PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Patient-Centered Outcomes Research Institute
Communications, Outreach and
Eng...
COEC Members
2
• Sharon Levine, MD (Chair)
• Debra Barksdale, PhD, RN
• Robert Jesse, MD, PhD
• Grayson Norquist, MD, MSPH...
3
COEC Report to the Board
I. Public Feedback on the Draft National Priorities and
Research Agenda
II. National Patient an...
4
I. Public Feedback on the Draft National
Priorities and Research Agenda
• Formal public comment period
o January 23-Marc...
5
I. Public Feedback on the Draft National
Priorities and Research Agenda
• Comments received to date
o 101 comments recei...
6
Comments Received by Stakeholder Type
0
5
10
15
20
25
30
35
40
#ofcommentsreceived
7
Comments Received by Geographic Location
8
II. National Patient and Stakeholder
Dialogue – February 27, 2012
• More than 900 individuals
pre-registered to particip...
9
II. National Patient and Stakeholder
Dialogue – Highlights
• Presentation by Board Member Harlan Krumholz on the draft
N...
10
• 57 public comments or statements provided:
– 11 panelists
– 46 individuals in person
– 8 individuals by phone
• Event...
Focus Groups – Additional Feedback on the
Draft National Priorities and Research Agenda
• Patient and Caregiver Focus Grou...
12
III. Clinician Focus Groups
Purpose, Objectives
• Obtain detailed feedback from clinicians discussing
PCORI’s draft Nat...
San Francisco, CA
• Group 1: Integrative Health Care
Practitioners
• Group 2: Physician Assistants
13
Focus Groups Nationw...
• Clinicians have mixed feelings about research. They use and appreciate research, but
have concerns about corporate agend...
“I want my patients to be involved in
their care. If they want to get involved,
that makes my job easier because
they’re m...
16
IV. Revising the Draft National Priorities and
Research Agenda
• PCORI will review input received from:
• Website surve...
17
V. Soliciting Feedback on Stakeholder and
Community Engagement associated with
Board Meetings
• Survey of Board Members...
VI. Ongoing Engagement and
Feedback Process
18
• PCORI website – www.pcori.org
• Join PCORI’s mailing list –
www.pcori.org...
19
Patient-Centered Outcomes Research Institute
Executive Director’s Report
PCORI Board of Governors
Baltimore MD
Monday Marc...
Freda Lewis-Hall MD
2012 Alumni Award for Distinguished Postgraduate Achievement in
the fields of Medicine and Healthcare ...
 Growing PCORI Staff
 PCORI Office Space
 Looking Ahead – next 6 months
 National Priorities & Research Agenda
 Fundi...
4
Introductions and Welcome
Pam Goodnow
Director of Finance
Susan Hildebrandt
Director,
Stakeholder Engagement
Judith Glan...
ED
COO
CSO
Scientists,
Program
Staff
Patient
Engagement
Communi-
cations
Stakeholder
Engagement
Strategic
Initiatives
Gran...
ED
COO
CSO
Scientists
Patient
Engagement
Communi-
cations
Stakeholder
Engagement
Strategic
Initiatives
Grants
Mgmt
Finance...
Next Steps in Hiring
• Research
• Chief Science Officer – position posted
• Scientists – approximately 9 in 2012
(intervie...
PCORI’s New Address
Projected move date:
by April 1
8
Next Steps – PCORI 2012
• Public Comment PeriodJan 23-Mar 15, 2012
• Clinician Focus Groups on draft priorities & agendaFe...
Next Steps – PCORI 2012
April 2012 • Board reviews Scored Pilot Project Applications
May 2012 • PCORI Pilot Project Awarde...
PCORI Funding Announcements
11 Other Targeted Announcements
12
Patient and Stakeholder Engagement 2012
 Building communities of patients and stakeholders – using
website, social med...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Patient-Centered Outcomes Research Institute
Finance, Audit, and Administrati...
2
Agenda
 SCCOI Nominations
 GAO Oversight and Compliance
 Financial Statement Audit
 Managing Cash Flow
3
SCCOI Nomination
 Bernard Lo, MD
‒ President, The Greenwall
Foundation
‒ Emeritus Professor of Medicine,
UCSF
‒ Emeritu...
4
SCCOI Nomination (cont’d)
Current Academic and/or
Research Activities
 Dr. Lo's general research area is clinical
medic...
