board of governors meeting, baltimore maryland

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE

Patient-Centered Outcomes Research Institute

Communications, Outreach and Engagement Committee (COEC) Report

PCORI Board of Governors Baltimore, MD March 5, 2012

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

• Gail Hunt

3

COEC Report to the Board

I. Public Feedback on the Draft National Priorities and Research Agenda

II. National Patient and Stakeholder Dialogue – February 27, 2012

III. Clinician Focus Groups

IV. Incorporating Input into Revisions of Draft National Priorities and Research Agenda

V. Stakeholder and Community Engagement Events Associated with Board Meetings

VI. Connecting with PCORI

4


• Formal public comment period

o January 23-March 15

o www.pcori.org/survey/priorities-agenda

o Responses received through www.pcori.org posted for public view on the website

o Opportunity for feedback by mail

http://www.pcori.org/survey/priorities-agenda



http://www.pcori.org/

5


• Comments received to date

o 101 comments received through March 1

o Distribution of comments received:

o By stakeholder type

o By geographic location

6

Comments Received by Stakeholder Type

05

10152025303540

# o

f co

mm

ents

rec

eive

d

7

Comments Received by Geographic Location

8

II. National Patient and Stakeholder Dialogue – February 27, 2012

• More than 900 individuals pre-registered to participate:

– 400 in person

– 530 by webcast or phone

– Actual participation exceeded 850

• Watch the archived webcast on pcori.org

– Visit Past Meetings & Events page

9

II. National Patient and Stakeholder Dialogue – Highlights

• Presentation by Board Member Harlan Krumholz on the draft National Priorities for Research and Research Agenda

“Our true North is our patients”

• Two panels:

• Patient and Caregiver Advocates (American Cancer Society, Autism Speaks, National Alliance for Hispanic Health, National Alliance on Mental Illness, National Health Council)

• Clinicians and Other Stakeholders (Aetna, American Academy of Family Physicians, American Medical Association, American Nurses Association, National Business Group on Health, PhRMA)

10

• 57 public comments or statements provided:

– 11 panelists

– 46 individuals in person

– 8 individuals by phone

• Event Evaluations by those Attending In Person:

– 90% of respondents felt event was informative regarding the National Priorities and Research Agenda.

– Just under 85% felt panel discussions helped provide context for the National Priorities and Research Agenda.

II. National Patient and Stakeholder Dialogue – Highlights

Focus Groups – Additional Feedback on the Draft National Priorities and Research Agenda

• Patient and Caregiver Focus Groups

– 12 groups in 4 cities, 96 participants

– Reported on at Jacksonville Board meeting

• Clinician Focus Groups

– 9 groups in 4 cities, 58 participants

– Conducted February 8-16

11

12

III. Clinician Focus Groups

Purpose, Objectives

• Obtain detailed feedback from clinicians discussing PCORI’s draft National Priorities for Research and initial Research Agenda.

• Explore research priorities from the clinicians’ perspective, their understanding and reaction to PCORI’s proposed priorities and agenda, as well as general opinions about PCORI’s work.

• Better understand practice needs, clinical issues, and how new research-based information can be helpful.

San Francisco, CA • Group 1: Integrative Health Care

Practitioners

• Group 2: Physician Assistants

13

Focus Groups Nationwide with Clinicians

Chicago, IL • Group 1: Advanced Practice Nurses

• Group 2: Cardiologists

Birmingham, AL • Group 1: Registered Nurses

• Group 2: Primary Care Physicians

Philadelphia, PA • Group 1: Mix of Nurses

• Group 2: Psychiatrists

• Group 3: Orthopedic Surgeons

Physicians, nurses, physician assistants and integrative health care practitioners representing a mix of tenure, practice setting and specialties.

• Clinicians have mixed feelings about research. They use and appreciate research, but have concerns about corporate agendas, FDA approval times, and feel several steps removed from research activity.

• Clinicians voluntarily articulate the need for many of the concepts behind “comparative effectiveness research” and “patient-centered outcomes,” but this is not their language.

