Improving Methods for Conducting Patient-Centered Outcomes Research - PowerPoint PPT Presentation

Improving Methods for Conducting Patient-Centered Outcomes Research Letter of Intent (LOI) Applicant Town Hall Cycle 2 2015 July 8, 2015 1

Agenda Submitting Questions: Introductions Submit questions via the chat function in Meeting Improving Methods Bridge. Requirements Administrative Ask a question via phone Requirements (an operator will standby to take your questions). Resources

PCORI CER Methods Program and Contracts Staff Maryan Zirkle, Andrea Heckert, Rachael Fleurence, PhD Emily Evans, PhD, Jason Gerson, PhD Kate McQueston, MPH MD, MS, MA PhD, MPH MPH Program Director, Associate Director, Program Associate, Program Officer, Program Officer, Program Officer, Methods and Methods Methods Methods and Methods Infrastructure Methods Infrastructure Jason Rotter, MHS Kathryn Smith, MPH Ashton Burton Program Associate, Program Assistant, Contracts Specialist, Methods Methods Contracts 3

Improving Methods Requirements

PFA Overview: Improving Methods for Conducting Patient-Centered Outcomes Research Objectives of this PFA Available Funds and Duration: PCORI seeks to fund projects to address gaps in methodological research relevant • A total of $12 million (direct + to conducting PCOR. indirect) for this cycle • Up to $750,000 in total direct The improvement of existing methods costs per project will benefit all stakeholders: • Maximum project period 3  researchers planning investigations years  policy makers weighing the value of healthcare interventions  patients, clinicians, and caregivers facing healthcare decisions

Revisions for Cycle 2 2015 Funding Cycle PFA no longer includes 3 Special Topics of Interest • Research related to Human Subjects Protections – Previously Special Topic of Interest #1, now Research Area of Interest #3 • Research related to Recruitment and Retention – Previously Special Topic of Interest #2, now part of Research Area of Interest #1 • Methods To Support Data Research Networks – Previously Special Topic of Interest #3, Now Research Area of Interest #6 Extra scrutiny for projects overlapping with current portfolio • While we will still consider applications related to analytic methods responsive to this PFA, these applications will undergo substantial scrutiny to ensure that the proposed research does not significantly overlap with previously funded projects or concurrent proposals. • See Research Areas of Interest #4 and #5 for more details.

Research Areas of Interest 1. Methods for patient and stakeholder engagement 2. Methods for Patient-Centered Outcomes (PCOs) and Patient-Reported Outcomes (PROs) 3. Research related to Human Subjects Protections 4. Methods to Improve Study Design 5. Methods To Improve Validity and Efficiency of Analyses 6. Methods To Support 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 September 8, 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/announcement/improving-methods- conducting-patient-centered-outcomes-research-cycle-2-2015

Key Dates What When

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, Administrative Official, and Financial Officer  Enter information into all required fields in the system  Upload the LOI in the system

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/content/research-inquiry  Call 202-627-1884 (programmatic inquiries)  E-mail sciencequestions@pcori.org Contact our Helpdesk  E-mail pfa@pcori.org  Call 202-627-1885 (administrative and technical inquiries)

Q&A Ask a question via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions). If we are unable to address your question during this time, e-mail the Helpdesk at pfa@pcori.org.