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November Board of Governors Meeting
November Board of Governors Meeting
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November Board of Governors Meeting

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  • As we’ve moved thru 2012, we have increasingly recognized just how important engagement to our strategy for Conducting and disseminating meaningful impactful research.
  • That brings us to Dr. Anne Beal who has now been with PCORI for more than a year. Anne has been overseeing, mentoringand supporting our engagement program to this point, along with many other responsibilities of the COO. Because of her skills and commitment to PCORI, I am able to delegate a wide range of responsibilities to Anne. I’m very pleased to announce today Anne’s promotion to the position of Deputy ED and COO – in recognition of this fact – that I can and do ask AnneTo shoulder a range of activities and responsiblities, beyond those of a COO.
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  • Purpose: Informational for PFA for Cycle I and Input regarding selection criteria
  • PCORI’s first Research Agenda includes five broad areas addressing currently unmet needs …..Assessment of Prevention, Diagnosis, and Treatment OptionsImproving Healthcare SystemsCommunication and Dissemination ResearchAddressing DisparitiesAccelerating PCOR and Methodological Research (Fall/Winter 2012)
  • When will all these happen….major deadlinesAdd LOI in same bo
  • How did we get here?After the applications came in, as shown in previous slide, PCORI conducted a 2 step merit review processPhase I: Determined scientific strengths and impact. It was conducted only by Scientists that were trained in PCORI 8 merit review criteria)Phase II: Focused Impact only and it included a new group of Scientists and Patients and Stakeholders that were trained to focus in criteria 2, 4 and 7.2. Research will change practice; Dissemination and implementation4. Patient centeredness as a criterion is unique and central to PCORI7. Patient and other stakeholder engagement is key to PCORI>Long term plan as recommended by BOG in Denver is to include Patients/Stakeholder in the entire review cycle: Then, the P/S will be involved in:1- Topic generation that lead to PCORI Funding Announcements2- Be Part of the research team that will work in the applications, do the project and support dissemination of finding3- Review of Application to be funded (in Cycle II – Application due Dec 17, the P/S will be included in the all phases of the review process)
  • These are the slate of applications per PFA that made it to Phase II
  • This shows all data that was collected for PFA (one question to be answered later – you can e-mail me, would be, is there anything else we should be colleting? – and the pdc already has had some suggestions
  • Proposal advancing to Phase II: Location and on
  • We want to mainly focus on 2, 4 and 7
  • We want to mainly focus on 2, 4 and 7
  • We want to mainly focus on 2, 4 and 7
  • We want to mainly focus on 2, 4 and 7
  • Selection Criteria: it is the next step after the merit review in making a decision to evaluate the alternatives against specific criteria. The goal should be to arrive to a decision that falls in line with PCORI mission and vision.Recommend and would like to hear your feedback:Final Score from Phase II: Includes scores from scientists + patients + stakeholdersCondition – be able to fund a broad set of applications that address several conditions, and Populations study – make sure that those applications are studying a broad range of populations1) Appoint BoG-Staff Selection Committee2) Review data on characteristic of high scoring application3) Select on basis of 3 criteria – overriding difference in Final Score 4) Board Approval in Public Meeting in December
  • Purpose: Informational for PFA for Cycle I and Input regarding selection criteria
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  • In this presentation, we will review the rationale for this initial targeted PFA effort. We will provide a summary of our PCORI process to date and share the final list of proposed topics for board consideration and vote. We look forward to sharing more details on the opportunity within each of the 3 topics for consideration and end on next steps.
  • This process builds on ongoing conversations and board direction. Our formative legislation calls for PCORI to build upon the work of the IOM in National CER priorities. Using the IOM’s multidisciplinary and stakeholder involved process, we are able to build our initial efforts in targeted specific funding through an targeted mechanism. We are able to accelerate these funding efforts because of our ability to build on previously vetted efforts, where experts, patients and stakeholders alike have provided their input on important CER topics and further prioritized research. We are a learning organization and are using these three areas as an opportunity to add to our long term topic generation and research prioritization efforts. All potential topics that come to PCORI will be included in our long-term prioritization efforts. Again, even prior to PCORI’s existence, there were calls for studying important patient centered outcomes research. Our targeted funding effort allows us to move forward in the first quarter of 2013 with specific funding efforts as well as allow for ongoing development of our Advisory panels and future targeted initiatives.
  • In a three step process, PCORI examined high-impact topics for targeted funding. Starting with the IOM Top 100 CER National priorities list, we acknowledged that in the last three years, some of these topics may have become out of date. This list provided a starting point. Then we examine an additional list of more than 300 topics from multiple sources, including patients, stakeholders and experts.To narrow down our list, our first filter was to examine those questions that came from two sources. PCORI combed the lists for overlapping topics of interest for PCORI.
  • Our next step was to perform a second leSalience, defined as obvious, recognizable importance – i.e., that the question being addressed is known to represent a fairly common problem.Short-term feasibility, indicates study results will be available within a 2-3 year time periodStakeholder vetting, defined by resulting from multiple stakeholder effortsResource constraints, indicates investments that could leverage existing funding, co-funding opportunities, or high-impact investments.
  • All PCORI Merit Criteria were used to evaluate potential topics. Each criteria was ranked on a scale of exceeds criteria to does not meet criteria. The criteria used included: Patient-centeredness, which is central to PCORI’s mission. Research findings need to have meaningful impact on the patients’ lives and need to answer questions that are impactful on patients, caregivers and providers. Impact, as captured traditionally by the burden of disease including the prevalence, incidence, mortality and morbidity and quality of life when applicable.Differences in benefits and harms that are significant enough between the interventions under consideration given what is known at the time of the funding announcement. The topic briefs will provide information about current studies and known benefits and harm.Reduction in uncertainty, by making the best assessment based on topic briefs, the research should reduce the uncertainty around treatment effects.Implementation in practice, as it captures how likely the research findings are to be implemented in practice and, therefore, change patient outcomes. PCORI will be evaluated as an institution on how its research impacts changes in patient care and outcomes.Duration of information, which captures if the intervention will still be current by the time the research is published and the length of time the research results are likely to remain relevant.Healthcare system performance, which addresses how the research impacts potential improvements in convenience or wasted resources while maintaining or improving patient outcomes.Inclusiveness of different populations, which refers to the inclusion of diverse populations and/or populations that are under studied (e.g. children, elderly, and patients with multiple chronic conditions).
  • Our process proceeded from the three-step process to rank 40 overlapping topics. The top 25 were then shared with the PDC,the PDC examined each topic further.
  • DO YOU WANT TO LEAVE THIS LONG LIST?
  • Using the full list of 25 topics, we examined each to ensure that we included important conditions for a range of populations. For example, we did not want to exclusively look at questions for only diabetics or children. Additionally, we examined the topics for the potential to impact patient centered outcomes, healthcare decision making, and healthcare system performance.
  • Using this process to generate a list o, we narrowed down to three topics for board approval.
  • In the past several weeks, we’ve had additional discussions with stakeholder groups and experts that convince us that These three topics truly meet our criteria of salience, timeliness, and opportunity for impact.
