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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
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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
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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
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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
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Comments Received by Stakeholder Type
05
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ents
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eive
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Comments Received by Geographic Location
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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
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II. National Patient and Stakeholder 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)
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• 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.
II. National Patient and Stakeholder 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
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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
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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
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“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?
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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.
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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
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• 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
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Patient-Centered Outcomes Research Institute
Executive Director’s Report
PCORI Board of Governors 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
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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
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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
IT HR
Engagement Science
Admin Staff
Senior Advisor
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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
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Next Steps – PCORI 2012
• Public Comment Period Jan 23-Mar 15, 2012 • Clinician Focus Groups on draft priorities & agenda Feb 8-16, 2012 • National Patient and Stakeholder Dialogue Feb 27, 2012 • Analysis of public comment received March-April 2012 • Adoption of National Priorities & Research Agenda April 2012
• Broad funding announcements issued May 2012 • Broad funding applications due July 2012 • Broad funding awards announced December 2012
• Issue conference grants Spring 2012 • Brainstorming workshop Summer 2012 • Advisory Groups Fall 2012
• Targeted funding announcements begin October 2012 • First targeted funding applications due December 2012 • First targeted funding awards announced May 2013
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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
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PCORI Funding Announcements
11 Other Targeted Announcements
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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
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Patient-Centered Outcomes Research Institute
Finance, Audit, and Administration Committee (FAAC) Report
PCORI Board of Governors Baltimore MD Monday March 5, 2012
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Agenda
SCCOI Nominations
GAO Oversight and Compliance
Financial Statement Audit
Managing Cash Flow
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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:
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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
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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:
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SCCOI Nomination (cont’d)
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
Education and Training
Master of Public Health, Columbia University School of Public Health
Bachelor of Arts in Philosophy, Reed College
About Arthur Levin
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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:
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SCCOI Nomination (cont’d)
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
Education and Training
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
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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.
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SCCOI Nomination (cont’d)
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
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GAO Oversight and Compliance
Request Motion to Accept Nominees
Nominations for Acceptance
Bernard Lo, MD
Arthur Levin, MPH
Harris Beach PLLC
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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/
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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
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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
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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.
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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
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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
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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?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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March 5, 2012
Patient-Centered Outcomes Research Institute
Methodology Committee (MC) Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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1. Finalizing the Methodology Report
2. Board- Methodology Committee Engagement
3. Beyond the Methodology Report
4. PCOR Definition
Agenda
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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Finalizing the Methodology Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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…”
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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
Tim
elin
e
Review Workshop Materials & Contractor
Reports
Review summary of draft recommended standards
Provide input on drafted Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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
Report Writing Process
• 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
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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
Report Writing Process
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
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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Methodology Committee – Board Engagement
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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
Key New points of engagement
Prepared weekly Status Reports on Committee
progress to PCORI Leadership
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
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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 Engagement Key:
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
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Beyond the Methodology Report
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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
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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:
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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
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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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.
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
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Thank You!
1
Patient-Centered Outcomes Research Institute
Program Development Committee(PDC) Report
PCORI Board of Governors Baltimore MD March 5, 2012
2 2
Update on PCORI Pilot Projects
PPP
3 3
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
4 4
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
5 5
Balance Criteria
Priority Score
Among Highest Scoring Applications
Area of Interest
Population
Methods
Geography
Discipline of PI
Seniority of PI
Condition
Stakeholder/Patient Involvement
6 6
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
Present to Board/Board Consideration
Present to Board/Board 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
8 8
Update on PCORI Pilot Projects
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
10 10
Public Comment Analytics
11 11
Public Comment Analytics
12 12
Update on PCORI Pilot Projects
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
Patient-Centered Outcomes Research Institute
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