Findings
Many researchers, patients, and other stakeholders lack clarity about when and how to engage as partners within the clinical research process . There is a clear need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research . Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes .

Recommendations
The PCORI Engagement Rubric provides a framework for operationalizing engagement to incorporate patients and other stakeholders in all phases of research . The Rubric includes principles of engagement, definitions of stakeholder types, key considerations for planning, conducting, and disseminating engaged research, potential engagement activities, and examples of promising practices from PCORI-funded projects . PCORI encourages applicants, awardees, and others to apply the rubric to shift the research paradigm from one of conducting research on patients as subjects to a pursuit carried out in collaboration with patients and other stakeholders to better reflect the values, preferences, and outcomes that matter to the patient community .

Regulatory Considerations
The paper does not provide specific regulatory considerations. The PCORI Engagement Rubric was designed to illustrate opportunities for engagement to researchers interested in applying for PCORI funding and to patients and other stakeholders interested in greater involvement in research .