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Technical Assistance Call for Applications to AHRQ's Research Centers for Excellence in Clinical Preventive Services:

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Transcript (continued)

Mary Barton: Dr. Mold, I really appreciate your question and I'm not—you know, my background personally is in research and not in education, so much, so I'm going to give you a research example. But maybe one of my colleagues can give more of an education or dissemination example. I think that out of four projects, three might need statistical help, and there's, you know, 2% of the statistician on each of three projects.

But the core envisions that there's going to be work done on advancing the methods that are used to, you know, analyze the priority population as compared to non-priority populations. So the core might have, you know, an additional 5% of the statistician time to work on a common method that will help each of the program projects, but it's still in development. And so the core's going to do it, and that may be the core would train, you know, do seminars to train fellows in how to do this new method.

And that would, you know, those are part of the training. It's not that we can pay stipends for post-docs but that there should be an effort to bring others in the institution. This, you know, we want this to be a beacon in the institution for people from all over.

So whether there's a hospital or a medical school or a health center, to say this is a cool place to come work and we want to see what you're doing and learn about it and be part of it ourselves.

Dr. Jim Mold: Thank you.

Coordinator: Our next question comes from Dr. Kemp. Your line is now open.

Dr. Ally Kemp: Thank you. I wanted to go back a little bit to the project. And the grant clearly states they needed to be, they need to be interrelated and synergistic. And of course, that could be in many different ways. For example, they could be, and on the other hand, you want to obviously see the scope of what's possible at the center in order for it to be nationally of interest. So could you give me any input about whether the synergy should be about methods? About focusing on specific types of recommendations or about diverse populations? Or you know, data sets that would include different kinds of potential methodologies? Are (there) sort of priorities amongst those?

Mary Barton: I don't think so. I think that the first step of related means that they all have to have something to do with the semantic area that you have chosen in your proposal. And so beyond that, we are hopeful that people will pursue any and all of those things that you've mentioned.

Dr. Ally Kemp: Okay. Okay, one followup question. I just want to confirm that if you're the PI, and you're a leader on a project, you have to be 35% FTE?

Mary Barton: We're looking up the details in the FOA. I know that we did specify something.

Dr. Ally Kemp: I think you, you said that you could drop back to 15(%) as the PI, I just want to confirm then you have to go to 5(%).

Mary Barton: So I think, the thing is, is that the project leaders are, you know, the most important thing is that the center leader be substantially involved with this program project. And so the, you know, you quoted the FOA correctly, "that the Center Director routinely would be expected to commit 20% annually but it would be permissible to drop back to 15% if the Center Director is also a project lead." So 20 plus 15 is 35.

Dr. Ally Kemp: Okay. What if the project, the PI, were part of one of the projects, but not the lead? Could there be something in between there? You know, say a senior investigator on one of them?

Mary Barton: I think that anything less than a lead on one of the projects...

Tess Miller: We're going to defer for a moment here, for one minute please.

Mary Barton: Thank you. Excuse us.

Mary Barton: So I think that the main message here is that the project leader is expected to devote 20% time to being the—I'm sorry, not the project leader, the PI—the PI of the grant. And if there (are) projects that want to put that person on their budget for 5% or 6% because they're valuable, that's great. And then the total of that person would be 26%.

Dr. Ally Kemp: Okay, okay. Got you. Thank you.

Coordinator: Our next question comes from Rodger Lutman. Your line is now open.

Roger Lutman: Hi. I'm interested in the types of implementation studies that you all see as most germane to this project. For example, I can imagine a large-scale demonstration project where the main measures may be pre- and post- and process measures, and I can envision randomized control trials and specific implementation methods, and I guess I also imagine something you may call basic implementation science, where the method is more the focus than the content. Can you say something about that?

Mary Barton: So, I think we would consider any of those as sitting under implementation research we'd like to see within a center.

Roger Lutman: Okay, a quick followup on that. Let's say in the process of implementing a nutrition counseling program, that might begin with the primary care provider making the referral, but then they need someplace to refer the patient to. You could argue the implementation might just focus on what the provider does to get the patient to go somewhere, or you could say you have to have somewhere to go, and this could support as part of implementation a study of a new intervention to use computer interactivity to teach people about nutrition. That would be a much more kind of basic thing along the chain of implementation, but quite distant in the chain. Would that be acceptable?

Mary Barton: I think so, yes. I think we could consider that, yes. I would only say what we said earlier, about linking back to the formal health care system is an important part of it, but I would imagine that what you're saying would be...

Robert Lutman: Yes.

Mary Barton: ...you know, that it would be a community partnership with the clinical system.

Robert Lutman: Right. Okay, thank you.

Coordinator: Our next question comes from Deborah Seltzer. Your line is now open.

