July 2020 Participant Town Hall

Can you explain the various groups or FHS generations and their names? 

This is a great question that we get a lot and I know it is very confusing. There are six cohorts in Framingham Heart Study. The original cohort was recruited in the late 1940s. They were randomly selected from all residents in Framingham. Approximately 25 years later, great minds decided to recruit the children of the original and they were identified as the Offspring. Which I like to call the second generation because, of course, the third generation are also offspring. In the early 1990s, Framingham was a much more ethnically diverse community than in the 1940’s, so a new cohort was recruited to reflect this diversity. The cohort, known as Omni 1, is made up of African-Americans, Hispanics, Asians and other ethnicities. And then in early 2000 they recruited the Third Generation, which is the children of the Offspring. The fifth and sixth cohorts were recruited simultaneously in 2003. The fifth includes the children and relatives of the Omni 1 cohort, thus they are referred to as Omni 2. The sixth (and last) cohort, named New Offspring Spouses, is small and made up of about 100 spouses that were not enrolled into the Offspring cohort. To be eligible for this cohort, they had to have at least two children in the Third Generation that completed their first exam.

Below is a link to the FHS website that will provide you with much more detail about each cohort, and below that is a summary table that shows the name of each cohort, how participants are in each and what year they were recruited.

https://www.framinghamheartstudy.org/participants/participant-cohorts/

How often does each group meet for appointments and what is the time frame?

This has changed over the years many different times, but currently, our model is to examine each cohort about every six years. The Original cohort is examined on its own. Offspring and Omni 1 are seen together, and the Third Generation, Omni 2 and New Offspring Spouses complete their exams at the same time.

Are there still living members from the original cohort?

Currently there are three alive at as of today.

What are the triggers for reopening in person visits? When will the Heart Study resume operations?

I want to step back a bit and first recount for you the basic principles that go behind our interpretation of the triggers and the timing of the examination .These principles are inviolate and they’ve been there with us for over 70 years your safety and the safety of our staff. Your trust which we hope to earn continuously, giving you a high quality experience while protecting your confidentiality and in the process, generating high quality data. So those are the principles we bide by. What are the triggers, the triggers deal with the science or the epidemiology of the pandemic in the country and in Massachusetts? The national pandemic is like a war, but all pandemics have local footprints, which are the battles, if you wish. So for us, what it means is that the triggers means we study the epidemiology of the virus, specifically in Massachusetts. For this purpose, we turn to national data from the CDC, but also mass.gov data which we scrutinize on a daily basis. And the triggers include what we call as six indicators and this six indicators deal with the healthcare system capabilities and the public health infrastructure in the State of Massachusetts. These include rolling averages measured over a period of days of the positive test rates for the SARS-CoV-2 virus. The number of hospitalizations, the number of deaths. The health system readiness in terms of the ICU beds available and that occupancy, the testing capacity in the state and also contact tracing. So we monitor these to see when Massachusetts is ready and as several of us know Massachusetts it is today in Phase three, we moved from the start, to the cautious, to the vigilance face, and for this purpose we turn towards the readiness of the Framingham Heart Study infrastructure itself to receive you. Just to clarify operations in the Framingham Heart Study that stopped were the in person visits. The Framingham Heart Study staff and investigators have been working during this pandemic through telework when working using a data to produce science. We have been bugging some of you with calls, medical health history updates, some of you with practice sessions for tele-exams, but the readiness to open and receive you, and welcome you back requires three sets of things that need to happen. We need to look at the engineering of the Perini building, the facilities and the equipment, its air conditioning and its readiness. We need to look at our administrative processes. How we manage our communications. How we manage our cleaning and disinfection. How we train our staff to receive all of you back. And then, the third category is what I refer to as the mandatory safety standards, the workplace, social distancing, hygiene protocols, staffing and operations, cleaning and disinfection. The number of approval processes required of us by the Boston University, and these are in process. They deal with the implementation of appropriate signage in the building directionality of the traffic, they include our review by the Environmental Health Services at Boston University to certify that we are ready to open an adaptation of the building. The retrofitting of our air conditioning with UV filters that required a series of steps that we are working through. But, most importantly, we also have to be vigilant about what is going on in Massachusetts, at any point of time. At this point we are thinking through the process and obtaining the requisite proposed approvals. It might take approximately two weeks after we are approved for us to be ready to receive you, by which I mean the research center starts getting active, we make sure all the protocols in are in place, the staff are trained and then we will start the process, slowly. We start with fewer participants, perhaps two per day, with social distancing and then we slowly climb up based on active pursuit of data from Massachusetts, which keeps telling us to go forward or not. We continue to maintain the same pace or do we need to step back at any point of time. So the mantra here, if you will, is to be vigilant to protect all of you and to respect your safety and also your trust.

