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 U.S. 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?
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?
- 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 meet study goals. It includes:
- A clear research plan with rigorous methods and key milestones and timeline clearly articulated
- A research team with necessary expertise
- 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
- A focus on a defined population for whom effectiveness information is particularly needed
- Will there be any matching funds or in-kind support from other sources that will help co-support the project?
Criterion 4. Patient-centeredness
The proposal demonstrates patient-centeredness. It addresses the following:
- Is the research focused on questions that affect outcomes that matter 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:
- 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?
Criterion 6. Potential for meaningful follow-on studies or grants
How likely is it that the expected results will be lead to meaningful follow-on PCOR or CER projects and externally funded grants?