1. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Board of Governors Meeting Washington, DC September 24, 2012 Larry Becker, Chair, SCCOI and Member, Board of Governors Standing Committee on Conflict of Interest (SCCOI)

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 Todays Agenda 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORIFUNDING ANNOUNCEMENT APPLICATIONS 483applica+onsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 OPERATIONALIZINGTHECOI RULESFORTHEMETHODOLOGY COMMITTEE(MC) 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 PCORIs 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. 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. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Elements of PCORIs 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. 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. 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. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORIFUNDING ANNOUNCEMENT APPLICATIONS 483applica+onsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 NEXTSTEPS 13. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Next Steps Operationalizing the COI Rules for the MC Develop and adopt the COI policy regarding external parties (e.g., advisory panels, consultants) Implement the firewalls for the Methodology Committee Monitor and regularly review COI compliance Next Steps 13 14. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORIFUNDING ANNOUNCEMENT APPLICATIONS 483applica+onsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 DISCUSSION 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. 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. 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. 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. 3 PCORIFUNDING ANNOUNCEMENT APPLICATIONS 483applica+onsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 PUBLICCOMMENTAND ONGOINGOUTREACH 20. 4 ProfessionalJournalAr+cle andAds WhyMethodsMaGer Webinars SocialMedia TargetedOutreach NewsRelease Outreach efforts for MC report comment period 21. 5 PCORI blog columns and associated videos pushed to targeted email lists Why Methods Matter 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. 7 >850,000totalan+cipated impressions Exposuretonearly13,000subscribers throughaHealthAairse-alert Professional JournalAr+cles andAds Threeblogposts 671totalblogviews 150totalvideoviews WhyMethods MaGer Twowebinars >650totalaGendees Strongaudienceinterestindicatedby lowfall-orate Webinars PCORImen+oned5,753+mesin TwiGerandsocialmedia conversa+onsoverthelastsix months(mid-Aprilthroughmid- September) Es+mated7.4millionimpressions, reachingindividualsthroughavariety ofonlinemedia. SocialMedia Threee-mailblaststoopt-in stakeholderlist(~4,600names) Openandclick-throughratesabove industrynorms: Firstalert:43.8%and50.3% Secondalert:35.2%and37.3% Thirdalert:26.2%and22.2% Addi+onalalertto3,143researchers throughPCORIscontractspla`orm. Targeted Outreach Newsreleaserepublished244+mes Coverageincluded:ThePinkSheet; MedicalDeviceDaily;Government HealthIT;InsideHealthPolicy; BioCentury;andCQHealthbeat NewsRelease Measures of Reach 6,500 pageviews 1,600 reportdownloads *Asof9/19/2012 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% Idonotunderstand Iunderstand somewhat Ihavegood understanding RateyourunderstandingoftheprocesstheMC usedtogeneratestandards Before Afer *Actualresponsesfrombothwebinarscombined 25. 9 26. 10 Results VeGedby Pa+entPanel AIRConducts Analysisof Public Comments PCORI Collects Public Comments Deliverables PublicCommentAnalysisDeliveredtoMC TransparentCommentDisposi+onTable MCStandardsandReport PublicCommentProcess 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. 11 Researchers, 33% Other,17%Industry,16% Unspecied, 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% RespondentsbyStakeholderCategory Public Comment Results 8 9 10 11 16 20 23 124 0 20 40 60 80 100 120 140 #ofcomments CumulaYveCommentsReceived,byWeek 28. 12 CommentsbyStakeholderCategory Relatedtoa specic chapter 39% Relatedto reportasa whole 36% Unrelatedto thereport 17% Relatedtoa specic 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 CommentsbyType 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. 14 PCORIFUNDING ANNOUNCEMENT APPLICATIONS 483applica+onsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 ReviewandRevisionsofStandards/RecommendedAc+o FutureDirec+ons METHODOLOGYCOMMITTEE 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. 