pcori annual report 2011

7/27/2019 PCORI Annual Report 2011

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Patient-Centered Outcomes Research Institute

2011 Annual Report

Improving health outcomes by putting patients rst


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VISIONPatients and the public have the inormation they need to

make decisions that reect their desired health outcomes.

MISSIONThe Patient-Centered Outcomes Research Institute (PCORI)

helps people make inormed health care decisions, and

improves health care delivery and outcomes, by producing

and promoting high-integrity, evidence-based inormation

that comes rom research guided by patients, caregivers,

and the broader health care community.


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I believe that our accountability is to patients. Ultimately, were going to be listening to a lot o

stakeholders, but our true north is going to be patientspatients and their caregivers, those

individuals who are working together grappling with these decisions, or whom the consequence

o the decisionmeans everything In this conception, I think maybe we have a chance to turn

the world upside down just a bit.

PCORI Board of Governors Member Harlan Krumholz, M.D

Members o the public, patients and consumers, can be a orce that can make these reorms succeed

i they are utilized, and the time is now to begin that communication

Florence Fee, President, No Health Without Mental Hea lth

IMPROVING

HEALTH

OUTCOMES

BY PUTTING

PATIENTS FIRST


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PCORI 2011 ANNUAL REP ORT

When the Patient-Centered Outcomes

Research Institute (PCORI) was created, two

years ago, it had a substantial statutory

mandateimprove clinical decision-making by

supporting research that careully considers the

unanswered questions and concerns o stakeholders,

with patients and their caregivers at the center o

that process.

Over the past year, were pleased to say, PCORI has

made substantial progress toward this ambitious goal,

which envisions essential changes in the way tradi-

tional medical research is conducted and more

eective and ecient mechanisms to ensure that the

results o that research are disseminated to stakehold-

ers and incorporated into practice.

Guided by our legal obligations, we started with the

basicscreating a workable denition o patient-

centered outcomes research and drating a set o

national priorities and an initial research agenda that

will serve as a road map or our work. We also moved

to establish research methods that support the

engagement and meaningul inclusion o patients and

other stakeholders at every step o the process, rom

the selection o study questions to the dissemination

o results. We also have taken a series o initial steps

toward unding research projects, with many more

scheduled to be unded in coming months.

Our success over the past year is the result o many

important actors, but perhaps none more so than thecommitment and collaborative spirit o our 21-member,

multi-stakeholder Board o Governors. We represent

consumers, patients, caregivers, clinicians, hospitals and

health systems, researchers, payers, insurers, industry,

and policymakers. And we have ound a remarkable

degree o agreement about what matters most as we

pursue our goal o laying the oundation or a unique

research enterprise.

Our work has expanded rapidly with the addition o

Joe Selby, M.D., M.P.H., our inaugural Executive Director,

and a ull-time permanent sta. And, as a learning

organization, we regularly solicit and use the input

rom a range o stakeholders to guide our eorts. The

public plays a critical role in helping dene patient-

centered outcomes research, providing early eedback

on our drat National Priorities or Research and

Research Agenda, and serving as merit reviewers or

our Pilot Projects awards program. As we continue to

bring on expert sta and build organizational capacity,

the volume and sophistication o our engagement and

input opportunities will grow.

Patients, clinicians, and other stakeholders want and

need research that directly addresses the health care

decisions they ace, and that refects their values,

preerences, and goals. Thats the kind o research we

want to und and sustain. Were condent that, buildingon the progress weve made in the past year, with a

oundation o signicant and ongoing engagement

with the many communities we serve, we are well on

our way.

Thank you or your interest in and support o PCORI.

We look orward to continue working with you to

ensure that patients and the public have better

inormation they can use to make decisions that refect

their desired health outcomes.

A. Eugene Washington, M.D.

Vice Chancellor, UCLA Health Sciences, andDean o the David Geen School o Medicine, UCLA

Chair, PCORI Board o Governors

Steven Lipstein, M.H.A.

President and Chie Executive Ofcer,

BJC HealthCare, St. Louis, Mo.

Vice Chair, PCORI Board o Governors

Eugene Washington and Steven Lipstein

Patients, clinicians, and other stakeholders want and need research

that directly addresses the health care decisions they ace, and

that reects their values, preerences, and goals. Thats the kind o

research we want to und and sustain.


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PCORI 2011 ANNUAL R EPORT

Joe Selby and Anne Beal

As a amily physician and a pediatrician, weve

cared or thousands o patients over the years.

Weve spent countless hours doing our best to

help our patients and their amilies nd their way

through complex, dicult, and sometimes rightening

health care decisions. And one o the biggest lessons

weve drawn rom these experiences is that, when

clinicians and patients have the right inormation they

need to make decisions, and do so as ully engaged

partners, everyone benets.

Sometimes, were ortunate to see this happen, not just

in our own practices but in our personal lives. For one

o us, it involved the case o an elderly parent who,

although struggling with a serious illness that required

making some tough choices, elt that his physician had

shared with him inormation about treatment options

that he trusted, and that took account o his personal

priorities and concerns.

Unortunately, this isnt as common a situation as we

might hope. We know physicians dont always have all

o the data wed like in order to help patients choose

between various clinical options, or the inormation we

do have doesnt indicate which option might best

address a patients particular needs. For example, what

i a patients biggest concern is pain, or physical or

mental debilitation? What i the main concern is

maintaining the ability to pursue amiliar day-to-day

activities, or the ability to take care o loved ones, like

ones own children?Not only do we have rsthand experience with these

challenges as clinicians, but weve also aced them

rom the other side o the exam table, when one o us

or one o our amily members has needed care. Even

as doctors, when in the role o patient or caregiver,

weve sometimes elt ar more let out o the clinical

decision-making process than we would have wanted

or expected, and have lacked the inormation most

relevant to our particular situation.

Addressing these concerns starts with recasting thenature o the research upon which we base the

options we present to our patients. Its our job, and

that o our colleagues at PCORI, to do just that, working

to reshape approaches to research so that patients and

other critical stakeholders are ully vested partners in

the quest or new knowledge that will benet them

directly. We can do so not just by careully and ully

listening to the communities we serve but by taking

their concerns to heart and incorporating them into

the work we do in ways that have lasting infuence.

This commitment to engaging patients in research is inour DNA, rom developing the questions to be explored

in a particular study to conducting the research itsel,

analyzing the results, and making that inormation

widely available in ways that can be readily understood

and used by patients and those who care or them.

We ully expect that, with PCORIs work, this patient-

centered approach can become a new standard or

clinical research. Were condent that the result will be

better inormation, better decisions, better care, better

outcomes, and better health or all o us.

Joe V. Selby, M.D., M.P.H.

Executive Director

Anne C. Beal, M.D., M.P.H.

Chie Operating Ofcer

We ully expect that, with PCORIs work, this patient-centered

approach can become a new standard or clinical research. Were

condent that the result will be better inormation, better decisions,

better care, better outcomes, and better health or all o us.


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PCORI: The path to a new model or research

The Nine Statutory Criteria That Drive PCORIs Work

The Patient-Centered Outcomes Research Institute

(PCORI) was authorized by the Patient Protection and

Aordable Care Act (PPACA) o 2010 to conduct

research to provide the best available evidence to help

patients and those who care or them make better-inormed

health care decisions.

Research undertaken and supported by PCORI is intended

to develop inormation that will give patients and those

who care or them a better understanding o the preven-

tion, treatment, and care options available and the science

that supports those choices, guided by nine criteria

outlined by law.

PCORI is unique both in our missionto ocus not just on

comparative clinical eectiveness research but on patient-

centered outcomes researchand in how we seek to ulll

it, namely by advancing research that is guided by patients,

caregivers, and other health care stakeholders.This report documents PCORIs activities over a 14-month

period, rom January 1, 2011, through the close o the public

comment period on our drat National Priorities or Research

and initial Research Agenda on March 15, 2012. During that

time, guided by our commitment to meeting both the letter

and the spirit o our statutory obligations, we made substan-

tial progress in establishing PCORI as a new national research

entity committed to engaging patients and a broad range

o other stakeholders in our work. That work includes:

PCORI has worked throughout the past 14 months to build a

major national health research institute rom the ground up,utilizing a rigorous stakeholder-driven process that empha-

sizes long-term patient engagement. These eorts have

been driven by our 21-member, multi-stakeholder Board o

Governors, while a 17-member Methodology Committee

has worked to develop and advance the science and

methodologies o comparative clinical eectiveness

research (CER) and PCOR. Members o the Methodology

Committee are experts in their elds, which include, but are


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We have adopted a wide range o approaches to

making real our commitment to transparency,

credibility, and open access in all aspects o our

operations. Our goal is to ensure that patients, caregivers,

clinicians, and other stakeholders not only trust the

research we support and the inormation we produce, butwill be motivated to participate substantively in our work,

rom the way the studies we und are designed and

implemented to how their results are disseminated and,

we hope, widely used to improve medical practice.

