Understanding Clinical Practice Guidelines, with Jeffrey Meyerhardt, MD, MPH, FASCO, and Scott Tagawa, MD, MS, FACP

ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests’ statements on this podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so data described here may change as research progresses. Brielle Gregory Collins: Hi, everyone. I'm Brielle Gregory Collins, a member of the Cancer.Net content team, and I'll be your host for today's Cancer.Net podcast. Cancer.Net is the patient information website of ASCO, the American Society of Clinical Oncology. Today, we're going to be talking about clinical practice guidelines, including what they are, how they're developed, and how they can impact care for people with cancer. Our guests today are Dr. Jeffrey Meyerhardt and Dr. Scott Tagawa. Dr. Meyerhardt is the Douglas Gray Woodruff Chair in Colorectal Cancer Research, clinical director, and senior physician at the Gastrointestinal Cancer Center at the Dana-Farber Cancer Institute. He is also the Cancer.Net Associate Editor for Gastrointestinal Cancers. Thanks for joining us today, Dr. Meyerhardt. Dr. Meyerhardt: Thanks Brielle. Brielle Gregory Collins: Dr. Tagawa is a professor of medicine and urology and the medical director of the Genitourinary Cancer Research Program at Weill Cornell Medicine. He is also the chair of ASCO's Evidence Based Medicine Committee, which works to create clinical practice guidelines. Thanks for joining us today, Dr. Tagawa. Dr. Tagawa: Thanks for the invitation. Brielle Gregory Collins: Before we begin, we should mention that Dr. Meyerhardt and Dr. Tagawa do not have any relationships to disclose related to this podcast, but you can find their full disclosure statements on Cancer.Net. Now to start, Dr. Tagawa, what are clinical practice guidelines? Dr. Tagawa: So as the name implies, there's clinical practice. So I as a practicing physician, for instance, might have a patient in front of me, and sometimes I want to know, what's the best thing to do? What is the best test that I might want to get? What is the best type of a treatment to use? I think these are especially important as the numbers of different types of cancers continues to grow, as we have more diagnostic tests and number of treatments that we have continues to grow. It's very hard for an average clinician to remember everything that's there. So we have guidelines that will give us information and general guidance for a particular situation, for a general patient population. Those don't necessarily mean that for an individual patient, that's something we have to do. But again, for the average patient in this individual situation, it helps us guide the physician or practice team in what we should do. Brielle Gregory Collins: Got it. Thank you so much for explaining that. And, Dr. Meyerhardt, how can guidelines impact care for people with cancer? Dr. Meyerhardt: Yes. So there's a lot of data that's out there for a lot of different cancers. And so to keep track of that, all of the different pieces of a study, it is helpful for groups of experts to get together and say what's really the right care for patients with this condition and what are the different options for them. And it really helps to really collate those all together and to be able to help clinicians decide what's the right initial step and subsequent steps for the care of a patient. As Dr. Tagawa said, it may not be the exact thing that's right for every patient. And the guidelines really do help with some of those caveats, like if the patient has certain liver function or if the patient has a certain molecular marker or something about their tumor that makes their cancer a little different, what would be the way to treat that as well? So guidelines really do help clinicians guide what's the right care for a patient at different steps along their cancer course. Brielle Gregory Collins: Okay, thank you. And Dr. Tagawa, I want to talk a little bit about how guidelines are created. So can you describe the overall guideline development process? Dr. Tagawa: Sure, there's a number of steps. So 1 step is identifying which guidelines are needed. So when there is a need. For instance, when there is more than 1 type of a treatment available and some data, then we generally consider that 1 of the most important types of topics to cover. When there 100% agreement with everyone in the world that 1 thing should always happen, that's less important for guidelines. And when there's zero data, that's also less important for guidelines. Although there are different types of guidelines. There's evidence-based, and you've mentioned the name of the committee that I'm on right now, Evidence-Based Medicine. But there can be consensus. So getting a group of different stakeholders, meaning physicians, nurses, etc., plus patients, together to come up with a consensus or expert opinion. So those do happen. But anyway, we identify a need, then we generally-- at least this is the way that we work it with ASCO, we get a panel together. At the very beginning of your statement, you mentioned conflicts. So we'll put together a panel of people with some sort of expertise, like maybe some scientific expertise or experience in treating, but also those that don't have at least too many conflicts on a research basis or financially, we will do a wide search to gather the best level of evidence, collect the evidence, and analyze the evidence into different levels. Some types of clinical trials, for instance, are more important than others. We will synthesize that, put it all together, and then we'll come up with guidelines. Actually, 1 thing I forgot to mention in the beginning is we'll come up with specific questions. So for lung cancer of a certain type that's never been treated, what are the top questions? So that will guide the search. And then coming back, once we have all that evidence collected and synthesized and put in order, we'll then answer those questions. So 1 type of lung cancer that has a specific type of tumor genetic mutation in that setting, then we'd say treatment A is the best option, with B and C as options, for example. And that will be synthesized into a guideline and then put out to the public. Actually, there is a review process-- sorry, a public review process that anyone, at least ASCO does, that anyone in the world can have input on. And then, when we talk about peer-reviewed literature for a journal, for instance, we send it out to independent people. There are people that will review this, comment upon, that will come in, and we will revise things. And then the different guidelines hopefully are going to be approved and then published in journal formats, in