Board of Governors Meeting, Jacksonville Florida

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE

January 19, 2012

Patient-Centered Outcomes Research Institute

Communications, Outreach and Engagement Committee (COEC) Report


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


COEC Report to the Board

3

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

II. Expanding Digital Communications (Update)

III. Stakeholder Engagement (Update)

IV. Speakers Bureau (Update)


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

4

• Formal public comment period

o 53 days from January 23-March 15

o www.pcori.org/provide-input

o Responses received through www.pcori.org will be displayed for public view on the website

o Input will also be accepted by mail

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



http://www.pcori.org/


Receiving Public Feedback on the National Priorities and Research Agenda

5

• Additional forums to obtain input

o National Patient and Stakeholder Dialogue – Will take place February 27

o Patient and Caregiver Focus Groups (on draft priority themes) – Completed Nov. 9-Dec. 8

o Clinician Focus Groups (on draft priorities and agenda) – Will take place in February



6

• National Patient and Stakeholder Dialogue

o February 27, 2012, in Washington, D.C., at the National Press Club

o Webcast and teleconference dial-in

o Stakeholder panel discussion

o 3.5 hours dedicated to public comment, a portion reserved for those participating by phone



7

• Patient and Caregiver Focus Groups:

o 12 focus groups took place in November and December

o 96 patients and caregivers participated across four cities and regions

o Identified the questions patients and caregivers have and the information they need to make informed health decisions

o Provided early, general feedback on PCORI’s developing National Priorities for Research

o The complete results of the focus groups will be considered in the priorities and agenda revision process


Patient and Caregiver Focus Groups

8

Columbus, OH (Dec. 7) • Parents of children with ADD/ADHD

(caregivers)

• Patients with Mental Health conditions

• Patients who survived Cancer

• Insured and uninsured

• Age: 30-70+

Phoenix, AZ (Dec. 8) • Patients with Respiratory Disease

(chronic bronchitis, emphysema)

• Hispanic patients with mix of chronic conditions

• Patients with Heart Disease


• Age: 21-69

Atlanta, GA (Nov. 21) • Patients with Diabetes

• Caregivers to Alzheimer’s patients

• Patients with Chronic Pain


• Age: 21-75+

Baltimore, MD (Nov. 9) • Patients with Arthritis

• Parents of children with Pediatric Asthma (caregivers)

• Patients with mix of chronic conditions


• Age: 21-69



9

• Clinician Focus Groups

o Clinician focus groups will take place in February o Philadelphia o Birmingham o California (site TBD) o Chicago

o Four groups of physicians and four groups of nurses

o Report will be delivered to the Board by March 1 to consider in the priorities and agenda revision process


National Priorities and Research Agenda

10

• Incorporating input received:

o PCORI will review all input received

o A report will be published on www.pcori.org that summarizes the input received with an explanation of how the collective input led to any changes in the draft priorities and agenda.

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

http://www.pcori.org/


II. Expanding Digital Communications

11

• PCORI website

• Growing email and stakeholder organizations lists

• Social media communications


PCORI Website: www.pcori.org

12

Recent key additions to the website include:

• “Executive Director's Corner”

• Web videos featuring Board and Methodology Committee members and Executive Director

• General feedback web form

• Easier process to subscribe to PCORI’s mailing list


0500

1000150020002500

Subscribers

13

2,117 subscribers as of Jan. 17

283 subscribers as of Feb. 7

• Does not include pro-active supplemental mailing lists for major announcements

• Individuals can conveniently subscribe online: http://www.pcori.org/subscribe/

Growing the PCORI Email List

http://www.pcori.org/subscribe/

http://www.pcori.org/subscribe/


14

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

Pcori.org Page Views By Month (Nov. 2010-Dec. 2011)

Board Meeting Webcasts Begin

PCOR Definition Input Process

Pilot Projects Grants Program

Grant Reviewer Application Process

Redesigned Website Launched


Social Media Communications

15

• PCORI is using social media to:

• Engage larger and more diverse audiences.

• Increase awareness of PCORI’s work among individuals tracking health conversations online

• Follow @PCORI on Twitter.

• Stay on top of PCORI activities, funding announcements, and engagement opportunities.

• Additional web-based and mobile technologies will be developed to support two-way engagement.


•Stakeholder discussion forum March 2011

St. Louis, MO

•Stakeholder discussion forum May 2011

New York, NY

•Two small group meetings with patients and caregivers

•Eight small group meetings with 43 stakeholder organizations

July 2011

Washington, DC

• Invited presentations from Pacific Northwest stakeholders September 2011

Seattle, WA

•Two site visits to local community health centers

• Invited presentations from Southeastern stakeholders

November 2011

New Orleans, LA

• Invited presentations from Florida stakeholders January 2012

Jacksonville, FL

III. Stakeholder Engagement

16

PCORI’s engagement with stakeholders around Board meetings


Jacksonville Stakeholder Engagement

17

• Wednesday evening stakeholder panel:

– Bridget Jennings, RN, CDE, American Diabetes Association – North Florida/South Georgia

– Nipa R. Shah, M.D., Department of Community Health and Family Medicine; Director, Patient-Centered Medical Home

– Karen van Caulil, Florida Health Care Coalition

– Bill Haley, M.D., Mayo Clinic Florida, Division of Health Sciences Research

– Yank Coble, M.D., University of North Florida, former president, American Medical Association and member of AHRQ’s National Advisory Council


Future Board Meeting Engagement Events

18

• Analyzing 2011 Events

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 in 2012?