  • After board approval during the public session of the board on November 19th, we can move forward with patient, stakeholder and expert input over the next month. After those sessions, we will work to have PFAs written and released before second quarter 2012.
  • From the stakeholder and expert convenings, multiple recommendations are possible. One such option is a call for evidence synthesis where PCORI would review study opportunities and gaps in evidence. We would then determine key research questions. Another option is that one key study opportunity may be the right approach to explore and answer a specific PCORI research question. Finally, we may need to engage with multiple researchers who address the topic through several methodological approaches with related study questions which over time would result in the high-impact results that patients and their caregivers are calling for.
  • As next steps, we need to ask for board approval to move forward with the three identified and recommended study topics. After approval, we will move forward quickly to release these topics to the public and convene expert panels. Finally, we would have 6 weeks after the stakeholder and expert panels to write and release the PFAs.
  • As next steps, we need to ask for board approval to move forward with the three identified and recommended study topics. After approval, we will move forward quickly to release these topics to the public and convene expert panels. Finally, we would have 6 weeks after the stakeholder and expert panels to write and release the PFAs.
  • Transcript

    • 1. Welcome and Approval of MinutesEugene Washington, Chair, MD, MScPCORI Board of Governors MeetingBoston, MANovember 2012
    • 2. Executive Director’s ReportJoe Selby, MD, MPHPCORI Board of Governors MeetingBoston, MANovember 19, 2012
    • 3. Engagement Topic Research Specific Engagement Generation Prioritization PFAsBoard of Governors Meeting, November 2012 3
    • 4. Transforming Patient-Centered Research:Building Partnerships and Promising ModelsOctober 26-28, 2012 170 in-person attendees 40 states represented~250 Webinar attendees each day Video of sessions posted at pcori.org 5 Board members, 1 MC member present Board of Governors Meeting, November 2012 4
    • 5. Transforming Patient-Centered Research:Building Partnerships and Promising ModelsBoard of Governors Meeting, November 2012 5
    • 6. Transforming Patient-Centered Research:Building Partnerships and Promising ModelsLessons Learned:• Patient community is prepared and enthusiastic about participating with us in a transformed research enterprise• PCORI’s proposed strategies for engagement endorsed, but refinements offered to many aspects of the process• Critical points added: • Researchers need training to engage with patients • Micro-grants could help bring patients and researchers together locally • Patients can play a stronger role in the application and in reporting/disseminating results Board of Governors Meeting, November 2012 6
    • 7. Upcoming Engagement EventsDecember 4: Stakeholder Engagement What Should PCORI Study? A Call for Topics from Patients and StakeholdersDecember 5: Research Prioritization PCORI Methodology Workshop for Prioritizing Specific Research TopicsBoard of Governors Meeting, November 2012 7
    • 8. Chief Officer for Engagement Leads continued development of PCORI’s strategic imperative of engagement - with the broad range of our stakeholders Builds on PCORI’s extensive engagement efforts to date, supports our engagement team in implementing engagement program Serves as a principal spokesperson and represents PCORI to the highest levels of key stakeholder organizations and convenes these organizations for planning and conduct of patient-centered outcomes research Works closely with PCORI Board of Governors, its Communications, Outreach, and Engagement Committee (COEC) and Methodology Committees, to strengthen our ongoing relationships with stakeholder communities and to evaluate and enhance our effortsBoard of Governors Meeting, November 2012 8
    • 9. Deputy Executive Director and ChiefOperating Officer: Dr. Anne Beal Deputy Executive Director Strategic Planning External Relations Chief Operating Officer Contracting Finance Communication HR Facilities Anne Beal, MD MPHBoard of Governors Meeting, November 2012 9
    • 10. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Laura Forsythe Brittany Jones David Hickam Research Associate Sr. Administrative Assistant Director, Comparative October 15, 2012 October 15, 2012 Assessment of Options Research Program October 29, 2012 Chad Boult Sean Grande Malik Dean Director, Improving Project Associate Sr. Administrative Assistant Healthcare Systems October 31, 2012 November 2, 2012 October 29, 2012
    • 11. P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE Natalie Wegener Tommesha Allen Camille Blackman Project Coordinator Sr. Administrative Assistant Project Coordinator September 24, 2012 September 24, 2012 September 26, 2012 Romana Aingyea Kellom Jim Convery Hasnain-Wynia Project Associate Director of Information Director, Health October 8, 2012 Technology Disparities Program October 8, 2012 October 1, 2012
    • 12. Executive Office Joe Selby Executive Director Vacant Anne Beal Vacant Deputy Executive Chief Science Chief Officer for Director and Officer Engagement Chief Operating OfficerBoard of Governors Meeting, November 2012 12
    • 13. Operations Anne Beal Deputy Director and Chief Operating OfficerPam Goodnow Martin Duenas James Mitch Eisman Bill Silberg Director, Director, Convery Director, Director, HR Finance Contracting Director, IT Communications Board of Governors Meeting, November 2012 13
    • 14. Science Vacant Chief Science OfficerLori Frank David Hickam Chad Boult Romana Vacant Vacant Director Director Director Hasnain-Wynia Director Director Director Communication Prevention, Improving Addressing andEngagement Diagnosis and Healthcare Health Accelerating Dissemination Research Treatment Systems Disparities Research PCOR Kara Odom Rachael Walker Fleurence Sr. Research Sr. Research Scientist Scientist Board of Governors Meeting, November 2012 14
    • 15. Engagement Vacant Chief Officer for Engagement Susan Sheridan Susan Hildebrandt Director Director Patient Engagement Stakeholder Engagement Vacant Greg Martin Deputy Director, Patient Deputy Director Engagement Stakeholder EngagementBoard of Governors Meeting, November 2012 15
    • 16. Preview – Today’s Meeting • Methodology Committee Report – Revised Standards • PCORI Advisory Committee Charters • Proposed 2013 Budget • Update on PCORI Pilot Projects • PFA Cycle 1 – Update on Review Process • Initial Targeted PCORI Funding Announcements • Nominating Committee – 2013 Committee AssignmentsBoard of Governors Meeting, November 2012 16
    • 17. November Board MeetingMethodology Committee BriefingSherine Gabriel, MDSharon-Lise Normand, PhD PCORI Board of Governors Meeting Boston, MA November 2012
    • 18. Goal for today  High level update of activities  Propose adoption of revised standards and recommended actions  Endorse dissemination initiative  Review next stepsBoard of Governors Meeting, November 2012 18
    • 19. Draft Methodology Report – Process 1 Methods • Working groups identified and prioritized major research methods Selection questions to be addressed 2 • Researchers contracted to address selected topics • Contractors developed research materials (e.g., reports, summary Committee Expertise Information templates for proposed standard) Gathering • MC solicited for external feedback on the translation table (RFI) • Workshops held to discuss contractor findings, with invited experts in attendance 3 • MC conducted in-depth internal review of materials developed by contractors, and support staff • MC independently submitted preliminary votes on proposed Internal Review standards • MC deliberated to reach consensus on recommendations to be endorsed in the report 4 Report • Presented to Board May 2012 • Posted for public comment July 2012 Generation
