Board of Governors Meeting, Washington DC

780
-1

Published on

Slide presentation from the September 24, 2012 Board of Governors Meeting in Washington, DC.

Published in: Health & Medicine, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
780
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
1
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Board of Governors Meeting, Washington DC

  1. 1. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Board of Governor’s Meeting Washington, DC September 24, 2012 Larry Becker, Chair, SCCOI and Member, Board of Governors Standing Committee on Conflict of Interest (SCCOI)
  2. 2. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Agenda 1.  Introduction – COI Rules Approved by the Board on June 19, 2012 2.  Operationalizing the COI Rules for the Methodology Committee 3.  Next Steps 4.  Discussion 2   Today’s Agenda
  3. 3. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E COI Rules Approved by the Board on June 19, 2012 3   Introduction §  Intended to “safeguard the integrity and public trust in the process for funding patient- centered outcomes research (PCOR)” Full text available at www.pcori.org  
  4. 4. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI  FUNDING   ANNOUNCEMENT   APPLICATIONS       •  483  applica+ons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012   OPERATIONALIZING  THE  COI   RULES  FOR  THE  METHODOLOGY   COMMITTEE  (MC)      
  5. 5. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E COI Rules Pertaining to the MC 5   Operationalizing the COI Rules for the MC §  Creates the MC-PFA Development Subcommittee* to function as a liaison to PCORI’s Board and staff −  These MC members will not be eligible to apply for PFA funding * Previously referred to as the Methodology Executive Subcommittee in Patient-Centered Outcomes Research Institute (PCORI) Draft Conflict of Interest Rules for Research Funding, June 19, 2012 Methodology Committee (MC) MC-PFA Development Subcommittee
  6. 6. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Operationalizing the COI Rules for the MC MC-PFA Development Subcommittee Jean Slutsky, PA, MSPH Clyde Yancy, MD Naomi Aronson, PhD Alfred Berg, MD, MPH Mike Lauer, MD Sherine Gabriel, MD (MC Chair)
  7. 7. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E The Methodology Committee will remain united in its mission to provide scientific guidance to PCORI… …the new operating model will not change this 7   Operationalizing the COI Rules for the MC
  8. 8. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Elements of PCORI’s COI Policy Regarding the Methodology Committee 8   Operationalizing the COI Rules for the MC Protect against COI when awarding funding for non – PFA research (RFPs) Non- Disclosure Agreements Firewalls for PFAs MC Recusal and COI Disclosure Require all members of PCORI community (e.g., MC, Board, staff) to preserve confidentiality of non- public information Create firewalls to preserve Methodology Committee eligibility for PFA funding
  9. 9. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Firewalls will be implemented to preserve eligibility of most MC members for PFAs 9   Operationalizing the COI Rules for the MC Firewall Goals: q  Avoid an unfair advantage for MC members q  Control access to information
  10. 10. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E MC Firewall Implementation Strategies 10   Operationalizing the COI Rules for the MC IT Governance Distribution Controls Meeting Controls Mitigating Time Advantage
  11. 11. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E SCCOI Guidance Operationalizing the COI Rules for the MC •  Importance of IT solutions to maintain firewalls •  Emphasis on policy training for the Board, Methodology Committee, and staff •  Encouragement of preparation of public-facing document that reinforces the significance of guarding against COI as a core PCORI value 11   Operationalizing the COI Rules for the MC
  12. 12. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI  FUNDING   ANNOUNCEMENT   APPLICATIONS       •  483  applica+ons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012   NEXT  STEPS  
  13. 13. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Next Steps Operationalizing the COI Rules for the MC Ø  Develop and adopt the COI policy regarding external parties (e.g., advisory panels, consultants) Ø  Implement the firewalls for the Methodology Committee Ø  Monitor and regularly review COI compliance Next Steps 13  
  14. 14. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI  FUNDING   ANNOUNCEMENT   APPLICATIONS       •  483  applica+ons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012   DISCUSSION  
  15. 15. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Questions or Comments? Operationalizing the COI Rules for the MC Discussion 15  
  16. 16. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E •  Appendix A: Proposed Internal Firewall Policies and Procedures Related to the Eligibility of Methodology Committee Members for PCORI Research Funding •  Appendix B: Checklist: Implementation of Firewalls for Methodology Committee •  Appendix C: PCORI Conflict of Interest Rules for Research Funding (June 19, 2012) 16   Appendix
  17. 17. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Board of Governors Meeting Washington, DC September 24, 2012 Jean Slutsky, Methodology Committee Lori Frank, PhD, Director, Engagement Research Bill Silberg, Director, Communications Update on Public Comment Period for Draft Methodology Report
  18. 18. 2   §  Submitted to the PCORI Board of Governors on May 10, 2012 §  Approved for posting by the PCORI Board of Governors on May 21, 2012 §  Public comment period: July 23, 2012 through September 14, 2012 §  Revised draft standards to be submitted to the Board of Governors November 2012 Methodology Report
  19. 19. 3   PCORI  FUNDING   ANNOUNCEMENT   APPLICATIONS       •  483  applica+ons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012   PUBLIC  COMMENT  AND   ONGOING  OUTREACH  
  20. 20. 4   Professional  Journal  Ar+cle   and  Ads   “Why  Methods  MaGer”   Webinars   Social  Media   Targeted  Outreach   News  Release   Outreach efforts for MC report comment period
  21. 21. 5   PCORI blog columns and associated videos pushed to targeted email lists “Why Methods Matter”
  22. 22. 6   Digital Ads released in Annals of Internal Medicine; Science Translational Medicine; JAMA; NEJM; Nature; and Health Affairs Professional Journal Article and Ads
  23. 23. 7   • >850,000  total  an+cipated   impressions   • Exposure  to  nearly  13,000  subscribers   through  a  Health  Affairs  e-­‐alert   Professional   Journal  Ar+cles   and  Ads   • Three  blog  posts   • 671  total  blog  views   • 150  total  video  views   “Why  Methods   MaGer”   • Two  webinars   • >650  total  aGendees   • Strong  audience  interest  indicated  by   low  fall-­‐off  rate   Webinars   • PCORI  men+oned  5,753  +mes  in   TwiGer  and  social    media   conversa+ons  over  the  last  six   months  (mid-­‐April  through  mid-­‐ September)   • Es+mated    7.4  million  impressions  ,   reaching    individuals  through  a  variety   of  online  media.   Social  Media   • Three  e-­‐mail  blasts  to  opt-­‐in   stakeholder  list  (~4,600  names)   • Open  and  click-­‐through  rates  above   industry  norms:   • First  alert:  43.8%  and  50.3%   • Second  alert:  35.2%  and  37.3%   • Third  alert:  26.2%  and  22.2%   • Addi+onal  alert  to  3,143  researchers   through  PCORI’s  contracts  pla`orm.   Targeted   Outreach   • News  release  republished  244  +mes   • Coverage  included:  The  Pink  Sheet;   Medical  Device  Daily;  Government   Health  IT;  Inside  Health  Policy;   BioCentury;  and  CQ  Healthbeat   News  Release   Measures of Reach 6,500     page  views   1,600     report  downloads   *  As  of  9/19/2012    
  24. 24. 8   •  Two webinars –  Setting Standards for Research Methods, August 3 –  Setting Standards for Patient-Centeredness and Patient Engagement in Research, August 14 Webinars 0%   20%   40%   60%   80%   100%   I  do  not  understand   I  understand   somewhat   I  have  good   understanding   Rate  your  understanding  of  the  process  the  MC   used  to  generate  standards   Before   Afer   *  Actual  responses  from  both  webinars  combined  
  25. 25. 9  
  26. 26. 10   Results   VeGed  by   Pa+ent  Panel   AIR  Conducts   Analysis  of   Public   Comments   PCORI   Collects   Public   Comments   Deliverables   Public  Comment  Analysis  Delivered  to  MC   Transparent  Comment  Disposi+on  Table   MC  Standards  and  Report   Public  Comment  Process   Collecting, Analyzing, & Transparently Communicating Public Comments •  Public Comment Contractor: American Institutes for Research (AIR) •  Criteria: –  Patient panel to review and refine comment analysis –  Extensive patient and stakeholder engagement experience –  Expertise in qualitative research methodology –  Significant experience with public comment process
  27. 27. 11   Researchers,   33%   Other,  17%  Industry,  16%   Unspecified,     12%   Caregiver  /   Pa+ent   Advocacy   Organiza+on,   8%   Clinician,  5%   Organiza+onal   Provider,  4%   Pa+ent,  2%   Policymaker,   1%   Caregiver,  1%   Pa+ent   Advocate,  1%   Respondents  by  Stakeholder  Category   Public Comment Results 8   9   10   11   16   20   23   124   0   20   40   60   80   100   120   140   #  of  comments   CumulaYve  Comments  Received,  by  Week  
  28. 28. 12   Comments  by  Stakeholder  Category   Related  to  a   specific   chapter   39%   Related  to   report  as  a   whole   36%   Unrelated  to   the  report   17%   Related  to  a   specific   standard   8%   12   55   414   125   48   175   227   25   400   6   227   0   50   100   150   200   250   300   350   400   450   Public Comment Results Comments  by  Type  
  29. 29. 13   MC Report Public Comment - Themes •  Role of standards in PCOR •  Feasibility of standards implementation •  Document accessibility •  Interest in training and resources to support PCOR and standards implementation •  Interest in more specific details regarding research methods
  30. 30. 14   PCORI  FUNDING   ANNOUNCEMENT   APPLICATIONS       •  483  applica+ons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012   •  Review  and  Revisions  of  Standards/Recommended  Ac+o •  Future  Direc+ons   METHODOLOGY  COMMITTEE  
  31. 31. 15   Systematic Review Dissemination Research Prioritization Causal Inference Heterogeneity of Treatment Effects Missing Data Trial Methodologies Diagnostic Testing Translation T able/ Registries Data Networks Patient Centeredness The MC will provide revisions to methodologic standards and recommended actions across each of the eleven research domains Review and Revision of Standards