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. 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. 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. 19 Submissionto Board DraReport Posted Public Comment Period Analysisof Public Comment Revise Standards/ Recommende dAcYons basedon analysis Update Standards/ Recommended AcYons/ Comment DisposiYon Table May-Jul2012 Aug-Sep2012 Oct-Nov2012 7/23PublicComment PeriodBegins 10/31MCConsensuson ProposedRevisions 11/19BoardVoteto AcceptFinal 5/21 Approvedfor Pos+ng 9/14PublicComment PeriodEnds Review and Revision of Standards Timeline 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. 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. 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. 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. 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. 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. 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 PCORIs foundational pillars and the implementation of its strategic plan 43. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 4 PCORIs 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E A Communications Framework That Advances Our Goals 5 PCORIs Key Audiences Multiple stakeholders, but particularly patients, caregivers, researchers, clinicians, public and private payers and policymakers PCORIs 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. 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 PCORIs 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. 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. 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. 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. 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, PCORIs 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Funding Announcements (PFAs) PCORIs 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. 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 PCORIs 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. 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 SiteTrac Visits 53. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E 14 15e-mailalertssenttostakeholders Averagealertopenrateis40%(industrystandardis19%) Goal:Growopt-ine-maillistto10,000byendof2012 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 Subscribers2/1/2011 283Subscribers 9/19/2012 4,800Subscribers 54. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Convening: PCORI Events 15 Na8onalPa8entandStakeholderDialogue APendedby850peopleinpersonorbywebcastand teleconference;46publiccommentsprovidedatevent byrepresentaRvesofdiversestakeholdersegment. Na8onalWorkshoptoAdvanceUseofElectronicData Convenedaselectgroupofresearchersandthoughtleadersto developideasforhowPCORIcanfacilitatethecreaRonorfuncRon ofanaRonaldatainfrastructuretosupporthighqualitypaRent- centeredoutcomesresearch;300+aMendeesliveandviawebcast. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Telling Our Story PCORIsworkhasbeenfeaturedindozensofreportsinhealth policyandtopnaRonalnewsoutlets,aswellasmajorjournals 57. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tracking Growth of @PCORI 18 TwiMerfollowervolume (six-monthsnapshot) Tweetsbymonth (viatweetstats.com) Total PCORI Twitter Impressions (Feb-Aug): 7.6 Million 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. 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. 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. Questions for Board Consideration 1 Isthistherightscopeforadvisorypanelac4vi4es? 2 Pleasecommentontheproposednumberandtypeofpanels. 2 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. 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 PCORIs mission and work 4 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. 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 *incollabora4onwithMC 66. Pa&entEngagement AssessmentofPreven&on,Diagnosis,andTreatmentOp&ons HealthDispari&es ImprovingHealthCareSystems First Panels: First Half of 2013 7 67. Communica&onandDissemina&on Infrastructure RandomizedClinicalTrials* RareDiseases* Future Panels: Second Half of 2013 8 *Required by statute 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. Composition Advisory Panel size will be 10-21 panel members, depending on the panels purpose Membership of each Advisory Panel will be selected based on the scope of work established in the charter 10 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. 