Best Practices: Study map can support informed consent review
Study map can support informed consent review
Use pictures, diagrams
Informed consent forms have one very daunting characteristic: They are visually numbing.
In addition to their many pages, medical terminology, legalese, and often higher-than-desired reading grade level, they are simply boring to look at, an informed consent expert suggests.
"I'm a visual person," says Megan A. Foradori, RN, MSN, a contractor with the Henry M. Jackson Foundation for the Advancement of Military Medicine and research agenda project consultant for the TriService Nursing Research Program of Bethesda, MD.
Foradori presented informed consent information to subjects for a recent study of decision-making and recovery among living kidney donors conducted at the Johns Hopkins University School of Nursing in Baltimore, MD.1
She sensed that they were nodding and smiling, but not retaining the IC information.
"So it made sense to make a picture," Foradori explains. "Our principal investigator thought it was a terrific idea."
Foradori found simple icons and then added words. The illustrations evolved into a single-page study map that is designed like an illustrated flow chart. The map contains simple bar-stick figures representing the research participant. At its top is a thought bubble, reading "Decision Making & Health," leading to the participant. An arrow points to the figure and says, "This is you in clinic today."
The study map contains these sections, each with arrows leading to them:
- A circle containing an illustration of two written pages and the words, "At your visit, today, we will go over the informed consent sheet. By signing this, you say that: You understand the information given; You agree to the conditions; You will participate in this study."
- An identical circle has dialogue saying, "Decision-making, your health, family relations, how you learned about donation, your ideas of the risks and benefits for you and the recipient."
- Connected to the decision-making circle is a circle with a folder in it, saying, "I will access your hospital records to learn about your health."
- Following that, the flow chart divides into two sections, with the first for participant who agree to fill out a survey and donate kidneys and the second for those who do not donate.
- It follows with a list of graphics illustrating what will happen at three months after surgery, six months after surgery, and one year after surgery; or three months from today in the case of those who do not donate.
- It ends with a box, saying, "Interviews for some participants, both donors and non-donors, in person or by phone at your convenience (we will contact you).1
"We enrolled participants who were considering donation but had not yet given approval," Foradori says. "They filled out a survey, and we made sure they understood there were two arms to the study and even if they were not selected, we wanted to hear from them two months after donation."
Thirty research participants were randomly assigned to a standard care group in which they received a verbal description of the study and written consent documents or an experimental group that received the standard of care plus a study map. The study found that all participants demonstrated high knowledge levels of the informed consent when given a simple quiz about the study.1
The participants were highly educated, with about 77% having had some college education, she notes.
"They had a high level of understanding of the study in both groups," she says. "People in different educational levels would have benefited more from a schematic."
There were intangible benefits from using the study map.
"Not only did the study map help research participants understand the study, it ensured new research nurses gave each person the same information," Foradori says. "Every participant received the same information, and the study map helped make that happen."
Using a visual study map could prove helpful for future studies and informed consent processes, she suggests.
"If people could have more visual representations of the decisions that need to be made in health care, the study map could help them make great decisions," Foradori adds.
- Foradori MA, Nolan MT. Effect of a study map intended to support informed consent in transplant research. Prog Transplant 2012;22(1):56-61.
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