Clinicians on

“Medical

Research”

• One of the biggest stumbling blocks with clinicians is the perception that PCORI is too broad, too over-reaching, and thus too idealistic to have a meaningful impact.

• Another communications challenge is that healthcare costs, access, and payer decisions overshadow discussions about clinical effectiveness.

Impressions of

PCORI

• Clinicians, as did patients and caregivers in earlier groups, agree that “assessing options” and “communication” are priority areas for PCORI. Clinicians also prioritize “improving healthcare systems.”

• Clinicians say that PCORI should start by focusing on one or two of its research priorities, and begin to build a track record.

Research Agenda

• Professional organizations are the preferred channel for these clinicians. They seem willing to engage with PCORI, if opportunities are convenient and specific to their practice/patient population/setting.

• Focus groups and online surveys are also mentioned as good ways to reach them.

• Many underscore that staying in touch will take diligence on PCORI’s part.

Advice for

Engagement

Key Findings from Clinician Focus Groups

14

“I want my patients to be involved in their care. If they want to get involved,

that makes my job easier because they’re motivated to change.”

(Birmingham, Primary Care Physicians)

“There is no coordination with anything. Everybody is doing their own thing. It seems

like there is no communication. We are struggling with this.” (Chicago, Cardiologists)

“A lot of times the patients are the best ones to tell you if this works or that doesn't work, but nobody

listens.” (Birmingham, Registered Nurses)

“If everything else is up and running, this should be a small thing.”

(San Francisco, Integrative Medicine)

“We have universities that train researchers – Penn and Hopkins.” (Philadelphia, Nurses)

Addressing Disparities

Improving Healthcare Systems Assessment of Prevention, Diagnosis

and Treatment Options

Communication and Dissemination

17%

22% 22%

24% 15%

Accelerating Patient-Centered

and Methodological Research

Focus Group Exercise: Pretend YOU are allocating PCORI resources. What percentage of resources would you invest in each area? (Your total needs to equal 100%.)

How Would Clinicians Allocate Funding?

15

16

IV. Revising the Draft National Priorities and Research Agenda

• PCORI will review input received from:

• Website survey and formal public comment process

• National Patient and Stakeholder Dialogue

• Patient, caregiver and clinician focus groups

• Formal and informal feedback received by Board members and staff at PCORI-related events

• Report to be published on www.pcori.org summarizing input received explaining how input led to changes in the draft priorities and agenda.

• Revised National Priorities and Research Agenda to be presented for adoption by PCORI’s Board of Governors during a special public meeting in April.


17

V. Soliciting Feedback on Stakeholder and Community Engagement associated with Board Meetings • Survey of Board Members on Past Stakeholder Events

Underway (March 2011-January 2012)

o What have we learned?

o Which formats have been most useful?

o How have the results informed our work?

o What can we accomplish this year?

• Soliciting feedback from stakeholder/community participants

• Planning for 2012

o Analyzing upcoming metro areas, their unique demographics and health needs

VI. Ongoing Engagement and

Feedback Process

18

• PCORI website – www.pcori.org

• Join PCORI’s mailing list – www.pcori.org/subscribe

• Follow PCORI on Twitter @PCORI

• Provide feedback at anytime – www.pcori.org/provide-input

• Request a speaker – www.pcori.org/contact-us


http://www.pcori.org/subscribe

http://twitter.com/

http://www.pcori.org/provide-input



http://www.pcori.org/contact-us/




Executive Director’s Report

PCORI Board of Governors Baltimore MD Monday March 5, 2012

Freda Lewis-Hall MD 2012 Alumni Award for Distinguished Postgraduate Achievement in the fields of Medicine and Healthcare Leadership” Howard University Board of Trustees

Debra Barksdale, FNP Ph.D. Outstanding Research Contribution on Cardiovascular Disease in African Americans Delta Sigma Theta Sorority , Chapel Hill Carrboro Chapter Annual Queen of Hearts Gala

