A randomized clinical trial found that including quantitative risk and benefit information in medication guides significantly improved patient comprehension without reducing readability.

The study assessed the comprehension of information on the abortion and miscarriage management medication mifepristone among 311 female participants using three formats: the U.S. Food and Drug Administration (FDA)-proposed one-page Patient Medication Information (PMI) sheet, a modified version incorporating quantitative risk-benefit data, and the pharmaceutical vendor’s multipage communication.

The "decision-critical" PMI that included numerical data resulted in significantly higher comprehension scores among patients compared with both the FDA's proposed format and vendor materials.

"Adding quantitative risk and benefit estimates increased participants' comprehension, as well as their ratings of the quality of the scientific evidence and usefulness of the communication, without reducing gains in readability," wrote Tamar Krishnamurti, PhD, of the University of Pittsburgh, and colleagues in JAMA Network Open.

The FDA and decision-critical versions scored similarly on readability, with both outperforming the vendor materials.

Participants also gave higher ratings to how well the quantitative version supported their decision-making about whether to use mifepristone and proper usage instructions. The researchers found these results were consistent regardless of participants' education level or stated willingness to use abortion medication.

The study included participants from states with varying abortion access policies, with 58.8% residing in states without restrictions and 40.2% living in states with full restrictions at the time of the study.

Study limitations included the use of paid volunteers, online-only responses, and the hypothetical nature of the evaluations. However, the authors noted that "succinct, readable, quantitative information can help patients understand drug risks and benefits. Such understanding may be especially important for drugs, such as mifepristone, that depend on patient self-management while being subject to widespread misinformation."

The report's results come as the FDA has proposed regulations requiring all prescriptions to include a one-page PMI sheet aimed at providing "essential information that patients need" for safe and effective medication use. However, the current proposal does not mandate inclusion of quantitative risk-benefit data.

The authors declared having no competing interests.