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Orthopedic Registry Funding Opportunity Announcement

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Technical Assistance Conference Call

This document is a transcript of a technical assistance teleconference call that took place on August 17, 2009, from the Agency for Healthcare Research and Quality (AHRQ) on the Agency's funding opportunity announcement (FOA), RFA-HS-10-1008: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50). Select to access the FOA.


Coordinator: Welcome and thank you for standing by. All lines will be in listen-only mode until the question and answer session. Please press star 1 to ask your question. Today's call is being recorded. If you have any objections, please disconnect.

I would like to introduce your host, Karen Siegel. Thank you. Please begin.

Karen Siegel: Thank you. Good afternoon, or good morning to those of you on the West Coast. I am Karen Siegel, a Health Scientist Administrator here at the Agency for Healthcare Research and Quality. I'm very pleased to welcome everyone to this technical assistance call for the Orthopedic Registry FOA [Funding Opportunity Announcement], RFA-HS-10-008.

The first person I would like to introduce to you all is Jean Slutsky, the Director of the Center for Outcomes and Evidence, who will make a few opening remarks.

Jean Slutsky: Thank you for your interest in this Funding Opportunity Announcement.

In 2003 the Medicare Prescription Drug, Improvement, and Modernization Act, or MMA, was enacted into law. Section 1013 of MMA authorized AHRQ [the Agency for Healthcare Research and Quality] to conduct research, demonstrations, and valuations designed to improve the quality, effectiveness, and efficiency of Medicare, Medicaid, and the State Children's Health Insurance Program, or SCHIP, thus establishing the Effective Health Care Program at AHRQ. The Effective Health Care Program focuses on evidence of the relative benefits and risks of alternative interventions. The program is intended to help build research capacity and provide for support that is specifically intended to fill priority research gaps informed by stakeholders and users. This Funding Opportunity Announcement was issued to help achieve the objectives of the Effective Health Care Program. Thank you again for your interest.

Karen Siegel: Thank you, Jean. Also here with me at AHRQ on this call are some other staff who will be involved in this Funding Opportunity Announcement in different capacities. And I'm going to ask them to introduce themselves to you.

George Gardner: My name is George Gardner. I'm the Chief Grants Management Officer.

Michelle Burr: My name is Michelle Burr. I'm from Grants Management here at AHRQ.

Debbie Rothstein: Hi. I'm Debbie Rothstein and I work in extramural research at AHRQ.

Ying Tian: Hi. This is Ying Tian. I'm the Scientific Review Officer at AHRQ.

Yen-pin Chiang: This is Yen-pin Chiang. I'm the Program Official here working with Karen on this FOA.

FOA Highlights

Karen Siegel: Thank you all. For today's call, first I'm going to provide you with a brief overview of the objectives and some specific elements of this Funding Opportunity Announcement. Following that, I will go through a set of frequently asked questions that we received or developed. And at the end, if there are any new questions from the audience that we will be able to respond to today, we will go over those as well.

The transcript of today's call, along with all the questions and answers that we address today, we hope to post on the AHRQ Web site by Friday, August 28.

I want to reiterate that the purpose of today's call is to review and clarify the Funding Opportunity Announcement. So if any statements we make today unintentionally contradict the FOA, the instructions in the Funding Opportunity Announcement will take precedence over our statements.

The goal of this Funding Opportunity Announcement is to support a large-scale multicenter registry that creates a sustainable data infrastructure that fosters the conduct of rigorous clinical and scientific research, including comparative effectiveness and safety research on hip and knee replacement devices and procedures from real-world experience.

AHRQ envisions that the approach will produce scientific evidence regarding the short- and long-term benefits and harms of implantable orthopedic devices and other related services. We hope the registry will be a model and basis for other national device and procedure registries, will actively disseminate study results into clinical practice, and ideally will serve as a resource for quality improvement initiatives.

I'd like to hit on some of the specific sections of the FOA and highlight some of the details for your attention.

As far as mechanism of support, this FOA will use the P50 Specialized Center Grant Mechanism.

Of the funds available, we intend to fund one application under this FOA for $12 million in total cost over 4 years. The total cost for each year must not exceed $3 million.

For eligible institutions, you may submit an application if your organization is a public or nonprofit private institution, such as a university, college, or a faith-based or a community-based organization. It could be a unit of a local or State government or an eligible agency of the Federal Government. Other possibilities include Indian or Native American tribal government that is either federally recognized, other than federally recognized, or a tribally designated organization.