5
SCCOI Nomination
 Arthur Aaron Levin, MPH
‒ Co-founder and the Director of the
Center for Medical Consumers
‒ Member of...
6
SCCOI Nomination (cont’d)
Activities
 The Center for Medical Consumers is a
New York City-based nonprofit
organization ...
7
SCCOI Nomination
 Annette Bar-Cohen, MA, MPH
‒ Executive Director, Center for NBCC
Advocacy Training
‒ Former Education...
8
SCCOI Nomination (cont’d)
Activities
 The Center for NBCC Advocacy
Training provides leadership and
direction for scien...
9
SCCOI Nomination
Proposal to serve as legal counsel to the
SCCOI:
 The highly credentialed Harris
Beach team’s strong p...
10
SCCOI Nomination (cont’d)
Karl J. Sleight
Government
Compliance and
Investigations Team
 Mr. Sleight served as the Exe...
11
GAO Oversight and Compliance
Request Motion to Accept Nominees
Nominations for Acceptance
 Bernard Lo, MD
 Arthur Lev...
12
GAO Oversight and Compliance
U.S. Government Accountability Office
(GAO)
Responsibility
The GAO is responsible for cond...
13
Financial Statement Audit
McGladrey & Pullen, LLP
Work Time Frame
The field work has begun
and will be complete by
Marc...
14
Managing Cash Flow
Discussion of the Issues
Text
Text
In preparation
for developing
a cash flow
model, there
are severa...
15
Managing Cash Flow
Assumptions for Cash Flow Model
 The model was created using three-year awards for
illustrative pur...
16
Managing Cash Flow
Multi-Year Cash Flow Model
 We can make commitments prior to receiving money in
the PCORI Trust.
In...
17
Managing Cash Flow
Annual Cash Flow Model
 We can make commitments only with monies already in
the PCORI Trust
In mill...
18
Questions for Discussion
• Should we plan to make grant commitments ahead of funds
available in the PCORI Trust?
• If w...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
1
March 5, 2012
Patient-Centered Outcomes Research Institute
Methodology Comm...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
2
1. Finalizing the Methodology Report
2. Board- Methodology Committee Engage...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
3
Finalizing the Methodology Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
4
Methodology Report Outline
• What is PCOR? (Based on our definition)
• What...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
5
Methodology Report Outline
CHAPTER 1.
Introduction
CHAPTER 2.
How we Develo...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
6
The four phases below illustrate the key
milestones which will take place d...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
7
The next two phases demonstrate the
process by which the Committee determin...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
8
During the last two phases, the Committee
will finalize the Report in prepa...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
9
Methodology Committee – Board
Engagement
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
10
Board of Governors Engagement
The Methodology Committee
has engaged with t...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
11
Synthesize contractor
reports, research, and
workshop results
Share Worksh...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
12
Beyond the Methodology Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
13
Maximizing the impact of the Report
Following the release of the first
Met...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
14
Looking Ahead & Extending our Reach
• Committee Member Feedback Sessions
•...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
15
Patient-Centered Outcomes Research Definition
Workgroup
Members:
Dave Flum...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
16
Patient-Centered Outcomes Research Definition
Patient Centered Outcomes Re...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
17
Thank You!
1
Patient-Centered Outcomes Research Institute
Program Development
Committee(PDC) Report
PCORI Board of Governors
Baltimor...
22
Update on PCORI Pilot Projects
PPP
33
PPP Selection Committee
Chair: Gray Norquist
Advisor: Christine Goertz non-voting
Members:
Kerry Barnett
Carolyn Clancy...
44
Pilot Projects Deliberations Process
Working Group
• Determines specific
criteria to be
considered by the
PCORI Selecti...
55
Balance Criteria
 Priority Score
Among Highest Scoring Applications
 Area of Interest
 Population
 Methods
 Geogra...
66
12/26 1/9 1/23 2/6 2/20 3/5 3/19 4/2 4/16 4/30 5/14 5/21 5/28
Merit Review (CSR)
Determine Balance
Criteria
Pull & Vet ...
7
PCORI Peer Review Evaluation
 Post Survey Instrument
- NIH administered PCORI-developed stakeholder and scientist
surve...
88
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...
1010
Public Comment Analytics
1111
Public Comment Analytics
1212
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 ...
14
 PFA prepared by PCORI staff, contracted research organization
(CRO) and Board participants
 CRO’s sign confidentiali...
