Board of Governors Meeting, Baltimore Maryland

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Patient-Centered Outcomes Research Institute
Communications, Outreach and
Engagement Committee (COEC)
Report
PCORI Board of Governors
Baltimore, MD
March 5, 2012

COEC Members
2
• Sharon Levine, MD (Chair)
• Debra Barksdale, PhD, RN
• Robert Jesse, MD, PhD
• Grayson Norquist, MD, MSPH
• Ellen Sigal, PhD
• Harlan Weisman, MD
• Gail Hunt

3
COEC Report to the Board
I. Public Feedback on the Draft National Priorities and
Research Agenda
II. National Patient and Stakeholder Dialogue – February 27,
2012
III. Clinician Focus Groups
IV. Incorporating Input into Revisions of Draft National Priorities
and Research Agenda
V. Stakeholder and Community Engagement Events Associated
with Board Meetings
VI. Connecting with PCORI

4
I. Public Feedback on the Draft National
Priorities and Research Agenda
• Formal public comment period
o January 23-March 15
o www.pcori.org/survey/priorities-agenda
o Responses received through www.pcori.org
posted for public view on the website
o Opportunity for feedback by mail

5
I. Public Feedback on the Draft National
Priorities and Research Agenda
• Comments received to date
o 101 comments received through March 1
o Distribution of comments received:
o By stakeholder type
o By geographic location

6
Comments Received by Stakeholder Type
0
5
10
15
20
25
30
35
40
#ofcommentsreceived

7
Comments Received by Geographic Location

8
II. National Patient and Stakeholder
Dialogue – February 27, 2012
• More than 900 individuals
pre-registered to participate:
– 400 in person
– 530 by webcast or phone
– Actual participation
exceeded 850
• Watch the archived webcast on
pcori.org
– Visit Past Meetings & Events
page

9
Dialogue – Highlights
• Presentation by Board Member Harlan Krumholz on the draft
National Priorities for Research and Research Agenda
“Our true North is our patients”
• Two panels:
• Patient and Caregiver Advocates (American Cancer Society,
Autism Speaks, National Alliance for Hispanic Health, National
Alliance on Mental Illness, National Health Council)
• Clinicians and Other Stakeholders (Aetna, American
Academy of Family Physicians, American Medical Association,
American Nurses Association, National Business Group on
Health, PhRMA)

10
• 57 public comments or statements provided:
– 11 panelists
– 46 individuals in person
– 8 individuals by phone
• Event Evaluations by those Attending In Person:
– 90% of respondents felt event was informative
regarding the National Priorities and Research Agenda.
– Just under 85% felt panel discussions helped provide
context for the National Priorities and Research Agenda.
Dialogue – Highlights

Focus Groups – Additional Feedback on the
Draft National Priorities and Research Agenda
• Patient and Caregiver Focus Groups
– 12 groups in 4 cities, 96 participants
– Reported on at Jacksonville Board meeting
• Clinician Focus Groups
– 9 groups in 4 cities, 58 participants
– Conducted February 8-16
11

12
III. Clinician Focus Groups
Purpose, Objectives
• Obtain detailed feedback from clinicians discussing
PCORI’s draft National Priorities for Research and initial
Research Agenda.
• Explore research priorities from the clinicians’ perspective,
their understanding and reaction to PCORI’s proposed
priorities and agenda, as well as general opinions about
PCORI’s work.
• Better understand practice needs, clinical issues, and how
new research-based information can be helpful.

San Francisco, CA
• Group 1: Integrative Health Care
Practitioners
• Group 2: Physician Assistants
13
Focus Groups Nationwide with Clinicians
Chicago, IL
• Group 1: Advanced Practice Nurses
• Group 2: Cardiologists
Birmingham, AL
• Group 1: Registered Nurses
• Group 2: Primary Care Physicians
Philadelphia, PA
• Group 1: Mix of Nurses
• Group 2: Psychiatrists
• Group 3: Orthopedic
Surgeons
Physicians, nurses, physician assistants and integrative health care practitioners
representing a mix of tenure, practice setting and specialties.

