Helen Osborne: Welcome to Health Literacy Out Loud. I’m Helen Osborne, President of Health Literacy Consulting, founder of Health Literacy Month and author of the book Health Literacy from A to Z: Practical Ways to Communicate Your Health Message. I also produce and host this podcast series, Health Literacy Out Loud.
Today, I’m talking with Sylvia Baedorf Kassis, whose work focuses on many aspects of clinical research. This includes understanding the experience of research participants and incorporating their insights into study processes.
Among her many accomplishments, Sylvia and her team created a health literacy website especially for clinical research stakeholders. This is part of a larger initiative from the Multi-Regional Clinical Trials, or MRCT, Center of Brigham and Women’s Hospital and Harvard.
Sylvia Baedorf Kassis: Thanks so much, Helen. It’s great to be on.
Helen Osborne: Clinical research studies and health literacy. Boy, that seems like a tough combination. For all our listeners who probably are more clinicians than researchers, can you just put this into context for us and make clear what you mean by clinical research studies?
Sylvia Baedorf Kassis: It’s a great question, Helen. I think we don’t often think about the fact that clinical research is a huge part of clinical care in medical treatments.
Research is how we find new treatments and learn about how well they work. Making sure that research is understandable and accessible to as many people as possible, I think, is what makes the eventual results that much more meaningful.
We want our study populations to reflect the populations that are most likely to benefit from the results. That’s why clear communication is so important.
Helen Osborne: You talk about the research. I come from a clinical background, so I didn’t see what people went off and did when they did their research, or I’d read their studies and it didn’t get to me for quite a while.
You also talked about study participants. I would be thinking in terms of patients or the public. We use different terms. Can you just tell us a quick overview of who’s involved in this and at what level? You talked about stakeholders. Make it clear for us.
Sylvia Baedorf Kassis: Sure. There are a lot of different stakeholders in the clinical research environment, if you will.
Of course, I’ll start with the public and I’ll start with thinking about the fact that people who are research participants are members of the public. They can be patients, or they can be healthy volunteers. There are a lot of different folks who could be research participants.
Then in terms of the clinical research stakeholders that we’re talking about, there are a lot of different people in those clinical ecosystems that are responsible for communicating with participants and the public, or creating materials for them even if they’re not doing direct communications with patients and participants on the ground.
That’s sponsors and life sciences companies who are maybe creating materials, or institutional review boards, the ethics boards that review research, and also investigators and study teams. There are a lot of people along the way that can help improve clinical research communications.
Helen Osborne: When you talk about communication, is it the one-to-one, like, “Would you like to be in our study?” or is a handout, like, “Here is our study. We’re looking for volunteers,” or is it the informed consent form or something else? What’s involved in that scope of communication about clinical studies?
Sylvia Baedorf Kassis: It’s great. It’s all of the above and more. We’re talking about the point at which people discover research as a concept to begin with. Maybe you’re talking about outreach into the community about what kinds of research studies have already been going on in their community and how they’ve been benefiting from those findings.
That’s one place. But you also then have recruitment materials and activities, which can be direct communication, “Would you like to be in my study?” but also pamphlets and fliers.
Then, of course, informed consent is that quintessential clear communication opportunity. There’s the document and then, for many studies, the actual interaction where you’re talking with folks about the study and letting them know all the info they need to know so they can make an informed choice about whether to continue.
Then what some folks forget is that there’s all this time after when the participants are in the study that you can still have these great moments of education and clear communication to help reinforce their participation and their continued activities on the study.
Also, thank them at the end. Give them results and let them know what the study found so they have a sense of ownership and also are thanked for their contributions to the research.
Helen Osborne: You made that really clear. I appreciate it. All the way from putting into context what a study is to “Here’s what we found, and thank you. You helped us come up with this.”
Sylvia Baedorf Kassis: Exactly.
Helen Osborne: No matter what they came up with. Sometimes it proves a point. Sometimes a study says, “That drug shouldn’t be used,” or something.
Is it all about drugs/medications?
Sylvia Baedorf Kassis: No, it’s not necessary all about drugs. A lot of clinical trials that come out of life sciences companies are looking at drugs and different treatments or devices to see whether they work for a certain condition. But there are a lot of types of research.
You can have sociobehavioral studies. You can have observational studies, so you’ll have questionnaires, or maybe you’ll test a yoga intervention. There are different ways to do research and to test different outcomes. We definitely are thinking about all the different types of studies, not just a drug trial.
Helen Osborne: Thank you. It’s a huge entity all unto its own. I know I’m the recipient of reading papers here and there. I really don’t know all that happens. It seems like you’ve got a big job communicating the scope of this and your own language and protocols to everybody.