15
National Priority
Board/MC
Member 1
Board/MC
Member 2
Board/MC
Member 3
PCORI Staff
Scientist
Identified
Comparative As...
16
Proposed Plan for Priority #5
• PFA written by PCORI staff, AHRQ staff, NIH staff, MC
• Separate Funding Announcement (...
17
Rationale for Contracting with AHRQ
• AHRQ and NIH have years of experience in this area that will be
invaluable in hel...
18
Analytic Methods
• Close collaboration with the MC
• AHRQ and NIH have a long track record of working on CER/PCOR
metho...
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
...
21
Dissemination Accelerating Components:
Proposed Checklist
Identify stakeholders (stakeholders include patients, caregiv...
22
Dissemination Accelerating Components:
Proposed Checklist (cont’d)
Describe how conflicts – true and perceived – will b...
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Transcript of " Board of Governors Meeting, Baltimore Maryland"

  1. 1. 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
  2. 2. COEC Members 2 • Sharon Levine, MD (Chair) • Debra Barksdale, PhD, RN • Robert Jesse, MD, PhD • Grayson Norquist, MD, MSPH • Ellen Sigal, PhD • Harlan Weisman, MD • Gail Hunt
  3. 3. 3 COEC Report to the Board I. Public Feedback on the Draft National Priorities and Research Agenda II. National Patient and Stakeholder Dialogue – February 27, 2012 III. Clinician Focus Groups IV. Incorporating Input into Revisions of Draft National Priorities and Research Agenda V. Stakeholder and Community Engagement Events Associated with Board Meetings VI. Connecting with PCORI
  4. 4. 4 I. Public Feedback on the Draft National Priorities and Research Agenda • Formal public comment period o January 23-March 15 o www.pcori.org/survey/priorities-agenda o Responses received through www.pcori.org posted for public view on the website o Opportunity for feedback by mail
  5. 5. 5 I. Public Feedback on the Draft National Priorities and Research Agenda • Comments received to date o 101 comments received through March 1 o Distribution of comments received: o By stakeholder type o By geographic location
  6. 6. 6 Comments Received by Stakeholder Type 0 5 10 15 20 25 30 35 40 #ofcommentsreceived
  7. 7. 7 Comments Received by Geographic Location
  8. 8. 8 II. National Patient and Stakeholder Dialogue – February 27, 2012 • More than 900 individuals pre-registered to participate: – 400 in person – 530 by webcast or phone – Actual participation exceeded 850 • Watch the archived webcast on pcori.org – Visit Past Meetings & Events page
  9. 9. 9 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)
  10. 10. 10 • 57 public comments or statements provided: – 11 panelists – 46 individuals in person – 8 individuals by phone • Event Evaluations by those Attending In Person: – 90% of respondents felt event was informative regarding the National Priorities and Research Agenda. – Just under 85% felt panel discussions helped provide context for the National Priorities and Research Agenda. II. National Patient and Stakeholder Dialogue – Highlights
  11. 11. Focus Groups – Additional Feedback on the Draft National Priorities and Research Agenda • Patient and Caregiver Focus Groups – 12 groups in 4 cities, 96 participants – Reported on at Jacksonville Board meeting • Clinician Focus Groups – 9 groups in 4 cities, 58 participants – Conducted February 8-16 11
  12. 12. 12 III. Clinician Focus Groups Purpose, Objectives • Obtain detailed feedback from clinicians discussing PCORI’s draft National Priorities for Research and initial Research Agenda. • Explore research priorities from the clinicians’ perspective, their understanding and reaction to PCORI’s proposed priorities and agenda, as well as general opinions about PCORI’s work. • Better understand practice needs, clinical issues, and how new research-based information can be helpful.
  13. 13. San Francisco, CA • Group 1: Integrative Health Care Practitioners • Group 2: Physician Assistants 13 Focus Groups Nationwide with Clinicians Chicago, IL • Group 1: Advanced Practice Nurses • Group 2: Cardiologists Birmingham, AL • Group 1: Registered Nurses • Group 2: Primary Care Physicians Philadelphia, PA • Group 1: Mix of Nurses • Group 2: Psychiatrists • Group 3: Orthopedic Surgeons Physicians, nurses, physician assistants and integrative health care practitioners representing a mix of tenure, practice setting and specialties.
