Cycle 1 2017: Improving Methods for Conducting Patient-Centered Outcomes Research (PCOR) Applicant Town Hall April 18, 2017
Agenda Programmatic Overview Administrative Overview Merit Review Criteria Questions and Answers Submit questions via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions).
Methods PFA: Science Program and Contracts Staff Science Program • David Hickam, MD MPH, Program Director • Emily Evans, PhD MPH, Program Officer • Lillian Agyei, MPH, Program Associate • Jason Gerson, PhD, Senior Program Officer • Arletta Praszczalek, Senior Administrative Assistant • Surair Bashir, Program Associate Contracts Management and Administration (CMA) • Scott Yoo, JD, Supervisor, Contracts Operations • Valerie Clark, LL.M, Associate, Contracts Operations • Ashton Ferrara, Associate, Contracts Operations • Mekia Winder, MPH MCHES, Administrator, Contracts Operations
Programmatic Overview David Hickam, MD MPH Program Director, Clinical Effectiveness and Decision Science
Improving PCOR Methods • PCORI was created to support research that provides high-integrity, evidence-based information PCORI’s Mission to patients, clinicians, and the broader healthcare community. Why Methods • Rigorous research methods are needed to produce relevant, trustworthy findings that can improve Matter patients’ healthcare outcomes. Methods for • Methods include the systematic processes, designs, and analytical approaches needed to ensure the PCOR/CER sound scientific and ethical conduct of PCOR/CER.
Improving PCOR Methods: Program Goals Identify Methods • Identify methodological gaps relevant to the conduct of PCOR/CER Gaps • Fund high impact studies which address Fund Research gaps in methodological research Disseminate • Disseminate and facilitate the adoption of Promising/Best new methods to improve the conduct of PCOR/CER Practices
Cycle 1 2017: Methods PFA Overview • The Methods Program seeks to fund Available Funds & applications that make a significant Project Duration: methodological contribution to PCOR/CER. • Proposals that simply apply • Up to $750,000 in total methodological approaches to a particular direct costs per project domain or seek to disseminate an approach will not align with programmatic • Projects should be priorities. completed within 3 • Novelty and/or strong engagement years cannot compensate for a lack of methodological contribution and scientific rigor. • The Cycle 1 2017 Methods PFA is available at http://www.pcori.org/Cycle-1-2017-methods/
Cycle 1 2017 PFA: Research Areas of Interest (RAIs) Resubmissions and New Applications • Research Related to Ethical and Human Subjects Protection (HSP) issues in PCOR/CER • Methods to Support Data Research Networks • Methods to Improve the Use of Natural Language Processing (NLP)
General Guidance from the Methods Program (1/2) • Background and Significance Identify, explain, and provide support for the specific anticipated methodological contributions to PCOR/CER. Projects that simply apply methods or approaches to a particular domain or seek to disseminate an approach will not align with program priorities. Novelty and strong engagement cannot compensate for lack of scientific rigor. • Study Design or Approach Provide a detailed description of the methodological work that is planned (e.g., theoretical development, simulation studies, data collection and analysis, empirical analyses, etc.). Applications must adhere to all relevant PCORI Methodology Standards.
General Guidance from the Methods Program (2/2) • Appropriate Data Sources Applications must justify why the chosen datasets are optimal for the project (rather than just convenient to obtain) • Evaluation Describe and justify an appropriate evaluative framework (including choice of methodological comparators, as applicable) and address potential limitations of the proposed approach. Identify and assess underlying research assumptions and describe how those assumptions will be examined and the potential impact of their violation.
Administrative Overview Ashton Ferrara Associate, Contracts Operations
LOI and Application • Full applications are invited based on the information provided in the LOI. • Changes to the following require PCORI’s approval: • Principal Investigator • Institution • Research question(s) • Specific Aims • Study Design • Comparators
Research Strategy • Maximum 20 pages in length • Use the Research Plan Template as your guide: • Background • Significance • Study Design or Approach • Study Population(s) • Research Team and Environment • Engagement Plan • Provide all the information requested, as outlined in the template. Page Limit 20
Dissemination & Implementation • Describe the potential for disseminating and implementing the results of this research in other settings. • Describe possible barriers to disseminating and implementing the results of this research in other settings. • Describe how you will make study results available to study participants after you complete the analyses. Page Limit 1
Consortium Contractual Arrangement • Describe the proposed components of the research project that will be performed by subcontracted organizations. • Explain the strengths that these partners bring to the overall project to ensure successful submission of contract deliverables in accordance with the milestone schedule. Page Limit 5
Appendix • Applicants can include additional materials that they believe are useful, but reviewers are not required to review the appendix materials in evaluating the application. Page Limit 10
People and Places Template - Biosketch • Required for all key personnel • Use NIH biosketch or PCORI’s format • List all partners within the Key Personnel section • Patient and/or stakeholder biosketches Page Limit 5 Per person
People and Places Template – Project/Performance Site(s) • Provide a description of the facilities that will be used during the project, including capacity, capability, characteristics, proximity, and availability to the project. Page Limit 15
Letters of Support • Letters of support should be addressed to the PI to demonstrate the commitment of key personnel and supporting organizations to the proposed project. • Letters of support should be organized in the following manner: • Letters of organizational support • Letters of collaboration • Letters confirming access to patient populations, data sets, and additional resources
Leadership Plan Template (Dual PI application) • Describe the governance and organizational structure of the leadership team and the research project; • Delineate the administrative, technical, scientific, and engagement responsibilities for each PI and the rationale for submitting a dual-PI application; • Discuss communication plans and the process for making decisions on scientific and engagement direction; • Describe the procedure for resolving conflicts . Page Limit 5
Milestones/Deliverables • Milestones • Significant events, deliverables, tasks, and/or outcomes that occur over the course of the project that mark progress toward the project’s overall aims • Deliverables • Measurable and verifiable outcomes or products that a project team must create and deliver according to the contract terms See Appendix 1 of the Application Guidelines for examples of milestones.
Budget Templates Budget Budget Summary Detailed Budget Justification A detailed budget is needed for each year of the project. Complete each budget section for the prime NOTE applicant.
Using the PCORI Online System Navigate to PCORI Online (https://pcori.force.com/engagement) Log into the PCORI system early Please only use Chrome, Safari, and Firefox browsers to access the system. The PI and the AO cannot be the same individual. PCORI Online Training Slides PCORI Online Application Cheat Sheet
Tips for Success • Adhere to the Application Guidelines for the appropriate PFA and funding cycle • Start and submit application early • Ensure that all team members can see the application in the system (check during the LOI stage) • Inform your AO of your intent to submit • Submit the completed application on/before the due date by 5:00 PM ET
What happens to your application after you submit it?
Administrative Screening Applicants must follow the administrative requirements stated in PCORI’s Application Guidelines . Applications may be administratively withdrawn for the following reasons: • Exceeding budget or time limitations • Not using PCORI’s required templates • Submitting incomplete sections or applications
Programmatic Screening Applications may be programmatically withdrawn for the following reasons: • Deviation from the approved LOI • Inclusion of cost-effectiveness analysis (CEA) • Inclusion of development and dissemination of clinical PCORI Mission practice guidelines (CPG) • Not responsive to the program-specific PFA
Merit Review Overview Susan Levine, MS, DVM, PhD Merit Review Officer
Merit Review Process pcori.org/content/merit-review-process
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