There are several potential barriers research teams and patient partners may encounter when attempting to conduct comprehensive patient engagement in PCTs. Many challenges reported are logistical in nature, while others relate to a lack of knowledge or experience (Ivany et al 2023; Brett et al 2012). This highlights the need for practical guidance, resources, and support to promote meaningful patient engagement in PCTs.

This section summarizes the challenges described in the literature and experienced by the NIH Pragmatic Trials Collaboratory Trials, along with solutions to consider. The next section, “Case Study: Patient Engagement in the OPTIMUM Trial,” offers an in-depth case study of the challenges experienced in OPTIMUM, an NIH Collaboratory Trial.

• Regulatory and administrative barriers: Because PCTs are often conducted across multiple health systems, research teams may encounter different regulations regarding engaging patient partners in research. There may also be regulatory or administrative barriers to providing compensation for patient partners. To avoid unwelcome surprises or delays, study teams should work to understand these regulations and processes before engagement begins.
• Lack of knowledge and experience: It is common for both researchers and patient partners to lack experience in patient engagement activities, which can result in misunderstandings or confusion. An engagement expert with patient experience can be a valuable addition to the research team. If this is not feasible, research teams can consider consulting with an expert to apply engagement practices to the specific context of the research. Research teams should also aim to create an environment of openness so that patient partners can ask questions throughout the engagement process. Time and budget can be allocated to allow patient partners and study team members to receive initial training, along with opportunities for continued education, related to their roles in patient engagement activities.
• Use of jargon or overly technical language is a challenge frequently described by patient partners (Bellows et al 2015; Ivany et al 2023; de Bruin et al 2022). Researchers can mitigate this barrier by communicating in a more understandable way, taking time to help orient partners as needed, and providing information to partners for review in advance of meetings. Study teams can also be mindful to prevent information overload by indicating the most relevant portions of reading materials and being very clear about requests of partners. After all, the goal is not for patient partners to become experts in research but to share their experiences and unique perspectives (Montreuil et al 2019).
• Budget restrictions: Patient engagement, especially when conducted through a comprehensive approach, costs money. In addition to compensation needed for patient partners, patient engagement activities involve increased workload for research staff or may require the addition of staff with specialized skills and experience (Brett et al 2012; PCORI 2020). Patient engagement can be funded by writing patient engagement monies into grants or applying for supplemental funding to support high-quality engagement activities.
• Time restrictions: Establishing trust and partnership takes time, which can be challenging if a study has a limited timeframe (Brett et al 2012; Bellows et al 2015). If time available to establish relationships is a barrier, researchers might leverage existing patient partnerships and continue maintaining them. Research teams can also ask for extended planning times to establish relationships prior to the study’s start. Legitimate patient engagement takes time to codevelop research, so short project timelines risk contributing to tokenistic engagement or “rubber stamping” rather than meaningful partnership (Bellows et al 2015).
• Patient partner schedules: Patient partners can be busy and not available during traditional working hours. Inquiring about and accommodating the schedules of patient partners can help ensure patient partners can participate in activities as well as promote a sense of respect and trust. Not all patient partners may be able to participate in each planned activity. Unexpected events (such as family responsibilities and health issues) can prevent some partners from attending at the last minute, so it may be helpful to over-recruit partners for patient engagement activities. Some patient partners have also expressed frustrations with the time needed for training, travel, and meeting attendance in order to participate, suggesting that open discussions about expectations and time commitments, including preparation time for activities, would be beneficial (Domecq et al 2014; Bellows et al 2015).
• Philosophical differences or conflicts: Bringing together people with diverse viewpoints and priorities can result in disagreements. Study teams have reported challenges managing conflicting feedback and navigating different perspectives during decision-making (Maurer et al 2023; Bellows et al 2015). For example, researchers may feel a commitment to scientific rigor and obtaining high-quality evidence while patient partners may be focused on the best outcomes for study participants or getting results quickly out of a sense of urgency. There may also be philosophical differences between patient partners and researchers. For patient partners, engagement work is likely very personal because it relates to lived experiences that have lasting importance for them. For researchers trained in the scientific process, engaging with partners to inform research design and conduct may be a more objective experience. Methods to help manage differences of opinion include focusing on inclusion, creating a respectful and welcoming environment, and maintaining open and intentional communication (Table; Maurer et al 2023). Researchers also described the need to be flexible, prioritize responsiveness to partners, and use collaborative approaches to decision-making.

Table. Engagement Approaches to Manage Differing Viewpoints and Priorities

Adapted from Maurer et al (2023).

• Tokenism: Avoiding tokenism or the perception of tokenism has been described as a challenge by both researchers and patient partners (Domecq et al 2014; Bellows et al 2015; Ivany et al 2023). Tokenism is discussed in more detail in Section 5. Briefly, to prevent patient partners’ role being only symbolic rather than true engagement, researchers can collaborate with partners to define the goals of engagement, communicate how patient partner input is implemented, promote transparency in study decision-making, take time to build mutual respect, ensure all voices are heard in discussions, employ consensus-building practices, and be responsive to patient partner feedback.