PCORI Review Criteria

Research proposals submitted in response to PCORI Funding Announcements are reviewed against five criteria. These criteria are consistent with patient-centeredness and are specifically designed to include a diverse set of perspectives in decision making.

These five criteria are used by PCORI’s review panels during the preliminary and in-person phases to score and evaluate all submitted applications:

Criterion 1. Impact of the condition on the health of individuals and populations
The proposal addresses the following questions:

  • Is the condition or disease associated with a significant burden in the US population in terms of prevalence, mortality, morbidity, individual suffering, or loss of productivity?
  • Alternatively, does the condition or disease impose a significant burden on a smaller number of people who have a rare disease?
  • Does the proposal include a particular emphasis on patients with one or more chronic conditions?

Criterion 2. Potential for the study to improve health care and outcomes
The proposal has the potential to lead to meaningful improvement in the quality and efficiency of care and to improvements in outcomes that are important to patients. It addresses the following questions:

  • Does the research question address a critical gap in current knowledge, as noted in systematic reviews, guideline development efforts, or previous research prioritizations?
  • Has it been identified as important by patient, caregiver, or clinician groups?
  • Do wide variations in practice patterns suggest current clinical uncertainty?
  • Is the research novel or innovative in its methods or approach, in the population being studied, or in the intervention being evaluated in ways that make it likely to improve care?
  • Do preliminary studies indicate potential for a sizeable benefit of the intervention, relative to current practice? How likely is it that positive findings could be disseminated and implemented quickly, resulting in improvements in practice and patient outcomes?

Criterion 3. Technical merit
The proposal has sufficient technical merit in the research design to ensure that the study goals will be met. It addresses the following questions:

  • Does the proposal delineate a clear conceptual framework/theory/model that anchors the background literature and informs the design, key variables, and relationships being tested?
  • Are the comparison interventions realistic options that exist in current practice?
  • Are the sample size and power estimates presented based on realistic and careful evaluations of the anticipated effect size?
  • Is the project timeline, including specific scientific and engagement milestones, realistic?
  • Does the research team have the necessary expertise to conduct the project?
  • Is the organizational structure and are the described resources appropriate to carry out the project?
  • Is there a diverse study population—with respect to age, gender, race, ethnicity, and clinical status—appropriate for the proposed research?

Criterion 4. Patient-centeredness
The proposal demonstrates patient-centeredness at every stage of the research. It addresses the questions:

  • Is the research focused on questions that affect outcomes of interest to patients and their caregivers?
  • Does the research address one or more of the key questions mentioned in PCORI’s definition of patient-centered outcomes research?

Criterion 5. Patient and stakeholder engagement
The proposal demonstrates that people representing the population of interest and other relevant stakeholders are engaged in ways that are appropriate and necessary in a given research context. It addresses the questions:

  • Are patients and other stakeholders engaged in:
    • Formulating research questions
    • Defining essential characteristics of study participants, comparators, and outcomes
    • Identifying and selecting outcomes that the population of interest notices and cares about (e.g., survival, function, symptoms, health-related quality of life) and that inform decision making relevant to the research topic
    • Monitoring study conduct and progress
    • Designing/suggesting plans for dissemination and implementation activities
  • Are the roles and the decision-making authority of all research partners clearly stated?
  • Does the proposal demonstrate the principles of reciprocal relationships, co-learning, partnership, trust, transparency, and honesty?

Posted July 25, 2013; Updated August 14, 2014