  32. 32. 16   Methodology Committee Goals 1.  Propose revisions to the standards and recommended actions based on public and Board comments (with justification) 2.  Provide summary of MC responses to public and Board comments 3.  Offer additional suggestions for methodological research gaps gleaned from public and board comment Review and Revision of Standards
  33. 33. 17   Can the substance of the standard be subsumed by other existing Standards with modest revision? Can the substance of the standard be framed as a recommended Action to inform PCORI policy? Provide strong justification why comments should not be addressed. Yes Provide specific revisions No Propose revisions to the standard that fully address comments (from board and public) in a meaningful and substantive manner. No Yes Should the Standard continue as is? No No Provide specific language for Draft PCORI Policy Yes Start   Review and Revision of Standards  
  34. 34. 18   1.  Review and propose responses and revisions to relevant Board and Public Comments. Include justification if no response/no change is recommended 2.  Discuss and propose next steps for translation table. Options include: •  No further changes. Maintain the translation table as it currently stands •  Propose RFP to develop v2 of Translation Tool which expands on current tool and creates additional versions for different audiences, e.g. Researchers, students, general public, policy makers etc. Review and Revision of Translation Table
  35. 35. 19   Submission  to   Board   Dra  Report   Posted   Public   Comment   Period   Analysis  of   Public   Comment   Revise   Standards/   Recommende d  AcYons   based  on   analysis   Update   Standards/   Recommended     AcYons/   Comment   DisposiYon   Table   May-­‐Jul  2012   Aug-­‐Sep  2012   Oct-­‐Nov  2012   7/23  –  Public  Comment   Period  Begins   10/31  –MC  Consensus  on   Proposed  Revisions   11/19  –  Board  Vote  to   Accept  Final   5/21  –   Approved  for   Pos+ng   9/14  –  Public  Comment   Period  Ends   Review and Revision of Standards Timeline
  36. 36. 20   •  Select Standards for further research in 2013 •  Develop a detailed Standards implementation and dissemination plan •  Incorporate standards into PFAs •  Incorporate principles of research prioritization into evaluation of the impact of standards on improving research quality and advancing PCORI mission •  Enhance methods for use of patient-reported outcomes •  Create PCOR methods training programs for patients and other stakeholders Priorities Future Direction  
  37. 37. 21   •  Contribute to PCORI patient engagement workshop •  Contribute to PCORI methods workshop •  Participate in PFA development (subset of MC members) •  Advise on methods-relevant dissemination (subset of MC members) Methods Leadership Future Direction  
  38. 38. 22   •  Ongoing outreach planned for Standards following completion of revision in November 2012 •  Further Standards development to be evaluated based on additional review by MC, Board, and patients and other stakeholders throughout the planned ongoing outreach and dissemination Future Direction   Moving toward Standards 2.0
  39. 39. 23   To those who provided comment on the MC Standards and Report: Thank you for your thoughtful input! To the Methodology Committee: Thank you for all your hard work in the development and revision of these document! Thank You  
  40. 40. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Communications Update 1 •  A communications framework that advances our goals •  Building infrastructure •  Building awareness •  Promoting our milestones •  Key metrics •  Future opportunities to consider and discuss
  41. 41. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Questions to Consider 2 •  How can we best refine our messaging as we build our research portfolio? •  What critical lessons do we want to impart from our research to date? •  What kinds of “stories” might we use to make our work “real” to our stakeholders and show how “research done differently” benefits them? •  How can we best collaborate with and leverage the work of others in the CER/PCOR space to advance our communications goals?
  42. 42. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 3 •  Define organizational messages, stakeholder audiences and goals •  Develop and implement a comprehensive plan that delivers those messages to key stakeholder audiences •  Refine and update the plan over time based on key performance indicators •  Continue close collaboration with COEC and other leadership to refine strategic and operational objectives •  Ensure support of PCORI’s foundational pillars and the implementation of its strategic plan
  43. 43. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 4 PCORI’s Key Messages •  To improve the quality and effectiveness of care, patients and those who care for them need evidence-based information that they trust and use in making better- informed clinical decisions. •  PCORI funds research that provides such trusted, high-quality information by requiring meaningful patient engagement in all aspects of the research process. •  PCORI advances its mission by convening, partnering, and soliciting the input and guidance of all stakeholders in the health and health care community.
  44. 44. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 5 PCORI’s Key Audiences •  Multiple stakeholders, but particularly patients, caregivers, researchers, clinicians, public and private payers and policymakers PCORI’s Key Goals •  Reshape research to meaningfully include patients’ concerns, with patients and caregivers as true partners •  Establish stakeholder partnerships that will advance our research and dissemination efforts •  Promote the adoption of rigorous methods and robust infrastructure to sustain PCOR over time •  Establish PCORI as a trusted “must-have” source of patient-centered outcomes research and information that will be widely used
  45. 45. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 6 Communications Plan Goals •  Provide a consistent stream of high-quality content and activities that support and advance PCORI’s strategic imperatives and goals in ways that build trust with stakeholders •  Be proactive in identifying communications opportunities and assessing and addressing challenges •  Be transparent in showing how PCORI is meeting its statutory obligations and delivering on its research agenda •  Establish and maintain a robust infrastructure that facilitates two-way communication and engagement with key stakeholder audiences •  Develop and track metrics that assess progress toward communications goals, refining activities as needed
  46. 46. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 7 Our Opportunities •  Telling the story of building a research institute and “brand” from scratch •  Creating a new approach to traditional research •  Convening multiple stakeholder groups to pursue a shared agenda Our Challenges •  Telling the story of building a research institute and “brand” from scratch •  Creating a new approach to traditional research •  Convening multiple stakeholder groups to pursue a shared agenda
  47. 47. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Building Infrastructure 8 •  Platforms, tools, and channels •  Staffing and resources •  Process and procedures •  Partnerships and relationships
  48. 48. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Building Awareness 9 •  We are a new organization building a track record of research •  Our story to date has been largely aspirational, organizational, and “stage- setting” but is evolving as our work continues •  We are measuring our progress in milestones •  We are building relationships with those who will help tell our story and advance our research and dissemination efforts
  49. 49. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Promoting Our Milestones 10 National Priorities for Research and Research Agenda •  503 comments received via web site, e-mail, or mail •  Hosted National Patient and Stakeholder Dialogue, PCORI’s largest stakeholder engagement event to date PCORI Pilot Projects •  Covered by Modern Healthcare, Politico, Kaiser Health News •  Special Board webinar to approve revisions to priorities and agenda and approve Pilot Projects attended by 421 stakeholders
  50. 50. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Funding Announcements (PFAs) •  PCORI’s PFA web page has received an average of >15,000 page views per month •  Secured >400,000 impressions through advertising in NEJM, JAMA, and Health Affairs Draft Methodology Report •  Two webinars for patients and stakeholders combined to draw >650 attendees •  Three columns and videos published explaining “Why Methods Matter” from the researcher, patients and industry perspective •  Social media hashtag: #WhyMethodsMatter Promoting Our Milestones 11  
  51. 51. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Promoting Our Milestones 12 Patient/Stakeholder Engagement Initiative Three workshops designed to engage patients and stakeholders in refining PCORI’s research agenda: •  Transforming Patient-Centered Research: Building Partnerships and Promising Models •  October 27-28 •  What Should PCORI Study? A Call for Topics From Patients and Stakeholders •  December 4 •  PCORI Methodology Workshop for Prioritizing Specific Research Topics •  December 5 Promotion through web site, e-mail, webcasts, media outreach, video
  52. 52. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Website Metrics 13 6-Month Snapshot •  >195,000 site visits, including > 98,000 unique visits •  The average site visitor spends nearly four minutes per visit •  May 23: PFAs announced; 4,200 new visitors logged on to the site 0   10,000   20,000   30,000   40,000   50,000   60,000   Site  Traffic   Visits  
  53. 53. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E 14 •  15  e-­‐mail  alerts  sent  to  stakeholders   •  Average  alert  open  rate  is  40%  (industry  standard  is  19%)   •  Goal:  Grow  opt-­‐in  e-­‐mail  list  to  10,000  by  end  of  2012   Growing Our E-mail List 0   1000   2000   3000   4000   5000   Feb-­‐11   Mar-­‐11   Apr-­‐11   May-­‐11   Jun-­‐11   Jul-­‐11   Aug-­‐11   Sep-­‐11   Oct-­‐11   Nov-­‐11   Dec-­‐11   Jan-­‐12   Feb-­‐12   Mar-­‐12   Apr-­‐12   May-­‐12   Jun-­‐12   Jul-­‐12   Aug-­‐12   Sep-­‐12   Subscribers  2/1/2011   283  Subscribers   9/19/2012   4,800  Subscribers    
  54. 54. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Convening: PCORI Events 15 Na8onal  Pa8ent  and  Stakeholder  Dialogue   APended  by  850  people  in  person  or  by  webcast  and   teleconference;  46  public  comments  provided  at  event   by  representaRves  of  diverse  stakeholder  segment.   Na8onal  Workshop  to  Advance  Use  of  Electronic  Data     Convened  a  select  group  of  researchers  and  thought  leaders  to   develop  ideas  for  how  PCORI  can  facilitate  the  creaRon  or  funcRon   of  a  naRonal  data  infrastructure  to  support  high  quality  paRent-­‐ centered  outcomes  research;  300+  aMendees    live  and  via  webcast.    