Deborah Seltzer: Hi. I was just wondering if the faculty that we show are just the faculty that are on the two to four projects that we're proposing, or do we want a bigger faculty for the center for our future work? Like we would at a traditional research center.

Mary Barton: I think that what we've laid out as the required areas in the core and then the potential additional areas in the core should make it clear that there would be other faculty that would be involved in the core. So we would expect, but I can't tell you who they would be, because I don't know what (you're) proposing.

Deborah Seltzer: Right.

Mary Barton: But the fact that planning for evaluation is going to take, you know, may take a team of experts, that the PI is one of them, but there are others involved. Or, you know, there's a, certainly if there's a health equity center that has a big focus on communication, I could imagine several kinds of people who have defects for communication who might be drawn upon by multiple projects and therefore appropriate to establishing a core.

Deborah Seltzer: Okay.

Coordinator: Our next question comes from Elaine Phillips. Your line is now open.

Elaine Phillips: Thank you. I was just wondering how broad your definition is of who the patients are in the clinical services? The reason I'm asking is, you know, we focus a lot on health care workers, but there are many inequities in the preventive services offered to health care workers as well as immunization issues, but they're not traditionally seen as patients, so I'm not sure if that would fall under this or if that would be considered a health care services issue?

Tess Miller: We're conferring here.

David Meyers: And some of the other questions we've had today are some of the things your peers, when they do the review, will get to decide. And so it's up to you to tell a story that explains why this is important...

Elaine Phillips: Okay.

David Meyers: ...why it meets the center goal. My first reaction would be an entire center focused on health disparities that only looked at health care workers and the disparities of health care workers would not be impressive to your reviewers of meeting the goals we're setting, moving our national quality and prevention agendas forward.

However, one project that says Latina medical assistants are not getting good help, then we're going to work with them as one of our projects. But then we have these other projects in other communities, that one project might be seen as expanding the scope and therefore very appropriate and helpful.

Elaine Phillips: All right.

Coordinator: Our next question comes from Wayne Miller. Your line is now open.

Wayne Miller: Yes, I have a question on the research projects. You (are) supposed to be able to produce at least one final project, and it says, "Made publically available." How do you define public? Are you talking about lay public or are you talking about the public of primary care providers or clinicians?

Mary Barton: Available means whoever wants to see it, they can find it. They can get it. So typically, we would think of a published journal article perhaps as being the most historically understood research product.

But the distinction is at least two of the four need to be of the scope where there would be findings and those findings would be made public. In contrast, the other two could be pilot projects or preliminary projects or, you know, something that wouldn't necessarily result in a final product.

Wayne Miller: Okay. One more question, dealing with the cross-over with screenings, or whatever that may be considered as target(ed) for individuals with a problem or condition. Anyway, what about something like obesity? I mean, you've got a condition of obesity, you could have screenings that may or may not be considered (the) first line of preventive defense for obesity. I mean, you're talking almost everything.

Mary Barton: Okay. I'm afraid that I don't understand your question.

Wayne Miller: The question is, and you had it on your slide, preventive services cannot be included, include something that's normally done for a patient with that condition. But what about a patient with obesity?

Mary Barton: Right. Obesity, as you probably know—CMS has not been, to the patient yet, declaring obesity to be a condition. I'm don't—I'm not saying if I agree with them or not, but I think it's part of a national conversation that's helping now.

Wayne Miller: I think it's defined as a condition but not as a disease.

Mary Barton: Thank you, not as a disease. So...

Wayne Miller: And then, the FOA says condition.

David Meyers: I think the simple answer would be counseling about getting referrals for bariatric surgery, which is a treatment for obesity but clearly not...

Wayne Miller: Right. But what I'm saying, an obese person screened for diabetes, an obese person screened for cardiovascular disease, an obese person screened (for) hypertension. Those are routinely done. Those are preventive services.

David Meyers: I'd refer you to the U.S. Preventive Services Task Force guidelines, which are highlighted throughout this FOA and the basis for the National Prevention Strategy, and look at what they recommend in these things. So screening for hypertension is not limited to people with obesity anyway, or screening for high cholesterol, which you named. Screening for diabetes actually has its own recommendation, which you might want to look at. But the idea that certain screenings are targeted to certain populations, not necessarily people with disease like diabetes, but rather the example we heard from Dr. Barton earlier, that older people might be screened for...

Mary Barton: Colorectal cancer.

David Meyers: ...colorectal cancer and younger people aren't, that's fine, that kind of distinction. So I would recommend that folks use the Task Force, (the) U.S. Preventive Services Task Force, and the ACIP recommendations for immunization as the basis for the intervention that they're going to study, the clinical preventive services that they're going to study.

Wayne Miller: Okay.

Coordinator: Our next question comes from Rita Cucaska. Your line is now open.

