BACKGROUNDPatients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact.OBJECTIVEWe aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned.DESIGNA self-report instrument was completed by researchers between 6 and 12 months following project initiation.PARTICIPANTSForty-seven principal investigators or their designees (94 % response rate) participated in the study.MAIN MEASURES Self-report of types of stakeholders engaged, stages and levels of engagement, facilitators and barriers to engagement, lessons learned, and contributions from engagement were measured.KEY RESULTSMost (83 %) reported engaging more than one stakeholder in their project. Among those, the most commonly reported groups were patients (90 %), clinicians (87 %), health system representatives (44 %), caregivers (41 %), and advocacy organizations (41 %). Stakeholders were commonly involved in topic solicitation, question development, study design, and data collection. Many projects engaged stakeholders in data analysis, results interpretation, and dissemination. Commonly reported contributions included changes to project methods, outcomes or goals; improvement of measurement tools; and interpretation of qualitative data. Investigators often identified communication and shared leadership strategies as “critically important” facilitators (53 and 44 % respectively); lack of stakeholder time was the most commonly reported challenge (46 %). Most challenges were only partially resolved. Early lessons learned included the importance of continuous and genuine partnerships, strategic selection of stakeholders, and accommodation of stakeholders’ practical needs.CONCLUSIONSPCORI Pilot Projects investigators report engaging a variety of stakeholders across many stages of research, with specific changes to their research attributed to engagement. This study identifies early lessons and barriers that should be addressed to facilitate engagement. While this research suggests potential impact of stakeholder engagement, systematic characterization and evaluation of engagement at multiple stages of research is needed to build the evidence base.Electronic supplementary materialThe online version of this article (doi:10.1007/s11606-015-3450-z) contains supplementary material, which is available to authorized users.

PurposeTo provide an overview of PCORI’s approach to engagement in research.MethodsThe Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 to fund patient-centered comparative effectiveness research. Requirements for research funding from PCORI include meaningful engagement of patients and other stakeholders in the research. PCORI’s approach to engagement in research is guided by a conceptual model of patient-centered outcomes research (PCOR), that provides a structure for understanding engagement in research.ResultsTo understand and improve engagement in research PCORI is learning from awardees and other stakeholders. Those efforts are described along with PCORI’s capacity building and guidance to awardees via the Engagement Rubric. PCORI’s unique model of engaging patients and other stakeholders in merit review of funding applications is also described. Additional support for learning about engagement in research is provided through specific research funding and through PCORI’s major infrastructure initiative, PCORnet.ConclusionPCORI requires engagement of stakeholders in the research it funds. In addition PCORI engages stakeholders in activities including review of funding applications and establishment of CER research infrastructure through PCORnet. The comprehensive approach to engagement is being evaluated to help guide the field toward promising practices in research engagement.

Background The medical research enterprise depends on public recognition of its societal value. In light of evidence indicating public mistrust, especially among minorities, inadequate enrollment and diversity of research participants, and poor uptake of findings, medical research appears to fall short of sufficient public regard. Community engagement in medical research, with special attention to minority communities, may help to remedy this shortfall by demonstrating respect for communities in practical ways. Approach We provide three case examples that illustrate how specific approaches to community-engaged research can build trust between researchers and communities, encourage participation among under-represented groups, and enhance the relevance and uptake of research findings. Discussion A common attribute of the specific approaches discussed here is that they enable researchers to demonstrate respect by recognizing community values and interests. The demonstration of respect for communities has intrinsic ethical importance. Conclusion Two potential outgrowths of demonstrating respect specifically through community engagement are (1) the production of research that is more relevant to the community and (2) the mitigation of asymmetry in the researcher-community relationship. We summarize practical resources available to researchers who seek to incorporate community engagement in their research.