PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
January 19, 2012
Patient-Centered Outcomes Research Institute
Communications,...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
COEC Members
2
• Sharon Levine, MD (Chair)
• Debra Barksdale, PhD, RN
• Rober...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
COEC Report to the Board
3
I. Receiving Public Feedback on the National Prior...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
I. Receiving Public Feedback on the National
Priorities and Research Agenda
4...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Receiving Public Feedback on the National
Priorities and Research Agenda
5
• ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Receiving Public Feedback on the National
Priorities and Research Agenda
6
• ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Receiving Public Feedback on the National
Priorities and Research Agenda
7
• ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Patient and Caregiver Focus Groups
8
Columbus, OH (Dec. 7)
• Parents of child...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Receiving Public Feedback on the National
Priorities and Research Agenda
9
• ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
National Priorities and Research Agenda
10
• Incorporating input received:
o ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
II. Expanding Digital Communications
11
• PCORI website
• Growing email and
s...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
PCORI Website: www.pcori.org
12
Recent key additions to the website include:
...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
0
500
1000
1500
2000
2500
Subscribers
13
2,117 subscribers
as of Jan. 17
283 ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
14
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
Pcori.org Pa...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Social Media Communications
15
• PCORI is using social media to:
• Engage lar...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
•Stakeholder discussion forum
March 2011
St. Louis, MO
•Stakeholder discussio...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Jacksonville Stakeholder Engagement
17
• Wednesday evening stakeholder panel:...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Future Board Meeting Engagement Events
18
• Analyzing 2011 Events
o What have...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
V. Speakers Bureau
19
• PCORI has presented at 49 meetings since March 2011
•...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
Upcoming Speakers Bureau Presentations
20
Jan. 26 – American Nurses Associati...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
21
1
Status Report to the Board of Governors
PCORI Dissemination Workgroup
“Can You Hear Us Now?”
PCORI Board of Governors
Ja...
2
Carolyn Clancy, Co-Chair
Sharon Levine, Co-Chair
Lawrence Becker
Allen Douma
Howard Holland
Gail Hunt
Freda Lewis-Hall
S...
3 Source: Affordable Care Act. Subtitle D—Patient-CenteredOutcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.
‘‘(c) PURPO...
4
Oct Nov Dec Jan
2011 2011 2011 2012
Timeline of Activities
Formal launch of
WG
AHRQ
Presentation to
WG (10/26)
RAND Pres...
5
 ―Success‖ for PCORI and AHRQ = impact on practice and patient
outcomes
 PCORI will disseminate results of PCORI-funde...
6
 PCORI has a related role and opportunity in creating demand for, and
receptivity to, PCOR in anticipation of evidence/...
7
First Steps: Learning from the Work of Others
 Defining ―successful dissemination‖ and potential obstacles/barriers
to ...
8
Existing Hurdles to Evidence Dissemination in the Health Care System
Limitations of the
scientific evidence
 Gaps in th...
9
Anticipated hurdles to CER
Dissemination:
Drivers of CER Dissemination:
 The public perception of CER and
its legitimac...
10
Building a Coherent
Strategy For
Dissemination –
Policy Choices
• Use consistent evidence ratings
• Integrate CER disse...
11
AHRQ’s PCOR Activities
– Dissemination, translation, and implementation goals include fostering
awareness and use of PC...
12
AHRQ’s PCOR Activities
Community
Forum Project
Dissemination
Contracts
– Its purpose is to improve and expand public an...
13
Important Take-Away Messages for PCORI
 Programs are most successful when
they are audience-centered and use
the audie...
14
RAND Briefing to PCORI
RAND Study Objectives
1. Developing a Dissemination Framework for assessing barriers and enabler...
15
RAND Briefing to PCORI
Case Study Topics and Results
 CATIE: Conventional antipsychotics had similar effectiveness and...
16
RAND Briefing to PCORI: Conceptual Framework
Source: Disseminationand Adoption of CER Findings when Findings Challenge ...
17
Study Findings
 Little to no practice change, even when interventions were favored by results (i.e.,
implementation of...
18
Important Take-Away Messages for PCORI
 Potential for CER results to influence
practice is not yet fully realized
 Cu...
19
Important Take-Away Messages for PCORI
(cont’d)
 CER results are sometimes outdated by
the time the study ends—is ther...
20
Developing an Overall Framework: Strategic
Issues Raised by Presentations
 How can PCORI, building on AHRQ’s work,
als...
21
Developing an Overall Framework: Strategic
Issues Raised by Presentations (cont’d)
 How do we set up a platform for
di...
22
 ―Success‖ for PCORI and AHRQ = impact on practice and patient
outcomes
 PCORI will disseminate results of PCORI-fund...
23
 PCORI has a related role and opportunity in creating demand for, and
receptivity to, PCOR in anticipation of evidence...
24
 Feedback from the Board at early stage (today; via COEC and PDC
ongoing)
 Building a framework for PCORI disseminati...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
2
Patient-Centered Outcomes Research Institute
Executive Director’s Report
Bo...
3
Introductions
LORI FRANK, PH.D
PCORI Scientist
Judy Glanz
Director, Stakeholder Engagement
Bill Silberg
Director, Commun...
4
Next Steps in PCORI Hiring
• Engagement
• Director of Patient Engagement – Offer extended
• Research and Methods
• Chief...
ED
COO
CSO
Scientific
Review
Officer
Scientists,
Program
Staff
Patient
Engagement
Communi-
cations
Stakeholder
Engagement
...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
1
Patient-Centered Outcomes Research Institute
Executive Director’s Report
Bo...
2
The Next Four Months ….
 Public Comment Period for Priorities and Agenda – (Jan 23–March 20)
 National Forum and Dialo...
 Preparing Broad Funding Announcements – target of May 1 release date
 Methodology Report – approving for mid-May 12 sta...
4
Funding Research in 2012
• Budget calls for commitment of $91M in research funding in CY 2012 – in
addition to Pilot Pro...
Plans for Engaging Stakeholders in 2012
– Stakeholders National Forum during public comment period
– Two Conference Grants...
See You in Baltimore!
March 5th and 6th 6
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
January 19, 2012
Patient-Centered Outcomes Research Institute
Finance Audit &...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
2012 Budget
Jacksonville, FL
Jan 18-19, 2012
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
3
2012 Budget Planning Process
 Iterative planning and costing process with ...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
4
2012 Budget Distribution – by Committee
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
5
Budget Allocations – by Strategic Pillar
*Both “rigorous methods” and “rese...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
6
Budget Allocations – by Strategic Pillar
18%
33%
17%
8%
8%
8%
8%
Allocation...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
7
Questions to be addressed in 2012
• Need to develop standard ways to concei...
Jacksonville, FL
Jan 18-19, 2012
Update on Standing Committee on
Conflict of Interest (SCCOI)
9
Charter
 Draft charter
 outlines purpose, membership, committee
operations, responsibilities
 Purpose:
 The SCCOI sh...
10
Proposed Membership
For approval today:
 Larry Becker, Chair
 Sherine Gabriel
 Robert Zwolak
For approval on March 7...
11
Schedule
Approval of initial three members: January 19, 2012
Approval of Charter: January 19, 2012
Approval of consu...
