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Board of Governors Meeting, South Sea Tea Washington

This document provides a summary of the September 19, 2011 report from the Communications, Outreach and Engagement Committee (COEC) of the Patient-Centered Outcomes Research Institute (PCORI). The summary includes updates on recent public input opportunities, promoting PCORI funding opportunities, redesigning the PCORI website, outreach plans, and growing the PCORI communications staff.

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PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE September 19, 2011 Patient-Centered Outcomes Research Institute Communications, Outreach and Engagement Committee (COEC) Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE COEC Members 2 • Sharon Levine, MD (Chair) • Debra Barksdale, PhD, RN • Robert Jesse, MD, PhD • Grayson Norquist, MD, MSPH • Ellen Sigal, PhD • Harlan Weisman, MD
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE COEC Charter 3 The Communication, Outreach and Engagement Committee shall advise and assist the Board of Governors of PCORI, and provide recommendations to the Board, regarding: 1. The Institute’s communications and branding work, 2. Strategies to engage all stakeholders in the work of PCORI, and 3. Methodologically sound approaches to disseminating and implementing the research results and ensuring their utility to patients and clinicians
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE COEC Report to the Board 4 I. Recent Opportunities for Public Input (Update) II. Promoting PCORI RFPs (Update) III. Redesigned PCORI Website (Update) IV. Outreach Plan for Pilot Project Funding Announcement (Recommendation for Decision) V. Stakeholder Outreach (Update) VI. Speakers Bureau (Update) VII.PCORI Communications Staff (Update)
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Recent Opportunities for Public Input 5 • Working definition of “patient-centered outcomes research” – Nearly 600 responses were received (July 20-September 2, 2011) – All responses received through the website or emailed PDFs will be posted on pcori.org – PCORI issued an RFP to solicit proposals for the analysis and summarization of the input received and for recommendations on methodologies to receive further input from patient audiences
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Analysis and Summary of Input on Working Definition of PCOR 6 Issue RFP (and reach out to potential applicants) August 24, 2011 Deadline for applications September 9, 2011 Complete review of applications September 16, 2011 Complete contract with chosen contractor September 19, 2011 Submit Phase I findings and draft questions for focus groups September 30, 2011 PCORI completes revision of PCOR Definition October 26, 2011 Revise questions for focus groups November 9, 2011 Focus Groups (or other way of seeking patient input) November 18, 2011 Report due to PCORI December 16, 2011 (with preliminary report in time for December 8 meeting) PCORI completes further revisions of PCOR Definition January 15, 2012 PCORI Board considers revised PCOR Definition January 18, 2012
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Working Definition of PCOR: A Foundation for PCORI’s Work 7 • At the time of PCORI’s creation, “patient-centered outcomes research” (PCOR) was not a commonly used term, nor had it been formally defined • Defining PCOR helps clarify PCORI’s focus and scope of work • Through iterative and transparent processes that elicit feedback from all stakeholders, including patients, we will continue to revise the definition, ensuring it: – Emphasizes the “patient-centered” focus of PCORI’s mission – Is consistent with the intent of the statute that established PCORI – Is broad enough to support the range of research PCORI should fund
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Recent Opportunities for Public Input 8 • Initial topics for PCORI pilot projects. – More than 150 responses were received (August 1-30, 2011) – Responses provided to the PDC Working Group to review and update topics as appropriate. • 89.26% Self Identified • 10.74% Anonymous • 59.76% Responded as Individual • 40.27% On behalf of an Organization Respondents • 40.94% Academia • 23.49% Provider • 17.45% Patient • 3.36% Industry • 0.67% Government • 11.41% Non-Identified Organizational Respondents
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Promoting PCORI RFPs 9 • To date PCORI has issued 4 Requests for Proposals (RFP) – Analysis of Input Received on Working Definition of “Patient-Centered Outcomes Research” – Review and Synthesis of Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research (Literature Review) – Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research (Interviews) – Methods for Setting Priorities in Research (White Papers) • For each RFP, PCORI performed outreach to: email list subscribers (620+), supplemental lists of clinical and translational research centers (60+), academic research institutions (30+), and provider and advocacy organizations (30+) • PCORI is an independent, non-profit, non-governmental organization. All PCORI funding announcements will be posted on pcori.org. PCORI funding announcements will not be published in the Federal Register
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Redesigned PCORI Website 10
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Redesigned PCORI Website 11 • Includes visual changes based on logo and color palette approved at July Board Meeting • Designed to be more user friendly • Will support the expansion of PCORI content and opportunities for interaction as work progresses • Expanded features include: – Easier mechanisms for joining PCORI mailing list and providing general input – An “Executive Director’s Corner” that provides regular updates on PCORI’s latest developments
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Outreach Plan for Pilot Project Funding Announcement 12 • Post announcement on pcori.org • Direct email to stakeholders and potential applicants • Conduct proactive media relations • Promote the opportunity though grassroots outreach • Integrate the announcement with speakers bureau presentations • Host a Q&A teleconference for applicants
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Stakeholder Outreach 13 PCORI’s engagement with stakeholders around Board meetings • Stakeholder discussion forum March St. Louis, MO • Stakeholder discussion forum May New York, NY • Two small group meetings with patients and caregivers • Eight small group meetings with 43 stakeholder organizations July Washington, DC • Invited presentations from Northwest Pacific stakeholders September Seattle, WA • Site visits to clinical care facilities November New Orleans, LA
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Seattle Stakeholder Engagement Forum 14 • PCORI has invited individuals and organizations from the Pacific Northwest to make brief presentations to the Board about their work or perspective and how it can inform PCORI’s work • Native American/Alaska Native perspectives • Complementary and alternative medicine researchers and providers • Outcomes and comparative effectiveness researchers • Monday, September 19, 7:00-9:00 p.m. PT • Open to the public
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Speakers Bureau 15 PCORI has presented at 24 meetings since March Recent Speaking Engagements • 7/25 – IOM CER Innovation Collaborative Meeting • 7/25 – Center for Medical Technology Policy CER Institute • 8/12 – Consumers United for Evidence Based Health Care Annual Meeting • 8/25 – Florida Chiropractic Association National Convention & Expo • 9/9 – University of Michigan School of Nursing • 9/16 – Oregon Institute for Patient-Centered Comparative Effectiveness Annual Research Intensive Upcoming Opportunities • 9/27 -- AdvaMed 2011 MedTech Conference • 9/28 – Partnership to Improve Patient Care Annual Membership Forum • 10/11 – NIH National Center for Research Resources Clinical and Translational Science Awards Program • 10/12 – Comparative Effectiveness Research Summit • 10/12 – American Academy of Nursing, Council of Advancement of Nursing Science 2011 Special Topics Conference • 10/19 – Health Industry Forum • 10/20 – Pfizer Health Advocates Leadership Breakfast
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE PCORI Communications Staff 16 • Seeking applicants for three positions: – Director of Communications – Director of Patient Engagement – Director of Stakeholder Engagement • Staff will develop and implement strategic communications plan • Distinct engagement officers for patients and other stakeholders, recognizing their need for different engagement mechanisms
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE September 19-20, 2011 Seattle, WA Executive Director Update Board of Governors PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Objectives for today  Highlight PCORI Activities since July 2011 BoG Meeting  Discuss Growing the PCORI Staff  Consider Critical Timelines/Milestones for Next 9 Months
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE PCORI Activities – (Staff, Board, MC together)  Establishing Policies and Practice  HR Policies  Purchasing/RFP policies  COI policies  Research Policies  Re-designing Website  Outreach  Developing IT Infrastructure  Growing Staff  Finding Long-term Space
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 4 • $48 per sq. foot • Attractive, not • extravagant • 13,000 sq feet • Close to Metro • Green building • Move-in: February PCORI’s Long-Term Home 1828 L Street, DC
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Urgent Issues Coming Out of July BoG Meeting:  Address the need for greater clarity in decision-making and take steps to find more time for substantive discussions among board, with MC  Patient Engagement! - Officer, Advisory Panel  Get started on the National Priorities and Research Agenda!  Support the PDC in preparing PCORI Pilot Projects RFP and review  Support the MC in getting the RFPs out for the Methodology Report
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Patient Engagement 6  Patient-Engagement Working Group formed;  Job Description for Director of Patient Engagement drafted  Directors of Stakeholder Engagement and Director of Communications Added  All three positions are posted and a search is underway Patient Engagement Communi- cations Stakeholder Engagement External Engagement
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Program Development Committee National Priorities and Research Agenda • C Clancy and A Epstein, co-chairs • Environmental scan on past CER analysis and developed an initial framework for the National Priorities which will serve as the foundation for developing specific priorities • Recognized the close link between the National Priorities and Research Agenda (H Krumholz and L Hole-Curry, co-chairs) • Developed a timeline and notional process for engaging stakeholders as part of the National Priorities development timeline
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Developing PCORI’s National Priorities and Research Agenda 8 Collect Stakeholder Input Develop Candidate Priorities Public Comment Finalize Priorities Develop Candidate Priorities Underway Sept - Nov Dec-Feb March Collect Stakeholder Input Public Comment Finalize Research Agenda April Feb - Mar Sept - Jan PRIORITIES: RESEARCH AGENDA:
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Program Development Committee PCORI Pilot Projects  C Goertz and G Hunt co-chairing this process.  Public Input has been reviewed and incorporated into revised “areas of interest” in the PCORI Funding Announcement (PFA)  An application form and instructions have been developed and revised  Working closely with NIH staff on defining each step in the application and review process
