Cycle 2 2015: Improving Methods for Conducting PCOR Applicant Town Hall September 17, 2015
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 Emily Evans, PhD, MPH Rachael Fleurence, PhD Jason Gerson, PhD Maryan Zirkle, MD, MS, MA Andrea Heckert, PhD, MPH Program Officer, Program Director, Methods Associate Director, Program Officer, Program Officer, Methods & Infrastructure Methods Methods Methods & Infrastructure Kate McQueston, MPH Kathryn Smith, MSc Ashton Burton Program Associate, Program Assistant, Contracts Specialist, Methods Methods Pre-Award Contracts
Programmatic Overview • Jason Gerson, PhD, Associate Director, Methods
Improving PCOR Methods • PCORI was created to support research that provides PCORI’s Mission high-integrity, evidence-based information 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 include systematic processes, designs, tools, and techniques used to generate the evidence needed to Methods for PCOR answer questions about which healthcare options work best for particular patients.
Improving PCOR Methods: Program Goals Identify Methods • Identify methodological gaps relevant to the conduct of PCOR 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 Practices
Improving Methods for Conducting PCOR Cycle 2 2015 PFA pcori.org/funding/opportunities
Cycle 2 2015 PFA: Improving Methods for Conducting PCOR Research Areas of Interest 1. Methods for Patient and Stakeholder Engagement 2. Methods for Patient-Centered Outcomes and Methods for Patient-Reported Outcomes 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
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. Replication and Reproduction of Research Findings • • Review the instructions provided in the Methods Applications Guidelines (pp. 17-18).
PCORI Monitors Projects Against Milestones and 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.
Milestone Schedule • Entered into the PCORI Online system • Distinct from the Project Milestones and Timeline for Completion in the Research Plan, under Research Strategy • Must provide 3-10 milestones per six-month period • See examples in Appendix A of the Cycle 2 Methods Application Guidelines • http://www.pcori.org/sites/default/files/PCORI-PFA-2015-Cycle-2-Methods- Application-Guidelines.pdf
Use action verbs that Example Milestone Schedule detail what will be done Be realistic, given the to accomplish the resources and scope of milestone the milestone Milestone Name Description Projected Completion Date A Contract Start Date - 1/1/2015 Complete selection and recruitment of patient advisory panel B1 Patient Advisory Panel 2/1/2015 members 1 st Patient Advisory Panel Meeting B2 Convene 1st patient advisory panel meeting. 3/1/2015 B3 Phase 1 Instrument Finalize focus group instrument for Phase 1. 3/15/2015 Develop IRB documentation for Phase 1. Submit and receive IRB B4 Phase 1 IRB Approval 4/1/2015 approval for study protocol and documents. Complete participant recruitment for Phase 1 focus groups. B5 Phase 1 Data Collection 6/15/2015 Complete focus group data collection. B Report Submission Submit Progress Report, Using Interim Progress Report Template 7/1/2015 C1 Phase 1 Data Analysis Finish Phase 1 focus group data analysis. 7/15/2015 2 nd Patient Advisory Panel Meeting C2 Convene 2nd patient advisory panel meeting. 8/1/2015 Finalize focus group and in-depth interview instruments for Phase C3 Phase 2 Instruments 9/1/2015 2. Develop study documentation for Phase 2. Submit and receive 9/15/2015 C4 Phase 2 IRB Approval IRB approval for amended study protocol and study documents. Initiate participant recruitment for Phase 2 focus groups and in- C5 Phase 2 Recruitment 10/15/2015 depth interviews. C Report Submission Submit Progress Report, Using Interim Progress Report Template 1/1/2016 Finish Phase 2 focus groups and in-depth interviews data D1 Phase 2 Data Collection 2/1/2016 collection.
Administrative Overview • Ashton Burton, Contracts Specialist, Contracts
Letter of Intent (LOI) and Application • Full applications invited based on the information provided in the LOI • Changes after the LOI require PCORI approval: • Changes to the PI • Changes to the Institution • Changes to the Study Design • Changes in Engagement
PCORI Online: Application ► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save
Project Information Technical Abstract Project Narratives Public Abstract
Key Personnel ► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
Milestones ► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
Templates and Uploads ► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review
Research Plan Template Research Strategy ► Dissemination & Implementation Potential ► Replication & Reproducibility of Research and ► Data Sharing Protection of Human Subjects ► Consortium Contractual Arrangements ► References Cited ► Appendix ►
Research Strategy • Maximum 20 pages in length • Use the Research Plan Template as your guide Background • Significance • Study Design/Approach • Project Milestones/Timeline • Patient Population (if applicable) • Recruitment Plan (if applicable) • Estimated Racial/Ethnic and Gender Enrollment Table (if applicable) • Research Team and Environment • Engagement Plan • • Provide all the information requested, as outlined Page in the template. Limit 20
Research Strategy • Two items to note: • Research questions and specific aims MUST be the same as in the approved LOI unless the applicant has explicit and documented approval from the program to which they will submit. • When completing the study design/approach section, applicants should cite the relevant PCORI Methodology Standards. • http://www.pcori.org/assets/2013/11/PCORI-Methodology-Report.pdf
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 your analyses. Page Limit 2
Replication & Reproducibility of Research and Data Sharing • Describe the ability to reproduce potentially important findings from this research in other data sets and populations. • Describe how you will make a complete, cleaned, de- identified copy of the final data set used in conducting the final analyses available within 90 days of the end of the final year of funding, or your data-sharing plan, including the method by which you will make this data set available, if requested. • Propose a budget to cover costs of your data-sharing plan, if requested (these cost do not need to be included in the Budget Template). Page Limit 2
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