This approach starts at the top. Our open bimonthly Board

meetings have eatured a number o community engage-

ment activities, such as presentations and roundtable

discussions with patients and patient advocates, clinicians,

researchers, and industry representatives, to explore

perceptions o the meaning o patient-centered outcomes

research, develop a deeper understanding o the kinds o

outcomes valued by patients, and learn where patients

now turn or health inormation. The Board has kept a

particular ocus on ensuring that the interests o patients,

caregivers, clinicians, and others in underserved communi-

ties are well represented in our work.

We have regularly and requently engaged patients,

caregivers, clinicians, and others through a series o ocus

groups on various aspects o our work, particularly our

development o the PCOR denition and our drat National

Priorities or Research and Research Agenda. Public

comment periods and associated outreach eorts are

required as part o the process o nalizing our priorities

and agenda and another critical resource, our rst

Methodology Report. Patients will be on the review panels

that will rank the primary research unding applications we

receiveapplications that will require researchers to

outline how they plan to engage patients in study design

and in disseminating their results to stakeholders or whom

the research is relevant.

We also began to build the structures needed to ensure

that the results o the research we support not only are

disseminated widely to the stakeholders with whom we

engage but are used by those audiences consistently and

eectively. Direction or this core unction, outlined in

our establishing legislation, was set by the Boards

Communications, Outreach and Engagement Committee

and the Methodology Committees Work Group on

Dissemination. A Dissemination Work Group, comprised

An evolving ramework or patient

and stakeholder engagement

SEPTEMBER OCTOBER NOVEMBER DECEMBER JANUARY FEBRUARY 2011

GAO appoints PCORI Board of Governors GAO appoints PCORI Methodology Committee

PCORI incorporated as non-prot corporation and holds rst Board meeting Methodology Committee holds rst in-person meeting

PCORI Board holds rst community engagement event

PCORI Timeline


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o PCORI Board members and sta rom the Agency

or Healthcare Research and Quality (AHRQ), PCORIs

ocial dissemination partner by statute, is working to

build a ramework or PCORI dissemination. The Work

Groups goal is to ensure complementary dissemina-

tion work that avoids duplication and acilitates

success, which or PCORI equals a positive impact on

practice and patient outcomes.

The Board and members o the Methodology

Committee met with patients, caregivers, patient

advocates, clinicians, nurses, researchers, payers, and

others rom the health care community in small

roundtable discussions at the March and May 2011

Board meetings in St. Louis and New York,

respectively. In Washington, D.C., in July, the Board

and Methodology Committee anned out in small

teams across the capital area to meet with 43

organizations representing patient advocacy groups,

nursing disciplines, medical specialties, medical

technology and research elds, and payers and

policymakers. In Seattle, in September, the Board

spent an evening with representatives rom health

service organizations and health care providers

(including the Indian Health Service), as well as

comparative eectiveness researchers engaged in

collaborations across the Pacic Northwest. In New

Orleans, in November, the Board heard rom an

invited panel o regional health care researchers and

clinicians, and visited two community clinics to hear

rom patients and their caregivers in underserved

communities. In Jacksonville, Florida, in January 2012,

PCORI heard rom a panel o regional patient, clinical

care, research, and payer representatives, as well as

individual patients.

As one o our patients so eloquently stated,

an outcome is where I end up. Thats what they

care about

Barbara Summers, PhD, RN; VP and Chie Nursing Ofcer

University o Texas MD Anderson Cancer Cente

APRIL MAY JUNE JULY AUGUST SEPTEMBER

Accepts public input on topics for Pilot

Projects Program

Joe V. Selby, MD, MPH, starts as rst Executive Director

Board approves Mission Statement Start of 45-day public comment period on patient-centered outcomes research denition

Methodology Commit tee star ts working on its repor t and translation table Launches new Web site, pcori.org

Starts receiving Pilot Projects applications

Starts to develop rst draft national priorities and initial research agenda


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CTOBER NOVEMBER DECEMBER JANUARY FEBRUARY MARCH

Starts to receive input on Draft Translation Table Framework

Awards contracts to review guidance documents for selecting PCOR methods

Releases draft National Priorities and initial Research Agenda for public comment

Begins analysis of public comment on draft

National Priorities and Research Agenda

Anne Beal, MD, MPH, starts as Chief Operating Ocer

Conducts patient and caregiver focus groups on denition of patient-centered outcomes research Creates Standing Committee on Conicts of Interest

Starts to conduct patient and caregiver focus groups to support priorities development (through December)

Awards RFP contracts to support Methodology Report development

Establishes Dissemination Working Group

Receives 349 stakeholder and 600 scientist reviewer applications for grants

Conducts webinars (850 registrants) on Pilot Projects Program

Engagement Activities at Board Meetings

(March 2011January 2012)

PCORI Timeline

Specic milestones achieved during the year included

relaunching www.pcori.org, starting to build out a robust

e-mail communications system, and establishing plans

or ongoing convening initiatives. We also put in place a

speakers bureau that arranged Board and sta talks at

dozens o national and local meetings and proessional

conerences with patients, clinicians, caregivers, researchers,

industry representatives, health care purchasers, and

policymakers. The goal o all o these activities is to bringto as many interested audiences as possible our message

o inclusion o all voices in the conversation about providing

better inormation to patients and the people who care

or them.

These and other initiatives, described in greater detail

in the table on the right, are just the beginning o our

eorts to serve patients and other stakeholders across

the nation. The goal is to establish and maintain an

increasingly sophisticated conversation about how we

can most eectively support research that will lead to

better-inormed health care decision-making. We wantstakeholders not only to learn about our activities but to

establish reliable and accessible mechanisms or them to

provide us with the eedback we need to help shape our

work in the longer term.


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Dening Patient-Centered

Outcomes Research

Despite Congress choice o PCORIs name, there wasno consensus in the eld on a ormal denition opatient-centered outcomes research, although the term

was in use. One o PCORIs oundational tasks, thereore,

was to clearly dene the term, as an initial step in honing

our ocus and scope o work, including how PCOR relatesto comparative eectiveness research.

In March 2011, the Methodology Committee began an

extensive, transparent process or dening PCOR. The

committee held a series o discussions that generated

several drat denitions, which were presented and

considered at the public Board meeting on March 8.

Feedback was incorporated into eight subsequent hours

o Committee deliberation to reach consensus on the

denitions specic language. The Committee approved a

drat denition in April and presented it to the Board or

approval at its May meeting.

The drat denition o PCOR was posted or a 45-day

comment period. Nearly 120 organizations and 450

individuals responded, representing virtually every perspec-

tive within the health care community. Comments were

analyzed and a report published summarizing respondents

reactions and suggestions.

We sought urther input by conducting six ocus groups

aimed at determining whether the drat denition resonated

with patients, caregivers, and the general public. About 60

people participated in three metropolitan areasChicago,

Richmond, and Phoenix. To ensure a diversity o perspec-

tives, one group was conducted in Spanish with Latino

patients and caregivers and one exclusively included

Arican-American patients and caregivers.

Based on eedback obtained through these orums, the

Committee made several recommendations to the Board

or urther revising the drat, summarizing its proposed

changes in an accompanying analysis. The Board adopted

the revised denition at its March 2012 meeting.

Adoption o the PCOR denition was not the end o the

process, however. We consider it a living document,

subject to ongoing revision and renement through a

rigorous and standardized process, as this eld o research

grows and the needs o patients and other stakeholders

continue to evolve and be identied. We believe that this

emphasis on soliciting eedback and incorporating it intoour work is a core value, and that committing to doing so

over time is proo o our vision or a new and more inclusive

model o research. It also is emblematic o our dedication to

being a learning organization.

A period o major milestones and accomplishments

PCORIs achievements over the past 14 months have laid a solid oundation or its uture work,

including issuing the rst in a continuing series o calls or applications or research unding.

