1. PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 1 PCORI Funding Announcement 5A: Methods Rachael Fleurence, PhD, Scientist Sherine Gabriel, MD, MSc, Chair, Methodology Committee PCORI Board of Governors Meeting Washington, DC September 24, 2012

2. 2 PCORI’s Research Agenda Five Board-Approved Priority Areas 1.Addressing Disparities 2.Communication and Dissemination 3.Assessment of Prevention, Diagnosis, and Treatment Options 4.Improving Health care Systems 5.Infrastructure and Methods

3. 3 Structure of Priority #5A/Methods Working Group Methodology Committee Members and Subgroups Patient Engagement Research Prioritization Research Methods Methodology Committee Members and Subgroups Patient Engagement Research Prioritization Research Methods Unidirectional Input PFA Development Subcommittee of the Methodology Committee -Naomi Aronson -Al Berg -Sherine Gabriel -Michael Lauer -Jean Slutsky -Clyde Yancy PDC/Board Representation: -Rick Kuntz PCORI Staff: -Executive Leadership: Joe Selby -Scientific Staff: Rachael Fleurence -Project Management PCORI Sr. Advisor and Staff to advise on firewall/COI issues as needed Working Group Structure Enables MC Feedback While Protecting Members From COI

4. 4 Combing Existing Sources for Research Questions, Comments, Gaps Methodology Report: -Research recommendations -Recommended actions -Text of the report -Review of 18 standards that were not included in the first draft of the report Review of the 17 Contractor Reports commissioned by the MC to develop the Report Summaries from Methodology Workshops held in March 2012, Baltimore

5. 5 Areas of Interest Methods for Patient Centeredness Methods for Research Prioritization General and Design-Specific Analytic methods

6. 6 Major Milestones Ahead for #5A Work First Draft of Methods PFA (PCORI Science Staff, in progress) First Draft of Methods PFA (PCORI Science Staff, in progress) Distill, incorporate public comments to Methodology Report as needed, as available (comments due 9/15) Adapt existing PCORI review criteria from current PFAs to meet Methods needs Share with PDC and Full Board for Comments PFA Development Subcommittee of the Methodology Committee reviews, revises first draft of Methods PFA Announce and Post Methods PFA to PCORI Web site (anticipated Nov., 2012) Announce and Post Methods PFA to PCORI Web site (anticipated Nov., 2012)