When will cancelled appointments begin again?

So, the recruiting team will make the appointments that were cancelled a high priority, but of course we will be dictated by the guidelines that Dr. Vasan Ramachandran and Dr. Joanne Murabito dictate for us to serve the wellbeing of the participants, but believe me, we’re most eager to get you all back in. So when we can call we will.

When does the next exam for Gen three start under these conditions?

Let’s talk about what the plans for gen 3 exams were pre pandemic. The terms of our contract, which determines our work schedule, was that gen 3 exam 2 – exam 4 and Omni exam 4 would begin in the fall of 2021. There would be a six month lead up period in the fall of 2021. Usually, we have the preparatory phase that we prepare the protocols, make sure everything is in place and then the examination begins. Now after the pandemic, things have changed and we are still in that gray area we are trying to determine how much they will change. So here are three things that will determine the exact timing of gen 3 exam 4. Approximately I said it’s the fall of 2021, but it will also depend on when the current ongoing gen 2 exam 10 or Omni exam 5, when that finishes. Like explained in the earlier part of the questions that we will scale up, we will schedule to finish the 10th examination of the offspring cohort, and the 5th examination of the Omni 1 sometime late summer, early fall of 2021. It looks like that would be pushed further into the fall of 2021. Again, that would depend upon the status of the pandemic in Massachusetts. If things go well and we manage to scale up, which is what we hope to do, which is what we anticipate, it is conceivable that gen 3 exam 2 might begin in early 2022. So we are hopeful. There’s one more factor besides the status of the pandemic and the completion of the ongoing offspring Omni exam, and that is that we need to have one or more of these studies funded to bring in the generation 3. So during this pandemic, a large number of investigators have been submitting grants that need to be funded. And then the participants come in, and then we have the content of the examination. So because we have worked hard and we are very hopeful that they will be funded. So tentatively, we are looking at early 2022 as the potential start date of gen 3 exam 4, Omni wave 2 exam 4. We hope to keep in touch and communicate with you. You all are very precious like each of our generations. It’s very important for us to make sure that we communicate the timing and tell you when we are ready to welcome you back.

Would like to learn how we intend to go forward?

It’s a broad question. So I will try to answer it in terms of broad principle. What’s our path forward? I think it involves vigilance with review of the metrics as related to messages. It’s enumerated in the answer to the previous question. A lot of it is anticipation, we anticipate based on the data, what’s going to happen in Massachusetts. To give you an example. There are several things, although today it looks like things are under control in Massachusetts, with the arrival of Labor Day, with the arrival of the students in the greater Boston area, with the arrival of the flu season, there’s a lot that we need to be able to anticipate. We need to listen and we need to learn. Listen to the public health experts, the center of the Department of Public Health and the Massachusetts government. Listen to you, which is the purpose of this initial first forum, and then based on those, there is a judgment made as to how do we move forward from our current protocol of starting small with a few exams to ratcheting up to a higher frequency. We also need to communicate. So the steps involve vigilance, anticipation, listening, learning, maintaining agility and flexibility to move up and scale up our examinations or scale down if the pandemic worsens. I believe this virus may be with us for some time, which means that these principles of anticipation, navigation, and communication are going to be cardinal steps in moving forward.

