Breast density reporting in Aotearoa New Zealand: policy imperatives and research priorities.

Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman’s breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.

A fter more than 20 years of regulating mammography facilities, the US Food and Drug Administration (FDA) recently proposed several policy changes that would update mammography quality standards, strengthen the agency's ability to address violations, and expand the amount of information that facilities are required to provide to patients and physicians. The changes would amend current regulations under the Mammography Quality Standards Act of 1992, which enables the FDA to oversee facilities that conduct mammograms through accreditation, certification, and annual inspections. The comment period for the proposed rules ended on June 26, 2019, and FDA officials will review submitted remarks before publishing a final rule. New regulations will become effective 18 months after publication.

Introduction: Socioeconomic, racial and ethnic disparities in the awareness and knowledge of dense breast notification (DBN) legislation have been documented, but its effect on women’s cognitive and emotional appraisal of the notification information which affect screening behavior remains unknown. Ambiguous screening and follow-up care for women with dense breasts may allow DBN to increase women’s anxiety, perceptions of risk, and worry, with unclear consequences for future screening decisions. We examined short- and long-term psychological responses to DBN and awareness of breast density (BD) by education, health literacy, nativity and dominant language. Methods: In a predominantly Latina and foreign-born New York City screening cohort (63% Spanish-speaking), ages 40-60, we assessed breast cancer worry, perceived absolute and comparative breast cancer risk, and uncertainties about breast cancer risk and screening choices, in short (approximately 1-3 months) and long-term (approximately 9-18 months) surveys following the enrollment screening mammogram (between 2016-2018). We compared psychological responses by women’s dense breast status (as proxy for DBN receipt) and BD awareness using cumulative, binary, and multinomial logistic regression. We examined multiplicative interaction by education, health literacy, nativity, and interview language. Results: In multivariable models using short-term surveys, BD awareness was associated with increased absolute perceived risk (Odds Ratio (OR): 2.27, 95% Confidence Interval (CI): 0.99, 5.20 for high, OR: 2.19, 95% CI: 1.34, 3.58 for moderate, vs. low risk) in the overall sample, and with increased uncertainty about risk (OR: 1.97 per 1-unit increase, 95% CI: 1.15, 3.39) and uncertainty about screening choices (OR: 1.73 per 1-unit increase, 95% CI: 1.01, 2.9) in women who are Spanish-dominant. DBN was associated with decreased perceived risk among women with at least some college education (OR: 0.32, 95% CI: 0.11, 0.89, for high, OR: 0.50, 95% CI 0.29, 0.89, for moderate vs. low risk) while those with a high school education or less experienced an increase (OR: 3.01, 95% CI: 1.05, 8.67 high vs. low risk). There were no associations observed between DBN or BD awareness and short-term breast cancer worry, nor with any psychological outcomes at long-term surveys. Conclusions: Associations of BD awareness and notification with breast cancer related psychological outcomes differed by education and language and were limited to short term increases in perceived absolute breast cancer risk and uncertainty around breast cancer risk and screening choices. Women with lower educational attainment or language barriers could specifically benefit from outreach to clarify the implications of breast density and reduce uncertainty around risk and screening choices. Citation Format: Erica J. Lee Argov, Carmen B. Rodriguez, Mariangela Agovino, Ying Wei, Rachel C. Shelton, Rita Kukafka, Karen M. Schmitt, Elise Desperito, Mary Beth Terry, Parisa Tehranifar. Breast cancer worry, uncertainty, and perceived risk following breast density notification in a longitudinal mammography screening cohort vary by educational attainment and dominant language [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B011.

