Board of Governors Meeting, Washington DC

PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E
Board of Governor’s Meeting
Washington, DC
September 24, 2012
Larry Becker, Chair, SCCOI and Member, Board of Governors
Standing Committee on Conflict
of Interest (SCCOI)

Agenda
1.  Introduction – COI Rules Approved by the Board on June 19,
2012
2.  Operationalizing the COI Rules for the Methodology Committee
3.  Next Steps
4.  Discussion
2

Today’s Agenda

COI Rules Approved by the Board on June
19, 2012
3

Introduction
§  Intended to “safeguard the
integrity and public trust in the
process for funding patient-
centered outcomes research
(PCOR)”
Full text available at www.pcori.org

PCORI
FUNDING

ANNOUNCEMENT

APPLICATIONS

•  483
applica+ons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

OPERATIONALIZING
THE
COI

RULES
FOR
THE
METHODOLOGY

COMMITTEE
(MC)

COI Rules Pertaining to the MC
5

Operationalizing the COI Rules for the MC
§  Creates the MC-PFA
Development Subcommittee*
to function as a liaison to
PCORI’s Board and staff
−  These MC members will not
be eligible to apply for PFA
funding
* Previously referred to as the Methodology Executive Subcommittee in Patient-Centered Outcomes Research
Institute (PCORI) Draft Conflict of Interest Rules for Research Funding, June 19, 2012
Methodology
Committee
(MC)
MC-PFA
Development
Subcommittee

MC-PFA
Development
Subcommittee
Jean Slutsky, PA, MSPH
Clyde Yancy, MD
Naomi Aronson, PhD
Alfred Berg, MD, MPH
Mike Lauer, MD
Sherine Gabriel, MD
(MC Chair)

The Methodology Committee will remain united in its
mission to provide scientific guidance to PCORI…
…the new operating model will not change this
7


Elements of PCORI’s COI Policy Regarding the
Methodology Committee
8

Protect against COI when awarding funding for non –
PFA research (RFPs)
Non-
Disclosure
Agreements
Firewalls for
PFAs
MC Recusal
and COI
Disclosure
Require all members of PCORI community (e.g.,
MC, Board, staff) to preserve confidentiality of non-
public information
Create firewalls to preserve Methodology
Committee eligibility for PFA funding

Firewalls will be implemented to preserve eligibility of
most MC members for PFAs
9

Firewall Goals:
q  Avoid an unfair advantage for MC members
q  Control access to information

MC Firewall Implementation Strategies
10

IT
Governance
Distribution
Controls
Meeting
Controls
Mitigating
Time
Advantage

SCCOI Guidance
•  Importance of IT solutions to maintain firewalls
•  Emphasis on policy training for the Board, Methodology Committee,
and staff
•  Encouragement of preparation of public-facing document that
reinforces the significance of guarding against COI as a core PCORI
value
11


PCORI
FUNDING

ANNOUNCEMENT

APPLICATIONS

•  483
applica+ons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

NEXT
STEPS

Next Steps
Ø  Develop and adopt the COI policy regarding external parties (e.g.,
advisory panels, consultants)
Ø  Implement the firewalls for the Methodology Committee
Ø  Monitor and regularly review COI compliance
Next Steps
13

PCORI
FUNDING

ANNOUNCEMENT

APPLICATIONS

•  483
applica+ons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

DISCUSSION

Questions or Comments?
Discussion
15

•  Appendix A: Proposed Internal Firewall Policies and Procedures
Related to the Eligibility of Methodology Committee Members for
PCORI Research Funding
•  Appendix B: Checklist: Implementation of Firewalls for
Methodology Committee
•  Appendix C: PCORI Conflict of Interest Rules for Research Funding
(June 19, 2012)
16

Appendix

PCORI Board of Governors Meeting
Washington, DC
September 24, 2012
Jean Slutsky, Methodology Committee
Lori Frank, PhD, Director, Engagement Research
Bill Silberg, Director, Communications
Update on Public Comment
Period for Draft Methodology
Report

2

§  Submitted to the PCORI
Board of Governors on May
10, 2012
§  Approved for posting by the
PCORI Board of Governors
on May 21, 2012
§  Public comment period:
July 23, 2012 through
September 14, 2012
§  Revised draft standards to
be submitted to the Board
of Governors November
2012
Methodology Report

3

PCORI
FUNDING

ANNOUNCEMENT

APPLICATIONS

•  483
applica+ons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

PUBLIC
COMMENT
AND

ONGOING
OUTREACH

4

Professional
Journal
Ar+cle

and
Ads

“Why
Methods
MaGer”
Webinars

Social
Media
Targeted
Outreach
News
Release

Outreach efforts for MC report
comment period

5

PCORI blog columns and
associated videos pushed to
targeted email lists
“Why Methods Matter”

6

Digital Ads released in Annals of Internal Medicine; Science
Translational Medicine; JAMA; NEJM; Nature; and Health Affairs
Professional Journal Article and Ads

7

• >850,000
total
an+cipated

impressions

• Exposure
to
nearly
13,000
subscribers

through
a
Health
Affairs
e-‐alert

Professional

Journal
Ar+cles

and
Ads

• Three
blog
posts

• 671
total
blog
views

• 150
total
video
views

“Why
Methods

MaGer”

• Two
webinars

• >650
total
aGendees

• Strong
audience
interest
indicated
by

low
fall-‐off
rate

Webinars

• PCORI
men+oned
5,753
+mes
in

TwiGer
and
social

media

conversa+ons
over
the
last
six

months
(mid-‐April
through
mid-‐
September)

• Es+mated

7.4
million
impressions
,

reaching

individuals
through
a
variety

of
online
media.

Social
Media

• Three
e-‐mail
blasts
to
opt-‐in

stakeholder
list
(~4,600
names)

• Open
and
click-‐through
rates
above

industry
norms:

• First
alert:
43.8%
and
50.3%

• Second
alert:
35.2%
and
37.3%

• Third
alert:
26.2%
and
22.2%

• Addi+onal
alert
to
3,143
researchers

through
PCORI’s
contracts
plaòrm.

Targeted

Outreach

• News
release
republished
244
+mes

• Coverage
included:
The
Pink
Sheet;

Medical
Device
Daily;
Government

Health
IT;
Inside
Health
Policy;

BioCentury;
and
CQ
Healthbeat

News
Release

Measures of Reach
6,500

page
views

1,600

report
downloads

*
As
of
9/19/2012

8

•  Two webinars
–  Setting Standards for
Research Methods,
August 3
–  Setting Standards for
Patient-Centeredness and
Patient Engagement in
Research, August 14
Webinars
0%

20%

40%

60%

80%

100%

I
do
not
understand
I
understand

somewhat

I
have
good

understanding

Rate
your
understanding
of
the
process
the
MC

used
to
generate
standards

Before

Afer

*
Actual
responses
from
both
webinars
combined

10

Results

VeGed
by

Pa+ent
Panel

AIR
Conducts

Analysis
of

Public

Comments

PCORI

Collects

Public

Comments

Deliverables

Public
Comment
Analysis
Delivered
to
MC

Transparent
Comment
Disposi+on
Table

MC
Standards
and
Report

Public
Comment
Process

Collecting, Analyzing, &
Transparently Communicating
Public Comments
•  Public Comment Contractor:
American Institutes for Research
(AIR)
•  Criteria:
–  Patient panel to review and
refine comment analysis
–  Extensive patient and
stakeholder engagement
experience
–  Expertise in qualitative research
methodology
–  Significant experience with
public comment process

11

Researchers,

33%

Other,
17%
Industry,
16%

Unspeciﬁed,

12%

Caregiver
/

Pa+ent

Advocacy

Organiza+on,

8%

Clinician,
5%

Organiza+onal

Provider,
4%

Pa+ent,
2%

Policymaker,

1%

Caregiver,
1%
Pa+ent

Advocate,
1%

Respondents
by
Stakeholder
Category

Public Comment Results
8
9
10
11

16
20
23

124

0

20

40

60

80

100

120

140

#
of
comments

CumulaYve
Comments
Received,
by
Week

12

Comments
by
Stakeholder
Category

Related
to
a

speciﬁc

chapter

39%

Related
to

report
as
a

whole

36%

Unrelated
to

the
report

17%

Related
to
a

speciﬁc

standard

8%

12

55

414

125

48

175

227

25

400

6

227

0

50

100

150

200

250

300

350

400

450

Public Comment Results
Comments
by
Type

13

MC Report Public Comment - Themes
•  Role of standards in PCOR
•  Feasibility of standards implementation
•  Document accessibility
•  Interest in training and resources to support PCOR and standards
implementation
•  Interest in more specific details regarding research methods