Are there any plans to partner with other medical facilities outside of Massachusetts to conduct the testing for those of us that live out our state?

It’s a great question, and it’s something that we need to think through more about, I think you asked two questions, two parts to your question one is about testing and being outside, Massachusetts.  I can certainly understand thinking about how one could travel safely at this time because states vary so widely Massachusetts and certainly everyone needs to follow the guidelines and within their state and certainly to stay safe. And so what we’ve been doing to allow people to participate in the current exam and be safe, is that we are working on tele visits, which is similar to what we’re doing here in the in this webinar with zoom, but it’s a one on one, where there’s one research center staff member or recruitment staff member and one participant. You can actually see each other in the TV. A recruitment staff member like Maureen reaches out and helps you set up a zoom and then a research center staff member like Emily reaches out to conduct the visit, and we are able to get a lot of really key and important information about your medical history and other important information like physical activity mood and mobility. So that’s one way that allows you to participate in the exam, without having to travel from your state to Massachusetts during this challenging time. There’s also other opportunities because sometimes we do what is called a call back exam. So some of our studies, I noticed someone asking about, for example, neurologic or brain exams. So sometimes our core exam does what we call a call back and when people come in for those other studies, we can do testing that would have been done at the time of our core exam when people come at a later time for that exam. So I think we have several opportunities for people to come in and participate in the exam. I think it’s a really important question and we definitely want everyone to participate and feel safe and doing so. So thank you so much for the question.

With more than seven decades of cutting edge research done using our and our kin’s personal health and heart data, I’ve often wondered, why have you never sought grant funding to offer health and heart health “patient” education learned from our data back to FHS Participants? (One good place for you to begin, would be to develop an FHS Participant portal that provides us free and open access to each and every published study that uses our FHS data.)?

First of all, thank you for raising that issue. I think it’s a great idea. It’s something that we have not done and I appreciate your calling us out on it. I think the idea of seeking grant funding for educating our participants and sharing the results of their own research with them through participant specific portals is a great idea and there are several other networks, which are participants centered. The bigger the network. And I think the active engagement or participants is a very good idea. So one of the things we would what we did, by our question. Think through in the coming months is how we would operationalize this beyond seeking and obtaining grant funding to do this. The second notion that you mentioned, which I think is very appealing is sharing the publications with you. And just to remind people that publications that we use federal grant funding they become open access after a period of time, which is an arrangement worked out with the parent journal It is possible that some of those publications may be made available through the participant specific portal that you have directed us towards. I also think that it’s possible for us. We have done that in the past marginally if I, if I may say so, through our newsletters, where we acknowledge important publications, but clearly from based on your feedback. We can do a much better job. We can have summaries of each of the research articles posted, while an embargo is in place, we can have the article posted with a summary which is focused towards the participants, so you’re right that we need to change our education modalities more to be participant focus. At this point, I would say it’s a stretch goal in the immediate next year, but it’s a goal worth pursuing and worth investing. The question has stimulated, some of us into doing a better job of sharing the results of your research directly with you all. So I appreciate your question.

Realistically, what are the chances that third generation recruitment will reopen so the children of offspring who were too young at the time of the original recruitment could possibly participate?

That’s a great question and I don’t know the answer. The time that we designed the recruitment goals of gen 3 we were aware of the fact that some of the people were young and they were not within the age range that was recruited. Either we treat some of these pre enrolled cohorts, pre enrolled because they’re already enrolled as closed cohorts, meaning no new recruitment so possible. But we have changed that in the past, we did include the new offspring spouses. So I would think hard about this question that if they are or they were too young to be included, but currently available, we’d have to identify a framework and the funding mechanism for including these again. And just like the answer that we heard to the thoughts of bringing in a fourth generation. This would not be as expansive a goal and would require a little bit of understanding of how many individuals would fall into that category. How many would be willing to contribute. But because we’ve collected information on family pedigrees from everyone over the course of many years we could construct some knowledge of how many people might fall into this category and then come back and ask the question, who would be interested in participating what the cost would be and what scientific knowledge, could we gain by adding these additional third generation sibling participants. We appreciate your reminding us about your children who are now growing up. We appreciate that reminder. It means we have additional homework to do. And we like that homework.

