1

Patient-Centered Outcomes Research Institute

Program Development Committee(PDC) Report

PCORI Board of Governors Baltimore MD March 5, 2012

2 2

Update on PCORI Pilot Projects

PPP

3 3

PPP Selection Committee

Chair: Gray Norquist

Advisor: Christine Goertz non-voting

Members:

Kerry Barnett

Carolyn Clancy

Arnie Epstein

Gail Hunt

Steve Lipstein

Sherine Gabriel

Clyde Yancy

Joe Selby

4 4

Pilot Projects Deliberations Process

Working Group

• Determines specific criteria to be considered by the PCORI Selection Committee in determining and recommending an appropriately balanced slate of awards.

PCORI Selection Committee

• Meets to review materials.

• Considers the balance of priority-scored applications across selected criteria, requesting additional analysis and options from staff, as needed.

• Prepares a recommended slate of selected projects for funding consideration.

Board of Governors

• Meets to consider the recommended slate.

• Reviews the slate based on priorities and balance to ensure appropriate distribution.

• Requests additional options, if needed.

• Approves a final slate of selected projects for funding.

PCORI Staff

• Analyzes the applications using priority score and the criteria.

• Provides a list of award options based on Working Group recommendations.

• Supports the PCORI Selection Committee and Board of Governors by providing revised options, as needed.

Initial recommendations made. Under review by Methodology Committee

5 5

Balance Criteria

Priority Score

Among Highest Scoring Applications

Area of Interest

Population

Methods

Geography

Discipline of PI

Seniority of PI

Condition

Stakeholder/Patient Involvement

6 6

12/26 1/9 1/23 2/6 2/20 3/5 3/19 4/2 4/16 4/30 5/14 5/21 5/28

Merit Review (CSR)

Determine Balance

Criteria

Pull & Vet Data & Load

Spread Sheet

Selection Committee

Recommendations

Development of Funding

Recommendations

Board Deliberations &

Final Decisions

Business Review Process

Awards Process

Pilot Projects Timeline

Merit Review Scores Received

Announcements Made

Present to Board/Board Consideration

Present to Board/Board Consideration

Present to Board/Board Consideration

7

PCORI Peer Review Evaluation

Post Survey Instrument

- NIH administered PCORI-developed stakeholder and scientist

surveys at the end of the merit review to gain insights into

the review experience

Observational Instrument

- Instrument was completed by PCORI observers in

attendance at 10 randomly selected review meetings

Merit Score Data

- We have data on preliminary and final scores for each

application, including information on the six PCORI Review

Criteria

8 8

Update on PCORI Pilot Projects

Public Comment Results

9

Public Comment Process and Timeline

Aggregate/Analyze Input

1

Assess Suitability of Themes

2

Conduct Initial Evaluations

3

Preliminary Voting

4

Voting Conference to Reach Consensus

Recommendations

5

Recommend Changes for Board Decision

6

March 15-March 26

March 27

March 28-April 6

April 9

April 11 (PDC F2F)

April 17 (Open meeting being planned)

Staff

PDC*

Staff

PDC*

PDC*

PDC*/Staff

*Any interested Board/MC Member is welcome to participate

10 10

Public Comment Analytics

11 11

Public Comment Analytics

12 12

Update on PCORI Pilot Projects

May, 2012 PFA Process and Timeline

13

1 2 3 4 5 6 7 8 9

Month Jan Feb Mar Apr May Jun July Aug Sept

Designate PFA WG Leads

Hire (Contract) PFA Writers

Draft Broad PFAs (May PFAs)

Targeted Priority #5 PFAs (July)

1st Draft of Literature Review; Knowledge Gaps; Example Questions

Incorporate PPP Input

Revised Version Incorporating Comments

Finalized PFA

PDC Calls

PDC F2F

Board of Governors’ Call

Board of Governors’ F2F

Grants Management Process

MC Report

Incorporate Public Comment Input

Timeline for Development of First PFAs

1

2

PFA WG Membership Specificity for May Announcements DECISIONS

Red Board of Governors Meetings Green Program Development Committee Milestones Purple Staff Blue Methodology Committee LEGEND

