Harms Of Breast Cancer Screening Research Articles

Abstract 3449: Is AI-enhanced breast ultrasound ready for breast cancer screening in low-resource environments? A systematic review

Abstract Purpose. Screening mammography is unavailable in many low-resource areas. We ask if the state-of-the-art in artificial intelligence (AI)-enhanced breast ultrasound (BUS) is sufficiently accurate to be used for primary breast cancer screening in low-resource regions. Background. Since the 1980s, high-income countries have implemented mammographic screening programs, leading to breast cancer mortality reduction in screened women.1 Mammography is unavailable in many low-resource regions, such as the USAPI. Furthermore, travel difficulties and lack of radiologists hinder implementation. AI combined with portable BUS may address limitations of the high-income paradigm. In this systematic review, we ask if AI-enhanced BUS can detect/segment lesions (Objective 1) and classify lesions as cancerous (Objective 2). Methods. Two reviewers independently assessed articles from 1/1/2016 to 8/6/2023 from PubMed, Google Scholar, and citation searching. Studies which report on AI development and report performance on a patient-wise, held-out test set met the inclusion criteria. Studies were characterized by AI task and clinical application time. Dataset composition and performance were examined via narrative data synthesis. QUADAS-2 bias assessment was performed using criteria for each AI task. Success in (2) is defined by meeting minimum screening performance guidelines.2,3 Results. PubMed yielded 281 studies, Google Scholar yielded 225 studies, and a manual citation search yielded 41 studies. From 382 unique full texts evaluated, 52 articles met all inclusion criteria: 3 frame selection, 2 real-time detection, 2 combination, 14 segmentation-only, and 31 classification-only. Lesion segmentation-only models achieved a 90th percentile Dice similarity coefficient of 0.913 on generally small datasets. The best evidence for lesion cancer classification reported 0.976 area under the curve. All studies faced elevated bias and applicability concerns under QUADAS-2. Conclusion. Reported performance for (1) is insufficient to introduce AI-enhanced BUS for breast cancer screening. Evidence supporting AI-enhanced BUS for (2) is dependent on few studies relying on internal datasets, limiting generalizability. Geographically diverse clinical trials are needed to confirm and improve robustness of performance of AI-enhanced BUS for (1) and (2). References. 1. Marmot MG, et al. The benefits and harms of breast cancer screening: an independent review. British journal of cancer. 2013;108(11):2205-2240. 2. Lehman CD, et al. National Performance Benchmarks for Modern Screening Digital Mammography: Update from the Breast Cancer Surveillance Consortium. Radiology. 2017-04-01 2017;283(1):49-58. doi:10.1148/radiol.2016161174 3. Rosenberg RD, et al. Performance Benchmarks for Screening Mammography. Radiology. 2006-10-01 2006;241(1):55-66. doi:10.1148/radiol.2411051504 Citation Format: Arianna Bunnell, Dustin Valdez, Fredrik Strand, Yannik Glaser, Peter Sadowski, John A. Shepherd. Is AI-enhanced breast ultrasound ready for breast cancer screening in low-resource environments? A systematic review [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3449.

Benefits and harms of breast cancer screening revisited: a large, retrospective cross-sectional study quantifying treatment intensity in women with screen-detected versus non-screen-detected cancer in Australia and New Zealand

ObjectivesNon-mortality benefits of breast cancer screening are rarely considered in assessments of benefits versus harms. This study aims to estimate the rate of overdiagnosis in women with screen-detected breast cancer...

Benefits and harms of breast cancer screening: Cohort study of breast cancer mortality and overdiagnosis.