  14. 14. • Clinicians have mixed feelings about research. They use and appreciate research, but have concerns about corporate agendas, FDA approval times, and feel several steps removed from research activity. • Clinicians voluntarily articulate the need for many of the concepts behind “comparative effectiveness research” and “patient-centered outcomes,” but this is not their language. Clinicians on “Medical Research” • One of the biggest stumbling blocks with clinicians is the perception that PCORI is too broad, too over-reaching, and thus too idealistic to have a meaningful impact. • Another communications challenge is that healthcare costs, access, and payer decisions overshadow discussions about clinical effectiveness. Impressions of PCORI • Clinicians, as did patients and caregivers in earlier groups, agree that “assessing options” and “communication” are priority areas for PCORI. Clinicians also prioritize “improving healthcare systems.” • Clinicians say that PCORI should start by focusing on one or two of its research priorities, and begin to build a track record. Research Agenda • Professional organizations are the preferred channel for these clinicians. They seem willing to engage with PCORI, if opportunities are convenient and specific to their practice/patient population/setting. • Focus groups and online surveys are also mentioned as good ways to reach them. • Many underscore that staying in touch will take diligence on PCORI’s part. Advice for Engagement Key Findings from Clinician Focus Groups 14
  15. 15. “I want my patients to be involved in their care. If they want to get involved, that makes my job easier because they’re motivated to change.” (Birmingham, Primary Care Physicians) “There is no coordination with anything. Everybody is doing their own thing. It seems like there is no communication. We are struggling with this.” (Chicago, Cardiologists) “A lot of times the patients are the best ones to tell you if this works or that doesn't work, but nobody listens.” (Birmingham, Registered Nurses) “If everything else is up and running, this should be a small thing.” (San Francisco, Integrative Medicine) “We have universities that train researchers – Penn and Hopkins.” (Philadelphia, Nurses) Addressing Disparities Improving Healthcare Systems Assessment of Prevention, Diagnosis and Treatment Options Communication and Dissemination 17% 22% 22% 24% 15% Accelerating Patient-Centered and Methodological Research Focus Group Exercise: Pretend YOU are allocating PCORI resources. What percentage of resources would you invest in each area? (Your total needs to equal 100%.) How Would Clinicians Allocate Funding? 15
  16. 16. 16 IV. Revising the Draft National Priorities and Research Agenda • PCORI will review input received from: • Website survey and formal public comment process • National Patient and Stakeholder Dialogue • Patient, caregiver and clinician focus groups • Formal and informal feedback received by Board members and staff at PCORI-related events • Report to be published on www.pcori.org summarizing input received explaining how input led to changes in the draft priorities and agenda. • Revised National Priorities and Research Agenda to be presented for adoption by PCORI’s Board of Governors during a special public meeting in April.
  17. 17. 17 V. Soliciting Feedback on Stakeholder and Community Engagement associated with Board Meetings • Survey of Board Members on Past Stakeholder Events Underway (March 2011-January 2012) o What have we learned? o Which formats have been most useful? o How have the results informed our work? o What can we accomplish this year? • Soliciting feedback from stakeholder/community participants • Planning for 2012 o Analyzing upcoming metro areas, their unique demographics and health needs
  18. 18. VI. Ongoing Engagement and Feedback Process 18 • PCORI website – www.pcori.org • Join PCORI’s mailing list – www.pcori.org/subscribe • Follow PCORI on Twitter @PCORI • Provide feedback at anytime – www.pcori.org/provide-input • Request a speaker – www.pcori.org/contact-us
  19. 19. 19
  20. 20. Patient-Centered Outcomes Research Institute Executive Director’s Report PCORI Board of Governors Baltimore MD Monday March 5, 2012
  21. 21. 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
  22. 22.  Growing PCORI Staff  PCORI Office Space  Looking Ahead – next 6 months  National Priorities & Research Agenda  Funding Announcements/Funding Cycles  Patient and Stakeholder Engagement Preview 2
  23. 23. 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