• Clinicians have mixed feelings about research. They use and appreciate research, but
have concerns about corporate agendas, FDA approval times, and feel several steps
removed from research activity.
• Clinicians voluntarily articulate the need for many of the concepts behind “comparative
effectiveness research” and “patient-centered outcomes,” but this is not their language.
Clinicians on
“Medical
Research”
• One of the biggest stumbling blocks with clinicians is the perception that PCORI is too
broad, too over-reaching, and thus too idealistic to have a meaningful impact.
• Another communications challenge is that healthcare costs, access, and payer decisions
overshadow discussions about clinical effectiveness.
Impressions of
PCORI
• Clinicians, as did patients and caregivers in earlier groups, agree that “assessing options”
and “communication” are priority areas for PCORI. Clinicians also prioritize “improving
healthcare systems.”
• Clinicians say that PCORI should start by focusing on one or two of its research priorities,
and begin to build a track record.
Research Agenda
• Professional organizations are the preferred channel for these clinicians. They seem
willing to engage with PCORI, if opportunities are convenient and specific to their
practice/patient population/setting.
• Focus groups and online surveys are also mentioned as good ways to reach them.
• Many underscore that staying in touch will take diligence on PCORI’s part.
Advice for
Engagement
Key Findings from Clinician Focus Groups
14

“I want my patients to be involved in
their care. If they want to get involved,
that makes my job easier because
they’re motivated to change.”
(Birmingham, Primary Care Physicians)
“There is no coordination with anything.
Everybody is doing their own thing. It seems
like there is no communication. We are
struggling with this.” (Chicago, Cardiologists)
“A lot of times the patients are the best ones to tell
you if this works or that doesn't work, but nobody
listens.” (Birmingham, Registered Nurses)
“If everything else is up and running,
this should be a small thing.”
(San Francisco, Integrative Medicine)
“We have universities that train researchers –
Penn and Hopkins.” (Philadelphia, Nurses)
Addressing Disparities
Improving Healthcare Systems
Assessment of Prevention, Diagnosis
and Treatment Options
Communication and Dissemination
17%
22% 22%
24%
15%
Accelerating Patient-Centered
and Methodological Research
Focus Group Exercise: Pretend YOU are allocating PCORI resources. What percentage
of resources would you invest in each area? (Your total needs to equal 100%.)
How Would Clinicians Allocate Funding?
15

16
IV. Revising the Draft National Priorities and
Research Agenda
• PCORI will review input received from:
• Website survey and formal public comment process
• National Patient and Stakeholder Dialogue
• Patient, caregiver and clinician focus groups
• Formal and informal feedback received by Board members
and staff at PCORI-related events
• Report to be published on www.pcori.org summarizing input
received explaining how input led to changes in the draft priorities
and agenda.
• Revised National Priorities and Research Agenda to be presented
for adoption by PCORI’s Board of Governors during a special public
meeting in April.

17
V. Soliciting Feedback on Stakeholder and
Community Engagement associated with
Board Meetings
• Survey of Board Members on Past Stakeholder Events
Underway (March 2011-January 2012)
o What have we learned?
o Which formats have been most useful?
o How have the results informed our work?
o What can we accomplish this year?
• Soliciting feedback from stakeholder/community participants
• Planning for 2012
o Analyzing upcoming metro areas, their unique demographics
and health needs

VI. Ongoing Engagement and
Feedback Process
18
• PCORI website – www.pcori.org
• Join PCORI’s mailing list –
www.pcori.org/subscribe
• Follow PCORI on Twitter @PCORI
• Provide feedback at anytime –
www.pcori.org/provide-input
• Request a speaker –
www.pcori.org/contact-us

Executive Director’s Report
Baltimore MD
Monday March 5, 2012

Freda Lewis-Hall MD
2012 Alumni Award for Distinguished Postgraduate Achievement in
the fields of Medicine and Healthcare Leadership”
Howard University Board of Trustees
Debra Barksdale, FNP Ph.D.
Outstanding Research Contribution on Cardiovascular Disease in
African Americans
Delta Sigma Theta Sorority , Chapel Hill Carrboro Chapter
Annual Queen of Hearts Gala
Christine Goertz DC, PhD
Chiropractor of the Year - 2012
American Chiropractic Association
Our Honored Board

 Growing PCORI Staff
 PCORI Office Space
 Looking Ahead – next 6 months
 National Priorities & Research Agenda
 Funding Announcements/Funding
Cycles
 Patient and Stakeholder Engagement
Preview
2

4
Introductions and Welcome
Pam Goodnow
Director of Finance
Susan Hildebrandt
Director,
Stakeholder Engagement
Judith Glanz
Director,
Patient Engagement
Sue Sheridan
Deputy Director,
Patient Engagement
Gail Shearer
Senior Advisor
Martin Duenas
Director,
Contracts Management

ED
COO
CSO
Scientists,
Program
Staff
Patient
Engagement
Communi-
cations
Stakeholder
Engagement
Strategic
Initiatives
Grants
Mgmt
Finance
Meetings
Manager
PCORI – A Growing Organization
4
Admin
Staff
Senior
Advisor
HR IT