Each accomplishment, outlined in detail in the ollowing pages, has been a critical step along

that path toward supporting research designed to make patients and caregivers meaningul

partners in the research process.

Establishing PCORIs First National Priorities or Research and Initial Research Agenda


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Pilot Projects Program

We developed our Pilot Projects program as part o oureort to rene the methods available or involvingpatients and other stakeholders in the process o establish-

ing national priorities or research, inorming the develop-

ment o a research agenda, and conducting and advancing

the dissemination and use o PCOR.

Public input was a critical component in shaping the

program. Originally proposing eight areas o interest, we

sought stakeholder comment on the Pilot Projects program

over a 30-day period, receiving 160 submissions through

our Web site, e-mail, and regular mail. The proposed ocus

areas were modied in response and, in September, we

issued a request or applications promoting observational

methodologies, systematic reviews, mixed methods and

qualitative methodologies, simulations, small pragmatic

pilot trials, and survey methods. Specically, we sought

proposals on:

The response rom the research community was extremely

robust, suggesting a readiness to embrace a larger shit

toward the institutes patient-centered ocus. We received

nearly 1,400 letters o intent, ollowed by 842 applications

that addressed a broad range o questions about methods

or engaging patients in the research and dissemination

process. To assist applicants, we held three webinars

explaining the application and unding process, drawing

850 registrants and answering 1,400 applicant questions.

Seeking broad stakeholder engagement was critical to the

next stage in the Pilot Projects process as well, as we issued

a call or reviewers to assess the unding applications

submitted. We received nearly 350 reviewer applications

rom stakeholders, nearly hal o those rom patients,

patient advocates, and caregivers. Six hundred scientists

also volunteered to serve as reviewers.

Merit reviews, conducted by interdisciplinary teams o 20

individuals each, took place in February. A Selection

Committee, made up o Board members, reviewed the

resulting merit scores and prepared a recommended slate

o projects or unding consideration, taking all areas o

interest into account in an eort to support a diverse set o

projects. The ull Board is to consider the recommendations

in late April with the goal o making unding decisions and

announcing awards by May.

Developing National Priorities or Research

We were charged with developing national prioritiesor research as one o the critical tasks to be com-pleted beore we could start unding primary research. The

process o drating these research road maps began in

August 2011 under the direction o the Boards Program

Development Committee, which conducted an extensive

review o nine previous national eorts to establishpriorities or comparative eectiveness research. Particular

attention was given to the degree to which each o these

prioritization eorts involved substantive stakeholder

engagement and public input.

The review identied 10 common themes that consistently

appeared as priority areas or research. These were mea-

sured against our working denition o patient-centered

outcomes research to determine ve cross-cutting areas

that would become our research priorities.

PCORIs Drat National Priorities or Research


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Establishing a Research Agenda

Using the drat priorities as a oundation, the Committeedeveloped an initial research agenda by applying to thepriorities the research criteria stipulated in our establishing

legislation (see page 4). Each o the research agendas

resulting areas o ocus represents a line o research inquiry

that addresses unmet needs and gaps in inormation

available to patients, their caregivers, clinicians, and other

stakeholders or making the best possible, personalized

decisions across a wide range o conditions and treatments.

Reections on the Process o Establishing

Priorities and a Research Agenda

The drat priorities and research agenda are intentionallybroad, and are not limited to specic conditions ortherapeutic interventions. We took that approach because

there are many important questions to be answered rom a

patient-centered outcomes research perspective. Focusing

on a narrow set o conditions at the start o our unding

process could have excluded many patients at a critical,

early stage in our work. We expect to see greater specicity

about conditions in the research we und as we continue to

solicit and weigh stakeholder inputa process we are

committed to pursuing in a transparent, systematic way so

that there is a clear path to reaching a more targeted set o

research questions.

We began incorporating patient and other stakeholder

perspectives early in the National Priorities and Research

Agenda process, tapping into the experience o Board

members and holding a series o meetings with organiza-

tions representing patients as well as other stakeholders tohelp inorm the drats developed or public comment. In

addition, patient and caregiver ocus groups were conducted

in November and December 2011 to provide early input

on developing the priorities. Our executive sta and Board

members also discussed the process with numerous

stakeholder organizations, including patient representatives.

We released our drat National Priorities or Research and

Research Agenda in January 2012 or a 53-day public

comment period, soliciting eedback through a Web-based

survey tool, e-mail and regular mail, clinician ocus groups,

print and online advertisements placed in a wide range o

consumer and proessional media, and our national Patient

and Stakeholder Dialogue event and associated webcast

that drew a total o nearly 850 participants. These outreach

eorts yielded nearly 500 comments rom individuals and

organizations by the close o the comment period.

Ater completing a careul review and analysis o the

comments, the Board will consider or adoption a revised

version o the drat priorities and agenda during a public

conerence call/webinar in late April, ollowed by the

issuance o initial unding announcements in May. A report

summarizing the eedback received and how it was

incorporated into recommended changes in the drat

priorities and agenda will be published on www.pcori.org

along with the revised document.

As with the PCOR denition, our National Priorities or

Research and Research Agenda are considered living

documents that will evolve as we gain greater understand-

ing o the gaps in patient-centered outcomes research. We

will continue to seek and incorporate the comments o

patients, their caregivers, and all stakeholders to ensure that

this guiding document remains ocused on and relevant tothe needs and concerns they identiy.


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Developing PCORIs First

Methodology Report

Just as PCORI is directed by statute to adopt NationalPriorities or Research and an initial Research Agenda asa road map or unding, so must our eorts be guided by

the work o our Methodology Committee, charged with

developing and periodically updating methodological

standards or CER and PCOR. The Committees goal is toestablish a rigorously developed oundation or continuing

work in the elda ramework that may be used by

researchers across discrete proessional sectors. The rst

product o this eort will be our drat Methodology Report,

a resource that we and the Committee hope to see rened,

improved, and widely utilized over time through broad

stakeholder input and collaboration.

PCORIs Methodology Committee is charged with

developing standards to:

The Committee undertook a ull slate o activities during

2011 that laid the groundwork to meet this goal and to

create a required translation table, a tool designed to

provide guidance in determining which research methods

should be used to address dierent research questions. Four

working groupson patient-centeredness, research

priorities, research methods, and report assimilationwere

established to guide the Committees work.

The Committee issued a request or inormation (RFI) to solicit

input rom methodologists on the translation table. The RFI

resulted in the submission o 24 responses, many rom leading

organizations and institutions in the eld. The Committee

developed requests or proposals (RFPs) to (1) review guid-

ance on selected research methods; (2) review and synthesize

evidence or eliciting the patients perspective in patient-

centered outcomes research (through literature review and

expert stakeholder interviews); and (3) develop white papers

on methods or setting priorities in research. The Committee

oversaw a rigorous proposal review process that resulted in

issuing 15 awards to major research organizations rom acrossthe country during 2011 and one more in early 2012. These

projects are listed on page 17.

In conjunction with the March Board meeting, two o the

Committees working groups held a series o expert

workshops to review the results o these projects as part o

the process o developing the rst set o standards or the

ull Committee report. A subgroup o the Committee also

continued work on the translation table.

The Patient Centeredness Work Group workshop involved

14 researchers rom the ve research teams contracted or

the group, along with eight outside inviteesexperts in

patient-centered outcomes research, health consumer

research, and patient-reported outcomes measurement, as

well as a patient representative. Participants reviewed

project ndings or stakeholder and expert input on

engaging patients in PCOR along with ndings on standards

or use o patient-reported outcome measures in PCOR, and

discussed ways in which the ndings could inorm method-

ological standards or PCOR.

Wed like to involve patients in order to see improved outcomesin terms o

the results o studies being outcomes patients care about. Wed also like to

establish a base o trust. I researchers partner with patient communities, this

will help bridge the gap between what wed like to achieve and getting there

Methodology Committee workshop participant


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The Research Priorities Work Group workshop was held

with researchers rom ve contracted research teams. The

purpose o this workshop was to gather perspectives on

how selected methods might be used by PCORI to inorm

the process o establishing research priorities. The research

areas addressed were approaches to topic generation, gap

analysis, value o inormation analysis (two projects), and

peer review or research prioritization. Two outside experts

served as acilitators.

As o the date o this report, the Committee was in the

process o using the work resulting rom these projects to

develop the rst set o standards that will appear in the rst

Methodology Report, to be submitted to the Board o

Governors as required by statute on May 10, 2012, and

published or public comment ollowing Board acceptance.