• Planning 2012

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


V. Speakers Bureau

19

• PCORI has presented at 49 meetings since March 2011

• Presentations have been made at events convened by the following stakeholder groups:

Patient groups and consumer

organizations Physicians Nurses Researchers

Biotechnology, pharmaceutical

and device industry Policy makers Employers

Complimentary and Alternative Medicine


Upcoming Speakers Bureau Presentations

20

Jan. 26 – American Nurses Association Nursing Quality Conference

Feb. 9 – National Health Council Annual Voluntary Health Leadership Conference

Feb. 15 – National Institute of Diabetes & Digestive & Kidney Diseases

Feb. 16 – VHA Clinical Conference

Feb. 20 – Healthcare Information and Management Systems Society (HIMSS) – Secondary Use of Data Symposium

Request a PCORI speaker for your event. Email [email protected]

mailto:[email protected]


21

1

Status Report to the Board of Governors PCORI Dissemination Workgroup “Can You Hear Us Now?” PCORI Board of Governors Jacksonville, Florida January 2012

2

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

3 Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.

‘‘(c) PURPOSE.—The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions ….and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items described in subsection (a)(2)(B). ‘‘(1) DISSEMINATION.—The Office of Communication and Knowledge Transfer (referred to in this section as the ‘Office’) at the Agency for Healthcare Research and Quality (or any other relevant office designated by Agency for Healthcare Research and Quality), in consultation with the National Institutes of Health, shall broadly disseminate the research findings that are published by the Patient Centered Outcomes Research Institute established under section 1181(b) of the Social Security Act (referred to in this section as the ‘Institute’) and other government-funded research relevant to comparative clinical effectiveness research. The Office shall create informational tools that organize and disseminate research findings for physicians, health care providers, patients, payers, and policy makers. The Office shall also develop a publicly available resource database that collects and contains government-funded evidence and research from public, private, not-for profit, and academic sources.”

Purpose

Legislation

4

Oct Nov Dec Jan 2011 2011 2011 2012

Timeline of Activities

Formal launch of WG

AHRQ Presentation to

WG (10/26)

RAND Presentation to WG (12/1)

WG three-hour teleconference (1/6)

5

―Success‖ for PCORI and AHRQ = impact on practice and patient outcomes

PCORI will disseminate results of PCORI-funded and conducted research and PCORI will also fund research on dissemination, but will complement and supplement what AHRQ/NIH are doing, not duplicate efforts

PCORI has unique opportunities – and leg requirements

Dissemination is essential and requires investment, which could occur in multiple ways:

‒ Encourage / require ―dissemination accelerating components‖ in all PFAs

‒ Provide rapid follow-on funding for dissemination for selected studies

PCORI Dissemination Assumptions

6

PCORI has a related role and opportunity in creating demand for, and receptivity to, PCOR in anticipation of evidence/research findings

Not a one-size fits all endeavor—translating results, and influencing behavior, is context-dependent

PCORI will be most effective by establishing partnerships early (with AHRQ, NIH, NGO‘s and private sector actors) and clarifying what PCORI will and will not do

Effective patient and stakeholder engagement, early on in the research endeavor, is the first step in planning and executing dissemination, and facilitating uptake

PCORI Dissemination Assumptions (cont’d)

7

First Steps: Learning from the Work of Others

Defining ―successful dissemination‖ and potential obstacles/barriers to success

Identifying dissemination activities of other organizations, namely AHRQ, to determine potential gaps that PCORI may fill

Lessons learned from dissemination studies that may be relevant to PCORI activities

Brainstorming strategies and assumptions to review with the Board of Governors, to inform PCORI‘s Dissemination Framework and Strategy

8

Existing Hurdles to Evidence Dissemination in the Health Care System

Limitations of the

scientific evidence

Gaps in the medical evidence due to the limits of scientific knowledge,

limitations of study design, or both

Constraints on practicing

clinicians

Little or no time to consult evidence or colleagues, limited reimbursement for

consulting evidence, and limited skills among some clinicians for consulting

electronic data sources

Constraints on patients Limited understanding of health care issues among many patients, and

limited capabilities to make health care choices comprehensible to patients

Limited incentives for

clinicians to change

practices

Lack of (or weakness of) financial and professional incentives for clinician

attention to evidence-based guidelines/adherence to protocols, clinician

distrust of an over-reliance on evidence (“cookbook medicine”), and

organizational inertia

Limitations in the

presentation of evidence

Unclear presentation, inconvenient formats, and lack of clear rationale for

action by the clinician or patient

Limited access to

evidence

Uneven distribution of health care IT infrastructure and other resources that

make evidence available in convenient forms

Source: From Evidence to Practice: Making CER Findings Work for Providers and Patients. Sept. 2010. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients

New England Healthcare Institute (NEHI)

http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients

9

Anticipated hurdles to CER Dissemination:

Drivers of CER Dissemination:

The public perception of CER and its legitimacy, including clinicians’ trust in systematic reviews and observational studies

