The most important people in a clinical trial may be the ones who never join it. Every "no" in a clinical trial is usually treated as the end of a conversation, but a new MUSC study suggests it might be the beginning of an important one.
While recruiting for a parent study, researchers at the Medical University of South Carolina (MUSC) were surprised to discover that patients with college experience were three times more likely to decline participation in an overdose prevention research study than those without a high school diploma. This finding prompted a closer look at who declines to participate in clinical trials.
A team of researchers, including professors of Psychiatry and Behavioral Sciences Erin A. McClure, Ph.D. ,and Kelly S. Barth, D.O. , and Ralph C. Ward, Ph.D. , a statistician and research associate professor in the Department of Public Health Sciences, looked at patient engagement from a different angle. The team's parent study tested whether support from a peer recovery specialist, a specially trained individual with lived experience of substance use, could improve outcomes for people treated in Emergency Departments after an opioid overdose. After being approached in the ED, 150 people enrolled in the study. Many more chose not to participate, and 46 people declined to take part but, instead, completed a brief anonymous exit survey on their demographics, substance use and reasons for declining.
Rather than treating those 46 refusals as lost opportunities, the researchers saw the chance to learn more about them and why they said no. "The people who declined to participate are a really interesting group that we don't ask enough questions about," said McClure. She and her team were driven by one big question: "What are the reasons why people would decline to participate?"
The findings challenged several assumptions about who is most likely to participate in research. Those with any college experience were three times more likely to decline than those without a high school diploma. People without health insurance were also three times more likely to say no than those with insurance. Lastly, the younger the patient, the greater the likelihood of their opting out.
"That's not what we expected to find," said McClure. Heretofore, researchers could only speculate about the reasons behind these patterns. Possible explanations have included stigma, misconceptions about research participation or differing attitudes toward treatment among younger adults.
However, through patient self-reporting, researchers learned that the most common reasons for declining participation were wanting to leave the ED as quickly as possible, feeling unwell, disinterest in research and feeling that the intervention wouldn't be helpful. Notably, many people who declined the study still wanted help. While 56.5% were not in treatment for their substance use, nearly two-thirds said they wanted treatment services. This finding indicates that declining research is not the same as declining care.
"This suggests to me that it's not something about the peer support itself that is not appealing to them. It's about being in a research study," said McClure. Timing and the ED setting both could be additional contributing factors in these cases.
"The desire is there," explained McClure. "They want peer support, but maybe just not right now."
They also explored the potential that researchers don't present opportunities in ways that resonate with participants.
"We expect a lot from people, and research studies can be highly burdensome for participants," explained McClure. "I see this as a call to action for the research community to improve our methods and improve the ways in which we engage people in research."
They determined that promising strategies include incorporating technology in a way that makes participation less taxing, like offering telehealth visits and delivering medication by mail. The researchers also cited the importance of connecting with participants when they are ready.
McClure believes institutions like MUSC may have opportunities to engage potential participants beyond the immediate aftermath of a medical crisis. Because MUSC uses an opt-out model for research recruitment , investigators can contact eligible patients later, when they may be more receptive to considering study participation.
Clinical trials are crucial not just for individual health but for that of the population at large. Data collected from those who agreed to take part in research studies can help scientists to develop new medications and treatments that benefit many. But the people who choose not to participate may have just as much to teach researchers. By understanding who said no and why, scientists may find new ways to make research more accessible, all-encompassing and effective.
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