For-profit organizations and foreign institutions may participate in projects only as members of consortia or as subcontractors.

Moving on to the principal investigator, any individual with the skills, knowledge, and resources necessary to carry out the proposed research as a principal investigator is invited to work with his or her organization to develop an application. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for AHRQ support. A minimum time commitment of 40 percent annual effort is expected from the principal investigator.

As far as cost sharing or matching is concerned, there is no cost-sharing requirement included in this Funding Opportunity Announcement, but AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources such as donated equipment or space, institutional-funded staff time and effort, or other resource investments to this effort. These resources can be included at the end of the budget justification section of the application. But institutional support dollars are not to be shown or included in the detailed section of the budget request.

I also would like to draw your attention to key dates in the announcement. Letters of Intent should be received by September 4, 2009. The application should be received by September 23 of this year.

Peer review: Generally, we expect peer review to occur within 4 months after the receipt date. The earliest anticipated start date for the research is generally 4 months after the peer review date.

Now going back to that Letter of Intent, that's due September 4. We will accept Letters of Intent from potential applicants, which will allow our staff to plan the peer review. Please include in the letter an acknowledgment of your interest in this funding opportunity that includes the number and title of the funding opportunity, a few comments on the subject of the proposed research, background expertise of key personnel, the nature and role of the participating institution, and the name and E-mail address of the principal investigator.

These Letters of Intent should be sent electronically by September 4, 2009, to me, Karen Siegel at the E-mail box I'll go ahead and spell that out. It's orthopedic, O-R-T-H-O-P-E-D-I-C, registry, R-E-G-I-S-T-R-Y. And that's one word altogether, no punctuation, no spaces, And this is in the Funding Opportunity Announcement.

When you submit the full application, we're requesting you use a paper Public Health Service form, PHS 398, to respond to this funding opportunity. And as I mentioned before, this must be received by September 23, 2009.

We want you to submit a signed, typewritten original of the application, including the checklists and three signed photocopies in one package, to the Center for Scientific Review at the National Institutes of Health [NIH]. That address is 6701 Rockledge Drive, Room 1040, MSD 7710, Bethesda, Maryland, 20892-7710 for regular mail. The ZIP for express or courier service is Bethesda, MD 20817. And again, that address is in the Funding Opportunity Announcement.

Also at the time of submission we request that two additional copies of the application and all copies of the appendix material be sent to me here at AHRQ. That's Karen Siegel, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality at 540 Gaither Road, Rockville, MD 20850.

The other item I want to draw to your attention is that personal delivery of the applications is no longer permitted. An explanation of that is in the NIH Guide. And that also is explained in the Funding Opportunity Announcement.

Finally, I want to discuss the application review criteria. Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group using the following criteria: significance, approach, innovation, investigators, environment, collaborative research experience, patient resources, and stakeholder involvement.

There are additional review criteria that include: degree of responsiveness, budget, inclusion, protection of human subjects from research risk, and privacy and security protections for patients.

So this concludes the overview of some specific elements of the Funding Opportunity Announcement.

Questions and Answers

Karen Siegel: I now will go through a set of frequently asked questions that we have developed based on questions that many of you have submitted via the Orthopedic Registry E-mail address.

Question 1: How many investigators are required in the application and what are their roles?

Answer: Only one principal investigator [PI] is allowed on the application at a minimum time commitment of 40 percent annually. The effort cannot be shared across more than one individual using the multiple PI format. The PI is the lead for the Research and Data Coordinating Center and assumes primary responsibility for overseeing the development and operation of the registry.

A lead co-investigator must be identified at each of at least five clinical centers or systems at a minimum effort of 25 percent annually per investigator. The PI may not serve as a lead co-investigator at one of the clinical centers. The PI may designate additional individuals to lead other activities to best meet the needs of the registry. Lead co-investigators for the proposed core research projects are not required to be different individuals from the clinical center leads or the PI unless desired by the PI. All investigator roles must be defined and justified in the budget.

Question 2: Can an application that proposes a different PD [program director] or PI structure be reviewed and fully considered for funding, such as the Research and Data Coordinating Center being a sub award from a clinical center where the PD or PI is located?

Answer: The Funding Opportunity Announcement describes separate roles for the PI at 40 percent annual effort and clinical center lead total investigators at 25 percent annually. The Research and Data Coordinating Center may be located at the same physical site as one of the clinical centers as long as a strong justification for this model is provided in the application.