  55. 55. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Communicating Through New Platforms PCORI Channel on YouTube •  Videos of Board meetings, workshops, webinars •  >9,000 views of 49 videos uploaded 16
  56. 56. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Telling Our Story PCORI’s  work  has  been  featured  in  dozens  of  reports  in  health   policy  and  top  naRonal  news  outlets,  as  well  as  major  journals    
  57. 57. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tracking Growth of @PCORI 18 TwiMer  follower  volume    (six-­‐month  snapshot)     Tweets  by  month   (via  tweetstats.com)     Total PCORI Twitter Impressions (Feb-Aug): 7.6 Million
  58. 58. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Future Opportunities 19 •  Refine our messaging as we build our research portfolio •  Develop a plan and structure in partnership with AHRQ for research dissemination efforts •  Mine programmatic efforts to show what we are learning; use more effective storytelling to make that work meaningful and “real” •  Continue to upgrade our infrastructure •  Review the CER/PCOR landscape to assess opportunities for collaboration in advancing our communications goals, focusing on our leadership in “research done differently” •  Take a strategic approach to speaking/publishing opportunities
  59. 59. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Questions to Consider 20 •  How can we best refine our messaging as we build our research portfolio? •  What critical lessons do we want to impart from our research to date? •  What kinds of “stories” might we use to make our work “real” to our stakeholders and show how “research done differently” benefits them? •  How can we best collaborate with and leverage the work of others in the CER/PCOR space to advance our communications goals?
  60. 60. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Board of Governors Meeting Washington, DC September 24, 2012 Anne Beal, MD, MPH, Chief Operating Officer Sue Sheridan, Acting Director, Patient Engagement Susan Hildebrandt, Director, Stakeholder Engagement Sharon Levine, Chair, COEC PCORI Advisory Panels
  61. 61. Questions for Board Consideration 1   Is  this  the  right  scope  for  advisory  panel  ac4vi4es?   2   Please  comment  on  the  proposed  number  and  type  of  panels.   2  
  62. 62. Advisory Panels: What the Law Says •  The Institute may appoint permanent or ad hoc expert advisory panels as determined appropriate to assist in identifying research priorities and establishing the research project agenda •  The Institute shall appoint expert advisory panels in carrying out randomized clinical trials under the research project agenda •  In the case of a research study for rare disease, the Institute shall appoint an expert advisory panel 3  
  63. 63. Advisory Panels: Purpose •  Advisory Panels will assist PCORI staff and Board in: –  Modeling robust patient and stakeholder engagement efforts, –  Refining and prioritizing specific research questions, –  Providing other scientific or technical expertise –  Addressing other questions that may arise relevant to PCORI’s mission and work 4  
  64. 64. Advisory Panels: Framework •  Each Advisory Panel will have –  A unique charter and duration –  Clearly defined scope of work •  Membership on each Advisory Panel will be based on ensuring those with appropriate expertise are selected to satisfy the scope of work established in its charter –  We are developing a plan for compensation of members 5  
  65. 65. Proposed Advisory Panels •  Patient Engagement •  Assessment of Prevention, Diagnosis and Treatment Options •  Health Disparities •  Improving Healthcare Systems •  Communication and Dissemination •  Infrastructure* •  Randomized Clinical Trials* •  Rare Diseases 6   *in  collabora4on  with  MC  
  66. 66. Pa&ent  Engagement   Assessment  of  Preven&on,  Diagnosis,  and  Treatment  Op&ons     Health  Dispari&es   Improving  Health  Care  Systems   First Panels: First Half of 2013 7  
  67. 67. Communica&on  and  Dissemina&on   Infrastructure   Randomized  Clinical  Trials*   Rare  Diseases*   Future Panels: Second Half of 2013 8   *Required by statute
  68. 68. Advisory Panels: What the Law Says An expert advisory panel shall include representatives of practicing and research clinicians, patients, and experts in scientific and health services research, health services delivery, and evidence-based medicine who have experience in the relevant topic and, as appropriate, experts in integrative health and primary prevention strategies. 9  
  69. 69. Composition •  Advisory Panel size will be 10-21 panel members, depending on the panel’s purpose •  Membership of each Advisory Panel will be selected based on the scope of work established in the charter 10  
  70. 70. Composition (continued) •  Panel may have a non-voting liaison from the PCORI Board of Governors or Methodology Committee as appropriate •  An Advisory Panel Chairperson will be selected from among the Panel members by the PCORI Board of Governors •  Members will be appointed for 1-year terms, with an opportunity for reappointment 11  
  71. 71. Conflict of Interest •  PCORI will consider implications for panel members’ eligibility for future PCORI funding in creating Advisory Panels –  The role will be advisory and participation will not affect eligibility for funding –  We will have firewalls similar to those surrounding the Methodology Committee regarding access to information –  Advise members before appointment about potential impact on eligibility for PCORI funding if they might receive non-public information –  Explore options to promote transparency of proceedings •  We will clarify that Advisory Panels’ roles are to provide input to the Board and staff, not to make decisions 12  
  72. 72. •  Board,  MC,  and/or   PCORI  staff  iden4fy   the  need  to  establish   an  Advisory  Panel   •  Staff  ini4ates  request   for  an  advisory  panel   by  submiRng  a   panel-­‐specific  charter   •  Board  may  authorize   charter  (proceed  to   step  3)   •  Board  may  request   revisions  to  the   charter  (return  to   step  1)   •  Staff  ini4ates  open   call  for  nomina4ons,   via  the  PCORI  Web   site  and  other   communica4ons   •  Nominees  submit  an   expression  of   interest,  via  the   PCORI  Web  site   •  Staff  evaluates   nominees,  per   evalua4on  criteria   unique  to  the  panel   charter     •  Staff  selects  and   proposes  a  panel   roster  to  the  Board   •  Board  authorizes   and  approves  the   panel  roster   Advisory Panel Establishment Process Staff    Ac&vates   Nomina&on  and   Selec&on  of  Panel   Par&cipants   Board  Approves   Panel  Par&cipants     Staff  DraI  and   Submit  Charter  for   an  Advisory  Panel   Board  Reviews  the   Proposed  Advisory   Panel  Charter   1 2 3 4 Staff Phase Board Phase 13  
  73. 73. Pa&ent  Engagement   Assessment  of  Preven&on,  Diagnosis,  and  Treatment  Op&ons     Health  Dispari&es   Improving  Health  Care  Systems   First Panels: First Half of 2013 14  
  74. 74. Proposed Panel: Patient Engagement •  Purpose: Assure the highest patient engagement standards and patient-centeredness in all aspects of PCORI’s work •  Term: 1 year •  Membership: Between 10–21 members with 75% patients, caregivers, and advocacy organizations and 25% researchers and other stakeholders •  Advisory Panels will provide advice and make recommendations to PCORI and help inform decisions of the Board of Governors, the Methodology Committee, and Institute staff, as requested 15  
  75. 75. Proposed Panel: Patient Engagement Selec&on   Criteria   •  Pa&ents  and  caregivers  who  can  represent  the   collec&ve  voice  of  their  communi&es/networks   •  Online  communi&es  and  organiza&ons  with  extensive   reach  into  high  priority  popula&ons   •  Represent  underserved/disparate  popula&ons  and   those  with  rare  diseases   •  Experience  in  pa&ent-­‐centered  research/proposal   review   •  Involvement  in  systems  improvement   •  Community-­‐  or  state-­‐based   16  
  76. 76. Questions for Board Consideration 1   Is  this  the  right  scope  for  advisory  panel  ac4vi4es?   2   Please  comment  on  the  proposed  number  and  type  of  panels.   17  
  77. 77. BOARD VOTE: Recommend Approval to Develop Advisory Panels •  Patient Engagement •  Assessment of Prevention, Diagnosis and Treatment Options •  Health Disparities •  Improving Health Care Systems
