The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors held a special open meeting on Wednesday, April 25, 2012, using a teleconference/webinar format. The Board discussed and voted on PCORI’s revised National Priorities for Research and Research Agenda as well as reviewed proposed Pilot Project funding awards.

1. Patient-Centered Outcomes
Research Institute
Special Public Board of Governors
Webinar and Teleconference
April 25, 2012

2. Welcome and Introduction
Eugene Washington, MD, MSc, Chair, PCORI Board of Governors
Joe Selby, MD, MPH, Executive Director, PCORI
Special Public Board of Governors Webinar and
Teleconference
April 25, 2012

3. PCORI Pilot Project Program Award
Recommendations
Christine Goertz, DC, PhD, Member, PCORI Board of Governors
Special Public Board of Governors Webinar and
Teleconference
April 25, 2012

4. The Process
The decision was made to eliminate all applications with a score
Step One: above 3.0 from consideration for further funding. This yielded a
Determine Universe potential fundable pool of 80 applications.
The criteria to be used for balancing were refined and two
Step Two: Determine options for selecting a base slate of applications were proposed.
Approach
Staff applied the two selection process options to the top 80
Step Three: Develop applications, yielding two possible sets of fundable applications
Core Slates (one with 37 selected; the other with 50).
Using the balancing criteria staff analyzed the balance of each of
the two possible sets to determine if balance was achieved or if
Step Four: Analyze
additional balancing activities would be required.
Balance
The Selection Committee reviewed the two possible sets of
fundable applications to determine if balancing was needed. The
Step Five: Make Final
group decided on two options for the Board and selected one for
Recommendation
recommendation.
The Board of Governors will vote on the recommendation.
Step Six: Approve
This process was completed using only generalized information regarding the applicant. No Selection

5. Rationale for Selection Method
The selection comm. considered all potential options for selecting the slate of
fundable applications and decided to go with an option that would use priority
score first and then ensure the top two applications were selected in each
review group. All selection committee members were blinded as to the names
and affiliations of the applicants.
• Percentiles (as noted on the NIH web site) are calculated usually for study
sections that have had at least three meetings – traditionally, the last three
rounds during a year. Thus, percentiles for the Pilot Projects Program do
not have the same meaning as NIH percentiles. They reflect the
application’s ranking within a single study section meeting.
• Priority scoring is likely to be the most reliable measure across all groups
since all reviewers had the same training regarding how to score.
• We don’t know (since there is no history to the review group) if a “poor”
score is due to a review group that just scores “harsher” or the grants they
had were just not very “good”.

6. Rationale (cont’d)
• NIH attempted to assign applications to reviewers based on areas
of interest, though it was difficult given the large number of
applicants and PI’s did not necessarily self-assign correctly as well
as listing more than more area. Thus, the assignment was
imperfect and an applicant that was not funded (if we used
percentiles as the primary selection criteria) could argue s/he
might have been funded had s/he been assigned “correctly”.
• However, we did want to take into consideration the potential that
some groups could be harsher and give some weight to ranking
within the review group – so, we decided to also pick up the top
two applications in each review group.

7. Balancing Criteria
Eight potential criteria were discussed and
refined. The top four were proposed as the
most appropriate for balancing.
Balancing
Definition Operationalization Source
Criteria
At least two members of the Selection
The eight areas of interest listed in At least 2 unique applications but no Committee read each application
Area of Interest*
the PFA more than 50% in any one area abstract and determined the primary
areas of interest.
Defined as addressing 1) Specific PCORI staff reviewed abstracts to
ethnic or cultural group, 2) At least 1 application in each of the determine if the application had a clear
Population*
disabled populations, 3) children, four categories focus on one or more of the four
and 4) elderly populations. populations.
The disease or condition used to No more than 25% in any major Staff reviewed the abstracts to
Condition*
demonstrate the approach category within the final slate. categorize conditions addressed, if any
The average score given by the Any application added to the core
Stakeholder/Patient The average score from the IRG review
three reviewers for this criterion in slate will have a score of 1 or 2 (except
Involvement* was used.
the initial merit review group methods focused applications)
Geographic location of institutional Will be reported but not used for The state or country on the application
Geography
affiliation balance. face page for the PI.
Only to be used if balance is needed
The innovation of the research The methodology committee would
Method within the area of interest related to
method make the determination, if needed.
methodologies (8).
Categorization of PI qualifications
PI Discipline Insufficient data to use
based on primary area of expertise
Whether the PI has received
PI Seniority Insufficient data to use

