Implementing the National Dense Breast Reporting Standard, Expanding Supplemental Screening Using Current Guidelines, and the Proposed Find It Early Act.

Thirty-eight states and the District of Columbia (DC) have dense breast notification laws that mandate varying levels of patient notification about breast density after a mammogram, and these cover over 90% of American women. On March 10, 2023, the Food and Drug Administration issued a final rule amending regulations under the Mammography Quality Standards Act for a national dense breast reporting standard for both patient results letters and mammogram reports. Effective September 10, 2024, letters will be required to tell a woman her breasts are "dense" or "not dense," that dense tissue makes it harder to find cancers on a mammogram, and that it increases the risk of developing cancer. Women with dense breasts will also be told that other imaging tests in addition to a mammogram may help find cancers. The specific density category can be added (eg, if mandated by a state "inform" law). Reports to providers must include the Breast Imaging Reporting and Data System density category. Implementing appropriate supplemental screening should be based on patient risk for missed breast cancer on mammography; such assessment should include consideration of breast density and other risk factors. This article discusses strategies for implementation. Currently 21 states and DC have varying insurance laws for supplemental breast imaging; in addition, Oklahoma requires coverage for diagnostic breast imaging. A federal insurance bill, the Find It Early Act, has been introduced that would ensure no-cost screening and diagnostic imaging for women with dense breasts or at increased risk and close loopholes in state laws.

Effect of an Educational Intervention on Women's Health Care Provider Knowledge Gaps About Breast Cancer Risk Model Use and High-risk Screening Recommendations.

OBJECTIVE: To assess effectiveness of a web-based educational intervention on women's health care provider knowledge of breast cancer risk models and high-risk screening recommendations. METHODS: A web-based pre- and post-test study including 177 U.S.-based women's health care providers was conducted in 2019. Knowledge gaps were defined as fewer than 75% of respondents answering correctly. Pre- and post-test knowledge differences (McNemar test) and associations of baseline characteristics with pre-test knowledge gaps (logistic regression) were evaluated. RESULTS: Respondents included 131/177 (74.0%) physicians; 127/177 (71.8%) practiced obstetrics/gynecology. Pre-test, 118/177 (66.7%) knew the Gail model predicts lifetime invasive breast cancer risk; this knowledge gap persisted post-test [(121/177, 68.4%); P = 0.77]. Just 39.0% (69/177) knew the Gail model identifies women eligible for risk-reducing medications; this knowledge gap resolved. Only 48.6% (86/177) knew the Gail model should not be used to identify women meeting high-risk MRI screening guidelines; this deficiency decreased to 66.1% (117/177) post-test (P = 0.001). Pre-test, 47.5% (84/177) knew the Tyrer-Cuzick model is used to identify women meeting high-risk screening MRI criteria, 42.9% (76/177) to predict BRCA1/2 pathogenic mutation risk, and 26.0% (46/177) to predict lifetime invasive breast cancer risk. These knowledge gaps persisted but improved. For a high-risk 30-year-old, 67.8% (120/177) and 54.2% (96/177) pre-test knew screening MRI and mammography/tomosynthesis are recommended, respectively; 19.2% (34/177) knew both are recommended; and 53% (94/177) knew US is not recommended. These knowledge gaps resolved or reduced. CONCLUSION: Web-based education can reduce important provider knowledge gaps about breast cancer risk models and high-risk screening recommendations.

Effect of an educational intervention on women's healthcare provider knowledge gaps about breast density, breast cancer risk, and screening.