Question 3: Must the research and data coordinating center be physically located at the PD or PI's institution?

Answer: The FOA requires that the PD or PI be the lead for the Research and Data Coordinating Center. So the application must provide a strong justification that this leadership can be accomplished effectively if the PI and the Research and Data Coordinating Center are at different physical locations.

Question 4: Is it possible for the percent effort for the lead PI and the clinical center lead co-investigators to be donated wholly or in part by the institution in a show of support, or must these amounts be included in the budget?

Answer: Investigator time can be donated by the institution. The percent investigator effort can be shown in the detailed budget request with an associated dollar value of zero. The value of this effort and institution contribution can be included in the text at the end of the budget justification section of the application.

Question 5: What are the required qualifications for the PI and clinical site co-investigator?

Answer: The reviewers will consider the expertise and experience of each investigator in any given application individually as well as the strength of the entire research team as a whole when scoring the application. The applicants are encouraged to document the proven leadership of the individual investigators and the research team in accomplishing complex clinical and research issues through collaborative effort across scientific disciplines and institutions. Such collaborative effort does not need to be limited to multicenter randomized controlled trials.

Question 6: What are the role and membership composition of the Registry Steering Committee, and how are the Registry Steering Committee chairperson and members selected?

Answer: The Funding Opportunity Announcement states that the Registry Steering Committee is the governing body of the registry development. Included in its voting members are the program director or principal investigator of the Research and Data Coordinating Center, the lead co-investigators of at least five clinical centers, a patient representative, and a chairperson, who will advise the principal investigator on research activities and functions and conduct the Registry Steering Committee meetings.

The chairperson and members of the Registry Steering Committee are appointed upon grant award. Accordingly, the FOA is silent on the selection of the chairperson except to say that the individual must be a well-regarded researcher with no substantial financial conflict of interest. The FOA does not preclude any other scientifically qualified individuals, including the lead co-investigators of the clinical centers, from being appointed as the chairperson of the Registry Steering Committee so long as the optimal functioning of the Registry Steering Committee and the objectivity and impartiality of the chairperson are ensured.

The Registry Steering Committee will also include the AHRQ program official and representatives from the Centers for Medicare & Medicaid Services and the Food and Drug Administration as nonvoting ex officio members.

Question 7: Can investigators from for-profit or non-U.S. institutions participate in the application?

Answer: The FOA states that foreign institutions and for-profit organizations may participate as members of consortia or subcontractors only. Therefore, any member of the research team except the PI could be located at one of these institutions and participate through a subcontract or as a member of a consortium.

Question 8: Can one of the collaborating sites in the registry participate in more than one application?

Answer: The FOA is silent on the subject, and there is no explicit stipulation prohibiting collaborating sites from participating in more than one application. Only one award will be made under this FOA.

Question 9: Can the application include more than five participating sites, including community-based practices?

Answer: The FOA requires that the application must include at least five clinical centers, each with sufficient patients to support recruitment in a variety of studies in the registry. The FOA expects that individual clinical centers will vary in nature and experience, and thus may represent both different patient populations and unique expertise.

The designated clinical centers could be a medical center with existing relationships with private or community hospitals and physician practices or any network or consortium structure of community hospitals and practices with demonstrated clinical research excellence and a proven ability to recruit patients from various racial or ethnic groups. As a whole, the registry will enroll eligible patients and assess clinical interventions on a broad range of diagnostics and therapeutics.

Question 10: Can you discuss "national" as it applies to a registry of five sites?

Answer: The application must describe the critical responsibilities of at least five clinical centers in recruitment of patients and data collection. It is expected that individual clinical centers will vary in nature and experience, and thus may represent both different patient populations and unique expertise. For example, the clinical centers could be geographically diverse major medical centers with existing relationships with private or community hospitals and physician practices. The objective of the FOA is to encourage the broad representation and the inclusion of a substantial number of patient populations receiving implantable orthopedic devices and other related services.

Question 11: What is the research plan page limitation? The FOA stated 25 double-spaced pages, while the default requirements for the PHS 398 Form used for the P50 grant application is 25 single-spaced pages.

Answer: The correct research plan page limitation should read 25 single-spaced pages. We published a Notice of Correction, Number NOT-HS-09-010 on August 6, 2009, to inform the scientific community that we are amending the erroneous instructions that appeared in the original FOA. And we will include the specific URL to this notice in the transcript. [The URL is]

Question 12: Should the three core projects be written as separate sections in the grant with their own specific aims, hypotheses, background and significance, preliminary studies, and research methods, or should these sections for the registry and core projects all be incorporated together under the same headings in the grant?

