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Tips on improving the consent document
These strategies will enhance readability
It’s not necessary to conduct a major research project each time a new informed consent form is written, but it’s only sensible to obtain the readability perspective from someone who is not familiar with the protocol vocabulary, an expert suggests.
It’s easy for investigators who are enmeshed in their own fields to become blind to the multiple uses of various words, says Michael Paasche-Orlow, MD, MPH, an assistant professor of medicine in the section of general internal medicine, department of medicine, Boston University School of Medicine.
"When you get into an investigational mindset, you can forget the pedestrian uses of those same words," Paasche-Orlow says. "But you can gain insight into this when you ask people who are not in your field to read it."
Also, there are sentence structures that are not common with the public, but which are common in the scientific community, he says. "A good example is that at the sixth grade reading level, no one is writing with semi-colons," Paasche-Orlow says. So when an investigator notes semi-colons in the informed consent document, that should be a signal that the form contains complex sentence structures and probably is not as readable as desired, he adds.
"You could easily simplify sentences that have semi-colons or subjunctive clauses," Paasche-Orlow says. "There’s almost no purpose to these, but you find them all the time."
Paasche-Orlow offers these other strategies for simplifying the informed consent document:
• Make good use of a layperson reader.
A layperson reader could highlight for investigators where text is written in too complicated a fashion, while the electronic readability tools will let text slide even if it’s written with arcane argot, Paasche-Orlow says.
An informed consent document could be loaded with words that don’t mean anything to subjects, but because they have fewer than three syllables, they do well on the readability tool, he notes.
"The readability system doesn’t know how rare words are," Paasche-Orlow says.
For example, a simple word like "diet" can have very different meanings to different people, Paasche-Orlow says.
"When doctors say the word diet’ they’re talking about all the food a person is eating, all of the caloric intake," he explains. "But when patients see the word diet,’ they think you’re talking about weight loss."
• Improve the font and text size.
"Not only is the typical informed consent document very long with information overload, but some people are printing materials in a font that is too small," Paasche-Orlow says. "Unless they’re going to check people’s vision, there’s almost no reason to have font that’s less than 14 points."
People with 20/60 vision can read 14 point font, but if it’s printed any smaller than that it might make it difficult for some target populations to read, he says.
"This may be more of an issue with an older patient population, and they may not even admit to you that they can’t see it," Paasche-Orlow says.
Also, when type face is enlarged, it increases reading speed for marginal readers, Paasche-Orlow notes.
"Another strategy is to have the whole text in the same type face," he says. "There’s no reason to go from Arial to Times to Garamond."
Informed consent forms sometimes will have different type faces to draw attention to particular sections of text, but this just makes it harder to read for marginal readers, Paasche-Orlow says.
As far as which type face to select, Courier gets good grades and so does Times New Roman, Paasche-Orlow notes.
"Most of the fonts people are using are okay, but bold is more effective than italics," he says. "I’ve seen people have difficulty with italics."
• Be more creative with headings.
Headings could be printed in bold-face or in a larger font, but the most important thing is to make the headings engaging, Paasche-Orlow says.
"So instead of having a heading that is bland and not personal, some people go with questions as headings," Paasche-Orlow says.
For example, headings could include these questions:
— What will happen in this study?
— What will I be asked to do?
"Questions like those are more interactive, and we want these documents to be a conduit, the platform through which the research assistant and potential subject get into an interaction in the process," Paasche-Orlow says. "The best thing is if these forms promote an interactive learning process."
These types of engaging headlines show the subject that the consent form is there for them to talk about and not just another disclaimer form like the ones they sign at the gym without actually reading, he says.
"There are disclaimers all over society, and if they have to engage in it as a legalistic ritual then they’re likely not going to understand what they’re signing on to," Paasche-Orlow says.
• Think about the research assistant’s role.
Investigators should think of informed consent documents as patient education tools, and they should understand that their research assistants also are heavily influenced by the forms, Paasche-Orlow notes.
"So if the form is arranged in such a way that research assistants are prompted to interact and teach subjects, then it’s possible to get past any misunderstandings that might happen," he says.
"I recommend the research assistant has his own version of the form that prompts him to ask questions," Paasche-Orlow says. "These prompts could be at the end of the text box."
For example, prompts might include the following:
"Get the potential subject to reflect on this information and not to just do this at the end," Paasche-Orlow says. "This should be done multiple times throughout the course of the trial."
Whoever is engaging in the informed consent process should be cued for teaching and confirming understanding, Paasche-Orlow adds.