Quantifying the benefits and harms of breast cancer screening accurately is important for planning and evaluating screening programs and for enabling women to make informed decisions about participation. However, few cohort studies have attempted to estimate benefit and harm simultaneously. We aimed to quantify the impact of mammographic screening on breast cancer mortality and overdiagnosis using a cohort of women invited to attend Australia's national screening program, BreastScreen. In a cohort of 41,330 women without prior breast cancer diagnosis, screening, or diagnostic procedures invited to attend BreastScreen Western Australia in 1994-1995, we estimated the cumulative risk of breast cancer mortality and breast cancer incidence (invasive and ductal carcinoma in situ) from age 50 to 85 years for attenders and non-attenders. Data were obtained by linking population-based state and national health registries. Breast cancer mortality risks were estimated from a survival analysis that accounted for competing risk of death from other causes. Breast cancer risk for unscreened women was estimated by survival analysis, while accounting for competing causes of death. For screened women, breast cancer risk was the sum of risk of being diagnosed at first screen, estimated using logistic regression, and risk of diagnosis following a negative first screen estimated from a survival analysis. For every 1,000 women 50 years old at first invitation to attend BreastScreen, there were 20 (95% CI 12-30) fewer breast cancer deaths and 25 (95% CI 15-35) more breast cancers diagnosed for women who attended than for non-attendees by age 85. Of the breast cancers diagnosed in screened women, 21% (95% CI 13%-27%) could be attributed to screening. The estimated ratio of benefit to harm was consistent with, but slightly less favourable to screening than most other estimates from cohort studies. Women who participate in organised screening for breast cancer in Australia have substantially lower breast cancer mortality, while some screen-detected cancers may be overdiagnosed.

Challenges and Changes of the Breast Cancer Screening Paradigm.

Since four decades mammography is used for early breast cancer detection in asymptomatic women and still remains the gold standard imaging modality. However, population screening programs can be personalized and women can be divided into different groups based on risk factors and personal preferences. The availability of new and evolving imaging modalities, for example, digital breast tomosynthesis, dynamic-contrast-enhanced magnetic resonance imaging (MRI), abbreviated MRI protocols, diffusion-weighted MRI, and contrast-enhanced mammography leads to new challenges and perspectives regarding the feasibility and potential harms of breast cancer screening. The aim of this review is to discuss the current guidelines for different risk groups, to analyze the recent published studies about the diagnostic performance of the imaging modalities and to discuss new developments and future perspectives. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY: Stage 6.

Factors affecting intention to screen after being informed of benefits and harms of breast cancer screening: a study in 5 European countries in 2021

BackgroundParticipation in mammography screening comes with harms alongside benefits. Information about screening provided to women should convey this information yet concerns persist about its effect on participation. This study addressed factors that may influence the intention to screen once a woman has been informed about benefits and harms of participation.MethodsA cross-sectional survey of women from five countries (Belgium, France, Italy, Spain, and the United Kingdom) was performed in January 2021. The survey contained a statement regarding the benefits and harms of mammography screening along with items to measure cognitive variables from the theory of planned behaviour and health belief model and the 6-item version of the European Health Literacy Survey Questionnaire (HLS-EU-Q6). Logistic regression and mediation analysis were performed to investigate the effect of cognitive and sociodemographic variables.ResultsA total of 1180 participants responded to the survey. 19.5% of participants (n = 230) were able to correctly identify that mammography screening carries both benefits and harms. 56.9% of participants (n = 672) responded that they would be more likely to participate in screening in the future after being informed about the benefits and harms of mammography screening. Perceived behavioural control and social norms demonstrated were significant in predicting intention, whereas, the effect of health literacy was limited.ConclusionsInforming women about the presence of benefits and harms of in mammography screening participation did not negatively impact upon intention to be screened. Information should also address perception on implementation factors alongside messages on benefits and harms. Overall, screening programme managers should not be discouraged by the assumption of decreased participation through increasing efforts to address the lack of knowledge on benefits and harms.

Abstract PO-257: Prevalence and correlates of false-positive results in screening mammography among uninsured women in a community outreach program