    • 20. Public Comment Summary 124 groups or individuals submitted comments Over 1400 comments, 503 applicable to standard topics T Workman et al. Comments Addressed 143 100 90 80 72 70 60 50 37 39 38 40 32 35 30 30 24 24 23 20 10 6 0Board of Governors Meeting, November 2012 20
    • 21. Major Themes From Public Comment Themes Guidance on Implementing Relation of Standards to Standards Research Funding Topic Gaps Document Accessibility Feasibility of Standards to Produce Patient-Centered Research FindingsBoard of Governors Meeting, November 2012 21
    • 22. Review of Comments, Revision of Standards and Recommended Actions July-September October November• 12 topic areas addressed • Full MC reviewed comments and • MC unanimously by Methodology Committee proposed revisions October 12-19 endorsed set of (MC) & Work Groups revised standards (WGs) • Full MC Consensus Meeting held to and recommended determine final MC revisions to actions• WGs met to discuss Standards and Recommended Actions comments and revisions to October 31 • MC delivered revised Standards and Standards and Recommended Actions Recommended• WGs solicited outside Actions for Board adoption expertise for research prioritization, HTE, diagn • MC drafted ostic test, and adaptive responses public trials comment themes• WGs drafted proposed revisions to Standards and Recommended Actions Board of Governors Meeting, November 2012 22
    • 23. Revisions to Methodological Standards 21 were revised  14 Significant changes in content  7 Revisions to wording 19 were deleted, expanded, or consolidated 21 were not changedBoard of Governors Meeting, November 2012 23
    • 24. Comment Summary of Example RevisionThe causal inference Standards were revised Define Analysis Population Using Covariate Historiesstandards seem to focus on to allow for time Information Available at Study Entryproblems involving point varying covariates. Decisions about whether patients are included in an analysisexposures/treatments. They should be based on information available at each patient’s timedo not seem to address of study entry and not based on future information such asproblems involving time- future changes in exposure in prospective studies or onvarying information from a defined time period prior to the exposure intreatments/exposures. retrospective studies. For time-varying treatment or exposureHowever, PCORI’s mission regimes, specific time points should be clearly specified and theincludes such longitudinal covariates history up to and not beyond those time pointsproblems….. should be used as population descriptors...could be expanded to The idea of ‘common Assess Report the assumptions underlying the construction ofinclude assessment of support’ or overlap Propensity Scores balance and the comparability of the resultingcommon support across was added to the groups in terms of the balance of covariates and overlap.comparison groups, and standard on propensity When conducting analyses that use propensity scores to balancepossibly greater clarity in the scores. covariate distributions across intervention groups, researchersdescription of the should assess the overlap and balance achieved across comparedpropensity score model. groups with respect to potential confounding variables.….believe intervention Intervention was Precisely Define the Timing of the Outcome Assessmentshould be changed to changed to exposure Relative to the Initiation and Duration of Interventionexposure as it is a more general Exposure term To ensure that an estimate of an exposure or intervention effect corresponds to the question that researchers seek to answer, the researchers must precisely define the timing of the outcome assessment relative to the initiation and duration of the intervention exposure.
    • 25. Revisions to Recommended Actions 13 were revised 25 were deleted, expanded, or consolidated  Some converted from standards to recommended actions 30 were not changedBoard of Governors Meeting, November 2012 25
    • 26. Next Steps Determine next round of strategic Report Revision Deliverable priorities Complete to Board Begin Adoption by Next round of Submission to MC Full Day Implementing Board Standards and Board Meeting Standards with Update Report Staff November December 2013Board of Governors Meeting, November 2012 26
    • 27. Dissemination and Implementationof the Standards 1. Adherence to the standards will require changes in the ways in which research is solicited, designed, reviewed and funded, conducted, monitored, reported, and disseminated. 2. Changing research practice will require multi-component, multi- level, multi-stakeholder coordinated efforts. 3. The Methodology committee with PCORI staff and Board (a) coordinate efforts with external groups: • including convening advisory committees as needed (b) prioritize and stage dissemination activityBoard of Governors Meeting, November 2012 27
    • 28. Implementation Plan: Questions for Board • Endorse COEC and MC to develop a new initiative to achieve widespread implementation of the standards • Endorsement of proposal to convene a new advisory group for this initiative comprising BoG, MC and external stakeholder representatives, with COEC as the key BoG liaison and oversight groupBoard of Governors Meeting, November 2012 28
    • 29. Goal for today  High level update of activities  Request approval of revised standards and recommended actions  Endorse dissemination initiative  Review next stepsBoard of Governors Meeting, November 2012 29
    • 30. Sharon-Lise Normand, PhDMethodology Committee Vice Chair Thank you for your commitment and service! 30
    • 31. BreakMeeting ScheduleDATE LOCATIONFebruary 3-5, 2013 San Francisco, CAMay 5-7, 2013 Chicago, ILSeptember 22-24, 2013 Washington, DCNovember 17-19, 2013 Atlanta, GA
    • 32. Advisory Panel Charters Anne Beal, MD, MPH Chief Operating Officer, Deputy Executive Director PCORI Board of Governors Meeting Boston, MA November 2012Reviewed by COEC, October 30, 2012 and PDC, November 13, 2012
    • 33. Getting Up to Speed: Advisory Panel Recap Legislative Authorization What does the law say expert advisory panels should include?• Expert advisory panels should include clinicians, researchers, patients, and other experts with the appropriate experience and knowledge to assist PCORI in achieving its goals. Purpose What is the purpose of advisory panels?• There is a lot of work to be done!• With PCORI’s staff, Methodology Committee, and Board of Governors, advisory panels will assure meaningful patient engagement in: (1) PCORI’s research activities; (2) identifying research priorities and topics; (3) conducting randomized clinical trials; and (4) performing special research studies.• Leveraging members’ expertise will help better inform PCORI’s mission and work. Framework and Composition How will they be structured?• Each 12-21 member panel will have a unique charter, term duration, and clearly defined scope of work.• PCORI staff presents a group of nominees to the Board for approval. The Board appoints a chairperson.• Members will be selected based on their expertise and ability to contribute to the work of specific panels.• Members will be compensated and appointed for an initial one-year term with an option to be re-appointment for a second year.Board of Governors Meeting, November 2012 33