We have a sense of the enormity of that and the challenge that you face. Health literacy, that’s my world. Probably a lot of my listeners are familiar with this, but talk about how health literacy really matters in clinical research.
Sylvia Baedorf Kassis: Clinical research, as we just saw, is complicated, even just from who’s involved and the responsibilities they have to communicate.
But clinical research also includes a lot of technical terms. It includes a lot of concepts that might be new to folks, maybe like “randomization,” “blinding” or things like that, maybe even “placebos.”
When you have these kinds of complex topics, and then you are introducing them at potentially stressful times in someone’s life, like they’re maybe considering a new diagnosis and then thinking about what their options are for clinical trials to maybe test a treatment, that’s a hard time to be introducing new, complicated concepts.
Health literacy really matters because we can be better setting up our professional clinical research community to communicate these hard concepts and make them clear to our potential participants so they can feel empowered to make the right choice for them.
Helen Osborne: Thanks. I’m curious. I want to hear one of your examples in a minute, because you raise such interesting words, like “randomization” and “placebos.”
Also, to me, it seems like you have a few audiences there. If you’re trying to make the case for health literacy and why this matters, you’ve got the communication you do with the public, volunteers or participants.
You also have to communicate why health literacy matters to researchers who may not live this day-to-day because chances are they are very well educated and very much caught up into their whole world of research protocols.
Is this hard to make a case for health literacy in clinical research?
Sylvia Baedorf Kassis: It’s a good question because it’s hard when it’s introduced as though it’s a new concept. It’s like, “Don’t make me have to figure out some new thing to integrate into my already busy schedule.”
But when we reframe health literacy as something like, “Clear communications benefit everyone,” there’s never been someone I’ve heard that says, “Oh, man, I wish that information was more complicated. I wish someone gave me something harder to understand.”
I think when we reframe it as an opportunity to make something more clear to teach, to have a moment to explain something in a way that people can really feel excited about, then that’s a shared connection.
I try to reframe it as an opportunity to make that research more accessible and understandable to a wider number of people. Most people like talking about the things that they’re working on and the stuff that they’re doing. So this is kind of a way for a wider audience to get excited about the work.
Plus, researchers should be excited about doing this as well because it will hopefully help them recruit more participants, keep those participants in the study and have that really important continuity throughout the trial with their participant population.
Helen Osborne: Thanks. You make a very compelling case for both clinical research studies and for health literacy and putting it all together.
Let’s reframe it a little bit for our listeners of Health Literacy Out Loud. As I said, my background is clinical. Probably a lot of our listeners are, too. Some are those learning the profession. Some are public health, librarians, teachers, community members and anyone who is interested in communicating clearly about all aspects of health.
What lessons have you learned by doing all of this that we can all apply, regardless of our settings?
I guess this is a good time to also let folks know, and we’ll have it on your Health Literacy Out Loud web page, that you have a lot of resources for everybody to access for free about health literacy and clinical research, correct?
Sylvia Baedorf Kassis: That’s right. We do have a website. It’s www.MRCTCenter.org/health-literacy. It is a great resource. It has a lot of different information for clinical research stakeholders, and it really walks people through all the different points at which clear communications are an opportunity in the clinical research pipeline.
Helen Osborne: Thanks. That’s a long URL, but we’ll get over it.
Tell us some tips and strategies we can all use, Maybe I can get this started. I noted some of the terms you talked about. I would be very curious how you explain a new concept and a multi-syllabic mouthful like “randomization” to someone who has never heard the term and may or may not want to participate in the study.
Sylvia Baedorf Kassis: I think the main thing that we try to emphasize is that it’s a communication process. As much as possible, when you’re explaining a complicated term, using something like teach-back, you give the definition and you ask the person what they think that means or some open-ended question that gets you a sense of whether or not they understand. There’s a bit of a dialog, a back-and-forth. That’s often the best way to explain a complicated term.
Of course, we want to try to use plain language, use glossaries that are out there. In fact, one that our center is working on and piloting right now is a plain-language glossary of some clinical research terms.
Without that, the main thing to be thinking about is asking people what they know about this concept and what questions they might have and having a bit of a back-and-forth to really get that information clearly to them.
Helen Osborne: Thank you.
When you’re using “randomization” in your materials or conversations, you explain what this is. I don’t know exactly what words you would use. I’m guessing. But would you then keep using the term “randomization,” or would you say it in plain language from then on and not use that technical term?
Sylvia Baedorf Kassis: That’s a great question. I think it depends on the outcome of your back-and-forth with your audience member, your potential participant.
For some folks, you might come up with something that sounds a little more colloquial, or maybe you’ll call it “random assignment,” which is, again, not super simplified.