Is FHS going to enroll a 4th generation?

It remains an aspirational goal for several of us who would love to see the extension of the spirit of altruism. The gift of your time, of your bio samples to Science and Public Health extended to a fourth generation. That would be amazing from where we stand within the heart study, we do have very distinctive questions we can ask for generational study that would be unmatched on this planet. That being said, the enrollment of a fourth generation would require suitable funding. Such cohort studies, as exemplified by the first generation, second generation, and the third generation, they tend to be expensive because they involve infrastructure. And involved, longer term commitments. But I’m of the strong believe that the return on investments for public health and science are absolutely amazing. And we have also been thinking about how we could do this so that the infrastructure is not as expensive as it used to be. In an era of digital medicine and digital connectivity. So a lot of thoughts in our minds, but at this moment, it remains an aspirational goal. I hope several members of our funding agency within the NIH, including the NHL bi are listening to these questions and there’s dialogue and they understand the extraordinary keen enthusiasm among the participants of the three generations to go does on to enroll a fourth generation. So I’m not sure I’ve answered your question other than saying that it remains an aspirational goal with something very much in our minds.  At the time of our 60th Anniversary back in 2008, the Director of National Heart, Lung, and Blood at that time. Dr. Betsy Nabil, who’s now the CEO Brigham and Women’s Hospital. Came to our town forum in Framingham and that question came up, then as well, 12 years ago. She said, at that time, I don’t see any good reason why this couldn’t happen that we can have a fourth generation. A key issue is that we wouldn’t be recruiting a fourth generation, simply because we want to. We’d be recruiting a fourth generation because the science is compelling and we’re able to justify the amount of funding that would be required for such an enormous endeavor. We’d have to have the right scientific questions, we’d have to be sure that what we’re attempting to do answers an unmet scientific need in the community. I’m sure we would have the passion on the part of our participants. I’m sure we can find the champions for this kind of study. But getting together the scientific questions, the compelling questions to ask and ensuring that there is a funding mechanism almost certainly National Institutes of Health, or National Heart, Lung, and Blood Institute funding for this would be a critical step.

I’m part of the Omni group and at the time that I guess they recruited the children of the Omni group. I was told they couldn’t reach me so my children cannot participate and I was wondering if that is permanently closed because it’s been a while now that that group started or whether there’s a possibility in the future?

Following up on the discussion that we just had. There are no options which are closed. Transgenerational studies in epidemiology are invaluable. I think the question becomes the identification of the key scientific questions we could ask and identifying a funding mechanism. And the heart study the leadership thinks a lot about this. So it’s not a closed option, it remains an option. It’s something that we need to work and figure out how to get to. So we appreciate the question. I apologize for not being able to give as convincing an answer, as I hope I would want to give

As a member of the Omni group, I was wondering how one gets to the point of tele visits that you have with some people or do we just sort of at some point stop following the people who are part of the older group? You know what’s happened to them and they’re health?

We always follow everyone so I hope you will be looking out for our contact for our phone call, Maureen or someone on her team will be calling. It takes it takes a bit to reach everyone we’ve just started piloting the tele visits so that’s probably why you have not been contacted. I’m sure you will be contacted in the future. And thank you very much for asking that question, we, we are interested in hearing from everyone, and follow everyone for as long as they are in the study. We have no hesitation about recruiting tele visits with folks. Perhaps we need to do a better job of communicating this to you and to others that every participant counts at Framingham. It’s a message, which is very consistent, but we need to communicate it more effectively repeatedly and I apologize if you have not done so in the last couple of months during the pandemic, but we’ll follow up on this. Thank you for participating in the Framingham Heart Study.