    • 34. Getting Up to Speed: Advisory Panel Recap Conflicts of Interest Will panel members be eligible for future PCORI funding?• Panel members are not making decisions on funding, programs, or operations.• Focus on transparency and building information firewalls will prevent conflicts from arising.• Advisory panel membership generally does not preclude eligibility for funding.• Members will be advised of unique instances where their role could result in disqualification. Panel Establishment When will advisory panels be established?• Three panels will be established in the first half of 2013.• More to come in the future. Board of Governors Meeting, November 2012 34
    • 35. Questions for Board Consideration Is the scope of work outlined in the three advisory panel 1 charters appropriate? Please comment on the proposed additional advisory 2 panels for Q1/2013.Board of Governors Meeting, November 2012 35
    • 36. Advisory Panel Establishment Process1 2 3 4 Staff Draft and Board Reviews Staff Activates Submit Charter the Proposed Nomination and Board Approves for an Advisory Advisory Panel Selection of Panel Panel Participants Panel Charter Participants • Board, Methodology • Board may authorize • Staff initiates open • Staff selects and Committee, and/or charter (proceed to call for nominations, proposes a slate of PCORI staff identify step 3) via the PCORI Web panel nominees to the need to establish site and other the Board an Advisory Panel • Board may request communications revisions to the • Nominees submit an • Board authorizes • Staff initiates request charter (return to expression of and approves the for an advisory panel step 1) interest, via the nominees for panel by submitting a PCORI Web site membership panel-specific • Staff evaluates charter • Board selects a nominees, per chairperson from evaluation criteria the panel unique to the panel membership charter Staff Phase Board Phase Board of Governors Meeting, November 2012 36
    • 37. Review First Three Advisory Panel Charters Patient Engagement Comparative Assessment of Options Health DisparitiesCharters are included in the appendices sectionFour Advisory Panels approved by the BOG, September 2012Board of Governors Meeting, November 2012 37
    • 38. Proposed Panel: Patient Engagement Purpose: To assure the highest patient engagement standards and a culture of patient-centeredness in all aspects of PCORI’s research and dissemination activities. Term: 2 years Membership: Between 12–21 members with 75 percent patients, caregivers, and advocacy organizations and 25 percent researchers and other stakeholders.Board of Governors Meeting, November 2012 38
    • 39. Proposed Panel: Comparative Assessmentof Options Purpose: To identify and prioritize critical research questions in PCORI-supported research and to advise PCORI on evaluating potential research topics related to the comparative effectiveness of alternative strategies for prevention, treatment, screening, diagnosis, and management of disease Term: 2 years Membership: Between 15–21 members. At least 25 percent of panel members will be patients, caregivers, and advocacy organizations. The remainder members will include clinicians, researchers and other stakeholdersBoard of Governors Meeting, November 2012 39
    • 40. Proposed Panel: Health Disparities Purpose: To identify and prioritize critical research questions for possible funding under PCORI’s research priority addressing health disparities, and provide ongoing feedback and advice on evaluating and disseminating the research conducted under this priority. The focus is on studies that will inform the choice of the best strategies to eliminate disparities rather than studies that describe the problem. The studies related to addressing disparities must focus on areas of importance to patients and their caregivers, where there are critical disparities that disadvantage members of a particular group and limit their ability to achieve optimal, patient-centered outcomes. Term: 2 years Membership: Between 15–21 members to include patients, caregivers, and advocacy organizations and as well as researchers and other stakeholders.Board of Governors Meeting, November 2012 40
    • 41. Future Panels: For Board DiscussionFour charter panels will be proposed for February/May 2013 Randomized Clinical Trials* Rare Diseases* Health Systems TBD*Required by statuteBoard of Governors Meeting, November 2012 41
    • 42. Questions for Board Consideration Is the scope of work outlined in the three advisory panel 1 charters appropriate? Please comment on the proposed additional advisory 2 panels for Q1/2013.Board of Governors Meeting, November 2012 42
    • 43. Board Vote: Recommend Approval Patient Engagement Comparative Assessment of Options Health DisparitiesBoard of Governors Meeting, November 2012 43
    • 44. Appendix A: Advisory Panel: Patient EngagementAppendix B: Advisory Panel: CERAppendix C: Advisory Panel: Health DisparitiesAppendix D: Selection Criteria: Patient EngagementAppendix E: Selection Criteria: HD & CER
    • 45. The 2013 Budget PlanKerry Barnett, Chair, FAACAnne Beal, Deputy Executive Director and Chief Operating OfficerPamela Goodnow, Director of FinancePCORI Board of Governors MeetingBoston, MANovember 2012
    • 46. Agenda Key Points Performance-Based Budgeting The 2013 Budget Projection for 2014 Comparative Analysis Commitments and Outstanding Obligations Cash Flow Questions and AnswersBoard of Governors Meeting, November 2012 46
    • 47. Key Points Align budget with strategic goals  Adjust to lower cash flow expectations  Provide flexibility for quick-turnaround, rapid response funding  Target for administrative expense set at 10%  Focus on infrastructure and operations activities Infrastructure and Operations Activities  Refine the staffing model  Reduced reliance on contract staffing  One-time investments in infrastructureBoard of Governors Meeting, November 2012 47
    • 48. Performance-Based Budgeting Definition  Performance budgets use the mission and goals to allocate resources to achieve specific objectives based on program goals and measured results.  The activities that are required to accomplish the program goals are defined and funded at the department level.Board of Governors Meeting, November 2012 48
    • 49. Performance-Based Budgeting PCORI Budget Process  Define long-term goals • Engaging patients and stakeholders so that they can participate in the PCORI research enterprise in a meaningful way • Advancing rigorous PCOR methods; methodology standards adopted as best practices across the nation • Funding PCOR so that PCORI impacts decision-making, practice, and patient outcomes • Communicating and disseminating PCOR findings • Developing a sustainable infrastructure for conducting PCORBoard of Governors Meeting, November 2012 49
    • 50. Performance-Based Budgeting  Refine the staffing model Office Provides Chief Executive Program support and general management Chief Science Pre-award PFA/TFA development Post-award monitoring and compliance Methodology Committee support Project management: intramural research Research Project management: extramural research Chief Operating General management and administrationBoard of Governors Meeting, November 2012 50
    • 51. Performance-Based Budgeting  Reduced reliance on contract staffing will save over $700,000 per month, which allows for 25 additional FTEs at little additional cost. DAILY OPERATIONS Staff Contractor Total 2012 FTE 34 38 72 2012 Monthly Spend $628,067 $1,090,000 $1,718,067 2013 FTE 88 9 97 2013 Monthly Spend $1,417,689 $326,250 $1,743,939Board of Governors Meeting, November 2012 51
