Understanding the Influence and Impact of Stakeholder Engagement in Patient-centered Outcomes Research: a Qualitative Study

Background Engaging patients and other stakeholders as partners in research offers promise in improving the relevance and usefulness of research findings. Objective To explore the influence and impact of patient and other stakeholder engagement on the planning and conduct of comparative effectiveness research studies. Design Qualitative study with virtual, hour-long semi-structured interviews. Participants Fifty-eight researchers and fifty-one partners from a diverse purposeful sample of fifty-eight studies funded by the Patient-Centered Outcomes Research Institute (PCORI). Approach Content and thematic analysis of interview data. Key Results Described as an integral, long-term part of the research process, engagement influenced all aspects of the design and execution of studies. Partner influence was also dynamic and iterative, taking different forms over the course of the study. Across studies, we identified 387 discrete examples of influence and classified each as one of five types of influence, derived inductively from the interview data: co-producing, redirecting, refining, confirming, and limited. Most projects exhibited multiple types of influence, with 50 researchers and 41 partners reporting two or more types of influence within a project. Of the 387 examples of stakeholder influence, 306 had at least one reported impact on the study. Such impacts included changes to reflect the needs and preferences of patients or clinicians, as well as impacts on study feasibility, study quality, engagement scope or quality, and study relevance. Both researchers and partners identified multiple types of impact within projects, with 42 researchers and 38 partners reporting two or more types within a project. Because of these observable impacts, researchers and partners described engagement as worthwhile. Conclusions Findings provide insights for funders and institutions supporting engagement, measurement efforts, and clinical researchers aiming to conduct engaged research and observe similar influences and impacts in their own studies.