Is it possible to share the test results with your PCP more extensively to put intervention in place if indicated?

All participants should know that we do send some results after every exam to PCP and healthcare providers that each participant designated designate when they come into an exam. We send things like the results of your blood pressure measurements, a copy of your ECG tracing and routine laboratory measurements, like your blood glucose or blood sugar. A hemoglobin, a one see test, which is a measure that reflects diabetes, your cholesterol, profile your kidney function, things like that. And then we return other results that we consider are actionable and what we mean by actionable, is that the test results may tell us something about a health condition that you have and that acting on it may have a preventive or treatment implication there are other tests that we do in the research center that really are just done for research purposes. We don’t send those test results because at present time. There’s nothing that we know of that could be done in terms of the health condition with those results. And we really don’t know what a PCP or other healthcare provider would do if we sent those test results out. So that’s the way we think about the tests that are done in a research center and how we think about what we what we report out.

Are there any plans to extend the time frame for the current exam so those of us that cannot travel safely will be able to complete the exam?

In part, timing is determined by the terms of our contract with The National Heart, Lung, and Blood Institute. And so there are fixed time frames that are defined, but these are unprecedented times. So we would have to renegotiate the timeframe of the exam and get the approvals in place. There is a precedent, you know, some of you might remember that exam three. And the only way to exam three which finished in 2019 we extended it by four weeks so that we could really get an additional participants towards the tail end of that examination cycle. So the answer is that will have to explore this. There’s also precedent at exam nine. We also extended the exam. A bit for other reasons. And we finished the exam with doing exams in the home after the research center portion of the exam completed. We did a number of visits in the home. So I think that we need to be very creative. Given the challenging times. You know, our very first goal is safety. Making sure you all are safe and that we’re communicating and that we have your trust. And so we will be thinking creatively about how we might be able to extend the exam to be sure that everyone has the opportunity to participate in this exam. And as I said earlier, we’ve already piloted tele visits so that at least we can get a great deal of the exam on by zoom or by telephone. And we can also get the exam done as a call back as when people come up at another time when they’re seeing the neurology, or the neuro psychology. Ancillary studies are collaborators for those very important studies. So I think we have a lot of options.

How safe is it for a 70 year old to return to work in an elementary school classroom?

This is a challenging question where, you know, the state is planning to reopen schools, and there are a lot of safeguards being put in place. Each school system is going to be taking slightly different approaches. Looking at the big picture covid-19’ the risk for more severe disease, is clearly higher in older individuals, and even more so in those that have underlying medical conditions. So somebody who’s over the age of 60 or 65 is definitely in higher risk even without any underlying conditions.

There’s some evidence that that younger children do not spread the disease as effectively as older children and this is good news. I mean, it’s been coming for a while, but most recently just published in the last few days as a study from South Korea. There’s a very large study, suggesting that there’s very limited transmission to families from children under 10. Now nobody’s really looked at transmission to teachers. But, but I think that’s good news. In contrast, older children those aged 10 to 19 are thought to transmit the disease, pretty much the same way in adult would. So there’s definitely higher risk in secondary school.  I think with appropriate precautions, including mask use or facial covering for the the seventy year old, the hand hygiene and then the distancing measures that are going to be implemented in school systems, would be reasonably safe, if  not completely safe. I’d say, it’d be reasonably safe for that person to return to work. But it definitely is something that needs to be considered. And it depends on how well you know how adherent for one: The children are but also how you know how careful a plan the school system has for trying to protect the health of their teachers.

Would you take a new and minimally tested vaccine?