Lack of standard methodologies

Speed of change in the evidence base

Strength of evidence

Heterogeneity of treatment effects

The “Learning Health Care System” concept and the contextualization of evidence

Patient-centered health care

Mass media




10

Building a Coherent Strategy For

Dissemination – Policy Choices

• Use consistent evidence ratings • Integrate CER dissemination

into the deployment of

health care IT

• Create partnerships with

stakeholder groups

• Utilize patient and clinician

incentives to promote

comparative clinical

effectiveness

• Select high priority targets for

dissemination

• Communicate directly with

the public and with patients



Note: The WG acknowledges that there is an engine in place (AHRQ) to address some of these issues, and there are required activities established under legislation


11

AHRQ’s PCOR Activities

– Dissemination, translation, and implementation goals include fostering

awareness and use of PCOR, informing professional and consumer

audiences about AHRQ’s Effective Healthcare Program, and driving

towards a greater degree of shared decision-making

Goals

Target

Audience

– Audience is broad and includes healthcare providers, consumers,

patients, caregivers, decision makers, policymakers, business leaders,

and advocates

– Audiences are diverse and information needs to be framed differently

for different audiences

Source: Overview of AHRQ’s ARRA-Funded PCOR Activities. Oct 2011. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients

Effective

Health Care

(EHC)

Program

– EHC offers continuing education and other resources, and does a

robust job of developing and testing various formats (received $300 M

for PCOR activities under ARRA)

– Emphasis on user-driven synthesis; has produced more than 100

products for clinicians, patients and families, and policy makers

– EHC conducts research on dissemination and partnerships


12

AHRQ’s PCOR Activities

Community

Forum Project

Dissemination

Contracts

– Its purpose is to improve and expand public and stakeholder

engagement in PCOR or CER

– It will identify useful and effective ways to engage stakeholders and the

general public in AHRQ Programs

– Support national awareness building, establishment of regional

partnerships, providing online continuing education, conducting

academic detailing, and a systematic program evaluation

Source: Overview of AHRQ’s ARRA-Funded PCOR Activities. Oct 2011. http://www.nehi.net/publications/47/from_evidence_to_practice_making_cer_findings_work_for_providers_and_patients

iADAPT

– Develop innovative ways to adapt and disseminate summary guides

for health consumers

– Supports Clinical Decision Support Systems, Culturally Tailored/Health

Literacy, Communication/Marketing, Academic Detailing/CME

Evaluation

– Evaluate effectiveness of publicity centers, regional offices, continuing

education, and academic detailing

– Determine the level of awareness, understanding, behavior

change/use, and benefits of PCOR among targeted audiences


13

Important Take-Away Messages for PCORI

Programs are most successful when they are audience-centered and use the audiences’ preferred formats and channels

Credentials are important in gaining access to healthcare providers

Health plans, health systems, and large medical groups are valuable sources of access to clinicians

Clinicians want unbiased and balanced information from a trusted and credible source

Disseminating new research differs from disseminating systematic reviews

14

RAND Briefing to PCORI

RAND Study Objectives

1. Developing a Dissemination Framework for assessing barriers and enablers to CER

translation into practice

2. Identifying barriers to and enhancers of CER translation

3. Developing recommendations for more effective CER translation

15


Case Study Topics and Results

CATIE: Conventional antipsychotics had similar effectiveness and side effects vs.

atypical antipsychotics

COURAGE: Optimal medical therapy (OMT) provided equivalent survival benefit and

comparable relief of angina to OMT + Percutaneous Coronary Intervention

COMPANION: Compared to optimal medical therapy, both cardiac resynchronization

therapy (CRT) and CRT + defibrillator reduced hospitalization rates, improved

functional status, and improved survival

SPORT: Surgery for lumbar spinal stenosis had better outcomes than non-operative

treatment in a cohort study

CPOE: Computerized Physician Order Entry significantly reduced the incidence of

serious medication errors vs. paper-based entry

16

RAND Briefing to PCORI: Conceptual Framework

Source: Dissemination and Adoption of CER Findings when Findings Challenge Current Practices. Dec 2011

Based upon literature review/environmental scan, RAND developed a conceptual framework that included four phases of translation

17

Study Findings

Little to no practice change, even when interventions were favored by results (i.e.,

implementation of results would have resulted in more aggressive or expansive

practice).

For each of 5 studies, RAND assessed factors that prevented or slowed uptake into

practice and root causes of incomplete translation were identified.

‒ Misalignment of financial incentives

‒ Ambiguity of CER results

‒ Cognitive biases

‒ Failure to address the needs of end users

‒ Inadequate use of decision support by patients and clinical professionals


18

Important Take-Away Messages for PCORI

Potential for CER results to influence practice is not yet fully realized

Current translation process is still ad hoc and post hoc with some exceptions

Significant barriers to CER translation may be addressed through a variety of policy levers, namely building CER-enabling infrastructure with a focus on governance, standards, financing, appeals to professionalism, education and marketing, and research and evaluation

Prospective studies of the CER translation process based on the proposed framework could guide future improvements

19

Important Take-Away Messages for PCORI (cont’d)

CER results are sometimes outdated by the time the study ends—is there a way to get answers faster?

Current under-appreciation for the roles of specialty societies in changing clinical practice

Additional information on best practices, but also the rate of diffusion, is needed

Need to create demand on the front end—this could be written into PCORI solicitations

PCORI may want to engage cognitive psychologists

20

Developing an Overall Framework: Strategic Issues Raised by Presentations

How can PCORI, building on AHRQ’s work, also work to address the “black box” between dissemination and uptake identified by RAND?