OBJECTIVES: We sought to assess the effect of an educational intervention, based on DenseBreast-info.org website content, on women's healthcare provider knowledge of breast density, its risk and screening implications, and comfort level discussing these topics with patients. METHODS: US-based women's healthcare providers participated in a web-based pretest/posttest study from May 14, 2019 to September 30, 2019. Pretest included demographics; comfort/knowledge discussing breast density impact on risk and screening; and educational material. Posttest contained the same knowledge and comfort questions. We assessed mean pretest/posttest score and comfort level differences (paired t tests) and pretest/posttest knowledge gap differences (McNemar test). We evaluated associations of baseline characteristics with pretest score and score improvement using multiple linear regression, and associations with knowledge gaps using logistic regression. RESULTS: Of 177 providers analyzed, 74.0% (131/177) were physicians and 71.8% (127/177) practiced obstetrics/gynecology. Average test score increased from 40.9% (5.7/14) responses correct pretest to 72.1% (10.1/14) posttest (P < 0.001). Pretest, 56.5% (100/177) knew women with extremely dense breasts have four-to-six-fold greater breast cancer risk than those with fatty breasts; 29.4% (52/177) knew risk increases with increasing glandular tissue; only 5.6% (10/177) knew 3D/tomosynthesis does not improve cancer detection in extremely dense breasts over 2D mammography; and 70.6% (125/177) would consider supplemental ultrasound after mammography in an average-risk 50-year old with dense breasts. Postintervention, these knowledge gaps resolved or reduced (all P < 0.005) and comfort in discussing breast density implications increased (all P < 0.001). CONCLUSIONS: Important knowledge gaps about implications of breast density exist among women's healthcare providers, which can be effectively addressed with web-based education.

Video Summary : http://links.lww.com/MENO/A753 .

Radiologic Technologist and Radiologist Knowledge Gaps about Breast Density Revealed by an Online Continuing Education Course.

OBJECTIVE: We sought to identify provider knowledge gaps and their predictors, as revealed by a breast density continuing education course marketed to the radiology community. METHODS: The course, continually available online during the study period of November 2, 2016 and December 31, 2018, includes demographics collection; a monograph on breast density, breast cancer risk, and screening; and a post-test. Four post-test questions were modified during the study period, resulting in different sample sizes pre- and postmodification. Multiple logistic regression was used to identify predictors of knowledge gaps (defined as > 25% of responses incorrect). RESULTS: Of 1649 analyzable registrants, 1363 (82.7%) were radiologic technologists, 226 (13.7%) were physicians, and 60 (3.6%) were other nonphysicians; over 90% of physicians and over 90% of technologists/nonphysicians specialized in radiology. Sixteen of 49 physicians (32.7%) and 80/233 (34.3%) technologists/nonphysicians mistakenly thought the Gail model should be used to determine "high-risk" status for recommending MRI or genetic testing. Ninety-nine of 226 (43.8%) physicians and 682/1423 (47.9%) technologists/nonphysicians misunderstood the inverse relationship between increasing age and lifetime breast cancer risk. Fifty-two of 166 (31.3%) physicians and 549/1151 (47.7%) technologists/nonphysicians were unaware that MRI should be recommended for women with a family history of BRCA1/BRCA2 mutations. Tomosynthesis effectiveness was overestimated, with 18/60 (30.0%) physicians and 95/272 (34.9%) technologists/nonphysicians believing sensitivity nearly equaled MRI. Knowledge gaps were more common in technologists/nonphysicians. CONCLUSIONS: Important knowledge gaps about breast density, breast cancer risk assessment, and screening exist among radiologic technologists and radiologists. Continued education efforts may improve appropriate breast cancer screening recommendations.

Safety of the HyperSound® Audio System in Subjects with Normal Hearing.

The objective of the study was to assess the safety of the HyperSound® Audio System (HSS), a novel audio system using ultrasound technology, in normal hearing subjects under normal use conditions; we considered pre-exposure and post-exposure test design. We investigated primary and secondary outcome measures: i) temporary threshold shift (TTS), defined as >10 dB shift in pure tone air conduction thresholds and/or a decrement in distortion product otoacoustic emissions (DPOAEs) >10 dB at two or more frequencies; ii) presence of new-onset otologic symptoms after exposure. Twenty adult subjects with normal hearing underwent a pre-exposure assessment (pure tone air conduction audiometry, tympanometry, DPOAEs and otologic symptoms questionnaire) followed by exposure to a 2-h movie with sound delivered through the HSS emitter followed by a post-exposure assessment. No TTS or new-onset otological symptoms were identified. HSS demonstrates excellent safety in normal hearing subjects under normal use conditions.