Research Funding Opportunities

We make a variety o external unding opportunitiesavailable throughout the course o our work, issuingRFPs and awarding contracts through a competitive process.

Calls or proposals are published on our Web site in the

Funding Opportunities section, sent to our opt-in e-mail

list, and promoted through a number o other outreach

mechanisms, including through relationships with stake-holders and other partners.

Proposals submitted ater an RFP is nalized will be

reviewed in a process that can incorporate scientic review

by the Methodology Committee and Board members,

when appropriate. We pay careul attention to exclusion o

reviewers with a confict o interest; all nal decisions are

made by the Executive Director. All awards upon approval

and the results o all unded projects, upon completion, wil

be published on www.pcori.org.

We used this award process in 2011 to support the work

o our Methodology Committee by issuing 15 contractsin response to RFPs across three areas to support the

development o our rst Methodology Report, as described

above; two additional contracts were issued in early 2012.

We also unded, through an RFP, analysis o the public

input received on the working denition o patient-

centered outcomes research and o the eedback

received rom patient and caregiver ocus groups

designed to assess their understanding o the denition.

The results o this research were used to revise the

denition and ensure that patient and caregiver perspec-

tives are refected in its language and intent.

For a complete listing o these contracts, see page 17.

2011 Requests or Proposals (RFPs) to Support

Methodology Report Development


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PCORI 2011 ANNUAL REP ORT4

Board reviews and adopts revised National

Priorities for Research and Research Agenda

Issues conference grants toadvance agenda specicity

Forms advisory groups to advance

agenda specicity

Issues targeted funding announcements

Announces broad

funding awards

Draft Methodology Report publiccomment period begins

First draft Methodology Reportdelivered to Board

Issues broad funding announcements

Broad funding applications due

First brainstorming workshop

to advance agenda specicity

The past year was one o critical structural growth

or PCORI, and 2012 promises to be a year o rapid

progress toward building a dynamic research

portolioone with patients needs and values at its core

and a ocus on building a sustainable patient-centeredresearch enterprise as its goal.

Through a continued ocus on enhancing patient and

stakeholder engagement, we will nalize our National

Priorities or Research and initial Research Agenda, hone

our methodological standards or research, approve 40 or

more Pilot Projects awards, and issue our rst call or broad

primary research unding proposals. As the year progresses,

we will issue targeted research unding announcements.

By years end, we plan to commit approximately $120 million

in primary research support and then start preparing or

additional unding cycles into 2013 and beyond.

As we move through our primary research unding cycles and

continue to grow as an organization, we will be guided by the

same mission, vision, and operating principles described

above. Three areas o ocus are worth particular mention.

1. The Primacy o Patient and

Stakeholder Engagement

This will remain our guiding principle as we build our

capacity as a scientic enterprise that contributes to

reshaping how research is conducted. Our sta will be

guided by strategic and operational plans designed to

address evolving stakeholder needs, and will continue tosolicit input to help shape the institutes initiatives.

We plan a wide array o multidirectional engagement

initiatives involving patients, caregivers, clinicians, and other

critical audiences. They will include live and virtual orums,

ocus groups, workshops, and meetings with groups o

patients, caregivers, clinicians, payers, and others. We are

especially committed to doing this work in communities

that experience health disparities across the U.S., to under-

stand and respond to the needs o those patients and

stakeholders oten overlooked by the research enterprise.

We also plan to establish advisory groups o patients, caregiv-

ers and other stakeholders to help shape the direction o the

organizations work in such areas as research networks,

dissemination, clinical trials and observational studies,

electronic health records, and building long-term PCOR

capacity. Driving home the value we place on engagement

will be the inclusion o criteria requiring a robust, detailed

engagement plan as part o all unding proposals.

2. Communications and Dissemination

as Critical Constructs

Just as we take our commitment to stakeholder engage-ment seriously, so too do we realize that conducting

researcheven in ways that more ully involve those

stakeholdersis not enough to meet our obligations.

Equally important is our ability to develop and eectively

deploy mechanisms that will communicate and disseminate

those research results to those who need them, in ormats

that are accessible, understandable, and relevant. Perhaps

even more critical is recognizing that even sophisticated

communication and dissemination initiatives are still only

part o the picture. The real goal is sustained uptake and use

o the research results we support in ways that measurably

improve practice and, ultimately, patient outcomes.

Our task here is clearly outlined in our establishing legislation,

which requires the Oce o Communications and Knowledge

Transer o the Agency or Healthcare Research and Quality

(AHRQ), in consultation with the National Institutes o Health

(NIH), to broadly disseminate the research ndings we

A look ahead: PCORIs plans or 2012

APRIL MAY JUNE JULY AUGUST SEPTEMBER OCTOBER NOVEMBER DECEMBER JANUARY 201

PCORI Timeline


17/50


publish to a range o stakeholder audiences. Doing so

eectively will require a robust PCORI-specic communica-

tions and dissemination ramework developed in close

collaboration with AHRQ, which has a rich history o exper-

tise in this eld. Eective implementation not only demands

that that collaboration continue and grow, but will necessi-

tate the establishment o a broad network o partnerships

with organizations and institutions across the spectrum o

stakeholder sectors, so that the eect o our outreach eorts

is steadily amplied and ripples outward through proes-

sional and other stakeholder communities.

PCORI is committed to using innovative and eective

communications throughout our work, including

dissemination. We know that existing communications

and dissemination methods have allen short o changing

practice and improving patient outcomes. That is why

advancing the science o communications and disseminationis a ocus o our Research Agendato determine how

patients and clinicians can best use CER and PCOR results to

enhance decision-making and achieve desired outcomes. To

underscore this commitment urther, we will explore ways to

make dissemination planning a requirement or the primary

research applications we will consider.

The Boards Communication, Outreach and Engagement

Committee, the Methodology Committees Dissemination

Work Group, and the PCORI-AHRQ joint Dissemination Work

Group will continue to provide guidance and oversight as

sta take on more o the operational duties.

3. Moving Toward a More Targeted

Research Portolio

As noted earlier, our National Priorities or Research and

initial Research Agenda were intentionally drated to be

broad so as not to exclude critical opportunities and

avenues or investigation early in the process. There always

has been an expectation, however, o moving toward

greater specicity in the conditions to be studied based on

ongoing interaction with stakeholders and on the research

proposals they will submit or unding.

Along with this organic path to a more targeted research

portolio, we plan a series o initiatives to drive the discus-

sion about greater specicity, including a series o grants to

support conerences on particular research needs with

long-lasting impact; a high-level brainstorming workshop

on how best to move toward more targeted research

priorities; and the advisory groups noted above as aplanned engagement tactic.

PCORI has accomplished a great deal in the past 14 months.

As this report summarizes, we have built a oundation or a

major new research institute; established strong links with

patients, clinicians, and other stakeholders who will ulti-

mately drive our work; drated a road map or our research

eorts; and moved to develop the necessary methodologica

ramework or carrying out the research we will support.

We still have important work ahead. When we next report

to Congress, the President, and the public, we will have

completed a wide range o start-up activities, have aresearch road map in hand, and have unded dozens o

primary research projects. We will be looking orward to

receipt o the initial sets o data that we believe will help to

transorm the kinds o inormation patients, their caregivers

and clinicians have at hand to help them make better-

inormed health care decisions. We will have moved to

establish the plans and partnerships that will eventually

translate the research we support into practice. And we

will be that much closer to our goalimproved health

outcomes that are most meaningul to patients.

There is a large component o research being done on

people, instead o with people. This is research that

is going to have to be done with people, and those

should be the guidelines and the principles that guide

all o PCORIs research

Adolph Falcon, SVP, National Alliance or Hispanic Health

PCORIs Path rom Priorities to

Research Patients Can Use


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Financial Highlights

Budget Distribution2012 Forecast 2012 Projections or Research Funding

The Patient-Centered Outcomes Research Institute is unded through the Patient-Centered Outcomes Research Trust Fund (PCORTF).

The ederal government distributes the unding to the PCORTF annually at the beginning o the government scal year (October 1 to

September 30) and, eective with the government scal year beginning on October 1, 2010, the Treasury Department transers 20% o

the annual appropriation to the U.S. Department o Health and Human Services and the Agency or Healthcare Research and Quality

or dissemination o PCORI-unded research ndings and to build capacity or comparative clinical eectiveness research.