8. Option 1: Balancing
Option 1 takes the applications with a priority score of 25 or better and ensures
at least the top two applications from each panel are included. This option
yields 50 applications and has only one balancing issue:
 Issue: Area of Interest 4--There are no applications within this slate with that
designation as a primary area of interest.
Developing, refining, testing, and/or evaluating methods to identify gaps in CE knowledge such as
tools for the ongoing collection and assessment of gaps as perceived by patients and providers. Of
special interest are gaps that are particularly relevant to vulnerable populations, including but not
limited to, low-income populations; underserved minorities; children; the elderly; women; and
people with disabilities, chronic, rare, and/or multiple medical conditions.
 Balancing Recommendation: There are no applications within the top 80
that have this designation as a primary area of interest. The committee
recommends we not balance on this area and propose it be a focus in one of
the new PFA’s or use a contract mechanism to address.

9. Option 2: Balancing
To remain as close to 40 grants (number approved by the BoG), option 2 takes applications
with a priority score of 24 or better and ensured the inclusion of the top application in each
review panel. This resulted in 37 applications.
1. Issue: Area of interest 4— This is the same issue encountered under Option 1.
Recommendation: This issue should be handled in the same way as in Option 1.
2. Issue: Area of interest 1—There is only 1 application within the slate that addresses this
area.
Developing, testing, refining, and/or evaluating new or existing methods (qualitative and quantitative) and
approaches that can inform the process of establishing and updating national priorities for the conduct of
patient-centered outcomes research (PCOR). This may include research prioritization approaches (such as Value
of Information (VOI), burden of illness, peer review/expert opinion/Delphi approaches) or methods for
incorporating the perspectives of patients or other stakeholders into the development of national priorities.
Recommendation: To add an additional application with a primary area of interest of
1, the committee looked within those applications with a priority score of 25. Within
that group there is one application with a primary area of interest of 1.

10. Discussion and Voting
Selection Committee
Recommendation
• The committee recommends the Board vote for Option 1 and that
we not try to balance on Area 4.

11. Board Discussion and Consideration
of PCORI Pilot Project Program
Award Recommendations
Special Public Board of Governors Webinar and
Teleconference
April 25, 2012

12. Draft National Priorities for
Research and Research Agenda
Leah Hole-Curry, JD, Member, PCORI Board of Governors
Special Public Board of Governors Webinar and
Teleconference
April 25, 2012

