 Okay, we can go ahead and get started if you'd like if you're ready. Absolutely. Yeah, might as well go for it. Thanks again for that introduction and thank you for the fantastic opportunity to present today at the our medicine conference. So this presentation is actually going to be about opportunities for clinicians using our in an unprecedented data set like the all of us research program. Again, my name is Caitlin dry spot you're welcome to call me Kate, and I am currently an assistant professor at the University of Rochester. And this presentation was prepared in tandem with my collaborator and dear friend, Dr Teresa Colette who's an assistant professor at the University of Pittsburgh. So before we begin our discussion today I just want to take a moment to familiarize familiarize you with some words and concepts that you're going to hear throughout the presentation. These terms are central to the all of us research program as they represent key components of what the program actually does, and how it's achieved, particularly at the interface with participants. Specific to this presentation, you'll hear a lot about engagement, especially of identifying diverse researchers who could benefit from using the data within the workbench. I want to disclose that both Dr Colette and I are funded in our respective research areas by the National Institutes of Health, and our all of us research ambassadors through an NIH contracting organization called picks as partners. Through our ambassador work we network and connect directly with researchers who are interested in using the all of us program data set. I'm also on the Community Advisory Board, and I'm actually also a registered participant so from every angle here, we've got you covered. So the outline for today's presentation is to describe the richness of the all of us research program data specific to this audience I also want to describe the workflow for accessing data within the workbench. And then we'll talk briefly about the analytic tools that are present within the workbench to assist researchers. So first question. What is the all of us research program. The all of us research program is an ambitious effort to gather health data from one million or more people living in the United States, with the goal to accelerate research that may improve health. The all of us research program is nurturing long standing partnerships with at least a million participants who reflect the diversity of the United States to help build one of the largest and most diverse health data sets in the country. The goal is to engage the participation of people and communities who have been historically left out of medical research in the past. So the program seeks to accelerate health research and medical breakthroughs, enabling individualized prevention treatment, and ultimately a little kitschy but the care of all of us. So the program captures a wide variety of data types, including survey responses, physical measurements, electronic health record data, genomic data, and even data from Fitbit wearables. All of this enables the acceleration of research breakthroughs. It's also a longitudinal data set so it follows participants as they move as they age as they get sick, and even as they try out different and new treatments. Data on this slide is actually a year out date from June of 2022, and to really highlight the acceleration of the participant enrollment updated numbers from last year. This show over 618,000 enrolled participants with over 450,000 participants completing the initial steps and data collection. So all of us began enrolling beta testers in May of 2017. This allowed the program to conduct end to end testing of the user experience, the platform and the associated systems. The program opened its doors for national enrollment on May 6 of 2018. And since then you can see here in this plot, the participation has steadily grown. So as I mentioned on the last slide, currently, all of us has over 618,000 participants, those are individuals who have completed the full consent process of these more than 450,000 as shown in green. Participants have completed all of the initial steps of the current protocol which is EHR authorization, initial surveys, and physical measurements. So this graph represents self reported races and ethnicities of participants who have completed the initial steps of the program so of that 450,000. All of us is aiming for 50% of participants to be from racial and ethnic ethnically diverse communities. Continuing to give you a broad look at who's enrolled in the All of Us program. Here are two plots one showing the age distribution and the other showing the geographic density of individuals across the United States. All of us is tracking a well balanced distribution across age and geographic area with participants from all 50 states. This continues to be opening new clinic sites around the country on a regular basis to enroll new participants. And to reach even more communities the program even has an interactive mobile exhibit that can actually travel around the country. The program does provide bilingual language support so it allows participation by a broader number of individuals. You can also enroll as a participant through direct contact with the All of Us research program. So all of us is working ultimately to earn the trust of communities previously disenfranchised by medical research and engage them in safe protected ways that can help enable a deeper understanding of disease biology, therefore, hopefully, leading to more precise approaches to care. And as many of us on this call can appreciate that multimodal data needed to paint a complete picture of human health whether that's biological environmental behavioral socio demographic is just not easy to capture especially to have all of this in one place. The NIH is really bringing this data together on a single platform and working to ensure that it's not only secure and protected, but also made available to diverse researchers from a wide range of settings, but particularly researchers who come