ED
COO
CSO
Scientists
Patient
Engagement
Communi-
cations
Stakeholder
Engagement
Strategic
Initiatives
Grants
Mgmt
Finance
Meetings
Manager
PCORI – A Growing Organization
ITHR
Engagement Science
Admin
Staff
Senior
Advisor
6

Next Steps in Hiring
• Research
• Chief Science Officer – position posted
• Scientists – approximately 9 in 2012
(interviews underway)
• Research Associates (interviews underway)
• Engagement
• Project Associates (interviews underway)
• Operations
• Director of Information Technology
• Financial and Grants Management Support
Staff
7

PCORI’s New Address
Projected move date:
by April 1
8

Next Steps – PCORI 2012
• Public Comment PeriodJan 23-Mar 15, 2012
• Clinician Focus Groups on draft priorities & agendaFeb 8-16, 2012
• National Patient and Stakeholder DialogueFeb 27, 2012
• Analysis of public comment receivedMarch-April 2012
• Adoption of National Priorities & Research AgendaApril 2012
• Broad funding announcements issuedMay 2012
• Broad funding applications dueJuly 2012
• Broad funding awards announcedDecember 2012
• Issue conference grantsSpring 2012
• Brainstorming workshopSummer 2012
• Advisory GroupsFall 2012
• Targeted funding announcements beginOctober 2012
• First targeted funding applications dueDecember 2012
• First targeted funding awards announcedMay 2013
9

Next Steps – PCORI 2012
April 2012 • Board reviews Scored Pilot Project Applications
May 2012 • PCORI Pilot Project Awardees announced
May 10, 2012 • Methodology Report presented to Board
May - July, 2012 • Public Comment Period for Methodology Report
July – Aug 2012 • Input analyzed and Methodology Report Revised
Aug 2012 • Revised Report Adopted by Board
10

PCORI Funding Announcements
11 Other Targeted Announcements

12
Patient and Stakeholder Engagement 2012
 Building communities of patients and stakeholders – using
website, social media, face-to-face meetings
 Strengthening ties with advocacy associations, professional
clinician organizations, purchaser organizations, research
community
 Refining the PCORI Research Agenda
 Convening multi-stakeholder workshops focused on
each of the National Priorities
 Forming multi-stakeholder Advisory panels
 Using social media, surveys to obtain broad input

Finance, Audit, and Administration
Committee (FAAC) Report
Baltimore MD
Monday March 5, 2012

2
Agenda
 SCCOI Nominations
 GAO Oversight and Compliance
 Financial Statement Audit
 Managing Cash Flow

3
SCCOI Nomination
 Bernard Lo, MD
‒ President, The Greenwall
Foundation
‒ Emeritus Professor of Medicine,
UCSF
‒ Emeritus Director, Program in
Medical Ethics, UCSF
Proposal for Membership (Ethicist) on
the SCCOI:

4
SCCOI Nomination (cont’d)
Current Academic and/or
Research Activities
 Dr. Lo's general research area is clinical
medical ethics. Specific interests
include: end-of-life care; talking to
patients about palliative care; the
doctor-patient relationship, particularly
the impact of the Internet; ethical
issues regarding HIV infection; ethical
issues in clinical and translational
research, particularly stem cell
research; conflicts of interest in
research, clinical care, and medical
education.
 197 peer-reviewed publications
 See Appendix for CV
Education and Training
 Medical School: Stanford
University
 Residency: University of
California, Los Angeles;
Stanford University
 Fellowship: Robert Wood
Johnson Clinical Scholars
Program, Stanford University
About Dr. Bernard Lo

5
SCCOI Nomination
 Arthur Aaron Levin, MPH
‒ Co-founder and the Director of the
Center for Medical Consumers
‒ Member of Institute of Medicine’s
Committee on the Quality of Health
Care (CQHC)
‒ Past chair of the NQF Consensus
Standards Approval Committee (CSAC)
‒ Co-chair of the NCQA Committee on
Performance Measures (CPM)
Proposal for Membership
(Consumer Member) on the SCCOI:

6
Activities
 The Center for Medical Consumers is a
New York City-based nonprofit
organization committed to informed
consumer and patient health care
decision-making; patient safety;
evidence-based, high quality medicine
and health care system transparency.
 Interests: transparency and conflict of
interest as it affects clinical guideline
development, the FDA advisory
committee process, and other aspects of
standard-setting in healthcare.
 See Appendix for Biography
 Master of Public Health,
Columbia University School of
Public Health
 Bachelor of Arts in Philosophy,
Reed College
About Arthur Levin