The association of smoking and alcohol use with age-related macular degeneration in the oldest old: the Study of Osteoporotic Fractures.

PURPOSE: To estimate the incidence of age-related macular degeneration (AMD) and the association of smoking and alcohol in a population of older women. DESIGN: Prospective cohort study. METHODS: Subjects were women who attended the Study of Osteoporotic Fractures year-10 and year-15 follow-up clinic visits and had fundus photographs taken at both visits (n = 1958; 245 Black and 1713 White subjects; mean age at year 10 visit, 78.2 years). Forty-five degree stereoscopic fundus photographs were graded for AMD. Logistic regression was used to test whether risk factors were associated with incident AMD. RESULTS: The overall 5-year AMD incidence was 24.1% (95% confidence interval [CI], 21.7 to 26.6) for early and 5.7% (95% CI, 4.6 to 6.8) for late. Early AMD incidence in White subjects ranged from 21.9% in those aged 74 to 79 years to 33.2% in those 80 to 84 years, but was observed at the slightly lower rate of 29.0% in subjects > or =85 years (trend P < .0001). After confounder adjustment, alcohol consumption was significantly associated with an elevated risk of incident early AMD (odds ratio [OR], 1.57; 95% CI, 1.18 to 2.11). There was an increased risk of early AMD among subjects aged 80 years or older who were smoking compared to those younger than 80 years who were not smoking (OR, 5.49; 95% CI, 1.57 to 19.20; P for interaction = .026). CONCLUSIONS: The magnitude of the greater-than-additive effect of smoking on the age-adjusted risk of AMD reinforces recommendations to quit smoking even for older individuals.

Postmenopausal hormone therapy and age-related maculopathy in older women.

PURPOSE: To examine the association between postmenopausal hormone therapy and Age-Related Maculopathy (ARM) in older women and to determine if these associations vary by smoking status. METHODS: A cross-sectional analysis of 1065 women of European origin aged > or = 74 years attending the year-10 examination of the Study of Osteoporotic Fractures was performed. Fundus photographs were graded for ARM using a modification of the Wisconsin Age-Related Maculopathy Grading System used in NHANES III. Multiple imputation methods were used to examine the associations of type and duration of postmenopausal hormone therapy use with early and late ARM as well as interactions with smoking history. RESULTS: Compared to never users, Neither estrogen alone (E), Estrogen plus progestin (E+P), nor duration of use was significantly associated with early ARM [odds ratio (OR) E = 1.01, 95% confidence interval (CI) 0.77-1.34; OR E+P = 0.85, 95% CI 0.55-1.35; OR < or = 3 years use = 1.04, 95% CI 0.74-1.47; OR > 3-12 years use = 0.93, 95% CI 0.64-1.35; OR > 12 years use = 0.95, 95% CI 0.65-1.37] or late ARM (OR any E/E+P = 0.59, 95% CI 0.29-1.19; OR < or = 3 years use = 0.73, 95% CI 0.30-1.77; OR > 3 years of use = 0.51, 95% CI 0.22-1.17), though power for late ARM was limited. Tests for smoking interactions were not significant. CONCLUSIONS: This study found no evidence to support an association between use of E, E+P, or duration of use and ARM risk.

Estrogen receptor alpha and matrix metalloproteinase 2 polymorphisms and age-related maculopathy in older women.

In this study, the authors sought to determine whether single nucleotide polymorphisms in the estrogen receptor alpha (ESR1) and matrix metalloproteinase 2 (MMP2) genes are associated with age-related maculopathy (ARM) in older women. Subjects comprised a random sample of Caucasian women aged > or =74 years participating in the Study of Osteoporotic Fractures year 10 follow-up (n = 906) in 1997-1998. Fundus photographs were graded for ARM using a modification of the Wisconsin Age-Related Maculopathy Grading System. The prevalences of early ARM and late ARM were 46% and 4%, respectively. The MMP2 rs2287074 single nucleotide polymorphism (G-->A) was associated with ARM. The A allele was present in 47%, 43%, and 30% of subjects with no, early, and late ARM, respectively (p = 0.01), and was associated with lower odds of any ARM (for AG vs. GG, odds ratio = 0.80, 95% confidence interval: 0.65, 0.99; for AA vs. GG, odds ratio = 0.64, 95% confidence interval: 0.42, 0.98). An interaction with use of postmenopausal hormone therapy was significant (p = 0.02). The MMP2 rs2287074 A allele may be associated with a lower likelihood of ARM in older Caucasian women, particularly those who have never used hormone therapy. The role of MMP2 rs2287074 in ARM should be further elucidated.