12
Discussion
 Discussion of motion to approve charter and Board and
Methodology Committee members of Committee
13
Motion to Approve
Appointments:
Larry Becker (chair)
Sherine Gabriel
Robert Zwolak
Charter of Standing Committee o...
Nominating Committee
Jacksonville, FL
Jan 18-19, 2012
15
Nominating Committee
(a) There shall be a Nominating Committee, composed of the Board
Chairperson and Vice Chairperson,...
16
Responsibilities of Nominating Committee
(i) In consultation with the Methodology Committee, to nominate the Chair and ...
17
Members of Nominating Committee
Gene Washington - Chair
Steve Lipstein – Vice-chair
Gail Hunt (PDC)
Robert Jesse (C...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
43
January 18-19, 2012
PCORI Methodology Committee
Progress Report
Sherine E....
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
44
Methodology Committee Structure
Methodology Committee Activities Overview
...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
45
Patient
Centeredness
Workgroup
Research
Methods
Workgroup
Research
Priorit...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
46
In service of the First Methodology Report,
due May 2012, the committee ha...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
47
Methodology Committee Awarded Contracts
Oregon Health &
Science University...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
48
Board of Governors Engagement
The Methodology Committee has
engaged with t...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
49
Continue to provide opportunities for the liaisons to
engage with the Pati...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
50
The Critical Role of Methods:
A case-based approach
Producing trusted, hig...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
51
• Incorporate the patient voice to choose outcomes
and comparisons that ma...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
52 Robinson and Goodman, 2011
In reports of RCTs published over 4 decades, fe...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
53
NORC Accomplishments
• Summarized the public input (Phase I)
• Conducted 6...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
54
Finalize Report
Writing Process
Develop the
report writing
team
Set up cal...
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
55
Thank You!
Patient-Centered Outcomes Research Institute
PCORI Pilot Project
Board of Governors Meeting
Jacksonville, FL
January 18-19...
Contents
 Key Accomplishments
 Overview of Four-Stage Review Process
 Description of the Merit Review Process
 Descrip...
Pilot Projects: Key Accomplishments
850
People who registered for
webinars
1375 Letters of Intent received
1400
Number of ...
PCORI Pilot Projects Applications
Thanks to
programmatic
reviewers:
• Anne Beal
• Carolyn Clancy
• Arnold Epstein
• Christ...
Overview of the 4-Step Process
Preliminary
Check
Merit Review
Deliberation
Business
Determination that the application mee...
Merit Review
Prior to the Review
Meeting
• Each application is
assigned to 3 reviewers
• Reviewers include
scientists and ...
PCORI Deliberations
Working Group
• Determines specific
data to be
considered by the
PCORI Balance
Committee in
determinin...
Timeline
 Sep 28, 2011 Posting of Funding Announcement
 Nov 1, 2011 List of potential Stakeholder and Scientific Reviewe...
Discussion
1
Developing PCORI’s
National Priorities for Research
and First Research Agenda
PCORI Board of Governors
January 2012
2 Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.
“Assist pa...
3
Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.
National P...
4
Research Agenda
Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, ...
5
Stakeholder Input
(surveys, focus groups, public
comment, stakeholder
meetings, etc.)Environmental
Scans
Pilot Project
A...
6
IncreasingSpecificity
National Priorities and Research Agenda: An
Iterative Feedback Process
Inputs
• Legislative Statut...
7 7
We’re on a Journey!
8
Task Aug Sept Oct Nov Dec Jan Feb Mar Apr May
NATIONAL PRIORITIES
Develop Framework
Develop Stakeholder
Engagement Proce...
9
National
Priorities
10
Environmental
scan of existing
priorities and
criteria
Candidate
priorities and
criteria
identified
Framework to
inter-...
11
Environmental Scan
Source Prevention
AcuteCare
Chronic
DiseaseCare
PalliativeCare
Care
Coordination
Patient
Engagement
...
12
Health Information
Technology
Prevention &
Screening
Acute Care
Impact of New
Technology
PCORI Draft National Prioritie...
13
Patient-Centered Priorities
Improving
Healthcare
Systems
Comparing healthcare system-level approaches to
improving acce...
14
Addressing
Disparities
Identifying potential differences in treatment effectiveness
or preferred clinical outcomes acro...
15
 Developed over 5-month period
 Built from prior prioritization efforts
 Stakeholder input incorporated along the wa...
16
Research
Agenda
17
Impact on Health of
Individuals and
Populations
PCORI Criteria – From Legislation
Improvability through
Research
Inclus...
18
Accelerating PCOR
and
Methodological
Research
• Impact on Health of Individuals
and Populations
• Improvability via Res...
19
...compare situations in which the
effectiveness of strategies for
prevention, treatment, screening,
diagnosis, or surv...
20
Improving
Healthcare
Systems
Research Agenda Item From a National Priority
…compares alternative system-
level approach...
21
Alternative clinical options
Patient differences in response to therapy
Patient preferences for various outcomes
Al...
22
 Promote patients and their caregivers –and key stakeholders in
implementation settings—as partners, with explicit rol...
23
 Commit to a diverse research portfolio with respect to patients,
geography, health care professionals, investigators,...
24
 Developed over 4-month period
 Stakeholder input incorporated
 First draft ready for public comment
 Will be modif...
25
 Proposed initial agenda is specific with respect to
study questions that will be supported, but not to
the conditions...
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Board of Governors Meeting, Jacksonville Florida

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Board of Governors Meeting, Jacksonville Florida

  1. 1. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE January 19, 2012 Patient-Centered Outcomes Research Institute Communications, Outreach and Engagement Committee (COEC) Report
  2. 2. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 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. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE COEC Report to the Board 3 I. Receiving Public Feedback on the National Priorities and Research Agenda II. Expanding Digital Communications (Update) III. Stakeholder Engagement (Update) IV. Speakers Bureau (Update)
  4. 4. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE I. Receiving Public Feedback on the National Priorities and Research Agenda 4 • Formal public comment period o 53 days from January 23-March 15 o www.pcori.org/provide-input o Responses received through www.pcori.org will be displayed for public view on the website o Input will also be accepted by mail
  5. 5. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Receiving Public Feedback on the National Priorities and Research Agenda 5 • Additional forums to obtain input o National Patient and Stakeholder Dialogue – Will take place February 27 o Patient and Caregiver Focus Groups (on draft priority themes) – Completed Nov. 9-Dec. 8 o Clinician Focus Groups (on draft priorities and agenda) – Will take place in February
  6. 6. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Receiving Public Feedback on the National Priorities and Research Agenda 6 • National Patient and Stakeholder Dialogue o February 27, 2012, in Washington, D.C., at the National Press Club o Webcast and teleconference dial-in o Stakeholder panel discussion o 3.5 hours dedicated to public comment, a portion reserved for those participating by phone
  7. 7. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Receiving Public Feedback on the National Priorities and Research Agenda 7 • Patient and Caregiver Focus Groups: o 12 focus groups took place in November and December o 96 patients and caregivers participated across four cities and regions o Identified the questions patients and caregivers have and the information they need to make informed health decisions o Provided early, general feedback on PCORI’s developing National Priorities for Research o The complete results of the focus groups will be considered in the priorities and agenda revision process
  8. 8. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Patient and Caregiver Focus Groups 8 Columbus, OH (Dec. 7) • Parents of children with ADD/ADHD (caregivers) • Patients with Mental Health conditions • Patients who survived Cancer • Insured and uninsured • Age: 30-70+ Phoenix, AZ (Dec. 8) • Patients with Respiratory Disease (chronic bronchitis, emphysema) • Hispanic patients with mix of chronic conditions • Patients with Heart Disease • Insured and uninsured • Age: 21-69 Atlanta, GA (Nov. 21) • Patients with Diabetes • Caregivers to Alzheimer’s patients • Patients with Chronic Pain • Insured and uninsured • Age: 21-75+ Baltimore, MD (Nov. 9) • Patients with Arthritis • Parents of children with Pediatric Asthma (caregivers) • Patients with mix of chronic conditions • Insured and uninsured • Age: 21-69
  9. 9. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Receiving Public Feedback on the National Priorities and Research Agenda 9 • Clinician Focus Groups o Clinician focus groups will take place in February o Philadelphia o Birmingham o California (site TBD) o Chicago o Four groups of physicians and four groups of nurses o Report will be delivered to the Board by March 1 to consider in the priorities and agenda revision process
  10. 10. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE National Priorities and Research Agenda 10 • Incorporating input received: o PCORI will review all input received o A report will be published on www.pcori.org that summarizes the input received with an explanation of how the collective input led to any changes in the draft priorities and agenda. o Revised National Priorities and Research Agenda will be considered for adoption by PCORI’s Board of Governors during a special public meeting in April.