7
SCCOI Nomination
 Annette Bar-Cohen, MA, MPH
‒ Executive Director, Center for NBCC
Advocacy Training
‒ Former Education Director, Cancer
Control Center, Minnesota Department
of Health
‒ Member, Steering Committee,
Electronic Data Methods Forum,
Academy Health
Proposal for Membership
(Patient/Consumer Member) on the SCCOI:

8
Activities
 The Center for NBCC Advocacy
Training provides leadership and
direction for science, education,
and training programs including
Project LEAD
 2011 AHRQ Annual Meeting:
Leading Through Innovation and
Collaboration
 ECRI Institute’s 18th Annual
Conference on the Use of Evidence
in Policy and Practice
 See Appendix for CV
 Master of Public Health, School of
Public Health, University of
Minnesota
 Master of Arts in Psychology,
Goddard College/Fellow, Medical
School, Tufts University
 Bachelor of Arts in Journalism,
Northeastern University
About Annette Bar-Cohen

9
SCCOI Nomination
Proposal to serve as legal counsel to the
SCCOI:
 The highly credentialed Harris
Beach team’s strong prosecutorial
and ethics backgrounds have made
it the firm of choice for
organizations of all sizes to handle
their high-risk, high-visibility
federal and state investigation and
compliance matters.

10
Karl J. Sleight
Government
Compliance and
Investigations Team
 Mr. Sleight served as the Executive
Director of the New York State Ethics
Commission from March 2001
through March 2007. During his
tenure, he was responsible for
conducting investigations of high
ranking government officials and
private sector entities that interact
with government officials. Mr. Sleight
also provided advice and
interpretation of the states ethics
and integrity laws to statewide
elected officials, including the
governor and attorney general as
well as private sector business
leaders that interacted with the
government.
 Mr. Sleight chaired the Due Process
and Investigations Subcommittee for
the NYS Bar Association’s 2011 Task
Force on Government Ethics. The
Subcommittee’s recommendations
have been credited with influencing
important aspects of the
groundbreaking Public Integrity
Reform Act of 2011. Mr. Sleight has
also served as Special Counsel to the
New York State Legislative Ethics
Commission and is a frequent
commentator on issues involving
ethics and compliance in the media.
 Mr. Sleight advises clients on matters
related to corporate compliance and
government investigations, and federal
and state regulatory actions.
 See Appendix for Harris Beach
materials

11
GAO Oversight and Compliance
Request Motion to Accept Nominees
Nominations for Acceptance
 Bernard Lo, MD
 Arthur Levin, MPH
 Harris Beach PLLC

12
GAO Oversight and Compliance
U.S. Government Accountability Office
(GAO)
Responsibility
The GAO is responsible for conducting a review of the audit
of PCORI’s financial statements.
Comptroller General
The Comptroller General of the
United States must report to
the Congress on the results of
PCORI’s financial statement
audit no later than April 1 of
each year.
Legal Counsel
GAO legal counsel to provide
insight into compliance
regulations that PCORI is
subject to (e.g., 2 CFR, Part
230/OMB Circular A-122 & OMB
Circular A-133, and Form 990).
Source: Logo from company website: http://www.gao.gov/

13
Financial Statement Audit
McGladrey & Pullen, LLP
Work Time Frame
The field work has begun
and will be complete by
March 12, 2012.
GAO Review
GAO will review the audit of
PCORI’s financial
statements in order to
prepare its annual report to
Congress due April 1, 2012.
Engagement
McGladrey & Pullen has been engaged to perform the audit
of the PCORI financial statements for the years ending
December 31, 2010 and 2011.
Source: McGladrey & Pullen, LLP operates under the McGladrey brand. Logo from company website: http://mcgladrey.com/About/About

14
Managing Cash Flow
Discussion of the Issues
Text
Text
In preparation
for developing
a cash flow
model, there
are several
assumptions
and there are a
number of
decisions that
need to be
made.
Set announcement, commitment,
and funding dates so that deadlines
can be anticipated
Text
There will be three funding cycles;
July, November, March
Text
The review process will take four to
six months
Text
Consider funding strategies that
commit more funding in early years
in order to increase PCORI’s impact

15
Managing Cash Flow
Assumptions for Cash Flow Model
 The model was created using three-year awards for
illustrative purposes only.
 When we make awards, we pay approximately 50% in the
first year, then 25% in years 2 and 3 of the award.
 Dollars available for awards are best estimates of funds
available from PCORI Trust.
 2012 Funding = $90M
 $112M less 20% Operations = $90M
 2013 Funding = $250M
 $72M plus $240M in fees = $312M less 20% Operations = $250M
 2014 to 2019 Funding = $403M/year
 $24M plus $480M in fees = $504M less 20% Operations = $403M
* All dollars are in millions.

