Table 2 PCORI engagement rubric, which lists key ways in which patient and stakeholder partners can participate during the three main phases of a study

Develop the research question and relevant outcomes to be studied to ensure that the project will be stakeholder communities

Define the characteristics of study participants to minimize exclusion due to criteria that are not relevant

Design the study to minimize disruption to study participants, thereby promoting retention

Draft or revise study materials and protocols to ensure feasibility for clinicians and patient participants

Participate in recruitment of study participants to increase and sustain recruitment and ensure viability of the study

Participate in data collection and data analysis to lend unique and varied perspectives on interpretation of the data

Participate in the evaluation of patient and stakeholder engagement to ensure authenticity and value of engagement

Serve as a patient representative on a data safety monitoring board to make the DSMB composition more robust and patient centered

Identify partner organizations for dissemination to ensure meaningful and direct connections with end users

Plan dissemination efforts, shaping study design and protocol from the very beginning to be focused on the final product

Participate in dissemination efforts, such as authoring manuscripts and presenting study findings, to offer the patient and stakeholder perspective and to reach new and different audiences

Identify opportunities to present or share information about the study, even as it is in progress, to move away from traditional models of dissemination and think more creatively about how to get information into the hands of those who need it