14

PCORI
FUNDING

ANNOUNCEMENT

APPLICATIONS

•  483
applica+ons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

•  Review
and
Revisions
of
Standards/Recommended
Ac+o
•  Future
Direc+ons

METHODOLOGY
COMMITTEE

15

Systematic
Review
Dissemination
Research
Prioritization
Causal
Inference
Heterogeneity
of Treatment
Effects
Missing
Data
Trial
Methodologies
Diagnostic
Testing
Translation T able/
Registries
Data
Networks
Patient
Centeredness
The MC will provide revisions to
methodologic standards and
recommended actions across each of
the eleven research domains
Review and Revision of Standards

16

Methodology Committee Goals
1.  Propose revisions to the standards and recommended actions
based on public and Board comments (with justification)
2.  Provide summary of MC responses to public and Board comments
3.  Offer additional suggestions for methodological research gaps
gleaned from public and board comment

17

Can the substance of the
standard be subsumed by
other existing Standards
with modest revision?
Can the substance of the
standard be framed as a
recommended Action to
inform PCORI policy?
Provide strong justification
why comments should not
be addressed.
Yes
Provide specific revisions
No
Propose revisions to the standard that fully address
comments (from board and public) in a meaningful
and substantive manner.
No
Yes
Should the Standard
continue as is?
No
No
Provide specific language
for Draft PCORI Policy
Yes
Start


18

1.  Review and propose responses and revisions to relevant Board and
Public Comments. Include justification if no response/no change is
recommended
2.  Discuss and propose next steps for translation table.
Options include:
•  No further changes. Maintain the translation table as it
currently stands
•  Propose RFP to develop v2 of Translation Tool which expands
on current tool and creates additional versions for different
audiences, e.g. Researchers, students, general public, policy
makers etc.
Review and Revision of Translation Table

19

Submission
to

Board

Dra
Report

Posted

Public

Comment

Period

Analysis
of

Public

Comment

Revise

Standards/

Recommende
d
AcYons

based
on

analysis

Update

Standards/

Recommended

AcYons/

Comment

DisposiYon

Table

May-‐Jul
2012
Aug-‐Sep
2012
Oct-‐Nov
2012

7/23
–
Public
Comment

Period
Begins

10/31
–MC
Consensus
on

Proposed
Revisions

11/19
–
Board
Vote
to

Accept
Final

5/21
–

Approved
for

Pos+ng

9/14
–
Public
Comment

Period
Ends

Timeline

20

•  Select Standards for further research in 2013
•  Develop a detailed Standards implementation and dissemination
plan
•  Incorporate standards into PFAs
•  Incorporate principles of research prioritization into evaluation of
the impact of standards on improving research quality and
advancing PCORI mission
•  Enhance methods for use of patient-reported outcomes
•  Create PCOR methods training programs for patients and other
stakeholders
Priorities
Future Direction

21

•  Contribute to PCORI patient engagement workshop
•  Contribute to PCORI methods workshop
•  Participate in PFA development (subset of MC members)
•  Advise on methods-relevant dissemination (subset of MC
members)
Methods Leadership
Future Direction

22

•  Ongoing outreach planned for Standards following completion of
revision in November 2012
•  Further Standards development to be evaluated based on
additional review by MC, Board, and patients and other
stakeholders throughout the planned ongoing outreach and
dissemination
Future Direction

Moving toward Standards 2.0

23

To those who provided comment on the MC
Standards and Report:
Thank you for your thoughtful input!
To the Methodology Committee:
Thank you for all your hard work in the development and
revision of these document!
Thank You

Communications Update
1
•  A communications framework that advances our goals
•  Building infrastructure
•  Building awareness
•  Promoting our milestones
•  Key metrics
•  Future opportunities to consider and discuss

Questions to Consider
2
•  How can we best refine our messaging as we build our research
portfolio?
•  What critical lessons do we want to impart from our research to date?
•  What kinds of “stories” might we use to make our work “real” to our
stakeholders and show how “research done differently” benefits them?
•  How can we best collaborate with and leverage the work of others in
the CER/PCOR space to advance our communications goals?

A Communications Framework That Advances Our Goals
3
•  Define organizational messages, stakeholder audiences and goals
•  Develop and implement a comprehensive plan that delivers those
messages to key stakeholder audiences
•  Refine and update the plan over time based on key performance
indicators
•  Continue close collaboration with COEC and other leadership to
refine strategic and operational objectives
•  Ensure support of PCORI’s foundational pillars and the
implementation of its strategic plan

4
PCORI’s Key Messages
•  To improve the quality and effectiveness of care, patients and those who care for
them need evidence-based information that they trust and use in making better-
informed clinical decisions.
•  PCORI funds research that provides such trusted, high-quality information by
requiring meaningful patient engagement in all aspects of the research process.
•  PCORI advances its mission by convening, partnering, and soliciting the input
and guidance of all stakeholders in the health and health care community.

5
PCORI’s Key Audiences
•  Multiple stakeholders, but particularly patients, caregivers, researchers,
clinicians, public and private payers and policymakers
PCORI’s Key Goals
•  Reshape research to meaningfully include patients’ concerns, with patients and
caregivers as true partners
•  Establish stakeholder partnerships that will advance our research and
dissemination efforts
•  Promote the adoption of rigorous methods and robust infrastructure to sustain
PCOR over time
•  Establish PCORI as a trusted “must-have” source of patient-centered outcomes
research and information that will be widely used

6
Communications Plan Goals
•  Provide a consistent stream of high-quality content and activities that support
and advance PCORI’s strategic imperatives and goals in ways that build trust with
stakeholders
•  Be proactive in identifying communications opportunities and assessing and
addressing challenges
•  Be transparent in showing how PCORI is meeting its statutory obligations and
delivering on its research agenda
•  Establish and maintain a robust infrastructure that facilitates two-way
communication and engagement with key stakeholder audiences
•  Develop and track metrics that assess progress toward communications goals,
refining activities as needed

7
Our Opportunities
•  Telling the story of building a research institute and “brand” from scratch
•  Creating a new approach to traditional research
•  Convening multiple stakeholder groups to pursue a shared agenda
Our Challenges
•  Telling the story of building a research institute and “brand” from scratch
•  Creating a new approach to traditional research
•  Convening multiple stakeholder groups to pursue a shared agenda

Building Infrastructure
8
•  Platforms, tools, and channels
•  Staffing and resources
•  Process and procedures
•  Partnerships and relationships

Building Awareness
9
•  We are a new organization building a track record of research
•  Our story to date has been largely aspirational, organizational, and “stage-
setting” but is evolving as our work continues
•  We are measuring our progress in milestones
•  We are building relationships with those who will help tell our story and
advance our research and dissemination efforts

Promoting Our Milestones
10
National Priorities for Research and Research Agenda
•  503 comments received via web site, e-mail, or mail
•  Hosted National Patient and Stakeholder Dialogue,
PCORI’s largest stakeholder engagement event to
date
PCORI Pilot Projects
•  Covered by Modern Healthcare, Politico, Kaiser
Health News
•  Special Board webinar to approve revisions to
priorities and agenda and approve Pilot Projects
attended by 421 stakeholders

PCORI Funding Announcements (PFAs)
•  PCORI’s PFA web page has received an average
of >15,000 page views per month
•  Secured >400,000 impressions through
advertising in NEJM, JAMA, and Health Affairs
Draft Methodology Report
•  Two webinars for patients and stakeholders
combined to draw >650 attendees
•  Three columns and videos published
explaining “Why Methods Matter” from the
researcher, patients and industry perspective
•  Social media hashtag: #WhyMethodsMatter
11