PCORIs 2012 budget is aligned with its strategic pillarsresearch, rigorous methods, stakeholder engagement, dissemination, and

inrastructure development. Top organizational priorities or the year include expanding stakeholder engagement, developing

patient-centered National Priorities or Research and a Research Agenda, unding the rst round o primary research, and design and

implementation o a sound inrastructure or operations.

2012 Budget(All dollars in thousands) Amount %

Program Services

Contracts:

Research $120,584 76%

Rigorous Methods 7,300 5%

Contracts Total 127,884 81%

Patient and Stakeholder Engagement 8,035 5%

Dissemination 2,435 2%

Total Program Services 138,354 88%

Supporting Services

PCORI General Administration 16,393 10%

Inrastructure Development 3,618 2%

Total Supporting Services 20,011 12%

Total Expenses $158,365 100%

Statement of Financial Position(All dollars in thousands) 2011 2010 Increase % Change

Assets $163,485 $49,874 $113,611 228%

Liabilities $ 2,514 $ 315 $ 2,199 697%

Net Assets $160,971 $49,558 $111,412 225%

Statement of Activities(All dollars in thousands) 2011 2010 Increase % Change

Revenues $120,024 $50,009 $ 70,015 140%

Expenses $ 8,612 $ 451 $ 8,161 1812%

Research76.1%

PCORI G&A10.4%

Patient and Stakeholder Engagement5.1%

Rigorous Methods4.6%

Inrastructure Development2.3%

Dissemination1.5%

Comparisons o Options33%

Pilot Projects18%

Health Systems17%

Disparities8%

Communication and Dissemination8%

Methods8%

Inrastructure8%


19/50


Contract Scope of Work Contracting Organization Principal Investigator Contract Amount

Evidence or Eliciting the Patients Perspective

in Patient-Centered Outcome Research

(Stakeholder Interviews)

University o Maryland,

Pharmaceutical Health Services

Research Department

Daniel Mullins, PhD $125,000



(Literature Review)

Mayo Clinic, Knowledge and

Evaluation Research Unit

M. Hassan Murad, MD, MPH $176,025



(Stakeholder Interviews)

Oregon Health & Science

University, The Center or

Evidence-Based Policy

Pam Curtis, MS $295,212

Review o Guidance Documents or

Selected Methods in PCOR

(Patient-Reported Outcomes Measures)

Oxord Outcomes, Ltd.,

Patient Reported Outcomes

Andrew Lloyd, PhD $69,705



(Patient-Reported Outcomes Measures)

Northwestern University/

UNC Chapel Hill

Zeeshan Butt, PhD

Bryce Reeve, PhD

$83,908



Johns Hopkins University Tianjing Li, MD, MHS, PhD $66,150



Johns Hopkins University

School o Medicine

Ravi Varadhan, PhD $69,231



Berry Consultants Scott Berry $74,200



Brown University Constantine Gatsonis, PhD $77,869



Brigham and Womens Hospital

and Harvard Medical School

Josh Gagne, PharmD, ScD $115,664



Outcome Science Richard Giklich, MD $87,066



University o Caliornia

San Diego (UCSD)

Lucila Ohno-Machado, MD, PhD $116,442

Methods or Setting Priorities in Research

(White Paper)

Hayes, Inc. Petra Nass, PhD $30,100


(White Paper)

NORC at the University

o Chicago

David Rein, PhD $34,906


(White Paper)

Duke Evidence-based

Practice Center

Gillian Sanders

Evan Myers, MD, MPH

$35,000


(White Paper)

Medical College o Wisconsin Theodore Kotchen, MD $12,484

Analysis o Input Received on Working Denition

o Patient-Centered Outcomes Research

NORC at the University

o Chicago

Wilhelmine Miller, MS, PhD $90,797

Prioritizing Future Research through Examination o

Patient-Centered Comparative Eec tiveness Research

(White Paper)

University o North Carolina

at Chapel Hill

Timothy S. Carey, MD, MPH $25,000

Patient-Centered Outcomes Research InstituteResearch Contracts Awarded January 2011February 2012


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Board o Governors

Debra Barksdale, PhD, RN

Kerry Barnett, JD

Lawrence Becker

Carolyn M. Clancy, MD

Francis S. Collins, MD, PhD

Leah Hole-Curry, JDAllen Douma, MD

Arnold Epstein, MD

Christine Goertz, DC, PhD

Gail Hunt

Robert Jesse, MD, PhD

Harlan Krumholz, MD

Richard E. Kuntz, MD, MSc

Sharon Levine, MD

Freda Lewis-Hall, MD

Steven Lipstein, MHA (Vice Chair)

Grayson Norquist, MD, MSPH

Ellen Sigal, PhDEugene Washington, MD, MSc (Chair)

Harlan Weisman, MD

Robert Zwolak, MD, PhD

Board o Governors

Committees

Finance, Audit and Administration

Kerry Barnett, JD (Chair)

Lawrence Becker

Allen Douma, MD


Robert Zwolak, MD, PhD

Program Development

Richard E. Kuntz, MD, MSc (Chair)


Francis S. Collins, MD, PhD

Leah Hole-Curry, JD

Arnold Epstein, MD

Christine Goertz, DC, PhD

Gail Hunt

Harlan Krumholz, MD

Communications, Outreach and Engagement

Sharon Levine, MD (Chair)

Debra Barksdale, PhD, RN

Robert Jesse, MD, PhD


Ellen Sigal, PhD

Harlan Weisman, MD

Methodology Committee

Naomi Aronson, PhD

Ethan Basch, MD, MSc

Alred O. Berg, MD, MPH

David Flum, MD, MPH

Sherine Gabriel, MD, MSc (Chair)

Steven Goodman, MD, MHS, PhDMark Heland, MD, MS, MPH

John Ioannidis, MD, DSc

Michael S. Lauer, MD

David O. Meltzer, MD, PhD

Brian S. Mittman, PhD

Robin Newhouse, PhD, RN

Sharon-Lise Normand, PhD (Vice Chair)

Sebastian Schneeweiss, MD, ScD

Jean R. Slutsky, PA, MSPH

Mary Tinetti, MD

Clyde Yancy, MD, MSc


Working Groups

Patient-Centeredness Working Group

Ethan Basch, MD, MSc (Chair)

Mary Tinetti, MD (Co-Chair)

Naomi Aronson, PhD


Research Prioritization Working Group

David O. Meltzer, MD, PhD (Chair)

John Ioannidis, MD, MSc



Research Methods Working Group

Steven Goodman, MD, MHS, PhD (Chair)

Robin Newhouse, PhD, RN (Co-Chair)


Sebastian Schneeweiss, MD, ScD

Sharon-Lise Normand, PhD

Report Assimilation Working Group

Mark Heland, MD, MS, MPH (Chair)

Alred O. Berg, MD, MPH

David Flum, MD, MPH

Sherine Gabriel, MD, MSc



21/50


Special Committees

Dissemination Work Group

Carolyn M. Clancy, MD (Co-Chair)

Sharon Levine, MD (Co-Chair)

Lawrence Becker

Allen Douma, MD

Christine Goertz, DC, PhDHoward E. Holland, Director, AHRQ Oce o

Communications and Knowledge Transer

Gail Hunt


Steven Lipstein, MHA


Robin Newhouse, PhD, RN



Subcommittee on Scientic Publications

Debra Barksdale, PhD, RN (Chair)

Harlan Krumholz, MD



Anne Beal, MD, MPH

Joe Selby, MD, MPH

Standing Committee on Conicts o Interest

Lawrence Becker, PCORI Board Member (Chair)

Robert Zwolak, MD, PhD, PCORI Board Member

Sherine Gabriel, MD, MSc, PCORI Member

Bernard Lo, MD, Ethicist, UC San Francisco

Proessor Emeritus

Annette Bar-Cohen, MPH, Consumer Advocate,

National Breast Cancer Coalition

Art Levin, MPH, Consumer Advocate, Center or

Medical Consumers

Mark Feldstein, PhD, Media Representative,

University o Maryland

Karl Sleight, JD, Counsel, Harris Beach, LLC

Gail Shearer, MPP, Senior Advisor, PCORI

PCORI Pilot Project Selection Committee

Grayson Norquist, MD, MSPH (Chair)

Christine Goertz, DC, PhD (Advisor, non-voting)