16
Managing Cash Flow
Multi-Year Cash Flow Model
 We can make commitments prior to receiving money in
the PCORI Trust.
In millions
Award
Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019 
2012 $210 $90 $60 $60
2013 $380 190 95 95
2014 $496 248 124 124
2015 $368 184 92 92
2016 $375 187 94 94
2017 $434 217 109 109
2018 $300 200 100
2019 $194 194
Funding $2,757 $90 $250 $403 $403 $403 $403 $403 $403 $2,757

17
Managing Cash Flow
Annual Cash Flow Model
 We can make commitments only with monies already in
the PCORI Trust
In millions
Award
Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019 
2012 $90 $45 $23 $23
2013 $250 125 63 63
2014 $403 202 101 101
2015 $403 202 101 101
2016 $403 202 101 101
2017 $403 202 101 101
2018 $403 202 101 101
2019 $403 202 201
Funding $2,757 $45 $148 $287 $365 $403 $403 $403 $403 $302 $2,757

18
Questions for Discussion
• Should we plan to make grant commitments ahead of funds
available in the PCORI Trust?
• If we pursue this strategy, do we commit ahead of funding only in
the early years of PCORI, or carry out this strategy through 2019?
• How do we manage the risks of this strategy; specifically, the risk
of making funding commitments against dollars not yet transferred
to the PCORI Trust?
• What level of refinement for the strategic plan and research
agenda do we want to implement this strategy?
• If we pursue this strategy, how aggressively should we commit
ahead of funding?

1
March 5, 2012
Methodology Committee (MC)
Report

2
1. Finalizing the Methodology Report
2. Board- Methodology Committee Engagement
3. Beyond the Methodology Report
4. PCOR Definition
Agenda

3
Finalizing the Methodology Report

4
Methodology Report Outline
• What is PCOR? (Based on our definition)
• What is the pressing need for a report on methods for
conducting PCOR?
• Who is this report for?
• Goals of the First MC Report
• Types of Research Addressed in this Report
CHAPTER 1.
Introduction
CHAPTER 2.
How we Developed
Standards
• What are standards?
• Categories for Rating Potential Standards
• Selecting Standards
• Formulating Research Questions (PICOTS*)
• Choosing a Data Source, Study Design, & Analysis Plan
• Methods for Conducting Research Studies
CHAPTER 3.
What is Patient –
Centeredness?
CHAPTERS 4-?
Standards for Selecting,
Designing, and Conducting
Research
• Public Review
• Dissemination and Implementation
• Plans for Updating
CHAPTER N.
Future Plans & Direction
*population, intervention, comparator, outcome, timeframe, setting
• How does patient centeredness apply in research
prioritization, identification of research questions, design of
studies (PICOTS*), and dissemination/implementation?
• What methods can make research more patient-centered?
• How is patient-centeredness balanced with feasibility and
other stakeholders' concerns?

5
Methodology Report Outline
CHAPTER 1.
Introduction
CHAPTER 2.
How we Developed
Standards
CHAPTER 3.
What is Patient –
Centeredness?
CHAPTERS 4-?
Standards for Selecting,
Designing, and Conducting
Research
CHAPTER N.
Future Plans & Direction
Example Section:
ENDORSED STANDARDS AND ACTIONS
RELATED TO MISSING DATA
I. Background
“Missing data is not only inevitable in human health studies and
trials, it is more likely…..”
The committee reviewed standards for methods including Last
Observation Carried Forward (LOCF), [insert other methods
here].
II. Recommended Standards
1. Adopted standard #1
2. Adopted standard #2
II. Rationale for Standards
“The committee believes these standards…”
II. Recommended Actions to support the Standards
1. “PCORI shall encourage training in the…”
2. “PCORI shall disseminate software to conduct…”

6
The four phases below illustrate the key
milestones which will take place during the
report writing process
1.
Workshops /
Contractor
Findings
2.
Consensus
Process / Voting
Meeting
3.
Draft & Revise
Sections of the
Report
4.
Delivery of
Methodology
Report
Report Writing Process
Key Board Engagement
March 2012 April 2012
Observe
Workshops
May 2012
Approve Report for
Public Comment
Timeline
Review Workshop
Materials & Contractor
Reports
Review summary of draft
recommended standards
Provide input on
drafted Report

