Broad PCORI Funding Announcement Applicant Town Hall Cycle 2 2015 September 17, 2015
Agenda Research Strategy Patient Engagement and Engagement Plan Additional sections required for your application The Merit Review Process Questions Submit questions via the chat function in Meeting Submitting Questions: Bridge. Ask a question via phone (an operator will standby to take your questions).
Introductions Cathy Gurgol, MS Lauren Azar, MHA Suzanne Schrandt, JD Program Officer Senior Program Associate Deputy Director Addressing Disparities Improving Healthcare Systems Patient Engagement Mari Kimura, PhD Maricon Gardner, CRA Merit Review Officer Contracts Associate, Pre-Award Merit Review Contracts Management and Administration
Your letter of intent (LOI) was reviewed and you have been invited to submit a full application…….. CONGRATULATIONS!
Letter of Intent and Application You were invited to submit a full application based on the information provided in the LOI; changes after the LOI require PCORI approval. Show stoppers include: Changes Changes to Changes Changes Changes to Changes to the the Budget/ to Changes to to the Research to the PI Study Period of Specific Comparators Institution Question Design Performance Aim
Preparing your application for submission – Research Strategy First things first……. Get prepared - Read and review the PCORI Application Guidelines Document http://www.pcori.org/sites/default/files/PCORI-PFA- Cycle 2 2015 Application-Guidelines.pdf - Re-read the funding announcement for which you are applying http://www.pcori.org/funding/opportunities - Review the PCORI Research Plan Template - Have a copy of your approved LOI readily accessible
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 - Recruitment Plan - Estimated Racial/Ethnic and Gender Enrollment Table - Research Team and Environment - Engagement Plan PLEASE provide all the information requested, as outlined in the template. Page 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. - While completing the study design/approach section, applicants should cite PCORI’s Methodology Standards. http://www.pcori.org/assets/2013/11/PCORI-Methodology- Report.pdf
Methodology Standards In any study, methods are critical . PCORI’s Methodology Committee developed Methodology Standards to which patient- centered CER must adhere Methodology Standards: 11 Broad Categories • Formulating Research • Data Networks Questions • Data Registries • Patient-Centeredness • Adaptive and Bayesian • Data Integrity and Rigorous Trial Designs Analyses • Causal Inference • Preventing/Handling Missing • Studies of Diagnostic Data Tests • Heterogeneity of Treatment • Systematic Reviews Effects
PCORI Monitors Projects Milestones: Significant events or accomplishments within the project; may have deliverables associated with them Deliverables: Measurable and verifiable outcomes or objects that a project team must create and deliver according to the contract terms
Example of Milestone Schedule
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. PCORI does not expect applicants to disseminate and Page implement findings at this time. 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. Page Limit 2
Protection of Human Subjects Describe the protection of human subjects who will be involved in your research. Refer to NIH standards for research involving human subjects Page Limit 5
Study Participant Protection Provide a Data and Safety Monitoring Plan that operates under the auspices of your institution Assure that key personnel are educated on human subjects protections Assure appropriate informed consent Establish procedures to minimize risks to participants Establish procedures to protect privacy and maintain confidentiality If you anticipate seeking waiver of individual informed consent, provide the rationale Refer to NIH standards for research involving human subjects
Consortium Contractual Arrangement Describe the proposed research projects that will be performed by subcontracted organizations; explain the strengths that these partners bring to the overall project. Page Limit 5
References Cited Following scholarly citation practice, list the source material cited in the Research Plan. Page Limit 10
Appendix PCORI applications may include an appendix for additional materials the investigators think may be useful Examples of additional materials are: – Survey instruments – Papers and publications from members of the research team; however, reviewers will not be required to include the appendices in the review and assessment of the project Page Limit 10
Recruitment Discuss past experiences with recruitment of the target population Provide preliminary evidence of the potential for successful recruitment Consider barriers to recruitment – and how you plan to overcome them Strategies for successful recruitment – Engaged clinical sites – Clinical advocates – Proactive, experienced research coordinator
Application Common Mistakes Inadequate support for the research question based on systematic reviews or identified gaps in clinical guidelines Studies of efficacy, not comparative effectiveness Low likelihood of study impact Limited, inappropriate, or non-specific patient-centered outcomes Inappropriate use or explanation of usual care as a comparator
Application Common Mistakes Missing key aspects of scientific design, such as well- justified power calculations Overly optimistic timeframe for enrollment -- failure to think through complexities of recruitment and enrollment Lack of support for key statements in the Research Plan Inadequately justified budgets
Addressing engagement in your application
Patient-Centeredness vs. Patient and Stakeholder Engagement Patient-Centeredness; do the question(s) and outcomes matter and are they important to patients and their caregivers? Patient and Stakeholder Engagement; are patients and other stakeholders involved in meaningful ways throughout the research process? Remember; patient partners are not the same as patient subjects or participants Remember: there are eight stakeholder categories in addition to patients and caregivers
The Engagement Rubric Planning the Study Conducting the Study Disseminating the Study Results PCOR Engagement Principles
Planning the Study Potential activities include but are not limited to; Identifying the research question and outcomes Drafting study protocol Examples; “ Mental Health” study name and materials amended by partners Diabetes study; clinician partners amended study design to more accurately reflect real-world practice settings
Conducting the study Potential activities include but are not limited to; Recruitment and retention of study participants Data collection Data analysis Examples; Patient partners in cancer imaging studies amended inclusion criteria to be more reflective realistic patient actions Parent partners in pediatric psychiatry study are delivering components of the intervention
Disseminating study results Potential activities include but are not limited to; Co-authoring publications such as journal articles Co-presenting at conferences Using social media outlets Examples; Neurology study results are being shared at a neurology patient advocacy organization conference Patient partners are co-authoring journal articles on a pain study
Embodying the Engagement Principles Six Engagement Principles - Partnership - Co-learning - Reciprocal relationships - Trust - Transparency - Honesty
Embodying the Engagement Principles (Cont’d) Real-World Examples - Providing financial compensation to patient and stakeholder partners - Providing training opportunities for patient, researcher, and stakeholder partners - Scheduling and locating meetings at mutually accessible times and locations
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