Rita Cucaska: Yes, I have a question about the scope of the projects. In one month's time, I'm thinking that it should be equivalent to an R01, but it sounds like it would be smaller? And then the second question is, are there different types of projects? For example, (a) formative (project) that would then lead into something of a more randomized controlled trial, would that be acceptable?

I know there's always issues about dependencies when you do things like that. So the two questions are the scope of the project and also the issue if we do formative work and then more or less the outcome type work that's not ran by trial, what about the issues of dependencies in proposing something like that?

Mary Barton: Well, I think 3 years' time is such that you wouldn't have a dependency issue necessarily, because the formative—if you had formative research as one of your four projects that would lead to a future RCT that was not funded by the 3-year program project, that would be okay.

Rita Cucaska: Okay.

Mary Barton: The scope question; you know, I think certainly some of the projects are going to come in with one of their four projects being R01 ties. And some might cobble it together so that none of them quite are. I think those are okay.

Rita Cucaska: Okay. Let me just clarify, so you're really not looking for something as big as a RCT?

Mary Barton: No, I can imagine all kinds of RCTs that one might be able to do within 3 years. As long as you're not trying to have a multinational (trial) with all kinds of people in it.

Rita Cucaska: Right, sort of a smaller scale. And my, another question I have is related to the training, because some of that was already answered, and thank you for that. But when I think about the training, there's new people bringing a new method. To what extent could those methods actually influence the project that we propose? So the training is not for the personnel for part of the project, (it's) more for the outside community?

I'm thinking of this as being more dynamic or not dynamic. If we propose, let's say, a novel method and then we use, we train our investigators at one of the projects, it's a novel method that might change what we initially proposed or be more fixed in terms of proposing right up front.

Mary Barton: In terms of the fix, you're pretty fixed.

Rita Cucaska: Okay.

Mary Barton: Proposing, but—I would say, what I think I heard is a different question. You know, would it be appropriate to train the center faculty? I would say probably, you know, again, it's going to be a question that your peers will, you know, stats and compare, you know, take a close look at the benefits that they would see.

David Meyers: You also would want to consider that while there's an initial 3-year period, that the grants and all of the projects proposed do need to be defined and conducting sometime during those 3-year periods. There's the plan for a 2-year renewal, so the idea is that you're doing in Year 1 and 2 a formative project that you can see how you would, and train your methodol(ogy)—and team up to be ready to do something novel with that information, so that when you put in for your continuation with the next 2 years, you would have a new study, or an expansion on the study, or building on the study that we've used.

So there is a way to be thinking about moving forward even within that. It's also important to remember here that the core is designed not to be completely (and) only limited to the four—two to four—projects defined here. I hope that you will be beaconed for the institution, for the country, and that you will find that the core will allow bringing people together to apply for other studies and support other research for the development of other research ideas and projects.

So very much we're hoping that the training will be a dynamic force that will lead the whole project forward.

Rita Cucaska: I'm sorry, I have one more followup to that. Should we be explicit about what we would propose in a 2-year extension? Should that come about?

Mary Barton: I think you are welcome, in this very limited space, if you feel like you have space, to say anything about, you know, a part of a paragraph on what you think the future work of such a center would be. That's okay, but you're absolutely not expected to lay out any plans for that next time period.

Rita Cucaska: Thank you.

David Meyers: We've got more pages.

Coordinator: Our next question comes from Khan Pao. Your line is now open.

Khan Pao: Yes. You indicated that one of the core functions would be related to evaluation. I was hoping that you could say something more about that. I assumed that that includes the evaluation of the center. If you could give us some sense of your expectations for evaluation of the center?

Mary Barton: Well, the Technical Systems Center will be facilitating this work and probably leading to a common, partially common, strategy across the three centers. But some, you know, conceivable things that I could imagine would be, that there would be evaluations of the value of the core, how many educational programs did they do, or how many different faculty in the institutions did they touch, or how did the advanced methods of that statistician that I mentioned before work? You know, end up drawing benefit for the different, you know, the small two to four projects that are being done. Those are the kinds of things. It is absolutely meant to be an evaluation of the center.

Khan Pao: Good, okay, that's very helpful. And we talked, you talked, a lot about the training core. Could you say something more about education, how you see education differing from training?

Tess Miller: I don't think we see any difference. Perhaps, could you ask something more specific, then we might be able to help you a little?

Khan Pao: Actually, you answered my question.

Tess Miller: Okay.

Coordinator: Our next question comes from Cynthia Boyd. Your line is now open.

Dr. Cynthia Boyd: Yes. I was interested in knowing if there is a specific structure of this core that you're looking for? Whether that you are looking for cores within it that perform these functions or if it's really meant to be one core that performs their required functions? And obviously, those that might enhance the ability of the center to be the beacon you described.