Abstract Introduction: False-positive mammographic screening results are one of the most important harms of breast cancer screening, and their prevalence in the insured population range from 8.7% to 16.3% during the first screening encounter. However, false-positive results have been rarely investigated among uninsured minority women screened through community outreach programs. For this study, we analyzed data from the Breast Screening and Patient Navigation (BSPAN) program participants with an aim to report prevalence and assess correlates of false-positive results in screening mammograms, stratified by age. Methods: BSPAN, created by Moncrief Cancer Institute, contracts with the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and uses a hub-and-spoke model to provide patient navigation and no-cost breast cancer screening and diagnostic services to under- and uninsured predominantly minority women in North Texas. We defined false-positive result as a positive screening mammogram (BI-RADS 0, 3, 4 or 5) followed by a negative diagnostic mammogram (BI-RADS 1, 2 or 3) or a negative biopsy within 9 months of the screen. We used multivariable logistic regression to assess associations of demographic and clinical covariates with false positive results for each age group (40-49 years and 50-64 years, which coincides with age eligibility for NBCCEDP). Results: BSPAN provided screening services to 21,022 women between 2012 and 2019. Prevalence of false-positive results in these women was 11.8% in the 40-49 age group and 9.6% in the 50-64 age group. Multivariable logistic regression demonstrated that, in the 40-49 age group, women who were non-menopausal, did not use hormone replacement therapy, and had prior mammograms had higher odds of false-positive results than those who were menopausal, used hormone replacement therapy and had no prior mammograms, respectively. In the 50-64 age group, women with a prior diagnostic mammogram had higher odds of false-positive results than those without a prior diagnostic mammogram. Discussion: This study establishes contemporary evidence regarding prevalence and correlates of false-positive rates in the unique BSPAN population, where women were predominantly Hispanic, under- and uninsured receiving no-cost screening and diagnostic services through a real-world outreach program. Our findings demonstrate that uninsured women who receive no-cost mammograms are similar to insured women in two aspects: prevalence of false-positive rates in our study is comparable to those among insured population, and we found higher false positive rates among younger women, compared to older women. Impact: Equitable screening outcomes in underserved population emphasizes the need for efforts to reduce false-positive screening rates among uninsured women served through community outreach programs. Citation Format: Rasmi G. Nair, Simon J. Craddock Lee, Hong Zhu, Firouzeh K. Arjmandi, Emily Berry, Keith E. Argenbright, Jasmin A. Tiro, Celette S Skinner. Prevalence and correlates of false-positive results in screening mammography among uninsured women in a community outreach program [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-257.

Reflecting on 20 years of breast cancer modeling in CISNET: Recommendations for future cancer systems modeling efforts.

Since 2000, the National Cancer Institute’s Cancer Intervention and Surveillance Modeling Network (CISNET) modeling teams have developed and applied microsimulation and statistical models of breast cancer. Here, we illustrate the use of collaborative breast cancer multilevel systems modeling in CISNET to demonstrate the flexibility of systems modeling to address important clinical and policy-relevant questions. Challenges and opportunities of future systems modeling are also summarized. The 6 CISNET breast cancer models embody the key features of systems modeling by incorporating numerous data sources and reflecting tumor, person, and health system factors that change over time and interact to affect the burden of breast cancer. Multidisciplinary modeling teams have explored alternative representations of breast cancer to reveal insights into breast cancer natural history, including the role of overdiagnosis and race differences in tumor characteristics. The models have been used to compare strategies for improving the balance of benefits and harms of breast cancer screening based on personal risk factors, including age, breast density, polygenic risk, and history of Down syndrome or a history of childhood cancer. The models have also provided evidence to support the delivery of care by simulating outcomes following clinical decisions about breast cancer treatment and estimating the relative impact of screening and treatment on the United States population. The insights provided by the CISNET breast cancer multilevel modeling efforts have informed policy and clinical guidelines. The 20 years of CISNET modeling experience has highlighted opportunities and challenges to expanding the impact of systems modeling. Moving forward, CISNET research will continue to use systems modeling to address cancer control issues, including modeling structural inequities affecting racial disparities in the burden of breast cancer. Future work will also leverage the lessons from team science, expand resource sharing, and foster the careers of early stage modeling scientists to ensure the sustainability of these efforts.

