Advanced Breast Imaging: Trends and Outcomes Associated with Recent Breast Density Reporting Legislation

7.摘要 自2009年以来，尽管证据不足，但已有24个州颁布了鼓励补充 使用先进的乳房成像技术对所有乳房致密的女性进行乳腺癌筛查。患者权益倡导 促成这项立法的努力认为，乳房密度可能会适度增加患乳腺癌的风险，但 降低筛查乳房X光检查的准确性。近3100万女性乳房丰满，超过 其中60%的人生活在有通知立法的州。因为增加癌症检测的可能性 对于超声波和磁共振成像(MRI)等测试，它们作为补充筛查的用途是 预计将克服筛查乳房X光检查的一些局限性。然而，这样的使用也将 增加假阳性和不必要的活检，因为超声和MRI的特异性低于 乳房X光检查。人们对过度治疗和过度诊断的可能性提出了进一步的担忧。 来自补充筛查。关键的问题是州一级的法律是否要求乳房密度 通知和鼓励使用辅助筛查测试将改善癌症的检测，降低- 当发现这些癌症时将其分期，并最终增加因乳腺癌而避免的死亡人数 癌症。为了填补这一证据空白，我们将利用由特定州形成的自然实验 立法和使用中断时间序列和比较序列来分析来自18个州的50个州的数据 每年(2001年1月1日至2018年12月31日)严格评估乳房密度的影响 报告关于以下方面的立法：1)乳腺癌成像(包括超声、核磁共振、断层合成)和诊断 使用一大群有商业保险的女性的索赔数据来计算体检和患者成本；2)乳房 使用癌症登记数据的癌症检测率。我们的主要假设是密度通知定律 导致诊断资源利用率显著增加，而没有相应的临床意义 晚期乳腺癌的检测率下降。我们已经组建了一个多学科的研究团队， 国际公认的临床医生和方法学家在卫生政策评估中，特别是使用 中断的时间序列和乳房密度和乳腺癌筛查政策。这项研究将推动 通过严谨的准实验设计和两个独特的 补充数据集，以解决这些关键且时间敏感的问题，这些问题涉及 密度通知立法。我们的研究可以为其他州正在进行的政策辩论提供信息 联邦一级。此外，通过检查诊断负担和经济成本，我们将为妇女和她们提供 临床医生提供了决定是否进行补充筛查所必需的信息。

7. ABSTRACT Since 2009, despite insufficient evidence, 24 states have enacted legislation that encourages supplemental breast cancer screening with advanced breast imaging to all women with dense breasts. Patient advocacy efforts that led to the legislation contend that breast density may modestly increase risk for breast cancer but reduce the accuracy of screening mammography. Nearly 31 million women have “dense breasts”, more than 60% of whom live in states with notification legislation. Because of the potential for increased cancer detection with tests such as ultrasound and magnetic resonance imaging (MRI), their use as supplemental screening is expected to overcome some of the limitations of screening mammography. However, such use will also increase false-positives and unnecessary biopsies as ultrasound and MRI have lower specificities than mammography. Further concerns have been raised about the potential for over-treatment and overdiagnosis from supplemental screening. The critical question is whether state-level laws requiring breast density notification and encouraging use of supplemental screening tests will improve the detection of cancer, down- stage these cancers when they are found, and ultimately, increase the number of deaths averted from breast cancer. To fill this evidence gap, we will capitalize on the natural experiment formed by state-specific legislation and use interrupted time series with comparison series to analyze data from 50 states spanning 18 years (January 1, 2001 through December 31, 2018) to rigorously assess the impact of breast density reporting legislation on: 1) breast cancer imaging (including ultrasound, MRI, tomosynthesis) and diagnostic workup and patient costs using claims data from a large cohort of commercially-insured women; and 2) breast cancer detection rates using cancer registry data. Our overarching hypothesis is that density notification laws have led to a significant increase in diagnostic resource utilization without a corresponding clinically significant decrease in detection of late stage breast cancer. We have assembled a multidisciplinary research team with internationally-recognized clinicians and methodologists in health policy evaluation, particularly the use of interrupted time series and in breast density and breast cancer screening policy. This research will move the field forward through the combination of a rigorous quasi-experiment design and two unique and complementary datasets to address these critical and time-sensitive questions about benefits and harms from density notification legislation. Our research can inform the ongoing policy debates in additional states and at the federal level. Further, by examining diagnostic burden and financial cost, we will provide women and their clinicians with information essential for deciding whether to undergo supplemental screening.