Cycle 3 2016: Improving Methods for Conducting Patient-Centered Outcomes Research (PCOR) Applicant Town Hall November 9, 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 CER Methods Program • David Hickam, MD MPH, Program Director Lillian Agyei, MPH, Program Associate • • Surair Bashir, Program Associate • Emily Evans, PhD MPH, Program Officer • Jason Gerson, PhD, Senior Program Officer • Arletta Praszczalek, Senior Administrative Assistant Jamie Trotter, MPA, 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, Administrator, Contracts Operations
Programmatic Overview David Hickam, MD MPH Program Director, 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
Cycle 3 2016: Methods PFA Overview • Funding Objectives The Methods Program seeks to fund applications that make a significant methodological contribution to PCOR/CER. The Cycle 3 2016 Methods PFA is available at pcori.org/funding/opportunities. • Available Funds Up to $750,000 in total direct costs per project (inclusive of required peer review budget) • Project Duration Projects should be completed within 3 years
Cycle 3 2016 PFA: Research Areas of Interest (RAIs) Previously Invited Applications* • Methods for Patient and Stakeholder Engagement • Methods for Patient-Centered Outcomes and Methods for Patient-Reported Outcomes • Methods to Improve Study Design • Methods to Improve Validity and Efficiency of Analyses Resubmissions and New Applications • Research Related to Ethical and Human Subjects Protections (HSP) in PCOR/CER • Methods to Support Data Research Networks * Eligibility limited to applicants previously invited to submit a full application to Cycle 1 (Spring) 2015, Cycle 2 2015, Cycle 3 2015, and Cycle 1 2016.
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.
Guidance for Research Involving the PCORnet Infrastructure • Identify Networks Name all participating PCORnet entities (CDRNs, PPRNs, Collaborative Research Groups, Health Plans, etc.) collaborating on the project and the affiliated sites • Data Sharing Describe how data will be shared between study sites, including whether data will be shared using the established PCORnet data operations center or if the sites will do peer-to-peer data sharing • Common Data Model Indicate if the PCORnet Common Data Model will be used • Coordinating Center Account for the PCORnet Coordinating Center as a partner on the proposal and budget accordingly (if the application intends to utilize any resources from the PCORnet Coordinating Center) Expertise • Describe an individual’s added contribution to the study beyond an individual’s name and PCORnet association Governance • Review PCORnet Governance Policies
Administrative Overview Mekia Winder, MPH Administrator, 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 (if applicable)
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 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 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
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 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
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 •
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