12
Patient/Stakeholder Engagement Initiative
Three workshops designed to engage patients and
stakeholders in refining PCORI’s research agenda:
•  Transforming Patient-Centered Research: Building Partnerships and Promising Models
•  October 27-28
•  What Should PCORI Study? A Call for Topics From Patients and Stakeholders
•  December 4
•  PCORI Methodology Workshop for Prioritizing Specific Research Topics
•  December 5
Promotion through web site, e-mail, webcasts, media outreach, video

Website Metrics
13
6-Month Snapshot
•  >195,000 site visits, including > 98,000 unique visits
•  The average site visitor spends nearly four minutes per visit
•  May 23: PFAs announced; 4,200 new visitors logged on to the site
0

10,000

20,000

30,000

40,000

50,000

60,000

Site
Traﬃc

Visits

14
•  15
e-‐mail
alerts
sent
to
stakeholders

•  Average
alert
open
rate
is
40%
(industry
standard
is
19%)

•  Goal:
Grow
opt-‐in
e-‐mail
list
to
10,000
by
end
of
2012

Growing Our E-mail List
0

1000

2000

3000

4000

5000

Feb-‐11

Mar-‐11

Apr-‐11

May-‐11

Jun-‐11

Jul-‐11

Aug-‐11

Sep-‐11

Oct-‐11

Nov-‐11

Dec-‐11

Jan-‐12

Feb-‐12

Mar-‐12

Apr-‐12

May-‐12

Jun-‐12

Jul-‐12

Aug-‐12

Sep-‐12

Subscribers
2/1/2011

283
Subscribers

9/19/2012

4,800
Subscribers

Convening: PCORI Events
15
Na8onal
Pa8ent
and
Stakeholder
Dialogue

APended
by
850
people
in
person
or
by
webcast
and

teleconference;
46
public
comments
provided
at
event

by
representaRves
of
diverse
stakeholder
segment.

Na8onal
Workshop
to
Advance
Use
of
Electronic
Data

Convened
a
select
group
of
researchers
and
thought
leaders
to

develop
ideas
for
how
PCORI
can
facilitate
the
creaRon
or
funcRon

of
a
naRonal
data
infrastructure
to
support
high
quality
paRent-‐
centered
outcomes
research;
300+
aMendees

live
and
via
webcast.

Communicating Through New Platforms
PCORI Channel on YouTube
•  Videos of Board meetings, workshops, webinars
•  >9,000 views of 49 videos uploaded
16

Telling Our Story
PCORI’s
work
has
been
featured
in
dozens
of
reports
in
health

policy
and
top
naRonal
news
outlets,
as
well
as
major
journals

Tracking Growth of @PCORI
18
TwiMer
follower
volume

(six-‐month
snapshot)

Tweets
by
month

(via
tweetstats.com)

Total PCORI Twitter Impressions (Feb-Aug): 7.6 Million

Future Opportunities
19
•  Refine our messaging as we build our research portfolio
•  Develop a plan and structure in partnership with AHRQ for research
dissemination efforts
•  Mine programmatic efforts to show what we are learning; use more
effective storytelling to make that work meaningful and “real”
•  Continue to upgrade our infrastructure
•  Review the CER/PCOR landscape to assess opportunities for
collaboration in advancing our communications goals, focusing on our
leadership in “research done differently”
•  Take a strategic approach to speaking/publishing opportunities

20
•  How can we best refine our messaging as we build our research
portfolio?
•  What critical lessons do we want to impart from our research to date?
•  What kinds of “stories” might we use to make our work “real” to our
stakeholders and show how “research done differently” benefits them?
•  How can we best collaborate with and leverage the work of others in
the CER/PCOR space to advance our communications goals?

Washington, DC
September 24, 2012
Anne Beal, MD, MPH, Chief Operating Officer
Sue Sheridan, Acting Director, Patient Engagement
Susan Hildebrandt, Director, Stakeholder Engagement
Sharon Levine, Chair, COEC
PCORI Advisory Panels

Questions for Board Consideration
1

Is
this
the
right
scope
for
advisory
panel
ac4vi4es?

2

Please
comment
on
the
proposed
number
and
type
of
panels.

2

Advisory Panels: What the Law Says
•  The Institute may appoint permanent or ad hoc expert
advisory panels as determined appropriate to assist in
identifying research priorities and establishing the
research project agenda
•  The Institute shall appoint expert advisory panels in carrying
out randomized clinical trials under the research project
agenda
•  In the case of a research study for rare disease, the
Institute shall appoint an expert advisory panel
3

Advisory Panels: Purpose
•  Advisory Panels will assist PCORI staff and Board in:
–  Modeling robust patient and stakeholder engagement efforts,
–  Refining and prioritizing specific research questions,
–  Providing other scientific or technical expertise
–  Addressing other questions that may arise relevant to PCORI’s
mission and work
4

Advisory Panels: Framework
•  Each Advisory Panel will have
–  A unique charter and duration
–  Clearly defined scope of work
•  Membership on each Advisory Panel will be based on ensuring
those with appropriate expertise are selected to satisfy the scope
of work established in its charter
–  We are developing a plan for compensation of members
5

Proposed Advisory Panels
•  Patient Engagement
•  Assessment of Prevention, Diagnosis and Treatment Options
•  Health Disparities
•  Improving Healthcare Systems
•  Communication and Dissemination
•  Infrastructure*
•  Randomized Clinical Trials*
•  Rare Diseases
6

*in
collabora4on
with
MC

Pa&ent
Engagement

Assessment
of
Preven&on,
Diagnosis,
and
Treatment
Op&ons

Health
Dispari&es

Improving
Health
Care
Systems

First Panels: First Half of 2013
7

Communica&on
and
Dissemina&on

Infrastructure

Randomized
Clinical
Trials*

Rare
Diseases*

Future Panels: Second Half of 2013
8

*Required by statute

Advisory Panels: What the Law Says
An expert advisory panel shall include representatives of
practicing and research clinicians, patients, and experts in
scientific and health services research, health services
delivery, and evidence-based medicine who have experience
in the relevant topic and, as appropriate, experts in integrative
health and primary prevention strategies.
9

Composition
•  Advisory Panel size will be 10-21 panel members, depending on
the panel’s purpose
•  Membership of each Advisory Panel will be selected based on the
scope of work established in the charter
10

Composition (continued)
•  Panel may have a non-voting liaison from the PCORI Board of
Governors or Methodology Committee as appropriate
•  An Advisory Panel Chairperson will be selected from among the
Panel members by the PCORI Board of Governors
•  Members will be appointed for 1-year terms, with an opportunity
for reappointment
11

Conflict of Interest
•  PCORI will consider implications for panel members’ eligibility for
future PCORI funding in creating Advisory Panels
–  The role will be advisory and participation will not affect
eligibility for funding
–  We will have firewalls similar to those surrounding the
Methodology Committee regarding access to information
–  Advise members before appointment about potential impact on
eligibility for PCORI funding if they might receive non-public
information
–  Explore options to promote transparency of proceedings
•  We will clarify that Advisory Panels’ roles are to provide input to
the Board and staff, not to make decisions
12

•  Board,
MC,
and/or

PCORI
staff
iden4fy

the
need
to
establish

an
Advisory
Panel

•  Staff
ini4ates
request

for
an
advisory
panel

by
submiRng
a

panel-‐specific
charter

•  Board
may
authorize

charter
(proceed
to

step
3)

•  Board
may
request

revisions
to
the

charter
(return
to

step
1)

•  Staff
ini4ates
open

call
for
nomina4ons,

via
the
PCORI
Web

site
and
other

communica4ons

•  Nominees
submit
an

expression
of

interest,
via
the

PCORI
Web
site

•  Staff
evaluates

nominees,
per

evalua4on
criteria

unique
to
the
panel

charter

•  Staff
selects
and

proposes
a
panel

roster
to
the
Board

•  Board
authorizes

and
approves
the

panel
roster

Advisory Panel Establishment Process
Staff

Ac&vates

Nomina&on
and

Selec&on
of
Panel

Par&cipants

Board
Approves

Panel
Par&cipants

Staff
DraI
and

Submit
Charter
for

an
Advisory
Panel

Board
Reviews
the

Proposed
Advisory

Panel
Charter

1 2 3 4
Staff Phase Board Phase 13

Pa&ent
Engagement

Assessment
of
Preven&on,
Diagnosis,
and
Treatment
Op&ons

Health
Dispari&es

Improving
Health
Care
Systems

First Panels: First Half of 2013
14

Proposed Panel: Patient Engagement
•  Purpose: Assure the highest patient engagement standards and
patient-centeredness in all aspects of PCORI’s work
•  Term: 1 year
•  Membership: Between 10–21 members with 75% patients,
caregivers, and advocacy organizations and 25% researchers and
other stakeholders
•  Advisory Panels will provide advice and make recommendations to
PCORI and help inform decisions of the Board of Governors, the
Methodology Committee, and Institute staff, as requested
15

Proposed Panel: Patient Engagement
Selec&on

Criteria

•  Pa&ents
and
caregivers
who
can
represent
the

collec&ve
voice
of
their
communi&es/networks

•  Online
communi&es
and
organiza&ons
with
extensive

reach
into
high
priority
popula&ons

•  Represent
underserved/disparate
popula&ons
and

those
with
rare
diseases

•  Experience
in
pa&ent-‐centered
research/proposal

review

•  Involvement
in
systems
improvement

•  Community-‐
or
state-‐based

16

Questions for Board Consideration
1

Is
this
the
right
scope
for
advisory
panel
ac4vi4es?

