Cycle 1 2016: Improving Methods for Conducting PCOR Applicant Town Hall April 21, 2016
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).
PCORI CER Methods Program and Contracts Staff • Lillian Agyei, MPH, Program Associate • Emily Evans, PhD MPH, Program Officer • Jason Gerson, PhD, Senior Program Officer • Andrea Heckert, PhD MPH, Program Officer • Kate McQueston, MPH Senior Program Associate • Arletta Praszczalek, Senior Administrative Assistant • Kathryn Smith, MSc, Program Associate David Hickam, MD MPH • Jamie Trotter, MPA, Program Associate Program Director, CER Methods • Scott Yoo, JD, Supervisor, Contracts Operations • Ashton Burton, Specialist, Contracts Operations • Valerie Clark, LL.M, Associate, Contracts Operations
Programmatic Overview Emily Evans, PhD MPH Program Officer, CER Methods Andrea Heckert, PhD MPH Program Officer, CER Methods
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
Improving Methods for Conducting PCOR Cycle 1 2016 PFA pcori.org/funding/opportunities
Cycle 1 2016 PFA: Improving Methods for Conducting PCOR Research Areas of Interest (RAIs): 1. Methods for Patient and Stakeholder Engagement 2. Methods for Patient-Centered Outcomes and Methods for Patient-Reported Outcomes 3. Research Related to the Ethical Conduct of PCOR/CER 4. Methods to Improve Study Design 5. Methods to Improve Validity and Efficiency of Analyses 6. Methods to Support Data Research Networks
General Guidance from the Methods Program • Significance • Identify and explain the specific anticipated contributions and applications of the proposed project to patient-centered outcomes research. • Programmatic Overlap • Differentiate the proposed research from projects already funded by the PCORI Methods Program, as applicable. • Study Design or Approach • Provide a detailed description of the methodological work that is planned and the specific ways in which it addresses the identified methodological gaps and the specific aims of your proposed project. • Engagement Plans • Review the instructions provided in the Methods Applications Guidelines (pp. 14- 15). Please see PCORI’s Engagement Rubric for additional information.
Administrative Overview Ashton Ferrara Specialist, Contracts Operations
Letter of Intent (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 • 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 2
Data Sharing • Describe your data management and sharing plan, including how you will make study data sets available in a manner that is consistent with applicable privacy, confidentiality, and other legal requirements, if requested. • Propose a budget to cover costs of your data-sharing plan, if requested. These cost should not be included in the Budget Template. Page Limit 2
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. 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
Milestones/Deliverables Template • 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.
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 Professional Profile/Biosketch 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; Page Describe the procedure for resolving conflicts . Limit 5
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 and any/each subcontractor.
Application: Common Submission Errors • Using the wrong browser to access PCORI Online • Use Chrome or Safari • Not entering information into all required fields in the system • Having multiple people working on the application at the same time • Having the incorrect file extension • Only PDF files can be uploaded • Not choosing the correct document type from the drop-down menu • Administrative Officer (AO) is unable to view the application
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 before the due date or on it by 5:00 PM ET 24
Resources Refer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding/opportunities) for the following resources: • PFA and Application Guidelines • PCORI Online User Manuals • Sample Engagement Plans • General Applicant FAQs: http://bit.ly/applicant_faqs • PCORI Online: https://pcori.fluxx.io/ • Research Methodology: http://www.pcori.org/node/4020
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 page limits, 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) PCORI Mission • Inclusion of development and dissemination of clinical practice guidelines (CPG) • Not responsive to the program-specific PFA 28
Merit Review Overview Roycelynn Mentor-Marcelle, PhD MPH Merit Review Officer
Merit Review Process pcori.org/content/merit-review-process
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