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Supporting Methodology Committee  Interim researcher process established; at least one already working  RFPs (2) for Patient-centeredness Working Group posted  RFP (1) for Research Prioritization Working Group posted  Review Process in Development, including COI policies for review
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Definition of PCOR  Input on the working definition of “patient-centered outcomes research” gathered (n=600); to be posted shortly after anonymization  RFP posted for qualitative analysis and summarization of the input received and for recommendations on methodologies to receive further input from patient audiences posted on PCORI website  12 responses received and reviewed  First PCORI research contract issued on 9/16 to National Opinion Research Center II MC I 9/16 9/30 11/15 12/31 Synthesis & Question Generation Revision of Definition Testing of Revised Definition Preparation of MS for Publication Led by MC
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Three Engagement Directors Applications Arrive LOI’s Arrive Growing PCORI Staff: 09/18/11 – 09/20/11 We are here 11/1/11 2/1/12 05/1/12 04/1/12 1/1/12 COO Begins Mark In! Director Finance Begins First Scientists Additional Scientists Additional Admin Ass’ts Director of Staff 12/1/11 3/1/12 Funding Decision Made Funding Issued Program Staff Hiring Begins Finance/Grant Staff
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Growing PCORI Staff 13 Research Scientist Patient engagement Research Research Scientist Stakeholder Engagement Research Scientist Communicaiton/Disseminat ion Research Research Scientist(s) Comparative Clinical Effectiveness Research Director Patient Engagement Director* Stakeholder Eng. Director Communications Chief Financial Officer (CFO) Director HR Director Director Grants Management Research Scientist(s) Evidence Synthesis External Engagement Executive Director Chief Operating Officer Chief Science Officer
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Critical Issues: September 2011 – June 2012 14  Gathering Stakeholder Input on National Priorities and Research Agenda  Thorough, balanced, incorporated September – November: November- December:  Finalizing First Draft of Priorities (Prior to Public Comment)  How are Priorities expressed, what’s in, is anything out? January – February:  Finalizing First Draft of Research Agenda (Prior to Public Comment)  What (specifically) is in, out – what will the first RFAs fund?  Data Infrastructure Grants?  Translation/Implementation Research?  Systems research?  Pharmacogenetics?  Large clinical trials?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Finance & Administration Committee September 20, 2011, Seattle, WA PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Bylaws Revisions • GAO currently reviewing • Committee Name Change: Finance, Administration & Audit • Adoption Proposed at November BOG Meeting
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Audit Update • Released this week • Bidders selected by annual revenues • Proposals by end of October • Recommendation to BOG • Field work in November/December • Completed audit by March • Provided to GAO for report to Congress due April 1st
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Financial Statements – August 31, 2011 • Statement of Financial Position: Total Assets of $46.3M; $5M Cash on Hand • Expenditures: – Budget: $7.5M – Actual: $3.7M – Positive variances in Board compensation, management fees, professional services, travel – Negative variance in conferences
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Conflicts of Interest Policy • Working group created Members: Larry Becker, Chair Debra Barksdale Arnie Epstein Sherine Gabriel Bob Jesse • Group is gathering key documents
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 1 September 19, 2011 PCORI Methodology Committee Progress Report Sherine E. Gabriel, MD, MSc Sharon-Lise T. Normand, PhD PCORI Methodology Committee
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 2 • Establishment • Overview • Timeline • Structure • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps Agenda
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 3 Methodology Committee Charge Establishes priorities to address gaps in research methods and their application The Methodology Committee shall make recommendations regarding methods for patient-centered outcomes research Provides guidance about the appropriate use of methods
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 4 Methodology Committee Structure Methodology Committee Co Chairs: Sherine Gabriel, MD, Mayo Clinic & Sharon-Lise Normand, PHD, Harvard Medical School Patient-Centeredness Research Prioritization Methods to incorporate the patient perspective into all phases of PCOR Methods to inform prioritization of new research studies Methods for using data, design, and statistical analyses to conduct PCOR Research Methods Report Assimilation
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 5 Methodology Committee Activity Timeline Research Methods Aug „11 Oct „11 Nov „11 Dec „11 Patient- Centeredness Jan „12 Feb „12 Mar „12 Apr „12 May „12 Workshop Final Report Workshop Identify Gaps/ Issues Translation Table/Tool Workshop Final Papers Due Final Draft Final Report Final Report Compile First Draft Legend Research Prioritization Report Assimilation Feb – Jul „11 Revise Report Outline & Edit Chapters Final Report Final Papers Due Electronic Data Systems Landscape Review Identify & Implement Voting Standards Process Solicitations: White Papers/Identify Experts Solicitations: Literature Review & Interviews MC Charter MC Work Plan Interim Researchers Staffed PCOR Definition Solicitation Commission White Papers Sep „11
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 6 Methodology Committee Discussion Points • Importance of methods generated by Patient Centeredness Work Group for incorporating patient engagement • Importance of methods generated by Research Prioritization Work Group vis-à-vis prioritization framework set by the board • Generation of tools/standards for Methods Report is a multiyear process • Importance of continuing to interact with Board to ensure coordination of efforts • Board/Methodology Committee teleconference calls were a productive forum to receive input from the Board regarding their needs and priorities
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 7 • Establishment • Overview • Structure • Timeline • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 8 Patient-Centeredness Workgroup Ethan Basch, MD Memorial Sloan-Kettering Cancer Center Workgroup Chair Mary Tinetti, MD Yale University School of Medicine Workgroup Co-Chair Naomi Aronson, PhD Blue Cross and Blue Shield Workgroup Member Brian Mittmann, MD VA Center for Implementation Practice & Research Support Workgroup Member David Flum, MD, MPH University of Washington Report Assimilation Group Liaison
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 9 - Patient Centeredness Mission/Scope of Work Development and prioritization of research questions Identify methodological standards for incorporating the patient perspective into three key areas: Design of study components, including selection of interventions, comparators, and outcomes (including patient-reported outcomes) Processes of clinical decision-making/care delivery
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 10 Patient Centeredness Progress to Date Released RFP for Literature Review Released RFP for Interviews “Review and Synthesis of Evidence for Eliciting the Patient‟s Perspective in Patient-Centered Outcomes Research” “Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient‟s Perspective in Patient-Centered Outcomes Research”
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 11 Proposals Due Awardee Announced Final Report Due Oct 6, 2011 Oct 13, 2011 March 1, 2012 Issue Open RFI Plan Workshop Develop Sections for Methodology Report Patient Centeredness Next Steps
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 12 Patient Centeredness Question How does this work complement ongoing and planned activities of the Board?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 13 Research Prioritization Workgroup David Meltzer, MD, PHD University of Chicago Department of Medicine Workgroup Chair John Ioannidis, MD, DSc Stanford Prevention Research Center Workgroup Member Jean Slutsky, PA, MSPH Agency for Healthcare Research and Quality Workgroup Member Clyde Yancy, MD Northwestern University Feinberg School of Medicine Workgroup Member Alfred Berg, MD, MPH University of Washington Department of Family Medicine Report Assimilation Group Liaison
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 14 Research Prioritization Mission Mission To provide guidance concerning the use of methods to inform the establishment of research prioritization approaches that best fulfill PCORI’s mission. • To the PCORI Board to aid in development and future refinement of Research Priorities] • To the broader multi-stakeholder communities to enhance understanding of PCORI’s approach to research prioritization and to encourage their engagement in PCORI’s research prioritization process
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 15 - Commission White Papers To prepare a section for the May 2012 Methodology Committee Report that addresses methods to inform the establishment of research prioritization Synthesize White Papers during January 2012 Workshop Research Prioritization Scope of Work Topic Generation Gap Analysis in Systematic Reviews Value of Information Analysis Peer Review Suggest strategies to identify possible future priority areas Suggest standards for how PCORI systematic reviews should be performed and used to generate research topics Provide PCORI Board and/or grant applicants with tools to quantify expected benefits of research to inform priorities Provide data to inform how PCORI might design, evaluate and continually improve its peer review process
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 16 Research Prioritization Progress to Date Identified Methodological Areas of Interest in Research Prioritization Identified Interim Researcher to Assist Workgroup Released RFA for White Papers on September 9, 2011
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 17 White Paper Proposals Due Review and select among White Paper proposals Awardee Announced Sept 30, 2011 Oct 1- 13, 2011 Oct. 14 2011 Explore the role of research prioritization methods vis-à-vis the broader PCORI research prioritization process Engage researchers as needed to fill in expected gaps from White Papers Research Prioritization Next Steps
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 18 Research Prioritization Question How can we best work with you to understand your evolving plans for research prioritization so the methods we are studying can be of most use to you?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 19 Research Methods Workgroup Steven Goodman, MD, MHS, PHD The John Hopkins University School of Medicine and Public Health Workgroup Chair Mike Lauer, MD National Institute of Health National Heart, Lung, and Blood Institute Workgroup Member Robin Newhouse, PHD RN University of Maryland School of Nursing Workgroup Member Sebastian Schneeweiss, MD, ScD Harvard Medical School Workgroup Member Mark Helfand, MD MPH MS Oregon Health & Science University School of Medicine Report Assimilation Group Liaison Sharon-Lise Normand, PHD Harvard Medical School Methodology Committee Chair
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 20 - Develop Translation Table/Tool (from research question to design and analysis) Identify Standards for the use of data, design, and statistical analyses to conduct patient centered outcomes research through: Review current methodological “state of the art” statements issued by expert bodies to guide PCORI research Research Methods Mission/Scope of Work Review existing data systems designed to permit exploration of causal questions from data gathered in the course of clinical practice. Identify PCORI role in this arena.