2

Please
comment
on
the
proposed
number
and
type
of
panels.

17

BOARD VOTE:
Recommend Approval to Develop Advisory Panels
•  Patient Engagement
•  Assessment of Prevention, Diagnosis and
Treatment Options
•  Health Disparities
•  Improving Health Care Systems

Washington, DC
September 24, 2012
Sue Sheridan, Acting Director, Patient Engagement
Susan Hildebrandt, Director, Stakeholder Engagement
Anne Beal, MD, MPH, Chief Operating Officer
Sharon Levine, MD, Chair, COEC
Engagement Update

Engagement: Questions to Consider
1

• What
recommenda.ons
does
the
Board
have
for
reaching
stakeholders
who

may
not
be
part
of
established
networks
and
are
more
diﬃcult
to
reach?

2

• What
are
the
measures
of
success
in
engaging
pa.ents,
caregivers,
and

stakeholders
that
the
Board
would
like
to
see
in
the
next
12
months?

3

• How
do
we
demonstrate
and
lead
“research
done
diﬀerently”
for
pa.ents,

caregivers,
stakeholders,
and
the
research
community?

2

Presentation Outline
•  Review of Strategic Priorities
•  Engagement “Touch Points” in the PCOR Process
•  Workshops
3

Engagement Priorities
1.  To invite, value, and use the wisdom and experience of patients,
caregivers, and other stakeholders nationwide in the PCORI research
enterprise; eliminate barriers to participation
2.  Establish a community of trained and informed patients and caregivers
as valued partners who participate in all stages of the research enterprise
3.  Communicate transparently and regularly about PCORI’s approach and
methods for prioritization, decision making, and funding to all stakeholders
to create trust
4.  Evaluate and refine patient engagement processes to continuously learn
and incorporate best practices and methods for developing a robust and
engaged community of stakeholders in PCORI work
•  PCORI Strategic Plan
4

Advise Us as to What PCORI
Should Study:
Tell Us How We Are Doing
Review Proposals and
Partner in Research
Help Us Share the Findings
Patients
and
Stakeholders
Patient and Stakeholder Engagement
in Patient-Centered Outcomes Research
5
What questions are most important?
(research prioritization)
What outcomes should be studied?
(topic generation)
Review research proposals for impact
and patient-centeredness
Participate in conducting research
How can we improve on what we are doing
and how we are doing it?
How do we best communicate
important research findings?

Patient View on Engagement in Research
6

Tell Us What PCORI Should Study
•  Conduct patient and stakeholder testing of content and language
on topic generation Web page
•  Solicit research topics in patient and stakeholder meetings and
PCORI roundtables
•  Host workshops
•  Patient Workshop (October 27-28)
•  Stakeholder Workshop (December 4)
•  Prioritization Workshop (December 5)
7

Review Proposals and
Partner in Research
•  Revamped pilot projects reviewer recruitment process
•  Created a user-friendly application and process
•  Reached out to extensive lists of key stakeholders
•  Vetted reviewer applications in-house
•  Contracted with expert vendor to develop merit review
training specifically for patients and other stakeholders
•  Will engage patients and stakeholders in process
improvement cycle
8

•  Patients and stakeholders will be
one-third of review panels
•  350 total applicants
•  242 with prior grant review
experience
•  102 from patient community
•  140 from stakeholder
community
•  58 selected in final vetting
•  Based on balanced criteria
•  Goal is to build a database of lay
reviewers of PCORI funding
applications
Patient and Stakeholder Reviewers
Patient, 25
Nurse,
3Physician,
5
Clinician or
Provider
Association
Rep, 4
Researcher, 5
Other
Stakeholders,16
9

Patient and Stakeholder Reviewers
8

7

6

4

3

2

1

10

“This is exciting
and will
lead to positive
outcomes.”
“17-year breast cancer
survivor and want to
see an end to the
disease.”
“Need to find ways
to optimize
healthcare system.”
“Need for more research
to meet current needs of
patients.”“Served as a PCORI
reviewer and experience
was fascinating."
“Stakeholder engagement is essential to
relevant and useful research and
evaluation: from identification of study
questions to dissemination and utilization
of findings.”
“Need to get
patients'
perspective and
find ways to get
them involved.”
“First time patient’s
voice is being
formalized.”
"I want do my part as a
patient, and I will be
honored with this
opportunity.”
"It's about
time this is
happening
in
healthcare.”
“Want to give back
Expertise, and this
is a great learning
opportunity.”
Source: Patient and Stakeholder Interviews. August 2012
What We Heard From Reviewers
11

Create

Communi.es

Engage

Meaningfully

Share
and

Adopt
Latest

Informa.on

12
Help Us Spread the Word

Stakeholder View on Dissemination
13

Pa.ents

14
Tell Us How We Are Doing

Patient Workshop: Objectives
Transforming Patient-Centered Research:
Building Partnerships and Promising Models
(October 27-28: Washington, DC)
•  Launch the creation of an informed and engaged community
•  Create consensus recommendations for patient engagement in
–  Generating and prioritizing research questions
–  Reviewing research proposals and the conduct of research
–  Disseminating and implementing research findings
–  Evaluating the success of PCORI’s engagement efforts
•  Write a “thought piece” on promising practices in patient
engagement in research
15

Patient Workshop: Selection Criteria
•  Invitation list developed with the goal of inclusiveness
•  Balance sought between and among disease incidence, prevalence,
burden, and disparities in the United States (with emphasis on
chronic conditions)
•  Total attendance will be limited to 150 participants
–  75% of participants will be patients, patient advocates,
caregivers, and individuals from patient/caregiver advocacy
organizations
–  25% of participants will be a mix of PCORI’s other stakeholders
16

Stakeholder Workshop: Objectives
What Should PCORI Study?
A Call for Topics From Patients and Stakeholders
(December 4: Washington, DC)
•  Solicit research topics for specific funding announcements using
breakout sessions on PCORI’s priority areas and generate list
•  Report on draft prioritization process (topic of December 5
workshop), allow participants to experiment with applying it to
their topics, and solicit feedback on the process
•  Report on Patient Engagement Workshop participants’ reactions to
PCORI’s engagement strategies and to seek additional input
17

Stakeholder Workshop: Other Criteria
Specific Experience With:
•  Research or work in PCORI Priority Areas
•  Leadership in PCORI Priority Areas
•  The health policy or research communities
•  Broad membership or responsibility for health care delivery
18

What’s Next
•  Advisory Panels
•  Additional Workshops
•  State-Based Events
19

Engagement: Questions to Consider
1

• What
recommenda.ons
does
the
Board
have
for
reaching
stakeholders
who

may
not
be
part
of
established
networks
and
are
more
diﬃcult
to
reach?

2

• What
are
the
measures
of
success
in
engaging
pa.ents,
caregivers,
and

stakeholders
that
the
Board
would
like
to
see
in
the
next
12
months?

3

• How
do
we
demonstrate
and
lead
“research
done
diﬀerently”
for
pa.ents,

caregivers,
stakeholders,
and
the
research
community?

