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Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
Special Board Meeting on National Priorities and Research Agenda, Pilot Projects
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Special Board Meeting on National Priorities and Research Agenda, Pilot Projects

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The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors held a special open meeting on Wednesday, April 25, 2012, using a teleconference/webinar format. The Board discussed and …

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors held a special open meeting on Wednesday, April 25, 2012, using a teleconference/webinar format. The Board discussed and voted on PCORI’s revised National Priorities for Research and Research Agenda as well as reviewed proposed Pilot Project funding awards.

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  • We followed a careful, multi-step process in developing these draft “roadmaps” for our future work. We reviewed major comparative effectiveness research initiatives undertaken previously and under way now and their results. We reviewed previous national priority-setting processes for related health research to identify common priority areas that were informed by stakeholder input. These were evaluated against the criteria laid out for PCORI in the health care reform law. This led to a focus on five priority areas, which we informally vetted with stakeholders through small group meetings and patient and caregiver focus groups. We’re now ready to receive formal input from the entire health community.As part of this process, and in our efforts going forward, we’re taking great care to build on and add value to the best work that others have done and continue to do, while filling in gaps and supporting promising new initiatives.
  • 12 groups total were conducted and 96 patients and caregivers participated. Nine of the groups were patients and three were caregivers. For the Atlanta groups and the Baltimore group on asthma, we oversampled African Americans to ensure we captured their perspective.For the Hispanic group in Phoenix, we conducted the event in Spanish, but the participants of their own choosing elected after the introductions to participate in English.
  • The clinician focus groups will allow us to have detailed, facilitated discussions (90 minutes to 2 hours) with small groups of physicians and nurses on the priorities and agenda.The feedback obtained through these groups will be incorporated into the public input process to revise the priorities and agenda.Tomorrow, in our committee workshop, we will discuss specifically which types of clinicians to recruit to participate in these focus groups – with an eye towards the populations they serve – and we will make recommendations to the staff, so that planning can proceed.We will begin work with the staff and Program Development Committee next week to develop the discussion guides that will be used in these focus groups.The goal is to complete all of the focus groups by February 15, so that a report can be provided to the Board by March 1.
  • PCORI is currently reviewing all input received on the draft National Priorities and Research Agenda.A report will be published summarizing the feedback and how it led to changes in the priorities and agenda.The revised National Priorities and Research Agenda will be adopted by Board of Governors during a special meeting – a public teleconference – in April.PCORI’s largest engagement event to dateBoard Member Harlan Krumholz: “Our true North is our patients”Uniform support for putting patient at center of PCORI research.Future workshops and advisory panels will challenge stakeholders to solve problems together, on behalf of patients.
  • No major gaps identified in the Priorities and no suggestions for additional PrioritiesThere was support for the National Priorities and Research Agenda
  • Transcript

    • 1. Patient-Centered Outcomes Research InstituteSpecial Public Board of Governors Webinar and Teleconference April 25, 2012
    • 2. Welcome and IntroductionEugene Washington, MD, MSc, Chair, PCORI Board of GovernorsJoe Selby, MD, MPH, Executive Director, PCORISpecial Public Board of Governors Webinar andTeleconferenceApril 25, 2012
    • 3. PCORI Pilot Project Program AwardRecommendationsChristine Goertz, DC, PhD, Member, PCORI Board of GovernorsSpecial Public Board of Governors Webinar andTeleconferenceApril 25, 2012
    • 4. The Process The decision was made to eliminate all applications with a score Step One: above 3.0 from consideration for further funding. This yielded a Determine Universe potential fundable pool of 80 applications. The criteria to be used for balancing were refined and twoStep Two: Determine options for selecting a base slate of applications were proposed. Approach Staff applied the two selection process options to the top 80 Step Three: Develop applications, yielding two possible sets of fundable applications Core Slates (one with 37 selected; the other with 50). Using the balancing criteria staff analyzed the balance of each of the two possible sets to determine if balance was achieved or if Step Four: Analyze additional balancing activities would be required. Balance The Selection Committee reviewed the two possible sets of fundable applications to determine if balancing was needed. The Step Five: Make Final group decided on two options for the Board and selected one for Recommendation recommendation. The Board of Governors will vote on the recommendation. Step Six: Approve This process was completed using only generalized information regarding the applicant. No Selection
    • 5. Rationale for Selection Method The selection comm. considered all potential options for selecting the slate of fundable applications and decided to go with an option that would use priority score first and then ensure the top two applications were selected in each review group. All selection committee members were blinded as to the names and affiliations of the applicants. • Percentiles (as noted on the NIH web site) are calculated usually for study sections that have had at least three meetings – traditionally, the last three rounds during a year. Thus, percentiles for the Pilot Projects Program do not have the same meaning as NIH percentiles. They reflect the application’s ranking within a single study section meeting. • Priority scoring is likely to be the most reliable measure across all groups since all reviewers had the same training regarding how to score. • We don’t know (since there is no history to the review group) if a “poor” score is due to a review group that just scores “harsher” or the grants they had were just not very “good”.