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 21 Research Methods Progress to Date Established initial specifications for dimensions to be used in translation instrument, with options for implementation Developing prototype for standards documents that combines expert statements, published examples and PCORI MC input Interviewing leading researchers of electronic data, from which research and methods recommendations will be developed
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 22 Research Methods Progress to Date (Detailed) Framework for Methods Standards / Recommendations 1. Method 2. Key sources 3. Major recommendations 4. PCORI MC commentary 5. Published examples 6. Tools for researchers Translation Table Dimensions Intrinsic Factors • Internal validity (aka bias) • External validity (aka generalizability, transportability) • Precision • Heterogeneity in risk or benefit (aka “personalized” evidence) • Ethical dimensions Extrinsic Factors • Timeliness (Rapidly changing technology, policy urgency) • Logistical burden (e.g. study size, complexity, cost) • Constraints (Data availability, randomization possible?) Question: condition, population, treatment & comparator, outcomes, setting
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 23 Finalize translation table dimensions and determine categories of development Finalize “standards” document format and determine categories of development Finish and summarize electronic data systems environmental scan Research Methods Next Steps (e.g. diagnostic tests, missing data, systematic reviews, etc.) (e.g. drug safety, therapeutic efficacy, etc.) Jan. 2012 Workshop
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 24 Research Methods Question Can the Board provide feedback on the preliminary formats developed (i.e., translation table dimensions and methods standards format)?
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 25 Report Assimilation Workgroup Mark Helfand, MD Oregon Health & Science University School of Medicine Workgroup Chair Alfred Berg, MD, MPH University of Washington Workgroup Member David Flum, MD, MPH University of Washington Workgroup Member Howard Balshem, MS Oregon Health & Science University Interim Researcher Sherine Gabriel, MD Mayo Clinic Workgroup Member Sharon-Lise Normand, PHD Harvard Medical School Workgroup Member
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 26 • Establishment • Overview • Structure • Timeline • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 27 Solicitation Responses and Questions Received to Date Methodology Committee Next Steps Letters of Intent Received** Questions Patient Centeredness WG -- Stakeholder Interviews 25 8* Patient Centeredness WG - Literature Review 26 4* Research Prioritization WG - White Papers 11 0 **as of 9/16 at 8:30 a.m. *This number of questions includes a document containing 13 individual sub-questions.
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 28 Administrative Review Content Review Programmatic Review Executive Decision 1. Clear, transparent and reproducible review process based on best practices (eg. NIH) 2. Aligned with PCORI Vision, Mission, Principles and Policies (eg CoI) 3. Timely (~Applicants notified of award two weeks after submission) Will be Established prior to receipt of first response (September 30, 2011) Solicitation Review Process and Principles Methodology Committee Next Steps
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 29 Methodology Committee Next Steps Research Methods Aug „11 Sep „11 Oct „11 Nov „11 Dec „11 Patient- Centeredness Jan „12 Feb „12 Mar „12 Apr „12 May „12 Workshop Final Report Workshop Identify Gaps/ Issues Translation Table/Tool Workshop Final Papers Due Final Draft Final Report Final Report Compile First Draft Legend Research Prioritization Report Assimilation Feb – Jul „11 Revise Report Outline & Edit Chapters Final Report Final Papers Due Electronic Data Systems Landscape Review Identify & Implement Voting Standards Process Solicitations: White Papers/Identify Experts Solicitations: Literature Review & Interviews MC Charter MC Work Plan Interim Researchers Staffed PCOR Definition Solicitation Commission White Papers
PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE 30 Thank You!
Presentation to PCORI Board of Governors September 20, 2011 PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE: Program Development Committee
Program Development Committee Committee Members • Carolyn Clancy • Francis Collins • Arnold Epstein • Christine Goertz • Leah Hole-Curry • Gail Hunt • Harlan Krumholz • Richard Kuntz Methodology Committee Representatives • Sherine Gabriel • Sharon-Lise Normand
Report Outline  PCORI Pilot Project Grant Program  National Priorities and Research Agenda  Landscape Review Program Program Development Committee
Presentation to PCORI Board of Governors September 20, 2011 Christine Goertz, DC, PhD PCORI Pilot Projects
Report Outline: • Purpose of PCORI Pilot Projects • PCORI Funding Announcement - Key Highlights • Areas of Interest • Overview of the Four-Stage Review Process • Application Review Criteria • Grant Application & Instructions • Webinar & Process to Handle Inquiries • Timeline, Key Dates, and Activities
Purpose of PCORI Pilot Projects The purpose of the PCORI Pilot Projects Grant Program is threefold: 1. National Priorities. Pilot projects will provide information to PCORI that informs future iterations of national research priorities for patient centered outcomes research. 2. Research Agenda. The program will support the collection of preliminary data that can be used to advance the field of patient- centered outcomes research, providing the platform for an evolving PCORI research agenda. 3. Methodologies. The program will support identification of research methodologies that advance patient-centered outcomes research
PCORI Funding Announcement: Key Highlights  Applicants must address at least one of the eight areas of interest.  Stakeholder involvement is required unless the application can sufficiently explain why it is not feasible.  Expect to commit approximately $13 million in FY 2012 to support approximately 40 projects.  Applicants can propose project periods of up to two years. Second year funding is subject to noncompetitive review by PCORI staff.  Direct costs are limited to $250,000 per year with an additional 40% of salary and fringe allowable as indirect costs.  Letters of intent are due on November 1 with applications due on December 1.  NIH will conduct the merit review process with all other aspects of grant awards and grants management handled by PCORI.
Areas of Interest: Development Areas of Interest Board Members Methodology Committee Stakeholder / Public Input Projects focused on developing, testing, and/or evaluating methods or approaches that:  Inform the evolving National Priorities  Bring together different stakeholders  Translate research into practice  Identify gaps in relation to issues for disadvantaged populations  Identify predictors of patient outcomes
Areas of Interest 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. Developing, testing, and/or refining existing methods for bringing together patients, caregivers, clinicians including non-traditional partners, and other stakeholders in all stages of a multi-stakeholder research process, from the generation and prioritization of research questions to the conduct and analysis of a study to dissemination of study results – including methods for training participants in participatory research and the potential use of new technologies to facilitate engagement. Developing, refining, testing, and/or evaluating patient-centered approaches, including decision-support tools, for translating evidence-based care into health care practice in ways that account for individual patient preferences for various outcomes. This may include developing or comparing conceptual models of translation or dissemination of CER research findings from the patient perspective. 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; minorities; children; elderly; women; people with disabilities, chronic, rare and/or multiple medical conditions.
Areas of Interest Identifying, testing, and/or evaluating patient-centered outcomes instruments. This may include predictive tools (eg: instruments that measure or predict outcomes of interest to patients) or identifying standards for measurement properties of patient-reported outcomes for use in comparative effectiveness research, across a variety of interventions and patient populations. Identifying, testing, and evaluating methods that can be used to assess the patient perspective when researching behaviors, lifestyles, and choices within the patient’s control that may influence their outcomes. Identifying, testing, refining and/or evaluating methods for studying the patient care team interaction in situations where multiple options for wellness, prevention, diagnosis or treatment exist. Of special interest are strategies that respect patient autonomy and promote informed decision-making, incorporating the best health care knowledge into the application of care. Advancing analytical methods for CER. Examples include but are not limited to the incorporation of mixed methods research designs (qualitative/quantitative), identifying existing methodology to statistically accommodate irregularly spaced multivariate longitudinal data, the use of instrumental variables; and potential solutions for assessing treatment heterogeneity in observational and randomized CER studies.
Overview of the 4-Step Process Preliminary Check Merit Review Deliberation Business Determination that the application meets the minimum technical requirements enumerated in the PFA and fits within programmatic priorities. PCORI Responsive/eligible applications will be forwarded for review. Remaining applications are assigned to 3 reviewers with appropriate expertise who will critique independently and then meet to discuss and designate a final score. NIH A rank-ordered list of applications and summary sheets The Pilot Projects Review Committee considers the merit review scores and programmatic balance across several categories to develop a recommended award slate for consideration by the BOG. PCORI Funding decisions are made. A final review for suitability to manage an award, adherence to human subjects requirements, receipt of IRB approval, budget review, etc. PCORI Negotiations, where needed Description Responsible Result
Preliminary Check Technical Requirements • Receipt of Letter of Intent • Eligible applicant • Stakeholder requirements • Page limit and formatting requirements • Deadline met and application properly submitted Programmatic Requirements • Does the application fit within PCORI program requirements listed in the PFA? Transfer to NIH • Applications meeting both technical and programmatic requirements will be forwarded to NIH for the Merit Review. Conducted by PCORI staff
Merit Review Prior to the Review Meeting • Each application is assigned to 3 reviewers • Reviewers include scientists and other stakeholders • Stakeholders without previous review experience will be trained • Reviewers assign an initial priority score of 1 to 9 based on PCORI-provided review criteria • Provides basis for discussion at in person meeting In-Person Review • In-person meeting of reviewers to discuss the most promising applications • Review and discuss applications based on impact, stakeholder involvement, innovation, and significance of the science • Provide a final priority score of 1 to 9 • Scientific Review Officer compiles a summary statement with reviewer critiques for each application Summary & Rankings • The review process results in a ranked, scored summary of applications for PCORI consideration Conducted by NIH
PCORI Deliberations PCORI Staff • Analyzes the applications using priority score and classification categories. • Creates funding scenario options based on analytics. • Supports the PCORI Review Committee and Board of Governors by providing revised options, as needed. PCORI Review Committee • Meets to review materials • Considers the balance of priority-scored applications across classification categories, 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 Classification categories may include: Applicability of the 8 areas of interest, geographic distribution, research methodology, and identification of target populations.
Recommended Funding Slate Analysis Following the Review Committee meeting, analysts will prepare the recommended slate along with accompanying analysis for consideration by the Board of Governors.