Christine Goertz DC, PhD Chiropractor of the Year - 2012 American Chiropractic Association

Our Honored Board

Growing PCORI Staff

PCORI Office Space

Looking Ahead – next 6 months National Priorities & Research Agenda Funding Announcements/Funding

Cycles Patient and Stakeholder Engagement

Preview

2

4

Introductions and Welcome

Pam Goodnow Director of Finance

Susan Hildebrandt Director, Stakeholder Engagement

Judith Glanz Director, Patient Engagement

Sue Sheridan Deputy Director, Patient Engagement

Gail Shearer Senior Advisor

Martin Duenas Director, Contracts Management

ED COO CSO

Scientists, Program

Staff

Patient Engagement

Communi- cations

Stakeholder Engagement

Strategic Initiatives

Grants Mgmt

Finance

Meetings Manager

PCORI – A Growing Organization

4

Admin Staff

Senior Advisor

HR IT

ED COO CSO

Scientists Patient

Engagement Communi-

cations Stakeholder Engagement

Strategic Initiatives

Grants Mgmt

Finance

Meetings Manager

PCORI – A Growing Organization

IT HR

Engagement Science

Admin Staff

Senior Advisor

6

Next Steps in Hiring

• Research • Chief Science Officer – position posted • Scientists – approximately 9 in 2012

(interviews underway) • Research Associates (interviews underway)

• Engagement

• Project Associates (interviews underway)

• Operations • Director of Information Technology • Financial and Grants Management Support

Staff 7

PCORI’s New Address

Projected move date: by April 1

8

Next Steps – PCORI 2012

• Public Comment Period Jan 23-Mar 15, 2012 • Clinician Focus Groups on draft priorities & agenda Feb 8-16, 2012 • National Patient and Stakeholder Dialogue Feb 27, 2012 • Analysis of public comment received March-April 2012 • Adoption of National Priorities & Research Agenda April 2012

• Broad funding announcements issued May 2012 • Broad funding applications due July 2012 • Broad funding awards announced December 2012

• Issue conference grants Spring 2012 • Brainstorming workshop Summer 2012 • Advisory Groups Fall 2012

• Targeted funding announcements begin October 2012 • First targeted funding applications due December 2012 • First targeted funding awards announced May 2013

9

Next Steps – PCORI 2012

April 2012 • Board reviews Scored Pilot Project Applications

May 2012 • PCORI Pilot Project Awardees announced

May 10, 2012 • Methodology Report presented to Board

May - July, 2012 • Public Comment Period for Methodology Report

July – Aug 2012 • Input analyzed and Methodology Report Revised

Aug 2012 • Revised Report Adopted by Board

10

PCORI Funding Announcements

11 Other Targeted Announcements

12

Patient and Stakeholder Engagement 2012

Building communities of patients and stakeholders – using website, social media, face-to-face meetings

Strengthening ties with advocacy associations, professional clinician organizations, purchaser organizations, research community

Refining the PCORI Research Agenda

Convening multi-stakeholder workshops focused on each of the National Priorities

Forming multi-stakeholder Advisory panels

Using social media, surveys to obtain broad input



Finance, Audit, and Administration Committee (FAAC) Report

PCORI Board of Governors Baltimore MD Monday March 5, 2012

2

Agenda

SCCOI Nominations

GAO Oversight and Compliance

Financial Statement Audit

Managing Cash Flow

3

SCCOI Nomination

Bernard Lo, MD

‒ President, The Greenwall Foundation

‒ Emeritus Professor of Medicine, UCSF

‒ Emeritus Director, Program in Medical Ethics, UCSF

Proposal for Membership (Ethicist) on the SCCOI:

4

SCCOI Nomination (cont’d)

Current Academic and/or Research Activities

Dr. Lo's general research area is clinical medical ethics. Specific interests include: end-of-life care; talking to patients about palliative care; the doctor-patient relationship, particularly the impact of the Internet; ethical issues regarding HIV infection; ethical issues in clinical and translational research, particularly stem cell research; conflicts of interest in research, clinical care, and medical education.