Little is known about whether women residing in states with mandated dense breast notification (DBN) have improved awareness, knowledge, or discussion with their doctors, or whether there are disparities by sociodemographic characteristics. We conducted a cross-sectional, national telephone survey to assess the primary outcomes intended by DBN legislation: informing women about personal breast density, increasing awareness of its making effect and association with increased cancer risk, and prompting discussions with providers. Specific efforts were made to include women from all race/ethnic groups, education strata, and literacy levels. Women aged >40 reporting a mammogram in <2 years, with no prior breast cancer diagnosis and having heard of the term ‘breast density’ were eligible. We conducted chi-square analyses for each outcome, comparing each by state DBN legislation status, age, income, race/ethnicity, health literacy, and two clinical breast cancer risk factors (family history, prior breast biopsy). Paired comparisons within each sociodemographic factor were tested using Z-tests (α=0.05). Multivariable, binary logistic regressions predicted each outcome using all variables above entered simultaneously as predictors. Secondary analyses tested whether sociodemographic differences in outcomes were moderated by state DBN status via interaction terms. The sample included 2,306 women; 1,782 residing in DBN states and 524 in non-DBN states. Half of the participants were white (50.3%), 23.1% non-Hispanic black, 14% Hispanic, 8.2% Asian, and 4.4% ‘other’. Women in DBN states were 1.55 (95% CI = 1.20, 1.99) times more likely to have received personal breast density information compared to women in non-DBN states after controlling for sociodemographic and risk factors. Those with lower incomes, Asian women, and those with lower health literacy were less likely to report receiving personal breast density information. Overall, 39% had a discussion with their provider about breast density, with women in DBN states being 1.82 times more likely to have done so (95% CI= 1.40, 2.37). There were no differences between women in DBN vs. non-DBN states related to knowledge of masking bias (OR=.99, 0.71, 1.39) or understanding that breast density is a cancer risk factor (OR=0.93, 0.71, 1.22). Hispanic and lower income women had less knowledge about these topics. Interaction models failed to reveal moderating effects of state DBN status, indicating that DBN legislation does not appear to be mitigating or worsening the observed sociodemographic differences. Findings suggest that mandated DBNs have had partial success informing women about their breast density. However, we saw few indications that DBNs increased knowledge and observed less knowledge among women with low income, racial/ethnic minority status and lower literacy. This ‘one size fits all’ policy approach to relaying breast density information appears to be inadequate in reducing disparities in breast density awareness and knowledge. Citation Format: Nancy R. Kressin, Jolie Wormwood, Tracy A. Battaglia, Priscilla J. Slanetz, Christine M. Gunn. Mixed success and persistent disparities in outcomes related to breast density legislation: A national survey [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-079.

Nationally legislated dense breast notification (DBN) informs women of their breast density (BD) and the impact of BD on breast cancer risk and detection, but consequences for screening participation are unclear. We evaluated the association of DBN in New York State (NYS)with subsequent screening mammography in a largely Hispanic/Latina cohort. Women aged 40-60 were surveyed in their preferred language (33% English, 67% Spanish) during screening mammography from 2016 to 2018. We used clinical BD classification from mammography records from 2013 (NYSDBN enactment) through enrollment (baseline) to create a 6-category variable capturing prior and new DBN receipt (sent only after clinically dense mammograms). We used this variable to compare the number of subsequent mammograms (0, 1, ≥ 2) from 10 to 30months after baseline using ordinal logistic regression. In a sample of 728 women (78% foreign-born, 72% Hispanic, 46% high school education or less), first-time screeners and women who received DBN for the first timeafter prior non-dense mammograms had significantly fewer screening mammograms within 30months of baseline (Odds Ratios range: 0.33 (95% Confidence Interval (CI) 0.12-0.85) to 0.38 (95% CI 0.17-0.82)) compared to women with prior mammography but no DBN. There were no differences in subsequent mammogram frequency between women with multiple DBN and those who never received DBN. Findings were consistent across age, language, health literacy, and educationgroups. Women receiving their first DBN after previous non-dense mammograms have lower mammography participation within 2.5years. DBN has limited influence on screening participation of first-time screeners and those with persistent dense mammograms.

