PFA Applicant Town Hall Improving Methods for Conducting Patient-Centered Outcomes Research

Letter of Intent Town Hall for
Applicants
August 2013 Cycle
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Agenda
Introductions
About PCORI
PCORI Funding Announcements (PFA)
Overview of PFA
Merit Review Criteria
Letter of Intent Overview
Resources
Live Q&A
Submitting Questions:
Submit questions via
the chat function in
Meeting Bridge
Ask a question via phone
(an operator will standby
to take your questions)
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Introductions
Martin Duenas, MPA
Contracts Director
James Hulbert
Contracts Administrator
Kirstin Margosian, MA
Contracts Coordinator
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Rachael Fleurence, PhD
Program Director

PCORI’s Mission and Vision
 The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit health
research organization authorized by the Patient Protection and Affordable Care Act of 2010.
 PCORI funds patient-centered research to assist patients, caregivers, and other stakeholders in
making informed health decisions.
Mission
PCORI helps people make
informed healthcare
decisions and improves
healthcare delivery and
outcomes by producing and
promoting high integrity,
evidence-based information
that comes from research
guided by patients,
caregivers, and the broader
healthcare community.
Vision
Patients and the public have
the information they need to
make decisions that reflect
their desired health
outcomes.
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Research Done Differently
PCORI’s unique contribution to this field of research is its dedicated focus on outcomes that matter
most to patients.
Inclusion of patient-centered outcomes is therefore a
necessary component of PCORI-funded research.
PCORI involves patients and the entire healthcare
community in every step of the research
process — from selecting research questions to study,
to the actual conduct of research, to sharing the
research findings through platforms and channels that
are accessible to everyone.
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Overview of PFAs
To solicit research proposals, PCORI regularly releases funding announcements that invite researchers
to submit applications to receive funding to conduct research projects:
Addressing Disparities
Assessment of Prevention, Diagnosis, and Treatment Options
Communication and Dissemination Research
Improving Healthcare Systems
Improving Methods for Conducting Patient-Centered Outcomes Research
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Improving Methods for Conducting Patient-Centered
Outcomes Research
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Improving Methods for Conducting
Patient-Centered Outcomes Research
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In this PFA, we seek to fund projects that:
 Improve methods for engaging patients/stakeholders in
PCOR and for evaluating the impact of this patient/
stakeholder engagement.
 Improve methods for systematic review of PCOR topics,
including selection and prioritization of topics.
 Improve the validity and/or efficiency of analytic methods
and data sources utilized in PCOR research.
 Improve methods to support the collection of Patient-
Reported Outcomes and Patient-Centered Outcomes.
 Improve methods to enhance the reproducibility,
transparency, and replication of PCOR research.
 Improve approaches for training researchers, patients, and
other stakeholders in PCOR methods.
Available funds: Up to $8 Million