Several of the areas identified by RAND for additional infrastructure focus are areas where PCORI could be involved: generation of CER; more effective translation; evaluation of impact; transparent governance

Can we learn from examples of where translation works well?

– Can we prospectively study both infrastructure and sociological factors that make things work?

– How do we incorporate elements that work into design?

21

Developing an Overall Framework: Strategic Issues Raised by Presentations (cont’d)

How do we set up a platform for dissemination that works and allows us to customize strategy to meet the needs of different audiences, given audience heterogeneity (diverse research, multilevel and multidimensional barriers, channels for dissemination)?

What can be required components of all funding announcements that can accelerate dissemination—e.g., requirement for stakeholder engagement in a strategic and planned way?

Can we provide additional, follow-on funding for dissemination and implementation when studies have meaningful findings?

How to anticipate and address potential resistance early in process?

22

―Success‖ for PCORI and AHRQ = impact on practice and patient outcomes

PCORI will disseminate results of PCORI-funded and conducted research and PCORI will also fund research on dissemination, but will complement and supplement what AHRQ/NIH are doing, not duplicate efforts

PCORI has unique opportunities – and leg requirements

Dissemination is essential and requires investment, which could occur in multiple ways:

‒ Encourage / require ―dissemination accelerating components‖ in all PFAs

‒ Provide rapid follow-on funding for dissemination for selected studies

PCORI Dissemination Assumptions

23

PCORI has a related role and opportunity in creating demand for, and receptivity to, PCOR in anticipation of evidence/research findings

Not a one-size fits all endeavor—translating results, and influencing behavior, is context-dependent

PCORI will be most effective by establishing partnerships early (with AHRQ, NIH, NGO‘s and private sector actors) and clarifying what PCORI will and will not do

Effective patient and stakeholder engagement, early on in the research endeavor, is the first step in planning and executing dissemination, and facilitating uptake

PCORI Dissemination Assumptions (cont’d)

24

Feedback from the Board at early stage (today; via COEC and PDC ongoing)

Building a framework for PCORI dissemination

Commissioning landscape review

Articulating potential ‗dissemination acceleration components‘ for PFA‘s released in May, 2012

Next Steps


2


Executive Director’s Report

Board of Governors Meeting Jacksonville, FL January 18-19, 2012

2

3

Introductions

LORI FRANK, PH.D

PCORI Scientist

Judy Glanz

Director, Stakeholder Engagement

Bill Silberg

Director, Communications

Melissa Stern, MBA

Director, Strategic Initiatives

4

Next Steps in PCORI Hiring

• Engagement

• Director of Patient Engagement – Offer extended

• Research and Methods • Chief Science Officer – Offer extended

• Scientific Review Officer – position posted

• Scientists – approximately 9 in 2012 (positions posted)

• Operations • Director of Finance – Offer Accepted!

• Grants Manager – interviews underway

• Associates (i.e., Project Managers) – approximately 10 (position posted)

• Financial and Grants Management Support Staff

ED

COO

CSO

Scientific

Review

Officer

Scientists,

Program

Staff

Patient

Engagement

Communi-

cations

Stakeholder

Engagement

Strategic

Initiatives

Grants

Management Finance

Meetings

Manager

PCORI – A Growing Organization

5


1


Executive Director’s Report


1

2

The Next Four Months ….

Public Comment Period for Priorities and Agenda – (Jan 23–March 20) National Forum and Dialogue Feb 27th, Focus groups with clinicians - February Ongoing 1:1 engagements with stakeholder groups, Analysis and incorporation of public comments, Final (Version 1) documents for approval in early April

Pilot Project Grants:

Development of selection criteria for funding by BoG – February Announcement of proposed criteria – March BoG criteria Application of criteria – late March Selection of funded applications – early April

Preparing Broad Funding Announcements – target of May 1 release date

Methodology Report – approving for mid-May 12 start of Public Comment

Engaging Stakeholders through Forums, Workshops and Advisory Groups to refine PCORI’s Research Agenda, begin to identify more specific funding opportunities and prepare those announcements

The Next Four Months ….

4

Funding Research in 2012

• Budget calls for commitment of $91M in research funding in CY 2012 – in addition to Pilot Projects

• Current strategy envisions “broad” funding announcements, consistent with language in Research Agenda on May 1, with possibility of some proportion of total funding reserved for “targeted” research identified in process of stakeholder engagement, advisory groups.

• Targeted research may use contracts or cooperative agreements rather than grants, and may involve distinct review processes.

Plans for Engaging Stakeholders in 2012

– Stakeholders National Forum during public comment period

– Two Conference Grants to inform Priorities and Agenda

– Ongoing events to further inform Priorities and Agenda

– Brainstorming workshop to inform the Agenda

– Brainstorming workshop for possible round 2 of Pilot Projects

– Form a PCORI Advisory Board on Research Networks

– Workgroup/Advisory Group on Dissemination

– Advisory committee on Clinical trials/observational studies

– Workshop and Advisory Group on EHR’s

– Workshop or Advisory Group on Building PCOR Capacity

– Workshop on Patient Engagement

– Conference on Patient-Centered Outcomes

5

See You in Baltimore!

