Poorly conducted informed consent often comes down to how researchers present the numbers.
“One of the problems in the informed consent world when we’re talking to patients is their lack of understanding of the risks and benefits,” says Angela Fagerlin, PhD, Salt Lake City VA researcher and professor and chair of population health sciences at the University of Utah in Salt Lake City.
Misunderstandings can arise from too much information in informed consent documents, she says. “They don’t know what to pay attention to in a 10-page document.”
When research participants receive too much information, they don’t know which parts are important. This results in poor-quality informed consent.
Research from the 1990s-2000s showed that when information is presented in a disorganized way to patients, they make suboptimal decisions, Fagerlin says.
For instance, suppose there are a number of characteristics of a study that participants should know. These could include visit times/days; number of blood draws and lab tests; participation incentives; costs, if any, to participants; length of participation; how to obtain results of the study; and risks and benefits.
Each of these items and more could be presented in the informed consent document, but the first priority for participants probably is the risks and benefits explanation. A consent form that focuses first on one of the more minor pieces of information, such as the number of blood draws, is not helping participants in their decision-making process, she says.
Informed consent should start with risks and benefits, explaining these in a way that is easy to understand and assess. Fagerlin offers these suggestions for improving informed consent:
• Write clearly and simply. “I come from a rural, lower-economic community in Michigan, and I know the people I grew up with are hesitant to ask questions of their doctors,” Fagerlin says. “They’re hesitant to disagree. They say, ‘What would you do, doc?’ And then they have to live with the outcomes of whatever decisions are being made.”
Knowing all of this has made Fagerlin concerned about patients’ and research participants’ long-term mental and physical health consequences. “I want to help people who are making really hard decisions.”
One way to do this is to write informed consent documents in language the average person can understand. Most informed consent language is written at such a high literacy and numeracy level that most people who read the forms cannot fully understand them, she says.
“Informed consent documents are written to protect the university, but not written in a way that patients can understand them,” Fagerlin says. “If you want patients to understand things, you don’t give them a 12-page document.”
Researchers and IRBs can create informed consent forms that are shorter and more readable, making it easier for people to make hard decisions.
• Use the same denominator when presenting risk numbers. It is confusing to participants to learn that one risk has a one in 250 chance and another is one in eight. Instead, informed consent forms should use the same denominator for each risk example. Even better, they should use 100 or 1,000 as the denominator because these are easiest for people to comprehend, Fagerlin says.
“It’s hard for people to make comparisons when all of the denominators are different,” she explains. “And if you use 100 or 1,000 as denominator, it’s easier for people to understand it as a percentage.”
• Use graphs and other visual information. Pictographs or other visual displays can help people understand risks and benefits.
“For people who are visual learners, having a picture graph is helpful for putting it into perspective,” she says.
• Apply patient decision aids. Decision aids present information in an easy-to-read format. They tailor information to the participant’s condition, and they provide risk numbers for each potential adverse event. Potential benefits also are presented numerically when such data are available. When participants are finished with the decision aid, they can complete a decision guide that asks them questions about the risks and benefits. Sample questions might include:
- How worried are you about getting a side effect if you enter the study?
- How common are the side effects if you participate in the study?1
“Decision aids are tools designed to help patients understand their diagnoses and benefits of treatment,” Fagerlin says. “I use these strategies to communicate to people how they can be more involved in these decisions and be more informed about risks and benefits.”
• Engage focus groups. One strategy for improving informed consent is to ask focus group participants for input. Researchers have used stakeholder focus groups to help develop better information about risks and benefits.
For example, a focus group of patients and other stakeholders can help researchers improve a research project’s informed consent and recruitment processes.
One recent study in which Fagerlin participated found that the best results could emerge from stakeholder/focus group meetings when there was a culture of mutual respect, all team members were actively involved, and leaders facilitated good communication. To accomplish this, researchers needed to beware of jargon and acronyms, privately check in with quiet people, have people introduce themselves with stories and not with titles, and offer orientation to everyone.2
The goal is to present information in the best possible way when obtaining informed consent, Fagerlin says. “So we need to try to figure out the best tools possible.”
1. Fagerlin A, Dillard AJ, Smith DM, et al. Women’s interest in taking tamoxifen and raloxifene for breast cancer prevention: response to a tailored decision aid. Breast Can Res Treat. 2011;127:681-688.
2. Witteman HO, Dansokho SC, Colquhoun H, et al. Twelve lessons learned for effective research partnerships between patients, caregivers, clinicians, academic researchers, and other stakeholders. J Gen Intern Med. 2018;33(4):558-562.