The Importance of Research in Healthcare

Podcast Transcript

Announcer:

Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute. These podcasts will help you learn more about your heart, thoracic and vascular systems, ways to stay healthy and information about diseases and treatment options. Enjoy!

Natalie Salvatore, RN:

Hello, my name is Natalie Salvatore. I'm a Registered Nurse at the Cleveland Clinic in the Heart, Vascular, and Thoracic Institute.

Eileen Hsich, MD:

Hi, I'm Dr. Eileen Hsich. I'm the Medical Director of Heart Transplant at the Cleveland Clinic and a researcher.

Natalie Salvatore, RN:

So, Dr. Hsich, I wanted to talk to you a little bit about research in general and specifically into heart failure. So why is research important to healthcare providers, our patients, and the system overall? What is the benefit of it?

Eileen Hsich, MD:

That's an important question. Research is really how we improve our healthcare. Without research, it's just your guess, my guess. And so, in order to actually know who's right, because you and I could have different opinions, we need to do research to figure out what is the right strategy to improve someone's outcome. And that outcome could be how to live longer, that outcome could be how to have fewer symptoms, or the outcome could actually be just testing, how do we correctly test for a disease? So, there's a lot of different types of research, but it is really important to do research to improve our healthcare for the future.

Natalie Salvatore, RN:

I think that's a great point using, and some of our patients may have heard this, we call it evidence based. So, looking at some of that research, looking at things that we've observed, and really finding out what treatments or medications or correlations there are between our patients and their symptoms or disease. Now you mentioned that there again, we're different types, so when I hear the word research or clinical trial, my mind immediately jumps to medication. Is there anything else that you can elaborate on for our patients that not everything is necessarily a drug trial or treatment?

Eileen Hsich, MD:

Yeah. I think that's super important. I remember I was first approached for research when I was pregnant, and because I was older having children, they wanted to determine if I had genetic abnormalities. And so, they had a new test, so rather than doing an invasive test to look for genetic abnormalities, they instead just wanted to do an ultrasound of my belly, the way they were doing ultrasounds before, but this time looking for certain features in the fetus to determine whether there was the presence of a genetic abnormality as the baby was developing. And there was really no risk to me in doing that. I was not getting feedback on what they were learning, so I want to be very clear. Yet, what I understood was that it was going to benefit the future, because we could go from a test that could be invasive that has some risk of losing the fetus or harming, even though it was a small risk, it was still there, to a test that could potentially just be rubbing gel on the skin with an ultrasound probe and getting the same information.

Later I benefited actually when they found out that that was a safe way to determine that genetic abnormality. And so, when I had my second child, this was now standard of care, and that could not have been done if they had not gathered the information and really kind of followed their participants the entire course of their pregnancy and determined the outcome of the pregnancy. So, they wanted to ensure that the things that they were collecting were actually associated with whether the child was healthy or not healthy, or whether they had genetic diseases or no diseases. So that's an example that was personal.

Natalie Salvatore, RN:

Thank you for sharing that. Now, part of these research studies is looking at the patients before us, right? So, we want to get an idea of how we need to treat the patient we have today. Has that always been the case? How have the inclusion or exclusion criteria evolved over the last several decades?

Eileen Hsich, MD:

Yeah. I think that's really incredibly important, because I think that when patients take medications and are recommended certain treatment plans, the assumption is that these treatment plans have been tested on patients that look like them, right? We're hoping it's someone included in this study that looks like me, that is similar to me, but that is not the case for the history of these devices and treatments. I think it's important to recognize that there were even times where they excluded all women in studies that were new drugs and devices when the women were childbearing ages and the new devices needed to be tested for safety. They were worried about harming an unborn child. And even if you weren't pregnant, you wouldn't be allowed in a study. The result of that was really that few women were included in any clinical trials between 1980 and 1990s until more regulation was in place to recognize the fact that women were not represented, and we didn't even know whether women benefited.

I think just an example of just that one little piece right there, we recognized that women were less likely than men to have heart attacks, and that women actually, when they developed menopause, they often took estrogen. So, the assumption was that estrogen must be good. And not that it's bad, but the assumption was that the estrogen tablet must be helpful to prevent heart attacks. And it wasn't until we did a study where we compared patients that took the hormone versus those that didn't, until we did that study, we did not know that there was a potential risk of causing heart attacks with hormone therapy. It's not all drugs. There are certain preparations and certain ages until we actually compared the difference between people who took the therapy and those that did not.

I think it's also important to recognize the fact that there were other patients that were included in studies where we did not have enough regulation and we did not always do the right thing. So, the African American population have even experienced harm early on. And so, therefore, I think it's important to recognize that we have now safety nets to prevent any of these things from ever happening again. So, there are laws, but more importantly, there's regulation to protect the rights of the patient. You have to consent, and that consent means that you have to have a shared discussion and decision-making with your care provider regarding the trial.

But I think it's also just as important that during the trial, your safety is considered at all times. These trials actually now have a requirement to have committees that review at very specified times whether or not treatment or anything we're doing is actually causing benefit or harm. And there are many trials that have stopped, so they will actually halt study and request people to go to better therapy. And they'll do the reverse. If they find harm, they will not continue. So, we have an enormous amount of regulation to prevent repetition of past concerns. And the FDA has a lot of regulation before allowing new devices and drugs to come on the market. There's actually a lot of regulation to guarantee that this is safe, but part of that is the research element for which there has to be participation in clinical trials to ensure that this is actually better for you.

