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.

Research Priorities: Assessment of Prevention, Diagnosis and Treatment Options; Improving Healthcare Systems; Communication & Dissemination Research; Addressing Disparities

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 condition?

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 quickly and affect changes in current practice?

Criterion 3. Technical merit

The proposal has the technical merit to ensure that the study goals are met. It includes:

  • A clear research plan with rigorous methods and key milestones clearly articulated
  • A research team with necessary expertise, and an appropriate project organizational structure
  • A research environment sufficient to support the conduct of the work with appropriate resources
  • A diverse study population with respect to age, gender, race, ethnicity, and clinical status as appropriate for research
  • A focus on a defined population for whom effectiveness information is particularly needed

Criterion 4. Patient-centeredness

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

  • Is the research focused on questions that affect outcomes of specific 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?
  • How credible are claims that engaged patients and stakeholders will exert meaningful influence on the design and conduct of the research, to ensure patient-centeredness of the questions and outcomes addressed?

Criterion 5. Patient and stakeholder engagement

The proposal integrates patients and stakeholders in the development of the research plan and in key elements of conducting the research. It addresses the following questions:

  • Does the proposal describe how patients and stakeholders were or will be identified and engaged in the research?
  • Are the roles of patients and key stakeholders significant in formulating the study’s research questions, hypotheses and design and in the study’s conduct and dissemination of results?
  • Are the roles proposed for patients and stakeholders in any planned dissemination or implementation plans meaningful and likely to be effective?
  • If engagement is not applicable to the proposed research, does the application justify why it is not?

 

Research Priority:  Accelerating Patient-Centered Outcomes Research and Methodological Research

Criterion 1. Impact on the field of PCOR methods

Refers to the extent that the proposed methods are needed in the field of PCOR. The proposal addresses the following questions:

  • How often would these methods be used, and how many PCOR studies would benefit from these improved methods?
  • Do existing methods weaken the validity of PCOR studies, and would improved methods therefore increase the validity of PCOR findings?

Criterion 2. Potential for the study to improve PCOR methods

Refers to the potential of the proposed methodological investigation and its results to change methodological practices in ways that improve PCOR and the decisions made by patients. The proposal addresses the following questions:

  • Does the research question address a critical gap in current methodological understanding as noted in the Methodology Committee Report or in other sources?
  •  Is the proposed approach feasible and likely to result in new standards or in the improvement of existing standards?

Criterion 3. Technical merit

Refers to the technical merit of the proposal.  The proposal addresses the following questions:

  • Is there a clear research plan with rigorous methods and key milestones clearly articulated?
  • Do the study methods reflect state‐of‐the‐art thinking and practice in the methodological area, so that results are likely to be accepted and heeded?
  • Is the research team appropriately trained and experienced to carry out the planned studies?
  • Is the research environment sufficient to support the conduct of the work, and are appropriate resources available?
  • Will the proposed methods help support the inclusion and study of diverse populations with respect to age, gender, race, ethnicity, geography, or clinical status, or, alternatively, do the methods support the inclusion of previously understudied populations in PCOR?

Criterion 4. Patient-centeredness

Refers to the level of patient-centeredness of the proposal. The proposal addresses the following questions:

  • Is the research focused on questions that affect outcomes of specific 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?
  • How credible are claims that engaged patients and stakeholders will exert meaningful influence on the design and conduct of the research, to ensure patient-centeredness of the questions and outcomes addressed?

Criterion 5: Patient and stakeholder engagement

Where applicable, proposals need to demonstrate patient and stakeholder engagement through the integration of patients and stakeholders in the development of the research plan and in key elements of the proposed project. The proposal addresses the following questions:

  • Does the proposal describe how patients and stakeholders were or will be identified and engaged in the research?
  • Are the roles of patients and key stakeholders significant in formulating the study’s research questions, hypotheses and design and in the study’s conduct and dissemination of results?
  • Are the roles proposed for patients and stakeholders in any planned dissemination or implementation plans meaningful and likely to be effective?
  • If engagement is not applicable to the proposed research, does the application justify why it is not?


Posted July 25, 2013; Updated September 6, 2013