Studies PCORI Is Not Soliciting Under This
PFA
Studies whose primary focus is not on improving methods
for PCOR: Studies should address gaps identified under the
research areas of interest in the PFA and the Methodology
Committee report.
Studies whose primary focus is on developing or studying
a disease-specific intervention, model, test, instrument,
tool or other items without the primary objective being
to address a methodological gap in PCOR as identified in
the Methodology Committee report or in other recognized
sources.
Examples of non-responsive studies:
1. Study whose main focus is to
evaluate the response to an
intervention in patients with
a specific disease.
2. Development of a tool to improve
patient-physician communication
around a difficult diagnosis.
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Broad Research Topics of Interest
The following topics areas are areas of research that PCORI might be interested in:
 Development of methods for patient-centeredness.
 Research in methods to conduct systematic reviews of patient-centered CER.
 Development of methods for generating, selecting, and prioritizing topics for research and for
including patients and stakeholders in the peer-review process.
 Development and refinement of general analytic methods.
 Development and refinement of design-specific analytic methods.
 Research that determines the validity and efficiency of data sources commonly used in PCOR.
 Research related to Patient-Centered Outcomes (PCOs) and Patient-Reported Outcomes (PROs).
 Research in methods to enhance the reproducibility, transparency, and replication of PCOR.
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Merit Review Criteria
Applicants must respond to the five PCORI Merit Review Criteria.
1. Impact on the field of PCOR
methods
2. Potential for study to
improve PCOR methods
3. Technical merit 4. Patient-centeredness
5. Patient and stakeholder
engagement
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Criterion 1: Impact on the field of
PCOR Methods
Refers to the extent that the proposed methods are needed in the field of PCOR.
 How often would these methods be used, and how many PCOR studies would
benefit from these improved methods?
 Do existing methods weaken the validity of PCOR studies, and would improved
methods therefore increase the validity of PCOR findings?
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Criterion 2: Potential for study to
improve PCOR Methods
Refers to the potential of the proposed methodological investigation and its results to
change methodological practices in ways that improve PCOR and the decisions made
by patients.
 Does the research question address a critical gap in current methodological
understanding as noted in the Methodology Committee Report or in
other sources?
 Is the proposed approach feasible and likely to result in new standards or in the
improvement of existing standards?
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Criterion 3: Technical merit
Refers to the technical merit of the proposal.
 Is there a clear research plan with rigorous methods and key milestones clearly
articulated? Do the study methods reflect state-of the-art thinking and practice in
the methodological area, so that results are likely to be accepted and heeded?
 Is the research team appropriately trained and experienced to carry out the
planned studies?
 Is the research environment sufficient to support the conduct of the work, and are
appropriate resources available?
 Will the proposed methods help support the inclusion and study of diverse
populations with respect to age, gender, race, ethnicity, geography, or clinical
status, or, alternatively, do the methods support the inclusion of previously
understudied populations in PCOR?
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Criterion 4: Patient-centeredness
Refers to the level of patient-centeredness of the proposal.
 Is the proposed methodological investigation specifically linked to improving PCOR
methods, and specifically to the improved study of comparisons and patient-
centered outcomes that are relevant and valued by patients, caregivers, and
clinicians?
 For relevant studies, how credible are the application’s claims that engaged
patients and stakeholders will exert meaningful influence on the design and
conduct of the research, to ensure patient-centeredness of the questions and
outcomes addressed?
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Criterion 5: Patient and
stakeholder engagement
Refers to the level of engagement of patients and stakeholders in the proposed
project.
 Where applicable, applications need to demonstrate patient and stakeholder
engagement through the integration of patients and stakeholders in the
development of the research plan and in key elements of the proposed project
including:
• Participation in formulation of research questions
• Defining essential characteristics of the study, participants,
comparators, and outcomes
• Monitoring study conduct and progress
• Dissemination of research results
 If the project has not included patient and stakeholder engagement (for example,
in the area of analytic methods), has the application justified their non-inclusion?
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Letter of Intent (LOI) Submission: Deep Dive
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Understanding the Letter of Intent (LOI)
A LOI is required in order to submit an
application.
LOI’s are NOT scored.
Applicants will NOT receive an invitation to
submit an application after submitting a LOI.
An Investigator can only be listed as a PI on
one.
Of note: PCORI encourages applicants to submit their LOI and application before
the stated due date. LOIs and applications are due 5:00 pm ET.
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Eligibility Requirements
Applications may be submitted by:
 Any private sector research organization, including any:
• non-profit organization
• for-profit organization
 Any public sector research organization, including any:
• university or college
• hospital or healthcare system
• Laboratory or manufacture
• unit of state or local government
 Foreign Organizations
 Nondomestic Components of Organizations based in the United States
Please Note: Individuals are not eligible to submit applications to PCORI.
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Budget and Period Limitations
Budget
• Maximum $250,000 direct costs per year
• Indirect costs are capped at 40%
• *Request for exception can be made during the
LOI submission
Period of Performance
• Maximum of three years
• PCORI encourages projects of shorter duration
• *Request for exception can be made during the
LOI submission
*Of note: Approval or denial decisions may take up to four months. Please
plan accordingly, and factor this into your decision to submit a request.
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Letter of Intent
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The Letter of Intent includes:
 Organizational information
 Information about Key Personnel
 Technical abstract (3,000 character limit)
• Background: State the problem or methodological gap your research
intends to address, including the rationale for tackling this problem.
• Objectives: Briefly describe the specific aims of the study, including the
methods gaps addressed.
• Methods: Give a concise description of the steps involved in the
development of the new methodology.
• Anticipated impact: Describe the anticipated impact the study results will
have on the field of PCOR methods.
Of note: This abstract may be used to determine programmatic fit.

Key Dates: August 15 2013
Key Dates: PCORI Funding Announcements
Action August 2013 Cycle
System Opening Date May 15
Letter of Intent (LOI) Due
Date
June 15
Informational Training
Programs
July – August
Application Deadline August 15
Merit Review Dates September - November
Awards Announced December / January
Earliest Start Date January
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Frequently Asked Questions
(Programmatic)
 How do I know if my research is of interest to PCORI?
• We encourage you to read the PCORI Funding Announcements (PFAs) carefully
and other background material on our website to understand our goals and the
PFA you are considering.
 Can I speak with someone at PCORI about the suitability of my research
question?
• Currently, PCORI does not have dedicated individuals to speak with applicants
regarding submission questions. Applicants and potential applicants with
questions should submit those inquiries via pfa@pcori.org.
 Is there a specific disease or condition that is a priority for PCORI?
• No. PCORI is concerned with patient outcomes, across a range of conditions
and treatments. PCORI will periodically issue PFAs that focus on specific
diseases or conditions within or across funding areas.
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Frequently Asked Questions
(Administrative)
 Can I switch PFAs after a LOI has been submitted?
• No. It is not possible to submit an LOI to one funding announcement and the
full application to another.
 How much can the research proposed in my application differ from that initially
described in my Letter of Intent (LOI)?
• The information provided in the LOI, including the study title, may be changed
in the final application. Only two things may not differ:
• The PFA may not change.
• The budget may not exceed direct cost and/or project period, as listed
within the PFA, if permission was not requested at LOI submission.
 Can I list a different PI in the final application than was listed in the Letter of Intent
(LOI)?
• Yes. The PI listed on your final application may differ from the PI listed in the
LOI.
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Resources
View training materials through
the Quick Links for Applicants
bar. Access:
• Application training
• Opportunities for webinars
• Reviewer training
Visit the Funding Center for:
• PFAs
• Templates
• Instructions
• Key dates
• FAQ’s
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Questions
Submitting Questions:
Submit questions via
the chat function in
Meeting Bridge
Ask a question via phone
(press #7 on your phone)
Please use this time to ask any
question you may have about the PFA
or the LOI submission process.
If we are unable to address your
question during this time, e-mail the
help desk at pfa@pcori.org.
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