  11. 11. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE II. Expanding Digital Communications 11 • PCORI website • Growing email and stakeholder organizations lists • Social media communications
  12. 12. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE PCORI Website: www.pcori.org 12 Recent key additions to the website include: • “Executive Director's Corner” • Web videos featuring Board and Methodology Committee members and Executive Director • General feedback web form • Easier process to subscribe to PCORI’s mailing list
  13. 13. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 0 500 1000 1500 2000 2500 Subscribers 13 2,117 subscribers as of Jan. 17 283 subscribers as of Feb. 7 • Does not include pro-active supplemental mailing lists for major announcements • Individuals can conveniently subscribe online: http://www.pcori.org/subscribe/ Growing the PCORI Email List
  14. 14. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 14 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 Pcori.org Page Views By Month (Nov. 2010-Dec. 2011) Board Meeting Webcasts Begin PCOR Definition Input Process Pilot Projects Grants Program Grant Reviewer Application Process Redesigned Website Launched
  15. 15. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Social Media Communications 15 • PCORI is using social media to: • Engage larger and more diverse audiences. • Increase awareness of PCORI’s work among individuals tracking health conversations online • Follow @PCORI on Twitter. • Stay on top of PCORI activities, funding announcements, and engagement opportunities. • Additional web-based and mobile technologies will be developed to support two-way engagement.
  16. 16. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE •Stakeholder discussion forum March 2011 St. Louis, MO •Stakeholder discussion forum May 2011 New York, NY •Two small group meetings with patients and caregivers •Eight small group meetings with 43 stakeholder organizations July 2011 Washington, DC •Invited presentations from Pacific Northwest stakeholders September 2011 Seattle, WA •Two site visits to local community health centers •Invited presentations from Southeastern stakeholders November 2011 New Orleans, LA •Invited presentations from Florida stakeholders January 2012 Jacksonville, FL III. Stakeholder Engagement 16 PCORI’s engagement with stakeholders around Board meetings
  17. 17. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Jacksonville Stakeholder Engagement 17 • Wednesday evening stakeholder panel: – Bridget Jennings, RN, CDE, American Diabetes Association – North Florida/South Georgia – Nipa R. Shah, M.D., Department of Community Health and Family Medicine; Director, Patient-Centered Medical Home – Karen van Caulil, Florida Health Care Coalition – Bill Haley, M.D., Mayo Clinic Florida, Division of Health Sciences Research – Yank Coble, M.D., University of North Florida, former president, American Medical Association and member of AHRQ’s National Advisory Council
  18. 18. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Future Board Meeting Engagement Events 18 • Analyzing 2011 Events 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 in 2012? • Planning 2012 o Analyzing upcoming metro areas, their unique demographics and health needs
  19. 19. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE V. Speakers Bureau 19 • PCORI has presented at 49 meetings since March 2011 • Presentations have been made at events convened by the following stakeholder groups: Patient groups and consumer organizations Physicians Nurses Researchers Biotechnology, pharmaceutical and device industry Policy makers Employers Complimentary and Alternative Medicine
  20. 20. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Upcoming Speakers Bureau Presentations 20 Jan. 26 – American Nurses Association Nursing Quality Conference Feb. 9 – National Health Council Annual Voluntary Health Leadership Conference Feb. 15 – National Institute of Diabetes & Digestive & Kidney Diseases Feb. 16 – VHA Clinical Conference Feb. 20 – Healthcare Information and Management Systems Society (HIMSS) – Secondary Use of Data Symposium Request a PCORI speaker for your event. Email info@pcori.org
  21. 21. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 21
  22. 22. 1 Status Report to the Board of Governors PCORI Dissemination Workgroup “Can You Hear Us Now?” PCORI Board of Governors Jacksonville, Florida January 2012
  23. 23. 2 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
  24. 24. 3 Source: Affordable Care Act. Subtitle D—Patient-CenteredOutcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010. ‘‘(c) PURPOSE.—The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions ….and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items described in subsection (a)(2)(B). ‘‘(1) DISSEMINATION.—The Office of Communication and Knowledge Transfer (referred to in this section as the ‘Office’) at the Agency for Healthcare Research and Quality (or any other relevant office designated by Agency for Healthcare Research and Quality), in consultation with the National Institutes of Health, shall broadly disseminate the research findings that are published by the Patient Centered Outcomes Research Institute established under section 1181(b) of the Social Security Act (referred to in this section as the ‘Institute’) and other government- funded research relevant to comparative clinical effectiveness research. The Office shall create informational tools that organize and disseminate research findings for physicians, health care providers, patients, payers, and policy makers. The Office shall also develop a publicly available resource database that collects and contains government-funded evidence and research from public, private, not-for profit, and academic sources.” Purpose Legislation
  25. 25. 4 Oct Nov Dec Jan 2011 2011 2011 2012 Timeline of Activities Formal launch of WG AHRQ Presentation to WG (10/26) RAND Presentation to WG (12/1) WG three-hour teleconference (1/6)
  26. 26. 5  ―Success‖ for PCORI and AHRQ = impact on practice and patient outcomes  PCORI will disseminate results of PCORI-funded and conducted research and PCORI will also fund research on dissemination, but will complement and supplement what AHRQ/NIH are doing, not duplicate efforts  PCORI has unique opportunities – and leg requirements  Dissemination is essential and requires investment, which could occur in multiple ways: ‒ Encourage / require ―dissemination accelerating components‖ in all PFAs ‒ Provide rapid follow-on funding for dissemination for selected studies PCORI Dissemination Assumptions
  27. 27. 6  PCORI has a related role and opportunity in creating demand for, and receptivity to, PCOR in anticipation of evidence/research findings  Not a one-size fits all endeavor—translating results, and influencing behavior, is context-dependent  PCORI will be most effective by establishing partnerships early (with AHRQ, NIH, NGO‘s and private sector actors) and clarifying what PCORI will and will not do  Effective patient and stakeholder engagement, early on in the research endeavor, is the first step in planning and executing dissemination, and facilitating uptake PCORI Dissemination Assumptions (cont’d)
  28. 28. 7 First Steps: Learning from the Work of Others  Defining ―successful dissemination‖ and potential obstacles/barriers to success  Identifying dissemination activities of other organizations, namely AHRQ, to determine potential gaps that PCORI may fill  Lessons learned from dissemination studies that may be relevant to PCORI activities  Brainstorming strategies and assumptions to review with the Board of Governors, to inform PCORI‘s Dissemination Framework and Strategy