Abstract SP006: Weighing the benefits and harms of breast cancer screening

Abstract Screening efficiency is the balance between health benefits and harms associated with screening. The balance sheet for breast screening needs to assess the benefits and harms associated with screening mammography, clinical breast examinations, adjunct imaging techniques (e.g., MRI, ultrasonography), biopsy procedures and therapies. Different groups have estimated the harm and benefit balance within the European and in the USA contexts. The contrasts in benefits estimated by different groups for the European context are glaringly obvious. The estimations of Loberg et al, 2015 and of the Research Council of Norway are comparable (Table). In these two reviews, the number of breast cancer death averted is derived from meta-analyses of randomised trials. Using pooled data from observational studies, the EuroScreen group obtained a 2 to 3-fold greater number of breast cancer deaths prevented by screening. Estimates for Europe are more convergent for false positive recalls and unnecessary biopsies. But estimates for overdiagnosis strongly differ because the EuroScreen group favoured results of studies that adjusted for lead-time, a controversial statistical manoeuvre that drastically reduces numbers of overdiagnosed breast cancer cases. The Table also highlights the salient contrasts in the harm-benefit balance between Europe and the USA. The substantial additional harm in the USA is documented by extensive data. In Europe, biennial screening between 50 and 69 years of age would result in 10 screening sessions. In the USA, women aged 40 to 74 years may attend up to 25 to 35 mammography screening sessions. As a consequence, it has been estimated that after 10 years of annual screening, one of two of screened US women have at least 1 false-positive mammogram result, whereas with triennial screening, one of eight 8 screened English women will have false positive result after 10 years. Of note, the cancer detection rates are similar in the European and in the US contexts, and declines in breast cancer mortality over time have been similar in the USA and high-income European countries, irrespective of the breast screening policies in place in European countries (e.g., high screening attendance since 1988 in the Netherlands vs. low screening attendance in Switzerland). So, the greater aggregated harm experienced by US women seems not compensated by a superior health benefit. A major limitation of harm-to-benefit balance studies done so far is the ignorance of the increasing potency of therapies. Randomised trials on breast screening were performed at a time effective therapies were non-existent or recently introduced. Because of the advent of effective therapies, more women need to be screened for preventing one death from breast cancer. In 2020, it could well be that breast cancer deaths averted thanks to screening displayed in the Table could be halved. However, the harms due to screening are not reduced by treatment improvement. Hence increasingly potent therapies steadily reduce the benefits from screening while keeping harms at the same level. This situation was similar for testis cancer, where the high effectiveness of cis-platinum based therapies, even for metastatic cancer, has rendered screening obsolete. Summary of harms and benefits of breast screeningEuropean contextUSA contextEuroscreen Paci et al, 2014 [3]Loberg et al, 2015 [1]Norway Research council of Norway, 2015 [4]Welch et al, 2014 [2]1,000 women screened every two years from 50 to 69 years, and followed until age 791,000 women screened every two years for 20 years starting at age 501,000 women offered 10 screening rounds starting a age 50 and followed until death1,000 women screened every year for 20 years starting at age 501,000 women screened every year for 30 years starting at age 40BenefitsAll-cause deaths avertedNR0NR00Breast cancer deaths averted7 to 92 †2.70.8 to 8.1 ‡0.9 to 9.7‡HarmsFalse positive recalls170200152880 to 12101390 to 1900Unnecessary biopsies303031130 to 170190 to 260Interval cancersNR3013--Overdiagnosed cancers needlessly treated41514.29 to 3410 to 45NR: not reported * Pooled analysis of IBM and of case-control studies † Breast cancer mortality reduction according to meta-analyses of randomised trials ‡ Taking results of the Swedish Two-county trial (Tabar et al, 1985 [16]) as the most optimistic scenario 1. Loberg M, Lousdal ML, Bretthauer M, Kalager M. Benefits and harms of mammography screening. Breast Cancer Res 2015;17:63. 2. Welch HG, Passow HJ. Quantifying the benefits and harms of screening mammography. JAMA Intern Med 2014;174(3):448-54. 3. Paci E, Broeders M, Hofvind S, Puliti D, Duffy SW, Group tEW. European Breast Cancer Service Screening Outcomes: A First Balance Sheet of the Benefits and Harms. Cancer Epidemiology Biomarkers & Prevention 2014;23(7):1159-1163. 4. The Research Council of Norway. Research-based evaluation of the Norwegian Breast Cancer Screening Program, Final report: Evaluation Division for Society and Health, www.forskningsradet.no/publikasjoner; 2015. Citation Format: P Autier. Weighing the benefits and harms of breast cancer screening [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SP006.