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. Board,MC,and/or PCORIstaiden4fy theneedtoestablish anAdvisoryPanel Staini4atesrequest foranadvisorypanel bysubmiRnga panel-speciccharter Boardmayauthorize charter(proceedto step3) Boardmayrequest revisionstothe charter(returnto step1) Staini4atesopen callfornomina4ons, viathePCORIWeb siteandother communica4ons Nomineessubmitan expressionof interest,viathe PCORIWebsite Staevaluates nominees,per evalua4oncriteria uniquetothepanel charter Staselectsand proposesapanel rostertotheBoard Boardauthorizes andapprovesthe panelroster Advisory Panel Establishment Process StaAc&vates Nomina&onand Selec&onofPanel Par&cipants BoardApproves PanelPar&cipants StaDraIand SubmitCharterfor anAdvisoryPanel BoardReviewsthe ProposedAdvisory PanelCharter 1 2 3 4 Staff Phase Board Phase 13 73. Pa&entEngagement AssessmentofPreven&on,Diagnosis,andTreatmentOp&ons HealthDispari&es ImprovingHealthCareSystems First Panels: First Half of 2013 14 74. Proposed Panel: Patient Engagement Purpose: Assure the highest patient engagement standards and patient-centeredness in all aspects of PCORIs work Term: 1 year Membership: Between 1021 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. Proposed Panel: Patient Engagement Selec&on Criteria Pa&entsandcaregiverswhocanrepresentthe collec&vevoiceoftheircommuni&es/networks Onlinecommuni&esandorganiza&onswithextensive reachintohighprioritypopula&ons Representunderserved/disparatepopula&onsand thosewithrarediseases Experienceinpa&ent-centeredresearch/proposal review Involvementinsystemsimprovement Community-orstate-based 16 76. Questions for Board Consideration 1 Isthistherightscopeforadvisorypanelac4vi4es? 2 Pleasecommentontheproposednumberandtypeofpanels. 17 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. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Engagement: Questions to Consider 1 Whatrecommenda.onsdoestheBoardhaveforreachingstakeholderswho maynotbepartofestablishednetworksandaremorediculttoreach? 2 Whatarethemeasuresofsuccessinengagingpa.ents,caregivers,and stakeholdersthattheBoardwouldliketoseeinthenext12months? 3 Howdowedemonstrateandleadresearchdonedierentlyforpa.ents, caregivers,stakeholders,andtheresearchcommunity? 2 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. 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 PCORIs 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. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient View on Engagement in Research 6 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. 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. 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. 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. 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 patients 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Create Communi.es Engage Meaningfully Shareand AdoptLatest Informa.on 12 Help Us Spread the Word 90. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Stakeholder View on Dissemination 13 91. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Pa.ents 14 Tell Us How We Are Doing 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 PCORIs engagement efforts Write a thought piece on promising practices in patient engagement in research 15 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 PCORIs other stakeholders 16 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 PCORIs 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 PCORIs engagement strategies and to seek additional input 17 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Whats Next Advisory Panels Additional Workshops State-Based Events 19 97. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Engagement: Questions to Consider 1 Whatrecommenda.onsdoestheBoardhaveforreachingstakeholderswho maynotbepartofestablishednetworksandaremorediculttoreach? 2 Whatarethemeasuresofsuccessinengagingpa.ents,caregivers,and stakeholdersthattheBoardwouldliketoseeinthenext12months? 3 Howdowedemonstrateandleadresearchdonedierentlyforpa.ents, caregivers,stakeholders,andtheresearchcommunity? 20 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Patient-Centered Outcomes Research Institute Executive Directors Welcome PCORI Board of Governors Meeting Washington, DC September 24, 2012 Joe V. Selby, MD, MPH, Executive Director 100. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E NewPCORIStasinceMay2012 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 NotShown: LorraineBell,SeniorProgramAssociateMay29,2012 DesireeFrank,ExecuEveAssistanttotheExecuEveDirectorJune19,2012 KimberlyHolloway,SeniorAdministraEveAssistantAugust27,2012 DavidHickam,ScienEcProgramLeader,HealthSystemResearchSeptember17,2012 JordanElliker,ProjectEventsCoordinatorSeptember19,2012 101. PCORIPILOTPROJECTS(PPP) 50projectsfunded(of856);mostly2-yearsinlength $31milliontotalfunding 102. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E FundedPCORIPilotProjectsin25StatesandDC 4 103. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORI Pilot Projects Areas of Interest AreaofInterest SubmiKed Funded InformingPCORInaEonalprioriEes 21 2 BringingtogetherpaEents,caregivers,andotherstakeholdersin allstagesofaresearchprocess 80 1 TranslaEngevidenceintohealthcarepracEceinwaysthat accountforindividualpaEentpreferencesforvariousoutcomes, includingdecision-supporttools 180 19 CollecEngandassessingpaEent-andprovider-perceivedgapsin evidence 26 0 IdenEfying,tesEng,and/orevaluaEngpaEent-centered outcomesinstruments 214 11 AssessingthepaEentperspecEvewhenresearchingbehaviors, lifestyles,andchoices 31 5 StudyingpaEentcareteaminteracEonsinsituaEonswhere mulEpleopEonsexist 45 6 AnalyEcalmethodsforCER 170 6 104. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Types of Organization Primes Subcontractors Overview:AllApplicaOons Type Primes Subs Funded Academic 561 235 38 Hospitals 80 98 4 ResearchorganizaEons 55 49 3 Non-prothealthsystems 28 54 2 Community-basedhealth centers 20 46 0 Consultants 18 32 1 ProviderassociaEons 16 19 0 PaEentassociaEons 10 40 1 Non-protfoundaEons 9 24 1 TechnologyorganizaEons 7 25 0 Government 5 16 0 For-prothealthbenets 2 0 0 For-protpharmaceuEcal 1 2 0 Other 0 52 0 6 105. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Target Populations Applicants & Awardees 0% 10% 20% 30% 40% 50% 60% PercentofTotalApplicaOons TotalApplicaOonsbyTarget PopulaOon PopulaOon All Funded Underserved 453 30 SpecicEthnic orCultural 243 21 Disabled 163 12 Urban&Rural 383 28 OnlyUrban 188 14 OnlyRural 22 1 Unspecied 224 8 106. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E MonitoringthePilotProjects 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. PCORIFUNDING ANNOUNCEMENTAPPLICATIONS 483applicaEonsreceived Reviewprocessunderway ~100awardsexpectedinDecember2012 108. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E DescripOonofApplicaOonsReceived Top15StatesApplying 483applicaOonsreceived ApplicaOonsbyPFA 71,15% 211,44% 92,19% 109,22% AddressingDispariEes AssessmentofPrevenEon,Diagnosis,andTreatmentOpEons CommunicaEonandDisseminaEonResearch ImprovingHealthcareSystems 0 10 20 30 40 50 60 CA PA MA NY MN TX WA FL NC MD MI IL GA OH IA 109. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E MenOonofSpecicCondiOons MulEplecondiEonsandstudydesignsmay 0 50 100 150 200 250 300 NumberofApplicaEons 110. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E StudyDesignsNotedinApplicaOons 0 10 20 30 40 50 60 70 80 90 Priority#1:AssessmentofPrevenOon,Diagnosis,andTreatment OpOons(n=211applicaOons) 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 Racialor EthnicGroup Rural Urban Veterans Women Priority#1:AssessmentofPrevenOon,Diagnosis,and TreatmentOpOons(n=211applicaOons) StudyPopulaOonsNotedinApplicaOons NumberofApplicaEons 112. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Reviewers Volunteers Total Applicants First Round Second Round TechnicalReviewers 800+ 483* 75-100 PaEentReviewers 225 -- 25 StakeholderReviewers 225 25 CommimeeChairs -- 10 113. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E PCORIs8ReviewCriteria 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E AgendaforTodaysMeeOng PaEentandStakeholderEngagement PrioriEzaEonofResearchTopics AdvisoryPanels ConictofInterestPolicyandPlanforMethodologyCommimee PCORIFundingAnnouncement5A-Methods MethodologyCommimeePublicComment 2012Budget CommunicaEonsUpdate 115. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Appendix A: PICORI Pilot Projects Update 17 Appendix 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. 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. 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 JUNE30,2012 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. 4 Unaudited June 30, 2012 Revised 2012 Budget The Board approved the 2012 budget subject to mid-year corrections. UNAUDITED PROJECTED REVISED JUNE30,2012 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] Therewillbe$96millionawardedforresearchinNovember2012. Non-operating Interest Income 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. 