Deadline: 31-May-23
The Patient-Centered Outcomes Research Institute (PCORI) Funding Announcement (PFA) seeks to fund studies that build an evidence base on engagement in research, including:
- Measures to capture structure/context, process, and outcomes of engagement in research
- Techniques that lead to effective engagement in research
- How effective engagement techniques should be modified and resourced for different contexts, settings, and communities to ensure equity in engagement and research
The Patient-Centered Outcomes Research Institute (PCORI) Funding Announcement (PFA) for Advancing the Science of Engagement, also referred to as the “SoE PFA,” PCORI aims to fund studies that address high-priority gaps in the science of engagement in research focused on development and/or assessment of validity of measures and the evaluation of engagement methods. For measurement proposals, PCORI will give preference to projects that rapidly develop and/or assess the validity of measures of engagement.
Focus Areas
PCORI’s PFA on the Science of Engagement will solicit applications that focus on:
- Development and validation of measures to capture structure/context, process, and outcomes of engagement, for both stakeholders and investigators
- Development and testing of engagement techniques to generate evidence on the most effective engagement approaches, particularly for underrepresented populations, and how effectiveness varies by context
Funding Information
- Funds Available Upto: $4.5 million
- Category 1: Development and/or assessment of validity of measures to capture structure/context, process, and outcomes of engagement in research. Less than or equal to $500,000 in direct costs
- Category 2: Development and/or testing of engagement methods to generate evidence on the most effective engagement approaches, particularly for underrepresented populations, and how effectiveness varies by context. Less than or equal to $1.5 million in direct costs
- Maximum Research Project Period
- Category 1: 2 years
- Category 2: 3 years
Categories of Nonresponsiveness
Applications to the Science of Engagement PFA that propose the following types of research will be considered nonresponsive:
- Engagement plans limited to activities that solely constitute stakeholder input, such as surveys and focus groups will not be considered engagement and will not be deemed responsive. This does not preclude applicants from conducting potentially necessary formative research as part of their proposed research project; however, research projects consisting solely of formative research will be considered nonresponsive.
- Research projects focused on patient activation/engagement in their own health care. This includes clinical shared decision-making interventions, interventions to increase patient adherence to recommended treatments (e.g., for diabetes or hypertension) or to increase use of recommended interventions by populations (e.g., evidence-based screening for cancer or treatment for underdiagnosed conditions).
- Research projects focused on engagement of patients and/or stakeholders in healthcare delivery and improvement (e.g., quality improvement, patient safety)
- Measurement research projects that don’t include steps to assess criterion and/or construct validity of the instrument
- Research projects evaluating engagement methods that solely use qualitative methods
- Consistent with PCORI’s authorizing law, PCORI does not fund research whose findings will include the following:
- Coverage recommendations
- Payment or policy recommendations
- Creation of clinical practice guidelines or clinical pathways
- Establishment of efficacy for a new clinical strategy
- Pharmacodynamics
- Study of the natural history of disease
- Basic science or the study of biological mechanisms
- Further, consistent with past funding announcements, PCORI will consider an application nonresponsive if the proposed research does the following:
- Conducts a formal cost-effectiveness analysis of alternative approaches to providing care
- Directly compares the costs of care between two or more alternative approaches to providing care
- Relies on cost simulation modeling to develop estimates of total costs of care beyond the scope and time horizon of the study
Outcomes Data
Important points that applicants should note related to the capture of the full range of outcomes data include the following:
- PCORI encourages all investigators to identify, collect data on, and describe the full range of patient-centered and clinical outcomes relevant to patients and other stakeholders. These outcomes should include relevant costs and other burdens. In their application, and where applicable, investigators should outline the relevance of the cost or other burdens they will examine in their proposed research.
- PCORI’s intention in the collection of the full range of outcomes data is to leverage researchers’ knowledge of and ability to obtain data relevant and linked to the primary clinical effectiveness outcomes of their research. As such, with respect to costs and other burdens, investigators should not focus on cost analysis but on collecting and summarizing data. If cost and economic burden data are collected, then PCORI expects investigators to provide descriptive summaries of these data in the Final Research Report in addition to the primary and other secondary outcomes collected as part of the study.
- PCORI will not fund studies for which costs and economic impacts are the primary outcomes.
- Relatedly, simulation modeling efforts, which generate estimates of cost that extend beyond the data collected, are outside of PCORI’s scope of interest. PCORI research awards will not support such cost modeling activities.
Eligibility Criteria
- In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the Federal Government, nonprofit and for-profit research organizations, and colleges and universities. Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions:
- abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract;
- comply with the PCORI methodological standards adopted by the Board of Governors;
- consult, as appropriate, with the expert advisory panels for clinical trials and rare disease;
- deposit de-identified data from the original research into a PCORI-designated repository to facilitate data sharing, as appropriate;
- have appropriate processes in place to manage data privacy and meet ethical standards for the research;
- comply with the requirements of PCORI for making the information available to the public; and
- comply with other terms and conditions determined necessary by PCORI to carry out the research project.
- Potential applicants are strongly encouraged to review the standard research contract prior to application.
- Individuals are not permitted to apply.
- Foreign Organizations and Nondomestic Components of U.S. Organizations must provide a thorough and thoughtful justification for the research’s ability to benefit the US healthcare system and that the engagement plans include US patients and stakeholders, and are relevant to US healthcare system.
Review Criteria
- Study identifies critical methodological gap(s) in the science of engagement
- Potential for the study to improve engagement measures or methods
- Scientific merit (research design, analysis, and outcomes)
- Investigator(s) and environment
- Patient-centeredness
- Patient and stakeholder engagement
For more information, visit PCORI.