March 5th and 6th 6


January 19, 2012


Finance Audit & Administration Committee


2012 Budget Jacksonville, FL Jan 18-19, 2012


3

2012 Budget Planning Process

Iterative planning and costing process with each committee – PDC, COEC, MC, and FAAC

Links to Strategic Planning process – by including specification of goals and strategies for each committee for 2012

Budget can now be examined in terms of expenditures by committees and G&A (the planning process), but also in terms of 5 strategic pillars: patient and stakeholder engagement, research funding, rigorous methods, infrastructure, and dissemination – see column “j” in each committee’s spreadsheet for assignment to pillar

Budget does not currently commit out-year funds – it only spends or commits 2011/2012 dollars


4

2012 Budget Distribution – by Committee


5

Budget Allocations – by Strategic Pillar

*Both “rigorous methods” and “research” represent grants and contracts


6

Budget Allocations – by Strategic Pillar

18%

33%

17%

8%

8%

8%

8%

Allocations for Research Funding Pilot Projects

Comparisons ofOptionsHealth Systems

Disparities

Communicationand DisseminationMethods

Infrastructure


7

Questions to be addressed in 2012

• Need to develop standard ways to conceive and discuss “administrative costs” as proportion of total costs:

• How to account for Stakeholder Engagement, Dissemination

• Whether to distinguish costs by pillar, or “dollars out” vs. “dollars spent internally

• We will develop a dynamic revenue flow budget to illustrate expenditures, commitments, and reserves on a monthly basis

• We need to consider funding strategies that may commit more funding in early years than are allocated in order to increase PCORI’s impact earlier in its lifespan

Jacksonville, FL Jan 18-19, 2012

Update on Standing Committee on Conflict of Interest (SCCOI)

9

Charter

Draft charter

outlines purpose, membership, committee operations, responsibilities

Purpose:

The SCCOI shall independently make recommendation to the BOG regarding issues of conflict of interest brought before it by the Board, the Board Chair or Vice Chair or the Executive Director of PCORI ….

10

Proposed Membership

For approval today:

Larry Becker, Chair

Sherine Gabriel

Robert Zwolak

For approval on March 7, 2012:

Ethicist

3 consumer members

from consumer organization, patient advocacy organization, the media

identification of candidates with help of directors of communication and stakeholder engagement

11

Schedule

Approval of initial three members: January 19, 2012 Approval of Charter: January 19, 2012

Approval of consumer members and ethicist: March 7, 2012

Organizing meeting of Standing Committee on Conflict of Interest: April 2012 [prepare for first round of PCOR grants]

Future meetings: as needed

12

Discussion

Discussion of motion to approve charter and Board and Methodology Committee members of Committee

13

Motion to Approve

Appointments: Larry Becker (chair) Sherine Gabriel Robert Zwolak

Charter of Standing Committee on Conflict of Interest

Nominating Committee Jacksonville, FL Jan 18-19, 2012

15

Nominating Committee

(a) There shall be a Nominating Committee, composed of the Board Chairperson and Vice Chairperson, and three (3) other members of the Board and one (1) member of the Methodology Committee appointed by the Board Chairperson and confirmed by Board vote. Chairs of the Standing Committees described in Section 5.5 shall not be eligible to serve on the Nominating Committee. The Board Chairperson shall be the Chair of the Nominating Committee.

(b) Members of the Nominating Committee shall serve one (1) year terms, with no more than two (2) consecutive terms allowed, except for the Board Chairperson and Vice Chairperson, who shall not be subject to such term limit.

16

Responsibilities of Nominating Committee

(i) In consultation with the Methodology Committee, to nominate the Chair and Vice Chair of the Methodology Committee; (ii) To nominate the Chairs of the three (3) Standing Committees described in Section 5.5; (iii) To advise the Board Chairperson, as requested, regarding committee membership; (iv) To advise the Comptroller General of the United States, if requested, regarding appointment of the Board Chairperson and Vice Chairperson; (v) To advise the Comptroller General of the United States, if requested, regarding appointment of new members of the Board; (vi) To advise the Comptroller General of the United States, if requested, and upon consultation with the Methodology Committee, regarding appointment of new members of the Methodology Committee; and (vii) To nominate for the following year the members of the Nominating Committee.

17

Members of Nominating Committee

Gene Washington - Chair Steve Lipstein – Vice-chair

Gail Hunt (PDC)

Robert Jesse (COEC)

Freda Hall Lewis (FAAC)

Robin Newhouse (MC)


43

January 18-19, 2012

PCORI Methodology Committee

Progress Report

Sherine E. Gabriel, MD, MSc

Sharon-Lise T. Normand, PhD

PCORI Methodology Committee


44

Methodology Committee Structure

Methodology Committee Activities Overview

Methodology Committee Contracts Summary

Methodology Committee-Board Engagement

Case Study Preview

Next Steps-Timeline

PCOR Definition

Agenda


45

Patient

Centeredness

Workgroup

Research

Methods

Workgroup

Research

Prioritization

Workgroup

Re

po

rt A

ssim

ila

tio

n W

ork

gro

up *

Identify methodological

standards to incorporate the

patient perspective

Produce methods to inform

prioritization of new research

studies

Produce methods for using

data, design, and statistical

analyses to conduct patient

centered outcomes research

In service of the First Methodology Report,

due May 2012, the committee has organized

as follows:

*Provides guidance to other workgroups and assmilates work products into the first Methodology Report