  29. 29. 8 Existing Hurdles to Evidence Dissemination in the Health Care System Limitations of the scientific evidence  Gaps in the medical evidence due to the limits of scientific knowledge, limitations of study design, or both Constraints on practicing clinicians  Little or no time to consult evidence or colleagues, limited reimbursement for consulting evidence, and limited skills among some clinicians for consulting electronic data sources Constraints on patients  Limited understanding of health care issues among many patients, and limited capabilities to make health care choices comprehensible to patients Limited incentives for clinicians to change practices  Lack of (or weakness of) financial and professional incentives for clinician attention to evidence-based guidelines/adherence to protocols, clinician distrust of an over-reliance on evidence (“cookbook medicine”), and organizational inertia Limitations in the presentation of evidence  Unclear presentation, inconvenient formats, and lack of clear rationale for action by the clinician or patient Limited access to evidence  Uneven distribution of health care IT infrastructure and other resources that make evidence available in convenient forms Source: From Evidence to Practice: Making CER Findings Work for Providersand Patients. Sept. 2010. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients New England Healthcare Institute (NEHI)
  30. 30. 9 Anticipated hurdles to CER Dissemination: Drivers of CER Dissemination:  The public perception of CER and its legitimacy, including clinicians’ trust in systematic reviews and observational studies  Lack of standard methodologies  Speed of change in the evidence base  Strength of evidence  Heterogeneity of treatment effects  The “Learning Health Care System” concept and the contextualization of evidence  Patient-centered health care  Mass media Source: From Evidence to Practice: Making CER Findings Work for Providersand Patients. Sept. 2010. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients New England Healthcare Institute (NEHI)
  31. 31. 10 Building a Coherent Strategy For Dissemination – Policy Choices • Use consistent evidence ratings • Integrate CER dissemination into the deployment of health care IT • Create partnerships with stakeholder groups • Utilize patient and clinician incentives to promote comparative clinical effectiveness • Select high priority targets for dissemination • Communicate directly with the public and with patients New England Healthcare Institute (NEHI) Source: From Evidence to Practice: Making CER Findings Work for Providersand Patients. Sept. 2010. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients Note: The WG acknowledges that there is an engine in place (AHRQ) to address some of these issues, and there are required activities established under legislation
  32. 32. 11 AHRQ’s PCOR Activities – Dissemination, translation, and implementation goals include fostering awareness and use of PCOR, informing professional and consumer audiences about AHRQ’s Effective Healthcare Program, and driving towards a greater degree of shared decision-making Goals Target Audience – Audience is broad and includes healthcare providers, consumers, patients, caregivers, decision makers, policymakers, business leaders, and advocates – Audiences are diverse and information needs to be framed differently for different audiences Source: Overview of AHRQ’s ARRA-Funded PCOR Activities. Oct 2011. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients Effective Health Care (EHC) Program – EHC offers continuing education and other resources, and does a robust job of developing and testing various formats (received $300 M for PCOR activities under ARRA) – Emphasis on user-driven synthesis; has produced more than 100 products for clinicians, patients and families, and policy makers – EHC conducts research on dissemination and partnerships
  33. 33. 12 AHRQ’s PCOR Activities Community Forum Project Dissemination Contracts – Its purpose is to improve and expand public and stakeholder engagement in PCOR or CER – It will identify useful and effective ways to engage stakeholders and the general public in AHRQ Programs – Support national awareness building, establishment of regional partnerships, providing online continuing education, conducting academic detailing, and a systematic program evaluation Source: Overview of AHRQ’s ARRA-Funded PCOR Activities. Oct 2011. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients iADAPT – Develop innovative ways to adapt and disseminate summary guides for health consumers – Supports Clinical Decision Support Systems, Culturally Tailored/Health Literacy, Communication/Marketing, Academic Detailing/CME Evaluation – Evaluate effectiveness of publicity centers, regional offices, continuing education, and academic detailing – Determine the level of awareness, understanding, behavior change/use, and benefits of PCOR among targeted audiences
  34. 34. 13 Important Take-Away Messages for PCORI  Programs are most successful when they are audience-centered and use the audiences’ preferred formats and channels  Credentials are important in gaining access to healthcare providers  Health plans, health systems, and large medical groups are valuable sources of access to clinicians  Clinicians want unbiased and balanced information from a trusted and credible source  Disseminating new research differs from disseminating systematic reviews
  35. 35. 14 RAND Briefing to PCORI RAND Study Objectives 1. Developing a Dissemination Framework for assessing barriers and enablers to CER translation into practice 2. Identifying barriers to and enhancers of CER translation 3. Developing recommendations for more effective CER translation
  36. 36. 15 RAND Briefing to PCORI Case Study Topics and Results  CATIE: Conventional antipsychotics had similar effectiveness and side effects vs. atypical antipsychotics  COURAGE: Optimal medical therapy (OMT) provided equivalent survival benefit and comparable relief of angina to OMT + Percutaneous Coronary Intervention  COMPANION: Compared to optimal medical therapy, both cardiac resynchronization therapy (CRT) and CRT + defibrillator reduced hospitalization rates, improved functional status, and improved survival  SPORT: Surgery for lumbar spinal stenosis had better outcomes than non-operative treatment in a cohort study  CPOE: Computerized Physician Order Entry significantly reduced the incidence of serious medication errors vs. paper-based entry
  37. 37. 16 RAND Briefing to PCORI: Conceptual Framework Source: Disseminationand Adoption of CER Findings when Findings Challenge Current Practices. Dec 2011 Based upon literature review/environmental scan, RAND developed a conceptual framework that included four phases of translation
  38. 38. 17 Study Findings  Little to no practice change, even when interventions were favored by results (i.e., implementation of results would have resulted in more aggressive or expansive practice).  For each of 5 studies, RAND assessed factors that prevented or slowed uptake into practice and root causes of incomplete translation were identified. ‒ Misalignment of financial incentives ‒ Ambiguity of CER results ‒ Cognitive biases ‒ Failure to address the needs of end users ‒ Inadequate use of decision support by patients and clinical professionals RAND Briefing to PCORI
  39. 39. 18 Important Take-Away Messages for PCORI  Potential for CER results to influence practice is not yet fully realized  Current translation process is still ad hoc and post hoc with some exceptions  Significant barriers to CER translation may be addressed through a variety of policy levers, namely building CER-enabling infrastructure with a focus on governance, standards, financing, appeals to professionalism, education and marketing, and research and evaluation  Prospective studies of the CER translation process based on the proposed framework could guide future improvements
  40. 40. 19 Important Take-Away Messages for PCORI (cont’d)  CER results are sometimes outdated by the time the study ends—is there a way to get answers faster?  Current under-appreciation for the roles of specialty societies in changing clinical practice  Additional information on best practices, but also the rate of diffusion, is needed  Need to create demand on the front end—this could be written into PCORI solicitations  PCORI may want to engage cognitive psychologists
  41. 41. 20 Developing an Overall Framework: Strategic Issues Raised by Presentations  How can PCORI, building on AHRQ’s work, also work to address the “black box” between dissemination and uptake identified by RAND?  Several of the areas identified by RAND for additional infrastructure focus are areas where PCORI could be involved: generation of CER; more effective translation; evaluation of impact; transparent governance  Can we learn from examples of where translation works well? – Can we prospectively study both infrastructure and sociological factors that make things work? – How do we incorporate elements that work into design?
