As the U.S. Food and Drug Administration prepares to roll out their breast density notification rule in early 2023, experts are cautioning that careful consideration is needed in the new rule’s language.
In commentary published in JAMA, Nancy R. Kressin, PhD, of Boston University Chobanian and Avedisian School of Medicine and colleagues shared examples from their own research that portray women’s general understanding of breast density notification letters [1]. The authors explained that these notifications can sometimes leave many patients feeling even more bewildered about their mammogram results than they were before being made aware of their dense tissue.
Prior studies that Kressin was involved in suggest that some women consider breast density notification letters impersonal and confusing. This was especially true for women of certain demographics and those with lower health literacy, which brings up another point of contention—some states’ notification letters surpass the general literacy level of women and also exceed an 8th grade reading level, which is recommended for medical communications by the FDA.
Although well-intentioned, these letters do not always convey the message they’re intended to—that is, that having increased breast density can raise a woman’s risk of developing cancer or having their cancer go undetected, and that women should have a proper conversation with their doctor about these risks and the potential need for supplemental screening.
While Kressin acknowledged that enacting federal breast density legislation is a positive move, it is also significant undertaking. With that in mind, she shared some recommendations that could perhaps make the process of relaying such an important message to women a bit more effective. The recommendations are listed below.
The FDA should carefully review the more than 50 published studies about women’s experiences with breast density notifications, paying close attention to the range of their responses to the letters.
The notification language should be carefully crafted with appropriate reading levels in mind.
The language should be tested for readability by patients with diverse backgrounds, including those who do not speak English as a first language.
Resources should be made available to ensure that women’s understanding of density notifications will appropriately lead to greater knowledge of breast density or to informative conversations with their healthcare providers.
Kressin noted that the new rule will likely require extensive testing and investment but stated that producing helpful information on the topic of breast density, rather than materials that would leave patients more confused, would be “significant for all women.”
“Only with such efforts will the implementation maximize equitable outcomes for women from all races and ethnicities, cultures, literacy levels, educational levels, and socioeconomic backgrounds.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.