Methodology Committee Structure

Standing Committees Scope Deliverables

Translation

Table

Methodology

Report


46

In service of the First Methodology Report,

due May 2012, the committee has

accomplished the following:

• 15 contracts have been awarded to date (of 48 submissions)

o 3 contracts relate to patient engagement

o 4 contracts relate to methods for research prioritization

o 8 contracts to review guidance documents for selecting methods for PCOR

o The workgroup members hold biweekly check in calls with the contractors

Request for Information (RFI) – Posted • 1 RFI to provide case studies for the development of the Translation Tool

In March 2012, two of the workgroups will hold a forum for contract awardees

to present findings in order to facilitate writing of first Methodology Report

Workshops – Planned

Over 34 interviews have been conducted including government, commercial,

and academia in order to assess how EHR and electronic data systems are

leveraged for CER/PCOR

Electronic Data Systems Interviews – On going

Methodology Committee Activities Overview

Contracts – Awarded

• Lori Frank, PCORI Scientist,

• Tim Carey, Research Prioritization Workgroup Interim Research

• Ed Reid, Report Assimilation Interim Contractor

• Medical Writers (TBD)

Resources


47

Methodology Committee Awarded Contracts

Oregon Health &

Science University, The

Center for Evidence-

Based Policy

Mayo Clinic, Knowledge and

Evaluation Research Unit

University of Maryland

School of Pharmacy,

Pharmaceutical Health

Services Research

Department

University of Wisconsin,

Medical College Medical Co

Duke University,

Evidence-Based Practice

Center

NORC at The

University of Chicago

RC at

Univ

Hayes, Inc.

15 contractors from across the country

are currently conducting research on

behalf of the Methodology Committee

Evidence for Eliciting the Patient’s Perspective

in Patient-Centered Outcome Research

(Stakeholder Interviews / Literature Review)

Methods for Setting Priorities in Research

(White Paper)

Review of Guidance Documents for Selected

Methods in PCOR

Or

Sc

Un

Sc

Un

Du

Ev

Ha

t The

ty of Chicago

t Th

Northwestern University/

UNC Chapel Hill

Johns Hopkins Bloomberg

School of Public Health

JoJo

Sc

Jo

Oxford

Outcomes

Ox

Ou

Berry Consultants

Brown University Br

Brigham & Women's

Hospital & Harvard

Medical School

Br

Ho

Outcome Sciences, Inc.

(A Quintiles Company)

Ou

(A

University of

California &

San Diego

Supercomp

uter Center

Un

Ca

Key Scope of Work

NortNo


48

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 two out of

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 11

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


49

Continue to provide opportunities for the liaisons to

engage with the Patient Centeredness Working Group

Board of Governors Engagement – Next Steps

The Methodology Committee has

strategized avenues for engagement and

intends to complete the following actions:

Methodologic

Importance

Methodology

Report

Schedule a teleconference to discuss the impact and

implications of methodologic decisions

Develop communication plan to ensure transparency and

involvement during Methodology Report Writing period (prior

to and following public comment)

Emphasis of Engagement Action Item

Board

Perspectives

Methodology

Committee

Progress

Submit Briefings/Status Updates

Present during Board Meetings


50

The Critical Role of Methods:

A case-based approach

Producing trusted, high quality and useful information….


51

• Incorporate the patient voice to choose outcomes

and comparisons that matter

• Use existing evidence

• Select the right study design

• Determine if/how treatments affect people differently

(heterogeneity of treatment effects)

Selected Methods to…


52 Robinson and Goodman, 2011

In reports of RCTs published over 4 decades, fewer

than 25% of preceding trials were cited, comprising

fewer than 25% of the participants enrolled in all

relevant prior trials…Potential implications

include ethically unjustifiable trials, wasted

resources, incorrect conclusions, and

unnecessary risks for trial participants.


53

NORC Accomplishments

• Summarized the public input (Phase I)

• Conducted 6 focus groups (Phase II)

o Focus groups sought input of general public and patients, with

outreach to patients with chronic illness, caregivers, African-

Americans, Spanish-speaking

Working Group Accomplishments

With the input of several Board Members, the group is considering revisions of the

PCOR definition as a result of:

• Synthesized Public comments

• Summarized output of 6 patient focus groups

• Distilled themes

Patient-Centered Outcomes Research Definition

Workgroup

Members: Dave Flum

Mary Tinetti

Jean Slutsky

Mark Helfand

Sebastian

Schneeweiss

Board

Members:

Harlan Weisman

Debra Barksdale

Gray Norquist

Rick Kuntz

Allen Douma

Gail Hunt

Harlan Krumholz


54

Finalize Report

Writing Process

Develop the

report writing

team

Set up calls with

Board Members

& PCORI Staff

Continually

update report

outline

Synthesize contractor

reports, research, and

workshop results

Discuss progress of

working drafts

Voting Standards

Meeting– April 3rd

Submit final drafts,

Review, & Finalize Report

Sections

Share Report & Receive

input from Board of

Governors

January

2012

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

Methodology Committee Next Steps

Board Engagement

Key:


55

Thank You!