Merit Review Criteria  Significance. Does the project address an important problem or a critical barrier to patient- centered outcomes research? Does the project address one of the key questions outlined in the PCOR definition described above? Is the project focused on one of the areas of interest identified in this PFA? Will the results produce new knowledge that can advance PCOR methods or infrastructure? Does the investigator demonstrate thorough knowledge of previous and ongoing work related to their proposed topic?  Patient/Stakeholder Engagement. Will the research make a unique contribution to learning about engagement of patients and non-traditional stakeholders in PCOR research efforts? Does the research team demonstrate authentic, feasible, sustainable, novel partnerships with patients, families and care givers, providers, and other appropriate non-traditional stakeholders? Is there evidence that non-traditional stakeholders were involved in the preparation of the research proposal?  Investigator(s). Is the research team well suited to the project? Is it multi-disciplinary? Is there appropriate scientific expertise? Does at least one member of the study team have experience in patient and other stakeholder engagement? Is there a high level of confidence that the Principle Investigator and rest of the study team will be able to achieve the study aims as described? Does the study team have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Merit Review Criteria (continued)  Innovation. Does the project either address a new method or approach or apply a proven method or approach in a novel way to the field of PCOR? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Will the strategy establish feasibility and will particularly risky aspects be managed? Is the proposed budget and timeframe appropriate for the research plan? Are there appropriate plans for dissemination among key PCOR stakeholders in education, practice and policy?  Environment. Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the research environment, community involvement, patient populations, or non-traditional stakeholder collaborative arrangements?
Grant Application & Instructions • Application is based on the NIH PHS 398 form with changes to ease responses and to meet the needs of PCORI. • Applicants will be bound by the Human Subjects policies of NIH and will include appropriate plans within the Research Strategy section. • Applicants will provide information related to classification categories to enable the Review Committee and Board to consider this information when developing a balanced slate for funding. Self-Reported Classification Categories: • Applicability of the “4 questions” to the research • 8 areas of interest • Identification of specific populations including: ― Underserved or disadvantaged populations ― Specific ethic or cultural populations ― Rural or urban populations ― Disabled populations
Webinar & Inquiry Process • Webinar for Applicants: October 12, 2011 at 2PM EST. • Policy for responding to inquiries: – A set of FAQs will be developed and issued along with the PFA with frequent updates posted on the PCORI website. Questions and answers will be framed in terms of general applicability. – Inquiries should be directed to the PCORI website at pcori.org. PCORI staff and appropriate consultants will receive, triage, route, and ensure answers are provided and shared generally through the website.
Timeline, Key Dates, and Activities 2011 09 /11 PFA Posted 11/01/11 Letters of Intent Due 12/1/11 Applications Due 11-12/11 Identification of Merit Reviewers 2012 12/11 Completeness/ Compliance/ Eligibility Check 2/12 Merit Review 3/12 Slate of Projects to Board & Selection Made 05/12/12 Award Notification & Funding PCORI Applicant NIH/PCORI Applicant PCORI NIH PCOR PCORI / Applicant
Questions? www.pcori.org
Request Approval
Arnold Epstein, MD Presentation to PCORI Board of Governors September 20, 2011 PCORI National Priorities Development
National Priorities are the critical beginning and will be dynamic Increasing Specificity National Priorities Research Agenda Individual PFAs
Develop Candidate Framework Engage Stakeholders Public Comment Finalize National Priorities Currently Underway September- November December- February March Proposed Timeline for National Priorities
Environmental scan of existing priorities and criteria Candidate priorities and criteria identified Framework to inter-relate Priorities and Criteria Reviewed initial stakeholder input advising us to not “reinvent the wheel.” Reviewed prior CER frameworks (e.g., IOM, FCCCER, National Priorities Partnership, NQF) Identified broad priorities and criteria that were used often in prior frameworks and fit PCOR. Framework to be used for refining priorities, and determining Research Agenda and PFAs. Initial Stakeholder feedback Development of a National Priorities Framework
Previous priorities have varied in granularity Granularity IOM 2009 (e. g., Compare the effectiveness of upper endoscopy utilization and frequency for patients with gastroesophageal reflux disease on morbidity, quality of life, and diagnosis of esophageal adenocarcinoma.) National Priorities Partnership (e. g., Engage patients and families in managing their health and making decisions about their care.) National Prevention Council (e. g., Elimination of health disparities) FCCCER (e.g., Expanding high-impact patient registries) National Quality Forum (e. g., Infrastructure – Information Technology) Least Most National Quality Strategy (e. g., Promoting effective communication and coordination of care)
Ten candidate priorities consistent with prior efforts Source Prevention Acute Care Chronic Disease Care Palliative Care Care Coordination Patient Engagement Safety Appropriate Use HIT to Improve Patient Experience Impact of New Technology IOM 2009: Priorities for CER √ √ √ √ √ √ √ √ √ Federal Coordinating Committee for CER √ √ √ √ √ AHRQ National Quality Strategy √ √ √ √ AHRQ Effective Health Care Program √ √ √ √ √ √ National Quality Forum √ √ √ √ √ √ √ √ National Prevention Council √ √ National Priorities Partnership √ √ √ √ √ √
Proposed criteria include those in statute and additional criteria Used in Prior Efforts Criterion Required in statute √ Impact on Health √ √ Improvability via Research √ √ Inclusiveness of Subpopulations √ √ Impact on Health System Performance √ √ Gaps in Knowledge √ √ Variation or Disparities in Delivery or Outcomes √ √ Potential to Inform Decision-Making at Point of Care √ √ Responsiveness to Expressed Needs √ Advances CER Methods Fits the Definition
•Impact on Health of Individuals and Populations •Probability of Improvability via Research •Inclusiveness of Different Sub-populations •Current Gaps in Knowledge / Variation in Care •Impact on Health System Performance •Current Health Disparities •Potential to Influence Decision-Making at Point of Care •Responsiveness to Expressed Needs •Advances CER Methods •Fits the Definition of PCOR Framework to Inspire Drafting of PCOR- Specific National Priorities Health Information to Improve Patient Experience Prevention & Screening Acute Care Impact of New Technology PCORI National Priorities (Illustrative Examples) Prevention & Screening Develop information that will guide patients and providers to improve outcomes in chronic conditions. Develop information to help patients coordinate their care across multiple providers and care settings. Develop evidence to help patients improve the safety of their health care. Appropriate Use PCORI Criteria Proposed PCORI Criteria Existing Priority Areas In Statute Chronic Disease Care Palliative Care & Pain Management Care Coordination Patient Engagement Safety
Stakeholder Engagement Guiding Principles Balanced Representation Transparency Facilitate Participation Enable an open engagement process that makes clear how participants can get involved and how their input will be incorporated Obtain feedback from a diverse and representative range of patients, health care stakeholders and the general public Provide easy, accessible forums for participants to provide feedback equitably
Stakeholder Engagement Overview Stakeholder Engagement Plan Identify Engage Track Assess Report
PATIENTS PROFESSIONAL ORGANIZATIONS Individuals with Disease Families Caregivers Patient Advocacy Groups General Public Providers & Practitioners Employers Payers Research Societies Academia Health Information Exchanges Federal/State/Local Government Congress Life Sciences Industry Who are PCORI’s stakeholders? Key Stakeholder Groups
Proposed Stakeholder Engagement Timeline Create Engagement Plan and Identify Stakeholders Decide on Content, Methods of Dialogue Conduct Dialogue with Stakeholders Review, incorporate and Report on Feedback September October November December Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 * * * Board Meetings *
Questions? www.pcori.org
Richard Kuntz, MD Presentation to PCORI Board of Governors September 20, 2011 Landscape Review Program
Goals of Landscape Reviews • Identify existing knowledge and gaps in existing knowledge related to PCOR and CER • Avoid funding patient-centered outcomes research that duplicates ongoing or existing research • Provide background information to spur innovation in research and methodology, and contribute to the infrastructure for conducting patient-centered outcomes research • Create shared understanding about the state of the art of dissemination and patient engagement strategies and contribute to best practices • Provide input into National Priorities and Research Agenda
Chronology of Landscape Review Development Initial Phase: Environmental Scan of Comparative Effectiveness Research Discovery Phase: Learning about Lewin Group Inventory of CER Refining the Scope of Landscape Reviews & Methodology Committee Requirements Coordination of Landscape Reviews across PCORI: Landscape Review Program Landscape Review Program: • Process to initiate and manage landscape reviews • Templates to develop contract specifications and budget requirements • Resource library to share findings
Landscape Review Process Overview Confirm questions to be answered Document known information & gaps Assess relevance / usefulness of information Engage with NIH, AHRQ, others to leverage work of interest to PCORI Identify additional information needed Prepare RFI as needed to acquire information PCORI RESOURCE LIBRARY
Landscape Reviews/Summaries Completed or Underway Report Status “Existing and Ongoing NIH Work Related to Dissemination of Research: Overview of NIH Briefing Book” Completed 06/04/2011 “Existing and Ongoing Work Related to Patient Involvement in Peer Review: Overview of NIH Briefing Book” Completed 06/04/2011 “Overview of Lewin CER Inventory Project” Completed 07/07/2011 “Organizations that Conduct CER” Completed 08/09/2011 Review and Synthesis of Evidence for Eliciting the Patient’s Perspective in Patient- Centered Outcome Research (Literature Review) RFP issued 8/31/2011 Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcome Research (Interviews) RFP issued 8/31/2011 Landscape review of existing methodological standards Under development by MC Landscape review of patient engagement Under consideration by COEC
Questions? www.pcori.org

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Board of Governors Meeting, South Sea Tea Washington

  • 1.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE September 19, 2011 Patient-Centered Outcomes Research Institute Communications, Outreach and Engagement Committee (COEC) Report
  • 2.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE COEC Members 2 • Sharon Levine, MD (Chair) • Debra Barksdale, PhD, RN • Robert Jesse, MD, PhD • Grayson Norquist, MD, MSPH • Ellen Sigal, PhD • Harlan Weisman, MD
  • 3.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE COEC Charter 3 The Communication, Outreach and Engagement Committee shall advise and assist the Board of Governors of PCORI, and provide recommendations to the Board, regarding: 1. The Institute’s communications and branding work, 2. Strategies to engage all stakeholders in the work of PCORI, and 3. Methodologically sound approaches to disseminating and implementing the research results and ensuring their utility to patients and clinicians
  • 4.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE COEC Report to the Board 4 I. Recent Opportunities for Public Input (Update) II. Promoting PCORI RFPs (Update) III. Redesigned PCORI Website (Update) IV. Outreach Plan for Pilot Project Funding Announcement (Recommendation for Decision) V. Stakeholder Outreach (Update) VI. Speakers Bureau (Update) VII.PCORI Communications Staff (Update)