BackgroundDense breast notification (DBN) legislation aims to increase a woman’s awareness of her personal breast density and the implications of having dense breasts for breast cancer detection and risk. This information may adversely affect women’s breast cancer worry, perceptions of risk, and uncertainty about screening, which may persist over time or vary by sociodemographic factors. We examined short- and long-term psychological responses to DBN and awareness of breast density (BD).MethodsIn a predominantly Hispanic New York City screening cohort (63% Spanish-speaking), ages 40–60 years, we assessed breast cancer worry, perceived breast cancer risk, and uncertainties about breast cancer risk and screening choices, in short (1–3 months)- and long-term (9–18 months) surveys following the enrollment screening mammogram (between 2016 and 2018). We compared psychological responses by women’s dense breast status (as a proxy for DBN receipt) and BD awareness and examined multiplicative interaction by education, health literacy, nativity, and preferred interview language.ResultsIn multivariable models using short-term surveys, BD awareness was associated with increased perceived risk (odds ratio (OR) 2.27, 95% confidence interval (CI) 0.99, 5.20 for high, OR 2.19, 95% CI 1.34, 3.58 for moderate, vs. low risk) in the overall sample, and with increased uncertainty about risk (OR 1.97 per 1-unit increase, 95% CI 1.15, 3.39) and uncertainty about screening choices (OR 1.73 per 1-unit increase, 95% CI 1.01, 2.9) in Spanish-speaking women. DBN was associated with decreased perceived risk among women with at least some college education (OR 0.32, 95% CI 0.11, 0.89, for high, OR 0.50, 95% CI 0.29, 0.89, for moderate vs. low risk), while those with a high school education or less experienced an increase (OR 3.01, 95% CI 1.05, 8.67 high vs. low risk). There were no associations observed between DBN or BD awareness and short-term breast cancer worry, nor with any psychological outcomes at long-term surveys.ConclusionsAssociations of BD awareness and notification with breast cancer-related psychological outcomes were limited to short-term increases in perceived breast cancer risk dependent on educational attainment, and increases in uncertainty around breast cancer risk and screening choices among Spanish-speaking women.

Introduction of breast density notification within BreastScreen South Australia - Results of an online client survey.

State-specific breast density notification legislation requires that women undergoing mammography be informed about breast density, with variation among states. Because mammography facilities are among the main points of contact for women undergoing mammography, research is needed to understand how facilities communicate information on breast density, cancer risk, and supplemental screening to women. A cross-sectional, 50-item, mailed survey of 156 American College of Radiology-certified mammography facilities in North Carolina was conducted in 2017 via the Tailored Design Method. Breast density notification practices, supplemental screening services, and patient educational materials were compared by supplemental screening availability via t tests and chi-square tests. All responding facilities (n=94; 60.3% response rate) notified women of their breast density in the mammography results letter. Breast cancer risk assessments were performed by 36.2% of the facilities, with risk information communicated in the final radiology report for the referring provider to discuss with the woman (79.4%) or in the results letter (58.8%). Supplemental breast cancer screening was offered by 63.8% of the facilities, with use based on multiple factors, including recommendations from the referring physician (63.3%) or reading radiologist (63.3%), breast density (48.3%), other risk factors (48.3%), and patient request (40.0%). Although 75.0% of the facilities offered breast density educational materials, only 36.6% offered educational materials on supplemental screening. In a state with a breast density notification law, mammography facilities communicate breast density, cancer risk, and supplemental screening information to women through various approaches. When supplemental screening is offered, facilities use multiple decision-making criteria rather than breast density alone.

To date, 38 states have enacted dense breast notification (DBN) laws mandating that mammogram reports include language informing women of risks related to dense breast tissue. Nationally representative survey to assess the association between residing in a state with a DBN law and women's awareness and knowledge about breast density, and breast cancer anxiety. Internet survey conducted in 2018 with participants in KnowledgePanel®, an online research panel. English-speaking US women ages 40-59years without a personal history of breast cancer who had received at least one screening mammogram (N = 1928; survey completion rate 68.2%). (1) Reported history of increased breast density, (2) knowledge of the increased risk of breast cancer with dense breasts, (3) knowledge of the masking effect of dense breasts on mammography, and (4) breast cancer anxiety. Women residing in DBN states were more likely to report increased breast density (43.6%) compared with women residing in non-DBN states (32.7%, p < 0.01, adjusted odds ratio, 1.70, 95% CI,1.34-2.17). Interaction effect between DBN states and education status showed that the impact of DBN on women's reporting of dense breasts was significant for women with greater than high school education, but not among women with a high school education or less (p value = 0.01 for interaction). Only 23.0% of women overall knew that increased breast density was associated with a higher risk of breast cancer, and 68.0% of women understood that dense breasts decreased the sensitivity of mammography. There were no significant differences between women in DBN states and non-DBN states for these outcomes, or for breast cancer-related anxiety. State DBN laws were not associated with increased understanding of the clinical implications of breast density. DBN laws were associated with a higher likelihood of women reporting increased breast density, though not among women with lower education.