Kerry Barnett, JD


Arnold Epstein, MD

Gail Hunt

Steven Lipstein, MHA

Sherine Gabriel, MD, MSc


Joe Selby, MD, MPH

Staf

Anne Beal, MD, MPH, Chie Operating Ocer

Martin Duenas, MPA, Director, Contracts Management

Lori Frank, PhD, Director, Engagement Research

Judith Glanz, Director, Patient Engagement

Pam Goodnow, Director, Finance

Susan Hildebrandt, MA, Director, Stakeholder EngagementJoe Selby, MD, MPH, Executive Director

Sue Sheridan, MBA, MIM, Deputy Director, Patient Engagement

William Silberg, Director, Communications

Melissa Stern, MBA, Director, Strategic Initiatives


22/50

Patient-Centered Outcomes Research Institute2011 Annual Report

APPENDIX TABLE OF CONTENTS

I. PCORI Confict o Interest Disclosures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A1A6

II. Patient-Centered Outcomes Research Institute Financial Report, December 31, 2011 . . . . . . . . . . A7A26

See A8 or Financial Reports internal Table o Contents


23/50

PCORI 2011 annual RePORt

Board o Governors

Debra Barksdale, PhD, RN(As of September 29, 2011)

Financial associations:

University of North Carolina at

Chapel Hill (Employer)

NIHreceive grant for research

Robert Wood Johnson Foundation

Executive Nurse Fellow

Personal associations:

National Organization of Nurse

Practitioner FacultiesPresident-Elect

National League for Nursingmember American Academy of Nurse

Practitionersmember

International Family Nursing

Associationmember

American Association of Colleges of

Nursing, Practice Leadership

Networkmember

American Nurses Associationmember

Southern Nurses Research

Societymember

American Heart Associationmember

North Carolina Nurses

Associationmember

Sigma Theta Tau International HonorSociety of Nursingmember

Kerry Barnett, JD(As of October 7, 2011)


The Regence Group and Aliates

(Employer)


United Way

Lawrence Becker(As of October 11, 2011)


Xerox Corporation (Employer)

Stock ownership:

-Aetna, Inc.

-GE

-Johnson & Johnson, Inc.

-Pzer, Inc.

-SPDR Biotech

-The Travelers Companies, Inc.

Beneld Group

LSB Consultants, LLCcompany

owned by wife


ERISA Industry CouncilBoard member

The National Quality ForumBoard

member

Rochester Regional Health Information

OrganizationBoard member

Carolyn M. Clancy, MD(As of December 21, 2011)


Director, Agency for Healthcare Research

and Quality (Employer)


Institute of Medicinemember American College of PhysiciansMaster

George Washington University School of

MedicineClinical Associate Professor

Francis S. Collins, MD, PhD(As of December 21, 2011)


Director, National Institutes of Health

(Employer)


Institute of Medicinemember

National Academy of Sciencesmember

Leah Hole-Curry, JD(As of November 21, 2011)


Washington State Department of Labor

and IndustriesMedical Administrator

(Employer)


None Identied

Allen Douma, MD(As of September 28, 2011)


None Identied


AARPBoard member

Jeerson Regional Health Alliance

Board member

Arnold Epstein, MD(As of October 19, 2011)


Harvard Universityfaculty (Employer)

Brigham and Womens Hospitalsta

(Employer)

New England Journal of

Medicineconsultant

Todd & Weld LLPconsultant

Thornton & Naumes, LLPconsultant

Levy Phillips & Konigsberg,

LLPconsultant

Partners HealthCare, Massachusetts

General Hospitalspouses employment


Center for Health Care Strategies

member of the Board of Trustees

AcademyHealthmember

American Association of

Professorsmember

American Society for Clinical

Investigationmember


Christine Goertz, DC, PhD(As of October 6, 2011)


Palmer College of ChiropracticVice Chancellor (Employer)

American Chiropractic

Associationconsultant

Healthwiseconsultant

University of Missouri, Kansas City

consultant (NIH grant)

Kansas City University of Medicine and

Biosciencesconsultant

Life Universityspeaking honoraria

Quality Insights of

Pennsylvaniaconsultant


American Medical Association

Measures, Instrumentation, and

Evaluation Advisory

Committeemember

Health Care Professionals Advisory

Committeealternate member

Iowa Chiropractic Societymember

Journal of Manipulative and Physiological

TherapeuticsEditorial Board

American Public Health

Associationmember

Womens Leadership Council of the Quad

CitiesUnited Waymember

PCORI Confict o Interest Disclosures

The Patient Protection and Aordable Care Act, which authorized the establishment of the Patient-Centered Outcomes Research Institute,

requires PCORI to disclose any conicts of interest of its Board of Governors, Methodology Committee, and executive sta. The Act denes

conict of interest as: An association, including a nancial or personal association, that have the potential to bias or have the appearance of

biasing an individuals decision in matters related to the Institute or the conduct of activities under this section. Below are the associations

reported by PCORIs Board of Governors, Methodology Committee, and executive sta that t within the denition of a conict of interest

specied by the law.


24/50


Gail Hunt(As o September 30, 2011)

FINANCIAL ASSOCIATIONS:

National Alliance for CaregivingCEO

(Employer)

-The Alliance receives grants romhealthcare-related groups

PERSONAL ASSOCIATIONS:

National Center on SeniorTransportationChair o the Board o

Directors

Long Term Quality AllianceSecretary of

the Board o Directors

Center for Aging Services

TechnologyCommissioner

Vinson Hall CorporationMember of the

Board o Directors

Center for Advancing HealthMember

o the Board o Trustees

Advisory Panel on Medicare

Educationmember American Society on Agingmember

National Council on the Agingmember Gerontological Society of

Americamember

International Alliance of Patient

Organizationsmember

International Federation on

Agingmember

Robert Jesse, MD, PhD(As o October 24, 2011)


Department of Veterans Aairs

Principal Deputy Under Secretary orHealth (Employer)

Virginia Commonwealth UniversityHealth System (Employer)


American Heart AssociationFellow

Richmond Metro Chapter of the

American Heart AssociationPresident

The Virginia BioTechnology Research

Partnership Authority BoardBoard

member

Vital Sensors, Inc.Board member

American Board of Internal

Medicinediplomate American College of CardiologyFellow

Society of Chest Pain CentersBoard

member

Harlan Krumholz, MD(As o October 19, 2011)


Yale UniversityProfessor of Medicine

(Employer) VHA Inc.consultant

United HealthcareChair, Scientic

Advisory Committee

Image COR, LLCFounder

American Heart Associationeditor

Massachusetts Medical Societyeditor

American Board of Internal Medicine

Board member

Institute of Healthcare Improvement

Chair, Scientic Advisory Group

Medtronic, Inc.Principal Investigator on

grant through Yale University


American College of CardiologyBoard

member

CV Outcomes, Inc.Secretary

Lifetech Development Partnersconsul-

tant and director

C2N Diagnostics LLCconsultant

Richard E. Kuntz, MD, MSc(As o October 4, 2011)


Medtronic, Inc. (Employer)

TengionBoard member (receives fee as

Director)


Minnesota Medical Foundation

Case Western Reserve Medical School

Board o Visitors

Chiari & Syringomyelia Foundation

Sharon Levine, MD(As o November 4, 2011)


The Permanente Medical Group,

Inc.Associate Executive Director

(Employer)


Reagan-Udall FoundationBoard

member

California Association of Physician

GroupsBoard member

Public Health InstituteBoard chair

Medical Board of CaliforniaBoard

member

Insure the Uninsured ProjectBoard

member (as o 1/2012)

Freda Lewis-Hall, MD(As o October 27, 2011)


Pzer, Inc. (Employer)

Investments:

-Pzer, Inc

-Pzer Savings Plan

-Pzer Supplemental Savings Plan

-Pzer/Pharmacia Retirement Plan

-Eli Lilly Dened Benet Pension Fund

-Bristol-Myers Squibb Dened Benet

Pension Plan

-Bristol-Myers Squibb Savings Plan

-Vertex 401k Plan

-Vertex Pharmaceuticals, Inc.