  78. 78. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Board of Governors Meeting Washington, DC September 24, 2012 Sue Sheridan, Acting Director, Patient Engagement Susan Hildebrandt, Director, Stakeholder Engagement Anne Beal, MD, MPH, Chief Operating Officer Sharon Levine, MD, Chair, COEC Engagement Update
  79. 79. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Engagement: Questions to Consider 1   • What  recommenda.ons  does  the  Board  have  for  reaching  stakeholders  who   may  not  be  part  of  established  networks  and  are  more  difficult  to  reach?   2   • What  are  the  measures  of  success  in  engaging  pa.ents,  caregivers,  and   stakeholders  that  the  Board  would  like  to  see  in  the  next  12  months?   3   • How  do  we  demonstrate  and  lead  “research  done  differently”  for  pa.ents,   caregivers,  stakeholders,  and  the  research  community?     2
  80. 80. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Presentation Outline •  Review of Strategic Priorities •  Engagement “Touch Points” in the PCOR Process •  Workshops 3
  81. 81. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Engagement Priorities 1.  To invite, value, and use the wisdom and experience of patients, caregivers, and other stakeholders nationwide in the PCORI research enterprise; eliminate barriers to participation 2.  Establish a community of trained and informed patients and caregivers as valued partners who participate in all stages of the research enterprise 3.  Communicate transparently and regularly about PCORI’s approach and methods for prioritization, decision making, and funding to all stakeholders to create trust 4.  Evaluate and refine patient engagement processes to continuously learn and incorporate best practices and methods for developing a robust and engaged community of stakeholders in PCORI work •  PCORI Strategic Plan 4
  82. 82. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Advise Us as to What PCORI Should Study: Tell Us How We Are Doing Review Proposals and Partner in Research Help Us Share the Findings Patients and Stakeholders Patient and Stakeholder Engagement in Patient-Centered Outcomes Research 5 What questions are most important? (research prioritization) What outcomes should be studied? (topic generation) Review research proposals for impact and patient-centeredness Participate in conducting research How can we improve on what we are doing and how we are doing it? How do we best communicate important research findings?
  83. 83. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient View on Engagement in Research 6
  84. 84. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tell Us What PCORI Should Study •  Conduct patient and stakeholder testing of content and language on topic generation Web page •  Solicit research topics in patient and stakeholder meetings and PCORI roundtables •  Host workshops •  Patient Workshop (October 27-28) •  Stakeholder Workshop (December 4) •  Prioritization Workshop (December 5) 7
  85. 85. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Review Proposals and Partner in Research •  Revamped pilot projects reviewer recruitment process •  Created a user-friendly application and process •  Reached out to extensive lists of key stakeholders •  Vetted reviewer applications in-house •  Contracted with expert vendor to develop merit review training specifically for patients and other stakeholders •  Will engage patients and stakeholders in process improvement cycle 8
  86. 86. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E •  Patients and stakeholders will be one-third of review panels •  350 total applicants •  242 with prior grant review experience •  102 from patient community •  140 from stakeholder community •  58 selected in final vetting •  Based on balanced criteria •  Goal is to build a database of lay reviewers of PCORI funding applications Patient and Stakeholder Reviewers Patient, 25 Nurse, 3Physician, 5 Clinician or Provider Association Rep, 4 Researcher, 5 Other Stakeholders,16 9
  87. 87. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient and Stakeholder Reviewers 8   7   6   4   3   2   1   10
  88. 88. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E “This is exciting and will lead to positive outcomes.” “17-year breast cancer survivor and want to see an end to the disease.” “Need to find ways to optimize healthcare system.” “Need for more research to meet current needs of patients.”“Served as a PCORI reviewer and experience was fascinating." “Stakeholder engagement is essential to relevant and useful research and evaluation: from identification of study questions to dissemination and utilization of findings.” “Need to get patients' perspective and find ways to get them involved.” “First time patient’s voice is being formalized.” "I want do my part as a patient, and I will be honored with this opportunity.” "It's about time this is happening in healthcare.” “Want to give back Expertise, and this is a great learning opportunity.” Source: Patient and Stakeholder Interviews. August 2012 What We Heard From Reviewers 11
  89. 89. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Create   Communi.es   Engage   Meaningfully     Share  and   Adopt  Latest   Informa.on   12 Help Us Spread the Word
  90. 90. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Stakeholder View on Dissemination 13
  91. 91. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Pa.ents   14 Tell Us How We Are Doing
  92. 92. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient Workshop: Objectives Transforming Patient-Centered Research: Building Partnerships and Promising Models (October 27-28: Washington, DC) •  Launch the creation of an informed and engaged community •  Create consensus recommendations for patient engagement in –  Generating and prioritizing research questions –  Reviewing research proposals and the conduct of research –  Disseminating and implementing research findings –  Evaluating the success of PCORI’s engagement efforts •  Write a “thought piece” on promising practices in patient engagement in research 15
  93. 93. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient Workshop: Selection Criteria •  Invitation list developed with the goal of inclusiveness •  Balance sought between and among disease incidence, prevalence, burden, and disparities in the United States (with emphasis on chronic conditions) •  Total attendance will be limited to 150 participants –  75% of participants will be patients, patient advocates, caregivers, and individuals from patient/caregiver advocacy organizations –  25% of participants will be a mix of PCORI’s other stakeholders 16
  94. 94. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Stakeholder Workshop: Objectives What Should PCORI Study? A Call for Topics From Patients and Stakeholders (December 4: Washington, DC) •  Solicit research topics for specific funding announcements using breakout sessions on PCORI’s priority areas and generate list •  Report on draft prioritization process (topic of December 5 workshop), allow participants to experiment with applying it to their topics, and solicit feedback on the process •  Report on Patient Engagement Workshop participants’ reactions to PCORI’s engagement strategies and to seek additional input 17
  95. 95. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Stakeholder Workshop: Other Criteria Specific Experience With: •  Research or work in PCORI Priority Areas •  Leadership in PCORI Priority Areas •  The health policy or research communities •  Broad membership or responsibility for health care delivery 18
  96. 96. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E What’s Next •  Advisory Panels •  Additional Workshops •  State-Based Events 19
  97. 97. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Engagement: Questions to Consider 1   • What  recommenda.ons  does  the  Board  have  for  reaching  stakeholders  who   may  not  be  part  of  established  networks  and  are  more  difficult  to  reach?   2   • What  are  the  measures  of  success  in  engaging  pa.ents,  caregivers,  and   stakeholders  that  the  Board  would  like  to  see  in  the  next  12  months?   3   • How  do  we  demonstrate  and  lead  “research  done  differently”  for  pa.ents,   caregivers,  stakeholders,  and  the  research  community?     20