So that’s an interesting question. I mean, I think there’s clearly a massive effort on going to try and develop a vaccine to protect people against covid-19. Just today actually data from two studies were released in The Lancet and very exciting early data showing both that the vaccines were safe, but also they induce a strong immune response. In developing a vaccine, vaccines go through multiple stages. They go through what are called Phase one and two development where they try and figure out what the optimal doses and do they induce an immune response, are they safe? Usually those studies involve hundreds or maybe 1000 people, then the next stage or phase three: trials where they try and show that the vaccine protects against a disease and in in doing those they continue to look at safety and the numbers of people in these studies are much larger often tens of thousands of people so they know if there’s a more rare safety problem associated the vaccine, they’ll start to get an idea of if that’s the case. You know by the time they finished phase three that there’s now a large body of evidence about the safety of the vaccines. If they prove effective in terms of preventing the disease then, they go to market. Based on my knowledge of the process and the large numbers of people that are tested in these different phases of development, I personally would feel comfortable taking a vaccine soon after it came to market. In fact, I’ve even been part of some Vaccine Protocols, not for this vaccine but for other vaccines under development In the past, and by the time they’re in phase three, usually there’s a good amount of safety information. So personally, I would feel very comfortable. And I think that, you know, this is going to be one of our key public health interventions to try and control this disease and allow us to get back to living our lives normally.

How does COVID affect the heart long term?

We are still in the early days of understanding the SARS CoV-2 virus, the agent that causes COVID-19. What are the long term consequences would depend upon long term follow up. And that’s an unknown question. But we do know something based on initial observations. We all know that it’s an illness where people get very sick. They often have pneumonia in the lung. And what that means is that there’s additional stress on the heart whenever you are sick with pneumonia. In addition, now there’s a wide recognition that the SARS CoV-2 virus, It has these pokey pokey spikes all around it. These pokey pokey spikes, they actually latch on to receptors, ace 2 receptors, which are then in the lining of the blood vessels, as well as on the heart. And initial observations suggest that because of that, the heart might get inflamed. Sometimes we use the word “myocarditis” to refer to the inflammation of the heart muscle. And when that happens, several things can happen. You could leak small amounts of biomarkers and a protein which is released when the heart muscle is injured so it might appear in the blood. Sometimes, it has been described that people present with symptoms of a heart attack, and then they go on to test positive for Covid-19. So the heart can get inflamed. That could be leakage of some proteins. Rhythm disturbances are common. And this is referred to as arrhythmias where the heartbeat goes irregular. Approximately between 10 and 20% of people with – who were hospitalized with COVID-19 have signs of cardiovascular damage. The long term sequence is something only time will show. It’s also important to understand that there are a lot of the people with COVID-19, about 20 to 30%, have blood clots in the lungs. And those blood clots in the lungs also have a bearing on your cardiac function and the function of the heart. About 5% of these people also have clots in the brain and they manifest as stroke. So there’s a widespread linkage to the vasculature. So the answer to the question is the heart affected, the long term sequel are not known, the several manifestations ranging from leakage of  proteins, myocarditis, symptoms of breathlessness in part due to pneumonia in part due to failure of the contraction of the muscle and also rhythm disorders and clotting in the lungs. In the acute illness, there are a lot of different insults that happened to different organ systems, including the heart and lungs. And I would also emphasize the vasculature. Clotting is an issue, but not just in the lungs, but in many different parts of the body, including leading to strokes and other complications. We don’t really know what the medium term or long term effect is.  You know we suspect and patients that have had it more severe, that they will have long term repercussions and complications in particular pulmonary disease but also this, you know, close to that is closely related to the heart function. So, I think time will tell. There are some longitudinal natural history studies that are starting that will help give us insight into some of these complications, because there are other complications neurologic kidney and so forth that that we’re starting to recognize. So it is an important question. I think we need more evidence to try and understand and hope that things to improve and not persist.

I live in Florida and I hear so much conflicting advice about how safe it is to reopen, who should I be listening to? the CDC?