-Howard University Retirement Plan


Society for Womens Health Research

Board member

Power To End Stroke, American Heart

AssociationBoard member

Foundation for the National Institutes ofHealthBoard member

Fellows of Harvard Medical School

Board member

New York Academy of MedicineBoard

member


American Psychiatric

Associationmember Healthcare Businesswomen

Associationmember

Steven Lipstein, MHA (Vice Chair)(As o November 1, 2011)

FINANCIAL ASSOCIATIONS: BJC HealthCarePresident and CEO

(Employer)

Emory University Healthcare Innovation

ProgramAdvisory Board member


Washington UniversityTrustee

Missouri Hospital AssociationBoard

member St. Louis Regional Health

Commissionmember

Grayson Norquist, MD, MSPH(As o September 27, 2011)


University of Mississippi Medical

SchoolChair, Department o Psychiatry

(Employer) Delta Health Alliancereceive grant

unding or salary


American Psychiatric Association

(APA)ellow APA Council on Research and

Qualitymember American Psychiatric Foundation

(component o APA)Board o Directors

Academy Healthfellow Mississippi Coast Interfaith Disaster

Task Force

Mississippi Psychiatric Association

member o Executive Board Tougaloo College

UCLADepartment of Psychiatry and

Biobehavioral Sciences


25/50


Ellen Sigal, PhD(As o October 31, 2011)


Stand Up To CancerMember of

Scientic Advisory Committee


Friends of Cancer Research

Founder and Chair o Board

Reagan-Udall FoundationVice-Chair o Board

Foundation for the National Institutes

o HealthChair o Public-PrivatePartnership Committee and Board

member American Association for Cancer

Research FoundationBoard member Duke University Cancer Center Board of

OverseersBoard member Research AmericaBoard member

M. D. Anderson Cancer CenterAdvisory

Board

The Sidney Kimmel Cancer Center, Johns

HopkinsMember, Advisory Council

Eugene Washington, MD, MSc (Chair)(As o November 1, 2011)


David Geen School of Medicine,

UCLAVice Chancellor and Dean(Employer)

Robert Wood Johnson Foundation

Board member

The California Wellness Foundation

Board member


None Identied

Harlan Weisman, MD(As o September 15, 2011)


Johnson & JohnsonChief Science and

Technology Ocer, Medical Devices &Diagnostics (Employer)

-Owns stock and has options


Board member of the following

organizations:

-University o PennsylvaniaCenter or

Bioethics External Advisory Board

-Johns Hopkins University School oMedicine; Institute or Basic BiomedicalSciences Advisory Council

-Chie Technology Ocer AdvisoryBoard, Research and Technology

-Executive Council o the CorporateExecutive Board

-McKinsey Product DevelopmentLeaders Roundtable

Memberships in Professional Societies:

-American College o Cardiology (Fellow)-American College o Chest Physicians

(Fellow)

-American College o Physicians-American Federation o Clinical

Research-American Heart Association

-Council on Clinical Cardiology (Fellow)

-Council on Arteriosclerosis, Thrombosis,and Vascular Biology (Fellow)

-American Medical Association

-New Jersey Medical Society/MercerCounty Medical Society

Robert Zwolak, MD, PhD(As o September 18, 2011)


Dartmouth-Hitchcock Clinic (Employer)

US Department of Veterans Aairs

(Employer)

Society for Vascular Surgeryhonoraria

received or teaching

American Podiatric Medical

Associationhonorarium received orinvited lectures

Medical College of South Carolinahon-

orarium or 2-day visiting proessorship Emory Universityhonorarium for 2-day

visiting proessorship EVA Corporationmedical device

manuacturerowns stock


Board of Directors Intersocietal

Commission or Accreditation o Carotid

Stent Facilities

AMA/Specialty Society Relative ValueUpdate Committeeprior ull member,

current member o two workgroups(lesser involvement than ull committee

member) Society for Vascular Surgery

Immediate Past-President, currentBoard o Directors member

American College of Surgeonsmember

Board o Governors in 2010, current

member o several committees andworkgroups o lesser status than

Governor Dartmouth Medical SchoolProfessor

(no salary)


Naomi Aronson, PhD(As o February 13, 2012)


Blue Cross Blue Shield Association,

Technology Evaluation Center (Employer)

-Under contract with Agency or Health

Research and QualityPERSONAL ASSOCIATIONS:

GAPPNET Planning Committee

Health Technology Assessment

International Health Policy Forum Institute of Medicine Genomics

Roundtable Steering Committee of the Chicago

AreaDEcIDE Research Center National Business Group on Health

Committee on Evidence-BasedBenet Design

University of Torontos internal Canada

Foundation or InnovationExternal

Reviewer in 2012-Pertinent Previous: Institute o Medicine

Forum on Drug Discovery Translationand Development (20052008)

Ethan Basch, MD, MSc(As o March 7, 2012)


Memorial Sloan-Ketering Cancer Center,

Associate Attending Physician (Employer)

Blue Cross Blue Shield (Consultant,

Progression Free Survival Report)


Member, American Society ofClinical Oncology

Co-Chair, Alliance Health

Outcomes Committee

Member, American Medical

Inormatics Association

Member, International Society of

Pharmacoeconomics and

Outcomes Research

Board member, International Society

or Quality and Lie Research

Alred O. Berg, MD, MPH(As o February 13, 2012)

FINANCIAL ASSOCIATIONS: University of Washington, Seattle, NIH

Investigator (Employer)


Member, American Academy of

Family Physicians

Member, Society of Teachers of

Family Medicine


26/50


David Flum, MD, MPH(As o March 16, 2012)


University of Washington

Department o Surgery (Employer) Surgical Consulting (Legal Consulting)

Benchmarket (Privately Owned Business)

Group Health Cooperative (Wifes

Employer) Shire (Received consulting fees and travelexpense or Diverticular Disease ScienticNeed/Working Group on 10/28/11)

Applied Medical (received fee for

symposium presentation on 10/25/11)

American College of Phlebology

(received honorarium and travel

expenses or speaking at annualmeeting 11/4/11)


American College of Surgeons

Washington State ChapterAmerican

College o Surgeons

American Society for Metabolic andBariatric Surgery

American Surgical Association

Henry N. Harkins Surgical Society

Seattle Surgical Society

Surgical Outcomes Club

Sherine Gabriel, MD, MSc (Chair)(As o February 29, 2012)


Mayo Clinic (Employer)

Genentech

Homan-LaRoche

NIH


Member, FDA/CDER Drug Safety and Risk

Management Advisory Committee

(2010present) Chair, FDA/CDER Drug Safety and Risk

Management Advisory Committee(2011present)

Member, External Advisory Board,

University o Puerto Rico Post-doctoral

Master o Science in Clinical ResearchProgram, School o Medicine and School

o Health Proessions (2006present) Member, Executive Board, Observational

Medical Outcomes Partnership,Foundation or the NIH (2008present)

Member, Scientic Advisory Board,

Excellence in Rheumatology

(2010present)

Member, International Coordination

Council, Bone and Joint Decade/Initiative(2010present)

Chair, CTSA Academic-Industry Working

Group (2010present)

Member, Steering Committee, Actemra

Cardiovascular Outcomes Trial(ENTRACTE), Roche (2009present)

Member, Pharmacoepidemiology

Advisory Board, Genentech(2009present)

Member, External Research Education

Advisory Board, University o Kentucky

CTSA (2011present)

Member, External Research EducationAdvisory Committee, GeorgetownUniversity (2011present)

Member, Oversight Board, Wellcome

Trust, HRB Dublin Centre or Clinical

Research (2011present) Chair, Methodology Committee,

Patient-Centered Outcomes ResearchInstitute (2011present)

Steven Goodman, MD, MHS, PhD(As o April 27, 2012)


Stanford University (Employer)

National Blue-Cross/Blue Shield,

Scientic Advisor to TechnologyAssessment Program

The American College of Physicians,

Associate Editor or Annals oInternal Medicine


None Identied

Mark Heland, MD, MS, MPH(As o February 10, 2012)


Sta Physician, Portland VA Medical

Center (Employer) Professor, Oregon Health & Science

University (Employer) Employer Receives Grants through

-Department o Veterans Aairs-Agency or Healthcare Research

& Quality-National Institutes or Health

Contracts at Oregon Health & Science

University through Oregon Evidence-

based Practice Center-Yale University Open Data Access

(YODA) Project, primary unding to Yaleis Medtronics

-Drug Evaluation Review Program,Center or Evidenced-based Policy,

OHSU, primary unders are several U.S.state governments and CMS, DHSS

-American Pain Society

Recently Completed Contracts with

-American College o Chest Physicians-Knight Cancer Institute, OHSU, primary

unding was Susan G Foundation

Consulting

-Consumer Union

-Society or Medical Decision Making


Editor in Chief, Medical Decision Making,

Society or Medical Decision Making

Member, Academy Health

Advisory Board, U.S. Cochrane Center

Fellow, American College of Physicians

Member, Society for General

Internal Medicine

John Ioannidis, MD, DSc(As o March 21, 2012)


Professor, Stanford University School of

Medicine (Employer)


Editor-in-chief, European Journal of

Clinical Investigation Editorial member of 26 international

peer-reviewed journals

Michael S. Lauer, MD(As o April 17, 2011)


National Institutes of Health (Employer)

Cleveland Clinic

-Cleveland Clinic Health Systems

Savings Investment Plan Putnam College Fund

UptoDate Inc.