  98. 98. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E •  Appendix A: Patient Engagement Workshop Outline •  Appendix B: Patient Engagement Workshop Timeline •  Appendix C: Stakeholder Engagement Workshop Outline •  Appendix D: Organizations Contacted 21 Appendix
  99. 99. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient-Centered Outcomes Research Institute Executive Director’s Welcome PCORI Board of Governors Meeting Washington, DC September 24, 2012 Joe V. Selby, MD, MPH, Executive Director
  100. 100. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E New  PCORI  Staff  –  since  May  2012     Kara Odom-Walker Scientist August 13, 2012 Katie Wilson Project Associate June 11, 2012 Orlando Gonzales Chief of Staff August 1, 2012 Michele Orza Senior Advisor to the Executive Director September 4, 2012 Gregory Martin Deputy Director, Stakeholder Engagement July 23, 2012 James Hulbert Contracts Administrator September 10, 2012 Marla Bolotsky Associate Director, Digital Media September 5, 2012 Ayodola Anise Project Associate August 13, 2012 Kelton Chapman Assistant Manager, Meetings and Special Events May 29, 2012 Not  Shown:     Lorraine  Bell,  Senior  Program  Associate  –  May  29,  2012   Desiree  Frank,  ExecuEve  Assistant  to  the  ExecuEve  Director  –  June  19,  2012   Kimberly  Holloway,  Senior  AdministraEve  Assistant  –  August  27,  2012   David  Hickam,  ScienEfic  Program  Leader,  Health  System  Research  –  September  17,  2012   Jordan  Elliker,  Project  Events  Coordinator  –  September  19,  2012  
  101. 101. PCORI  PILOT  PROJECTS  (PPP)       •  50  projects  funded  (of  856);  mostly  2-­‐years  in  length   •  $31  million  total  funding  
  102. 102. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Funded  PCORI  Pilot  Projects  in  25  States  and  DC   4  
  103. 103. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Pilot Projects Areas of Interest Area  of  Interest   SubmiKed   Funded   Informing  PCORI  naEonal  prioriEes   21   2   Bringing  together  paEents,  caregivers,  and  other  stakeholders  in   all  stages  of  a  research  process   80   1   TranslaEng  evidence  into  health  care  pracEce  in  ways  that   account  for  individual  paEent  preferences  for  various  outcomes,   including  decision-­‐support  tools   180   19   CollecEng  and  assessing  paEent-­‐  and  provider-­‐perceived  gaps  in   evidence   26   0   IdenEfying,  tesEng,  and/or  evaluaEng  paEent-­‐centered   outcomes  instruments   214   11   Assessing  the  paEent  perspecEve  when  researching  behaviors,   lifestyles,  and  choices   31   5   Studying  paEent  care  team  interacEons  in  situaEons  where   mulEple  opEons  exist   45   6   AnalyEcal  methods  for  CER   170   6  
  104. 104. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Types of Organization Primes   Subcontractors   Overview:    All  ApplicaOons   Type   Primes   Subs   Funded   Academic   561   235   38   Hospitals   80   98   4   Research  organizaEons   55   49   3   Non-­‐profit  health  systems   28   54   2   Community-­‐based  health   centers   20   46   0   Consultants   18   32   1   Provider  associaEons   16   19   0   PaEent  associaEons   10   40   1   Non-­‐profit  foundaEons   9   24   1   Technology  organizaEons   7   25   0   Government   5   16   0   For-­‐profit  health  benefits   2   0   0   For-­‐profit  pharmaceuEcal     1   2   0   Other     0   52   0   6  
  105. 105. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Target Populations – Applicants & Awardees 0%   10%   20%   30%   40%   50%   60%   Percent  of  Total  ApplicaOons   Total  ApplicaOons  by  Target   PopulaOon   PopulaOon   All   Funded   Underserved   453   30   Specific  Ethnic     or  Cultural   243   21   Disabled   163   12   Urban  &  Rural   383   28   Only  Urban   188   14   Only  Rural   22   1   Unspecified   224   8  
  106. 106. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Monitoring  the  Pilot  Projects   Two-year competitive contract awarded to AcademyHealth (A Rein, PI) to do the following: §  Work closely with PCORI to monitor the 50 pilot projects for achievement of specific aims §  Assess learnings on patient engagement in research from all 50 projects §  Identify 5 subgroups with common themes, convene and create joint products within each thematic area 8  
  107. 107. PCORI  FUNDING   ANNOUNCEMENT  APPLICATIONS       •  483  applicaEons  received   •  Review  process  underway   •  ~  100  awards  expected  in  December  2012  
  108. 108. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E DescripOon  of  ApplicaOons  Received   Top  15  States  Applying   483  applicaOons  received   ApplicaOons  by  PFA   71,  15%   211,  44%   92,  19%   109,  22%   Addressing  DispariEes   Assessment  of  PrevenEon,  Diagnosis,  and  Treatment  OpEons   CommunicaEon  and  DisseminaEon  Research   Improving  Healthcare  Systems   0   10   20   30   40   50   60   CA   PA   MA   NY   MN   TX   WA   FL   NC   MD   MI   IL   GA   OH   IA  
  109. 109. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E MenOon  of  Specific  CondiOons   MulEple  condiEons  and  study  designs  may   0   50   100   150   200   250   300   Number  of  ApplicaEons  
  110. 110. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Study  Designs  Noted  in  ApplicaOons     0   10   20   30   40   50   60   70   80   90   Priority  #1:    Assessment  of  PrevenOon,  Diagnosis,  and  Treatment   OpOons  (n=211  applicaOons)    
  111. 111. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E 0   10   20   30   40   50   60   70   80   Disabled   Persons   Elderly   Other   Pediatric   Racial  or   Ethnic  Group   Rural   Urban   Veterans   Women   Priority  #1:  Assessment  of  PrevenOon,  Diagnosis,  and     Treatment  OpOons  (n=211  applicaOons)   Study  PopulaOons  Noted  in  ApplicaOons     Number  of  ApplicaEons  
  112. 112. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Reviewers   Volunteers   Total   Applicants   First     Round   Second     Round   Technical  Reviewers   800+   483*   75-­‐100   PaEent  Reviewers   225   -­‐-­‐   25   Stakeholder  Reviewers   225   25   Commimee  Chairs   -­‐-­‐   10  
  113. 113. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI’s  8  Review  Criteria   1.  Impact of the Condition 2.  Innovation and Potential for Improvement 3.  Impact on Healthcare Performance 4.  Patient-Centeredness 5.  Rigorous Research Methods 6.  Inclusiveness of Different Populations 7.  Team and Environment 8.  Efficient Use of Resources 15  
  114. 114. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Agenda  for  Today’s  MeeOng   PaEent  and  Stakeholder  Engagement   PrioriEzaEon  of  Research  Topics   Advisory  Panels   Conflict  of  Interest  Policy  and  Plan  for  Methodology  Commimee   PCORI  Funding  Announcement  5A  -­‐  Methods   Methodology  Commimee  Public  Comment     2012  Budget   CommunicaEons  Update  
  115. 115. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E •  Appendix A: PICORI Pilot Projects Update 17   Appendix
  116. 116. 1 Finance, Audit, and Administrative Committee (FAAC) Report PCORI Board of Governors Washington, DC September 24, 2012 Kerry Barnett, JD, Chair Anne Beal, MD, MPH, COO Pamela Goodnow, Director of Finance
  117. 117. 2 •  Unaudited Financial Statements ~ Results of Operations •  Revised 2012 Budget •  Budget Assumptions •  Cash Flow Appendix •  Financial Statements •  CBO Updated Estimate for the Insurance Coverage Provisions of the Affordable Care Act Agenda
  118. 118. 3 Results of Operations Unaudited Financial Statements The GFY 2013 Appropriation of $150 million will be received on October 1, 2012, and will be taken into Operating Revenue at that time. UNAUDITED JUNE  30,  2012 OPERATING REVENUE $0 Program Expenses Communication and Engagement 1,435,365 Research 1,888,897 Methodology 3,054,947 Total Program Expenses 6,379,209 Administrative Expenses Board 739,262 Management and General 3,312,271 Total Administrative Expenses 4,051,533 35,190 NET INCOME (LOSS) ($10,395,552) Non-operating Interest Income
