Methods and impact of engagement in research, from theory to practice and back again: early findings from the Patient-Centered Outcomes Research Institute

PURPOSE: Since 2012, PCORI has been funding patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders in the research, a requirement that is unique among the US funders of clinical research. This paper presents PCORI’s evaluation framework for assessing the short- and long-term impacts of engagement; describes engagement in PCORI projects (types of stakeholders engaged, when in the research process they are engaged and how they are engaged, contributions of their engagement); and identifies the effects of engagement on study design, processes, and outcomes selection, as reported by both PCORI-funded investigators and patient and other stakeholder research partners. METHODS: Detailed quantitative and qualitative information collected annually from investigators and their partners was analyzed via descriptive statistics and cross-sectional qualitative content and thematic analysis, and compared against the outcomes expected from the evaluation framework and its underlying conceptual model. RESULTS: The data support the role of engaged research partners in refinements to the research questions, selection of interventions to compare, choice of study outcomes and how they are measured, contributions to strategies for recruitment, and ensuring studies are patient-centered. CONCLUSIONS: The evaluation framework and the underlying conceptual model are supported by results to date. PCORI will continue to assess the effects of engagement as the funded projects progress toward completion, dissemination, and uptake into clinical decision making. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11136-017-1581-x) contains supplementary material, which is available to authorized users.