Well, this is an important question. As you know I think that  there is central collection and coalition of data from all the states at the federal level. There’s been some issues in the news about some of this going to HHS rather than CDC but I’ve actually been in touch with colleagues at CDC about this. And that was really meant to consolidate hospital level data so they can do a better job making sure there’s enough supplies for hospitals. The CDC is one option, I think, actually, most states, including the state of Massachusetts have developed their own dashboards that are really practical sources for information. And the sort of dashboard that the state of Massachusetts has developed has a number of different components. I think they were mentioned in the beginning but some of the key ones are to let you know what is the number of new infections, what’s the seven day average for a proportion of tests that are positive. And right now, the number of new infections is very low, the number, the proportion of positive test is quite low. Certainly compared to Florida, Arizona, Texas, many other parts of the country. And there’s some other measures hospitalization deaths. I think they’re not that useful unless there’s a real raging epidemic. So all these can be used by the state and the public to try and track the state of an epidemic. And I think that it’s important for the State Public Health authorities and politicians to use these to guide opening, but also potentially the need to pull back if opening is done too quickly. And our state Massachusetts is in really good shape right now, but I’m really worried about the next couple months. I mean, given the number of cases in different parts of the US and outside of the United States, but there’s not a lot of incoming travelers, but the potential for introduction of new, you know, patients are individuals with infections in the state and then spread is substantial and so You need to really keep up our guard and, you know, the use of masks and all the other public health measures social distancing  minimizing congregations of people are going to need to continue, I think through the fall and probably through the winter.

The long term health impacts of COVID-19 survivors, including cardiovascular are obviously unclear, but will be vitally important. Do you anticipate including such measures in F HS protocols going forward?

We have. The answer is yes, we have several applications, scientific applications, pending where we are trying to explore the possibility of studying the impact of COVID -19 on Framingham heart study participants, I think, as a first step, we would need funding and we are exploring different mechanisms within the NIH to get that funding. And the steps would be administering a questionnaire to the participants across the generations questionnaires that ask symptoms related to COVID-19 to ascertain whether or not you had mild, moderate, or severe COVID-19 unless it would also involve testing of the blood or antibodies at a point of time when reliable antibody tests become available. And then putting the two together and then linking it to long term follow up that all of you have been steadfast contributing over the decades. You can just imagine the power of Framingham, if you are able to determine the status of COVID-19, of the antibody response and the previous information we had and the future information that you all will give. We are also partnering with sister cohort studies across the entire United States. And one of those includes approximately about 45,000 people. So we are waiting to find out the results of those grant writing exercises to see when we could knock on your doors and tell you that will be administering a questionnaire. Maybe we need a pinprick and a small amount of blood to test for the antibodies and then we do track you and Maureen and Emily will chase you till you come back and we can link the two together. So the answer is yes. The plans are there. We hope to have greater clarity. Hopefully in the next month or so. So again, we will communicate these ongoing plans to you as they become clearer.

Where are people going who were in hospitals for months?  We have heard that many need long-term care or rehab?

Sure, that’s a great question. You know, just one quick comment, the virus that causes this disease was named after the original SARS virus (severe acute respiratory syndrome). This one is SARS CoV-2 and the disease it causes is COVID-19. I think for some noted that at the beginning, but the nomenclature could be a little bit confusing. They’re clearly patients that have had moderate to severe disease, in particular those that were critically ill have had a lot of complications in many different organ systems. And they’ve lost a lot of weight they they’re very debilitated there. They have protein calorie malnutrition. I mean, they’re going to need extensive rehabilitation, whether it be at a high level, rehab facility, you know, more of a skilled nursing facility or home, physical therapy, so You know, I think  of that a lot. There are a lot of patients that have sort of moved from in hospital level care to long term care facilities as a step before they go home. And in I think that that that’s a cohort. That’s going to be really important for us to understand how they do over time is I’m really worried about the potential complications. They may have But they definitely you know it’s a group that needs a lot of rehabilitation. A lot of physical therapy and occupational therapy.