20

•  Appendix A: Patient Engagement Workshop Outline
•  Appendix B: Patient Engagement Workshop Timeline
•  Appendix C: Stakeholder Engagement Workshop Outline
•  Appendix D: Organizations Contacted
21
Appendix

Patient-Centered Outcomes Research Institute
Executive Director’s Welcome
Washington, DC
September 24, 2012
Joe V. Selby, MD, MPH, Executive Director

New
PCORI
Staﬀ
–
since
May
2012

Kara Odom-Walker
Scientist
August 13, 2012
Katie Wilson
Project Associate
June 11, 2012
Orlando Gonzales
Chief of Staff
August 1, 2012
Michele Orza
Senior Advisor
to the Executive Director
September 4, 2012
Gregory Martin
Deputy Director,
Stakeholder Engagement
July 23, 2012
James Hulbert
Contracts Administrator
September 10, 2012
Marla Bolotsky
Associate Director,
Digital Media
September 5, 2012
Ayodola Anise
Project Associate
August 13, 2012
Kelton Chapman
Assistant Manager,
Meetings and Special Events
May 29, 2012
Not
Shown:

Lorraine
Bell,
Senior
Program
Associate
–
May
29,
2012

Desiree
Frank,
ExecuEve
Assistant
to
the
ExecuEve
Director
–
June
19,
2012

Kimberly
Holloway,
Senior
AdministraEve
Assistant
–
August
27,
2012

David
Hickam,
ScienEﬁc
Program
Leader,
Health
System
Research
–
September
17,
2012

Jordan
Elliker,
Project
Events
Coordinator
–
September
19,
2012

PCORI
PILOT
PROJECTS
(PPP)

•  50
projects
funded
(of
856);
mostly
2-‐years
in
length

•  $31
million
total
funding

Funded
PCORI
Pilot
Projects
in
25
States
and
DC

4

PCORI Pilot Projects Areas of Interest
Area
of
Interest
SubmiKed
Funded

Informing
PCORI
naEonal
prioriEes
21
2

Bringing
together
paEents,
caregivers,
and
other
stakeholders
in

all
stages
of
a
research
process
80
1

TranslaEng
evidence
into
health
care
pracEce
in
ways
that

account
for
individual
paEent
preferences
for
various
outcomes,

including
decision-‐support
tools
180
19

CollecEng
and
assessing
paEent-‐
and
provider-‐perceived
gaps
in

evidence
26
0

IdenEfying,
tesEng,
and/or
evaluaEng
paEent-‐centered

outcomes
instruments
214
11

Assessing
the
paEent
perspecEve
when
researching
behaviors,

lifestyles,
and
choices
31
5

Studying
paEent
care
team
interacEons
in
situaEons
where

mulEple
opEons
exist
45
6

AnalyEcal
methods
for
CER
170
6

Types of Organization
Primes

Subcontractors

Overview:

All
ApplicaOons

Type
Primes
Subs
Funded

Academic
561
235
38

Hospitals
80
98
4

Research
organizaEons
55
49
3

Non-‐profit
health
systems
28
54
2

Community-‐based
health

centers

20
46
0

Consultants
18
32
1

Provider
associaEons
16
19
0

PaEent
associaEons
10
40
1

Non-‐profit
foundaEons
9
24
1

Technology
organizaEons
7
25
0

Government
5
16
0

For-‐profit
health
benefits
2
0
0

For-‐profit
pharmaceuEcal

1
2
0

Other

0
52
0

6

Target Populations – Applicants & Awardees
0%

10%

20%

30%

40%

50%

60%

Percent
of
Total
ApplicaOons

Total
ApplicaOons
by
Target

PopulaOon

PopulaOon
All
Funded

Underserved
453
30

Speciﬁc
Ethnic

or
Cultural

243
21

Disabled
163
12

Urban
&
Rural
383
28

Only
Urban
188
14

Only
Rural
22
1

Unspeciﬁed
224
8

Monitoring
the
Pilot
Projects

Two-year competitive contract awarded to
AcademyHealth (A Rein, PI) to do the following:
§  Work closely with PCORI to monitor the 50 pilot projects for
achievement of specific aims
§  Assess learnings on patient engagement in research from all
50 projects
§  Identify 5 subgroups with common themes, convene and
create joint products within each thematic area
8

PCORI
FUNDING

ANNOUNCEMENT
APPLICATIONS

•  483
applicaEons
received

•  Review
process
underway

•  ~
100
awards
expected
in
December
2012

DescripOon
of
ApplicaOons
Received

Top
15
States
Applying

483
applicaOons
received

ApplicaOons
by
PFA

71,
15%

211,
44%

92,
19%

109,
22%

Addressing
DispariEes

Assessment
of
PrevenEon,
Diagnosis,
and
Treatment
OpEons

CommunicaEon
and
DisseminaEon
Research

Improving
Healthcare
Systems

0
10
20
30
40
50
60

CA

PA

MA

NY

MN

TX

WA

FL

NC

MD

MI

IL

GA

OH

IA

MenOon
of
Speciﬁc
CondiOons

MulEple
condiEons
and
study
designs
may

0

50

100

150

200

250

300

Number
of
ApplicaEons

Study
Designs
Noted
in
ApplicaOons

0

10

20

30

40

50

60

70

80

90

Priority
#1:

Assessment
of
PrevenOon,
Diagnosis,
and
Treatment

OpOons
(n=211
applicaOons)

0

10

20

30

40

50

60

70

80

Disabled

Persons

Elderly
Other
Pediatric
Racial
or

Ethnic
Group

Rural
Urban
Veterans
Women

Priority
#1:
Assessment
of
PrevenOon,
Diagnosis,
and

Treatment
OpOons
(n=211
applicaOons)

Study
PopulaOons
Noted
in
ApplicaOons

Number
of
ApplicaEons

Reviewers

Volunteers

Total

Applicants

First

Round

Second

Round

Technical
Reviewers
800+
483*
75-‐100

PaEent
Reviewers
225
-‐-‐
25

Stakeholder
Reviewers
225
25

Commimee
Chairs
-‐-‐
10

PCORI’s
8
Review
Criteria

1.  Impact of the Condition
2.  Innovation and Potential for Improvement
3.  Impact on Healthcare Performance
4.  Patient-Centeredness
5.  Rigorous Research Methods
6.  Inclusiveness of Different Populations
7.  Team and Environment
8.  Efficient Use of Resources
15

Agenda
for
Today’s
MeeOng

PaEent
and
Stakeholder
Engagement

PrioriEzaEon
of
Research
Topics

Advisory
Panels

Conﬂict
of
Interest
Policy
and
Plan
for
Methodology
Commimee

PCORI
Funding
Announcement
5A
-‐
Methods

Methodology
Commimee
Public
Comment

2012
Budget

CommunicaEons
Update

•  Appendix A: PICORI Pilot Projects Update
17

Appendix

1
Finance, Audit, and Administrative
Committee (FAAC) Report
PCORI Board of Governors
Washington, DC
September 24, 2012
Kerry Barnett, JD, Chair
Anne Beal, MD, MPH, COO
Pamela Goodnow, Director of Finance

2
•  Unaudited Financial Statements
~ Results of Operations
•  Revised 2012 Budget
•  Budget Assumptions
•  Cash Flow
Appendix
•  Financial Statements
•  CBO Updated Estimate for the Insurance
Coverage Provisions of the Affordable Care
Act
Agenda

3
Results of Operations
Unaudited Financial Statements
The GFY 2013 Appropriation of $150 million will be received on
October 1, 2012, and will be taken into Operating Revenue at that time.
UNAUDITED
JUNE
30,
2012
OPERATING REVENUE $0
Program Expenses
Communication and Engagement 1,435,365
Research 1,888,897
Methodology 3,054,947
Total Program Expenses 6,379,209
Administrative Expenses
Board 739,262
Management and General 3,312,271
Total Administrative Expenses 4,051,533
35,190
NET INCOME (LOSS) ($10,395,552)
Non-operating Interest Income

