discussion. Someone over a 20 percent risk, we strongly recommend that a discussion should occur.

On the flip side of it, because we recommended moderate or low potency and those kind of things, we say what those are. We say what the expected benefits would be from randomized controlled trials and the cost of the agents, those kind of things so that that decision making process is as easy as possible.

Dr. Meuser:  You've nicely described the simplified means. Did you worry at all when you coined the simplified term that it would reinforce the hidden curricular around family docs being lesser beings than the others?

Dr. Allan:  It's interesting. You're the second person today to bring that up to me. This is the first time I've ever heard that.

Dr. Meuser:  Is that so?

Dr. Allan:  Yeah. I did not even begin to perceive that. I saw guidelines as broken, in part because of their complexity. The guideline itself, I'm not talking about the evidence section, but the guideline itself, 200 pages. It's just too cumbersome for us in primary care.

I've always thought that simple is better and that speaks to our tools for practice in lots of what we do. If you can say something in 10 words or a hundred words, why would you say it in a hundred? I actually thought it was quite a cunning marketing ploy. Now I see that...

Dr. Meuser:  [laughs] .

Dr. Allan:  ...like most of my great ideas, it has faults. [laughs]

Dr. Meuser:  In fact, I think the elements you described are all compelling around handing people the most useful tool possible. You're right. The most useful tool in some way is the one where how to use it is obvious.

Mike, we'll be talking with the Canadian Diabetes Association about the guideline. It's clearly an important one for driving care in family physicians' offices across the country. Any specific comments on the CDA guideline?

Dr. Allan:  The CDA guideline has some of the things that I've mentioned earlier, the challenges that are present in guidelines. There's no doubt that some of that exists. Anyone who is listening could probably piece that together, but they do have a very difficult task.

Maybe, you've noticed that the simplified group hasn't embraced doing a diabetic guideline, and maybe that's because they're afraid of it.

[laughter]

Dr. Allan:  It's such a huge topic. Certainly, if we were to do it, we wouldn't include Type 1 diabetes, which they do. We would cover a lot less topics than they do. They try and hit every little target. I don't mean that target like A1C target. They try and hit every area of...

Dr. Meuser:  A minor relevance to the treatment.

Dr. Allan:  There'll be a whole section on photocoagulation and eye disease related to diabetes. There'll be a section on neuropathy. That is just not possible for something like our group and probably not possible to do a true evidence based guideline as I described.

If you had 10 questions, just for the eyes. If it takes us, with a whole team of people working around the clock, five months minimum to get 10 questions done. Can you imagine when we're talking about something else? There's challenges there that are quite big.

I personally wouldn't want to be trying to decide right now what's the second line therapy in diabetes. I would not want to be confronted with that. It's a very charged and challenging debate right now.

If you're truly evidence based, you would have to pick the ones with hard outcomes. That means you're picking expensive drugs. That means you're making a lot of people angry. It's a bit of a quagmire that I'm quite happy to let them [laughs] get stuck in and try and wade their way out of.

Dr. Meuser:  What strikes me that unlike you, they've got to send their guidelines out to a broad audience, not a narrow audience. It's more than family physicians that they're interested in.

Dr. Allan:  For sure.

Dr. Meuser:  In fact, that might change everything if you decided to only provide guidelines for questions that are going to be of value or interest to primary care.

[crosstalk]

Dr. Meuser:  You talked about...in your cannabinoid guidelines    having patients involved in the process.

Dr. Allan:  In the actual committee.

Dr. Meuser:  Can you talk a bit about how it changed the conversation in the room?

Dr. Allan:  Unfortunately, we had two, but one had to drop out for personal reasons. We were left with one, and then we still included the peer review of more. Our new guideline that we're working on right now has two.

There's almost a sense with the dynamics that when clinicians are in the room, patients sometimes will feel almost like, "Well, maybe the doctors know better," or, "Maybe, the healthcare providers know better."

We're toying with the idea of in the future actually creating a separate committee to give them a voice that's going to allow them more ability to influence the process. As I mentioned right from the onset, I don't have the right answers yet, but we're still experimenting with how to do this right.

Dr. Meuser:  You've talked a bit about how the patients are involved. How about the when?

Dr. Allan:  I would think it's critical in two parts    the choosing of the questions, but the second piece is at the end. When we do the guidelines, we try and keep things separated. We have a guideline committee. We have the evidence committee. We have a peer review committee.

Only when the guideline's written do they send it out. They take all of the information, and we're sending it out for 50 people.

They take that feedback. They try and see, "Does this have merit? Do I actually understand it when I read the guideline?" They end up doing so much work in the end that they're authors on the guideline, because it changes it substantially.