"Donnainformata-mammografia": a decision aid developed and validated in the Italian setting

The decision aid "Donnainformata-mammografia" (https://www.donnainformata-mammografia.it/en/) has been developed with the aim of providing clear information on the benefits and harms of breast cancer screening, and the controversies on the relationship between mortality reduction and overdiagnosis. It was evaluated in a randomized clinical trial showing it increases informed choice and does not decrease participation in screening.This article describes the framework, the guiding principles, and the operational phases of the tool development.The project was developed within the national screening programme. The promoters decided to state their placement, to start from the information needs of women and what is already known, and to balance spontaneous navigation with "nudging" to key contents. Three focus groups with 18 women and 4 interviews were organized. Participants expressed a favourable attitude towards screening, and no knowledge of the debate on screening efficacy and overdiagnosis. A literature review and a comparison of decision aids were conducted. The online tool included the results of these steps. The home page presents key information with links to relevant topics, so that the person can decide to stop there having an overview or to continue. The «ready to decide» button, which leads to the section of decision support, can be clicked on every page. Here, the person can evaluate a list of key points on the basis of her values, in order to decide to participate in screening or not.

Elección informada en el cribado del cáncer de mama: el papel del nivel educativo

ObjectiveTo evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. MethodSecondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. ResultsThe intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. ConclusionsA decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened.

Eliciting women’s preferences for breast cancer screening

Over the past decade, the balance between the benefits and harms of breast cancer screening (BCS) has been widely debated. To date, no French study has interrogated women's points of view and preferences (in the economic sense) for this controversial screening. This study aims to bridge this gap. We aimed to elicit women's trade-offs between the benefits and harms of BCS. A discrete choice experiment questionnaire was developed and administered by a survey institute to French women in order to elicit their preferences and trade-offs between the benefits and risks of BCS (i.e., overdiagnosis and false-positive mammography). Eight hundred and twelve women, representative of the French general population (age, socioeconomic level, and geographical location), completed the survey. The women would be willing to accept on average 14.1overdiagnosis cases (median=9.6) and 47.8women with a false-positive result (median=27.2) to avoid one BC-related death. Results from our simulations predict that less than 50% of women would be willing to accept 10overdiagnosis cases (respectively, 30women with a false-positive mammography) for one BC-related death avoided. Women are sensitive to both the benefits and harms of BC screening and their preferences are highly heterogeneous. Providing balanced information on both benefits and harms to women through an informed decision-making process would be more respectful of women's preferences.

Double reading in breast cancer screening: considerations for policy-making.

In this article, we explore the evidence around the relative benefits and harms of breast cancer screening using a single radiologist to examine each female's mammograms for signs of cancer (single reading), or two radiologists (double reading). First, we briefly explore the historical evidence using film-screen mammography, before providing an in-depth description of evidence using digital mammography. We classify studies according to which exact version of double reading they use, because the evidence suggests that effectiveness of double reading is contingent on whether the two radiologists are blinded to one another's decisions, and how the decisions of the two radiologists are integrated. Finally, we explore the implications for future mammography, including using artificial intelligence as the second reader, and applications to more complex three-dimensional imaging techniques such as tomosynthesis.

Effect of cost exposure on medical students’ preferred mammography screening strategies: A randomized comparison

Introduction: Many high value care educational interventions have focused on shaping clinical decision-making for individual patients. Few have investigated how trainees integrate cost information into recommendations within a public health context.Methods: Third-year medical students at the University of California San Francisco participated in a small group on benefits and harms of breast cancer screening. We randomly assigned half of small groups to view estimated total costs of different screening strategies. Students selected a screening strategy for coverage by a publicly funded program and one they would recommend to a hypothetical patient. We used the chi-square test for independence and chi-square test for trend to compare proportions.Results: A total of 267 third-year medical students participated. Exposure to costs was associated with selection of significantly less intensive screening strategies for coverage by a publicly funded program (p < 0.05). We found no significant differences in perspectives that involved recommendations for individual patients.Discussion: Students weigh cost considerations more heavily when making decisions about populations, rather than individual hypothetical patients. We suggest that it may be easier for students to relate cost considerations to populations. Initial curricular activities can be framed from this perspective with subsequent activities focusing on individual patient care.

Systematic reviews as a 'lens of evidence': Determinants of benefits and harms of breast cancer screening.