197 peer-reviewed publications

See Appendix for CV

Education and Training

Medical School: Stanford University

Residency: University of California, Los Angeles; Stanford University

Fellowship: Robert Wood Johnson Clinical Scholars Program, Stanford University

About Dr. Bernard Lo

5

SCCOI Nomination

Arthur Aaron Levin, MPH

‒ Co-founder and the Director of the Center for Medical Consumers

‒ Member of Institute of Medicine’s Committee on the Quality of Health Care (CQHC)

‒ Past chair of the NQF Consensus Standards Approval Committee (CSAC)

‒ Co-chair of the NCQA Committee on Performance Measures (CPM)

Proposal for Membership (Consumer Member) on the SCCOI:

6


Activities

The Center for Medical Consumers is a New York City-based nonprofit organization committed to informed consumer and patient health care decision-making; patient safety; evidence-based, high quality medicine and health care system transparency.

Interests: transparency and conflict of interest as it affects clinical guideline development, the FDA advisory committee process, and other aspects of standard-setting in healthcare.

See Appendix for Biography


Master of Public Health, Columbia University School of Public Health

Bachelor of Arts in Philosophy, Reed College

About Arthur Levin

7

SCCOI Nomination

Annette Bar-Cohen, MA, MPH

‒ Executive Director, Center for NBCC Advocacy Training

‒ Former Education Director, Cancer Control Center, Minnesota Department of Health

‒ Member, Steering Committee, Electronic Data Methods Forum, Academy Health

Proposal for Membership (Patient/Consumer Member) on the SCCOI:

8


Activities

The Center for NBCC Advocacy Training provides leadership and direction for science, education, and training programs including Project LEAD

2011 AHRQ Annual Meeting: Leading Through Innovation and Collaboration

ECRI Institute’s 18th Annual Conference on the Use of Evidence in Policy and Practice

See Appendix for CV


Master of Public Health, School of Public Health, University of Minnesota

Master of Arts in Psychology, Goddard College/Fellow, Medical School, Tufts University

Bachelor of Arts in Journalism, Northeastern University

About Annette Bar-Cohen

9

SCCOI Nomination

Proposal to serve as legal counsel to the SCCOI:

The highly credentialed Harris Beach team’s strong prosecutorial and ethics backgrounds have made it the firm of choice for organizations of all sizes to handle their high-risk, high-visibility federal and state investigation and compliance matters.

http://www.harrisbeach.com/

10


Karl J. Sleight Government Compliance and Investigations Team

Mr. Sleight served as the Executive Director of the New York State Ethics Commission from March 2001 through March 2007. During his tenure, he was responsible for conducting investigations of high ranking government officials and private sector entities that interact with government officials. Mr. Sleight also provided advice and interpretation of the states ethics and integrity laws to statewide elected officials, including the governor and attorney general as well as private sector business leaders that interacted with the government.

Mr. Sleight chaired the Due Process and Investigations Subcommittee for the NYS Bar Association’s 2011 Task Force on Government Ethics. The Subcommittee’s recommendations have been credited with influencing important aspects of the groundbreaking Public Integrity Reform Act of 2011. Mr. Sleight has also served as Special Counsel to the New York State Legislative Ethics Commission and is a frequent commentator on issues involving ethics and compliance in the media.

Mr. Sleight advises clients on matters related to corporate compliance and government investigations, and federal and state regulatory actions.

See Appendix for Harris Beach materials

11


Request Motion to Accept Nominees

Nominations for Acceptance

Bernard Lo, MD

Arthur Levin, MPH

Harris Beach PLLC

12


U.S. Government Accountability Office (GAO)

Responsibility

The GAO is responsible for conducting a review of the audit of PCORI’s financial statements.

Comptroller General

The Comptroller General of the

United States must report to

the Congress on the results of

PCORI’s financial statement

audit no later than April 1 of

each year.