It’s a hard concept to grasp, so I think if you’re able to at least ensure that they understood what that term was to begin with, you can probably continue to use it and just test back again, “Just to be sure you still understand what this means or you know what this will mean for you when you go through the study, how do you think you’ll be assigned to a study arm?” You can test it that way.
Helen Osborne: You make it more personal, more focused on that person. “How do you think you may be assigned to it?”
You also raised a term there. You said you don’t want to make it super simple. Is there a range of when you may not use the most simple terms?
I don’t know how you explain “randomization.” I’m guessing it might be, “You can be either in Study A or Study B. We don’t know who’s in which one.” I’m guessing. How do you do it? How do you explain it?
Sylvia Baedorf Kassis: You’re really pushing me to find the definition of “randomization” for you.
Helen Osborne: I am.
Sylvia Baedorf Kassis: I love that. In my own colloquial way, I think about randomization as a way that people, study participants, would be put into one study treatment group or another.
It’s by chance. It’s not decided by the investigator. There’s no one who says, “You go into this arm, and you go into that one.” It is a random chance. It’s kind of like pulling a name out of a hat or some method like that.
We’re just careful about some of these kinds of examples because we don’t want participants to feel like the experience of being in a trial is also just a fluke, chance experience. We want to respect and honor that it’s a big decision to be in a study, so that’s why I was hedging a little bit on how we explain randomization.
We don’t want people to feel like their care is by chance or the way that the researcher will treat them well is lucky. We want them to feel like they can make a decision on whether or not being in a study where they won’t know exactly what treatment arm they might be in is something that they’re comfortable with.
Helen Osborne: Sylvia, thank you for putting up with my question and pushing you a little bit. The reason I was doing this was, yes, I was curious. But all of us communicating health information are faced with dilemmas about that. How simple do we want to explain something?
You eventually got to the words “random” and “chance.” Then you used a metaphor “like pulling a name out of a hat.” But you had caveats in there, too. You didn’t want it to go too simple. But you have such good respect for health literacy, you didn’t want it to be the hardest way possible.
I think all of us communicating health information struggle with that good balance in between.
We only have a few more moments here. What other tips and strategies would you recommend for all of us? We’re faced with the same universal challenges even though our topics may differ.
Sylvia Baedorf Kassis: I think one thing I love to emphasize in the work of health literacy, and this applies I think to anyone, is the idea of usability testing, of getting folks who are like your intended audience to take a look at the materials to get their feedback on them and see whether or not those materials are serving the purpose you want them to serve.
We actually have an example of that. We have a case study library on our website. There was one study team that actually was having a hard time with their follow-up data collection, and so they got input from people who are like their intended audience, some patient caregiver groups, about whether the research information was clear to them.
They had these follow-up letters reviewed by this group, and they actually noticed an improvement in their follow-up data collection because the letter changed from something really formal and dense to something a little bit simpler, a little bit better design to it and just a bit more of a comfortable tone, a little bit more of a friendlier tone.
I think one other thing I want to really highlight is that effective communication is all about relationships and it’s all about establishing yourself as someone whose information can be trusted.
I think that when we make an effort to improve our research material, we build the trustworthiness of the research enterprise and it really improves equity and accessibility.
Helen Osborne: That’s neat. As you’re explaining it, I’m hearing that not only were you using metaphors, plain language and teach-back, but you’re also including stories, the human part and, of course, the most important part of all, finding out how people really understand, use and make sense of this information.
Sylvia, I thank you for putting this together for us about clinical studies and health literacy, for telling us about your URL, and I will ask you to say that one more time because I can’t remember it all, but I have it bookmarked on my computer. For really making a compelling case about why this matters and, to top if off, for sharing it with us on Health Literacy Out Loud.
One more time, what’s the URL for your website?
Sylvia Baedorf Kassis: It’s www.MRCTCenter.org/health-literacy.
Helen Osborne: Thank you so much, Sylvia, for all of it and for being a guest on Health Literacy Out Loud.
Sylvia Baedorf Kassis: Thanks so much for having me on.
Helen Osborne: As we just heard from Sylvia Baedorf Kassis, it’s important to consider health literacy in all aspects of health messaging. That includes clinical research studies. But communicating clearly, simply and in ways people can understand is really hard to do.
For help clearly communicating your health message, take a look at my book Health Literacy from A to Z. You might be especially interested in Chapter 8 that looks at decision aids and shared decision-making.
Health Literacy Out Loud podcasts come out every few weeks. You can get all the episodes automatically, for free, by subscribing at www.HealthLiteracyOutLoud.com. You can also find us on iTunes, Google Play, Spotify, iHeartRadio, RadioPublic, Stitcher and probably many other places you can find podcasts.
Please help spread the word about health literacy and Health Literacy Out Loud. Together, let’s let the whole world know why this matters.
Until next time, I’m Helen Osborne.