 So with the background that Cindy just provided, I'm going to talk about a decision aid that we created to help parents make informed decisions about participating in the study and also to help them think through the preferences that they have for learning different kinds of sequencing results. I'll also present some preliminary data that we have about parents, how parents use the decision aid to make these choices and some other outcomes that shed light on the kinds of genetic information that parents may want to learn. So why a decision aid? While newborn screening looks for specific conditions that are treatable and affect a child's health or survival, sequencing makes it possible to test for countless more conditions. Asking parents to decide whether to receive many different categories of genetic information, some of which don't have the same level of actionability, medical actionability as those found through traditional newborn screening, prevents many communication challenges. For example, how do we help parents manage the scope of these decisions without overwhelming them with information? Most people don't have a deep understanding of genetics or what sequencing might mean for them and their families. And this sets limited common ground from which we can share information about a difficult topic. Lastly, in most but not all cases, two parents are involved in these decisions for a child. And so for NC NEXAS, we learned or it became clear very early on that we would need to adopt a decision-making model that would fit the needs of individual parents as well as parents making choices together. With these challenges in mind, our approach was to develop an interactive web-based decision aid grounded in theories and principles of informed decision-making. Broadly speaking, decision aids are print or audio-visual materials designed to provide information about the decision to be made, what the options are, and the potential outcomes of those options. Also to suggest strategies for weighing options against what the decision-maker is trying to achieve, and then help people plan a course of action. Crucially, decision aids are not meant to persuade or advocate people to adopt a specific choice over a different one. Instead, the goal is to ensure that the decision-making is informed and values-based. So while we were developing the decision aid, we followed an iterative process to both develop it, test it, and then refine it in different stages. Our focus was to create materials that would be accessible and relevant to parents without sacrificing accuracy. So we definitely relied heavily on the NC NEXAS expert group to get feedback and review while we were developing the content, but we also used a variety of methods to gather and use parental input throughout the development process. First we conducted several rounds of user testing, and this was used to identify and correct areas of confusion related to content and navigation. We also conducted interviews with parents to understand how couples communicate with one another and make decisions about screening or about getting receiving genomic screening results for their child. And lastly, we conducted an online experiment with over 1,200 parents of young children to understand which characteristics of genetic health conditions impact their decisions to learn different kinds of sequencing results. So the insights that we learned from these research activities helped shape the content and design of the NC NEXAS decision aid. We learned that couples wanted to collaborate in their decision-making. By and large, they looked to one another for support and to arrive at a joint understanding. We also learned that potential benefits and concerns that parents had about learning their child's sequencing results, which we used in the educational portions of the decision aid and as examples in the values clarification task that was part of it. We also found that different sequencing results categories were perceived differently by participants. So for example, we observed greater differences of opinion within couples over categories like non-medically actionable childhood conditions and carrier status. With the next few slides, I'll share a few screenshots for the completed decision aid. In general, the content was organized into three broad sections, an education section, a deliberation portion, and then a choice section. Most of the education sections focused on defining terms and explaining what decisions we would ask parents to make. So this included describing the NC NEXAS study procedures, as well as some background on newborn screening, genomics, and sequencing. The deliberation portions of the decision aid were a set of interactive tasks, and these were designed to engage parents in the decision-making process and to think critically about the decision options that they were presented with and how those fit with what matters most to them. And then lastly, the choice sections allowed parents to indicate what they intended to do and provided tailored next steps based on those intentions. Throughout, we applied user-centered design principles. This included a lot of different features, but I'll just highlight a couple of them. So the interface allowed users to go at their own pace, repeating and reviewing information as needed. We also used plain language and clear communication principles and strategies to present ideas using familiar terms as best we could. Invariably, when you're dealing with genetics and genomics, there's going to be some unfamiliar terms. And those, we did our best to define and give those definitions to participants. And then also the decision aid uses a combination of text, graphics, and audio to convey challenging concepts. So in addition to those sort of general characteristics, we also had three tailoring variables in the decision aid, which in essence, we ended up developing alternative versions to better fit parents' needs. So tailoring was done using a computer algorithm with data that was collected before people used the decision aid. It was offered in two different languages, English and Spanish. We also had a version that was designed for single moms to complete on their own, as well as one for couples to complete together. There were some, you know, a few differences on some screens depending on the relationship status. And then lastly, there were some differences between the decision aids based on the cohort that parents were in, so either the diagnosed or the well-child cohorts. Then due to the design of the NCNX randomized trial, we really had decision aids, two decision aids, that were organized around different sequencing results categories. So in the first one, all parents made the first decision whether or not to have their child sequenced and to learn results from medically actionable childhood onset conditions, those are the NGS, NBS conditions. And then a randomly selected, not half, two-thirds, were given the option to receive additional sequencing results related to non-medically actionable childhood conditions, medically actionable adult conditions, and carrier status. We organized the second decision aid so that there were distinct education, deliberation and choice categories or choice sections for each of the additional categories. And parents were