from or live within underrepresented communities that we know bear a disproportionate burden of disease. Our workbench includes survey based data that are self reported on say basic health things like physical emotional and social determinants of health. Participants also have an opportunity to link their electronic health records through their health care system, and that data can flow into the All of Us data data center. At the detailed level though the data set also includes specific physical measurements such as blood pressure, heart rate, BMI, and even for some physical activity and heart rate from their connected Fitbit wearable. And what some of you may also be interested in is the expanse of genomic data. While these are only available in the controlled tier our highest level of access, which I'll talk a little bit more about in the upcoming slides. Genomic data is a massive resource, really for overcoming the intensive cost of genomic sequencing to associate different conditions with polymorphisms. Because all of us is continuing to expand and innovate the data that are actually available. Upcoming are also biospecimens from individual participants that could offer a new layer of detail and further study. And then highlighting the value of this data, or when you start combining different types of data together. So that as you can see on the right here on the slide. So if you're interested in associating a specific genomic, you know, polymorphism say with data from electronic health records and survey responses. We can quickly identify a sample that's far larger than what a single researcher principal investigator could do, or what a single institution could do alone. And working together on a larger scale helps to accelerate the science beyond our traditional approach. And earlier this year, all of us research or all of us research program released their first wave of social determinants of health survey data, allowing researchers to understand a broader set of factors that influence health, such as neighborhood security, housing stability, the built environment, social support, even discrimination in both everyday and medical contexts, and then food insecurity. And as we all can appreciate the continued impact of the COVID-19 pandemic on our health care system. So we have the data assessing factors related to an individual's COVID-19 experience, which are now available within the researcher workbench within the data available from the all of us program. Some topics that are covered that also apply more broadly to other research questions include stress, resilience, loneliness, perception of vaccines, and even social support. And if you want to drill down further on your own, please feel free to use this QR code to access the publicly available data through what's called the data browser and the associated data snapshots. The first few slides of this presentation were actually data snapshots and they were all taken from the all of us research program website. So this QR code will take you to the research hub, which is sort of you could deem it the headquarters for getting started on the workbench. And I did upload the slides into the our medicine conference program so you can also scan it from there as well. So what's impressive about this collaborative effort is, in my opinion, the strong emphasis on making the data accessible to researchers across different stages and settings. In June of this year, right now there are actually over 5700 registered researchers from over 530 institutions that represent students at all levels and even if you can believe it at the high school level, academic researchers, clinicians, nurses, physicians, nurse practitioners, and even trainees at again at every stage. So what's most exciting is that the transition of these analyses into peer reviewed publications with the opportunity to actually translate the work to the clinical setting or even to the bedside. The top conditions studied so far within the workbench include major conditions that you know represent high incidence across our country things like cardiovascular disease, hypertension, mental health, cancer and diabetes. All of us is committed to reaching a diverse researcher cohort to promote the responsible and ethical use of data, ultimately, to optimize and return value to participant communities. And, you know, as I've mentioned several times to accelerate that research impact. And what's very impressive is their continuing encouragement of students and early stage investigators even like myself to bring fresh creative perspectives and innovative research outcomes. So it's also exciting to me, which I realize I've already said a few times, very excited. But for me as a reproductive health researcher and a former labor and delivery nurse is the recent appointment of Dr. Sarah van der Roest, who is who was tapped to lead the pediatric enrollment for the program. So she will serve as the program's first director of pediatrics, and she'll pioneer how people under the age of 18 can participate in the all of us research program. So let's get into the details of actually accessing this data. So this is a nice infographic showing the steps of how the data are collected and piped into the workbench that researchers can access the data through. So first participants share their data, as I described, through multiple sources depending on the data type. The data are sent to a secure cloud environment managed by the data and research center or the DRC at Vanderbilt University. So the participant data is received by the data and research center and pushed through a curation pipeline. The pipeline primarily checks the data for a certain quality standard. It validates it against other data and maps the data to the observational medical outcomes partnership or the OMOP data model. Many of you are probably familiar. So in steps three and four as shown on this slide researchers can explore the data that are available and register for the researcher workbench, which is an essential step in order to gain access. So I'll talk