Background:New York State law mandates that women with dense breasts receive a written notification of their breast density (BD) and its implications, but data on the impact of dense breast notification (DBN) on BD awareness and knowledge in diverse populations remain limited.Methods:Between 2016 and 2018, we collected survey and mammographic data from 666 women undergoing screening mammography in New York City (ages 40–60, 80% Hispanic, 69% Spanish-speaking) to examine the impact of prior DBN on BD awareness by sociodemographic and breast cancer risk factors, and describe BD knowledge by sources of information.Results:Only 24.8% of the overall sample and 34.9% of women receiving DBN had BD awareness. In multivariable models adjusting for DBN, awareness was significantly lower in women who were Spanish-speaking [OR, 0.16; 95% confidence interval (CI), 0.09–0.30 vs. English speakers], were foreign-born (OR, 0.31; 95% CI, 0.16–0.58 vs. U.S.-born), and had lower educational attainment (e.g., high school degree or less; OR, 0.14; 95% CI, 0.08–0.26 vs. college or higher degree). Women receiving DBN were more likely to be aware of BD (OR, 2.61; 95% CI, 1.59–4.27) but not more knowledgeable about the impact of BD on breast cancer risk and detection. However, women reporting additional communication about their BD showed greater knowledge in these areas.Conclusions:DBN increases BD awareness disproportionately across sociodemographic groups.Impact:Efforts to improve communication of DBN must focus on addressing barriers in lower socioeconomic and racially and ethnically diverse women, including educational and language barriers.

Background: Most U.S. states require written notification of breast density after mammograms, yet effects of notifications on knowledge are mixed. Little is known about potential misunderstandings. Methods: We used a sequential mixed-methods study design to assess women's knowledge about breast density, after receiving a notification. We conducted a telephone survey among a racially/ethnically and health-literacy level diverse sample (N = 754) and qualitative interviews with 61 survey respondents. Results: In survey results, 58% of women correctly indicated that breast density is not related to touch, with higher accuracy among non-Hispanic White women and those with greater health literacy. Next, 87% of women recognized that breast density is identified visually via mammogram, with no significant differences in responses by race/ethnicity or health literacy. Most (81%) women recognized that a relationship exists between breast tissue types and density; Non-Hispanic White women were less likely to respond correctly. Only 47% of women correctly indicated that having dense breasts increases one's risk of breast cancer; women with low health literacy were more often correct. Qualitative results revealed additional dimensions of understanding: Some women incorrectly reported that density could be felt, or dense breasts were lumpier, thicker, or more compacted; others identified "dense" tissue as fatty. Interpretations of risk included that breast density was an early form of breast cancer. Conclusion: We found areas of consistent knowledge and identified misperceptions surrounding breast density across race/ethnicity and health literacy levels. Further education to address disparities and correct misunderstandings is essential to promote better knowledge, to foster informed decisions.

Whether the benefits of notifying women about breast density outweigh the potential harms to inform current and future mammogram screening practice remains unknown. To assess the effect of mammographic breast density notification and information provision on women's intention to seek supplemental screening and psychological outcomes. A 3-arm online randomized clinical trial was conducted from August 10 to 31, 2021. Data analysis was conducted from September 1 to October 20, 2021. Participants included Australian residents identifying as female, aged between 40 and 74 years, with no history of breast cancer who were residing in jurisdictions without existing breast density notification with screening mammograms. Women were randomized to receive 1 of the following hypothetical breast screening test result letters: screening mammogram result letter without breast density messaging (control), screening mammogram result letter with breast density messaging and an existing density information letter taken from a screening service in Australia (intervention 1), and screening mammogram result letter with breast density messaging and a health literacy-sensitive version of the letter adapted for people with lower health literacy (intervention 2). Primary outcomes were intention to seek supplemental screening; feeling anxious (uneasy, worried, or nervous), informed, or confused; and having breast cancer worry. A total of 1420 Australian women were randomized and included in the final analysis. The largest group consisted of 603 women aged 60 to 74 years (42.5%). Compared with the control cohort (n = 480), women who received density notification via intervention 1 (n = 470) and intervention 2 (n = 470) reported a significantly higher intention to seek supplemental screening (0.8% vs 15.6% and 14.2%; P < .001) and feeling anxious (14.2% vs 49.4% and 48.5%; P < .001), confusion (7.8% vs 24.0% and 23.6%; P < .001), and worry about breast cancer (quite/very worried: 6.9% vs 17.2% and 15.5%; P < .001). There were no statistically significant differences in these outcomes between the 2 intervention groups. In this randomized clinical trial, breast density notification and information integrated with screening mammogram results increased women's intention to seek supplemental screening and made women feel anxious, confused, or worried about breast cancer. These findings have relevance and implications for mammogram screening services and policy makers considering whether and, if so, how best to implement widespread notification of breast density as part of mammography screening. ACTRN12621000253808.