None Identied

David O. Meltzer MD, PhD(As o April 22, 2012)


University of Chicago (Employer) Norvartis

CVS

ABIM

Peoplechart

Cubist

InHealth

Grants from:

-National Institutes or Health-Agency or Healthcare Research

and Quality-Robert Wood Johnson Foundation

-National Pharmaceutical Council

Stocks holding in Acadia Pharmaceuticals

and Valeant PharmaceuticalsPERSONAL ASSOCIATIONS:

Member of ABIM, SGIM, SHM, MDM

University of Chicago

4


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Brian S. Mittman, PhD(As o March 1, 2012)


VA Greater Los Angeles Healthcare

System, U.S. Dept. o Veterans Aairs(Part-time Employee)

Sepulveda Research Corporation

(Part-time Employee)

UCLA (Consultant, research grantsand ellowship training)

University of Washington in St. Louis

(Consultant, training program)

Westat (Consultant, AHRQunded Health Care Innovations

Exchange Programs)

U.S. Department of Energy Oak Ridge

Institute or Science and Education(Consultant, CMS-unded Innovation

Advisors Program)

Purdue Pharmaceuticals (Consultant,

Development o FDA-mandated Risk

Evaluation and Mitigation Strategy orprescription misuse)

National Institutes of Health

(Consultant to the Hill Group)

Institute for Healthcare

Improvement (Consultant)

Rand Corporation (Consultant)


Member, Association of American

Medical Colleges, Advisory Panelon Research

Member, AcademyHealth,

Methods Council

Member, Knowledge Translation Canada,

International Scientic Advisory Board

Member, Singapore Ministry of Health,International Scientic Advisory Board

or Health Services Research Member, University of Miami Center

or Prevention ImplementationMethodology, Scientic Advisory Board

Robin Newhouse, PhD, RN(As o Februar y 14, 2012)


University of MarylandSchool of

Nursing, Chair, Organizational Systems

and Adult Health (Employer)


Chair, Research and Scholarship Advisory

Council, Sigma Theta Tau InternationalHonor Society o Nursing

Research Council Member, American

Nurses Credentialing Center

Chair, Review Committee for Student

Posters, 2012 AcademyHealth

Research Meeting


(Vice Chair)(As o March 19, 2012)


Harvard Medical School (Employer)

Provides statistical consulting services for

-YaleNew Haven Hospital System-The Massachusetts Medical Society

-Institute or Clinical Evaluative Sciences(not-or-prot Canadian Organization)

Brown University, Department of

Biostatics (Husbands employer, has been

awarded a grant rom MethodologyCommittee to provide standards or

diagnostic testing)


Scientic Advisory Board member,

Institute o Clinical Evaluative Sciences,Toronto, Canada

Board member, Frontier Science

and Technology

Product Oversight Committee member,

American Board o Internal Medicine Medicare Evidence Development and

Coverage Advisory Committee member

Sebastian Schneeweiss, MD, ScD(As o Februar y 9, 2012)


Brigham and Womens Hospital

Most health care products

Harvard School of Public Health

WHISCON LLC

Booz & Co.


Member of- ISPE- ASCPT

Fellow of

-The American College o Pharm

-The American College o Epidemiology

Jean R. Slutsky, PA, MSPH(As o March 21, 2012)


Agency for Healthcare Research

and Quality (Employer)


None Identied

Mary Tinetti, MD(As o March 2, 2012)


Yale University (Employer)


Hartford Foundation

YaleNew Haven Hospital


None Identied



Northwestern University, Feinberg

School o Medicine (Employer)

-Aligned with Northwestern MemorialHospital Corporation

Northwestern Medical Family

Foundation (Employer)

-Aligned with Northwestern MemorialHospital Corporation


Agency for Healthcare Research

and Quality FDA (Special government employee,

chair, Cardiovascular Devices Panel)


Former President of the American Heart

Association (20092010) Committee Member, American

Hospital Association Committee Member, American

College o Cardiology

Member, American Collegeo Physicians

Member, the Heart Failure

Society o America Member, the Heart Rhythm

Society o America

Member, the Association of

Black Cardiologists


28/50


29/50

Patient-Centered OutcomesResearch Institute

Financial ReportDecember 31, 2011


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Contents

Independent Auditors Report 1 2

Managements Discussion and Analysis 3 7

Financial Statements

Statements of Financial Position 8Statements of Activities 9Statements of Cash Flows 10Statements of Functional Expenses 11 12

Notes to Financial Statements 13 16

Independent Auditors Report on Internal Control over Financial Reportingand on Compliance and Other Matters Based on an Audit of FinancialStatements Performed in Accordance With Government Auditing Standards 17 18


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1

Independent Auditors Report

To the Audit CommitteePatient-Centered Outcomes Research InstituteWashington, D.C.

We have audited the accompanying statements of financial position of Patient-Centered OutcomesResearch Institute (PCORI) as of December 31, 2011 and 2010, and the related statements of activities,cash flows, and functional expenses for the year ended December 31, 2011, and for the period fromNovember 10, 2010 (Inception) through December 31, 2010. These financial statements are the

responsibility of PCORIs management. Our responsibility is to express an opinion on these financialstatements based on our audits.

We conducted our audits in accordance with auditing standards generally accepted in the United Statesof America and the standards applicable to financial audits contained in Government Auditing Standards,issued by the Comptroller General of the United States. Those standards require that we plan andperform the audit to obtain reasonable assurance about whether the financial statements are free ofmaterial misstatement. An audit includes consideration of internal control over financial reporting as abasis for designing audit procedures that are appropriate in the circumstances, but not for the purpose ofexpressing an opinion on the effectiveness of PCORIs internal control over financial reporting.

Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidencesupporting the amounts and disclosures in the financial statements. An audit also includes assessing theaccounting principles used and significant estimates made by management, as well as evaluating the

overall financial statement presentation. We believe that our audits provide a reasonable basis for ouropinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, thefinancial position of Patient-Centered Outcomes Research Institute as of December 31, 2011 and 2010,and the changes in its net assets and its cash flows for the year ended December 31, 2011, and for theperiod from November 10, 2010 (Inception) through December 31, 2010, in conformity with accountingprinciples generally accepted in the United States of America.

In accordance with Government Auditing Standards, we have also issued our report dated, April 20,2012, on our consideration of PCORIs internal control over financial reporting and on our tests of itscompliance with certain provisions of laws, regulations, contracts, and grant agreements and othermatters. The purpose of that report is to describe the scope of our testing of internal control over financialreporting and compliance and the results of that testing, and not to provide an opinion on the internalcontrol over financial reporting or on compliance. That report is an integral part of an audit performed inaccordance with Government Auditing Standards and should be considered in assessing the results ofour audits.


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2

Managements Discussion and Analysis, on pages 3 7, is not a required part of the basic financialstatements but is supplementary information to the financial statements under accounting principlesgenerally accepted in the United States of America. We have applied certain limited procedures, whichconsisted principally of inquiries of management regarding the methods of measurement andpresentation of the supplementary information in conformity with the financial statements. However, wedid not audit the information and express no opinion on it.

Vienna, VirginiaApril 20, 2012


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Patient-Centered Outcomes Research Institute

Managements Discussion and Analysis

3

The Patient-Centered Outcomes Research Institute (PCORI) was established by federal law (42 U.S.C.1301 et. seq.) in 2010 to conduct research to provide information about the best available evidence to

help patients and their health care providers make more informed decisions. PCORIs research isintended to give patients a better understanding of the prevention, treatment, and care options availableand the science that supports those options.

PCORI is unique both in its mission and how it seeks to fulfill it. PCORI helps people make informedhealth care decisions and improves health care delivery and outcomes by producing and promotinghigh integrity, evidence-based information that comes from research guided by patients, caregivers, andthe broader health care community.

PCORI is a 501(c)(1) non-profit corporation, governed by a 21-member Bo