  • 5.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Recent Opportunities for Public Input 5 • Working definition of “patient-centered outcomes research” – Nearly 600 responses were received (July 20-September 2, 2011) – All responses received through the website or emailed PDFs will be posted on pcori.org – PCORI issued an RFP to solicit proposals for the analysis and summarization of the input received and for recommendations on methodologies to receive further input from patient audiences
  • 6.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Analysis and Summary of Input on Working Definition of PCOR 6 Issue RFP (and reach out to potential applicants) August 24, 2011 Deadline for applications September 9, 2011 Complete review of applications September 16, 2011 Complete contract with chosen contractor September 19, 2011 Submit Phase I findings and draft questions for focus groups September 30, 2011 PCORI completes revision of PCOR Definition October 26, 2011 Revise questions for focus groups November 9, 2011 Focus Groups (or other way of seeking patient input) November 18, 2011 Report due to PCORI December 16, 2011 (with preliminary report in time for December 8 meeting) PCORI completes further revisions of PCOR Definition January 15, 2012 PCORI Board considers revised PCOR Definition January 18, 2012
  • 7.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Working Definition of PCOR: A Foundation for PCORI’s Work 7 • At the time of PCORI’s creation, “patient-centered outcomes research” (PCOR) was not a commonly used term, nor had it been formally defined • Defining PCOR helps clarify PCORI’s focus and scope of work • Through iterative and transparent processes that elicit feedback from all stakeholders, including patients, we will continue to revise the definition, ensuring it: – Emphasizes the “patient-centered” focus of PCORI’s mission – Is consistent with the intent of the statute that established PCORI – Is broad enough to support the range of research PCORI should fund
  • 8.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Recent Opportunities for Public Input 8 • Initial topics for PCORI pilot projects. – More than 150 responses were received (August 1-30, 2011) – Responses provided to the PDC Working Group to review and update topics as appropriate. • 89.26% Self Identified • 10.74% Anonymous • 59.76% Responded as Individual • 40.27% On behalf of an Organization Respondents • 40.94% Academia • 23.49% Provider • 17.45% Patient • 3.36% Industry • 0.67% Government • 11.41% Non-Identified Organizational Respondents
  • 9.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Promoting PCORI RFPs 9 • To date PCORI has issued 4 Requests for Proposals (RFP) – Analysis of Input Received on Working Definition of “Patient-Centered Outcomes Research” – Review and Synthesis of Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research (Literature Review) – Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research (Interviews) – Methods for Setting Priorities in Research (White Papers) • For each RFP, PCORI performed outreach to: email list subscribers (620+), supplemental lists of clinical and translational research centers (60+), academic research institutions (30+), and provider and advocacy organizations (30+) • PCORI is an independent, non-profit, non-governmental organization. All PCORI funding announcements will be posted on pcori.org. PCORI funding announcements will not be published in the Federal Register
  • 10.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Redesigned PCORI Website 10
  • 11.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Redesigned PCORI Website 11 • Includes visual changes based on logo and color palette approved at July Board Meeting • Designed to be more user friendly • Will support the expansion of PCORI content and opportunities for interaction as work progresses • Expanded features include: – Easier mechanisms for joining PCORI mailing list and providing general input – An “Executive Director’s Corner” that provides regular updates on PCORI’s latest developments
  • 12.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Outreach Plan for Pilot Project Funding Announcement 12 • Post announcement on pcori.org • Direct email to stakeholders and potential applicants • Conduct proactive media relations • Promote the opportunity though grassroots outreach • Integrate the announcement with speakers bureau presentations • Host a Q&A teleconference for applicants
  • 13.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Stakeholder Outreach 13 PCORI’s engagement with stakeholders around Board meetings • Stakeholder discussion forum March St. Louis, MO • Stakeholder discussion forum May New York, NY • Two small group meetings with patients and caregivers • Eight small group meetings with 43 stakeholder organizations July Washington, DC • Invited presentations from Northwest Pacific stakeholders September Seattle, WA • Site visits to clinical care facilities November New Orleans, LA
  • 14.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Seattle Stakeholder Engagement Forum 14 • PCORI has invited individuals and organizations from the Pacific Northwest to make brief presentations to the Board about their work or perspective and how it can inform PCORI’s work • Native American/Alaska Native perspectives • Complementary and alternative medicine researchers and providers • Outcomes and comparative effectiveness researchers • Monday, September 19, 7:00-9:00 p.m. PT • Open to the public
  • 15.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Speakers Bureau 15 PCORI has presented at 24 meetings since March Recent Speaking Engagements • 7/25 – IOM CER Innovation Collaborative Meeting • 7/25 – Center for Medical Technology Policy CER Institute • 8/12 – Consumers United for Evidence Based Health Care Annual Meeting • 8/25 – Florida Chiropractic Association National Convention & Expo • 9/9 – University of Michigan School of Nursing • 9/16 – Oregon Institute for Patient-Centered Comparative Effectiveness Annual Research Intensive Upcoming Opportunities • 9/27 -- AdvaMed 2011 MedTech Conference • 9/28 – Partnership to Improve Patient Care Annual Membership Forum • 10/11 – NIH National Center for Research Resources Clinical and Translational Science Awards Program • 10/12 – Comparative Effectiveness Research Summit • 10/12 – American Academy of Nursing, Council of Advancement of Nursing Science 2011 Special Topics Conference • 10/19 – Health Industry Forum • 10/20 – Pfizer Health Advocates Leadership Breakfast
  • 16.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE PCORI Communications Staff 16 • Seeking applicants for three positions: – Director of Communications – Director of Patient Engagement – Director of Stakeholder Engagement • Staff will develop and implement strategic communications plan • Distinct engagement officers for patients and other stakeholders, recognizing their need for different engagement mechanisms
  • 17.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE September 19-20, 2011 Seattle, WA Executive Director Update Board of Governors PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
  • 18.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Objectives for today  Highlight PCORI Activities since July 2011 BoG Meeting  Discuss Growing the PCORI Staff  Consider Critical Timelines/Milestones for Next 9 Months
  • 19.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE PCORI Activities – (Staff, Board, MC together)  Establishing Policies and Practice  HR Policies  Purchasing/RFP policies  COI policies  Research Policies  Re-designing Website  Outreach  Developing IT Infrastructure  Growing Staff  Finding Long-term Space
  • 20.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 4 • $48 per sq. foot • Attractive, not • extravagant • 13,000 sq feet • Close to Metro • Green building • Move-in: February PCORI’s Long-Term Home 1828 L Street, DC
  • 21.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Urgent Issues Coming Out of July BoG Meeting:  Address the need for greater clarity in decision-making and take steps to find more time for substantive discussions among board, with MC  Patient Engagement! - Officer, Advisory Panel  Get started on the National Priorities and Research Agenda!  Support the PDC in preparing PCORI Pilot Projects RFP and review  Support the MC in getting the RFPs out for the Methodology Report
  • 22.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Patient Engagement 6  Patient-Engagement Working Group formed;  Job Description for Director of Patient Engagement drafted  Directors of Stakeholder Engagement and Director of Communications Added  All three positions are posted and a search is underway Patient Engagement Communi- cations Stakeholder Engagement External Engagement
  • 23.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Program Development Committee National Priorities and Research Agenda • C Clancy and A Epstein, co-chairs • Environmental scan on past CER analysis and developed an initial framework for the National Priorities which will serve as the foundation for developing specific priorities • Recognized the close link between the National Priorities and Research Agenda (H Krumholz and L Hole-Curry, co-chairs) • Developed a timeline and notional process for engaging stakeholders as part of the National Priorities development timeline
  • 24.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Developing PCORI’s National Priorities and Research Agenda 8 Collect Stakeholder Input Develop Candidate Priorities Public Comment Finalize Priorities Develop Candidate Priorities Underway Sept - Nov Dec-Feb March Collect Stakeholder Input Public Comment Finalize Research Agenda April Feb - Mar Sept - Jan PRIORITIES: RESEARCH AGENDA:
  • 25.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Program Development Committee PCORI Pilot Projects  C Goertz and G Hunt co-chairing this process.  Public Input has been reviewed and incorporated into revised “areas of interest” in the PCORI Funding Announcement (PFA)  An application form and instructions have been developed and revised  Working closely with NIH staff on defining each step in the application and review process
  • 26.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Supporting Methodology Committee  Interim researcher process established; at least one already working  RFPs (2) for Patient-centeredness Working Group posted  RFP (1) for Research Prioritization Working Group posted  Review Process in Development, including COI policies for review
  • 27.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Definition of PCOR  Input on the working definition of “patient-centered outcomes research” gathered (n=600); to be posted shortly after anonymization  RFP posted for qualitative analysis and summarization of the input received and for recommendations on methodologies to receive further input from patient audiences posted on PCORI website  12 responses received and reviewed  First PCORI research contract issued on 9/16 to National Opinion Research Center II MC I 9/16 9/30 11/15 12/31 Synthesis & Question Generation Revision of Definition Testing of Revised Definition Preparation of MS for Publication Led by MC
  • 28.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Three Engagement Directors Applications Arrive LOI’s Arrive Growing PCORI Staff: 09/18/11 – 09/20/11 We are here 11/1/11 2/1/12 05/1/12 04/1/12 1/1/12 COO Begins Mark In! Director Finance Begins First Scientists Additional Scientists Additional Admin Ass’ts Director of Staff 12/1/11 3/1/12 Funding Decision Made Funding Issued Program Staff Hiring Begins Finance/Grant Staff
  • 29.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Growing PCORI Staff 13 Research Scientist Patient engagement Research Research Scientist Stakeholder Engagement Research Scientist Communicaiton/Disseminat ion Research Research Scientist(s) Comparative Clinical Effectiveness Research Director Patient Engagement Director* Stakeholder Eng. Director Communications Chief Financial Officer (CFO) Director HR Director Director Grants Management Research Scientist(s) Evidence Synthesis External Engagement Executive Director Chief Operating Officer Chief Science Officer
  • 30.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Critical Issues: September 2011 – June 2012 14  Gathering Stakeholder Input on National Priorities and Research Agenda  Thorough, balanced, incorporated September – November: November- December:  Finalizing First Draft of Priorities (Prior to Public Comment)  How are Priorities expressed, what’s in, is anything out? January – February:  Finalizing First Draft of Research Agenda (Prior to Public Comment)  What (specifically) is in, out – what will the first RFAs fund?  Data Infrastructure Grants?  Translation/Implementation Research?  Systems research?  Pharmacogenetics?  Large clinical trials?