4
Unaudited June 30, 2012
Revised 2012 Budget
The Board approved the 2012 budget subject to mid-year corrections.
UNAUDITED PROJECTED
REVISED
JUNE
30,
2012 3Q/4Q BUDGET
OPERATING REVENUE $0 $120,000,000 $120,000,000
Program Expenses
Communication and Engagement 1,435,365 4,347,026 5,782,391
Research 1,888,897 7,701,268 9,590,165
Methodology 3,054,947 3,002,344 6,057,291
Total Program Expenses 6,379,209 15,050,637 21,429,846
Administrative Expenses
Board 739,262 1,414,026 2,153,288
Management and General 3,312,271 3,274,663 6,586,934
Total Administrative Expenses 4,051,533 4,688,689 8,740,222
35,190 37,500 72,690
NET INCOME (LOSS) ($10,395,552) $100,298,174 $89,902,622
[1]
[1]

There
will
be
$96
million
awarded
for
research
in
November
2012.
Non-operating Interest Income

5

Budget Assumptions
$320 million estimated for GFY 2013 less HHS/AHRQ
Revenue Projections
PCORI receives $120 million in direct appropriation
Partial year collected on covered lives for
PCOR fee on health plan providers and the self-insured
IRS will collect the fee annually on the Quarterly Federal Excise Tax
Return Form 720 due July 31 of the following year
PCORI receives $28 million between August 15, and October 15, 2013
Partial year collected on covered lives for
PCOR fee on Medicare/Medicaid/CHIP
PCORI receives $6 million on July 31, 2013; actual timing unknown

6
Net Revenue
(Dollars in millions)
Cash Flow
2012 2013
CASH
BALANCE $162 $241
Appropriation $150 $150
PCOR
Fee 0 34
Subtotal 150 184
Less
AHRQ/HHS (30) (37)
Less
Program
and
Operating
Expenses
(30) (41)
Net
Revenue $90 $106
Research
Contract
Commitments $127 $300
Research
Outflows
2012 ($11) ($21)
2013 (139)
Total

Outflows ($11) ($160)
CASH
BALANCE $241 $188

7
Appendix
•  Financial Statements
•  CBO Updated Estimate for the Insurance Coverage Provisions
of the Affordable Care Act

PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E
1

Washington, DC
September 25, 2012
Rick Kuntz, MD, Member, PCORI Board of Governors,
Chair, Program Development Committee
PCORI Funding Announcement 5B:
Infrastructure

2

Strategic
Ques-ons
Around
Infrastructure
PFA

1.  Feedback
on
feasibility,
opportunity
for
a

“hybrid”
approach
to
Infrastructure
PFA

2.  Strategic
considera@ons
for
an
Itera@ve,

Progressive
PFA
Process

3

Two
Dis-nct
(and
Complementary)
Approaches
Emerge

from
Palo
Alto

PCORI
Na-onal
Workshop
to

Advance
Use
of
Electronic
Data

Clinical Data
Research
Network (CDRN)
Patient-Powered
Research
Network (PPRN)

4

Infrastructure
Subgroup
Is
Formed

Program
Development

CommiJee
Members
and
Guests

•  Carolyn
Clancy

•  Francis
Collins

•  Arnie
Epstein

•  Sherine
Gabriel

•  Chris@ne
Goertz

•  Leah
Hole-‐Curry

•  Gail
Hunt

•  Harlan
Krumholz

•  Rick
Kuntz

•  Mike
Lauer

•  Nancy
Miller

•  Jean
Slutsky

PCORI
Execu-ve

Leadership
and
Staﬀ

•  Joe
Selby

•  Ka@e
Wilson
(Project

Management)

5

An
Itera-ve,
Strategic
Proposal
for
Funding

Proposed
Progression
of
PFAs

Phase
One
Phase
Two

PFA
#1:

Clinical
Data
Research

Network

Answers
Ques*on:

Can
direct
involvement
of

pa@ents
improve
the

efficiency
and

effec@veness
of
large

data
networks
for

conduc@ng
clinical

research?

PFA
#2:

Pa@ent-‐Powered

Research
Network

Answers
Ques*on:

Can
pa@ent
organiza@ons

and
networks
play
a

leading
role
in

compara@ve

effec@veness
research?

PFA
#3:

Pa@ent-‐Centered

Outcomes
Research

Network
(PCORNet)

Builds
on
PFAs
#1
&
#2:

With
a
stable
founda@on

for
the
conduct
of
many

different
research
studies,

now
the
projects
need
to

be
defined;
may
include

coordina@ng/convening

center
award

6

Phase
One:
Clinical
Data
Research
Network
(1
of
3)

Funding
Opportunity

Invite
consor@a
of
mul@ple
health
services
organiza@ons
to
apply
for

support
of
research
infrastructure:

•  Goal
#1:
build
large
interoperable
network(s)
capable
of
suppor@ng
large

scale
compara@ve
eﬀec@veness
trials
of
mul@ple
research
ques@ons,

including
preven@on
and
treatment,
at
low
marginal
cost,
with

substan@ve
pa@ent
involvement
throughout

•  Goal
#2:
embed
research
ac@vity
within
a
func@oning
health
care
system

without
disrup@ng
the
business
of
providing
health
care;
thus,
business

case
for
the
health
care
system
to
par@cipate
must
be
addressed

•  Goal
#3:
demonstrate
ability
to
mobilize
and
engage
substan@al
pa@ent

popula@ons
within
the
covered
popula@on
for
at
least
three
condi@ons

•  Goal
#4:
ensure
health
care
organiza@on
leaders
have
meaningful
role
in

governance,
including
a
voice
in
iden@fying
meaningful
research

priori@es
for
their
organiza@on

7

Phase
One:
Clinical
Data
Research
Network
(2
of
3)

Criteria

1.  Pa@ent,
provider,
and
health
system
involvement
at
all
levels
of
consor@um
design,

implementa@on,
governance,
and
use

2.  Health
care
organiza@on
leaders
must
have
a
voice
in
research
priori@es
(discouraging

studies
that
are
not
feasible,
iden@fying
meaningful
ques@ons
for
their
organiza@ons)

3.  Access
to
at
least
1,000,000
pa@ents

4.  Poten@al
for
longitudinal
follow
up
across
care
sefngs

5.  Diversity
in
age,
gender,
socioeconomic
status,
race/ethnicity

6.  Ability
to
obtain
informed
consent,
using
central
IRB

7.  Ability
to
establish
at
least
three
disease-‐speciﬁc
cohorts
that
achieve
par@cipa@on
of

pa@ents
within
the
network,
but
also
include
outreach
to
established
pa@ent
networks

focused
on
those
same
disorders
(see
PFA
#2)

8.  Electronic
health
records
with
meaningful
use
for
research

9.  Buy-‐in
and
ac@ve
par@cipa@on
from
the
health
care
system(s)
in
which
care
is
delivered

10.  Ability
to
conduct
observa@onal
and
interven@onal
(individual
or
cluster
randomized)
trials

11.  Data
access
policies
that
promote
broad
research
use
but
protect
privacy,
conﬁden@ality

12.  Poten@al
to
obtain
and
store
biological
specimens

8

Phase
One:
Clinical
Data
Research
Network
(3
of
3)

Allowable
Items
to
Include
in
Proposal
and
Budget
Request

•  Permanent
research
staﬀ
support

•  Incen@ves
for
the
health
system
to
support
embedded
research
in
the
system

•  Pa@ent
network
outreach
coordinator

•  Communica@on
staﬀ

•  Establishment
of
IT
connec@vity
between
consor@um
members

•  Costs
of
consent
for
research

•  Pilot
research
studies,
ideally
in
partnership
with
relevant
pa@ent
groups

•  Biobank
costs

•  Pa@ent
surveys
to
assess
interest
in:

o  Genera@ng
research
ques@ons

o  Using
the
database

o  Ability
to
communicate
with
other
pa@ents

o  Providing
pa@ent-‐reported
informa@on

o  Par@cipa@ng
in
appropriate
RCTs

9

Phase
One:
Pa-ent-‐Powered
Research
Network
(1
of
3)

Funding
Opportunity

Invite
pa@ent-‐centered
organiza@ons
with
speciﬁc
disease
or
condi@on

focus
to
apply
for
support:

•  Goal:
ini@ally
to
provide
pilot
funding
to
help
groups
organize
and

develop
the
necessary
infrastructure
to
deﬁne
the
most
important

pa@ent-‐centered
research
ques@ons
and
to
prepare
for
vigorous,

broad
par@cipa@on;

