It’s a nationwide effort to enroll one million people in a first of its kind research program. Mylanda Massart, MD, PhD, Co-investigator, All of Us Pennsylvania explains what the program is about and why she hopes you’ll get involved.
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– This podcast is for informational and educational purposes only. It is not medical care or advice. Clinicians should rely on their own medical judgments when advising their patients. Patients in need of medical care should consult their personal care provider.
– Maybe you’ve received a flyer in the mail or have seen an ad on TV. So, what is the All of Us Research Program all about, and why should you care? Hi, I’m Tonia Caruso. Welcome to this UPMC HealthBeat Podcast. And joining us right now is Dr. Mylynda Massart. She is one of the co-investigators for All of Us Pennsylvania. Thank you so much for joining us.
– Thank you for having me.
– OK, so this is part of a larger initiative from the National Institutes of Health. What is this all about?
– As you might know, in 2022, we have come so far in understanding medicine, but yet there is still so much more we do not yet understand. I think every single one of us can think about one of our own health conditions or a health condition that has affected one of our family members where science and medicine still hasn’t come up with a great answer, a solution, or a treatment. So, the National Institute of Health launched this massive research project to recruit 1 million of the most diverse individuals across our country to amass a research data set that can be studied decades going forward to try to finally understand and solve some of these ongoing, really critical medical questions.
– So, recruiting a million people, that’s a lofty goal. So, then, each state is taking part. And tell me about the efforts underway here.
– Yeah, so almost every state is taking part. In order to reach a million people and to reach the most diverse research set that we’ve ever had historically in our country, we really need a massive and grassroots effort. So, there are numerous academic institutions across the country that are participating, as well as even more community-based organizations that are out there, really boots on the ground, interacting with our patient populations, both well and sick, to try to recruit them to participate in this study.
– And we talk about diversity. Why is that important? Where are the gaps in research?
– As you may know, and I think many of us are aware, that historically, research has not been done on a very diverse patient population. And we have really prided ourself on practicing what we call evidence-based medicine, where we take the best evidence from the research that’s been done and then bring it back to the bedside to take care of our patients. However, when the data set hasn’t been done on a very diverse population, then that actual evidence-based medicine only applies to a very small subset of patients. And as a family medicine physician, I want that evidence to apply to every patient sitting in front of me.
– In theory, this sounds like a great idea. Of course, we should all get involved. We should help mankind. This could save our own family members. Then there’s this whole other side of, “Is this time-consuming? What’s involved? What are they doing with my information?” So give folks a sense of how they sign up, but, then, what happens and what they have to go through?
– Yeah. Actually, enrolling is very, very easy. It can be done virtually online. It can be done through the telephone. Whichever is easiest for each unique individual. And once someone expresses interest in joining, there are some online consent videos, which can be, again, watched from home on any of your own devices or could be watched in one of our enrollment centers, if that’s easier. After those consent videos are completed, there’s that initial signing up for the study and giving consent. There’s some very basic blood sample, urine sample collections, body measurement, like height and blood pressure, that are obtained. And then, really after that, everything is much more passive. There are some periodic surveys that go out to collect information about your life, your family, your history, your exposures, because it turns out all of these contribute to our overall health and wellness and development of disease. And then we also are consenting to allow our de-identified electronic health records from our medical facility to be sent periodically over time to the research database. And, again, I said de-identified, because that information is not connected to our names, or ages, or our addresses, and researchers who will be able to access this information for decades to come will not know which individuals this information came from. However, that longitudinal data that’s being shared over time is critically important, because if you think of your own health, your health is not the same as it was five years ago, or maybe even three years ago. It’s constantly evolving. And, so, we really need to look at that big picture over time to be able to put all the pieces together and understand how our genetics, our environment, our exposures, our histories, our traumas, all add up to our unique health.
– In theory, you would obviously want someone to take part in every step of it. Is there room for, you know, if someone joins and they take part in that first step, and then, you know, the surveys are coming, “Eh, that’s a lot of work. I don’t want to do it.” Or, are there certain questions people can refuse to answer? Talk about that process and what you want people to know.
– Absolutely. As part of informed consent for any research study, there is always an option to remove yourself from the research study if you change your mind at some later time. There’s also the ability to participate on various levels. As you said, we would love for everyone to be a full participant, but we know life is busy. Things are unpredictable. You might miss a survey or two, but even that initial enrollment and that passive, de-identified health record data is a massive contribution to science.
– You’re saying, you know, the initial urine test, blood test. Someone’s watching this, someone’s listening to this. Where do I have to go to make that happen? Are you out in different communities?
– Yeah, we are out in many, many different areas around the Pittsburgh metropolitan area, but then in western Pennsylvania, our rural population is just as important in terms of diversity and including and representing our rural population in the data set. So we do have sites that are in Altoona, we have sites that are in Erie, and then we have what are called pop-up sites, where sometimes we will send out a bunch of postcards to a region and then hold one or two events where we bring our team there. So, teams don’t have to travel into Pittsburgh and into Oakland to join the study. We’ve also added a newer form of the study, where we are actually able to send collection kits directly out to participants’ homes. DNA can be captured through a blood drop, but it can also be captured through saliva, through a mouth swab as well.
– How many people are you looking to recruit throughout Pennsylvania? And where are we in that point?
– So far, locally, we have recruited over 32,000 western Pennsylvanians, which is tremendously exciting. As you can imagine, the pandemic created a large difficulty. Everyone did have to shut down for some time, but we are back up and fully running and operationally. In western Pennsylvania, we would like to recruit around 100,000 participants. Nationally, I mentioned earlier, we are aiming for a goal of a million participants. So, you can imagine, if we succeed and get 100,000 western Pennsylvanians, we and our health is going to be very well-represented in that data set.
