Imagine an informed consent form that can talk and provide animated versions of what risks and benefits a patient may face when following a particular course of treatment.

People who have a hard time understanding what’s on the ubiquitous printed forms (most people) might have a better idea of what they are being told and be able to make better decisions about their health care.

This is the logic that guided researchers from Michigan and Florida to develop drug risk/benefit information with animated and computerized text and graphics. They hoped to increase the clarity of these forms and make patients truly informed.

Study Methods

The researchers used a convenience sample of patients at the University of Michigan Cardiovascular Center for their study. Participants were randomized to receive information about the risk and benefits of taking statins for hypercholesterolemia on the iPad in four different formats: text/numbers, pie chart, bar graph, and pictograph. The information was viewed as intuitive but there was an assistant available to help patients as necessary.

The materials were initially created by the researchers and a graphic designer. The researchers piloted the materials with lay and expert individuals prior to using them in the study. The materials contained a common introduction and voice over narrative discussing the benefits and risks of statin use.

Participants were informed that this information was not relevant to their individual medical needs. Statins were selected because the researchers thought most participants would be aware of them.

After reviewing the materials, participants were asked to fill out a questionnaire that demonstrated their understanding of the risks and benefits of taking statins. Participants were also asked about whether the materials were user friendly for them. Researchers also tested participants’ health literacy and ability to understand numerical values.

Key Findings

The study analysis included 200 participants. For each of the four groups, approximately half of the participants were college educated, which is much higher than the population nationally (about 30%). Participants preferred pictographs and bar graphs over other methods of providing risk and benefit information. The only significant difference in understanding among groups based on the ability to understand statistical numbers was for bar graphs. Those with a higher ability to understand statistical numbers had a better understanding of bar graphs than those with a lower understanding.

Overall, there was a statistically significant preference for graphs over text (82.5% vs 17.5%, P < .001) with men preferring graphs even more than women. Significantly more participants preferred receiving the information on the tablet device compared to printed media.

This is an important indicator for providers of informed consent documents that consumers are ready for a shift to information in electronic formats which could save quite a bit of paper and potentially link easily to other electronic records being maintained for patients. One of the more important findings was that subjects whose preferred message format matched their randomly assigned format (preference match) had significantly greater understanding – a key signal that tailoring is likely to matter in this area.

Future Concerns

The results of this research indicate that iPad or other devices may be useful for presenting risk/benefit information prior to participants signing an informed consent document. These devices enable providers to easily provide patients with a variety of formats.

In the future, participants could be asked which format they prefer for viewing risk and benefit information. After selecting a particular format, they could then receive the information in a way that leads to the greatest understanding for them. This is important information for researchers in various fields that recruit patients daily into studies and also for clinicians that ask patients to provide informed consent on a regular basis.

Hospitals can also benefit from this information because they can incorporate different types of consent into their daily practice thereby empowering their patients to make better, informed decisions about their care. Future research in this area could include using these different presentation approaches with different languages (such as Spanish and Mandarin).

Also, animated information could include scenarios which are culturally relevant when such information is likely to increase understanding.
Finally, the group of patients in this study were quite educated compared to the general population, so further research is needed on populations which are more reflective of the nation with regard to health literacy and general educational background.