Mary Barton: Hi, Dr. Boyd.

Dr. Cynthia Boyd: Hello.

Mary Barton: I think that the—I think that however a center wants to call it is not that important to the fact that there might be some centers that propose just a group of, you know, eight faculty and then go on to describe what expertise is going to come from out of the core, out of those eight people. And other places might because maybe your institution is going to require you to subcontract over to the school of public health or something, I don't know. So you might, you know, there might be reasons why you have to name this is the methods core, or this is the programming core, but really, I think that depends on the particular situation.

Dr. Cynthia Boyd: May I ask a followup question that's related?

Mary Barton: Sure.

Dr. Cynthia Boyd: If so, could you speak a little bit about the target of dissemination and whether that might vary depending on which of the themes that you were doing? The patient safety versus equity versus implementation.

Mary Barton: I think that it would vary depending on the area.

Dr. Cynthia Boyd: So that sort of is open for us to argue our case for who we think the important people...

Mary Barton: I think it goes back to that, you know, you think about telling a story...

Dr. Cynthia Boyd: Right, right, right.

Mary Barton: ...in terms of the dissemination, you know, who is the important people to learn what you've learned? And I do think that would vary depending on the area.

Dr. Cynthia Boyd: Thank you.

David Meyers: It might even come up on the project.

Mary Barton: Yes, yes.

Dr. Cynthia Boyd: Thank you.

Coordinator: Our final question in queue is from Dick Warley. Your line is now open.

Dick Warley: Yes. Question related to a specific type of project dealing with prescription abandonment, which is up to somewhere in the neighborhood of 20% to 30% of prescriptions that are written in the U.S., and looking at methodologies to debate and growth and also the whole area. You mentioned the clinical area, and so a pharmacy is a clinical area, but it would be related back to the physician, so that type of project, it is providing education of the practitioner as well as patients. Does that fit within that scope of patient safety?

Mary Barton: While we certainly would say that pharmacists are part of the formal health care system, the abandon, you know, the fact that people just don't fill their prescriptions is not what we see as an important part of clinical preventive services. It's an important thing, but it's not an important part of clinical preventive services.

Dick Warley: Okay.

Coordinator: There are no further questions in queue.

Mary Barton: We're going to mute for just one second here.

Okay, well thank you so much for your patience. We had gotten a few questions before the call, and we wanted to make sure that if there was any of them that was very important to clarify, that we took this opportunity to clarify it.

So, someone had asked whether this program project would look like, would work like, an NIH program project, and our best answer to that is to look at this FOA and look at the specifics and the detail in this AHRQ Funding Opportunity Announcement and let that be your guide. Another question had come in about whether an eligible institution had to have a research background, and the answer is yes. I think that there are ways that one could imagine a coalition that included different types of institutions. But it is hard to imagine the peer review comparing an institution without any research experience to what I expect will be a number of center applications from places that have significant history of NIH-funded or AHRQ-funded research, then it would be hard to compete.

Another question was about, and actually this came up earlier in this call, about whether something the size of an R01 couldn't be done. And I do just want to point out that 70% of the annual budget is expected to be based on the research—30% on the core, 70% on the research. So you're talking in the neighborhood of $1 million a year, and you can apportion that among your 2- to 4-year project as you would like. It doesn't have to be equally proportioned, it could be some big, some small. So it certainly seems feasible that there would be an R01 sized project in there that could be done in 3 years.

So I just wanted to be sure that you all left with that same impression that we have. Are there any final questions, Erin, that we can ask our audience if they have?

Coordinator: You do have one more in queue, would you like to take it at this time?

Mary Barton: Sure.

Coordinator: Okay. Ally Kemp, your line is now open.

Dr. Ally Kemp: Sorry, one more followup.

Coordinator: Ally Kemp, your line is now open.

Dr. Ally Kemp: Thank you. One more followup question, quite specific. Letters of support: for example, from collaborators in the projects or, specifically as mentioned, a need for institutional support. Are those part of the 3-page limit?

Mary Barton: No.

Dr. Ally Kemp: Okay, so are they included then in the appendix? We should put that in the appendix? That's a DVD or CD or some...

Mary Barton: Yes, it's at the end of the application. Yes, or at the end of the application be sure to put in the table of contents that that's where you got the letters of support, and the reviewers will find them.

Dr. Ally Kemp: Great, so not part of the 30 pages.

David Meyers: Right.

Dr. Ally Kemp: Terrific. Thank you.

Mary Barton: Well, thank you all so very much for your interest and we look forward to answering any other questions that you have. You have that contact list with our E-mail addresses, and we will be posting both the transcript and the recording of this call, as well as potentially some other questions that come in by E-mail. So thank you all very much.

Coordinator: Thank you for your participation in today's conference call. You may disconnect at this time.

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