    • 52. Performance-Based Budgeting Target for administrative expense set at 10%  Program expenses are goods and services distributed to fulfill the mission of the organization  Administrative expenses are costs of business management, record keeping, budgeting, and finance and other management and administrative activities  The percentage of administrative expenses is a measure of a non-profits efficiency.  The industry standard is 15%.Board of Governors Meeting, November 2012 52
    • 53. Performance-Based Budgeting One-time investment of $6.5 million in infrastructure for program support and operations Investment in Infrastructure  Website for interactive Methodology Report  Researcher datamart  Customer Relationship Management software  Digital communications platform  Post-award contract management and compliance  Cash management and financial reporting  Network hardware and softwareBoard of Governors Meeting, November 2012 53
    • 54. The 2013 Budget Revenue Assumptions: Appropriation  $120 million  No adjustment has been made for the potential loss of revenue in the sequestration processBoard of Governors Meeting, November 2012 54
    • 55. The 2013 Budget Revenue Assumptions: Fees  Assessed on plan years ending October 1 through December 31, 2012 (partial year), and estimated at 25 percent of original funding  Timing: funding based on estimates will be received between August 15 and October 15, 2013, in installments and the balance will be received in CY 2014  Transfer dates from the CMS Trust Funds have not been publishedBoard of Governors Meeting, November 2012 55
    • 56. The 2013 Budget Expense Goals, Objectives, and Activities  The Methodology Committee and each of the program departments have developed projected expenses at the activity level to achieve their priorities  Board governance  Priorities for general management and administrative support include commitments to infrastructure, security, and oversight for cash managementBoard of Governors Meeting, November 2012 56
    • 57. The 2013 Budget IN MILLIONS OPERATING REVENUE $147.2 Program Expenses 136.6 86.68% Administrative Expenses 21.0 13.32% OPERATING EXPENSE 157.6 Non-operating Interest Income 0.3 NET INCOME ($10.1) * *Does not include monies carried over from 2012.Board of Governors Meeting, November 2012 57
    • 58. Projection for 2014 IN MILLIONS OPERATING REVENUE $543.0 Program Expenses 272.0 91.58% Administrative Expenses 25.0 8.42% OPERATING EXPENSE 297.0 Non-operating Interest Income 1.1 NET INCOME $247.1Board of Governors Meeting, November 2012 58
    • 59. Comparative Analysis Administrative Expense 13.35% $7.5 $21.0 Methodology Committee Research $21.0 Engagement $12.7 Administrative Expense 8.42% Program Development and $95.3 Evaluation $10.7 Administrative $25.0 Methodology Committee $30.0 Research 2013 $15.4 Engagement Program Development and Evaluation $215.8 Administrative 2014Board of Governors Meeting, November 2012 59
    • 60. Commitments and Outstanding Obligations Contracts awarded have two and three year life cycles  Contract negotiation for $31 million in PCORI Pilot Project awards will be complete in 2012  Contract negotiation for $96 million in research for the 2012 PFA 1 award cycle will be complete in 1Q2013  PCORI expects to award $300 million in research contracts during CY2013  There will be $304 million in outstanding obligated funding at December 31, 2013Board of Governors Meeting, November 2012 60
    • 61. Commitments and Outstanding Obligations Commitments and Outstanding Obligations IN MILLIONS COMMITMENTS Pilot Projects $31.0 PFA 2012 96.0 PFA 2013 300.0 427.0 PCORTF Payments (123.0) OUTSTANDING OBLIGATIONS $304.0Board of Governors Meeting, November 2012 61
    • 62. Cash Flow Cash Flow  Current projections indicate that PCORI will close CY2012 with an available cash balance of $233 million  Cash receipts projected at $147 million including interest earnings  Cash payments of $112 million will be made on basic research contracts  Cash needed for operations: $60 million  Projected cash carryover to 2014: $208 millionBoard of Governors Meeting, November 2012 62
    • 63. Cash Flow Cash available at the end of 2013 IN MILLIONS OPENING CASH BALANCE $233.0 Cash Receipts 147.3 Cash Requirements (172.7) PROJECTED CASH BALANCE $207.6  Reconciliation to financial statements: IN MILLIONS BUDGETED EXPENSES $157.6 Advance research payments 13.4 Difference in accounts payable 1.7 CASH REQUIREMENTS $172.7Board of Governors Meeting, November 2012 63
    • 64. Questions and Answers Open for discussionBoard of Governors Meeting, November 2012 64
    • 65. LunchMeeting ScheduleDATE LOCATIONFebruary 3-5, 2013 San Francisco, CAMay 5-7, 2013 Chicago, ILSeptember 22-24, 2013 Washington, DCNovember 17-19, 2013 Atlanta, GA
    • 66. November Board MeetingPilot Project ManagementLori FrankMichele OrzaJoe SelbyPCORI Board of Governors MeetingBoston, MANovember 2012
    • 67. Pilot ProjectsThe pilot projects will  Advance the field of patient-centered outcomes research by exploring methods for PCOR  Help identify gaps to inform PCORI research agenda on methods Total Awards: $31 million over two yearsBoard of Governors Meeting, November 2012
    • 68. Pilot Projects—Methods to:  Inform the PCORI national priorities  Bring together patients, caregivers, and other stakeholders in all stages of a research process  Translate evidence-based care into healthcare practice in ways that account for individual patient preferences for various outcomes  Identify gaps in comparative effectiveness knowledge  Evaluate patient-centered outcomes instruments  Assess the patient perspective when researching behaviors, lifestyles, and choices  Study the patient care team interaction in situations where multiple options exist  Advance analysis of comparative effectiveness research dataBoard of Governors Meeting, November 2012
    • 69. Funded PCORI Pilot Projects in 25 Statesand DCBoard of Governors Meeting, November 2012 69
    • 70. Post-Review Questionnaire:Reviewer Experience Have you previously participated in a CSR Review? Scientific Reviewers Stakeholder Reviewers 69% 250 250 200 200 31% 150 150 100 100 87% 13% 50 50 0 0 No Yes No Yes (109) (245) (39) (6) N = 354 N = 45Board of Governors Meeting, November 2012 70
    • 71. Post-Review Questionnaire:Scientific Reviewer Receptivity To what extent were SCIENTIFIC reviewers receptive to the comments made by STAKEHOLDER reviewers? Scientific Reviewers Stakeholder Reviewers Dont Know Dont 10% Know, 7% Some Extent Some 35% Extent, 37% Small Extent Great Great 3% Extent Extent, 51% No Extent 51% Small 1% Extent, 5% N = 354 N = 43Board of Governors Meeting, November 2012 71
    • 72. Post-Review Questionnaire:Stakeholder Reviewer Receptivity To what extent were STAKEHOLDER reviewers receptive to the comments made by SCIENTIFIC reviewers? Scientific Reviewers Stakeholder Reviewers Some Extent Dont Know Some Extent 16% 7% Dont Know 27% 30%Small Extent 4% Great Extent 77% Great Extent 39% N = 349 N = 43Board of Governors Meeting, November 2012 72
    • 73. Post-Review Questionnaire:Scientific Reviewer Compared to other reviews you’ve participated in, to what extent did having an emphasis on patient engagement impact overall scoring? Dont Know, 1% Some Extent, 27% Small Extent, 8% No Extent, 1% Great Extent, 63% N = 282Board of Governors Meeting, November 2012 73
    • 74. Post-Review Questionnaire:Stakeholder Reviewer How would you describe the degree of emphasis stakeholder reviewers placed on the patient perspective relative to that placed by scientific reviewers? Scientific Reviewers Stakeholder Reviewers 60% 60% 50% 45% 50% 50% 36% 40% 31% 40% 27% 30% 30% 20% 20% 6% 5% 10% 10% 0% 0% I don’t know Less More Same Dont Know More Same (94) (20) (108) (126) (2) (21) (19) N = 348 N = 42Board of Governors Meeting, November 2012 74
    • 75. Review Criteria:Distribution of Scores 1,259 unique grant reviews across 16 panels 9 8 7 6 Scores 5 4 3 2 1 Approach Significance Stakeholder Innovation Investigator FinalWith thanks to Michael Lauer, Richard Fabsitz, and Mona Puggal, 10/12 75
