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).