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What aspects of the study should include stakeholder engagement? 

Patient, stakeholder, and community partners should be involved in all stages of the research. Researchers should collaborate with stakeholders on a variety of aspects within a study, including refining study questions and design, reviewing outcome measures and study protocols, strategizing on recruitment strategies and informed consent processes, and interpreting the data collected.

While we have learned that study teams have found it useful to solicit input from a large group of stakeholders using quick-turnaround methods (e.g., focus groups, surveys, crowdsourcing, virtual or in-person roundtables and community forums), we expect the engagement of stakeholders via ongoing consultative groups (e.g., advisory committees, working groups); collaborative arrangements; and leadership positions (e.g., co-investigators, multidisciplinary steering committees) that are sustained over the course of the award. While solicitation of input is helpful and appropriate at certain stages, PCORI encourages applicants to consider approaches that are further along the continuum of engagement that will best support the unique needs of the study throughout different stages.

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