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<p><strong>You Are Here:</strong> <span class="crumb_link"><a href="/" class="crumb_link">AHRQ Archive Home</a> &gt; <a href="granarch.htm" class="crumb_link">Grant Archive</a> &gt; Technical Assistance Conference Call</span></p>
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<td><h1><a id="h1" name="h1"></a>Orthopedic Registry Funding Opportunity Announcement</h1> </td>
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<p>This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: <a href="https://info.ahrq.gov/">https://info.ahrq.gov</a>. Let us know the nature of the problem, the Web address of what you want, and your contact information. </p>
<p>Please go to <a href="https://www.ahrq.gov/">www.ahrq.gov</a> for current information.</p></div>
<h2>Questions and Answers</h2><h3>Highlights from Technical Assistance Call</h3>
<hr />
<p>The following questions and answers were submitted during 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), <strong>RFA-HS-10-1008: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50).</strong> Select to access the <a href="http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-008.html">FOA</a>.</p>
<hr />
<p><strong>Question:</strong> How many
investigators are required in the application and what are their roles?</p>
<p><strong>Answer:</strong> 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. </p>
<p>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. </p>
<p> The PI
may designate additional individuals to lead other activities to best meet the
needs of the registry. </p>
<p>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. </p>
<p>All
investigator roles must be defined and justified in the budget.</p>
<p><strong>Question:</strong> Can an
application that proposes a different program director (PD) 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?</p>
<p><strong>Answer:</strong> 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.</p>
<p> 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.</p>
<p><strong>Question:</strong> Must the
research and data coordinating center be physically located at the PD or PI's institution?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> 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?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> What are the
required qualifications for the PI and clinical site co-investigator?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> What are the
role and membership composition of the Registry Steering Committee, and how are
the Registry Steering Committee chairperson and members selected?</p>
<p><strong>Answer:</strong> The FOA 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.</p>
<p> 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.</p>
<p> The
Registry Steering Committee will also include the AHRQ program official and representatives from the
Centers for Medicare &amp; Medicaid Services (CMS) and the Food and Drug
Administration (FDA) as nonvoting ex officio members.</p>
<p><strong>Question:</strong> Can
investigators from for-profit or non-U.S. institutions participate in the
application?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> Can one of
the collaborating sites in the registry participate in more than one
application?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> Can the
application include more than five participating sites, including
community-based practices?</p>
<p><strong>Answer:</strong> 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.</p>
<p> 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.</p>
<p> As a
whole, the registry will enroll eligible patients and assess clinical
interventions on a broad range of diagnostics and therapeutics.</p>
<p><strong>Question:</strong> Can you
discuss &quot;national&quot; as it applies to a registry of five sites?</p>
<p><strong>Answer:</strong> 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.</p>
<p> 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.</p>
<p><strong>Question:</strong> 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.</p>
<p> 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 <a
href="http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-010.html">http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-010.html</a>.]</p>
<p><strong>Question:</strong> 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?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> Is the
primary goal of this request for applications (RFA) to create a national
registry or to conduct comparative effectiveness research?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> 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?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> Should this
registry address orthopedic practice beyond total joint replacements? What
about drugs, as mentioned in the title?</p>
<p><strong>Answer:</strong> 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.</p>
<p> 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.</p>
<p><strong>Question:</strong> What
outcomes is AHRQ most interested in studying within the 4-year timeframe of
this FOA?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> Does the FOA
require a process for the collection of patient-reported outcomes?</p>
<p><strong>Answer:</strong>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.</p>
<p><strong>Question:</strong> Can you
explain the relationship you expect with national specialty societies and Federal
agencies established before the award and during the application preparation?</p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> The FOA specifies collection of &quot;all data from all patients.&quot; Genetic
studies are often difficult to do with so many sites. Does this characterization
of all data for all patients included genetic data?</p>
<p><strong>Answer:</strong> 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, those data can potentially be included in
the research plan.</p>
<p><strong>Question:</strong> As I read
the FOA, it doesn't seem that it's necessary 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. 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? </p>
<p><strong>Answer:</strong> 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.</p>
<p><strong>Question:</strong> To what
extent is AHRQ 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?</p>
<p><strong>Answer:</strong> Yes, those
types of things can be included. 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.</p>
<p><strong>Question:</strong> This question
is related to subcontracts from the primary. What guidance is there regarding
subcontract budgets related to indirect costs and caps on salaries? Are there specific
thresholds that were required, or preapproval from the agency?</p>
<p><strong>Answer:</strong> There's no
specification in the FOA with regard to percentage of facilities and administrative (F&amp;A) 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. </p>
<p><strong>Question:</strong> 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.</p>
<p> 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?</p>
<p> 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.</p>
<p><strong>Answer:</strong> As far as
combining prospective and retrospective data, that is certainly possible. As
far as continuing funding, this is initial effort in the area, and we can't
comment on whether there would be additional opportunities for funding in the
longer term.</p>
<p><strong>Question:</strong> Regarding
the data confidentiality section of the plan, would there be any special
protections for registry data from discoverability in the event of legal
actions against device companies or payers or anything of that nature related
to safety?</p>
<p><strong>Answer:</strong> 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: <a
href="/fund/datamemo.htm">https://www.ahrq.gov/fund/datamemo.htm</a>. </p>
<p class="size2"><a href="orthregtacall.htm">Return to Technical Assistance Conference Call</a></p>
<p class="size2"><em>Current as of August 2009</em></p>
<!-- <hr />
<p class="size2"><strong>Internet Citation:</strong></p>
<p class="size2"><em>Technical Assistance Conference Call for Applications to
AHRQ's Orthopedic Registry Funding Opportunity Announcement: Questions and Answers</em>. August 2009. Agency for Healthcare
Research and Quality, Rockville, MD. https://www.ahrq.gov/fund/orthregqa.htm</p>
<hr /> -->
<p>&nbsp;</p>
<div class="footnote">
<p> The information on this page is archived and provided for reference purposes only.</p></div>
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