Dense breast notification laws enacted in over 35 states mandate written disclosure of information to women with high mammographic breast density (high MBD), as defined by the heterogeneously or extremely dense breast classification of the Breast Imaging-Reporting and Data System. In most states, the notification informs women with high MBD about higher breast cancer (BC) risk and lower sensitivity of mammography in women with dense breasts. It also advises women to consult their doctors about their risk and any need for additional imaging. We examined personal history of high MBD in relation to breast density awareness, and BC-related emotional (BC worry) and cognitive (perceived BC risk and mammogram benefits) factors. We further investigated whether these associations varied by race/ethnicity, educational attainment and language proficiency in 649 women presenting for screening mammography (40-60 years, 80% Hispanic, 47% high school or less education, 70% Spanish speaking). Only 24% of women reported having heard of breast density (awareness), of whom, 68% correctly reported a personal history of high MBD, but only 23% reported having initiated a discussion about breast density with their physicians. In multivariable models, breast density awareness was higher for women with a history of high MBD (OR=2.4, 95% CI: 1.5, 4.0), a history of follow-up after screening mammography for any reason (e.g., multiple recalls vs none OR=4.2, 95% CI: 1.9, 9.6), and family history of BC (OR=2.0, 95% CI: 1.0, 3.9). In the same multivariable model, awareness was lower for women who were foreign-born (e.g., OR=0.3, 95% CI: 0.2, 0.6 vs U.S.-born), Spanish speaking (OR=0.2, 95% CI: 0.1, 0.4 vs English speaking), and had lower education (e.g., OR=0.1, 95% CI: 0.1, 0.3 high school or less vs college vs higher degree). High MBD was associated with increased breast density awareness in all racial/ethnic, nativity, educational, and language proficiency groups. Breast cancer-related psychological outcomes differed only by breast density awareness but not by high MBD history. Women with breast density awareness reported higher worry (e.g., OR=2.5, 95% CI: 1.6, 3.9 for sometimes vs rarely/never worry), and higher absolute and comparative perceived BC risk (e.g., OR=2.8, 95% CI: 1.6, 5.0 for more risk vs less risk compared to average women). Women who knew about breast density also perceived less mammography benefits for earlier detection of breast tumors (OR=0.2, 95% CI: 0.1, 0.5) and reduced BC mortality (OR=0.4, 95% CI: 0.2, 0.6). In conclusion, dense breast notification to women with high MBD increases general and personal awareness of breast density; however, awareness remains low in women with racial/ethnic minority and lower socioeconomic backgrounds due to lower prevalence of dense breasts in these population groups. Dense breast notification increases feelings of worry and perceptions of future risk of breast cancer and reduces perceptions of mammography benefits, which may affect breast cancer screening participation. Citation Format: Mariangela D. Agovino, Carmen B. Rodriguez, Mary Beth Terry, Rachel Shelton, Karen Schmitt, Elise Desperito, Ying Wei, Rita Kukafka, Parisa Tehranifar. Dense breast notification, breast density awareness, and breast cancer-related cognition and emotions in a predominantly Hispanic screening population [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C095.

Influences of race and breast density on related cognitive and emotion outcomes before mandated breast density notification

What effect does mammographic breast density have on lesion detection in digital mammography?