Then the last piece, the last committee    so this is four committees to do one guideline    the fourth committee is the knowledge translation committee. They're the ones that turn it into something usable for patients and clinicians, and we have patients on that. That does make a difference. Again    always learning I think we can strengthen that part a little bit better.

Dr. Meuser:  You talked a little bit about the intersection between electronic medical records and user guidelines. Can we better integrate clinical practice guidelines into the medical recordkeeping that we do?

Dr. Allan:  Keeping that dream alive. I started to research healthcare costs back in my residency over 20 years ago. I looked at the idea of providing cost information to improve prescribing to reduce cost for equivalent drugs.

There were promising studies there indicating that, but if you could find one that showed a reduction in cost, you could find another one that showed no reduction in cost.

This whole thing about medical reminders and embedded information into our EMRs, it still has promise, but we can't let the cart get ahead of the horse. We have to prove that these things are effective before we jump onboard too quickly.

Dr. Meuser:  It takes us a little bit towards the redundifying of care that...

Dr. Allan:  Absolutely.

Dr. Meuser:  ... you cited at the beginning as a downside to guideline based care.

Dr. Allan:  A real risk. We have some things to figure out before we integrate some of these into care. We have to make sure that they don't make our life more complicated rather than less.

Dr. Meuser:  We'll finish with the $64 million question. It really is. Good guidelines    I'm sure you know better than most are not cheap.

Dr. Allan:  No.

Dr. Meuser:  You don't do them for nothing. If they are an essential tool for high quality care, who should pay?

Dr. Allan:  Actually, it should be a shared payment. Universities have a role to play. Governments have a role to play. I don't actually think societies have as big a role to play, but you've probably guessed, I would gravitate away from that kind of guideline writing because of the system that it's built on.

We should be having a different approach. It should be kind of a shared model. We have academics who have time. It can't be just academics doing it. That has a lot of danger because they lose sight of some of the key elements of the way practice really is.

Our guidelines spend a ton of time choosing those family doctors    rural, making sure they're not academics, all of these kind of things. The actual leadership of it in that kind of role, that takes someone who can carve out time. Academics have that time to carve out. That, but having excellent representation from the community.

Dr. Meuser:  Sounds like    for all the reasons you've cited    who does it, how it's done, is probably more important than who pays for it. Who pays for it becomes a question you can settle when the rest of those questions are well taken care of.

Dr. Allan:  I agree. I'd love to see, if anyone from government is listening and you want to send us millions of dollars, we would take it. [laughs] Or some non profit organization.

Dr. Meuser:  Well, they're all listening.

[laughter]

Dr. Allan:  They all are, I'm sure. It's tough, because I think everyone has a strong belief system. The system that's built right now is built around the traditional model that we have. For our government colleagues to just suddenly abandon that approach and switch would be very, very challenging for them. I'm hopeful that we can start to show them that there's a hunger within primary care.

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Christine:  Thank you for listening to this episode of Clinically Speaking. It was produced and edited by Pippy Scott Meuser at the Center for Effective Practice.

Dr. Meuser:  Special thanks to our guest this episode, Mike Allen, for taking time out of his busy schedule to talk with us.

Christine:  If you're interested in learning more about the Center for Effective Practice, please visit our website at cep.health. Don't forget to subscribe on iTunes, our website, or wherever else you get your podcasts.

What has shaped evidence-based medicine?

Episode 1

Dr. Gord Guyatt, one of the founders of the evidence-based medicine movement, provides an overview of the forces and factors that stimulated the birth of evidence based medicine and have influenced its development.

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Dr. Jamie Meuser:  You're listening to "Clinically Speaking," a podcast that explores the past, present and future of evidence based medicine in primary care, brought to you by the Center for Effective Practice. I'm Jamie Meuser, a family physician practicing home palliative care in Toronto.

Christine Papoushek:  I'm Christine Papoushek, a pharmacist practicing at a family health team in Toronto.

It only made sense for us to start this pursuit to unpack evidence based medicine with one of its earliest and most effective champions, Dr. Gord Guyatt.

Dr. Meuser:  While at McMaster University, Gord spearheaded the initial idea of evidence based medicine and further developed this concept with Landmark Publications and the "Journal of the American Medical Association."

His series of more than 34 articles, collected into to the "Users' Guide to the Medical Literature," has provided the basis of EBM curricula in medical schools and residency programs nationally and internationally.

Today, EBM continues to be a method for appraising applying evidence, but also a movement that characterizes how we understand optimal approaches to medical practice in the modern age.

Christine:  Gord's contribution to the profession cannot be overstated. We are grateful that he could take time to speak with us today. He candidly shares his perspective on the early days of EBM, the motivation behind it, the surprising wins, and the unforeseen shortcomings of the approach.

We delve into how EBM has evolved since the challenges of bringing EBM into everyday practice, the hijacking by the pharmaceutical industry and the hopes that have been realized. He also shares his visions for the opportunities that lie ahead for EBM. Stick around.