7
The next two phases demonstrate the
process by which the Committee determines
which Standards and Recommendations will
be adopted for inclusion in the Report
1.
Workshops /
Contractor
Findings
2.
Consensus
Process /
Voting Meeting
• Two workshops will be held to
discuss the findings of research
groups contracted by the MC in
order to facilitate writing of first
Methodology Report
• 15 Reports will be delivered in
March outlining findings and
recommendations of each
research team
• The Committee has defined an
approach to select standards and
recommendations for inclusion in
the May Report
• During the April 3 Meeting, the
Committee will come to consensus
on standards to be included in the
first Methodology Report
March 1-15, 2012 April 3, 2012

8
During the last two phases, the Committee
will finalize the Report in preparation for
delivery to the Board and Public Comment
3.
Draft & Revise
Sections of the
Report
4.
Delivery of
Methodology
Report
April 2012 May 10, 2012
• The Report Writing Team and
workgroups will collaborate to
finalize the report
• Four experienced report
writers have been brought on
board to develop the Report
• Leading up to May 10, the
Committee will prepare the
Report for delivery to the
Board
• Upon Board Approval, the
Methodology Report will be
posted for Public Comment
Period

9
Methodology Committee – Board
Engagement

10
Board of Governors Engagement
The Methodology Committee
has engaged with the Board in
a number of ways in order to
accomplish the following
objectives:
Participates in at least five
bi-monthly Board Meetings
with a total of approx. 25
hours of direct interaction
Orchestrated three
teleconference calls to
engage the Board in
discussion of the report
outline and translation tool
Established Liaisons to the
Patient Centeredness Working
Group: Ellen Sigal & Gray
Norquist
Submitted approximately
12 Briefings since Sept.
2011
Invited Board Members to
participate in reviews of
contractor proposals:
Leah-Hole Curry, Harlan
Weisman, Debra Barksdale,
Rick Kuntz, Steve Lipstein
Provided input regarding
methodologic research on
the Research Agenda and
Pilot Projects
Shared highlights of the
electronic data task &
solicited approximately 6
candidates for interview
referred by Harlan Weisman,
Richard Kuntz, Steve Lipstein.
& Harlan Krumholz
Gained support of two
Committee Members with
framing the PCORI Funding
Announcement (PFA)
Collaborated with Board
Members to develop a joint
Dissemination Plan
Prepared weekly Status
Reports on Committee
progress to PCORI
Methodology Committee
members to attend the
Closed Board Session at
March Board Meeting
Two Methodology Committee
members will participate as
members of the PCORI Pilot
Project Selection Subcommittee

11
Synthesize contractor
reports, research, and
workshop results
Share Workshop
Executive Summary &
Contractor Reports
Voting Standards
Meeting– April 3rd
Submit final drafts,
Review, & Finalize
Report Sections
Share Report & Receive
input from Board of
Governors
February
2012
March
2012
April
2012
Prepare for meeting to
vote on proposed
standards
May
2012 Submit Report to the
Board
Post for Public Comment
‘Case Study’
Teleconference
Call with Board
Review & Revise
Outlines
Provide proposed
recommendations
Draft sections of
the report
Board EngagementKey:
Engagement Next Steps
The below steps outline the opportunities
for the Board to engage with the
Methodology Committee during the
development of the May Report
Discuss and Approve
Dissemination Plan

12
Beyond the Methodology Report

13
Maximizing the impact of the Report
Following the release of the first
Methodology Report, the MC
intends to enhance adoption of
the recommended standards and
best practices within the broader
research and health care
communities by acting as a
convener, communicator, and
catalyst

14
Looking Ahead & Extending our Reach
• Committee Member Feedback Sessions
• Dissemination/Implementation of Standards
• June 2012 Retreat Strategic Planning
• Professional societies and stakeholders (Advisory Groups)
− Electronic Data Systems
− Implementation
− Novel Delivery Tools
− Systems Engineering
• 1st Annual PCOR conference
In the months following the release of
the May Report, the Committee plans
to engage in the following activities:

15
Patient-Centered Outcomes Research Definition
Workgroup
Members:
Dave Flum
Mary Tinetti
Jean Slutsky
Mark Helfand
Sebastian
Schneeweiss
Board
Members:
Debra Barksdale
Bob Jesse
Harlan Weisman
Gray Norquist
Rick Kuntz
Sharon Levine
Allen Douma
Gail Hunt
Harlan Krumholz
Working Group Accomplishments
• Reached consensus on changes to PCOR definition in response to
public input
− Added reference to improving communication and including caregivers
− Modified question four so that mention of healthcare system emphasizes
role of the system in getting better decisions
• Prepared revised document that explains proposed response to
public input