Legal Counsel

GAO legal counsel to provide

insight into compliance

regulations that PCORI is

subject to (e.g., 2 CFR, Part

230/OMB Circular A-122 & OMB

Circular A-133, and Form 990).

Source: Logo from company website: http://www.gao.gov/

http://www.gao.gov/

13

Financial Statement Audit

McGladrey & Pullen, LLP

Work Time Frame

The field work has begun

and will be complete by

March 12, 2012.

GAO Review

GAO will review the audit of

PCORI’s financial

statements in order to

prepare its annual report to

Congress due April 1, 2012.

Engagement

McGladrey & Pullen has been engaged to perform the audit of the PCORI financial statements for the years ending

December 31, 2010 and 2011.

Source: McGladrey & Pullen, LLP operates under the McGladrey brand. Logo from company website: http://mcgladrey.com/About/About

http://mcgladrey.com/About/About

14

Managing Cash Flow

Discussion of the Issues

Text

Text

In preparation for developing a cash flow model, there are several assumptions and there are a number of decisions that need to be made.

Set announcement, commitment, and funding dates so that deadlines can be anticipated

Text There will be three funding cycles; July, November, March

Text The review process will take four to six months

Text

Consider funding strategies that commit more funding in early years in order to increase PCORI’s impact

15

Managing Cash Flow

Assumptions for Cash Flow Model

The model was created using three-year awards for illustrative purposes only.

When we make awards, we pay approximately 50% in the first year, then 25% in years 2 and 3 of the award.

Dollars available for awards are best estimates of funds available from PCORI Trust.

2012 Funding = $90M

$112M less 20% Operations = $90M

2013 Funding = $250M

$72M plus $240M in fees = $312M less 20% Operations = $250M

2014 to 2019 Funding = $403M/year

$24M plus $480M in fees = $504M less 20% Operations = $403M

* All dollars are in millions.

16

Managing Cash Flow

Multi-Year Cash Flow Model

We can make commitments prior to receiving money in the PCORI Trust.

In millions

Award

Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019

2012 $210 $90 $60 $60

2013 $380 190 95 95

2014 $496 248 124 124

2015 $368 184 92 92

2016 $375 187 94 94

2017 $434 217 109 109

2018 $300 200 100

2019 $194 194

Funding $2,757 $90 $250 $403 $403 $403 $403 $403 $403 $2,757

17

Managing Cash Flow

Annual Cash Flow Model

We can make commitments only with monies already in the PCORI Trust

In millions

Award

Year Commitments 2012 2013 2014 2015 2016 2017 2018 2019

2012 $90 $45 $23 $23

2013 $250 125 63 63

2014 $403 202 101 101

2015 $403 202 101 101

2016 $403 202 101 101

2017 $403 202 101 101

2018 $403 202 101 101

2019 $403 202 201

Funding $2,757 $45 $148 $287 $365 $403 $403 $403 $403 $302 $2,757

18

Questions for Discussion

• Should we plan to make grant commitments ahead of funds available in the PCORI Trust?

• If we pursue this strategy, do we commit ahead of funding only in the early years of PCORI, or carry out this strategy through 2019?

• How do we manage the risks of this strategy; specifically, the risk of making funding commitments against dollars not yet transferred to the PCORI Trust?

• What level of refinement for the strategic plan and research agenda do we want to implement this strategy?

• If we pursue this strategy, how aggressively should we commit ahead of funding?


1

March 5, 2012


Methodology Committee (MC) Report


2

1. Finalizing the Methodology Report

2. Board- Methodology Committee Engagement

3. Beyond the Methodology Report

4. PCOR Definition

Agenda


3

Finalizing the Methodology Report


4

Methodology Report Outline

• What is PCOR? (Based on our definition) • What is the pressing need for a report on methods for

conducting PCOR? • Who is this report for? • Goals of the First MC Report • Types of Research Addressed in this Report

CHAPTER 1. Introduction

CHAPTER 2. How we Developed

Standards

• What are standards? • Categories for Rating Potential Standards • Selecting Standards

• Formulating Research Questions (PICOTS*) • Choosing a Data Source, Study Design, & Analysis Plan • Methods for Conducting Research Studies

CHAPTER 3.

