Transform the informed consent process
Transform the informed consent process
Using on-line electronic media: How and why
Electronic tools can be intimidating. They can be costly. Often they take us out of our comfort zones and challenge processes we have grown accustomed to. However, as increased scrutiny falls upon researchers to ensure subject protection, electronic media may offer compelling methods for educating the public and obtaining voluntary consent of research subjects.
Ironically, use of these new technologies and strategies, in some ways, is being driven by very basic realities. The first of those realities is the current state of informed consent documents, which commonly run 15-20 pages and even longer in studies with more complex protocols or of more complex disease states.
Literacy rates in the United States
Add the current state of literacy in the United States, says Susan Brink, DrPH, president and CEO, ConsentSolutions, Inc., Washington, DC, to these complex informed consent documents and you see the problem compounded.
In Brink's presentation at the 44th Annual Drug Information Association meeting in Boston, MA,1 the statistics were sobering: 14% of American adults are functionally illiterate, 29% have marginal literary skills, and only 13% can perform complex literary tasks.1
"So, basically, it's complex literary tasks that we're asking them to do," notes Brink. "We're asking that they read a document that typically is full of medical terms that they don't understand — they may have heard them, but they don't understand them — and we're asking them to take that information, and decide to participate.
"We also know from studies that sometimes people decide to participate not because they want to be part of research," she adds, "but because they think they're going to get better medical care. They think that this particular problem is going to be solved by the study drug.
"I recently put together a recruitment video for a prostate trial and had my husband — who can perform these complex tasks — watch it," tells Brink. "He said 'I really like it, but I'm not so sure about this clinical trial stuff. I wouldn't want to be in the clinical trial if I didn't think I was going to get the trial drug.' That's the reaction of many people."
Importance of using 'living room' language
So we have to ask what don't people understand. "Well, they don't know what a polyp is," says Brink, "or what a growth or lesion is. People understand what vomit is. You're going to throw up and be sick as a dog all night. They understand that.
"Malignant and terminal are understood by less than 20%," Brink adds. "Once you tell people they have cancer, sometimes they just don't hear those other words."
Brink has also found they have limited knowledge of their bodies.
"When I first started doing research with prostate cancer, we did focus groups with men to find out what they knew about prostate cancer," Brink says. "Boy was I surprised. We found out they didn't know where their prostate is. So we had big problems.
"Not only did they not know where it is," she adds, "they called it prostrate. They just didn't use these terms. So, we have to be very careful with what people understand and not only talk to them about being in research, but also about what these terms mean to them, what they're thinking, and figure out how best to approach them."
What Brink likes to encourage is the use of "living room language."
"When you're at the sponsor level and you're doing legal documents, or talking to the PI, it's very important that you make sure they understand this problem of language when communicating with the patients."
How people get information
"We as a group of highly educated professionals, may be a bit unusual in how we get information," explains Brink. "We know that many medical providers still get their information from journals and texts.
"But these text-based ways of getting information are decreasing," acknowledges Brink. "Newspapers are struggling to survive and slowly dying. Nobody reads books. People don't necessarily get information that way.
"More and more people are using the internet and will increasingly get information via cell phones," adds Brink. "People are really changing the way information comes into them. It's almost as though we're going back to a storytelling culture in which everything comes to us in an audio or audio-visual fashion."
Interestingly, people are still getting information from friends, family, and acquaintances. Perhaps even more so, notes Brink, with the growth of social networking sites.
"If we look at who is using what," says Brink, "we have some big numbers." As of July 2007:
- 301 million Americans; 293 million cell phone users;
- 73% of Americans have computer/internet access;
- 58% of Americans ages 50-64 are internet users;
- 22% of Americans older than age 65 use a computer (up 47% since 2000);
- 30 countries around the world have 100% cell phone penetration;
- experts estimate 100% cell phone penetration in the United States by 2013.
Making an informed decision
With these changes at play, Brink suggests that rather than a text-based document at the heart of the informed consent process, we may need to look at some other ways of giving people information that may be more effective and may help them better understand what's going on.
"So for me the question is how do we turn information into comprehension, action, and collaboration?" posits Brink. "We don't want them just to understand, we want them to enroll, show up at their appointments every time, or at least call us, tell us they can't make it, and reschedule.
"We have great information about how cancer patients make decisions about clinical research participation (see graphic on decision making, below) says Brink. "People look at information, they look at their preferences and values — often they really want to help — and they look at their daily lives — can it fit with their daily lives or will it take all day to get to an appointment," Brink explains.
"Those are the kinds of things people think about and they go into the decision-making model," she says. "And we need to be sure to include these things in the informed consent."
The role of electronic media
"The big pay-off of electronic media," explains Brink, "is that these web-based tools can track time and include comprehension measures. We see this especially in hospitals where they're moving quickly to electronic signatures as they adopt electronic medical records.
"Electronic tools also can build in links to explain the more complex ideas," she adds. You can take anatomy out of the abstract, for example, and show patients exactly where the prostate is. This may even make the core consent form shorter, depending on the patient and his or her level of comprehension, or at least more digestible.
"You also get to move beyond the checked box," Brink says. "How many times have you gotten to the end of an informed consent discussion and wondered how much the patient understood? With electronic media you can add comprehension checks along the way — and importantly, you can track how much time the patient spends on each section."
This also gets to the time and space issue, notes Brink. "It's a little bit uncomfortable sitting there with your doctor, the PI, who is asking: 'Wouldn't you want to be in this study, let me tell you about it.' And so, can we back up a little bit and give patients the opportunity for self-assessment of values and preferences and the on-line consent form with additional explanations?
"This is an opportunity for people to think through what's going on in this study and how it coincides with their personal and time barriers," explains Brink. "One patient may want to do this and may have family support. Or, the patient may want to do the study but doesn't have family support. How is he going to get to appointments on his own?"
These are the tools that improve clinical research and informed consent, say Brink. By increasing comprehension and approaching patients in much the same way they're receiving other forms of information and communication, electronic media ultimately help patients make informed decisions.
Reference
- Radical ideas for transforming the informed consent process. Presented at the 44th Annual Meeting of the Drug Information Association; Boston, MA; June 26, 2008.
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