in more detail about the registration in a few slides it's really the focus of this of this talk really. Research researchers then can create a research project in a collaborative workspace using Jupiter notebook and either are or Python programming language with special tools just within the all of us researcher workbench like the cohort builder, which can helps you to construct the data that are of interest to you. So there are three tiers of accessing the data within all of us. First at the top you can see here is the public tier that actually anyone can visit. There are data snapshots on characteristics of the data that are available, and the data browser where you can identify actually counts of specific conditions that you want to research say certain procedures certain drugs for example. And also the survey explorer that elect that allows you to look at what survey questions are asked of participants, and then the projects directory where you can review projects that are currently happening and get a sense of the work that's being done. So beyond the public tier is what they call the researcher workbench access to the researcher workbench requires a complete registration and affiliation with an institution that has a data use agreement with all of us research program. We'll talk about that on the next slide actually in the registered tier users can access curated individual level data, including again surveys wearables measurements each our data and the like. At the highest level of access is what's called the control tier, where users with specific institutional agreements can access the data available, including expanded demographic sets, unshifted event dates, and again what may be of interest to us is actually the genomic data. It's important to know that counts between each tier may vary because there's actually a time lag in the data curation process, which is not unexpected but that lag could be several months depending on when you're trying to access it. But the public, the public available to everyone data is updated daily to report current program enrollment and data collection status. All of us operates under what's called the data passport model. So unlike other programs that determine data access on a project by project basis, say if, if even they grant access to external researchers at all. All of us alternatively uses this passport model, which grants approved researchers to a broad permission to explore the data for a wide range of studies within certain parameters. Three tiers that we've described. Research or access is available as long as you have three things. First is identity verification using era commons, which for those of you on the call is the same system for for those who apply for NIH grants. The second is a data use agreement, which can actually be searched at the bolded link on this web page so you can type in your institution and see what data access or data agreements are available. And then three, researchers need to complete the all of us responsible conduct of research training, which is a specific set of modules built into the all of us workbench. So to encourage folks to get started all of us does offer a starter amount of $300 for computation within their secure cloud environment, which should be plenty for a standard study if not many standard studies. And where it can, where the cost can get higher is with the genomic data, because obviously there's just more input there, but plans for cost of that data storage and computation can be arranged beyond that $300. But it's a nice boost to get you started, and even opportunity to play around, especially again for trainees and early stage investigators. The screenshot of the researcher workbench provides sort of a glimpse of what you might expect to see after completing the registration and logging in. And within the workbench you can see all of your workspaces, which each workspace represents a single project. Within a workspace you can see various components of your study, including the cohort, the associated variables that you've chosen, and then the notebooks again with either our Python code depending on your preference. And the workspaces are shareable, which helps to increase collaboration. So, just to chat a little bit about the powerful analytic tools and support and I've already talked about many of them throughout this talk, but let's just quickly run it down. So from left to right first you have the workspaces. So approved users can use workspaces to access store and analyze data for your specific research project workspaces are collaborative and can be shared among members of a project team. Then there are the notebooks. So researchers again with our or Python experience can perform high powered queries and analyses within the all of us data set using the integrated web based Jupyter notebook environment. That's where the actual code execution and data set will run into. So then you have the data set builder, and that allows researchers to search and save collections of health informations about cohorts, which are called concept sets so the set of variables that you want to know about a particular cohort. Researchers can search and save different concept sets from a particular domain and use them in the data set builder. Then you have the cohort builder, which is a custom point and click tool that allows researchers researchers to create, review and annotate participants or their cohort within the all of us data set. And then finally is the support hub. So the support hub is a publicly accessible and contains a variety of resources that demonstrate how to use the tools and navigate the data within the researcher workbench. Articles on data and tools, video tutorials, guides and a designated help desk are all available to assist researchers in their activities. So as an overview, these are the steps to be an all of us researcher. And again you can use this QR code to navigate directly to the research registration page. But first, and you could probably check this box already, you want to learn more about the