What is Patient – Centeredness?

CHAPTERS 4-? Standards for Selecting,

Designing, and Conducting Research

• Public Review • Dissemination and Implementation • Plans for Updating

CHAPTER N. Future Plans & Direction

*population, intervention, comparator, outcome, timeframe, setting

• How does patient centeredness apply in research prioritization, identification of research questions, design of studies (PICOTS*), and dissemination/implementation?

• What methods can make research more patient-centered? • How is patient-centeredness balanced with feasibility and

other stakeholders' concerns?


5

Methodology Report Outline

CHAPTER 1. Introduction

CHAPTER 2. How we Developed

Standards

CHAPTER 3. What is Patient –

Centeredness?

CHAPTERS 4-? Standards for Selecting,

Designing, and Conducting Research

CHAPTER N. Future Plans & Direction

Example Section:

ENDORSED STANDARDS AND ACTIONS RELATED TO MISSING DATA

I. Background

“Missing data is not only inevitable in human health studies and trials, it is more likely…..”

The committee reviewed standards for methods including Last Observation Carried Forward (LOCF), [insert other methods here].

II. Recommended Standards

1. Adopted standard #1 2. Adopted standard #2

II. Rationale for Standards

“The committee believes these standards…”

II. Recommended Actions to support the Standards 1. “PCORI shall encourage training in the…” 2. “PCORI shall disseminate software to conduct…”


6

The four phases below illustrate the key milestones which will take place during the report writing process

1. Workshops / Contractor Findings

2.

Consensus Process / Voting

Meeting

3. Draft & Revise Sections of the

Report

4. Delivery of

Methodology Report

Report Writing Process

Key Board Engagement

March 2012 April 2012

Observe Workshops

May 2012

Approve Report for Public Comment

Tim

elin

e

Review Workshop Materials & Contractor

Reports

Review summary of draft recommended standards

Provide input on drafted Report


7

The next two phases demonstrate the process by which the Committee determines which Standards and Recommendations will be adopted for inclusion in the Report

1. Workshops / Contractor Findings

2.

Consensus Process /

Voting Meeting


• Two workshops will be held to discuss the findings of research groups contracted by the MC in order to facilitate writing of first Methodology Report

• 15 Reports will be delivered in March outlining findings and recommendations of each research team

• The Committee has defined an approach to select standards and recommendations for inclusion in the May Report

• During the April 3 Meeting, the

Committee will come to consensus on standards to be included in the first Methodology Report

March 1-15, 2012 April 3, 2012


8

During the last two phases, the Committee will finalize the Report in preparation for delivery to the Board and Public Comment

3. Draft & Revise Sections of the

Report

4. Delivery of

Methodology Report


April 2012 May 10, 2012

• The Report Writing Team and workgroups will collaborate to finalize the report

• Four experienced report

writers have been brought on board to develop the Report

• Leading up to May 10, the Committee will prepare the Report for delivery to the Board

• Upon Board Approval, the Methodology Report will be posted for Public Comment Period


9

Methodology Committee – Board Engagement


10

Board of Governors Engagement

The Methodology Committee has engaged with the Board in a number of ways in order to accomplish the following objectives:

Participates in at least five

bi-monthly Board Meetings

with a total of approx. 25

hours of direct interaction

Orchestrated three teleconference calls to engage the Board in

discussion of the report outline and translation tool

Established Liaisons to the Patient Centeredness Working

Group: Ellen Sigal & Gray Norquist

Submitted approximately 12 Briefings since Sept.

2011

Invited Board Members to

participate in reviews of

contractor proposals:

Leah-Hole Curry, Harlan

Weisman, Debra Barksdale,

Rick Kuntz, Steve Lipstein

Provided input regarding methodologic research on the Research Agenda and

Pilot Projects

Shared highlights of the electronic data task &

solicited approximately 6 candidates for interview

referred by Harlan Weisman, Richard Kuntz, Steve Lipstein.