  24. 24. ED COO CSO Scientists, Program Staff Patient Engagement Communi- cations Stakeholder Engagement Strategic Initiatives Grants Mgmt Finance Meetings Manager PCORI – A Growing Organization 4 Admin Staff Senior Advisor HR IT
  25. 25. ED COO CSO Scientists Patient Engagement Communi- cations Stakeholder Engagement Strategic Initiatives Grants Mgmt Finance Meetings Manager PCORI – A Growing Organization ITHR Engagement Science Admin Staff Senior Advisor 6
  26. 26. 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
  27. 27. PCORI’s New Address Projected move date: by April 1 8
  28. 28. Next Steps – PCORI 2012 • Public Comment PeriodJan 23-Mar 15, 2012 • Clinician Focus Groups on draft priorities & agendaFeb 8-16, 2012 • National Patient and Stakeholder DialogueFeb 27, 2012 • Analysis of public comment receivedMarch-April 2012 • Adoption of National Priorities & Research AgendaApril 2012 • Broad funding announcements issuedMay 2012 • Broad funding applications dueJuly 2012 • Broad funding awards announcedDecember 2012 • Issue conference grantsSpring 2012 • Brainstorming workshopSummer 2012 • Advisory GroupsFall 2012 • Targeted funding announcements beginOctober 2012 • First targeted funding applications dueDecember 2012 • First targeted funding awards announcedMay 2013 9
  29. 29. Next Steps – PCORI 2012 April 2012 • Board reviews Scored Pilot Project Applications May 2012 • PCORI Pilot Project Awardees announced May 10, 2012 • Methodology Report presented to Board May - July, 2012 • Public Comment Period for Methodology Report July – Aug 2012 • Input analyzed and Methodology Report Revised Aug 2012 • Revised Report Adopted by Board 10
  30. 30. PCORI Funding Announcements 11 Other Targeted Announcements
  31. 31. 12 Patient and Stakeholder Engagement 2012  Building communities of patients and stakeholders – using website, social media, face-to-face meetings  Strengthening ties with advocacy associations, professional clinician organizations, purchaser organizations, research community  Refining the PCORI Research Agenda  Convening multi-stakeholder workshops focused on each of the National Priorities  Forming multi-stakeholder Advisory panels  Using social media, surveys to obtain broad input
  32. 32. 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
  33. 33. 2 Agenda  SCCOI Nominations  GAO Oversight and Compliance  Financial Statement Audit  Managing Cash Flow
  34. 34. 3 SCCOI Nomination  Bernard Lo, MD ‒ President, The Greenwall Foundation ‒ Emeritus Professor of Medicine, UCSF ‒ Emeritus Director, Program in Medical Ethics, UCSF Proposal for Membership (Ethicist) on the SCCOI:
  35. 35. 4 SCCOI Nomination (cont’d) Current Academic and/or Research Activities  Dr. Lo's general research area is clinical medical ethics. Specific interests include: end-of-life care; talking to patients about palliative care; the doctor-patient relationship, particularly the impact of the Internet; ethical issues regarding HIV infection; ethical issues in clinical and translational research, particularly stem cell research; conflicts of interest in research, clinical care, and medical education.  197 peer-reviewed publications  See Appendix for CV Education and Training  Medical School: Stanford University  Residency: University of California, Los Angeles; Stanford University  Fellowship: Robert Wood Johnson Clinical Scholars Program, Stanford University About Dr. Bernard Lo
  36. 36. 5 SCCOI Nomination  Arthur Aaron Levin, MPH ‒ Co-founder and the Director of the Center for Medical Consumers ‒ Member of Institute of Medicine’s Committee on the Quality of Health Care (CQHC) ‒ Past chair of the NQF Consensus Standards Approval Committee (CSAC) ‒ Co-chair of the NCQA Committee on Performance Measures (CPM) Proposal for Membership (Consumer Member) on the SCCOI:
  37. 37. 6 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
  38. 38. 7 SCCOI Nomination  Annette Bar-Cohen, MA, MPH ‒ Executive Director, Center for NBCC Advocacy Training ‒ Former Education Director, Cancer Control Center, Minnesota Department of Health ‒ Member, Steering Committee, Electronic Data Methods Forum, Academy Health Proposal for Membership (Patient/Consumer Member) on the SCCOI:
  39. 39. 8 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
  40. 40. 9 SCCOI Nomination Proposal to serve as legal counsel to the SCCOI:  The highly credentialed Harris Beach team’s strong prosecutorial and ethics backgrounds have made it the firm of choice for organizations of all sizes to handle their high-risk, high-visibility federal and state investigation and compliance matters.