Bone mineral density and age-related maculopathy in older women.

OBJECTIVES: To determine whether bone mineral density (BMD) is associated with age-related maculopathy (ARM) risk in older women. DESIGN: Cross-sectional analysis at Year 10 (1997/98) of the Study of Osteoporotic Fractures (SOF). SETTING: Four clinical centers in the United States. PARTICIPANTS: One thousand forty-two randomly sampled SOF participants who attended the Year 10 clinic visit. MEASUREMENTS: ARM status was determined from fundus photographs using a modification of the Wisconsin Age-Related Maculopathy Grading System 6-level severity scale used in the National Health and Nutrition Examination Survey III. Total hip BMD was measured at Year 10 using dual-energy x-ray absorptiometry. Information on potential confounders, including age, reproductive hormone exposures, body mass index, smoking, alcohol consumption, nutrition, education, diabetes mellitus, hypertension, and physical activity, was ascertained with questionnaires. RESULTS: The prevalence of ARM was 50% (46% had early ARM and 4% had late ARM). After potential confounder adjustment, greater BMD was associated with lower odds of ARM (odds ratio (OR) per 1 standard deviation increase in BMD=0.82, 95% confidence interval (CI)=0.70-0.96). Women in the highest quartile of BMD had lower odds of ARM than those in the lowest quartile (OR=0.63, 95% CI=0.41-0.97) and those in the lowest three quartiles combined (OR=0.66, 95% CI=0.48-0.91). CONCLUSION: Higher levels of BMD may be associated with lower risk for ARM. The underlying mechanism is unknown, although BMD may be a marker for lifetime endogenous estrogen exposure. Future studies are needed to replicate these findings and further investigate the nature of the relationship between BMD and ARM.

Self-concept in adult survivors of childhood acute lymphoblastic leukemia: a cooperative Children's Cancer Group and National Institutes of Health study.

BACKGROUND: Self-concept was compared between adult survivors of childhood acute lymphoblastic leukemia (ALL) and sibling controls. Adult survivor subgroups at greatest risk for negative self-concept were identified. PROCEDURE: Survivors (n = 578) aged > or =18 years, treated before age 20 years on Children's Cancer Group (CCG) ALL protocols, and 396 sibling controls completed a telephone interview and the Harter Adult Self-Perception Profile (ASPP). RESULTS: Survivors global self-worth scores were significantly lower than sibling controls (mean 3.09 vs. 3.18; P = 0.022). Unemployed survivors reported lower global self-worth scores than employed (mean 2.77 vs. 3.12; P = 0.0001), whereas employment status was not associated with self-worth in controls. Among survivors, predictors of negative self-concept included unemployment (odds ratio (OR) = 2.87; 95% CI: 1.50-5.50), and believing that cancer treatment limited employability (OR = 3.17; 95% CI: 1.79-5.62). Unemployment increased the odds for negative self-concept among survivors who received combinations of central nervous system (CNS) irradiation (CRT) and intrathecal methotrexate (IT-MTX), except high CRT with no or low dose IT-MTX. Employed survivors who perceived that treatment limited their employability showed increased odds of negative self-concept for all treatment groups compared to those who did not. Minority ethnic group membership was a borderline significant predictor of negative self-concept (OR = 1.79; 95% CI: 0.94-3.33). CONCLUSIONS: Global self-worth was significantly lower in ALL survivors than sibling controls, however, 81% of survivors had positive self-concept. Survivor subgroups most vulnerable to negative self-concept were the unemployed survivors, believing that cancer treatment affected employability, and ethnic minority group members. Targeted intervention may have greater clinical relevance for these subgroups.