    • 6. Rationale (cont’d) • NIH attempted to assign applications to reviewers based on areas of interest, though it was difficult given the large number of applicants and PI’s did not necessarily self-assign correctly as well as listing more than more area. Thus, the assignment was imperfect and an applicant that was not funded (if we used percentiles as the primary selection criteria) could argue s/he might have been funded had s/he been assigned “correctly”. • However, we did want to take into consideration the potential that some groups could be harsher and give some weight to ranking within the review group – so, we decided to also pick up the top two applications in each review group.
    • 7. Balancing CriteriaEight potential criteria were discussed andrefined. The top four were proposed as themost appropriate for balancing. Balancing Definition Operationalization Source Criteria At least two members of the Selection The eight areas of interest listed in At least 2 unique applications but no Committee read each applicationArea of Interest* the PFA more than 50% in any one area abstract and determined the primary areas of interest. Defined as addressing 1) Specific PCORI staff reviewed abstracts to ethnic or cultural group, 2) At least 1 application in each of the determine if the application had a clearPopulation* disabled populations, 3) children, four categories focus on one or more of the four and 4) elderly populations. populations. The disease or condition used to No more than 25% in any major Staff reviewed the abstracts toCondition* demonstrate the approach category within the final slate. categorize conditions addressed, if any The average score given by the Any application added to the coreStakeholder/Patient The average score from the IRG review three reviewers for this criterion in slate will have a score of 1 or 2 (exceptInvolvement* was used. the initial merit review group methods focused applications) Geographic location of institutional Will be reported but not used for The state or country on the applicationGeography affiliation balance. face page for the PI. Only to be used if balance is needed The innovation of the research The methodology committee wouldMethod within the area of interest related to method make the determination, if needed. methodologies (8). Categorization of PI qualificationsPI Discipline Insufficient data to use based on primary area of expertise Whether the PI has receivedPI Seniority Insufficient data to use
    • 8. Option 1: Balancing Option 1 takes the applications with a priority score of 25 or better and ensures at least the top two applications from each panel are included. This option yields 50 applications and has only one balancing issue:  Issue: Area of Interest 4--There are no applications within this slate with that designation as a primary area of interest. Developing, refining, testing, and/or evaluating methods to identify gaps in CE knowledge such as tools for the ongoing collection and assessment of gaps as perceived by patients and providers. Of special interest are gaps that are particularly relevant to vulnerable populations, including but not limited to, low-income populations; underserved minorities; children; the elderly; women; and people with disabilities, chronic, rare, and/or multiple medical conditions.  Balancing Recommendation: There are no applications within the top 80 that have this designation as a primary area of interest. The committee recommends we not balance on this area and propose it be a focus in one of the new PFA’s or use a contract mechanism to address.
    • 9. Option 2: Balancing To remain as close to 40 grants (number approved by the BoG), option 2 takes applications with a priority score of 24 or better and ensured the inclusion of the top application in each review panel. This resulted in 37 applications. 1. Issue: Area of interest 4— This is the same issue encountered under Option 1. Recommendation: This issue should be handled in the same way as in Option 1. 2. Issue: Area of interest 1—There is only 1 application within the slate that addresses this area. Developing, testing, refining, and/or evaluating new or existing methods (qualitative and quantitative) and approaches that can inform the process of establishing and updating national priorities for the conduct of patient-centered outcomes research (PCOR). This may include research prioritization approaches (such as Value of Information (VOI), burden of illness, peer review/expert opinion/Delphi approaches) or methods for incorporating the perspectives of patients or other stakeholders into the development of national priorities. Recommendation: To add an additional application with a primary area of interest of 1, the committee looked within those applications with a priority score of 25. Within that group there is one application with a primary area of interest of 1.
    • 10. Discussion and Voting Selection Committee Recommendation • The committee recommends the Board vote for Option 1 and that we not try to balance on Area 4.
