Background There is growing interest in patient and stakeholder engagement in research, yet limited evidence about effective methods. Since 2012, the Patient-Centered Outcomes Research Institute (PCORI) has funded patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders as research partners in study planning, conduct, and dissemination. This requirement, unique among large healthcare research funders in the US, provides an opportunity to learn about challenges encountered and specific strategies used by PCORI-funded study teams. The primary objective of this study is to describe -- from the perspective of PCORI investigators and research partners—the most common engagement challenges encountered in the first two years of the projects and promising strategies to prevent and overcome these challenges. Methods Descriptive information about investigators, partners, and their engagement was collected from investigators via annual (N = 235) and mid-year (N = 40) project progress reporting to PCORI, and from their partners (N = 260) via voluntary survey. Qualitative data were analyzed using content and thematic analyses. Results Investigators and partners most often described engagement challenges in three domains: (1) infrastructure to support engagement, (2) building relationships, and (3) maintaining relationships. Infrastructure challenges related to financial and human resources, including funding support and dedicated staff, identifying diverse groups of partners, and partners’ logistical needs. Challenges for both building and maintaining relationships encompass a variety of aspects of authentic, positive interactions that facilitate mutual understanding, full participation, and genuine influence on the projects. Strategies to prevent or mitigate engagement challenges also corresponded overall to the same three domains. Both groups typically described strategies more generally, with applicability to a range of challenges rather than specific actions to address only particular challenges. Conclusion Meaningful engagement of patients and other stakeholders comes with challenges, as does any innovation in the research process. The challenges and promising practices identified by these investigators and partners, related to engagement infrastructure and the building and maintenance of relationships, reveal actionable areas to improve engagement, including organizational policies and resources, training, new engagement models, and supporting engagement by viewing it as an investment in research uptake and impact.

Expanding third-party reimbursement for care coordination services may help reduce pediatric asthma disparities.

This article reports on an evaluation of the Merck Childhood Asthma Network, Inc. (MCAN) initiative using pooled cross-site data on patient-reported outcomes pre- and postintervention to quantify the changes experienced by children in five program sites supported by the network. The results show a consistent pattern of improvement across all measured outcomes, including symptoms, hospital and emergency department use, school absences, and caregiver confidence. Children who started with uncontrolled asthma experienced larger improvements than children with controlled asthma at baseline. However, even considering the significant gains made by children with uncontrolled asthma at baseline, after 12 months, most of the outcomes for these children were significantly worse than the 12-month outcomes for children with controlled asthma at baseline. The evaluation of the MCAN initiative offers a model that can be used in cases where resources must be balanced between evaluation and delivering services to children. The design process and results from the common survey instrument provide information for future initiatives seeking to translate evidence-based interventions in a community-based setting.

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.

The Merck Childhood Asthma Network, Inc. (MCAN) initiative selected five sites that had high asthma burden and established asthma programs but were ready for greater program integration across schools, health care systems, and communities. MCAN supported a community-based approach that was tailored to the needs of each program site. As a result, each site was unique in its combination of interventions, but all sites served common goals of integration of care, incorporation of evidence-based programs, and improvement in knowledge, self-management, health, and quality of life. This case study of the MCAN cross-site evaluation discusses the challenges associated with evaluating interventions involving multiple stakeholders that have been adjusted to fit the unique needs of specific communities. The evaluation triangulates data from site-specific monitoring and evaluation data; site documents, site visits, and cross-site meetings; qualitative assessments of families, organizational partners, and other stakeholders; and quantitative data from a common instrument on health indicators before and after the intervention. The evaluation employs the RE-AIM framework--reach, effectiveness, adoption, implementation, and maintenance--to assess the barriers and facilitators of translation from theory into practice. Our experience suggests trade-offs between rigor of evaluation and burden of assessment that have applicability for other community-based translational efforts.