internet formats, podcast format, etc., to hopefully get the message out. Brielle Gregory Collins: Okay, thank you. I want to clarify the recommendations that are within guidelines. So basically, these panelists get together and they review the necessary evidence to make the recommendations. Is that correct? Dr. Tagawa: Correct. And there are different levels of evidence and different levels or strengths of recommendations. So when there's a lot of high-quality evidence, and it all points in the same direction, that is going to be a very strong recommendation with a high level of evidence. And then there's intermediate, and then there's less evidence or extrapolated evidence, in which case, there still might be a recommendation because some of the time, let's say, for instance, in a rare tumor type or a common  tumor type that has a manifestation, say the cancer that spread to the brain, called brain metastasis, that hasn't been studied before, but we want to know what to do if we get into that situation. So sometimes there are statements that will say in this situation with the best available evidence, our panel recommends this. Brielle Gregory Collins: Okay. That makes sense. And Dr. Meyerhardt, I want to talk a little bit about the role of clinical trials in guideline development. So can you talk a little bit about that role that clinical trials play in the development process? Dr. Meyerhardt: Yeah, I think particularly for treatment for patients, a clinical trial is really critical. So a clinical trial is basically asking a question about a treatment. Sometimes it may be that everyone gets the exact same treatment. Sometimes it's just trying to find initially a dose of a treatment. And then ultimately trials often will be randomized to either something that's standard treatment or comparing 2 different treatments to see which has more efficacy and safety and considering quality of life and other factors that are important in the treatment of patients. And as Dr. Tagawa said, the level of evidence is important in considering guidelines. And so when a guideline is being created, we do look at trials that are particularly randomized trials, trials that have larger populations, trials that may have a more diverse population, so we can understand how certain treatments may be different based on various demographic factors of the participants in that trial. And they really are critical because you could do a trial of 10 or 20 patients, which occasionally is enough to enter a trial depending on the condition. But for the most part, there could be some just randomness to the results where it's not as clear that it’s as effective as we hoped if we did it in a much larger population. So really understanding how the trial was conducted, and for the most part, clinical trials will be presented in a meeting and eventually published in the literature where there are experts in that field who would then review the manuscript, the paper related to it, and really can kind of dissect how was the trial done and the importance of the trial and critically make sure that the results that are out there that are then used by guidelines really do reflect, hopefully, what the drug is doing for patients and how they're tolerating it and other factors. Brielle Gregory Collins: Okay, so let's say a guideline publishes, and then new research comes out. What happens at that point? Dr. Meyerhardt: Yeah. And there's different guidelines that are used by clinicians. So ASCO, the American Society of Clinical Oncology, puts out guidelines that are a very comprehensive review of the literature and provide all that sort of data from the literature that was reviewed. There are other groups that put out guidelines more in a little bit of a table format. And how new research gets fit in is different depending on the organization. So, for example, with ASCO, there's occasionally situations where there's already a guideline that something will change and they have different mechanisms. They have the provisional clinical opinion mechanism. So a way to sort of quickly put out something that really will change the standard and really needs to be considered as a change. There are trials ongoing constantly. And if there are things that really should be considered for patients sooner than some set time period, there's ways to help incorporate those results, and how do we think about using it for our patients? Brielle Gregory Collins: And Dr. Tagawa, what changes or advances do you see developing in clinical practice guidelines? Dr. Tagawa: I think that we want to retain the type of guideline that is evidence-based and will in a way, every time a change is going to be made, still start from scratch and make sure nothing is missed and be comprehensive. But at the same time, being nimble and be able to make changes, sometimes in real-time. Fortunately for physicians that treat cancer as well as our patients and their families, we're making new advances all the time. So hopefully we can match those with the evidence and produce guidelines. But then also on the user end, I'll call the user the average oncologist who may just want to make sure they're doing the right thing or sometimes is not sure what to do, to have it in a format that's very easy, sitting in the clinic about to see a patient or seeing the patients saying, "What should I do?" To have that readily available, for instance, at form. And then even better for some of us that spend a lot—I think some of you might go to your doctor and he or she is typing on a computer. We're trying to keep up. If the guidelines are melted into what's called an electronic medical record, we just put in the diagnosis and the stage and what the patient has received before. That might pop up to, number 1, help the doctor in that situation, but also help prove that that doctor is providing what's called evidence-based medicine. So maintain the evidence base, but have it as user-friendly as possible is at least one of the goals over the next several years, hopefully. Brielle Gregory Collins: Very nice. Thank you both so much for your time and for sharing your expertise today, Dr. Meyerhardt and Dr. Tagawa. Dr. Tagawa: It’s a pleasure. Dr. Meyerhardt: Thank you so much. Brielle Gregory Collins: And if you're interested in learning more about ASCO guidelines, Cancer.Net is a great place to go to find patient-friendly summaries of those guidelines. ASCO: If this podcast was useful, please take a minute to subscribe, rate, and review the show wherever you listen to podcasts. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds lifesaving research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at CONQUER.ORG/Donate.