This systematic review, stimulated by inconsistency in secondary evidence, reports the benefits and harms of breast cancer (BC) screening and their determinants according to systematic reviews. A systematic search, which identified 9,976 abstracts, led to the inclusion of 58 reviews. BC mortality reduction with screening mammography was 15–25% in trials and 28–56% in observational studies in all age groups, and the risk of stage III+ cancers was reduced for women older than 49 years. Overdiagnosis due to mammography was 1–60% in trials and 1–12% in studies with a low risk of bias, and cumulative false‐positive rates were lower with biennial than annual screening (3–17% vs 0.01–41%). There is no consistency in the reviews’ conclusions about the magnitude of BC mortality reduction among women younger than 50 years or older than 69 years, or determinants of benefits and harms of mammography, including the type of mammography (digital vs screen‐film), the number of views and the screening interval. Similarly, there was no solid evidence on determinants of benefits and harms or BC mortality reduction with screening by ultrasonography or clinical breast examination (sensitivity ranges, 54–84% and 47–69%, respectively), and strong evidence of unfavourable benefit‐to‐harm ratio with breast self‐examination. The reviews’ conclusions were not dependent on the quality of the reviews or publication date. Systematic reviews on mammography screening, mainly from high‐income countries, systematically disagree on the interpretation of the benefit‐to‐harm ratio. Future reviews are unlikely to clarify the discrepancies unless new original studies are published.

Overstated Harms of Breast Cancer Screening? A Large Outcomes Analysis of Complications Associated With 9-Gauge Stereotactic Vacuum-Assisted Breast Biopsy.

The purpose of this study was to assess the rate, type, and severity of complications related to 9-gauge stereotactic vacuum-assisted breast biopsy (SVAB) and to delineate associated factors that may contribute to a higher rate of complications. This retrospective study included 4776 patients who underwent SVAB between 2003 and 2016. A total of 319 patients with documented postbiopsy complications were identified. Complications were subcategorized as bleeding, pain, lightheadedness, bruising, and other complications, and their severity was classified as minor, moderate, or severe. Hematoma volumes were correlated with biopsy location and complication severity. A group of control subjects who underwent SVAB but had no complications was compared with the group of study patients with regard to age, biopsy location, lesion type, and pathologic findings. Postbiopsy screening adherence was assessed. Statistical analyses were performed using the Fisher exact, Mann-Whitney, Kruskal-Wallis, and Spearman rank correlation tests. Of the 319 patients with complications who were identified (representing 6.7% of the 4776 patients who underwent SVAB), 307 (96.2%) had mild complications, 12 (3.8%) had moderate complications, and no patients had severe complications. The most common complication was bleeding or hematoma (89.3% of patients [285/319]), followed by pain (6.9% [22/319]), lightheadedness (0.9% [3/319]), bruising (0.9% [3/319]), and other complications (1.9% [6/319]). No significant differences were noted between the study group and the control group in terms of age (p = 0.474), biopsy location (p = 0.065), histologic findings (p = 0.056), or lesion type (p = 0.568). Hematoma volume (median, 7.5 cm3) did not correspond to the severity of complications. Larger hematoma volumes were associated with a posterior biopsy location (p = 0.008). The rate of return to annual screening after biopsy was not adversely affected by the presence of biopsy complications. Clinically significant complications associated with SVAB were exceedingly rare (0.3%) in this large study spanning 13 years.

Correction: Harms of Breast Cancer Screening.

Correction: Harms of Breast Cancer Screening.

Tomosynthesis Impact on Breast Cancer Screening in Patients Younger Than 50 Years Old.