    • 76. Review Criteria: Measure of ImportanceWhich of the sub-component scores are the most important determinantsof the final score, given all the others and given groupings within panels? Test Statistic 600 Random Forest Mixed Linear Model 500 400 300 200 100 0 Approach Significance Stakeholder Innovation InvestigatorData from Michael Lauer, Richard Fabsitz, and Mona Puggal, 10/12 76
    • 77. Initiating PCORI’sActive Portfolio Management 1. Actively manage and connect awardees 2. Facilitate and accelerate learning across projects 3. Develop and refine engagement framework 4. Elicit the patient view of research engagementBoard of Governors Meeting, November 2012 77
    • 78. Advancing PCOR Through the Pilot Projects• Learn about facilitators, barriers, and impact of involving patients in the full cycle of research• Develop a conceptual framework of PCOR• Implement a strategy to measure project progress• Facilitate peer-to-peer learning• Critically appraise lessons learned• Identify implications for PCORI research agenda Board of Governors Meeting, November 2012 78
    • 79. Pilot Project Management Plan August – September October – November December• AcademyHealth • Awardee contracts • Coordinate selected finalized subgroup communication• Review of pilot • Topic/methods • Plan for project content subgroups identified subgroup and related to facilitate cross- convenings literature learning and quick sharingBoard of Governors Meeting, November 2012 79
    • 80. Conceptual Framework Literature review 1. PubMed search and other databases searched, 2005 – present 2. 325 articles filtered through inclusion/exclusion criteria 3. > 50 articles abstracted and reviewed Framework – initial draft Constructed based on literature and input from the Patient, Consumer, Researcher Roundtable along with team discussionBoard of Governors Meeting, November 2012 80
    • 81. Conceptual Framework-Structure Elements 1. Culture of the research entity 2. Governance infrastructure 3. Patient identification and selection infrastructure 4. Engagement infrastructure 5. Training/education infrastructure 6. Support infrastructure 7. Evaluation infrastructure 8. Accountability and transparency infrastructureBoard of Governors Meeting, November 2012 81
    • 82. Conceptual Framework-Process Elements 1. Nature of engagement 2. Patient identification and selection 3. Patient segmentation and selection 4. Establishing and defining goals and accountability 5. Culture of engagement (research project–specific) 6. Nature and channels for communication and provision of input 7. Continuity and frequency of engagement 8. Stage(s) of the research process 9. Confidentiality and transparencyBoard of Governors Meeting, November 2012 82
    • 83. Conceptual Framework-Outcomes Components 1. Attitudes and perceptions 2. Modifications or refinements 3. Concept appeal 4. Relationships and buy in Longer Term Outcomes Components: 1. Increased quality of research 2. Increased relevance of research 3. More informed and expansive decision making/uptake of research 4. Improvements in dissemination of and access to research 5. Policy deliberations/changes 6. Improvements in health outcomes and health statusBoard of Governors Meeting, November 2012 83
    • 84. Cycle I Funding Announcement:Merit Review Update Martin A. Dueñas, Director, Contracts Management Joe Selby, Chief Executive Officer Anne Beal, Chief Operating Officer PCORI Board of Governors Meeting Boston, MA November 2012
    • 85. Questions for Board Consideration Feedback regarding selection criteria? 1 Any additional information PCORI should be collecting? 2Board of Governors Meeting, November 2012 85
    • 86. Overview PFA & Timeline Merit Review Criteria: Phase I + Phase II Applications for Final Review Data Collected Recommended Selection Approach and ActionsBoard of Governors Meeting, November 2012 86
    • 87. PCORI’s Four PFA Areas PCORI Funding Announcements (PFAs) focus on four areas of research addressing currently unmet needs of patients, their caregivers, clinicians, and other healthcare system stakeholders. 1. Assessment of Prevention, Diagnosis, and Treatment Options 2. Improving Healthcare Systems 3. Communication and Dissemination Research 4. Addressing DisparitiesBoard of Governors Meeting, November 2012 87
    • 88. TimelineLetter of Internal Quality Panel I: Scientific Panel II: Impact PCORI ReviewIntent/Application Control Review Review andDeadline • August 1 – 15, 2012 • August 15 – October • Thursday, November Board Approval• June 15, 2012 (LOI) 26, 2012 15, 2012 • November 16–• July 31, 2012 December 15, 2012 (Application) 88 Board of Governors Meeting, November 2012 88
    • 89. Merit ReviewPhase II: Focus on Impact Phase I Review CriteriaDetermines Scientific Soundness and Impact 1. Impact of the condition on the health of individuals and populations Phase II Review Criteria 2. Innovation and potential for Focuses on Impact Improvement through research 3. Impact on healthcare performance 2. Innovation and potential for Improvement through 4. Patient-centeredness research 5. Rigorous research methods 4. Patient-centeredness 6. Inclusiveness of different 7. Research team and populations environment 7. Research team and environment 8. Efficient use of research resources Overall ScoreBoard of Governors Meeting, November 2012 89
    • 90. Advanced to Phase II Addressing CER• Phase I Overall Scores Disparities 61/210 26/70 (29%)• Criteria: (37%) Phase II — Represent the best scoring Applications applications 152/481 (32%) — Include about twice the Improving Comm. & number expected to be Healthcare Dissemination Systems funded or about 32% of top 35/109 30/92 scores, depending on score (32%) (32%) distributionsBoard of Governors Meeting, November 2012 90
    • 91. Data Collected for PFAsBoard of Governors Meeting, November 2012 91
    • 92. Proposal Advanced to Phase II: Location:30 States + CanadaBoard of Governors Meeting, November 2012 92
    • 93. Proposal Advanced to Phase II:PopulationBoard of Governors Meeting, November 2012 93
    • 94. Proposal Advanced to Phase II:ConditionBoard of Governors Meeting, November 2012 94
    • 95. Proposal Advanced to Phase II:MethodsBoard of Governors Meeting, November 2012 95
    • 96. Proposal Advanced to Phase II:DesignBoard of Governors Meeting, November 2012 96
    • 97. Selection Approach and Actions 1. Appoint Board of Governors – Staff Selection Committee 2. Review Data on Characteristic of High Scoring Application 3. Select on basis of 3 Criteria: • Final Score from Phase II • Condition Studied • Populations Studied 4. Board Approval in Public Meeting in DecemberBoard of Governors Meeting, November 2012 97
    • 98. Board Considerations Feedback regarding selection criteria and actions. 1 Is there any additional information PCORI should be 2 collecting?Board of Governors Meeting, November 2012 98
    • 99. BreakMeeting ScheduleDATE LOCATIONFebruary 3-5, 2013 San Francisco, CAMay 5-7, 2013 Chicago, ILSeptember 22-24, 2013 Washington, DCNovember 17-19, 2013 Atlanta, GA
    • 100. Initial Targeted FundingAnnouncementsKara Odom Walker, MD, MPH, MSHSJoe Selby, MD, MPH, Executive DirectorPCORI Board of Governors MeetingNovember 2012
    • 101. Overview Rationale for targeted funding announcements now Process for identifying high priority topics Proposed Topics Topic Information Next StepsBoard of Governors Meeting, November 2012 101