  119. 119. 4 Unaudited June 30, 2012 Revised 2012 Budget The Board approved the 2012 budget subject to mid-year corrections. UNAUDITED PROJECTED   REVISED JUNE  30,  2012 3Q/4Q BUDGET OPERATING REVENUE $0 $120,000,000 $120,000,000 Program Expenses Communication and Engagement 1,435,365 4,347,026 5,782,391 Research 1,888,897 7,701,268 9,590,165 Methodology 3,054,947 3,002,344 6,057,291 Total Program Expenses 6,379,209 15,050,637 21,429,846 Administrative Expenses Board 739,262 1,414,026 2,153,288 Management and General 3,312,271 3,274,663 6,586,934 Total Administrative Expenses 4,051,533 4,688,689 8,740,222 35,190 37,500 72,690 NET INCOME (LOSS) ($10,395,552) $100,298,174 $89,902,622 [1] [1]     There  will  be  $96  million  awarded  for  research  in  November  2012. Non-operating Interest Income
  120. 120. 5     Budget Assumptions $320 million estimated for GFY 2013 less HHS/AHRQ Revenue Projections PCORI receives $120 million in direct appropriation Partial year collected on covered lives for PCOR fee on health plan providers and the self-insured IRS will collect the fee annually on the Quarterly Federal Excise Tax Return Form 720 due July 31 of the following year PCORI receives $28 million between August 15, and October 15, 2013 Partial year collected on covered lives for PCOR fee on Medicare/Medicaid/CHIP PCORI receives $6 million on July 31, 2013; actual timing unknown
  121. 121. 6 Net Revenue (Dollars in millions) Cash Flow 2012 2013 CASH  BALANCE $162 $241 Appropriation $150 $150 PCOR  Fee 0 34 Subtotal 150 184 Less  AHRQ/HHS (30) (37) Less  Program  and  Operating  Expenses   (30) (41) Net  Revenue $90 $106 Research  Contract  Commitments $127 $300 Research  Outflows 2012 ($11) ($21) 2013 (139) Total    Outflows ($11) ($160) CASH  BALANCE $241 $188
  122. 122. 7 Appendix •  Financial Statements •  CBO Updated Estimate for the Insurance Coverage Provisions of the Affordable Care Act
  123. 123. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 1   PCORI Board of Governors Meeting Washington, DC September 25, 2012 Rick Kuntz, MD, Member, PCORI Board of Governors, Chair, Program Development Committee PCORI Funding Announcement 5B: Infrastructure
  124. 124. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 2   Strategic  Ques-ons  Around  Infrastructure  PFA   1.  Feedback  on  feasibility,  opportunity  for  a   “hybrid”  approach  to  Infrastructure  PFA   2.  Strategic  considera@ons  for  an  Itera@ve,   Progressive  PFA  Process  
  125. 125. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 3   Two  Dis-nct  (and  Complementary)  Approaches  Emerge    from  Palo  Alto     PCORI  Na-onal  Workshop  to   Advance  Use  of  Electronic  Data   Clinical Data Research Network (CDRN) Patient-Powered Research Network (PPRN)
  126. 126. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 4   Infrastructure  Subgroup  Is  Formed   Program  Development   CommiJee  Members  and  Guests   •  Carolyn  Clancy   •  Francis  Collins   •  Arnie  Epstein   •  Sherine  Gabriel   •  Chris@ne  Goertz   •  Leah  Hole-­‐Curry   •  Gail  Hunt   •  Harlan  Krumholz   •  Rick  Kuntz   •  Mike  Lauer   •  Nancy  Miller   •  Jean  Slutsky   PCORI  Execu-ve   Leadership  and  Staff   •  Joe  Selby   •  Ka@e  Wilson  (Project   Management)  
  127. 127. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 5   An  Itera-ve,  Strategic  Proposal  for  Funding     Proposed  Progression  of  PFAs   Phase  One   Phase  Two   PFA  #1:     Clinical  Data  Research   Network   Answers  Ques*on:     Can  direct  involvement  of   pa@ents  improve  the   efficiency  and   effec@veness  of  large   data  networks  for   conduc@ng  clinical   research?   PFA  #2:     Pa@ent-­‐Powered   Research  Network   Answers  Ques*on:     Can  pa@ent  organiza@ons   and  networks  play  a   leading  role  in   compara@ve   effec@veness  research?   PFA  #3:     Pa@ent-­‐Centered   Outcomes  Research   Network  (PCORNet)   Builds  on  PFAs  #1  &  #2:     With  a  stable  founda@on   for  the  conduct  of  many   different  research  studies,   now  the  projects  need  to   be  defined;  may  include   coordina@ng/convening   center  award  
  128. 128. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 6   Phase  One:  Clinical  Data  Research  Network  (1  of  3)   Funding  Opportunity   Invite  consor@a  of  mul@ple  health  services  organiza@ons  to  apply  for   support  of  research  infrastructure:   •  Goal  #1:  build  large  interoperable  network(s)  capable  of  suppor@ng  large   scale  compara@ve  effec@veness  trials  of  mul@ple  research  ques@ons,   including  preven@on  and  treatment,  at  low  marginal  cost,  with   substan@ve  pa@ent  involvement  throughout   •  Goal  #2:  embed  research  ac@vity  within  a  func@oning  health  care  system   without  disrup@ng  the  business  of  providing  health  care;  thus,  business   case  for  the  health  care  system  to  par@cipate  must  be  addressed     •  Goal  #3:  demonstrate  ability  to  mobilize  and  engage  substan@al  pa@ent   popula@ons  within  the  covered  popula@on  for  at  least  three  condi@ons   •  Goal  #4:  ensure  health  care  organiza@on  leaders  have  meaningful  role  in   governance,  including  a  voice  in  iden@fying  meaningful  research   priori@es  for  their  organiza@on  
  129. 129. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 7   Phase  One:  Clinical  Data  Research  Network  (2  of  3)   Criteria   1.  Pa@ent,  provider,  and  health  system  involvement  at  all  levels  of  consor@um  design,   implementa@on,  governance,  and  use   2.  Health  care  organiza@on  leaders  must  have  a  voice  in  research  priori@es  (discouraging   studies  that  are  not  feasible,  iden@fying  meaningful  ques@ons  for  their  organiza@ons)   3.  Access  to  at  least  1,000,000  pa@ents   4.  Poten@al  for  longitudinal  follow  up  across  care  sefngs   5.  Diversity  in  age,  gender,  socioeconomic  status,  race/ethnicity   6.  Ability  to  obtain  informed  consent,  using  central  IRB   7.  Ability  to  establish  at  least  three  disease-­‐specific  cohorts  that  achieve  par@cipa@on  of   pa@ents  within  the  network,  but  also  include  outreach  to  established  pa@ent  networks   focused  on  those  same  disorders  (see  PFA  #2)   8.  Electronic  health  records  with  meaningful  use  for  research   9.  Buy-­‐in  and  ac@ve  par@cipa@on  from  the  health  care  system(s)  in  which  care  is  delivered   10.  Ability  to  conduct  observa@onal  and  interven@onal  (individual  or  cluster  randomized)  trials   11.  Data  access  policies  that  promote  broad  research  use  but  protect  privacy,  confiden@ality   12.  Poten@al  to  obtain  and  store  biological  specimens  
  130. 130. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 8   Phase  One:  Clinical  Data  Research  Network  (3  of  3)   Allowable  Items  to  Include  in  Proposal  and  Budget  Request   •  Permanent  research  staff  support   •  Incen@ves  for  the  health  system  to  support  embedded  research  in  the  system   •  Pa@ent  network  outreach  coordinator   •  Communica@on  staff   •  Establishment  of  IT  connec@vity  between  consor@um  members   •  Costs  of  consent  for  research   •  Pilot  research  studies,  ideally  in  partnership  with  relevant  pa@ent  groups   •  Biobank  costs   •  Pa@ent  surveys  to  assess  interest  in:     o  Genera@ng  research  ques@ons   o  Using  the  database   o  Ability  to  communicate  with  other  pa@ents   o  Providing  pa@ent-­‐reported  informa@on   o  Par@cipa@ng  in  appropriate  RCTs  
  131. 131. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 9   Phase  One:  Pa-ent-­‐Powered  Research  Network  (1  of  3)   Funding  Opportunity   Invite  pa@ent-­‐centered  organiza@ons  with  specific  disease  or  condi@on   focus  to  apply  for  support:   •  Goal:  ini@ally  to  provide  pilot  funding  to  help  groups  organize  and   develop  the  necessary  infrastructure  to  define  the  most  important   pa@ent-­‐centered  research  ques@ons  and  to  prepare  for  vigorous,   broad  par@cipa@on;     •  Goal  (latent  objec@ve):  increase  access  to  partnership  and   par@cipa@on  in  research  for  a  broadly  diverse  popula@on  of   individuals  with  common  health  issues      