– And so how does it work? Do you wait until a million people are involved before this research begins, or is this being used immediately?
– It’s actually being used immediately. It’s a really great question. I think there was always the intent to start research projects, initially, as we were already achieving those initial early registrations. But then, again, in our constantly evolving world, an opportunity came up during the pandemic, immediately, where we were able to ask a research question that said, “When was the first cases of COVID traveling around the United States?” We knew about the first major outbreak in the nursing home in Seattle. Subsequently, later, we heard about a case in February, retroactively, in California. Well, it turned out we were collecting biosamples all over the country in late 2019 and early 2020. So the researchers formulated a study, went back and looked, and sure enough, they found nine different positive COVID samples that had been collected between the very last week of December 2019 and the first week of January 2020. So because of All of Us, we actually know COVID was already circulating in the U.S. at that timeframe.
– That’s a really good example as to how this can be used and the advantage of this massive database to go back and check. Are there low-hanging fruits of other diseases or illnesses? What are some of the, in your opinion, some of the simplest things that research projects could then be built around?
– It’s so vast and so complex that it’s hard to select any one particular low-hanging fruit kind of a concept. But I know there are already many, many studies that are in progress, several publications that have already been released over this last year, looking at some of the initial electronic health record data, really focusing in on social determinants of health, really moving away from looking at biological differences among human beings, but really looking about the impact of our environments: our access to food, nutrition, exercise, activity, and how that’s impacting our health. But I think there are so many questions. In fact, I feel like everyone I speak to, there is easily a handful of questions that need to be addressed. I myself practiced obstetrics for many, many years as a family medicine physician. And I just think about, you know, preterm labor and preeclampsia. We still don’t have all of the answers for why that’s happening. What about cancer? Cancer’s so vast, and while we have made huge advances, how much further could we go with all this information? All of the neurodegenerative disorders like Parkinson’s disease, multiple sclerosis, dementia, impacting so much of our society: How much better could we understand and come up with treatments and therapies, or even possible ways to prevent them from happening? So, I just think it’s endless, the number of questions that still exist in 2022. And I truly believe that this data is going to contribute to solving some of these questions for decades now to come.
– And you touched on some of the safety protocols in place. Because everybody thinks HIPAA, and we’re always concerned about HIPAA, and then the other side of the coin is, “Oh, I’m going to hand over all of my medical information to these folks.”
– What do you want to say to that? Does every piece of your medical information have to be handed over? What does that look like?
– So it is not selective. It is consenting to share all of that data. The data, and security, and privacy that goes with the informed consent for research, actually it has a higher level than HIPAA of safety and protection. They are constantly thinking about new ways to protect data and to make it secure. I also say to everyone, there’s never a chance that anyone can guarantee 100% that there won’t be a breach of data safety and security. And really, I think we’re entering into an era where instead of thinking about, “Can someone access my data?” we’re really trying to develop techniques so that if someone ever accessed my data, how can we make sure it can never be used against me in a negative way? And one example I give is the social security number. Twenty years ago, we were terrified of someone getting access to our social security number. And now I think my 17-year-old could probably google anyone’s social security number in five minutes or less, but we’ve put so many more precautions in place that that data now becomes useless. And so, it’s the same thing with genetic information and health and privacy information. We need to constantly legislate and make higher and stronger protections so that that information, if God forbid it was ever accessed, could not be used against us.
– We talked in the beginning about the need for diversity. For women, for people of color in particular, how important is this that they are taking part in this program?
– It is absolutely critically important. We have learned that major fundamental errors have occurred when we have not had gender, gender diversity, gender identity, ancestry diversity, ethnicity identity, included in our research. When we do not have that diversity, we have the ability to make huge mistakes. And one of my favorite stories that I love to teach to the medical students is the Ambien story. And if you might remember when Ambien first came out, all these crazy stories came out about women who were sleep driving, you know, driving through a Taco Bell in the middle of the night while they were half-asleep, sleep eating, having a very hard time waking up. When they went back, they looked at the data, and the initial data had not been done on an adequate number of women. And it turns out that women metabolize that medication much more slowly than men. And so the medication was accumulating to a higher level and disappearing at a slower rate, and it had a major severe consequence. And, in fact, the FDA had to come out and change the dosing guidelines and cut them in half. That is a perfect example of what happens if we do not make sure that research data represents everyone. We will miss something. We will make a mistake. It is critically important that we make sure that all data that we are using to advance health and research be as inclusive as possible.
– And tell me how you became the co-investigator, your background, and how you’re involved in this.
– So I’m a board-certified family medicine physician and previously had done my PhD in molecular biology. And so I built my career integrating genetics and genomics into primary care, which really is the basis for precision medicine. So as precision medicine evolved, this became the perfect opportunity for me to become involved both as a leader and co-investigator on the research project. But as an educator, a communicator, I have a tremendous opportunity to get to go out into the community and engage and discuss the research opportunities, address concerns one-on-one with individuals and patients. It has really been a highlight of the last several years of my work.
– And do you believe, ultimately, this research program will lead to precision medicine?
– I believe so much in this program that I am actually participant No. 8 out of a million. And I do think that this is going to really lead to answering questions that have remained unanswered. It is so hard as a clinician in 2022 to tell patients that I’m sorry that we still don’t understand why you have this health condition, and we still don’t have a great treatment for it. I want that to be different. And I think this is the research that’s going to make that change.
– Let’s remind folks before we close how they can get involved again.
– Yes. So, they can get involved by going to our website, which is JoinAllofUsPA.org, or calling the number that’s on the website. And I think we’ll put those up on the podcast.
– Well, we thank you so much for coming in and spending some time with us today. Some really interesting information. We appreciate your time.
– Thank you so much for having me.
– I’m Tonia Caruso. This is UPMC HealthBeat.
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