Presentation Slides

Improving Methods for Conducting
Patient-Centered Outcomes
Research
LOI Applicant Town Hall Webinar
Washington, DC
February 11, 2015 at 2:00 pm ET
1
Agenda
Introductions
Improving Methods
Requirements
Administrative
Requirements
Resources
2
Submitting Questions:
Submit questions via the
chat function in Meeting
Bridge.
Ask a question via phone
(an operator will standby
to take your questions).
PCORI CER Methods Program and Contracts
Staff
Andrea Heckert,
PhD, MPH
Program Officer,
Methods
Rachael Fleurence, PhD Jason Gerson, PhD
Associate Director,
Program Director,
Methods
Methods and
Infrastructure
Emily Evans, PhD,
MPH
Program Officer,
Methods
Maryan Zirkle,
MD, MS, MA
Program Officer,
Methods and
Infrastructure
Kathryn Smith, MPH
Program Assistant,
Methods
Jason Rotter, MHS
Program Associate,
Methods
3
Nora McGhee, PhD
Merit Review
Officer
Ashton Burton
Contracts Specialist,
Contracts
3
Kate McQueston, MPH
Program Associate,
Methods
Improving Methods Requirements
PFA Overview: Improving Methods for Conducting
Patient-Centered Outcomes Research
Objectives of this PFA:
Research findings that can be trusted
should be generated using valid, rigorous,
patient-centered research methods.
PCORI seeks to fund projects to address
gaps in methodological research relevant
to conducting PCOR.
Improving existing methods to benefit all
stakeholders, including researchers
planning investigations, policy makers
weighing the value of healthcare
interventions, and patients, clinicians, and
caregivers facing healthcare decisions.
Available Funds and Duration:
• A total of $12million (direct +
indirect) for this cycle
• Up to $750,000 in total direct
costs per project
• Maximum project period 3
years
Revisions for Spring 2015 Funding Cycle
Decrease of award size from $1,000,000 to $750,000 in total direct costs
Research related to human subjects protections and novel interventions for recruitment
and retention are now designated as Special Topics of Interest
Revised Special Topic of Interest focusing on methods for network-based data in research
The current PFA does not include a special emphasis on PROMIS related projects. We
will still consider projects that include PROMIS measures, provided they align with the S15
PRO/PCO priorities
No support for methods related to research prioritization and systematic reviews
Research Areas of Interest
Development of methods for patient and other stakeholder
engagement in research
Development and refinement of general analytic methods
Development and refinement of design-specific analytic methods
Research related to patient-centered outcomes (PCOs) and
patient-reported outcomes (PROs)
 Research on usefulness of patient-reported data in clinical care
 Research on PRO score interpretability, with a focus on clinical
meaningfulness
 Research on the collection of PRO data for multiple purposes
 Research on integrating PROs into clinical practice
 Research on the use of PROs in registries
Special Topics of Interest
Research on issues related to human subjects protections
Research on novel methods, interventions, or strategies for
increasing recruitment and retention of participants
Development of methods to support data research networks
 Methods to improve distributed analyses in data research networks
 Methods to obtain longitudinal and complete data in data research
networks
Patient and Stakeholder Engagement Plan
Description of the plan for engaging patients, caregivers,
and/or other stakeholders over the course of the project
 Justification for choice of patients, caregivers, and/or other
stakeholders
 Delineation of their roles and expected contributions
Consider engaging other stakeholders in the
methodological process and dissemination and
implementation plans
 Examples: data architects, clinicians, domain experts, health
services researchers with different expertise than members of the
research team, policy makers, etc.
Administrative Requirements
Eligibility to Submit a Proposal
Any private sector (non-profit or for-profit) research
organization
Any public sector research organization (university or
college hospital or healthcare system, laboratory or
manufacturer, unit of local, state, or federal government)
Non-domestic components of organizations based in the
US and foreign organizations may apply, as long as there is
demonstrable benefit to the US healthcare system and US
efforts in the area of patient-centered research can be
clearly shown.
Individuals are not permitted to apply.
Budget and Period Limitations
Funds & Budget
Total Direct costs up to $750,000 over the life of the project
Indirect costs: up to 40%
Institutional base salary up to $200,000
Period of Performance
Maximum of 3 years
Letter of Intent (LOI)
This is a competitive LOI process:
Only those LOIs deemed most responsive to this PFA will be invited to submit a
full application.
All applicants will be notified of their status by March 23, 2015 by 5:00pm ET.
Download the LOI Template from the Funding Center to begin your LOI.

LOIs cannot exceed 3 pages and margins cannot be altered .

Adhere to the formatting and template requirements in the Application
Guidelines.

You must upload your LOI as a PDF in PCORI Online.
Please refer to the PFA, Application Guidelines, and Applicant Resources in the
Funding Center here http://www.pcori.org/assets/2014/08/PCORI-PFA-2014-FallMethods-Application-Guidelines.pdf
Submission & Key Dates
What
When
LOI-Applicant Town Hall
February 11, 2015 at 2:00 pm ET
LOI due in PCORI Online
March 6, 2015 by 5:00pm ET
Applicants notified as to
whether they have been
selected to submit a full
application
March 23, 2015 by 5:00pm ET
Application Deadline (by
invitation only)
May 5, 2015 by 5:00pm ET
Merit Review Dates
August 6-7, 2015
Awards Announced
September 30, 2015
Earliest Start Date
November 2015
31
Using the PCORI Online System
 Apply through PCORI Online
(https://pcori.fluxx.io)
 Access the website using Chrome or Safari
browsers only
 Create a new request and begin the LOI
 Designate the LOI with the following
individuals:
• PI, PI Designee, AO, and Financial Officer
 Enter information into all required fields in the
system
 Upload the LOI in the system
 Save information by clicking the ‘Save and
Review’ button on the save and review page
and on the side navigation pane
Where can I find help?
Visit pcori.org/apply
 Application Guidelines
 FAQs
 PCORI Online User Manuals
 Sample Engagement Plans
Schedule a Call with a Program Officer
 Submit a request at pcori.org/programmatic-inquiry
 Call 202-627-1884 ( programmatic inquiries)
 Submit a request at pcori.org/about-us/contact-us
Contact our Helpdesk
 E-mail [email protected]
 Call 202-627-1885 ( administrative and
technical inquiries)
Questions
Please use this time to ask any
programmatic and administrative
questions you may have about the PFA or
LOI submission process.
If we are unable to address your question
during this time, e-mail the help desk at
[email protected].
Submitting Questions:
Submit questions via the
chat function in Meeting
Bridge.
Ask a question via phone
(press 7 on your phone).