    • 11. Board Discussion and Considerationof PCORI Pilot Project ProgramAward RecommendationsSpecial Public Board of Governors Webinar andTeleconferenceApril 25, 2012
    • 12. Draft National Priorities forResearch and Research AgendaLeah Hole-Curry, JD, Member, PCORI Board of GovernorsSpecial Public Board of Governors Webinar andTeleconferenceApril 25, 2012
    • 13. Objectives for Today  Review Genesis of National Priorities and Research Agenda  Review Public Comment Process  Share Public Comment Findings  Recommend PCORI Response  Board Vote on Recommended Changes13
    • 14. The What and Why of National Priorities and ResearchAgenda  Mandated in the legislation (including Public Comment period)  Pre-requisite for releasing funding announcements  Preliminary roadmap for PCORI research activities  Envisioned as a living document14
    • 15. Development of Draft National Priorities andResearch Agenda Environmental Framework to Candidate Initial Stakeholder scan of existing inter-relate priorities and feedback priorities and Priorities and criteria identified criteria Criteria Reviewed initial Reviewed prior CER Identified broad Developed stakeholder input frameworks (e.g., priorities from prior Framework to be advising us to not IOM, FCCCER, frameworks and the used for refining “reinvent the wheel” National Priorities statutory criteria for priorities and for Partnership, and PCORI determining NQF) Research Agenda and funding announcements15
    • 16. Establishing PCORI’s First National Prioritiesfor Research and Initial Research Agenda First primary 9 5 Corresponding Public input Priorities and fundingCriteria outlined Draft priorities received and agenda revised agenda drafted announcements by law proposed evaluated and approved issued Aug-Dec 2011 Jan-Apr 2012 May 2012 16
    • 17. Patient and Caregiver Focus Groups Baltimore, MD (Nov. 9) Atlanta, GA (Nov. 21) • Patients with Arthritis • Patients with Diabetes • Parents of children with Pediatric • Caregivers to Alzheimer’s patients Asthma (caregivers) • Patients with Chronic Pain • Patients with mix of chronic • Insured and uninsured conditions • Age: 21-75+ • Insured and uninsured • Age: 21-69 Columbus, OH (Dec. 7) Phoenix, AZ (Dec. 8) • Parents of children with ADD/ADHD • Patients with Respiratory Disease (caregivers) (chronic bronchitis, emphysema) • Patients with Mental Health • Hispanic patients with mix of conditions chronic conditions • Patients who survived Cancer • Patients with Heart Disease • Insured and uninsured • Insured and uninsured17 • Age: 30-70+ • Age: 21-69
    • 18. Receiving Public Feedback on the NationalPriorities and Research Agenda• Clinician Focus Groups o Clinician focus groups took place in cities across the US o Philadelphia o Birmingham o California o Chicago o Four groups of physicians and four groups of nurses o Behavioral Health Professionals o Physician Assistants18
    • 19. A commitment to public engagementFormal 53-day Public Comment Period• Nearly 500 comments received through website, e-mail or postal mail• All comments will be posted at pcori.orgAdditional Forums• National Patient and Stakeholder Dialogue• Patient, caregiver and clinician focus groups• Individual meetings with diverse mix of stakeholders 19
    • 20. Public Comment Yielded Diverse Array of Inputand Feedback Broad range of comment sources 301 Web survey (64%) 116 Email/ letter (24%) 474 Total Comments 57 Stakeholder event (12%)20
    • 21. Those Who Commented Said They Understandthe National Priorities… Assessment of Options Improving Healthcare Systems Communications and Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research “How well do you understand the National Priorities?”21
    • 22. Rigorous, Systematic Review and Analysisof Comments Computer algorithm to identify key terminology Each narrative comment reviewed and analyzed by 3 people Stakeholder comments aggregated to 15 key themes Themes compared to National Priorities and Research Agenda to identify gaps Gaps reviewed to determine options for PCORI response to themes22
    • 23. Options for Response  Change Language Within the Research Agenda  Embed in PCORI Operations and Processes  Address in Summary Document  Future Consideration23
    • 24. PCORI Response to Key Themes-1 Recommends that PCORI choose a specific condition, disease PCORI has proposed a condition-neutral Research Agenda and has introduced area, or other issues in the Research Agenda and National specificity through its comparative nature and emphasis on patient centeredness. Priorities While future funding announcements may specify conditions, the overall mission of PCORI is not served by excluding any conditions if there is compelling reason for a patient centered, comparative clinical effectiveness study. We added language to elaborate on our position. Recommends that PCORI partner with organizations and PCORI is committed to efficient use of its research investments. Where appropriate, stakeholders to carry out its mission PCORI will partner with other organizations after a transparent decision-making process and consideration of conflicts of interest. This theme impacts PCORI processes, rather than funding subjects, so no specific language changes were made to the document. Recommends greater focus on the patient, with particular PCORI has fully endorsed and appreciates the centrality of patient engagement to its attention to methods of engagement mission. The National Priorities and Research Agenda reflect the patient centered focus of PCORI and include many of the themes from the public comments. Language has been added to the Agenda to specifically reflect the need for study of self care and to more clearly define personalized medicine. Recommends a greater focus on care coordination PCORI appreciates the need to study care coordination and has expanded the language in the Research Agenda to reflect its importance. Recommends funding towards improving patient and provider Improving communication between patient and provider is one of the five PCORI health literacy and education National Priorities for Research. Language has been added to the Research Agenda24 to reflect the importance of health literacy to achieving this goal.