  42. 42. 21 Developing an Overall Framework: Strategic Issues Raised by Presentations (cont’d)  How do we set up a platform for dissemination that works and allows us to customize strategy to meet the needs of different audiences, given audience heterogeneity (diverse research, multilevel and multidimensional barriers, channels for dissemination)?  What can be required components of all funding announcements that can accelerate dissemination—e.g., requirement for stakeholder engagement in a strategic and planned way?  Can we provide additional, follow-on funding for dissemination and implementation when studies have meaningful findings?  How to anticipate and address potential resistance early in process?
  43. 43. 22  ―Success‖ for PCORI and AHRQ = impact on practice and patient outcomes  PCORI will disseminate results of PCORI-funded and conducted research and PCORI will also fund research on dissemination, but will complement and supplement what AHRQ/NIH are doing, not duplicate efforts  PCORI has unique opportunities – and leg requirements  Dissemination is essential and requires investment, which could occur in multiple ways: ‒ Encourage / require ―dissemination accelerating components‖ in all PFAs ‒ Provide rapid follow-on funding for dissemination for selected studies PCORI Dissemination Assumptions
  44. 44. 23  PCORI has a related role and opportunity in creating demand for, and receptivity to, PCOR in anticipation of evidence/research findings  Not a one-size fits all endeavor—translating results, and influencing behavior, is context-dependent  PCORI will be most effective by establishing partnerships early (with AHRQ, NIH, NGO‘s and private sector actors) and clarifying what PCORI will and will not do  Effective patient and stakeholder engagement, early on in the research endeavor, is the first step in planning and executing dissemination, and facilitating uptake PCORI Dissemination Assumptions (cont’d)
  45. 45. 24  Feedback from the Board at early stage (today; via COEC and PDC ongoing)  Building a framework for PCORI dissemination  Commissioning landscape review  Articulating potential ‗dissemination acceleration components‘ for PFA‘s released in May, 2012 Next Steps
  46. 46. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 2 Patient-Centered Outcomes Research Institute Executive Director’s Report Board of Governors Meeting Jacksonville, FL January 18-19, 2012 2
  47. 47. 3 Introductions LORI FRANK, PH.D PCORI Scientist Judy Glanz Director, Stakeholder Engagement Bill Silberg Director, Communications Melissa Stern, MBA Director, Strategic Initiatives
  48. 48. 4 Next Steps in PCORI Hiring • Engagement • Director of Patient Engagement – Offer extended • Research and Methods • Chief Science Officer – Offer extended • Scientific Review Officer – position posted • Scientists – approximately 9 in 2012 (positions posted) • Operations • Director of Finance – Offer Accepted! • Grants Manager – interviews underway • Associates (i.e., Project Managers) – approximately 10 (position posted) • Financial and Grants Management Support Staff
  49. 49. ED COO CSO Scientific Review Officer Scientists, Program Staff Patient Engagement Communi- cations Stakeholder Engagement Strategic Initiatives Grants Management Finance Meetings Manager PCORI – A Growing Organization 5
  50. 50. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 1 Patient-Centered Outcomes Research Institute Executive Director’s Report Board of Governors Meeting Jacksonville, FL January 18-19, 2012 1
  51. 51. 2 The Next Four Months ….  Public Comment Period for Priorities and Agenda – (Jan 23–March 20)  National Forum and Dialogue Feb 27th,  Focus groups with clinicians - February  Ongoing 1:1 engagements with stakeholder groups,  Analysis and incorporation of public comments,  Final (Version 1) documents for approval in early April  Pilot Project Grants:  Development of selection criteria for funding by BoG – February  Announcement of proposed criteria – March BoG criteria  Application of criteria – late March  Selection of funded applications – early April
  52. 52.  Preparing Broad Funding Announcements – target of May 1 release date  Methodology Report – approving for mid-May 12 start of Public Comment  Engaging Stakeholders through Forums, Workshops and Advisory Groups to refine PCORI’s Research Agenda, begin to identify more specific funding opportunities and prepare those announcements The Next Four Months ….
  53. 53. 4 Funding Research in 2012 • Budget calls for commitment of $91M in research funding in CY 2012 – in addition to Pilot Projects • Current strategy envisions “broad” funding announcements, consistent with language in Research Agenda on May 1, with possibility of some proportion of total funding reserved for “targeted” research identified in process of stakeholder engagement, advisory groups. • Targeted research may use contracts or cooperative agreements rather than grants, and may involve distinct review processes.
  54. 54. Plans for Engaging Stakeholders in 2012 – Stakeholders National Forum during public comment period – Two Conference Grants to inform Priorities and Agenda – Ongoing events to further inform Priorities and Agenda – Brainstorming workshop to inform the Agenda – Brainstorming workshop for possible round 2 of Pilot Projects – Form a PCORI Advisory Board on Research Networks – Workgroup/Advisory Group on Dissemination – Advisory committee on Clinical trials/observational studies – Workshop and Advisory Group on EHR’s – Workshop or Advisory Group on Building PCOR Capacity – Workshop on Patient Engagement 5
  55. 55. See You in Baltimore! March 5th and 6th 6
  56. 56. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE January 19, 2012 Patient-Centered Outcomes Research Institute Finance Audit & Administration Committee
  57. 57. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 2012 Budget Jacksonville, FL Jan 18-19, 2012
  58. 58. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 3 2012 Budget Planning Process  Iterative planning and costing process with each committee – PDC, COEC, MC, and FAAC  Links to Strategic Planning process – by including specification of goals and strategies for each committee for 2012  Budget can now be examined in terms of expenditures by committees and G&A (the planning process), but also in terms of 5 strategic pillars: patient and stakeholder engagement, research funding, rigorous methods, infrastructure, and dissemination – see column “j” in each committee’s spreadsheet for assignment to pillar  Budget does not currently commit out-year funds – it only spends or commits 2011/2012 dollars
  59. 59. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 4 2012 Budget Distribution – by Committee
  60. 60. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 5 Budget Allocations – by Strategic Pillar *Both “rigorous methods” and “research” represent grants and contracts
  61. 61. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 6 Budget Allocations – by Strategic Pillar 18% 33% 17% 8% 8% 8% 8% Allocations for Research Funding Pilot Projects Comparisons of Options Health Systems Disparities Communication and Dissemination Methods Infrastructure
  62. 62. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 7 Questions to be addressed in 2012 • Need to develop standard ways to conceive and discuss “administrative costs” as proportion of total costs: • How to account for Stakeholder Engagement, Dissemination • Whether to distinguish costs by pillar, or “dollars out” vs. “dollars spent internally • We will develop a dynamic revenue flow budget to illustrate expenditures, commitments, and reserves on a monthly basis • We need to consider funding strategies that may commit more funding in early years than are allocated in order to increase PCORI’s impact earlier in its lifespan
  63. 63. Jacksonville, FL Jan 18-19, 2012 Update on Standing Committee on Conflict of Interest (SCCOI)
  64. 64. 9 Charter  Draft charter  outlines purpose, membership, committee operations, responsibilities  Purpose:  The SCCOI shall independently make recommendation to the BOG regarding issues of conflict of interest brought before it by the Board, the Board Chair or Vice Chair or the Executive Director of PCORI ….