13. Objectives for Today
 Review Genesis of National Priorities and Research Agenda
 Review Public Comment Process
 Share Public Comment Findings
 Recommend PCORI Response
 Board Vote on Recommended Changes
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14. The What and Why of National Priorities and Research
Agenda
 Mandated in the legislation (including
Public Comment period)
 Pre-requisite for releasing funding
announcements
 Preliminary roadmap for PCORI research
activities
 Envisioned as a living document
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15. Development of Draft National Priorities and
Research Agenda
Environmental Framework to
Candidate
Initial Stakeholder scan of existing inter-relate
priorities and
feedback priorities and Priorities and
criteria identified
criteria Criteria
Reviewed initial Reviewed prior CER Identified broad Developed
stakeholder input frameworks (e.g., priorities from prior Framework to be
advising us to not IOM, FCCCER, frameworks and the used for refining
“reinvent the wheel” National Priorities statutory criteria for priorities and for
Partnership, and PCORI determining
NQF) Research Agenda
and funding
announcements
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16. Establishing PCORI’s First National Priorities
for Research and Initial Research Agenda
First primary
9 5 Corresponding
Public input Priorities and
funding
Criteria outlined Draft priorities received and agenda revised
agenda drafted announcements
by law proposed evaluated and approved
issued
Aug-Dec 2011 Jan-Apr 2012 May 2012
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17. Patient and Caregiver Focus Groups
Baltimore, MD (Nov. 9) Atlanta, GA (Nov. 21)
• Patients with Arthritis • Patients with Diabetes
• Parents of children with Pediatric • Caregivers to Alzheimer’s patients
Asthma (caregivers) • Patients with Chronic Pain
• Patients with mix of chronic • Insured and uninsured
conditions • Age: 21-75+
• Insured and uninsured
• Age: 21-69
Columbus, OH (Dec. 7) Phoenix, AZ (Dec. 8)
• Parents of children with ADD/ADHD • Patients with Respiratory Disease
(caregivers) (chronic bronchitis, emphysema)
• Patients with Mental Health • Hispanic patients with mix of
conditions chronic conditions
• Patients who survived Cancer • Patients with Heart Disease
• Insured and uninsured • Insured and uninsured
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• Age: 30-70+ • Age: 21-69

18. Receiving Public Feedback on the National
Priorities and Research Agenda
• Clinician Focus Groups
o Clinician focus groups took place in cities across the US
o Philadelphia
o Birmingham
o California
o Chicago
o Four groups of physicians and four groups of nurses
o Behavioral Health Professionals
o Physician Assistants
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19. A commitment to public engagement
Formal 53-day Public Comment Period
• Nearly 500 comments received through
website, e-mail or postal mail
• All comments will be posted at pcori.org
Additional Forums
• National Patient and Stakeholder Dialogue
• Patient, caregiver and clinician focus groups
• Individual meetings with diverse mix of
stakeholders
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20. Public Comment Yielded Diverse Array of Input
and Feedback
Broad range of comment sources
301 Web survey (64%) 116 Email/ letter (24%)
474 Total Comments
57 Stakeholder event (12%)
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21. Those Who Commented Said They Understand
the National Priorities…
Assessment of Options Improving Healthcare Systems Communications and Dissemination Research
Addressing Disparities Accelerating PCOR and Methodological Research
“How well do you understand
the National Priorities?”
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22. Rigorous, Systematic Review and Analysis
of Comments
Computer algorithm to identify key terminology
Each narrative comment reviewed and analyzed by
3 people
Stakeholder comments aggregated to 15 key
themes
Themes compared to National Priorities and
Research Agenda to identify gaps
Gaps reviewed to determine options for PCORI
response to themes
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23. Options for Response
 Change Language Within the Research Agenda
 Embed in PCORI Operations and Processes
 Address in Summary Document
 Future Consideration
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24. PCORI Response to Key Themes-1
Recommends that PCORI choose a specific condition, disease PCORI has proposed a condition-neutral Research Agenda and has introduced
area, or other issues in the Research Agenda and National specificity through its comparative nature and emphasis on patient centeredness.
Priorities While future funding announcements may specify conditions, the overall mission of
PCORI is not served by excluding any conditions if there is compelling reason for a
patient centered, comparative clinical effectiveness study. We added language to
elaborate on our position.
Recommends that PCORI partner with organizations and PCORI is committed to efficient use of its research investments. Where appropriate,
stakeholders to carry out its mission PCORI will partner with other organizations after a transparent decision-making
process and consideration of conflicts of interest. This theme impacts PCORI
processes, rather than funding subjects, so no specific language changes were made
to the document.
Recommends greater focus on the patient, with particular PCORI has fully endorsed and appreciates the centrality of patient engagement to its
attention to methods of engagement mission. The National Priorities and Research Agenda reflect the patient centered
focus of PCORI and include many of the themes from the public comments.
Language has been added to the Agenda to specifically reflect the need for study of
self care and to more clearly define personalized medicine.
Recommends a greater focus on care coordination PCORI appreciates the need to study care coordination and has expanded the
language in the Research Agenda to reflect its importance.
Recommends funding towards improving patient and provider Improving communication between patient and provider is one of the five PCORI
health literacy and education National Priorities for Research. Language has been added to the Research Agenda
24 to reflect the importance of health literacy to achieving this goal.