  41. 41. 10 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
  42. 42. 11 GAO Oversight and Compliance Request Motion to Accept Nominees Nominations for Acceptance  Bernard Lo, MD  Arthur Levin, MPH  Harris Beach PLLC
  43. 43. 12 GAO Oversight and Compliance U.S. Government Accountability Office (GAO) Responsibility The GAO is responsible for conducting a review of the audit of PCORI’s financial statements. Comptroller General The Comptroller General of the United States must report to the Congress on the results of PCORI’s financial statement audit no later than April 1 of each year. Legal Counsel GAO legal counsel to provide insight into compliance regulations that PCORI is subject to (e.g., 2 CFR, Part 230/OMB Circular A-122 & OMB Circular A-133, and Form 990). Source: Logo from company website: http://www.gao.gov/
  44. 44. 13 Financial Statement Audit McGladrey & Pullen, LLP Work Time Frame The field work has begun and will be complete by March 12, 2012. GAO Review GAO will review the audit of PCORI’s financial statements in order to prepare its annual report to Congress due April 1, 2012. Engagement McGladrey & Pullen has been engaged to perform the audit of the PCORI financial statements for the years ending December 31, 2010 and 2011. Source: McGladrey & Pullen, LLP operates under the McGladrey brand. Logo from company website: http://mcgladrey.com/About/About
  45. 45. 14 Managing Cash Flow Discussion of the Issues Text Text In preparation for developing a cash flow model, there are several assumptions and there are a number of decisions that need to be made. Set announcement, commitment, and funding dates so that deadlines can be anticipated Text There will be three funding cycles; July, November, March Text The review process will take four to six months Text Consider funding strategies that commit more funding in early years in order to increase PCORI’s impact
  46. 46. 15 Managing Cash Flow Assumptions for Cash Flow Model  The model was created using three-year awards for illustrative purposes only.  When we make awards, we pay approximately 50% in the first year, then 25% in years 2 and 3 of the award.  Dollars available for awards are best estimates of funds available from PCORI Trust.  2012 Funding = $90M  $112M less 20% Operations = $90M  2013 Funding = $250M  $72M plus $240M in fees = $312M less 20% Operations = $250M  2014 to 2019 Funding = $403M/year  $24M plus $480M in fees = $504M less 20% Operations = $403M * All dollars are in millions.
  47. 47. 16 Managing Cash Flow Multi-Year Cash Flow Model  We can make commitments prior to receiving money in the PCORI Trust. In millions Award Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019  2012 $210 $90 $60 $60 2013 $380 190 95 95 2014 $496 248 124 124 2015 $368 184 92 92 2016 $375 187 94 94 2017 $434 217 109 109 2018 $300 200 100 2019 $194 194 Funding $2,757 $90 $250 $403 $403 $403 $403 $403 $403 $2,757
  48. 48. 17 Managing Cash Flow Annual Cash Flow Model  We can make commitments only with monies already in the PCORI Trust In millions Award Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019  2012 $90 $45 $23 $23 2013 $250 125 63 63 2014 $403 202 101 101 2015 $403 202 101 101 2016 $403 202 101 101 2017 $403 202 101 101 2018 $403 202 101 101 2019 $403 202 201 Funding $2,757 $45 $148 $287 $365 $403 $403 $403 $403 $302 $2,757
  49. 49. 18 Questions for Discussion • Should we plan to make grant commitments ahead of funds available in the PCORI Trust? • If we pursue this strategy, do we commit ahead of funding only in the early years of PCORI, or carry out this strategy through 2019? • How do we manage the risks of this strategy; specifically, the risk of making funding commitments against dollars not yet transferred to the PCORI Trust? • What level of refinement for the strategic plan and research agenda do we want to implement this strategy? • If we pursue this strategy, how aggressively should we commit ahead of funding?
  50. 50. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 1 March 5, 2012 Patient-Centered Outcomes Research Institute Methodology Committee (MC) Report
  51. 51. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 2 1. Finalizing the Methodology Report 2. Board- Methodology Committee Engagement 3. Beyond the Methodology Report 4. PCOR Definition Agenda
  52. 52. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 3 Finalizing the Methodology Report
  53. 53. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 4 Methodology Report Outline • What is PCOR? (Based on our definition) • What is the pressing need for a report on methods for conducting PCOR? • Who is this report for? • Goals of the First MC Report • Types of Research Addressed in this Report CHAPTER 1. Introduction CHAPTER 2. How we Developed Standards • What are standards? • Categories for Rating Potential Standards • Selecting Standards • Formulating Research Questions (PICOTS*) • Choosing a Data Source, Study Design, & Analysis Plan • Methods for Conducting Research Studies CHAPTER 3. What is Patient – Centeredness? CHAPTERS 4-? Standards for Selecting, Designing, and Conducting Research • Public Review • Dissemination and Implementation • Plans for Updating CHAPTER N. Future Plans & Direction *population, intervention, comparator, outcome, timeframe, setting • How does patient centeredness apply in research prioritization, identification of research questions, design of studies (PICOTS*), and dissemination/implementation? • What methods can make research more patient-centered? • How is patient-centeredness balanced with feasibility and other stakeholders' concerns?
