Cycle 1 2019: Treatment Options for Age-Related Hearing Loss PFA - - PowerPoint PPT Presentation
Cycle 1 2019: Treatment Options for Age-Related Hearing Loss PFA Applicant Town Hall January 15, 2019 Todays Presenters Sarah Philbin, MPH Thuy-Vy Do, PhD Denese Neu, PhD Mary Gardner Laura Sheehan Program Associate Program Officer
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Mary Gardner Administrator, Contract Management Program Support and Information Management Thuy-Vy Do, PhD Program Officer Clinical Effectiveness and Decision Science Denese Neu, PhD Engagement Officer Public and Patient Engagement Sarah Philbin, MPH Program Associate Clinical Effectiveness and Decision Science Laura Sheehan Merit Review Officer Program Support and Information Management
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Submit questions via the Question box in GoToWebinar
About PCORI pcori.org
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About PCORI pcori.org
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Objectives of this PFA
the treatment of age-related hearing loss or presbycusis.
Available Funds and Project Period
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Research funded by PCORI must adhere to the PCORI Methodology Standards, which represent minimal requirements for the design, conduct, analysis, and reporting of patient-centered
The 54 standards can be grouped into 2 broad categories and 13 topic areas.
Cross-Cutting Standards
Analyses
Data
Effects Design-Specific Standards
*The first standard for Causal Inference Methods (CI-1) is considered cross-cutting and applicable to all PCOR/CER studies.
About PCORI pcori.org
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PCORI Community
Patient/ Consumer Caregiver/ Family Member of Patient Clinician Patient/ Caregiver Advocacy Org Hospital/ Health System Training Institution Policy Maker Industry Payer Purchaser
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The rubric is intended to provide guidance to applicants, merit reviewers, awardees, and engagement/program
regarding engagement in the conduct of research. It is divided into three segments:
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the names of partnering individuals and organizations available to credit the contributions
you have obtained appropriate permission to disclose their identity to PCORI and for PCORI to use their names in public communications.
(e.g., caregiver to husband with COPD, breast cancer survivor of 20 years).
those described by pseudonym or categorical descriptor) will be listed on the project description page along with the other information about your project (such as abstract and PI).
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*Specific Aims *Significance *Background *Study Design or Approach
appropriateness of the research environment to conduct the study.
and possible barriers to disseminating and implementing the results of this research in other settings.
Common Rule.
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deliverables in accordance with the milestone schedule.
article title and journal or book title, the volume number, the page numbers, and the year of publication.
review the appendix materials in evaluating the application.
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subcontractor organization proposed in your application. All personnel information must be entered in the Personnel tab corresponding to that year in this template. Add additional rows for personnel as needed.
entire Research Project Budget and Peer-Review Budget for all research and peer-review-related costs. Include the federally negotiated or independently audited indirect cost rate letter (prime contractor) and fringe benefit rate policy verification document (prime contractor).
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www.pcori.org/content/merit-review-process
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1. Potential for the study to fill critical gaps in evidence 2. Potential for study findings to be adopted into clinical practice and improve delivery of care 3. Scientific merit (research design, analysis, and outcomes) 4. Investigator(s) and environment 5. Patient-centeredness 6. Patient and stakeholder engagement ▪ Each application is reviewed by three scientists, one patient, and
▪ PCORI’s Board of Governors makes funding decisions based on merit review and staff recommendations.
Funding Announcement: https://www.pcori.org/sites/default/files/PCORI-PFA-2019-Cycle-1-Hearing-Loss.pdf (see pg 16-19)
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end-user) the study findings (not the intervention) this study produces, such as local and national stakeholders?
stakeholders—and describe strategies to engage these end-users?
end-users?
stakeholders? If so, provide an example. How likely is it that positive findings could be reproduced by others, resulting in improvements in practice and patient outcomes? Identify the potential barriers that could hinder adoption of the intervention by others.
publication in peer-reviewed journals and at national conferences?
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informs the design, key variables, and relationship between interventions and outcomes being tested?
Methodology Standards?
for the population?
and well-justified? If “usual care” is one of the arms, is it adequately justified, and will it be sufficiently measured?
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activities? Is there evidence of sufficient clinical or statistical expertise (if applicable)?
similar size, scope, and complexity?
expertise? Are the leadership, governance, and organizational structures appropriate for the project?
work.
(including patient populations, samples, and collaborative arrangements) to carry out the proposed research?
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stakeholder involvement? Does the study include the right individuals (e.g., patients, caregivers, clinicians, policy makers, hospital and health system representatives, payers, purchasers, industry, researchers, and training institutions) to ensure that the projects will be carried out successfully?
stakeholders throughout the research process (e.g., formulating questions, identifying outcomes, monitoring the study, disseminating, and implementing)? Is the frequency and level of patient and stakeholder involvement sufficient to support the study goals?
throughout the project?
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Visit pcori.org/apply ▪ Application Guidelines ▪ FAQs ▪ PCORI Online User Manuals ▪ Sample Engagement Plans Schedule a Call with a Program Officer ▪ Submit a request ▪ Call 202-627-1884 (programmatic inquiries) ▪ E-mail sciencequestions@pcori.org Contact our Helpdesk ▪ E-mail pfa@pcori.org ▪ Call 202-627-1885 (administrative and technical inquiries)
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