In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. Both also participated in a discussion session about the challenges and value of results dissemination. DeBar is a principal investigator of the BackInAction and PPACT NIH Collaboratory Trials, and Morone is the principal investigator of the OPTIMUM NIH Collaboratory Trial.
They described sharing results as important now more than ever. Dissemination can be a feasible and respectful way to keep patients involved in the study. It can also combat misinformation and promote trust.
An Ethical Obligation
DeBar and Morone said they are often surprised by the number of research participants, particularly older patients, who participate in trials based on altruism or with the goal of contributing to advancing science.
“We have done focus groups about why people participate in research, and many times it is the altruism,” Morone said. “People want to help others, and they very specifically said they want to know what’s going on with the study.”
In this case, there may especially be a moral obligation to share results with patients.
“I think it’s an obligation because they were generous in giving us their time, but also, they requested it,” DeBar said. “I think we have that responsibility.”
Engaging With Community Advisory Boards
Both researchers highlighted how valuable community stakeholder insight is in how to best communicate results with patients. Community advisory boards can provide a wealth of information.
“Having materials vetted by folks that represent your population is really valuable,” Morone said. “As a physician, I will start using medical language with my patients, and as a researcher, I may use research language. It’s just so automatic.”
That’s why removing jargon and making results accessible is so important, and community experts can provide that necessary insight, Morone explained. Stakeholder perspectives may also change over time, so research teams should be flexible.
Morone recalled an instance when community advisory board representatives requested testimonials from participants on the research project’s website.
“When you have someone with lived experienced sharing the results, it just carries a weight that I do not [as a researcher],” Morone said.
DeBar highlighted that results can and can be presented in creative and engaging ways. Lay summaries, videos, and graphics can help complicated research results be more accessible.
Communicating Results Over Time
Especially in the context of pragmatic trials, and when trials take place over many years, teams should not wait until the end of the study to share information, they said.
“If they are informed, participants can be better partners,” DeBar explained.
Sharing results over the course of the study can be a mechanism for engaging participants. Even if individual data can’t be shared, aggregate data provides insight.
“We aren’t waiting to the end of the study. We are updating our website, and we send them newsletters with information because they ask us for it,” Morone said.
She noted that when patients are engaged and treated as partners in research, they will often be part of the dissemination efforts.
DeBar highlighted that sharing anecdotes, when they align with data, can be a powerful way to communicate results with participant partners.
“I like the phrase fact-congruent stories,” she said. “Those are the things that are really compelling to people. You definitely need the results of the study, but if it can be packaged in ways that really bring that to life, it makes a big difference.”