PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE PCORI Board of Governors Meeting Washington, DC September 24, 2012 Anne Beal, MD, MPH, Chief Operating Officer.

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Presentation transcript:

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 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

Questions for Board Consideration 11 Is this the right scope for advisory panel activities? 22 Please comment on the proposed number and type of panels. 2

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

Advisory Panels: Purpose Advisory Panels will assist PCORI staff and Board in: – Modeling robust patient and stakeholder engagement efforts, – Refining and prioritizing specific research questions, – Providing other scientific or technical expertise – Addressing other questions that may arise relevant to PCORI’s mission and work 4

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

Proposed Advisory Panels Patient Engagement Assessment of Prevention, Diagnosis and Treatment Options Health Disparities Improving Healthcare Systems Communication and Dissemination Infrastructure* Randomized Clinical Trials* Rare Diseases 6 *in collaboration with MC

Patient Engagement Assessment of Prevention, Diagnosis, and Treatment OptionsHealth Disparities Improving Health Care Systems First Panels: First Half of

Communication and Dissemination InfrastructureRandomized Clinical Trials* Rare Diseases* Future Panels: Second Half of *Required by statute

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

Composition Advisory Panel size will be panel members, depending on the panel’s purpose Membership of each Advisory Panel will be selected based on the scope of work established in the charter 10

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

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

Board, MC, and/or PCORI staff identify the need to establish an Advisory Panel Staff initiates request for an advisory panel by submitting a panel-specific charter Board, MC, and/or PCORI staff identify the need to establish an Advisory Panel Staff initiates request for an advisory panel by submitting a panel-specific charter Board may authorize charter (proceed to step 3) Board may request revisions to the charter (return to step 1) Board may authorize charter (proceed to step 3) Board may request revisions to the charter (return to step 1) Staff initiates open call for nominations, via the PCORI Web site and other communications Nominees submit an expression of interest, via the PCORI Web site Staff evaluates nominees, per evaluation criteria unique to the panel charter Staff initiates open call for nominations, via the PCORI Web site and other communications Nominees submit an expression of interest, via the PCORI Web site Staff evaluates nominees, per evaluation criteria unique to the panel charter Staff selects and proposes a panel roster to the Board Board authorizes and approves the panel roster Staff selects and proposes a panel roster to the Board Board authorizes and approves the panel roster Advisory Panel Establishment Process Staff Activates Nomination and Selection of Panel Participants Board Approves Panel Participants Staff Draft and Submit Charter for an Advisory Panel Board Reviews the Proposed Advisory Panel Charter Staff PhaseBoard Phase 13

Patient Engagement Assessment of Prevention, Diagnosis, and Treatment OptionsHealth Disparities Improving Health Care Systems First Panels: First Half of

Proposed Panel: Patient Engagement Purpose: Assure the highest patient engagement standards and patient-centeredness in all aspects of PCORI’s work Term: 1 year Membership: Between 10–21 members with 75% patients, caregivers, and advocacy organizations and 25% researchers and other stakeholders Advisory Panels will provide advice and make recommendations to PCORI and help inform decisions of the Board of Governors, the Methodology Committee, and Institute staff, as requested 15

Proposed Panel: Patient Engagement Selection Criteria Patients and caregivers who can represent the collective voice of their communities/networks Online communities and organizations with extensive reach into high priority populations Represent underserved/disparate populations and those with rare diseases Experience in patient-centered research/proposal review Involvement in systems improvement Community- or state-based 16

Questions for Board Consideration 11 Is this the right scope for advisory panel activities? 22 Please comment on the proposed number and type of panels. 17

BOARD VOTE: Recommend Approval to Develop Advisory Panels Patient Engagement Assessment of Prevention, Diagnosis and Treatment Options Health Disparities Improving Health Care Systems