  54. 54. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 5 Methodology Report Outline CHAPTER 1. Introduction CHAPTER 2. How we Developed Standards CHAPTER 3. What is Patient – Centeredness? CHAPTERS 4-? Standards for Selecting, Designing, and Conducting Research CHAPTER N. Future Plans & Direction Example Section: ENDORSED STANDARDS AND ACTIONS RELATED TO MISSING DATA I. Background “Missing data is not only inevitable in human health studies and trials, it is more likely…..” The committee reviewed standards for methods including Last Observation Carried Forward (LOCF), [insert other methods here]. II. Recommended Standards 1. Adopted standard #1 2. Adopted standard #2 II. Rationale for Standards “The committee believes these standards…” II. Recommended Actions to support the Standards 1. “PCORI shall encourage training in the…” 2. “PCORI shall disseminate software to conduct…”
  55. 55. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 6 The four phases below illustrate the key milestones which will take place during the report writing process 1. Workshops / Contractor Findings 2. Consensus Process / Voting Meeting 3. Draft & Revise Sections of the Report 4. Delivery of Methodology Report Report Writing Process Key Board Engagement March 2012 April 2012 Observe Workshops May 2012 Approve Report for Public Comment Timeline Review Workshop Materials & Contractor Reports Review summary of draft recommended standards Provide input on drafted Report
  56. 56. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 7 The next two phases demonstrate the process by which the Committee determines which Standards and Recommendations will be adopted for inclusion in the Report 1. Workshops / Contractor Findings 2. Consensus Process / Voting Meeting 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
  57. 57. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 8 During the last two phases, the Committee will finalize the Report in preparation for delivery to the Board and Public Comment 3. Draft & Revise Sections of the Report 4. Delivery of Methodology Report 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
  58. 58. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 9 Methodology Committee – Board Engagement
  59. 59. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 10 Board of Governors Engagement The Methodology Committee has engaged with the Board in a number of ways in order to accomplish the following objectives: Participates in at least five bi-monthly Board Meetings with a total of approx. 25 hours of direct interaction Orchestrated three teleconference calls to engage the Board in discussion of the report outline and translation tool Established Liaisons to the Patient Centeredness Working Group: Ellen Sigal & Gray Norquist Submitted approximately 12 Briefings since Sept. 2011 Invited Board Members to participate in reviews of contractor proposals: Leah-Hole Curry, Harlan Weisman, Debra Barksdale, Rick Kuntz, Steve Lipstein Provided input regarding methodologic research on the Research Agenda and Pilot Projects Shared highlights of the electronic data task & solicited approximately 6 candidates for interview referred by Harlan Weisman, Richard Kuntz, Steve Lipstein. & Harlan Krumholz Gained support of two Committee Members with framing the PCORI Funding Announcement (PFA) Collaborated with Board Members to develop a joint Dissemination Plan Prepared weekly Status Reports on Committee progress to PCORI Methodology Committee members to attend the Closed Board Session at March Board Meeting Two Methodology Committee members will participate as members of the PCORI Pilot Project Selection Subcommittee
  60. 60. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 11 Synthesize contractor reports, research, and workshop results Share Workshop Executive Summary & Contractor Reports Voting Standards Meeting– April 3rd Submit final drafts, Review, & Finalize Report Sections Share Report & Receive input from Board of Governors February 2012 March 2012 April 2012 Prepare for meeting to vote on proposed standards May 2012 Submit Report to the Board Post for Public Comment ‘Case Study’ Teleconference Call with Board Review & Revise Outlines Provide proposed recommendations Draft sections of the report Board EngagementKey: Engagement Next Steps The below steps outline the opportunities for the Board to engage with the Methodology Committee during the development of the May Report Discuss and Approve Dissemination Plan
  61. 61. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 12 Beyond the Methodology Report
  62. 62. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 13 Maximizing the impact of the Report Following the release of the first Methodology Report, the MC intends to enhance adoption of the recommended standards and best practices within the broader research and health care communities by acting as a convener, communicator, and catalyst