•  Goal
(latent
objec@ve):
increase
access
to
partnership
and

par@cipa@on
in
research
for
a
broadly
diverse
popula@on
of

individuals
with
common
health
issues

10

Phase
One:
Pa-ent-‐Powered
Research
Network
(2
of
3)

Criteria

1.  Applicant
group
must
demonstrate
that
they
are
considered
credible
and

effec@ve
by
those
with
the
condi@on

2.  Must
represent
a
substan@al
number
of
affected
individuals,
ideally
with

diversity
in
demographics
and
disease
severity,
and
with
long
term

involvement
of
most
par@cipants,
as
appropriate
given
the
condi@on

3.  Group
leadership
must
be
representa@ve
in
some
way
and
be
able
to
receive

and
act
upon
broad
input
of
affected
individuals,
reflec@ng
their
needs
and

have
processes
in
place
to
nego@ate
divergent
opinions

4.  Must
have
sufficient
administra@ve
and
financial
accoun@ng
structures
to
be

able
to
receive
and
account
for
grant
funds
(PCORI
staff
may
need
to
help

here)

5.  Must
have
interest
in
and
capacity
to
expand
membership
to
include

historically
under-‐represented
pa@ent
groups
with
the
condi@on

11

Phase
One:
Pa-ent-‐Powered
Research
Network
(3
of
3)

Allowable
Items
to
Include
in
Proposal
and
Budget
Request

•  Staff
support
to
build
and
expand
network
of
affected
individuals,
establish
databases

•  Administra@ve
staff
for
grants
management
and
grant
prepara@on

•  Infrastructure
support
to
enhance
interac@ve
communica@on
with
pa@ents
and
caregivers

•  Funds
for
workshops
to
convene
pa@ents,
clinicians,
and
other
stakeholders,
to
iden@fy
the

most
important
research
ques@ons

•  Funds
to
address
approaches
to
obtaining
clinical
electronic
health
record
data
on
pa@ents

in
the
group

•  Funds
for
outreach
and
enrollment
of
pa@ents
from
tradi@onally
under-‐representa@ve

popula@ons

•  Pa@ent
surveys
to
assess
the
demographic
and
clinical
characteris@cs
of
enlisted
pa@ents

and
to
study
their
interest
in:

o  Genera@ng
research
ques@ons

o  Using
the
database

o  Ability
to
communicate
with
other
pa@ents

o  Providing
pa@ent-‐reported
informa@on

o  Par@cipa@ng
in
appropriate
RCTs

12

Phase
Two:
Research
Projects

•  Disease-‐speciﬁc
applica-ons:

•  Ideally
come
jointly
from
a
PPRN
applicant
and
a
CDRN
applicant

•  PPRN:
Highly
mo@vated,
poten@ally
less
generalizable

•  CDRN:
Less
mo@vated,
poten@ally
more
representa@ve

•  Condi@ons
not
represented
by
a
PPRN
could
be
proposed
with
the
CDRN
Group

to
help
catalyze
such
a
group,
star@ng
with
their
own
members,
and
extending

more
broadly

•  Outside
inves-gators
could
apply
for
the
opportunity
to
run
observa@onal
or

interven@onal
research
studies
through
the
CDRN
and
PPRN,
ideally
focused
on

condi@ons
represented
by
the
PPRN

•  Applica-ons
focused
on
preven-on
strategies
might
need
to
come
from
an
CDRN,

or
from
an
outside
inves@gator
proposing
to
have
the
CDRN
conduct
the
study

•  Applica-ons
coming
from
health
care
organiza-ons
ensure
leaders
have

meaningful
role
in
governance,
including
a
voice
in
iden@fying
meaningful
research

priori@es
for
their
organiza@on

Pa-ent-‐Centered
Outcomes
Research
Network

13

Next
Steps

•  Finalize
Hybrid
Vision

•  Conduct
Inventory
of
Exis@ng
Pa@ent
Data
Networks
for

Feasibility
Planning,
Taxonomy
of
Networks

•  Release
First
Infrastructure
PFA
Q1,
2013

14

Strategic
Ques-ons
Around
Infrastructure
PFA

1.  Feedback
on
feasibility,
opportunity
for
a

“hybrid”
approach
to
Infrastructure
PFA

2.  Strategic
considera@ons
for
an
Itera@ve,

Progressive
PFA
Process

15

Strategic Document: PCORI Funding Opportunity 5b—Infrastructure
for Research (document to be circulated)
Appendix

Washington, DC
September 24, 2012
Debra J. Barksdale, PhD,RN, Chair, SPC
Bill Silberg, Director of Communications
Scientific Publications
Subcommittee Update

Planning and Managing Our Publishing Opportunities
2
•  Subcommittee activities, policies, and procedures
•  Tracking the pipeline
•  Coordination with COEC and AHRQ
•  Strategic publishing plan
•  Next steps
•  Questions to consider

Subcommittee Members
3
•  Debra J. Barksdale, Chair
•  Harlan Krumholz
•  Sharon-Lise Normand
•  Alfred O. Berg
•  Michael Lauer
•  Anne Beal
•  Joe Selby

4
•  How can we more strategically generate ideas for PCORI-
associated papers and other scientific communication
opportunities?
•  How might we improve our processes for helping to turn those
ideas into realities?
•  How should we develop and support policies designed to make
our supported research as widely available as possible?

Activities, Policies and Procedures
5
•  Facilitate the process of publication of papers written on behalf of PCORI
o  Consider and approve manuscript ideas initiated by Board or MC
members or staff and identify appropriate authors
o  Review article requests from outside entities (ie, solicited by journals)
o  Ensure no overlap with papers already in development.
•  Manage courtesy review of papers not written on behalf of PCORI and apply
disclaimer

Tracking the pipeline
6
•  Four PCORI-related papers published, one in review and one
more cleared for submission
•  Improvements to consider
o  Prioritizing papers to improve turnaround time and follow-up
o  More effective means of notifying the subcommittee of article
ideas
o  Plan for informing Board, MC and staff of published papers, tied
to PCORI document delivery system to ensure broad access

Tracking the Pipeline
Recent
publica-ons
of
note

7

Coordination With COEC and AHRQ
8
•  Coordination with COEC is critical to see that scientific publishing
activities are appropriately aligned with PCORI’s broader
communications, outreach, and engagement goals
•  Coordination with AHRQ is critical to meet statutory
requirements for dissemination of primary research results
o  Develop plan for coordinating dissemination efforts
o  Assess how best to interpret and meet “90-day rule”
o  Determine how to best serve multiple audiences

Strategic Publishing Plan
9
•  Proactively assess and take advantage of opportunities to pursue
publishing activities that advance our goals
•  Build relationships with key influencers – journal editors – to assist in
dissemination, use, and impact of PCOR
•  Seek ways to support new forms of scientific publishing and
communication (blogs, multimedia) that will tell the story of our mission
and supported research
•  Support polices that provide broad and open access to PCORI-supported
work
•  Consider how subcommittee’s work might apply to consumer media

Next Steps
10
•  Improve process for soliciting ideas for papers and other opportunities
•  Address authorship issues (eg, “corporate authorship”)
•  Assess subcommittee’s role in helping manage PCORI-related content
other than scientific articles (eg, white papers, reports, blog posts)
•  Consider how the subcommittee’s work might apply to consumer media
•  Consider ways to better support workflow and prioritize/track articles
•  Advise on PCORI policy on open access issues
•  Formalize strategic publishing plan

11
•  How can we more strategically generate ideas for PCORI-related
papers and other scientific communication opportunities?
•  How might we improve our processes for helping to turn those
ideas into realities?
•  How should we develop and support policies designed to make
our supported research as widely available as possible?

