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 operator will standby to take your questions).

PCORI CER Methods Program and Contracts Staff

David Hickam, MD MPHProgram 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 researchFund 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 outlinedin the template.

PageLimit

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.

PageLimit

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.

PageLimit

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.

PageLimit

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.

PageLimit

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

PageLimit

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.

PageLimit

15Professional

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 Processpcori.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 toimprove 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, or (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 outcomes)

• 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.