    • 102. Rationale Responds to widespread concerns that PCORI has NOT gotten specific or identified high-priority research areas Responds to board directive to move forward with identifying several high-priority, stakeholder-vetted topics for targeted PFAs Jumpstarts PCORI’s long-term topic generation and research prioritization effort Leverages stakeholder input from before PCORI’s existence Allows us to build on our engagement workBoard of Governors Meeting, November 2012 102
    • 103. Process for Identifying Topics forInitial Targeted Funding Announcements Progress to Date Next Steps Multiple Identification of Staff Expert and Board Stakeholder Overlapping Application of Stakeholder Approval Efforts Topics Review Criteria Input Backlog of Compile lists of PCORI Review Criteria Board-Approved High- Targeted Through critical vetted important CER • Patient-centeredness • Impact of the priority Topics Multiple Modes CER topics questions condition • Expert Panels • Innovation, potential • Webinars for improvement • Public Sessions • Impact on healthcare performance • Inclusiveness Targeted Funding Announcement filter • Salience • Short-term feasibility • Stakeholder vetting • Resource constraints # of topics # of topics # of topics # of topicsBoard of Governors Meeting, November 2012 103
    • 104. First Filter: Seeking Topics EndorsedThrough Multiple Processes Institute of • Generated by multiple Medicine Top 100 stakeholders CER National Priorities Overlapping Topics • Generated with input 300+ Topics from patients, other Considered stakeholders, experts, other fundersBoard of Governors Meeting, November 2012 104
    • 105. Second Filter: Targeted Funding SpecificFactors Salience: of obvious, recognizable importance— i.e, that the question being addressed is known to represent a fairly common problem Short-term feasibility: indicates that study results could be available within a two to three year period Unmet research need: unlikely to be funded without PCORI support Resource constraints: moderate investments could suffice or could leverage existing co-fundingBoard of Governors Meeting, November 2012 105
    • 106. Third Filter: PCORI Merit Criteria 1 Patient centeredness Impact of the condition on the health of individuals and 2 populations (prevalence, incidence, other measures of burden of disease) 3 Potential for improvement: • Preliminary evidence of important differences • Opportunity to reduce current uncertainty • Likelihood of implementation into practice • Durability of information 4 Potential for impact on healthcare performance 5 Potential for inclusiveness of different populations Ranked on a scale of ―does not meet criteria to exceeds criteria‖Board of Governors Meeting, November 2012 106
    • 107. Ranking Process: Staff Members Members Tool Topics Top 25 Six reviewers:  Independent  Staff ranked  Top 25 list • Four ranking of 40 potential presented to Science criteria topics Program Team staff  Criteria Development • Two Non- weighted, with Committee science emphasis on Team staff PFA-specific filterBoard of Governors Meeting, November 2012 107
    • 108. Top 25 Topics From Staff Ranking1. Treatment of uterine fibroids2. Treatment of localized prostate cancer3. Diagnosis of suspected renal colic4. Management of asthma in African Americans5. Management of maternal fetal and neonatal health outcomes6. Sleep apnea detection and management7. Obesity treatment in diverse populations8. Health system interventions to improve coordination for cancer care9. Patient navigation and disease management for diverse populations10. Clinical decision support tools among youth with ADHD11. Various primary care treatment strategies for ADHD in children12. Understanding chronic disease self-management programs in patients with multiple chronic conditions13. Management of elderly patients with back pain14. School based vs. medical setting health services for diverse populations15. Clinical decision support systems for imaging in emergency departments16. Effective and efficient methods to disseminate interventions for chronic condition17. Breast cancer screening with film, digital/3D mammography, and mammography plus MRI18. Treatment strategies for neck and back pain19. Advanced imaging modalities and biomarker tests for prostate cancer20. Polypharmacy and mortality in schizophrenia21. Fracture prevention strategies22. Prevention of falls in the elderly23. Self-management strategies to manage multiple chronic conditions24. Effectiveness of comprehensive care coordination programs25. Management of complex, co-morbid conditionsBoard of Governors Meeting, November 2012 108
    • 109. Initial Targeted Funding AnnouncementBalancing Criteria Focus on Balance Study Population Condition(s) Addressed + Potential for ImpactBoard of Governors Meeting, November 2012 109
    • 110. Recommended Topics1. Treatment of uterine fibroids2. Treatment of localized prostate cancer3. Management of asthma in African Americans4. Management of maternal fetal and neonatal health outcomes5. Prevention of falls in the elderly6. Sleep apnea detection and management7. Obesity treatment in diverse populations8. Health system interventions to improve coordination for cancer care9. Various primary care treatment strategies for ADHD in children10. Treatment-related mortality in schizophrenia11. Treatment strategies for neck and back pain 110
    • 111. Recommended Topics Treatment Options for Uterine Fibroids Safety and benefits of treatment options for severe asthma in African Americans Fall Prevention in the ElderlyBoard of Governors Meeting, November 2012 111
    • 112. Topics in Current Headlines Treatment ―Learning from city councilor’s Options for fibroid condition‖ Uterine April 16, 2012 Fibroids Management of Severe ―Minority children affected by Asthma in disparities in asthma health care‖ African May 31, 2012 Americans Fall ―Scientists weigh in on fall prevention‖ Prevention in July 12, 2012 the Elderly Source: Hyperlinks to respective online articles from each newspaper. Logos from respective Web sites.Board of Governors Meeting, November 2012 112
    • 113. Proposed Next Steps: Timeline for InitialTargeted Funding Announcements Item Nov Dec Jan Feb Mar Board Approval 19 Expert and Stakeholder 30 Input TFAs Ready for 2Q13 Six Weeks for PFA 15 Writing PFAs CreationBoard of Governors Meeting, November 2012 113
    • 114. Potential Funding Strategies Convene Stakeholder/Expert Panels  Call for Evidence Synthesis A Single Study Portfolio of Studies • Summarize what is known • Identify specific study • Decide to issue open call for  disseminate design multiple study options • Identify gaps in evidence, • Issue RFP for Contract • Solicit multiple study and determine key research • Prioritize short turnaround approaches and specific questions for future funding results research questions • Portfolio of projects, including sequencing projects over timeBoard of Governors Meeting, November 2012 114
    • 115. Next Steps Get Board approval to focus on three topics Refine important research questions in each topical area Convene stakeholder/expert panels for each topic Prepare and release PFAsBoard of Governors Meeting, November 2012 115
    • 116. Call for Vote   Treatment Options for Uterine Fibroids Safety and Benefits of Treatment Options   for Severe Asthma in African Americans   Falls Prevention in the Elderly   Other? Additional?Board of Governors Meeting, November 2012 116
    • 117. Appendix Appendix A: Topic Briefs Reference articles and reports (separate booklet)Board of Governors Meeting, November 2012 117