  • 31.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Finance & Administration Committee September 20, 2011, Seattle, WA PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
  • 32.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Bylaws Revisions • GAO currently reviewing • Committee Name Change: Finance, Administration & Audit • Adoption Proposed at November BOG Meeting
  • 33.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Audit Update • Released this week • Bidders selected by annual revenues • Proposals by end of October • Recommendation to BOG • Field work in November/December • Completed audit by March • Provided to GAO for report to Congress due April 1st
  • 34.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Financial Statements – August 31, 2011 • Statement of Financial Position: Total Assets of $46.3M; $5M Cash on Hand • Expenditures: – Budget: $7.5M – Actual: $3.7M – Positive variances in Board compensation, management fees, professional services, travel – Negative variance in conferences
  • 35.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE Conflicts of Interest Policy • Working group created Members: Larry Becker, Chair Debra Barksdale Arnie Epstein Sherine Gabriel Bob Jesse • Group is gathering key documents
  • 36.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 1 September 19, 2011 PCORI Methodology Committee Progress Report Sherine E. Gabriel, MD, MSc Sharon-Lise T. Normand, PhD PCORI Methodology Committee
  • 37.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 2 • Establishment • Overview • Timeline • Structure • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps Agenda
  • 38.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 3 Methodology Committee Charge Establishes priorities to address gaps in research methods and their application The Methodology Committee shall make recommendations regarding methods for patient-centered outcomes research Provides guidance about the appropriate use of methods
  • 39.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 4 Methodology Committee Structure Methodology Committee Co Chairs: Sherine Gabriel, MD, Mayo Clinic & Sharon-Lise Normand, PHD, Harvard Medical School Patient-Centeredness Research Prioritization Methods to incorporate the patient perspective into all phases of PCOR Methods to inform prioritization of new research studies Methods for using data, design, and statistical analyses to conduct PCOR Research Methods Report Assimilation
  • 40.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 5 Methodology Committee Activity Timeline Research Methods Aug „11 Oct „11 Nov „11 Dec „11 Patient- Centeredness Jan „12 Feb „12 Mar „12 Apr „12 May „12 Workshop Final Report Workshop Identify Gaps/ Issues Translation Table/Tool Workshop Final Papers Due Final Draft Final Report Final Report Compile First Draft Legend Research Prioritization Report Assimilation Feb – Jul „11 Revise Report Outline & Edit Chapters Final Report Final Papers Due Electronic Data Systems Landscape Review Identify & Implement Voting Standards Process Solicitations: White Papers/Identify Experts Solicitations: Literature Review & Interviews MC Charter MC Work Plan Interim Researchers Staffed PCOR Definition Solicitation Commission White Papers Sep „11
  • 41.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 6 Methodology Committee Discussion Points • Importance of methods generated by Patient Centeredness Work Group for incorporating patient engagement • Importance of methods generated by Research Prioritization Work Group vis-à-vis prioritization framework set by the board • Generation of tools/standards for Methods Report is a multiyear process • Importance of continuing to interact with Board to ensure coordination of efforts • Board/Methodology Committee teleconference calls were a productive forum to receive input from the Board regarding their needs and priorities
  • 42.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 7 • Establishment • Overview • Structure • Timeline • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps
  • 43.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 8 Patient-Centeredness Workgroup Ethan Basch, MD Memorial Sloan-Kettering Cancer Center Workgroup Chair Mary Tinetti, MD Yale University School of Medicine Workgroup Co-Chair Naomi Aronson, PhD Blue Cross and Blue Shield Workgroup Member Brian Mittmann, MD VA Center for Implementation Practice & Research Support Workgroup Member David Flum, MD, MPH University of Washington Report Assimilation Group Liaison
  • 44.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 9 - Patient Centeredness Mission/Scope of Work Development and prioritization of research questions Identify methodological standards for incorporating the patient perspective into three key areas: Design of study components, including selection of interventions, comparators, and outcomes (including patient-reported outcomes) Processes of clinical decision-making/care delivery
  • 45.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 10 Patient Centeredness Progress to Date Released RFP for Literature Review Released RFP for Interviews “Review and Synthesis of Evidence for Eliciting the Patient‟s Perspective in Patient-Centered Outcomes Research” “Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient‟s Perspective in Patient-Centered Outcomes Research”
  • 46.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 11 Proposals Due Awardee Announced Final Report Due Oct 6, 2011 Oct 13, 2011 March 1, 2012 Issue Open RFI Plan Workshop Develop Sections for Methodology Report Patient Centeredness Next Steps
  • 47.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 12 Patient Centeredness Question How does this work complement ongoing and planned activities of the Board?
  • 48.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 13 Research Prioritization Workgroup David Meltzer, MD, PHD University of Chicago Department of Medicine Workgroup Chair John Ioannidis, MD, DSc Stanford Prevention Research Center Workgroup Member Jean Slutsky, PA, MSPH Agency for Healthcare Research and Quality Workgroup Member Clyde Yancy, MD Northwestern University Feinberg School of Medicine Workgroup Member Alfred Berg, MD, MPH University of Washington Department of Family Medicine Report Assimilation Group Liaison
  • 49.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 14 Research Prioritization Mission Mission To provide guidance concerning the use of methods to inform the establishment of research prioritization approaches that best fulfill PCORI’s mission. • To the PCORI Board to aid in development and future refinement of Research Priorities] • To the broader multi-stakeholder communities to enhance understanding of PCORI’s approach to research prioritization and to encourage their engagement in PCORI’s research prioritization process
  • 50.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 15 - Commission White Papers To prepare a section for the May 2012 Methodology Committee Report that addresses methods to inform the establishment of research prioritization Synthesize White Papers during January 2012 Workshop Research Prioritization Scope of Work Topic Generation Gap Analysis in Systematic Reviews Value of Information Analysis Peer Review Suggest strategies to identify possible future priority areas Suggest standards for how PCORI systematic reviews should be performed and used to generate research topics Provide PCORI Board and/or grant applicants with tools to quantify expected benefits of research to inform priorities Provide data to inform how PCORI might design, evaluate and continually improve its peer review process
  • 51.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 16 Research Prioritization Progress to Date Identified Methodological Areas of Interest in Research Prioritization Identified Interim Researcher to Assist Workgroup Released RFA for White Papers on September 9, 2011
  • 52.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 17 White Paper Proposals Due Review and select among White Paper proposals Awardee Announced Sept 30, 2011 Oct 1- 13, 2011 Oct. 14 2011 Explore the role of research prioritization methods vis-à-vis the broader PCORI research prioritization process Engage researchers as needed to fill in expected gaps from White Papers Research Prioritization Next Steps
  • 53.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 18 Research Prioritization Question How can we best work with you to understand your evolving plans for research prioritization so the methods we are studying can be of most use to you?
  • 54.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 19 Research Methods Workgroup Steven Goodman, MD, MHS, PHD The John Hopkins University School of Medicine and Public Health Workgroup Chair Mike Lauer, MD National Institute of Health National Heart, Lung, and Blood Institute Workgroup Member Robin Newhouse, PHD RN University of Maryland School of Nursing Workgroup Member Sebastian Schneeweiss, MD, ScD Harvard Medical School Workgroup Member Mark Helfand, MD MPH MS Oregon Health & Science University School of Medicine Report Assimilation Group Liaison Sharon-Lise Normand, PHD Harvard Medical School Methodology Committee Chair
  • 55.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 20 - Develop Translation Table/Tool (from research question to design and analysis) Identify Standards for the use of data, design, and statistical analyses to conduct patient centered outcomes research through: Review current methodological “state of the art” statements issued by expert bodies to guide PCORI research Research Methods Mission/Scope of Work Review existing data systems designed to permit exploration of causal questions from data gathered in the course of clinical practice. Identify PCORI role in this arena.