  65. 65. 10 Proposed Membership For approval today:  Larry Becker, Chair  Sherine Gabriel  Robert Zwolak For approval on March 7, 2012:  Ethicist  3 consumer members  from consumer organization, patient advocacy organization, the media  identification of candidates with help of directors of communication and stakeholder engagement
  66. 66. 11 Schedule Approval of initial three members: January 19, 2012 Approval of Charter: January 19, 2012 Approval of consumer members and ethicist: March 7, 2012 Organizing meeting of Standing Committee on Conflict of Interest: April 2012 [prepare for first round of PCOR grants] Future meetings: as needed
  67. 67. 12 Discussion  Discussion of motion to approve charter and Board and Methodology Committee members of Committee
  68. 68. 13 Motion to Approve Appointments: Larry Becker (chair) Sherine Gabriel Robert Zwolak Charter of Standing Committee on Conflict of Interest
  69. 69. Nominating Committee Jacksonville, FL Jan 18-19, 2012
  70. 70. 15 Nominating Committee (a) There shall be a Nominating Committee, composed of the Board Chairperson and Vice Chairperson, and three (3) other members of the Board and one (1) member of the Methodology Committee appointed by the Board Chairperson and confirmed by Board vote. Chairs of the Standing Committees described in Section 5.5 shall not be eligible to serve on the Nominating Committee. The Board Chairperson shall be the Chair of the Nominating Committee. (b) Members of the Nominating Committee shall serve one (1) year terms, with no more than two (2) consecutive terms allowed, except for the Board Chairperson and Vice Chairperson, who shall not be subject to such term limit.
  71. 71. 16 Responsibilities of Nominating Committee (i) In consultation with the Methodology Committee, to nominate the Chair and Vice Chair of the Methodology Committee; (ii) To nominate the Chairs of the three (3) Standing Committees described in Section 5.5; (iii) To advise the Board Chairperson, as requested, regarding committee membership; (iv) To advise the Comptroller General of the United States, if requested, regarding appointment of the Board Chairperson and Vice Chairperson; (v) To advise the Comptroller General of the United States, if requested, regarding appointment of new members of the Board; (vi) To advise the Comptroller General of the United States, if requested, and upon consultation with the Methodology Committee, regarding appointment of new members of the Methodology Committee; and (vii) To nominate for the following year the members of the Nominating Committee.
  72. 72. 17 Members of Nominating Committee Gene Washington - Chair Steve Lipstein – Vice-chair Gail Hunt (PDC) Robert Jesse (COEC) Freda Hall Lewis (FAAC) Robin Newhouse (MC)
  73. 73. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 43 January 18-19, 2012 PCORI Methodology Committee Progress Report Sherine E. Gabriel, MD, MSc Sharon-Lise T. Normand, PhD PCORI Methodology Committee
  74. 74. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 44 Methodology Committee Structure Methodology Committee Activities Overview Methodology Committee Contracts Summary Methodology Committee-Board Engagement Case Study Preview Next Steps-Timeline PCOR Definition Agenda
  75. 75. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 45 Patient Centeredness Workgroup Research Methods Workgroup Research Prioritization Workgroup ReportAssimilationWorkgroup* Identify methodological standards to incorporate the patient perspective Produce methods to inform prioritization of new research studies Produce methods for using data, design, and statistical analyses to conduct patient centered outcomes research In service of the First Methodology Report, due May 2012, the committee has organized as follows: *Provides guidance to other workgroups and assmilates work products into the first Methodology Report Methodology Committee Structure Standing Committees Scope Deliverables Translation Table Methodology Report
  76. 76. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 46 In service of the First Methodology Report, due May 2012, the committee has accomplished the following: • 15 contracts have been awarded to date (of 48 submissions) o 3 contracts relate to patient engagement o 4 contracts relate to methods for research prioritization o 8 contracts to review guidance documents for selecting methods for PCOR o The workgroup members hold biweekly check in calls with the contractors Request for Information (RFI) – Posted • 1 RFI to provide case studies for the development of the Translation Tool In March 2012, two of the workgroups will hold a forum for contract awardees to present findings in order to facilitate writing of first Methodology Report Workshops – Planned Over 34 interviews have been conducted including government, commercial, and academia in order to assess how EHR and electronic data systems are leveraged for CER/PCOR Electronic Data Systems Interviews – On going Methodology Committee Activities Overview Contracts – Awarded • Lori Frank, PCORI Scientist, • Tim Carey, Research Prioritization Workgroup Interim Research • Ed Reid, Report Assimilation Interim Contractor • Medical Writers (TBD) Resources
  77. 77. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 47 Methodology Committee Awarded Contracts Oregon Health & Science University, The Center for Evidence- Based Policy Mayo Clinic, Knowledge and Evaluation Research Unit University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department University of Wisconsin, Medical CollegeMedical Co Duke University, Evidence-Based Practice Center NORC at The University of Chicago RC at Univ Hayes, Inc. 15 contractors from across the country are currently conducting research on behalf of the Methodology Committee Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcome Research (Stakeholder Interviews / Literature Review) Methods for Setting Priorities in Research (White Paper) Review of Guidance Documents for Selected Methods in PCOR Or Sc Un Sc Un Du Ev Ha t The ty of Chicago t Th Northwestern University/ UNC Chapel Hill Johns Hopkins Bloomberg School of Public Health JoJo Sc Jo Oxford Outcomes Ox Ou Berry Consultants Brown UniversityBr Brigham & Women's Hospital & Harvard Medical School Br Ho Outcome Sciences, Inc. (A Quintiles Company) Ou (A University of California & San Diego Supercomp uter Center Un Ca Key Scope of Work NortNo
  78. 78. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 48 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 two out of 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 11 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
  79. 79. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 49 Continue to provide opportunities for the liaisons to engage with the Patient Centeredness Working Group Board of Governors Engagement – Next Steps The Methodology Committee has strategized avenues for engagement and intends to complete the following actions: Methodologic Importance Methodology Report Schedule a teleconference to discuss the impact and implications of methodologic decisions Develop communication plan to ensure transparency and involvement during Methodology Report Writing period (prior to and following public comment) Emphasis of Engagement Action Item Board Perspectives Methodology Committee Progress Submit Briefings/Status Updates Present during Board Meetings
  80. 80. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 50 The Critical Role of Methods: A case-based approach Producing trusted, high quality and useful information….
