Jennifer M. Poger, Hsin-Chieh Yeh, Cindy L. Bryce, Jennifer K. Carroll, Lan Kong, Erica B. Francis, and Jennifer L. Kraschnewski
Though engaging the community in research is not a novel concept, specific guidelines and support for meaningful engagement of nontraditional partners throughout the research process has recently garnered increased attention. Over the last decade, funders have recognized the significant contributions various stakeholders play in enhancing patient-centered outcomes and accelerating findings to improve lives. Instead of conducting research on the community in a traditional research paradigm, research teams are increasingly conducting research with the community. Specifically, this involves research teams and community members partnering to prioritize research questions, co-investigate and allow for feedback implementation at each research phase, and increase relevancy and uptake of findings to groups who may benefit most. These partnerships enhance study decisions, improve study design, processes, and outcomes selection, and help keep patient-centeredness at the focus.1
Despite widespread support for stakeholder-engaged research, specific activities or practices for encouraging engagement are limited in the literature, variable in nature, and lack comparative data.2-6 This is particularly true for natural experiments, which do not have many of the key phases where engagement activities can feasibly occur (i.e. recruitment, informed consent, data collection). However, natural experiments are widely recognized as an increasingly important research design in addressing real-world public health concerns due to greater access to more diverse study populations, potentially lower study costs, and faster dissemination of study results.7 They are particularly valuable in evaluating policy and determining policy effectiveness where randomization is not ethically or politically possible.7 Failing to identify engagement strategies for natural experiments would be a missed opportunity for patients and stakeholders to shape study design, strengthen outcomes by ensuring patient-centeredness and serve as valuable outlets for dissemination. Our PaTH to Health: Diabetes study, funded by the Patient-Centered Outcomes Research Institute (PCORI), engaged a diverse group of stakeholders in an observational study examining how policy changes for intensive behavioral therapy has affected service utilization and impacted weight and diabetes outcomes for patients with or at risk of type 2 diabetes. Our team was challenged to identify meaningful ways of engaging stakeholders in a natural experiment that extracts and analyzes data from a Clinical Data Research Network (CDRN), as best practices for this type of engagement have not been specifically identified in the literature.
Our paper, “PaTH to Partnership in Stakeholder-Engaged Research: A Framework for Stakeholder Engagement in the PaTH to Health Diabetes Study” published in Healthcare: The Journal of Delivery Science and Innovation, outlines our novel framework for engagement of nontraditional research partners throughout the PaTH to Health: Diabetes study. We offer key engagement activities that were most effective in sustaining meaningful engagement throughout the project life with patient partner and stakeholder supplements throughout. We found that engaging a diverse stakeholder group, including patients, clinicians, policy makers, and leadership from national professional organizations as partners in research supports the pursuit of patient-centered outcomes and accelerates results dissemination through the far-reaching professional networks. Utilizing the Patient-Centered Outcomes Research (PCOR) Engagement Principles and applying adult learning theories to training opportunities also enhanced our stakeholder-investigator collaborations. Regularly scheduled study meetings with stakeholders were vital to streamlining communication, offering a platform for stakeholder voices to be shared, and increasing study productivity. Ongoing engagement evaluations provided an important opportunity to assess engagement activities and improve processes moving forward. Together, these approaches support meaningful stakeholder engagement in a natural experiment, filling an important gap in the literature. We hope readers find the recommendations for replication in similar studies helpful in developing and implementing their own engagement plans.
1Forsythe L, Heckert A, Margolis MK, Schrandt S, Frank L. Methods and impact of engagement in research, from theory to practice and back again: early findings from the Patient-Centered Outcomes Research Institute. Qual Life Res. 2018;27: 17-31.
2Forsythe LP, Ellis LE, Edmundson L, et al. Patient and stakeholder engagement in the PCORI pilot projects: description and lessons learned. J Gen Intern Med. 2016;31(1):13-21.
3Concannon TW, Fuster M, Saunders T, et al. A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research. J Gen Intern Med. 2014;29(12):1692-1701.
4Domecq JP, Prutsky G, Elraiyah T, et al. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014;14:89.
5Esmail L, Moore E, Rein A. Evaluating patient and stakeholder engagement in research: moving from theory to practice. J Comp Eff Res. 2015;4(2):133-145.
6Absolom K, Holch P, Woroncow B, Wright EP, Velikova G. Beyond lip service and box ticking: how effective patient engagement is integral to the development and delivery of patient-reported outcomes. Qual Life Res. 2015;24(5):1077-1085.
7Scott T. Leatherdale. Natural experiment methodology for research: a review of how different methods can support real-world research, Int J Soc Res Methodol. 2019;22(1):19-35.