  63. 63. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 14 Looking Ahead & Extending our Reach • Committee Member Feedback Sessions • Dissemination/Implementation of Standards • June 2012 Retreat Strategic Planning • Professional societies and stakeholders (Advisory Groups) − Electronic Data Systems − Implementation − Novel Delivery Tools − Systems Engineering • 1st Annual PCOR conference In the months following the release of the May Report, the Committee plans to engage in the following activities:
  64. 64. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 15 Patient-Centered Outcomes Research Definition Workgroup Members: Dave Flum Mary Tinetti Jean Slutsky Mark Helfand Sebastian Schneeweiss Board Members: Debra Barksdale Bob Jesse Harlan Weisman Gray Norquist Rick Kuntz Sharon Levine Allen Douma Gail Hunt Harlan Krumholz Working Group Accomplishments • Reached consensus on changes to PCOR definition in response to public input − Added reference to improving communication and including caregivers − Modified question four so that mention of healthcare system emphasizes role of the system in getting better decisions • Prepared revised document that explains proposed response to public input
  65. 65. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 16 Patient-Centered Outcomes Research Definition Patient Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as: 1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” 2. “What are my options and what are the potential benefits and harms of those options?” 3. “What can I do to improve the outcomes that are most important to me?” 4. “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?” To answer these questions, PCOR: • Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; • Is inclusive of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life; • Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and • Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives.
  66. 66. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 17 Thank You!
  67. 67. 1 Patient-Centered Outcomes Research Institute Program Development Committee(PDC) Report PCORI Board of Governors Baltimore MD March 5, 2012
  68. 68. 22 Update on PCORI Pilot Projects PPP
  69. 69. 33 PPP Selection Committee Chair: Gray Norquist Advisor: Christine Goertz non-voting Members: Kerry Barnett Carolyn Clancy Arnie Epstein Gail Hunt Steve Lipstein Sherine Gabriel Clyde Yancy Joe Selby
  70. 70. 44 Pilot Projects Deliberations Process Working Group • Determines specific criteria to be considered by the PCORI Selection Committee in determining and recommending an appropriately balanced slate of awards. PCORI Selection Committee • Meets to review materials. • Considers the balance of priority- scored applications across selected criteria, requesting additional analysis and options from staff, as needed. • Prepares a recommended slate of selected projects for funding consideration. Board of Governors • Meets to consider the recommended slate. • Reviews the slate based on priorities and balance to ensure appropriate distribution. • Requests additional options, if needed. • Approves a final slate of selected projects for funding. PCORI Staff • Analyzes the applications using priority score and the criteria. • Provides a list of award options based on Working Group recommendations. • Supports the PCORI Selection Committee and Board of Governors by providing revised options, as needed. Initial recommendations made. Under review by Methodology Committee
  71. 71. 55 Balance Criteria  Priority Score Among Highest Scoring Applications  Area of Interest  Population  Methods  Geography  Discipline of PI  Seniority of PI  Condition  Stakeholder/Patient Involvement
  72. 72. 66 12/26 1/9 1/23 2/6 2/20 3/5 3/19 4/2 4/16 4/30 5/14 5/21 5/28 Merit Review (CSR) Determine Balance Criteria Pull & Vet Data & Load Spread Sheet Selection Committee Recommendations Development of Funding Recommendations Board Deliberations & Final Decisions Business Review Process Awards Process Pilot Projects Timeline Merit Review Scores Received Announcements Made Present to Board/Board Consideration Present to Board/Board Consideration Present to Board/Board Consideration
  73. 73. 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
  74. 74. 88 Update on PCORI Pilot Projects Public Comment Results
  75. 75. 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
  76. 76. 1010 Public Comment Analytics
  77. 77. 1111 Public Comment Analytics
  78. 78. 1212 Update on PCORI Pilot Projects May, 2012 PFA Process and Timeline
  79. 79. 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
  80. 80. 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
  81. 81. 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
  82. 82. 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
  83. 83. 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
  84. 84. 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.
  85. 85. 19 March 5, 2012 Patient-Centered Outcomes Research Institute PCORI Dissemination Workgroup
  86. 86. 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
  87. 87. 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
  88. 88. 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
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