allowed to choose all some or none of those additional categories. So for the remainder of the presentation, I'll show some preliminary findings. First, here are some demographic characteristics of parents who completed the first decision aid. In all, there were 190 couples and 14 single moms out of this. So when you see the fathers and the moms, there were dyads. These were represented couples. A majority of the parents were non-Hispanic white, though the racial and ethnic diversity of participants tracks pretty well with the population of North Carolina. Overall, there was a slightly or a larger proportion of college graduates and affluent parents in this group. Now, with this slide, what I really want to highlight is that top row, where consistent with what we found in some of the formative work that we did, that most couples reported working on the decision aid together. There really isn't a difference between mothers and fathers, which is nice to see that there is a disagreement there. But overall, that's what working on it together was a strategy that parents took. Now, within the deliberation portion of the decision aid, we had a series of tasks that people did. So what I'll first talk about is that we had a sorting task where people were shown five reasons for or reasons that they might be interested in sequencing. And then they were presented with five reasons against and asked to sort those in as important, unimportant. And if they were in a couple, whether or not they agreed on that. And so one of the things that is interesting here is that when you look at, based on the choice that people made within, this is within the decision aid, the people who either were undecided or leaned more towards saying yes tended to rank a higher number of reasons for or a large number of reasons for and relatively few reasons against. Whereas the people in the no group tended to have more of a balanced set of things that they found important from both the reasons for and the reasons against categories. This is pretty consistent with standard behavioral theory, though it is interesting that in the no group that there was that balance and not a disproportionate number of reasons against. And then in this next slide, so we asked, before they did that sorting task, we asked which way that they were leaning. So basically to get a sense of what they were thinking after they completed the educational portions of the decision aid. And then we did a similar question after the values clarification task just to see if we could see any real differences there, to see if the values clarification had an impact on their choices. For the most part those were very consistent throughout. And then also after the decision aid then the people would schedule a follow-up visit, an in-person visit to go through an actual consent process or so the decision aid was really in augmented that. And again here, the people who said no in the decision aid didn't have the option to have the in-person visit but between the undecideds and the decideds there's slightly more people in the yes group who continued through with it than in the other one. So with this slide we asked, this was after the decision aid was done in a follow-up survey. We asked a number of different questions trying to get a sense of what people thought about the decision aid and working through that process. I'll focus on the bottom row which is an average of all of these items combined. So looking at this the questions were on a scale of one to six where higher values were related to more favorable perceptions of the decision aid for both mothers and fathers and in the decision aid one and decision aid two, perceptions of the decision aid itself were highly favorable which was nice for us to see even though that it didn't seem with the previous slide if you look at how it actually impacted their decisions it didn't seem to do much but this gives us a sense that it helped them in some way with the decision-making process or feeling better about the decision-making process itself even if it didn't impact choices. So then we're also looking at how parents with a newborn versus one with a diagnosed child differed on some outcomes or even just the flow through the study. So in all of these there were no differences between these two groups in terms of whether or not they were undecided or said yes on decision aid one as well as the consent at the sequencing visit and then in terms of the types of additional results that people in these two groups chose for the most part, a majority of parents did choose to receive if they had the option to receive the additional results though numerically slightly higher in the diagnosed group. Then we also asked a few sort of decision outcomes to get a better sense of how people felt about the decision process, the decisions that they made. So in terms of decision regret and satisfaction with partner decision-making these were two questions that were asked on scales that range from one to six. Again here the decision regret a higher number means that there would have been more regret which is so we want to lower a number on that one. Satisfaction with partner decision-making the higher the number the better and by and large across the two decision arms are the control arm versus the decision arm and then across mothers and fathers there's very no statistical differences and overall in terms of decision regret it's fairly low on that scale and then satisfaction with partner decision-making is fairly high. Again with test-related distress and concerns about the child's future health these were rated on scales that range from one to four. Again no differences across these groups. Test-related distress was fairly low not quite as good as the decision regret and satisfaction with partner decision-making on average and then concerns about the child's future health were slightly higher but again no differences between the control group and the decision arm. So what we're seeing here what we can feel pretty confident about is that having the option to receive the additional results that are different from what you would get from standard newborn screening didn't cause a lot of distress for those participants who had that option. So just a few conclusions from here is that participants made up their minds about NGS NBS early on largely by the end of the educational section of the decision aid they seem to have made up their mind whether that was made up while they were completing the decision aid that's not clear it might have been done even before that just in terms of interest in these results leading people to join the study to begin with. Also parents tended to think the decision aid was helpful which was nice to see having worked on the decision aid development team and then lastly the control and randomized parent groups didn't differ from one another on several decision outcomes like regret, satisfaction with partner decision-making, distress or concerns about the child's health. Then with that I'll just acknowledge the large team that worked on this project and that's all I have. Thank you. So now we'll have one more presentation before we go to break and we will be hearing from Robert Green who will be speaking from Brigham and Women's Hospital to talk about. Yeah, the baby seek project.