Answer: The FOA specifies a 25-page limit for the research plan. The general instructions on completing the PHS 398 also apply. Within those guidelines the PI can choose whatever format best presents the research plan.

Question 13: Is the primary goal of this RFA [request for applications] to create a national registry or to conduct comparative effectiveness research?

Answer: The purpose of this FOA is to develop a large, multicenter, preferably national orthopedic registry; to conduct rigorous clinical and scientific research with a primary focus on comparative effectiveness and safety research; and to develop scientific evidence regarding the short- and long-term benefits and harms of implantable orthopedic devices, drugs, and procedures. The two goals are complementary to one another.

Question 14: What should be the balance between a focus on comparative effectiveness vs. a focus on safety? And what type of safety research is AHRQ interested in from this registry?

Answer: Comparative effectiveness research is the conduct and synthesis of research comparing both the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. Therefore, safety is included within the scope of comparative effectiveness. One goal of this registry initiative is to support the development of a sustainable data infrastructure and to conduct rigorous clinical and scientific research including comparative effectiveness and safety research. So some safety questions could be answered within the 4-year core research studies and others in the long term through the infrastructure created by the registry.

Question 15: Should this registry address orthopedic practice beyond total joint replacements? What about drugs, as mentioned in the title?

Answer: The initial focus of the registry effort should be to develop the necessary infrastructure for data collection and comparative effectiveness research activities, with concentration on hip and knee replacement. The FOA does not preclude study aims in other areas of orthopedic practice, provided hip and knee joint replacement devices and procedures also are included within the scope of the overall project. The inclusion of drug data in the registry is an integral part of the comparative effectiveness research activities in ascertaining patient outcomes associated with joint replacement and other procedures.

Question 16: What outcomes is AHRQ most interested in studying within the 4-year timeframe of this FOA?

Answer: Some examples of the core research studies that would be responsive to the research plan requirements were included in the FOA. And those examples did include possible outcomes. However, the PI is free to choose the outcomes that best meet the aims of the research study proposed in the application.

Question 17: Does the FOA require a process for the collection of patient-reported outcomes?

Answer: The FOA states that the application should describe the willingness of all clinical centers in the study to collect all data elements across all study participants. Patient outcomes are no different from any other data element in that regard. It is expected that the applications describe the proposed data collection plans and infrastructure. The PI has flexibility in developing such plans to meet the goal. And such plans will be evaluated for responsiveness by the reviewers.

Question 18: Can you explain the relationship you expect with national specialty societies and Federal agencies established before the award and during the application preparation?

Answer: The FOA states the PI must hold preliminary discussions with relevant orthopedic specialty societies and other important stakeholders regarding any ongoing data standardization and transmission effort. Any discussions that help inform the proposed data collection plans and infrastructure may be useful prior to the award, but the PI has flexibility in developing plans to meet the goals of the FOA. Such plans will be evaluated for responsiveness by the reviewers.

This concludes our review of the prepared questions and answers.

Open Forum Questions and Answers

Karen Siegel: With the time remaining, we will now open the phones to participants for questions on topics we have not already discussed. I encourage you to ask general questions that will be of broad interest to all participants on the call. We may need to defer answers to questions about specific study elements on a per-investigator basis to a later time.

We are now ready for our first question.

Coordinator: Thank you. If you would like to ask your question, please press star 1 on your touch-tone phone. You will be announced prior to asking your question. To withdraw your question, press star 2. Once again, star 1 for any questions. One moment please for our first question.

Questioner 1: Thank you. We are thinking about the genetics and data collection around genetics. And you stated "all data from all patients." Genetic studies are often difficult to do with so many sites. And so we're wondering if this characterization of all data for all patients included genetic data?

Karen Siegel: Please stand by while we discuss the answer to your question.

Thank you for your question. Based on discussion here, those types of data are certainly not precluded from study by the FOA. The clinical centers participating need to agree to that. And provided you adequately describe the study and it's adequately powered, individuals here feel that that those data can potentially be included in the research plan.

Next question?

Coordinator: And I do have one more question.

Questioner 2: Hi. This is a similar question as it relates to collecting all data elements on all patients at all centers. As I read the FOA, it doesn't seem it's necessary, for example, to collect—it doesn't matter what data element we're talking about, but that every single center has to collect every single data point. If you go back to the goal of the project to develop an infrastructure that can be translatable into a national registry as well as do the core projects, that wouldn't be necessary in the research plan to accomplish that goal.