6 Net Revenue (Dollars in millions) Cash Flow 2012 2013 CASHBALANCE $162 $241 Appropriation $150 $150 PCORFee 0 34 Subtotal 150 184 LessAHRQ/HHS (30) (37) LessProgramandOperatingExpenses (30) (41) NetRevenue $90 $106 ResearchContractCommitments $127 $300 ResearchOutflows 2012 ($11) ($21) 2013 (139) TotalOutflows ($11) ($160) CASHBALANCE $241 $188 122. 7 Appendix Financial Statements CBO Updated Estimate for the Insurance Coverage Provisions of the Affordable Care Act 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. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 2 StrategicQues-onsAroundInfrastructurePFA 1. Feedbackonfeasibility,opportunityfora hybridapproachtoInfrastructurePFA 2. Strategicconsidera@onsforanItera@ve, ProgressivePFAProcess 125. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 3 TwoDis-nct(andComplementary)ApproachesEmerge fromPaloAlto PCORINa-onalWorkshopto AdvanceUseofElectronicData Clinical Data Research Network (CDRN) Patient-Powered Research Network (PPRN) 126. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 4 InfrastructureSubgroupIsFormed ProgramDevelopment CommiJeeMembersandGuests CarolynClancy FrancisCollins ArnieEpstein SherineGabriel Chris@neGoertz LeahHole-Curry GailHunt HarlanKrumholz RickKuntz MikeLauer NancyMiller JeanSlutsky PCORIExecu-ve LeadershipandSta JoeSelby Ka@eWilson(Project Management) 127. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 5 AnItera-ve,StrategicProposalforFunding ProposedProgressionofPFAs PhaseOne PhaseTwo PFA#1: ClinicalDataResearch Network AnswersQues*on: Candirectinvolvementof pa@entsimprovethe eciencyand eec@venessoflarge datanetworksfor conduc@ngclinical research? PFA#2: Pa@ent-Powered ResearchNetwork AnswersQues*on: Canpa@entorganiza@ons andnetworksplaya leadingrolein compara@ve eec@venessresearch? PFA#3: Pa@ent-Centered OutcomesResearch Network(PCORNet) BuildsonPFAs#1: Withastablefounda@on fortheconductofmany dierentresearchstudies, nowtheprojectsneedto bedened;mayinclude coordina@ng/convening centeraward 128. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 6 PhaseOne:ClinicalDataResearchNetwork(1of3) FundingOpportunity Inviteconsor@aofmul@plehealthservicesorganiza@onstoapplyfor supportofresearchinfrastructure: Goal#1:buildlargeinteroperablenetwork(s)capableofsuppor@nglarge scalecompara@veeec@venesstrialsofmul@pleresearchques@ons, includingpreven@onandtreatment,atlowmarginalcost,with substan@vepa@entinvolvementthroughout Goal#2:embedresearchac@vitywithinafunc@oninghealthcaresystem withoutdisrup@ngthebusinessofprovidinghealthcare;thus,business caseforthehealthcaresystemtopar@cipatemustbeaddressed Goal#3:demonstrateabilitytomobilizeandengagesubstan@alpa@ent popula@onswithinthecoveredpopula@onforatleastthreecondi@ons Goal#4:ensurehealthcareorganiza@onleadershavemeaningfulrolein governance,includingavoiceiniden@fyingmeaningfulresearch priori@esfortheirorganiza@on 129. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 7 PhaseOne:ClinicalDataResearchNetwork(2of3) Criteria 1. Pa@ent,provider,andhealthsysteminvolvementatalllevelsofconsor@umdesign, implementa@on,governance,anduse 2. Healthcareorganiza@onleadersmusthaveavoiceinresearchpriori@es(discouraging studiesthatarenotfeasible,iden@fyingmeaningfulques@onsfortheirorganiza@ons) 3. Accesstoatleast1,000,000pa@ents 4. Poten@alforlongitudinalfollowupacrosscaresefngs 5. Diversityinage,gender,socioeconomicstatus,race/ethnicity 6. Abilitytoobtaininformedconsent,usingcentralIRB 7. Abilitytoestablishatleastthreedisease-speciccohortsthatachievepar@cipa@onof pa@entswithinthenetwork,butalsoincludeoutreachtoestablishedpa@entnetworks focusedonthosesamedisorders(seePFA#2) 8. Electronichealthrecordswithmeaningfuluseforresearch 9. Buy-inandac@vepar@cipa@onfromthehealthcaresystem(s)inwhichcareisdelivered 10. Abilitytoconductobserva@onalandinterven@onal(individualorclusterrandomized)trials 11. Dataaccesspoliciesthatpromotebroadresearchusebutprotectprivacy,conden@ality 12. Poten@altoobtainandstorebiologicalspecimens 130. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 8 PhaseOne:ClinicalDataResearchNetwork(3of3) AllowableItemstoIncludeinProposalandBudgetRequest Permanentresearchstasupport Incen@vesforthehealthsystemtosupportembeddedresearchinthesystem Pa@entnetworkoutreachcoordinator Communica@onsta EstablishmentofITconnec@vitybetweenconsor@ummembers Costsofconsentforresearch Pilotresearchstudies,ideallyinpartnershipwithrelevantpa@entgroups Biobankcosts Pa@entsurveystoassessinterestin: o Genera@ngresearchques@ons o Usingthedatabase o Abilitytocommunicatewithotherpa@ents o Providingpa@ent-reportedinforma@on o Par@cipa@nginappropriateRCTs 131. