What it takes to produce a good clinical practice guideline

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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.

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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.

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.

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