Dr. Meuser:  Gord, just as a bit of background, you've got a long history, a substantial reservoir of expertise and a clear passion for evidence based medicine. You were there, I think it's safe to say, at the very beginning of the time when applying evidence to the clinical decision making we undertake as physicians became much more important, almost de rigueur.

Can you give us a bit of an idea, Gord, what was envisioned and what was intended when you conceived the idea of evidence based medicine as a touchstone of how we practice?

Dr. Gord Guyatt:  I still remember being at the Toronto Western Hospital as a second year resident in internal medicine and being told about how one should read the literature. The advice was, read the introduction and the discussion because of the accurate perception that one wouldn't be able to understand the methods and results.

A vision that Dave Sackett, who is my mentor, began with was, "Clinicians should be able to understand the methods and results, and so be able to distinguish what was trustworthy from what was less trustworthy."

At the start, there were a lot of practices that people were doing for which the evidence was not very satisfactory. In fact, the evidence might be that they were doing more harm than good and lots of other things that people weren't doing for which there was good evidence.

Clinicians should be able to look at the original medical literature, be able to understand what was there and distinguish what was useful from what was not useful. It's evolved quite a bit since that, but I would say that that was the original vision at the start.

Christine:  Gord, in your opinion, what hopes were realized, or what were some of the lasting effects on the medical profession and community more broadly?

Dr. Guyatt:  The big hope is that the medical community in general and associated communities, anywhere from pharmacists to nurses to occupational and physiotherapists, have adopted the vision of the requirements of an evidence based approach that is a critical look at the available evidence should inform clinical decision making.

As a result in North America, certainly, and increasingly in other parts of the world as well, both undergraduate and residency education in medicine, in nursing, and in other affiliated health professionals, the teaching of the concepts of evidence based medicine is seen as a core competency.

The licensing and accreditation of medical programs requires them to demonstrate that they are teaching their trainees these activities.

For people already out in practice, there's this general acceptance to that approach should be used. Many, many, many textbooks are called "Evidence Based Cardiology," "Evidence Based Anesthesia," "Evidence Based Pediatrics," and so on.

Analysis has become a selling point to say, "The practices that we are promulgating or encouraging are, in fact, based on evidence." Then in the electronic medical textbooks that have become extremely popular and, in fact, displaced old medical text, such as "UpToDate" and "DynaMed" sell themselves and, I think, try to be evidence based resources as well.

It's basically been accepted over a period of about 25 years as a fundamental of medical practice.

Christine:  In the 25 years, since and reflecting back on the original impetus behind the approach, can you tell me, have there been any unforeseen outcomes or unintended consequences?

Dr. Guyatt:  Well, it's actually ended up as something quite different, in at least two ways. One thing was that if you look at what we wrote at the beginning, the notion of values and preferences and value and preference sensitive decisions was really not there at all.

It only emerged over the first five years of the evolution of EBM, which it's been exciting to be involved in these 25 years or more now because it does keep evolving. What we realized after a while was that evidence never actually tells you what to do. The reason is that so many of our alternative decisions, the alternatives have both upsides and downsides.

Often those ups and downsides are relatively closely balanced. One paradigmatic situation we often use is atrial fibrillation.

Depending on how you feel about the burden of anticoagulation, and how you feel about the bleeding risks with anticoagulants versus the stroke prevention, two individuals in exactly the same situation based on the same evidence, one might very well say yes, anticoagulation is right for me, and another might say no.

There are many, many, many decisions within medical practice that are value and preference sensitive in this way. We've come to say an ironic principle of evidence based medicine is evidence never tells you what to do. There's always evidence in the context that patient values and preferences.

That's been one major shift from the beginning. The other major shift is the realization that clinicians do not have the time to actually read the medical literature in the way we might have envisioned it first. In fact, to really do it properly takes training, that the basics of knowing about what evidence based practice is about, will not take you there.

As a result, we have much more of the focus on pre appraised resources, systematic reviews, more and more guidelines, and presentation evidence summaries. In keeping now, this is a frontier area, decision aids for the practice encounter where both the patient and the clinician have the evidence summarized for them.

Those two things, the importance of values and preferences and the awareness that clinicians are not going to be doing the typical appraisal of the original literature themselves. They need to appreciate the fundamental principles, but then they need high quality clinical practice guidelines to help them achieve evidence based practice.

Dr. Meuser:  Someone we talked to recently talked about the shift from evidence based medicine being a individual skill that clinicians would exercise, usually through clinical appraisal of articles.

It's evolved from being that, as you said, to being more of an exercise of using a trusted source that has packaged evidence in particular ways. Clinical practice guidelines are probably the very best example. I think that's what you're talking about.