But we need to be included in the clinical trials to make sure that we really benefit. And there are certain groups that are currently frequently excluded. So, we often exclude elderly patients, defined by the FDA as greater than 75 years of age. And so, many studies actually do not include those age groups, so it's important to recognize that. I think that's probably one of the most important.

The other would be those that happen to have kidney disease, there are often cutoffs. If your kidney is not really very good, they will actually exclude you from the trials. Yet so many people do have kidney disease, so how do you know when you're starting a drug whether this really will have the same benefit in you compared to the person without the kidney disease for whom it was tested?

Natalie Salvatore, RN:

I think you brought up a great point about why it is so important that we have a diverse population represented in these trials. It's a mix of everyone and everybody's different, and that's what makes healthcare so amazing is there's no one-size-fits-all. And having a diverse population represented in these trials allows more of that diversity to be represented and really gives our healthcare team a better idea of how a patient might react or respond to that treatment, whether it's, as you mentioned, a device or a drug.

And I think the other key thing that you hit was the shared decision-making. So being involved in a clinical trial or a research study is all about a discussion with your healthcare team and the patient and the patient's family and what that looks like. And I think it's important that our patients recognize they are not alone. If they agree and consent, we talk about informed consent, making sure our patients really understand the ins and outs of what's being looked at, they're not alone. They have so much support going on throughout the process. So, I think that's one of the key points to really drive home is if a patient does consent to being in a research study that their care does not stop. We still are caring for them and making sure that they remain safe with as little risk as possible.

Eileen Hsich, MD:

Absolutely. I think that that's super important. You have a relationship with your care provider. They're the people you trust and they're the people who want to help you. And so, the people who may approach you for the research may be a different group, but it is perfectly acceptable and expected that you have that discussion with your doctor and nurse practitioners and all care providers to make sure that this is really best for you and what your fears are, right? I think it's important to discuss that.

We're also in an era for which we have technology, so not all visits have to always be in person. Clinical trials now are actually including virtual visits, which I know as we get older, those are kind of intimidating, how to get onto the computer. But it's also important to actually say, "Look, I'm scared." Right? "I don't want to die. I don't want to take something new. And what happens if I don't get the treatment?" All those things are very normal to have as a reaction.

I just want to tell you what we've learned. For heart failure, we found out that women are more likely to develop heart failure at older ages than men. There are different risk factors for developing heart failure. So, women are more likely to develop heart failure from high blood pressure, or men are more likely to develop heart failure from heart attacks.

And we've also learned that survival is different. We learned also that when we have an acute event for which we are filling up with fluid, that the testing, a blood test called natriuretic peptides, this blood test has slightly different results in women versus men, even when we tried to figure out the strength of their heart, because we already knew that it was related to strength of heart. But now there's actually also another element, which is that women and men, even with similar heart strength have different levels of this test.

And so, it's important to recognize that all that came from research to figure this out. And as expected, if we don't look the same, if we have different hormones, we're just different, then we're going to have different responses to treatment as well, right? In order for us to better understand these differences so that we know that it's safe and effective, we actually need to participate.

But it's also okay to say no, that in the end, your provider still wants the best outcome for you. And so, saying no doesn't mean that they're going to think differently of you. And that's important, that things are different now than they were before. There's a lot of regulation at many different levels to ensure your safety. And so, it is important to recognize that it is good to be a participant, and it's sometimes good to be the control, where you don't get the therapy, because there's no other way to contrast and figure out whether something is better or worse.

Natalie Salvatore, RN

I think you brought up a great point too, that if your provider does suggest or offer you to participate in a clinical trial, if you say, no, that's totally fine. It's not going to affect your care whether you participate or not. It is totally voluntary, and you shouldn't be afraid or worried to say no. It might not be the right time or something that you have an interest in, and that's totally okay.

Eileen Hsich, MD:

Yeah, absolutely.

Natalie Salvatore, RN:

So, as we wrap up, what would be the one piece of advice you would leave for our patients?

Eileen Hsich, MD:

I think the most important thing I'd like to say is that we all share the same thing. We all want to get better. We all want to have improved quality, longer life, and our care providers want that for us as well. And we all assume that the treatment that we're getting has actually been studied in somebody that looks like us, but the answer to that question is no. If we're afraid to participate, how many others actually did participate?

And I can say that there has been underrepresentation of minorities, there's underrepresentation of elderly patients as well as very young patients, and there's underrepresentation of women in many clinical trials, and there is a history behind that. There are reasons behind this that may at times have been for different reasons, but now moving forward for healthcare to be better, we all need to actually realize that there are safety guards in place to ensure that we are safe.

And at the same time, it is important to recognize that we do need to randomize patients to a treatment or a diagnostic test versus somebody who doesn't get it in order to determine what is best for you and future generations.

Natalie Salvatore, RN:

Thank you so much.

Eileen Hsich, MD:

Thank you.

Announcer:

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