Provider-Related Issues

10 Steps to Increase Participants Understanding of Clinical Trial Risks and Benefits

Last Updated: Jul 24, 2014

Applying specific strategies to improve patients' understanding of benefits and risks may help patients' decision making. 

Linda Parreco's Image

We know that the decision to participate in a clinical trial is complex. For example, one component of the complexity is talking with the potential participant about the risks and benefits of multiple options. For many participants, low health literacy and/or lack of numeracy skills can cause difficulty in understanding these concepts. Clear communication of medical information is essential to secure a truly informed medical decision.

In this helpful article Angie Fagerlin and colleagues provide ten recommendations for improving risk communication:

1. Use plain language to make written and verbal materials more understandable.
2. Present data using absolute risks.
3. Present information in pictographs if you are going to include graphs.
4. Present data using frequencies.
5. Use an incremental risk format to highlight how treatment changes risks from preexisting baseline levels.
6. Be aware that the order in which risks and benefits are presented can affect risk perceptions.
7. Consider using summary tables that include all of the risks and benefits for each treatment option.
8. Recognize that comparative risk information (e.g., what the average person’s risk is) is persuasive and not just informative.
9. Consider presenting only the information that is most critical to the patients’ decision making, even at the expense of completeness.
10. Repeatedly draw patients’ attention to the time interval over which a risk occurs.

Certainly most of us have experienced difficulty explaining treatment options and associated risk and benefits to prospective trial participants? What strategies have you found effective when recruiting patients to clinical trials? Have you incorporated any of the ones mentioned above?

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