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 9 PhaseOne:Pa-ent-PoweredResearchNetwork(1of3) FundingOpportunity Invitepa@ent-centeredorganiza@onswithspecicdiseaseorcondi@on focustoapplyforsupport: Goal:ini@allytoprovidepilotfundingtohelpgroupsorganizeand developthenecessaryinfrastructuretodenethemostimportant pa@ent-centeredresearchques@onsandtoprepareforvigorous, broadpar@cipa@on; Goal(latentobjec@ve):increaseaccesstopartnershipand par@cipa@oninresearchforabroadlydiversepopula@onof individualswithcommonhealthissues 132. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 10 PhaseOne:Pa-ent-PoweredResearchNetwork(2of3) Criteria 1. Applicantgroupmustdemonstratethattheyareconsideredcredibleand eec@vebythosewiththecondi@on 2. Mustrepresentasubstan@alnumberofaectedindividuals,ideallywith diversityindemographicsanddiseaseseverity,andwithlongterm involvementofmostpar@cipants,asappropriategiventhecondi@on 3. Groupleadershipmustberepresenta@veinsomewayandbeabletoreceive andactuponbroadinputofaectedindividuals,reec@ngtheirneedsand haveprocessesinplacetonego@atedivergentopinions 4. Musthavesucientadministra@veandnancialaccoun@ngstructurestobe abletoreceiveandaccountforgrantfunds(PCORIstamayneedtohelp here) 5. Musthaveinterestinandcapacitytoexpandmembershiptoinclude historicallyunder-representedpa@entgroupswiththecondi@on 133. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 11 PhaseOne:Pa-ent-PoweredResearchNetwork(3of3) AllowableItemstoIncludeinProposalandBudgetRequest Stasupporttobuildandexpandnetworkofaectedindividuals,establishdatabases Administra@vestaforgrantsmanagementandgrantprepara@on Infrastructuresupporttoenhanceinterac@vecommunica@onwithpa@entsandcaregivers Fundsforworkshopstoconvenepa@ents,clinicians,andotherstakeholders,toiden@fythe mostimportantresearchques@ons Fundstoaddressapproachestoobtainingclinicalelectronichealthrecorddataonpa@ents inthegroup Fundsforoutreachandenrollmentofpa@entsfromtradi@onallyunder-representa@ve popula@ons Pa@entsurveystoassessthedemographicandclinicalcharacteris@csofenlistedpa@ents andtostudytheirinterestin: o Genera@ngresearchques@ons o Usingthedatabase o Abilitytocommunicatewithotherpa@ents o Providingpa@ent-reportedinforma@on o Par@cipa@nginappropriateRCTs 134. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 12 PhaseTwo:ResearchProjects Disease-specicapplica-ons: IdeallycomejointlyfromaPPRNapplicantandaCDRNapplicant PPRN:Highlymo@vated,poten@allylessgeneralizable CDRN:Lessmo@vated,poten@allymorerepresenta@ve Condi@onsnotrepresentedbyaPPRNcouldbeproposedwiththeCDRNGroup tohelpcatalyzesuchagroup,star@ngwiththeirownmembers,andextending morebroadly Outsideinves-gatorscouldapplyfortheopportunitytorunobserva@onalor interven@onalresearchstudiesthroughtheCDRNandPPRN,ideallyfocusedon condi@onsrepresentedbythePPRN Applica-onsfocusedonpreven-onstrategiesmightneedtocomefromanCDRN, orfromanoutsideinves@gatorproposingtohavetheCDRNconductthestudy Applica-onscomingfromhealthcareorganiza-onsensureleadershave meaningfulroleingovernance,includingavoiceiniden@fyingmeaningfulresearch priori@esfortheirorganiza@on Pa-ent-CenteredOutcomesResearchNetwork 135. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 13 NextSteps FinalizeHybridVision ConductInventoryofExis@ngPa@entDataNetworksfor FeasibilityPlanning,TaxonomyofNetworks ReleaseFirstInfrastructurePFAQ1,2013 136. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 14 StrategicQues-onsAroundInfrastructurePFA 1. Feedbackonfeasibility,opportunityfora hybridapproachtoInfrastructurePFA 2. Strategicconsidera@onsforanItera@ve, ProgressivePFAProcess 137. PA TIENT -CENTE RED O UTCOMES RE SEAR CH I NST I TU T E 15 Strategic Document: PCORI Funding Opportunity 5bInfrastructure for Research (document to be circulated) Appendix 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. 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. 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. 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. 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. 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. PATI ENT-C ENTER ED OUTCOMES RESEARCH INST I TU T E Tracking the Pipeline Recentpublica-onsofnote 7 145. 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 PCORIs 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. 