1


PCORI Pilot Project


2

Contents

Key Accomplishments

Overview of Four-Stage Review Process

Description of the Merit Review Process

Description of PCORI Deliberative Process

Timeline

3

Pilot Projects: Key Accomplishments

850 People who registered for webinars

1375 Letters of Intent received

1400 Number of applicant questions answered

842 Number of applications received

Issued first PCORI Funding Announcement

Held three applicant webinars

Developed and continue to refine Frequently Asked Questions

Received, vetted, and forwarded qualified scientific and stakeholder reviewers to NIH.

Received and processed letters of intent.

Received and processed 842 grant applications.

4

PCORI Pilot Projects Applications

Thanks to programmatic reviewers: • Anne Beal • Carolyn Clancy • Arnold Epstein • Christine Goertz • Leah Hole-Curry • Gail Hunt • Harlan Krumholz • Joe Selby • Harlan Weisman

5

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

A BOG Working Group develops criteria for analytics regarding how PCORI will “balance” the pilot projects portfolio from a programmatic perspective

PCORI Balance criteria determined

The Pilot Projects Balance 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

Preparation for

Deliberation

6

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 applications

Summary & Rankings

• The review process results in a ranked, scored summary of applications for PCORI consideration

Conducted by NIH

7

PCORI Deliberations

Working Group

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

PCORI Balance 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

PCORI Staff

• Analyzes the applications using priority score and classification categories.

• Provides funding scenario options based on analytics developed by the BOG Working Group.

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

8

Timeline

Sep 28, 2011 Posting of Funding Announcement

Nov 1, 2011 List of potential Stakeholder and Scientific Reviewers to the NIH

Nov 1, 2011 Letter of Intent Due

Nov 2, 2011 Letters of Intent sent to NIH

Dec 1, 2011 Applications due

Dec 8, 2011 Programmatic review begins

Feb, 2012 Merit review

Mar, 2012 Review committee recommends slates

Mar/Apr, 2012 Slate of projects to board and selection

May, 2012 Award Notification

9

Discussion

1

Developing PCORI’s National Priorities for Research and First Research Agenda

PCORI Board of Governors January 2012


“Assist patients, clinicians, purchasers,

and policy-makers in making informed

health decisions by advancing the quality

and relevance of evidence…[relevant to]

the manner in which diseases, disorders

and other health conditions can

effectively and appropriately be

prevented, diagnosed, treated,

monitored, and managed through

research and evidence synthesis.”

Purpose

PCORI Purpose: Defining Legislation


National Priorities for Research

“The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section.”

4

Research Agenda

Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.

“The Institute shall establish and update a research project agenda for research to address the priorities identified under subparagraph (A), taking into consideration the types of research that might address each priority and the relative value (determined based on the cost of conducting research compared to the potential usefulness of the information produced by research) associated with the different types of research, and such other factors as the Institute determines appropriate.”

5

Stakeholder Input (surveys, focus groups, public

comment, stakeholder meetings, etc.)

Environmental Scans

Pilot Project Applications

Pilot Project Results

PCORI Board

Methodology Committee

PCORI National Priorities and Research Agenda Versions 1

Solicitation

5

Generating Greater Specificity: Inputs

Legislative Statute

6

In

creasin

g S

pecific

ity

National Priorities and Research Agenda: An Iterative Feedback Process

Inputs • Legislative Statute • Board of Governors • Program Development Committee • Methodology Committee • Environmental Scans • PCORI Pilot Projects • Stakeholder Input and Feedback

Research Agenda

Version 1

National Priorities Version 1

Individual PFAs

Version 1

7 7

We’re on a Journey!

8

Task Aug Sept Oct Nov Dec Jan Feb Mar Apr May

NATIONAL PRIORITIES

Develop Framework

Develop Stakeholder Engagement Process

Dialogue w/ Stakeholders

Design and implement web-based survey

Public Comment

Incorporate Public Comment

RESEARCH AGENDA

Environmental Scan for RA Development

Draft Research Agenda

Dialogue w/ Stakeholders

Public Comment

Incorporate Public Comment

2011 2012

Nat’l Priorities v1.0

Research Agenda v1.0

Timeline for Development of National

9

National Priorities

10

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 from prior frameworks and the statutory criteria for PCORI

Developed Framework to be used for refining priorities and for determining Research Agenda and funding announcements

Initial Stakeholder

feedback

Development of a National Priorities Framework

11

Environmental Scan

Source P

reve

nti

on

Acu

te C

are

Ch

ron

ic

Dis

eas

e C

are

Pal

liati

ve C

are

Car

e

Co

ord

inat

ion

Pat

ien

t En

gage

me

nt

Safe

ty

Ap

pro

pri

ate

U

se

HIT

to

imp

rove

p

t. e

xpe

rie

nce

Imp

act

of

Ne

w

Tech

no

logy

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

√ √ √ √ √ √

8

12

Health Information

Technology

Prevention &

Screening

Acute Care

Impact of New

Technology

PCORI Draft National Priorities

Appropriate Use

Frequently Cited Priority Areas

Chronic Disease Care

Palliative Care & Pain

Management

Care Coordination

Patient Engagement

Safety

Addressing

Disparities

Accelerating PCOR

and Methodological

Research

Communication and

Dissemination

Research

Improving Health

Care Systems

Comparative Assessment

of Options for Prevention,

Diagnosis, and Treatment

Consideration of Criteria in

Statute

Fits the Definition of PCOR

Making PCORI Priorities Patient-Centered

13

Patient-Centered Priorities

Improving

Healthcare

Systems

Comparing healthcare system-level approaches to improving access, supporting patient self-care, innovative use of health information technology, coordinating care for complex conditions, and deploying workforce effectively.

