The criteria below apply to the following four priority areas: Addressing Disparities, Assessment of Prevention, Diagnosis, and Treatment Options, Communication and Dissemination Research, and Improving Healthcare Systems.​

Criterion 1. Potential for the study to fill critical gaps in evidence

The application should address the following questions:

• Does the application convincingly describe the clinical burden?
• Does the application identify a critical gap in current knowledge as noted in systematic reviews, guideline development efforts, or previous research prioritizations?
• Does the application identify a critical gap in current knowledge, evidenced by inconsistency in clinical practice and decision making?
• Would research findings from the study have the potential to fill these evidence gaps?

Criterion 2. Potential for the study findings to be adopted into clinical practice and improve delivery of care

The application should describe how evidence generated from this study could be adopted into clinical practice and delivery of care by others. The application should also address the following questions:

• Does the application identify who will make the decision (i.e., the decision maker) or use (i.e., the end-user) the study findings (not the intervention) this study produces, such as local and national stakeholders?
• Does the application identify potential end-users of study findings—such as local and national stakeholders—and describe strategies to engage these end-users?
• Does the application provide information that supports a demand for this kind of a study from end-users?
• Would this study’s research findings have the potential to inform decision making for key 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.
• Does the application describe a plan for how study findings will be disseminated beyond publication in peer-reviewed journals and at national conferences?

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

The application should show sufficient technical merit in the research design to ensure that the study goals will be met. The application should also address the following questions:

• Does the application describe a clear conceptual framework anchored in background literature which informs the design, key variables, and relationship between interventions and outcomes being tested?
• Does the Research Plan describe rigorous methods that demonstrate adherence to the PCORI Methodology Standards?
• Is the overall study design justified?
• Are the patient population and study setting appropriate for the proposed research question?
• Does the application provide justification that the outcome measures are validated and appropriate for the population?
• Are each of the comparators (e.g., active intervention arm and comparator arm) described clearly and well-justified? If “usual care” is one of the arms, is it adequately justified, and will it be sufficiently measured?
• Are the sample sizes and power estimates appropriate? Is the study design (e.g., cluster randomized design, randomized controlled trial, or observational study) accounted for and is the anticipated effect size adequately justified?
• Is the study plan feasible? Is the project timeline realistic, including specific scientific and engagement milestones? Is the strategy for recruiting participants feasible? Are assumptions about participant attrition realistic, and are plans to address patient or site attrition adequate?

Criterion 4. Investigator(s) and environment

The application should demonstrate 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. Assessment of this criterion should not focus on the institution’s reputation, but rather on the breadth and depth of its available personnel and resources.

The application should also address the following questions:

• 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

The application should demonstrate that the study focuses on improving patient-centered outcomes and employs a patient-centered research design – that is a design informed or endorsed by patients. (NOTE: The study can be patient-centered even if the end-user is not the patient, as long as patients will benefit from the information.)

The application should also address the following questions:

• Does the application include a thorough description about which outcomes (both benefits and harms) are important to patients, and are those outcomes included in the study plan?
• Does the application provide information that indicates that closing the evidence gap is important to patients and other stakeholders?
• Are the interventions being compared in the study available to patients now, and are they the best options for comparison (including whether they would be chosen by patients and their healthcare providers for managing the condition being studied)?

Criterion 6. Patient and stakeholder engagement

The application should demonstrate the engagement of relevant patients and other stakeholders (e.g., patients, caregivers, clinicians, policy makers, hospital and health system representatives, payers [insurance], purchasers [business], industry, researchers, training institutions) in the conduct of the study. Quality of engagement will be evaluated based on scope, form, and frequency of patient and stakeholder involvement throughout the research process.

The application should also address the following questions:

• Does the application provide a well-justified description of how the research team incorporates 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?
• Does the application show evidence of active engagement among scientists, patients, and other 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?
• Is the proposed engagement approach appropriate and tailored to the study?
• Are the roles and the decision-making authority of all study partners described clearly?
• Are the organizational structure and resources appropriate to engage patients and stakeholders throughout the project?

View the Broad PFA

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Posted: February 15, 2019; Updated: April 27, 2021