16
Patient-Centered Outcomes Research Definition
Patient Centered Outcomes Research (PCOR) helps people and their caregivers
communicate and make informed health care decisions, allowing their voices to
be heard in assessing the value of health care options. This research answers
patient-centered questions such as:
1. “Given my personal characteristics, conditions and preferences, what should I expect
will happen to me?”
2. “What are my options and what are the potential benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
4. “How can clinicians and the care delivery systems they work in help me make the best
decisions about my health and healthcare?”
To answer these questions, PCOR:
• Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative,
or health delivery system interventions to inform decision making, highlighting
comparisons and outcomes that matter to people;
• Is inclusive of an individual’s preferences, autonomy and needs, focusing on
outcomes that people notice and care about such as survival, function,
symptoms, and health-related quality of life;
• Incorporates a wide variety of settings and diversity of participants to address
individual differences and barriers to implementation and dissemination; and
• Investigates (or may investigate) optimizing outcomes while addressing burden
to individuals, resource availability, and other stakeholder perspectives.

17
Thank You!

1
Program Development
Committee(PDC) Report
Baltimore MD
March 5, 2012

22
Update on PCORI Pilot Projects
PPP

33
PPP Selection Committee
Chair: Gray Norquist
Advisor: Christine Goertz non-voting
Members:
Kerry Barnett
Carolyn Clancy
Arnie Epstein
Gail Hunt
Steve Lipstein
Sherine Gabriel
Clyde Yancy
Joe Selby

44
Pilot Projects Deliberations Process
Working Group
• Determines specific
criteria to be
considered by the
PCORI Selection
Committee in
determining and
recommending an
appropriately
balanced slate of
awards.
PCORI Selection
Committee
• Meets to review
materials.
• Considers the
balance of priority-
scored applications
across selected
criteria, requesting
additional analysis
and options from
staff, as needed.
• Prepares a
recommended slate
of selected projects
for funding
consideration.
Board of
Governors
• Meets to consider
the recommended
slate.
• Reviews the slate
based on priorities
and balance to
ensure appropriate
distribution.
• Requests additional
options, if needed.
• Approves a final
slate of selected
projects for funding.
PCORI Staff
• Analyzes the
applications using
priority score and
the criteria.
• Provides a list of
award options based
on Working Group
recommendations.
• Supports the PCORI
Selection Committee
and Board of
Governors by
providing revised
options, as needed.
Initial
recommendations
made. Under
review by
Methodology
Committee

55
Balance Criteria
 Priority Score
Among Highest Scoring Applications
 Area of Interest
 Population
 Methods
 Geography
 Discipline of PI
 Seniority of PI
 Condition
 Stakeholder/Patient Involvement

66
12/26 1/9 1/23 2/6 2/20 3/5 3/19 4/2 4/16 4/30 5/14 5/21 5/28
Merit Review (CSR)
Determine Balance
Criteria
Pull & Vet Data & Load
Spread Sheet
Selection Committee
Recommendations
Development of Funding
Recommendations
Board Deliberations &
Final Decisions
Business Review Process
Awards Process
Pilot Projects Timeline
Merit Review Scores Received
Announcements
Made
Present to Board/Board
Consideration
Consideration
Consideration

7
PCORI Peer Review Evaluation
 Post Survey Instrument
- NIH administered PCORI-developed stakeholder and scientist
surveys at the end of the merit review to gain insights into
the review experience
 Observational Instrument
- Instrument was completed by PCORI observers in
attendance at 10 randomly selected review meetings
 Merit Score Data
- We have data on preliminary and final scores for each
application, including information on the six PCORI Review
Criteria

88
Public Comment Results

9
Public Comment Process and Timeline
Aggregate/Analyze Input
1
Assess Suitability of
Themes
2
Conduct Initial
Evaluations
3
Preliminary Voting
4
Voting Conference to
Reach Consensus
Recommendations
5
Recommend Changes for
Board Decision
6
March 15-March 26
March 27
March 28-April 6
April 9
April 11 (PDC F2F)
April 17 (Open meeting
being planned)
Staff
PDC*
Staff
PDC*
PDC*
PDC*/Staff
*Any interested Board/MC Member is welcome to participate