Dr. Guyatt:  That's exactly right. Clinicians still have to be able to understand the output of those.

Dr. Meuser:  In our day, there might be two or three different packages of evidence around a particular topic. Sometimes, in fact, quite often, coming to different conclusions or providing different recommendations for what the right next thing to do with patients would be. Which means that the evidence is not neutral.

It's malleable. It's manipulable. Is that a good thing by and large, would you say so?

Dr. Guyatt:  Great point. Clinicians, they do need to be able to identify a trustworthy guideline. There are some guidelines that are trustworthy and some that are less trustworthy. Guidelines based on well done systematic reviews are much more trustworthy than those that are not so based.

The clinicians, they need to be able to look at the outputs. What we would hope is less the evidence is malleable in that well done systematic reviews would come to more or less similar evidence summaries.

However, the inference is that one makes from that may differ and that goes back again to the underlying values and preferences. For instance, American medical practice is different in many ways from Canadian and definitely Europeans. The Americans put, I would say, a much higher value on small and uncertain benefits from highly costly therapies.

Canadians and Europeans, particularly Canadians, to some extent less, Europeans, in many countries even less so, so that same evidence summary in different environments because of different values and preferences lead to different decisions.

What the clinicians needs to be able to do is identify good evidence summary, understand that evidence summary, and help their patients with value and preference sensitive decision.

What follows is that there are many situations in which with the same evidence the patient presents the same way, but the right decision differs between patients depending on their values and preferences. That mandates shared decision making and shared decision making unequivocally is a challenge.

First of all, the clinician has to be able to present it in a way that the patient will be able to understand. They have to have the time to do this in what is for just about everybody a very time constrained practice. How we can make this as efficient as possible is still a big challenge.

For quite a while, there have been decision needs available, which are essentially information from patients and that can be helpful, but it doesn't really facilitate the shared decision making that we think is crucial or it only facilitates it to a limited extent.

Much more and more now we are experimenting with electronic accounts, or decision made designed to be looked at simultaneous and worked to together and understand together.

We think that that has the potential to revolutionize the process of shared decision making, whether it will or not remains to be seen. We've got a long way to go in terms of making the process of shared decision making efficient enough that it actually becomes a standard part of medical practice for most clinicians.

Dr. Meuser:  You probably have heard, as I have, part or more cynical colleagues make the assertion that evidence based medicine to some extent has been hijacked. Hijacked by commercial interests who have a stake in persuading decision makers that their way of approaching a clinical problem that is in the interests of their product should be followed. Do you think there's anything to that?

Dr. Guyatt:  Absolutely, yes. It is certainly the goal of those who are making money within medicine whether they be for diagnostic procedures or for drugs or for devices. It is the smart people in those areas and there is a lot of them, have recognized that using the language, concepts, and presentations of evidence based medicine is a great way to sell your product.

It's their job to present the evidence in such a way. Often, they somewhat distorted way, but nevertheless done in a way that looks convincing to persuade the practitioners and the patients to use their products. No question that goes on and characterizing it as a hijacking of evidence based medicine is quite appropriate.

The big push back then is encouraging physicians not to follow the guidance from their local pharmaceutical representative, but rather look to unbiased, high quality trustworthy guidelines.

Dr. Meuser:  You've talked a fair bit about engagement of patients in clinical decision making and use of evidence that is aimed simultaneously at the clinician and the patient. Are there any other ways that you see evidence based medicine evolving over the next few years?

Dr. Guyatt:  Conflict of interest is still a problem. The optimal production and dissemination of the evidence summaries in ways that are attractive and compelling to clinicians. The uniform application of well done systematic reviews to provide the information for the guideline.

All of that can be improved, but a lot of organizations are doing pretty well now. What we need to do is just raise the bar for everybody who's producing guidelines so that clinicians, when they go through a guideline, can feel comfortable that it is trustworthy.

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Dr. Meuser:  Gord, you've been really generous and helpful. Thank you again.

Dr. Guyatt:  You're very welcome. It's been a pleasure for me to talk to you.

Christine:  Thank you for listening to this episode of Clinically Speaking. It was produced and edited by Pippi Scott Meuser at the Center for Effective Practice.

Dr. Meuser:  Special thanks to our guests this episode Gord Guyatt for taking time out of his busy schedule to talk with us. If you like what you heard today, we encourage you to share with your friends and colleagues. Your support goes a long way.

Christine:  Don't forget to subscribe on iTunes, our website, or wherever else you get your podcasts.

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Introducing Clinically Speaking

Teaser

Over the next few months, Dr. Jamie Meuser and Christine Papoushek will explore different perspectives on evidence-based medicine (EBM) in primary care - from its origins to what it may look like in the future. Don’t miss an episode, subscribe and join us as we explore some of the most pressing questions and issues in primary care.

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