  132. 132. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 10   Phase  One:  Pa-ent-­‐Powered  Research  Network  (2  of  3)   Criteria   1.  Applicant  group  must  demonstrate  that  they  are  considered  credible  and   effec@ve  by  those  with  the  condi@on   2.  Must  represent  a  substan@al  number  of  affected  individuals,  ideally  with   diversity  in  demographics  and  disease  severity,  and  with  long  term   involvement  of  most  par@cipants,  as  appropriate  given  the  condi@on   3.  Group  leadership  must  be  representa@ve  in  some  way  and  be  able  to  receive   and  act  upon  broad  input  of  affected  individuals,  reflec@ng  their  needs  and   have  processes  in  place  to  nego@ate  divergent  opinions   4.  Must  have  sufficient  administra@ve  and  financial  accoun@ng  structures  to  be   able  to  receive  and  account  for  grant  funds  (PCORI  staff  may  need  to  help   here)   5.  Must  have  interest  in  and  capacity  to  expand  membership  to  include   historically  under-­‐represented  pa@ent  groups  with  the  condi@on  
  133. 133. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 11   Phase  One:  Pa-ent-­‐Powered  Research  Network  (3  of  3)   Allowable  Items  to  Include  in  Proposal  and  Budget  Request   •  Staff  support  to  build  and  expand  network  of  affected  individuals,  establish  databases   •  Administra@ve  staff  for  grants  management  and  grant  prepara@on   •  Infrastructure  support  to  enhance  interac@ve  communica@on  with  pa@ents  and  caregivers   •  Funds  for  workshops  to  convene  pa@ents,  clinicians,  and  other  stakeholders,  to  iden@fy  the   most  important  research  ques@ons   •  Funds  to  address  approaches  to  obtaining  clinical  electronic  health  record  data  on  pa@ents   in  the  group   •  Funds  for  outreach  and  enrollment  of  pa@ents  from  tradi@onally  under-­‐representa@ve   popula@ons   •  Pa@ent  surveys  to  assess  the  demographic  and  clinical  characteris@cs  of  enlisted  pa@ents   and  to  study  their  interest  in:   o  Genera@ng  research  ques@ons   o  Using  the  database   o  Ability  to  communicate  with  other  pa@ents   o  Providing  pa@ent-­‐reported  informa@on   o  Par@cipa@ng  in  appropriate  RCTs  
  134. 134. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 12   Phase  Two:  Research  Projects   •  Disease-­‐specific  applica-ons:     •  Ideally  come  jointly  from  a  PPRN  applicant  and  a  CDRN  applicant   •  PPRN:  Highly  mo@vated,  poten@ally  less  generalizable   •  CDRN:  Less  mo@vated,  poten@ally  more  representa@ve   •  Condi@ons  not  represented  by  a  PPRN  could  be  proposed  with  the  CDRN  Group   to  help  catalyze  such  a  group,  star@ng  with  their  own  members,  and  extending   more  broadly   •  Outside  inves-gators  could  apply  for  the  opportunity  to  run  observa@onal  or   interven@onal  research  studies  through  the  CDRN  and  PPRN,  ideally  focused  on   condi@ons  represented  by  the  PPRN   •  Applica-ons  focused  on  preven-on  strategies  might  need  to  come  from  an  CDRN,   or  from  an  outside  inves@gator  proposing  to  have  the  CDRN  conduct  the  study   •  Applica-ons  coming  from  health  care  organiza-ons  ensure  leaders  have   meaningful  role  in  governance,  including  a  voice  in  iden@fying  meaningful  research   priori@es  for  their  organiza@on   Pa-ent-­‐Centered  Outcomes  Research  Network  
  135. 135. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 13   Next  Steps   •  Finalize  Hybrid  Vision   •  Conduct  Inventory  of  Exis@ng  Pa@ent  Data  Networks  for   Feasibility  Planning,  Taxonomy  of  Networks   •  Release  First  Infrastructure  PFA  Q1,  2013  
  136. 136. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 14   Strategic  Ques-ons  Around  Infrastructure  PFA   1.  Feedback  on  feasibility,  opportunity  for  a   “hybrid”  approach  to  Infrastructure  PFA   2.  Strategic  considera@ons  for  an  Itera@ve,   Progressive  PFA  Process  
  137. 137. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 15   Strategic Document: PCORI Funding Opportunity 5b—Infrastructure for Research (document to be circulated) Appendix
  138. 138. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Board of Governors Meeting Washington, DC September 24, 2012 Debra J. Barksdale, PhD,RN, Chair, SPC Bill Silberg, Director of Communications Scientific Publications Subcommittee Update
  139. 139. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Planning and Managing Our Publishing Opportunities 2 •  Subcommittee activities, policies, and procedures •  Tracking the pipeline •  Coordination with COEC and AHRQ •  Strategic publishing plan •  Next steps •  Questions to consider
  140. 140. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Subcommittee Members 3 •  Debra J. Barksdale, Chair •  Harlan Krumholz •  Sharon-Lise Normand •  Alfred O. Berg •  Michael Lauer •  Anne Beal •  Joe Selby
  141. 141. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Questions to Consider 4 •  How can we more strategically generate ideas for PCORI- associated papers and other scientific communication opportunities? •  How might we improve our processes for helping to turn those ideas into realities? •  How should we develop and support policies designed to make our supported research as widely available as possible?
  142. 142. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Activities, Policies and Procedures 5 •  Facilitate the process of publication of papers written on behalf of PCORI o  Consider and approve manuscript ideas initiated by Board or MC members or staff and identify appropriate authors o  Review article requests from outside entities (ie, solicited by journals) o  Ensure no overlap with papers already in development. •  Manage courtesy review of papers not written on behalf of PCORI and apply disclaimer
  143. 143. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tracking the pipeline 6 •  Four PCORI-related papers published, one in review and one more cleared for submission •  Improvements to consider o  Prioritizing papers to improve turnaround time and follow-up o  More effective means of notifying the subcommittee of article ideas o  Plan for informing Board, MC and staff of published papers, tied to PCORI document delivery system to ensure broad access
  144. 144. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tracking the Pipeline Recent  publica-ons  of  note   7  
  145. 145. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Coordination With COEC and AHRQ 8 •  Coordination with COEC is critical to see that scientific publishing activities are appropriately aligned with PCORI’s broader communications, outreach, and engagement goals •  Coordination with AHRQ is critical to meet statutory requirements for dissemination of primary research results o  Develop plan for coordinating dissemination efforts o  Assess how best to interpret and meet “90-day rule” o  Determine how to best serve multiple audiences
  146. 146. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Strategic Publishing Plan 9 •  Proactively assess and take advantage of opportunities to pursue publishing activities that advance our goals •  Build relationships with key influencers – journal editors – to assist in dissemination, use, and impact of PCOR •  Seek ways to support new forms of scientific publishing and communication (blogs, multimedia) that will tell the story of our mission and supported research •  Support polices that provide broad and open access to PCORI-supported work •  Consider how subcommittee’s work might apply to consumer media
  147. 147. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Next Steps 10 •  Improve process for soliciting ideas for papers and other opportunities •  Address authorship issues (eg, “corporate authorship”) •  Assess subcommittee’s role in helping manage PCORI-related content other than scientific articles (eg, white papers, reports, blog posts) •  Consider how the subcommittee’s work might apply to consumer media •  Consider ways to better support workflow and prioritize/track articles •  Advise on PCORI policy on open access issues •  Formalize strategic publishing plan
  148. 148. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Questions to Consider 11 •  How can we more strategically generate ideas for PCORI-related papers and other scientific communication opportunities? •  How might we improve our processes for helping to turn those ideas into realities? •  How should we develop and support policies designed to make our supported research as widely available as possible?