1212
May, 2012 PFA Process and Timeline

13
1 2 3 4 5 6 7 8 9
Month Jan Feb Mar Apr May Jun July Aug Sept
Designate PFA WG Leads
Hire (Contract) PFA Writers
Draft Broad PFAs (May PFAs)
Targeted Priority #5 PFAs (July)
1st Draft of Literature Review;
Knowledge Gaps; Example
Questions
Incorporate PPP Input
Revised Version Incorporating
Comments
Finalized PFA
PDC Calls
PDC F2F
Board of Governors’ Call
Board of Governors’ F2F
Grants Management Process
MC Report
Incorporate Public Comment Input
Timeline for Development of First PFAs
1
2
PFA WG Membership
Specificity for May Announcements
DECISIONS
Red Board of Governors Meetings
Green Program Development Committee Milestones
Purple Staff
Blue Methodology Committee LEGEND
1
2

14
 PFA prepared by PCORI staff, contracted research organization
(CRO) and Board participants
 CRO’s sign confidentiality agreement and are barred from
submitting application to any of the 5 PFAs until 3rd round – March
2013
 Open competition
 Applications reviewed by CSR a la PPP’s
 Successful applications administered by PCORI
Current Plans – Priorities 1 - 4

15
National Priority
Board/MC
Member 1
Board/MC
Member 2
Board/MC
Member 3
PCORI Staff
Scientist
Identified
Comparative Assessment of Options for
Prevention, Diagnosis, and Treatment
Harlan
Krumholz
RFP Issued
Improving Healthcare Systems
Arnie
Epstein
Christine
Goertz
Leah Hole-
Curry
RFP Issued
Communication and Dissemination
Research
Gray
Norquist
Dominick
Frosch
Addressing Disparities
Carolyn
Clancy
Anne
Beal
RFP Issued
Accelerating PCOR and Methodological
Research
Michael
Lauer
Jean
Slutsky
Contract
with
AHRQ/NIH
PFA Development Teams

16
Proposed Plan for Priority #5
• PFA written by PCORI staff, AHRQ staff, NIH staff, MC
• Separate Funding Announcement (i.e., separate from that written
for analytic methods)
• Solicitation and Review managed by AHRQ and NIH through
contracts from PCORI to AHRQ and NIH
• “Focused Competition” – with clear data and governance
requirements, including engagement of relevant stakeholders
• Funding through Cooperative Agreement grant mechanism with
shared as well as project-specific goals.
Clinical Research Data Infrastructure

17
Rationale for Contracting with AHRQ
• AHRQ and NIH have years of experience in this area that will be
invaluable in helping to write the PFA and overseeing the research
• We have a clearer idea of gaps and opportunities– the PFA must be
fairly specific (i.e., targeted)
• AHRQ and NIH staff have knowledge of current state of the science
• The proposed funding arrangement is a cooperative agreement,
where grantees work together with PCORI, AHRQ, and NIH
• AHRQ and NIH have expertise running cooperative agreements
• The statute explicitly encourages PCORI to contract with AHRQ,
NIH and other federal funders of CER; experience of AHRQ and
NIH  efficiency and value for taxpayers

18
Analytic Methods
• Close collaboration with the MC
• AHRQ and NIH have a long track record of working on CER/PCOR
methods research – having them involved helps minimize risks of
redundancy
• PFA is more likely to be targeted than priorities 1-4 but probably
not as targeted as that for research data infrastructure.
• Not as clear this would be a cooperative agreement, though it
could be.

19
March 5, 2012
PCORI Dissemination Workgroup

20
Carolyn Clancy, Co-Chair
Sharon Levine, Co-Chair
Lawrence Becker
Allen Douma
Howard Holland
Gail Hunt
Freda Lewis-Hall
Steve Lipstein
Brian Mittman
Robin Newhouse
Grayson Norquist
Jean Slutsky
Members of the Workgroup

21
Dissemination Accelerating Components:
Proposed Checklist
Identify stakeholders (stakeholders include patients, caregivers,
clinicians, communities, policy makers and institutions) relevant to
your proposed study
Describe at which points in your proposed study stakeholders will be
engaged
Describe how you will engage stakeholders at each identified point
during the study and at its conclusion
Stakeholders
Engagement
Points
Engagement
Type
Governance
Plan
Please describe how you will develop a governance plan for the
project that articulates specific roles and responsibilities for the
research team and stakeholder groups and defines rules for decision
making, especially in the context of different opinions

22
Dissemination Accelerating Components:
Proposed Checklist (cont’d)
Describe how conflicts – true and perceived – will be managed
Describe how you will convey study results to stakeholders and study
participants
Please describe how you will assess barriers and facilitators to
incorporating the results into practice, beyond communicating the
study results to stakeholders
Conflict
Management
Study
Results
Barriers
Assessment

Board of Governors Meeting, Baltimore Maryland

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