    • 25. PCORI Response to Key Themes-2 Recommends funding for and use of health IT The foundation for performing comparative clinical effectiveness requires substantial infrastructure, networks, tools and patient data acquisition efforts health IT and data infrastructure. The National Priorities and Research Agenda in and outside the practice setting contain substantial language about this infrastructure. Therefore, no additional language was added to the document. PCORI will support reusable infrastructure for comparative clinical effectiveness research. Recommends that PCORI pay greater attention to the role of PCORI appreciates the role of caregivers in patient centered care and has mentioned caregivers and other stakeholders in the patient decision making them in the document and included studies of caregiving in the Research Agenda. process Therefore, no additional language was added to the document. Recommends that PCORI pay greater attention to access to Access to care is a key issue for patients. Language has been added in both the care, including the social and environmental determinants that comparative assessment and the healthcare systems Research Agenda topics to determine access and use of care include the comparative study of access as a determinant of health. Recommends that PCORI provide greater rationale and PCORI is committed to fully transparent processes as it works towards achieving its transparency in the public comment, grants, and research mission. The Research Agenda articulates the ongoing engagement that will occur evaluation processes, as well as the performance measurement continuously as PCORI evolves and funds research. Therefore, no additional process for PCORI as a whole changes were made to the document. PCORI intends to roll out a comprehensive communications and engagement plan that will clearly define when and how stakeholders can provide input into PCORI decision making. Recommends that PCORIs research and funding should impact PCORI is fully committed to the idea that its research should improve decision making the practice setting, with particular attention to patient and and help patients at the point of care. Language has been added to the section provider behavioral change needed to obtain true shared decision “Establishing the Scope of the Research Agenda” to emphasize the importance of making using the evidence developed through PCORI research to change the way medicine25 is practiced.
    • 26. PCORI Response to Key Themes-3 Recommends that PCORI place stronger emphasis on patients PCORI understands the difficulty of managing multiple chronic conditions when most with multiple conditions, especially chronic conditions evidence is generated in trials that exclude these patients. Language has been added to emphasis this in the Research Agenda. Recommends that PCORI study new and expanded roles for PCORI recognizes the diverse health professionals involved in patient centered care. allied health professionals In the Research Agenda, the description of allied health professionals has been expanded to be more inclusive of all of potential members of a health care team. Recommends paying attention to international models PCORI recognizes the significant achievements of many countries in developing the methods and practices of patient engaged comparative clinical effectiveness research that may inform investigators as they seek PCORI funding. As this is not central to PCORI research, no change is proposed to the priorities or agenda. Recommends exploring novel methods to obtain patient centered PCORI supports the approach of exploring innovative methods for focusing on the focus patient. The fundamental basis of PCOR, however, is the science of evidence-based medicine. PCORI will support and promote approaches that seek rigorous, scientific results; therefore no changes were made to the document. Recommends that PCORI study rare diseases PCORI recognizes the challenges faced in studying rare diseases. In the Research Agenda, language about rare disease has been expanded.26
    • 27. Discussion
    • 28. Vote on Changes Outlined in Slides 13-15
    • 29. Thanks  PCORI Stakeholders  Thank you for your thoughtful input into the first version of the PCORI National Priorities for Research and Research Agenda  PCORI Program Development Committee  Thank you for all your hard work in the development and refinement of these documents  The detailed Summary Document of changes to the National Priorities and Research Agenda will be posted on pcori.org by April 30, 201229
    • 30. Patient-Centered Outcomes Research InstituteSpecial Public Board of Governors Webinar and Teleconference April 25, 2012

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