    • 118. Treatment Options for Uterine Fibroids Description • What is the relative effectiveness of the available procedural or nonprocedural treatments for uterine fibroids, including:  Procedural treatments (hysterectomy, myomectomy, uterine artery embolization(UAE), magnetic resonance image-guided focused ultrasound, endometrial ablation)  Nonprocedural treatments (hormonal therapies, oral contraceptives, and nonsteroidal anti- inflammatory drugs)Question  Complementary and alternative medicine  Lifestyle changes  Watchful waiting (no treatment) • What is the optimal sequencing of therapies, considering womens clinical characteristics and preferences? • What are the most important subpopulations to predefine (childbearing aim, race/ethnicity, age, and therapeutic goals)? • Uterine fibroids are the most common gynecological condition among women, with an incidence that isPopulation highest among women ages 30 to 40. Cumulative incidence approaches 70 percent among white women by age 50 and is even higher among African American women. • Treatment options of uterine fibroids include surgical, minimally invasive, and hormonal therapies or other medications. Most women who have uterine fibroids will not experience symptoms severe enoughResearch to seek treatment, but for those who do, uterine fibroid disease poses a significant cost and quality of lifeNeed burden. • Due to the complexity of treatment options, further research is needed to help women target specific treatment options that effectively manage their symptoms.Mechanism • Expert and stakeholder panel Board of Governors Meeting, November 2012 118
    • 119. Safety and Benefits of Treatment Optionsfor Severe Asthma in AfricanAmericans Description • Compare management strategies for severe asthma in African Americans for a rangeQuestion of clinical, functional, and healthcare utilization outcomes. • Asthma affects nearly 20 million Americans. African Americans are one of the highestPopulation populations at risk from asthma with almost 4.5 million reports in 2010. • Treatment options include fast-acting inhalers and long-term controlling substances, such as long-acting beta-adrenoceptor agonists (LABAs). African Americans may also be especially sensitive to LABAs. Further research studies are needed to examine the impact of various medical treatments and health education programs to reduce the rate of asthma-associated illness and death in the African American population.Research • In any patient case, a large Cochrane systematic review for the effectiveness and safetyNeed of LABAs has provided evidence that LABAs are safe and beneficial in control of asthma; intriguingly, subgroup analyses indicate that this is true when inhaled corticosteroids are used and in their absence. • There remains a question about which subgroup risk factors may predispose African Americans to increased rates of adverse events–whether it is genetic factors, disease severity, or access to ongoing comprehensive treatment strategies.Mechanism • Expert and stakeholder panel Board of Governors Meeting, November 2012 119
    • 120. Fall Prevention in the Elderly Description • Compare the effectiveness of primary prevention methods to prevent falls, such as exercise and balance training, versus clinical treatments in older adults at varying degrees of risk, including:  Assessing the potential of combining therapeutic agents to achieve additive or synergistic treatment benefits.Question  Improving adherence to clinical protocols by developing and testing less burdensome dosing regimens or routes of administration and exploring approaches that reduce drug side effects.  Using improved predictors of fracture risk that incorporate aspects of an individuals environment, lifestyle, and medical history to target multi-component prevention programs to high-risk individuals.  Investigating the effect of genetic variation on response to treatments. • Between 30 and 40 percent of community-dwelling persons 65 years or older fall at least once per year.Population • Falls are the leading cause of fatal and nonfatal injuries among persons 65 years or older. • Despite the depth of research into interventions, additional research is needed to confirm the context in which multifactorial assessment and intervention, home safety interventions, vitamin D supplementation, and other interventions are effective. • Evidence underpinning the U.S. Preventive Services Task Force recommendations regarding fallResearch prevention in older adults comes from time-limited, randomized, controlled trials involving heterogeneousNeed populations that participated in different combinations of balance, strength, endurance, or general exercise programs in various settings under the supervision of diverse groups of experts (eg, physical therapists, nurses, and exercise physiologists). The trials provide general guidance but no details as to how to construct or conduct a clinical exercise program.Mechanism • Expert and stakeholder panel Board of Governors Meeting, November 2012 120
    • 121. References: Treatment Options for UterineFibroids Deng L, Wu T, Chen XY, Xie L, Yang J. Selective estrogen receptor modulators (SERMs) for uterine leiomyomas. Cochrane Database of Systematic Reviews 2012, Issue 10. Gliklich RE, Leavy MB, Velentgas P, Campion DM, Mohr P, Sabharwal R, et al. Identification of Future Research Needs in the Comparative Management of Uterine Fibroid Disease. A Report on the Priority-Setting Process, Preliminary Data Analysis, and Research Plan. Effective Healthcare Research Report No. 31. (Prepared by the Outcome DEcIDE Center, under Contract No. HHSA 290-2005-0035-I, TO5). AHRQ Publication No. 11-EHC023-EF. Rockville, MD: Agency for Healthcare Research and Quality. 2011; Available at: http://effectivehealthcare.ahrq.gov/reports/final.cfm. Gupta JK, Sinha A, Lumsden M, Hickey M.Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database of Systematic Reviews. 2012; Issue 5. Stovall, DW. Alternatives to hysterectomy: focus on global endometrial ablation, uterine fibroid embolization, and magnetic resonance-guided focused ultrasound. Menopause: The Journal of the North American Menopause Society. 2011; 18(4):437. Toor SS, Jaberi A, Macdonald DB, McInnes MDF, Schweitzer ME, Rasuli P. Complication Rates and Effectiveness of Uterine Artery Embolization in the Treatment of Symptomatic Leiomyomas: A Systematic Review and Meta-Analysis. American Journal of Roentgenology. 2012; 199(5):1153. Tristan M, Orozco LJ, Steed A, Ramírez-Morera A, Stone P. Mifepristone for uterine fibroids. Cochrane Database of Systematic Reviews. 2012; Issue 8.Board of Governors Meeting, November 2012 121
    • 122. References: Safety and Benefits of TreatmentOptions for Severe Asthma in AfricanAmericans Cazzola M, Matera MG. Safety of long-acting β2-agonists in the treatment of asthma. Therapeutic Advances in Respiratory Disease. 2007; 1(1):35. Press VG, Pappalardo AA, Conwell WD, Pincavage AT, Prochaska MH, and Arora VM. Interventions to Improve Outcomes for Minority Adults with Asthma: A Systematic Review. J Gen Intern Med. 2012; 27(8):1001. Torgerson DG, Ampleford EJ, Chiu GY, Gauderman WJ, Gignoux CR, Graves PE, et al. Meta-analysis of Genome-wide Association Studies of Asthma In Ethnically Diverse North American Populations. Nat Genet. 2011; 43(9):887.Board of Governors Meeting, November 2012 122
    • 123. References: Falls Prevention in the Elderly Moyer, VA, on behalf of the U.S. Preventive Services Task Force. Prevention of Falls in Community- Dwelling Older Adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2012; 157(3):197. Tinetti ME, Brach JS. Translating the Fall Prevention Recommendations Into a Covered Service: Can It Be Done, and Who Should Do It? Ann Intern Med. 2012; 157:213.Board of Governors Meeting, November 2012 123
    • 124. Public Comment Period
    • 125. Nominations
    • 126. Wrap-up and Adjourn
    • 127. BreakMeeting ScheduleDATE LOCATIONFebruary 3-5, 2013 San Francisco, CAMay 5-7, 2013 Chicago, ILSeptember 22-24, 2013 Washington, DCNovember 17-19, 2013 Atlanta, GA

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