Conducting PCOR Applicant Town Hall April 21, 2016 Agenda - - PowerPoint PPT Presentation

Applicant Town Hall April 21, 2016

Cycle 1 2016: Improving Methods for Conducting PCOR

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

• perator will standby to take

your questions).

PCORI CER Methods Program and Contracts Staff

David Hickam, MD MPH Program Director, CER Methods

• 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
• Jamie Trotter, MPA, Program Associate
• 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

• PCORI was created to support research that

provides high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community.

PCORI’s Mission

• Rigorous research methods are needed to produce

relevant, trustworthy findings that can improve patients’ healthcare outcomes.

Why Methods Matter

• Methods include the systematic processes, designs,

and analytical approaches needed to ensure the sound scientific and ethical conduct of PCOR/CER.

Methods for PCOR/CER

Improving PCOR Methods

• Identify methodological gaps relevant to

the conduct of PCOR/CER

Identify Methods Gaps

• Fund high impact studies which address

gaps in methodological research

Fund Research

• Disseminate and facilitate the adoption of

new methods to improve the conduct of PCOR/CER

Disseminate Promising/Best Practices

Improving PCOR Methods: Program Goals

Improving Methods for Conducting PCOR Cycle 1 2016 PFA

pcori.org/funding/opportunities

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

Cycle 1 2016 PFA: Improving Methods for Conducting PCOR

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

• 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

Consortium Contractual Arrangement

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
• 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.

Milestones/Deliverables Template

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

Professional Profile/Biosketch

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

Detailed Budget Budget Summary Budget Justification NOTE

A detailed budget is needed for each year of the

• project. Complete each budget section for the prime

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

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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

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PCORI Mission

Applications may be programmatically withdrawn for the following reasons:

• Deviation from the approved LOI
• Inclusion of cost-effectiveness analysis (CEA)
• Inclusion of development and dissemination of clinical

practice guidelines (CPG)

• Not responsive to the program-specific PFA

Merit Review Overview

Roycelynn Mentor-Marcelle, PhD MPH Merit Review Officer

Merit Review Process

pcori.org/content/merit-review-process

Application Review

Applications are reviewed against five criteria:

• 1. Study identifies critical

methodological gap(s) in PCOR/CER

• 2. Potential for the study to

improve PCOR/CER methods

• 3. Scientific merit
• 4. Patient-centeredness
• 5. Patient and stakeholder

Engagement

• Each application is reviewed by

either: (1) two scientists, one patient, and one other stakeholder,

• r (2) three scientists.
• PCORI’s Board of Governors makes

funding decisions based on merit review and staff recommendations.

Criterion 1. Study identifies critical methodological gap(s) in PCOR/CER

• Does the application identify and make a persuasive argument for

addressing critical gaps in current PCOR/CER methods as noted in the Methodology Report or in the published scientific literature?

Criterion 2. Potential for the study to improve PCOR/CER Methods

• Does the application clearly articulate how the development, refinement, or

comparison of methods, and/or the novel application of methods to PCOR/CER improves the validity, trustworthiness, and usefulness of PCOR/CER findings?

• Are the PCOR/CER methods generated from this study likely to inform best

practices or standards for PCOR/CER?

Criterion 3. Scientific merit (research design, analysis, and

• utcomes)
• Does the application provide a clear conceptual framework or theoretical model and

empirical evidence that inform the study design, key variables or constructs, analytic approach, and relationships being tested or explored?

• Does the application describe methods that reflect state-of-the-art thinking and

practice in the relevant methodological area?

• Are the study scope and timeline realistic, including the completion of specific scientific

and engagement milestones?

• Does the research team have complementary and integrated expertise to successfully

conduct the study?

• Are the research environment and resources adequate to successfully conduct the

study?

Criterion 4. Patient-Centeredness

• Does the application articulate clearly how the study will improve

PCOR/CER methods that address outcomes of interest to patients and their caregivers?

• Note: A study can be patient-centered even if the end-user is not the

patient, as long as patients will benefit from the study findings (e.g., methods to produce more valid, trustworthy, and useful PCOR/CER findings).

Criterion 5. Patient and Stakeholder Engagement

• Are patients and/or other relevant stakeholders meaningfully engaged in

appropriate phases of the research?

• Does the proposal demonstrate the principles of reciprocal relationships; co-

learning; partnership; and trust, transparency, and honesty?

• If engagement is deemed inappropriate in some or all aspects of the proposed

research, does the application justify why it is not appropriate?

Engagement

Effective engagement strategies can take different forms.

• PCORI’s Engagement Rubric
• http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf
• Sample Engagement Plans for the Methods Program
• http://www.pcori.org/sites/default/files/PCORI-Sample-Methods-

Engagement-Plans.pdf

• Engagement in Research website page
• http://www.pcori.org/content/engagement-research
• PCORI’s Methodology Standards PC-1 to PC-4
• http://www.pcori.org/assets/PCORI-Methodology-Standards1.pdf

Submission and Key Dates

What When Application Deadline June 6, 2016 by 5:00pm ET Merit Review Dates September 2016 Awards Announced November 2016 Earliest Start Date January 2017

Where can I find help?

Visit pcori.org/apply

• Application Guidelines
• FAQs
• PCORI Online User Manuals
• Sample Engagement Plans

Schedule a Call with a Program Officer

• Submit a request at pcori.org/content/research-inquiry
• 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)

Q&A

Ask a question via the chat function in Meeting Bridge. Ask a question via phone (an operator will be on standby to take your questions).

If we are unable to address your question during this time, e-mail the Helpdesk at pfa@pcori.org.