“How many cohorts have contracted covid-19?

We do not know the answer to this. We are very eager to find out the answer to this question I referred to in response to an earlier question. The fact that we have pending. Grant initiatives that a funded would position as to administer the questionnaires to all the cohorts participants that are currently following up with us to exactly answer this question through two mechanisms. One is the question database as an attainment of symptoms, but we do know that a lot of the people can be asymptomatic. So we would couple it with reliable antibody test to document the exposure through testing of the blood. So we don’t know the answer, but we can’t wait to find out the answer. Hopefully you’ll be hearing us from us in the fall, or soon.

Given the vulnerable populations of color, might the FHS make any further research linkages to the Omni cohorts ahead?

We do hope to make these linkages pending obtaining funding. We really want to understand what the truth looks like. We know that a third of the severely sick COVID patients are from underrepresented groups, sometimes referred to as minorities. Multiple mechanisms that people have postulated and they all may be intertwined and entangled socio economic factors. Cultural factors lifestyle factors, perhaps the genetic predisposition. It’s well known that some of the underrepresented groups also have a higher prevalence of cardiovascular risk factors such as high blood pressure, obesity or insulin resistance. We also know that they have an increased propensity for admissions for infections of the acute respiratory tract increased burden of vitamin D deficiency. So how do you disentangle this? What we do know is this very strong social patterning of disease we observe in this country and the disentangling this entanglement of that web will require a lot of details studies cited stop over there with the expression of interest in doing it perhaps collaboratively with other larger groups across the country. So this is a complicated question that I think none of us know the answer to. Yet there’s clear evidence that blacks that next and and actually Native Americans are all appear to be at higher risk for more severe disease and complications from COVID-19. But the question is, is that because of race and some genetic factor or is it because they have other risk factors? There’s a lot of obesity in these populations obesity has been shown to be a clear risk factor for severe disease and COVID-19. And then there are underlying diabetes and in other medical problems. So I think trying to disentangle all those factors and trying to figure out whether it’s those factors that are increasing risk or is it some other genetic factor. But compounding. That is, is really the sort of social economic conditions housing conditions where these people live and they may be living in. Housing that you know where they have more people in the home. They have a lot more contact. Many of them were working the service industry. So they’re out they have to take public transportation, they have more exposures, both at work and on the way to and from work. So it’s really a complicated situation. And I think we do need to try and look at different groups have different cohorts to try and understand this across the country to have a better feel for what the factors are so that we can address them in the future.

I feel it would be so incredibly valuable to have random sampling of all stages of studies to have blood samples previous before COVID vaccine and then also follow up after a vaccine. This would be a reason to acquire additional investments for the Framingham Heart Study. What are your thoughts?

I’m all all supportive of this. I’ll turn to David again who might be leading some of the efforts related to vaccination and what happens after vaccination, David, you want to comment on this. I mean, this is an interesting question. I think that there’s going to be a need for more studies. That look at sort of the longitudinal impact of COVID-19 and different populations. The Framingham heart study is such a great platform to look at some of these questions and it’s really going to require long term follow up looking at immune response. The duration of immunity. Does that immunity lead to protection against future episodes of disease or subsequent episodes? If they occur more severe or less severe? And then once the vaccine becomes available for those who received the vaccine. How well does it protect? How long does the protection last? and there’s just an immense number of questions that could be asked in the context of a study like this.

Will future studies focus on long term physical and psychological, social and emotional impacts of the pandemic?

Yes, like I mentioned, we hope to obtain the funding to study the impact at the level of the individual. At the level of the families. We are a multi- generational family study and at a societal level as well. We want to look at the physical impact, but we also want to look at the psychological impact the emotional impact the impact on cognition, the economic impact. And the social network impact of this complex disease. So you’re spot on with this question, Marjorie, we hope to address this in our research in the coming months, two years.