So again, I think it's similar to the last question on genetic data. Do you really expect, for example, if we have 15,000 patients a year, to collect all data points on all patients on all centers or just what we consider the minimum data set on all patients at all centers? Does that make sense?

Karen Siegel: Yes. We understand the question. Stand by.

Just to expand on what you've said, in terms of the FOA, there is certainly a set of data that we would like all clinical centers to agree on. But for the purposes of sub study, we would agree that there are additional data elements that could be added to meet the research aims for some additional study.

Questioner 2: Thank you.

Coordinator: And as a reminder, if there are any further questions, please press star 1.

And we do have a question.

Questioner 3: Thank you. I just wanted to ask to what extent AHRQ was interested in what happens to the patient before joint replacement surgery?  For example, if there's a physical therapy program that may be beneficial both before and after surgery, would that fall under this FOA?

Karen Siegel: Yes, those types of things can be included. And if you look under the section on clinical centers participating in the registry, there's a list of about nine examples of types of data that could be included. Rehabilitation is one example of the types of data that are listed in that section.

Questioner 3: Thank you.

Coordinator: There's another question.

Questioner 4: This question is related to subcontracts from the primary. What guidance is there regarding subcontract budgets related to indirect costs and caps on salaries? That's all.

George Gardner: There's no specification in the FOA with regards to percentage of F&A [facilities and administrative] costs allowed for the sub-recipients. In accordance with the HHS Grants Policy Statement, cost has to be reasonable, allocable, consistently applied, and in conformance with the terms and conditions of the award. This would also apply to sub-recipient cost as well. Did that answer your question?

Questioner 4: Yes. Thank you. It didn't know if there were specific thresholds that were required or preapproval from the agency.

George Gardner: No. There's no specific requirement regarding that in the FOA.

Questioner 4: Okay. Thank you.

George Gardner: But the salary cap in general does apply to any of your grants for personnel.

Questioner 4: Thank you.

Coordinator: We have another question.

Questioner 5: Hi. Thank you very much. The 4-year timeframe is not very long term when it comes to typical complications of joint replacements. For example, for hips and knees, many of the complications seen are 5 and 10 years out from implantation.

So I have a two-part question to AHRQ. The FOA talks a lot about prospective studies. To get 5- and 10-year outcomes, we may need to combine retrospective with prospective studies. Is that permissible?

And second, if we are to do prospective studies that look 5 and 10 years out, some of these studies would of course be part of the sustainable registry you discussed. But the question is whether AHRQ envisions continued funding beyond the 4-year timeframe. Looking for 5-year outcomes would be impossible given the FOA as designed.

Karen Siegel: As far as your first question about combining prospective and retrospective data, that is certainly something that's possible. And as far as continuing funding, this is initial effort in the area. And I can't really comment on this, at this point, as to whether there would be additional opportunities for funding in the longer term.

Questioner 5: Thank you.

Coordinator: Another question.

Questioner 2: Hi. Thank you. Actually the last question was exactly what I was going to ask. So it's been answered. Thanks.

Coordinator: And the next question.

Questioner 1: Pass. My question's been answered.

Coordinator: There is another question.

Questioner 6: Hi. I had a question regarding the data confidentiality section of the plan. I wondered if you could at all discuss if there would be any special protections for registry data from discoverability in the event of legal actions against device companies...

Man:  Or payers...

Questioner 6: ...or payers or anything of that nature related to safety?


Karen Siegel: Okay. We do have some documentation that covers some of this. But I think the best thing to do is for us to spend a little bit more time looking into this and have a more detailed answer in the transcript that we post online.

[The answer is as follows: The AHRQ Web site contains a legal analysis offered to be of assistance to potential grant applicants on the confidentiality of sensitive data collected for the Agency for Healthcare Research and Quality (AHRQ) research projects:]

Questioner 6: Thank you.

Coordinator: And if there are any further questions, please press star 1.

Karen Siegel: Okay, hearing none, I would like to thank all of you for participating in today's call.

As we've mentioned several times today, the transcript of today's call with all the questions and answers that we've addressed will be posted on our Web site, hopefully by Friday, August 28. Thank you for your participation. That concludes today's call.

Coordinator: Thank you. You may disconnect at this time.

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Current as of August 2009


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