  149. 149. Topic Generation and Research Prioritization Joe V. Selby, MD, MPH, Executive Director Rachael Fleurence, PhD, Scientist Rick Kuntz, MD, MSc, Chair, PDC PCORI Board of Governors Meeting Washington, DC 20008 September 24, 2012,
  150. 150. Strategic Questions to Consider •  Strategic  ques-ons  to  consider   •  Does the research prioritization process engage patients and stakeholders at the appropriate level? Is the process transparent and rigorous? •  Will the process enable PCORI to develop a balanced portfolio in line with its mission? •  Does the process enable the optimal level of engagement between the Board of Governors and Advisory Panels? 2
  151. 151. PCORI’s  Research  Agenda   Five  Board-­‐Approved  Priority  Areas   1.  Addressing  Dispari-es   2.  Communica-on  and   Dissemina-on   3.  Assessment  of  Preven-on,   Diagnosis,  and  Treatment  Op-ons   4.  Improving  Healthcare  Systems   5.  Infrastructure  and  Methods   3
  152. 152. Inves;gator-­‐Generated  Research  Just  One  Part  of  the  Process   PCORI  issues  broad   funding  announcements   Researchers  partner  with  stakeholders  to   generate  ques-ons   Researchers,  stakeholders  apply   review  criteria  in  their  applica-ons     Peer  review  priori-zes   applica-ons  by  level   of  alignment   with  criteria       2 Complementary Approaches for Developing PCORI’s National Research Agenda Diverse  Research  Por.olio  answering  key   ques7ons  for  pa7ents    and  clinicians     4
  153. 153. Pa;ent/Stakeholder-­‐Led  Approach   PCORI  and  stakeholders  generate  and  priori-ze  ques-ons   based  on  review  criteria   PCORI  issues  specific,  funding  announcements   for  highest  priority  topics   Researchers  and  stakeholders   develop  responsive  proposals   Peer  review  priori-zes   applica-ons  by  level   of  alignment   with  criteria       Patient/Stakeholder-Led Approach Unique to PCORI Diverse  Research  Por.olio  answering  key   ques7ons  for  pa7ents  and  clinicians     5
  154. 154. Building  on  the  Exis;ng  Evidence  Base                    and  Prior  Experience     Exis;ng  Scien;fic   Work  and  Literature   Methodology  CommiKee   and  Methodology  Report   Experience  of     Other  Agencies   6
  155. 155. PCORI’s Process Transparent, Rigorous Final  Selec-on  for   Specific  PFAs   (PCORI  Board)   Topic  Genera-on   (Through  Mul7ple  Modes)   Gap   Confirma-on   Research   Opportuni-es   Research   Priori-za-on   Pa;ents  &  Stakeholders:   • Web  Page   • Social  Media   • Workshops   PCORI:   • Con-nuous  PorTolio   Review   Other  agencies:   • AHRQ  gaps     • NIH  gaps   7
  156. 156. Phase 1: Topic Generation ü  Answer  a  clinical  ques-on  around  a   health  care  decision   ü  Be  compara-ve   ü  Not  be  related  to  cost/cost   effec-veness   ü  Align  with  at  least  one  of  PCORI’s   Na-onal  Priori-es  for  Research     PCORI  “Filter”—All   Nominated  Topics  Must:   Gap   Confirma;on   Topic     Nomina;on   •  Web  page     •  Social  media/marke-ng   •  In-­‐person  workshops,  focus  groups   •  Topic  genera-on  discussed  at   Pa-ent  and  Stakeholder   Workshops  in  the  Fall     •  AHRQ:  Future  Research  Needs  (FRNs)   Reports,  Systema-c  Gap  Review   •  Other  guidelines  development   processes  (such  as  NQF)   •  Gaps  iden-fied  by  NIH,  other  funding   agencies   •  Building  on  exis-ng  work  or  other   organiza-ons,  priori-za-on  exercises   (eg,  IOM  100)   Process  Begins  with  Pa7ents   and  Stakeholders   8
  157. 157. 9
  158. 158. Phase 2: Gap Confirmation AHRQ  Topic  Review  and   Disposi-on   Topics Provided to AHRQ for Gap Confirmation Answer  already   known,  or   research  underway     Potential Determinations Evidence  Synthesis   Needed   New  Primary   Research  Needed   In  collabora7on  with  AHRQ;  contract  under  development   Research   Priori-za-on   Dissemina-on   Next Steps 10
  159. 159. Phase 3: Research Prioritization Advisory  Panels   Pa7ents  and  Stakeholders     Board  of   Governors   Research   Priori-za-on   Process  Using     PCORI  Criteria   Preven-on,  Diagnosis,   Treatment  Op-ons   Communica-on   and  Dissemina-on   Dispari-es   Improving  Health   Care  Systems   Infrastructure  and   Methods   Rare  Diseases   Selected  From     Priori7zed  List   Crea7on     of  PFAs   Research  Ques7ons   Needing  Priori7za7on   ✔   ✔   ✔   ý   ý   ý   ý   ✔   ✔   ý   Priori7zed  List     of  Topics   1.  D   2.  D   3.  D   4.  D   5.  D   6.  D   7.  D   8.  D   9.  D   10.  d   11.  D   12.  D   13.  D   14.  D   15.  D   16.  D   17.  D   18.  D   19.  D   20.  d   11
  160. 160. Five Prioritization Criteria Adapted From PCORI Funding Criteria 2 Impact of the condition on the health of individuals and populations (prevalence, incidence, and other measures of burden of disease) 3 Potential for improvement: •  Are the differences in benefits between the interventions sufficient to warrant conducting a research study? •  Will the study reduce the uncertainty around the effect of the interventions? •  How likely are the findings to change practice? •  How long will the information be valid? 4 Potential for impact on health care performance 5 Potential for inclusiveness of different populations 1 Patient centeredness 12
  161. 161. Developing Topic Briefs for Prioritization of Questions Sample  PCORI  Topic  Brief   Each  Topic  Brief   explores  a   research   ques-on  for   which  a  gap  has   been  iden-fied   Topic  Brief  addresses  PCORI’s  criteria:  pa-ent   centeredness,    impact  of  disease,  poten-al   for  improvement,  etc.   13
  162. 162. Piloting the Process with Patients and Stakeholders The revised process will be used by Advisory Panels in Winter 2013 with topics generated from patients and stakeholders across the country. 1 2 3 4 Patients and stakeholders will participate in a pilot prioritization exercise using topic briefs and online tools. Participation will be by open application. The pilot group will convene via several teleconferences to discuss topic briefs and results of initial ranking exercises. The pilot group will meet in person to reach consensus on a final prioritized list, and to provide feedback to PCORI. The group will present at the December 5th workshop. 14
  163. 163. Research Prioritization Timeline Aug   Sep   Oct   Nov   Dec   Jan   Feb   Mar   PCORI  Science  Team  proposes   ini-al  RP  Process   Technical  Working  Group  tests/ provides  feedback  on  RP   Process;  supports  development   of  PCORI  RP    Process   Pa-ents,  Stakeholders  pilot  RP   process   Revised  Priori-za-on  Process   presented  at  PCORI  Methods   Workshop  December  5th   Pa-ent/Stakeholder  Advisory   Panel    training  on  Research   Priori-za-on  Methods   Advisory  Panels  conduct   Research  Priori-za-on  Process   for  nominated  topics  and   submit  to  the  Board   15
  164. 164. PCORI’s Research Prioritization Team PCORI Staff and Leadership: •  Joe Selby, Executive Director •  Rachael Fleurence, Scientist •  Katie Wilson, Project Management •  Natalie Wegener, Project Coordination Technical Working Group: •  Arnie Epstein (BoG) •  Gail Hunt (BoG) •  Neil Kirschner (Stakeholder Representative) •  David Meltzer (Methodology Committee) •  Linda Morgan, RPh, MBA (Patient Representative) •  Jean Slutsky (Methodology Committee) •  Clyde Yancy (Methodology Committee) Pilot Workshop Participants: •  Approximately 15-20 patients, stakeholders, researchers, and experts trained and prepared in PCORI’s research prioritization process 16
  165. 165. Summarizing PCORI’s Unique Approach to Research Prioritization Patients and stakeholders engaged in each step of a transparent process: •  Patients and stakeholders involved in developing the process, providing feedback, and members of the future Advisory Panels PCORI criteria for research prioritization: •  Criteria developed to achieve research that will improve patient’s health outcomes, is impactful, and has a high probability of changing clinical practice Transparency/visibility embedded in the process: •  Process shared with public for input and comment •  Pilot group open to applications •  Research prioritization methods workshop on December 5th broadcast via Web cast 17
  166. 166. Revisiting the Strategic Questions •  Does the research prioritization process engage patients and stakeholders at the appropriate level? Is the process transparent and rigorous? •  Will the process enable PCORI to develop a balanced portfolio in line with its mission? •  Does the process enable the optimal level of engagement between the Board of Governors and Advisory Panels? 18
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.

×