  • 56.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 21 Research Methods Progress to Date Established initial specifications for dimensions to be used in translation instrument, with options for implementation Developing prototype for standards documents that combines expert statements, published examples and PCORI MC input Interviewing leading researchers of electronic data, from which research and methods recommendations will be developed
  • 57.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 22 Research Methods Progress to Date (Detailed) Framework for Methods Standards / Recommendations 1. Method 2. Key sources 3. Major recommendations 4. PCORI MC commentary 5. Published examples 6. Tools for researchers Translation Table Dimensions Intrinsic Factors • Internal validity (aka bias) • External validity (aka generalizability, transportability) • Precision • Heterogeneity in risk or benefit (aka “personalized” evidence) • Ethical dimensions Extrinsic Factors • Timeliness (Rapidly changing technology, policy urgency) • Logistical burden (e.g. study size, complexity, cost) • Constraints (Data availability, randomization possible?) Question: condition, population, treatment & comparator, outcomes, setting
  • 58.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 23 Finalize translation table dimensions and determine categories of development Finalize “standards” document format and determine categories of development Finish and summarize electronic data systems environmental scan Research Methods Next Steps (e.g. diagnostic tests, missing data, systematic reviews, etc.) (e.g. drug safety, therapeutic efficacy, etc.) Jan. 2012 Workshop
  • 59.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 24 Research Methods Question Can the Board provide feedback on the preliminary formats developed (i.e., translation table dimensions and methods standards format)?
  • 60.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 25 Report Assimilation Workgroup Mark Helfand, MD Oregon Health & Science University School of Medicine Workgroup Chair Alfred Berg, MD, MPH University of Washington Workgroup Member David Flum, MD, MPH University of Washington Workgroup Member Howard Balshem, MS Oregon Health & Science University Interim Researcher Sherine Gabriel, MD Mayo Clinic Workgroup Member Sharon-Lise Normand, PHD Harvard Medical School Workgroup Member
  • 61.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 26 • Establishment • Overview • Structure • Timeline • Mission • Scope of Work • Progress to Date • Next Steps • Questions 1. Methodology Committee 2. Methodology Committee Workgroups 3. Wrap Up • Next Steps
  • 62.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 27 Solicitation Responses and Questions Received to Date Methodology Committee Next Steps Letters of Intent Received** Questions Patient Centeredness WG -- Stakeholder Interviews 25 8* Patient Centeredness WG - Literature Review 26 4* Research Prioritization WG - White Papers 11 0 **as of 9/16 at 8:30 a.m. *This number of questions includes a document containing 13 individual sub-questions.
  • 63.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 28 Administrative Review Content Review Programmatic Review Executive Decision 1. Clear, transparent and reproducible review process based on best practices (eg. NIH) 2. Aligned with PCORI Vision, Mission, Principles and Policies (eg CoI) 3. Timely (~Applicants notified of award two weeks after submission) Will be Established prior to receipt of first response (September 30, 2011) Solicitation Review Process and Principles Methodology Committee Next Steps
  • 64.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 29 Methodology Committee Next Steps Research Methods Aug „11 Sep „11 Oct „11 Nov „11 Dec „11 Patient- Centeredness Jan „12 Feb „12 Mar „12 Apr „12 May „12 Workshop Final Report Workshop Identify Gaps/ Issues Translation Table/Tool Workshop Final Papers Due Final Draft Final Report Final Report Compile First Draft Legend Research Prioritization Report Assimilation Feb – Jul „11 Revise Report Outline & Edit Chapters Final Report Final Papers Due Electronic Data Systems Landscape Review Identify & Implement Voting Standards Process Solicitations: White Papers/Identify Experts Solicitations: Literature Review & Interviews MC Charter MC Work Plan Interim Researchers Staffed PCOR Definition Solicitation Commission White Papers
  • 65.
    PATIENT-CENTERED OUTCOMES RESEARCHINSTITUTE 30 Thank You!
  • 66.
    Presentation to PCORIBoard of Governors September 20, 2011 PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE: Program Development Committee
  • 67.
    Program Development Committee CommitteeMembers • Carolyn Clancy • Francis Collins • Arnold Epstein • Christine Goertz • Leah Hole-Curry • Gail Hunt • Harlan Krumholz • Richard Kuntz Methodology Committee Representatives • Sherine Gabriel • Sharon-Lise Normand
  • 68.
    Report Outline  PCORIPilot Project Grant Program  National Priorities and Research Agenda  Landscape Review Program Program Development Committee
  • 69.
    Presentation to PCORIBoard of Governors September 20, 2011 Christine Goertz, DC, PhD PCORI Pilot Projects
  • 70.
    Report Outline: • Purposeof PCORI Pilot Projects • PCORI Funding Announcement - Key Highlights • Areas of Interest • Overview of the Four-Stage Review Process • Application Review Criteria • Grant Application & Instructions • Webinar & Process to Handle Inquiries • Timeline, Key Dates, and Activities
  • 71.
    Purpose of PCORIPilot Projects The purpose of the PCORI Pilot Projects Grant Program is threefold: 1. National Priorities. Pilot projects will provide information to PCORI that informs future iterations of national research priorities for patient centered outcomes research. 2. Research Agenda. The program will support the collection of preliminary data that can be used to advance the field of patient- centered outcomes research, providing the platform for an evolving PCORI research agenda. 3. Methodologies. The program will support identification of research methodologies that advance patient-centered outcomes research
  • 72.
    PCORI Funding Announcement: KeyHighlights  Applicants must address at least one of the eight areas of interest.  Stakeholder involvement is required unless the application can sufficiently explain why it is not feasible.  Expect to commit approximately $13 million in FY 2012 to support approximately 40 projects.  Applicants can propose project periods of up to two years. Second year funding is subject to noncompetitive review by PCORI staff.  Direct costs are limited to $250,000 per year with an additional 40% of salary and fringe allowable as indirect costs.  Letters of intent are due on November 1 with applications due on December 1.  NIH will conduct the merit review process with all other aspects of grant awards and grants management handled by PCORI.
  • 73.
    Areas of Interest:Development Areas of Interest Board Members Methodology Committee Stakeholder / Public Input Projects focused on developing, testing, and/or evaluating methods or approaches that:  Inform the evolving National Priorities  Bring together different stakeholders  Translate research into practice  Identify gaps in relation to issues for disadvantaged populations  Identify predictors of patient outcomes
  • 74.
    Areas of Interest 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. Developing, testing, and/or refining existing methods for bringing together patients, caregivers, clinicians including non-traditional partners, and other stakeholders in all stages of a multi-stakeholder research process, from the generation and prioritization of research questions to the conduct and analysis of a study to dissemination of study results – including methods for training participants in participatory research and the potential use of new technologies to facilitate engagement. Developing, refining, testing, and/or evaluating patient-centered approaches, including decision-support tools, for translating evidence-based care into health care practice in ways that account for individual patient preferences for various outcomes. This may include developing or comparing conceptual models of translation or dissemination of CER research findings from the patient perspective. 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; minorities; children; elderly; women; people with disabilities, chronic, rare and/or multiple medical conditions.
  • 75.
    Areas of Interest Identifying,testing, and/or evaluating patient-centered outcomes instruments. This may include predictive tools (eg: instruments that measure or predict outcomes of interest to patients) or identifying standards for measurement properties of patient-reported outcomes for use in comparative effectiveness research, across a variety of interventions and patient populations. Identifying, testing, and evaluating methods that can be used to assess the patient perspective when researching behaviors, lifestyles, and choices within the patient’s control that may influence their outcomes. Identifying, testing, refining and/or evaluating methods for studying the patient care team interaction in situations where multiple options for wellness, prevention, diagnosis or treatment exist. Of special interest are strategies that respect patient autonomy and promote informed decision-making, incorporating the best health care knowledge into the application of care. Advancing analytical methods for CER. Examples include but are not limited to the incorporation of mixed methods research designs (qualitative/quantitative), identifying existing methodology to statistically accommodate irregularly spaced multivariate longitudinal data, the use of instrumental variables; and potential solutions for assessing treatment heterogeneity in observational and randomized CER studies.
  • 76.
    Overview of the4-Step Process Preliminary Check Merit Review Deliberation Business Determination that the application meets the minimum technical requirements enumerated in the PFA and fits within programmatic priorities. PCORI Responsive/eligible applications will be forwarded for review. Remaining applications are assigned to 3 reviewers with appropriate expertise who will critique independently and then meet to discuss and designate a final score. NIH A rank-ordered list of applications and summary sheets The Pilot Projects Review Committee considers the merit review scores and programmatic balance across several categories to develop a recommended award slate for consideration by the BOG. PCORI Funding decisions are made. A final review for suitability to manage an award, adherence to human subjects requirements, receipt of IRB approval, budget review, etc. PCORI Negotiations, where needed Description Responsible Result
  • 77.
    Preliminary Check Technical Requirements • Receiptof Letter of Intent • Eligible applicant • Stakeholder requirements • Page limit and formatting requirements • Deadline met and application properly submitted Programmatic Requirements • Does the application fit within PCORI program requirements listed in the PFA? Transfer to NIH • Applications meeting both technical and programmatic requirements will be forwarded to NIH for the Merit Review. Conducted by PCORI staff
  • 78.
    Merit Review Prior tothe Review Meeting • Each application is assigned to 3 reviewers • Reviewers include scientists and other stakeholders • Stakeholders without previous review experience will be trained • Reviewers assign an initial priority score of 1 to 9 based on PCORI-provided review criteria • Provides basis for discussion at in person meeting In-Person Review • In-person meeting of reviewers to discuss the most promising applications • Review and discuss applications based on impact, stakeholder involvement, innovation, and significance of the science • Provide a final priority score of 1 to 9 • Scientific Review Officer compiles a summary statement with reviewer critiques for each application Summary & Rankings • The review process results in a ranked, scored summary of applications for PCORI consideration Conducted by NIH
  • 79.
    PCORI Deliberations PCORI Staff •Analyzes the applications using priority score and classification categories. • Creates funding scenario options based on analytics. • Supports the PCORI Review Committee and Board of Governors by providing revised options, as needed. PCORI Review Committee • Meets to review materials • Considers the balance of priority-scored applications across classification categories, 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 Classification categories may include: Applicability of the 8 areas of interest, geographic distribution, research methodology, and identification of target populations.
  • 80.