  81. 81. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 51 • Incorporate the patient voice to choose outcomes and comparisons that matter • Use existing evidence • Select the right study design • Determine if/how treatments affect people differently (heterogeneity of treatment effects) Selected Methods to…
  82. 82. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 52 Robinson and Goodman, 2011 In reports of RCTs published over 4 decades, fewer than 25% of preceding trials were cited, comprising fewer than 25% of the participants enrolled in all relevant prior trials…Potential implications include ethically unjustifiable trials, wasted resources, incorrect conclusions, and unnecessary risks for trial participants.
  83. 83. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 53 NORC Accomplishments • Summarized the public input (Phase I) • Conducted 6 focus groups (Phase II) o Focus groups sought input of general public and patients, with outreach to patients with chronic illness, caregivers, African- Americans, Spanish-speaking Working Group Accomplishments With the input of several Board Members, the group is considering revisions of the PCOR definition as a result of: • Synthesized Public comments • Summarized output of 6 patient focus groups • Distilled themes Patient-Centered Outcomes Research Definition Workgroup Members: Dave Flum Mary Tinetti Jean Slutsky Mark Helfand Sebastian Schneeweiss Board Members: Harlan Weisman Debra Barksdale Gray Norquist Rick Kuntz Allen Douma Gail Hunt Harlan Krumholz
  84. 84. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 54 Finalize Report Writing Process Develop the report writing team Set up calls with Board Members & PCORI Staff Continually update report outline Synthesize contractor reports, research, and workshop results Discuss progress of working drafts Voting Standards Meeting– April 3rd Submit final drafts, Review, & Finalize Report Sections Share Report & Receive input from Board of Governors January 2012 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 Methodology Committee Next Steps Board Engagement Key:
  85. 85. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 55 Thank You!
  86. 86. Patient-Centered Outcomes Research Institute PCORI Pilot Project Board of Governors Meeting Jacksonville, FL January 18-19, 2012
  87. 87. Contents  Key Accomplishments  Overview of Four-Stage Review Process  Description of the Merit Review Process  Description of PCORI Deliberative Process  Timeline
  88. 88. Pilot Projects: Key Accomplishments 850 People who registered for webinars 1375 Letters of Intent received 1400 Number of applicant questions answered 842 Number of applications received  Issued first PCORI Funding Announcement  Held three applicant webinars  Developed and continue to refine Frequently Asked Questions  Received, vetted, and forwarded qualified scientific and stakeholder reviewers to NIH.  Received and processed letters of intent.  Received and processed 842 grant applications.
  89. 89. PCORI Pilot Projects Applications Thanks to programmatic reviewers: • Anne Beal • Carolyn Clancy • Arnold Epstein • Christine Goertz • Leah Hole-Curry • Gail Hunt • Harlan Krumholz • Joe Selby • Harlan Weisman
  90. 90. Overview of the 4-Step Process Preliminary Check Merit Review Deliberation Business Determination that the application meets the minimum technical requirements enumerated in the PFA and fits within programmatic priorities. PCORI Responsive/eligible applications will be forwarded for review. Remaining applications are assigned to 3 reviewers with appropriate expertise who will critique independently and then meet to discuss and designate a final score. NIH A rank-ordered list of applications and summary sheets A BOG Working Group develops criteria for analytics regarding how PCORI will “balance” the pilot projects portfolio from a programmatic perspective PCORI Balance criteria determined The Pilot Projects Balance Committee considers the merit review scores and programmatic balance across several categories to develop a recommended award slate for consideration by the BOG. PCORI Funding decisions are made. A final review for suitability to manage an award, adherence to human subjects requirements, receipt of IRB approval, budget review, etc. PCORI Negotiations, where needed Description Responsible Result Preparation for Deliberation
  91. 91. Merit Review Prior to the Review Meeting • Each application is assigned to 3 reviewers • Reviewers include scientists and other stakeholders • Stakeholders without previous review experience will be trained • Reviewers assign an initial priority score of 1 to 9 based on PCORI-provided review criteria • Provides basis for discussion at in person meeting In-Person Review • In-person meeting of reviewers to discuss the most promising applications • Review and discuss applications based on impact, stakeholder involvement, innovation, and significance of the science • Provide a final priority score of 1 to 9 • Scientific Review Officer compiles a summary statement with reviewer critiques for each applications Summary & Rankings • The review process results in a ranked, scored summary of applications for PCORI consideration Conducted by NIH
  92. 92. PCORI Deliberations Working Group • Determines specific data to be considered by the PCORI Balance Committee in determining and recommending an appropriately balanced slate of awards. PCORI Balance Committee • Meets to review materials • Considers the balance of priority- scored applications across classification categories, 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 classification categories. • Provides funding scenario options based on analytics developed by the BOG Working Group. • Supports the PCORI Balance Committee and Board of Governors by providing revised options, as needed.
  93. 93. Timeline  Sep 28, 2011 Posting of Funding Announcement  Nov 1, 2011 List of potential Stakeholder and Scientific Reviewers to the NIH  Nov 1, 2011 Letter of Intent Due  Nov 2, 2011 Letters of Intent sent to NIH  Dec 1, 2011 Applications due  Dec 8, 2011 Programmatic review begins  Feb, 2012 Merit review  Mar, 2012 Review committee recommends slates  Mar/Apr, 2012 Slate of projects to board and selection  May, 2012 Award Notification
  94. 94. Discussion
  95. 95. 1 Developing PCORI’s National Priorities for Research and First Research Agenda PCORI Board of Governors January 2012
  96. 96. 2 Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010. “Assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence…[relevant to] the manner in which diseases, disorders and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.” Purpose PCORI Purpose: Defining Legislation
  97. 97. 3 Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010. National Priorities for Research “The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section.”
  98. 98. 4 Research Agenda Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010. “The Institute shall establish and update a research project agenda for research to address the priorities identified under subparagraph (A), taking into consideration the types of research that might address each priority and the relative value (determined based on the cost of conducting research compared to the potential usefulness of the information produced by research) associated with the different types of research, and such other factors as the Institute determines appropriate.”
  99. 99. 5 Stakeholder Input (surveys, focus groups, public comment, stakeholder meetings, etc.)Environmental Scans Pilot Project Applications Pilot Project Results PCORI Board Methodology Committee PCORI National Priorities and Research Agenda Versions 1 Solicitation 5 Generating Greater Specificity: Inputs Legislative Statute
  100. 100. 6 IncreasingSpecificity National Priorities and Research Agenda: An Iterative Feedback Process Inputs • Legislative Statute • Board of Governors • Program Development Committee • Methodology Committee • Environmental Scans • PCORI Pilot Projects • Stakeholder Input and Feedback Research Agenda Version 1 National Priorities Version 1 Individual PFAs Version 1
  101. 101. 7 7 We’re on a Journey!