Topic Generation and Research
Prioritization
Joe V. Selby, MD, MPH, Executive Director
Rachael Fleurence, PhD, Scientist
Rick Kuntz, MD, MSc, Chair, PDC
Washington, DC 20008
September 24, 2012,

Strategic Questions to Consider
•  Strategic
ques-ons
to
consider

•  Does the research prioritization process engage
patients and stakeholders at the appropriate level? Is
the process transparent and rigorous?
•  Will the process enable PCORI to develop a balanced
portfolio in line with its mission?
•  Does the process enable the optimal level of
engagement between the Board of Governors and
Advisory Panels?
2

PCORI’s
Research
Agenda

Five
Board-‐Approved
Priority
Areas

1.  Addressing
Dispari-es

2.  Communica-on
and

Dissemina-on

3.  Assessment
of
Preven-on,

Diagnosis,
and
Treatment
Op-ons

4.  Improving
Healthcare
Systems

5.  Infrastructure
and
Methods

3

Inves;gator-‐Generated
Research
Just
One
Part
of
the
Process

PCORI
issues
broad

funding
announcements

Researchers
partner
with
stakeholders
to

generate
ques-ons

Researchers,
stakeholders
apply

review
criteria
in
their
applica-ons

Peer
review
priori-zes

applica-ons
by
level

of
alignment

with
criteria

2 Complementary Approaches for Developing
PCORI’s National Research Agenda
Diverse
Research
Por.olio
answering
key

ques7ons
for
pa7ents

and
clinicians

4

Pa;ent/Stakeholder-‐Led
Approach

PCORI
and
stakeholders
generate
and
priori-ze
ques-ons

based
on
review
criteria

PCORI
issues
speciﬁc,
funding
announcements

for
highest
priority
topics

Researchers
and
stakeholders

develop
responsive
proposals

Peer
review
priori-zes

applica-ons
by
level

of
alignment

with
criteria

Patient/Stakeholder-Led Approach Unique
to PCORI
Diverse
Research
Por.olio
answering
key

ques7ons
for
pa7ents
and
clinicians

5

Building
on
the
Exis;ng
Evidence
Base

and
Prior
Experience

Exis;ng
Scien;ﬁc

Work
and
Literature

Methodology
CommiKee

and
Methodology
Report

Experience
of

Other
Agencies

6

PCORI’s Process Transparent, Rigorous
Final
Selec-on
for

Speciﬁc
PFAs

(PCORI
Board)

Topic
Genera-on

(Through
Mul7ple
Modes)

Gap

Conﬁrma-on

Research

Opportuni-es

Research

Priori-za-on

Pa;ents
&
Stakeholders:

• Web
Page

• Social
Media

• Workshops

PCORI:

• Con-nuous
PorTolio

Review

Other
agencies:

• AHRQ
gaps

• NIH
gaps

7

Phase 1: Topic Generation
ü  Answer
a
clinical
ques-on
around
a

health
care
decision

ü  Be
compara-ve

ü  Not
be
related
to
cost/cost

effec-veness

ü  Align
with
at
least
one
of
PCORI’s

Na-onal
Priori-es
for
Research

PCORI
“Filter”—All

Nominated
Topics
Must:

Gap

Confirma;on

Topic

Nomina;on

•  Web
page

•  Social
media/marke-ng

•  In-‐person
workshops,
focus
groups

•  Topic
genera-on
discussed
at

Pa-ent
and
Stakeholder

Workshops
in
the
Fall

•  AHRQ:
Future
Research
Needs
(FRNs)

Reports,
Systema-c
Gap
Review

•  Other
guidelines
development

processes
(such
as
NQF)

•  Gaps
iden-fied
by
NIH,
other
funding

agencies

•  Building
on
exis-ng
work
or
other

organiza-ons,
priori-za-on
exercises

(eg,
IOM
100)

Process
Begins
with
Pa7ents

and
Stakeholders

8

Phase 2: Gap Confirmation
AHRQ
Topic
Review
and

Disposi-on

Topics Provided to
AHRQ for Gap
Confirmation
Answer
already

known,
or

research
underway

Potential
Determinations
Evidence
Synthesis

Needed

New
Primary

Research
Needed

In
collabora7on
with
AHRQ;
contract
under
development

Research

Priori-za-on

Dissemina-on

Next
Steps
10

Phase 3: Research Prioritization
Advisory
Panels

Pa7ents
and
Stakeholders

Board
of

Governors

Research

Priori-za-on

Process
Using

PCORI
Criteria

Preven-on,
Diagnosis,

Treatment
Op-ons

Communica-on

and
Dissemina-on

Dispari-es

Improving
Health

Care
Systems

Infrastructure
and

Methods

Rare
Diseases

Selected
From

Priori7zed
List

Crea7on

of
PFAs

Research
Ques7ons

Needing
Priori7za7on

✔

✔

✔

ý

ý

ý

ý

✔

✔

ý

Priori7zed
List

of
Topics

1.  D

2.  D

3.  D

4.  D

5.  D

6.  D

7.  D

8.  D

9.  D

10.  d

11.  D

12.  D

13.  D

14.  D

15.  D

16.  D

17.  D

18.  D

19.  D

20.  d

11

Five Prioritization Criteria Adapted From
PCORI Funding Criteria
2 Impact of the condition on the health of individuals and
populations
(prevalence, incidence, and other measures of burden of disease)
3 Potential for improvement:
•  Are the differences in benefits between the interventions
sufficient to warrant conducting a research study?
•  Will the study reduce the uncertainty around the effect of the
interventions?
•  How likely are the findings to change practice?
•  How long will the information be valid?
4 Potential for impact on health care performance
5 Potential for inclusiveness of different populations
1 Patient centeredness
12

Developing Topic Briefs for
Prioritization of
Questions
Sample
PCORI
Topic
Brief

Each
Topic
Brief

explores
a

research

ques-on
for

which
a
gap
has

been
iden-ﬁed

Topic
Brief
addresses
PCORI’s
criteria:
pa-ent

centeredness,

impact
of
disease,
poten-al

for
improvement,
etc.

13

Piloting the Process with Patients
and
Stakeholders
The revised process will be used by Advisory Panels in
Winter 2013 with topics generated from patients and
stakeholders across the country.
1
2
3
4
Patients and stakeholders will participate in a pilot
prioritization exercise using topic briefs and online
tools. Participation will be by open application.
The pilot group will convene via several
teleconferences to discuss topic briefs and results of
initial ranking exercises.
The pilot group will meet in person to reach
consensus on a final prioritized list, and to provide
feedback to PCORI. The group will present at the
December 5th workshop.
14

Research Prioritization Timeline
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar

PCORI
Science
Team
proposes

ini-al
RP
Process

Technical
Working
Group
tests/
provides
feedback
on
RP

Process;
supports
development

of
PCORI
RP

Process

Pa-ents,
Stakeholders
pilot
RP

process

Revised
Priori-za-on
Process

presented
at
PCORI
Methods

Workshop
December
5th

Pa-ent/Stakeholder
Advisory

Panel

training
on
Research

Priori-za-on
Methods

Advisory
Panels
conduct

Research
Priori-za-on
Process

for
nominated
topics
and

submit
to
the
Board

15

PCORI’s Research Prioritization Team
PCORI Staff and Leadership:
•  Joe Selby, Executive Director
•  Rachael Fleurence, Scientist
•  Katie Wilson, Project Management
•  Natalie Wegener, Project Coordination
Technical Working Group:
•  Arnie Epstein (BoG)
•  Gail Hunt (BoG)
•  Neil Kirschner (Stakeholder Representative)
•  David Meltzer (Methodology Committee)
•  Linda Morgan, RPh, MBA (Patient Representative)
•  Jean Slutsky (Methodology Committee)
•  Clyde Yancy (Methodology Committee)
Pilot Workshop Participants:
•  Approximately 15-20 patients, stakeholders, researchers,
and experts trained and prepared in PCORI’s research
prioritization process 16

Summarizing PCORI’s Unique Approach
to Research Prioritization
Patients and stakeholders engaged in each step
of a transparent process:
•  Patients and stakeholders involved in developing
the process, providing feedback, and members of
the future Advisory Panels
PCORI criteria for research prioritization:
•  Criteria developed to achieve research that will
improve patient’s health outcomes, is impactful,
and has a high probability of changing clinical
practice
Transparency/visibility embedded in the process:
•  Process shared with public for input and
comment
•  Pilot group open to applications
•  Research prioritization methods workshop on
December 5th broadcast via Web cast
17

Revisiting the Strategic Questions
•  Does the research prioritization process engage
patients and stakeholders at the appropriate level?
Is the process transparent and rigorous?
•  Will the process enable PCORI to develop a balanced
portfolio in line with its mission?
•  Does the process enable the optimal level of
engagement between the Board of Governors and
Advisory Panels?
18

Board of Governors Meeting, Washington DC

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