The question of benefits versus harms of breast cancer screening for women younger than 50 years old has been the subject of debate. We investigate if the addition of tomosynthesis to mammography improves screening performance outcomes for women in this age group. Screening performance for 59,921 patients (41,542 digital mammography and 18,379 tomosynthesis) younger than 50 years old was collected from a community-based screening network from January 1, 2015, to December 31, 2015. Patients were offered tomosynthesis if it was available. Parameters including recall, biopsy, and cancer detection rates were compared. Mixed effects regression analysis was used to estimate rates with screening modality, age, and density as fixed effects and screening site as a random effect. Rates for patients with dense breast tissue were also evaluated. Model adjusted rates per 1000 screenings with digital mammography were compared with digital mammography plus tomosynthesis, respectively: recall rate decreased from 117 to 108 (difference, -8.3; p = 0.003); biopsy rate increased from 13.5 to 16.6 (difference, 3.1; p = 0.003); and cancer detection rate increased from 1.9 to 2.6 (difference, 0.8; p = 0.060). Model adjusted rates for patients with dense breast tissue were: recall rate decreased from 135 to 132 (difference, -3.2; p = 0.44); biopsy rate increased from 16.0 to 20.5 (difference, 4.5; p = 0.004); and cancer detection rate increased from 2.1 to 3.5 (difference, 1.3; p = 0.03). Tomosynthesis in a community setting resulted in decreased recall rates for patients younger than 50 years old. For the subgroup of women with dense breast tissue, cancer detection rates also increased.

Women's Awareness of and Responses to Messages About Breast Cancer Overdiagnosis and Overtreatment: Results From a 2016 National Survey.

Scientists, clinicians, and other experts aim to maximize the benefits of cancer screening while minimizing its harms. Chief among these harms are overdiagnosis and overtreatment. Although available data suggest that patient awareness of these harms is low, we know little about how patients respond to information about these phenomena. Using the case of breast cancer screening, this study assesses women's awareness of and reactions to statements about overdiagnosis and overtreatment. We draw on data from a 2016 population-based survey of US women aged 35-55 years that oversampled women of lower socioeconomic position (those living at or below 100% of federal poverty level) (N=429). Results showed that women's awareness of overdiagnosis (16.5%) and overtreatment (18.0%) was low, and women under age 40 were least likely to have heard about overdiagnosis. Most women did not evaluate statements about these harms positively: <1 in 4 agreed with and found statements about overdiagnosis and overtreatment to be believable, and even fewer evaluated them as strong arguments to consider in their own mammography decision making. Women with a recent mammogram history were particularly unconvinced by overdiagnosis and overtreatment arguments. A majority of women were unaware of 2 important harms of breast cancer screening: overdiagnosis and overtreatment. Most did not find statements about these harms to be believable and persuasive. Communication interventions, supported by evidence from health communication research, are necessary to improve patient understanding of screening's harms, promote informed decision making, and, in turn, ensure high-value care.

The effect of information about the benefits and harms of mammography on women\u2019s decision-making: study protocol for a randomized controlled trial

BackgroundThe decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences.The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening.MethodsA two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP.The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2–3 weeks after the intervention.DiscussionThis is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country.Trial registrationClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Women’s Benefits and Harms Trade-Offs in Breast Cancer Screening: Results from a Discrete-Choice Experiment

BackgroundOver the past decade, the benefits and harms balance of breast cancer (BC) screening has been widely debated. ObjectivesTo elicit women’s trade-offs between the benefits and harms of BC screening and to analyze the main determinants of these trade-offs. MethodsA discrete-choice experiment with seven attributes depicting BC screening programs including varying levels of BC mortality, overdiagnosis, and false-positive result was used. Eight hundred twelve women aged 40 to 74 years with no personal history of BC recruited by a survey institute and representative of the French general population (age, socioeconomic level, and geographical location) completed the discrete-choice experiment. Preference heterogeneity was investigated using generalized multinomial logit models from which individual trade-offs were derived, and their main determinants were assessed using generalized linear models. Screening acceptance rates under various benefits and harms ratios were simulated on the basis of the distribution of individual preferences. ResultsThe women would be willing to accept on average 14.1 overdiagnosis cases (median = 9.6) and 47.8 false-positive results (median = 27.2) to avoid one BC-related death. After accounting for preference heterogeneity, less than 50% of women would be willing to accept 10 overdiagnosis cases for one BC-related death avoided. Screening acceptance rates were higher among women with higher socioeconomic level and lower among women with poor health. ConclusionsWomen are sensitive to both the benefits and the harms of BC screening and their preferences are highly heterogeneous. Our study provides useful results for public health authorities and clinicians willing to improve their recommendations of BC screening on the basis of women’s preferences.