& Harlan Krumholz

Gained support of two Committee Members with

framing the PCORI Funding Announcement (PFA)

Collaborated with Board Members to develop a joint

Dissemination Plan

Key New points of engagement

Prepared weekly Status Reports on Committee

progress to PCORI Leadership

Methodology Committee members to attend the Closed Board Session at

March Board Meeting

Two Methodology Committee members will participate as members of the PCORI Pilot

Project Selection Subcommittee


11

Synthesize contractor reports, research, and

workshop results

Share Workshop

Executive Summary & Contractor Reports

Voting Standards Meeting– April 3rd

Submit final drafts, Review, & Finalize

Report Sections

Share Report & Receive input from Board of

Governors

February 2012

March 2012

April 2012

Prepare for meeting to vote on proposed

standards

May 2012 Submit Report to the

Board Post for Public Comment

‘Case Study’ Teleconference Call with Board

Review & Revise

Outlines

Provide proposed recommendations

Draft sections of the report

Board Engagement Key:

Engagement Next Steps

The below steps outline the opportunities for the Board to engage with the Methodology Committee during the development of the May Report

Discuss and Approve

Dissemination Plan


12

Beyond the Methodology Report


13

Maximizing the impact of the Report

Following the release of the first Methodology Report, the MC intends to enhance adoption of the recommended standards and best practices within the broader research and health care communities by acting as a convener, communicator, and catalyst


14

Looking Ahead & Extending our Reach

• Committee Member Feedback Sessions

• Dissemination/Implementation of Standards

• June 2012 Retreat Strategic Planning

• Professional societies and stakeholders (Advisory Groups)

− Electronic Data Systems

− Implementation

− Novel Delivery Tools

− Systems Engineering

• 1st Annual PCOR conference

In the months following the release of the May Report, the Committee plans to engage in the following activities:


15

Patient-Centered Outcomes Research Definition

Workgroup Members:

Dave Flum Mary Tinetti Jean Slutsky

Mark Helfand Sebastian Schneeweiss

Board Members:

Debra Barksdale Bob Jesse Harlan Weisman Gray Norquist Rick Kuntz

Sharon Levine Allen Douma Gail Hunt Harlan Krumholz

Working Group Accomplishments

• Reached consensus on changes to PCOR definition in response to

public input

− Added reference to improving communication and including caregivers

− Modified question four so that mention of healthcare system emphasizes

role of the system in getting better decisions

• Prepared revised document that explains proposed response to

public input


16

Patient-Centered Outcomes Research Definition

Patient Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as:

1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”

2. “What are my options and what are the potential benefits and harms of those options?”

3. “What can I do to improve the outcomes that are most important to me?”

4. “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?”

To answer these questions, PCOR: • Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative,

or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people;

• Is inclusive of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life;

• Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and

• Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives.


17

Thank You!

1


Program Development Committee(PDC) Report

PCORI Board of Governors Baltimore MD March 5, 2012

2 2

Update on PCORI Pilot Projects

PPP

3 3

PPP Selection Committee

Chair: Gray Norquist

Advisor: Christine Goertz non-voting

Members:

Kerry Barnett

Carolyn Clancy

Arnie Epstein

Gail Hunt

Steve Lipstein

Sherine Gabriel

Clyde Yancy

Joe Selby

4 4

Pilot Projects Deliberations Process

Working Group

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

PCORI Selection Committee

• Meets to review materials.

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

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

Board of Governors

• Meets to consider the recommended slate.

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

• Requests additional options, if needed.

• Approves a final slate of selected projects for funding.

PCORI Staff

• Analyzes the applications using priority score and the criteria.