Comparative

Assessment of Options

for Prevention,

Diagnosis, and

Treatment

Comparing the effectiveness and safety of alternative preventive, diagnostic and treatment options.

14

Addressing

Disparities

Identifying potential differences in treatment effectiveness or preferred clinical outcomes across patient populations and the health care required to achieve best outcomes in each population.

Communication &

Dissemination

Research

Comparing approaches to providing CER information and supporting shared decision-making between patients and their providers.

Accelerating

PCOR and

Methodological

Research

Improving the nation’s capacity to conduct patient-centered outcomes research, by building data infrastructure, improving analytic methods, training researchers, patients and other stakeholders.

Patient-Centered Priorities (cont’d)

15

Developed over 5-month period

Built from prior prioritization efforts

Stakeholder input incorporated along the way

First Draft now ready for public comment

Can be modified based on public comment, or thereafter through a transparent process of stakeholder engagement

PCORI’s Draft National Priorities

16

Research Agenda

17

Impact on Health of Individuals and

Populations

PCORI Criteria – From Legislation

Improvability through Research

Inclusiveness of Different Populations

Addresses Current Gaps in

Knowledge/Variation in Care

Patient-Centeredness

Impact on Health Care System Performance

Potential to Influence Decision-Making

Rigorous Research Methods

Efficient Use of Research Resources

18

Accelerating PCOR

and

Methodological

Research

• Impact on Health of Individuals

and Populations

• Improvability via Research

• Inclusiveness of Different Populations

• Addresses Current Gaps in Knowledge/Variation

in Care

• Impact on Health Care System Performance

• Potential to Influence Decision Making

• Patient-Centeredness

• Rigorous Research Methods

• Efficient Use of Research

Resources

Addressing

Disparities

Improving

Healthcare

Systems

Communication

& Dissemination

Research

Priorities Comparative Assessment

of Options for

Prevention, Diagnosis,

and Treatment PCORI Criteria

PCORI

Research

Agenda

Framework for Developing PCORI Research Agenda from National Priorities

19

...compare situations in which the effectiveness of strategies for prevention, treatment, screening, diagnosis, or surveillance have not been adequately studied against alternative options where better evidence is needed to support decision-making by patients, caregivers, and health care professionals.

Research Agenda Item From a National Priority

Comparative

Assessment of

Options for

Prevention,

Diagnosis, and

Treatment

PCORI Criteria

20

Improving

Healthcare

Systems

Research Agenda Item From a National Priority

…compares alternative system-level approaches to supporting and improving patient access to care, receipt of appropriate care, coordination of care across health care services or settings for patients with complex chronic conditions, and personal decision-making and self-care.

PCORI Criteria

21

Alternative clinical options

Patient differences in response to therapy

Patient preferences for various outcomes

Alternative system interventions

Improvements in the effectiveness and efficiency of care

Patient-centeredness

Improvements in shared decision-making

Alternative strategies for dissemination of evidence

Alternative interventions/strategies to eliminate disparities

Improvements in alignment of decisions with preferences

Improvements study designs and analytic methods of PCOR

Building and improving clinical data networks

Better methods for training researchers, patients to participate in PCOR

Facilitating the study of rare diseases

Addressing

Disparities

Improving

Healthcare

Systems

Accelerating

PCOR and

Methodological

Research

Communication

& Dissemination

Research

Comparative

Assessment of Options

for Prevention,

Diagnosis, and

Treatment

Content of PCORI Research Agenda

22

Promote patients and their caregivers –and key stakeholders in implementation settings—as partners, with explicit roles in the design, governance, review, and dissemination of research.

Seek to understand core questions from the expressed perspective of the patient and their caregivers.

Emphasize open and transparent science that involves participants in decisions about making data available for further study, seeking to ensure that the research produces as much new investigative activity as possible and that sharing of information and knowledge among diverse investigators is required.

Select Features of PCORI Research Agenda

23

Commit to a diverse research portfolio with respect to patients, geography, health care professionals, investigators, and organizations, seeking to catalyze activity across a broad range of patients, sites, conditions, and questions.

Emphasize knowledge that is likely to make a positive difference in the lives of patients and their caregivers and is suitable for dissemination and application; and emphasize outcomes that are important to patients and their caregivers and likely to be useful in their decision-making.

Emphasize ideas that emerge from the community of patients, caregivers, clinicians and researchers, seeking to listen and learn from the wisdom of those whose lives are most affected by these conditions and those who are committed to generating new knowledge that will promote better decisions and outcomes.

Features of PCORI Research Agenda

24

Developed over 4-month period

Stakeholder input incorporated

First draft ready for public comment

Will be modified and expanded thereafter through a transparent process of stakeholder engagement

PCORI’s Draft Research Agenda

25

Proposed initial agenda is specific with respect to study questions that will be supported, but not to the conditions (or treatments) that can be studied

This non-specificity allows for a flexibility in the search for the best opportunities

Continuing input from stakeholders will contribute to refinement of research agenda over time

PCORI’s Draft Research Agenda

Board of Governors Meeting, Jacksonville Florida

Health & Medicine

Transcript of Board of Governors Meeting, Jacksonville Florida