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 subcommittees work might apply to consumer media 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 subcommittees role in helping manage PCORI-related content other than scientific articles (eg, white papers, reports, blog posts) Consider how the subcommittees 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. 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. 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. Strategic Questions to Consider Strategicques-onstoconsider 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. PCORIsResearchAgenda FiveBoard-ApprovedPriorityAreas 1. AddressingDispari-es 2. Communica-onand Dissemina-on 3. AssessmentofPreven-on, Diagnosis,andTreatmentOp-ons 4. ImprovingHealthcareSystems 5. InfrastructureandMethods 3 152. Inves;gator-GeneratedResearchJustOnePartoftheProcess PCORIissuesbroad fundingannouncements Researcherspartnerwithstakeholdersto generateques-ons Researchers,stakeholdersapply reviewcriteriaintheirapplica-ons Peerreviewpriori-zes applica-onsbylevel ofalignment withcriteria 2 Complementary Approaches for Developing PCORIs National Research Agenda DiverseResearchPor.olioansweringkey ques7onsforpa7entsandclinicians 4 153. Pa;ent/Stakeholder-LedApproach PCORIandstakeholdersgenerateandpriori-zeques-ons basedonreviewcriteria PCORIissuesspecic,fundingannouncements forhighestprioritytopics Researchersandstakeholders developresponsiveproposals Peerreviewpriori-zes applica-onsbylevel ofalignment withcriteria Patient/Stakeholder-Led Approach Unique to PCORI DiverseResearchPor.olioansweringkey ques7onsforpa7entsandclinicians 5 154. BuildingontheExis;ngEvidenceBase andPriorExperience Exis;ngScien;c WorkandLiterature MethodologyCommiKee andMethodologyReport Experienceof OtherAgencies 6 155. PCORIs Process Transparent, Rigorous FinalSelec-onfor SpecicPFAs (PCORIBoard) TopicGenera-on (ThroughMul7pleModes) Gap Conrma-on Research Opportuni-es Research Priori-za-on Pa;ents&Stakeholders: WebPage SocialMedia Workshops PCORI: Con-nuousPorTolio Review Otheragencies: AHRQgaps NIHgaps 7 156. Phase 1: Topic Generation Answeraclinicalques-onarounda healthcaredecision Becompara-ve Notberelatedtocost/cost eec-veness AlignwithatleastoneofPCORIs Na-onalPriori-esforResearch PCORIFilterAll NominatedTopicsMust: Gap Conrma;on Topic Nomina;on Webpage Socialmedia/marke-ng In-personworkshops,focusgroups Topicgenera-ondiscussedat Pa-entandStakeholder WorkshopsintheFall AHRQ:FutureResearchNeeds(FRNs) Reports,Systema-cGapReview Otherguidelinesdevelopment processes(suchasNQF) Gapsiden-edbyNIH,otherfunding agencies Buildingonexis-ngworkorother organiza-ons,priori-za-onexercises (eg,IOM100) ProcessBeginswithPa7ents andStakeholders 8 157. 9 158. Phase 2: Gap Confirmation AHRQTopicReviewand Disposi-on Topics Provided to AHRQ for Gap Confirmation Answeralready known,or researchunderway Potential Determinations EvidenceSynthesis Needed NewPrimary ResearchNeeded Incollabora7onwithAHRQ;contractunderdevelopment Research Priori-za-on Dissemina-on Next Steps 10 159. Phase 3: Research Prioritization AdvisoryPanels Pa7entsandStakeholders Boardof Governors Research Priori-za-on ProcessUsing PCORICriteria Preven-on,Diagnosis, TreatmentOp-ons Communica-on andDissemina-on Dispari-es ImprovingHealth CareSystems Infrastructureand Methods RareDiseases SelectedFrom Priori7zedList Crea7on ofPFAs ResearchQues7ons NeedingPriori7za7on Priori7zedList ofTopics 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. 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. Developing Topic Briefs for Prioritization of Questions SamplePCORITopicBrief EachTopicBrief exploresa research ques-onfor whichagaphas beeniden-ed TopicBriefaddressesPCORIscriteria:pa-ent centeredness,impactofdisease,poten-al forimprovement,etc. 13 162. 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. Research Prioritization Timeline Aug Sep Oct Nov Dec Jan Feb Mar PCORIScienceTeamproposes ini-alRPProcess TechnicalWorkingGrouptests/ providesfeedbackonRP Process;supportsdevelopment ofPCORIRPProcess Pa-ents,StakeholderspilotRP process RevisedPriori-za-onProcess presentedatPCORIMethods WorkshopDecember5th Pa-ent/StakeholderAdvisory PaneltrainingonResearch Priori-za-onMethods AdvisoryPanelsconduct ResearchPriori-za-onProcess fornominatedtopicsand submittotheBoard 15 164. PCORIs 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 PCORIs research prioritization process 16 165. Summarizing PCORIs 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 patients 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. 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