25. PCORI Response to Key Themes-2
Recommends funding for and use of health IT The foundation for performing comparative clinical effectiveness requires substantial
infrastructure, networks, tools and patient data acquisition efforts health IT and data infrastructure. The National Priorities and Research Agenda
in and outside the practice setting contain substantial language about this infrastructure. Therefore, no additional
language was added to the document. PCORI will support reusable infrastructure for
comparative clinical effectiveness research.
Recommends that PCORI pay greater attention to the role of PCORI appreciates the role of caregivers in patient centered care and has mentioned
caregivers and other stakeholders in the patient decision making them in the document and included studies of caregiving in the Research Agenda.
process Therefore, no additional language was added to the document.
Recommends that PCORI pay greater attention to access to Access to care is a key issue for patients. Language has been added in both the
care, including the social and environmental determinants that comparative assessment and the healthcare systems Research Agenda topics to
determine access and use of care include the comparative study of access as a determinant of health.
Recommends that PCORI provide greater rationale and PCORI is committed to fully transparent processes as it works towards achieving its
transparency in the public comment, grants, and research mission. The Research Agenda articulates the ongoing engagement that will occur
evaluation processes, as well as the performance measurement continuously as PCORI evolves and funds research. Therefore, no additional
process for PCORI as a whole changes were made to the document. PCORI intends to roll out a comprehensive
communications and engagement plan that will clearly define when and how
stakeholders can provide input into PCORI decision making.
Recommends that PCORI's research and funding should impact PCORI is fully committed to the idea that its research should improve decision making
the practice setting, with particular attention to patient and and help patients at the point of care. Language has been added to the section
provider behavioral change needed to obtain true shared decision “Establishing the Scope of the Research Agenda” to emphasize the importance of
making using the evidence developed through PCORI research to change the way medicine
25 is practiced.

26. PCORI Response to Key Themes-3
Recommends that PCORI place stronger emphasis on patients PCORI understands the difficulty of managing multiple chronic conditions when most
with multiple conditions, especially chronic conditions evidence is generated in trials that exclude these patients. Language has been added
to emphasis this in the Research Agenda.
Recommends that PCORI study new and expanded roles for PCORI recognizes the diverse health professionals involved in patient centered care.
allied health professionals In the Research Agenda, the description of allied health professionals has been
expanded to be more inclusive of all of potential members of a health care team.
Recommends paying attention to international models PCORI recognizes the significant achievements of many countries in developing the
methods and practices of patient engaged comparative clinical effectiveness research
that may inform investigators as they seek PCORI funding. As this is not central to
PCORI research, no change is proposed to the priorities or agenda.
Recommends exploring novel methods to obtain patient centered PCORI supports the approach of exploring innovative methods for focusing on the
focus patient. The fundamental basis of PCOR, however, is the science of evidence-based
medicine. PCORI will support and promote approaches that seek rigorous, scientific
results; therefore no changes were made to the document.
Recommends that PCORI study rare diseases PCORI recognizes the challenges faced in studying rare diseases. In the Research
Agenda, language about rare disease has been expanded.
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27. Discussion

28. Vote on Changes Outlined in Slides 13-15

29. Thanks
 PCORI Stakeholders
 Thank you for your thoughtful input into the first version
of the PCORI National Priorities for Research and
Research Agenda
 PCORI Program Development Committee
 Thank you for all your hard work in the development and
refinement of these documents
 The detailed Summary Document of changes to the National
Priorities and Research Agenda will be posted on pcori.org
by April 30, 2012
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30. Patient-Centered Outcomes
Research Institute
Special Public Board of Governors
Webinar and Teleconference
April 25, 2012