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

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

Initial recommendations made. Under review by Methodology Committee

5 5

Balance Criteria

Priority Score

Among Highest Scoring Applications

Area of Interest

Population

Methods

Geography

Discipline of PI

Seniority of PI

Condition

Stakeholder/Patient Involvement

6 6

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

Merit Review (CSR)

Determine Balance

Criteria

Pull & Vet Data & Load

Spread Sheet

Selection Committee

Recommendations

Development of Funding

Recommendations

Board Deliberations &

Final Decisions

Business Review Process

Awards Process

Pilot Projects Timeline

Merit Review Scores Received

Announcements Made

Present to Board/Board Consideration



7

PCORI Peer Review Evaluation

Post Survey Instrument

- NIH administered PCORI-developed stakeholder and scientist

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

the review experience

Observational Instrument

- Instrument was completed by PCORI observers in

attendance at 10 randomly selected review meetings

Merit Score Data

- We have data on preliminary and final scores for each

application, including information on the six PCORI Review

Criteria

8 8


Public Comment Results

9

Public Comment Process and Timeline

Aggregate/Analyze Input

1

Assess Suitability of Themes

2

Conduct Initial Evaluations

3

Preliminary Voting

4

Voting Conference to Reach Consensus

Recommendations

5

Recommend Changes for Board Decision

6

March 15-March 26

March 27

March 28-April 6

April 9

April 11 (PDC F2F)

April 17 (Open meeting being planned)

Staff

PDC*

Staff

PDC*

PDC*

PDC*/Staff

*Any interested Board/MC Member is welcome to participate

10 10

Public Comment Analytics

11 11

Public Comment Analytics

12 12


May, 2012 PFA Process and Timeline

13

1 2 3 4 5 6 7 8 9

Month Jan Feb Mar Apr May Jun July Aug Sept

Designate PFA WG Leads

Hire (Contract) PFA Writers

Draft Broad PFAs (May PFAs)

Targeted Priority #5 PFAs (July)

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

Incorporate PPP Input

Revised Version Incorporating Comments

Finalized PFA

PDC Calls

PDC F2F

Board of Governors’ Call

Board of Governors’ F2F

Grants Management Process

MC Report

Incorporate Public Comment Input

Timeline for Development of First PFAs

1

2

PFA WG Membership Specificity for May Announcements DECISIONS

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

1 2

14

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

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

Open competition

Applications reviewed by CSR a la PPP’s

Successful applications administered by PCORI

Current Plans – Priorities 1 - 4

15

National Priority Board/MC Member 1

Board/MC Member 2

Board/MC Member 3

PCORI Staff Scientist

Identified

Comparative Assessment of Options for Prevention, Diagnosis, and Treatment

Harlan Krumholz

RFP Issued

Improving Healthcare Systems Arnie

Epstein Christine Goertz

Leah Hole-Curry

RFP Issued

Communication and Dissemination Research

Gray Norquist

Dominick

Frosch

Addressing Disparities Carolyn Clancy

Anne Beal

RFP Issued

Accelerating PCOR and Methodological Research

Michael Lauer

Jean Slutsky

Contract

with AHRQ/NIH

PFA Development Teams

16

Proposed Plan for Priority #5

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

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

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

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

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

Clinical Research Data Infrastructure

17

Rationale for Contracting with AHRQ

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

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

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

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

• AHRQ and NIH have expertise running cooperative agreements

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

18

Analytic Methods

• Close collaboration with the MC

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

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

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

19

March 5, 2012


PCORI Dissemination Workgroup

20

Carolyn Clancy, Co-Chair

Sharon Levine, Co-Chair

Lawrence Becker

Allen Douma

Howard Holland

Gail Hunt

Freda Lewis-Hall

Steve Lipstein

Brian Mittman

Robin Newhouse

Grayson Norquist

Jean Slutsky

Members of the Workgroup

21

Dissemination Accelerating Components: Proposed Checklist

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

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

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

Stakeholders

Engagement

Points

Engagement

Type

Governance

Plan

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

22

Dissemination Accelerating Components: Proposed Checklist (cont’d)

Describe how conflicts – true and perceived – will be managed

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

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

Conflict

Management

Study

Results

Barriers

Assessment

board of governors meeting, baltimore maryland

Health & Medicine