1 2

14

PFA prepared by PCORI staff, contracted research organization (CRO) and Board participants

CRO’s sign confidentiality agreement and are barred from submitting application to any of the 5 PFAs until 3rd round – March 2013

Open competition

Applications reviewed by CSR a la PPP’s

Successful applications administered by PCORI

Current Plans – Priorities 1 - 4

15

National Priority Board/MC Member 1

Board/MC Member 2

Board/MC Member 3

PCORI Staff Scientist

Identified

Comparative Assessment of Options for Prevention, Diagnosis, and Treatment

Harlan Krumholz

RFP Issued

Improving Healthcare Systems Arnie

Epstein Christine Goertz

Leah Hole-Curry

RFP Issued

Communication and Dissemination Research

Gray Norquist

Dominick

Frosch

Addressing Disparities Carolyn Clancy

Anne Beal

RFP Issued

Accelerating PCOR and Methodological Research

Michael Lauer

Jean Slutsky

Contract

with AHRQ/NIH

PFA Development Teams

16

Proposed Plan for Priority #5

• PFA written by PCORI staff, AHRQ staff, NIH staff, MC

• Separate Funding Announcement (i.e., separate from that written for analytic methods)

• Solicitation and Review managed by AHRQ and NIH through contracts from PCORI to AHRQ and NIH

• “Focused Competition” – with clear data and governance requirements, including engagement of relevant stakeholders

• Funding through Cooperative Agreement grant mechanism with shared as well as project-specific goals.

Clinical Research Data Infrastructure

17

Rationale for Contracting with AHRQ

• AHRQ and NIH have years of experience in this area that will be invaluable in helping to write the PFA and overseeing the research

• We have a clearer idea of gaps and opportunities– the PFA must be fairly specific (i.e., targeted)

• AHRQ and NIH staff have knowledge of current state of the science

• The proposed funding arrangement is a cooperative agreement, where grantees work together with PCORI, AHRQ, and NIH

• AHRQ and NIH have expertise running cooperative agreements

• The statute explicitly encourages PCORI to contract with AHRQ, NIH and other federal funders of CER; experience of AHRQ and NIH efficiency and value for taxpayers

18

Analytic Methods

• Close collaboration with the MC

• AHRQ and NIH have a long track record of working on CER/PCOR methods research – having them involved helps minimize risks of redundancy

• PFA is more likely to be targeted than priorities 1-4 but probably not as targeted as that for research data infrastructure.

• Not as clear this would be a cooperative agreement, though it could be.

19

March 5, 2012

Patient-Centered Outcomes Research Institute

PCORI Dissemination Workgroup

20

Carolyn Clancy, Co-Chair

Sharon Levine, Co-Chair

Lawrence Becker

Allen Douma

Howard Holland

Gail Hunt

Freda Lewis-Hall

Steve Lipstein

Brian Mittman

Robin Newhouse

Grayson Norquist

Jean Slutsky

Members of the Workgroup

21

Dissemination Accelerating Components: Proposed Checklist

Identify stakeholders (stakeholders include patients, caregivers, clinicians, communities, policy makers and institutions) relevant to your proposed study

Describe at which points in your proposed study stakeholders will be engaged

Describe how you will engage stakeholders at each identified point during the study and at its conclusion

Stakeholders

Engagement

Points

Engagement

Type

Governance

Plan

Please describe how you will develop a governance plan for the project that articulates specific roles and responsibilities for the research team and stakeholder groups and defines rules for decision making, especially in the context of different opinions

22

Dissemination Accelerating Components: Proposed Checklist (cont’d)

Describe how conflicts – true and perceived – will be managed

Describe how you will convey study results to stakeholders and study participants

Please describe how you will assess barriers and facilitators to incorporating the results into practice, beyond communicating the study results to stakeholders

Conflict

Management

Study

Results

Barriers

Assessment