data that are available. So hopefully I've given you enough information to at least, you know go on to the website and search a condition of your choice, and kind of gauge what data might be available in your, in your area, either clinical area research area and the like. The second is to check for your institutions agreement again this is a critical component and if your institution does not have an agreement. Please feel free to reach out to me. And I can best support you and connect you to the right folks to see if we can get that started. The third is to actually register as a researcher by verifying your identity and then finally completing the all of us responsible conduct of research training. And then lastly you'll sign a data user code of conduct, as would be expected, and then you can jump right in into your analysis. So quickly I just want to highlight the expansive projects that are already being conducted with this data. So you can explore how researchers are using this data by browsing research projects directly, and checking out different profiles on research, all of us.org. Some very broad and general examples include developing improved risk assessments and prevention strategies to help preempt disease, investigating health disparities and finding new approaches to improve health equity, providing earlier or more accurate diagnoses to reduce illness burden, and then increasing wellness and resilience by promoting healthy living. And then you can even listen to researchers in their own voice in their own lens about the power of this data set, and how they're using it to further their own research. These are just a snapshot of a few of them and they're found directly on YouTube. Importantly for those on the call who are in the cycle of grant applications, NIH is providing funding resources and opportunities specific to using the all of us data. So please check out current funding proposal opportunities. So it's important to know that all of us is deeply committed to the community and has leveraged these long standing relationships within their community and provider network to ensure that the program is operating with the goal of doing the most good possible. Organizations like the YMCA, faith based organizations, the American Colleges of the American Association of Colleges of Nursing, the Black Greek Consortium, and even the American Public Health Association, all have that deep reach into their associated communities that for which many have been historically underrepresented in biomedical research. The organizations listed on this slide help build trust and serve as program validators and communities across the country. All of us also works directly with academic institutions and health systems to recruit manage recruit participants manage the data and direct engagement opportunities across the US. Again they are listed here on this slide. So if anything I've mentioned sounds even of remote interest to you. Please stay in touch. You can sign up for the research roundup newsletter and stay up to date on the latest that's coming from all of us. And with that thank you so much. I've listed my email and Dr Colex email on this slide and would love to hear from you if you have any questions about specific data that are available if you go on to check in your institution doesn't have a data use agreement. We would love to be of support so thank you so much. Thank you Caitlin. We do have a couple minutes for questions and there are a few questions in the chat. I'm going back up to the top of your time here to Eva's question is it open for use for non US researchers. Oh, that's a great question. That's a fantastic question. Yes. And I can double check this to be sure. If you are not a US citizen but you have an era Commons login, and you haven't, you're affiliated with an institution with an agreement, then yes. However, international partners so if your say company is based abroad, then no, but that is a strong push of the program so there should be more upcoming, but if you have a specific if somebody has a specific question about their case I'm happy to help support. It also looked like someone had a question about the institutional agreements I can pop the website here directly into the chat and you can look up your exact institution. Right now. Great. Thank you. Yeah. We have another question from Peter Higgins is the, our participants map to their census tracks. Oh, that's also a great question. I don't believe so, but I can certainly look that up. I can certainly get back to that person and who has that question Peter that's stuck. Yeah, Dr. Peter Higgins. Okay, Dr. Higgins. Thanks for that question. So the interesting and as you can imagine in order to keep this data secure, all of the data has to be stored within the researcher workbench within the cloud. Within the cloud system, yes, you do need Chrome in order to optimize the workbench. So that makes sense. I have a couple of questions. The data are not exported off the workbench so all of the computation has to occur within the notebooks and within the workbench. So, in terms of like, making sure that the, the data are de identified, I'm not sure how, how they could be mapped to census tracks. But I can definitely figure that out. I have a question from Noel Foster is the data de identified at the point of collection or in the DRC. Oh, I believe at the DRC level but I, if that's of interest I can certainly follow up on that as well. It's interesting so I'm definitely not an all of us expert. I'm truly a researcher by my own background and have taken up, you know, sort of sharing and trying to get more researchers involved but I do apologize I do not have all of the answers, but I can certainly get them. Of course. And I know we're at time but just this last question here. What is the role of verily in all of us. Oh, I wouldn't be able to answer that. But yeah, happy to connect individuals who can. Thank you. And so thank you for, for that talk. Wonderful session lots of great feedback and comments in the chat here. And for our next session.