A new study looks at whether breast density letters are too difficult for the typical woman to understand. Plus: The FDA issues a warning on fluconazole and miscarriage. Also, do irregular menses provide protection against ovarian cancer or increase risk?
The recent push to educate women about the effects of breast density on breast cancer screening may not be as effective as was hoped due to poor understanding of the notifications sent to them, according to a research letter published in JAMA.
The researchers looked at the laws requiring dense breast notifications (DBNs) that went into effect as of January 1, 2016. Much of the legislation sets out the exact language that must be used in the DBN. They measured the readability of the DBNs using both the Flesch-Kincaid reading grade level in Microsoft Word (range: theoretical lower bound, -3.4; no upper bound) and the Dale-Chall readability score (range ≤ 4 to ≥ 16). The Patient Education Materials Assessment Tool (range, 1% to 100%) was used to measure understandability. Further, the researchers acquired data on the proportion of adults who lacked basic prose literacy skills in the researched states.
Overall there were 24 states that required a DBN; letters from all except Delaware were analyzed. For 19 states (83%) the letters contained specific language mandated by the state legislature; only certain components required by the legislature were included in the DBN from the other 4 states (17%). Thirty percent of the states required that a generic DBN be provided to any woman who received a screening mammogram. The other states only require notification of women who were found to have dense breasts.
All of the DBNs mentioned increased cancer risk; 17 mentioned the link between breast density and increased cancer risk; and 15 of the DBNs mentioned supplemental screening. Of the 15 DBNs that mentioned additional screening, 6 said that further screening may provide a benefit and 4 mentioned specific modalities.
In terms of understandability, the DBNs had a Flesch-Kincaid readability level that ranged from 7 to 19.4 (average, 11.1), in excess of the recommended reading level of grades 7 – 8. A similarly high range was seen with the Dale-Chall readability score. None of the DBNs scored well with the Patient Education Materials Assessment Tool. Only 3 states had a DBN with a readability level of grade 8 or less and the states with the highest readability grade levels on the DBNs were likely to have the lowest literacy levels.
FDA warning about fluconazole and miscarriage
Caution is warranted in prescribing oral fluconazole during pregnancy, according to a new drug safety communication from the US Food and Drug Administration (FDA). The agency will issue final conclusions and recommendations about the treatment for yeast infections when its review of data on the drug is complete.
The announcement was issued on the heels of a report by Danish researchers that linked use of oral fluconazole in pregnancy with a statistically significant increased risk of spontaneous abortion compared with risk among unexposed women and women with topical azole exposure in pregnancy. In that nationwide register-based cohort study, published in JAMA, data from more than 1.4 million fluconazole-exposed pregnancies in Denmark recorded between 1997 and 2013 were analyzed. Those pregnancies were compared with up to 4 unexposed pregnancies matched for propensity score, maternal age, calendar year, and gestational age. (Gestational age was the first day of treatment and eligible controls survived through that date.)
Of the 3315 women exposed to oral fluconazole during weeks 7 through 22 of their pregnancies, 147 (4.4%) had a spontaneous abortion, compared with 563 among the 13,246 (4.2%) matched women who had not been exposed to that drug formulation. Risk of spontaneous abortion was significantly increased in the women with the oral fluconazole exposure (HR, 1.48; 95% CI, 1.23-1.77). When exposures to topical and oral fluconazole were compared, the oral formulation also was associated with an increased risk of spontaneous abortion (HR, 1.62 [95% CI, 1.26-2.07]). Contemporary OB/GYN’s editor-in-chief points out that the actual rates of spontaneous abortion were extremely low in both exposed and unexposed cohorts, raising the issue of systematic bias.
Concern about the safety of fluconazole in pregnancy also was raised by the FDA in 2011, when the agency issued a warning that chronic high doses (400 mg/day to 800 mg/day) during the first trimester might be associated with specific birth defects. A single low dose (150 mg) of the drug, however, did not appear to raise the risk. That safety alert was based on several published case reports of birth defects in infants whose mothers were treated with high-dose fluconazole for serious and life-threatening fungal infections during most or all of the first trimester.
In its latest warning, the FDA said that health care professionals should be aware of Centers for Disease Control and Prevention guidelines for fluconazole, which recommend use of only topical antifungal products to treat women with vulvovaginal yeast infections, including for longer periods than usual if the infections persist or recur. The agency also encouraged healthcare professionals and patients to report any adverse events or side effects related to the drug to the FDA’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/Report.
Do irregular menses alter ovarian cancer risk?
A new prospective study published in the International Journal of Cancer seems to indicate that rather than reducing the risk of ovarian cancer, irregular menses may actually increase the risk of developing the disease.
The researchers conducted a 50-year prospective study that included 15,528 mothers who were in the Child Health and Developmental Studies cohort, which was recruited from the Kaiser Foundation Health Plan between 1959 and 1966. Irregular menses were identified through medical record and self-report at age 26. Using linkage to the California Cancer Registry and Vital Statistics, the investigators found 116 cases of ovarian cancer and 84 deaths in the women in the cohort.
Women with irregular menses, the authors determined, were at a higher risk of ovarian cancer and death due to the disease over the course of 50 years of follow-up and those associations increased with age (P<0.05). By age 70 years, incidence and mortality due to ovarian cancer was increased two-fold in that subgroup (95% confidence interval [CI] = 1.1, 3.4). By age 77 years, the increase was 3-fold that of women who did not have irregular menses at age 26 (95% CI = 1.5, 6.7 for incidence; 95% CI = 1.4, 5.9 for mortality). Risk of mortality from serous tumors also was 3-fold higher (95% CI = 1.3, 7.6) and did not vary by age.
The researchers concluded that there is a link between ovarian cancer risk and irregular menses. Irregular menses and other early biomarkers may serve as a way to detect ovarian cancer earlier, they said, leading to better chances of survival.