    Recommended Funding Slate Analysis Followingthe Review Committee meeting, analysts will prepare the recommended slate along with accompanying analysis for consideration by the Board of Governors.
  • 81.
    Merit Review Criteria Significance. Does the project address an important problem or a critical barrier to patient- centered outcomes research? Does the project address one of the key questions outlined in the PCOR definition described above? Is the project focused on one of the areas of interest identified in this PFA? Will the results produce new knowledge that can advance PCOR methods or infrastructure? Does the investigator demonstrate thorough knowledge of previous and ongoing work related to their proposed topic?  Patient/Stakeholder Engagement. Will the research make a unique contribution to learning about engagement of patients and non-traditional stakeholders in PCOR research efforts? Does the research team demonstrate authentic, feasible, sustainable, novel partnerships with patients, families and care givers, providers, and other appropriate non-traditional stakeholders? Is there evidence that non-traditional stakeholders were involved in the preparation of the research proposal?  Investigator(s). Is the research team well suited to the project? Is it multi-disciplinary? Is there appropriate scientific expertise? Does at least one member of the study team have experience in patient and other stakeholder engagement? Is there a high level of confidence that the Principle Investigator and rest of the study team will be able to achieve the study aims as described? Does the study team have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
  • 82.
    Merit Review Criteria (continued) Innovation. Does the project either address a new method or approach or apply a proven method or approach in a novel way to the field of PCOR? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Will the strategy establish feasibility and will particularly risky aspects be managed? Is the proposed budget and timeframe appropriate for the research plan? Are there appropriate plans for dissemination among key PCOR stakeholders in education, practice and policy?  Environment. Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the research environment, community involvement, patient populations, or non-traditional stakeholder collaborative arrangements?
  • 83.
    Grant Application &Instructions • Application is based on the NIH PHS 398 form with changes to ease responses and to meet the needs of PCORI. • Applicants will be bound by the Human Subjects policies of NIH and will include appropriate plans within the Research Strategy section. • Applicants will provide information related to classification categories to enable the Review Committee and Board to consider this information when developing a balanced slate for funding. Self-Reported Classification Categories: • Applicability of the “4 questions” to the research • 8 areas of interest • Identification of specific populations including: ― Underserved or disadvantaged populations ― Specific ethic or cultural populations ― Rural or urban populations ― Disabled populations
  • 84.
    Webinar & InquiryProcess • Webinar for Applicants: October 12, 2011 at 2PM EST. • Policy for responding to inquiries: – A set of FAQs will be developed and issued along with the PFA with frequent updates posted on the PCORI website. Questions and answers will be framed in terms of general applicability. – Inquiries should be directed to the PCORI website at pcori.org. PCORI staff and appropriate consultants will receive, triage, route, and ensure answers are provided and shared generally through the website.
  • 85.
    Timeline, Key Dates,and Activities 2011 09 /11 PFA Posted 11/01/11 Letters of Intent Due 12/1/11 Applications Due 11-12/11 Identification of Merit Reviewers 2012 12/11 Completeness/ Compliance/ Eligibility Check 2/12 Merit Review 3/12 Slate of Projects to Board & Selection Made 05/12/12 Award Notification & Funding PCORI Applicant NIH/PCORI Applicant PCORI NIH PCOR PCORI / Applicant
  • 86.
  • 87.
  • 88.
    Arnold Epstein, MD Presentationto PCORI Board of Governors September 20, 2011 PCORI National Priorities Development
  • 89.
    National Priorities arethe critical beginning and will be dynamic Increasing Specificity National Priorities Research Agenda Individual PFAs
  • 90.
  • 91.
    Environmental scan of existing prioritiesand criteria Candidate priorities and criteria identified Framework to inter-relate Priorities and Criteria Reviewed initial stakeholder input advising us to not “reinvent the wheel.” Reviewed prior CER frameworks (e.g., IOM, FCCCER, National Priorities Partnership, NQF) Identified broad priorities and criteria that were used often in prior frameworks and fit PCOR. Framework to be used for refining priorities, and determining Research Agenda and PFAs. Initial Stakeholder feedback Development of a National Priorities Framework
  • 92.
    Previous priorities havevaried in granularity Granularity IOM 2009 (e. g., Compare the effectiveness of upper endoscopy utilization and frequency for patients with gastroesophageal reflux disease on morbidity, quality of life, and diagnosis of esophageal adenocarcinoma.) National Priorities Partnership (e. g., Engage patients and families in managing their health and making decisions about their care.) National Prevention Council (e. g., Elimination of health disparities) FCCCER (e.g., Expanding high-impact patient registries) National Quality Forum (e. g., Infrastructure – Information Technology) Least Most National Quality Strategy (e. g., Promoting effective communication and coordination of care)
  • 93.
    Ten candidate priorities consistentwith prior efforts Source Prevention Acute Care Chronic Disease Care Palliative Care Care Coordination Patient Engagement Safety Appropriate Use HIT to Improve Patient Experience Impact of New Technology IOM 2009: Priorities for CER √ √ √ √ √ √ √ √ √ Federal Coordinating Committee for CER √ √ √ √ √ AHRQ National Quality Strategy √ √ √ √ AHRQ Effective Health Care Program √ √ √ √ √ √ National Quality Forum √ √ √ √ √ √ √ √ National Prevention Council √ √ National Priorities Partnership √ √ √ √ √ √
  • 94.
    Proposed criteria include thosein statute and additional criteria Used in Prior Efforts Criterion Required in statute √ Impact on Health √ √ Improvability via Research √ √ Inclusiveness of Subpopulations √ √ Impact on Health System Performance √ √ Gaps in Knowledge √ √ Variation or Disparities in Delivery or Outcomes √ √ Potential to Inform Decision-Making at Point of Care √ √ Responsiveness to Expressed Needs √ Advances CER Methods Fits the Definition
  • 95.
    •Impact on Healthof Individuals and Populations •Probability of Improvability via Research •Inclusiveness of Different Sub-populations •Current Gaps in Knowledge / Variation in Care •Impact on Health System Performance •Current Health Disparities •Potential to Influence Decision-Making at Point of Care •Responsiveness to Expressed Needs •Advances CER Methods •Fits the Definition of PCOR Framework to Inspire Drafting of PCOR- Specific National Priorities Health Information to Improve Patient Experience Prevention & Screening Acute Care Impact of New Technology PCORI National Priorities (Illustrative Examples) Prevention & Screening Develop information that will guide patients and providers to improve outcomes in chronic conditions. Develop information to help patients coordinate their care across multiple providers and care settings. Develop evidence to help patients improve the safety of their health care. Appropriate Use PCORI Criteria Proposed PCORI Criteria Existing Priority Areas In Statute Chronic Disease Care Palliative Care & Pain Management Care Coordination Patient Engagement Safety
  • 96.
    Stakeholder Engagement Guiding Principles Balanced Representation Transparency Facilitate Participation Enablean open engagement process that makes clear how participants can get involved and how their input will be incorporated Obtain feedback from a diverse and representative range of patients, health care stakeholders and the general public Provide easy, accessible forums for participants to provide feedback equitably
  • 97.
  • 98.
    PATIENTS PROFESSIONAL ORGANIZATIONS Individualswith Disease Families Caregivers Patient Advocacy Groups General Public Providers & Practitioners Employers Payers Research Societies Academia Health Information Exchanges Federal/State/Local Government Congress Life Sciences Industry Who are PCORI’s stakeholders? Key Stakeholder Groups
  • 99.
    Proposed Stakeholder EngagementTimeline Create Engagement Plan and Identify Stakeholders Decide on Content, Methods of Dialogue Conduct Dialogue with Stakeholders Review, incorporate and Report on Feedback September October November December Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 * * * Board Meetings *
  • 100.
  • 101.
    Richard Kuntz, MD Presentationto PCORI Board of Governors September 20, 2011 Landscape Review Program
  • 102.
    Goals of LandscapeReviews • Identify existing knowledge and gaps in existing knowledge related to PCOR and CER • Avoid funding patient-centered outcomes research that duplicates ongoing or existing research • Provide background information to spur innovation in research and methodology, and contribute to the infrastructure for conducting patient-centered outcomes research • Create shared understanding about the state of the art of dissemination and patient engagement strategies and contribute to best practices • Provide input into National Priorities and Research Agenda
  • 103.
    Chronology of LandscapeReview Development Initial Phase: Environmental Scan of Comparative Effectiveness Research Discovery Phase: Learning about Lewin Group Inventory of CER Refining the Scope of Landscape Reviews & Methodology Committee Requirements Coordination of Landscape Reviews across PCORI: Landscape Review Program Landscape Review Program: • Process to initiate and manage landscape reviews • Templates to develop contract specifications and budget requirements • Resource library to share findings
  • 104.
    Landscape Review ProcessOverview Confirm questions to be answered Document known information & gaps Assess relevance / usefulness of information Engage with NIH, AHRQ, others to leverage work of interest to PCORI Identify additional information needed Prepare RFI as needed to acquire information PCORI RESOURCE LIBRARY
  • 105.
    Landscape Reviews/Summaries Completedor Underway Report Status “Existing and Ongoing NIH Work Related to Dissemination of Research: Overview of NIH Briefing Book” Completed 06/04/2011 “Existing and Ongoing Work Related to Patient Involvement in Peer Review: Overview of NIH Briefing Book” Completed 06/04/2011 “Overview of Lewin CER Inventory Project” Completed 07/07/2011 “Organizations that Conduct CER” Completed 08/09/2011 Review and Synthesis of Evidence for Eliciting the Patient’s Perspective in Patient- Centered Outcome Research (Literature Review) RFP issued 8/31/2011 Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcome Research (Interviews) RFP issued 8/31/2011 Landscape review of existing methodological standards Under development by MC Landscape review of patient engagement Under consideration by COEC
  • 106.