Summary

PCORI is seeking applications for comparative clinical effectiveness research (CER) designed to provide information that will inform critical decisions that face patients, caregivers, clinicians, policy makers, and healthcare system leaders. These decisions must be consequential and occurring now in the absence of sound evidence about the comparative effectiveness of alternative approaches. There must be substantial potential that patients and caregivers will benefit from the new knowledge in ways that are important to them. The premise of this research is that the new knowledge will inform critical healthcare choices by patients and other stakeholders. This knowledge will provide insight about the comparative benefits and harms of the options and provide information about outcomes that are important to patients.

Funds Available Up To: $32 million

Maximum Project Budget (Total Direct Costs): $2 million

Maximum Research Project Period: Three years

Return to the Broad PCORI Funding Announcements page for key dates.

Introduction

The Patient-Centered Outcomes Research Institute (PCORI) funds patient-centered outcomes research (PCOR), a type of comparative clinical effectiveness research (CER) that focuses on outcomes that matter to patients, their caregivers, and their families. The studies that PCORI funds must include the perspectives of patients and other healthcare stakeholders.

To be considered responsive, applications must describe research that compares at least two alternative approaches. Approaches may address diagnostic methods, screening strategies, interventions for prevention or treatment of disease, or strategies to improve the healthcare system. Through its various funding announcements, PCORI is interested in studies of interventions that may include:

• Specific drugs, devices, and procedures
• Medical and assistive devices and technologies
• Psychological therapies
• Organizational models and policies within and across healthcare systems (e.g., patient-centered medical homes, clinical protocols, and pathways)

PCORI is seeking applications designed to provide evidence to inform critical decisions facing patients and caregivers, clinicians, policy makers, and healthcare system leaders. These decisions must be consequential and occurring now in the absence of sound evidence about the comparative effectiveness of alternative approaches. There must be substantial potential for patients and caregivers to benefit from the new knowledge in ways that are important to them. The premise of this research is that the new knowledge will inform critical choices of patients and stakeholders in health care. This knowledge will provide insight about the comparative benefits and harms of the options, and also provide information about outcomes that are important to patients.

The public entrusts PCORI to fund research that matters to patients, their caregivers, and other stakeholders (defined as clinicians and clinician societies; hospitals and health systems; payers [insurance]; purchasers [business]; industry; researchers; policy makers; and training institutions). PCORI seeks to change the way in which research is conducted by emphasizing the role of diverse research teams that include varying perspectives. PCORI distinguishes itself by supporting research in which patients, caregivers, practicing clinicians, and the broader stakeholder community are actively engaged in generating research questions, reviewing research applications, conducting research, disseminating research findings, promoting the implementation of research findings, and using the results to understand and address patient and other stakeholder needs.

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Research of Interest

Patients, caregivers, and clinicians often lack the appropriate evidence required to make the best choices regarding prevention, screening, diagnosis, monitoring, or treatment. Where therapies or technologies have been approved and marketed, there are often gaps in research comparing their effectiveness with that of other clinical options, and prior research may not have included outcomes that are important to patients and their caregivers. In addition, the existing evidence base might not be relevant for certain patient populations, such as those at the extremes of age or with multiple comorbid conditions.

For this particular PCORI Funding Announcement (PFA) on the Assessment of Prevention, Diagnosis, and Treatment Options, PCORI seeks to fund investigator-initiated research that:

• Compares the effectiveness of two or more strategies for prevention, treatment, screening, diagnosis, or management that are known to be efficacious but have not been adequately compared in previous studies; interventions without sufficient evidence of efficacy will be considered only when they are in reasonably common use. PCORI is particularly interested in studies that are conducted in typical clinical populations and that address the full range of relevant patient-centered outcomes (PCOs).
• Addresses a high-priority evidence gap, as identified by prior systematic reviews, clearly defined gaps in clinical guidelines, or other credible evidence reviews.
• Investigates, among compared groups, factors that account for variation in treatment outcomes, with attention paid to demographic, biological, clinical, social, economic, or geographic factors; comorbidities; and other factors that may influence those outcomes. Strategies may focus on patient populations with a single condition or involve patients with a range of conditions.

For this PFA, proposed projects should address the comparison of specific clinical services or strategies that are defined clearly and can be replicated in other clinical settings with minimal adaptations or changes. The funding announcement does not support research projects that have the primary goal of developing and testing decision aids or testing the use of lay personnel who perform ancillary services in healthcare settings. 

This funding opportunity is broad-based and is not confined to specific clinical services or patient populations. However, the program’s goal is to expand the evidence base that pertains to clinical services that would be chosen by clinicians, patients, and caregivers in usual clinical delivery settings. The services of interest include:

• Prescription drugs and biologics
• Surgical and other interventional procedures
• Techniques for disease screening
• Vaccinations and other interventions to prevent diseases
• Counseling and behavioral interventions
• Complementary and integrative services
• Rehabilitative services
• Diagnostic tests and procedures

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