  102. 102. 8 Task Aug Sept Oct Nov Dec Jan Feb Mar Apr May NATIONAL PRIORITIES Develop Framework Develop Stakeholder Engagement Process Dialogue w/ Stakeholders Design and implement web-based survey Public Comment Incorporate Public Comment RESEARCH AGENDA Environmental Scan for RA Development Draft Research Agenda Dialogue w/ Stakeholders Public Comment Incorporate Public Comment 2011 2012 Nat’l Priorities v1.0 Research Agenda v1.0 Timeline for Development of National
  103. 103. 9 National Priorities
  104. 104. 10 Environmental scan of existing priorities and criteria Candidate priorities and criteria identified Framework to inter-relate Priorities and Criteria Reviewed initial stakeholder input advising us to not “reinvent the wheel” Reviewed prior CER frameworks (e.g., IOM, FCCCER, National Priorities Partnership, NQF) Identified broad priorities from prior frameworks and the statutory criteria for PCORI Developed Framework to be used for refining priorities and for determining Research Agenda and funding announcements Initial Stakeholder feedback Development of a National Priorities Framework
  105. 105. 11 Environmental Scan Source Prevention AcuteCare Chronic DiseaseCare PalliativeCare Care Coordination Patient Engagement Safety Appropriate Use HITtoimprove pt.experience ImpactofNew Technology IOM 2009: Priorities for CER √ √ √ √ √ √ √ √ √ Federal Coordinating Committee for CER √ √ √ √ √ AHRQ National Quality Strategy √ √ √ √ AHRQ Effective Health Care Program √ √ √ √ √ √ National Quality Forum √ √ √ √ √ √ √ √ National Prevention Council √ √ National Priorities Partnership √ √ √ √ √ √ 8
  106. 106. 12 Health Information Technology Prevention & Screening Acute Care Impact of New Technology PCORI Draft National Priorities Appropriate Use Frequently Cited Priority Areas Chronic Disease Care Palliative Care & Pain Management Care Coordination Patient Engagement Safety Addressing Disparities Accelerating PCOR and Methodological Research Communication and Dissemination Research Improving Health Care Systems Comparative Assessment of Options for Prevention, Diagnosis, and Treatment  Consideration of Criteria in Statute  Fits the Definition of PCOR Making PCORI Priorities Patient-Centered
  107. 107. 13 Patient-Centered Priorities Improving Healthcare Systems Comparing healthcare system-level approaches to improving access, supporting patient self-care, innovative use of health information technology, coordinating care for complex conditions, and deploying workforce effectively. Comparative Assessment of Options for Prevention, Diagnosis, and Treatment Comparing the effectiveness and safety of alternative preventive, diagnostic and treatment options.
  108. 108. 14 Addressing Disparities Identifying potential differences in treatment effectiveness or preferred clinical outcomes across patient populations and the health care required to achieve best outcomes in each population. Communication & Dissemination Research Comparing approaches to providing CER information and supporting shared decision-making between patients and their providers. Accelerating PCOR and Methodological Research Improving the nation’s capacity to conduct patient- centered outcomes research, by building data infrastructure, improving analytic methods, training researchers, patients and other stakeholders. Patient-Centered Priorities (cont’d)
  109. 109. 15  Developed over 5-month period  Built from prior prioritization efforts  Stakeholder input incorporated along the way  First Draft now ready for public comment  Can be modified based on public comment, or thereafter through a transparent process of stakeholder engagement PCORI’s Draft National Priorities
  110. 110. 16 Research Agenda
  111. 111. 17 Impact on Health of Individuals and Populations PCORI Criteria – From Legislation Improvability through Research Inclusiveness of Different Populations Addresses Current Gaps in Knowledge/Variation in Care Patient-Centeredness Impact on Health Care System Performance Potential to Influence Decision-Making Rigorous Research Methods Efficient Use of Research Resources
  112. 112. 18 Accelerating PCOR and Methodological Research • Impact on Health of Individuals and Populations • Improvability via Research • Inclusiveness of Different Populations • Addresses Current Gaps in Knowledge/Variation in Care • Impact on Health Care System Performance • Potential to Influence Decision Making • Patient-Centeredness • Rigorous Research Methods • Efficient Use of Research Resources Addressing Disparities Improving Healthcare Systems Communication & Dissemination Research Priorities Comparative Assessment of Options for Prevention, Diagnosis, and Treatment PCORI Criteria PCORI Research Agenda Framework for Developing PCORI Research Agenda from National Priorities
  113. 113. 19 ...compare situations in which the effectiveness of strategies for prevention, treatment, screening, diagnosis, or surveillance have not been adequately studied against alternative options where better evidence is needed to support decision-making by patients, caregivers, and health care professionals. Research Agenda Item From a National Priority Comparative Assessment of Options for Prevention, Diagnosis, and Treatment PCORI Criteria
  114. 114. 20 Improving Healthcare Systems Research Agenda Item From a National Priority …compares alternative system- level approaches to supporting and improving patient access to care, receipt of appropriate care, coordination of care across health care services or settings for patients with complex chronic conditions, and personal decision- making and self-care. PCORI Criteria
  115. 115. 21 Alternative clinical options Patient differences in response to therapy Patient preferences for various outcomes Alternative system interventions Improvements in the effectiveness and efficiency of care Patient-centeredness Improvements in shared decision-making Alternative strategies for dissemination of evidence Alternative interventions/strategies to eliminate disparities Improvements in alignment of decisions with preferences Improvements study designs and analytic methods of PCOR Building and improving clinical data networks Better methods for training researchers, patients to participate in PCOR Facilitating the study of rare diseases Addressing Disparities Improving Healthcare Systems Accelerating PCOR and Methodological Research Communication & Dissemination Research Comparative Assessment of Options for Prevention, Diagnosis, and Treatment Content of PCORI Research Agenda
  116. 116. 22  Promote patients and their caregivers –and key stakeholders in implementation settings—as partners, with explicit roles in the design, governance, review, and dissemination of research.  Seek to understand core questions from the expressed perspective of the patient and their caregivers.  Emphasize open and transparent science that involves participants in decisions about making data available for further study, seeking to ensure that the research produces as much new investigative activity as possible and that sharing of information and knowledge among diverse investigators is required. Select Features of PCORI Research Agenda
  117. 117. 23  Commit to a diverse research portfolio with respect to patients, geography, health care professionals, investigators, and organizations, seeking to catalyze activity across a broad range of patients, sites, conditions, and questions.  Emphasize knowledge that is likely to make a positive difference in the lives of patients and their caregivers and is suitable for dissemination and application; and emphasize outcomes that are important to patients and their caregivers and likely to be useful in their decision-making.  Emphasize ideas that emerge from the community of patients, caregivers, clinicians and researchers, seeking to listen and learn from the wisdom of those whose lives are most affected by these conditions and those who are committed to generating new knowledge that will promote better decisions and outcomes. Features of PCORI Research Agenda
  118. 118. 24  Developed over 4-month period  Stakeholder input incorporated  First draft ready for public comment  Will be modified and expanded thereafter through a transparent process of stakeholder engagement PCORI’s Draft Research Agenda
  119. 119. 25  Proposed initial agenda is specific with respect to study questions that will be supported, but not to the conditions (or treatments) that can be studied  This non-specificity allows for a flexibility in the search for the best opportunities  Continuing input from stakeholders will contribute to refinement of research agenda over time PCORI’s Draft Research Agenda

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