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

The application should address the following:

  • Does the application identify and make a persuasive argument for addressing critical gaps in current PCOR/CER methods and provide sufficient support from the published scientific literature?

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

The application should address the following:

  • Does the application articulate clearly 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)

The application should address the following:

  • Does the application provide a clear conceptual framework or theoretical model and empirical evidence that inform the study design, key variables or constructs, analytical approach, and relationships being tested or explored?
  • Does the application demonstrate adherence to the relevant PCORI Methodology Standards and 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?

Criterion 4. Investigator(s) and environment

This criterion should assess the appropriateness (e.g., qualifications and experience) of the investigator(s)/team and the environment’s capacity (e.g., resources, facilities, and equipment) to support the proposed project. It should not be an assessment of the institution’s quality.

The application should also address the following:

  • How well-qualified are the PIs, collaborators, and other researchers to conduct the proposed activities? Is there evidence of sufficient clinical or statistical expertise (if applicable)?
  • Does the investigator or co-investigator have demonstrated experience conducting projects of a similar size, scope, and complexity?
  • If the project is collaborative or dual-PI, do the investigators have complementary and integrated expertise? Are the leadership, governance, and organizational structures appropriate for the project?
    • (Dual-PI Option Only) Does the Leadership Plan adequately describe and justify PI roles and areas of responsibility?
  • Is the level of effort for each team member appropriate for successfully conducting the proposed work?
  • Does the application describe adequate availability of and access to facilities and resources (including patient populations, samples, and collaborative arrangements) to carry out the proposed research?
  • Is the institutional support appropriate for the proposed research?

Criterion 5. Patient-centeredness

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).

The application should address the following:

  • Does the application articulate clearly how the study will improve PCOR/CER methods that address outcomes of interest to patients and their caregivers?

Criterion 6. Patient and stakeholder engagement

The application should address the following:

  • Are patients and/or other relevant stakeholders meaningfully engaged in appropriate phases of the research?
  • Does the proposed study 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 study, does the application justify why it is not appropriate?

View the Methods PFA

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Posted: February 15, 2019; Updated: January 28, 2021

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